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Infected Blood Inquiry
The Report
Overview and
Recommendations
•
•
•
•
•
Summary
Overview
Lessons to be Learned
Recommendations
List of Chapters
1 of 7
20 May 2024
HC 569-I
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 SUU, Alm.del - 2024-25 - Bilag 9: Henvendelse af 7/10-24 fra Danmarks Bløderforening om den engelske blødersag Infected Blood Inguiry
Infected Blood Inquiry
The Report
Presented to Parliament pursuant to section 26 of the
Inquiries Act 2005.
20 May 2024
HC 569-I
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Infected Blood Inquiry |
The Report
Contents
1.1 Summary
1.2 List of Chapters
1.3 Overview
1.4 Lessons to be Learned
1.5 Recommendations
2
8
11
200
221
Summary
2
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1.1 Summary
Patients have received blood or blood products from the NHS since it began in 1948. Many
of those treated with them, particularly between 1970 and 1998, died or suffered miserably,
and many continue to suffer. This was not as a direct result of the underlying condition or
illness that took them to the NHS in the first place, but as a result of the treatment itself.
This would be catastrophic enough if they were the only victims. But the treatment has
caused others to suffer too – partners, family, children, friends – some by being themselves
infected, some by having to watch loved ones die, some by having to give their lives to
caring; and almost every one of them, infected and affected, suffering in almost every aspect
of their lives.
I have to report a catalogue of failures which caused this to happen. Each on its own is
serious. Taken together they are a calamity. Lord Winston famously called these events
“the
worst treatment disaster in the history of the NHS”.
I have to report that it could largely,
though not entirely, have been avoided. And I have to report that it should have been.
I have also to report systemic, collective and individual failures to deal ethically, appropriately,
and quickly, with the risk of infections being transmitted in blood, with the infections when
the risk materialised, and with the consequences for thousands of families.
There were around 4,000 to 6,000 people with bleeding disorders in the UK at any one time.
Around 1,250 were infected with HIV. The best estimate is that this included 380 children.
Almost all infected with HIV were also infected with Hepatitis C and some with Hepatitis
B and Hepatitis D as well. Three quarters of these 1,250 adults and children have died. A
larger number still (between 2,400 and 5,000 people with bleeding disorders) who were not
infected by HIV received blood products infected with one or more hepatitis viruses, and
developed chronic Hepatitis C.
People who were infected by transfusions, rather than by blood products, were infected in
even greater numbers. Between 80 and 100 were infected with HIV after a blood transfusion.
Approximately 26,800 were infected with Hepatitis C after a blood transfusion, often linked
with childbirth or surgery, but also from transfusions to treat thalassemia, sickle disease,
or leukaemia, or tissue transfer. It has not been possible to estimate the number of people
infected with chronic Hepatitis B due to limited data.
A significant number of people who received blood products and some who received blood
transfusions have since been told that they are at an increased risk of vCJD, and should
alert their medical practitioner or dentist prior to treatment. This in turn has compromised
their access to that treatment.
The scale of what happened is horrifying. The most accurate estimate is that more than
3,000 deaths are attributable to infected blood, blood products and tissue.
2
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To understand the failings, it is necessary to set out the reasoning behind my conclusions in
some detail. They need to be explained and set in context. That will follow in the chapters
of this Report.
What follows makes for hard reading. For now, though, the headline points are these:
The principal infections considered by the Inquiry are Hepatitis (B and C) and HIV. The
transmission of vCJD is also considered.
It was well known from at least the early 1940s, and became clear beyond doubt in the mid-
1940s, that blood transfusions or the use of plasma could transmit “serum hepatitis”. It was
known that this could be fatal, or lead to serious long-term disease, liver failure, cirrhosis
and cancer. The virus responsible for Hepatitis B was identified by the early 1970s. The virus
responsible for Hepatitis C was not identified until 1988, but it was apparent at least from
the mid 1970s that non-A non-B Hepatitis (as it was known prior to 1988) was responsible
for the majority of post-transfusion hepatitis cases and that just as Hepatitis B could have
serious long-term consequences, so too might non-A non-B Hepatitis.
Awareness of AIDS began in 1981, and it was apparent by mid 1982 that whatever was
causing AIDS might be transmissible by blood and blood products.
What follows is
not
intended as a comprehensive account; for that the Report should be
read in full. Set out below are some of the key failings.
Infections, leading to deaths, illness and suffering were caused needlessly to
people with
bleeding disorders
by:
• Failures in the licensing regime – in particular (but not only) by allowing the
importation and distribution from 1973 of blood products (Factor 8 concentrates)
made in the US or Austria which carried a high risk of causing hepatitis, and were
understood to be less safe than current domestic treatments for bleeding disorders.
• A failure to ensure a sufficient supply of Factor 8 concentrates from the plasma
of UK donors to meet reasonable foreseeable demand without the need to import
any products from abroad (ie failure to achieve “self-sufficiency”). In part this arose
from the inept, fragmented system by which the blood services of England and
Wales operated; and in larger part because (a) the fractionation facilities in England
(“BPL”) were in great need of redevelopment, but this was badly delayed; and (b)
new fractionation facilities in Scotland (“PFC”) which had been designed and funded
to produce blood products for the North of England as well as Scotland were not
utilised for that purpose.
• Increasing the size of the pools used to manufacture factor concentrates (both 8
and 9) in the UK, although it was well known that this would markedly increase the
risks of viral transmission.
• Whilst presiding over this increase, failing to encourage and finance research into
methods of viral inactivation of factor concentrates (both 8 and 9).
Summary
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• By failing to do so, failing to achieve the total or at least partial viral inactivation
of hepatitis viruses (in domestic production) by around 1980/1981 which would
probably have resulted from such research if it had been pursued earlier (no new
technology was needed). Viral inactivation could have prevented many infections
(hepatitis and later HIV) and deaths.
• Also, by failing to do so, failing to provide factor concentrates which would with rare
exceptions have been free of active HIV virus.
• Failing to ensure sufficiently careful and rigorous donor selection and screening
(and allowing continued collection of blood from prisons).
• Adopting an attitude of denial towards the risks of treatment with factor concentrates.
• Treating people with ever increasing volumes of concentrates despite the increased
risks of viral transmission.
• Failing to respond to serious risks of infection by making adjustments to treatment
regimes to make them safer: such adjustments might have included greater use of
cryoprecipitate (and, on a temporary basis, fresh frozen plasma) and of DDAVP,
taking a more conservative approach to treatment, reducing the amount of home
treatment, avoiding prophylactic treatment, adopting batch dedication policies, and
deferring elective or non-urgent surgery.
• Treating children at Treloar’s with multiple, riskier, commercial concentrates,
prophylactically and as objects for research.
• Treating children unnecessarily with concentrates (especially commercial ones)
rather than choosing safer treatments.
• Failing to provide advice, guidance and information to clinicians to ensure that safer
treatment practices were adopted.
• Adopting the wrong approach by looking for conclusive proof of what was the cause
of AIDS rather than asking if there was a real risk that blood might transmit it.
• Falsely reassuring the public and patients – that blood did not carry AIDS; that the
risk of AIDS for people with bleeding disorders was small; and that non-A non-B
Hepatitis (Hepatitis C) was relatively mild and inconsequential.
• Taking a decision in July 1983 not to suspend the continued importation of
commercially produced blood products.
• Having made that decision, failing to keep it under review.
• Failing to tell people of the risks of treatment and of available alternative treatments,
thus treating them without their informed consent.
4
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• Conducting research on people without, in many cases, telling them (or in the case
of children, their parents) beforehand, or informing them of the risks and whether
the research would enhance their treatment or primarily benefit others, and without
obtaining properly informed consent.
• In some cases, failing to tell people that they were infected and thereby denying
them the opportunity to control the progression of their own illness more effectively
and to prevent the spread of infection to others close to them.
Infections, leading to deaths, illness and suffering were caused needlessly to
people who
received blood transfusions
by:
• Failing to ensure sufficiently careful and rigorous donor selection and screening
(and allowing continued collection of blood from prisons).
• Failing to take all reasonable steps to deter high risk donors, in particular by
delay in the production of AIDS donor leaflets and failing to ensure their effective
distribution and wording.
• Missing the opportunity to screen out some high risk donors by surrogate testing as
a response to the risk of HIV transmission.
• Failing to introduce surrogate testing for anti-HBC and ALT when it could and
should reasonably have been introduced to reduce transmission of non – A non – B
Hepatitis (Hepatitis C).
• Delaying universal screening of blood donations for the presence of HTLV-3 (HIV)
despite it being urgent (it was a public emergency) to begin this.
• Delaying universal screening of blood donations for the presence of Hepatitis C.
• In particular, delaying screening for HIV and or Hepatitis C by unreasonably
requiring, or if required delaying, an evaluation of different tests (which would have
been reasonably effective) to see which was best (making the best the enemy of
the merely good).
• Failing to warn patients of the risks of transfusion at least in situations where they
reasonably had a choice.
• Giving too many transfusions when they were not clinically needed, or when less
would have sufficed, or over-riding a patient’s wish not to be transfused.
• Failing to make maximum use of alternatives to transfusion.
• Failing to take sufficient and timely steps to ensure the better use of blood by
hospitals and clinicians.
• Failures of record keeping to enable each unit of blood to be traced from donation
to use in treatment.
Summary
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• Failing to carry out any lookback at the time universal screening of donations for
Hepatitis C was introduced.
• Delaying telling patients they had Hepatitis C, or should be tested for it, thereby
preventing the individual from controlling its worst effects, seeking timely treatment,
and limiting the spread to others.
So far as
both people with bleeding disorders and people receiving transfusions
were
concerned, clinicians and the health service in particular failed them
1
by:
• Being complacent about the risks of non-A non-B Hepatitis (Hepatitis C) and being
slow to respond to the risks of AIDS.
• Being too slow to establish an expert advisory committee on AIDS and too slow to
establish an overarching body with responsibility for blood safety.
• Failing to tell people of the risks of treatment or transfusions, and failing to seek
their consent on a properly informed basis.
• Failing to offer people reasonable alternatives to treatment or transfusions.
• In far too many cases, using insensitive and inappropriate means to tell people of
their infections.
• Testing samples (which in most cases patients did not know were to be retained for
the purpose) without their knowledge or consent.
• Delaying informing people of their infections by weeks, months and sometimes years.
• Too often compromising patient confidentiality and adding to stigma by prominent
indications that these patients were a high risk to others.
• Failures of record-keeping, such that many people’s medical records have been
destroyed or lost or are materially incomplete.
So far as
all the people who were infected and affected were (and are) concerned,
the
harms done to them were compounded by:
• Repeated and ongoing
have been infected.
failures
to
acknowledge
that
they
should
not
• The absence of any meaningful apology and redress.
• Repeated use of inaccurate, misleading and defensive lines to take which cruelly
told people that they had received the best treatment available.
1
I acknowledge that many clinicians devoted a life to serving medicine, and there may have been a
range of reasons why people allowed these failings to happen or caused them by their own actions.
This sadly does not diminish the appalling nature of what occurred.
Summary
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• A lack of openness, transparency and candour, shown by the NHS and government,
such that the truth has been hidden for decades.
• Deliberate destruction of some documents and the loss of others.
• Failing to provide psychological support and counselling to people who had been
infected and their families.
• Difficulties and delays in accessing appropriate specialist treatment and monitoring
for Hepatitis C.
• Failures of palliative care for those dying in consequence of infection with
HIV or hepatitis.
• Refusal to provide compensation (on the ground there had been no fault).
• Long delays in agreeing to provide even ex gratia financial support.
• Establishing ex gratia payment schemes which were underfunded and did not
function in the best interests of those infected and affected.
• Failing to reform those ex gratia schemes promptly and failing to ensure that the
national schemes which replaced them offered parity of support across the UK.
• Responding to calls for a public inquiry by producing flawed, incomplete and unfair
internal reports.
• Failing, until 2017, to decide to establish a public inquiry.
• Failing as yet to respond to many of the recommendations of Sir Robert Francis KC,
and those of this Inquiry in its second interim report.
The chapters that follow make clear who is responsible for each of these failings, though
in general I can say that responsibility for much lies with successive governments, even
though others may share some of it.
It will be astonishing to anyone who reads this Report that these events could have happened
in the UK. It may also be surprising that the questions why so many deaths and infections
occurred have not had answers before now. Those answers cannot be as complete as they
might have been thirty years ago, and I acknowledge that despite the vast number of pages
of documents which the Inquiry has examined, some questions must remain unanswered.
Any errors, any omissions, any shortcomings are mine alone.
I have no doubt however that, despite the difficulties of time and scale, the conclusion that
wrongs were done on individual, collective and systemic levels is fully justified by the pages
that follow; that a level of suffering which it is difficult to comprehend, still less understand,
has been caused to so many, and that this harm has, for those who survived long enough to
face it and for those who, infected and affected, are now able to read this, been compounded
by the reaction of the government, NHS bodies, other public bodies, the medical professions
and others as described in the Report.
Summary
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1.2 List of Chapters
Volume 1
Overview and Recommendations
1.1 Summary
1.2 List of Chapters
1.3 Overview
1.4 Lessons to be Learned
1.5 Recommendations
Volume 2
2.1 People’s Experiences
2.2 Treloar’s
Volume 3
What happened and why?
Basic Concepts
3.1 Risk
3.2 Consent
3.3 Blood and Transfusion
3.4 Nature of the Diseases
3.5 Treatment of Bleeding Disorders
Knowledge
3.6 Knowledge of Risk Before 1970
3.7 Hepatitis Risks 1970 and After
3.8 Knowledge of the Risks of AIDS
Blood Services
3.9 Organisation of the Blood Services
3.10 Regional Transfusion Centres
3.11 Response to Risk by the Blood Services
8
List of Chapters
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Blood Products and Addressing Risk
3.12 Regulation of Commercial Factor Concentrates
3.13 Self-Sufficiency
3.14 Viral Inactivation
3.15 Pool Sizes
Volume 4
What happened and why?
4.1 Role of Government: Response to Risk
4.2 Haemophilia Centres: Policies and Practice
4.3 Pharmaceutical Companies
4.4 Haemophilia Society
Volume 5
What happened and why?
5.1 Blood Transfusion: Clinical Practice
Screening
5.2 Hepatitis C Surrogate Screening
5.3 HIV Surrogate Screening
5.4 HIV Screening
5.5 Hepatitis C Screening
Lookbacks
5.6 HIV Lookback
5.7 Hepatitis C Lookback
5.8 Public Health
5.9 vCJD
Volume 6
Response of Government and Public Bodies
6.1 The Initial Government Response 1985-1988
6.2 HIV Haemophilia Litigation
List of Chapters
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6.3 Macfarlane Trust
6.4 Government Response to HIV Infections through Blood or Tissue Transfer
6.5 Eileen Trust
6.6 Government Response to Hepatitis C Infections
6.7 Skipton Fund
6.8 Government Response to the Archer Inquiry
6.9 Caxton Foundation
6.10 Medical Records
6.11 National Support Schemes
6.12 Access to Treatment
6.13 Inquests, Fatal Accident Inquiries and Death Certificates
Volume 7
Response of Government
7.1 Document Destruction
7.2 Self-Sufficiency Report
7.3 Lines to Take
7.4 Delay in Holding a Public Inquiry
7.5 Accountability in the Absence of a Public Inquiry
7.6 Scotland
7.7 Northern Ireland and Wales
7.8 The Government’s Response to Calls for Compensation 2020-2024
7.9 Commentary on the Government Response
10
List of Chapters
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1.3 Overview
Introduction
The scope of this Inquiry has been exceptionally wide in four particular ways:
(1)
(2)
(3)
(4)
the
scale
of the harm: the number of those infected amounts to tens of thousands,
many of whom have died (and continue to die);
the
geographical scope,
encompassing as it does all four nations within the
United Kingdom;
the
timeframe:
since the NHS began, exploring over five decades of decision-
making, action and inaction;
the
remit,
which has been to examine not only the events which caused or
contributed to the infection of so many people (“what
happened and why”?)
but
also the response of government, the NHS and others in the decades following
the transmission of infection, and how that response has compounded the harms
already inflicted.
I shall say a little more in this Introduction about each of these aspects.
As to
scale,
more than 3,000 deaths are attributable to infected blood and blood products.
Around 380 children with bleeding disorders were infected with HIV, a third of the 1,250
people with bleeding disorders infected with HIV, with the majority also being coinfected
with Hepatitis C and some with Hepatitis B and other infections as well. Three quarters
of those with bleeding disorders who were infected with HIV have died. Between 80 and
possibly up to about 100 people were infected with HIV through transfusions. About 85% of
those have died.
Around 26,800 people were infected with Hepatitis C through blood transfusions between
1970 and 1991, of whom about 22,000 were chronically infected beyond the initial six months,
with 2,700 surviving to the end of 2019. Between 2,400 and 5,000 people with bleeding
disorders were infected with Hepatitis C without being infected with HIV, but sometimes
with Hepatitis B and other infections as well. There is insufficient evidence to estimate the
numbers of people infected with Hepatitis B through blood and blood products. There were
five recorded cases of confirmed or probable blood-borne variant Creutzfeldt-Jakob disease
(“vCJD”) infections. Three were symptomatic and all have died.
2
It is important not to lose sight of the fact that behind those statistics are individuals, each
with a story of suffering and loss that is personal to them. People infected and affected
2
See Statistics Expert Panel Transcript 9 November 2022 pp32-197 INQY1000258, the Expert
Reports to the Infected Blood Inquiry: Statistics Group EXPG0000049 and EXPG0000132, and Note
by Counsel to the Inquiry on the number of children with bleeding disorders who were infected with
HIV INQY0000387
11
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have told powerful stories of pain, sickness and loss, of lives damaged and destroyed,
unrecognisable from before their infection and unrecognisable from all their hopes and
dreams for their lives. Each person who has felt able to give evidence and each person who
has supported them and continues to provide support and solidarity through the ongoing
suffering and loss deserves respect. This account builds on their accounts, taken together
with the evidence and input of all others who have participated in this Inquiry: participants
not only in name but in a collective endeavour.
As to
geographical remit,
this Inquiry has sought to examine, as far as possible, relevant
decision-making in England, Scotland, Wales and Northern Ireland. It is right to note,
however, that many of the decisions and actions which this Report examines were taken in
Westminster, by the UK government. The available evidence suggests that for the most part,
and certainly in the period prior to legislative and executive devolution, Wales and Northern
Ireland (and to a lesser extent Scotland) followed the path charted by the Department of
Health.
3
That is inevitably reflected in the focus of some of the chapters in this Report.
The
timeframe
examined by this Report is extensive, covering over five decades of decision-
making.
4
That has brought with it additional challenges, as has the fact that an inquiry did
not take place at a much earlier stage.
5
Documents that existed years ago no longer exist.
6
There are individuals, from government, from the medical profession, from pharmaceutical
companies and elsewhere, who played an important part in events, from whom the Inquiry
has been unable to hear, either because they are dead or because of impairments of health
or age. Some of those who did give evidence had little independent memory of events, save
to the extent that they were prompted by contemporaneous documents. Notwithstanding
these challenges it has been possible in this Report to reach conclusions on the central
questions raised by the Inquiry’s Terms of Reference.
The broad
remit
of the Inquiry is reflected in the structure of this Report. The Report begins
with an examination of impact, through a narrative of the experiences of people who were
infected and affected,
7
and with an analysis of events at Treloar’s, which both illustrates and
highlights the nature of, and many of the reasons for, the national treatment disaster which
was infected blood.
8
The Report then looks at the question of “What happened and why?”
3
4
5
6
7
8
12
The Department was the Department of Health and Social Security (“DHSS”) until July 1988, at which
point it became the Department of Health, before being renamed the Department of Health and Social
Care (“DHSC”) in 2018.
Whilst the primary focus of the Inquiry has been events from 1970 onwards, there are some areas
where it has been important to consider earlier events (see for example the chapters on
Knowledge
of Risk Before 1970
and
Self-Sufficiency).
That is entirely consistent with the Inquiry’s Terms of
Reference: the phrase “in
particular since 1970”
makes clear that events prior to 1970 can and should
be examined where relevant.
The failure to hold an inquiry earlier is addressed in the chapter on
Delay in Holding a Public Inquiry.
The circumstances in which some of those documents have disappeared are considered in the
chapter on
Document Destruction.
See the chapter on
People’s Experiences.
See the chapter on
Treloar’s.
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through an examination of the actions and inactions of governments,
9
the blood transfusion
services,
10
haemophilia centres and their directors,
11
and pharmaceutical companies,
12
and
an examination of transfusion practices.
13
It considers specific areas where opportunities
to reduce risk were missed, such as the failure to achieve self-sufficiency in England and
Wales,
14
the failure to introduce surrogate screening for either HIV or Hepatitis C,
15
and the
delays in introducing screening for HIV and for Hepatitis C.
16
The Report then turns to consider how governments, the NHS and others responded to the
infections of so many people. Amongst other matters it looks at the refusal over decades
to provide compensation and the decision-making that led (after delays) to agreements
in principle to establish ex gratia payment schemes;
17
the ways in which those schemes
(the Alliance House Organisations) operated and their replacement with national support
schemes;
18
difficulties in accessing appropriate treatment and care;
19
problems created by
missing or incomplete or inaccurate medical records;
20
and the defensiveness of government,
through its publication of a self-sufficiency chronology, its repeated use of indefensible lines
to take and its refusal over decades to hold a public inquiry.
21
The picture that emerges overall from the findings in this Report is one in which people
have been failed, not once but repeatedly, by their doctors, by the bodies (NHS and other)
responsible for the safety of their treatment, and by their governments. Six particular
themes are prominent.
The first is the failure to make patient safety the paramount focus of decision-making and of
action – whether it be decisions by individual clinicians, haemophilia centres or hospitals, or
decisions taken at a regional level by transfusion centres, or decisions taken at a national
level by governments.
9
10
11
12
13
14
15
16
17
18
19
20
21
See for example the chapters on
Regulation of Commercial Factor Concentrates
and
Role of
Government: Response to Risk,
although the role of government (in particular the role of the
Department of Health and Social Security/Department of Health) appears in most chapters in some
form or another.
See the chapters on
Blood Services.
See the chapter on
Haemophilia Centres: Policies and Practice.
See the chapter on
Pharmaceutical Companies.
See the chapter on
Blood Transfusion: Clinical Practice.
See the chapter on
Self-Sufficiency.
See the chapters on
Hepatitis C Surrogate Screening
and
HIV Surrogate Screening.
See the chapters on
HIV Screening
and
Hepatitis C Screening.
See the chapters on
The Initial Government Response 1985-1988, Government Response to HIV
Infections through Blood or Tissue Transfer, Government Response to Hepatitis C Infections
and
Government Response to the Archer Inquiry,
as well as
The Government’s Response to Calls for
Compensation 2020-2024.
See the chapters on
Macfarlane Trust, Eileen Trust, Skipton Fund, Caxton Foundation
and
National
Support Schemes.
See the chapter on
Access to Treatment.
See the chapter on
Medical Records.
See the chapters on
Self-Sufficiency Report, Lines to Take, Delay in Holding a Public
Inquiry,
and
Accountability in the Absence of a Public Inquiry
as well as
Commentary on the
Government Response.
13
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The second theme is the slow and protracted nature of much of the decision-making
examined in this Report: by way of example, the length of time taken for haemophilia
centres to adapt treatment policies and practices, or the length of time taken by clinicians
and NHS organisations to recognise the need for better transfusion practice, or the delays
with regard to AIDS donor leaflets, or the delayed decision-making by government regarding
the introduction of Hepatitis C screening of blood donations and the delay in deciding to
undertake a lookback.
The third is the profoundly unethical lack of respect for individual patient autonomy, which
will be most starkly apparent to readers from the chapters on
People’s Experiences
and
Treloar’s
and from parts of the chapters on
Haemophilia Centres: Policies and Practice
and
Blood Transfusion: Clinical Practice.
The fourth theme, closely related to the third, speaks of the dangers of clinical freedom.
Clinical freedom is the idea that doctors should be free to do what they believe to be
right for an individual patient. But the danger of clinical freedom in the context of infected
blood and blood products is that it allowed doctors to follow unsafe treatment policies and
practices (such as administering commercial factor concentrates to young children, or giving
unnecessary transfusions to postpartum women), and it meant that others (in particular the
health departments and Chief Medical Officers) held back from providing advice, guidance
or information in the misguided belief that this would interfere with clinical freedom.
The fifth theme is that of institutional defensiveness, from the NHS and in particular
from government, compounded by groupthink amongst civil servants and ministers, and
a lack of transparency and candour. These factors drove the response of government
over the decades.
The institutional defensiveness identified above is damaging to the public interest. But
the sixth principal theme that emerges from this Report is the damage that was done by
that defensiveness and the accompanying lack of transparency and candour to the very
people whose lives had been destroyed by infection. The harms already done to them were
compounded by the refusal to accept responsibility and offer accountability, the refusal
to give the answers that people fervently sought, the refusal to provide compensation,
leaving people struggling and in desperate circumstances, the thoughtless repetition of
unjustified and misleading lines to take, and the lack of any real recognition and of any
meaningful apology.
The purpose of this Overview is to provide a chapter-by-chapter summary to help readers
navigate the Report.
22
Some chapters lend themselves relatively easily to a neat summary;
others tell a more multifactorial story, sometimes spanning decades, and are harder to
compress. The summaries below are not intended as a substitute for reading the individual
chapters, but will perhaps help readers to identify the chapters that are of the most
22
The summaries in the Overview contain some direct quotations from documents, statements and
transcripts. Readers will find the references for each such quotation in the main chapters of the
Report, rather than in the summaries below.
Overview
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importance or relevance to them. Where conclusions are expressed in a chapter they may
be more nuanced than appears from the short summary given here, and the context against
which they are drawn should be read if the conclusions are to be fully appreciated.
In the course of some of the
Overview,
abbreviations or acronyms are used: such as
UKHCDO (UK Haemophilia Centre Directors’ Organisation) or ACVSB (Advisory Committee
on the Virological Safety of Blood). They are explained when they first appear in the text
and used for brevity thereafter – but a glossary and brief chronology come at the end, for
ease of reference.
Volume 2
2.1 People’s Experiences
This chapter considers the impact of infected blood and blood products on people who have
been infected and affected.
The Inquiry received over four thousand statements, each of which has been read carefully.
The stories shared so powerfully in each statement and in the two intermediaries’ reports
were amplified, illustrated and confirmed by the oral evidence which the Inquiry heard.
Although it is not possible to refer to each and every statement or transcript, every individual
story has made a valuable contribution to the findings, conclusions and recommendations
of this Report.
For many people this was the first time they had spoken about their ordeal, and I pay tribute
to all those who felt able to do so – in a written statement; in private to an intermediary; in
the hearing room; or by video link. From so many different perspectives and backgrounds
they have painted such a compelling overall picture that, taken together, some conclusions
have become overwhelmingly obvious.
The chapter explores people’s experiences through the following themes:
• communication of risk
• communication of diagnosis with HIV, Hepatitis C and/or Hepatitis B
• the effects of infection with HIV
– the physical effects
– the mental health effects
– the impact of treatment
• the effects of infection with Hepatitis C
– the physical effects
– the mental health effects
Overview
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– the impact of treatment
• the effects of infection with Hepatitis B
– the physical effects
– the mental health effects
• vCJD notifications
• other infections
• the impact of lack of accountability
• bereavement
– the deaths of partners
– the deaths of parents
– the deaths of children
– the deaths of siblings
– burial arrangements
– the impact of stigma
– lack of support
– permanence of loss
– misplaced feelings of guilt
– family breakdown
– families with bleeding disorders
• the impact on family and social life
• the impact of caring
• marriage and relationships
• family, childbirth and being unable to have children
• fear of infecting others
• stigma associated with HIV
• stigma associated with hepatitis
• wider impacts:
– impact on education
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– impact on work
– finance
– housing
– travel
– former blood donors
• wider impacts on medical treatment
– dental care
– loss of trust in the medical profession
– counselling and psychological support
• consent and communication.
This chapter is, however, no substitute for reading the written statements and intermediaries’
reports or for watching and listening to the oral evidence from people who are infected or
affected. Doing so now brings with it an additional poignancy, because some of those who
gave such powerful written and oral testimony to the Inquiry have since died.
2.2 Treloar’s
The focus of this chapter is the tragedy that was Treloar’s. The Inquiry understands that only
around 30 of the 122 pupils with haemophilia who attended the school between 1970 and
1987 survive. What happened at Treloar’s both illustrates and highlights the nature of, and
many of the reasons for, the national treatment disaster which was infected blood.
Research was a fundamental part of the activities of the haemophilia centre at Alton,
beginning in the 1960s and continuing into the late 1970s – when the haemophilia centre
relocated to the school – and the 1980s. The reasons for an intense focus on research
are not difficult to understand. Dr Rosemary Biggs, a central figure in haemophilia care at
the time, observed in December 1970 that “the
collection of 49 haemophilic patients at the
Alton School makes this a unique opportunity to study the disease.”
Each year a number of
studies were in progress: research was conducted at Treloar’s to an extent which appears
unparalleled elsewhere.
Of particular note were three sets of research at Treloar’s: prophylactic therapy; hepatitis;
and appropriate dosage regimes for different target joints. Three prophylaxis trials, involving
injections of increasing frequency, are described in the chapter. The incidence of hepatitis
was studied from 1970, with a prospective study in 1975 of hepatitis associated with the
use of factor concentrates. The dosage trial involved some pupils being given lower doses
than would otherwise have been thought appropriate for their treatment, which risked those
doses being ineffective.
Overview
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The few surviving former pupils who had been among the research subjects in the trials
gave a consistent account that there had been no meaningful consultation with their parents,
or with them. The risks of hepatitis from treatment, and the increased risks from the use of
commercial concentrates and from treatment on a prophylactic basis, were not explained.
The approach to treatment at Treloar’s involved a deliberately heavy use of concentrates,
in which different products – mainly commercial – was used indiscriminately (except
when it was thought necessary for some research study to focus upon a particular type of
concentrate). Most individual patients received multiple types of concentrate and by 1978
cryoprecipitate use had declined almost to nil. Dr Anthony Aronstam, the director of the
haemophilia centre from 1977, recognised that the usage at Treloar’s was high: in 1978 he
referred to the routine use of prophylaxis “in
many clinical situations”
and described having
secured “all
the material we need for our admittedly enthusiastic programme”;
later he said
expressly that his policy was that bleeds should be “treated
vigorously”
where they involved
adolescents. There was neither consistency as to the source or brand of the concentrate
used, nor the adoption of any approach which sought to minimise the exposure of the pupil
to the risk of receiving an infected dose. It was not until after 1984 (when it had become clear
that many people with haemophilia had been infected with HIV, and potentially with AIDS, in
consequence of repeated treatment with blood products) that the amount of Factor 8 given
per transfusion reduced “significantly”.
There is no doubt that the risks of viruses, in particular hepatitis, being transmitted through
blood or blood products were well known to Treloar’s clinicians. Moreover, practice at Treloar’s
shows that the clinical staff were well aware that their heavy use of commercial concentrate
risked causing AIDS. From as early as February 1983, individual records show that pupils
were examined for any signs of the “stigmata of AIDS”. The records showed results thought
possibly significant in relation to AIDS. Yet neither this, nor the recommendations of the
UKHCDO following a meeting of reference centre directors in May 1983, nor the knowledge
in later 1983 that people who had had commercial concentrate had contracted AIDS and
that at least one had died, led to
any
change in treatment, or approach. Save for switching
to heat-treated commercial concentrate in November 1984 (although unheat-treated NHS
concentrate continued to be used) Dr Aronstam did little to reduce the risk of AIDS. He
did not even tell others about the risk until it became inescapable. When Professor Arthur
Bloom informed him that one of the pupils had received some of the same batch as the
Cardiff patient who had developed AIDS, he identified that the boy was one of fifteen boys
who had reversed T-cell ratios. This was an indicator of possible problems with their immune
system. But this knowledge does not seem to have caused him noticeably to adjust his
treatment policies. The prophylaxis programme continued – indeed, as late as December
1984, a pupil had been on prophylaxis “almost
the whole length of this term”,
using unheated
concentrates until that November, and it was proposed that during the Christmas holidays
this intensive use of concentrate be continued.
There was no general system or process for telling parents of the risks of viral infection. Nor
were pupils told of those risks. Parents were not given details, or even core information,
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about their children’s treatment at Treloar’s for haemophilia. Little truly informative was
said to pupils and Dr Aronstam played down the risks both of hepatitis and AIDS. None of
the boys were told that they were being tested for HIV (when the tests became available)
nor that before that they had been checked to see whether they had any signs that they
were developing AIDS. When it emerged in late 1984 that there were infections, Treloar’s
clinicians told the boys that it had been an unavoidable accident.
There was no consistent practice in telling individuals that they had been infected with HIV.
Some were never told by the school and only found out from their home doctor. Others
were told in groups: “the
staff went around the room saying ‘YES, NO, YES, NO’ to indicate
whether they were HIV positive.”
Neither the headmaster nor the housemaster was involved
in telling any pupil of his infection. If and when pupils were first told at the school that they
had tested positive, they had no supporting presence. Their parents were not present. Nor
was there any structured facility for giving support after that.
A large percentage (probably about 70%) of those pupils with haemophilia who attended
Treloar’s School died in consequence of their infection; of those who were pupils in the early
1980s, a great majority were infected with HIV; and very few, whether suffering from HIV or
not, avoided being infected with hepatitis.
What occurred was not an inevitable course of events. It was not a tragic accident, in the
sense of something that was unavoidable. It was not the result of an unknown against which
steps could not be taken effectively.
In summary, as regards the treatment of pupils at Treloar’s:
• The pupils were often regarded as objects for research, rather than first and
foremost as children whose treatment should be firmly focused on their individual
best interests alone. This was unethical and wrong.
• There were multiple research projects during the 1970s to early 1980s where
informed consent for participation was neither sought nor given. This was
unethical and wrong.
• The risks of treatment, including viral risks, were well known to the clinicians involved
in decision-making regarding haemophilia treatment at Treloar’s. Those risks were
not explained to parents or to pupils, such that pupils were treated in the absence of
informed consent. This was unethical and wrong.
• Those responsible for treatment adopted treatment policies and practices (including
the widespread use of commercial concentrates, prophylaxis and treating individual
boys with multiple different products and batches) which had the effect of increasing
the risks of viral infection. This was wrong.
• Those responsible for treatment failed to respond to the risk of AIDS by making any
significant changes to the treatment regimes. This was wrong.
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• Tests were undertaken on pupils, both in relation to liver function and, in 1984-85,
in relation to HIV, without the knowledge or consent of pupils or parents. This was
unethical and wrong.
• Some pupils and parents were never informed by Treloar’s that they had tested
positive for HIV. This was unconscionable.
• The way in which other pupils were informed of the fact that they had tested positive
was unsupportive, insensitive and wrong.
• Insufficient support was provided to pupils after diagnosis. This too was wrong.
The outcome at Treloar’s of this combination of events, for these reasons, demonstrates
in microcosm much of what went wrong in the way in which many haemophilia clinicians
treated their patients across the UK.
Volume 3 What happened and why?
This volume begins with five chapters about basic concepts:
23
3.1
3.2
3.3
3.4
3.5
Risk
Consent
Blood and Transfusion
Nature of the Diseases
Treatment of Bleeding Disorders
3.6 – 3.8 Knowledge
These three chapters examine what was, or should have been, known about the risks of
hepatitis and HIV at the time of the events under examination.
24
Set out below is a selection
of the materials which are referred to in the chapters.
3.6 Knowledge of Risk Before 1970
Well before the inception of the NHS in 1948, scientists, state authorities and medical
practitioners in the field knew that after any transfusion of blood or plasma there was a risk
that hepatitis would develop. Knowledge of this “post-transfusion hepatitis” became well
established during the Second World War at the latest, in particular after an epidemic of
hepatitis amongst US and Allied troops inoculated against yellow fever.
23
24
These chapters on basic concepts are not summarised in this Overview.
This is an important point. These chapters on knowledge look at the information that was available
at
the time
to clinicians, civil servants and ministers, pharmaceutical companies, NHS bodies and others
with a role in ensuring the safety of treatment.
Overview
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At least by the time the NHS was established in 1948 it was known that:
• transfusions carried a risk of post-transfusion hepatitis
• this was often a delayed complication
• hepatitis was transmitted by a virus
• it could be fatal
• people transfused with plasma from a large pool of donations (up to 500 at that
time) experienced higher rates of jaundice than people receiving single donations
of whole blood.
Although serum hepatitis (as post-transfusion hepatitis was often called) was known to be
caused by a viral infection, the viruses which caused it were not identified for many years.
But it was not necessary to know the precise microbiological configuration of the viruses to
understand that post-transfusion hepatitis could have serious consequences. This was well
understood, whether the transfusion was of whole blood or plasma. In 1946 Dr William d’A
Maycock noted that users of plasma “must
be told that it is a potentially lethal fluid which
should be used with discretion.”
Though in many cases the effects of serum hepatitis might appear short-lived, it was known
both by scientists and in government that in other cases chronic infection – and possibly
fatal liver failure or cancer – would follow. A Scottish Home and Health Department (“SHHD”)
memo in December 1964 said that “All
blood for transfusion must be regarded as potentially
contaminated … The most important transmissible disease in this country is homologous
serum hepatitis … No transfusion should be undertaken unless the benefits outweigh the
risk of hepatitis.”
In 1952, the World Health Organization (“WHO”) reported serum hepatitis as a serious
problem and suggested five measures to reduce the risks: selection of donors, control of
pool size, treatment of plasma, the maintenance of proper records, and reporting. If these
measures had been taken in relation to the supply of blood and blood products in the UK, it
is reasonable to believe that a significant part of the harm on which this Inquiry is focused
could have been prevented.
In 1965, researchers identified an antigen which was associated with serum hepatitis.
This led to a virus being isolated in 1967, termed Hepatitis B. By around 1970, there was
finally a test to screen blood for the presence of Hepatitis B, although it was not sensitive
enough to identify every case of infection in the blood. Testing of donations was introduced
in regional transfusion centres during 1971 and 1972; testing of plasma for fractionation was
introduced in late 1971.
In Germany, from 1965 onwards, all blood donated for possible transfusion was tested to see
if it contained abnormally high levels of a liver enzyme, alanine transaminase (“ALT”). Italy
also introduced ALT testing of donations with effect from 1970. This increased the protection
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against infections which might cause hepatitis but which Hepatitis B testing, particularly in
its early forms, failed to spot. The UK never adopted ALT screening.
3.7 Hepatitis Risks 1970 and After
In February 1970, Professor Richard Titmuss published
The Gift Relationship.
Professor
Titmuss drew attention to a series of studies demonstrating the risk of hepatitis incurred by
those who received transfusions of whole blood or blood products, to support his case that
a system relying on voluntary non-remunerated donations was very much safer not only
in theory but in reality. Shortly afterwards Professor Garrott Allen of Stanford University
confirmed that same message (one which he had drawn attention to publicly since 1959): the
hepatitis risk from blood commercially sourced was markedly higher than the risk from blood
and plasma sourced from truly voluntary donors. Professor Garrot Allen also emphasised
the seriousness of transfusion hepatitis.
It began to be apparent as soon as 1972 that despite the introduction of testing for Hepatitis
B there was still a significant risk of post-transfusion hepatitis. It was increasingly reported
that hepatitis was occurring after transfusion, yet when tested the patient was suffering
neither from Hepatitis A nor Hepatitis B. Of particular note was the report by Dr Alfred Prince
and others in
The Lancet
in August 1974 that an agent other than Hepatitis B (which
became known as non-A non-B Hepatitis (“NANBH”)) was the cause of 71% of cases of
post-transfusion hepatitis; this article warned of the possibility that “non-B
hepatitis may play
a role in the aetiology of some forms of chronic liver disease.” The Lancet
was one of the
most widely-read journals by clinicians in the UK: no clinician dealing with transfusions had
any reason to be unaware of this conclusion.
In January 1975, Professor Garrott Allen wrote to Dr Maycock to try to persuade him against
the continued import of factor concentrates from the US. He said that one commercial
product – which “as
you know”
was sourced “100
percent from Skid-row derelicts”
– was
extraordinarily hazardous: a 50-90% rate of hepatitis developed from its use. In May 1975
the WHO advised self-sufficiency for all nations and the use of voluntary non-remunerated
blood donations. A 1974 outbreak of hepatitis at the haemophilia centre in Bournemouth
after the administration of Hemofil, a commercial factor concentrate, was the subject of a
report in
The Lancet
in August 1975. Later that year another significant warning was given:
the memorable World in Action
Blood Money
programmes in December 1975 reported the
high risk of hepatitis in blood products sourced from prisons and “skid row” paid donors.
For some time a number of doctors held the view that NANBH was a mild or benign disease.
The view that the disease was mild rested centrally on assertion and/or wishful thinking
rather than evidence and was reached by a comparison with Hepatitis B in the acute phase
rather than on epidemiological studies. This represented a serious and collective failure of
judgement amongst the many who asserted it. Unless there was good evidence to show that
Hepatitis B on its own had caused almost all the serious effects previously attributed globally
to “serum hepatitis”, NANBH viruses simply could not be assumed to be any less harmful.
The observed effects of serum hepatitis might just as well have been caused by the major
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viral component of serum hepatitis (NANBH) as by what now seemed the lesser (Hepatitis
B). There could have been no proper confidence that NANBH would not have serious long-
term consequences; those consequences would emerge only after an extended period of
chronicity. Publications in the mid 1970s by eminent clinicians (such as Dr Harvey Alter,
who was later to be awarded the Nobel Prize for his work in this area) rightly observed that
“chronic
non-A, non-B hepatitis is not necessarily a benign infection and may be the cause
of a significant proportion of chronic hepatitis not identifiable as type B disease”.
By 1978 there were a number of reports showing that NANBH was linked to persistent
liver damage. Amongst them was a paper published in September 1978 in
The Lancet,
authored by Dr Eric Preston and colleagues in Sheffield. In his oral evidence to the Inquiry,
Dr Mark Winter said that this paper “blew
out of the water instantly the idea that this
[NANB
hepatitis]
was nothing to worry about because their study showed, as did other studies, that
most of these patients had very significant chronic liver disease”.
He thought doctors had
been unwilling to think that NANBH might be a problem, because factor concentrate had
brought “such
spectacular benefits”:
it was this reluctance to face the facts described in
scientific journals that had prevented earlier acceptance of the seriousness of the problem.
By February 1979 the Medical Research Council (“MRC”) had been told by the chief scientist
of the Department for Health and Social Security (“DHSS”) that non-A non-B Hepatitis was
“being
given high priority by the Department”.
At the end of April 1979 Dr Peter Kernoff,
the co-director of the haemophilia reference centre at the Royal Free Hospital, described
NANBH as “a
serious disease with long-term consequences”.
In May 1979 the North East
Thames Regional Association of Haematologists Haemophilia Working Party recognised that
“Despite
the generally mild nature of acute non-A non-B hepatitis it seems very possible that
there may be serious long-term sequelae and the acute disease may sometimes be fatal.”
During an international symposium into “Unresolved
problems in Haemophilia”
held in
Glasgow in September 1980, attended by many haemophilia clinicians, Dr Howard Thomas
and Dr David Triger (both hepatologists) explained that “we
are just building up trouble”
and
“it
is in 10 years time that we shall see the problems. Bearing in mind the proportion of the
patients that are infected, or have persistent abnormal liver function tests, anything from 60
to 80 per cent, it will be an enormous problem when it happens.”
And by September 1980 Dr Diana Walford of the DHSS was confident enough to write
a memo saying: “I
must emphasise that 90% of all post-transfusion (and blood-product
infusion) hepatitis in the USA and elsewhere is caused by non-A non-B hepatitis viruses
which (unlike hepatitis B) cannot, at present, be detected by testing donor blood. This form
of hepatitis can be rapidly fatal … or can lead to progressive liver damage. It can also result
in a chronic carrier state, thus increasing the ‘pool’ of these viruses in the community.”
By the very start of the 1980s, therefore, it was clear that hepatitis caused by a blood
transfusion, or treatment with a blood product, carried with it a serious risk of long-term
consequences, and it was known that this could not be linked simply to Hepatitis B infection.
Yet the view that NANBH was relatively benign and non-progressive remained difficult to
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shift in the early 1980s. It has been described to the Inquiry as the generally held view but
this does not fit very closely with the contemporaneous evidence.
3.8 Knowledge of the Risks of AIDS
In June 1981 the Centers for Disease Control and Prevention (“CDC”) in the US reported a
cluster of five cases of people suffering from a failure of their immune systems, allowing a
form of pneumonia (pneumocystis carinii pneumonia (“PCP”)) to develop; the cluster was
in the gay community. By July the CDC was reporting in the
Morbidity and Mortality Weekly
Report
(“MMWR”) that it had found approximately 10 more such cases, again amongst
gay men, and in addition 26 cases of gay men who had developed Kaposi’s sarcoma
(“KS”), a skin lesion, which had been diagnosed within the previous two and a half years.
By August 1981, an additional 70 cases of PCP and KS amongst gay men were reported;
and by December 1981 the same failure of the immune system which gave rise to these
characteristic opportunistic infections was seen in intravenous drug users. By March 1982
the possibility that the cause of AIDS was an infectious agent had been developed as a
leading hypothesis in the US.
By now, the context was that there was growing concern about AIDS throughout the world.
In the UK the first patient known to have AIDS had been identified in late 1981. By mid
summer 1982 Terrence Higgins had died and what was initially called the Terry Higgins
Trust was being formed by his friends. It was a growing illness, and already known that
people who suffered from it were highly likely to die, after a wasting sickness.
In June 1982 the Second International Symposium on Infections in the Immunocompromised
Host was held in Stirling, Scotland. Few haematologists attended, though Dr Ian Hann and
(he thought) at least one representative of the Scottish National Blood Transfusion Service
(“SNBTS”) did. Dr Hann left the conference realising that developing information about AIDS
might be relevant to haemophilia patients, and later commented that what he heard was “a
bombshell”
in terms of the severity of the new disease. He described this as “part
of the
burgeoning knowledge that began to explode at that time.”
On 9 July 1982 the Assistant Surgeon-General of the US wrote to all haemophilia centres
in the US to alert them to the spread of AIDS to people with haemophilia. On 14 July the
National Hemophilia Foundation in the US alerted its members that there was a risk to
people with haemophilia. Dr Harold Gunson, consultant adviser on blood transfusion to the
Chief Medical Officer (“CMO”) and thereby the DHSS, was alerted to this development very
shortly thereafter.
Then, in the MMWR of 16 July 1982, the CDC reported three cases which had been
confirmed in people with haemophilia who had developed AIDS.
An internal DHSS memo on 16 July 1982 alerted the Medicines Division to possible adverse
publicity about the risks of US Factor 8 concentrates and that the licences of certain
manufacturers of imported blood products might have to be revoked. In August 1982, the
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Communicable Disease Surveillance Centre (“CDSC”) took steps to introduce national
surveillance for AIDS in the UK, and the journal
Science
carried an article headed “New
Disease Baffles Medical Community”
which described how more than 470 people in the US
had AIDS, that almost half had died, and that an infectious agent appeared likeliest to be the
cause. Ominously, it noted that the signpost “opportunistic” infections were first noticed in
mid 1979 – ominous, because it suggested that if the cause was an infectious agent it had
a long incubation period.
On 3 October 1982 the US National Hemophilia Foundation urged pharmaceutical companies
to stop using plasma collected from gay men, intravenous drug users and people who had
recently been in Haiti as a “precautionary
measure”.
On 5 November 1982 Dr John Craske of the Public Health Laboratory Service (“PHLS”)
produced a report which identified an infectious agent as the most likely of the possible
causes of AIDS.
Given this history, there can be little doubt that possibly by March 1982, and certainly
from July 1982 onward, it was known in the UK to both some clinicians and some within
government that there was a real risk that blood, and blood products in particular, might
transmit the cause of AIDS.
In November 1982
The Observer
reported that people with haemophilia in the US were
suffering from AIDS and that there was a “major
speculation”
that the AIDS virus was “carried
in the blood”.
Though there was no certainty as yet, the risk that this was the case was clear.
Then, in December 1982, the MMWR reported the case of a baby who had received multiple
transfusions shortly after birth and had contracted the symptoms of AIDS. This – the San
Francisco baby case, as it has often been referred to – was powerful evidence in support of
the infectious agent theory and of transmission by blood. The same MMWR disclosed that
the three individuals whose cases had been reported in the 16 July 1982 MMWR had since
died, and that four additional cases of AIDS in haemophilia patients had been identified,
together with a further “highly
suspect”
case of a 7-year-old child with severe haemophilia.
All had received Factor 8 concentrates and two of the five had died.
By the end of 1982, Dr Joseph Smith, the director of the National Institute for Biological
Standards and Control, had formed the view that the cause of AIDS was almost certainly
a virus, and haemophilia centre directors (according to Dr Charles Rizza, the director of
the Oxford Haemophilia Reference Centre) knew there was a real risk that AIDS could
be transmitted by an infectious agent carried by blood products. In the Netherlands, the
Central Laboratory of the Blood Transfusion Services was convinced by the end of 1982
that people with bleeding disorders were at risk and started to coordinate a response with
the Netherlands Haemophilia Society, haemophilia clinicians and the Netherlands National
Institute for Public Health and Environmental Protection.
On 7 January 1983 the MMWR reported that two female sexual partners of males with AIDS
and four female sexual partners of intravenous drug users had developed either AIDS, or
PCP, or opportunistic infections typical of AIDS, indicating that the cause was highly likely
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to be viral, transmissible by sex as well as blood, and similar to Hepatitis B. On the same
day Alpha Pharmaceutical, a US company which produced blood products, issued a press
release about people with haemophilia who had been infected: “The
evidence suggests,
although it does not absolutely prove, that a virus or other disease agent was transmitted to
them in the Factor VIII concentrate, derived from pooled human plasma.”
The prestigious and widely read
New England Journal of Medicine
stated in its 13 January
1983 editorial that “The
fact that haemophiliacs are at risk from AIDS is becoming clear. If
the use of cryoprecipitate will minimize this risk the current home-infusion program needs
to be revised.”
This article, and the cases that had been reported in the MMWRs, were
discussed at a meeting of UKHCDO’s Hepatitis Working Party on 19 January 1983.
On 24 January 1983 at a meeting at Heathrow those attending, which included 21
haemophilia doctors, were told by Dr Craske that the disease was “intractable”, that by
December 1982 45% of people infected had died, that ten people with haemophilia in the
US had been affected, of whom five had died, and that the disease appeared to have an
incubation period of between six months and two years.
The Lancet
of 29 January 1983 concluded that a blood-borne agent was likely to be the
cause of AIDS and the
New Scientist
of 3 February 1983 reported that the “prime
suspect”
was a blood-borne virus.
On 7 March 1983 Dr Bruce Evatt of the CDC wrote in a letter to Professor Bloom that the
AIDS epidemic was evolving “with
a frightening pace”.
There were now 13 confirmed AIDS
cases in the US among people with haemophilia, and a further 5 highly suspect cases under
investigation; all had received factor concentrates. Preliminary data suggested that half of
people with haemophilia in the US had T-cell abnormalities, with 13% markedly abnormal, as
in AIDS patients. There is no evidence that Professor Bloom circulated this letter at the time.
Around this time some haemophilia doctors in the UK began to check patients for signs
of AIDS as a routine measure: doing this shows they must already have recognised that
receiving factor concentrate therapy carried a real risk of leading to AIDS.
Concern about AIDS became more widespread when the BBC screened a
Horizon
programme which identified “the
4 Hs”
in the major risk groups – “Homosexual
males, IV
Drug (Heroin) users, Haitians and Haemophiliacs”
on 25 April 1983. There were also reports
in the mainstream press at the start of May 1983, notably an article by Susan Douglas in
The Mail on Sunday
on 1 May, with the banner headline “Hospitals
using killer blood”.
She
reported an epidemiologist as saying “It
seems madness that our blood supplies are coming
from a country suffering from an epidemic”.
Despite this, and despite having reported to the CDSC on 26 April a probable case of AIDS
in a young man with haemophilia treated at the Cardiff Haemophilia Centre, on 4 May 1983
a statement from Professor Bloom was sent to Haemophilia Society members saying that
the “cause
of AIDS is quite unknown and it has not been proven to result from transmission
of a specific infective agent in blood products”,
that the number of AIDS cases was small,
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and that “in
spite of inaccurate statements in the press”
he was unaware of any proven case
in “our
own haemophilic population”.
Professor Bloom advised no change to therapy with
factor concentrates.
Saying that the number of AIDS cases was small was a surprising thing to write without
any qualification: it may have been true that the number of people with haemophilia known
(so far) to have developed AIDS was small, but the popular press were already reflecting a
considerable concern that a deadly unidentified disease was growing amongst the general
population in epidemic form. Further, reports of two German patients with haemophilia
developing AIDS became known during 1983, by late April. Professor Bloom ought to have
realised that the number of cases in which the infection had become sufficiently developed
to show themselves as cases of AIDS were potentially only the tip of a very much larger
iceberg:
The Observer
had made this very point in terms clearly understandable by a layman
let alone a scientist.
Professor Bloom may have been saying one thing for public consumption, whilst advocating
a different tack within his own haemophilia centre. Only two weeks after his letter to the
Haemophilia Society,
Haemophilia Treatment Policy Guidelines
for use in Cardiff were
issued. They advised using DDAVP, cryoprecipitate and
only
NHS factor concentrates for
children and those with mild haemophilia, and even when it came to those with severe
haemophilia advised using only NHS concentrate for those who had never received
commercial concentrate “where
possible”
and cryoprecipitate for in-patient treatment “where
feasible”.
This can only have been on the basis that imported factor concentrates created
such a risk of AIDS that they should not be used unless there was no alternative.
If what Professor Bloom had said had been faithful to the facts, and he had advised the
Haemophilia Society that there was a real risk that taking factor concentrates risked
contracting AIDS, and that the likelihood of the risk becoming a certainty appeared to be
growing stronger by the month, it is not difficult to see that the events that followed might
have taken a different turn.
On 9 May 1983 Dr Spence Galbraith (in his capacity as director of the CDSC, which had
the role of identifying threats to public health from communicable diseases) wrote a paper
entitled “Action
on AIDS”
which he sent to the DHSS, stating: “I
have reviewed the literature
and come to the conclusion that all blood products made from blood donated in the USA after
1978 should be withdrawn from use until the risk of AIDS transmission by these products
has been clarified.”
A special meeting of UKHCDO reference centre directors on 13 May 1983 considered
it “circumspect” to use only NHS materials to treat young children and people with mild
haemophilia, but the minutes stated that there was “as
yet, insufficient evidence to warrant
restriction of the use of imported concentrates in other patients in view of the immense
benefits of therapy. The situation shall be kept under constant review.”
Dr Walford (DHSS)
attended the meeting. On the same day she recorded Dr Galbraith’s recommendation as
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“premature
in relation to the evidence and unbalanced in that it does not take into account
the risks to haemophiliacs of withdrawing a major source of their FVIII supplies”.
Also in May, the Council of Europe Committee of Experts on Blood Transfusion and
Immunohaematology concluded that although “Absolute
proof that AIDS is caused by a
transmissible infectious agent is not yet available”
nonetheless “it
should be regarded as
such and that a recommendation should be made to the Council of Ministers at the meeting
in June to take necessary steps to minimise the transmission of AIDS by the transfusion of
blood products.”
The Council of Europe accepted the recommendations in June 1983.
On 20 May 1983 the isolation of a viral particle (then called “LAV”) by Dr Luc Montagnier
and his team in Paris did not attract significant attention at the time, but was later said to
have made it clear scientifically that the cause of AIDS was indeed a virus.
By July,
Transfusion International,
a journal directed to transfusionists, observed in an
editorial by an eminent physician that “There
is relatively strong evidence indicating that
[AIDS]
may be transmitted by blood.”
August 1983 saw the first known UK death from AIDS of a person with haemophilia.
Nonetheless, when UKHCDO held its annual general meeting on 17 October, Professor
Bloom dismissed a suggestion that patients should revert to cryoprecipitate, saying “he
felt
that there was no need for patients to stop using the commercial concentrates because at
present there was no proof that commercial concentrates were the cause of AIDS.”
On 12 January 1984
The New England Journal of Medicine
published a report of a study of
18 suspected cases of AIDS associated with transfusion. None of the recipients possessed
any risk factor other than being the receipt of blood components. The conclusion of
The
New England Journal of Medicine
was that blood components could transmit AIDS, that
exposure to one infected unit might result in transmission, and that symptomless donors
could be infectious
By March 1984 all blood products manufacturers in the US were warning of the risk of
contracting AIDS from using their products.
On 23 April 1984 it was announced at a press conference in the US that Dr Robert Gallo
had found the virus which caused AIDS, terming it “HTLVIII”; Dr Gallo had identified exactly
that which Dr Montagnier had called LAV. From now on the overwhelming consensus was
that the cause of AIDS was infection with HTLV-3 (LAV) which was later renamed HIV.
The risk that blood transfusion or factor concentrates could cause AIDS was apparent in
mid 1982. Everyone involved in treating patients with blood or blood products (or involved in
decision-making regarding the use of blood or blood products) either knew, or should have
known, of the risk by the end of 1982. It became increasingly apparent as a serious risk until
it came to be regarded as a near certainty in April 1984. This risk had to be addressed when
it first became recognised as a real risk, by the end of 1982 or January 1983 at the latest; all
the more so since the context was a developing epidemic.
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3.9 – 3.11 Blood Services
These next three chapters evaluate the organisation and role of the blood transfusion
services in England, Wales, Scotland and Northern Ireland up to the early 1990s, and how
they responded to the risks of viral transmission through blood. What is set out below will
provide an indication of the issues explored within the chapters, but for a comprehensive
narrative readers are referred to the chapters themselves.
3.9 Organisation of the Blood Services
This chapter explores the organisation of the blood services in the UK. The blood services
in England and Wales were an amalgamation of autonomous regional services. There
were divergences in practice between regional transfusion centres (“RTCs”), and efforts
to standardise the medical selection of donors and other functions were only ever partially
successful as there was no obligation on regional transfusion directors (“RTDs”) to adopt
national policy, particularly where it came into conflict with regional priorities. At their head
from the Second World War until 1978 – though with only a role of advising and persuading
– was Dr Maycock. His formal role was as Consultant Advisor on Blood Transfusion to the
CMO, and the CMO headed the medical hierarchy in the DHSS. Until 1978 Dr Maycock
also had a role as director of the Blood Products Laboratory (“BPL”) which despite the term
“Laboratory” was principally a unit which was responsible for producing blood products from
plasma supplied by the regions, though itself being under separate control from them.
At a special meeting between RTDs and DHSS representatives, held in 1970 to consider a
green paper on the future structure of the NHS, the RTDs advanced a case for the reintroduction
of a national service. They complained that the existing structure of independent RTCs was
leading to fragmented administration. A strong recommendation by RTDs in 1973 that the
service be reorganised around “a
unified system of central administration”
was rejected
when the NHS was reorganised. Instead the centres remained under local management by
regional health authorities. No national executive was established to control blood services
policy or management.
RTDs remained sceptical about the effectiveness of this structure. An ad hoc committee
was set up to consider their concerns, and whether any change should be made in the
organisation of the blood transfusion services in England and Wales. This committee, though
recognising the force of many reasons for centralising administration of the national blood
services, was unconvinced that responsibility for administration and providing services
should be taken away from regional health authorities, although a Central Committee for
the National Blood Transfusion Service (“NBTS”) was created in 1975 to keep under review
the operation of the blood service in England and Wales, and to advise the DHSS on the
development of the blood service.
In 1977 RTDs proposed to the Royal Commission on the NHS that the blood transfusion
service had assumed an increasingly national role which had suffered from constraints
arising from regional development, inadequate central coordination and financing, and a
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poor integration of the activities of regional transfusion centres. The current structure of the
transfusion service was described as a “loose
confederation of 14 Regional Transfusion
Centres, independently financed, each providing services which vary considerably from
Region to Region, and three central laboratories financed by the DHSS.”
The structure of the blood services across the UK was linked to the supply to the fractionation
centres in England and in Scotland of sufficient plasma to enable them to utilise production
facilities to the full. Regional health authorities had little incentive to provide plasma for
fractionation if those health authorities were not themselves going to see a benefit for
patients within their own region, the BPL itself was suffering from an extended period of
underinvestment, and there was an accompanying lack of funds and incentive for research
to be conducted into producing safer products.
An Advisory Committee on the NBTS was established in 1981 to advise the DHSS and
the Welsh Office on the coordination of the development and work of RTCs. Difficulties in
establishing national standardisation nonetheless persisted: Dr Harold Gunson, who had
succeeded Dr Maycock in his role relating to transfusion (though not his role in respect of
BPL) was later to highlight that the inconsistent and inadequate supply of plasma to BPL,
and the difficulties in implementing HIV testing were examples of problems caused by a lack
of an effective national policy for decision-making.
By the start of 1983 the UK service was still one in which there were a number of autonomous
parts: regional transfusion centres, organised in England and Wales into three districts but
still consisting of individual RTCs, each under the financial and administrative control of
their respective regions, and the services in Scotland and Northern Ireland. The Advisory
Committee on the NBTS was advisory only and remained unable to exercise executive
control over the service as a whole.
The directors of all the RTCs in England and Wales repeatedly noted that if plasma supply
to BPL were to be sufficient to support the goal of self-sufficiency, this required national
management. The DHSS was aware too that research and development were duplicated
unnecessarily across regional transfusion centres, BPL, and the Protein Fractionation
Centre (“PFC”) due to a lack of central coordination.
A National Directorate, intended formally to co-ordinate the blood transfusion services in
England and Wales, was set up as from July 1988 but lacked executive authority, which
remained with the RTCs and their regional health authorities. It was not until April 1993 that a
single body with executive authority, the National Blood Authority, was established in England.
The position in Scotland was different. The SNBTS was set up in 1940 and comprised
five regional transfusion centres. From 1974 responsibility for the service rested with the
Common Services Agency. Its funding was received centrally, rather than from regional
budgets as in England and Wales. Northern Ireland had a single regional transfusion centre.
Problems of a lack of coordination and the lack of any one person or body exercising
executive authority contributed to the failure of the UK as a whole to achieve the goal of
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self-sufficiency in blood products. A lack of coordination between England, Wales, Northern
Ireland and Scotland from the early to mid 1970s onwards added to this. The lack of
centralised funding led to research being a poor orphan of the service so far as funding and
resources were concerned.
The fragmented nature of the blood services also contributed to a failure to achieve as
much plasmapheresis as would probably have resulted had there been one national point
of executive control, and made it more difficult to mount an effective coordinated national
approach to achieving a greater use of packed red blood cells, and to introduce measures
to help minimise the use of transfusions where possible. When it came to a need to
pass information on to donors (through measures such as the donor leaflets produced in
response to the HIV epidemic), to screen donors consistently, and to facilitate the screening
of donations, a nationally coordinated response would likely have achieved more than was
done: it was difficult to achieve it under the system as it stood.
3.10 Regional Transfusion Centres
This next chapter considers in more detail the role and functions of the RTCs. Again what
follows below is a summary of some of the main points only.
Throughout the 1970s and 1980s each RTC served its own region. In England and Wales
each RTC’s activities were shaped by the services required by the hospitals they served,
and the adequacy of the funding provided by the regional health authority. Many of the RTCs
were in old, cramped, inadequate buildings, which curtailed what they could do. Some were
inadequately staffed.
A common arrangement in England and Wales was one where hospitals within the region
had their own blood banks, which were supplied by the RTC. This could lead to a disconnect
between those using the blood (at the hospital) and those who were concerned with securing
future blood supplies (the RTC), which may in part be responsible for what was a sluggish
change of practice from the over-enthusiastic use of whole blood for transfusion to both the
more general use of concentrated red blood cells and a more sparing approach to giving
transfusions. In Scotland, by contrast, four out of the five Scottish RTCs carried out blood
banking for the hospitals in which they were based. All five of the RTCs were centrally
funded. Despite this, the national SNBTS director, Professor John Cash, did not have any
power to compel the RTCs to adopt any particular policy and so any decisions that were
to be implemented nationally had to be reached by consensus. The Scottish RTCs also
suffered from poor facilities and inadequate staffing which in some instances limited what
they could offer.
Most of the RTCs in England and Wales provided plasma to BPL for fractionation, then
received back and distributed the fractionated products. Some RTCs were involved in the
purchase of commercial Factor 8. There was no formal national system for RTCs which
collected more than they needed to help RTCs with shortages caused by the donor population
not necessarily matching the demand. Professor Cash noted the need for a national system,
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when he observed that when private hospitals in London could not secure blood from the
RTC, they obtained blood supplies from Europe and occasionally this was passed to NHS
hospitals. This is the only evidence the Inquiry has found that the UK received blood (as
opposed to blood products) to use in the NHS which did not come from voluntary non-
remunerated donors living in the UK.
The system of national plasma targets for BPL with regional funding was fundamentally
flawed and ultimately unsuccessful. Until 1981 the system was that the overall target would
be divided between RTCs on the basis of population size, but product would be delivered
back in proportion to the numbers who had been treated in the previous year. In April 1981
the pro rata system was introduced but it still had a number of flaws: the targets set for each
RTC were not based on the amount of concentrate a region needed by on its population; the
pro rata system did not provide the RTCs with certainty as to the amount of factor products
they would receive back from BPL in any given year; and some RTCs pushed back against
the targets set by BPL because they did not agree that they were set at the right level.
Finally in April 1989 an improved cross-charging system was introduced with RTCs selling
their plasma to BPL, buying back the fractionated products and selling these to hospitals
in their region.
The drive to provide more plasma to BPL led to two changes in RTC practices: discouraging
hospitals from using whole blood for transfusions where the patient needed only the red
blood cells (as the remaining plasma could be sent to BPL); and adding a solution called
SAG-M to blood to make red cell concentrate easier to administer. Almost all the RTCs had
some form of plasmapheresis programme by the end of the 1980s or beginning of the 1990s.
The Scottish transfusion centres did not experience difficulties of supply. In fact, the centre
in Edinburgh would sometimes send its surplus red cells to an English RTC to address their
shortages. As in England and Wales, SNBTS encouraged the use of red cell concentrates
over whole blood, using SAG-M, and adopting plasmapheresis.
Prior to 1982 the transfusion centre in Belfast sent only time-expired liquid plasma to BPL
for fractionation and received only a small amount of Factor 8 from BPL in return. From the
end of 1982 all Northern Irish plasma was sent to PFC in Edinburgh.
The fact that the system was regionally funded and regionally controlled in England and
Wales led to problems, and tensions within the service. So far as blood was concerned, there
was a tension between the supply of it, and the clinicians’ demand for it. This rarely caused
problems on its own, but when demand for plasma for fractionation rose, this demand,
together with those of the clinicians, had to be balanced against the available supply.
The system was inefficient when it used whole blood for transfusion where only red blood
cells were required, wasting the plasma, and also when whole blood was used as the source
of plasma for fractionation or cryoprecipitate, wasting the red blood cell component. Efforts
were made to persuade clinicians to change their prescribing habits, and to adopt the use
of SAG-M to enable the red blood cell component to be more easily used. Education and
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persuasion were ultimately reasonably successful. But this success could and should have
been achieved more quickly than it was.
3.11 Response to Risk by the Blood Services
The process of selecting a donor involves choosing whom to approach to give blood,
screening those who answer the call, and testing donations. This chapter examines the
approaches of the blood services to the first two of these, and whether they effectively
reduced risk as far as they reasonably could and should have done. The testing of donations
is examined in later chapters.
Prisons were regarded as a valuable source of blood donations from the 1950s until the
1970s. Following the introduction of screening for Hepatitis B in the early 1970s, it became
clear that there was a markedly higher incidence of Hepatitis B amongst prisoners. The
American Red Cross stopped collecting blood from prisons in the US in July 1971 because
the incidence of hepatitis was ten times greater among prisoners than among voluntary
unpaid donors. Despite this, it was still Home Office policy in the early 1980s to encourage
prisoners to become donors as it was believed to help with rehabilitation. The collection of
blood from closed prisons and borstals in England and Wales only finally stopped at the end
of 1984 and from the last open prison in 1986. In Scotland the practice finally stopped from
March 1984 and in Northern Ireland from October 1983. The blood services should have
resisted earlier and more effectively: prison donations continued for much too long.
The armed forces were another source of blood donors throughout the 1970s and 1980s
for some RTCs, despite this cohort of donors giving rise to risks not far removed from those
seen in the prison population, because of the difficulty in disclosing personal risk factors in
front of fellow members of the armed forces.
Workplace sessions were an important source of donations and although there was no
evidence to suggest higher levels of blood-borne viruses in such donors, there was a
risk that employees might feel pressured to donate and unable to admit to risk factors in
conditions where workmates might become aware of them.
Screening by assessing donor health was primarily a matter for the donors themselves
who were said to be “the
best judge”.
The blood services relied on donors answering their
questions truthfully. There was little privacy at donor centres and questions about the donor
having an infectious disease might easily be overheard. This problem became particularly
acute when the blood service introduced leaflets setting out eligibility criteria for donors
in response to the threat of HIV and AIDS. The North London Blood Transfusion Centre
developed a system which allowed donors who felt under pressure to donate (if they had
come with work colleagues for instance) to declare their health conditions privately.
It would not necessarily have been easy to introduce direct confidential questioning about
the private lives of donors: but it is regrettable that it was not done, at least in some form,
when AIDS first emerged.
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Prior to 1976 any donor with a history of jaundice was, or should have been, excluded
but this was relaxed following the issue of circulars in 1977, and the Memorandum on
the Selection, Medical Examination and Care of Donors was amended in 1977 to allow
people with a history of jaundice or hepatitis to donate as long as they had not suffered
from jaundice or hepatitis in the preceding 12 months and as long as their blood tested
negative for Hepatitis B. Scotland followed a similar approach from 1980. This approach
should have been reconsidered much earlier than it was. In 1989 the blood services of the
UK published the first edition of the “Red Book” transfusion guidelines. The criteria with
respect to hepatitis and jaundice were that a donor should be allowed to donate 12 months
after recovery. That was unwise, since chronic infection could persist. It was not until the
second edition of the Red Book in 1993, that the guidelines explicitly ruled out potential
donors infected with Hepatitis C.
Although from 1977 those who were suspected of or admitted to illicit drug-taking were in
theory debarred from donating, it is unclear how such individuals would be identified or even
what attempts were made to identify them. The form which donors were asked to sign made
no reference to this and there were no specific measures in place to prevent those with a
history of intravenous drug abuse from giving blood.
In 1982 the DHSS published a report making recommendations as to the role of RTCs
in promoting good practice in blood transfusion, including “economies
in blood usage”.
A
circular issued by the DHSS in 1983 recommended regular meetings between RTCs and
hospital consultants to consider such matters. Similar recommendations were produced by
SNBTS. In practice the extent to which individual RTDs played a role in educating clinical
colleagues on the use of blood varied from centre to centre and over time. One of the
obvious steps that treating clinicians could (and should) have taken once it was understood
that HIV was a blood-borne infection, was to reduce all patients’ exposure to blood and blood
products as far as reasonably practicable. However, RTDs did not, on the whole, consider
that they had a role in trying to influence treating clinicians to prescribe one product over
another on the grounds of safety. The principal reason for this was respect for the clinical
freedom of doctors.
All RTC directors (for England, Wales and Northern Ireland) who were in post in the years
1982-1984 before blood products were heat treated against HIV gave evidence that if they
had been asked to increase their production of cryoprecipitate (a much lower-risk product)
during the mid 1980s, they would have been able to do so, and quickly. They were all clear
that no such request was made of them by treating clinicians and so no steps were taken to
achieve this. In Scotland Professor Cash emphasised the role of cryoprecipitate and raised
concerns about the purchase of commercial products and Dr Brian McClelland produced a
paper which suggested reassessing the role of single-donor or small pool cryoprecipitate.
However the extent to which these actions influenced the prescribing practices of haemophilia
clinicians in Scotland is doubtful.
AIDS was first discussed at the regular meeting of RTDs on 18 May 1983, some ten months
after the MMWR had reported three cases of suspected AIDS in people with haemophilia
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in the US. Four options were identified for consideration: questioning donors at sessions,
discontinuing sessions in areas of high-risk donors, pamphlets explaining AIDS to donors,
and information in newspapers. In Scotland, although there was passing reference to AIDS
at meetings in January 1983 and March 1983, it was not until 24 May 1983 that there was
a discussion about the implications of AIDS for blood donation. The blood services were
too slow to react to the threat of AIDS. On 16 July 1982 (at the latest) the blood services in
England and Wales and the Government became aware that its cause might well be blood
borne. The only immediately available defence was careful donor selection and screening.
The failure on the part of the blood services to give any kind of collective consideration
to what could be done prior to May 1983 was wrong. Few centres took proactive steps in
advance of receipt of the first AIDS leaflet for donors, which were not in general use until
September 1983, and there were variable means of distributing such leaflets. A much more
active approach to distribution of the leaflets should have been adopted from the outset.
Doing more, more quickly, would have prevented some infections. Deterring or preventing
people in high-risk groups from donating should have been a priority. Acting swiftly was not
just the responsibility of ministers, and officials. It was also the responsibility of the blood
services. Although some within the services did more than others, this was not true overall:
in general the blood services did too little, too late.
3.12 – 3.15 Blood Products and Addressing Risk
The next four chapters look at the particular risks posed by certain blood products, and
examine the way in which the known risks described in earlier chapters were dealt with
by government, ministers, civil servants, the blood services and fractionation centres, and
influenced by clinicians who set out their needs and preferences.
3.12 Regulation describes how the Licensing Authority (technically, composed of
ministers of state covering the UK, and in practice operated by them through
the DHSS) regulated the importation, licensing, and distribution of blood
products under the Medicines Act 1968.
3.13 Self-Sufficiency looks at how the government policy of UK “self-sufficiency” in
blood products was approached.
3.14 Viral Inactivation examines how steps were taken to eliminate or reduce the
harmful effects of viruses such as hepatitis and HIV contained in blood products.
3.15 Pool sizes looks at the way in which pools from which batches of blood product
were made became larger and larger, increasing the risks that any treatments
taken from those batches might infect the recipients, and considers the extent
to which the pool sizes used in the UK departed from what had been regarded
as an upper safe limit for roughly 20 years before 1970.
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3.12 Regulation of Commercial Factor Concentrates
The principal issues explored in this chapter are the system for the grant of licences
granted for the importation of factor concentrates; whether the decisions to grant licences
in the 1970s were wrong; and whether actions should have been taken in 1983 to stop the
importation of factor concentrates.
The chapter concludes, on the limited information now available to the Inquiry, that in 1973
the Licensing Authority should not have permitted the importation into the UK of concentrates
manufactured in the US and in Austria where the Licensing Authority was informed of the
large pool sizes from which it was made, and that the plasma came from “donors
who do not
inspire confidence”
who were selling their plasma to the company concerned. It decides that
the decision not to suspend imports of commercial concentrates in July 1983 was wrong.
It explores whether more should have been done to control the distribution in the UK of
products which were made from plasma collected in the US before March 1983.
The chapter also considers the approach to the licensing of heat-treated concentrates
and the Licensing Authority’s role in gathering and communicating information regarding
risks: these matters have not been summarised below but can be found in the latter part
of the chapter.
The Licensing Authority
The Committee on Safety of Medicines (“CSM”) was a group of independent experts
appointed by ministers on the advice of the Medicines Commission. The CSM’s role was to
advise the Licensing Authority (i.e. the relevant ministers through their officials) on the safety,
quality and efficacy of medicines. When an application was made for a licence to distribute
pharmaceutical products, it was considered in the first instance by the Medicines Division
of the DHSS. Where their reports related to blood products, these were usually submitted
to the Sub-Committee on Biological Products (“CSM(B)”). The reports summarised any
risks and expressed the view of the assessors. The CSM(B) would consider the report and
agree a recommendation for the CSM, usually accepting the assessors’ recommendations,
perhaps with some additional conditions.
The proceedings of the CSM (and its sub-committees) were confidential and the available
information about the details of discussions is incomplete. The Inquiry’s view of the quality of
decisions to permit the importation of blood products in the 1970s and 1980s is necessarily
based on the limited evidence available.
The Medicines Act 1968 required the Licensing Authority to consider the product’s safety,
efficacy and quality. It allowed the Licensing Authority, in deciding whether to recommend
the grant of a licence, to consider whether another product might be safer.
Professor Sir Michael Rawlins (member of the CSM from 1980 and CSM chair 1993-1998)
told the Inquiry, “if
you’re treating some lethal condition, then you’re prepared to put up with
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more adverse reactions, perhaps, than something relatively mild. So it was a judgment of
balancing safety and efficacy.”
Licensing in the 1970s
The first licensing applications for Factor 8 concentrates were submitted in 1972 and were
for Kryobulin and Hemofil.
In October 1972 Dr Duncan Thomas (a medical assessor within the Medicines Division)
inspected Hyland Laboratories and a blood bank in California in relation to the application
for a licence to sell Hemofil in the UK. Dr Thomas noted the hepatitis risk associated with
Hyland products: that they were made from “very
large plasma pools”,
and the donors “do
not inspire confidence”.
He added that: “no
attempt is made to disguise the risk of hepatitis,
and it may be considered that the decision to use this material could be left to the individual
clinician who can balance the potential hazard against the anticipated therapeutic benefit to
the patient”.
He recommended the grant of a licence. The CSM(B) accepted his advice and
recommended a product licence for Hemofil in January 1973. The minutes do not indicate
any discussion about hepatitis risks. The CSM(B)’s recommendation was in turn accepted
by the CSM; again no discussion regarding hepatitis risks was recorded in the minutes.
In respect of the Kryobulin application, Dr Thomas reported that it was prepared from pools
of 1,000 donors, with all donors tested at each donation and permanently excluded for
any evidence of hepatitis. Nonetheless, he commented that “the
risk of transmission of
serum hepatitis can only be diminished and not completely eliminated.”
The information
provided was that donors came from Austria and Germany; there was no suggestion that
they were volunteers. Dr Thomas advised that CSM(B) might consider requesting the
Austrian authorities to carry out an inspection. Whilst the CSM(B) minutes record that “the
manufacturer of Kryobulin PL/0215/0003 had not been visited recently, but the licensing
authority intended to ask the Austrian authorities to carry out an inspection on its behalf”
it is unclear why the CSM(B) recommended the grant of a licence without waiting for the
inspection and considering its findings.
There were growing concerns at this time about the blood and plasma from which commercial
products were made. It was understood that the risk of causing hepatitis from blood taken
from paid donors was markedly higher than from volunteer donors. If the CSM and CSM(B)
had wished to consider whether another, safer product might be readily available to treat
patients, Dr Rosemary Biggs and Dr Katharine Dormandy had publicly reported that
patients with haemophilia could be adequately treated with the use of cryoprecipitate. NHS
concentrates were also understood to be safer.
Once the decisions to licence Hemofil and Kryobulin had been made in 1973, the grant of a
licence for Profilate in 1975 was inevitable.
In 1976 licences were granted in respect of Koate and Factorate. In relation to Koate,
Dr Andrews (medical assessor) noted in his assessment report of Koate that the plasma
for the product was supplied by 54 firms under different ownership (including US state
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prisons). He pointed out that in the past the CSM had recommended conditions regarding
donations and donors. In early 1976, the CSM(B) and CSM recommended the grant of
a licence but subject to conditions, including information about the reasons for, and rate
of, donor rejection on a centre-by-centre basis. Although there was then correspondence
between the Licensing Authority and the pharmaceutical company on other issues, that
correspondence did not address further the question of donor rejection rate or provide
the information requested. In due course the product licence was issued with no condition
regarding the provision of ongoing data about donor rejections.
Dr Andrew’s report on the Factorate application noted the hepatitis risk associated with
Factorate when Armour applied for a licence, and the CSM(B) recommended the grant of a
licence with conditions that included information about donor sources and donor rejection.
The importance of the proposed condition on the rate of rejection of donors or donations
was emphasised at a DHSS meeting the day after the broadcast of part two of
Blood Money:
“What
was needed was to strengthen the requirements in the product licence, and to insist
on returns from each collecting centre including the rate of rejection of donors or donations.”
The
Blood Money
programme led also to a meeting with the Minister of State, Dr (later Lord)
David Owen, followed by a submission which noted that “seems
best to assume that all blood
products of this nature coming from the USA may be obtained from plasma taken under the
worst circumstances and any protective measures should be achieved by other means.”
The information provided by Armour in response to the proposed conditions was limited
and there is no evidence that the Licensing Authority took any further steps to clarify these
matters. If, as the evidence suggests, they did not press Armour further, then given the
knowledge that collection of plasma in the US invited rather than limited risks of infection,
this was a failure of regulation.
When licences were given to Hemofil and Kryobulin in 1973 they did essentially the same job
– increasing Factor 8 levels – as NHS concentrates and locally produced cryoprecipitates.
Why, then, was the safety of recipients put at risk by permitting a more widespread
distribution of commercial concentrates than when imported on a named person basis? One
of the reasons may have been to satisfy a desire of clinicians in the UK to use a product with
the advantages of factor concentrates.
Once a product is licensed practitioners are likely to consider that an indication of its safety,
quality and efficacy. They know that regulatory authorities whose primary concern is safety
have authorised its marketing and distribution. Summarising what one clinician ruefully said
to the Inquiry, surely, if it was licensed it was safe?
Given the belief in 1973 that commercially manufactured blood products sourced from
paid donors and manufactured in large pools were less safe than either NHS concentrate
or cryoprecipitate, and given the absence of any evidence that failure to import factor
concentrates put patient safety at risk, the chapter concludes that the decisions to license
Hemofil and Kryobulin were wrong. They led to the decisions about Profilate, Koate and
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Factorate. The evidence available to the Inquiry suggests that safety was not put first – as
it should have been.
The CSM(B) and CSM meetings in July 1983
In late March 1983, Dr Joseph Smith, the chair of the CSM(B) proposed a meeting to
consider AIDS in relation to licensed blood products. The meeting did not take place until
13 July 1983 and was attended by nine members of the CSM(B) together with invited
experts including Professor Bloom, Dr Craske, Dr Galbraith and Dr Gunson. Officials from
the Medical Division also attended. The upshot of the meeting was that no action was taken
in response to the risks from imported factor concentrates. The CSM(B) considered only two
papers at that meeting: a paper from Dr Keith Fowler and an annotated agenda prepared by
Dr Smith. An important letter that had been sent to the DHSS by Dr Galbraith on 9 May 1983
was not circulated, nor any other paper from the CDSC. At its meeting on 21-22 July 1983
the CSM endorsed the recommendations of its Biologicals Sub-Committee. There appears
to have been little by way of discussion, if any.
The decision of the CSM(B) and the adequacy of the information which it considered are
examined in detail in the chapter. The conclusions reached by the Inquiry are in summary:
• The meeting was unusual in having suggested conclusions on the very issues to be
discussed, which probably led the discussion towards drawing conclusions of that sort.
• The chair probably discussed these suggested conclusions beforehand with
Dr Fowler, Professor Bloom and Dr Richard Lane; each of whom had their own
distinctive views. Neither Dr Fowler’s nor Professor Bloom’s stands up to logical
analysis; Dr Lane’s inevitably reflected his perspective as a director of BPL,
manufacturing blood products, and thus concerned with future supplies of plasma if
much of it was diverted to local production of cryoprecipitate.
• The CSM(B)’s approach to risk conflated incidence with risk.
• It regarded US factor concentrates as “life-saving” (true, in some cases – but so
also were cryoprecipitate and NHS concentrates, and this was not acknowledged
as a balanced view required).
• It did not recognise what the Inquiry knows, that it would not have been difficult to
ensure adequate supplies of cryoprecipitate from regional transfusion centres for
treatment. Nor did it take adequate steps to investigate the potential level of supply
(despite the minutes reading that “supply” was a – indeed, was the – critical factor).
• As Dr Walford acknowledged in her evidence, there were two non-sequiturs
in its reasoning.
• The chair had a misguided view of the likelihood of self-sufficiency being achieved
in the very near future.
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• The meeting did not have a number of important documents before it: Dr Galbraith’s
letter of 9 May; the Council of Europe recommendations; Dr Evatt’s letter to Professor
Bloom – it only had Dr Fowler’s report, and an agenda with suggested conclusions.
• It seems likely that Professor Bloom’s views were overly influential.
• The CSM(B) appear to have relied on the assertion (presumably by Professor
Bloom) that UKHCDO had adopted a policy for use of commercial Factor 8 “in
order
to minimise risks as far as possible”.
There is no evidence that the CSM(B) actually
saw, or asked to see, the policy itself, and such a policy could not be described on
any view as minimising risks as far as possible. Insofar as the CSM(B) assumed
that in practice clinicians had a treatment policy that minimised risks as far as was
possible, that assumption was simply fallacious.
The chapter concludes that the decision was flawed in the way in which it was taken and
in the reasoning that was advanced. There is no doubt – not only in retrospect – that it was
wrong. If paramount consideration were to be given to patient safety as it should have been,
it should have resulted in a stay on further imports of commercial concentrate, coupled with
an increase in local supplies of cryoprecipitate, whilst reserving NHS concentrates for those
occasions when their use was truly life-saving, appropriate to provide cover for elective
surgery, or used for patients only after careful consideration between clinician and patient
as to the balance of risk and remedy.
The CSM(B) recognised that its view of the risk at the meeting of 13 July 1983 might evolve
and should be reviewed. The Inquiry has not been able to find any evidence of such a
review. That was a further failure of regulation.
“Dumping” of riskier products in the UK
The Food and Drug Administration (“FDA”) had formally recommended in March 1983 that
pharmaceutical companies should not fractionate plasma collected from “the
four Hs”.
The
logical corollary of that recommendation is that products made from “pre-March plasma”
should not be used, as supplying them would give rise to an increased risk of AIDS. The
chapter next considers the steps that were taken in the UK in respect of pre-March products.
These are not repeated here, but in summary:
• There was a marked change in the approach of those responsible for regulating
the importation of blood products between the end of March 1983 and the end of
August. Within five months the approach had changed from, in effect, “There shall
be no dumping here” to “There shall be no restriction on dumping here”.
• The reason for not wanting dumping was the worry that pre-March products would
pose a greater risk of AIDS to the patient receiving them than post-March products.
It is obvious that the recommendations of the FDA that firms should not accept
donations of plasma from those in groups at high risk of AIDS compared to others
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were designed to reduce the risk of AIDS as far as practicable by aiming to make
the sources of plasma safer.
• It is thus equally obvious that to impose no restriction on the continued import
of products made from such plasma sources put the British public at some
additional risk.
• Why, then, was there a U-turn? The reasons given for it relate to a textual
interpretation of Dr Joseph Smith’s draft on the minutes of the CSM(B) but there is
no record of his having been asked if, when he recommended that the use of pre-
March plasma be avoided, he was actually countenancing that its supply should
continue for as long as there were stockpiles of previously manufactured products.
If he had been asked, as he should have been, there might have been a clearer
answer. From what he has subsequently said – that he expected self-sufficiency
within a few months – it is difficult to think he would have said this, for there would
then be no need to use commercial products, whenever produced.
• The grounds were simply that supply would be insufficient without reliance on
the riskier product. The Inquiry has found no convincing evidence that this was
the case; nor that there was detailed consideration of how much “post-March”
plasma was available to augment the mix of NHS concentrate and cryoprecipitate
which was available for treatment; nor any step “in between” which could have
led to discussions between clinician and patient, such as obliging pharmaceutical
companies to label, clearly, the date of the collection of the source plasma. It was
however noted that (when looking at August stock levels) all of Miles’ pre-March
1983 stock and around 70% of the Alpha and Armour stock had been “collected
in accordance with companies’ special precautions”.
These “special
precautions”
were individual companies’ practices to meet the possibility that factor concentrates
transmitted the cause of AIDS which each of the major firms had adopted prior to
24 March 1983 when the FDA made its recommendations.
• Even if the importation of all commercial blood products should not have been
suspended for a period, the decision to allow continued importation of pre-March
1983 plasma products is difficult to justify on the evidence available to the Inquiry.
• Although the increased risk posed by “pre-March” plasma products was appreciated,
nothing was done to try to reduce this risk or help clinicians and patients to identify
the additional risk to which they might be exposed. The possibility of imposing a
requirement to state the date of collection of the source plasma was contemplated
by the DHSS but this remained only a suggestion. It did not result in the DHSS
doing anything.
• If the DHSS was not going to take action to prevent the importation of pre-24 March
products, the least it could do was to take steps to mitigate the additional risk
which it was permitting by going down the route of a labelling requirement; and/
or making clear to haemophilia centre directors/UKHCDO the fact that pre-March
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1983 products would continue to be available on the market for a further period,
thus enabling haemophilia centre directors to take informed decisions about
whether to use such products or not and/or to provide information to patients and
the Haemophilia Society.
3.13 Self-Sufficiency
Despite being the policy of governments since the end of 1974 to achieve self-sufficiency
in the production of blood products to treat haemophilia throughout the UK, this was not
achieved in England and Wales until after 1990. This chapter examines the causes of this,
looking at each factor individually, except for finance which is a theme present throughout.
The story of the efforts to achieve self-sufficiency is a complicated one: whilst the summary
below identifies some key points, readers are likely to need to read the entire chapter to
understand the reasoning behind the conclusion that self-sufficiency could and should have
been achieved significantly earlier than it was.
A simple definition of self-sufficiency in blood products is producing from a country’s own
resources enough factor concentrate to meet clinical need without having to import any.
Clinical need is not easy to identify objectively, for example, three treating clinicians may
all have different approaches to treatment as to what the patient’s clinical need is. This
question is made more difficult if the hospital administrator, who is seeking to save costs
to make the most of limited resources, is asked. In the context of organising the supply of
blood and blood products the “needs” of the population as a whole had to be determined.
When the NHS began operating on 5 July 1948 the supply of blood was almost entirely
from domestic sources. The supply of blood products to patients however could be traced
through both domestic and commercial routes. Domestic supply can be traced back to the
start of the Second World War, and to arrangements which were inherited when the NHS
first began. Commercial supply involved the importation of blood products (mainly clotting
factor concentrates) for use for those who required them. “Self-sufficiency” relates principally
to Factor 8, since there was generally enough Factor 9 and cryoprecipitate (and more of the
latter could have been produced if requested).
There were three blood product manufacturing units in the UK: the Blood Products Laboratory
(“BPL”) in Elstree, the Plasma Fractionation Laboratory (“PFL”) in Oxford, and the Protein
Fractionation Centre (“PFC”) in Edinburgh/Liberton.
By April 1967 it was being said in
The British Medical Journal
(based on a paper presented
in September 1966) that cryoprecipitate was an “extremely
valuable therapeutic material”
and that from “many
points of view it is the therapeutic material of choice.”
Blood product
usage now focussed upon cryoprecipitate: and thus, so did production. Cryoprecipitate was
the major therapeutic material used for “on demand” treatment of bleeds. It could be made
regionally at transfusion centres with relative ease. Centralised production facilities were
largely unnecessary to provide it.
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By 1973 the manufacturing facilities at BPL were inadequate, out of date, and struggling,
as they had not been designed to manufacture factor concentrates. It was expected that
new, more efficient facilities at Liberton would provide approaching half the needs of
mainland UK. But it had not been recognised that BPL would need to be either extended or
completely redeveloped.
In January 1973 Dr Maycock urged the DHSS to “have
constantly in mind the need to develop
our own sources in the UK transfusion services.”
This was a plea for the Government to
expand the capability of the UK to produce its own product.
In March 1973 the new Expert Group on the Treatment of Haemophilia agreed that 400,000
units of concentrate and cryoprecipitate would be needed annually (300,000 donor units
were anticipated for that year’s treatment). Dr Biggs pressed the case for higher figures
through the MRC’s Blood Transfusion Working Party. Her paper noted that calculations
based on pupils at Treloar’s indicated that between 547,540 and 750,000 blood donations a
year would be required to treat everyone with haemophilia in the UK.
Between 1974 and 1975, for the first time, the use of commercial concentrate exceeded the
use of NHS concentrate so far as the consumption of concentrates was concerned: but two
thirds of the total product used for factor replacement was still cryoprecipitate.
Between October 1974 and the end of the year, the policy on self-sufficiency evolved
internally. In December 1974 a letter to regional administrative officers set it out. The DHSS
recognised that there was an immediate need to provide antihaemophilic globulin (“AHG”)
concentrate, equivalent (now) to some 275,000 blood donor units. The DHSS regarded it
“as
of the greatest importance… that the NHS should become self-sufficient as soon as
practicable in the production of PPF and other blood products.”
This was due to the cost
of commercial alternatives, and the potential threat to the voluntary donor system, should
commercial firms consider establishing panels of paid donors in the UK.
On 22 January 1975 the Minister of State, Dr Owen answered a written parliamentary
question: “I
believe it is vitally important that the National Health Service should become self-
sufficient as soon as practicable in the production of Factor VIII including AHG concentrate.
This will stop us being dependent on imports and make the best-known treatment more
readily available to people suffering from haemophilia. I have, therefore, authorised the
allocation of special finance to boost our own production with the objective of becoming self-
sufficient over the next few years.”
On 25 and 26 February 1975 he again pointed in Parliament to the £500,000 of special
financing which was “to
increase the existing production of Factor VIII”.
In evidence to the
Inquiry, Lord Owen explained that he was motivated by the safety of people with haemophilia
in view of the dangers of hepatitis, and the increased risks from the pool sizes used by
commercial companies.
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By July 1975 the DHSS had set targets for 1977 of plasma from 337,000 blood donations.
“This
is some 20% more than the total of 275,000 recommended by the Expert Group on
Haemophilia but that figure must be regarded as the minimum.”
In January 1976 Dr Ethel Bidwell, director of the PFL, calculated that the need for plasma
would be for between 970,920 and 1,213,650 donations and that the DHSS target (which
would be met 18 months later) would produce only around a third of what was needed.
Roland Moyle, then Minister of Health, reported to Parliament in 1978 that the DHSS goal of
340,000 donations had been met by the middle of 1977 but recognised that the commitment
to self-sufficiency had “not
yet”
been achieved.
The next year there was again an upward shift in estimates of future needs. Current demand
for Factor 8 was probably in the region of 60 million international units though it might
well approach the 100 million international units per annum mark in the near to medium
future. Those figures helped inform planning for the capacity which would be necessary
at a redeveloped BPL. In 1979 Dr Lane considered that a redeveloped BPL could be
commissioned to increase its production capacity to 90 million international units between
1985 and 1990, as an intermediate stage, and then might need to scale up production to
120 million units for the years that followed.
By 1982, planning was eventually under way for a new building to constitute BPL at Elstree.
The approval given by the Treasury in November 1982 for the reconstructed BPL was for a
plant capable of fractionating 400,000 kilograms per annum.
The therapies thought desirable for the treatment of people with bleeding disorders during
the 1970s required larger and larger amounts of factor concentrate. Home therapy was a
significant driver in increasing demand, as well as the improved lifespan and more active
lifestyles of people with bleeding disorders. Operations requiring factor concentrate also
became more common. Unfortunately, the figures used as a basis for Dr Owen’s agreed
expenditure of £500,000 were outdated even before the policy was announced. The DHSS
understood that production facilities needed to be improved and expanded alongside more
plasma being collected.
There needed to be an effective, coordinated approach to achieve self-sufficiency.
This centrally depended on both there being sufficient plasma collected from the regions to
enable sufficient product to be made to meet the growing demands, and the capability of
BPL, given sufficient plasma, to make it into product.
There were a number of ways of achieving an increase in the amount of plasma collected:
• more donations, whether whole blood or plasma from plasmapheresis
• avoiding unnecessary transfusions
• reducing the number of units transfused
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• increasing the use of concentrated red blood cells
• single plasma packs, which improved the quantity and quality of plasma collected
• using a solution (SAG-M) to recover one and a half times as much plasma
from a donation
The chapter examines the problems there were in obtaining a reliable and sufficient supply
of plasma. It concludes that these measures, taken together, would have helped to secure
close to the amount of plasma which BPL on its own could handle when re-developed.
25
Single plasma packs and SAG-M were introduced swiftly once operationally feasible. But
the other measures could and should have been adopted from at least the early 1970s. It
seems that this did not happen because of a misplaced fear that clinicians might view this
as restricting their clinical freedoms.
The principal reason why self-sufficiency was not achieved in England and Wales until the
end of the 1980s was not these difficulties in obtaining a sufficient supply of plasma. It was
that the redeveloped BPL only became fully functional at that point. Until then it lacked the
manufacturing capacity necessary. BPL and PFL could not deliver what was needed because
they had not been designed as production units. It is plain from what Dr Maycock and others
were saying in the first half of the 1970s that a substantial redevelopment was necessary at
BPL. It was on too small a site, and was ill equipped. It was expected that if and when the
Medicines Inspectorate inspected BPL’s premises they would be highly critical – in fact, when
they did so (later than at first expected) in 1979 they effectively condemned it, only allowing
it to continue with the then limited production because it was necessary for national supplies
of concentrate for it to do so. However, this necessitated remedial work which diverted
funds, and caused some delay to the process of starting redevelopment. Government did
not give sufficient thought to planning to meet the future needs of haemophilia therapy in
England, Wales and Northern Ireland (this did happen in Scotland).
The delays between 1978 when planning began towards a redeveloped BPL and 1982
when a decision in principle was made to do it was some four years; and that between
April 1979, when the Medicines Inspectorate condemned the BPL premises as unsuitable
for a pharmaceutical company, and the middle of May 1983, when construction began,
was just over four years. Dr Walford was right to describe the delays as “unconscionable”.
A decision to plan in earnest for redevelopment should have been made no later than the
end of 1976, when it was already known that the BPL premises simply could not produce
enough products to meet the government’s, clinicians’ and patients’ requirements. A full
account of these delays is set out in the chapter.
The failure to make full use of the PFC in Edinburgh to meet UK problems in achieving self-
sufficiency contributed significantly to the problems with supply.
25
ie when its manufacturing capacity allowed it to cope with greater supplies of plasma.
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Immediately after the Second World War it had been decided that there should be two
production units in the UK – one in the south, and one in the north (Edinburgh) – to provide
sufficient production of blood products for the whole country. Factor concentrates were not
then in contemplation.
Over time, it became clear that these units (and PFL) would need to develop capacity for
making factor concentrates, along with immunoglubulins and albumin as they had before.
They were ill suited for this.
In Scotland, Dr Robert Cummings advocated forward planning. As a result, in 1965 the
Ministry of Health agreed with the SHHD that PFC would fractionate what was needed for
Scotland, and would supply at least one third of England’s needs as well, using plasma
collected by Newcastle, Leeds, Manchester and Liverpool to do so.
In December 1968, in light of the financial pressures, the SHHD sought a contribution from
the DHSS for the capital cost of a new Edinburgh plant The DHSS eventually invested
£400,000 towards the capital costs of PFC, which would amount to somewhere between a
quarter and a third of the costs as then estimated.
In March 1969, in line with the approach thus far, Dr Maycock indicated that he expected
one third of the plasma from England would be processed at Liberton.
Construction began in 1971. It continued until 1974. PFC then progressively, though slowly,
came on stream.
The financial commitment from the DHSS showed the intent that BPL, PFC and PFL together
should supply the blood products needed for the whole UK. Throughout the early 1970s it
was said repeatedly at meetings of various committees that PFC and BPL should together
serve the whole UK. The commercial viability of PFC, as designed in accord with this plan,
depended to some extent on fractionating plasma from England, and a small amount of
English plasma was supplied to it. Despite this, the position changed when Dr Lane took over
from Dr Maycock as director of BPL in 1979, having been director designate in 1977. From
then, the BPL and PFC were seen as primarily serving England and Scotland separately,
rather than the joint interests of both. Dr Lane saw PFC as a rival, bidding for funds that
were needed to renew BPL, rather than as a partner in an enterprise to ensure UK-wide
self-sufficiency. He was sceptical about the abilities of PFC to manufacture products in the
quantities claimed. Though some attempts were made in 1980 and 1981 to see whether
Scotland could (as it was said in Scotland that it could) still make a contribution, in the event
the plans which had been developed, and funded, in the mid 1960s envisaging two equal
units of production were no longer pursued.
The delays in taking a decision to rebuild BPL were indeed “unconscionable” – and
allowing that delay during the years from 1978 until 1982, all the while offering more risky
commercial products, was a disgrace. The consequences of the missed opportunities was
that commercial concentrates carrying HIV virus, as well as non-A non-B Hepatitis, were
supplied in greater quantities to patients in England, Wales and Northern Ireland than would
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otherwise have been the case. This lasted until the late 1980s (in relation to Hepatitis C) as
the UK, with the exception of Scotland, was still not self-sufficient.
It is highly likely that if self-sufficiency had been achieved significantly earlier there would
have been less infection, in particular with HIV.
Overall, the DHSS bears a greater part of responsibility for the failures to achieve self-
sufficiency. Ministerial indecision contributed to delay in the late 1970s and early 1980s,
but (so far as can now be determined given that many of the submissions to ministers are
no longer available) ministers may have been inadequately briefed. The documents that
have survived suggest that ministers were not consulted about the decision to abandon the
UK-wide approach. However, ministers also bear some responsibility for the systems that
contributed to the delays.
3.14 Viral Inactivation
This chapter’s primary focus is on the question of whether viral inactivation could have been
achieved earlier than it was. It decides that this could reasonably have been achieved: if
research had been encouraged and funded adequately by central government no later than
the mid 1970s, as should have happened, it is reasonable to conclude that a heat-treated
product likely to reduce the risk of hepatitis would have been available no later than 1980/81,
and quite possibly earlier. It also considers other issues relevant to viral inactivation, including
the events which led to the withdrawal of Armour’s heat-treated Factorate in October 1986.
Before 1970, it was known that hepatitis transmitted by blood or blood products was caused
by a virus, and that that virus (or those viruses) might be inactivated by one of a number of
means. Among those means was the possibility that heat might inactivate the virus, another
possibility was that solvent detergents could be used to destroy the lipid coating and render
such a virus inactive. It was known that some possibilities could be discounted: in 1950
attempts to inactivate serum hepatitis by irradiation with UV light had failed. Throughout the
1970s a number of attempts were made to inactivate hepatitis. Not all involved heat.
There is no evidence that research into viral inactivation or removal occurred at the BPL or
PFL in the early to mid 1970s. Conversely, Dr Peter Foster was appointed as head of the
R&D Department at the PFC in April 1974 where he found that research was underway
there to find a means of physically removing Hepatitis B virus from factor products.
By 1978 three companies (Behringwerke, Hyland, and Cutter) were actively engaged in
what was seen as promising research into heat treating factor products to inactivate hepatitis
viruses. Whereas Behringwerke used a “wet heat” approach, akin to pasteurisation, Cutter
and Hyland both used dry heat, applying the heat to a product which had already been
freeze-dried. Behringwerke presented its process to the medical public at the International
Haemophilia Conference in Bonn. Dr Cash returned from that conference and told Dr Foster
who had previously thought it “inconceivable” that heat could be used to inactivate a virus in
Factor 8 or Factor 9 due to the vulnerability of the proteins. Dr Foster, and other fractionators,
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believed those proteins so vulnerable to heat that their coagulation activity could not be
preserved. Yet within about three years, PFC had also developed a method of heat treating
factor concentrate.
By the early 1980s, other major pharmaceutical companies had begun to prepare both wet
and dry heated factor concentrates for active marketing. Dr Lane, director of BPL, recorded
that no work to research heat treatment was done by BPL during 1981. On 27 February
1981 Dr James Smith proposed to Dr Lane some first outline proposals for programmes to
research tackling the transmission of viruses by coagulation factor concentrates. Dr Lane
reported to the Scientific and Technical Committee of the Central Blood Laboratories Authority
(“CBLA”) during the next month that “a
research project into the development of coagulation
factor concentrates with reduced risk of hepatitis transmission, was an appropriate case
for central funding.”
BPL’s work on heat treatment only really started in 1982, and was in
relation to Factor 9 only.
From mid 1982 onwards the risk that people with haemophilia treated with blood products
might suffer AIDS (in addition to the risks they had of contracting hepatitis) became more
apparent. There was some encouragement for the potential of heat treatment in Factor 8
in the journal
Transfusion
in late 1982, though this was focused on hepatitis, not on the
suspected viral cause of AIDS.
At the end of 1982, Dr Walford wrote a minute flagging that Travenol (Hyland) were planning
a symposium in early 1983 to launch a reduced hepatitis risk product. A handwritten note
from Stanley Godfrey of the DHSS indicates there was concern as to whether doctors might
insist on using such a “hepatitis-free” product at great cost and would “turn
away from the
BPL product”.
He also expressed his concern that should BPL obtain the technology on
licence the yield would reduce and “Goodness
knows what size factory we’d need!”
BPL began working on heat-treated Factor 8 at the start of 1983. In July 1984 BPL started
intensive development of what was to become 8Y and by autumn it was shown that heat
treatment appeared to inactivate the HTLV-3 virus which had by then been identified as
the cause of AIDS. The purpose of introducing heat treatment was to eliminate or reduce
hepatitis, although it was recognised that the heat might destroy other viruses too. It was
speculated that heat treatment might reduce or eliminate AIDS if the cause was viral. Some
haemophilia centre clinicians had started to use heat-treated concentrates for their patients
by mid 1984 in this hope.
In September 1984
The Lancet
published an article which in its summary said that the findings
reported in it “support
the possible role of retroviruses in AIDS, and indicate that factor VIII
concentrates must be heated to inactivate these infectious viruses.”
In early November, it
was reported to the annual symposium about blood transfusion in Groningen that heating at
68ºC for 24 hours inactivated HIV. Internationally, there was a move to abandon the use of
factor concentrate products which had not been heat treated.
Dr Lane had written to Dr Edmund Harris at the DHSS to notify him of his plan to dry heat all
the Factor 8 to be produced “on
the empirical basis that it has a satisfactory process efficacy
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for inactivation of HTLV-III”.
Dr Harris did not agree immediately and responded by asking
Dr Lane to refer his plan to an advisory group to consider if the evidence for inactivation of
HTLV-3 by heat was “sufficient
to warrant”
taking such a step, “particularly
if a screening
test can be made available.”
Dr Lane did not wait for the meeting to which Dr Harris had
referred the issue. Although on 13 November 1984 his team gave him a “very
provisional”
date of 1 April 1985 for the implementation of heat treatment, and said it was “impossible
to
judge its feasibility”,
by 19 November the CBLA was announcing that they planned to heat
all Factor 8 manufactured at BPL/PFL from April 1985.
Later that November the NBTS Working Group on AIDS met. Scotland had started to heat
Factor 8 stocks to inactivate HTLV-3. Considering heat treatment more broadly, the meeting
report said: “although
there is not yet the evidence to guarantee that this is satisfactory; the
view was nevertheless unanimous that it should be done. This should be in addition to using
a screening test when available … Some expressed the view that we should stop the import
of Factor VIII not heat treated.”
By the start of 1985 Scotland was self-sufficient in heat-treated Factor 8 product. It had been
tested successfully in Edinburgh, and a continuous supply would be provided in sufficient
quantities to enable non heat-treated product to be recalled. Scotland was later described
as the first country to be self-sufficient in Factor 8 heated to eliminate a risk of AIDS, and
only heat-treated product capable of eliminating HTLV-3/HIV was issued from 10 December
1984. This product did not, however, prevent the transmission of hepatitis (that took over
another two years).
By early May 1985 all Factor 8 concentrate issued by BPL had been heat treated. There
was no recall of unheated stocks of domestic product in England and Wales, as had been
done in Scotland. One reason may be that BPL in 1984 was not in a position to produce
heat-treated product more quickly. Dr Terence Snape also commented that “At
the time, the
unheated UK product was still considered to be ‘a product of choice’ by many physicians
and the product was not withdrawn … Some UK haemophilia specialists took the decision
to continue to use unheated NHS concentrate, in preference to heated (US) commercial
concentrate, until such time as 8Y was readily available.”
It was not until Dr Harris wrote to
all haemophilia centre directors on 15 August 1985 to confirm availability of heated Factor 8
concentrates from various sources and advised “There
would thus appear to be no longer
any need to use un-heat-treated Factor VIII concentrate”
that there was a definitive DHSS
response to the threat to patient safety from the use of unheated product.
Some clinicians were reluctant to embrace commercial heat-treated products. There was as
yet little direct evidence of how reliable the claims about commercial heat-treated products
were in practice. Although there was no evidence of side-effects after a year of use in the
US, heat-treated commercial products were not licensed for use in the UK until early in
1985. It is not difficult to see why clinicians may have preferred to wait for domestic product
rather than change their treatment practices. Further, commercial products were believed to
be more likely to carry hepatitis than domestic ones. Understandable though this reluctance
may have been, it did not excuse continued use of unheated products beyond a short period
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into 1985. Nor was it, ethically, the clinician’s choice. Patients should have been alerted to
the balance of risks and advantages, and given information about other treatment options to
make that decision. Yet the evidence is clear that, in the main, this did not happen.
The failure to recall stocks of unheated Factor 8 product, at least by the start of the next
financial year (after 31 March 1985) cannot be justified. By that time commercial heat-treated
product was licensed, and it was obvious that supplying unheated product was taking an
unjustified risk with the safety of any patient.
The UK was self-sufficient in Factor 9 for the treatment of Haemophilia B. Heat-treated
Factor 9 was issued routinely from the beginning of October 1985, and any stocks of the
unheated DEFIX (Scotland) and Factor 9 (England) were recalled and destroyed.
Could and should heat-treated products have come sooner in the UK? The answer the
chapter gives is “yes”. Pharmaceutical companies, working independently of one another,
all began actively to develop heat treatment to inactivate viruses at about the same time
in the late 1970s, when there was more pressure to improve market share. Research into
viral inactivation to protect recipients of blood products should have been encouraged, and
funded adequately, by government no later than the mid 1970s. If this had happened, it
is reasonable to conclude that a heat-treated product likely to reduce the risk of hepatitis
would have been available no later than 1980/81, and quite possibly earlier. And if this had
happened – albeit by chance – the risk that any recipient would have suffered HIV infection
would have been reduced almost to extinction.
Factorate
The chapter considers the handling by Armour Pharmaceutical Company Limited (“Armour”)
and by the Licensing Authority of developing concerns regarding the safety of heat-treated
Factorate. The full chronology of events is not repeated here. In summary, however, the
behaviour of Armour gives rise to a number of concerns. Armour did not report the possible
seroconversion in Lewisham to the DHSS until February 1986, despite being aware of
it since July 1985. Its letter of 3 October 1985 to the DHSS was potentially misleading
in its omission of reference to that case. Armour did not, as far as the contemporaneous
documentation suggests, bring Dr Prince’s concerns about the effectiveness of its heat
treatment process to the attention of the DHSS: it could have communicated those concerns
whilst also drawing attention to the conflicting results obtained by others. Armour confirmed
to the DHSS that all product now being supplied to the UK was from donors who had been
individually tested, but there remained in stock product from unscreened donors that Armour
was apparently open to supplying. Armour did not voluntarily withdraw all such material, as
it should have done in the interests of ensuring patient safety. The letter sent by Armour to
haemophilia centre directors in March 1986 was misleading by omission in the absence of
any reference to the Lewisham patient. When in July 1986 Armour finally wrote to directors
recommending the return of all non-donor tested Factorate, it did so having effectively had
its hand forced by the decisions of its parent company in the US. The contemporaneous
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documentation supports an inference that patient safety was not accorded the weight that it
should have had during this sequence of events.
The conduct of the regulatory authority from February 1986 was also wanting. It did not
take any regulatory step to ban or secure the withdrawal of the product until October 1986
when it did belatedly achieve a withdrawal by Armour. It is surprising, and disappointing,
that Armour were not asked to recall all the stocks which had been distributed and came
from untested source plasma. Although the issue came promptly to the attention of the
CSM(B), its decision, subsequently endorsed by the CSM, that there was insufficient
evidence for action to be taken failed to place safety at the centre of decision-making. The
Expert Advisory Group on AIDS (“EAGA”)’s agreed statement in March 1986 went even
further, concluding that there was “no
evidence”
that HIV had been transmitted in heat-
treated concentrates and thus ignoring the Lewisham case. It took the report from Dr Hill in
Birmingham of further seroconversions for the DHSS to act. Whilst action then was prompt,
it should not have taken that report to push the licensing authority into action. It is further
surprising and disappointing to note that the CMO’s immediate response to Dr Peter Jones’
actions in February 1986 (when he broadcast his concerns about seroconversions at a
conference on AIDS) was to condemn them, at a point in time when the CMO could not have
known whether Dr Jones’ claims were capable of substantiation or not, and that a DHSS
spokeswoman felt able to say that the Netherlands case could be discounted, when the
DHSS could not have known at that time whether or not the Netherlands case was one of
seroconversion caused by Factorate. These responses, and those of the CSM(B), CSM and
EAGA, are unhappily redolent of the “no
conclusive proof”
line that had been erroneously
adopted by the DHSS in 1983.
3.15 Pool Sizes
This chapter looks at one of the two most significant matters which determine whether
plasma or a blood product made from plasma may transmit infection: the number of donors
whose donations have contributed to the pool from which it is drawn. The chapter shows
that – alarmingly – those responsible for the administration of blood products in the UK
knew the risks, took little notice, and presided over an increase in the risk to levels which
were more than 300 times higher than they had been at the start of the 1970s.
The need for caution with regard to pool sizes, and the importance of restricting their size,
was recognised in the 1940s in the UK, and by 1951 the use of large pool plasma had been
abandoned. In 1952 the WHO’s Expert Committee on Hepatitis recommended control of
pool size amongst other methods of reducing the spread of serum hepatitis.
In 1967 pressure grew for an increase in pool sizes. Dr Rosemary Biggs wrote to the MRC
referring to a conversation with Dr Maycock, to say that he “also
thought that we should
probably consider the question of serum hepatitis and, in view of the American activities,
whether or not it would be reasonable to increase the pool size for fractionation.”
By
contrast, in early 1968 Dr Cumming at Edinburgh briefed Dr Maycock that the expanded
blood products unit would use a pool of 8 litres, equivalent to approximately 40 donors.
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At the end of the 1960s and start of the 1970s Factor 8 and Factor 9 were being made at
the PFL in Oxford. In 1971 the mean pool size for Factor 8 was 192 donations. Larger pools
were used for Factor 9, with 300 donations in 1971. Thus, at the start of the 1970s, so far as
NHS plasma was concerned, pool sizes were larger than had been accepted in and since
the early 1950s, but were still relatively small in scale compared to what was yet to come,
and compared to those in use in the US.
In March 1973 PFC began planning to produce high purity Factor 8 concentrates, with a
planned production capacity of one pool of 200 litres per week, and by June 1973 BPL had
plans to move to a pool size of 250 litres (around 1,250 donations). There was no discussion
in advance about the increased viral risks from increasing pool sizes but those risks were
nonetheless widely appreciated.
In 1975 Dr John Craske reported on the Bournemouth hepatitis outbreak, and the risk of
using large pool concentrates: “The
risk is greatly increased with factor-VIII concentrates
prepared from pools of more than a thousand donations.”
By 1977 the pools used to make
NHS concentrates at BPL contained 2,000 donations. That increased to 5,000 donations
by September 1980, 7,500 donations by 1983, and it was 10,000 in March 1985. It follows
that the pools used to manufacture Factor 8 concentrate in 1983 could be almost 40 times
as large as the number of donations used to treat patients at Oxford in 1971. Whilst these
calculations are estimates based on the available data, and cannot be relied on for precise
accuracy, the true figure will be close to the estimate.
There is no evidence of high level discussions in the DHSS about the size of pools or that
ministers, or the CMO, were alerted to the dramatic increase. It is unlikely that this was not
known to the CMO’s consultant advisers on blood transfusion (Dr Maycock, succeeded by
Dr Tovey, and then by Dr Gunson), and they should have alerted the CMO.
In 1980, at an international symposium on hepatitis from blood products, Professor Manucci
pointed out that strict adherence to the “small
pool concept”
in Sweden had given rise
to “a
very low incidence”
of post-transfusion hepatitis in people with Haemophilia B. He
suggested that the adoption of this concept would be “a
significant step forward in the
prevention of posttransfusion hepatitis and liver disease in hemophiliacs.”
The Council of
Europe’s Committee of Ministers recommended in April 1980 that blood collection agencies
and pharmaceutical companies should provide detailed information about blood and blood
related products, including the nature of the donor pool from which the products were made.
The evidence establishes that Dr Lane, and Dr Maycock before him, were aware that
increasing the pool size increased the risk of hepatitis transmission but decided to do so
nonetheless. It establishes that clinicians too knew of the increasing risk with increasing
pool sizes. But it does not show clear evidence, despite these various events, that the
DHSS saw the issue of pool sizes as one on which it should take some action.
There is less data available to determine pool sizes in Scotland but contemporaneous
documents suggest pool sizes ranging from a minimum of 800 donations to 2,200. This had
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increased by 1984: 4,000 donors appear to have contributed to the implicated batch of PFC
product identified as having infected Edinburgh patients with HTLV-3.
Pool sizes mattered. Some claims have been made that they did not matter much, because
people with bleeding disorders required frequent treatment, and so – whether cryoprecipitate
or factor concentrates were used – they would suffer in any event. Non-A non-B Hepatitis
could not be screened out until 1989: so there was simply no way of knowing for sure if any
treatment was or was not infective so far as that was concerned.
This argument ignores a number of points. First, it does not apply to people who were
infrequently treated. Second, people receiving frequent treatment would be exposed to a
much greater extent to multiple viruses, some of which might not yet be identifiable but
were nonetheless potentially threatening. Third, it significantly increased the risk of new
viruses taking a hold (as was shown with HIV). Fourth, single donor cryoprecipitate was
recommended for children and the newly diagnosed to avoid the risks of hepatitis, precisely
to avoid the risks of infection. Fifth, the claim of inevitable infection would suggest that
commercial concentrates were no worse than NHS concentrates or cryoprecipitate: yet the
weight of the evidence shows that this is not so.
If there is an acknowledged risk that treating a patient with a single donation product might
transmit hepatitis, why should that risk then be increased multiple times on every occasion
the patient needs treatment? If cryoprecipitate or small pool fractions had been more widely
available, it is probable that the same extent of infection would not have occurred.
Product labels used at PFL and BPL contained statements as to the maximum pool size (eg
“Less
than 7,500 plasma donations were used in the preparation of this batch”),
and some
indication as to risk (“The
preparation is of human origin and cannot be assumed to be free
of hepatitis virus”).
There was no warning as to the risk specifically of AIDS until late 1985,
and then on vials of 8Y, a product which was heat-treated. By 1987 the reference to donor
numbers had been removed from the label.
In Scotland in 1978 there was a warning for Factor 8 that “Product
may carry the risks of
transmitting serum hepatitis”;
and for Factor 9 that “none
of these tests are of sufficient
sensitivity to eliminate the possibility of transmitting hepatitis ... the risk of transmission
cannot be disregarded.”
In 1984 the vial labels stated that “This
preparation is of human
origin and cannot be assumed free of hepatitis virus”
(for unheated Factor 8 concentrate);
and the same wording was used for unheated Factor 9 concentrate. By 1985 it was “The
freeze dried product has been heat treated but cannot be assumed to be non-infective”
(for
heat-treated Factor 8 concentrate with the label dated 1985). Nothing was said about AIDS
or HIV specifically.
The purpose of warnings is to communicate that there is a risk to those who need to know of
it. A proper approach by manufacturers to risk – that is, they should alert professional users
and patients to risks of which they are aware once there is enough material to show that
there is such a risk – is one aspect of a system which has three points at which notice of a
risk may be given: by the manufacturer, by the regulator, by the prescribing clinician. The
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system should ensure that the patient is properly informed of the risk. It cannot achieve this
if the manufacturer does not say sufficient about the risk but leaves that to the regulator or
clinician, if the regulator in turn does not require a full account of the risks or prevents the
manufacturer from talking of risk because it looks for certainty, and if the clinician leaves it to
the manufacturer (or regulator) to reveal the risk. What could be a “triple fail-safe” in effect
becomes instead a system in which each part leaves the matter to the other. In the case of
BPL/PFC the same failings of product labelling were evident as they were in respect of the
labelling and product warnings given in respect of commercial concentrates.
Volume 4 What happened and why?
This volume has four chapters, which at 4.1 considers the response of the government to
risk; at 4.2 examines haemophilia centres, their policies and practice (those interested in
Treloar’s should look at chapter 2.2); at 4.3 looks at pharmaceutical companies; and at 4.4
the Haemophilia Society.
4.1 Role of Government: Response to Risk
It was the responsibility of the DHSS, and of the Secretary of State for Health, and of those in
positions of equivalent responsibility in Scotland, Wales and Northern Ireland, to ensure, as
much as possible, that treatment given through the NHS was safe. This chapter examines
in detail the extent to which this responsibility was satisfactorily discharged and concludes
that government failed to discharge its fundamental duty to ensure the safety of the public
so far as recipients of blood and blood products were concerned. What is set out below is
no more than a summary of the key facts and issues which are examined in greater depth
in the chapter.
Knowledge of risk of infection from blood and blood products
By the early 1970s it was well known among the responsible government officials that
treatment with blood and blood products carried a risk of transmission of viral hepatitis.
The seriousness of Hepatitis B was well understood. Nobody who received the minute from
Dr Walford in September 1980 stating that NANBH could potentially lead to severe chronic
disease could have been under any illusion about that. However, the DHSS did nothing to
ensure that the serious nature of this condition was also properly understood by doctors,
representative bodies (such as the Haemophilia Society) or the public.
Collection of blood from prisons
Both the DHSS and the SHHD knew from the early 1970s that the collection of blood from
prisons and similar institutions led to an increased risk of transmission of Hepatitis B. Despite
this indication that prison donation might not be safe, blood collection from prisons was a
common practice in the UK throughout the 1970s and early 1980s.
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In May 1975 a “Dear Doctor” letter from the CMO, Sir Henry Yellowlees, advised that
collections could continue, despite the higher risk of Hepatitis B. This letter, which relied
on the fact that there were other high risk groups such as drug users as a reason to
continue to collect from prisons, contained deeply flawed logic and effectively endorsed and
encouraged this practice. The hands off approach of the DHSS and SHHD, leaving blood
safety entirely to the judgement of local RTDs, was wholly unacceptable. It should have
been taken seriously by government and was not. It was also wrong not to bring the issue
of prison donation to the attention of ministers. It was not raised with a Scottish minister until
May 1983; it was never raised with ministers in the DHSS.
Response to AIDS July 1982-April 1983
On 16 July 1982 – the same date as the MMWR carried a report of AIDS in three haemophilia
patients in the US – the possibility of AIDS being transmitted through blood was explicitly
drawn to the attention of civil servants within the DHSS by Dr Harold Gunson. This led to
an exchange of memos by civil servants in July. Beyond this, however, there is no evidence
of there being, over the next few months, within the DHSS, any documented discussions
or planning or any consideration of what steps might need to be taken with regard to the
safety of blood or blood products in light of this grave new threat. Indeed, other than this
exchange of memos, there is no record of discussions about AIDS and blood within the
DHSS between 16 July 1982 and the end of 1982.
It would have been clear from a paper prepared by Dr Craske in November 1982, which was
copied to Dr Mary Sibellas of the DHSS, that he considered an infectious agent to be the
most likely cause of AIDS.
At the CBLA’s first meeting in December 1982, attended by the Deputy CMO and civil
servants from the DHSS, there was no discussion about AIDS. Nor was there any such
discussion at the meeting of the Advisory Committee on the NBTS which met at the DHSS
under the chairmanship of the Deputy CMO on 10 January 1983, or at the CBLA’s meeting
on 26 January 1983. There was a brief discussion about AIDS at the CBLA’s meetings on
23 March and 27 April but with no action identified for the DHSS to take.
Dr Walford told the Inquiry that by the beginning of 1983 she understood it was likely that
AIDS was transmissible through blood and blood products. She thought that the San
Francisco baby case was “a
sort of watershed”
and “rang
all sorts of alarm bells.”
She
thought that gradually the feeling within the DHSS was that it was “looking
more and more
likely that blood and blood products are certainly capable of transmitting this agent”.
Dr Walford believed at the time, as did others in the DHSS, that the hazards of transmission
were unproven and that people with severe haemophilia desperately needed factor
concentrates. This was wrong – and not just with hindsight. The hazards of AIDS may have
been “unproven”, and the extent of the risk at that stage unclear, but it was clear that there
was a risk and that the consequences of infection were grave and this should have weighed
more heavily in the balance. As for the desperate need for concentrates, the DHSS did not
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sufficiently understand the availability of alternative treatment strategies, and over-inflated
the risks to people with bleeding disorders of not having factor concentrates available to
them for treatment.
There is no evidence, in the period up to May 1983, of any issues relating to AIDS and blood
being brought to the attention of the Secretary of State or other ministers.
May-June 1983
It was not until May 1983 that there was within the DHSS any real focus on how best to
respond to the risks of AIDS from blood or blood products and that was as a response
to press reporting, which led to a briefing note and line to take being prepared for the
Prime Minister.
On 6 May 1983 Dr Spence Galbraith of CDSC telephoned Dr Sibellas at the DHSS to
report that the Cardiff patient had the right symptoms and signs for a diagnosis of AIDS,
and to flag up the three cases in Spain. He asked that the DHSS “consider
the matter as
a priority – and asks that any top level meeting should include CDSC”.
On 9 May he wrote
to Dr Ian Field at the DHSS. He referred to the Cardiff patient and probable cases of AIDS
in people with haemophilia in Spain and the US, attached a paper outlining his reasoning,
and said: “I
have reviewed the literature and come to the conclusion that all blood products
made from blood donated in the USA after 1978 should be withdrawn from use until the risk
of AIDS transmission by those products has been clarified.”
Dr Galbraith’s reasoning was impeccable. His views deserved to be given great weight
and circulated widely. Unfortunately, that did not happen. His paper was the subject of
internal comment by Dr Walford but was not acted on or shared more widely. The DHSS
did not share the letter with CSM(B) or the CSM, as it should have. It was not circulated
to haemophilia centre directors or to RTDs, to allow a fully informed and comprehensive
debate and discussion. It was not brought to the attention of ministers, or to the CMO. The
DHSS’s response to it was inadequate.
In dismissing, or at least ignoring, Dr Galbraith’s position, the whole issue of concentrate use
was seen as an all or nothing scenario of either continuing with the status quo or providing
people with haemophilia with no treatment at all. That was the wrong way to look at it:
there were other ways in which people with haemophilia could receive treatment which were
not considered.
An internal DHSS meeting to consider AIDS took place on 3 June 1983, at which there was
no discussion whatsoever of Dr Galbraith’s letter and paper, nor any discussion about any
different approaches to the treatment of bleeding disorders. This reflected the departmental
position that, having regard to the principle of clinical freedom, it was not the role of the
DHSS to provide guidance or advice to clinicians. This was a short-sighted position for the
DHSS to adopt and ultimately a dereliction of its responsibility to patients.
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Council of Europe recommendations
In June 1983, the Council of Europe’s Committee of Ministers published a resolution which
was addressed to the governments of member states. Its overarching recommendation
was “to
take all necessary steps and measures with respect to”
AIDS. The first detailed
recommendation was “to
avoid wherever possible the use of coagulation factor products
prepared from large plasma pools; this is especially important for those countries where self-
sufficiency in the production of such products has not yet been achieved”.
The government
took no steps in response to this recommendation.
The second recommendation was to tell clinicians and patients about the risks of treatment
with blood and blood products and the possibilities of minimising the risks. The UK
government took no steps in response to this recommendation. Dr Walford’s explanation
was that this would not be a usual course of action for the DHSS. But this was a situation
in which there was a very real risk that the very treatment being provided by the NHS – for
which the DHSS bore ultimate responsibility – would directly transmit to patients a fatal,
untreatable and new viral disease. Whatever the normal approach of the DHSS, this was a
different situation, and one in which there was a culpable failure to act.
The last specific recommendation was “to
provide all blood donors with information on the
Acquired Immune Deficiency Syndrome so that those in risk groups will refrain from donating”.
Action was taken on this, with leaflets being produced for donors, although too slowly.
Reversion to cryoprecipitate, alternative approaches to treatment and guidance to
doctors and patients
The DHSS did not seriously consider alternatives to treatment with imported concentrates,
such as a temporary increase in use of cryoprecipitate. It relied on Dr Gunson, who said
this was not feasible, and Dr Lane who said it was not possible to produce small pool freeze
dried cryoprecipitate. The issue was not, however, explored with the RTCs. The DHSS did
not regard it as its role to issue any kind of advice or guidance or steer to clinicians advising,
or even simply encouraging, them to consider alternative approaches to treatment. It was
a failing on the part of the DHSS not to take such measures, particularly as they did so in
other cases. In September 1982 the Secretary of State for Health, Norman Fowler, issued
a statement about whooping cough. That statement gave information about the numbers
of cases; the importance of immunisation; the risks of the disease and the benefits of
vaccination in reducing that risk. The DHSS believed this campaign saved lives.
In September 1983 it was known to the DHSS that a patient with haemophilia had died from
AIDS. It was also known that some of the commercial Factor 8 concentrate from the batches
administered to the patient in Bristol who had died had found their way to hospitals which
were not haemophilia centres. This fact should have – but did not (or, if it did, no action was
taken) – alerted the DHSS to the fact that, given that some people with haemophilia were
treated elsewhere than at haemophilia centres, those treating them might have a limited
understanding of the risks of treatment. Neither the CMO nor the DHSS could have made
any assumptions about the state of knowledge of those hospitals. This risk should have
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been an impetus to the dissemination of information, whether by the CMO or the DHSS
directly, but did not lead to any action.
No conclusive proof
Press coverage early in May 1983 led to officials providing briefing for Prime Minister’s
Questions on AIDS. The first use of “no
conclusive proof”
appears in a line to take drafted
for the Prime Minister: “It
is important to put this in perspective: there is as yet no conclusive
proof that AIDS has been transmitted from American blood products.”
The accompanying
briefing note included the sentence: “As
yet there is no conclusive proof that AIDS is
transmitted by blood as well as by homosexual contact but the evidence is suggestive that
this is likely to be the case.”
The line was used on 31 May 1983 in a letter from Lord David Trefgarne to Nicholas Baker
MP which stated: “I
can well appreciate the anxiety, particularly amongst haemophiliacs and
their families, which recent press reports on AIDS may have caused and would first of all
like to put matters into perspective: the cause of AIDS is as yet unknown and there is no
conclusive proof that the disease has been transmitted by American blood products.”
Lord
Trefgarne did not know why the caveat in the briefing note (“but
the evidence is suggestive
that this is likely to be the case”)
had been omitted from the letter drafted for him by officials.
On 1 July 1983 a paper sent to Lord Simon Glenarthur referred to “increasing
evidence
that AIDS may be transmitted by the transfusion of blood … Blood products … may also
transmit AIDS and haemophiliacs are at particular risk ... It is believed that there may be
under-reporting of cases … Although there is no conclusive evidence, it seems very likely
that AIDS is caused by an as yet unidentified virus.”
On 14 July 1983 the “no
conclusive proof”
line was used in Parliament: Lord Glenarthur
stated that “Although
there is no conclusive evidence that AIDS is transmitted by blood
or blood products, the department is considering the publication of a leaflet indicating the
circumstances in which blood donations should be avoided.”
26
In the course of the debate,
Baroness Susan Masham posed a question to which Lord Glenarthur said he would
“find
out and let her know.”
Dr Walford’s proposed draft response to Baroness Masham
included the following: “There
is no conclusive proof that AIDS can be transmitted by blood,
cryoprecipitate or Factor VIII concentrates but the assumption is that such transmission
may be possible.”
The letter then sent to Baroness Masham stated that “There
is, in fact,
no conclusive proof that AIDS can be transmitted by blood, cryoprecipitate or Factor VIII
concentrates.”
The qualifying phrase (“but
the assumption is that such transmission may be
possible”)
in Dr Walford’s original draft had been dropped.
26
It is an essential part of the narrative of the Report to describe, where relevant, statements made
in Parliament: see, by way of further example, the chapter on
Lines to Take.
If (which has not been
authoritatively determined) parliamentary privilege as set out in Article 9 of the Bill of Rights applies
to the proceedings of the Inquiry (see further Note from Counsel to the Inquiry on Parliamentary
Privilege 11 January 2023 INQY0000432) it does not breach parliamentary privilege for the Report to
describe what was said to Parliament as part of its account of, and findings about, decision-making
and policy-making.
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On 25 August 1983 Lord Glenarthur wrote to Nicholas Baker, providing information about
the monitoring of AIDS cases by CDSC; his letter ended “Finally,
I would like to stress that
there is as yet no proof that AIDS is transmitted by blood or blood products.”
On 26 August 1983 Lord Glenarthur wrote to Clive Jenkins, the general secretary of the
Association of Scientific Technical and Managerial Staffs. His letter read: “I
think that
I should emphasise, firstly, that there is no conclusive evidence that AIDS is transmitted
through blood products.”
It continued “Nevertheless
we are taking all practicable measures
to reduce any possible risks to recipients of blood and blood products.”
On 1 September 1983 the publication of the AIDS donor leaflet was announced with a press
release in which Kenneth Clarke said “It
has been suggested that AIDS may be transmitted
in blood or blood products. There is no conclusive proof that this is so.”
This line was picked
up and repeated in press reports.
At the 17 October 1983 meeting of the Advisory Committee on the NBTS the minutes record
a contribution from Dr Walford that “Although
there was as yet no conclusive proof of a link
between AIDS and blood products the Department had, in conjunction with RTDs produced
a leaflet aimed at reducing the risk of transmission of AIDS by blood donation.”
A newspaper report of the death of the patient in Bristol prompted a civil servant to ask
Dr Walford on 23 November “is
it Ok for me to continue to say
‘there
is no conclusive proof
that the disease has been transmitted by American blood products’”,
to which Dr Walford
replied “Yes
it is ok”.
On 14 November 1983 Kenneth Clarke told Parliament that “There
is no conclusive evidence
that acquired immune deficiency syndrome (AIDS) is transmitted by blood products.”
On 16 November 1983 Lord Glenarthur wrote to Jerry Wiggin MP. The letter read “I
can
well appreciate the anxiety, particularly amongst haemophiliacs and their families which
recent press reports on AIDS may have caused and would first of all like to put matters into
perspective: the cause of AIDS is as yet unknown and there is no conclusive proof that the
disease has been transmitted by American blood products.”
Forwarding the letter to his
constituent, Jerry Wiggin expressed the hope that “Lord
Glenarthur’s reply will reassure
you on the Government’s stand on this issue”.
The same line appeared in a letter dated
16 December 1983 from Lord Glenarthur to John Maples MP.
A handwritten note on 26 March 1984 stated that “We
dropped ‘there is no conclusive
proof that AIDS is transmitted through blood or blood products’ from our standard line
some time ago.”
This line to take, whilst technically correct, was indefensible. It did not spell out the real
risk. It gave false reassurance. It lacked candour and by not telling the whole truth was
misleading. It was not an accurate reflection of the DHSS’ actual understanding, which was
that it was likely that AIDS was transmitted through blood and blood products. No minister
challenged the “no
conclusive proof”
line. They should have done. Far from seeking to
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reassure those taking blood or blood products that doing so came without significant risk,
the authorities ought to have been emphasising that there were indeed risks.
The AIDS leaflet
Until a screening test was available, the only way to reduce the risk of AIDS transmission
in the domestic blood supply was to ensure, as far as possible, that donors most likely to
transmit the virus did not donate. Given that the risk of transmission of AIDS through blood
or blood products was known by the DHSS since mid 1982, it took far too long until the
production of a leaflet was first discussed in May 1983. Though rightly described as urgent
within the DHSS, it then took too long for the leaflet to be finalised and made available to
regional transfusion centres at the beginning of September 1983. Further, although it should
have been obvious that the issue of the leaflet with donor call-up cards was more likely to
meet the public health objective of the exercise, it was decided that RTDs should be given
the discretion to decide the most effective means of distribution in their own regions, which
would be reviewed after three months. The decision to leave the method of distribution to
RTDs rather than ensure from the outset that the leaflets reached donors to the greatest
possible extent was wrong.
The wording of this first leaflet was problematic. First, those in the risk groups were merely
requested not to give blood, rather than being instructed that they should not or must not
give blood. Second, the request was contingent upon the donor thinking “they
may either
have the disease or be at risk from it”,
but the leaflet twice described the disease as rare,
and in terms of the numbers of cases in the UK indicated that “about
a dozen cases have
been reported, by the middle of 1983.”
Donors might, not unreasonably, have thought it
unlikely that they themselves would be at risk of such a rare disease and thus thought that
they did not need to self-exclude. Third, the risk group in relation to homosexual men was
limited to those “who
have many different partners”:
this was problematic both in terms of
the present tense (“have”) and in terms of the reference to “many
different partners”
– those
who had only one partner or more than one (but not “many” – whatever that meant) would
not think to self-exclude; nor would they have thought themselves excluded if they had had
only one partner, but that partner had had several others before him. Fourth, the risk group
in relation to IV drug use was limited to “Drug
addicts”:
those who had previously engaged
in IV drug use but no longer did so, or who had used drugs but did not consider themselves
to be “addicts”, would not necessarily think to self-exclude. Fifth, the risk group in relation to
sexual contacts was limited to the sexual contacts of those suffering from AIDS, rather than
sexual contacts of people at risk of AIDS.
Lord Glenarthur argued against six months as a trial period, insisting on three. Accordingly,
the three month trial period for distribution of the first leaflet should have led to a review
at the end of November or the beginning of December 1983. It did not. Instead, there
was substantial delay in evaluating whether the content of the first leaflet was sufficient
to achieve its purpose and whether there should be a changed approach to distribution of
the leaflets. It was only in August 1984 that ministers were asked to agree more effective
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distribution and to a revision of the leaflet to include a stronger warning to high-risk groups
not to donate. It then took until January 1985 for the revised leaflet to be finally approved,
meaning that for the year from January 1984 – and as a result of multiple delays – a leaflet
with wording agreed not to be sufficiently strong, which was not being distributed in the best
way to deter high-risk donors, continued to be used.
The second leaflet was an improvement on the first, but two of the risk groups were still
ambiguously and confusingly described. The first was described as “Practising
homosexual
and bisexual men”.
Whilst there was no longer the reference to “many
different partners”,
the word “practising” was ambiguous and would exclude those who (perhaps because of
fear of transmission of AIDS) might have stopped having sexual relations with men. Drug
“addicts” had been replaced by “Drug
abusers”,
but this was qualified by the phrase “who
inject drugs”:
the present tense thus did not encompass those who had previously injected
drugs but no longer did. By the time the second leaflet was issued, it had already been
recognised that it needed further redrafting.
The AIDS leaflet was one of the few measures that could be taken to try to ensure that those
donors most likely to transmit the virus did not donate. The safety of the blood supply should
have been the central focus rather than a preoccupation with adverse publicity.
The potential consequences of the failure to act earlier and more decisively are starkly
illustrated in the case of the Wessex donor. This donor was diagnosed with AIDS at
Bournemouth Hospital in autumn 1984, and had previously donated blood, including in late
March 1984. Transfusions had been given to three people all of whom were infected with
HIV. The donor’s plasma was also part of the source material for one batch of Factor 8
concentrate which was used in the treatment of 38 people with bleeding disorders in Wessex
and South Wales, and transmitted HIV to a number of them.
Reliance upon Professor Bloom
Professor Arthur Bloom’s views overly influenced the way the DHSS viewed the emergence
of AIDS and the threat posed to people with bleeding disorders. He was the only haemophilia
expert who participated in the meeting of the CSM(B) on 13 July 1983. He shaped the views
of the Haemophilia Society, who in turn made representations to the DHSS about the correct
response to AIDS. He was, amongst other roles, a member of the CBLA and its Committee
on Research and Development in Blood Transfusion, the MRC Working Party on AIDS, the
EAGA and the Working Group on AIDS of the Advisory Committee to the NBTS. There was
an uncritical acceptance of his line of thinking and a failure to probe his advice.
Failure to establish the Expert Advisory Group on AIDS earlier
Allied with the over-reliance on a single haemophilia clinician was the failure to establish a
body such as the EAGA until late 1984.
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It is not clear why a working group on AIDS was rejected by the DHSS in May 1983. This
would have provided a multidisciplinary forum for discussion and might have led to more
decisive and earlier action. The EAGA met for the first time in January 1985.
Lack of involvement of the Chief Medical Officer
The role of the Chief Medical Officer (“CMO”) was to inform “Ministers
and the public of
risks to Public Health and advising on policy measures to minimise these risks. He was also
responsible for giving guidance to clinicians, health boards and patients where he thought
it appropriate.”
However, the CMO was conspicuous by his absence from discussions and decision-
making relating to AIDS in the period from mid 1982 to late 1984. There is little evidence of
involvement by Sir Henry Yellowlees. It took Dr (later Sir) Donald Acheson, his successor,
too long to appreciate, and respond to, the gravity of the situation. It was not until late 1984
that there began to be any real involvement by the CMO, and by the Secretary of State, in
the response to AIDS.
There is ample evidence of the CMO’s active involvement from late 1984 onwards. What
is unclear is why there was no such active engagement at an earlier stage, at least from
mid 1982 onwards.
The role of ministers
The evidence available to the Inquiry demonstrates that officials failed to bring many
important matters to the attention of ministers. There was no particular logic or consistency
in what went to ministers and what did not. They were not told of the CSM/CSM(B) decision-
making. They were not told of Dr Galbraith’s recommendations. Lord Glenarthur was not
told in late 1984 that a number of individuals in Scotland had been infected with HIV through
NHS Factor 8 produced at the PFC.
It is not the fault of ministers if civil servants do not bring matters to their attention. It is,
however, the responsibility of ministers to demonstrate a degree of proactivity and to
challenge. Viewed overall ministers appeared to have lacked curiosity in the early period of
the developing public health crisis. No minister, for example, asked officials to investigate
what other steps could be taken to protect people short of stopping the importation
of concentrates.
Committees and working groups
A number of different committees and groups were responsible for advising DHSS officials
and ministers on blood safety during the 1970s and 1980s. There was no overarching
advisory committee on blood safety until the establishment of the Advisory Committee on
the Virological Safety of Blood (“ACVSB”) in 1989. The repetition of advice from more than
one committee covering the same subject may seem reassuring. However, given the small
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number of leading experts in haemophilia, fractionation plants, and the blood transfusion
service the same people were often involved in different bodies. Instead of cultivating
assurance through a range of advice, this masked the reality and perhaps discouraged
ministers from asking whether there were other views. Decision-making on something so
fundamental to the health of the nation as blood safety should have been better organised.
One of these committees was the Advisory Group on Hepatitis, set up in part to consider
and advise on non-A non-B Hepatitis. Despite the need for the expert group having been
identified in July 1979, it was not established until the autumn of 1980. The first meeting
of this new Advisory Group on Hepatitis was on 3 October 1980: there was no discussion
about NANBH. The second meeting was on 5 December 1980: again no discussion about
NANBH. The third was on 11 May 1981: still no discussion of NANBH. The fourth meeting
was in October 1981: again nothing on NANBH. A year then elapsed before the fifth meeting
in October 1982: Hepatitis A and Hepatitis B were both considered, but not NANBH. The
next meeting took place a year later, in October 1983: on this occasion AIDS was discussed
as well as Hepatitis B, but not NANBH. Nor was NANBH considered at either of the Advisory
Group’s 1984 meetings, nor at its October 1985 meeting, nor its July 1987 meeting. The
February 1989 meeting merely noted that there was a paper on “NANB
virus in blood for
transfusion”
but there was no discussion about the issue. By this time the ACVSB was being
set up. The December 1990 meeting of the Advisory Group on Hepatitis again contained no
consideration of NANBH/Hepatitis C, other than recording that the blood transfusion service
would be testing donations from 1991. This was symptomatic of a wider problem within
government in the 1980s, namely the lack of attention paid to NANBH and its transmission
through blood and blood products.
As for the establishment of the ACVSB, it is surprising, and disappointing, that – the need
for such a committee having been identified in June 1988 (a need that should in any event
have been identified long before) – it took until April 1989 for it to be in a position to meet.
The delay was particularly concerning because the purpose of the group was to provide
advice so that the DHSS could “enable
quick reactions to be made to new developments in
screening techniques and new epidemiological information.”
Northern Ireland
The Northern Ireland Department of Health and Social Services (“DHSSNI”) played a very
limited role in decision-making regarding blood safety in the 1970s and 1980s. This was in
part due to the fact that direct rule from Westminster was introduced in March 1972 following
the suspension of devolved government.
There is comparatively little contemporaneous documentation available, but it is clear
that overall the DHSSNI followed the policy decisions made by the DHSS in London and
that the DHSSNI had little observable influence on those decisions. Two particular factors
contributed to that state of affairs. The first was that in reality security and political aspects
“took
up a significant amount of ministerial time”.
The second was that the responsibilities of
the relatively small number of medical and administrative civil servants in Northern Ireland
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covered a broad range of matters, with less expertise and (in reality) less time devoted to
matters of blood and blood products.
Wales
The role played by the Welsh Office was, on occasions, a little more active than the Northern
Ireland Office, but with Wales still following the lead of the DHSS on matters of health
policy regarding blood and blood products. There was no independent Welsh Office action
concerning the risk of hepatitis from blood and blood products, although it was recognised
as a hazard. There were some discussions within the Welsh Office regarding AIDS,
independent of the decision-making being undertaken by the DHSS in the period 1983 to
1984 regarding AIDS. On 4 May 1983, for example, a meeting was convened involving the
CMO for Wales and a number of medical officers, as well as Professor Bloom and the RTD
for Cardiff, Dr Tony Napier. This meeting did not result in any action.
Scotland
Scotland had its own separate health and transfusion services, as well as a large
degree of independence in matters of health policy and administration. Health was the
responsibility of the SHHD.
The first recorded discussion concerning AIDS which included officials from the SHHD
occurred at a meeting held between SNBTS and Scottish haemophilia centre directors on
21 January 1983. The minutes do not record that any action to minimise the risks in Scotland
of AIDS was to be taken by SHHD (or anyone else). A briefing was sent to the minister in
May 1983; no specific steps to be taken by the SHHD were identified, nor was the minister
asked to make any decision or take any action. Just as with the DHSS, the reaction of the
SHHD was to do too little and to do it too late. The SHHD wrongly adopted and used the “no
conclusive proof” line.
The SHHD appears to have been content to sit back and let the DHSS take the lead in
respect of decision-making on the AIDS leaflet. Too much faith was placed in the safety of
the domestic blood supply in Scotland because of the voluntary donor system.
There is every reason to suppose that decision-makers in Scotland became aware of the
risk of AIDS at broadly the same time as the DHSS in Westminster. It was thus unlikely to be
long before it reached blood donors in Scotland, and thus transfused patients, and people
with bleeding disorders, unless effective precautions were taken. Despite this, there is little
sense of the need for urgent action.
4.2 Haemophilia Centres: Policies and Practice
This is a lengthy and detailed chapter examining the treatment policies and practices of
haemophilia centres in the 1970s and 1980s. The chapter considers the following issues:
• the organisation of haemophilia centres
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• the shift from cryoprecipitate to factor concentrates, explored first through UKHCDO
meetings and then through the treatment policies and practices at the reference
centres (Newcastle, Cardiff, Manchester, St Thomas’ Hospital, the Royal Free
Hospital, Oxford, Edinburgh, Glasgow Royal Infirmary, Belfast, Sheffield) and at
some of the larger non-reference centres (Birmingham, Royal London, Leeds)
• the Glasgow symposium in the autumn of 1980 and what it revealed about the
risks of hepatitis
• the emergence of AIDS and the response of UKHCDO
• treatment practices and policies 1982-1984 (examining in particular Newcastle,
Birmingham, Royal Free, Edinburgh, Glasgow Royal Infirmary, Belfast, Cardiff,
Oxford, Bradford, St George’s, Guy’s Hospital, Margate, Royal London, Leeds,
Liverpool, Sheffield, and Leicester)
• Haemophilia B
• von Willebrand disorder
• the use of PFC concentrates in Scotland 1985-1987
• relationships with pharmaceutical companies
• research
• the treatment of children, explored first through examination of the paediatric
haemophilia centres (Alder Hey, Birmingham Children’s Hospital, Royal Manchester
Children’s Hospital, Royal Belfast Hospital for Sick Children, Great Ormond Street
Hospital, Royal Hospital for Sick Children (Yorkhill), Bristol Children’s Hospital,
Sheffield Children’s Hospital) and then through examination of how children were
treated at other haemophilia centres
• ethical failings: consent and testing
The chapter includes detailed data, drawn mainly from annual returns, showing product
usage in the second half of the 1970s. That data is not replicated here but can be read
in the chapter.
What follows below is a summary only of some of the central points: readers should refer to
the full chapter for a proper understanding of the Inquiry’s analysis and findings.
Treatment policies and practices in the 1970s: UKHCDO meetings
The 1970s saw a gradual shift from the almost exclusive use of cryoprecipitate, largely in
hospitals, to the extensive use of factor concentrates, both in hospitals and in home treatment.
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Home treatment
Home treatment was discussed by haemophilia centre directors in October 1972: it was
at a very early stage but had been discussed in some centres. Over the following years
home treatment programmes became more widespread. At a directors’ meeting in January
1974 it was recorded that some directors were buying commercial concentrates for use
in home therapy. At the 1975 annual meeting of haemophilia centre directors, 25 centres
were reported to be using home therapy: 20 of those centres were using commercial
concentrates for some home treatment, 12 centres were using some cryoprecipitate. 1977
saw the establishment of UKHCDO’s Home Treatment Working Party. At the reference
centre directors’ meeting in January 1978, it was unanimously agreed “that
freeze dried
concentrates were the material of choice for home treatment and the Reference Centre
Directors recommend that all patients on home treatment should have freeze dried
concentrates.”
There was no discussion about the relative safety of cryoprecipitate versus
concentrate, or of the increased risk of viral transmission in consequence of such a change.
Supply issues and the growth of concentrate use
Concerns about insufficient supplies of NHS Factor 8 were a feature of UKHCDO meetings
throughout the 1970s. The October 1972 meeting recorded that many directors were pressing
for permission to purchase the “good
commercial products”
manufactured overseas. At a joint
meeting of directors of haemophilia centres and blood transfusion directors in January 1974
there was “a
wide ranging discussion about the relative merits of cryoprecipitate and freeze
dried concentrates with regard to ease of manufacture, recovery from the original plasma,
ease of administration and recovery of activity in the patients”.
Notably, the discussion did
not include relative safety. The minutes recorded the general feeling that “larger
supplies of
concentrated preparations were required now and urgently”
and that none of those present
would prefer cryoprecipitate if freeze-dried concentrates were freely available.
Hepatitis
Hepatitis was also a constant theme of discussion in the 1970s but increasing awareness
of the risks of hepatitis, in particular those of non-A non-B Hepatitis, did not influence the
approach to treatment. In December 1975 the World In Action documentary “Blood
Money”
was broadcast. The minutes of the meeting two months later indicate no discussion of the
issues raised but note that taking part in TV programmes could “distort
the facts and present
biased views which were embarrassing to doctors and could be alarming to patients”.
1977 saw the establishment of UKHCDO’s Hepatitis Working Party. The very establishment
of a working party to study “knowledge
of transfusion hepatitis in British haemophiliacs
and its sequelae”
reinforces the conclusion that it was, rightly, understood that hepatitis
(including NANBH) was something serious, requiring further investigation, rather than, as
some clinicians have claimed, something believed at the time to be benign and mild. At
the very least it shows that clinicians did not truly know what the consequences were, and
that if they thought despite that lack of knowledge that the disease was benign, it was
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“wishful
thinking”.
The 1978 report of the Hepatitis Working Party referred to studies carried
out at Chapel Hill hospital in the US: “They
have carried out almost 100 liver biopsies on
patients with chronically elevated serum transaminases in a collaborative survey, and nearly
50% of these have histological changes compatible with cirrhosis, chronic active or chronic
persistent hepatitis. These patients have had up to ten years of treatment with freeze dried
factor VIII concentrates of different brands.”
The evidence is clear that haemophilia clinicians in the 1970s knew or ought to have known
that hepatitis might well have serious long-term consequences, that there was still much to
be learned, and it was a real threat. By 1975 there had been an epidemic in Bournemouth,
it was recognised that cases not presenting as jaundice were a real problem, and that the
pool sizes for commercial concentrates were more likely to cause infection. There is no
point at which the minutes of the various meetings suggest that as a group the haemophilia
centre directors reflected whether they should continue with ever more product from even
larger donor pools of uncertain origin, or whether they should offer their patients alternatives.
Safety was not the paramount consideration which it should have been.
Treatment policies and practices in the 1970s: the reference centres
Six features emerge from the treatment of patients with Haemophilia A in the 1970s:
(a)
(b)
(c)
(d)
(e)
(f)
the increasing use of concentrates (particularly commercial)
the insufficiency of NHS concentrates outside Scotland: many clinicians complained
of a “shortfall” in what was available from BPL
the decreasing use of cryoprecipitate
the lack of express consideration given to safety
the growth in use of greater quantities of Factor 8 therapies, especially for home
treatment, but also for some prophylaxis
the limited use of risk mitigation or reduction measures such as DDAVP and batch
dedication policies
Underpinning the approach to treatment was an assumption that hepatitis was “an
inconvenience, but essentially harmless”:
an assumption “of
the kind that doctors should
not make.”
An elementary principle is that if a certain process or procedure carries risks
with it then reasonable steps should be taken to eliminate those risks or, if they cannot be
eliminated, to reduce them. Scant regard is paid to this principle if no attempt is made to
take any such step.
Newcastle
This centre was an early proponent of home treatment and commercial concentrates were
an established part of its treatment practices by or soon after 1973. Dr Jones’ policy from
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the 1970s was to treat young children with “locally
produced”
cryoprecipitate rather than
factor concentrates but from the age of six (or possibly younger), depending on their veins
and parental expertise, home therapy could begin, and this involved factor concentrates
including substantial amounts of commercial concentrates. Prophylaxis was also a feature of
the treatment policy. The risks of hepatitis from use of concentrates (particularly commercial
ones) were well known to Dr Jones. In a 1980 newsletter he said both that “the
dangers of
viral disease transmission inherent in intensive transfusion are far from over, and that these
dangers are compounded by the use of large plasma pools from commercial sources”,
and
that the risk of infection with non-A non-B Hepatitis “is
almost always a very mild one”.
In
Newcastle, as in so many other Centres, the knowledge of almost inevitable infection with
non-A non-B Hepatitis and risk of chronic liver disease was not shared with patients as it
should have been.
Cardiff
By 1976 a home treatment programme had been established in Cardiff. Over the following
years there was a substantial increase in the amount of commercial concentrates used. As
to hepatitis risks, Professor Bloom’s approach is apparent from a letter he wrote in February
1975 to another clinician about a patient with haemophilia who had “been
selected for home
treatment”
with Factor 8 concentrate, stating that: “A
small percentage of these freeze dried
preparations contain, unavoidably, the virus of serum hepatitis and therefore potentially
dangerous to the patient, his relatives etc.”
In a report for the HIV Haemophilia Litigation
Professor Bloom wrote that most patients with haemophilia were infected with both Hepatitis
B and non-A non-B Hepatitis. The impact of this recognition on his treatment practice was,
however, marginal: “The
general recommendation however was that bleeding was still the
main cause of morbidity and mortality and that treatment with concentrates should continue
except perhaps that treatment with cryoprecipitate may have been more circumspect in
general in young children and that DDAVP should be used, within its constraints, in mildly
affected patients with haemophilia A.”
Manchester
Manchester was slower than some other large centres to institute home treatment and appears
to have used cryoprecipitate for home treatment at least until 1978. Dr Richard Wensley
was described as a “powerful
advocate of cryoprecipitate”
whose “thoughts
were that yields
of cryoprecipitate over those of concentrate are roughly 70% compared to 20%, and the
risks of transfused virus are certainly less.”
He was described by a colleague as being
“very
much alone on this point at one time.”
The annual returns in the second half of the
1970s reveal use of cryoprecipitate, NHS concentrate and commercial concentrates in
significant quantities.
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St Thomas’ Hospital
Professor Ilsley Ingram, the centre director until 1979, was an early advocate of home
treatment and in 1974 wrote “Until
the N.H.S. provision is adequate, it is cruel not to make
good the shortfall from the large supplies of good commercial material which … are now
available.”
In his statement to the Archer Inquiry, his successor as centre director, Professor
Geoffrey Savidge, wrote that:
“extra
money when found was spent on the purchase of commercial imported factor
VIII concentrate, usually from the US, in preference to the safer cryoprecipitate
that was the recommend
[sic]
treatment of children and mild haemophilia patients
(assuming failure with DDAVP) generally available (in some regions in excess).
The US commercial concentrate was considered to be more user friendly, it could
be stored at room temperature and was eminently more suitable for patients on
home care programmes.”
By 1978 commercial concentrates were the products most in use at St Thomas’.
The Royal Free Hospital
It was, prior to 1978, the policy of Dr Dormandy, the centre director, to use cryoprecipitate for
home treatment. Following her death Dr Kernoff and Dr (later Professor) Edward Tuddenham
“came
in in 1978 and very rapidly changed everybody to concentrate.”
Dr Kernoff was well
aware of the risks from commercial concentrates. Writing in April 1979, he recorded non-A
non-B Hepatitis being a “serious
disease with long-term consequences”
and that there were
“both
clinical and moral reasons for preferring the N.H.S. material.”
The shortfall in NHS
concentrates was “met
by buying commercial concentrate.”
Oxford
NHS Factor 8 was (according to Dr Rizza, the centre director, writing in 1984) always in
very short supply and reserved “as
far as possible”
for young children and adolescents:
“Ultimately
most severely affected patients are changed from NHS to commercial factor
VIII especially those who use larger amounts of factor VIII.”
By 1977 no cryoprecipitate
was being used. Dr Rizza produced a report for the HIV Haemophilia Litigation suggesting
that during the first half of the 1970s “hepatitis
was probably not perceived as a long term
problem in haemophiliacs”
but that more detailed follow up of people with haemophilia
during the late 1970s showed a significant number had persistently abnormal liver function
tests and chronic liver disease.
Edinburgh
During the 1970s cryoprecipitate was the preferred treatment of Dr Davies, with no
commercial concentrates being used even for the treatment of inhibitors. Dr Davies’
preference for cryoprecipitate was because of the risks associated with hepatitis viruses
and a reluctance to introduce new viruses to the local population.
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Glasgow Royal Infirmary
Commercial concentrates were in use in Glasgow in 1974 and 1975, although cryoprecipitate
was the predominant product in both years, and the centre strongly advocated home
treatment. From 1976, the use of concentrates (NHS and commercial) exceeded the use
of cryoprecipitate. According to Professor Charles Forbes’ evidence to the Penrose Inquiry,
the December 1975 World In Action documentary “was
the talk of the haemophilia part of
the hospital. Very much so.”
However, he suggested that “at
the end of the day the risk of
dying of bleeding was always much greater and that was what drove all of us to use these
products despite the possible downside.”
Belfast
Concentrate was first used in Belfast in 1971. Thereafter Hemofil was the commercial
concentrate used for the next three years. In the mid 1970s Dr Elizabeth Mayne instituted
a home treatment programme using commercial concentrate. Her policy was that all home
treatment patients would be treated with Kryobulin and all hospital treatment would be
with Hemofil. Children would continue to be treated with cryoprecipitate. Little or no NHS
concentrate was used in the second half of the 1970s. A pharmaceutical sales representative
described in 1978 that
“Dr
Mayne is not prepared to change her present policy concerning human
factor VIII. She uses Hemofil for operations and Immuno for home treatment
(22 patients). She realises this is an expensive policy, but feels that treatment
changes are something best avoided with Haemophiliacs. She is very concerned
about liver enzyme changes, but at least she knows what to expect with products
which have been used for some years. There is also loyalty to Hemofil, because
Baxter obviously gave her considerable financial help in the early days.”
Sheffield (Royal Hallamshire)
From 1977 there was a substantial reduction in the use of cryoprecipitate, and by 1980 the
mainstay of treatment was commercial concentrate. The limited use of cryoprecipitate at
Sheffield may have reflected Dr Preston’s view that cryoprecipitate was “not
an option for
the treatment of severe haemophiliacs.”
Dr Preston also indicated that although the hepatitis
risk from commercial products was substantially greater than from NHS products, “there
were insufficient NHS products for the treatment of Royal Hallamshire Hospital patients.”
Dr Preston’s approach was to purchase a number of different commercial concentrates but
to “keep
individual patients on the same concentrate, and the same ‘batch’ for as long as
possible to minimise exposure to different blood donations.”
Birmingham (Queen Elizabeth Hospital)
By the late 1970s there was little cryoprecipitate being used and substantial quantities of
commercial concentrates were used. Professor Frank Hill told the Inquiry that he believed
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in the late 1970s that non-A non-B Hepatitis was a minor self-limiting condition with no
serious long-term consequences. However, the minutes of the November 1976 West
Midlands working party meeting show him concerned about “the
hepatitis risk in respect of
freeze dried Factor VIII concentrate obtained from commercial sources”.
He asked whether
it might be advantageous to reserve the NHS Factor 8 for children, “leaving
the concentrate
obtained from commercial sources, largely of foreign origin, for adults.”
Royal London
By 1975 Dr Brian Colvin “was
aware that there was at least a possibility of chronic liver
disease in haemophilia”.
He described Dr Craske’s August 1975 paper on the Bournemouth
hepatitis outbreak as: “a
watershed moment, after which it was known that there was quite
a significant problem for the future, at least in terms of numbers … We didn’t know what
was going to happen next but I think we knew that it was going to happen to a lot of people.”
By the late 1970s cryoprecipitate was seen as the past, used only for the treatment of very
small children, and otherwise concentrate was the treatment of choice. No analysis of the
relative risks of cryoprecipitate and factor concentrates was undertaken.
Leeds
By 1977 Leeds was using a substantial volume of commercial concentrates. By 1978 little
cryoprecipitate was in use and the 1979 return recorded the use of no cryoprecipitate at
all. There does not appear to have been any system of batch dedication, nor any other
evidence of a risk reduction or minimisation strategy.
The Glasgow symposium in autumn 1980
In September 1980 a symposium “Unresolved
Problems in Haemophilia”
was held in
Glasgow. It immediately followed the annual meeting of haemophilia centre directors and it
is reasonable to assume that most directors attending the annual meeting would also have
attended the symposium.
Dr Craske gave the first presentation. He stated that most cases of non-A non-B Hepatitis
were mild illnesses, but he also observed that: “About
40 patients have undergone biopsy
in the UK and approximately 50% of these have histological evidence of chronic persistent
hepatitis … Other patients showed evidence of chronic liver disease or cirrhosis … Most of
the patients in this group are children or young adults, though the age range at Oxford is
6-70 years. It seems likely that some patients will develop severe chronic liver disease over
the next 10 years.”
Following a talk from Dr Thomas and colleagues at the Royal Free, the discussion included
this further contribution from Dr Thomas:
“if
we are to believe that this illness at the most has been going on since 1974
when the commercial concentrates were first introduced, then this period is short
in the course of the disease. There are some indications that these patients may
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have lesions which will turn to fibrosis or cirrhosis … It is really now a question of
how long it takes. Just because we have not seen it in this six-year period, it does
not mean that it will not happen. I think the thinking is that it takes ten or twenty
years, or even thirty years for these lesions to progress. I think we have to realise
that these are young patients, with many years ahead, when we are considering
the significance of these lesions.”
A talk by Dr Preston, Dr Triger and Dr Underwood (from Sheffield) stated that they had now
examined liver biopsies from 19 patients with haemophilia, including 5 children (from 2 to
10), and one patient with von Willebrand disorder. “The
biopsy findings ranged from chronic
persistent hepatitis, present in the majority of our cases, to severe chronic active (aggressive)
hepatitis with evolving or established cirrhosis.”
Dr Thomas (Royal Free) observed that for
patients with haemophilia “The
prediction is that it will be a more significant progressive
illness, and I think they will develop fibrosis. Indeed, Dr Triger’s studies have shown that
a significant proportion have cirrhosis.”
Dr Triger emphasised that “We
are dealing with
chronic liver disease, in which 5 to 7 years is a very short time – as we all know. 10 to 20
years may be a long time, but we have been looking at liver biopsies of children under the
age of 10 years, and what we are concerned with is what is likely to happen to them when
they should be fit, healthy 25 year olds … I think we are just building up trouble.”
Dr Thomas
agreed: “it
is in 10 years time that we shall see the problems. Bearing in mind the proportion
of the patients that are infected, or have persistent abnormal liver function tests, anything
from 60 to 80 per cent, it will be an enormous problem when it happens.”
Dr Mark Winter, in his oral evidence to the Inquiry, rightly described the 1978 Sheffield study
as showing NANBH to be a “really
serious evolving clinical problem”
and as an “absolutely
key moment, where any haemophilia doctor should have switched from a viewpoint
[from]
‘they
have probably got a mild form of the virus’ to ‘I’m very concerned’”;
it was “one
of
the great sea change moments”.
But for any haemophilia clinician working in that capacity
in 1980 who had not picked up on the significance of the Sheffield study, the Glasgow
symposium in September 1980 was another “absolutely key moment” and should have
driven home the message that NANBH could not be dismissed as “benign” or “mild” or as a
risk that did not need to be taken seriously.
Yet treatment with factor concentrates continued unabated throughout the early 1980s.
The Hepatitis Working Party continued to meet and discuss its various studies; the
reference centre directors turned their attention to concerns about the new concentrates
said to be hepatitis-free or hepatitis-reduced and noted that the annual returns for 1980
showed that the amount of Factor 8 concentrates used had again increased, especially
commercial materials; the haemophilia centre directors met again in the autumn of 1981
and received Dr Craske’s report on behalf of the Hepatitis Working Party for 1980-81 with
its recommendations that the surveillance should continue, as should further studies. But
for most centres little or nothing changed. The chapter summarises data from the annual
returns for 1980 to 1982 for Newcastle, Royal Free, Cardiff, Belfast, Glasgow Royal
Infirmary, Edinburgh, Sheffield, St Thomas’ Hospital, Manchester Royal Infirmary, Oxford,
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Birmingham, Bristol, Leeds, Liverpool, Royal London, Lewisham, Cambridge, Coventry and
Kent. The Glasgow symposium, and what ought on any view to have been understood to
be the risks of transmission of NANBH and the potentially serious nature of NANBH, did not
lead to any noticeable difference of approach to treatment, or even of any consideration of
whether a changed approach was warranted. Nor was there any consideration or discussion
about the position of patients and the information that should be provided to them about the
risks of treatment.
UKHCDO response to the emergence of AIDS
Possibly by March 1982, and certainly from July 1982 onward, some clinicians and some
in government knew that there was a real risk that blood, and blood products in particular,
would transmit the cause of AIDS.
Yet by September 1982 the haemophilia centre directors were only beginning enquiries into
this risk – when they commissioned Dr Craske to obtain more information about the reports
from the US because there was “a
remote possibility that commercial blood products had
been involved.”
There was no sense of urgency, despite – on any reasonable view at that
stage – the role of commercial blood products being more than a “remote possibility”.
In December 1982, the Royal Free Hospital began to measure the ratio of T4 to T8 cells
in patients with haemophilia. This was plainly a reaction to a perceived threat of AIDS, and
implies a belief that AIDS might be transmissible by blood or blood products.
On 7 January 1983 Alpha pharmaceutical issued a press release: “The
evidence suggests,
although it does not absolutely prove, that a virus or other disease agent was transmitted
to
[patients with haemophilia who had contracted AIDS]
in the Factor VIII concentrate
… AIDS has jumped from the seventh to the second most common cause of death in
hemophiliacs within a year”
On 11 January 1983 Professor Bloom and Dr Rizza issued a letter to all haemophilia centre
directors which discussed the attempts by commercial companies to reduce the risk of
hepatitis transmission through heat treatment and emphasised the importance of finding
out “by
studies in human beings to what extent the infectivity of the various concentrates
has been reduced.”
Professor Bloom and Dr Rizza suggested that “The
most clear cut way
of doing this is by administering those concentrates to patients requiring treatment who
have not been previously exposed to large pool concentrates,”
and encouraged directors to
avoid the use of such concentrates on a named patient basis, because this “might
seriously
hinder controlled studies in the future.”
This letter is important for three reasons: there is a
complete absence of
any
reference to AIDS; it shows that UKHCDO
could
give advice and
information to haemophilia centre directors where it thought this warranted; and the letter
proposed giving large pool concentrates to patients who had not previously received them
at the very time
when the emergence of AIDS should have led clinicians to avoid that.
On 13 January 1983 the widely read
New England Journal of Medicine
published an
editorial stating that “The
fact that haemophiliacs are at risk from AIDS is becoming clear”
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and advocating a revised approach to treatment. At the Heathrow meeting later that month
no one questioned that AIDS was likely to result from the transmission of an infectious
agent, and Dr Craske informed those present that the disease was intractable, had a lengthy
incubation period and a high mortality rate. No one present at that meeting could have been
left in any doubt as to the seriousness of the position.
By May 1983, while treatment continued as normal, a young man with haemophilia in
Wales had developed symptoms of AIDS. Kevin Slater was 20 years old when his AIDS
symptoms were first identified and just 22 when he died in 1985. He was suspected of
suffering from AIDS in March 1983, following a visit to University Hospital Wales. Professor
Bloom was aware of his case and told the audience at a 22 April 1983 Haemophilia Society
meeting that one of his patients “may
have a mild form”
of the syndrome. Around 6 May
1983, the CDSC published a weekly report identifying Kevin’s case (without naming him)
and observing that “this
is the first report of AIDS in a patient with haemophilia in the United
Kingdom known to CDSC.”
Dr Spence Galbraith, director of the CDSC, notified the DHSS of
this development on 6 May.
Dr Walford was invited to attend the special meeting of haemophilia reference centre
directors on 13 May, which was chaired by Professor Bloom and attended by Dr Craske,
Dr Peter Hamilton, Dr Kernoff, Dr Ludlam, Dr Savidge, Dr Preston, Dr Irvine Delamore and
Dr Rizza. The minutes record that: “It
was agreed that there was insufficient information
available from the U.S. to warrant changing the type of concentrate used in any particular
patient.”
It was suggested that “many
directors have up until now reserved a supply of
National Health Service concentrates for children and mildly affected haemophiliacs and
it was considered that it would be circumspect to continue with that policy.”
There was no
discussion about any measures such as: reverting to cryoprecipitate (even if only on a
temporary basis); batch dedication; more conservative treatment including less prophylaxis;
cancelling or postponing elective surgery.
The decisions in the meeting were taken in ignorance of the 9 May 1983 paper from
Dr Galbraith to the DHSS advising against using imported factor concentrates, and Professor
Bloom did not tell the meeting that Dr Evatt of the CDC had told him that “the
evolution of
the epidemic is occurring with a frightening pace”
and that there were now 13 confirmed
cases in people with haemophilia in the US, with five more highly suspect cases under
investigation. Once again, there was no discussion about advising patients of the risks.
Following the May meeting, Professor Bloom and Dr Rizza wrote to all Haemophilia Centre
Directors on 24 June. This letter was the only advice issued by the UKHCDO until December
1984. It suggested that treatment should continue as before, despite the risks of AIDS in
addition to hepatitis. The complacency, and absence of any practical advice to reduce the
risk, represent a failure of leadership and a missed opportunity.
At the October 1983 annual meeting of Haemophilia Centre Directors, by which time the first
death of a patient with haemophilia with AIDS was known, Dr Morag Chisholm (Southampton)
raised the question of patients refusing to take commercial Factor 8 concentrate because
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of the AIDS scare. She wondered whether directors could revert to using cryoprecipitate
for home therapy. Professor Bloom replied that “he
felt that there was no need for patients
to stop using the commercial concentrates because at present there was no proof that the
commercial concentrates were the cause of AIDS.”
After discussion it was “agreed
that
patients should not be encouraged to go over to cryoprecipitate for home therapy but should
continue to receive the NHS or commercial concentrates in their usual way.”
It is astonishing that in October 1983 Professor Bloom felt able to say to Dr Chisholm that
there was “no
proof”
that commercial concentrates were the cause of AIDS, and astonishing
that the directors as a whole agreed that patients should not be encouraged to switch to a
substantially safer treatment. It was an unsustainable and misleading position in the autumn
of 1983. It was tantamount to telling clinicians that they did not need to do anything. It is
surprising that Professor Bloom was not challenged on this by his peers at the meeting.
Thus the position as at the end of 1983 was that far too little had been done by UKHCDO
or the reference centre directors in response to the emergence of AIDS. The focus was
on surveillance and research rather than on taking urgent steps to reduce the risk of
transmission. The only guidance that had been provided – the 24 June letter – was woefully
inadequate. It amounted to “carry on as you are already probably doing”. The reference centre
directors were apparently unaware of key pieces of information – Dr Galbraith’s paper and
the Council of Europe recommendations – and thus their advice (such as it was) was issued
in ignorance of them. The risks were assessed on the basis of the number of cases which
had emerged, when the focus should have been on what might be already on the way. And
the risks to people with bleeding disorders were consistently, and unjustifiably, downplayed.
During the following year, despite the increase in cases of AIDS, and despite being told
that “One-third
of the Centres
[in Europe]
had changed their treatment regimes for patients
following the onset of the AIDS problem”,
there was no further thought to treatment policy,
risk reduction or further advice. It was not until December 1984, some two or more years
after the risks of transmission of AIDS should have been apparent to all centre directors,
that the implications for treatment were finally addressed, with the product of an “AIDS
Advisory Document”.
It is difficult to understand why the UKHCDO and the reference centre directors were so
dangerously slow to recognise and react to the risks of AIDS being transmitted to their
patients. It was wrong.
Treatment practices and policies 1982-1984
Haemophilia centre directors knew or ought to have known no later than the end of 1982
(and probably earlier) of the risks of transmission of AIDS by blood and blood products. Put
more colloquially by Dr Winter, “however
many alarm bells a human being has, they should
all have been ringing at this stage.”
Yet it is clear that those alarm bells were not ringing
for many, indeed most, haemophilia clinicians – or if they were, they did not lead to any
substantial changes in treatment policies and practices.
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At Newcastle commercial concentrates continued to be the mainstay of treatment in
1983 and 1984 and there were no significant changes in approach to treatment until the
introduction of heat treated concentrates in December 1984. In Birmingham Professor Ian
Franklin’s evidence was that “I
think … in Birmingham the feeling was to carry on, but
probably to carry on in the hope that we would eventually get more NHS material.”
There
was no change in the Royal Free’s treatment policies until heat-treated products became
available at the end of 1984.
In Edinburgh Dr Ludlam had reversed his predecessor’s policy of using cryoprecipitate and
moved from cryoprecipitate to predominantly PFC Factor 8 concentrates. He substantially
increased the number of patients on home treatment and the volume of product used.
Dr Ludlam thought that he first became aware of cases of AIDS in people with haemophilia
in August-October 1982. In his oral evidence to the Inquiry, he was at pains to emphasise
“the
uncertainty that there was at the time about the cause of AIDS.”
There was no significant
change of approach to treatment in 1983 and 1984 at Edinburgh because Professor Ludlam
thought the PFC concentrates were reasonably safe: “we
felt it reasonable to go on with
using cryoprecipitate in decreasing amounts and using local concentrate for treating the
patients.”
In the autumn of 1984 Professor Ludlam sent a number of stored samples to
Dr Tedder for testing without the knowledge or agreement of the patients involved. He was
told the results in October. He did not tell patients then. It was not until in response to
impending publication in the
Yorkshire Post
that a group meeting of people with haemophilia
was called on 19 December 1984 and it was then left to people to make contact with the
Centre to find out if they had been tested and what their test results were. It was not until
1985 that the process began of informing individual patients of their test results. Until then,
some who were infected with HIV were not aware of the need to avoid infecting others;
others continued to treat themselves with concentrates in the erroneous belief that PFC
concentrates were entirely safe.
In Glasgow the usage of cryoprecipitate declined markedly in 1982, with NHS (PFC)
concentrates as the mainstay of treatment. Dr Forbes told the Penrose Inquiry that by March
1983 “already
we were starting to look rather differently at our patients to see if they had any
of the features that might be an early warning of AIDS.”
He also acknowledged that in 1983
there was a potential for contamination of blood products “even
from local, home-grown
sources
…
that was always a concern, that HIV would come into the donor population of the
UK.”
There is no evidence of any significant change of approach to treatment.
In Belfast in 1982-1984 patients continued to be extensively treated with commercial
concentrates with no evidence of any risk reduction measures. In a report for the HIV
Haemophilia Litigation, Dr Mayne suggested that some risk reduction measures would
have denied “the
goal of haemophilia treatment, namely to minimise pain and disability
and to prolong life.”
She objected to restriction of “the
choice of treatment available to the
physicians in charge of the patient: the person in possession of all the information regarding
the patient’s needs.”
This characterisation of the physician as being “in
charge of”
the patient,
“in
possession of all the information regarding the patient’s needs”
is paternalism writ large.
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In Cardiff Professor Bloom materially downplayed the risks of transmission at this critical
time. There can be no doubt that in early 1983 Professor Bloom had more information
than other haemophilia clinicians. By April he also knew that one of his own patients had
AIDS. Yet he continued to minimise the risk, as seen by the advice which he provided to the
Haemophilia Society.
There is evidence to suggest that following the special meeting of reference centre directors
on 13 May 1983, Cardiff produced written guidelines for haemophilia treatment. There are
four observations to make regarding those guidelines: the first is that their production in May
1983 suggests that no steps were taken prior to that date in response to the risk of AIDS.
The second is that the picture revealed by the annual returns is not consistent with the full
implementation of those guidelines. The third is that the guidelines drew little distinction
between the use of NHS concentrate and cryoprecipitate, yet the former was made from
large donor pools and on any view carried a substantially greater risk of transmitting both
NANBH and the agent causing AIDS. The fourth point is that the guidelines may relate
only to treatment in hospital. Professor Bloom’s view on home treatment was that there
was no need for patients to stop using commercial concentrates and they should not
switch to cryoprecipitate for home therapy but “continue
to receive the NHS or commercial
concentrates in the same way.”
It is clear from both the returns and the statements from
people treated in Cardiff that home treatment continued unabated.
In Oxford Dr Rizza knew by at least September 1982 that three US patients with haemophilia
were reported to have AIDS. On 8 October 1982 he wrote to Dr Craske referring to the US:
“one
very senior physician has withdrawn his factor VIII concentrates from the accident
room and insists on vetting the patients himself before any dose was given.”
In November
1983 Dr Rizza was provided with a copy of Dr Craske’s paper on AIDS, and he attended
the Hepatitis Working Party and the Heathrow meetings in January 1983. Yet there is no
evidence of any change in treatment. The 1983 and 1984 annual returns show that almost
no cryoprecipitate was used for the treatment of Haemophilia A. Only in December 1984,
when the Centre placed its first order for heat-treated concentrates, was there any significant
change of approach.
This section of the chapter also considers the position in relation to the haemophilia centres
in Bradford, St George’s Hospital, Guy’s Hospital, Margate, the Royal London, Leeds,
Liverpool, Sheffield and Leicester. The latter is of particular note as one of the very few
centres where there is evidence of positive steps being taken to attempt to reduce the risk of
transmission (in particular by a greater use of cryoprecipitate than other centres).
The chapter concludes that clinicians should all have been alert to a risk of AIDS by the
end of 1982, if not earlier, and that in light of this the steps that could and should have been
taken by Haemophilia Centres (but generally were not taken) were:
• stop using commercial concentrates, as they carried the greatest risk
• take a conservative approach to treatment, using less concentrate (or cryoprecipitate),
and treating only where strictly necessary
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• return to using cryoprecipitate in place of concentrates (commercial or NHS), or
fresh frozen plasma for Haemophilia B
• suspend home treatment and stop prophylactic treatment
• avoid treating patients with multiple products and multiple batches: introduce
batch dedication
• defer elective / non-essential surgery
• maximise the use of DDAVP and tranexamic acid
• provide advice and encouragement to individuals on reducing the risk of bleeds
• above all, discuss the risks and alternatives (and the gaps in knowledge) with each
patient individually, as fully as reasonably possible, and be guided by their view of
what mattered to them.
These failures lie with the Haemophilia Centres and their directors, particularly the more
senior and experienced, who failed to provide guidance when it was required; they failed to
adjust treatment policies as they should and failed to tell patients adequately of the risks to
them as individuals.
Haemophilia B
This section of the chapter examines the approach to treatment of people with Haemophilia
B. By the late 1970s, if not earlier, the potential for non-A non-B Hepatitis to have serious
effects should have been appreciated in relation to Factor 9 concentrates just as for
Factor 8. By the late 1970s pool sizes for Factor 9 were at least seven times, and often
more, than at the start of the decade. The average use of Factor 9 per patient rose from
21,000 units in 1978 to just over 36,000 in 1984. The increased awareness of serious long-
term consequences of hepatitis demonstrated in the Glasgow symposium had no obvious
effect on practice. On the contrary, as the risk of long-term disease grew greater, so did the
amount of Factor 9 prescribed.
As for the response to AIDS, although there was much less to be said in favour of fresh
frozen plasma as a form of alternative treatment than there was to be said for considering
cryoprecipitate as an alternative to Factor 8 concentrate (it had to be administered in large
volumes to be effective, and that created its own risks), nonetheless in the guidelines
circulated after 10 December 1984 FFP was recommended as the treatment of choice
for mild cases of Haemophilia B, previously untreated patients, and children. There was
plainly some role for it, even if relatively limited, and that role should have been spelt out to
patients, so that they could assess risks for themselves and take their own decisions. A step
that should have been taken, but was not, would have been to limit home treatment and
suspend prophylaxis using unheated Factor 9 concentrates.
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Von Willebrand disorder
This next part of the chapter looks at the treatment of people with von Willebrand disorder.
Cryoprecipitate, Factor 8 concentrates and DDAVP ( as well as FFP) were all treatments that
could be (and were in varying degrees) used for the treatment of von Willebrand. DDAVP
in particular gave rise to no risk of viral transmission: it was not a biological product. It was
one of a number of alternative treatments (available from 1977 onwards) which ethically
should have been discussed with a patient in advance of treatment, together with the other
possibilities. The meetings of haemophilia clinicians in 1980, 1982 and the advice given in
June 1983 all show that haemophilia clinicians were alive to the risk that using concentrates,
especially commercial concentrates, risked transmitting viral infection and should best be
avoided if possible. Yet people with von Willebrand disorder were typically not given advice
or information about the risks of treatment (insofar as those risks related to transmission
of hepatitis or HIV) and were not given information about safer alternatives. The evidence
available to the Inquiry indicates that DDAVP was not used to the extent that it should
have been, given the risks of viral transmission; and that whilst cryoprecipitate was used,
concentrates (including commercial concentrates) were used more frequently than they
should have been for the treatment of people with von Willebrand disorder, particularly after
the risks of AIDS had become apparent from mid 1982 onwards.
The use of PFC concentrates in Scotland 1985-1987
Heat-treated Factor 8 concentrate produced by PFC (known as NY) was available from
December 1984. It was believed to (and did) inactivate HIV; it did not, however, prevent
the transmission of non-A non-B Hepatitis. It was not until April 1987 that PFC produced a
Factor 8 concentrate (Z8) that was effective against non-A non-B Hepatitis. By contrast the
heat-treated concentrate produced by BPL (8Y) over the same period transmitted neither HIV
nor non-A non-B Hepatitis. Thus there was in Scotland a continuing need for particular care
to be taken by clinicians in relation to people with bleeding disorders who were untreated
or minimally treated and who thus had not been, or were unlikely to have been, previously
exposed. Haemophilia clinicians should have been alert to this, so as to avoid such patients
receiving NY unless absolutely necessary. Appropriate systems should have been in place
to address this. If such a patient were to be offered NY, they needed to be told in advance
of their treatment what the options were (including the possibility of alternative treatment eg
with DDAVP or cryoprecipitate), what the risks and benefits were, and in particular it should
have been explained to them what by now was on any view abundantly clear – that non-A
non-B Hepatitis was a serious illness which could cause long term (and potentially fatal)
liver disease and that treatment with NY would in all probability infect them with it.
This part of the chapter concludes that such systems were lacking and that appropriate
information and choices were not provided, leading to infection with Hepatitis C
that was avoidable.
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Relationships with pharmaceutical companies
In the 1970s and 1980s there were regular, usually cordial, interactions between sales
representatives of pharmaceutical companies and haemophilia centre clinicians. Sometimes
gifts were provided, sometimes sponsorship or funding for research. More commonly
funding was provided to cover the costs of attendance at international conferences and the
close relationship between haemophilia centre directors and pharmaceutical companies is
evidenced in contemporaneous documents. An internal Cutter memo in May 1985 describes
how the author “sought
out and visited briefly with Prof. Bloom during the AIDS Conference
in Atlanta. He asked if he could visit with Cutter the week following the San Diego meeting
… He will need room reservations in the city for Saturday, Sunday and Monday, plane
reservations from San Diego. He will be accompanied by his wife.”
Professor Tuddenham
recalled hospitality from pharmaceutical companies that was: “overwhelmingly
lavish … at
various stages … you would be going to the best – – to a conference on haemophilia,
there would be the very best restaurants, the river cruises, the – – all the paraphernalia of
marketing products.”
Asked why the companies were spending that money, the answer was
“Because
they could gain influence with it.”
Professor Liakat Parapia described “Extravagant
hospitality”
being available “for
Centres using large amounts of their products”,
adding that
for attendance at scientific meetings support from pharmaceutical companies was the only
way for clinical staff to attend: “There
was no money in the NHS”.
Professor Michael Rawlins, giving evidence in October 1984 to the Royal College of
Physicians Working Party on the Ethics of the Relationship between Physicians and the
Pharmaceutical Industry, described the “fundamental
ethical issue”
as being based on the
fact that “doctors
spent very large sums of public money each year, and that the public
could reasonably expect doctors to prescribe drugs with deference to their efficacy, safety
and economy.”
He felt strongly that “consultancies
and their financial details”
should be
disclosed, that money should “not
go to one person but to a department”,
that the General
Medical Council should give doctors “positive
advice concerning their relationships with the
Industry”,
and that hospitality should be “totally
divorced from promotion”.
In light of the above, it is not surprising that many core participants expressed in their
submissions to the Inquiry serious concerns about the relationship between haemophilia
centre directors and pharmaceutical companies. It is always difficult to ascertain the extent
of bias – whether conscious or subconscious. At this distance of time, and where the
clinicians most prominently associated with pharmaceutical companies (such as Professor
Bloom, Dr Kernoff, Dr Aronstam, and Professor Savidge) are dead, it is no longer possible
to determine what impact these relationships and these offers of funding had on clinical
decision-making. But if clinicians accepted funding (whether for hospitality or attending
conferences, or research) it was all the more incumbent on them to ensure that their clinical
recommendations and the risks and benefits of treatment were fully explained to their
patients. As this Report finds, the failure to do so was widespread and profound.
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Research
The organisation of haemophilia centres in the United Kingdom “made
it possible to carry out
collaborative research which was not so easily done elsewhere.”
(Dr Biggs). The “collection
of 49 haemophilic patients at the Alton School makes this a unique opportunity to study the
disease.”
(also Dr Biggs). They – the “almost
unique group of haemophiliacs we have in
Edinburgh because they have never received commercial concentrate”
– “are,
therefore …
useful material for a variety of studies in relation to liver disease.”
(Dr Christopher Ludlam).
“Although
initial production batches may have been tested for infectivity by
injecting them into chimpanzees it is unlikely that the manufacturers will be able
to guarantee this form of quality control for all future batches. It is therefore very
important to find out by studies in human beings to what extent the infectivity of
the various concentrates has been reduced. The most clear cut way of doing
this, is by administering those concentrates to patients requiring treatment
who have not been previously exposed to large pool concentrates.”
(Professor
Bloom and Dr Rizza).
“So
what are we? Are we human beings or are we just material?”
That rhetorical question,
posed by a campaigner in his oral evidence to the Inquiry, conveys the understandable –
and in many respects well-founded – feelings of many people with bleeding disorders who
were infected in consequence of their treatment with concentrates: that they were, often
without their knowledge or consent, objects of research.
The requirement for informed consent to participation in research is fundamental. It was
reflected in the terms of the Nuremberg Code in 1947, with the first principle that “The
voluntary consent of the human subject is absolutely essential.”
Similar stipulations were
set out in the 1964 Declaration of Helsinki. Where there is a therapeutic benefit to the
participant, the doctor should “obtain
the patient’s freely given consent after the patient
has been given a full explanation”;
where there is no therapeutic benefit, “The
nature, the
purpose and the risk of clinical research must be explained to the subject by the doctor.”
This section of the chapter examines: some of the research projects undertaken involving
the Oxford Haemophilia Centre; Dr Craske’s hepatitis studies; a hepatitis pilot study involving
Treloar’s, Newcastle and Oxford; a study of patients treated with concentrate for the first
time (“PUPs” – previously untreated patients); the culture of research within haemophilia
centres; a study undertaken at the Royal Free haemophilia centre; research in Edinburgh,
in particular Dr Ludlam’s “AIDS Study”; the immune studies undertaken in Glasgow; and the
Liberate trials in the early 1990s. It also considers the question of post-mortem research.
These various studies differed in nature from one other and each gives rise to its own ethical
considerations; this part of the chapter therefore requires to be read with care. However, a
number of general considerations arise. The evidence before the Inquiry has shown that
in the great majority of cases people were participating in research without full knowledge
and consent. The research described in this chapter did not lead to patient benefit. It did
not lead to safer treatment. Worse still, much was undertaken with no reasonable prospect
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of advancing the immediate personal treatment of the patient. It was often conducted in
ways that were unacceptable. Patients were frequently viewed as research subjects rather
than first and foremost as individuals with varying clinical needs whose informed consent
should have been central to the studies that were undertaken. Patients were regularly
monitored for the presence of diseases that might be transmitted by their treatment. Blood
samples were taken from them repeatedly without any clear explanation of what they were
for. Samples were retained, without the knowledge and consent of those whose blood it
was. There is limited evidence of any kind of effective oversight by ethics committees in the
1970s and early 1980s.
There were four major failings in relation to research:
(a)
Research was conducted when it exposed patients to a greater risk of harm than
they should have faced, in the light of the best available medical knowledge at the
time, without there being any commensurate benefit for them.
This was done without (i) (in many cases) telling patients that research was being
conducted, and (ii) (in most cases) giving the patient sufficient information on risks,
benefits and alternatives to enable consent to be properly given. On occasion it is
clear that it was imposed on the patient concerned, as where one clinician wrote to
another to seek their permission to conduct the research on one of their patients,
or to thank the other clinician for having given it with no record of the patient having
been consulted.
Patients were unaware that they were the subjects of studies and (in particular) of
prospective research, such that:
When results were received which showed that those patients had become infected,
or had seriously compromised immune systems, they were not told. They did not
know to ask, because they did not know they had been tested.
(b)
(c)
(d)
These failings were aggravated by the way in which previously untreated patients – in
particular children – were sought out to become the subject of research, and in some
cases to be given treatments which were unnecessary, or conferred no advantage but only
additional risk. The ethics of this are clear. It was, and is, unacceptable.
The treatment of children
Around 380 children with bleeding disorders were infected with HIV. Many of those died
in childhood or young adulthood, having endured a level of pain and fear that no child or
young person should ever have to face. Some survived but have lived their lives under the
shadow of HIV and AIDS, with an appalling toll on physical and mental health. All those
children infected with HIV were also infected with Hepatitis C. Others escaped HIV infection
only to learn later that they had been infected with Hepatitis C, sometimes with deadly
consequences. Those who survive have suffered profound ill health and endured the horror
of the early treatments with interferon. Some were also infected with Hepatitis B.
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This section of the chapter looks at the available evidence about treatment practices at
seven paediatric haemophilia centres, and then at evidence of how children were treated at
general haemophilia centres.
The way in which children were treated is so problematic that it is difficult to summarise; this
section of the chapter requires to be read in full.
The seven paediatric centres whose policies and practices are examined are: Alder Hey;
Birmingham Children’s Hospital; Royal Manchester Children’s Hospital; Royal Belfast
Hospital for Sick Children; Great Ormond Street Hospital; Royal Hospital for Sick Children
(Yorkhill); Bristol Children’s Hospital; and Sheffield Children’s Hospital.
More information is available for some of these centres than for others. It is in particular
plain that the treatment regimes at Alder Hey, Yorkhill and Birmingham Children’s Hospital,
where commercial concentrates were the mainstay of treatment, were utterly unacceptable.
It is plain also that most clinicians responsible for children with haemophilia did not pay
sufficient regard to the dangers to their patients. They had all the information they needed to
do better. They did not use it and as a result children suffered.
The comparison between Alder Hey and Sheffield on either side of the Pennines is telling.
At Sheffield, Dr Lilleyman expressly sought to use cryoprecipitate because he foresaw that
using products made from the plasma of much larger numbers of donors who were from
foreign countries would create more risk of infection. There appears to have been a huge
difference in outcome.
The treatment of children with bleeding disorders at general (non paediatric) haemophilia
centres reveals an equally disturbing picture. The chapter looks at a number of individual
cases in order to try to understand how so many children came to be infected with fatal
viruses. The examples discussed reveal that, in general haemophilia centres, just as in the
paediatric haemophilia centres:
• Children were treated with factor concentrates without their parents having been
provided with any (or sufficient) information about the risks of treatment. They were
thus treated without informed consent having been given. It was unconscionable
to treat children with concentrates capable of transmitting serious viruses without
explaining those risks clearly to their parents.
• Children were treated with factor concentrates when cryoprecipitate would have
been a significantly safer option. Consideration was not given by those treating
them to reverting to cryoprecipitate in response to the risk of AIDS.
• Children were treated with imported commercial concentrates, which were rightly
understood to carry a greater risk of infection.
• Children were treated on a prophylactic basis, thus increasing their exposure to
viral infections.
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• Children were treated with concentrates even where their haemophilia was mild, or
where they did not have a bleeding disorder at all.
• In the general haemophilia centres there was no clear or consistent understanding
of who was to be regarded as a child for treatment purposes. That will no doubt
be surprising to those reading this Report. It might be thought that it is obvious
that “child” encompasses those who are under 18. However, for the purposes of
centres’ treatment policies, the position is much less clear-cut. Children were,
in effect, treated like adults, often after the age of four or five (or in some cases
whilst still babies).
The Inquiry has received many more statements detailing the treatment of children in
haemophilia centres, which raise similar issues and themes to the cases discussed in the
chapter. This evidence, taken together with the evidence relating to the way in which children
were treated at paediatric haemophilia centres, point to a single, inescapable conclusion:
that children were not treated in a way that prioritised their safety above other considerations.
Ethical failings: consent and testing
The final section of this chapter examines the evidence relating to informed consent, testing
and how people were informed that they had been infected.
The evidence before the Inquiry overwhelmingly establishes that people with bleeding
disorders were not properly advised of the risks of hepatitis or AIDS. They had the right to
know that factor concentrates might infect them with a serious or fatal disease for which
there was no treatment. Parents had the right to know that such treatments might infect their
children. In practice, either they were given no information at all about such risks, or they
were falsely reassured that the treatments were safe.
The evidence further shows that, in many (although not all) haemophilia centres, testing for
HIV in the mid 1980s and later for Hepatitis C was undertaken without the knowledge – and,
it follows, without the consent – of patients (or in the case of children, their parents).
One of the consequences of people not being told that tests were being undertaken, quite
apart from the affront to their personal autonomy, was that the results of such testing then
came out of the blue.
The evidence before the Inquiry shows that there was no uniform approach to people being
told that they, or their child, had been infected with HIV or with Hepatitis B or C. It is right to
acknowledge that some were told in person, as they should have been, and that attempts
were made to explain the position to them and to help them understand on the basis of
the (sometimes limited) information that was then available. In some instances testing was
undertaken soon after it became available and there were no significant delays before the
results were communicated. But for many more that was simply not the case. Some were
told in groups. Some were told by letter. Some were told casually, in passing. Some were not
told at a special appointment, but at their next routine visit: one problem with that approach
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was that people, unaware that they had been tested, would not attend for the appointment,
and thus remained ignorant of a positive test result. Some were not told at all for years.
Some of the evidence which the Inquiry heard from clinicians sought to explain that the 1970s
and 1980s, and even the 1990s, were an era of clinical paternalism, where things were done
differently – one implication being that they should not be judged by the standards of today.
However, a different perspective was offered by the expert panel of medical ethicists who
provided a written report to the Inquiry and gave oral evidence over two days in January
2021. There are, as the experts told us and as the Report also finds, certain fundamental
ethical norms and principles which lie at the heart of medical decision-making and doctor/
patient interactions. Of central importance to this Inquiry are the principles of respect for
autonomy, beneficence (the imperative to do good – “you should promote people’s well-
being”) and non-maleficence (“you shouldn’t harm people”).
It was unethical and wrong that people were not told the risks of factor concentrates. The
failure to do so resulted in people being treated without their informed consent.
It was unethical and wrong that people were not told that they were being tested for HIV or
for hepatitis. The failure to tell them was a denial of their personal autonomy.
It was unethical and wrong that people were not told, or not told promptly, of the result of
such tests. As explained by the ethics experts, “once
a diagnosis is known by the doctor,
then the doctor needs to inform the patient because … without that information the patient
cannot actually exercise their autonomous choice about what to do next and what kind of
treatment to explore and they will need accurate and transparent information about this
particular diagnosis, even if it means doing nothing.”
A culture of paternalism, a “doctor-knows-best” attitude, may explain some of these ethical
failures, but it does not excuse or justify them.
4.3 Pharmaceutical Companies
This chapter describes:
• the supply of plasma and the donor pool used in the commercial manufacture
of blood products imported into the UK, including the inspection and control of
plasmapheresis centres and the use of plasma from prisoners and groups selected
on the basis of having a high titre of antibody to Hepatitis B;
• the pool sizes used in the production of commercial blood products;
• labelling and product information, in particular warnings given (or not given) about
the risks of infection with hepatitis and AIDS;
• the response to the emerging threat of AIDS in the period between the first reports
of AIDS in 1981 and the isolation of HTLV-3/HIV in April 1984;
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• the approach taken to measures which might reduce the risks of transmission of
AIDS, such as enhanced measures of donor screening and exclusion, surrogate
testing, and the recall of products manufactured from plasma obtained from a donor
known or suspected to have developed AIDS.
The focus of the chapter is on how these issues affected blood products that were made
available to NHS patients in the UK.
In the period relevant to the Inquiry, the main commercial Factor 8 products sold in the
UK were: Hemofil (manufactured by Hyland/Travenol, licensed in the UK from 19 February
1973); Kryobulin (manufactured by Immuno, licensed in the UK from 22 March 1973);
Profilate (manufactured by Abbott/Alpha, licensed in the UK from 22 May 1975); Factorate
(manufactured by Armour, licensed in the UK from 25 March 1976); and Koate (manufactured
by Miles/Cutter, licensed from 27 August 1976). It is pointed out in the preface to the
chapter that the use of these names is for easy readability: it needs to be borne in mind
that UK companies importing, licensing and distributing products were not themselves the
manufacturers: distinct companies in the US and Austria were; and although some of the
same names may be in use today a number of the companies sharing those names have
ceased to exist during the period covered by the Inquiry.
Estimated figures for annual UK sales from the commercial manufacturers obtained by the
DHSS in 1983 showed that total usage of commercial Factor 8 products had risen over the
previous seven years from 10.6 million international units to between 42 and 48.5 million.
Plasma and donors
In the early 1970s increases in demand for blood products and limitations on domestic
supply and regulation resulted in American companies seeking blood and plasma from what
were then low-income countries. Plasmapheresis centres supplied US companies from
Nicaragua, Mexico, Belize, the Dominican Republic, Costa Rica, El Salvador, Colombia
and Haiti. The US Government then decided to transfer responsibility for regulation of the
blood industry to the FDA, which led to the possibility of greater intervention and inspection
(although a 1995 report of the US Institute of Medicine was critical of the FDA’s regulation
of blood products in the early 1980s, in particular that it had failed to take a proactive
approach, had relied too heavily on the pharmaceutical industry, and did not adequately
use its regulatory authority). The inspection regime was introduced in around 1977. Various
sources of evidence suggest that in the 1970s sources of plasma outside the US or Europe
were used in the production of some factor concentrates. As manufactured product might
have a shelf life of two years, concentrates derived from plasma imported into the US and
manufactured in 1978 might still have been in use as late as 1980. By 1983 the position had
changed: when the DHSS collated the responses of pharmaceutical companies to questions
about their plasma supply, Armour, Alpha, Travenol/Hyland, Miles/Cutter and Immuno all
confirmed that their plasma came from plants in the US or Europe that were licensed by the
FDA, and that the origins of their plasma were identifiable.
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The evidence shows that both Hyland and Cutter obtained plasma from plasmapheresis
centres in US prisons in the US, and used that plasma to make factor concentrates.
Contemporaneous documents record that prison plasma accounted for 2% of the total
plasma collected in the US as of the middle of 1982 and was obtained from six to eight
centres. Three prison centres were included in a list of plasma sources in a document dated
8 February 1983 included in the UK product licence application for Koate. That inclusion
strongly suggests that plasma from the prisons was used in blood products that were
licensed for use in the UK. The investigative film-maker, Kelly Duda, explored much of the
evidence relating to prisons in Arkansas and has given evidence to the Inquiry that many
inmates told him of the extent of subterfuge that was practised in order to enable them to
earn a few dollars by selling their plasma.
Prisoners were undoubtedly a high-risk group. It is highly likely that prison blood conveyed
blood-borne disease; that it is likely to have contributed to the spread of hepatitis, both
Hepatitis B and non-A non-B Hepatitis, amongst users of commercial concentrates, and that
previously unidentified infections such as HIV were transmitted through this route.
Plasma companies sought out gay men as donors because their plasma was rich in Hepatitis
B antibodies: it was termed “hyperimmunised”. In August 1982, in response to the risk of
AIDS, Hyland and other companies were urged to refrain from using plasma to make factor
concentrates where that plasma had most likely been obtained from gay men. In December
1982 Dr Michael Rodell, vice president, wrote that Hyland had stopped using such plasma
for factor concentrates: “Within
the past several months, we have made a commitment to
withhold from AHF
[antihemophilic factor]
manufacture any plasma obtained as a result
of specific recruiting activities aimed at the gay community … we no longer allow this
plasma to enter those pools leading to AHF manufacture.”
An internal Cutter memorandum
of 30 August 1982 recorded that: “Until
recently, Cutter’s anti-HBs plasma (all collected
from centers dealing predominantly with homosexuals) has been used in the manufacture
of coagulation products.”
Evidence shows that three of the four major US pharmaceutical
producers of concentrates were using plasma from donors at very high risk of Hepatitis B
until August or September 1982. Any product made before then would remain available for
distribution and used for another two years.
The licensing authority in the UK would be aware of the sources of the products which had
been declared as part of the licensing applications seeking permission for distribution in this
country. Though there is evidence therefore that they knew that some plasma was sourced
from US prisons (in the case of some manufacturers), there is nonetheless no evidence
that the authorities were alert to the particular heightened risks that this posed. Nor is there
evidence that the licensing authority or the DHSS more widely had been told of the use of
hyperimmunised plasma, or at least that it too might end up being used in the manufacture
of factor concentrates, as well as vaccines for Hepatitis B.
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Pool sizes in pharmaceutical companies’ products
In February 1984, the size of donor pools was discussed at a meeting between civil servants,
American and British fractionators, clinicians and scientists:
“it
was pointed out that the pool sizes used by the commercial fractionators ranged
from 1,000 to 10,000 litres of plasma, though sometimes pools were combined
at the cryoprecipitate stage, giving a possible maximum of 20,000 litres of
plasma equivalent. The average volume collected from plasmapheresis donors
was 680 ml, with a minimum pool size of around 1,500 donors and maximum of
around 30,000 donors. The maximum pool size used by NHS producers is 1,000
kg of
[cryoprecipitate – corrected by hand to plasma],
incorporating material from
about 5,000 donors.”
This is consistent with other evidence considered by the Inquiry. The minimum pool size
(1,000 litres and around 1,500 donors) may refer to the approach taken by Armour and
possibly Immuno; a maximum of around 30,000 donors is broadly consistent with the figure
given in
The Lancet
for heat-treated Profilate produced by Alpha; combined plasma pools
containing 20,000 donations is consistent with the evidence concerning Cutter.
When evidence of large pool sizes is combined with the purchase of plasma from the
cheapest sources, and the policy of using residual material from hyperimmune plasma to
make concentrates, it is fair to say that commercial concentrates fully deserved the reputation
they had had since the start of the 1970s as being riskier than domestic concentrates,
and far riskier than single-donor cryoprecipitate. It is unsurprising that they were a principal
source of HIV infection in the UK.
Product labelling and information
There were three elements to the product information provided for factor concentrates.
Most visible was the text used on the packets and labels for the products. The amount
of information conveyed in this way was naturally limited by the space available and so a
longer exposition was contained in the product leaflet that would be included as an insert in
the package. The third element was the data sheet, which could be provided independently
of the product, for example to clinicians who wished to know more about it. Data sheets
were similar in length and detail to the product leaflet but were not necessarily identical. The
evidence of those pharmaceutical representatives involved in the licensing process in the
1970s and 1980s is that the product information was intended to be read by the clinicians
responsible for prescribing the products, and was not intended for patients.
All the pharmaceutical companies told the UK licensing authority, at the time of licensing,
that their products carried a risk of transmitting and thus causing hepatitis. It was not hidden.
There was a contrast when it came to the risk of AIDS, when warnings were much less
emphatic. However, Alpha did issue a press release on 7 January 1983 warning of a risk
that its products might transmit a virus which caused AIDS.
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Two of these leading pharmaceutical companies issued warnings in starker form than the
others: thus the warning on the Hemofil bottle was unqualified (“The
risk of transmitting
hepatitis is present”)
although the package leaflet was less clearcut, and to the effect that
the risk of hepatitis was “unknown”. Cutter advised in respect of Koate that the presence of
hepatitis virus “should
be assumed”:
this was the clearest and starkest warning. Immuno,
Abbott/Alpha, and Armour used formulations which could be read as suggesting that their
product was really not very likely to transmit hepatitis. Thus Immuno said the risk “cannot
be entirely excluded”,
and by these words which suggested it could largely be excluded
(coupled with references to “healthy” donors and to having tested all donations for hepatitis
associated antigens) conveyed a picture of minimal risk. Abbott/Alpha described that tests
had been negative for the presence of hepatitis, but not “all
units”
of “potentially” infectious
plasma could be detected so the risk (the inference is, only a little) was “still
present”
(their
later data sheets did however advise the use of single-donor products where possible);
and Armour, in common with Immuno and Alpha, began by emphasising the precautions
taken to render the product safe before saying that despite those the product “may
contain
causative agents of viral hepatitis”;
and rather than say, as Cutter did – “assume there is a
risk” – it said, in a roundabout formulation that “freedom
from the causal agents of hepatitis
cannot be assumed.”
Haemophilia clinicians, and the licensing authority, either knew of the risks of non-A non-B
Hepatitis or should have done. The warnings were addressed to them. If they had been
read by a patient receiving home treatment, it is highly unlikely they would have understood
that if they used the product there were risks to their health. It was for their clinician to tell
them of these risks. However, though factor concentrates were distributed through hospitals
and clinics, some clinicians who did not regularly care for people with bleeding disorders
might use them and they would not necessarily know of the risk if they were not alerted by
a product warning. In the absence of wording to the effect that it should be assumed that
a virus was present which would cause hepatitis, with potentially serious consequences,
which could not be excluded by any available test, the warnings about hepatitis were
therefore inadequate for the UK market. They did not sufficiently identify a risk of non-A
non-B Hepatitis by referring generally to hepatitis, especially in the case of warnings which
spoke about the product having been tested and found non-reactive, for testing could not at
the time have extended to non-A non-B Hepatitis.
Although the pharmaceutical companies involved in the production of concentrates did not,
with the exception of Alpha, acknowledge in public until well after the start of 1983 that there
was a real risk that AIDS might be transmitted or caused by using factor concentrates, they
nonetheless were (or ought to have been) well aware of this risk. Evidence suggests that by
March 1984 Alpha’s product sheets spoke of the possibility of “AIDS causative agents” being
present in and transmitted through the product. For Cutter, the earliest product warning
which the Inquiry has been able to identify is also from March 1984. The Inquiry has an
extensive selection of data sheets and product leaflets relating to Kryobulin produced by
Immuno in the early and mid 1980s, though, and none mention AIDS, HTLV-3, LAV or HIV.
Nor were there warnings in the product literature identified by the Inquiry for Factorate and
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High Potency Factorate, Armour’s products, in this period. Warnings could have been given
earlier. They could have been given on product data sheets. If the very firms whose products
were said by many third parties to be most implicated as being potentially causative had
confirmed that, as they themselves also saw it, there was a realistic case that they might
indeed be linked to AIDS this would have been a powerful reaffirmation of the risk.
The response to AIDS
Two measures in particular were considered of importance by the CDC in late 1982 and early
1983: the exclusion of high-risk donors and surrogate testing. Pharmaceutical companies
were amenable on the former but, with the exception of Cutter and to a lesser extent Hyland,
resistant on the latter.
In December 1982 the pharmaceutical companies were asked to commit to avoiding
collection centres in “high risk” areas and to improve the education and screening of donors
from “high
risk populations”
– gay men, Haitians and intravenous drug users.
Alpha was the first of the companies to take significant measures in this respect, in December
1982. The measures taken on donor education and exclusion had a rapid and significant
effect. Within the first three weeks, 308 gay donors had been excluded. By the summer of
1983, 800 potential donors had “voluntarily
disqualified themselves from the pool.”
These
steps were prospective, affecting plasma that was yet to be collected and processed, not
that which had already entered the system. There is no evidence identified by the Inquiry
to show that previous plasma donated by the donors who were excluded as a result of the
enhanced screening was discarded, or that product was recalled. This means that although
Alpha is to be applauded for taking the steps it did at some apparent cost to its business,
the claim to have taken “all
possible steps”
cannot be taken literally. The other companies
subsequently adopted their own enhanced screening measures, including those in respect
of questioning those who came to sell their plasma and medical examinations. Hyland did
so in late January or early February 1983, and Cutter and Armour in February 1983.
In 1982 and 1983 various surrogate markers were suggested, discussed and studied. Anti-
HBc testing came to be regarded, and argued over, as the most likely surrogate test, not
least because the epidemiological pattern of AIDS was considered to be similar to that of
Hepatitis B. With the notable exceptions of Cutter and Hyland, pharmaceutical companies
joined with most blood banking organisations in opposing such tests. Surrogate testing was
raised at the Blood Products Advisory Committee meeting on 3 and 4 December 1982,
where the minutes recorded “a
sense of urgency because of the continuing spread of AIDS
and because of its long incubation time.”
However, the committee did not recommend
any immediate changes in regulations or regulatory activities, instead noting that several
investigations were being “intensely
pursued”
by the relevant agencies, organisations and
companies. Surrogate testing was raised again at the public meeting in Atlanta on 4 January
1983. Shortly afterwards, on 14 January 1983, the National Hemophilia Foundation called a
meeting bringing together pharmaceutical companies, blood bankers, regulators, the CDC,
clinicians and the National Hemophilia Foundation. Before the meeting, representatives of
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the major fractionation firms and the American Blood Resources Association met together to
determine their strategy. This was to seek to delay the implementation of surrogate testing,
by arguing that although they accepted the concept it should wait until a more specific test
was available. The attendees at this meeting agreed that “whenever
possible we would try
to deflect activity to the NIH
[National Institutes of Health]/FDA” rather than the CDC which it
was agreed “was
getting increasingly involved in areas beyond their area of expertise”.
The
companies’ concerns about the impending introduction of surrogate testing were not realised
at the meeting. The recommendations from the National Hemophilia Foundation’s Medical
and Scientific Advisory Committee were for, “Evaluation
and implementation (if verified) of
surrogate laboratory tests that would identify individuals at high risk of AIDS transmission.”
The immediate request was, therefore, for more research. This approach – accepting
the potential value of surrogate testing but emphasising the need for further research –
was maintained by the majority of the US pharmaceutical companies and blood banking
organisations until HTLV-3 was isolated and a specific test for it had been developed.
Product recall
In response to the question of what was to be done over the recall of batches of concentrates
that contained a donation from someone known or suspected to have developed AIDS, the
pharmaceutical companies were united in adopting and encouraging consideration on a
case-by-case basis, rather than the introduction of firm rules or guidance from the FDA that
would result in a policy of automatic recall in given circumstances.
The decision to leave recall to be decided on a case-by-case basis was effectively to permit
the distribution of product where there was not only a known risk that it might cause AIDS,
but an enhanced risk of this happening. It was almost a year before the first commercial
products heat treated to inactivate HIV were made available on a named patient basis,
not yet licensed, in the UK. In the meantime, UK patients remained exposed to risks that
products made from the plasma of donors showing some of the symptoms of AIDS or its
precursor would be distributed in this jurisdiction.
4.4 Haemophilia Society
The Haemophilia Society was formed in 1950 by a small group of volunteers, with experience
of the largest haemophilia treatment centres. The Society gained significant media and
political traction but had limited resources. Its views on treatment and risks were effectively
dictated by a small number of senior and influential haemophilia clinicians, in particular,
Professor Arthur Bloom.
The Society is open to criticism for not urging the risks of non-A non-B Hepatitis more
strongly; and for retreating to the comfort of the status quo so far as treatment policy went
when first faced with considering the risks of AIDS that factor concentrates clearly presented.
Though it did not have sufficient expertise to challenge the views of Professor Bloom, which
were so influential in 1983 and early 1984, it gave a platform for those views to be voiced,
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without asking questions about them so it could better understand their basis. It could and
should have asked those questions. It is clear, however, that the Society was not given the
full facts which Professor Bloom knew, including that on 26 April 1983 he had reported a
patient to the CDSC as a probable case of AIDS. His behaviour in misleading the Society
and its members is “unfathomable”.
The Society opposed any ban on importing commercial concentrates from the US. The
Executive Committee appears to have accepted without serious question that any form of
haemophilia was more dangerous than AIDS. In August 1983 they wrote to the DHSS asking
that there should “be
no attempt to suspend the importation of US Commercial Products
[without]
definite evidence that this would be necessary.”
For some time after the start of
September 1983 the Society did not convey generally to its members what the evidence
shows to have been some growing concerns about the position it had adopted. It had
adopted it in good faith, in reliance on what Professor Bloom was saying, but doubts were
developing. It failed to pick up what should have been increasingly clear from other sources.
Members were being told that – although they should take the advice of their haemophilia
consultants – they should continue with their current treatment regimes; there was no urging
of government, nor of the regulator, to revisit whether permission for importation should
continue. The Society did not warn members that their haemophilia centre might be using
pre-March 1983 stocks of blood product, and they should seek to have only products from
plasma sourced after that date. Nor did it advise treatment policies which would lessen the
risks of infection. It continued the approach that “factor
VIII concentrates must continue to
be imported from the USA”.
By 1986 the Society was campaigning for compensation for people infected with HIV, and
sought advice about its members’ prospects in litigation. The Society shared the advice
that those prospects were weak with haemophilia clinicians, and government officials. This
may have been part of a strategy to secure some money from government sooner for a
greater number of people. It was not unreasonable to adopt this strategy, though it might
have been preferable simply to point to the difficulties in the way of success (leaving open
at least some possibility of it) rather than express a considered legal view that in the light
of those problems there was no chance. It happened that the strategy almost certainly
resulted in sufferers receiving some money much earlier than they otherwise would have
done, and did avoid the risk that individuals might fail altogether in their claims. It was bold,
but it worked – to an extent. Nonetheless, sending a negative opinion of Counsel to leading
haemophilia clinicians remains an indefensible action, potentially harmful to some members
of the Society whilst giving no benefit to the others.
The Society was slow in reacting to the risks of Hepatitis C and probably unduly hesitant in
beginning to mount a campaign for it. However, the fact that it did so, and that it was well
served by Karin Pappenheim (the CEO of the Society) in this respect, ultimately bore fruit
especially when it focused on Scotland as a part of the UK that might be more responsive
to its arguments.
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These criticisms must be seen in the context of a small charity, whose volunteer Executive
Committee consisted of members most of whom had haemophilia and were using
blood products.
Volume 5 What happened and why?
After examining clinical practice in Blood Transfusion over the relevant periods (chapter
5.1) the volume examines one of the ways in which the risks of infection could be
reduced – screening.
Before HIV and Hepatitis C became identifiable by a laboratory test, the only ways in
which the chances of these infections entering the blood supply could be reduced were by
selecting donors as carefully as possible, relying on them to say if they thought they had any
illness (often in both cases with the help of a donor questionnaire or more general leaflet)
or by some other laboratory screen which might identify either that the would-be donor had
signs of having or having had an infection closely linked to groups thought to be at high risk
of either or both HIV or non-A non-B Hepatitis (surrogate screening). In both cases, when
direct tests became available time was taken before they were universally applied to all
donations given in the UK. Thus a direct test of HIV was available (to a limited extent) in
July/August 1984, but universal screening was not introduced until 14 October 1985. In the
case of Hepatitis C, a test (a “first generation” test) became available first in April 1989, but
universal screening in the UK did not begin until 1 September 1991 (by which time a second
generation test had become available and was used). Undoubtedly, therefore, appreciable
time passed in each case between a test being available, and being applied. The chapters
consider whether this was appropriate, or whether it represented a delay which should
not have occurred.
5.1 Blood Transfusion: Clinical Practice
This chapter examines clinical practices relating to blood transfusions and the adequacy
of the steps that were taken to reduce the risks of viral transmission through transfusion. It
should be read in conjunction with, in particular, the chapters on the
Blood Services.
Despite the knowledge of the risks of viral infection arising from blood transfusion, in the
UK in the 1970s and 1980s blood was often administered by clinicians without a detailed
consideration of the risk to patients of transfusion-transmitted infections. Further, the
evidence of patients, clinicians and academics, demonstrates that from the 1970s to
1990s blood was given to some patients unnecessarily. Either a transfusion was not strictly
required, or patients were given more blood than they needed.
Prior to the emergence of HIV, the minority of clinicians who pressed for a reduction in the
use of blood transfusion, did not reflect mainstream medical practice and the administration
of blood was wrongly seen by many to be low or no risk. It took until 1998, with the creation
of the Better Blood Transfusion initiative, for a UK-wide framework addressing the best
practice for blood transfusion to be established and a concerted effort to be made to reduce
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unnecessary blood transfusions. It appears that there was a level of complacency about the
safety of blood resulting in measures not being taken earlier throughout the UK to improve
the overall safety of blood transfusions. It is clear had such measures been taken earlier, it
is likely that lives would have been saved.
In 1951 Professor Patrick Mollison published the textbook that became known as the “‘bible’
of blood transfusion”.
It stated that, in treating anaemia, it must “never
be forgotten that
transfusion carries risks which are large compared with those of conservative treatment.”
Dr George Discombe’s 1960 textbook highlighted the danger of hepatitis as one that “must
never be forgotten when assessing the need for transfusion.”
He described the “very
common”
use of blood transfusion for treating pre-operative anaemia as “inexcusable”. In
1967, Professor Mollison’s updated book emphasised that pre-operative transfusions “could
be avoided if it were a routine practice to determine the patient’s haemoglobin concentration
at the time when operation is first considered, as there would then more often be time to
treat the anaemia with iron, etc.”
Despite this recommendation, the evidence received by
the Inquiry suggests that pre-operative iron was not commonplace. In the 1983 edition,
Professor Mollison noted that a higher percentage of women than men were transfused
after an operation involving blood loss “because
there is a tendency to use the same level of
haematocrit (or Hb) in women as in men in deciding whether transfusion is required. There
would be a substantial saving in blood if the normal difference in haematocrit between men
and women were taken into account in deciding the need for transfusion”.
On the ground, it appears that, despite the training received and the content of medical
textbooks, in the 1970s and 1980s many UK clinicians viewed blood as safe and effective.
On the whole – and with notable exceptions – there was generally a liberal approach in
practice to the use of blood. This was especially the case in certain medical disciplines.
With the advent of AIDS there began to be a change in attitude on the safety of blood.
Dr Roger Moore, the deputy national director of the NBTS from 1989 to 1992, explained that:
“Originally
the benefits of a blood transfusion had been seen as overwhelming compared
with the risk. A patient either had a certainty of dying at once of blood loss or a vague
possibility of an infection years into the future. The advent of AIDS changed perceptions,
patients and their doctors were very concerned about getting AIDS from a transfusion, the
risk/benefit equation changed.”
In the circumstances of high-volume, acute blood loss, it is clear that blood transfusions
were and are necessary. However, from the 1970s a so-called “top
up”
of one or two units of
blood after labour was commonly given to women even with minor blood loss to help get a
woman “up
and about”
and caring for the baby. Professor Mollison’s 1983 edition described
“topping up” as “widespread” but with “very
variable opinions as to what constitutes an
acceptable level”
of haemoglobin. This practice extended to using two units where one
would suffice and appears to have been both widespread and persistent. A 2017 study of
two large maternity units in Texas and London found that from 1988 to 2000 obstetricians
prescribed two units six times more than one unit “even
when the
[estimated blood loss]
and
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pre-transfusion haemoglobin suggest that one unit would be sufficient”.
It was noted that
this practice “continues
to deviate from recommended guidelines”.
Topping up blood with two units was also customary for some general and orthopaedic
surgeons. In the 1985
Principles and Practice of Surgery,
the transmission of viral hepatitis
was described as “the
most serious and frequent complication of the administration of blood
and blood products … The best preventative measure is to avoid unnecessary transfusion.”
It noted that the use of haemoglobin and haematocrit measures was “notoriously
misleading”
and the best approach to assessing haemorrhage was frequent clinical observations.
Dr Lorna Williamson told the Inquiry that the Hepatitis C lookback revealed that “some
patients who had planned surgery did not know whether or not they had been transfused
while under anaesthetic.”
The Inquiry has received many statements where individuals state
that they were not informed of the risks of blood transfusions, and others where they were
not even told that they had received blood and for many it was not recorded in the medical
records that were retained after their hospital stay.
Many of the alternatives to blood transfusions used today only became widespread in the
2000s. However, iron supplements were available well before the 1970s, and could have
replaced transfusion, where that was not essential. It is unclear why they were not used more
widely much earlier. Tranexamic acid assists in clotting and is effective in major trauma. It
“cuts
surgical bleeding by about one third to one quarter and has an excellent safety profile.”
It was sometimes used in the 1970s in dental extractions and other procedures for people
with bleeding disorders. Evidence that tranexamic acid prevents surgical bleeding, reducing
the need for blood transfusion, has only been available “for
over a decade”
but although
tranexamic acid is now much more widely available and there are NICE (“National Institute
for Health and Care Excellence”) guidelines for its use, usage still appears to be lower
than it should be.
Significant steps to address the use of unnecessary blood transfusions were not taken until
the 1990s and beyond. It is not clear why. The CMOs should earlier have added their weight
in a “Dear Doctor” letter advising doctors to be sparse in their use of transfusions of red
blood, and where possible to take advantage of alternatives.
The measures eventually taken include the creation of specialist working groups and
committees (leading to greater awareness amongst practitioners, and ultimately to haemo-
vigilance); auditing (with comparisons of blood usage); maximum blood ordering schedules
(standardised for specific procedures); hospital transfusion practitioners; hospital transfusion
committees; the establishment of the Serious Hazards of Transfusion (“SHOT”) which
reports on infections and other adverse effects, and the Better Blood Transfusion initiative.
In June 1998 Sir Kenneth Calman, the English CMO, noted that the emergence of vCJD
had “caused
concern for patients and the public”
about the safety of blood. The UK CMOs
together hosted a conference in London in July 1998 addressing how better blood transfusion
might be encouraged and supported. This was the origin of the Better Blood Transfusion
initiative. The most recent conference held in March 2019 acknowledged that “Over
the last
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10 years there has been considerable improvement in transfusion practice supported by
evidence from clinical trials, implementation of guidelines and process improvements that
have resulted in an overall reduction in blood use and significant cost savings for the NHS”.
It also noted that: “However,
there is evidence of ongoing variability in transfusion practice
within and between hospitals that may impact on patient outcomes needing further action”,
and made a number of recommendations.
The fact that the National Blood Transfusion Committee has demonstrated by audit that
around 20 to 30% of transfusions in major specialisms are currently outside the national
recommendations shows that there is still work to be done, despite a considerable reduction
in the use of red blood cells over the last 25 years.
For too long and despite repeated advice, blood and blood components were given too
readily, were frequently given in too great a quantity, with insufficient consideration of
whether they were needed, and little or no consideration of alternatives which had less risk
(not being biological products) such as tranexamic acid, pre-operative iron, or intra-operative
cell salvage. Most importantly perhaps, little or no advantage was taken of the opportunity
to discuss the desirability of transfusions, their risks and benefits, and any alternatives
(including no transfusion) with patients. Though plainly in emergency circumstances this
may not be practicable, this should have happened in almost all other cases.
Too much blood was given unnecessarily to patients. This was particularly problematic
in the treatment of pregnant and postpartum women and in non-emergency surgery. The
risks of transfusion were rarely discussed with patients. The widespread failure to warn
patients of the risks of infection meant that they were not alert to the signs of what in too
many cases turned out to be Hepatitis C. Responsibility for this rests generally with the
profession. Alternatives to transfusion were not used enough – with responsibility resting
with the profession, the health departments and the blood services.
In summary:
• Over many years blood was used unnecessarily, being wrongly seen by many
clinicians to be little or no risk. There was an unacceptable level of complacency
about the safety of blood.
• The unnecessary use, and overuse, of blood was particularly problematic in the
treatment of pregnant and postpartum women and in the undertaking of non-
emergency surgery.
• It took until 1998, and the creation of the Better Blood Transfusion initiative, for a
UK-wide framework addressing best practice in transfusion to be established and
a concerted effort to be made to reduce unnecessary blood transfusions. This, or
something as effective, should have happened earlier and there is no good reason
why it took so long for coordinated action to be taken.
• Earlier action could and should have included the issue by CMOs of “Dear Doctor”
letters or health circulars regarding both overuse of blood and the use of alternatives.
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• There were measures that could and should have been introduced earlier than they
were: audits of blood usage; the creation of maximum blood ordering schedules;
and the engagement of specialist transfusion practitioners.
• Hospital transfusion committees should have been established earlier than they were.
• There was (and remains, particularly in regard to tranexamic acid) insufficient use
of alternatives to transfusion: in particular iron supplements, tranexamic acid and
red cell salvage.
• SHOT, or a similar haemovigilance scheme, should have been established
earlier, in the 1980s.
The measures outlined above would, if addressed earlier, have reduced the level of infection
and (in all likelihood) have saved lives.
There was a widespread (and wrong) failure to warn patients of the risks of transfusion,
and of alternatives, where they could reasonably have been warned, both so that they
could give informed consent and so that they could be alert to, and take steps with regard
to, the possible health consequences of the treatment. Many transfusions (whether on an
emergency basis or because of a serious long-term condition) were undoubtedly necessary,
but even in such cases patients should have been given information about the risks of
viral transmission so that they too could be alert to the possible consequences and take
appropriate steps to mitigate those consequences. In all cases transfusion could and should
have been properly recorded in patients’ medical notes.
Screening
The next four chapters examine the decision making regarding surrogate screening
for Hepatitis C, surrogate screening for HIV, the introduction of HIV screening and the
introduction of Hepatitis C screening.
5.2 Hepatitis C Surrogate Screening
The virus responsible for NANBH, later identified as Hepatitis C, was not discovered until
1988, and a specific test to screen blood donations was only introduced in September 1991.
In the absence of a specific test, there were alternative methods to lessen the risk of
transmitting NANBH through blood transfusions through the usage of “surrogate” markers.
The primary markers considered were elevated ALT, which indicate liver abnormalities,
and Hepatitis B core antibody (“anti-HBc”), which signifies a past infection (a known factor
in exposure to NANBH), either applied separately or in tandem. Blood was already being
screened for Hepatitis B surface antigen to identify active infections of Hepatitis B.
The principal issues for consideration were: whether screening out blood donations with
raised ALT levels and/or positive anti-HBc results would reduce the likelihood that transfusion
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recipients would be infected with NANBH; and whether the drawbacks of introducing such
screening (reducing the number of donors) justified the anticipated benefits.
The chapter concludes that the UK’s approach to the question of whether to introduce
surrogate screening of blood donations for NANBH was flawed. Responsibility for this lies
with both the blood services and with the government (both the DHSS and the SHHD).
A major study in the US, which had prospectively followed 1,513 transfusion recipients
between 1974 and 1979 was published in April 1981 in the
New England Journal of Medicine.
It found that the incidence of hepatitis was directly related to elevated ALT levels in blood
donors. The authors advocated ALT screening due to its “high
correlation”
with transfusion
infectivity. A further study the same year from the US National Institutes of Health published
a report in the
Journal of the American Medical Association
which showed similar results.
Though it was thought that some 40% of NANBH infections could be excluded by testing
for these higher ALT levels, the downside was that fewer units of blood would be available
for transfusion generally, because a number of donors who did not in fact carry NANBH
would be excluded. The authors of this study described the situation as a “tenuous
balance
between risk and benefit”
and one that would require thought and planning.
By early 1982 US and Australian research suggested that screening for elevated ALT or
anti-HBc could potentially prevent over a third or more of NANBH infections.
In the UK, in September 1982, a newly formed working party on Transfusion-
Associated Hepatitis (which knew of these American and Australian studies) agreed that
Dr Brian McClelland would produce a study proposal on surrogate screening methods.
There was evidence that nothing then came of the proposed study, due to attention being
taken up with HIV/AIDS, and the working party did not meet again until November 1986.
The chapter deals with repeated discussions after that, in some detail, which are best
summarised in this chronology (beginning before the US research from the long prospective
studies was published, and taking matters up to 1988):
• On 14 February 1980 research was called for to identify the size of the problem of
NANBH in relation to blood transfusions.
• On 25 June 1981 a proposal for a prospective study was present; nothing happened.
• On 27 September 1982 it was agreed that an outline study protocol would be
produced; nothing happened.
• On 10 January 1983 an outline proposal was produced (again) – and it was agreed
some form of study was needed; nothing happened.
• On 25 April 1986 the regional transfusion directors’ meeting discussed whether the
NBTS should carry out a study; nothing happened.
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• In May 1986 Dr Contreras (the director of the North West Thames RTC) wrote to the
DHSS saying that a study of anti-HBc in British blood donors should be undertaken.
• On 4 September 1986 a study was discussed again between Dr Fraser (Bristol) and
Dr Cash (Scotland) and on 18 September 1986 Dr Contreras wrote again to the DHSS.
• On 8 October 1986 the regional transfusion directors for England and Wales proposed
a prospective study; Dr Gunson wrote a paper to suggest this; no study took place.
• On 24 November 1986 a working party proposed to “consider
a protocol”.
• By January 1987 what was being considered was now an approach for funding to
undertake a study. There was no funding, nor had any study yet begun.
• Some four months later, at the very end of April, a funding proposal was submitted.
A year passed waiting for a decision.
• In June 1987 Dr McClelland, Professor Cash and Scottish transfusion directors
accepted in a letter that the benefit from surrogate testing could not accurately be
established without a large prospective UK study. However, they noted that it was
now too late to begin such a study, since an answer would only be given from the
study in 3-4 years time.
Much of the failure of the Scottish transfusion directors to persuade the SHHD that surrogate
testing should be introduced related to the view taken by Dr John Forrester of the SHHD.
He said, in the second half of the 1980s, that NANBH was “relatively
benign”.
There was no
proper basis to say this, other than unjustified assumption.
The letter from Dr McClelland, Dr Cash and the Scottish transfusion directors gave three
reasons why the introduction of NANBH surrogate screening was “virtually
inescapable”:
European legislation on strict product liability; enhanced safety of pooled plasma products
(pending the introduction of heat-treated products); and consumers wanting NANBH-tested
products. The authors emphasised that the question was not if but rather when the UK
transfusion services would align with US and European practices in donor screening.
By the time the multi-centre study started, the Chiron Corporation had made significant
advances by identifying and cloning the NANBH virus (now known as Hepatitis C), and
developing a prototype immunoassay: it was reported they had done this on 10 May 1988.
While surrogate screening for NANBH remained a possibility, in practical terms the focus
shifted towards implementing a direct test for Hepatitis C.
There remained some purpose in surrogate screening, notwithstanding the impending
availability of direct tests. In September 1989 Dr Gunson prepared a paper (this time for the
Advisory Committee on Transfusion Transmitted Diseases (“ACTTD”)) recommending that
routine screening of anti-HCV should be introduced when practical.
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The ACVSB (a separate body from the ACTTD) supported the general introduction of the
Chiron test if approved by the FDA, but saw no justification for using surrogate tests for
NANBH, effectively ending the UK’s consideration of such measures.
Throughout this period there is little evidence of active involvement by the DHSS, the
CMO, or ministers. The lack of a clear structure for decision-making probably contributed
to this. Further, the disbanding of the MRC Working Party and the apparent failure of the
Blood Transfusion Service Working Party to meet more regularly over the period between
September 1983 and late 1986 resulted in there being no appropriate forum where the
important issue of surrogate testing could be discussed and resolved.
The unique epidemiology of NANBH in the UK compared to that of the US highlighted
the need for localised data, yet urgency for research into this was lacking, leading to
indecisive discussions about the necessity of surrogate screening. Unfortunately, the
discussion became circular: surrogate screening could not be justified without further study,
but the necessary further study could not itself be justified. The result was a paralysis in
decision-making. The failure to take timely decisions, to carry out further research into the
effectiveness of surrogate testing or to introduce such testing notwithstanding limitations
in the data, in order to prioritise patient safety, was coupled with a desire to search for
more knowledge as a prerequisite for taking precautionary action. This failed to address the
needs of public health with speed, and in searching for more knowledge was the enemy of
achieving progress in safety.
Whether to introduce surrogate screening for NANBH in the UK was a complex decision,
and the arrival of AIDS undoubtedly diverted attention between 1983 and 1986. However,
the complexity of the decision provides little or no justification for a failure to ensure that
timely decisions were taken – and implemented – around the need for further study and
data collection. While the AIDS crisis diverted attention and resources away from NANBH,
arguably, it should have brought into sharper focus the need to avoid delay in taking decisions
in the interest of patient safety, even where those decisions had to be made on the basis of
incomplete or limited information.
Would introducing surrogate testing sooner have made a difference? The answer is,
probably, yes. Dr Alter noted in November 1989 and again in 1998 that surrogate assays
for anti-HBc and ALT could have identified about half of the anti-HCV-positive donors linked
to hepatitis transmission in the US. It was this which led to the US introduction of such
screening. Similarly, a Canadian study found that 70% of Hepatitis C infections would
have been avoided by the use of the two surrogate markers, ALT and anti-HBc. The US
introduced surrogate screening for HCV in 1986. The chapter concludes that surrogate
testing could have been introduced in the UK in the first half of the 1980s, and that following
the publication of the research by Drs Alter and Dienstag in early 1986 there was no proper
justification for the failure thereafter to introduce surrogate testing in the UK no later than
January 1987, and probably by mid 1986.
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The chapter concludes that the case that surrogate screening should have been introduced
is stronger still when the evidence on HIV surrogate screening is considered. If anti-HBc
testing of donations had been introduced as a surrogate test for HIV, it would have also
functioned as a partial surrogate screen for NANBH.
5.3 HIV Surrogate Screening
Until the AIDS virus had been identified, it was not possible to test blood donations directly.
The only preventative measures included avoiding transfusions unless absolutely necessary,
minimising the use of blood or blood products, excluding high-risk donors, and employing
surrogate testing methods that indicate a high risk of infection.
During a meeting on 22 September 1983, RTDs recognised that no tests for AIDS were
available, but early data suggested that high-risk populations, such as promiscuous
homosexual men, could often be identified by positive result for Hepatitis B core antibody,
Hepatitis B surface antigen and antibody, and TPHA syphilis, with the Hepatitis B core
antibody potentially serving at the most valuable marker.
In February 1984 Dr John Petricianni of the FDA highlighted the US experience, claiming that
the anti-Hepatitis B core antibody was positive in more than 90% of AIDS cases. Later that
month Bristol RTC outlined a protocol for a study, proposing that 50,000 donors from Bristol
and Edgware would be screened for Hepatitis B core antibody to identify past infection and
correlate these with high-risk AIDS groups. Both the DHSS and the MRC were asked to
support the proposal.
By April 1984, Dr Gunson pushed for funding approval from the MRC and DHSS, emphasising
the importance of the study due to the potential pressures from US developments to
implement anti-HBc screening. The proposal was for a two year study to begin in November
1984. However, by summer 1984, developments in screening tests for HTLV-3/HIV indicated
that the study might already be outdated.
This lack of urgency in responding to the potential for blood transmission of AIDS was
problematic, especially given the emerging epidemic. Despite the potential for transmission
by blood and blood becoming apparent during 1982, research funding was only requested
in April 1984 for a study which would not conclude until November 1986. In the teeth of an
impending epidemic, this was far too slow.
The introduction of direct HIV screening in October 1985 was a significant advancement,
yet earlier actions to exclude high-risk donors were impeded by a lack of consensus on
costs and benefits. Donor leaflets were never likely to dissuade all high-risk donors. The
responsibility for these missed opportunities to screen out some high-risk donors rests with
the DHSS and the SHHD (primarily the former) and the blood services.
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5.4 HIV Screening
Only once the cause of AIDS was known to be a virus transmitted by blood and it was
possible to identify the virus itself, would it have been possible with any confidence to
eliminate the risks altogether, though they could be reduced.
On 23 April 1984 Professor Robert Gallo announced his identification of the HTLV-3 virus.
At a press conference that day the US Secretary of State for the Department of Health and
Human Services predicted that a test to screen blood for the virus would be available in
six months. By June 1984 five pharmaceutical companies in the US had been chosen to
manufacture blood tests. In the UK Dr (later Professor) Richard Tedder (Middlesex Hospital)
and Professor Robin Weiss (Chester Beatty Institute) also began developing a test.
The importance of a test soon was reflected in an internal DHSS memo on 10 July which
said that it was of “paramount” importance to maintain public confidence in the NBTS “by
introducing a screening test as quickly as possible”
and to “ensure
that ‘our’ blood is OK
by the most up to date means.”
The minute proposed that the DHSS should press those
concerned to proceed with research and development as quickly as possible (including
going to ministers for money), considered the operational implications of screening and
ended: “In
short we must give this top priority.”
The background to this was a wide and increasing public concern about the epidemic spread
of AIDS, and the fear that it might be a real threat within the UK as well as elsewhere.
By the end of August,
The Guardian
announced that a test had been developed.
The Lancet
reported that people with haemophilia receiving pooled concentrates in North London had
been tested and 34% showed positive.
At that time the test used was that developed by Dr Tedder and Professor Weiss. The
DHSS internal note shows it seemed “possibly
more reliable”
than other tests in the
US and elsewhere.
Yet it took more than a year until blood donations throughout the UK were regularly screened
to prevent HIV from entering the blood supply. It is not possible to determine how many
infections resulted, and how many deaths might have been avoided, within this period if
screening had been introduced earlier. The probability is that some would have been.
Screening is costly. In November 1984, the Minister of State for Health, Kenneth Clarke,
did not think that screening would be cost effective since there were so few AIDS cases. He
concluded that the use of the central reserve fund would be inappropriate, and that the cost
of any screening should be met by the existing budgets of regional health authorities.
An Advisory Group on AIDS met in November 1984. Though there was a unanimously
“strong
view”
that antibody tests for HTLV-3 “must
be used for all NBTS donors as soon
as possible”
there was (in the words of one participant) “no
clear picture of when or how a
serviceable assay will be provided.”
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A screening test to be applied to the many thousands of donations given in the UK each
year needed to be available in sufficient quantity – any prototype had to be capable of being
“scaled up” for production both with speed and without sacrificing its sensitivity or specificity.
On New Year’s Eve 1984, Alison Smithies of the DHSS set out the position to the CMO:
“It
is not possible to predict when this test will be available for universal use in the RTCs
because a number of scientific problems have to be overcome, but with luck it may be
available although less well validated at about the time that the test from the USA will be on
the market, that is in the first quarter of 1985.”
Since regional transfusion centres in the UK already used a radioimmunoassay (“RIA”) test
to screen for Hepatitis B, and had the expertise and equipment readily available to do this,
the DHSS favoured the UK test which was of an RIA type. The US test kits were all of the
enzyme immunosorbent assay (“ELISA”) type. The ELISA test was seen as the test of the
future – cheaper, more reliable, easier to scale up for mass production, and easier to us
and the evidence of Professor Tedder as to the position in January 1985 was that “we
were
already thinking that we needed to get away from RIA to EIA”.
Wellcome (the commercial
partners Weiss and Tedder had chosen to scale up the test) let it be known to them that it
would produce an ELISA, but not an RIA test.
Clinicians and transfusion directors pressed for early screening. Matters culminated in early
January 1985. There was a submission to ministers seeking approval in principle for a
screening test for AIDS antibodies in the NBTS, referring to the Tedder/Weiss test which was
by then being used at both the Middlesex Hospital and the Central Public Health Laboratory
at Colindale. Though the approval was granted in principle, it was at that stage that the
DHSS began to consider a need to evaluate the various tests available before introducing
any one of them.
There was then a period when little appears to have happened. The DHSS had decided to
evaluate available tests. Four weeks after this, the evaluation process had not yet started.
Matters were at the preliminary stage of “arranging” that tests should be evaluated. Three
weeks later the DHSS still spoke of “plans” to evaluate, on which “work
will be started as
soon as possible”.
By late in March there was no progress.
It was clear that the Wellcome test was not imminent; there had been a lack of understanding
about whether the test would be of RIA or ELISA type; and the results of the FDA evaluation
confirmed the desirability of some evaluation in the UK. But there was, overall, a need for
speed in the interests of patients’ safety and public health. The CMO began to confront these
questions. He went one Friday evening late in March to meet Dr Tedder, Professor Weiss
and Professor Michael Adler. They confirmed that though their test worked reasonably well
as a laboratory tool, adequate scaling up was still to be achieved if it was to be used. It
was agreed that it would probably be necessary for the BTS to go ahead and use the first
successful test that became available, which was unlikely to be the Tedder/Weiss test at first.
Though by April it had been decided that the evaluation (which had still not begun) should
take place in two stages – an initial laboratory stage, followed by a field test of those still
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considered suitable – a month later it had still not started. The CMO was told that in US and
Australia screening was already taking place; Finland had started it as routine; Switzerland
was beginning; France expected to start by July; and West Germany had started testing as
routine for the Red Cross and University Transfusions Services, and it was to be mandatory
there no later than 1 October.
By the end of May progress was still being expressed in terms that anticipated a start, rather
than reporting that there had been one. John Patten, the Parliamentary Under-Secretary of
State for Health, heard of this and entered the fray. He questioned the CMO “on
the overall
position and it is quite clear that Ministers need to know of the timescale for the evaluation
of the test and, if satisfactory, for the introduction of the test at every transfusion centre”.
His
intervention had some but limited success in galvanising matters. Evaluation began (at the
first stage); by mid July raw data had been obtained, and the results were reported at the
end of July. The second stage was dispensed with, and in August DHSS announced that
screening would begin on 14 October 1985.
NHS Blood and Transplant (“NHSBT”) submitted at the close of the Inquiry that it was “unclear
why it took around 4 months for the work of PHLS reviewing the tests to be completed”;
that
“Considering
the general agreement that testing be introduced as soon as possible, it is
unfortunate that the first stage of the review was not completed at an earlier stage”;
and
“Thus,
on the evidence currently available there is a case for saying that the first stage of
the review of the tests was slower than was necessary.”
The chapter concludes it was right
in these submissions. There has been no clear reason why an evaluation process could not
have been conducted in a much shorter timescale, as was appropriate to meet the urgency
of the situation. It took considerable time, not so much in the process of evaluation itself
once begun, but for it to begin.
It took a year from a test being developed to being used to test individual patients. This
does not seem consistent with urgency. In May 1985, the CMO had been advised about
the progress other countries were making and at that stage screening was already taking
place in the US and Australia, with Finland, Switzerland, France and West Germany. What
took most of the time was not the evaluation itself, rather the processes surrounding that
evaluation. The drafting of a protocol, consideration by potential applicants, organising and
then beginning the evaluation process took over five months. The overall timescale, including
the laboratory evaluations which then proceeded, could and should have been quicker.
The problems that proceeding with a test would create – whether to tell donors, the
availability of confirmatory testing, any hypothetical knock-on effect on the blood donation
system – were secondary. Blood safety should have been the priority. It was not.
5.5 Hepatitis C Screening
This chapter considers the progress of the UK towards introducing a universal screening
test, after the availability of such a test was announced on 21 April 1989. When the UK
introduced one on 1 September 1991 (two and a half years later) it was one of the last
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developed nations to begin the testing of all blood donations directly for the presence of
Hepatitis C infection. Many countries implemented testing on dates between 18 months and
12 months before the UK.
Chiron/Ortho test
The Chiron Corporation in California announced, on 10 May 1988 that it had cloned a protein
of the blood-borne NANBH virus. This made it possible to develop a test to screen blood for
the virus (now named Hepatitis C).
Once it was announced, it was clear that an effective screening test was likely to be available
soon. Preparatory work for the introduction of universal screening could have started
immediately. It is clear that the purpose of any such test was to identify infected donations.
It follows that what donors of those units should be told needed to be considered. Questions
of how best to confirm that the donation was or was not infected so that the implicated
donor could be given the most reliable information of their infective status would need to
be resolved. It could also be foreseen that when an acceptable test emerged, finance to
implement it would need to be in place. All of this work could have begun from May 1988
onwards. No such preparatory work was undertaken.
Hepatitis C testing in the UK
The identification of Hepatitis C and the fact that a test for it was under development gave
rise to concerns over the implications for the blood donation system in the UK. They began
to be discussed before a test became available, but in anticipation that it would. The UK
appeared to have fewer cases of post-transfusion NANBH than the US “without
any form of
donor screening.”
Issues also arose over whether central funding would be provided
An anti-HCV ELISA test was announced by Chiron/Ortho on 21 April 1989 in
Science.
It
was reported that the new test had a high level of sensitivity and specificity, with positive
results usually appearing three to six months after the transfusion believed to have caused
the infection. The article concluded that the “sensitive
test for HCV antibody described here
should improve the safety of the world’s blood supply as well as provide an important clinical
diagnostic tool.”
While evaluation of the Chiron/Ortho test for Hepatitis C was taking place a new body was
set up to give advice on the necessary steps for ensuring the virological safety of blood
in the UK. The new body was established and named the Advisory Committee on the
Virological Safety of Blood (“ACVSB”). At the same time the National Directorate of the NBTS
established a UK Advisory Committee on Transfusion Transmitted Diseases (“ACTTD”).
In May 1989, the ACVSB met and agreed that testing blood donations for Hepatitis C should
not be introduced until a UK trial had been completed. There was disagreement between
the members who regarded “the
matter to be a priority”
and the Department of Health which
sought to “keep
the issue of testing under review.”
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A further meeting took place on 3 July 1989. Dr Gunson tabled a paper on non-A non-B
Hepatitis screening in ten other countries and showed other countries were trialling or
planning to trial the Chiron/Ortho anti-HCV test.
On 26 August 1989,
The Lancet
carried two letters on the topic of “Screening
for Hepatitis C
Virus Antibody”.
The first, from Dr Contreras and Dr Barbara, acknowledged the Chiron/
Ortho test to be a welcome advance, but argued that “in
the context of donor screening,
precipitate action should be avoided.”
At “The First International Meeting on the Hepatitis C Virus” held in Rome on 14 and
15 September 1989, representatives from Europe and the US presented their preliminary
investigations into the Chiron/Ortho anti-HCV test. It was reported that it had rapidly been
introduced in a large number of blood transfusion laboratories throughout the world.
Dr Gunson attended and reported (to ACTTD) that although the studies presented were
small scale, they had consistently shown that the test was indeed detecting a viral marker
associated with Hepatitis C. He drew a number of conclusions from the information presented
at the symposium, including that “Evidence
presented suggested that routine anti-HCV tests
on blood donations would reduce the incidence of transfusion transmitted NANBH”.
He also
added that every effort must be made to ensure that a confirmatory test was available in the
UK at the time routine donor screening was introduced.
In November 1989 the ACVSB said it would support the general introduction of the Ortho test
“if
the FDA approves it, and the
[planned]
pilot shows it to be feasible and non-problematic.”
A submission was sent to Baroness Gloria Hooper, Parliamentary Under-Secretary of State
for Health, in February 1990, noting that the ACVSB felt there was not sufficient scientific
information about the Ortho test to advise its routine introduction. The submission did not
mention that at that point, Australia was introducing routine screening, France was about to
introduce it, and Japan had been screening since November.
By February 1990, Dr Frank Boulton of SNBTS expressed concern that “there
appears to
be little doubt that people have contracted HCV as a result of transfusions which they would
not have received had those transfusions been screened for HCV antibody.”
On 24 April 1990, the ACVSB decided not to approve the introduction of general screening,
but to commence a further pilot study: a confirmatory test was needed that could be used in
RTCs and not just specialised laboratories; it would be reassuring if the FDA approved the
test; and there was a need to learn more about the donor panels and the significance of a
positive reaction to the test.
The FDA approved the use of the Ortho test on 4 May 1990. The next ACVSB meeting
was held in July 1990, and the committee agreed, following the FDA decision, to introduce
screening in the UK as a public health measure (with the pilot study on the Ortho and Abbott
tests determining which test to use). The expected reduction in infections was not included
in the minutes, but Dr Metters, the Deputy CMO who chaired the ACVSB, stated later that
Professor Zuckerman “spoke
in terms of at least 30% of such cases could be avoided,
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possibly more.”
There was no need to wait for FDA licensing; the UK had not done so with
the test used for HIV, and could have evaluated the test for itself.
It had earlier been agreed that roll out of screening should take place on one and the same
date across the country. Following the decision, as recommended by the ACVSB in July
1990, Dr Gunson wrote to RTC directors in February 1991 informing them that the agreed
date to implement testing donations for anti-HCV was 1 July 1991.
On 3 April Dr Gunson wrote again to the RTC directors and Professor Cash, advising that
a “second-round” evaluation of anti-HCV test kits had been agreed (which, he said, was
“undoubtedly
in our interest”)
and that screening would now start on 1 September 1991.
Professor Cash replied that this later start date “has
the SNBTS Directors’ fullest support.”
David McIntosh of SNBTS said in evidence to this Inquiry that a “misplaced
desire for
Anglo-Scottish solidarity was the clear cause of the unnecessary delays in the universal
implementation of HCV testing in Scotland.”
He remains convinced “that
it was utterly
inappropriate and resulted in a sub-optimal outcome in terms of blood and plasma product
safety, to the detriment of patients in Scotland.”
There is little evidence that the public health benefits of testing were kept in the forefront
of decision-making during this period. Implementation of the less specific first-generation
tests in the first instance, with evaluation and introduction of the second-generation tests
undertaken at the same time as a national screening programme, would have avoided
additional infections with Hepatitis C.
In April 1991, Dr Huw Lloyd decided that Newcastle RTC should begin testing unilaterally.
He had a phone call with Dr Gunson on 29 April, explaining that he had started routine
screening in the previous week using the second-generation Abbott test. Dr Gunson reported
Dr Lloyd’s decision to the Liaison Committee of the UK blood services and informed the
Department of Health. It was noted that “This
action has caused problems in that the other
major competitor company feels disadvantaged, and has also caused problems in Scotland.”
On 2 May 1991 Dr Lloyd wrote to all RTC directors informing that in his view, “not
to test
now that we have the ability to test would be indefensible under the current Product Liability
Legislation.”
He noted that other directors might take a different stance but did not consider
that Newcastle’s decision would “materially
alter that judgement.”
In response to Dr Lloyd’s
decision, the evaluation of second-generation tests was modified to accommodate the
screening programme in Newcastle.
As for government, on 30 July 1991, John Canavan recommended to Baroness Hooper
that a “low
key announcement”
be released to mark the introduction of anti-HCV testing. He
noted that “there
may be questions about why testing was not introduced earlier as it was
in some other countries.”
As country after country introduced screening, the UK’s position
became increasingly indefensible.
The focus of the ACVSB had become obtaining more, and better, data, rather than the
public health implications of not introducing routine screening. Dr Robert Perry, in giving
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evidence to the Penrose Inquiry and this Inquiry, thought that the ACVSB was unduly biased
to virology and neglected the public health perspective. His observation was that “the
best
became an enemy of the good”
and that the search was for “perfect
outcomes rather than
good outcomes that could meet a public health need.”
It was reasonable for the SHHD to take the position initially that the decision to commence
routine testing would be made simultaneously throughout the UK. But they did not shift from
this stance and give proper consideration to going ahead with screening in Scotland.
Responsibility for the failure to ensure the timely introduction of Hepatitis C screening lies
primarily with the Department of Health, which was regarded as very much in the lead on
this issue. However, it is a responsibility shared with the SHHD, and with the blood services
more generally for failing to push for earlier introduction of testing.
There was no credible evidence to show that safety would or might be compromised by
introduction of the Chiron test in early 1990. Although there was room for scientific debate
about the accuracy of the test in identifying all cases of infection, that does not detract from
the fact that it still identified many. It would have saved many individuals from suffering with
infections, cirrhosis and some early deaths.
Mr Justice Burton concluded that universal screening should have been adopted by March
1990. This Inquiry agrees. Blood safety should have been prioritised. It was not.
5.6 HIV Lookback
The term “lookback” means identifying patients who were given blood from donors who
were later shown to be infected with a blood-borne virus. There were two different types
of HIV lookback:
• a reverse lookback – where a patient presented with AIDS and an investigation was
undertaken to identify whether the patient had received blood or blood products,
and if so from whom.
• a targeted lookback – where an infected blood donation was identified and recipients
traced to see whether or not they had been infected.
Blood was screened for HIV from 14 October 1985, at which time, the HIV lookback started.
The scope of the UK-wide HIV lookback was to consider five years prior to the date the
infected blood was given.
The lookback was organised centrally and began at the same time across all four nations.
The regions however experienced the lookback differently, with some regions requiring
significant amounts of work, whilst others required significantly less. There was no national
database that held the identity of blood donors and recipients, which meant that tracing blood
donations was time consuming and often required busy practitioners to search a donor and/
or patient’s medical records (that were often incomplete). Differing levels of enthusiasm and
engagement amongst clinicians resulted in different degrees of success in tracing patients.
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There was limited encouragement and support from the DHSS or the CMO for a formal
HIV lookback. No formal lookback scheme or policy was published. There was little to no
guidance produced to encourage clinicians to speak with patients about whether or not
they had donated blood, save for a brief note in a CMO’s “Dear Doctor” letter. In light of
the decentralised nature of blood services in the UK during the 1980s top-down guidance
or advice could have played a particularly significant role. As a result of this there were
disparities in the approaches adopted by RTCs in relation to HIV lookbacks.
Prior to the introduction of screening blood for the HIV virus, the only type of lookback that
could be undertaken was a reverse lookback. Until the introduction of a universal screening
test for HTLV-3 in October 1985 such lookbacks were reactive rather than proactive.
The HIV lookback emerged when Dr Galbraith contacted Dr Gunson in March 1984 about
problems that might arise when an AIDS patient had previously been a blood donor. A plan
was created that contained the steps that should be taken when a patient was diagnosed
with AIDS and had donated or received blood or blood products. The plan was subsequently
circulated by Dr Gunson at the RTD meeting on 11 April 1984. Around the same time
Dr Craske visited the CDC in Atlanta. Upon his return he provided an update to haemophilia
centre directors that the CDC believed that the incubation period for AIDS could be as
long as five years.
In late September/early October 1984 a blood donor was diagnosed with AIDS at Bournemouth
Hospital, which resulted in a series of lookback investigations to try and find the recipients of
his blood. Transfusions had been given to three recipients who had tested HTLV-3 positive.
The donor’s plasma was part of the source material for one batch of Factor 8 concentrate of
which 38 people with haemophilia in Wessex and South Wales had received.
Dr Patricia Hewitt noted that this was in accordance with the protocol agreed on 4 April
1984. She describes this as an example of a “necessarily
reactive rather than pro-active”
lookback due to the fact that screening was yet to be introduced.
The first meeting of the Advisory Committee on the National Blood Transfusion Service
Working Group on AIDS was held in November 1984 and it was agreed that donors should
be told that their donations would be tested for HTLV-3. Donors whose donations tested
positive should be informed, but there was no unanimity on how this should be done. The
follow up of, and communication to donors and patients, and contact tracing arrangements
were being considered by the communicable diseases division of the DHSS.
27
On 30 November 1984, Dr Craske outlined a new approach to be adopted for investigating
the cause of AIDS for people with haemophilia. Further investigations were to be focussed
on individuals with clinical features suggestive of AIDS and possibly contaminated
batches of Factor 8.
27
Referred to elsewhere as IMCD division.
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When EAGA met in May 1985, they discussed a paper indicating that people who received
counselling “modified
their sexual behaviour and that counselling also alleviated distress
and confusion.”
It recommended both brief counselling training and a more detailed course
“lasting
for a month for those intending to run their own AIDS counselling courses and those
responsible for a large number of patients with AIDS related problems.”
At the EAGA meeting in July 1985, Dr Gunson advised that screening could start in October
1985. Dr Gunson outlined the process the Centres would adopt if a blood donor tested
positive. The Centre would send a letter and an appointment arranged for the donor to be
interviewed “by
a doctor trained in counselling.”
Prior to the introduction of screening, 160
people were to be trained prior in counselling and it was hoped that by the time screening
was introduced there would be a number of individuals from different regions who would be
trained in counselling.
EAGA met on 26 November 1985 and was updated on the screening of donations.
Discussions were ongoing about increasing the number of training courses for counselling.
At the next meeting, held on 15 January 1986, no progress had been made in relation to
proposals to extend the counselling.
In April 1986 the CMO sent a “Dear
Doctor”
letter to all doctors in England in which he asked
clinicians to enquire whether any HTLV-3 patients had previously been blood donors. The
CMO stated that “it
would be helpful to discuss this in an appropriate confidential manner
with your Regional Transfusion Director.”
On 8 October 1986 at a meeting of RTDs, in the context of a discussion about participation
in an epidemiological study of patients who had received infected blood, proposed by
Dr Timothy Wallington of Bristol, the issue of “what
action should be taken about informing
recipients of HIV infected blood”
arose again.
By February 1992 it was noted at a meeting of DHSS officials, CDSC and Dr Gunson that
about 90% of all HIV positive donors who could be traced had been informed of their HIV
status and told not to donate again.
Dr Craske shared interim results from a retrospective study of HIV infections associated
with NHS Factor 8 and 9 at a UK Haemophilia Centre Directors’ Organisation meeting on
9 October 1986. He thought there was “under-reporting
from the Directors and about 30%
under-reporting of AIDS/ARC cases nationally generally to CDSC”.
By February 1992 it was noted at a meeting of DHSS officials, the CDSC and Dr Gunson
that about 90% of all HIV positive donors who could be traced had been informed of their
HIV status and told not to donate again.
Dr Kenneth Calman (CMO) wrote in April 1992 (after the Eileen Trust had been established
to provide financial support to people infected with HIV through transfusions) to a wide
range of clinicians and public health professionals. He asked for help in identifying patients
who might be entitled to payment. RTDs were asked to “check
their records and remind
consultants of any donations from donors subsequently found to be HIV positive.”
Dr Calman
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stated that the CDSC would write “on
a confidential basis”
to consultants who had already
reported cases to them.
There were limitations to the lookback: deficiencies in record keeping, no centralised
database of HIV positive donors and patients, reliance on previous donors returning (as a
way of identifying those who were HIV positive), lack of formal government guidance and
varying enthusiasm among clinicians.
Nonetheless, these shortcomings should not detract from the fact that the lookback operated
effectively to prevent a number of infections and, probably, deaths.
5.7 Hepatitis C Lookback
This chapter considers why a lookback did not take place on the date universal screening
began, as it had for HIV; and some of the difficulties and questions which arose
during the process.
From 1988 when Hepatitis C was first cloned and a test was likely to follow, the topic of a
national lookback was regularly raised, and deferred, in national committees. Many of the
individuals involved had experienced the earlier UK-wide HIV lookback but there was little
appetite for a national Hepatitis C lookback because of the cost and resource implications.
From 1 September 1991 blood donations in the UK were screened for Hepatitis C. By the
end of 1991 there was no agreement on full lookback, though identifying donors when a
patient presented with hepatitis was carried out on an ad hoc basis. Dr Jack Gillon, at the
South East Scotland Blood Transfusion Service, told the Inquiry that he found this situation
“entirely
unacceptable”,
highlighting the ethical need to inform affected individuals about
their potentially serious condition for better management and future treatment eligibility.
Dr Gillon was supported in undertaking a Hepatitis C lookback if he described it as a “pilot
study”
and published the results. The results from the first six months of his study showed
that 15 of the 20 donors found to be Hepatitis C positive were regular donors. There was
little evidence of false positives and all the recipients identified were Hepatitis C positive.
This pilot effectively demonstrated the feasibility and necessity of a lookback, since it
showed that infections could be discovered, people informed and treatment made possible,
as well as enabling individuals to adjust their lives in the knowledge of their infection and
its implications.
In December 1994 a submission to Tom Sackville, the Parliamentary Under-Secretary of
State for Health, set out the advice that a lookback programme should begin. It further noted
the need for “persuading
the Scottish Office to stay with a UK-wide approach”
due to legal
advice that they had received.
Later that month the Scottish Office wrote to SNBTS asking them to take forward “as
expeditiously as possible”
a Hepatitis C lookback for all of Scotland. The responsible Scottish
Office Minister, Lord Peter Fraser, informed Tom Sackville that the advice he had received
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“is
such that I consider that it is no longer a matter of policy but of legal liability, and that the
look-back should take place as soon as possible in Scotland.”
On 22 December 1994 a more detailed submission to Tom Sackville noted that around 3,000
people were believed to have been infected with Hepatitis C by transfusion, and a further
3,000 people with haemophilia through blood products. It shared the advice of departmental
lawyers that: “Secretary
of State may have a duty of care to do whatever can reasonably be
done to identify, inform, counsel and treat any who may have become infected as a result of
NHS treatment […] and if no such action is taken the SofS
[Secretary of State]
might have
a case to answer.”
Tom Sackville agreed to the recommended Hepatitis C lookback and agreement between
the three health departments was reached by 10 January 1995. The press release
stated that “procedures
have been established which make it possible to trace those at
risk”
and acknowledged that people who had received a blood transfusion before 1991
“may
be worried”.
A lookback working party met in January 1995 and agreed that the initial focus should be on
donors who had given blood before universal screening began in September 1991 and were
later found to be positive upon subsequent donations. It was decided not to pursue donors
who had not returned as the efforts required were deemed disproportionate to the benefits.
A helpline which had been set up told callers that the lookback “is
a process of identifying
patients who were previously given blood from donors who have since been shown to be
Hepatitis C positive.”
People may have reasonably understood that if they were not contacted
then they had not been infected. That impression was wrong: donors who did not return to
give blood were not identified and their donations may have transmitted Hepatitis C. The
CMO issued a “Dear Doctor” letter on 3 April 1995 with guidance and procedures for the
UK-wide lookback. There was no indication in the guidance that the procedures were limited
to donors who returned to donate again after 1991.
During the late 1990s the lookback slowly wound down as fewer cases were identified.
The lookback was less successful than it should have been largely because of delay. It
began in April 1995, four years after the blood of any identified donors had been given to a
recipient, making it harder to trace them. The lookback relied on testing the blood of repeat
donors who had returned after April 1995. The Inquiry heard that tracing other donors would
have involved contacting at least 200,000 people each year prior to 1991. The Scottish
Government thought it would be “logistically
extremely difficult”
and “any
benefit would
be disproportionate to the benefit required”.
While there were good reasons not to trace
donations given before 1991, the decision not to run an awareness campaign to offer testing
for all recipients of blood before 1991 was an error. This is especially so as the information
about the lookback exercise (for the public and GPs) appeared to suggest that anyone who
was infected would be identified. The Inquiry has heard evidence that individuals, and GPs,
assumed that if patients had contracted Hepatitis C they would have been informed through
the lookback. This was not correct, as individuals discovered when diagnosed at a later date.
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The Inquiry has heard evidence from women who, when they were identified through the
lookback, were mothers of young children and worried about how they might have infected
their children in the intervening years.
The Department of Health was essentially responsible for preventing Scotland from
introducing lookback earlier because that might expose other regions to litigation. Deliberate
delay is not prioritising the protection of patients, but rather working to the lowest common
dominator – the pace of the slowest. The lack of patient focus is fundamental to these
issues. A person who had received infected blood had a right to know this so they could
take decisions about their life, which were for them to make and not health professionals.
They had a right to know whether or not treatment was available for them. They needed to
know so that they could avoid harming others, and tell any others they wished about their
condition. The patient perspective – in particular their safety and autonomy – featured very
little in the various discussions.
There was no good reason for distinguishing Hepatitis C and HIV infections when it came to
lookback. The latter began almost immediately when there was universal screening. There
is no good reason why the same approach was not adopted for Hepatitis C.
The responsibility for this delay lies mainly with government. The Department of Health, the
blood services in England and the National Blood Authority were principally responsible for
this. The administration in the devolved nations could be forgiven for following their lead –
though a concern for public health in their own nations should have led them to press for
more action to resolve the paralysis of decision-making.
5.8 Public Health
This chapter traces the history of organised public health in the UK, from the middle of the
nineteenth century. It also considers the functions of the PHLS and CDSC.
The chapter notes that a substantial reorganisation of the NHS took place in 1974 with health
functions transferring to regional and area health authorities and health boards. The newly
established regional and area health authorities in England and Wales, and health boards
in Scotland, were to be responsible for a range of services contributing to the prevention,
control and treatment of communicable disease. The statutory powers for communicable
disease control, however, remained with the local authorities, although these were “with
weakened capacity and complex working arrangements with new health authorities.”
It
has been suggested that “the
loss of the Medical Officer of Health was a grave strategic
error, because he was a person of importance, influence, with substantial independence
in the local authority and he was powerful … The public health voice was weakened by
this reorganisation.”
The Expert Report to the Inquiry on Public Health and Administration
agreed with this.
High-profile communicable disease control failures in the 1980s – the 1984 salmonella
outbreak at Stanley Royd Hospital and the 1985 Legionnaires’ disease outbreak in Stafford
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– spurred the formation of the Committee of Inquiry into the Future Development of the
Public Health Function, chaired by CMO Sir Donald Acheson. The report of this committee
noted that both the events leading up to its establishment and the AIDS epidemic “remind
us of the crucial continuing need for an effective system for the prevention, surveillance and
control of communicable disease and infection.”
It identified key problems that emerged
after 1974: unclear statutory responsibilities, ineffective cooperation between health and
local authorities, divided accountability and other issues within the office of the medical
officer of health (“MOH”), and a general confusion about roles and responsibilities. The
report found a “set
of measures which have evolved over time and which taken together,
have created a system which is complicated and at times unclear, even to those who have
to operate it. To others it can be positively baffling.”
Less than 15 years after a former CMO (of England) had reported on the future of the
public health function, another CMO, Sir Liam Donaldson, went to press on the same topic,
though with an even greater focus on communicable disease prevention. The opening
words of the executive summary of his report
Getting Ahead of the Curve: A strategy for
combating infectious diseases
express the view that the basis on which the 1974 reforms
had been made had been mistaken, at least so far as communicable disease control was
concerned: “Infectious
diseases have been a threat to people’s survival, health and well-
being since human life began. Post-war optimism that their conquest was near has proved
dramatically unfounded.”
He went on to say: “One
important issue is the scale of emergence
of new or previously unrecognised infectious diseases. Since the early 1970s at least 30
previously unknown infectious diseases have become prominent, for which there is no fully
effective treatment. Infectious diseases recognise no international boundaries, so that a
newly emergent disease in another part of the world must be assessed as a potential threat
to this country.”
This report emphasised that “It
is essential to expect the unexpected”
and that “Good
surveillance, early assessment of potential problems and strong contingency plans are
clearly essential if we are to recognise them early and respond efficiently to minimise their
impact.”
Its proposals led to the establishment of the Health Protection Agency in 2003.
There is wide agreement in the evidence to the Inquiry that public health protections
reduced significantly after 1974, as a consequence of the mindset that led to the changes
made in the health service reorganisation of that year – that the threat posed by infectious
disease had largely been overcome; that the emphasis now should be on protection by
promoting lifestyle changes (health promotion), rather than the less individual dangers of
communicable disease (health protection); that the need for expert medical epidemiology at
a local level had lessened and would diminish further.
A consequence was as the Expert Group on Public Health and Administration have identified
in their report to the Inquiry:
“Public
health services in the UK have been the target of several major
reorganisations in the last 50 years, which have been associated with budgetary
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cuts, closures, and loss of staff and expertise. The sheer number and scale of
reorganisations has inevitably been extremely disruptive, firstly weakening, and
then removing, communicable disease control at local level and, from 1990,
increasing marketisation and outsourcing. The overall effect has been to make
public health services more fragmented and less cohesive, reducing the number
of specialists, particularly those with medical training, and also reducing the
overall expertise of the workforce.”
A system which had been largely effective, and admired internationally, in which the MOH
of a local authority had a central role to play in protection against the spread of infectious
disease was partly dismantled when the post of MOH was abolished in 1974. A number
of respected commentators reflect similar views about the weakened nature of the public
health response to infectious disease after 1974, and have given broadly similar views about
what might be required to put this right. Thus, in 1981 Dr Galbraith (of the CDSC) identified
a need for there to be a clinical epidemiologist in each district, alongside the district medical
officer, and thought that the resulting local epidemiology units should be linked through
regionally located specialist epidemiologists to a national specialist unit, thus providing a
degree of coordination between local identification and control of disease and the national
centre that had been lacking. In 1982, the chairman of the PHLS Board observed that:
“As
there are now so few Medical Officers (Environmental Health) with substantial
experience of communicable disease control in post, active intervention
by PHLS laboratories is playing an increasing part in the investigation and
control of infectious disease incidents and such intervention in several places
simultaneously requires co-ordination … As the incidence of infectious diseases
decline, not only does knowledge and competence to diagnose and control them,
but the need for vigilance increases as herd immunity diminishes.”
By 1986, the Acheson Report identified the adverse effects of the 1974 changes on public
health protection, complaining of its effect on the morale of community physicians, the
reduction in the number of posts, and uncertainty about the number and nature of future
jobs. The evidence put to his committee suggested that this continued uncertainty was
likely to mean that fewer able doctors would in future enter the specialty. As a result, health
authorities, local authorities and the public could lose access to appropriate public health
advice. The Acheson Report called for an increase in the number of consultants in public
health medicine. Despite these ambitions the numbers in post had dropped to 405 (less than
half the number per million of the population which the Acheson Report had recommended)
by 2021. The same theme of unease at the readiness of the system nationally to face
serious threats of infectious disease was repeated in Sir Liam Donaldson’s 2002 report.
In short, it is impossible to avoid the conclusion that the control of communicable disease
by public health measures was given less value in the years 1970 to 2000 than it had been
given earlier; suggesting improvements to the system did not reach ears as willing to listen
as they would have been in the 1940s and 1950s when the systems in operation to control
communicable disease worked well.
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5.9 vCJD
This chapter does not seek to replicate the work of the BSE inquiry – rather it traces the
steps taken by government in response to the risk that vCJD might be transmissible by
blood or blood products.
Bovine spongiform encephalopathy (“BSE”) was first confirmed in cattle in September
1985 at a farm in Sussex. Further cases followed, rapidly rising in number. By April
1990 a Spongiform Encephalopathy Advisory Committee (“SEAC”) was set up to advise
government: and the National Creutzfeldt-Jakob Disease Research and Surveillance Unit
(“NCJDRSU”) to monitor cases of CJD.
On 8 March 1996 Dr Robert Will and Dr James Ironside formally identified that BSE had
crossed from cows to people, becoming known as vCJD.
By 16 September 1997, the SEAC had considered the results of two studies due to be
published in
Nature
and accepted this evidence of the link between BSE and vCJD.
Although the primary candidate for transmitting the disease was eating infected beef, it
was theoretically possible that it might be transmitted between humans through blood. The
CMO issued a statement on 6 October 1997 that three people (and possibly a fourth) who
had suffered from vCJD had been blood donors. The statement noted that “there
is no
epidemiological evidence to suggest that classic CJD has been transmitted between humans
through blood transfusions or the use of blood products. However we do not know whether
the same will apply to nvCJD
[new variant Creutzfeldt-Jakob disease].” BPL identified that
between them these donors had provided seven donations of plasma, six of which had
been included in fractionation pools for the production of blood products. Recipients of the
products made from pools containing this plasma had not been notified and a debate began
as to whether they should be told of the risks they now faced.
A meeting of the Advisory Committee on the Microbiological Safety of Blood and Tissue
recommended that when the blood services were informed of confirmed cases of vCJD
the recipients of any donation from those people would have to be traced – as well as
continuing with the vCJD lookback. This meeting also debated whether to inform recipients.
The decisive reason for not doing so, in the chair’s view, was “whether
we could do anything
about a situation”.
Disagreement about this continued for the next seven years.
There was no such debate about recall. On 30 October 1997 the National Blood Authority
stated that it had recalled albumin and Factor 8 from 26 sites in England on the basis that a
blood donor who had developed vCJD had contributed to that batch.
By 1998, precautions were being taken to reduce the risk of transmission of vCJD through
blood: screening donors to exclude riskier donations (from 1 August 1996 blood transfusion
services throughout the UK had been required to ask all blood donors whether they had a
family history of CJD, and if so not to give blood); recalling and destroying blood products
linked to donations from someone later found to have had CJD; a look-back to check if
people with CJD had themselves received blood or blood products and if donations from
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people later shown to have CJD had caused symptoms in recipients. In July a £70 million
programme of removing most of the white blood cells from blood destined for transfusion
was started (following the advice of SEAC): this process, leucodepletion, became universal
in the UK by October 1999. In November a £30 million programme began to phase out
UK-sourced plasma for the manufacture of blood products; using recombinant factor
concentrates as the first choice of treatment for some people with haemophilia or, if not
available, concentrates made from plasma collected outside the UK; contacting the small
number of people who had received donations of blood from donors known subsequently to
have developed vCJD to advise them appropriately.
Some of these precautions involved considerable expense and effort. Yet the risk of
transmission through blood or blood products was still purely theoretical. By contrast
with both clinical and governmental reaction to the risk of AIDS in the early 1980s, the
lack of conclusive proof was not used to justify inaction. Rather, the approach was to act
first, just in case.
In December 2002 the Department of Health purchased the largest remaining independent
plasma collector, the US company Life Resources Incorporated, to ensure continuity of
supply without needing to rely on UK sourced plasma. This step was taken before the first
case of a person known to have contracted vCJD from transfusion was reported.
On 17 December 2003 the Secretary of State for Health, Dr John Reid, informed Parliament
that earlier in the autumn a patient who had received blood in March 1996 from an infected
donor had died. That donor had died some three years later of vCJD. Dr Reid explained that:
“In
the light of the facts which I have outlined, it is therefore possible that the disease was
transmitted from donor to recipient by blood transfusion, in circumstances where the blood
of the donor was infectious, three years before the donor developed vCJD, and where the
recipient developed vCJD after a six and a half year incubation period. This is a possibility
not a proven causal connection.”
This possible case led to further precautionary measures:
15 people who had received transfusions of blood from donors who subsequently developed
vCJD were informed. People who had received blood products made from human plasma,
and were concerned, were invited to call NHS Direct.
Less than a week later research findings were published which suggested a prevalence
of infection of about 1 in 4,000 people, albeit from a study of limited size. This stimulated
reconsideration of whether people who received blood from a donor later found to have
vCJD should be notified, and whether to notify members of high-risk groups so that they did
not donate blood, or have surgery without telling the surgeon of the increased risks.
The advice from the NHS Executive to NHS medical directors in February 1998 was that
ethics experts and advisory bodies believed there was no need to inform patients of their
exposure because it was thought unlikely that vCJD would be transmitted this way; there
was no diagnostic test for vCJD; and there was no preventative treatment for vCJD: “In
these circumstances the general view is that patients will not benefit from this knowledge,
and that uncertainty created by informing patients could have the contrary effect causing
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unjustified worry and creating a permanent blight on their lives in relation, for example, to
obtaining life or health care insurance.”
The advice then added that it was for individual
clinicians to decide whether to follow the ethical advice.
The Advisory Committee on the Microbiological Safety of Blood and Tissue had agreed
that “in
the spirit of openness”
and “contracts
with donors”
the blood services would need
to consider telling, or offering to tell, the donor why their blood could not be accepted.
However, discussions with such donors were to be managed on a case-by-case basis, and
the appropriate health department contacted in the first instance. A protocol to deal with this
was to be developed.
This Inquiry has heard evidence about Mark Buckland who was infected with vCJD
in September 1997 in his early 20s as a result of receiving a blood transfusion during
surgery, informed of the risk that the transfusion had transmitted vCJD in January 2004
in circumstances where this had been known since August 2000. That information should
have been provided sooner.
People with a bleeding disorder were informed by their haemophilia centre in September
2004 that they were at risk of having received blood products, given an opportunity to
discuss the implications and to find out if they had received an implicated batch.
By January 2005 the Health Protection Agency reported that approximately 4,000 people
with bleeding disorders had been told they were at risk from vCJD. It had identified 12
other patients who by reason of their conditions and exposure to plasma products were
at sufficient risk to be notified. By this time nine plasma donors who were known to have
developed vCJD had been identified. Their 23 blood donations had been made into 187
batches of various plasma products.
By July 2005 it was known that three patients had developed vCJD almost certainly as a
result of receiving blood transfusions. Between them, they had received the blood of 110
donors. Those donors were then traced, and advised that they should not give any further
donations, nor should their tissues or organs be donated. In January 2007 a fourth case of
vCJD transmission was associated with blood transfusion and reported to the press.
At this point none of the identified cases related to a person with a bleeding disorder.
However, on 7 September 2009 it was confirmed that a post mortem carried out on a man
with haemophilia found the vCJD prion in his spleen. He did not die of vCJD; nor was it
present in the brain. However, the probability was that he had been infected and that the
likeliest cause was his treatment with a plasma product. An early report of this case in
The Sunday Telegraph
on 15 February 2009 prompted an update to people with bleeding
disorders that “The
information from this case does not change the public health ‘at risk’
status of any patients with bleeding disorders”.
By the middle of 2014, it appeared that the worst fears of a rapid rise in the number of cases
of vCJD had not been realised. As of the date of this report, there have been 178 cases of
vCJD in the UK and no new case of vCJD has been identified since 2016. No one now living
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in the UK has been diagnosed with vCJD. There have been five known cases where vCJD
was spread through the transfusion of blood or blood products.
On the day the BSE Inquiry report was published in October 2000, the Government announced
a fund to ensure improvement in the quality of care for victims of vCJD. It also announced
a compensation scheme to operate through a special trust fund. This scheme was set up
in April 2001 and interim payments of £25,000 were made on an ex gratia basis to families
of people diagnosed with vCJD. The scheme was to be administered by an independent
body, the vCJD Trust, and provide payments of up to a maximum of £55 million for the first
250 cases with a discretionary fund capped at £5 million. In addition, the Government would
pay an additional £50,000 to each victim or their family, to take account of legal and other
difficulties the first families had had to encounter and the additional pressures they had
faced. It was chaired by a serving High Court Judge.
There are two important differences between vCJD on the one hand, and HIV and hepatitis
on the other. People infected with vCJD did not have experience stigma of the nature
endured by people infected with HIV in particular, but also by many with Hepatitis C; and
they did not have to wait so long for substantial financial support, or a public inquiry.
Other differences highlight the inadequacies of the response to HIV infection in particular. In
the case of vCJD significant, and expensive, precautionary and protective steps were taken
to prevent transmission through blood and blood products.
In the face of unknown diseases which were potentially transmissible by blood the
government was able in the 1990s and early 2000s to demonstrate that taking a proactive,
precautionary approach could avert much disease – it will have left many people infected
and affected by Hepatitis C or HIV both disappointed and angry that such an approach
could not have been taken in response to earlier blood-borne infections.
Volume 6 Response of Government and Public Bodies
Volumes 3, 4 and 5 have set out to answer the questions “What happened and why?”. The
remaining chapters of the Report focus on the response of government and public bodies to
the infection of so many people with hepatitis viruses and HIV.
6.1 The Initial Government Response 1985-1988
This chapter focuses on the first three years after the introduction of both HIV screening and
the viral inactivation of blood products, at least so far as HIV was concerned. It describes
how the Macfarlane Trust originated.
The Government decided against any form of “compensation” to people infected with HIV
at an early stage. On 25 February 1985, Kenneth Clarke, Minister of State for Health,
stated, “There
has never been a general State scheme to compensate those who suffer the
unavoidable adverse effects which can unhappily arise from many medical procedures.”
The
characterisation of AIDS, with high mortality and lack of treatment, as one such “unavoidable
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adverse effect”
was ill-considered and demonstrated some lack of curiosity about what had
actually happened. It set the tone for the Government’s response for many years.
By 1986 the suffering of people infected with HIV through blood products was plain to see
with children, parents, partners, siblings experiencing horrific physical and mental suffering,
and dying, while their families desperately tried their best to care for them.
In January 1987
The Northern Echo
began a campaign (described as “the
public cry for
justice”)
seeking compensation. It anticipated that a number of people were preparing to
take legal claims against the Government, a health authority, or a treating doctor.
In May 1987 the Haemophilia Society’s
Haemofact
publication sought to make clear its
“unanimous
and strong view”
that people with haemophilia who were HIV positive deserved
special financial support from the Government. Irrespective of legal responsibility, it
argued that the Government had a “clear
moral duty”
to provide recompense. Meanwhile,
Dr Smithies, attending the UKHCDO’s AIDS Group meeting on 11 May, responded to a
question about compensation by saying that there was “no
government scheme at present
nor were there any plans for setting up such a scheme. Patients who felt they had a case
would have to apply for compensation through the courts.”
The House of Commons’ Social Services Committee had announced an enquiry into AIDS
in November 1986 and as it neared the end of that process it heard on 13 May 1987 from
the Secretary of State (Norman Fowler), the Minister of State (Tony Newton) and the CMO.
In relation to compensation Tony Newton suggested that it was very difficult to discern a
basis to distinguish between “medical
treatment with blood products given in good faith
and without negligence and medical treatment of any other kind that results in an injury
or prolonged disabling condition … there has never been a general state scheme in this
country to compensate those who suffer the unavoidable adverse effects which may arise
from some medical procedures.”
The Committee’s report, when published, noted the
Government’s position but suggested that “Calls
for compensation for haemophiliacs and
others who have become HIV positive as a consequence of infected blood transfusions and
for special life insurance arrangements for haemophiliacs deserve careful consideration.”
At a press conference in June 1987, Tony Newton, asked why there was a refusal to provide
compensation, answered that “we
see it very difficult to draw distinctions between people
who experience, say, a tragic problem of this kind in this way when the treatment is on the
best available knowledge and in good faith, and medical accidents that can occur in other
ways.”
However he began to have doubts about the continued position against compensation
in the summer of 1987.
On 7 July 1987 a submission from Dr Roger Moore referred to the Haemophilia Society’s
campaign, which was expected to launch in September, and advised that in anticipation
of increased pressure officials were examining ways of “compensating
haemophiliacs as
a special case.”
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On 26 August Tony Newton wrote to the Secretary of State, John Moore, that it was “quite
clear that we will be under considerable parliamentary and public pressure after the recess
to do something for infected haemophiliacs … It will be emotive and highly charged.
I would expect it to attract considerable support on all sides of the House.”
John Moore
was unconvinced, responding that he felt that the present line against compensation
should be maintained.
It was against this background that in September 1987 the Haemophilia Society sought a
meeting with the Secretary of State about compensation for people with haemophilia who
had been infected with HIV, and launched a campaign. Pleading with the Government to stop
“prevaricating” and to act swiftly, the Society wrote: “The
tragedy of twelve hundred people
dying as a result of National Health Service treatment is a disaster in its own right. The
Social and financial implications surrounding their infection and possible death place that
disaster upon epic proportions. The Government is the only institution capable of minimising
the distress of all those concerned.”
At this stage John Moore remained firm in his view that there should be no compensation,
writing to the Prime Minister on 24 September: “I
have looked at the case for compensation
again carefully in the light of the impending campaign but have concluded that the line taken
with the Social Services Committee was right. Any special arrangements for compensation
could cost a minimum of £3 million and could only be funded at the expense of other
priorities. Moreover, it is logistically difficult to distinguish the claim by haemophiliacs from
the claim of many others damaged in the course of their medical treatment. And there is no
doubt that compensating haemophiliacs would lead to pressure from many other groups for
similar treatment. While all of us must have every sympathy for haemophiliacs who have
been infected with the HIV virus, I do not feel it would be wise to set a general precedent by
accepting that the Government should provide a special compensation scheme.”
In October 1987, in advance of the meeting, the Haemophilia Society provided a submission
to the Government. It recorded that of the 1,200 people understood to have been exposed
to HIV from within the haemophilia community, to date 60 had been notified as having AIDS
and 45 had died. It described the intolerable financial, social and family burden, and asked
for “immediate,
positive and compassionate government action.”
And in anticipation of the
meeting,
The Northern Echo
stepped up its campaign, sending a special campaigning
supplement entitled
A Fight For Justice
to every MP.
At some point before the meeting with the Haemophilia Society, John Moore’s stance began
to shift. On or around 30 October Tony Newton sent a minute to the Prime Minister referring
to John Moore’s minute of 24 September, but adding that “Whilst
John and I still consider
those arguments to be intellectually valid, there is a powerful practical case for recognising
the particular circumstances of the infected haemophiliacs.”
Referring to the “very
strong
support”
for the Society’s campaign, “particularly
from our own supporters inside and outside
the House”,
John Moore and Tony Newton had concluded that the line which had been
taken was “unlikely
to prove politically sustainable.”
Their proposal was to tell the Society
that the Government sympathised, was considering how best to respond, and would talk to
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them again when a decision had been reached, and to discuss the options with colleagues
in advance of a further meeting with the Society with the aim “to
identify an acceptable
response which runs the least risk of setting a precedent and keeps direct Government
involvement to a minimum.”
By the time of the meeting between John Moore, Tony Newton and the Society, the media
pressure was intense. The meeting was on 3 November 1987. What then happened is
described in the words of a civil servant, Dr Roger Moore, who was there: “it
was a very
incredible meeting. I have been to thousands of meetings but that one is very clear in my
mind.”
The Haemophilia Society chair and its general secretary brought with them three
young men who had contracted HIV from blood products. What occurred is best described
in the words of Dr Moore:
“what
struck us, actually, was that these were people who had a right to be angry
and they weren’t; they were only concerned about the families that they would
leave behind. And we listened and we were really moved. I mean, I don’t think
I’ve ever seen a minister weep before but John Moore – – and we were totally,
totally dumbfounded, really. And, anyway, the Haemophilia Society delegation
left, and we sat round and it wasn’t a question of whether we do anything, it
was, you know, what can we do? What actually can we do? And I’ve never really
seen any meeting that’s kind of changed direction so quickly or to such great
effect as that.”
On 4 November 1987, John Moore proposed to a Cabinet Sub-Committee that special
financial assistance for people with haemophilia suffering from AIDS should be given. A
lobby of MPs was due on the following day; the Haemophilia Society campaign enjoyed the
backing of many Government supporters, and his memorandum said it was “unlikely
that
we shall be able to sustain the present line.”
The memorandum noted that the Haemophilia
Society had successfully got across their view that people with haemophilia’s problems with
AIDS were due to the Government’s failure to ensure self-sufficiency in blood products. This
was “difficult
to refute convincingly in presentational terms.”
The memorandum therefore
proposed that special financial help should be given to people with haemophilia and that
this should take the form of a grant of up to £10 million. The memorandum was considered
by the Sub-Committee on AIDS on 10 November 1987. A briefing paper advised that DHSS
ministers had consistently resisted compensation; that a campaign had attracted a good
deal of political and public support, such that the position was not sustainable unless
concessions were made; and that “The
case for reversing the present line and singling
out haemophiliacs for special compensation is essentially a political one.”
The proposed
grant to the Society was “not
compensation – which could run to hundreds of thousands of
pounds per person – but a gesture of limited financial assistance to meet particular needs.”
£10 million would be sufficient to provide an average payment of around £8,300 to each of
those affected: “This
does not seem a great deal”.
At the conclusion of the discussion there was agreement to the announcement of a sum of
£10 million to be made available for administration by the Haemophilia Society. A statement to
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the House of Commons from Tony Newton followed on 16 November 1987, which made clear
that this was “not
a compensation scheme”.
Following further discussions the Macfarlane
Trust was set up as a body separate from the Haemophilia Society to administer the sum.
The Government plainly formed the view, at an early stage, that nothing had been done
wrong, and that no financial assistance would be provided to people with bleeding disorders
who had been infected with HIV. It did so without any proper investigation either into what had
caused the infections or into the appalling plight of those infected. Had it done so this would
have revealed systemic failures that contributed to what had occurred. Government fear of
setting a precedent outweighed considerations of moral responsibility or compassion. It was
largely public and political pressure which led to the change of position in November 1987.
6.2 HIV Haemophilia Litigation
During 1989, nearly 1,000 individuals in England and Wales brought claims against
defendants including the Department of Health, the Welsh Office, the Licensing Authority,
and the Committee on the Safety of Medicines, as well as against multiple health authorities.
The fact that nearly 1,000 people with haemophilia chose the insecurities and stresses
of litigation, in an effort to achieve recognition that they should not have been infected,
shows the strength of their collective view and it is in itself a sad commentary on what had
happened already that litigation seemed the only viable route to establish the facts. Similar
claims were made, a little later, in Scotland.
This chapter looks at three principal areas concerning the litigation: the reaction of those
in the Department of Health and Government to the litigation when it began, with a “line to
take” being adopted that people received the best treatment in light of knowledge at the
time; the process of settlement – how it began, and from whom the initiative came; and how
it came about that the “waiver” was required (although not in the Scottish settlement) when
the claim was not for hepatitis but for HIV infection.
The Department of Health identified some classes of documents for which they claimed
public interest immunity. That issue of public interest immunity was considered by the Court
of Appeal in September 1990 which observed that the Department of Health had a duty
to take the immunity point. It should not therefore be criticised for doing so. However, the
practical effect of the immunity point being taken was twofold: first, it prolonged the litigation,
because the claim of public interest immunity had first to be evaluated by a judge, and then
there was an appeal to the Court of Appeal; second, it emphasised the power imbalance
between the parties in terms of knowledge. There remained some categories of documents
that would not be disclosed, and those documents that were to be produced were for
inspection by the judge, for him then to determine if they should be disclosed to the plaintiffs.
In June 1989 a submission was sent to the Minister of State for Health, David Mellor, on
26 June. Its focus was on immediate procedural steps; it also sought Ministers’ views on
the question of “ultimate
liability”.
In the background information it was said: “We
believe
that the government has a fair chance of successfully defending its role, given that at every
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stage it has acted as swiftly as possible to minimise the risk of infecting haemophiliacs with
AIDS in the light of the best expert opinion available at the time.”
Although the litigation itself
raised difficult questions of law, this statement of belief contained an assertion of fact, about
the speed of action.
The statement was made without any qualification, or even a suggestion that there might be
another, legitimate view, and was done without investigation to check the facts. No one who
saw the submission or was involved in its drafting queried the basis for the assertion.
The similar view was repeated both at this time and subsequently that patients had had
the best available treatment in the light of medical knowledge at the time. Both statements
make bold claims. Any such claim, as to fact, should be based upon a solid foundation of
evidence. Yet those who adopted the phrase had no knowledge of any particular fact finding
that had led to it. The position owed more to a sense that the Department of Health was
defending the position of those who had worked in the health service and in government,
and that this statement was what they would prefer to believe rather than having any clear
factual basis for doing so. On the face of it, it is not only a bold but an astonishing claim
that over 1,000 people had been treated with blood products and had contracted HIV as a
result, and that a number of people had been given transfusions and had contracted HIV
as a result, and yet that they had had the best available treatment at the time, and that
government had done everything it could, as quickly as possible, to avoid what happened. It
could have been so, but the idea is so counter-intuitive that asserting that it was indeed so
required careful and critical examination of the available factual material.
In October 1989 a submission to ministers reviewed the position on the litigation and on
the Macfarlane Trust, and in a separate part considered options for making more money
available to “the
haemophiliacs”.
The five options were: an out-of-court settlement; increasing
the Macfarlane Trust funds; making an ex gratia payment; establishing a commission of
enquiry; and publicising the Government’s position, by responding to the “allegations
and
misinformation contained in the Sunday Times campaign”
for example with “a
parallel history
of the facts”
forming the basis of a press release.
Kenneth Clarke, Secretary of State for Health, wrote to the Prime Minister that there was no
negligence on the part of the clinicians or the Government. He was against the suggested
out-of-court settlement because of the liability implications for NHS treatment generally, and
the “enormous” cost consequences. However, in light of public sympathy he secured her
approval to a further allocation of £20 million as an additional payment to the Macfarlane
Fund (ultimately £24 million, or £20,000 each to 1,200 people).
In June 1990 the trial judge took the unusual step of writing to the parties to set out his view
that compromise was desirable because it was “cardinally
important”
that people should not
die before knowing the outcome of the litigation: “A
government which takes upon itself the
role of public provider of medical advice and clinical services is in a very different position
to any commercial organisation. It is clearly arguable that their duty to innocent citizens
who suffer injury under the aegis of such treatment has a moral dimension to it which
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should distinguish their assessment of their position from that criteria to be adopted by other
defendants of a corporate character. Government owes a duty under this to its shareholders
or insurers. It should also mean that the public may be entitled to expect from government
an appraisal of their position which is not confined solely to legal principles to be found in
the law of negligence, or problems of proof.”
He added “I
believe that the legal profession has a duty to do its best to see that the legal system
does not become a scapegoat in the eyes of the public for what I fear may be perceived as
the unjust and inhumane denial of any significant measure of compensation to the plaintiffs.
‘The law must take its course’ is not an attractive principle in the context of this case.”
Whilst the CMO supported the judge’s recommendation, senior civil servants took a different
view and recommended that the route mapped out by the judge should not be followed.
That too was the view of Kenneth Clarke and of the Chief Secretary to the Treasury.
On 9 November the lawyers representing the plaintiffs proposed settlement for an amount
of approximately £42 million to cover all the people with haemophilia registered with the
Macfarlane Trust. William Waldegrave was now Secretary of State for Health. In evidence
to the Inquiry he explained that two arguments were key to winning the negotiation with the
Treasury: “The
victims’ lawyers have come forward with an offer that they say will be seen as
fair by their clients. This will not recur, we’ve got to do this and do it quickly. And look at the
numbers; you can afford them, we can afford them. We both knew the issues surrounding
the people. This was why it had to be done now and quickly. And it was affordable.”
On
7 December he wrote to the Prime Minister (then John Major), concluding that the cost of
the proposed settlement would be higher than the most favourable outcome from winning
the case, but much lower than the cost of losing the case badly. John Major agreed to the
proposals and announced the settlement in Parliament on 11 December 1990, indicating
that the settlement still had to be formally approved by individual plaintiffs. The timing of an
announcement of that settlement in principle created a pressure on plaintiffs to accept its
terms, but it was not intended to be unfair to them.
The Haemophilia Society, whilst praising both William Waldegrave and John Major,
expressed “grave
disappointment”
that the settlement was “so
low”.
The following month
David Watters wrote to William Waldegrave: “While
the vast majority of our members
have indicated their intention to accept, this is being done with resignation and disquiet,
recognising that there is really no option since it is financially impossible to fight on.”
It is
plain too from the evidence which the Inquiry has received that many of those involved as
plaintiffs in the litigation felt that they had no real choice but to accept the settlement. There
was a mismatch in terms of finance, resources, and in access to knowledge between a
Government and a collection of individual plaintiffs represented together as a cohort. Many
of the plaintiffs were legally aided and the risk that this funding might cease if a reasonable
settlement were to be refused (especially if only by a handful of plaintiffs) might well have
been in the minds of some of the plaintiffs or their lawyers. Some were not entitled to legal
aid and were having to make financial contributions towards the costs of the litigation. There
may also have been a desperation for individuals to avoid any delay in getting further funds
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necessary to avoid the worst of their financial poverty. There is, however, little evidence
that the Government intentionally used its power and position to browbeat the plaintiffs into
settlement. Nor is there any evidence that the defendants used the likely short lifespan of
many of the plaintiffs as a means to persuade the plaintiffs to take an otherwise inadequate
settlement. The plaintiffs would nonetheless be very much aware of it. The real vice is that
people were forced to litigate at all, rather than being offered – without the need for litigation
– that proper compensation which they are yet to receive.
Settlement negotiations in Northern Ireland and in Scotland proceeded separately from
those in England and Wales, although the expectation within the Department of Health was
that settlement would be on the same basis. Those who pursued claims in Scotland should
have been consulted.
Under the settlement that was negotiated regarding plaintiffs in England and Wales, anyone
who wished to take advantage of the settlement sums, and anyone who had not been a
plaintiff but had been infected with HIV by treatment with blood or blood products prior to
13 December 1990, would have to sign a document (a “waiver”) with an undertaking not to
bring proceedings. As such waivers were usual in litigation, lawyers acting for both parties
would not have been surprised to see this precluding any further action arising from the
same set of facts. Some form of waiver was contemplated from the time that settlement was
reached in principle and was reflected in every draft.
It was only in the later drafts that the word “hepatitis” appeared. Whilst the first reference to
hepatitis in this context of which there is any documentary record appears in a memo from
Dr Andrzej Rejman (a senior medical officer in the Department of Health) in February 1991,
the express reference to hepatitis viruses in the draft settlement terms was put forward as
an amendment by the plaintiffs’ lawyers in April 1991.
The evidence to this Inquiry is that many plaintiffs felt that they had no choice but to sign the
waiver. The evidence also indicates that few, if any, of those infected had been told enough
for them to be in a position to understand the importance of what they might be signing
away – they did not know they had been infected with hepatitis. They could not exercise
an informed choice whether they should sign or refuse to sign the waiver. It follows that to
insist, by relying upon the waiver, that a person who had suffered hepatitis as a result of
being infected (and had probably been infected before 13 December 1990) could not sue
for being infected with hepatitis would be unfair. Fairness would demand that the infection
and its consequences be known in broad terms if further proceedings in respect of them
were to be excluded.
By contrast, following negotiation, the settlement in Scotland was made on the basis that
it did not preclude any future action in respect of hepatitis. The undertakings to be given
by Scottish litigants were different from those applying in England and Wales. In the latter,
an undertaking not to make or continue any claim in respect of hepatitis as well as HIV
was required, whereas in Scotland it was not. There is no record which clearly sets out the
reasons why English and Welsh plaintiffs were excluded from making future claims in respect
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specifically of hepatitis as well as HIV. The lack of reasons reinforces the overall conclusion
that its inclusion was indeed unfair, at least without a condition providing that the courts
should have a discretion to permit cases to proceed where it would be unjust not to do so.
Overall, the reality is that the settlement did not – and did not purport to – compensate
people for the damage which had been done to them. It did not remove the financial burden
from them. It was “a
blunt instrument in the attempted righting”
of the wrong done to people
through infecting them with HIV.
6.3 Macfarlane Trust
The Macfarlane Trust was set up as an autonomous body, and the trust deed finalised on
10 March 1988. The £10 million paid by the government was subject to the terms of the trust
whose objects were: “to
relieve those persons suffering from haemophilia who as a result of
receiving infected blood products in the United Kingdom are suffering from Acquired Immune
Deficiency Syndrome or are infected with human immunodeficiency virus and who are in
need of assistance or the needy spouses parents children and other dependants of such
persons and the needy spouses, parents, children or other dependants of such persons
who have died.”
Two features of this provision are highlighted: first, the class of beneficiaries
was not restricted to those who had been directly infected – it specifically included spouses,
parents and children (including the spouses, parents and children of those who had died)
and even went so far as to include a class of people (“other
dependants”)
who did not
necessarily have any immediate familial relationship; and second, “need” was not defined
as financial need, nor was “assistance” specifically limited to the provision of money.
The way the Trust was established led to five central problems:
(a)
The basis for the ex gratia payments was the additional difficulties caused by HIV
for people already living with haemophilia but no detailed assessment was made of
the particular financial impacts, without which whether any particular sum of money
was appropriate was pure guesswork, and the amount provided was always likely
to fall far short of need.
The Trust was set up as a charity which led to many people feeling forced to hold
out a begging bowl.
It was unclear what assumptions were being made about future needs and there
was no assurance built into the scheme that further funds would be provided to
meet future needs. This led inexorably to trustees being cautious about how much
money they could allocate to grants in any particular year.
The lack of funds became ever more apparent over time. In 1987 few expected many
of those infected to survive for long. People’s needs changed as they now faced
the problems of survival, with continuing illness and treatment. Even with inspired
leadership, adapting to these changed circumstances would have been a challenge.
(b)
(c)
(d)
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(e)
The charity was small by comparison with many other grant-making bodies, meaning
it was especially vulnerable to the absence of any staff member.
Relations with beneficiaries
After a positive start to its work, relations with beneficiaries began to deteriorate in the
second decade. Susan Daniels, a caseworker, reported to trustees on a 2005 visit in
Birmingham, commenting: “I
feel deeply saddened, after all my years with the Trust and the
excellent work it has done in the past, that it has now come to the point when registrants
inform me that ‘The MFT is a major stress point in my life’ and are frightened by the prospect
of my visit.”
Jude Cohen, the head of support services from 2004 to 2005, was clear in
her evidence that there was a “horrible
undercurrent”
of distrust in both directions. Many
beneficiaries felt misinformed by, and fearful of, the then chief executive, Martin Harvey;
some trustees distrusted the beneficiaries. There is no material to show that the Macfarlane
Trust actively addressed these reports of a growing loss of confidence.
In February 2005 a report by Kingston Smith (chartered accountants) identified that
consultation with beneficiaries in respect of changes in funding was necessary; and that
the Trust’s application forms and literature “should
be clear and user friendly and should
include … what the trust will and will not support”
and include “any
upper or lower limits
on grant size”.
Katie Rendle (a Macfarlane trustee) carried out a survey of communications between the
Trust and beneficiaries, reporting to the Board in January 2013. Overall, around two thirds
of beneficiaries reported that they did not receive enough information about grants, causing
confusion, frustration and delay. One of the strongest themes was that there appeared to
be a practice of withholding information from beneficiaries. More than half of those who
responded complained that they did not understand and had not been consulted about the
way in which the Trust distributed its funds.
No substantive action was taken in response to these reviews.
What upset many – indeed, it seems, most – beneficiaries was the lack of anything more
than the rudimentary information they were being given. They knew they could apply for a
grant, but did not have clarity about how to do it, what it could be for, how much would be
allowed, when they should apply, how long it would take, and what criteria would be applied
in determining it. This was then coupled for those who did apply with a process which
was time-taking and bureaucratic, required (usually) more than one quote, had to have
support in most cases from their treating clinician, might involve giving details of income
and expenditure (despite the fact that many of the details had already been provided), might
involve being visited at home or photographs being taken of the quality of their environment
in order to show it was sufficiently poor, and required it to be shown that other sources of
support and funding were not available. Both the lack of information from the Trust and the
characteristics of the process described above were unfair to, and caused unnecessary
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distress and anxiety to, applicants; this was obviously not the right way to treat people who
had already been profoundly harmed by the state.
Insecurity of funding and failure sufficiently to meet need
Some 18 months after operating under the Trust deed, it was becoming clear to the trustees
that the expenditure was exceeding the income received from investments. Trustees raised
the question of future funding from the Department of Health. The response fell short of
a commitment to make further payments, and did not say how much might be provided.
This left the Trust with uncertainty as to the appropriate level at which it should disburse
its capital, and concerned to keep a reserve if it could to meet the considerable financial
uncertainties of the future.
This pattern was repeated over the following years. It remains unclear why the Department
of Health was reluctant to be open and transparent with the Macfarlane Trust from the
outset as to their specific intentions to top up the Trust on a periodic basis. It may have been
because ultimately spending decisions depended on the Treasury, which had to balance a
range of commitments. If, however, its reticence was intended to discourage the Macfarlane
Trust from being too generous in its disbursements of the funds then it was effective. By
March 1993, assets had dropped to just over £4 million and in that year there had been a
decrease by 3.6% from the previous year on the sums paid out to beneficiaries.
The Inquiry heard evidence from Peter Stevens that during this period, the Macfarlane Trust
was underfunded. Charles Lister gave evidence that during his tenure the Department of
Health always found the money that the Macfarlane Trust asked for, and sometimes even
a little more. However, this may reflect the fact that the Trust was very careful about what it
asked for from the Department of Health in terms of funding, not wanting to appear “greedy”.
The Trust only asked for what they thought they would receive.
Peter Stevens requested a top-up payment of £4 million for 2001-02 from the Government
to meet needs which had been identified in a strategic review of 1999 which revealed that
poverty and despair about money were common; that many were bogged down by debt;
that few had any leeway to meet unexpected bills. The review recommended that the Trust
should approach the Department of Health to secure an assurance of continued funding, and
that this should be at a level sufficient to meet registrants’ needs. However, Peter Stevens
told the Inquiry that this suggestion was “kicked
into the long grass”
by the Department
of Health. Despite an apparent acceptance of the case being put forward by the Trust for
increased funding the Department commissioned a further review of the Trust.
The financial history of the first 14 years of operation of the Macfarlane Trust is one of a
fear, on the part of the Trust, that funds might in future prove inadequate to meet the very
real needs with which they had to deal day by day. General reassurances were given that
money might be found if really necessary, but no particular level of income was assured on
a continuing basis. Nor had sums been given annually. Funding was ad hoc. This was not
a satisfactory way of funding any organisation. The impact of these funding uncertainties
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before 2003 caused problems for the trustees of the Macfarlane Trust in that it affected
their ability to respond to requests made to the Trust and hampered any proper long term
planning as to how to best meet the needs of beneficiaries.
A bid for the Trust’s funding was included by Charles Lister within the bids for the Spending
Review (covering the 2003-2005 period). As a result of this, the Trust was allocated a budget
for three years within the Spending Review, with the first payment of £3 million being paid
in May 2003). Thus it was not until 14 years into its existence that the Macfarlane Trust had
some level of financial security from the Department of Health. Nonetheless, the needs of
the beneficiaries were still far from satisfied by these sums.
In 2003 there was a further review – “the Long-Term Review” conducted by Hilary Barnard.
This was seen as a means to establish new priorities for the Trust and to look at different
ways to use limited funds: its commissioning reflected that the trustees wanted to establish
“a
firm basis on which the Department
[of Health]
would be unable to resist
[their]
pleas
for more money.”
This long-term review was entitled
A Full Life – Not Just Existence.
It
concluded that: “The
Trust is not and should not be solely a grant giving Trust but has
equal and integral roles in providing non financial help to the registrants, infected intimates,
widows and dependents
[sic]” and that it should aim “to
support lives, not just existence.”
It
said: “It
is rare that the Trust has much to do with parents these days but some remain as
significant carers who the Trust should keep close contact with. Longer term survival of sick
registrants carries with it far greater demands and impact on the lives of their supporters …
Addressing the needs of widows and dependents
[sic]
is a significant and extended claim
on the resources of the Trust and its funder, the Government.”
Although the report had suggested approaching the Government in the immediate future,
this did not happen. The reason it was not pursued straight away was because the focus of
Peter Stevens’ work, and that of Martin Harvey, had now (August 2003) shifted to setting up
the Skipton Fund. The delayed business case was eventually put to the Government in late
November 2005. Peter Stevens commented that the Trust had started out with £10 million
and had been expected to last five to seven years. It was “topped
up, topped up, topped
up, at some stage you actually had to say no, we started in the wrong place, we’ve got to
start again at a much higher level.”
He asked for an increase in funding to £7 million per
year, supported by the business case. The business case did not reach the relevant junior
minister’s office until the middle of June 2006. By the time the information came to her, she
was told that nothing more than £400,000 was available, and was advised that blood policy
colleagues did not consider any increase in overall funding was justified. It is unclear how
officials could have come to this view after reading the business case, supported as it was
by the Barnard review. On 28 July Caroline Flint wrote to Peter Stevens with the decision to
increase funding by £400,000.
By September 2007 there was something of an impasse between the Trust and the
Department of Health regarding funding. The Trust, now under the chairmanship of
Christopher FitzGerald, met the Department of Health on 4 September 2007. The minutes
record that the board of trustees “are
unable to satisfactorily fulfil their objectives set out
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in the Trust Deed to ‘relieve the need of its beneficiaries’ and the Department are not in a
position to increase the annual level of funding it grants to the Trust”.
The incoming Minister
of State, Dawn Primarolo, was informed in a letter from Christopher FitzGerald that the
trustees considered the level of funding to be inadequate and he gave evidence to that
effect at the Archer Inquiry. He added: “I
would simply wish to reiterate that it is simply
unacceptable on any basis, whether you call it moral, legal or whatever – – it is simply
unacceptable that the funding the consequences of the greatest catastrophe in the history
of the NHS should be constrained by the current financial difficulties or incompetencies in
the NHS.”
Christopher FitzGerald wrote to the Government to complain that unless more
money were given the Trust could not meet its objectives adequately and said the same
to officials, though the Archer Inquiry was his main hope. He did eventually achieve an
assurance in 2008 that there would be annual funding indefinitely. This allowed for a gradual
reduction in the amount of the reserves since (given that assurance) they no longer had to
be maintained as insurance against the uncertainty of funding in the future. Further, following
the report of the Archer Inquiry the Government announced that in future there would be
annual payments of £12,800 to each infected individual “thus
eliminating the need for them
to make repeated detailed applications”
and, in effect, doubling their current average annual
payments (these payments were made through a limited company called MFET Ltd, so that
they were not dependent upon an assessment in each case of the precise charitable needs
the payment was to meet). It also agreed to increase the funding to Macfarlane Trust for
dependants, whose applications for funding would continue to be dealt with by the trustees
on a case by case basis.
In 2012 the Trust came under repeated pressure to meet some of its expenses from its
reserves. The Department of Health asked that a business case be submitted to support its
funding request. It asked that the case should detail why the reserve had not been used for
charitable purposes and what had changed to merit its distribution now. It asked specifically
for an analysis of the data that had been obtained from a survey the Macfarlane Trust had
commissioned, including an anonymised assessment of each beneficiary’s current ability
to pay for items, for a statement as to the standard of charitable need the Trust intended
to apply to applications for grants from reserves, and to be told how the Trust planned to
assess need. Although Roger Evans accepted this was none of the Department of Health’s
business – which it was not: they were plainly over-reaching themselves – he did not say
so to the Department of Health in writing. Nor did he say that he was unwilling to provide
information on the three points just mentioned. He told the Inquiry he had nonetheless made
these points orally – it was not his “style
to put immoderate words into a letter and email.”
The leadership of the Macfarlane Trust was less independent of its paymaster, and less
observant of its obligation to serve the interests of its beneficiaries, than it should have been:
and it suggests that there was in consequence a lack of vigour in pursuing better funding.
There is also disturbing evidence of serious tensions between board members which
went well beyond those normally to be expected in healthy debate, and were sometimes
expressed in unnecessarily personal terms.
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The extent to which those reserves were exhausted began to affect, even more, the Trust’s
ability to meet the needs of its beneficiaries. By November 2014 the annual shortfall
experienced by the Trust between the Department of Health’s allocation and their grant
giving programme was £800,000. In a letter from Roger Evans to the Department of Health,
the Trust made the point that its “inability
to meet this need remains as a result of continued
underfunding.”
By October 2015 the Trust’s position had become serious. It was made clear
to the Department of Health in a meeting that, leaving £750,000 in reserve in accordance
with reserves policy, there was only enough money to supplement the annual allocation for
disbursements until March 2017. However, by the end of 2016 it was plain that the writing
was on the wall for the Trust. It would continue to operate for a while during the financial
year 2017/2018, and for that period the Department of Health intended to provide quarterly
allocations. However, it was made clear to the Trust that during that period it would be
expected to use up much of its reserve.
Decisions on allocation of funds
Throughout there was a lack of openness and transparency. This was despite a number of
“wake-up calls”, and despite the fact that each witness who had been involved in running
the Trust who was asked in evidence about the criteria and processes accepted that
they needed to be open, transparent, and fair. The absence of sufficient information for
beneficiaries stemmed from a misplaced distrust of them by the trustees. This distrust led
to policies which demanded that need be established in some detail, and that two or three
quotations were to be obtained. For ease of administration, office staff were permitted to
authorise grant applications in accordance with broad “office guidelines”. However, these
guidelines were not published to the beneficiaries. Peter Stevens said that no guidelines
were published because “they
became shopping lists”.
His view was also that if a guideline
had provided, say, for the purchase of a mattress up to a particular maximum sum, there
would instantly be a lot of requests for that sort of mattress, costing that sort of money.
Regular payments (“Regpay”) required the completion of a census form setting out, in
broad terms, household income, and single grants required other sources of potential
funding to have been exhausted; three quotes to have been obtained; sometimes the
submission of details of household income and expenditure; and usually the support of
a medical practitioner (normally the applicant’s haemophilia clinician). With requirements
of this nature, it is not difficult to understand why applying to the Trust for support was not
only seen as bureaucratic but also as demeaning, intrusive, demotivating and embittering.
By 2009 the National Support Services Committee (“NSSC”) had adopted “exceptional
circumstances”
as the principal criterion for assessing grant applications, but there was no
definition of this test until mid 2012 and even then it lacked precision. The NSSC having
become quite bureaucratic in its approach, it was replaced by a Grants Committee but it
took over 16 months for the Trust to introduce new guidelines for grants.
One of the issues which epitomises the way in which difficulties for beneficiaries were made
worse than they needed to have been, with distressing consequences, was the issue of
assistance with conception: the failure of the Trust, over a number of years, to adopt a
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clear, humane and compassionate approach to funding applications for assistance with
conception is detailed in this chapter.
Perceptions of uncaring attitude
The lack of openness and transparency was accentuated by the poor quality of personal
relations. There were mechanisms for engagement such as a consultative panel and the
Partnership Group but this ultimately fell into disuse.
Peter Stevens referred to the Partnership Group as a “lot
of moaners”,
and did not object to
phrases such as “the
great unwashed”
being used to describe beneficiaries. He forwarded a
courteous email from Haydn Lewis to his colleague Martin Harvey describing Haydn Lewis
as “thick” and coming up with “such
meddlesome suggestions”.
He agreed in evidence this
was totally inappropriate, and indeed at the time went to Cardiff to meet with Haydn and his
brother to apologise for his use of language.
In March 2006, a letter to Clair Walton from Peter Stevens led to a formal complaint and
ultimately an apology from the subsequent chair, Christopher Fitzgerald. Incidents such as
these became known and created a perception, especially among beneficiaries involved in
support or campaign groups, that trustees did not respect them as individuals. The processes
required to apply for funds were seen, with justification, as indicating a failure to recognise
the ill-health of beneficiaries, and the manifestation of a callous indifference towards them.
A dispute between the Haemophilia Society and the Trust soured their relations and further
reinforced the negative views many beneficiaries had of the Trust. Following the All-Party
Parliamentary Group (“APPG”) report on the Trusts and Schemes Liz Carroll, CEO of the
Society, wrote on 10 February 2015 to the Minister to respond to this publication, suggesting
that Jan Barlow and Roger Evans “expressed
the opinion that the Department of Health
should wait before responding to Penrose so more people will have died and they will have
less to pay out.”
This incident has assumed a significance beyond that deserved, and was
a sorry episode. It caused further upset and irritation to many beneficiaries, seeming to
justify their suspicion that neither Roger Evans nor Jan Barlow had their interests at heart.
There was no evidence that Roger Evans expressed any such opinion; whilst Liz Carroll’s
evidence to the Inquiry was that Jan Barlow did, it remains uncertain whether or not the
words were spoken as reported, though the likeliest scenario is that what happened owed
much to the way in which the protagonists thought of each other at the time and that Liz
Carroll may have heard what she expected to hear rather than what was actually being said.
Liz Carroll did not act professionally by not calling out what was said at the time, if it was as
she a little while later recalled hearing it; and by including the allegation that she heard it in a
widely copied letter to the Minister without first telling Jan Barlow and Roger Evans. In other
hands the matter would have been resolved differently.
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Closure of the Trust
Once it was decided that the Alliance House Organisations would be replaced by four
separate schemes, one for each of the four nations, the Macfarlane Trust had to decide
how to dispose of any remaining assets. At a meeting in July 2017, the Board decided to
distribute the reserves through a targeted, time-limited grants programme but by November
2018, there were still substantial reserves. At its meeting in November 2018, the trustees
decided to remove the restriction on the Honeycombe Memorial Fund (support to widows
and bereaved partners without children) and add it to the unrestricted reserves, and to
transfer the remaining funds and assets to the Terrence Higgins Trust. Beneficiaries were
not consulted about this transfer. There was ample time to do this and beneficiaries would
have had the chance to raise the concerns which have subsequently been expressed. The
consequence for many has been a perpetuated sense of grievance.
In conclusion, the worst aspect of the approach of the Macfarlane Trust is the impact on
a group of people who deserved to be supported properly and were not. People whose
hardship was supposed to be alleviated by the payment scheme instead had that
exacerbated: they felt kicked, and kicked again, when they were already down. They were
repeatedly rebuffed in their attempts to argue that they deserved more and better from
authority. The Government’s response to serious failures of regulation, administration and
treatment on its part, by setting up this Trust – operated in the way it was – added further
layers of psychological, economic, and social damage to an already devastating infection
with its resulting poor health, stigma and isolation.
As a summary of the chapter’s findings:
• The Trust should not have been set up as it was: as a charity, redolent of the begging
bowl; without any assessment of actual financial needs; with no guarantees of,
or plan for future funding, leading to insecurities about funding; with inadequate
resources, both of money and of staffing; and too small to function as well as it might.
• The Trust should not have been run as it was:
– The Trust felt itself subordinate to the Government when it should not have been,
and as a result did not campaign when campaigning might have been productive.
– A climate of anxiety, fear and distrust was created, recognised by at least some
chief executives and chairs, and left unaddressed.
– The decision to have “office guidelines” which were not to be published to
beneficiaries was simply wrong.
– A consequence was unfairness, added distress and anxiety.
– Decisions were delayed, though needs were urgent.
– The way in which the Trust dealt with some applications made in respect of needs
is epitomised by its handling up to 2005 of the issue of assistance for those of
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its beneficiaries who sought to have a baby as safely as was possible. The Trust
could and should have dealt with this issue better: promptly, decisively, keeping
in mind the human suffering at its heart.
– The Trust was found weak in monitoring and evaluation, without which it would
be unable to answer whether it was helping those in greatest need, yet appears
to have done nothing to rectify this;
– The application process for grants was time-taking and bureaucratic; had to have
support in most cases from the treating clinician; might involve giving details of
household income and expenditure (despite the fact that many of the details had
already been provided); might involve being visited at home or photographs being
taken of the quality of the home in order to show it was sufficiently poor; required
it to be shown that other sources of support and funding were not available;
– the Trust started to require applicants for grants to show “exceptional
circumstances” without applicants having any clear idea of what they could be,
and how they were defined;
– the criteria and process for appealing the refusal of a grant were unclear and
poorly understood; it may not even have been recognised by an applicant that
there was that possibility;
– the Trust did not sufficiently ensure any effective way in which the views of
beneficiaries could be fed back to trustees.
– the leadership of the Trust between 2012 and 2016 lacked the vigour it should
have had in pursuing better funding, and was less observant of its duty to serve
the interests of its beneficiaries;
– beneficiaries were treated by some trustees, and by Martin Harvey as CEO, in an
apparently uncaring, dismissive, disparaging and disdainful manner;
– Peter Stevens spoke (with Martin Harvey) and wrote internally in unacceptable
and disdainful terms about some beneficiaries;
– Roger Evans when chair recognised that aspects of the system were “humiliating
and intrusive”,
causing unhappiness amongst beneficiaries, and “the
whole thing
was not the right way to go about it”:
allowing that to be the case was wrong,
but what was worse was that when it was realised that this was the case little or
nothing was done to rectify it;
– when a survey of beneficiaries was reported to the trustees in 2013, identifying
sources of dissatisfaction, Jan Barlow was asked to take steps to action its
recommendations but did not;
– the Trust received a report from the APPG in 2015 identifying failings and did little
or nothing in response;
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– relations between the trustees became very difficult such that the Board did not
function as it should have done: this was largely the fault of Roger Evans;
– when the Trust was superseded by the England Infected Blood Support Scheme,
Welsh Infected Blood Support Scheme, Scotland Infected Blood Support Scheme
and Northern Ireland Infected Blood Payment Scheme, the process of disbursing
its reserves (including the Honeycombe monies) should have been determined
in consultation with the beneficiaries, in a way which best ensured the funds were
distributed fairly and contemporaneously amongst beneficiaries.
6.4 Government Response to HIV Infections through Blood or
Tissue Transfer
This chapter considers the Government’s response to the question whether to make
payments to individuals infected with HIV by blood transfusion or tissue transfer. Such
individuals were deliberately not included in the November 1987 announcement of the
£10 million ex gratia payment to provide financial help to people with haemophilia infected
with HIV and their families.
In February 1988 it was noted that a number of MPs had written seeking special financial
payments for those infected with HIV by blood transfusions in line with the ex gratia
payments for people with haemophilia. The suggested line to take was that “After
careful
consideration”
the DHSS concluded that the combination of circumstances applicable to
those with haemophilia “does
not apply to those who unfortunately have become infected
with HIV through blood transfusion.”
In July 1988 officials advised against introducing a
scheme of payment, “although
that may seem a harsh view to take”,
for three main reasons:
it could not be ring-fenced as the haemophilia scheme had been; reaching fair decisions
would be “extremely
difficult”
(especially if extended to those who may have been infected
overseas); and “the
wider we extend help for those with HIV infection, the more we raise the
general issue of compensation for NHS linked infection.”
On 25 July 1988, John Moore was succeeded as Secretary of State for Health by Kenneth
Clarke, and by 28 July 1988 the decision had been taken not to make any ex gratia payments
to transfusion recipients infected with HIV.
The focus within Government then shifted to the HIV haemophilia litigation and any active
consideration of financial support for transfusion patients infected with HIV appears to have
receded for the next 18 months or so.
MPs pressed for support to be provided: John Marshall MP said that “To
argue that we are
compensating haemophiliacs because their illness is hereditary but will not compensate
others is bad morality, poor logic and bad politics.”
Robin Cook MP, writing to the Secretary
of State on 31 January 1991, expressed the view that the purported distinction was
“wholly
untenable”.
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As the negotiations in the HIV Haemophilia litigation neared conclusion, a submission in
April 1991 argued strongly against expanding financial support to transfusion recipients.
In May 1991, a campaign was launched by
The Observer
to “win
compensation for the
forgotten NHS victims of AIDS”.
The issue was taken up in Parliament by MPs “across
the political spectrum. Nearly 100 have now signed an Early Day Motion calling on Health
Secretary William Waldegrave to reverse his department’s ‘callous and illogical’ refusal to
compensate the non-haemophiliac NHS victims.” The Observer
commented that the delay
in agreeing to provide payments to people with haemophilia had meant that many had died
before they or their families could receive anything.
The Government’s position remained that no payments should be made but by November
1991 the Secretary of State’s (William Waldegrave) view had changed. In December 1991,
he wrote to the Chief Secretary to the Treasury that, if the Government continued “to
refuse
any help there is a real prospect that the campaign will gather pace and become a damaging
and running sore over the next few months.”
He proposed that the Government should move
to resolve the matter by “recognising
the needs of these people and their families in the
same way as we have recognised those of haemophiliacs.”
The Chief Secretary disagreed
and commented that, by “compensating
those acquiring HIV from blood transfusion, we will
be taking a further long stride towards no-fault compensation in general.”
In early February 1992, the Prime Minister was provided with a Department of Health briefing
which maintained its support for the existing ring-fence around people with haemophilia.
However, the cover note from William Chapman, the PM’s Private Secretary, commented
that the Government would have to give way and better to do that sooner. He questioned the
logic of a ring-fence for people with haemophilia, and said that the “Government’s
position
seems increasingly untenable.”
After further discussion it was announced on 17 February
1992 that financial support would be extended to people infected with HIV as a result of
blood transfusion or tissue transfer and that the scheme would include spouses, partners
and children who had also been infected.
Two features of this decision-making process stand out. First, the decision-making process
took too long. Second, despite some politicians being responsive to the claims for financial
support, civil servants remained determined in their opposition to this. In oral evidence,
Sir John Major described the government as being “sometimes
like a great tanker”
which
“takes
time to turn around”.
He explained that he would not “argue
with the argument that it
could have been done sooner. I can only say in retrospect you could often see things a little
more clearly than you can when you have a dozen other things in front of you at the same
time and perhaps that was true of everyone involved.”
I accept that policies which require significant expenditure may need to be developed
incrementally. There is also little doubt that fears about a precedent being set were real,
though once a decision had been taken to establish the Macfarlane Trust the obvious ring-
fence was around the nature of the disease transmitted by NHS treatment rather than the
condition which caused people to seek treatment in the first place. However this does not
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justify the lengthy period it took the government to change its position. The context was
crucial: patients had been infected several years earlier with a life-altering – and possibly
fatal – virus. Patients and their families did not have time on their side. The Government
should have recognised that its position was logically unsustainable and have changed
course significantly earlier than it did. If any group was to be kept waiting, it should not
have been this one.
There is, further, a strong sense that departmental officials were keen throughout to advise
their ministers of the risks, rather than the justice, of what ministers had asked them to explore.
6.5 Eileen Trust
The Eileen Trust was established in April 1992, with initial capital funding of £500,000,
to make payments for people infected with HIV through NHS blood or tissue transfer. It
began work at the end of March 1993 and paid fixed sums to people directly and indirectly
infected in different categories, depending on whether they were adult, were married, and
had dependent children.
The staff were shared with the Macfarlane Trust for ease of administration. The total number
of beneficiaries remained in the region of 20 to 30 at any one time, though it varied from
year to year. The number was rather lower than government had anticipated. The Eileen
Trust made regular payments from August 1993, with increases in January 1994 and a
health-related supplement from March 1994. Widows and widowers with children received
regular payments from 1998. The Trust preferred beneficiaries to have regular income to
give them greater personal autonomy. Single grants were also available on a case-by-case
basis, on the basis of either financial or health need. People knew what they could apply for
thanks to regular contact with staff and a newsletter.
The Eileen Trust did not suffer to the same extent from the difficulties which beset registrants
of the Macfarlane Trust. There was a similar lack of written information given to beneficiaries
and a similar degree of subjectivity in the assessment of individual grant applications, but
the relations between the trustees and the beneficiaries did not give rise to similar problems.
A principal problem was identifying those who might benefit, although the number of
beneficiaries of the Eileen Trust increased as more people became aware of its existence.
The increases were small in comparative terms, but they were significant for a small
organisation and the Trust’s expenditure increased. However as Peter Stevens stated in his
evidence to the Archer Inquiry “the
DoH have shown no understanding of, or willingness to
increase ET’s funding for, increases in the number of ET registrants.”
The approach taken by successive governments to funding the Eileen Trust was of the
same kind taken when first funding the Macfarlane Trust: it did not reflect in any meaningful
way the individual needs of the beneficiaries but was rather an arbitrary sum.
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6.6 Government Response to Hepatitis C Infections
When, in 1992, the Government (with some reluctance) agreed to make ex gratia payments
to transfusion and tissue recipients infected with HIV, it did so on the basis that the line would
be drawn at this group and that further groups would not receive similar treatment. For over
a decade it maintained that line, refusing to provide any form of financial assistance or ex
gratia payment to those infected with Hepatitis C through blood or blood products. This
chapter examines the maintenance of this position and the circumstances which led, finally,
to a change of position.
During 1994 the Government’s position was that there were “no
plans to extend the
settlement scheme for haemophilia patients with HIV to those who may have been
infected with hepatitis.”
It was noted in December 1994 by Roger Scofield (the head of the
Department of Health’s Corporate Affairs Operational Unit) that there had been “increased
interest”
in Hepatitis C and that “we
can expect the campaign for compensation for those
infected through NHS treatment to be stepped up over the next few months.”
Hepatitis C
had, he said, moved from being “a
problem on the horizon to a highly political and volatile
policy issue”.
The pressure was “building
up.”
In March 1995 the Haemophilia Society launched its campaign for financial help for people with
haemophilia infected with Hepatitis C. A statement from the Reverend Tanner explained that
“People
with haemophilia were infected with the hepatitis C virus through
contaminated blood products … Many were not told that there was a risk of
hepatitis when they were given the treatment. They were infected in exactly the
same way as over 1,200 people with haemophilia contracted the HIV virus –
through treatment with contaminated blood products. Yet while those infected
with HIV receive financial help from the government those with HCV receive
nothing … The government have said that they do not intend to provide financial
help for people infected with hepatitis C. I would ask the government how many
more should die before they decide that HCV is an immediate threat to people
with haemophilia … parliamentarians are taking the subject seriously. I would like
the government to take it seriously as well and would make the plea for them to
accept their moral responsibility and act swiftly and decisively to provide help for
people with haemophilia infected with this dreadful disease.”
That same month John Marshall MP, who had been instrumental in the efforts to obtain
assistance for transfusion recipients infected with HIV, met the Minister of State for Health,
Gerald Malone, to discuss this question. This intervention plainly had some impact upon
the Minister, because he agreed that the Department of Health should give very careful
consideration to whether those suffering from the worst complications of Hepatitis C might
be granted ex gratia payments. This willingness on the part of the Minister of State simply
to consider John Marshall’s proposal gave rise to consternation in the Department. Officials,
other ministers and the Permanent Secretary discouraged it. Whether as a result of the
firm advice from the Permanent Secretary, or the opposition of ministerial colleagues, or
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otherwise, by May 1995 Gerald Malone changed his mind, and at a meeting in June 1995
it was “agreed
that it would be desirable to maintain the status quo and not extend the
principle of no-fault compensation either to those infected with Hepatitis C or CJD. The
precedent of payments to those infected with HIV/AIDS through blood and blood products
was not helpful in this context but it was agreed that a justifiable distinction could be drawn
between HIV/AIDS and other viruses.”
In December 1995 the Haemophilia Society had published a report which it had commissioned
to examine the needs of people with haemophilia and Hepatitis C. John Horam, the new
Parliamentary Under Secretary of State, indicated that he would like to read the Haemophilia
Society’s report thoroughly and that he would be interested to hear details of the “relatively
modest and restricted proposal”
made by John Marshall MP during a parliamentary debate
on the issue. Just as his predecessor Gerald Malone’s willingness to consider the possibility
of a shift in policy had caused consternation within government, so too did John Horam’s.
Concern was expressed by the Treasury and by civil servants within the Department of
Health. One official wrote to the Permanent Secretary as follows:
“The
Permanent Secretary may wish to be aware of the attached minute. I
mentioned to him the other day that PS (H)
[Parliamentary Under-Secretary of
State for Health]
was clearly not happy with the firm line Ministers have taken up
to now on compensation for haemophiliacs infected with hepatitis C. It is quite
clear that he is trying to change the line, little by little. He has had plenty of
briefing (written and oral) on the subject, but his sympathy for those concerned
is clearly uppermost in his mind. Cost comes second – hence his readiness to
consider proposals for a scheme limited to those who have actually developed
chronic illness, rather than extending to all who have been infected.”
The decision, however, was not to make any form of payments for those infected with
Hepatitis C and this was communicated to the Haemophilia Society in October 1996.
Alf Morris MP and John Marshall MP continued to press for a change of position. In a powerful
speech in Parliament on 11 December 1996 John Marshall emphasised that many would
die from Hepatitis C, and that for many others “the
quality of life will deteriorate dramatically,
and they will suffer severe physical and economic hardship”.
He was indeed right, as the
evidence which this Inquiry has heard attests. John Horam, in response, maintained the
government line.
On 1 May 1997 a general election was held. A new government, under Tony Blair, came
in. A new Secretary of State for Health, Frank Dobson, was appointed. The Haemophilia
Society renewed its efforts to persuade the Government to establish a financial assistance
scheme for those infected with Hepatitis C. Frank Dobson was sympathetic and in March
1998 decided to write to the Prime Minister on the question. This alarmed officials. With
echoes of the departmental response to former ministers Gerald Malone and John Horam,
they sent a minute the next day to Dr Graham Winyard, the Deputy CMO, “expressing
concern that while SoS accepts that the Government could not afford a large compensation
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package, he feels that a small hardship fund like the MacFarlane Trust would be possible.
Officials are concerned that significant funds would need to be diverted from patient care
to fund it and that Treasury remain fundamentally opposed.”
A meeting to discuss the issue
subsequently took place between Frank Dobson and Baroness Jay on 13 July 1998 and it
appears to be at this meeting that Frank Dobson agreed to maintain the existing policy. That
decision was communicated to the Haemophilia Society on 28 July 1998. The Secretary
of State explained that the Government had decided not to set up any form of payment
scheme for the “inadvertent
harm”
of people with haemophilia infected with Hepatitis C.
Thus Frank Dobson joined the small group of ministers (Gerald Malone, John Horam) who
had seemingly wanted to make some provision for some Hepatitis C sufferers at least but
who encountered resistance within the Department and ultimately continued the existing
departmental line.
The Haemophilia Society did not let matters rest there and continued to press its campaign.
There was no change of policy on the part of the Government, however, and the line was
maintained in Parliament and in correspondence. It is clear from the evidence considered
by the Inquiry that the Government was finding it increasingly difficult to justify the distinction
between HIV and Hepatitis C.
In March 2000 Lord Hunt asked about the scope for doing more for people with haemophilia
infected with Hepatitis C and requested an outline costing of a hardship fund. This advice
was provided on 27 March and said that such a fund would be unlikely to be acceptable and
that there would be a continuing demand for parity with the HIV scheme. In October 2000
Lord Hunt sought advice on what could be offered in terms of a package of care for those
who had contracted Hepatitis C from blood products – with it being suggested that he was
hoping to seek the permission of the Secretary of State “to
work up something more for HCV.”
In 2001 there was a further intensification of the campaign for financial assistance,
with requests from Lord Morris and Edward O’Hara MP to meet the Prime Minister,
campaigners from the Manor House Group and Haemophilia Action UK staging a protest
march demanding compensation; an adjournment debate in the House of Lords; repeated
parliamentary questions from Lord Morris; an Early Day Motion from Dr Brian Iddon MP;
and the Haemophilia Society commencing a “Carpet of Lilies” campaign in May. Moreover
on 26 March 2001 the judgment of Mr Justice Burton in
A and Others v National Blood
Authority
was handed down, which set out the High Court’s judgment that, on the facts,
surrogate screening for HCV should have been introduced, and direct screening should
have begun no later than May 1990.
In July 2001 the Parliamentary Under-Secretary of State for Public Health, Yvette Cooper,
requested a position paper in light of the High Court judgment, setting out options. The
range of options identified included lump sum payments and/or a hardship fund for all or
some people with haemophilia infected with Hepatitis C. The advice from officials was that
if ministers wished to consider payments, the recommended option was a hardship fund
solely for people with haemophilia whose Hepatitis C had caused severe liver disease.
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At the beginning of October 2001, the Scottish Parliament’s Health Community Care
Committee published a report calling on the Scottish Executive to provide financial support
to all who were infected with Hepatitis C as a result of blood transfusion or blood products
in Scotland. The report further recommended that the level of financial assistance awarded
should be determined on the basis of need. A briefing prepared for the meeting of the Joint
Ministerial Committee on Health (involving ministers from across the UK) on 22 October
2001 recognised that the existing line would be difficult to sustain in the rest of the UK if the
Scottish Executive “commits
to the Scottish Parliament report.”
On 13 November the Minister of State for Health John Hutton agreed to hold the policy line
that no payments would be made in respect of Hepatitis C infection through blood and blood
products except where awarded by the courts. The next day, responding to an adjournment
debate, and whilst acknowledging that the issue of compensation was “the
most difficult
decision of all,”
he reiterated the policy of successive governments (“that
compensation,
or other financial help to patients, is paid only when the NHS or individuals working in it
are at fault”)
and his belief that the NHS had not been at fault. The same day he spoke to
Susan Deacon MSP, explaining that he was “holding
the line on compensation.”
He told her
that there was “anxiety” that a new administration in Scotland might opt for a “different
and
conscious change of position”,
which would “create
significant difficulties for us if people
in Scotland can be compensated but those in England cannot.”
Susan Deacon indicated
that she was not planning to do so (although she recognised that she could not predict the
position “further
down track”)
and that the Scottish Executive wanted to look at the issue
from a UK perspective (“this
is an issue which shouldn’t have a different approach north and
south of the border.”)
By February 2002 the decision had been taken in Scotland to establish an expert committee
under the chairmanship of Lord Donald Ross to report on the question of compensation. In
May 2002 Charles Lister advised Yvette Cooper that “Until
late last year, Scottish Ministers
were taking the same line as us on the hepatitis C compensation issue. Under pressure from
the Scottish Parliament, this can no longer be guaranteed.”
It was also noted that Michael
Connarty MP had made a request for papers relating to Frank Dobson’s consideration
of the compensation issue, which had been made “under
the assumption that a detailed
analysis would have been undertaken by the Department.”
Charles Lister advised that the
papers showed this not to have been the case, and that the debate had been focused
around concerns that such a scheme would open the floodgates to further claims. Further,
if the papers were released, “they
will show that Frank Dobson was minded to support a
scheme limited to haemophiliacs with hepatitis C but was persuaded from this by officials
and Margaret Jay.”
On 4 November 2002 Malcolm Chisholm, the Minister for Health and Community Care in
the Scottish Government, called Alan Milburn to inform him that the expert group under
Lord Ross was about to publish a preliminary report calling for financial and other practical
support for all people infected with Hepatitis C through blood, blood products and tissues,
and that Scottish ministers felt that they “had
to offer something”.
It was intended that an
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announcement would be made on 6 November. The Secretary of State suggested that this
would be a “grave
mistake”,
“a
slippery slope to payments running into millions across the
UK”
and that Malcolm Chisholm should “tough
it out.”
On 29 January 2003 the Scottish
Executive Cabinet agreed that £25,000 be paid to those currently alive with Hepatitis C and
a further £25,000 to those who developed cirrhosis. A review of costings by Scottish officials
led to a decision that the figures would be £20,000 and £25,000 and this was reported to
the Health and Community Care Committee in a statement from Malcolm Chisholm. It was
subject to resolution of the issue regarding devolved powers, in relation to which the advice
of Law Officers was sought.
Handover notes prepared in May 2003 by Charles Lister for his successor recorded the
current position that: “Ministers
here are sticking strongly to the no compensation line but
Scottish Ministers have weakened … SofS asked us to see if a way could be found to stop
this. The result was a legal challenge saying that any payment scheme to haemophiliacs
would be a social security scheme and therefore outside Scotland’s devolved powers. This
issue is currently with the law officers for a determination and we are expecting them to give
a view very soon.”
On 13 June 2003 John Reid replaced Alan Milburn as Secretary of State for Health and
on 17 June 2003 Richard Gutowski, who had taken over from Charles Lister, provided
a background note and a line to take for the Secretary of State which described some
recipients of blood products having been “inadvertently
infected”
prior to the viral inactivation
of blood products in 1984 and the introduction of donor screening in 1991. Officials saw no
justification to move away from the existing line to take. A few days later the Law Officers’
opinion was received confirming that this was a devolved matter. The effect of this was that
the UK Government had no power to stop Scotland proceeding with its proposed scheme.
By 23 June the new Secretary of State had formed the view that “given
both the precedent
on HIV and the likely Scottish decision to now go ahead, it looks as though we will on the
basis of fairness have to go down the compensation (ex-gratia) route.”
A meeting with the
Chief Secretary to the Treasury and the Secretaries of State for Scotland and for Work and
Pensions took place on 25 June, at which it was agreed that “Wales
and Northern Ireland
will also need to be brought on board”.
The Chief Secretary to the Treasury was “very
non-
committal”
on the financing of an English scheme. Further discussions took place between
officials and ministers over the following weeks about how a scheme could be structured
and what payments should be made. As at 31 July 2003 a UK wide scheme was favoured,
but Wales and Northern Ireland had not yet been informed of developments.
On 29 August 2003 John Reid announced that England would have an ex gratia payment
scheme, a decision made “on
compassionate grounds”.
Similar announcements were
made in Scotland, Wales and Northern Ireland. This resulted in the establishment of the
Skipton Fund in 2004.
Ten days after taking up his position as Secretary of State, John Reid reversed the line
that had been adhered to for over ten years, and opted for a form of financial support for
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Hepatitis C sufferers infected through blood and blood products (albeit one that still fell far
short of being compensatory in nature). Lord Reid told the Inquiry that he did not take this
decision on the basis the Scottish Government had done so – rather the decision of the
Scottish Government was, he said, the catalyst for prompting these discussions and making
him think about it. Lord Reid added “if
the line is wrong, you change the line.”
These events reveal a deep institutional reluctance within government to, and the lack of an
open mind to, the provision of financial support to those infected with Hepatitis C through
blood and blood products. A line was adopted, and adhered to for over a decade, for reasons
that do not, on analysis, stand up to scrutiny. Those ministers who, from time to time, voiced
the wish to make some (albeit limited) provision were firmly steered away from that course
by civil servants in the Department of Health.
Three factors predominated in the decision-making of the Department of Health on this
issue: the fear that the making of payments to people infected with Hepatitis C would be a
major step on the slippery slope to a general system of no-fault compensation; the belief
that those infected had received the best treatment available at the time; and the attempt to
distinguish the position of those infected with HIV through blood or blood products, from the
position of those infected with Hepatitis C through the same route.
The fear that the making of payments to those infected with Hepatitis C would, or might, lead
to no-fault compensation more generally was misplaced and illogical. If it was necessary to
establish a ring fence, that could easily have been done with a scheme where the relevant
cohort was those infected through blood, blood products or tissue. As for the belief that
those infected had received the best treatment available, the difficulty with the Department
of Health’s position is that it was simply wrong to view the treatment in that light. There was
no proper basis for saying that those people who were infected by their treatments were
given the best possible treatment in the light of available medical knowledge, let alone to say
it repeatedly, let alone for over a decade. The attempt to hold the line by distinguishing the
position in respect of HIV and Hepatitis C involved the Department of Health in searching for
differences rather than dispassionately considering the similarities: those who contracted it
from treatment were infected in the same way, from the same sources, with viral conditions
that had similar consequences. Both could be debilitating and lead to death. It is plain in any
event from the narrative above that those within the Department of Health were well aware of
the difficulties of maintaining this distinction. Thus Tom Sackville observed, this was “a
tricky
one: if HIV, why not Hepatitis”,
officials in Scotland considered that “the
‘no-compensation’
position is becoming increasingly untenable”;
in Wales the view was that “it
would be difficult
to sustain rejection of claims for compensation on the grounds of a distinction between
those infected with HIV and HCV”;
officials in Northern Ireland thought it difficult “from
point
of view of equity to resist comparisons with HIV compensation”;
Departmental officials tacitly
recognised in 1996 that the distinction was “looking
increasingly tenuous”;
in 1999 it was
described as difficult to explain logically. Rather than face these difficulties, the Government
clung to this distinction in the mistaken belief that the sky would fall in – in terms of no-fault
compensation – if it did not.
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The Government became so fixated on maintaining that ring fence that it lost sight of
the desperate circumstances of those whose lives had been and were continuing to be
devastated as a result of their treatment by the NHS. The question of moral responsibility,
and the compelling need for a compassionate response, did not feature in the Government’s
thinking until a combination of factors – the campaigning of the Haemophilia Society, of
other campaign groups and of individuals, the events in Scotland (themselves the product
of the actions of campaigners), the High Court judgment in
A and Others v National Blood
Authority,
and a change of Minister to one who was unpersuaded by the Department – brought
about a rethink and a change of direction. That mounting political pressure might eventually
render the maintenance of the policy untenable and force the Government to concede was
recognised within the Department of Health by the mid 1990s. It should also have been
apparent that if Government waited until that point, almost certainly towards the start of the
2000s there would inevitably be individuals who had died, in desperate circumstances and
without any financial support other than social security (which was not designed to provide
for the needs of those with this debilitating illness), in the intervening period.
It took until 2003 for any form of payment to be announced for those with Hepatitis C and
no payment was actually to be made until 2004. This deprived those individuals, and their
families, of some valuable support before then. It prolonged and exacerbated the suffering
of those who survived. And it further entrenched deep feelings of injustice.
6.7 Skipton Fund
The Skipton Fund was set up as a corporation, and operated specifically as an agent of the
Department of Health. It had a board of directors, a secretary and administrator, supported
in part by a financial team shared with other Alliance House Organisations. Appeals
against the refusal of an application were made to a body independent of the Skipton Fund
and of government.
There was no discretion as to the amount to be paid. “Stage 1” lump sum payments, initially
of £20,000, were made to applicants who could prove on the balance of probabilities that
they had “contracted
the hepatitis C virus because of receiving blood, blood products or
tissue from the NHS prior to September 1991 or, in certain circumstances … from a person
who has received such treatment”.
A further “Stage 2” payment of £25,000 was payable to a qualifying person who “has
an
advanced stage of illness due to hepatitis C virus because of receiving blood, blood products
or tissues from the NHS prior to September 1991. In this context, persons with cirrhosis or
primary liver cancer and those who have received, or are on the waiting list to receive, a
liver transplant are eligible to apply”.
Only people who were alive on 29 August 2003 and who had received the relevant
transfusion or treatment before September 1991 could be an eligible “qualifying
person”.
People who had acquired Hepatitis C but had “spontaneously
cleared the virus in the acute
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stage”
and never developed chronic (lasting more than six months) Hepatitis C infection
were not eligible for payments.
The applicant had to complete an online registration form, providing basic details, after
which a paper form was completed by the applicant’s doctor. The purpose was to “‘confirm
that the patient has been chronically infected’”
and also “‘that
the infection most probably
arose through treatment with NHS blood or blood products’”.
There was no opportunity for
applicants to provide any direct evidence themselves as to whether they had received blood
or blood products prior to September 1991. The application process became more onerous
after the first administrator, Keith Foster, defrauded the Fund of around £400,000, despite
there being no criticism of the integrity of any applicant.
Around one fifth of applications were declined, with the main grounds being that the applicant
was a “natural clearer” (around one third of applicants were initially declined on this basis);
a lack of evidence of transfusion and/or lack of medical records; intravenous drug use,
and that the implicated blood product or transfusion was received after 1 September 1991.
There may be many reasons for this but less than one quarter of those who were probably
infected as a result of treatment made a claim.
The exclusion of Hepatitis B was unfair (and persists in the national support schemes to this
day). Whilst in 1972 blood donations began to be screened for Hepatitis B throughout the
UK, the screening tests used then were imprecise; Hepatitis B not infrequently continued to
be transmitted by blood at least until the early 1980s when screening tests became much
improved. Moreover, the availability of screening was not the only precautionary measure.
Avoiding unsatisfactory or risky donors was another. So too was ensuring that transfusions
were given only when needed, and then only in no greater quantity than actually required.
When a person developed Hepatitis B after a transfusion, there could and should have
been a check back to see from whom the donation had come. Records were frequently
inadequate for this purpose, or were missing. Considerations such as these are persuasive
of the need for a compensation scheme to include support for those with Hepatitis B as a
result of their treatment.
A clear-cut rule such as the date of 1 September 1991 used by the Skipton Fund can be
helpful for administrators and consistent for applicants. However, in this case it ruled out
some infections. Screening picks up viral loads only above a minimum which might not be
reached in the early stages of incubating a virus. A virus in a donation made during this
“window period” would then continue to incubate and to replicate. If that blood donation
is then transfused, it may manifest itself eventually in infection. The rule excluding any
donation made after 1 September 1991 could not accommodate such a case, however
deserving. It was a mistake not to allow the Skipton directors to exercise discretion for the
genuinely exceptional case.
There was disagreement as to the approach to natural clearers. There were three
problems in particular. First, the uncertainties around natural clearers at the start of the
Fund’s operations meant that a number of applicants were not put forward by their doctors
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but would have qualified once the position had been clarified. There is no record of any
deliberate attempt to invite them to re-apply. Second, the application form did not allow a
person to explain why they considered that they had continued to suffer Hepatitis C infection
beyond six months, nor could the Fund examine their evidence on the point. Third, there
were cases in which psychological or psychiatric damage had resulted, though there was
no physiological damage. The Fund did not account for these so these long-lasting effects
remained unrecognised.
Applicants had to prove the cause of their infection. The fact of having had a blood
transfusion would often not be recorded. Records which identified a particular blood
transfusion were comparatively rare. In the absence of medical records showing that there
had been a transfusion linked to emerging symptoms, a claim would be rejected by Skipton.
This was despite it being wholly unrealistic to assume there would be records, and that
these (or a discharge letter to a GP) would show whether there had been a transfusion. This
was indefensible: a person infected in the course of NHS treatment was now faced with
a failure of record keeping in the NHS, which led to the failure of their claim for help from
the Skipton Fund.
In his oral evidence to the Inquiry Professor Thomas explained that the expert group had
been looking for objectivity in relation to stage 2 payments and felt that the development of
cirrhosis was such a “solid
break-point”.
This understanding was overtaken by developments
in medical knowledge and the rules were amended to allow stage 2 payments to people
who, though not (or not yet) cirrhotic, were experiencing significant symptoms from
chronic hepatitis.
The Skipton Appeals Panel generally worked well. It had no hesitation in reaching a
conclusion different from that reached by the office team and did so in around half of the
cases. The evidence suggests this was likely to have been a combination of incorrect first
decisions, and more information being available on appeal. However, there was no scope
for oral hearings such that the Appeals Panel could hear from the individual personally,
which was unfair, and the Panel provided only short reasons for a refusal.
There were a number of flaws in how Skipton operated:
• there was no opportunity in the application process for applicants to provide any of
their own evidence
• too much emphasis was placed on records to show the individual had received a
blood transfusion – despite the fact that such records were too often unavailable
• the lack of records will inevitably have led to applications being declined when they
should not have been
• the Fund operated a policy which regarded any possibility of intravenous drug use
as excluding a claim altogether – this was unfair, as there was no scope for the
individual to be invited to a short hearing where their evidence about possible drug
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use could be assessed, and as the Ramsay report, on which the Fund relied, was
not provided to applicants
• the original criteria for the Stage 2 payment were too narrow, and ruled out claims
from people who were very ill but did not yet have cirrhosis
• the exclusion of people infected with Hepatitis B was wrong
The responsibility for these shortcomings rests with the Department of Health and not those
involved in the day-to-day administration of the Fund.
6.8 Government Response to the Archer Inquiry
The Archer Inquiry – an independent, privately funded, inquiry, under Lord Peter Archer –
published its report on 23 February 2009. Amongst its conclusions were: that a full public
inquiry should have been held much earlier to address the concerns of the haemophilia
community; that there had been “procrastination
in achieving national self-sufficiency to
avoid the use of high-risk blood products from overseas”;
and that “Commercial
priorities
should never again override the interests of public health.”
The Archer Inquiry made a number of recommendations including: the establishment of a
statutory committee to advise on the management of haemophilia in the UK; the issue of
cards to people infected entitling the holder to benefits not freely available under the NHS;
funding for the Haemophilia Society; improving access to insurance; a lookback exercise to
identify individuals who might have been unknowingly infected by infected blood products.
Of particular importance was the Archer Inquiry’s recommendation that there should be
direct financial relief, with payments at least equivalent to the scheme in Ireland.
The day after it was published, on 24 February 2009, Dr Rowena Jecock, who was the
head of blood policy within the Department of Health, sent a note to the Minister of State for
Public Health, Dawn Primarolo. The note summarised Lord Archer’s recommendations and
set out the policy team’s “Initial
Reactions”
to each of them. On the question of payments,
the note stated that a review of the payments system would need to be carefully considered
and costed: “However,
the financial implications are enormous if we were to operate in line
with the Irish system, as Archer recommends. (An initial estimate applying the average
Irish payment to our 4-5,000 cases would be £3-3.5 billion. We need more work to properly
quantify these recommendations.)”.
The strong recommendation was that there should be
no immediate commitment to a timetable for response, and that the necessary consultation,
costing of options, and decision time “may
require three months.”
The Minister’s Assistant Private Secretary, Morven Smith, commented that:
•
“The
Government at the time (1980s) did not accept that there was a case
to be answered and did not accept blame. In Ireland, the Government did
accept blame and thus offered compensation.
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• Response to this report does not intend to revisit decision to not accept
blame. I asked officials about reasons why the Government of the day did
not accept blame – no information about this is held.
• Officials are seeking legal advice on how apologising and using the terms
‘health disaster’ might affect us.”
In relation to the first of these comments, this reason for distinguishing the position in Ireland
(that the Irish Government “did
accept blame and thus offered compensation”)
became a
central refrain in the Government’s response to the Archer report. In relation to the second
comment, it is surprising to read that “no
information
[was]
held”
about the reasoning of the
Government of the day for not accepting blame. As for the third point, that officials were
seeking legal advice on the effect on the Department of Health of apologising and using the
term “health
disaster”
suggests that a primary focus of the Department of Health may have
been the reputational or litigious consequence for the Department rather than the position of
those whose lives, and the lives of those close to them, had been devastated by infection.
Dawn Primarolo was not satisfied with the note from Rowena Jecock: “It
is clearly not
acceptable in such tragic & unique circumstances for DH to claim no liability and no more
money to Trust.”
She asked the blood policy team to provide further information and analysis
in order to formulate a response to the Archer report.
A briefing provided to ministers in advance of a meeting with Lord Archer on 11 March
2009 set out the Government’s position as including the following: that while “this
is a
tragedy and there is every sympathy for those infected”,
the treatment given to people with
haemophilia “was
the best available at the time and action was taken in good faith”
and
technologies to improve safety (heat treatment and testing) had been introduced as soon as
available. For reasons explained elsewhere in this Report, these lines were incorrect. The
briefing noted that several of Lord Archer’s recommendations were based on measures that
had been implemented in Ireland, and stated that: “The
situation in the UK is different to that
in Ireland, where it was acknowledged that action to reduce the risk could have been taken
earlier. The Irish Blood Service issues an apology acknowledging ‘failures’ in the past and
their payment regime reflects this admission of mistakes.”
A submission from April 2009 put forward, at the Minister’s request, some more positive
options, including increasing annual payments made by the Macfarlane and Eileen Trusts to
either £10,000 or £12,800 per year. The Minister preferred the latter option. These figures
were arrived at on the basis of what was affordable and which ministers could “live
with
politically”:
there was no assessment of need and in that sense the figure was arbitrary.
The Government’s formal response to the Archer Inquiry’s report was published on 20 May
2009. The recommendation concerning financial assistance was addressed by the increase
in annual payments from the Macfarlane and Eileen Trusts. However, the recommendation
that payments should be at least the equivalent of those in Ireland was not mentioned. The
Haemophilia Society was fiercely critical of the Government’s response.
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In discussions following the publication of the Government’s response, Dawn Primarolo
sought further information from officials, in particular as regards the substantive reasons
for thinking that the situation in Ireland was very different. A submission was sent to her
on 2 June but before she could make any decision, there was a Cabinet reshuffle. A brief
for her successor, Gillian Merron, sought to explain that in Ireland an inquiry had found
the blood transfusion service to have been responsible for failures which led to infection
and this explanation was repeated in subsequent briefings. This line was repeated by the
minister in response to questions about the position in Ireland.
In August 2009 campaigner Andrew March brought judicial review proceedings challenging
the government’s reasoning (based on the Irish government accepting liability, and that it
had been found at fault, whereas it had begun making such payments without any such
acceptance) in failing to accept Lord Archer’s recommendation of payments equivalent to
those in Ireland. Judgment was delivered in April 2010 with the judge concluding that the
Government’s approach to the recommendation regarding parity with Ireland had been
“infected
by an error”.
The claim for judicial review succeeded, and the Government would
have to take a fresh decision.
Following the general election, officials provided a submission to the new minister, Anne
Milton, with advice as to how to approach making a new decision. The recommendation
was made at that point to reject the recommendation “on
the basis that it is unmeritorious,
on grounds of both: (i) the factual difference between RoI & UK; and (ii) affordability.”
In
respect of the first, the findings of the Finlay Tribunal in Ireland were again relied upon as
a relevant distinguishing factor, notwithstanding the outcome of the judicial review claim. In
respect of the second, the rough initial costing of £3-3.5 billion to achieve parity was said to
be “an
underestimate.”
An international comparison of contaminated blood compensation
schemes was provided in an annex to the briefing. The briefing also suggested that the
Minister should reconsider the previously announced decision to bring forward the review of
the Skipton Fund; as the review had not yet commenced, the Minister could decide whether
it should proceed.
In October 2010 a written ministerial statement was published:
“Having
carefully compared the circumstances pertaining here and in the
Republic of Ireland during the period when most of the infections occurred,
and having taken account of the fact that this tragedy similarly affected many
other countries; I do not consider there is a case for accepting Lord Archer’s
recommendation 6(h) that levels of payment here should match those made in
Ireland. Every country must make its own decisions on financial support for those
affected, taking account of its own particular circumstances, and affordability.
The scheme in Ireland was set up on that basis, and has not been replicated in
any other country, as far as we know. However, our ex-gratia payment schemes
for HIV compare well with those of other countries.
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In addition, it is estimated that implementing a similar scheme to Ireland’s here in
the UK, would cost in excess of £3 billion.”
Consideration of the Archer Inquiry recommendations led to some changes. Additional
measures were announced on 10 January 2011: an increase in stage 2 Skipton Fund
payments from £25,000 to £50,000, an annual payment of £12,800 for people infected with
Hepatitis C who reached stage 2, and the establishment of what became the Caxton Trust.
The response of the Department of Health had been to avoid endorsing the Archer
Inquiry. Though it provided documents this did not amount to an unfettered access to the
Departmental files. It did not facilitate the appearance of witnesses. It did not waive legal
professional privilege. The Archer Inquiry lacked the powers available to a statutory inquiry,
or the resources necessary to conduct a full investigation. As a result its conclusions were
always likely to fall short of a full picture of what had happened, and why.
Thus, repeatedly, officials repeated that there was no proper comparison with Ireland
because the government there had accepted blame, and had been found at fault. They
had been told this was not so, yet it took a further court case (of judicial review) to confirm
it. Linked to the Irish issue was a reluctance to accept the financial recommendations the
Archer Inquiry made. Although the belief that nothing wrong had been done, that there was
no fault, and that the best available treatment was given was waning it was nonetheless
proving hard to shake off. Its influence is clear in the Department of Health response to the
Archer Inquiry and in its persistent belief in the difference between the UK and Ireland. The
response to the Archer Inquiry was too concerned with the financial consequences that
might follow. The events highlight how civil servants repeatedly took care to steer ministers
away from anything that might involve expenditure, or be an implicit acceptance of fault. If
there had been such an acceptance, expenditure would be bound to follow. They also show
how long it may take for government to take a fresh look at evidence to see if the facts do
indeed support some of its views, or to look again at practices hallowed by their repetition
repeatedly over years.
What is most disappointing about the response to the Archer Inquiry is the sense it leaves
that government was looking to see what was the least that was required of it.
6.9 Caxton Foundation
People who contracted Hepatitis C from NHS treatment were entitled to specific payments
from the Skipton Fund, but not to one-off payments to meet particular needs. The Archer
Inquiry highlighted the considerable difficulties this could cause. Partly in response to its 2009
report, the Government set up the Caxton Foundation in March 2011 to provide such grants.
The Caxton Foundation faced a number of challenges:
• Raising awareness among those eligible: the likelihood is that a very large number
of potential beneficiaries (registered with the Skipton Fund) needed the further
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assistance they could get from Caxton but it actively served only a small proportion
of those entitled to its support.
• Relations with government: Though technically independent as a charity, Caxton
was required to account for its expenditure to government and not allowed to retain a
reserve. It was reluctant to press its case for additional funds too strongly, or publicly.
• Staffing levels: The lack of sufficient staff to perform essential tasks, let alone
consider improvements, caused many of the operational problems.
• Dealing with each beneficiary with sensitivity: Beneficiaries were likely to feel
aggrieved by the fact that due to being infected they were now forced to seek what
felt like charity.
The evidence was all one way by the end of 2012. The Caxton Foundation was not working
effectively. Grants were initially paid by means of a voucher system, which was stigmatising.
It took far too long to process applications. In the first 6 months of active operation a third of
applications were left undecided because more information was needed. By the end of the
next six months it was still more than one in five.
Beneficiaries felt they were being repeatedly quizzed about the same details of their income
and expenditure. Although over half the applicants were recognisably in poverty, and (by
definition) had a chronic infection, they were expected to provide additional financial details,
and then sometimes further details, and then wait.
As late as June 2013 no guidance had been made available to beneficiaries about support
for which they could apply. Not sharing the guidelines left beneficiaries invited to register
with a trust which could give them money, but would not tell them how much they might get
or what for. No proper explanation was given to the Inquiry as to why the Caxton Foundation
needed to be so secretive. The absence of clear published criteria for assessing applications
must have made it difficult to ensure consistency.
Pressure was put on funding by a rise in the number of beneficiaries. Four months into the
2014/15 financial year the Department of Health asked the Skipton Fund to contact anyone
who had ever received a Skipton Stage 1 payment, but with whom there had been no
subsequent communication. The result was that the number of Caxton beneficiaries rose
by nearly 60 per cent. The business case requesting increased funding for 2014-15 was
rejected in February 2014.
The difficulties which beset the Caxton Foundation, and contributed to poor relations
between beneficiaries and the Foundation, were principally:
• an absence of a user trustee (although Charles Gore had experience of Hepatitis C
and Margaret Kennedy was appointed in 2014 as someone who could represent
the user voice)
• the close links with the Macfarlane Trust where dissatisfaction had been expressed
by beneficiaries
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• the failure to take more proactive steps to ensure that those who would be eligible
to apply to Caxton were aware of its existence
• the poorer practices during Caxton’s first year of operation
• the initial shortage of staff to achieve a proper turnaround of applications
• the frequent referral back to applicants for further information
• the feeling of many that they were supplicants rather than applicants
• a lack of any clear information as to what might be applied for, and on what basis an
application was determined, coupled with uninformative rejections of applications
• the absence of any developed forum for an exchange of views between the Board
and the beneficiaries.
The Caxton Foundation was proactive in supporting beneficiaries dealing with debt. They
hired debt counsellors to advise beneficiaries how they might access other sources of
funding, and the counsellors were able to act as advocates in managing debt on favourable
terms. This deserves to be recognised as an achievement.
6.10 Medical Records
The Inquiry has heard evidence from many infected and affected individuals who have
identified either incomplete, inaccurate or missing medical records. This chapter examines
the problems faced by individuals, the possible reasons for these issues as well as evidence
from individual clinicians and NHS trusts and boards regarding record-keeping policies,
retention policies and destruction policies.
The lack of availability of records is so widespread that many people who were infected
through blood or blood products have wondered whether the reason is something more
sinister than the result of the passing of time, and human error.
It is without doubt that the destruction and disappearance of medical records has caused
both practical difficulties and significant anxieties for individuals who were infected and
their family members. The effectiveness of the HIV and Hepatitis C lookback exercises
were significantly hindered due to incomplete, inaccurate and missing medical records.
More recently, individuals have faced issues in accessing support schemes and financial
assistance, because medical records have been destroyed or could not be obtained from
hospitals, GPs and health boards, meaning that people have struggled to evidence the
source of their infection.
For adults who were infected as children, there is a particular desire to understand what
happened to them as children. Family members of deceased individuals have a desire to
understand their family members’ treatment and what caused their death, particularly so for
children seeking to reconstruct what happened to their parent or parents who were infected.
The emotional toll of trying to obtain the records has been significant for some people.
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The legal framework that applies to medical records, has changed with guidance being
issued over the years requiring records to be kept for specified retention periods. In very
broad terms, until the 1980s the guidance required records to be kept for 6 years after the
end of treatment or the death of a patient. From 1980 there were different rules for patients
depending on whether adult, paediatric or obstetric. In all four nations obstetric records
were to be retained for 25 years with these rules in other cases:
• In England and Wales, adult records were to be kept for 8 years after the end of
treatment or the death of the patient; and paediatric records until the patient turned
25 (or 26 if 17 at the time of treatment) or 8 years after the patient’s death
• In Scotland, adult records were to be retained for 6 years after the last entry or 3
years from death, and paediatric records until 25 (or 26 if 17 at the time of treatment)
or 3 years after death
• In Northern Ireland adult records were to be retained for 8 years after the end of
treatment or death, and paediatric until 25 (or 26 if 17 at the time of treatment) or 8
years after a death before the age of 18.
Nevertheless, accessing records has continued to be problematic. A fundamental difficulty
lies in the fact that there was, and remains, no central system where medical records
are held. These issues have been made worse through the closures of a large number
of hospitals, particularly maternity hospitals, which has resulted in medical records having
been destroyed without any prior notification to patients. The very widely experienced delays
in diagnosis of Hepatitis C inevitably meant that for many people these dates had passed by
the time they had a need to request their records.
There has been no consistency in the responses from hospital trusts and boards given
to people trying to access their records. Some hospital trusts and boards have failed to
respond, some have provided vague replies and for some there have been long delays
and hard work involved in obtaining records. On the other hand, some have been better
equipped to provide a speedy, substantive response.
The Inquiry obtained evidence from a sample of NHS trusts and health boards that confirmed
that they currently follow national guidance and provide current policies on document
destruction, and they believe that guidance was followed historically, though copies of older
policies have generally been unavailable.
From the evidence it is apparent that there are a number of possible reasons why medical
records have been destroyed or lost:
• reorganisations in the NHS
• records management across multiple locations with separate repositories, later
transferred to centralised records, with opportunities for human error
• multiple changes in computer systems removing access to earlier systems
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• changes in name, address etc
• haemophilia centre patient records being kept separately from the main
hospital records
• physical damage caused by water or fire.
When records have been obtained by individuals, a number of concerns have been
raised about the quality and content of medical records. In particular, concerns relate to
inconsistency between what is recorded in the notes and the information that was given, or
not given, to a patient; and inaccurate information being recorded in the records. The Inquiry
has heard substantial evidence about the differences between what individuals recall being
told, or not told, orally and what is recorded in their medical records. There are examples of
matters recorded in medical records which simply have been wrong. One common concern
for a number of witnesses of this is the accuracy, or otherwise, of references to alcohol use,
particularly for those with Hepatitis C.
There are a handful of examples that raise serious issues of intentional interference in
medical records. Due to the passage of time, it is difficult to reach any firm conclusions on
what happened in these individual situations. They do however raise concerns that there
may have been a closing of ranks in certain situations resulting in somebody thinking it
would be wise to remove items from medical records.
Professor David Armstrong gave evidence about the poor quality of records systems and
said that despite attempts to bring structure and coherence to medical records, removing
what was extraneous continued to be haphazard “everywhere”.
What lessons are to be learned from this? On any view the destruction and disappearance
of medical records has caused significant harm to individuals. It has also resulted in a loss
of trust that is harmful both to patients and to the NHS more widely. It is critical to the future
of the NHS that patients can generally trust what they are told, and trust that the NHS has
their best interests at heart. Keeping accurate and complete records, and making them
available on request, demonstrates the openness, transparency and rigour which patients
and those close to them associate with a careful, caring system of healthcare.
There is considerable material to show that patient records were not well kept, and had not
been well kept for years before the periods of central interest to the Inquiry.
Given the evidence of the general poor quality of records systems across the whole of
the NHS, the likelihood is that in the majority of cases records were not available due to a
mixture of incompetence, a lack of proper systems, and the problems inherent in keeping
paper records. Although there are suspicions that some health authorities or individuals
hid, removed or destroyed records that might be an embarrassment, there is no evidence
sufficient to make a general finding of that nature.
The possibility that there may have been occasions in the past when records may have
been left incomplete deliberately or have been filleted nonetheless still remains. The filleting
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of records by some health professionals in respect of blood-borne infections would be much
less difficult to achieve, may involve no other health professionals, and is thus perhaps
easier to contemplate as having happened.
6.11 National Support Schemes
This chapter sets out the evidence on how the current National Support Schemes
were established.
Dissatisfaction with the Alliance House Organisations increased during the 2000s and by
2013 reform began to be considered by ministers. Anna Soubry expressed exasperation
about the time it took “to
sort anything out”;
and heard that “the
systems set up by successive
Governments are divisive and people are being dealt with in an uncompassionate and
ineffective way.”
She told the Inquiry that when briefed about the schemes she “could
not
understand why there were different funds or why they were so complicated and difficult for
applicants to access. It struck me as illogical and profoundly wrong”
and that “the
‘cap in
hand’ nature of it was humiliating for the beneficiaries.”
She asked her officials to provide her
with options for reforming the Hepatitis C payments system, although her recollection was
that there was little political will to change the system. Jane Ellison succeeded Anna Soubry
in that ministerial role in October 2013, and also sought advice on options for reform.
The issue reached Prime Minister David Cameron, and when he met a group of campaigners
with Alistair Burt MP he came to believe “the
system was not fit for purpose.”
A submission
to ministers in January 2014 suggested that there was no additional money available for
reform and that “we
will need to consider what might be done to reform the current system
to address the key concerns of campaigners and MPs, within the current, or lower, budget
envelope of the system.”
The submission noted that the payment levels under the existing
system were “for
the most part arbitrary, and, with some exceptions, not based on any
assessment of impact or need.”
In November 2014 the Prime Minister was asked to approve a proposed consultation about
the different schemes, but a view appears to have been taken that this should await the
delivery of the Penrose report. In January 2015 the APPG published its “Inquiry
into the
current support for those affected by the contaminated blood scandal in the UK”,
accurately
describing the current position as “a
haphazard financial support system, established
piecemeal by successive governments”.
On 25 March 2015 (the date of publication of the Penrose report) the Prime Minister
announced a consultation into reform of the payment schemes and pledged up to £25 million
that financial year to support transitional arrangements to a better system. A meeting of the
UK health departments took place on 17 April 2015 to discuss reforming the infected blood
payments scheme reform. The minutes of the meeting record the desire of the English,
Welsh and Northern Ireland Health Departments to work towards a UK-wide approach, and
although it was noted that some “affected
patients”
in Scotland favoured a Scottish scheme
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in Scotland, Shona Robison was said to recognise that a UK-wide scheme would reduce
service delivery costs.
On 30 June 2015 the Secretary of State for Health Jeremy Hunt wrote to David Cameron,
suggesting that it was “basically
impossible”
to bridge the gap between the expectations
of families who had suffered “and
what we can realistically afford.”
Three options were
advanced: (a) austerity; (b) one-off payments to people infected and bereaved, shutting
down the schemes, but providing accelerated access to direct acting antiviral treatments
to everyone who had been infected, or (c) funding accelerated treatment for those in the
early stages of the disease. The Prime Minister’s response was “I
don’t think these work.
A scheme that is meant to help but actually takes money away from people who currently
get it is hopeless. And I accept we don’t have £480m
[the estimated cost of the second
option that Jeremy Hunt personally favoured]
lying around. Surely there is a route where we
increase the £25m to £100m or some such and fill in the worst payment gaps & merge all the
charities into 1.”
Following further deliberations, a submission to Jane Ellison and Jeremy
Hunt in early August 2015 identified three different options, observing that “The
reputational
risk of failing to make substantive changes to the scheme is high. Successive Governments
have promised to address the concerns of beneficiaries for a number of years.”
One of these
options was to reform the current schemes into one, with £25m additional funding a year for
the next five years. In November 2015 the Spending Review resulted in an agreement that
a further £25m a year would be allocated from Department of Health central funds to the
financial support schemes over the following five years.
In December 2015 the Scottish Financial Review Group (established following the publication
of the Penrose Report) made a number of recommendations including that annual payments
be increased to reflect Scottish full-time gross median income and that bereaved partners
should receive a pension of 100% of the annual payment in the first year and 75% thereafter.
The Group “favoured
a new Scottish scheme that would not be constrained by UK-wide
discussions/agreement”.
The recommendations were accepted by the Scottish Government
in March 2016, and resulted in the establishment of the Scottish Infected Blood Support
Scheme which began operations on 1 April 2017.
In January 2016, ten months after the publication of the Penrose Report, the Department
of Health launched its consultation on reform of the Alliance House Organisations, setting
out a number of proposals for a new scheme in England. Little notice of the consultation
was given to health ministers in Scotland, Wales and Northern Ireland. In July 2016 the
Department of Health published its response to the consultation, and David Cameron
announced the decision that there would be a single scheme administrator for England from
2017/2018 (later confirmed to be the NHS Business Services Authority).
In October 2017, the Department of Health announced, following further consultation, a
“special category” mechanism to allow a beneficiary with a stage 1 infection with a substantial,
long-term negative impact on daily life to apply for a higher annual payment. Annual support
payments were also increased. The England Infected Blood Support Scheme (“EIBSS”)
started work on 1 November 2017.
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Advance notice of the Department of Health’s response to the consultation on reform of the
Alliance House Organisations had not been provided to Northern Ireland. A submission to
ministers in July 2016 explained that the Department of Health had informed the devolved
administrations that no additional money would be available to them. In December 2016
the Minister for Health announced that the new provisions in England were being replicated
in Northern Ireland. In January 2017 the Northern Ireland Executive collapsed, leaving the
Department of Health without a minister and limited ability to implement reforms. The Infected
Blood Payment Scheme Northern Ireland began work on 1 November 2017, although with
no special category mechanism.
Wales likewise did not receive advance notice of the consultation or the DH’s response. In
October 2016 Vaughan Gething, noting that the UK wide nature of the schemes had “now
fragmented through new schemes announced for Scotland and England”,
announced that
as an interim measure payments for the remainder of the 2016-17 financial year would be at
the same levels as England. Following consultation a new scheme, the Wales Infected Blood
Support Scheme (administered by Velindre NHS Trust), began to operate in October 2017.
In mid-2017 the Scottish Government asked Professor David Goldberg to establish an
expert group to assess the health and wellbeing of individuals, chronically infected with
the Hepatitis C virus (at stage 1) who had not yet reached advanced Hepatitis C (eligible
for Skipton Fund stage 2). In addition to recommending that renal disease be added to the
latter criteria, the group considered the method of assessment used by the scheme. The
group noted that any entirely clinically-based assessment would ignore the considerable
non-clinical, especially psychosocial, impacts described in its report and recommended
that people with chronic Hepatitis C, including those who had cleared their virus through
treatment, or their widows, widowers or partners who were eligible for support were asked
to “self-declare
hepatitis C impact”
based on whether the infection had affected their life
but not seriously (lower award), had seriously affected and continued to affect their life
(higher award) or had not appreciably affected their life (no award). This was an innovative
approach which the Inquiry has been told works well with no claim that the system has
encouraged overpayment.
Changes have been made to all four schemes since their inception, often following dogged
campaigning by those infected and affected.
On 30 April 2019 the Prime Minister announced that £30 million of additional funding would
be made available. This announcement coincided with the first day on which the Inquiry
heard evidence; it appears likely that the publicity of the start of the Inquiry hearings focused
the departmental/governmental mind. This was an announcement that applied only in
England and intensified calls for parity between the four schemes.
In summer 2020 Penny Mordaunt (then Paymaster General) wrote to the Chancellor of the
Exchequer, Rishi Sunak, to explain the work being undertaken to resolve the remaining
disparities in support between the schemes. She pointed out that this was “one
of the
main requests of the victims and their families”
and her “strong
belief”
that “it
would be
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the right thing to do.”
Penny Mordaunt wrote to the Chancellor again on 21 September
2020 providing the costings for parity of financial support and seeking his views “on
how
this additional funding would be integrated best into the 2020 Comprehensive Spending
Review.”
She wrote “I
cannot stress enough the urgency of taking long overdue action on
financial support and compensation.”
By the end of 2020 there had been no significant
progress and in February 2021 Penny Mordaunt wrote to the Secretary of State for Health,
Matt Hancock, setting out her view that resolving the disparities was “a
matter of justice”
and that the Government “must
find a way to fund this – either through existing budgets or
by making a further approach to the Treasury.”
On 25 March 2021 Penny Mordaunt announced that the UK Government would provide
funding to enable broad parity of annual and lump sum payments between the four national
schemes. These changes were backdated to April 2019. Equivalent statements were made
in the other nations and changes to the schemes were made within the following months.
Although there have been some criticisms of the operation of the national support schemes
(in particular EIBSS), there is little doubt that the decision to cease funding the Alliance
House Organisations and establish different schemes was inevitable. Scotland and Wales
took particular advantage of the opportunity to improve provision by introducing (in Scotland)
ongoing support for bereaved partners and self-assessment to identify the full impact of
infection with Hepatitis C in Scotland, and by introducing (in Wales) more holistic support to
people infected and affected. Both seem to have worked well.
There are two significant areas where the response of governments fell short. The first is
the time it took to move to the new schemes, given what was increasingly apparent about
the unsatisfactory ways in which they had been functioning. Though it takes time to arrange
a consultation on potential change, and consider the responses, four years was too long.
Responsibility for this delay lies with the Department of Health.
The second is that the way in which the new schemes were set up meant that there were
significant disparities from the outset. The support provided was a response to what was
a UK problem, the seeds of which were sown long before any devolution of government.
However, when the Department of Health consultation was carried out on changes to
the schemes, the devolved administrations were not informed about that consultation or
the resulting decisions. Given the decisions made in England and Scotland, Wales and
Northern Ireland were left with no real alternative but to set up their own schemes, which
was responsible for some of the disparity. It is, of course, inherent in devolution that each
nation of the UK was constitutionally free to do this. Nonetheless, as part of the UK it is
reasonable that where common issues cross the borders there should be an attempt at
joined up planning. It did not happen at the start of the national schemes. It took too long
after that to achieve a reasonable degree of parity. Responsibility for this lies with the
departments of health, but principally the Department of Health in Westminster.
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6.12 Access to Treatment
Where harm has been done, it might be thought that, as a matter of justice, the state should
do all that it reasonably can to alleviate the consequences of that harm. With that thought in
mind, this chapter examines four aspects of medical treatment: lack of access to specialist
treatment; the availability of treatments for Hepatitis C, palliative and end of life care; and
the availability of recombinant factor product.
Lack of access to specialist treatment
People with bleeding disorders who became infected with HIV or hepatitis were too often
treated for those infections by doctors whose expertise was the treatment of bleeding
disorders. Instead, they should have been treated by expert clinicians or multidisciplinary
teams (as were people infected through transfusions). It is clear from accounts provided
to the Inquiry that this often did not happen. Treatment of HIV or hepatitis by haemophilia
doctors also meant that people were often obliged to see the same doctor (who had given
the implicated treatment), and in whom they had lost trust.
It is also clear from accounts given to the Inquiry that people infected through transfusions
have faced wide variations in provision, with not all receiving treatment from an appropriate
specialist multidisciplinary team.
People who have been infected with such serious viruses as HIV and hepatitis in the course
of NHS treatment, deserve nothing less from the NHS than the reassurance of the right
expertise, the absence of delay, and the knowledge that their continuing health problems
are dealt with by specialists. Having been infected by the NHS, it was and is incumbent upon
the health service to do all that could reasonably be done to alleviate the consequences.
Treatment of Hepatitis C
A common account provided to the Inquiry has been of difficulties or delays in accessing
treatments for Hepatitis C, often caused by lack of resources.
In the period from licensing interferon in 1994 to 2000 there were repeated difficulties
for some in accessing interferon treatment under the NHS in England. Provision was not
consistent across the country. There was no central funding and whether patients received
it or not was up to their local health authority. Measures that could have helped to address
problems over access to treatment, such as clinical guidelines, purchasing guidelines and
centralised funding, were still not in place after five years. In his written statement to the
Inquiry, Professor Sir Kenneth Calman noted that the issues “were
common across the
NHS when new drugs or treatments emerged.”
Dr Rejman noted in his statement that “it
appears that DH
[Department of Health]
was encouraging the use of Interferon, where it
was appropriate, but accepting that the final decision rested with the purchasers.”
In Scotland a working party of the Royal College of Physicians of Edinburgh produced a
report on Hepatitis C in February 1996 and noted: “There
is currently no general agreement
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as to who should meet the drugs costs, general practitioner or hospital … In the smaller
regions the additional numbers generated by a lookback survey are relatively modest and
may be largely absorbable into existing budgets. In the west of Scotland, in particular, the
additional costs are likely to be substantial.”
Dr Aileen Keel “advised
that ‘ring fenced’ funding
for interferon treatment would not materialise.”
In April 1999, the National Institute for Clinical Excellence (“NICE”) was established to
provide clinical guidelines for England and Wales and reduce postcode prescribing. In May
1999 ribavirin was licensed for distribution in the UK and in October 2000 NICE guidelines
for the use of interferon and ribavirin were introduced. While interferon had low cure rates,
the addition of ribavirin increased cure rates of Hepatitis C “quite
significantly”.
The NICE
guidelines recommended that combination therapy be used to treat moderate to severe
Hepatitis C. Pegylated interferon was licensed as a combination therapy with ribavirin, and
recommended by NICE on 28 January 2004. Between 2002 and 2010, all four nations of
the United Kingdom developed action plans to improve treatment services for Hepatitis C.
In 2006, an article on the variation in Hepatitis C services across the UK, based on a survey
conducted in 2002, found that 72% of consultants who responded identified funding as
a barrier to treatment. The survey found that the majority of patients were not receiving
antiviral treatment, in contrast with practice in Europe.
From 2014 new direct-acting antivirals (“DAAs”) became available which were a combination
of sofosbuvir and other agents (without interferon). However the costs were high and caps
on the number of people who could receive treatment in each area limited access. In
England, the first early access programme began in April 2014 and provided treatment with
sofosbuvir to patients with decompensated cirrhosis, “at
risk of death or irreversible harm
within 12 months”
with either decompensated cirrhosis, other life-threatening complications
and/or awaiting liver transplantation. Access for “critically
urgent”
patients was considered
on an individual basis by NHS England clinical experts. In 2015 it became clear that funding
was affecting access to treatment. NICE issued guidelines for treatment with sofosbuvir
in February but at NHS England’s request there was an extension of the period for their
implementation. Following the implementation of NICE guidelines, funding for DAAs was
provided through operational delivery networks across England. Each one was provided
with a proportion of the budget for Hepatitis C treatment based on the estimated treatment
figures for the area covered and the local prevalence of Hepatitis C. There were some
examples of patients not receiving treatment due to the resultant limit on allocations, and
the experience of patients, as described to the Inquiry, is that there have been difficulties
with access to treatment.
Wales had previously experienced a “postcode
lottery”
where availability and quality differed
across parts of Wales but the announcement in September 2015 of funding for interferon-
free treatment was seen as a turning point, and there was no central process of capping the
numbers of patients who could be treated with DAAs. In Northern Ireland there were delays
in accessing the treatments but this resulted from the limited capacity of the hepatology
service rather than funding constraints.
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Had the failures detailed in this Report not occurred, there would have been less need for
sofosbuvir-based treatments than arose. If it had been appreciated by then, as it should
have been, that the infections from blood and blood products were serious failures for which
authority was ultimately responsible, those infected by blood and blood products would have
had priority for funding; and therefore there should not have been any such difficulty as there
was in England in receiving treatment with direct-acting antiviral drugs such as sofosbuvir.
Funding was tight across government: but this was a question not of extra spending, so
much as one of allocating priorities. And it would have been fair as a priority to allocate
enough funding to help moderate the harm done to individuals as a result of the several,
interconnecting, failures that led to their having to live with otherwise relentless infection.
Ongoing monitoring
Evidence provided to the Inquiry demonstrates that a lack of ongoing monitoring is an area
of concern for people who were infected with Hepatitis C and have cleared the virus. The
Expert Group on Hepatitis advised the Inquiry that successful treatment for Hepatitis C can
considerably reduce (by approximately 70%) but not eliminate the risk of cancer. The major
factor determining the long-term impact of Hepatitis C is the degree of liver fibrosis at the
time when the Hepatitis C PCR test became negative. People with significant fibrosis or
cirrhosis are likely to require lifelong surveillance for the risk of hepatocellular carcinoma,
with six monthly testing usually involving an ultrasound of the liver and an alpha fetoprotein
(“AFP”) blood test. The expert group advised that people who did not have such liver scarring
may be discharged from specialist care.
Professor Michael Makris recommends that patients with an inherited bleeding disorder who
have cleared Hepatitis C should be seen by a consultant hepatologist and have blood tests,
an ultrasound scan and a fibroscan. Where patients have no signs of advanced fibrosis/
cirrhosis but have abnormal liver enzymes, these should be assessed and they should be
given advice on lifestyle factors to minimise the risk of liver failure. He recommends that
patients with advanced fibrosis or cirrhosis are entered into a hepatocellular screening
program, with six-monthly ultrasound scans and regular hepatology follow-up to detect early
signs of liver failure.
Leigh Day solicitors submitted that one of the most important issues for their clients infected
with Hepatitis C through transfusions was access to monitoring and follow up after having
“cleared” the virus. They are understandably worried about the harm of long-untreated
Hepatitis C and their increased risk of developing end-stage liver disease or hepatocellular
carcinoma. In February 2020 at the end of the hearings with the hepatitis experts I said: “I
would like to draw the attention publicly now of NHS England and hospital trusts and boards
throughout the country to the fact that the need for specialist treatment by professionals
who have a special understanding of infected blood and blood products has not gone away,
now that there is greater success in treatment of the underlying conditions – that there is
a need to ensure that the standards of follow-up of those who have cleared hepatitis C but
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have been left with a compromised liver are maintained in accordance with what the experts
have set out this week.”
The consistent delivery of appropriate follow-up monitoring is a legitimate concern. For this
reason, the Recommendations include that those bodies responsible for commissioning
hepatology services in each of the home nations should publish the steps they have taken
to satisfy themselves that the services they are commissioning meet the particular needs of
this group of people harmed by NHS treatment.
Palliative care
There is variability throughout the UK in referral to specialist palliative care and access to
palliative care services for patients with chronic liver disease. In some cases palliative care
services have struggled to provide adequate care for people suffering from Hepatitis C, or
hospitals have failed to recognise that palliative care was necessary.
Advanced liver disease is characterised by a multitude of distressing physical and
psychological symptoms, poor quality of life, frequent hospital admissions and a high burden
on caregivers. Palliative care can help alleviate distress and is of demonstrable benefit
to patients and carers. Despite a growing body of evidence supporting the integration of
palliative care in the management of advanced liver disease, the provision of palliative care
for patients with advanced liver disease remains patchy across the UK. The patient and
carer experience of healthcare for advanced liver disease too often remains very poor.
HIV was a life-threatening disease. In the days before highly active antiviral therapy began
it called out for palliative care. Though palliative care should have been an integral part
of the care pathway in the 1990s, the stigma of HIV tended to make it less likely to be
offered or accepted.
The provision of palliative and end of life care – these are not identical, though the first may
overlap with the second) – to many of those infected by NHS blood and blood products has
been inadequate, and a further way in which people infected and affected have been let
down through a lack of access to good care.
Recombinant factor products
As a precaution against the transmission of blood-borne viruses, synthetic forms of treatment
were developed using advanced recombinant DNA technology. Modern recombinant factor
products are widely understood to be free of transfusion transmitted viruses.
Recombinant Factor 8 was made available to UK health services in 1994. It was not cheap
and concerns about the lack of availability of recombinant Factor 8 due to cost started to
arise during the next year. A survey reported to the Secretary of State for Health in late 1995
suggested that only two centres had secured the funds to purchase recombinant for some
or all of their patients outside clinical trials. The position at the end of 1996 was that the
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government did not intend to provide any extra money or advise or require health authorities
to fund recombinant – it would be a matter for health authorities to decide.
Concerns about the possible transmission of vCJD by blood led to a decision in 1998 to
introduce leucodepletion. It also led, in February 1998, to an announcement from Frank
Dobson, the Secretary of State for Health, that recombinant products would be made
available to children under 16 and previously untreated patients. There were however no
plans to roll out recombinant to all patients.
In May 2001, the Haemophilia Society led a national campaign for the universal availability
of recombinant Factor 8. The society encouraged individuals to write to their local MPs
or government officials outlining the importance of funding recombinant Factor 8 for all
Haemophilia A patients, and that “treatment
by postcode is unfair and distressing to the
haemophilia community.”
Wales decided in 1997 to make recombinant Factor 8 available to everyone with
Haemophilia A, and it achieved this over the next two years. It was the first country,
anywhere, to offer recombinant Factor 8 to all its patients. By the end of 2000 Scotland and
Northern Ireland had confirmed that all haemophilia patients would be placed on recombinant
treatment. In England, it was decided in January 2001 that recombinant would be made
available for all adult haemophilia patients on a phased basis over a 4-5 year period starting
in 2002-03. Due to issues with funding, it was not until the financial year 2004/2005 that all
patients with Haemophilia A, of whatever age, had access to recombinant Factor 8.
Recombinant was desirable for two reasons. First, many people with haemophilia who had
been alive before 1992, and survived, had been infected with HIV, and more (possibly almost
all) had been infected with Hepatitis C. They would have seen many of their friends die,
often painfully, and had to face indignities and stigma. They knew their families and close
friends had been significantly affected in almost every aspect of their lives. In each case, the
cause was blood products of human origin. They – and parents also concerned about the
treatment available for the next generation – had every right to be seriously worried. This
group had been harmed by treatment from the NHS which was now threatening to expose
them to harm again, as they reasonably saw it, and they were (generally) in no position to
fund more acceptable treatment for themselves.
Second, the predominant concern should be the safety of the patient. It is right to acknowledge
that using money to fund one treatment may deprive another patient with a different condition
from having their treatment funded. However, recombinant was undoubtedly safer so that
even before risks of vCJD being transmitted by blood there was a powerful argument for
recombinant being funded for everyone who needed it. Once those risks were recognised
it became unanswerable. Recombinant treatment should have been funded earlier than it
was across the whole of the UK.
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6.13 Inquests, Fatal Accident Inquiries and Death Certificates
This chapter looks at death certification, and identifies differences in the approaches of
different coroners that have been taken to recording death from, or causatively related to, HIV.
The right to life is of fundamental importance. When a person dies, it is important to know if
this has been interfered with, either by the state or in a way which the state could put right. It
is important for their family and friends to know why the death has occurred and for society
more generally to know that it has happened and what the cause was – especially because
there may be lessons to be learned from one death which will help prevent other deaths
occurring in a similar manner.
A fatal accident inquiry (in Scotland) or investigation by a coroner (in England, Wales
and Northern Ireland) is usually the first time that people bereaved by a death can have
an independent professional review the circumstances of that death. This is particularly
significant where the death may have been caused by failings within a state-funded
organisation such as the NHS.
There were clearly weaknesses in the system of death certification and investigation: it
was described as fragmented, inconsistent in its standards, and failing to satisfy the public
interest in the true causes of death in the population. These weaknesses have since been
addressed, including by the Shipman Inquiry and legislation following a Fundamental
Review in 2003 (England and Wales) and a review by Lord Cullen in 2009 (Scotland).
Death certificates
It would be difficult to obtain much statistically useful information from death certificates
produced during the 1970s and 1980s, and indeed into the 1990s, because of the lack
of consistency in the language used to reveal (or avoid revealing) that hepatitis or HIV
infections were the underlying cause of the death. There was little to no guidance and
training available to doctors during the relevant period on how to fill out death certificates.
Any apparent trends would always be surrounded by uncertainties.
The Inquiry has heard a range of views on whether or not AIDS, HIV or Hepatitis C should
have been recorded on death certificates. Some families made a specific request for the
information to be withheld due to concerns about people finding out about the deceased’s
true cause of death and the stigma involved. Others, however, felt the truth should have
been recorded. For some, the information on the death certificate has caused further pain.
Some have told the Inquiry that they felt not referring to AIDS, HIV or Hepatitis on death
certificates was an attempt to cover up the truth and to protect doctors, not the deceased or
their families.
The evidence provided to the Inquiry shows wide differences of view as to what should
have been recorded and also highlights the importance of respect for the autonomy of
the bereaved individual or family, and their wishes. Experiences of paternalism (even if
well meant) led to distress, and misunderstanding of motives. The Inquiry’s sense is that
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doctors may not have appreciated the importance of the wording of death certificates to the
bereaved. It is unclear why a system that allowed AIDS to be confidentially recorded was
not established.
Disparities in coronial practices
Until 2013, when the role of Chief Coroner was introduced, there was no oversight of the
practices of individual coroners. Some coroners held inquests into cases involving infected
blood and blood products but some did not. Whilst there is no evidence that this was specific
to infected blood, it appears that some coroners sought and would have welcomed guidance
on how to deal with inquests in these cases.
The disparity in investigations by coroners across England and Wales was a reflection of the
way the coronial system operated. The autonomy of local coroners meant that determinations
were unpredictable and often too dependent on their relationships with local clinicians.
In Scotland, the disparities were less apparent in that no Fatal Accident Inquiries were
held into deaths caused by infected blood and blood products, although there was a wide
discretion there too. Judicial reviews were brought before the Scottish courts in respect of
this failure, which were upheld, resulting in the Penrose Inquiry being established.
This system was intended to provide answers, to establish the prevalence of certain causes
of death, and to inform public health. As it was, until well into this millennium, it proved
an unreliable source of information, which hid rather than revealed causes of death. An
opportunity was missed.
Volume 7 Response of Government
7.1 Document Destruction
This chapter examines the circumstances in which three separate sets of documents have
been lost or destroyed: files relevant to the HIV litigation; papers relating to the Advisory
Committee on the Virological Safety of Blood (“ACVSB”), in particular from 1989-91; and the
Private Office papers of Lord David Owen.
The exploration of what happened to these documents is not easy to summarise. What is set
out below, therefore, are simply the main conclusions that have been reached. The evidence
on which those conclusions are based is described in some detail in the chapter itself.
When a class action in respect of Hepatitis C was mooted, an early question was whether
the number of people “who
might have been saved from infection”
could be estimated and it
was thought that the ACVSB papers might provide the answer.
A number of registered files containing ACVSB papers (referred to as GEB/1) had been sent
to the Departmental Records Office repository in early 1993. In mid 1995 it was discovered
that one of the volumes, covering part of 1989, had been destroyed. Steps were not then
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taken, as they should have been, to ensure that the remaining files were properly looked
after, or to reconstruct the missing file.
The file in question (registered file GEB/1 volume 4) had been destroyed on 29 September
1994. This was before the 19 July 1995 date set for its branch review (in other words, a
review which considers whether the documents should continue to be retained). The file
should never have been destroyed at all, but in any event it should not have been destroyed
in advance of its review date.
The other GEB/1 files had been reviewed on dates between December 1994 and April 1997
but were not destroyed until between October 1997 and November 1998. None of these
files should have been destroyed, given their nature and importance. If the files had been
recalled by September 1997, these documents would have been saved.
Copies of ACVSB papers kept by Dr Metters, the Deputy CMO who had chaired the ACVSB,
were destroyed shortly after his retirement in 1999. The likelihood is that these copies were
destroyed to make room for his successor’s files and the evidence does not establish who
was responsible for that.
In November 1999, the Department of Health agreed to voluntary disclosure to claimants
in the Hepatitis C litigation. This led to work to identify documents, including the ACVSB
papers. Although some of the missing documents were found from other sources, it was
recognised that “the
registered files are irreplaceable”
and the Department was advised by
leading counsel (who described his reaction as being “how
could this possibly have been
allowed to happen?”)
to undertake an internal investigation to try to establish why the files
were destroyed.
The Department of Health’s internal audit department undertook the investigation and
concluded that “an
arbitrary and unjustified decision, most likely taken by an inexperienced
member of staff, was responsible for the destruction of a series of files containing the
minutes and background papers of the ACVSB.”
The chapter concludes that the audit investigation was ineffectual in finding out what had
actually happened. It ought to have been relatively easy to identify the person responsible
for the destruction of the documents, to ask them why the documents had been marked for
destruction, and why those files were destroyed related to litigation about Hepatitis C. The
audit investigation did not interview all those who should have been interviewed, nor did it
seek to ask each person who worked in the relevant section of the Department of Health at
the time what had happened.
There has never been a satisfactory explanation for the loss of the ACVSB documents.
The files were deliberately destroyed. The issue is why they were. The chapter concludes
that it is more likely than not that their destruction was authorised because the documents
contained material dealing with delays in the UK to the introduction of screening of blood
donations for Hepatitis C. It was a deliberate attempt to make the truth more difficult to
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reveal. It is not, however, now possible to identify the individual responsible for marking
them for destruction.
It is possible but not probable that the same person was responsible for the loss of documents
relevant to the HIV litigation. Some documents (in particular relating to self-sufficiency) that
were relevant to the HIV litigation were lost prior to 1990 and were not available during the
litigation. Some were lost after the conclusion of the litigation; they were discovered to have
been lost in 1996 (although some of those were subsequently located).
In relation to Lord Owen’s private office papers, which were destroyed at an unknown date
and in unknown circumstances, there is no sufficient evidence of impropriety to lead to a
conclusion that Lord Owen’s papers were destroyed because of their contents, rather than
because destruction was thought to be an appropriate procedure. There was at the time a
regrettable lack of clarity, and some confusion, about what should happen to private office
papers in the Department of Health
7.2 Self-Sufficiency Report
This chapter examines the origins of, and the drafting of, a report that was published by
the Department of Health in 2006: a report entitled
Self-Sufficiency in Blood Products in
England and Wales: a Chronology from 1973 to 1991.
In June 2002 the Parliamentary Under-Secretary of State for Public Health, Yvette Cooper,
decided that a formal internal review should be undertaken on self-sufficiency between
about 1973 and 1985, because the Department “did
not have a clear account of decisions
that had been taken in the 1970s and 1980s, and therefore I could not be confident in the
advice I was being given to answer campaigners’ serious questions, nor could I be confident
that previous official advice or subsequent Ministerial decisions on this issue were right as
a result.”
She expected the review to address the destruction of Departmental papers and
Lord Owen’s Ministerial papers.
Peter Burgin, a senior executive officer at the Department of Health, started work in
September 2002, reviewing documents and carrying out a small number of interviews. He
emailed his draft report to Charles Lister on 24 December 2002.
There were substantial differences between the project as envisaged initially and as
eventually made public in 2006:
• Whereas Peter Burgin considered the period from 1973-1985, the report published
covered from 1973 to 1991.
• It was originally intended to be an internal review, to assess gaps from missing
documentation so that ministers could take informed decisions, but became a
published document.
• It moved from a factual account of what documents said about self-sufficiency to
one expressing opinions about what had happened.
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• There were very significant changes in the content of the document. None of those
who might be thought responsible for producing the document accept that this was
the result of their input. They seek to say that the Self-Sufficiency Report, as it
became known, was in essence the same as the initial report, with no change to the
substance of what was reported. This is not the case.
There was very considerable delay in finalising the report. It had been substantially
completed by Peter Burgin when he handed over a draft on Christmas Eve 2002. But it was
not published until 27 February 2006, over three years later. The delay was inexcusable.
In June 2003 Charles Lister was succeeded by Richard Gutowski as the civil servant
principally responsible for blood policy. In his handover notes Charles Lister said the
report needed an executive summary, references to the documents quoted and to back
up statements which otherwise would remain unsubstantiated; and that a final draft should
be shared with some of the people consulted for comments on the factual accuracy. Due
to other work pressures, Richard Gutowski decided external consultants were required to
finalise the report and a contract with Dianthus Medical Ltd was signed on 7 June 2004.
Dianthus sent their final version of the report to Richard Gutowski in October 2004. A further
version was produced by July 2005, with there being only one minor change after that
before eventual publication.
In the draft produced by Peter Burgin, there was material supportive of an argument that
although risks of infection were known by clinicians and virologists, and that many of them
saw these risks as potentially serious, little was done to advise patients of this or to protect
them from those risks. The documents reviewed by his draft report might fuel an argument
that commercial concentrates carried with them greater risks than the concentrates that
would have been available to patients in the UK if self-sufficiency had been achieved. The
draft report supported the view that these risks arose because of the nature of the populations
from which the plasma supplies to make the products were drawn, but also because of the
pool sizes used. He noted that self-sufficiency remained the policy throughout this period
and his review showed that the problems in achieving this were linked to BPL’s capacity.
There is a striking contrast between these matters and the messages the Government felt
able to relay from the final version of the report in 2006. By the time the review was to be
published in February 2006 the communications unit of the Department of Health briefed
the Parliamentary Under-Secretary of State for Public Health that:
“The
review concludes that:
• Clinicians acted in the best interest of their patients in the light of the
evidence available at the time.
• The more serious consequences of hepatitis C only became apparent in
1989 and the development of reliable tests for its recognition in 1991.
• Attempts to devise a procedure to make the virus inactive, tests were
developed and introduced as soon as practicable.
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• Self sufficiency in blood products would not have prevented haemophiliacs
from being infected with hepatitis C. Even if the UK had been self sufficient,
the prevalence of hepatitis C in the donor population would have been
enough to spread the virus throughout the pool.”
These comments would not have represented a fair reading of the material which Peter
Burgin had set out over three years earlier.
In evaluating the evidence about the development of this report, the first question is whether
Peter Burgin’s draft was a fair reflection of the documents available to him. There is nothing
to suggest it was not. The next question is why it was changed. One reason may be the
decision to publish, which necessitated an executive summary, and full references. Another
reason may be that the period covered was extended from 1973 to 1985 to 1973 to 1991.
Part of the reason is more troubling: there was clearly also a change of approach. Yvette
Cooper’s purpose in commissioning the study was to see if the conclusions of fact which had
hitherto been expressed by ministers and by the Department of Health were justified or not,
and to find out what had become of Lord Owen’s papers. The document became, instead,
one intended for publication with conclusions in support of the official government line to take.
A particularly egregious example of this is the very last words before the conclusions are
stated: “It
is now known that it is an indisputable reality that very few counties [sic] are
capable of completely satisfying their blood needs (i.e. becoming self-sufficient) without
acquiring a proportion of blood from paid donors [158].”
The reference for this is an article
which says what is effectively the opposite. “Unpaid
donation is proven to be much safer
for receivers and supply problems can be attributed fundamentally to inefficiencies in the
organization of transfusion services. Voluntary and non-remunerated donation may be
sufficient for a country/region to cover all its blood product needs, but requires an efficient
organization and the elimination of ‘spurious altruism’, non-monetary forms of compensation
that harm the social image of voluntary donation and obstruct its further development.”
In
other words, if countries organise their transfusion services efficiently there is no supply
problem, and safety is provided better by a system of voluntary donations than one which
involves supplies which are bought from individual people wishing to sell their blood.
The doctor from Dianthus working on the report appears to have been looking for material
which might be taken to support the Departmental line as taken thus far. She must have
thought this is what the Department of Health wanted. Ultimately, what started out as a
project to inform ministers about self-sufficiency, so that they could consider whether the
current line was properly justified, became itself a document which attempted to justify
that line. The likeliest cause of the changes is that Dianthus took their line from what they
experienced as the prevailing attitudes within the Department of Health – essentially, that
the Department of Health was keen to defend the position they had habitually adopted.
The production of the Self-Sufficiency Report in the form it eventually took was part of the
government response to what had happened. The Self-Sufficiency Report was promised,
expected and then unjustifiably delayed. As this Inquiry now knows, but the public receiving
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the report will not have realised until very recently if, indeed, at all, it represented a report
which had undergone substantial change from draft to draft, altering the timescale, and its
essential nature. As published it was defensive of the line which had been taken but, as
examined elsewhere in this Inquiry, much of what was recorded in it presented an incomplete
picture of the material that was there to be seen.
The Self-Sufficiency Report was an inadequate response to the request made by Yvette
Cooper and a disservice to campaigners who, despite the challenges of ill-health and grief,
had determinedly pieced together a fuller understanding of self-sufficiency than the report
published by the Department of Health.
7.3 Lines to Take
This chapter explores the repeated use of “lines to take” by successive governments, lines
which repeatedly asserted or suggested that there was no wrongdoing or fault.
The use of three particular lines to take are examined: the line that people were given “the
best treatment available”; the line that screening for Hepatitis C was introduced as soon
as it could be; and the characterisation of what had happened and the harm which it had
caused as “inadvertent”. Some examples are set out below, but the use of these lines is
considered in more detail in the chapter.
“Best
treatment available”
In November 1989, Prime Minister Margaret Thatcher stated at a Downing Street meeting
that people infected with HIV from blood products “had
been given the best treatment
available on the then current medical advice, and without it many of the haemophiliacs
would have died.”
The line was thus first used as part of the justification for not providing
compensation to people with haemophilia who had been infected with HIV.
There are then multiple examples of this line being used over the following years: in
correspondence, in briefings, and in Parliament. A briefing for Prime Minister John Major in
November 1994 included that: “We
have great sympathy with those who may have been
infected with hepatitis C through NHS treatment. These patients will have received the best
treatment available in the light of the medical knowledge at the time.”
There were, said the
briefing, no plans to extend the HIV settlement scheme to those infected with Hepatitis C.
A briefing prepared for a parliamentary question in the House of Lords in January 1995
included that: “These
patients received the best treatment available in the light of medical
knowledge at the time”.
It was further suggested that non-A non-B Hepatitis was considered
to be an “acceptable
side effect”
of treatment with blood products, “both
by physicians
and the patients themselves.”
There is no evidence of any enquiries being undertaken to
justify the assertion that patients regarded Hepatitis C as an “acceptable
side effect”
of
their treatment
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Another use of the line in January 1995 covered people infected with Hepatitis C following
transfusion in addition to people infected through blood products. A briefing included the line
that: “We
do not accept that there has been negligence. These patients will have received
the best treatment available in the light of medical knowledge at the time. We therefore have
no plans to compensate those who may have been infected with Hepatitis C.”
The same line was adopted in Scotland and in Wales to justify not providing compensation.
The line continued to be used under the next government. In December 1998 the Department
of Health, writing to an individual with regard to the Government’s decision not to set up
a special payment scheme for people infected with Hepatitis C, stated that: “Regrettably,
some people were infected with hepatitis C through NHS treatment, but this was not through
negligence. Patients received the best treatment available based on the knowledge which
existed at the time.”
In May 2006, at a time of renewed calls for a public inquiry, Lord Norman
Warner, Minister of State within the Department of Health, asserted that: “This
was blood
given to people when it was a matter of life or death whether they received that blood, and
we were acting on the best scientific and clinical advice at the time.”
The “best treatment available” line was used by officials advising ministers on how to respond
to the Archer report. The briefing for a meeting in March 2009 between the Secretary of
State (Alan Johnson) and Lord Archer emphasised that it was “important
to remember”
that “the
treatment given to haemophiliacs was the best available at the time and action
was taken in good faith”;
and in June 2009 a submission to the Minister of State for Public
Health sought to distinguish the position in Ireland on the basis that “The
Government here
has never accepted any liability. We believe that people were offered the best treatment
available at the time”.
The reality is that this use of this blanket line to take – sometimes applied to the position
of people with bleeding disorders, sometimes to all those infected with Hepatitis C from
blood or blood products – was inappropriate. It was wrong and its use was unacceptable. It
became a mantra and was never questioned.
Hepatitis C screening
A further line to take which began to feature prominently in the 2000s was the assertion that
screening for Hepatitis C could not have been introduced earlier than September 1991. This
line was used even after the judgment of Mr Justice Burton in
A and Others v National Blood
Authority,
in which he concluded that surrogate testing should have been introduced at the
latest by March 1987, and that Hepatitis C screening should have been routinely introduced
by March 1990, and even after campaigners pointed out that it was wrong.
Thus, by way of example, in September 2003 Baroness Kay Andrews asserted on behalf
of the Government that “there
was no liability when this unfortunate event occurred. There
was no test until 1991 for hepatitis C”.
This was based on a briefing that asserted that
“The
NHS introduced measures to reduce the risk of transmitting Hep C in blood or blood
products as soon as the technology existed to do so.”
A briefing for an oral parliamentary
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question in January 2004 suggested the following answer to any call for a public inquiry:
“Donor
screening for hepatitis C was introduced in the UK in 1991 and the development of
this test marked a major advance in microbiological technology, which could not have been
implemented before this time.”
A brief by Scottish Executive officials for the meeting of the Minister for Health and Community
Care with the Scottish Haemophilia Groups Forum on 1 February 2005 stated, in relation
to the introduction of Hepatitis C screening in 1991, that this development was introduced
“as
early as
[it]
reasonably could be in the light of the current scientific knowledge and
technical capabilities at that time.”
And an update for the Secretary of State dated 29 March
2005 emphasised that “Donor
screening for hepatitis C was introduced in the UK in 1991
and the development of this test marked a major advance in microbiological technology,
which could not have been implemented before this time.”
In a letter to the Haemophilia
Society on 8 February 2006, Caroline Flint repeated that “Donor
screening for hepatitis C
was introduced in the UK in 1991 and the development of this test marked a major advance
in microbiological technology, which could not have been implemented before this time.”
This was advanced as part of the rationale for rejecting a public inquiry.
On 2 June 2009 a submission to the Minister of State for Public Health, Dawn Primarolo,
regarding the Government’s response to the Archer report stated, as part of an explanation
why the position in Ireland was different, that “as
soon as blood screening tests were
available they were implemented.”
The repetition of this line to take at this stage is particularly incomprehensible because the
Archer report had itself set out the facts regarding testing, and Mr Justice Burton’s judgment
and conclusions, very clearly. No one reading the Archer report could have genuinely
believed that “as
soon as blood screening tests were available they were implemented.”
The line that the screening of blood for Hepatitis C was introduced as soon as possible
was untrue. It must have been known to be untrue by the Department of Health, given the
judgment in
A and Others v National Blood Authority.
There has been no explanation as to
how the line came to be formulated in the first place or why it was parroted without question
for years. Poor corporate memory is not an adequate answer, though it explains why use
of the line persisted for so long. It is clear that the claim that the screening of blood for
Hepatitis C was introduced as early as it could have been influenced the decision-making of
successive governments. In particular: it influenced the decision as to whether there should
be a payment scheme for those infected with Hepatitis C; it was advanced as a reason as to
why no such scheme should be established. It influenced the response to the Archer report.
It influenced the decision not to hold a public inquiry.
“Inadvertent”
Numerous documents from the Department of Health in the time periods discussed above
also referred to the infection of people with HIV or Hepatitis C from blood or blood products
being “inadvertent”. To suggest, in this context, that something was inadvertent is to suggest
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that it was accidental and unintentional. It hints at something that could not have been
known about – a mishap, a chance by-product. Yet the risks of transmission of hepatitis
were well known. Such transmission was not the purpose of the treatment, but that it might
result was well recognised by clinicians and within government. It had been known for years
in medical and public health circles. To characterise it as inadvertent is thus to downplay the
significance of what happened.
In their repeated use of these lines to take, successive governments were more concerned
about reputational damage than openness and honesty; more defensive than candid; more
interested in avoiding financial exposure than in admitting shortcomings.
7.4 Delay in Holding a Public Inquiry
The question why it took until 2017 for a UK wide public inquiry to be established into
the worst treatment disaster in the history of the NHS is considered in this chapter. The
summary below describes some of the occasions when the possibility of an inquiry was
raised or considered but a more detailed narrative is set out in the chapter.
By 1986 the Government can have been under no illusion about the scale of what had
happened to people with haemophilia – many had been infected with HIV, a virus with an
exceptionally high mortality rate for which there was no known treatment, and sufferers
experienced public hostility. The Government knew that the direct cause of this disaster was
the treatment which they had received from the NHS. Public inquiries were not unknown
in the 1980s. Yet there is no documentary evidence to show that it occurred to anyone
within Government before 1989 either that there might be an important public interest in
investigating and understanding precisely how this had occurred, or that those whose lives
had been devastated in this way might deserve answers as to how and why it had happened.
It ought to have been clear that there were lessons to be learned for the future if something
similar were not to recur.
In June 1990 a submission on the HIV litigation was sent to the Minister of State for Health,
Virginia Bottomley, following Mr Justice Ognall’s suggestion of an out-of-court settlement.
This referred to the alternative option of a Commission of Enquiry, but noted this might be
no quicker than allowing the litigation to take its course and could set a precedent.
In June 1999 Prime Minister Tony Blair responded to Lord Morris’s request for a meeting
about the case for a public inquiry: “Though
I recognise that people with haemophilia and
their families feel a sense of injustice, I am not convinced that a public inquiry would provide
greater insight into the problem or pave the way for any further improvements in the safety
controls which are now in place.”
In December 1999, a petition called on the Scottish Parliament “to
hold an independent
inquiry into hepatitis C and other infections of people with haemophilia contracted from
contaminated blood products in Scotland.”
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In July 2001 a briefing to Yvette Cooper, Parliamentary Under-Secretary of State for Public
Health, noted there was “considerable
parliamentary concern on this issue. Lord Morris
… and a number of backbench MPs regularly raise questions in both Houses.”
It also
referenced the “high
profile”
campaign by the Haemophilia Society that was “calling
again
for a Public Inquiry.”
The briefing included a list of options following the judgment of Mr Justice Burton in
A and
Others v National Blood Authority.
One option was a public inquiry alongside the provision
of a lump sum and hardship fund. The arguments against this stated that the relevant facts
were largely established and the information was in the public domain. Further arguments
against included the concern that a “Public
Inquiry would raise the profile of potential no
fault compensation at a time when litigation in the NHS is an increasing problem.”
In December 2003 Lord Warner told the House of Lords that: “I
have to make it as clear in
as gentle a way as I can that the Government does not accept that any wrongful practices
were employed, and do not consider that a public inquiry is justified”.
In Scotland Andy Kerr, Minister for Health and Community Care, stated in November 2004
that “It
is our view that there is nothing to be learned from a public inquiry that has not
already been learned. We have, however, stated that should any new evidence come to
light that this would be reconsidered.”
In a briefing to Westminster ministers in June 2006, the “considerable
pressure”
for a
public inquiry was noted and that “patient
groups continue to press for higher levels of
compensation and believe an inquiry could help to achieve this by demonstrating the
Department was culpable”.
The advice of officials was that, on balance, “we
consider an
inquiry to be disproportionate and not justified in the circumstances.”
Lord Warner suggested that rather than a public inquiry the powers under the National
Health Service Act 1977 could be used “to
commission a review of ALL the documents (new
ones, old ones and if possible Scottish ones) with a view to producing an independent legal/
judicial commentary on them and putting all these into the public arena.”
He thought a retired
judge or Queen’s Counsel could do this with an administrative support team. Ultimately,
this review was carried out internally by a Departmental official. When asked whether the
internal review fulfilled its objective Sir Hugh Taylor (Permanent Secretary of the Department
at that time) stated that it: “could
be said to have met its, inevitably limited, objectives.
However, reflecting on this question now, there is a limit to how far an internal Departmental
review of this kind was likely to assuage public concern, given its limitations. The review
rehearsed rather than re-examined the Department’s previous analysis of the history, which
the new documentation did not appear to undermine, but which was still being challenged
by campaigners. It was not resourced to put the original decision making on these issues
under the microscope in the way that, given the passage of time that had already elapsed,
only a statutory inquiry with the power to call witnesses and with the resources and expertise
to apply an objective forensic analysis to the evidence could do.”
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In August 2007, it was confirmed that a separate Scottish inquiry would be held, and the
Penrose Inquiry was announced in April 2008. Throughout the period of that inquiry, the
campaign for a public inquiry in England continued. The Department of Health’s position
remained that no public inquiry was required.
On 25 March 2015, the Penrose Inquiry report was published. On the same day the Prime
Minister, David Cameron, made an apology in the House of Commons. In a Commons
debate the following day, Andy Burnham MP stated: “The
2010 to 2015 Parliament will be
remembered for some extraordinary work to right historical wrong – on Bloody Sunday,
on Hillsborough, on child abuse – but as it comes to an end this Parliament has not made
enough progress on perhaps the greatest injustice of them all: the loss and ruination of
many thousands of lives through the use of contaminated blood.”
He asked for “a
further
process of Inquiry in the next Parliament”.
Jane Ellison, Parliamentary Under-Secretary of State for Public Health, replied that: “The
Government’s initial reaction is that another inquiry would not be in the best interests of
sufferers and their families as it would further delay action to address their concerns. The
strong message I have had is that it is time for action”.
Jeremy Hunt told the Inquiry that it was made clear to him when he became Secretary of
State for Health in 2012 that “the
Treasury would not support an inquiry because of the
potential cost to the taxpayer which (taking into account any decisions on financial support
which might follow, such as a recommendation for a compensation scheme similar to that in
place in Ireland) could amount to billions of pounds.”
He did not therefore pursue the issue
and followed the official Government line in correspondence with all campaigners.
Following further pressure from Diana Johnson MP, a submission on 7 July 2017 noted that
the leaders of opposition parties had written to the Prime Minister Theresa May calling for
a public inquiry and that pressure for an inquiry had increased because of recent events
“including
the announced inquiry into the Grenfell Tower fire and recent media articles on
infected blood”.
It concluded with a recommendation that the Government announce its
intention to establish an inquiry. Jeremy Hunt informed the Prime Minister on 10 July that he
was minded to hold an inquiry. In identifying the turning point in the Government’s stance,
he said: “I
think the real thing that caused, if I can put it this way, the goal to be open, was the
threat of losing a vote in Parliament which was subsequent to this when the Speaker said
that he would allow a debate. And I think that was really what allowed me to go to Theresa
May and say, ‘Look, I think this is the right thing to do and this is the moment to do it.’”
This Inquiry was announced on 11 July 2017. The concerns expressed in 2017 were
largely the same concerns that had been voiced by campaigners and others (including
parliamentarians) for the previous two and a half decades.
The reasons that were given over the years for declining to hold a public inquiry do not
stand up to scrutiny. It was said that there was no evidence of wrongdoing. But that was a
self-serving assessment. Given the extensive concerns raised by campaigners and others
there was an imperative for an independent inquiry to examine and determine the question
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of fault rather than leave the Department of Health to mark its own homework. It was said
that the relevant facts were all in the public domain. They self-evidently were not. It was
suggested that this was a problem linked to the state of science and technology. That
was (plainly) an exceptionally and unduly restrictive way of looking at the issues (and, as
detailed in the
Lines to Take
chapter, the Department of Health repeatedly asserted that
“technology” for Hepatitis C screening was not available before 1991, when in fact it was).
It was even said that these matters had been looked at by Lord Archer and Lord Penrose,
in circumstances where the Department of Health had sought to distance itself from each. It
was said that these events were historic. They were not, and are not, to those who survived
and live with the impact of the infections and to the families of those who had died. Perhaps
most astonishing was the assertion that an inquiry would not help those infected and their
families: to do so would not be in their interests. Just as clinicians had purported to know
what was in patients’ interests in terms of the treatment that infected them, now politicians
and civil servants purported to know better than those whose lives had been devastated.
There are many who, having been repeatedly denied a public inquiry, have felt obliged
to try and piece together the truth themselves, whether through undertaking careful and
painstaking research, targeted Freedom of Information requests; patiently raising questions
through MPs time and again; or participating in demonstrations. The people infected and their
families, and the campaigning organisations they formed, have demonstrated persistence
and resilience as they were answered with repeated variations of the same lines to take.
They were “fobbed
off time and time again.”
One reason to refuse an inquiry was an inherent defensiveness – a reluctance for the
decisions, actions and omissions of both the NHS and government to be assessed and
exposed. Jeremy Hunt said that the state, including the civil service, “didn’t
have an open
mind to this issue. They basically had decided that the State in the 1970s and 80s had done
the best it could in the circumstances”.
The second and related reason was what Jeremy
Hunt described as the “massive
institutional reluctance in the NHS to listen to the stories
of ordinary people when things have gone wrong … there was certainly a very strong view
that harm to patients is part of the cost of doing business. It’s part of what happens.”
That
description is as equally applicable to government as to the NHS.
This was a collective failure by civil servants and ministers of successive governments, and
is all the more serious for being so.
7.5 Accountability in the Absence of a Public Inquiry
In the absence of a public inquiry, some of the people infected tried to get answers and/or hold
people and organisations to account by other means: NHS complaints, the Ombudsman,
the General Medical Council and the police.
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NHS complaints procedures
The Inquiry has reviewed a number of different complaints made under the informal processes
of a number of NHS trusts and health boards. No particular patterns are discernible in the
type of complaint made, or the likelihood of the outcome.
The adequacy of NHS internal complaints procedures has been analysed and subjected to
criticism by external bodies over the years – see, for example, the 1994 Wilson Report
Being
Heard,
the 1999 Public Law Project report
Cause for Complaint?,
the Department of Health’s
publication in 2003 of
NHS Complaints Reform – Making things Right,
the fifth report of the
Shipman inquiry in December 2004, the report of the public inquiry into Mid Staffordshire
NHS Foundation Trust, and a December 2015 report into the quality of NHS complaints
which found that 40% of investigations were not adequate to find out what happened and
there was a wide variation between and within trusts in terms of how patient safety incidents
were investigated. It also found that “Worryingly,
medical records, statements and interviews
were missing from almost a fifth of investigations making it even harder for trusts to arrive at
what went wrong and why.”
In light of these earlier analyses, this Inquiry does not need to make any additional findings
about the limitations of the complaints procedures. It notes, however, that whilst a complaint
about a specific clinician or hospital might address specific concerns regarding the treatment
of an individual, such complaints could not be a substitute for a public inquiry into how so
many people had been infected.
Ombudsman
Individuals who were not satisfied with the outcome of their complaint under NHS procedures
could take the matter to one of the Ombudsman services across the four nations. As with
the NHS complaints processes, there is in the material available to the Inquiry considerable
variety in the complaints that have been made to an ombudsman.
The Parliamentary and Health Service Ombudsman can consider complaints about
government departments. The limitations of that role are apparent from the terms of a letter
in response to a complaint about the Department of Health: “I
see no evidence here of
maladministration in the government’s decision-making process and so there is no basis on
which I could reasonably question the merits of the decisions reached, or ask for them to be
reviewed. […] While I do not, of course, condone the Department’s premature destruction
of key papers, they have investigated how and why this occurred; and they have taken
appropriate action to help prevent a recurrence. They have also apologised … I can find no
evidence in the papers that would lead me to question the Department’s explanation, and so
there is no basis to justify my intervention.”
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General Medical Council
The General Medical Council (“GMC”) is the professional regulator responsible for the
regulation of doctors. It is empowered to undertake fitness to practise investigations and to
erase or suspend a doctor’s right to practise in the UK.
There were, unsurprisingly, a number of complaints to the GMC by individuals who had
been infected with HIV or Hepatitis C in relation to the clinicians who had treated them with
blood or blood products. The GMC has told this Inquiry that the question of consent was
raised in the majority of the complaints it received against clinicians in relation to infections
caused by blood transfusion or blood products, and that there were “no
cases where a
finding was made that a doctor’s fitness to practise was impaired or where a doctor was
found guilty of serious professional misconduct. No action was taken on the registration of
any of the doctors complained about.”
In closing submissions on behalf of core participants, the GMC’s process as it was in
earlier years was characterised as being “such
an opaque complaints procedure that the
complaints were never properly investigated, and patients were never given sight of the
response evidence provided by doctors”
and as a “woeful
response”.
Police
Some people have also felt driven to go to the police but the Inquiry does not have any
evidence of investigations being pursued beyond an initial stage. As observed in submissions
to the Inquiry, “it
is incontrovertible that campaigners looked down every alley in their search
for justice”.
They should not have had to do so.
The Public Administration Select Committee in 2005 referred to the six functions of an
inquiry identified by Sir Ian Kennedy: the recognition and identification of different, genuine
perceptions of the truth; learning; healing; catharsis; prescribing; and accountability. Plainly
none of the other avenues – NHS complaints, the Ombudsman, the GMC, the police – that
people infected and their families felt driven to pursue could have met these objectives.
In particular none could have provided a full and fair account of what had happened, or
provide any real form of accountability.
7.6 Scotland
The purpose of this chapter is to consider the response of the government within Scotland
to the position of people who were infected and their families.
Prior to 1999, there was administrative devolution in Scotland: other than matters such as
foreign policy, defence and social security, everything – including policy in relation to health
– fell within the powers of the Scottish Office. At the same time, “we
were one Government”.
On matters of health, the Scottish Office, through the SHHD, largely followed the lead of the
Department of Health. That position fundamentally changed in 1999 with the establishment
of the Scottish Parliament and of a Scottish Executive.
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This chapter considers the following issues: the calls for compensation for people with
haemophilia infected with HIV; the HIV litigation; the response to the position of people
infected with HIV through transfusion; the use of “lines to take”; the calls for compensation
for people infected with Hepatitis C; the Scottish Executive’s investigation and report;
the investigation by the Health and Care Committee of the Scottish Parliament; and the
approach to holding a public inquiry.
On the question of calls for compensation for people with haemophilia infected with HIV,
ministers and civil servants adopted a “no negligence, no compensation” approach, following
the lead of the Department of Health. The Secretary of State for Scotland did attend the
Cabinet sub-committee which decided in November 1987 to make the ex gratia payment
that led to the establishment of the Macfarlane Trust, but there is no evidence of Scottish
Office involvement in the announcement two years later to make a further payment to the
Macfarlane Trust.
There was, as described in the chapter on the
HIV Haemophilia Litigation,
no prior
consultation with the Scottish Office before the announcement by Prime Minister John
Major in December 1990 that the Government had agreed in principle to proposals to settle
the litigation, and there had been no parallel negotiations with Scottish litigants and their
lawyers. The claims in Scotland were eventually settled on terms similar, although not
identical, to those in England and Wales.
On the question of making ex gratia payments to people infected with HIV through
transfusion, William Waldegrave’s letter of 2 December 1991 to the Chief Secretary to the
Treasury, recommending a change of policy, was copied, among others, to the Secretary of
State for Scotland, Ian Lang. Scottish officials recommended he support the proposal, noting
that the media was sympathetic and that the arguments defending the differences between
people with haemophilia and this group of patients “have
increasingly been recognised as
untenable.”
Michael Forsyth, the Minister of State for Scotland, had previously expressed
the view that the scheme should be extended to those infected through transfusion, but
had been told by officials that “The
Scottish Office could not adopt a policy which would
undermine the stance taken by other UK Health Departments.”
The “best treatment available” line was used by Scottish officials and ministers, with the
aim of ensuring “a
consistent line between Health Departments”,
as was the suggestion
of “inadvertent
harm”.
Professor Aileen Keel, who had been a senior medical officer in the
SHHD in the 1990s, sought to defend the “best available treatment” line in her evidence to
the Inquiry, but the line was a wrong one to take.
In August 1995 the CMO of Scotland, Dr Robert Kendall, advised the Minister of State at
the Scottish Office (who had expressed some sympathy with the calls for compensation for
Hepatitis C) that financial redress for infection with Hepatitis C would have to be decided on
a UK basis. He drew attention to a recent statement by the Secretary of State for Health,
Stephen Dorrell, which “very
strongly”
suggested that the Department of Health would resist
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offering compensation and advised that it would be extremely difficult for Scotland to attempt
to adopt a different policy.
This was the position when the Scotland Act 1998 created the Scottish Parliament and the
Scottish Executive took over responsibility for health from 1 July 1999.
In July 1999 a briefing to the Minister for Health and Community Care, Susan Deacon,
informed her about the Haemophilia Society’s continuing campaign for compensation for
people with haemophilia infected with Hepatitis C. In August 1999, the Health and Community
Care Committee called for an immediate Executive inquiry into delays in introducing heat-
treated concentrates in Scotland. Susan Deacon told the Inquiry that she then decided to
instruct officials to pool together “proper
facts”.
The chapter considers in some detail the
approach taken by the Scottish Executive in undertaking this investigation and finds that the
process was flawed.
The resulting report was published in late October 2000. It did not consider more general
questions about the infections, as the Haemophilia Society had asked and anticipated
from their meetings with the minister and officials. The Haemophilia Society was gravely
disappointed as it did not address their concerns that patients had not been given information
about the risks of their treatment; that some patients had been tested and not told the
results; that in many cases there was delay (“well
over a decade”)
in being told; and that
in some centres testing had not been done properly. The report had concluded that there
was “no
evidence that clinicians had a policy to deliberately mislead their patients about
the risks of using Factor VIII.”
The Haemophilia Society observed that in order to reach
this conclusion the authors of the report had spoken only to doctors, and had not obtained
information directly from patients.
The Health and Community Care Committee of the Scottish Parliament undertook its own
evidence gathering exercise and in September 2001 issued a report which considered three
principal issues: whether ALT testing should have been introduced; the delay in introducing
heat treatment for Scottish concentrates; and the failure to inform patients fully of the risks
involved. The Committee also considered what it described as a fundamental question of
fairness and consistency. It pointed to the recent
A and Others v National Blood Authority
decision, and the existence of the Macfarlane Trust, and was persuaded by the moral case
for providing financial assistance to people infected with Hepatitis C through blood and
blood products, concluding that: “financial
and other practical assistance, awarded on a no-
fault basis, is the clearest solution to the issues raised in these petitions. We believe as a
matter of fairness that individuals who have suffered serious, long-term harm as a result of
NHS treatment should receive some practical assistance. We also believe that this solution
is required for reasons of consistency, in recognition of the fact that HIV sufferers already
receive assistance, under clearly analogous circumstances, via the MacFarlane Trust.”
The
committee recommended that a mechanism for achieving this should be set up and come
into operation within a period of twelve months.
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On 11 December the Executive announced it would establish an expert group to look at
“the
pros and cons of a system to offer financial and other support for people who have
been harmed by health service treatment and where the NHS is not at fault.”
The press
release stated that extending the current regime to people infected with Hepatitis C would
be unfair to those affected by “other
conditions in a similar way”
and would create a risk-
averse culture within the NHS.
The expert group was established under Lord Ross. Its preliminary report in September
2002 concluded that it was inequitable that people infected with Hepatitis C had not received
any financial support, and recommended that they receive specific lump sum payments. In
November 2002 the Scottish Executive’s response noted the complex medical, legal and
financial considerations, and that the Executive needed to “think
carefully about who needs
help, what is the best way to design a scheme and structure payments so that the individuals
involved benefit fully, while taking account of the costs of any payment scheme in the light
of other health priorities.”
In January 2003 Malcolm Chisholm who had replaced Susan Deacon as Minister for Health
and Community Care sought Cabinet agreement to an approach for making lump sum
payments to people experiencing long-term symptoms or signs of liver inflammation, with
increased awards to those developing more serious conditions such as cirrhosis. Three
options were identified, with the Minister supporting the third option (£25,000 (later adjusted
to £20,000) + £25,000).
The final Expert Group report in March 2003 confirmed the recommendation that the Scottish
Executive should agree to make compensation payments as a matter of urgency to anyone
who could demonstrate on the balance of probabilities that they had been infected with
Hepatitis C from blood, blood products or tissue received in the NHS in Scotland. The group
believed there was a moral obligation to provide compensation and that justice would not be
done unless its recommendations were implemented.
In fact, none of the Ross recommendations were implemented. A combination of reluctance
in the Scottish Executive to commit to the expenditure and the alarm engendered in
Westminster, led eventually to the introduction of the more limited scheme that became
the Skipton Fund.
Continued campaigning activities, a call from the Health and Care Committee in 2006 for an
independent public inquiry, the judicial review claims which succeeded before the Court of
Session in early 2008, and the new Scottish Government’s commitment to a public inquiry,
led to the announcement in April 2008 of the Penrose Inquiry.
The chapter concludes that in the period prior to July 1999 the Scottish Office essentially
followed the path mapped out by the Department of Health. Accordingly, the same
damaging approach – an unwillingness to provide financial support, a misplaced fear of
setting precedents, the repetition of inaccurate and harmful lines to take, the absence of any
meaningful or robust or independent investigation – was mirrored in Scotland.
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The chapter further concludes that the move to devolved government in 1999 did not bring
about the sea change campaigners had hoped for.
7.7 Northern Ireland and Wales
This chapter looks at the (very limited) evidence available as to the response of government
within Wales and Northern Ireland.
In Northern Ireland the response of the DHSSNI in the 1990s and 2000s (both before
and after the enactment of the Northern Ireland Act 1998) largely echoed the response of
government in Westminster. On matters relating to the infection of people with hepatitis and
HIV through blood and blood products, the relationship largely remained one of “mirrored
subservience”.
Thus, there is no evidence to suggest any substantive involvement in the
decision-making that led to the decision to make a payment of £10 million to what became
the Macfarlane Trust. There is little evidence of any meaningful involvement of ministers
within the Northern Ireland Office in the decision-making that led to the announcement of an
additional payment to the Macfarlane Trust in November 1989. There is little evidence relating
to the involvement of the Northern Ireland Office in the settlement discussions relating to
the HIV haemophilia litigation. The Secretary of State for Northern Ireland, Peter Brooke,
supported the proposal from William Waldegrave to make ex gratia payments available to
those infected with HIV through blood transfusion, expressing the view that “there
is little
public understanding or sympathy for the Government’s position on this matter and that the
campaign for a settlement is likely to gather momentum in the months ahead.”
In 1995 John
Breen, a civil servant who worked in the Health Promotion branch, prepared a submission
dated 31 May 1995 which noted that many similar representations could be expected over
the coming months. The submission suggested that preliminary estimates would put the
number infected with Hepatitis C through blood transfusions or blood products in Northern
Ireland at about 100, of whom approximately 50 had haemophilia. Reference was made to
the Department of Health in London’s “standard
response indicating that the Government
does not propose to pay compensation since there was no question of negligence on the
part of the NHS and that it believes that the most effective use of resources is to seek to
improve the understanding, management and treatment of the disease”.
John Breen told the Inquiry that he passed on the line approved by Ministers in London and
that “The
policy in Northern Ireland, as I understood it, was to follow the policy adopted in
London.”
He felt it was premature to make any concessions in respect of compensation
“because
the matter had not been firmly decided by the Department of Health in London.”
An attempt was made by the Department of Health in mid 1995 to “establish
the views
of the Territorial Health Departments”.
A handwritten SHHD file note, undated but written
after 9 May 1995, refers to the author having received phone calls from John Breen (and
from Peter Davenport in the Welsh Office) regarding the issue of compensation for those
infected with Hepatitis C. The note records that “Both
Wales and N.I. were concerned
about the financial implications of what seems to be a marked softening in the DoH attitude
towards compensation. Apparently the sum of £60,000 is being considered per case and
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the Treasury have already made it clear that the funds must be found from within existing
resources.”
A “council
of war”
with the Welsh Office and Northern Ireland Office had been
agreed. The position of officials in Northern Ireland as communicated to the Department of
Health in early June 1995 was that “Officials’
view is that it is difficult from point of view of
equity to resist comparisons with HIV compensation. But this could mean a substantial drain
on health resources. The views of Ministers have not been sought yet.”
The response of the Welsh Office and, post devolution, the Welsh Assembly Government
in the 1990s and 2000s to the position of people infected with hepatitis through blood and
blood products largely echoed the approach taken by the Department of Health in London.
David Hunt, who was the Secretary of State for Wales in the early 1990s, explained that the
“room
for manoeuvre”
that he had in that role was “in
practice very limited in most instances,
except at the margins of policy.”
As with Northern Ireland, ministers within the Welsh Office
had little if any direct involvement in the decision-making that led to the initial payment to
the Macfarlane Trust or to the further payment announced in November 1989; there is little
evidence of Welsh Office involvement in the settlement discussions in the HIV haemophilia
litigation; and the Welsh Office took its lead from the Department of Health on the question
of financial support for those infected with Hepatitis C. The same position was maintained
by the Welsh Assembly Government in the 2000s.
It is a sad commentary on these arrangements (in respect of infected blood) that no-one
involved in health policy at the Welsh or Northern Ireland Office queried that policy following
the decision in
A and Others v National Blood Authority
in 2001 – for this cast a very different
light on the facts from that presented by the Department of Health in London.
In theory, devolution of health powers meant that Northern Ireland and Wales had
more freedom but in practice, the Department of Health policy continued (largely) to be
followed in the 2000s.
What has been said about the response of the government in England thus applies to
Northern Ireland and Wales too – except for the added criticism that policy on infected
blood was determined with a lack of curiosity as to whether the English position was
actually justified.
7.8 The Government’s Response to Calls for Compensation
from 2020-2024
This chapter considers the calls for compensation since 2020 and the Government’s
response. It does so at a time when it is still not known how the Government intends to
respond to the recommendations that have been made, save that the Victims and Prisoners
Bill has at the time of writing reached the report stage and provides for the establishment of
an Infected Blood Compensation Authority and on 30 April 2024 an amendment requiring
the scheme to be set up within three months of the Bill receiving Royal Assent was accepted.
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On 13 July 2020 the Paymaster General Penny Mordaunt wrote to the Chancellor of
the Exchequer, Rishi Sunak, on compensation: “Following
the stakeholder meeting in
January, Minister
[Oliver]
Dowden wrote to the Prime Minister setting out agreed actions
to address the most pressing issues of support, including consideration of a framework
for compensation … I believe it to be inevitable that the Government will need to provide
substantial compensation … I believe we should begin preparing for this now, before the
Inquiry reports.”
The Paymaster General wrote again to the Chancellor on 21 September
2020. She repeated her expectation that the Inquiry would make recommendations about
levels of financial support. It was, she said, “inevitable
that the Government will need to
provide substantial compensation.”
She indicated that the costs were likely to be high and
she firmly believed that the Government should “begin
preparing for this now – before the
Inquiry reports.”
She said “I
cannot stress enough the urgency of taking long overdue action
on financial support and compensation.”
The question of compensation was not new in 2020. An awareness that compensation might
be recommended was a central factor in the unwillingness of successive governments to
establish a public inquiry.
Penny Mordaunt told the Inquiry that she would expect anyone in Government with a
working knowledge of the infected blood scandal to understand that people were continuing
to suffer and continuing to die – that this was not only a matter of historical injustice. One
purpose of raising at that stage the “inevitable
outcome”
of compensation was so that the
Treasury could start to make appropriate provision and so that all Government departments
were “aware
of what is likely to need to happen and prepare for that.”
She wanted to give
the Treasury “some
encouragement to grip the issue”.
There was no formal response to this letter but on 25 March 2021 she was able to announce
that: “To
meet the Government’s commitment to consider a framework for compensation, we
can confirm our intention to appoint an independent reviewer to carry out a study, looking at
options for a framework for compensation, and to report back to the Paymaster General with
recommendations, before the Inquiry reports.”
This study would provide advice on “potential
compensation framework design and solutions which can be ready to implement upon the
conclusion of the Inquiry, should the Inquiry’s findings and recommendations require it.”
It
was her expectation that the Government’s response would be published and shared with
the Inquiry so that the Inquiry would have the benefit of considering it.
Giving evidence to the Inquiry in May 2021 the then Secretary of State for Health Matt
Hancock agreed that there was a moral responsibility on the Government to address the
impact of what has happened to those infected and affected. He added: “should
the Inquiry’s
recommendations point to compensation, then of course we will pay compensation and
Sir Robert Francis’s Review on compensation is there in order that the Government will be
able to respond quickly to that … what I can say to you is that we will respect the outcome
of the Inquiry and if the Inquiry points to compensation, as opposed to a support scheme, in
the future then the Government will pay compensation.”
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Sir Robert Francis KC was appointed and delivered his report
Compensation and Redress
for the Victims of Infected Blood – Recommendations for a Framework
on 14 March 2022.
The Paymaster General Michael Ellis, who had succeeded Penny Mordaunt, explained that:
“It
is my intention to publish the Study and the Government response, in time for the Inquiry
and its core participants to consider them before Sir Robert gives evidence to the Inquiry.”
On 22 March he gave the same message, and again on 31 March 2022, and on 27 April, that:
“It
is my intention to publish the compensation framework study alongside the Government’s
response as soon as possible, and in sufficient time for the infected blood inquiry and its
core participants to consider them before Sir Robert gives evidence to the inquiry.”
Despite the Government making it clear, in these various statements, (a) that it would
publish its response to Sir Robert’s study at the same time as the study itself and (b) that
it understood the importance for those infected and affected to be able to consider the
Government’s response before Sir Robert gave evidence to the Inquiry, on 7 June 2022 the
Government published the study but
no
response from the Government to that study. What
was said on this occasion by Michael Ellis was that: “There
is a great deal of complexity
to the issues that the study covers and a wide range of factors to be taken into account in
considering Sir Robert’s recommendations. This analysis cannot be completed hurriedly
but officials across government are focussing on this so that the government can be ready
to respond quickly to the Inquiry’s recommendations, as was intended when the study
was commissioned.”
On 9 June, the Paymaster General told the House of Commons that the Government was
considering Sir Robert’s recommendations, that he would update the House as the work
progressed, and that “Sir
Robert will give evidence to the Inquiry on 11 and 12 July, so just a
few weeks from now, and the Government will need to reflect very carefully on his evidence
to the Inquiry in considering his study.”
In response to further questions, the Paymaster
General said that Sir Robert’s recommendations needed “careful
consideration”,
which it
would be “remiss” of the Government to “rush”: “It
is most important that we are able to
reflect on his evidence, which he is due to give in four or five weeks’ time, and we will do so
after that.”
The Government would, he indicated, “want
to hear what
[Sir Robert]
has to say.
We will study it very carefully and will act as expeditiously as possible after that.”
This statement would be reasonably understood as the Government indicating that it
would
respond to the compensation framework study once it had considered Sir Robert’s oral
evidence (on 11 and 12 July 2022).
Sir Robert gave evidence to the Inquiry on 11 and 12 July 2022. On 14 July Dame Diana
Johnson MP reminded the Paymaster General that people infected had continued to die
since the announcement of the Inquiry (“Time
is pressing”).
In response he assured her
that the matter was being given “expeditious
consideration”
and that the Government would
respond to Sir Robert’s recommendations “just
as soon as possible.”
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Despite many more parliamentary questions, over two years after Sir Robert delivered
his study to the Government, people who are infected and affected still do not know the
Government’s response to his recommendations.
The Inquiry’s First Interim Report was published on 29 July 2022. This recommended that
an interim payment, of no less than £100,000, as recommended by Sir Robert, should be
made without delay to all those infected and all bereaved partners.
The Government responded promptly to this recommendation, announcing on 17 August
2022 that interim payments of £100,000 would be made to infected individuals and
bereaved partners.
In February 2023 the Inquiry stated that it would be publishing a second interim report, about
the Compensation Framework Study by Sir Robert Francis KC. The Inquiry published that
report on 5 April. The principal recommendation was that a compensation scheme should
be set up “now” and should begin work “this
year”
(i.e. 2023). A further recommendation
was that an interim payment should be paid “to
recognise the deaths of people to date
unrecognised and thereby alleviate immediate suffering.”
This reflected the fact that “some
people have died as a result of infected blood and blood products without any payment
being made in respect of their death, leaving bereaved parents, children or siblings who
have suffered profound distress and loss which has to date been unremedied.”
On 12 June 2023 UK, Scottish and Welsh Ministers, and the Northern Ireland Department
of Health Permanent Secretary, met for the first time to discuss compensation. A joint
communique noted agreement that working together to enable a response as soon as
possible after the Inquiry concludes did “not
preclude earlier announcements as work
progresses.”
There have, however, been no such announcements.
In July 2023 the Prime Minister told the Inquiry that the work was not concluded and no
decisions had been made: the Government did not yet have options that were ready to
implement on conclusion of the Inquiry. Jeremy Hunt, giving evidence in his capacity as
Chancellor of the Exchequer, told the Inquiry that “we
are genuinely in a situation where no
decisions have been made about the level of compensation or how it will be funded.”
He
could not say where the funding would come from or what the timescales were. He did think
that “good
progress has been made”
but there was more work to do.
The above narrative speaks for itself. It needs little commentary, beyond a brief highlighting
of the chronology:
• The Government did not do what it said it would: publish its response to the
Compensation Framework Study alongside the study itself and in advance of
Sir Robert’s evidence to the Inquiry.
• The Government then failed to publish its response after Sir Robert’s evidence,
despite saying that it would “act
as expeditiously as possible after that.”
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• The Government has not yet (as at today) published any response to the
Compensation Framework Study.
• Little appears to have been done before late 2022. The fact that the first cross –
government meeting of senior officials took place in November 2022, that it was
only decided in early 2023 to establish a DHSC team to undertake costs analysis,
that the Small Ministerial Group met for the first time on 22 February 2023, and
that the first ministerial meeting involving the devolved administrations was not until
June 2023 have the appearance of working at a sluggish pace.
• The Government said it was planning to be ready to respond to compensation
recommendations that it expected to arrive in mid and then autumn 2023. On that
timescale, its work should now be complete.
• Such evidence as there is suggests that this is not the case and that key decisions
may still remain to be made.
• At several stages Government has said that it would update Parliament with as
much detail as it could as work progressed. It is a matter of regret to this Inquiry that
the Government has found little to report.
The effect of what has happened is that the Inquiry’s own consideration of compensation
has not been able to be informed by the Government’s response to the Compensation
Framework Study, that the Government’s response has (thus far) escaped the scrutiny
of the Inquiry; and that those infected and affected have felt a lack of transparency and
openness characteristic of what they have had to face, and have been fighting, for nearly
half a century.
The rationale of waiting for this Report, as explained to the Inquiry, begs for a better explanation.
This is not a case in which the Government is expecting a report that says everything was
done as it should have been. The expectation of the then Paymaster General, Jeremy Quin,
as at 25 July 2023 was that the full report would put the compensation proposals “into
further and – I fear in many ways – deeply upsetting context.”
He confirmed a month later
in his oral evidence his expectation that the final report “will
unveil very, very significant
issues that happened over many decades and should never ever have happened.”
Penny
Mordaunt recognised in Parliament in October 2023 that people have suffered “layer
upon
layer of injustice”.
The Prime Minister has acknowledged that what has happened “has
been an appalling scandal … thousands of people … have suffered for decades, and they
have suffered a layer of injustices at that … this is not just about historic wrongs, people are
suffering and being impacted today.”
Despite this, and the Government’s acceptance of the
moral case for compensation in December 2022, the Government has insisted upon waiting
for this Report, despite knowing that the Inquiry’s Second Interim Report contains its full
recommendations on compensation.
Campaigners and Parliamentarians have continued to press the Government to share
information. Jeremy Quin suggested the final report “will
enable the Government to see
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those recommendations in their full context”
and that “Being
able to put the Government’s
response into the context of those findings is a useful and helpful thing to do in justifying our
actions”.
Jeremy Hunt expressed the view that it was “responsible
and right to the taxpayers,
who are funding this, for Government ministers to see the full context of the horrific scandal
that this was, before we make the final decision as to how the compensation will work.”
But
when the Government knows, as it clearly does, that what happened was a terrible injustice,
that people deserve redress, and that lack of redress perpetuates the injustice, then to
delay, and thus deny, justice in order to await the “full
context”
seems hard to justify.
7.9 Commentary on the Government Response
This chapter seeks to pull together some of the threads and themes from the preceding
chapters in order to answer the Inquiry’s Terms of Reference.
The Terms of Reference of the Inquiry include whether there was a “cover-up”. A better
expression to convey what happened is “hiding the truth”. Hiding the truth includes not only
deliberate concealment but also a lack of candour: the retelling of half-truths such as the
“no conclusive proof” line; and failing to tell people about the risks inherent in treatment or
the alternatives to that treatment, that they had been tested for infection, or been used in
research, or were suffering from a potentially serious and fatal disease.
Clinicians and the NHS
A number of individual witnesses who gave evidence, or provided statements, record
that they were told by their doctors that the risks to them of their contracting non-A non-B
Hepatitis were relatively unimportant. Some people who had bleeding disorders were told
that the risk of AIDS was undoubtedly far less than the dangers of not being treated with
concentrate. In both cases, the seriousness of what the patient was facing was underplayed.
In an even greater number of cases, people were given no information whatsoever about the
risks of viral transmission from transfusion, or from treatment with blood products. There is
overwhelming evidence, from a large number of people, of differing backgrounds, different
ages, and different ways of expressing themselves, to exactly this effect. When coupled
with the evidence as to what was or should have been known about non-A non-B Hepatitis
and the risks of AIDS, and what was, frankly, not yet known but was entirely possible, there
can be no other conclusion save that the whole truth was not given to them. Clinicians, or
civil servants, often did not in fact know: but they did not admit to this, and instead assumed
a more comfortable “truth” which had no adequate basis. And for some people the very
fact that they had been infected, or the means by which they had been infected, was not
disclosed to them, sometimes for years.
The evidence before the Inquiry that the truth was concealed or suppressed in this sense
and in these ways is overwhelming.
The chapter then considers three specific examples: the first involves the provision of
information by a haematologist at the Cardiff haemophilia centre to journalist Susan Douglas,
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and the response of the Press Council to the subsequent publication of Susan Douglas’
article; the second involves a deception perpetrated on a woman who had just given birth
and who was reassured that blood was heat treated; the third is of a clinician withholding
from the wife of a deceased patient the fact that her husband had been infected with HIV
following treatment.
The NHS did not respond to the infection of thousands of people with HIV and hepatitis,
through transfusion or treatment with blood products, by undertaking investigations,
providing detailed explanations, making sincere apologies and doing everything that could
be done to learn lessons. Instead, what is apparent is a defensive closing of ranks.
There have without doubt been individual apologies from clinicians that were heartfelt and
sincere; and there has been, in this Inquiry, some insightful organisational self-reflection.
But most apologies have never been accompanied by any admission of anything having
been done wrong.
The response of government
Just as the NHS responded defensively, so too did successive governments. The Report has
found that the government resolved against any form of compensation at an early stage. It
wrongly described the infection of thousands of people with fatal viruses as the unavoidable
adverse effects of medical treatment. It thought at the outset that no one could or should be
held responsible and that nothing had been done wrong. It assumed, without listening to the
patients themselves, that doctors and the NHS had done nothing wrong and that the risks
had been explained. Financial and reputational considerations predominated.
Five features characterise the government response. First, when financial support payments
have been agreed at different points – initially for people with haemophilia infected with HIV,
then for people infected through transfusion, and later for people infected with Hepatitis C
– this has been in response to intense parliamentary, media and/or public pressure. The
second feature is the slow and protracted nature of the government response: decision-
making has taken far too long. Third is that governments have generally sought to provide the
least that they can, to limit expenditure on financial support, despite the recommendations
of the Ross expert group in Scotland, and the Archer Inquiry. The fourth feature is that in the
past any steps towards some form of recognition have been accompanied by an insistence
that nothing had been done wrong. The fifth is that, although now accepting that wrongs
were done, the Government does not yet appear to be clear as to what lessons it has
already learned, or seeks to learn, from the history it now accepts.
Standing back, and viewing the response of the NHS and of government, the answer to the
question “was there a cover up?” is that there has been. Not in the sense of a handful of
people plotting in an orchestrated conspiracy to mislead, but in a way that was more subtle,
more pervasive and more chilling in its implications. To save face and to save expense,
there has been a hiding of much of the truth.
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This failure to bring the true facts to life has come partly from the inertia of groupthink;
but partly, it must be recognised from instinctive defensiveness, to save face and to save
expense. When thousands of families had their lives irrevocably changed, though, it
should not have taken decades for the truth to come out. That is a collective failing of
successive governments.
This Report has found that there was deliberate destruction of documents of relevance. It
has found that the Self-Sufficiency Report published in 2006 was self-justifying and that its
redrafting had the effect of hiding significant information. It has found that over decades
successive governments repeated lines to take that were inaccurate, defensive and
misleading. Its persistent refusal to hold a public inquiry, coupled with a defensive mindset
that refused to countenance that wrong had been done, left people without answers, and
without justice. This has also meant that many people who are chronically ill have felt
obliged to devote their time and their energies to investigating and campaigning, often at
great personal cost.
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Glossary for the Overview
ACTTD
ACVSB
ALT
APPG
AFP
AHG
BPL
BSE
CDC
CBLA
CMO
CSM
CDSC
DHSS
DH
DDAVP
DAA
EIBSS
ELISA
EAGA
FDA
GMC
anti-HBc
HTLV-3
KS
MFT
MOH
MRC
192
Advisory Committee on Transfusion Transmitted Diseases
Advisory Committee on the Virological Safety of Blood
alanine transaminase
All-Party Parliamentary Group
alpha fetoprotein
antihaemophilic globulin
Blood Products Laboratory
bovine spongiform encephalopathy
Centers for Disease Control and Prevention
Central Blood Laboratories Authority
Chief Medical Officer
Committee on Safety of Medicines
Communicable Disease Surveillance Centre
Department for Health and Social Security
Department of Health
desmopressin
direct-acting antivirals
England Infected Blood Support Scheme
Enzyme immunosorbent assay
Expert Advisory Group on AIDS
Food and Drug Administration
General Medical Council
Hepatitis B core antibody
Human T-Lymphotropic Virus Type 3
Kaposi’s sarcoma
Macfarlane Trust
medical officer for health
Medical Research Council
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MP
MSP
MMWR
NBTS
NCJDRSU
NHS
NICE
NSSC
nvCJD
NHSBT
NANBH
DHSSNI
PFL
PCP
PUPs
PFC
PHLS
RIA
RTC
RTD
Regpay
SHOT
SHHD
SNBTS
SEAC
CSM(B)
UKHCDO
vCJD
WHO
Overview
Member of Parliament
Member of Scottish Parliament
Morbidity and Mortality Weekly Report
National Blood Transfusion Service
National Creutzfeldt-Jakob Disease Research and Surveillance Unit
National Health Service
National Institute for Health and Care Excellence
National Support Services Committee
new variant Creutzfeldt-Jakob disease
NHS Blood and Transplant
non-A non-B Hepatitis
Northern Ireland Department of Health and Social Services
Plasma Fractionation Laboratory
pneumocystis carinii pneumonia
previously untreated patients
Protein Fractionation Centre
Public Health Laboratory Service
Radioimmunoassay
regional transfusion centre
regional transfusion director
regular payments
Serious Hazards of Transfusion scheme
Scottish Home and Health Department
Scottish National Blood Transfusion Service
Spongiform Encephalopathy Advisory Committee
Sub-Committee on Biological Products
UK Haemophilia Centre Directors’ Organisation
variant Creutzfeldt-Jakob disease
World Health Organization
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Chronology for the Overview
This brief chronology is provided to help readers navigate some of the time lines discussed
in the Overview to the Report. It is not by any means comprehensive. The story told by this
Report is very often of things not being done when they should have been. This chronology
does not attempt to capture the dates of things that should have been done but were not: it
is very difficult sometimes to give an accurate date for when a thing was not done.
1946
July 1948
Dr William d’A Maycock noted that users of plasma “must
be told that
it is a potentially lethal fluid which should be used with discretion.”
Establishment of the NHS, by which time it was known that transfusions
carried a risk of post-transfusion hepatitis; that this was often a delayed
complication; that hepatitis was transmitted by a virus; and that it could
be fatal
World Health Organization Expert Committee on Hepatitis
recommended five measures to reduce risks (selection of donors,
control of pool size, treatment of plasma, maintenance of records,
reporting)
Introduction of ALT testing of all blood donations in Germany
Discovery by Dr Baruch Blumberg of the Australia Antigen (the virus
that would subsequently become known as Hepatitis B)
Dr Judith Pool discovered how to use cryoprecipitate for haemophilia
treatment
Publication of
The Gift Relationship
by Professor Richard Titmuss
Hepatitis B testing of donations and plasma for fractionation introduced
in the UK
The first grant of a licence for commercial factor concentrates by the
Licensing Authority (for Hemofil; followed by the grant of a licence for
Kryobulin in March 1973)
Outbreak of hepatitis in Bournemouth haemophilia centre following
the administration of Hemofil
Report by Prince and others in
The Lancet
that an agent other than
Hepatitis B was the cause of most cases of post-transfusion hepatitis
and that it may play a role in the development of chronic liver disease
(neither A nor B, hence Non-A, Non-B Hepatitis
1952
1965
1965
1966
February 1970
1971-1972
January 1973
1974
August 1974
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January 1975
Letter from Professor Garrott Allen to Dr Maycock warning of risks of
US commercial concentrates
Policy of UK self-sufficiency in blood products announced by
Dr David Owen
May 1975
WHO advised self-sufficiency for all nations and use of voluntary non-
remunerated blood donations
The Licensing Authority granted a licence for Profilate
Dear Doctor letter from the CMO for England advising that blood
collections from prisoners could continue
December 1975
1976
September 1978
7 February 1979
April 1979
September 1980
Broadcast of World in Action
Blood Money
programmes
The Licensing Authority granted licences for Koate and Factorate
Publication in The Lancet of
Percutaneous Liver Biopsy and Chronic
Liver Disease in Haemophiliacs
by Dr Preston and others
Chief Scientist of DHSS “has
informed the
[MRC]
that
[NANBH]
is
being given a high priority by the Department”
Dr Peter Kernoff described NANBH as “a
serious disease with long-
term consequences”
Glasgow Symposium into
Unresolved Problems in Haemophilia
considered the risks of NANBH
Memo from Dr Diana Walford DHSS described NANBH as a form
of hepatitis that could be “rapidly
fatal”
or “can
lead to progressive
liver damage”
June 1981
December 1981
March 1982
16 July 1982
CDC (in USA)reported a cluster of cases of people suffering from
immune system failure and PCP
Report of same failure of immune system and opportunistic infections
in intravenous drug users
Possibility that infectious agent was the cause of AIDS had developed
as a leading hypothesis in the US
MMWR reported three cases of AIDS in people with haemophilia
Dr Harold Gunson notified the DHSS of the possibility of AIDS being
transmitted through blood
November 1982
Dr Craske’s report to haemophilia doctors identified an infectious
agent as the most likely of the possible causes of AIDS
Overview
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Final approval given for the redevelopment of BPL
December 1982
MMWR reported case of baby infected with AIDS following transfusion
(San Francisco baby case) and additional AIDS cases in people
with haemophilia.
In the Netherlands, the Central Laboratory of the Blood Transfusion
Services starts to coordinate a response with the Netherlands
Haemophilia Society, haemophilia clinicians and the Netherlands
National Institute for Public Health and Environmental Protection, to
avoid using factor concentrates where possible
January 1983
Alpha press release 7 January “The
evidence suggests, although it
does not absolutely prove, that a virus or other disease agent was
transmitted to them in the Factor VIII concentrate”
Editorial in New England Journal of Medicine 13 January “The
fact
that haemophiliacs are at risk from AIDS is becoming clear”
Discussion about AIDS at 19 January meeting of Hepatitis Working Party
Discussion about AIDS at Heathrow meeting of haemophilia doctors
and others on 24 January
February 1983
7 March 1983
24 March 1983
Pupils at Treloar’s began to be examined for “stigmata
of AIDS”
Dr Bruce Evatt (CDC) wrote to Professor Arthur Bloom that the AIDS
epidemic was evolving “with
a frightening pace”
FDA made recommendations to pharmaceutical companies in US
that they should not manufacture any product from plasma collected
before this date from high-risk groups (Haitians, male homosexuals,
IV drug users)
Professor Bloom reported probable case of AIDS to CDSC of a young
man treated at the Cardiff Haemophilia Centre
Mail on Sunday
article
Hospitals using killer blood
Beginning of the “no
conclusive proof”
line to take
Professor Bloom’s statement published by the Haemophilia Society
that the “cause
of AIDS is quite unknown”
and that he was unaware of
any proven case “in
our own haemophilic population”
Letter from Dr Spence Galbraith (CDSC) to Dr Field (DHSS) advising
that all blood products made from blood donated in the US after 1978
should be withdrawn from use until the risk of AIDS transmission had
been clarified
Overview
26 April 1983
1 May 1983
3 May 1983
4 May 1983
9 May 1983
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13 May 1983
20 May 1983
June 1983
Special meeting of UKHCDO reference centre directors. Draw up
guidance but do not yet circulate it.
Isolation of a viral particle (LAV) (the viral agent causative of AIDS) by
Dr Luc Montagnier and team in Paris.
Recommendations from the Council of Europe to avoid wherever
possible the use of large plasma pool products and to tell clinicians and
patients about the risks of treatment and the possibilities of minimising
the risks
Letter to haemophilia centre directors on 24 June 1983 from Professor
Bloom and Dr Rizza
13 July 1983
Meeting of the Biologicals Sub-Committee of the Committee on
Safety of Medicine (CSM(B)) concluded that the importation of US
concentrates should not be suspended
Death of first person with haemophilia in UK from AIDS
Introduction of first AIDS donor leaflet
UKHCDO annual meeting at which Professor Bloom said that “he
felt that there was no need for patients to stop using the commercial
concentrates because at present there was no proof that the
commercial concentrates were the cause of AIDS.”
August 1983
September 1983
17 October 1983
10 December 1983
British Medical Journal
article “There
is no evidence that any product,
commercial or volunteer, is free from the risk of transmitting AIDS”
23 April 1984
September 1984
October 1984
November 1984
December 1984
December 1984
January 1985
Press conference announcement that Dr Robert Gallo had found the
virus causing AIDS (HTLV-3), and test would follow soon.
34% of people with haemophilia tested for HTLV-3 are positive
CDC announce heating factor 8 concentrate can inactivate HTLV-3
Meeting of UK Transfusion Directors unanimous that a screening test
for HTLV-3 must be developed as soon as possible
UKHCDO meeting at Elstree, issue of AIDS Advisory Document
After this, all Scottish factor 8 concentrate heat-treated (but not BPL
concentrates as yet)
First meeting of the Expert Advisory Group on AIDS
DHSS wrote that there is a need to evaluate all the HIV/AIDS screening
tests to see which is the most suitable
February 1985
Overview
Issue of second AIDS donor leaflet
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March 1985
September 1985
All BPL concentrates issued had been heat-treated. First releases of
8Y concentrate
BPL was now heat treating all its Factor 8 at 80 degrees for 72 hours
(“8Y”). This inactivated both HIV and NANBH effectively. BPL produced
only enough for a quarter of the needs of England and Wales
Screening of blood donations for HIV introduced
PFC issues Factor 8 that does not transmit NANBH
Statement to Parliament that £10 million would be made available to
the Haemophilia Society to administer payments to people infected
with HIV
Identification of the virus responsible for NANBH (Hepatitis C)
Establishment of the Macfarlane Trust
14 October 1985
April 1987
November 1987
1988
4 April 1989
First meeting of the Advisory Committee on the Virological Safety of
Blood
Availability of test for Hepatitis C announced
November 1989
Announcement of additional funding for Macfarlane Trust
1 September 1991
Screening of blood donations for Hepatitis C introduced
February 1992
April 1992
January 1995
October 1997
1998
Announcement to extend ex gratia financial support to people infected
with HIV through blood transfusion or tissue transfer
Establishment of Eileen Trust
Decision to undertake Hepatitis C lookback
CMO statement that three people who had suffered from vCJD had
been blood donors
Launch of Better Blood Transfusion initiative
Various measures in response to vCJD including leucodepletion
August 2003
February 2009
March 2011
2017
July 2017
Announcement of Hepatitis C payment scheme (Skipton)
Publication of the Archer Inquiry Report
Caxton Foundation set up
Establishment of the four national support schemes in place of the
Alliance House Organisations
Announcement of a public inquiry
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July 2018
March 2021
March 2022
October 2022
April 2023
December 2023
Inquiry terms of reference laid in Parliament
Announcement of a Compensation Framework Study
Compensation Framework Study submitted to government
Interim compensation to people infected and bereaved partners
Inquiry publishes Second Interim report and final recommendations
on compensation
Government accepted the moral case for compensation
Overview
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1.4 Lessons to be Learned
Introduction
It is clear from the first chapters of this Report onwards that most infections could and should
have been avoided. It is clear that mistakes were made. The way in which institutions, and in
particular the government, reacted to what had happened after 1985 was in many respects
shameful. This should never happen again. The first step in deciding how best the mistakes
of the past can be consigned to the past, and kept there, is to understand the lessons to be
learned from what happened.
One of the lessons is that wishful thinking is all too easy and should be avoided.
It would be wishful thinking to suggest that because we can now see what combined to
cause the greatest treatment disaster in the history of the NHS
28
and recognise steps that
need to be taken to guard against it happening again, that something similar will not do so.
When this Inquiry began it was thought certain that there would be future serious viral threats
to be met. I had not realised how soon that would prove true in the form of COVID-19.
The focus of this Inquiry has been on a different viral threat: blood-borne infections. Blood
inherently varies from person to person, and some of those variations are harmful. Every
blood transfusion carries risks with it, which go beyond those risks inherent in breaking the
skin in order to insert a transfusion line. Currently, transfusion-transmitted infection risks
appear low but it remains essential to identify future threats transmissible through blood,
and deal with them. Public health threats must be faced up to; doctors must be both alert to
unfamiliar symptoms following transfusion, prompt in their reporting of them (in case they
are emerging elsewhere in the UK too) and candid with their patients about any risks; and
both the blood services and government should be ready to react quickly and effectively to
new or emerging threats.
To ensure the greatest possible safety, we need to avoid complacency. There is no basis for
assuming that threats are all in the past: but watchfulness and learning the lessons of what
happened in the infected blood disaster are critical to this.
What, then, (in addition to avoiding wishful thinking and complacency) are these lessons?
28
200
Lord Robert Winston’s famous description.
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Guiding principle: patient safety
The first, and most important lesson, is that the first, and paramount consideration should
always be safety. What happened would not have happened if safety of the patient had
been paramount throughout.
Clear examples of when observing this would have made a difference are when clinicians
took the decision to give their patients (a variety of) factor concentrates as a matter of
convenience (see the
Treloar’s
chapter) despite both the theoretical and the demonstrable
risks to which this led (see the chapters on
Hepatitis Risks 1970 and After
and the
Knowledge of the Risks of AIDS);
the failure of regulation in 1973 in licensing products
which the manufacturers made clear carried with them a real risk of hepatitis, and were
made from donors who did “not
inspire confidence”
29
– if safety had been paramount this
should not have happened; and when it was acknowledged during the arguments about
whether to introduce surrogate testing for non-A non-B Hepatitis (Hepatitis C) that if safety
had been given the weight it should have had, there could be no dispute about the need to
introduce the tests. They were not introduced.
30
Had they been, people would have been
spared infections.
Risk
Risk needs to be understood better. Few, if any, treatments come without risk. All
pharmaceuticals have side-effects. All medical procedures have side-effects. Doing nothing
(“conservative treatment”) may also have repercussions. The further lessons as to risk
which emerge from the events examined by the Inquiry are these:
Understanding risk
is critical in ensuring safety. Mistakes were made. What is to be avoided
for the future are:
• Confusing
certainty
with whether there is a
real risk calling for a response.
– A risk is just that: a real possibility that something might happen. It is recognition
of such a risk which first calls for a response. Certainty (or near-certainty) that
the potential event will actually occur (or is starting to occur) is not required.
Thus if there is credible evidence that a hurricane might be approaching the
coast, there will be no certainty for some time that it will make landfall rather than
change direction. But no-one should wait for 100% certainty before evacuating
the coastal region. To wait until there is a certainty that it will make landfall and be
destructive is to wait too long.
– Allied to that, the
response should be prompt.
A lesson from the Inquiry is that
to wait for more research to be done to identify more precisely the degree of risk,
29
30
Dr Duncan Thomas’ observation set out in the chapter on
Regulation of Commercial Factor
Concentrates.
Written Statement of Dr Duncan Thomas para 2.52 WITN6405001
See the chapter on
Hepatitis C Surrogate Screening.
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or identify more closely the cause of it, but in the meantime to do nothing but wait
until the research is concluded, is to take far too long.
•
A risk is a risk irrespective of whether further research might help to
understand it (and how to fight it) better.
– The question should always be asked whether conducting research will enable
the risk which is apparent to be met more easily, and in a better way: but waiting
for the answer should not prevent measures to reduce that risk being taken in the
meantime merely because the research has not yet been concluded. Instead of
research leading to effective action, calling for more research has too often led to
inaction. Examples are the repeated failure to grasp the nettle of surrogate testing
for non-A non-B Hepatitis/Hepatitis C because it was said more studies needed
to be done; the failures to conduct a lookback as soon as testing for Hepatitis C
became universal, because repeatedly it was left for further consideration; and
the search to identify more exactly what was causing AIDS to develop in patients,
leading to a desire for “conclusive proof” (of, to be noted, exact cause and effect
rather than the risk of AIDS, though the
risk
was clear beyond doubt).
•
A risk exists even if the mechanism by which the risk is created is unclear.
– So long as there is a real possibility that A causes B, there is no need to understand
precisely how it does so before responding. When John Snow’s research in the
1850s showed that the source of a cholera outbreak in Soho was associated
with the use of the Broad Street pump, science did not yet understand the vibrio
form bacteria which caused cholera. It did not need to do so in order for people
to stop using the pump, and avoiding the illness which doing so brought. Science
did not yet understand why: but so long as the effect was clear, people did not
need to understand the mechanism of cause and effect in order to take protective
measures. Tying these (and the countless similar examples provided by the
history of epidemiology) to the Inquiry, when it was clear that the development of
swollen lymph glands in people with bleeding disorders was associated with their
use of factor concentrates it was unnecessary to understand precisely why this
was before taking measures to reduce the risk. Whether concentrate overloaded
the immune system by adding too many foreign proteins for it to cope; whether it
transmitted an infectious particle; or whether it caused existing benign infections
to reawaken and damage the immune system, the link was clear. Treatment with
concentrate risked getting AIDS. It did not need a close understanding of cause
and effect to show at least that.
– In particular, the fact that there was no conclusive proof that the cause of AIDS
was transmissible by blood and blood products did not mean that there was no
evidence that it might not be happening.
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•
Avoid asking the wrong question.
– Allied to the wrongful search for certainty, the wrong question was asked in the
approach to the risks caused by non-A non-B Hepatitis and AIDS.
– There was sufficient evidence that there was a risk that non-A non-B Hepatitis
caused chronic serious long-term consequences leading to cirrhosis, liver cancer
and death. This risk did not cease to be a risk by clinicians or others preferring
to think the disease was benign. They assumed the best. They used wishful
thinking. They might have been right (had facts turned out otherwise) but that is
beside the point. The proper approach to the risk was to assume the reasonable
worst-case scenario until it was proven that it was not the case. A lack of evidence
that chronic non-A non-B Hepatitis in time led disproportionately to advanced
liver disease
31
was not evidence that it did not do so. No evidence of effect is not
evidence of no effect.
– A similar question arose in respect of the risk of AIDS. Given sufficient material to
show there was a real risk, the right question to ask was whether there was any
evidence or reason to consider that blood products were free of it?
32
– Instead of the wrong question – “Is there conclusive proof this is the effect?” – the
right question – “Is there any conclusive proof that it isn’t?” – should have been
the one that was asked. Only in that way is safety satisfied.
•
Risk must not be confused with incidence.
– Whether an infection leads very quickly to symptoms, or whether it has an
incubation period to be measured in years, is important in assessing the risk of it
spreading. If it is known that there is a real possibility that symptoms will emerge
from infections only after several months, or longer, it is a simple error to look
around, see there are very few infections at present, and therefore think that the
risk is low. What matters is what is being incubated while you are looking around
at what has already emerged. Elsewhere in this Report the analogy is given of
seeing only the tip of the iceberg.
•
If risk exists somewhere else in the world it could still be a threat here.
– The early response of the UK Haemophilia Centre Directors’ Organisation
(“UKHCDO”),
33
and Professor Arthur Bloom in particular, was to regard much
of the problem of AIDS, and therefore of people with haemophilia contracting
AIDS, as being an American problem. This led to a sluggish response to what
turned out to be HIV.
31
32
33
The Inquiry does not accept that this is an accurate understanding of the state of the evidence about
non-A non-B Hepatitis before 1980, but the point is directed towards those who assumed the best
because the worst could not be conclusively proved.
See the Commentary section in the chapter on
Knowledge of the Risks of AIDS.
Later the UK Haemophilia Centre Doctors’ Organisation.
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– It is too easy to dismiss a disease as being limited to particular countries or parts
of the world; if a disease is prevalent somewhere else in the world, it is likely to
be only a matter of time before it is transmitted to, and then within, the UK, unless
(that is) measures are taken in the light of the knowledge that it is elsewhere in
order to prevent it taking hold here.
•
Risks should not be ignored because they are thought inevitable.
– In 1975, for instance, Professor Bloom described hepatitis as an inevitable
consequence of therapy with factor concentrates. In truth, there was nothing
inevitable about it. The likely incidence could have been reduced. Hepatitis
transmission through blood and blood products was, eventually – but only
eventually – almost completely eliminated. To regard something as inevitable
is an excuse for inaction: regarding it in that way may comfort a clinician who
prescribes a medication when their patient suffers symptoms as a result, but it
does not help the patient or their safety. If a consequence happens so frequently
as to be “inevitable” this should not be a cause for comfort, but should, rather,
be regarded as a challenge to take action in order to reduce or remove the risk
of it happening.
•
Healthcare professionals should take a reflective approach to risk.
– Thus, where it is considered that healthcare workers deserve protection
against particular risks, so too do their patients unless there are very particular
circumstances. There is evidence, for instance, of patients who had been ignorant
of risks being approached by healthcare workers in what seemed to be Hazmat
protection when they, the patients, had been unaware of any risk (or if they knew
they had some infection, of the potential severity of it); at a time when some
were saying to patients that non-A non-B Hepatitis was “nothing to worry about”
healthcare workers often wore significant protection.
• Finally, though the goal must be to eliminate the risk completely, this may not easily
be achieved:
reduction of risk is worthwhile even if full elimination of risk is
not yet possible.
– As the US Institute of Medicine said:
“In
a crisis, decisionmakers may become so preoccupied with seeking
solutions that will dramatically reduce danger that they will fail to implement
solutions that are less effective but are likely to improve public safety to
some degree. Partially effective risk-reducing improvements … can save
lives, pending the development of more efficacious safety measures. In
order that the perfect not be the enemy of the good … Where uncertainties
or countervailing public health concerns preclude completely eliminating
potential risks,
[the authority]
should encourage, and where necessary
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require,
[the industry]
to implement partial solutions that have little risk of
causing harm.”
34
– There were effective means of reducing the risk from transfused blood by adopting
surrogate testing. The reduction in risk would not eliminate all risk. However, a
reduction – particularly in the case of those with a clinical need for only one or
two units of blood – would be well worth having.
– Similarly, the fact that a first-generation blood screening test (either for HTLV-3,
or, later, for Hepatitis C) might be superseded by a second-generation test was
part of the reasoning for delaying the introduction of screening, so that if the
second test proved better it could be used. However, the first-generation test
would nonetheless have been effective even if not as good. The lessons of the
past had not been learned – a different, and right, approach had been used in
the 1970s when blood was first screened for Hepatitis B by a test, although it
left more infected donations undetected than detected. It is clear that although
better tests for Hepatitis B were to be anticipated in due course (and indeed
arrived) the use of the first test nonetheless spared some patients from becoming
infected. In the 1970s, therefore, there was no waiting until there was a better
test. In the 1980s, by contrast, there was waiting. The difference in approach
came from looking for perfection, rather than something which was merely good.
The consequences are obvious in retrospect: they could and should have been
obvious then, looking forward.
Delay
• One of the more significant lessons to be learned is the
need to minimise delay in
response to a real risk of infection.
It is an obvious point that lives will be affected
if there is delay in a response to potential infection.
– There are two aspects to the delays which are described repeatedly in different
chapters of this Report. First, there was a delay in recognising risk (aspects of
which are discussed above). But, secondly, there were delays in response to
those risks which were identified.
– Thus, there was delay in the 1970s in responding to the risk posed by hepatitis
in blood products. The delay was in providing the resource and encouragement
needed to address the possibility of viral inactivation.
– There were delays in making any change in treatment for bleeding disorders
despite knowledge that factor concentrates posed a risk (even if not conclusively
proved) to those who took them.
34
Leveton et al
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
1995
pp240-241 JREE0000019
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– There was an unconscionable delay in the UKHCDO issuing guidance having
considered the question of AIDS. It decided in May 1983 to do so, but no guidance
document was issued until some six weeks later, and no further guidance was
issued until December 1984. That was too long. In itself, it would (ironically) have
achieved little if the first document had been published earlier since it was very
much advice to “continue as before”, advice which in itself demonstrated an
unreasonable delay in engaging with the realities of what was unfolding.
– The introduction of screening tests for HIV in the blood was delayed, largely
because of delay and uncertainties about the need for, and the process of,
evaluation. If it had taken place earlier, lives would not have been put at
risk as they were.
– There were delays in taking a decision about surrogate testing for non-A non-B
Hepatitis, followed by a significant and substantial delay in introducing screening
for Hepatitis C, followed by a four-year delay in conducting a lookback which
ought to have accompanied the universal screening.
– There was delay in embracing the better use of blood by giving fewer transfusions
or using safer alternatives, which meant many more people were infected with
Hepatitis C (see the chapter on
Blood Transfusion: Clinical Practice).
These are only some examples of what was seemingly systemic delay.
Where a safety measure is available which will reduce a risk to patient safety, it should
generally be introduced without delay, and in particular without waiting for national
coordination. There is of course a judgement to be made here: for the dangers of introducing
a remedy that may cause more of a problem than it solves, and the implications which any
cost will have on other desirable healthcare measures have to be balanced against the need
for a quick adoption of it. An example was that when heat-treated Factor 9 concentrates
were first considered for use in the UK, there were not unreasonable concerns that the
nature of the treatment might lead to greater risks of thrombosis.
35
However, this judgement
should be reached as quickly as reasonably practicable.
•
Protective measures should be introduced as soon as possible, even
if only locally.
– Where a protective measure is to be introduced nationally there may be no good
reason why it cannot be provided as soon as a region is able to introduce it: to wait
until other regions or areas are in a position to introduce the same test is to work
patient safety to the lowest common denominator. For instance, the overriding
concern in waiting for a UK-wide introduction of blood screening for Hepatitis C
was not patient safety. It should have been. Dr Huw Lloyd in Newcastle was
35
The good track record in their use in the US was persuasive of the case in their favour: but to ask the
question, where it was reasonable to do so, was sensible. However, every effort should be made to
avoid unreasonable delay.
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right to proceed with Hepatitis C screening in his region. The fierceness of the
criticism to which he was unjustly exposed for having done so demonstrates that
this lesson needed to be learned. (See the chapter on
Hepatitis C Screening).
Coordinated action (unless it is itself necessary for there to be safety) should
come second to safety.
Decision-making
Decision-making suffered significantly from delay. Sometimes there was paralysis when
there should have been a decision. Delays that occurred in relation to infected blood have
already been described as “seemingly systemic”. A large part of the reason for delays in
decision-making was because part of the system involved a range of different advisory
committees, discussing aspects of the same issues without having any executive power or
mechanism for politicians to know what was being discussed, unless officials chose to brief
them or they happened to ask a question that prompted proper briefing.
•
A range of committees
should be avoided.
considering
essentially
the
same
issues
– Paul Sartain, a core participant, asked the Inquiry to investigate “paralysis
in
decision-making, accountability and responsibility”,
drawing on his experience of
being a civil servant to explain why it seemed entirely tenable, in his view, that
there were problems with self-sufficiency and early award of compensation;
36
Professor Ian Hann called for a “bit
less democracy and a bit more guidance”.
37
– When it came to dealing with AIDS it was not until 1985 that an expert advisory
group on AIDS was assembled. An overarching, truly influential committee
reflecting expertise in different relevant disciplines should have been established
much earlier: if it had been it could have avoided the problems of a number of
committees, including the Biological Sub-Committee of the Committee on Safety
of Medicines, taking decisions without the best available information.
– That there were different committees considering aspects of the same issue led
Dr Brian McClelland to describe decision-making (in relation to surrogate testing
for non-A non-B Hepatitis) as “going
round in very small circles some distance
away from the target 
”.
38
– There was a similar to-ing and fro-ing between committees when it came to
whether, and more particularly when, there should be a lookback in respect
of Hepatitis C.
– Similarly, there was a paralysis of decision-making when it came to the
redevelopment of the Blood Products Laboratory, essential to enable production
36
37
38
Written Statement of Paul Sartain para 119, para 121 WITN1013001
Professor Ian Hann Penrose Inquiry Transcript 6 May 2011 p53 PRSE0006021
Dr Brian McClelland Transcript 28 January 2022 p103 INQY1000178
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in the greater volume which would ensure a greater degree of self-sufficiency.
Dr Diana Walford was right to describe this as “unconscionable”.
39
•
Openness and transparency can aid decision-making.
– Part of the problem creating the repetition in different bodies of discussion of
closely related issues was the secrecy which some committees adopted, in
particular the Committee on Safety of Medicines
40
and the Advisory Committee
on the Virological Safety of Blood. It could leave people who had not been part of
those meetings unsighted and prevented an open and transparent debate about
crucial safety issues.
•
Forward planning could have reduced infection and saved lives.
– Some of what caused delay was caused by an absence of forward planning.
Forward planning, looking a number of years ahead, is not only desirable but is
likely to be essential where capital expenditure is to be anticipated.
– Dr Robert Cummings said that one of the important features of a successful
voluntary blood donor system is forward planning. His influence led to the timely
redevelopment of the Protein Fractionation Centre in Edinburgh, which came on
stream in the mid 1970s.
41
– By contrast, the Blood Products Laboratory in London suffered from a lack of
planning ahead. Prescient voices (such as that of Dr Rosemary Biggs, who in
1967 was calling for better production facilities to meet foreseeable demand) were
raised, but it nonetheless took until 1986 to achieve a satisfactory redevelopment
at the Blood Products Laboratory. A failure to plan ahead meant that the
development came too late to achieve self-sufficiency at a time when it would
have mattered most for safety’s sake. (It also cost more money for the Treasury
buying commercial concentrates, and implementing stopgap solutions at the
Blood Products Laboratory which were necessary because of the poor state to
which it had sunk over time whilst unreconstructed: delay was a false economy).
•
Decisions to adopt policies, especially clinical policies and those relating to
safety, need to be kept under review.
– Thus it was promised by the Committee on Safety of Medicines Biological Sub-
Committee of 13 July 1983 that the decision not to suspend the importation of
factor concentrates would be kept under review. Yet there is no sign that it was.
An advisory group on hepatitis was set up in 1980. Despite that being a year
39
40
Dr Diana Walford Transcript 20 July 2021 p29 INQY1000137
In principle, there was good reason for commercial secrecy, but not otherwise. However, this was not
the deliberate action of any member of the Committee on Safety of Medicines. It was thought that
section 118 of the Medicines Act 1968 required complete confidentiality, and it was not realised that
this was not the case until 1989.
See the chapter on
Self-Sufficiency.
Lessons to be Learned
41
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in which the Department of Health and Social Security expressed particular
concern about non-A non-B Hepatitis this group never discussed the topic until
1989 – and the context there was to decide when screening of donations might
start. No one and no body appears to have monitored these failures to carry out
promised reviews.
•
“Corporate memory” should be valued.
– Forward planning involves taking care not to repeat the mistakes of the past.
It is apparent there has been no mechanism to ensure that there is a sufficient
corporate memory in the Civil Service of why previous decisions were, or
were not taken, and the facts that informed those decisions so the reasons
could be understood.
– Thus, though a number of witnesses were asked, none actually knew the facts
underpinning a number of “lines to take” adopted in the 1990s: and when they
slipped into what they preferred to believe, rather than taking an objective view
of the past, they were supported by a degree of groupthink rather than by a true
“corporate memory”.
–
Curiosity has a significant part to play in asking the right questions,
for civil
servants but also for ministers who because of multiple responsibilities cannot
be expected to assemble the facts themselves. Politicians of different political
persuasions had largely failed to be sufficiently curious of the lines they were
advised to take (because those lines had been adopted for so long that they had
become customary) or to consider what legal cases had to tell them; by contrast,
it is when some ministers have been more curious that the truth started to emerge
Questioning the status quo
It is often natural for people to become invested in the way in which they do things, so that
they cease to question what is being done, and how. One of the lessons to be learned
from the Inquiry is that
everyone has a responsibility for patient safety
– from the
government, whether in the departments of health, or as responsible for the NHS, or as the
licensing authority; the blood transfusion services; hospital trusts and boards; clinicians;
plasma fractionators; those overseeing the system and practice of medicine; and those who
are professional advisers, educators or representative bodies including the General Medical
Council, and Royal Colleges. All have a part to play in safety.
• All must
beware of “sacred cows”
in relation to medicine and clinical practice.
– For instance, haemophilia doctors, and the Haemophilia Society, became
convinced (for good reason) of the correctness of the principle that domestic
concentrates were better and safer than foreign imported concentrates. However,
there is some evidence of clinicians becoming so convinced that they were safe
(as opposed to “safer”, which is not the same) that they would hear no criticism
Lessons to be Learned
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of domestic concentrates, nor conceive that they could possibly transmit serious
infections. There is no doubt that they were safer: but so valued was the principle
of voluntary non-remunerated blood donation that it tended to be thought that
little harm would follow from using domestic concentrate.
– Undue reverence for the comparative safety of voluntary non-remunerated donor
blood in the UK played a part in thinking, wrongly, that the increase in pool size,
domestically, of plasma given by voluntary donors would be of little consequence.
It was important to recognise the value of voluntary non-remunerated blood
donation, but not so as to lose sight to its potential shortcomings.
– Blind respect for the voluntary donor principle was probably responsible for a
slowness in asking groups who were at higher risk of transmitting infection not to
do so. It was too easily assumed that each donor would be responsible enough
not to come forward if feeling unwell. Accordingly, donor leaflets were slow in
emerging; donor selection was weak; and screening of the donors (as distinct
from screening of their donations) fought shy of being more searching.
Allied to the need to be wary of “sacred cows” is a need to
beware of becoming too tied to
the status quo:
to the habits of practice.
– Importantly, there is a strong sense that haemophilia clinicians became very
attached to factor concentrates during the 1970s, because of their much greater
convenience of use and the extent to which the speed and ease of infusion
permitted patients to enjoy a fuller life than they otherwise would have done
(assuming no infection). They were thought of as miracle drugs. This in turn
caused those using them to tend to be blind to their shortcomings, such that there
was a reluctance to alter therapy when, in 1982 into 1983, it became clear that
giving factor concentrates might cause AIDS in addition to non-A non-B Hepatitis.
– The faith placed in factor concentrates led to a reluctance to “go back in time” to
using cryoprecipitate.
42
– It led, also, to some downplaying of the impact cryoprecipitate had had on life
expectancy. Cryoprecipitate, not factor concentrate, was responsible for the
large increase in life expectancy during the late 1960s and 1970s. Though factor
concentrate did have an impact, it was more modest than often portrayed.
– Strong incentives to maintain the status quo often exist, and require a strong
countervailing force concerned with the safety of blood and blood products.
43
Here that force existed, but it was weak.
42
Although it remained in use, and had been in extensive use until only some four or five years prior
to the first intimations that AIDS might be transmitted by factor concentrates and continued to be
used in other countries, which experienced lower incidences of AIDS among people with bleeding
disorders as a result.
The US Institute of Medicine expressed an identical view in relation to the US experience with AIDS,
but the words are as applicable in the UK as they were for the US. Leveton et al
HIV and the Blood
Lessons to be Learned
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•
Disturbing the status quo.
– It is plain that for a minority condition (bleeding disorders) a system whereby
funding for treatment was paid out of regional health authority budgets gave rise
to problems. The reasons for this system owed more to a desire not to disturb
existing arrangements than to think afresh about the problems they might cause.
– The splintered nature of the blood service in England and Wales, though it was
a service common to all regions, added to the difficulties in responding both to
initiatives to increase plasma production, to decrease the use of whole blood and
increase the use of red blood cells as a separate component, and most probably
slowed the initial development of the Better Blood Transfusion initiative (see the
chapter on
Blood Transfusion: Clinical Practice).
– The blood services wanted reform, and that reform to the system would have
helped people with a minority condition at significant safety risk, and yet the
system remained in place.
Consent and communication
•
Communication means listening:
It is more talking with, than talking to.
•
Care must be taken to communicate.
– Communication should have been much better – telling a patient what the
professional as an expert clinician knows about (a) risk; (b) alternatives; (c)
consequences; (d) the nature of any tests to be performed and what they might
show of significance to the patient; (e) what the results of those tests have been;
(f) in particular, informing the patient that they are infected, as soon as it is known
that they are; and listening properly to what the patient has to say; hearing their
worries and questions, and goals and preferences for treatment.
– Communication about a treatment involving risk to the patient and potentially
their family members should explain (a) that there is a risk; (b) how serious a risk
it is; (c) what steps can be taken to avoid or minimise that risk, including what
alternatives are available; and (d) whether it is unreasonable, or unreasonably
difficult, to take those steps. The clinician should bear in mind that the question
is not whether taking the steps to avoid or minimise risk is reasonable – the fact
that a step could be taken to prevent or minimise the risk of harm means it should
be taken unless it would be unreasonable not to do so. That is a more demanding
standard than simply doing what is reasonable in the circumstances.
– Communication of a diagnosis or test result should in the first instance be to
the patient: the lesson to be learned is that dismay and distress is caused when
there is communication to others before patients themselves are told personally –
Supply: An Analysis of Crisis Decisionmaking
1995 p110 JREE0000019
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there is evidence of GPs, receptionists, nurses, and even headteachers and
pharmaceutical companies being told in advance of patients themselves.
– The likes of what happened at Treloar’s to communicate the results of testing
must never happen again. It was unacceptable for children at Treloar’s to be
told in batches of five, “you
have, you haven’t”
44
and be delivered the news of
the presence or absence of a deadly disease, and then to be expected to return
to class for the afternoon’s education. Not at home. No parent. No counsellor.
This is so appalling that the fact it happened could be used to show doctors
in training that even clinicians, like Dr Anthony Aronstam, who portrayed a
sympathy to the boys he treated yet behaved like this, may slip into conduct
which is to be condemned.
– Similarly, the practice of a group meeting for people with haemophilia at which
some were told they were infected, and others not, or were given to understand
that if they wanted further information they had to ask for it (rather than be given
it) shows that a degree of panic and confusion amongst clinicians can lead to a
lack of sensitivity, and compassion.
– People given devastating, unexpected news, who were liable to feel the stigma
of their infection(s) in the popular mind, were likely to require some psychological
support.
45
The term “counselled” often appeared in medical records. At that time,
it meant telling a person that they were infected, advising them of a reduced
life expectancy, telling them they should not become pregnant or father a child,
and advising them what not to do. There is very little evidence of professional
psychological counselling.
• There can be
no proper consent without adequate communication,
in particular
of the risks and alternatives, but also so that the care of the patient respects the
patient’s ownership of their own body and life.
46
– Consent is not a matter of obtaining a tick or a signature on a sheet of paper, but
a real process of information, discussion and co-decision.
47
– Consultation with the people affected by a treatment decision, which goes
beyond telling the individual what is to be done but amounts to a process of co-
determination in which the patient is involved, is fundamental, for the evidence
before the Inquiry shows the ill effects of it being absent.
44
45
46
47
Adrian Goodyear Transcript 5 June 2019 p83 INQY1000014
I have dealt with this fully in the second report of the Inquiry, which is why it needs no further
expansion here. Infected Blood Inquiry Second Interim Report 5 April 2023 INQY0000453
The autonomy of patients was stressed by the Inquiry’s ethical experts. Expert Report to the Infected
Blood Inquiry: Medical Ethics April 2020 INQY0000241
As is generally accepted now in medicine the process of treatment of a patient by a clinician is a
collaborative process in which the patient makes the eventual decision.
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• It is a
mistake to assume that patients truly know and understand something,
unless their treating clinician has actually told them
and in sufficient detail for
them to deal with it.
– The evidence was that too many clinicians assumed people with bleeding disorders
knew of the risks of hepatitis or HIV because the Haemophilia Society would
have told them, or the newspapers gave the information. This misunderstands
the relationship, which is one in which the patient expects (and is entitled to
expect) the person who is a clinical expert in
their
care to give information they
can actually rely on to make decisions. The clinician has the power of expert
knowledge, which the patient lacks: but the patient has the power of ultimate
decision, which the clinician must not usurp.
– Too many doctors assumed that a patient knew (from previous clinicians) of their
infection status. The consequence when the false assumption became apparent
was unnecessary distress.
– Politicians and civil servants tended to assume that doctors would have told their
patients of risks, tests being conducted, infective status, how their infections
affected others, available treatments, and available support schemes. These
assumptions should not have been made without evidence (ie asking patients).
– Thus, Susan Deacon tasked an investigation on behalf of the Scottish Executive
“to
examine evidence about the information given to patients with haemophilia
in the 1980s about the risks of contracting HCV from blood products”
48
and its
conclusion was that: “We
accept that clinicians would have had available to them
information about the general risks of blood-borne disease, including hepatitis,
and that they would have been able to pass this information on to patients”,
49
which shows an assumption of communication without any actual evidence of it.
•
Communication should not be withheld or delayed because the message
conveyed may be difficult.
– The weight of the evidence is overwhelming that patients were more often than
not left unaware that they had been tested. This may have contributed to making it
difficult for clinicians to tell patients they had tested positive for an infection, when
they did not know that they had been tested. But, difficult as it may sometimes
be, it is part of a clinician’s duty to be able to deliver bad news to their patient,
and to aim to do it sympathetically rather than by providing false reassurance.
– To tell an adolescent they have two years to live, during which they may waste
away, that they are likely to face social revulsion and repudiation even by those
48
49
Memo from Christine Dora to PS/Minister for Health and Community Care 21 January 2000 p2
SCGV0000170_071
Scottish Executive Health Department
Hepatitis C and heat treatment of blood products for
haemophiliacs in the mid 1980s
October 2000 p13 GGCL0000010
213
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they regard as friends, that ideally they should share the information with no-one,
and should avoid being sexually active, is not easy. But the adolescent has a right
to know. Without delay. (See the chapters on
Treloar’s, People’s Experiences,
and
Haemophilia Centres: Policies and Practice).
Candour between doctor and patient
Consent and communication both require candour.
•
Candour is essential in the relationship between clinicians and patients.
Both
patients, in accepting treatment, and clinicians, in advising on it, are badly affected
by its absence.
– Advice as to risks, prognosis, potential treatments and their side-effects needs
to be realistic.
– Many witnesses report being told that non-A non-B Hepatitis was benign,
when the truth was that though many doctors thought it would turn out to be,
no-one knew for sure, and many others thought serious consequences would
emerge over time.
– Some were told that because they had tested HIV positive they would probably
not suffer from AIDS (it was not necessarily unreasonable for individual doctors
in the early stages of grappling with AIDS to think that the development of
antibodies would be protective, but, again, no-one knew for sure, and most
feared the worst).
50
– Most significantly, patients were told in 1983 and 1984 – wrongly – that there was
very little risk and they should continue to take their factor concentrate treatment
as before. Learning that the truth was otherwise has damaged the relationship
with their clinicians, usually beyond repair, and caused a loss of trust in all doctors
and the NHS – yet despite that patients with bleeding disorders had no option but
to return for further treatment.
•
Meaningful counselling and specialist psychological support
is of real
importance. A lesson from what occurred is that too little thought was given
to providing it.
– Good communication needs sensitivity. Witnesses have testified to the
dehumanising way in which they were told – or, worse, it was implied without
saying – that they were infected with HIV and/or hepatitis, or advised starkly that
they should not have a child. This called for better communication: but it also
highlighted the need for proper counselling to be available.
50
In particular, those conducting the tests, such as Dr Richard Tedder, did not think that in this
instance the antibodies were protective. The degree of dismay with which individual clinicians
viewed the results when they received them also suggests that many had few illusions about what a
positive test implied.
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– Where information is being given by a clinician to a patient which it will be difficult
for that patient to come to terms with, a good communicator should be alive to
that fact. A thoughtful clinician should also realise that, however good they think
they are with patients, there are others who have more training and experience
than they do in handling the potential psychological consequences of life-
changing bad news.
Candour and transparency between government and citizen
•
Care needs to be taken that presentation does not override substance.
– “Lines to take” are an example. Clear presentation of political issues is important
to aid understanding in a democracy, and to enable proper debate. It should not,
however, misrepresent the substance.
– The unqualified line “no conclusive proof” is liable to be misunderstood by people
who hear it. Trust, in the political system where it concerns healthcare, and the
NHS, is essential. That trust is easily sacrificed. It needs honesty, openness and
transparency if there is not to be a loss of trust which is harmful to patient care.
– The line “the best available treatment in the light of medical knowledge at the
time” has been shown by the evidence before this Inquiry to be wrong. When
the line was used it was well known that the treatment had resulted in over a
thousand people suffering from AIDS, and a substantially larger number from
hepatitis. In the light of that, the line defied logic unless it could be based on
carefully considered foundations of fact. But this was what the government was
asking people to accept, with the implication that it had performed that careful
scrutiny of the facts.
– A perceived need to be on the right side of the media also led to Susan Deacon’s
office describing her meeting with the Haemophilia Society to discuss an
investigation into aspects of Hepatitis C as “a
PR exercise”.
51
•
Government should not be ashamed or embarrassed to admit that it does not
know the true facts, if the truth is that it does not.
– Dealing with uncertainty in a system which values certainty of outcome is not
easy. Civil servants draft letters for ministers; they prepare briefing documents
and submissions, or contribute to them. By virtue of their position, they may feel
that they
ought
to know. They need to be alert to the fact that their own sources
may feel the same. Those sources may – and in the case of medicine and health
often will – not be sure what is correct. It may be embarrassing to admit this. It is,
however, even worse to volunteer a “fact” or “half-truth” when there is no proper
factual basis for it; or to dress it up in misleading text. If exposed, the result is a
51
Email from Karen Jackson on behalf of First Minister to Sandra Falconer and others 23 September
1999 SCGV0000170_152
215
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loss of face, and – more importantly – a loss of trust by others in what is being
said, because it may be no more accurate than the exposed half-truth. Worse
still, the purpose of a governmental official or body asserting a fact is that others
should be able to rely on it. Where the assertion was not accurate, they may
have suffered as a result.
– Thus, the “no conclusive proof” line will have been heard as “no proof”, equalling
“the claim that concentrates transmit AIDS is baseless”. Clinicians will have relied
on this to continue treatment as before; patients will have relied on it to continue
accepting that treatment.
– The initial draft of the “no conclusive proof” line had the important qualification
that the evidence suggested that what had not yet been proved was indeed the
case. The qualification was not used in public pronouncements.
52
There is no
record of any civil servant querying this with a minister’s office, and pointing out
that the wording was capable of misleading. Yet honesty is the obligation of the
Civil Service as a whole, not just individual civil servants.
– Other lines to take (see the chapter on
Lines to Take)
such as the “best treatment
available” were offered without any who used it being aware of any proper factual
basis for the words.
•
Citizens need to be trusted with the truth rather than misleadingly reassured.
– Government in a democracy should trust its citizens to know the facts which
government knows, unless there is a proper reason for secrecy. Those facts
should convey the unvarnished truth: government does not need to assume that
its citizens need to be protected against bad news, or news that alerts them
to a particular risk, for fear they may panic. Citizens need to be told, rather
than reassured.
– Thus the attempts at reassurance in respect of the risk of AIDS were misleading.
If the messaging had been more faithful to the facts, from the start, then more
protective action may have followed, and followed more quickly, with the result
that fewer deaths and less suffering would have been caused.
•
Extravagant claims should not be made.
– An adult faced with advertising claims in the media is used to reacting to a claim
that something is “the best” with cynicism and scepticism. Medical treatment is
not selling a product; nor is government in the same position as an advertiser.
More is to be expected of both. The lesson to be learned is that claims for near
perfection, or that what was done to a patient could not have been improved on
(it was simply “the best”), need to have a sound basis in fact if they are to be
52
216
See the chapter on
Role of Government: Response to Risk.
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advanced. All of us would like our treatment from the NHS to be the best that
there could be, but wishing it is not the same as being it.
– Too often civil servants drafted unqualified statements for their minister to make
in public, when they deserved to be qualified. Too often they made statements
(“the best available treatment”) which required justification in fact, when no basis
of fact has been identified to make the statement; or made statements in the
same vein which strained the facts beyond reality.
– To say that testing for Hepatitis C was introduced at the first available opportunity
was equally to overstate the fact: as the chapter on
Hepatitis C Screening
shows,
the UK lagged well behind a large number of comparable countries, and a legal
case had determined that it should have been introduced earlier.
– It destroys trust that there has to be a legal case to point out the lack of candour,
as happened with references to the Irish payment scheme. Civil servants made
or drafted statements (one example being claims about the basis of the Irish
payment scheme for Hepatitis C sufferers) when government had been told of
the true position, yet ignored this.
– Civil servants (and ministers) should be sure of the factual basis, especially where
what is asserted is about long past events and prone to a malleable corporate
memory, where bold claims are made.
•
Civil servants must ensure that the information given to ministers is accurate.
• Civil servants in health departments may draw some of their information from what
clinicians tell them; but
clinicians may draw some of their information from
what civil servants say.
Care should be taken that the process does not lead to
one statement justifying the next which in turn is used to justify the first.
•
Just as bad policy should never be implemented as a response to press
coverage, good policy should not wait for media pressure before
being given effect.
– It should not require lobbying and media pressure to build up before taking action.
– The evidence tells us that the timing of government action often corresponded
with the timing of media and lobbying pressure. The timing of the introduction
of the Macfarlane Trust owed much to such pressures (see the chapter on the
Macfarlane Trust).
– Governmental approval of screening blood for HIV was accelerated by the
knowledge of infections following transfusion when these were highlighted in
the popular press.
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Involvement in a decision of those affected by it
•
People affected by decisions need to be involved in them.
– This is true not only in respect of their own medical treatment. It is necessary for
any support schemes to involve the people affected by them. (See the chapters
on the
Macfarlane Trust, Eileen Trust, Caxton Foundation, Skipton Fund
and
National Support Schemes).
– There is a fear, now, that the design of the compensation scheme to meet the
recommendations made in the second report of the Inquiry may not involve those
people whom it most centrally affects.
• Paternalism is misplaced. This is true not simply of clinical practice (see the report
of the ethical experts to the Inquiry) but also true of those administering support and
true of politicians.
Medical records
Ensuring that sources and routes of infection can be easily established, and therefore
infections better dealt with, relies on a good record-keeping system. The evidence is that
historically either accuracy was not achieved; or records which may well have been accurate
were lost, damaged, or destroyed. Too many were not accessibly retained. It is doubtful
that even today accuracy and sufficiency of medical records has been achieved. (See the
chapter on
Medical Records).
•
A patient needs to be able to access their records with ease,
both to correct
any inaccuracy but also to ensure that they have ownership of the records which
relate to them.
•
Any failure of record-keeping is likely to result in some loss of trust in the
system
the records serve.
• It is important that records are accurate.
– It is also important that they are complete (so far as potentially relevant
information is concerned).
Though there are now procedures under data protection legislation for correcting records
known to be incomplete or inaccurate they are often cumbersome and expensive if they
involve eventual complaint to the Information Commissioner’s Office, or legal action, so
it may well be that these challenges will not disappear with electronic records, unless the
general system is carefully designed.
•
There is no place for gratuitous comments in records.
Records should be statements of what was found clinically. They are not occasions for
clinicians passing personal comments about patients – records are meant to be read, later,
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and they are the patient’s records, so making a personal comment which has nothing directly
to do with the treatment given may lead to a lack of trust. If the comment is derogatory, it
may cause offence; if, by contrast, it is complimentary of the patient’s attitude, demeanour
or character it may risk being seen as patronising. The remedy is to restrict what is written
to that which is clinically relevant.
Public health and complacency
•
Complacency is the enemy of safety.
The chapter on
Public Health
shows how
public health protections against communicable disease diminished in the 1970s to
1990s because it was wrongly assumed that communicable disease was no longer
a problem as it had been in the past. There is a danger that complacency takes
the place of active scrutiny, and allows risk to flourish into reality when it might
otherwise be prevented from doing so.
Final words
Where things appear to have gone wrong, and safety has been compromised, an attempt
should be made to learn the lessons as quickly as possible.
The approach of other industries to health and safety is instructive. Where there is a serious
accident on construction sites or in industry, the Health and Safety Executive are likely to
investigate. Where there is a near miss between airliners, or a part of the plane falls off
in flight, as well as when there is a tragedy, there is always an investigation. When the
Aberfan disaster took place, there was an inquiry. When the Piper Alpha oil rig exploded,
it was followed by an inquiry. The purpose is not so much to attribute blame (though that
may follow) but to learn the lessons of the past, to prevent something similar happening, or
happening as badly, in the future.
So far as infected blood is concerned, the need to learn lessons has been clear throughout
the evidence: when the Bournemouth outbreak of hepatitis occurred in 1974, said to be
Hemofil-related, a study followed but it is not clear that lessons were learned more generally.
• When it became apparent in the mid 1980s how many people had suffered serious
illness as a result of their treatment with blood or blood products by the NHS, there
was little apparent effort to establish precisely why that was, and to learn the lessons
for the future.
• It is most likely the case that practices have changed as a result, and significant
improvements have been made in haemovigilance and blood safety. So too, if
belatedly, viral inactivation (of the infections in central focus) has been achieved
in blood products; and it may be that experience of HIV infections informed the
approach which was taken to meet what was for some time only a theoretical risk
that vCJD could be transmitted through blood.
Lessons to be Learned
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• Nonetheless, in the other industries mentioned the approach has been systematic.
The need was for a similar systematic approach to events such as described in this
Report so that lessons which might improve patient safety could be learned. Part
of such a system is to hold a public inquiry. People who were infected or affected
by blood or blood products have said they wanted to know what lessons are to be
learned. There has not been a systematic approach to identify them, until now.
There are several lessons to be learned from what happened, and why; and also from
the way in which we as a nation responded to what had happened. It is helpful to recap
what should have been a shorter chapter, had there not been so many lessons to learn. In
conclusion, a summary of the principles of approach which should be adopted is set out in
the chapter on
Hepatitis C Surrogate Screening.
Though they were expressed in relation
to that particular chapter, they summarise central themes which have run through most
aspects of the Inquiry and feature in chapter after chapter. They bear repeating.
(1)
(2)
(3)
First and foremost, patient safety should have been the paramount,
guiding principle.
Second, a search for certainty can be, and in this case was, an enemy of
achieving progress.
Third, risks to public health need to be addressed with speed, consistency,
and an objective look at such evidence as there is without making
unjustified assumptions.
Fourth, what aids the process is a clear structure for decision-making. Instead
of effective decision-making here, there was “decision paralysis”.
Finally, cost, though a relevant factor, should not be the starting point. Patient
safety should be.
(4)
(5)
Sadly, these principles were honoured more in the breach than in the observance.
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1.5 Recommendations
Introduction
In the light of all the evidence available to the Inquiry, and the submissions made to it, I have
a number of recommendations to make. There is a danger in inquiries making too many
recommendations: it becomes difficult to see whether action is truly being taken to avoid the
errors of the past being repeated. Of the many recommendations which might have followed,
therefore, this Report will concentrate upon a small number. I acknowledge that some
participants may regret that I may not have chosen one which is their particular concern.
Some of the lessons to be learned which were set out in the previous chapter
Lessons
to be Learned
might also have resulted in additional recommendations made formally by
the Inquiry. This should not, however, prevent anyone from applying the lessons identified
there, avoiding in future the mistakes which have been identified, and using the content of
that chapter as a basis for taking further action, and does not diminish the importance of
learning those lessons.
1. Compensation
My principal recommendation remains that a compensation scheme should be set up now.
The Government accepted the moral case for compensation in December 2022 and my
recommendations for compensation were made in the Inquiry’s Second Interim Report
of 5 April 2023.
53
2. Recognising and remembering what happened to people
The scale of what happened, famously and accurately termed “the
worst treatment disaster
in the history of the NHS”,
requires recognition and a tangible reminder for future generations.
Too many people have lived for too long in the shadows of infected blood. Society needs to
show that it now sees what happened to them in its proper light.
Such public recognition involves a formal act of apology from those who had responsibility
for what happened, and for failures of response to it. This should be meaningful: an apology
on its own will be thought hollow if it does not give sufficient detail as to what the apology
is for. It may not be enough (for example) for the Government, or NHS bodies, to say that
they apologise for the suffering which has happened. This is an apology, true, but unless
more is said, there is insufficient recognition in the words “we apologise” that the suffering
is the result of errors made, wrongs done, and delays incurred – first in respect of what
happened and why, and second in respect of what then happened by way of organisational
response. There have (rightly) been said to be “three
components of full apologies: affect
53
Hansard parliamentary statement on Infected Blood Inquiry 15 December 2022 p2 COLL0000022,
Infected Blood Inquiry Second Interim Report 5 April 2023 INQY0000453
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(regret, remorse), affirmation (admission of fault), and action (compensation, reparation).
Expressing sorrow or regret, whilst an important part of the healing process, is at best a
partial apology.”
54
An apology should not only give some detail as to what is being apologised for, but to
be understood by those to whom it is addressed as sincere and meaningful, it should
lead to action. Compensation is part of this. Setting up a compensation scheme and
making compensation payments this year, including interim payments as recommended
in the Inquiry’s Second Interim Report, would be a powerful statement underpinning the
sincerity of an apology.
It is so obvious that an apology should be given that the risk of it being seen as given
because it was formally recommended might detract from the force of the apology. I have
not therefore listed it below, because though I expect one I do not think I need to say any
more about it than I have.
In order to provide the public recognition and tangible reminder that is so obviously required,
there should be a suitable national memorial. Funds have already been raised in Scotland
with a view to there being such a memorial there. I recommend that a steering committee
be formed to decide what memorials should be provided, and where, at public expense.
55
Essential voices which should be heard amongst the members of such a steering committee
are people who have been infected and affected. The membership should reflect all routes
of transmission; it will necessarily contain representatives of the governments of the nations
of the UK. The memorial has to be meaningful, and its position appropriately prominent to
act as a proper memorial and focus for those who survive, and for people who have been
or are carers or who have been bereaved by infection, as well as being capable of being a
public reminder.
I recommend that there should also be a memorial dedicated specifically to the children
infected at Treloar’s school. The memorial should be agreed with those who were pupils at
Treloar’s and should also be funded at public expense.
Funding should be made available for a biannual networking/support event for those infected
and affected, to be organised by a working party of similar composition to the memorial
steering committee, save that, although government will no doubt need to have input as
to the overall funding, any government representatives should only be part of the working
party at the invitation of the other members. Funding should be for a period of at least
three events after the publication of this Report.
56
One of the aspects of the operation of
the Macfarlane Trust which many found helpful was that in its first few years it organised
54
55
56
Quick
Duties of Candour in Healthcare: The Truth, the Whole Truth and Nothing but the Truth?
Medical
Law review 2022 p11 RLIT0002448. Professor Oliver Quick quotes the words of Professor Gijs van
Dijck as having “neatly
summarised”
the proposition.
Though there should remain a place for public subscription by those individuals or organisations who
wish to contribute or who already have done so for a memorial in Scotland
This recommendation was put forward to the Inquiry by the clients of Collins solicitors and is similar to
one put forward by the clients of Leigh Day solicitors for a forum where people can continue to meet
virtually and in-person and share their experiences. Submissions on behalf of the core participants
Recommendations
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occasional weekend events which brought registrants of the Trust together. Though there
was little professional psychological support given at the time, many have said that they
valued the mutual support given by these. The time that people have been able to spend
meeting others who have been similarly affected at, and in the margins of, the Inquiry, has
also been important to many. The opportunity to stay in contact remains important now,
since a large number of people who have been impacted by what happened otherwise
live in isolation.
The working party may wish to consider the suggestion made by Collins Solicitors on behalf
of their clients that such an event could “usefully
be combined with a public presentation/
update as to the ongoing process of providing compensation and implementing the other
recommendations.”
57
Accordingly, I recommend:
2. Recognising and remembering what happened to people
(a)
A permanent memorial be established in the UK and consideration be given to
memorials in each of Northern Ireland, Wales and Scotland. The nature of the
memorial(s), their design and location should be determined by a memorial
committee consisting of people infected and affected and representatives of
the governments. It should be funded by the UK government.
A memorial be established at public expense, dedicated specifically to the
children infected at Treloar’s school. The memorial should be such as is
agreed with those who were pupils at Treloar’s.
There should be at least three events, approximately six months apart,
drawing together those infected and affected, the nature and timing of which
should be determined by a working party as described above, facilitated by
some central funding.
(b)
(c)
3. Learning from the Inquiry
The previous chapter
Lessons to be Learned
draws attention to a number of lessons which
are not necessarily intuitive. They are starkly obvious to anyone who has read the rest of
the Report, but few people in training for a career in medicine may take that opportunity.
A very real danger is that the lessons of the past are forgotten when a fresh history is
being made in the years to come, and only then, after another disaster, are remembered.
All those responsible for medical education should take steps to ensure that those “lessons
to be learned” which relate to clinical practice do indeed become part of every doctor’s
represented by Collins Solicitors December 2022 p202 SUBS0000063, Recommendations on behalf
of the core participants represented by Leigh Day 17 June 2022 pp22-23 SUBS0000003
Closing Submissions on behalf of the core participants represented by Collins Solicitors December
2022 p202 SUBS0000063. Initial submissions on behalf of the Core Participants represented by
Collins Solicitors on non-financial recommendations June 2022 p5 SUBS0000015. They had in mind
that the minister then responsible should give this, since it would underline the apology.
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training. However, it is above all the hard and awful facts of what happened that doctors
need to understand so that the errors are not repeated. A package of training materials, with
excerpts from oral and written testimony would underpin what can happen in healthcare,
and must be avoided in future.
It has been pointed out by Christine Braithwaite, director of standards and policy at the
Professional Standards Authority for Health and Social Care, that:
“We
have noted in the course of our work that once a review or inquiry is
complete, usually after publication, that the secretariat tends to be disbanded.
The publication of an inquiry’s findings, conclusions and recommendations can
bring to light information that others may need to act on. In particular, professional
regulators may want to obtain information to help them identify people described
anonymously in a report, if there is evidence that calls into question their conduct
or competence. This becomes challenging if a review/inquiry team is no longer
operational. An example of this is the review into failings at Shrewsbury and
Telford Matenity Services
58
which reported
[in March 2022]”.
59
The real problem here is access to the material which an Inquiry will have considered in the
course of drawing its conclusions, and making its recommendations. Christine Braithwaite’s
words are a powerful reason for ensuring that the key documents considered by the Inquiry
remain available and accessible at no cost to any person who wishes to access them. The
material uncovered by the Inquiry (as will be seen by the copious references throughout this
Report) underpins conclusions about safety and “next steps”, and though maintaining it in a
usable form will not be without some cost, it is a small price to pay if by doing so the cause
of future patient safety can be advanced. Accordingly, I recommend that the Inquiry website
is maintained with full functionality online. Thus I recommend:
3. Learning from the Inquiry
(a)
The General Medical Council, and NHS Education for Scotland, Health
Education and Improvement Wales, Northern Ireland Medical and Dental
Training Agency and NHS England, should take steps to ensure that those
“lessons to be learned” which relate to clinical practice should be incorporated
in every doctor’s training.
They should look favourably upon putting together a package of training
materials, with excerpts from oral and written testimony, to underpin what
can happen in healthcare, and must be avoided in future.
The Inquiry website is maintained online.
(b)
(c)
58
59
224
Ockenden Report – Findings, Conclusions and Essential Actions From the Independent Review of
Maternity Services at The Shrewsbury and Telford Hospital NHS Trust 30 March 2022 WITN7523009
Written Statement of Christine Braithwaite para 12 WITN7523001
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4. Preventing future harm to patients: achieving a
safety culture
The account in the chapters of this Report sets out the history of a failure to focus on risk, a
failure to put safety first, a failure to listen to voices advising a different course. It also contains
a history of systemic failures – a large number of committees, advisory bodies and working
groups, many of which seemed partly to cover the same ground as each other, and lacking
executive power or sufficient status to demand the ear of those who did have that power. It
describes widespread failures of record keeping. The recommendations which follow thus
arise out of the Inquiry’s Terms of Reference – but it is noticeable that similar failings have
been identified throughout healthcare in other inquiries and suggest a wider problem still.
In the NHS there are three particular aspects which demand action:
• First,
changing the culture,
such that safety is embedded as a first principle, and
is regarded as an essential measure of the quality of care. Though performance,
efficiency, and expense are all important, it should be the safety of care in any
health institution that is the aspect in which all its staff take particular pride.
• Second, a
more rational approach to regulation and safety management,
resolving the problems created by the current systems for trying to deliver safer
care: which are fragmented, overlapping, confusing, and poorly understood.
• Third,
ensuring a coherent approach to data
– for patients to whom that data
relates, and by a body (preferably just one, but if more than one is necessary, then
as few as possible) which, with the appropriate consent of the patients concerned,
can make use of that data to help identify threats and trends, and better inform
protection for others.
To understand the link between these three, it is important to recognise: first, that there
have, over the last five decades, been multiple high profile failures of care which have
themselves been the subject of earlier public inquiries and recommendations;
60
and second,
that it has long been pointed out that the regulatory framework for the NHS is overly complex
and disjointed. Thus, for example, in 2002 Professor Kieran Walshe argued that “Current
regulators vary widely in their statutory authority, powers, scope of action, and approach.
The resulting mosaic of regulatory arrangements is highly fragmented and some roles
are duplicated.”
61
60
61
There is a useful snapshot of some of these inquiries in the period up to 2001 in: Walshe and
Higgins
The use and impact of inquiries in the NHS
British Medical Journal 19 October 2002 pp1-2
RLIT0002403. Some of the more recent inquiries, such as the inquiry into the Mid Staffordshire NHS
Foundation Trust, are referred to in the main text of this chapter.
Walshe
The rise of regulation in the NHS
British Medical Journal 20 April 2002 p2 RLIT0002387. In
2016 the chief executive of the Nuffield Trust argued that “oversight
from so many different bodies
creates the potential for confusion and the risk of the ‘problem of many hands’, in which accountability
is distributed and it is not clear who is responsible for key actions.”
Edwards
Burdensome regulation of
the NHS
British Medical Journal 20 June 2016 p1 RLIT0002413
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By 2019, it was revealed just how much further this fragmentation and duplication had
gone when Professor Charles Vincent and others set out in an attempt (for the first time)
to describe and understand what body regulated what process within the NHS in England,
to what extent, and with what powers. Their study showed that there were then over 126
organisations which exercised some regulatory influence on NHS provider organisations.
Three were national overseeing bodies; 18 were statutory regulators. They commented:
“The
multitude of organisations that are simultaneously involved in various types
of activities overseeing healthcare is striking … There is no reason to think that
all these organisations should do exactly the same thing, but the variability in
approach and overlapping functions suggest that there is no overall integrated
regulatory approach … Evidence of overlapping responsibilities, duplication,
practical challenges in coordinating regulatory compliance and providing
assurance have been extensively documented.”
62
There seems an inevitability about the conclusion that:
“The
regulatory system of the NHS has evolved rather than been designed and is
not fully understood even by professional regulators and it is almost impossible for
the general public to navigate the system. Regulation is important and the actions
of thoughtful and well-intentioned regulatory organisations have the potential to
improve health service standards. However, the overall impact of the regulatory
system hinders the effectiveness of regulatory actors and can be challenging for
NHS providers detracting from safety and quality improvement initiatives.”
63
If safety is to be regulated properly, it needs to be easy for an ordinary user of the system to
know to whom they can express any concerns they may have about it, who will take up their
cause, and what they can expect from them. At the same time, those who are busy working
within the system, especially those in leadership roles or on the boards of hospital trusts
and health boards, need to have clarity as to what, precisely, is expected of them.
Yet, so far as England is concerned, the Parliamentary and Health Service Ombudsman,
64
Rob Behrens, as recently as 17 March 2024 drew attention (amongst other matters) to
the difficulties of navigating the regulatory system. He also saw another problem caused
by the current system – he is quoted as saying that there are now “too
many regulators
in the health service – too many bodies doing roughly the same thing – [and] they’re not
sufficiently joined up, which means that decisive action which should be taken isn’t taken,
because ministers aren’t getting one voice about what should happen.”
65
62
63
64
65
Oikonomou et al
Patient safety regulation in the NHS: mapping the regulatory landscape of healthcare
BMJ Open 9 July 2019 pp6-8 RLIT0001735
Oikonomou et al
Patient safety regulation in the NHS: mapping the regulatory landscape of healthcare
BMJ Open 9 July 2019 p8 RLIT0001735
Each of the four nations has its own ombudsman: the others are the Scottish Public Services
Ombudsman, Public Services Ombudsman Wales and Northern Ireland Public Services Ombudsman.
The Guardian
NHS ombudsman Rob Behrens: ‘There are serious issues of concern’
17 March
2024 p2 RLIT0002366
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The Professional Standards Authority for Health and Social Care, which has a remit to
oversee the statutory regulators of health professionals (including the General Medical
Council and the Nursing and Midwifery Council which respectively regulate doctors and
nurses across the UK)
66
pointed out that “the
Paterson, Cumberlege, and Ockenden reports
describe a fragmented system with patient safety concerns falling through the gaps and
the patient voice being lost”
67
in its report “Safer
care for all”
published in September 2022.
The Professional Standards Authority concluded that “The
health and social care safety
system, of which inquiries and reviews are an integral part, is made up of a complex jigsaw
of institutions. Each has a specific remit, and no single body is tasked with ensuring that
together they create an effective safety system that protects patients and service users.”
68
The Authority considers that there is a problem with:
“Harm
and risk of harm going unaddressed because:
• patients and service users are not listened to
69
• data is not collected
• information/ intelligence/ data is held in the wrong place and/or not shared
with the appropriate bodies
• the extent of a risk is not identified because bodies are not pooling their
intelligence/data
• trends that can only be spotted by taking a bird’s-eye view are not identified
• a joined-up response is required but none is forthcoming as a result of
remit apathy (‘not my responsibility’) and/or lack of accountability for
joint working.”
70
The solution proposed by the Professional Standards Authority for Health and Social Care
was that there should be a Safety Commissioner in each nation with an overarching role
66
67
68
69
The remit of the Professional Standards Authority for Health and Social Care encompasses the
statutory bodies that regulate health professionals across the UK, and the statutory body that
regulates social workers in England.
Professional Standards Authority for Health and Social Care
Safer care for all: Solutions from
professional regulation and beyond
September 2022 p6 RLIT0001837
Written Submission of Professional Standards Authority January 2024 p1 RLIT0002406
The examples given were Mid Staffordshire, Cumberlege, and Morecambe Bay. These inquiry and
investigation reports are as follows: Report of the Mid Staffordshire NHS Foundation Trust Public
Inquiry RLIT0001757, First Do No Harm: The report of the Independent Medicines and Medical
Devices Safety Review RLIT0001379, The Report of the Morecambe Bay Investigation WITN7523007
Written Statement of Christine Braithwaite para 11 WITN7523001. Christine Braithwaite identified
a lack of candour with patients and families (giving as examples Bristol, Mid Staffordshire,
Morecambe Bay, Cumberlege – two of which predated the statutory duty of candour becoming
law); and gave examples of inquiries which had shown that data was not shared or acted upon
(Paterson, Cumberlege, Shrewsbury and Telford). Written Statement of Christine Braithwaite para 15
WITN7523001. The other inquiry and investigation reports are as follows: The Report of the Public
Inquiry into children’s heart surgery at the Bristol Royal Infirmary 1984-1995: Learning from Bristol July
2001 DHSC5030766, Report of the Independent Inquiry into the Issues raised by Paterson February
2020 WITN7523006, Ockenden Report – Findings, Conclusions and Essential Actions From the
Independent Review of Maternity Services at The Shrewsbury and Telford Hospital NHS Trust March
2020 WITN7523009
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focussed on ensuring that the various bodies charged with protecting the public work
together as an effective system, rather than as a collection of disparate institutions and
activities. In its view, the remit should not simply be limited to medicines and devices, for
this was likely to add a further layer of complexity to an already fragmented system – what
it saw as needed was an overall, independent, transparent body concerned with all aspects
of patient safety.
71
There is now a Patient Safety Commissioner for England. Dr Henrietta Hughes began her
role with effect from September 2022. However, her role is by statute one in relation to the
safety of medicines and medical devices, not overall patient safety. She nonetheless was
able to say in a report on her first 100 days that it was clear from what she had been told by
patients, healthcare professionals and senior leaders that “the
focus of the health service
is on productivity, operational performance, and financial control. Medicine is industrialised
when it needs to be humanised. As well as asking ‘What’s the matter with you?’ we should
be asking ‘What matters to you?’ so that healthcare is personal, meaningful, and safer.”
72
There is provision, too, in Scotland for a Patient Safety Commissioner.
73
In Scotland the
powers are not focussed on medicines and medical devices, but being “Independent
of
Government and the NHS and accountable to the Scottish Parliament, the commissioner
will have complete freedom to consider or investigate any issue they believe to have a
significant bearing on patient safety in healthcare, and will be able to hear from patients and
their families as well as gather information from healthcare providers, to inform their work.”
74
The Act establishing this post became law on 7 November 2023.
75
It has yet to be seen how
this works in practice, though on the face of it the remit provides for a wider responsibility
than that of the English equivalent.
Simplification of the structures by which safety is promoted or supervised with the NHS is
(obviously) highly desirable. One means of moving in this direction would be a coherent
safety management system which those who work within the NHS and the patients whose
choices of treatment inform healthcare can buy into.
76
There is little time to waste. Dr Henrietta Hughes, Patient Safety Commissioner in England,
said in the report reflecting on her first 100 days in post that “It
is clear that the culture
is getting worse and unless leaders set out a strategic intention to listen and act, we are
71
72
73
74
75
76
Professional Standards Authority for Health and Social Care
Safer care for all: solutions from
professional regulation and beyond
September 2022 p14 RLIT0001837, Written Statement of
Christine Braithwaite para 18, para 40 WITN7523001
Patient Safety Commissioner
100 Days Report
2 February 2023 p2 RLIT0002394
There are presently no plans for a Patient Safety Commissioner in Northern Ireland. On 27 February
2024 the Minister for Health and Social Services in Wales stated he had no plans to introduce such a
role in Wales. Senedd Cymru answer given on 27 February 2024 RLIT0002458
Law Society of Scotland
Patient Safety Commissioner Bill passes final stage
28 September
2023 RLIT0002428
Patient Safety Commissioner for Scotland Act 2023 RLIT0002436
Written Statement of Dr Rosie Benneyworth paras 34-40 WITN7689001, Written Statement of
Dr Rosie Benneyworth WITN7689012. Dr Benneyworth is chief executive officer of the Health Services
Safety Investigations Body.
Recommendations
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heading straight back to the days of Mid Staffs and other health scandals, severe harm, and
death.”
77
Over a year has passed since then.
Similarly, on 26 March 2024 Patient Safety Learning (a charity and independent voice
for improving patient safety) published a report entitled
We are not getting safer: Patient
safety and the NHS staff survey results.
This considered the NHS Staff Survey 2023 for
England, and saw in it a need to raise awareness of the urgency of action to create a patient
safety culture.
78
The culture will not change unless candour is ensured as best we can.
The duty of candour
On 6 December 2023 the Lord Chancellor Alex Chalk announced to Parliament that the
Deputy Prime Minister Oliver Dowden had that day signed what was to be known as the
“Hillsborough Charter” on behalf of the Government. The Charter had been proposed
by Bishop James Jones, former Bishop of Liverpool, in his report on the Hillsborough
disaster, entitled
The patronising disposition of unaccountable power.
79
Alex Chalk
acknowledged in his response on behalf of the Government that it had taken too long for the
Government to respond.
80
Bishop James Jones had written:
“The
experience of the Hillsborough families demonstrates the need for a
substantial change in the culture of public bodies. To help bring about that cultural
change, I propose a charter drawn from the bereaved families’ experiences and
made up of a series of commitments to change – each related to transparency
and acting in the public interest.”
81
There are six undertakings in the charter. Apart from the first (which relates to a public
tragedy of the kind which happened at Hillsborough) all are applicable to the subject of this
Report. They are:
77
78
79
80
81
Patient Safety Commissioner
100 Days Report
2 February 2023 p3 RLIT0002394
Amongst its findings in relation to this survey were: “Turning
to questions on clinical safety, the
responses to this year’s survey show that the percentage of staff who feel secure raising such
concerns is now at a five-year low. We note that it is difficult to imagine that such figures in other
safety critical industries, where the consequences of incidents may also be serious injury or loss of life,
would be deemed acceptable”
and that “Overall,
the results in this section of the survey are a clear
indication that we remain far away from the NHS vision of creating a patient safety culture throughout
the health service.”
Patient Safety Learning
We are not getting safer: Patient safety and the NHS staff
survey results
26 March 2024 p4, p11 RLIT0002386
The report had been produced six years earlier. The Right Reverend James Jones
The patronising
disposition of unaccountable power: A report to ensure the pain and suffering of the Hillsborough
families is not repeated
1 November 2017 COLL0000025
Hansard parliamentary statement on Hillsborough: Bishop James Jones Report 6 December
2023 p2 RLIT0002396
The Right Reverend James Jones
The patronising disposition of unaccountable power: A report
to ensure the pain and suffering of the Hillsborough families is not repeated
1 November 2017
p13 COLL0000025
229
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“2.
Place the public interest above our own reputation.
3. Approach forms of public scrutiny … with candour, in an open, honest and
transparent way, making full disclosure of relevant documents, material and
facts. Our objective is to assist the search for the truth. We accept that we should
learn from the findings of external scrutiny and from past mistakes.
4. Avoid seeking to defend the indefensible or to dismiss or disparage those who
may have suffered where we have fallen short.
5. Ensure all members of staff treat members of the public and each other with
mutual respect and with courtesy. Where we fall short, we should apologise
straightforwardly and genuinely.
6. Recognise that we are accountable and open to challenge. We will ensure
that processes are in place to allow the public to hold us to account for the work
we do and for the way in which we do it. We do not knowingly mislead the public
or the media.”
82
This is aimed at organisations: the language (“we” and “our”) is that of the organisation
which signs up to the charter, as the UK Government and a number of other organisations
(including the police forces in England and Wales) have done. In responding, Alex Chalk
said that Bishop James Jones had made it clear that he wanted to “help
bring about
cultural change”
through commitments to change “related
to transparency and acting in the
public interest.”
83
The Hillsborough report and charter derived from a disaster of a very different kind from that
which has been the subject of this Report. However, in both there have been allegations of
cover-up, and a lack of frankness or desire to tell the truth, a hiding of documents, and a
making of assertions for which there was no proper basis in fact – or which, as likely to be
read, would in practice be misleading.
84
Bishop James Jones’ approach applies with equal
force to disasters in the health context, which are likely to arise out of a series of individual
experiences revealing some systemic or individual failing.
85
Recommendations of previous inquiries to change the culture
It is a sad fact that very few inquiries into aspects of the health service or parts of it have
ended without recognition that the culture needed to change. Over the past 50 to 60 years
there have been several inquiries, of different types – but nearly all have had some such
recommendation.
82
83
84
85
The Right Reverend James Jones
The patronising disposition of unaccountable power: A report
to ensure the pain and suffering of the Hillsborough families is not repeated
1 November 2017
p13 COLL0000025
Hansard parliamentary statement on Hillsborough: Bishop James Jones Report 6 December
2023 p2 RLIT0002396
See the detail throughout the full Report.
Such as the Shrewsbury and Telford Hospital Review, the Bristol Royal Infirmary Report and the
Shipman Report.
Recommendations
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An example is that of the Inquiry into children’s heart surgery at the Bristol Royal Infirmary
1984-1995, optimistically entitled
Learning from Bristol.
Recommendations made by the
Bristol Inquiry included:
“To
promote a new culture within the NHS: a three-way partnership of respect,
honesty and openness between:
– NHS and public;
– professionals and patients; and
– professionals and professionals.”
Thus:
“–
The patient must be at the centre of everything which the NHS does …
– There must be openness and transparency in everything which the NHS does …
– The safety of patients must be the foundation of the NHS’s commitment to the
quality of its services;
– Sentinel events, that is, errors, other adverse events, and near misses, which
occur during the care of patients, must be seen as opportunities to learn, not just
as reasons to blame.”
86
The Bristol Report emphasised the need for change in culture. It also recognised that there
was a link between candour and safety. Being open and transparent about a “sentinel
event”
enables possible shortcomings to be treated as an opportunity to improve the quality (that
is, the safety) of the NHS.
87
In short, candour is not simply a matter of ensuring trust as
between patient and professional, or between both patient and professional on the one
hand and the organisation of which the professional is part on the other. It is a matter, more
importantly still, of ensuring safety for the future.
Following both the Bristol Royal Infirmary Inquiry report, and
An organisation with a memory
(a study by the Chief Medical Officer of England’s expert group on learning from adverse
events in the NHS),
88
a National Patient Safety Agency was proposed. One was set up in
2002, and was absorbed into NHS England in 2012. Professor Ian Kennedy had envisaged
that it would keep a national database of sentinel events, and anticipated that the culture he
proposed should contribute to sentinel events being identified.
89
When Sir Robert Francis KC reported in the Mid Staffordshire NHS Foundation Trust public
inquiry, he noted that the National Patient Safety Agency had however not been alerted to
86
87
88
89
The Report of the Public Inquiry into children’s heart surgery at the Bristol Royal Infirmary 1984-1995:
Learning from Bristol July 2001 pp444-445 DHSC5030766
The Report of the Public Inquiry into children’s heart surgery at the Bristol Royal Infirmary 1984-1995:
Learning from Bristol July 2001 p270 DHSC5030766
Department of Health
An organisation with a memory: Report of an expert group on learning from
adverse events in the NHS
2000 RLIT0002440
Professor Kennedy chaired the Bristol Inquiry. The Report of the Public Inquiry into children’s
heart surgery at the Bristol Royal Infirmary 1984-1995: Learning from Bristol July 2001
pp368-372 DHSC5030766
231
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the concerns which he exposed in his Report. He recommended, as recommendation 12 that
“Reporting
of incidents of concern relevant to patient safety, compliance with fundamental
standards or some higher requirement of the employer needs to be not only encouraged
but insisted upon. Staff are entitled to receive feedback in relation to any report they make,
including information about any action taken or reasons for not acting.”
90
I shall come back to the words “not
only encouraged but insisted upon.”
The existing statutory and professional obligations of candour
Regulations were made in the year following the Mid Staffordshire report.
91
These were
the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
92
They
cover England. Regulation 20 is headed “Duty
of candour”.
It provides that “(1)
Registered
persons must act in an open and transparent way with relevant persons in relation to care
and treatment provided to service users in carrying on a regulated activity.”
(A
“registered
person”
means, in relation to a regulated activity, a person who is the service provider, and
thus includes NHS trusts; “regulated
activity”
includes treatment by the NHS of a patient;
a patient is a “service
user”
for these purposes.) Regulation 20 continues: “(2)
As soon as
reasonably practicable after becoming aware that a notifiable safety incident has occurred a
registered person must”
(in summary):
(a)
(b)
(c)
(d)
(e)
notify the patient that the incident has occurred and provide them with
reasonable support;
give them an account of all the facts the registered person knows about the incident
at the time to the best of its knowledge;
say what further enquiries the registered person believes are appropriate;
include an apology (though not necessarily an admission of liability); and
record the notification in a written record to be kept securely by the registered person.
93
With the exception of the provision of reasonable support, it is an offence not to comply,
though the health service body has a defence if it proves that it took all reasonable steps
and exercised all due diligence to prevent the breach that occurred.
94
At the centre of this regime is a “notifiable
safety incident”
which is defined as:
90
91
92
93
94
232
The report was now just over ten years ago, itself being just over ten years after the Bristol report. This
recommendation followed from facts set out in chapter 2 of his report. Report of the Mid Staffordshire
NHS Foundation Trust Public Inquiry Volume 1: Analysis of evidence and lessons learned (part 1)
February 2013 p246 DHSC5113232
The statutory authority for these was under the Health and Social Care Act 2008.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 SI 2014 No. 2936
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Regulation 20 (2) and
(3) RLIT0002451
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Regulation 22 RLIT0002451
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“any
unintended or unexpected incident that occurred in respect of a
[patient]
during the provision of
[treatment]
that, in the reasonable opinion of a health care
professional, could result in or appears to have resulted in (a) the death of the
service user
[the patient],
where the death relates directly to the incident rather
than to the natural course of the service user’s illness or underlying condition
or (b) severe harm, moderate harm or prolonged psychological harm to the
service user”.
95
It appears from a number of the submissions made to me that some core participants were
not aware that a duty of candour existed, and in particular were unaware of the terms in
which it is expressed.
The duty of candour is imposed upon the health service body, not upon an individual health
care professional. (Although the word “candour” is used in the regulation as a heading, and
it is not defined, the substance of what is meant by candour in this context appears from
regulation 20, the material parts of which are set out above.)
However, so far as individual doctors, nurses and midwives are concerned, there is also a
duty which may have practical consequences for them if breached. The General Medical
Council and the Nursing and Midwifery Council regulate the professional standards expected
of any doctor, nurse or midwife. It is unprofessional for such a person to behave without
candour towards a patient. The professional obligation of a health professional is to put the
patient first. That means putting self-interest to one side; it means being frank, as well as
open and transparent.
96
The Care Quality Commission has issued guidance which sums up the position: “Both
the
statutory duty of candour and professional duty of candour have similar aims – to make sure
that those providing care are open and transparent with the people using their services,
whether or not something has gone wrong.”
97
It would be helpful if after the words “open
and transparent”
were added the words “and
forthcoming”:
it is all very well to be open and transparent when asked by a patient about an
event. It may be another thing to volunteer to the patient the question the patient might have
asked, and its answer, had the patient only realised that something which the professional
understood to have gone wrong had done so, even though the patient was ignorant of it.
Candour is more than being open and transparent, valuable though both qualities are.
In circumstances where a patient has suffered harm or distress, the General Medical Council
and Nursing and Midwifery Council express the duty as being to “explain
fully and promptly
95
96
97
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Regulation 20
(8) RLIT0002451
See the GMC’s guidance Good Medical Practice January 2024 paras 45-46 RLIT0002452, the NMC’s
guidance The Code October 2018 para 14 RLIT0002453; and their joint guidance Openness and
honesty when things go wrong: The professional duty of candour June 2015 RLIT0002454
Care Quality Commission
Regulation 20: Duty of candour
June 2022 p2 RLIT0002426
233
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what has happened and the likely short-term and long-term effects”:
this in effect equates to
being forthcoming.
98
Health is a devolved issue. The text thus far has concentrated upon the position in
England – though the General Medical Council and Nursing and Midwifery Council have
a UK wide remit.
The Scottish Government introduced a statutory duty broadly similar to that in England, for
NHS bodies, in 2018, under the Duty of Candour Procedure (Scotland) Regulations 2018.
As is the case south of the border, the duty rests on organisations, not individuals.
99
The Duty of Candour Procedure (Wales) Regulations 2023
100
establish an equivalent duty
in Wales, requiring NHS organisations in Wales to be open and honest with service users
receiving care and treatment in the event of a “notifiable
adverse outcome”.
101
98
Though in the joint guidance (2015, predating the guidance using the word “fully”) on “Openness
and honesty when things go wrong: The professional duty of candour”
the obligation is expressed
differently – “You
should share all you know and believe to be true about what went wrong and why,
and what the consequences are likely to be.”
The effect is similar.
As to “near miss” incidents, the guidance says:
“21.
… You must use your professional judgement when considering whether to tell patients about
near misses. Sometimes there will be information that the patient needs to know or would want to
know, and telling the patient about the near miss may even help their recovery. In these cases, you
should talk to the patient about the near miss, following the guidance in paragraphs 11–17.
22. Sometimes failing to be open with a patient about a near miss could damage their trust and
confidence in you and the healthcare team. However, in some circumstances, patients may not
need to know about an adverse incident that has not caused (and will not cause) them harm, and to
speak to them about it may distress or confuse them unnecessarily. If you are not sure whether to
talk to a patient about a near miss, seek advice from your healthcare team or a senior colleague.”
GMC
Openness and honesty when things go wrong: The professional duty of candour
June
2015 RLIT0002454
The Organisational guidance says that:
“The
organisational duty of candour procedure is a legal duty which sets out how organisations should
tell those affected that an unintended or unexpected incident appears to have caused harm or death.
They are required to apologise and to meaningfully involve them in a review of what happened.
When the review is complete, the organisation should agree any actions required to improve the
quality of care, informed by the principles of learning and continuous improvement.
They should tell the person who appears to have been harmed (or those acting on their behalf) what
those actions are and when they will happen.
The duty of candour procedure provisions reflect our commitment to place people at the heart of
health and social care services in Scotland.
We recognise that when unexpected or unintended incidents occur during the provision of treatment
or care, openness and transparency is fundamental. This promotes a culture of learning and
continuous improvement.”
Duty of Candour Procedure (Scotl248and) Regulations 2018 RLIT0002455, Organisational Duty of
Candour guidance March 2018 WITN7671005
The Scottish Public Services Ombudsman has reported 12 cases between March 2021 and December
2023 which have included issues about the duty of candour not being fully observed.
National Health Service, Wales The Duty of Candour Procedure (Wales) Regulations
2023 WITN5712003
It applies “if
the care we provide has, or may have contributed to unexpected or unintended moderate
or severe harm, or death”.
A Summary of the Duty of Candour Procedure states:
“On first becoming aware that the duty of candour applies, the NHS must notify the service user or a
person acting on their behalf. This contact should be ‘in person’, which means by telephone, video call
or face to face.
Recommendations
99
100
101
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Northern Ireland consulted on introducing a statutory duty in 2021. The responses are
currently being analysed. Legislation is not yet in place. The reasons for calling for a
statutory duty given by John O’Hara QC (now Mr Justice O’Hara) in his report of The Inquiry
into Hyponatraemia-related Deaths resonate with experience elsewhere:
“The
reticence of some clinicians and healthcare professionals to concede error
or identify the underperformance of colleagues was frustrating and depressing,
most especially for the families of the dead children … It should not have been
so. Health service guidance for 25 years and more has repeatedly recommended
transparency and openness in the interests of the patient. This has proved
inadequate to the problem which is why this Report must recommend a statutory
duty of candour in Northern Ireland.”
102
Between them, the legislative duties of candour cover healthcare organisations; the
professional duties and professional regulators cover individual healthcare professionals
– but there remains a gap. Though there are some in leadership roles in NHS Trusts and
health boards who are subject to professional duties as doctors or nurses, and though it
may rightly be said that organisational duties have ultimately to be performed by individuals,
there are many leaders who are as yet subject to no individual accountability for candour
within their organisation.
Recent developments
When Alex Chalk responded to Bishop James Jones’ charter, he said that the Government
intended to conduct a review of the effectiveness of the duty of candour for health and social
care providers. He said this was “In
response to recent concerns about openness”.
103
The
review is intended to consider:
“1.
To what extent the policy and its design are appropriate for the health and
care system in England.
2. To what extent the policy is honoured, monitored and enforced.
The purpose of the ‘in person’ notification is to offer an apology, provide an explanation of what is
known at that time, offer support, explain the next steps and provide point of contact details.
The service user or person acting on their behalf will be sent a letter within five working days,
confirming what was said in the ‘in person’ notification.
The NHS will undertake an investigation to find out what happened and why, and how we can prevent
it from happening again.
This will take place according to the NHS Wales ‘Putting Things Right’ Procedure.
The named point of contact provided as part of the Duty of Candour procedure will give you more
information about this process and what happens next.
If you do not want us to contact you, or if you would prefer someone to act on your behalf, please let
us know and we will make the necessary arrangements.”
A service user guide to The Duty of Candour p2 RLIT0002446
102 The Inquiry into Hyponatraemia-related Deaths Report January 2018 p28 RLIT0002450
103 Hansard parliamentary statement on Hillsborough: Bishop James Jones Report 6 December 2023 p3
RLIT0002396, UK Home Office
A Hillsborough legacy: the government’s response to Bishop James
Jones’ report
13 December 2023 pp41-42 RLIT0002429
Recommendations
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3. To what extent the policy has met its objectives.”
104
It is to be noted that it does not grapple with how well known the duty is to the wider public:
if some participants in this Inquiry were unaware there was such a duty, this indicates that
the architecture of the NHS is difficult for individual users of it to navigate.
On the same day as Alex Chalk responded, to Parliament, the Parliamentary and Health
Service Ombudsman for England, Rob Behrens, said:
“I
have long called for closer openness and transparency when things go wrong
in the NHS. The duty of candour was intended to reinforce this. However, a
decade after its introduction, our Broken Trust report into avoidable deaths in the
NHS found that the duty is not always implemented as it should be and called
for a full review to assess its effectiveness … Despite it being a statutory duty to
be open and honest when things go wrong with a patient’s care, I know from the
cases we investigate that this doesn’t always happen. Patients and their families
deserve better.”
105
What the
Broken Trust
report had found was that “the
physical harm patients experienced
was too often made worse by inadequate, defensive and insensitive responses from NHS
organisations when concerns were raised.”
One of the four broad themes of failings leading
to avoidable death was the failure to listen to the concerns of patients or their families.
106
The
Broken Trust
report went on to say:
“We
also looked at the further harm – sometimes called compounded harm –
that happens when families, who have already experienced the devastating
consequences of losing a loved one, try to understand what has happened but
are met with a poor response from NHS organisations. We identified several
factors which contribute to compounded harm:
• a failure to be honest when things to wrong
• a lack of support to navigate systems after an incident
• poor-quality investigations
• a failure to respond to complaints in a timely and compassionate way
• inadequate apologies
• unsatisfactory learning responses.”
107
104
Department of Health and Social Care
Duty of candour review: terms of reference
December 2023
pp4-5 RLIT0002425. The announcement said the review would be published in spring 2024 but a call
for evidence was only opened in April 2024, with an indication that the review will be published “this
year”.
Duty of candour review 16 April 2024 RLIT0002456
Parliamentary and Health Service Ombudsman
Ombudsman Rob Behrens comments on DHSC
review into duty of candour
6 December 2023 p2 RLIT0002424
Parliamentary and Health Service Ombudsman
Broken trust: making patient safety more than just a
promise
June 2023 p8 WITN7706002
Parliamentary and Health Service Ombudsman
Broken trust: making patient safety more than just a
promise
June 2023 p8 WITN7706002
Recommendations
105
106
107
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This is not just an English perspective. The Ombudsman in Wales published a report
Groundhog Day 2: An opportunity for cultural change in complaint handling?
in June 2023.
The report described “A
lack of openness and candour”,
“clear
evidence of maladministration
or service failure not identified during local investigations”,
“A
lack of objective review of
clinical care and treatment”,
and recorded that “Sometimes,
the individual clinicians who
have delivered the care are involved in complaints responses.”
108
Over 20 years after Bristol, and over ten since Mid Staffordshire, it appears from this that
too little has changed. This demonstrates how difficult it can be to change culture.
Professor Kennedy rightly observed that “Cultural
and institutional change takes time and
can be slow, requiring patience and forbearance.”
Nonetheless, he anticipated that changes
in the culture would follow the implementation of the recommendations he made. He had
seen the recommendations as forming an interlocking whole.
109
It is a sad indictment of
the system’s ability to effect a change of culture over such a long timescale that the same
concerns continue to surface. The concerns discussed above have been recognised in
inquiry after inquiry. They have led to a strengthening of whistleblower protection, have led
to a statutory duty of candour upon health service bodies in England, Scotland and Wales,
have led to stern warnings from the Parliamentary and Health Service Ombudsman – but
have not yet effected a change in culture.
Speaking up
In England, the role of the Freedom to Speak up Guardian was created in response to
recommendations made in Sir Robert Francis KC’s report “The
Freedom to Speak Up”.
110
There are now 1,000 such guardians across England, reporting through a National Guardian
to the Secretary of State for Health and Social Care. This system aims to encourage a
listening culture, in which people working in the health service feel free to speak up.
111
As to whistleblower protection, the Public Interest Disclosure Act 1998 introduced provisions
into the Employment Rights Act 1996 to protect a “worker” from any detriment in their
employment as a result of their making a disclosure of a kind covered by the Act.
112
This
108
109
110
111
Ombudsman Wales
Groundhog Day 2: An opportunity for cultural change in complaint handling?
June
2023 p15, p17 RLIT0002447
The Report of the Public Inquiry into children’s heart surgery at the Bristol Royal Infirmary 1984-1995:
Learning from Bristol July 2001 p444, p446 DHSC5030766
Francis
Freedom to Speak Up: an independent review into creating an open and honest reporting
culture in the NHS Report
11 February 2015 RLIT0002459
There are Confidential Contacts as part of the Scottish Speak Up Network and the Scottish Public
Services Ombudsman has taken up the role of the Independent National Whistleblowing Officer in
Scotland. Healthcare organisations in Wales have a Speaking Up Safely Board Champion who is
independent and an executive director as Speaking Up Safely Executive Lead.
What is covered is: “information
which, in the reasonable belief of the worker making the disclosure, is
made in the public interest and tends to show one or more of the following–
(a) that a criminal offence has been committed, is being committed or is likely to be committed,
(b) that a person has failed, is failing or is likely to fail to comply with any legal obligation to
which he is subject,
(c) that a miscarriage of justice has occurred, is occurring or is likely to occur,
237
112
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includes the disclosure of information tending to show that “the
health or safety of any
individual has been, is being or is likely to be endangered.”
It is thus capable of covering the
“sentinel
events”
(as Professor Kennedy in Bristol described them), and “notifiable
safety
incidents”
or “notifiable
adverse outcomes”
as described in the regulations establishing the
duty of candour in the health service. The disclosure is to be made to specified classes of
people, depending on the circumstances.
Whistleblowers are recognised as capable of providing a valuable service. The protection
given to them consists of ensuring they do not suffer a detriment for making the revelations
which they do. However, the system is one in which it is almost assumed that, but for the Act,
a whistleblower would otherwise be subject to blame. It is that cultural assumption which
most needs to be addressed. What most needs to be valued
113
is ensuring that reporting
near misses (“sentinel
events”)
as well as harmful acts is prized, so that we may learn how
to avoid them next time a similar situation occurs.
If a culture of learning from mistakes and near misses is to work most successfully, and
if being frank and forthcoming is to be regarded as essential for patient safety then it is
insufficient for me simply to add the voice of this Inquiry to an increasingly long list of those
which have asked for a change of culture, but have failed to achieve it.
Something more is required if culture is to change.
There are, in my view, two aspects which are vital if culture is to change. They are “insisting
upon the reporting of concerns” on the part of those in a leadership role, and the better
organisation of the systems dealing with safety across healthcare.
113
(d) that the health or safety of any individual has been, is being or is likely to be endangered,
(e) that the environment has been, is being or is likely to be damaged, or
(f) that information tending to show any matter falling within any one of the preceding paragraphs has
been, is being or is likely to be deliberately concealed.”
Employment Rights Act 1996 Section 43B(1) RLIT0002435. The Act applies to Scotland, Wales and
England: there are near identical provisions in an Order in Council applicable to Northern Ireland.
Current legislation may be seen as being complex, giving a protection in carefully delineated
circumstances, which are dealt with under the provisions of Part IVA of the Employment Rights Act
1996 (ss 43A – 43L). The provisions are rightly directed at the particular circumstances that call for
protection (including that the disclosure must be of information, as opposed to allegation or opinion;
that the whistleblower must have a “reasonable
belief”
that the disclosure is in the public interest and
that the information they are revealing “tends to show” that there has been a “relevant
failure”
– ie a
criminal offence; a breach of legal obligation; a miscarriage of justice; a danger to health and safety
of an individual; damage to the environment or related to a deliberate attempt to conceal any of these
matters; and that information relating to any of the above has been, or is likely to be deliberately
concealed. The information must in the first instance be given to the whistleblower’s employer (or
other responsible person as defined by s.43C). It is unnecessary for present purposes to give more
detail, save to say that the legislation is not simple, and may seem to be focused more on the acts and
behaviour of the whistleblower than on the direct protection of a person from harm, or other people in
a similar situation in future from potential harm.
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Insisting on the reporting of concerns
I said I would return to the words which Sir Robert Francis used in recommendation 12 of
his report into the Mid Staffordshire Trust. “Reporting
of incidents of concern relevant to
patient safety … needs to be not only encouraged but insisted upon.”
114
Andrew Bragg, who was infected by treatment under the NHS and is a chemical engineer
and chartered scientist by background, has a lifetime of experience working with high hazard
chemicals – substances that could, in his words “seriously
impact both our employees, our
neighbours and people who use
[them]”.
115
He has worked with regulation all his life. It is
worth quoting part of what he had to say to the Inquiry:
“So
every time I have been with the NHS I have been a professional observer of
organisational systems. So I have been looking at how the medical teams who are
treating me are functioning. It is not always a very pretty picture. So there are lots
of examples of where – – poor team working, poor communication, unsystematic
working, working from memory – – so lots of boxes which, in my business, we
would not accept but seems to be fairly routine in the Health Service. The type
of things I’m looking for is not really specific to my industry. There are lots of
industries where you face complex challenges which potentially put lives at risk.
So the chemical industry, oil and gas industry, offshore, nuclear industry, aviation,
building complex structures. In all of these, managing risk, managing personal
safety, managing the safety of third parties is absolutely the core of what you do.
But I see very little of that thinking in the NHS.
So, how do we end up so good at this and perhaps NHS not so good? Well, we
have external regulatory drivers that keep us honest. So in the UK we have the
Health and Safety Executive. So they are responsible for managing safety for
all businesses, operations in the UK. So if we have an instance or an accident
which results in serious harm or death, we will be externally audited in a very
rigorous way and all our failings will be exposed and we will be expected to put
it right and make sure it never happens again. We also have external inquiries,
like this one.”
116
I do not propose a culture in which there is no blame, but rather one where the blame
falls in the right place. To take Andrew Bragg’s example of the aviation industry. The
expectation is not that people who are concerned with the safety of an airliner are blamed
when fault occurs,
117
but that they are blamed for not taking steps to bring to attention their
concerns that it might do so. Rather than seeing a whistleblower as needing protection from
114
115
116
117
Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry Volume 1: Analysis of evidence
and lessons learned (part 1) February 2013 p246 DHSC5113232
Andrew Bragg Transcript 17 January 2023 p164 INQY1000266. He worked for ICI, and today works as
a global sustainability and regulation manager; he has been a lead auditor.
Andrew Bragg Transcript 17 January 2023 pp166-167 INQY1000266
The principle is stated broadly in the text, but there will be some occasions on which blame will
necessarily follow eg where there has been a serious neglect of duty.
239
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retribution which would otherwise follow, the culture should be one in which the reporting
of the concerns of which Sir Robert Francis speaks is recognised as a human, professional
and statutory duty. The duty is to report matters which it is reasonable to think may have
an adverse impact on patient safety. A failure to do so, when the substance of what might
be reported is known to one or more people, but has not been reported by them, may be
regarded as a breach of professional duty,
118
and might usefully underpin the statutory duty
of candour. However, the duty also rests on those to whom a report is made. In the case of
someone in a leadership role, they may choose to escalate a report, resolve it, or deal with
it as appropriate, but in any case they should consider it properly. A failure to give the report
proper consideration should be regarded as culpable.
119
Further, if any action in this context
is deserving of disciplinary action by the employer it is failing to speak up, or failing to act on
a report, rather than regarding a whistleblower as a maverick, or as a “tell-tale”.
Incentivising change
A failure to check or tighten bolts on an aircraft wing may not lead to a crash – but it could
constitute a near miss. Reporting that it has happened is valued. In the mining industry, the
use of canaries in cages was largely superseded by the role of a “deputy”
120
whose job it
was to ensure the mine was safe
121
before a shift began, and tell underground workers to
leave the moment there was information that suggested there was a risk it might not be. This
initially Victorian development to protect workers has been credited as a principal reason
why the UK coal mining industry was one of the safest. Industry dealing with offshore safety;
the handling of hazardous chemicals, aerospace, maritime, and nuclear power enterprises
systematise safety checks, and highlight cases where they may not have been performed.
These industries have each adopted a safety management system. The NHS has not.
Speaking up about a “sentinel event” (or, in terms used by Healthcare Improvement
Scotland, a “significant adverse event”, in Northern Ireland “serious adverse incident” or
in England and Wales “patient safety events” or incidents) is a first stage. Andrew Bragg
submitted that there should be a statutory responsibility to report, formally, when one has
118
See for example the GMC’s Good Medical Practice (“You
must act promptly if you think that patient
safety or dignity is, or may be, seriously compromised”
and “If
patients are at risk because of
inadequate premises, equipment or other resources, policies or systems, you should first protect
patients and put the matter right if that’s possible. Then you must raise your concern in line with your
workplace policy and our more detailed guidance on Raising and acting on concerns about patient
safety.”)
GMC
Good medical practice
came into effect 30 January 2024 para 75 RLIT0002452.
See also the GMC’s guidance Raising and acting on concerns about patient safety which stipulates
that “All
doctors have a duty to raise concerns where they believe that patient safety or care is
being compromised by the practice of colleagues or the systems, policies and procedures in the
organisations in which they work. They must also encourage and support a culture in which staff can
raise concerns openly and safely”
GMC
Raising and acting on concerns about patient safety
12 March
2012 para 7 RLIT0002457
Some reports may be misunderstandings, but even then misunderstandings may be shared, and
it may be useful to put them right. The duty on the person to whom a concern about a sentinel
event is reported should arise only if that person is identifiable as an appropriate person to whom to
make such a report.
Later, a Regulation 12 manager.
From fire, flood, gas, movement of the strata, and collapse in particular.
Recommendations
119
120
121
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occurred should be required of all employees within the NHS, including those who are not
medical or nursing professionals.
122
The second stage is investigation and review, to see
what if any action is desirable. The third is implementation of the actions it is thought will be
effective to prevent recurrence. The fourth is audit – to check that the action appears to be
having the anticipated effect. Each step needs to be taken and logged: the data should be
collated nationally, as Professor Kennedy suggested in his report on Bristol.
123
Since 2003/04, the NHS in England has collated patient safety incident records uploaded
from local risk management systems. NHS England now collects over 2.3 million patient
safety incident records each year, which can lead to National Patient Safety Alerts.
124
NHS Wales uses Datix Cymru to gather data on all patient safety incidents, including
near-misses.
125
Northern Ireland’s system is called the Datix Risk Management system.
126
Healthcare Improvement Scotland has had a database of all category 1 significant adverse
event reviews since 2020 and work is underway to standardise adverse event data
reporting in Scotland.
127
Where an individual is responsible for something going wrong that was, or might have been,
harmful, they should not usually be blamed for “owning up” (for that enables patient safety
to be better achieved), but they should certainly be blamed if they keep silent.
The existing professional duties of candour in healthcare are good starting points, so far as
those currently subject to such duties are concerned. However, others who are not covered
by these obligations should be subject to reciprocal duties. Reporting concerns about the
healthcare being provided, or the way it is being provided, where there reasonably appears
to be a risk that a patient might suffer harm, or has done so, is critical to realising risks, and
122
123
124
125
126
127
Andrew Bragg Transcript 17 January 2023 p175 INQY1000266. Following his submission the Inquiry
gathered written statements from organisations with roles in patient safety including:
Healthcare Improvement Scotland: Written Statement of Lynsey Cleland WITN7671001
NHS Wales: Written Statement of Judith Paget WITN5712002
Department of Health in Northern Ireland: Written Statement of Peter May WITN7461007
DHSC: Written Statement of William Vineall WITN4688083
The Report of the Public Inquiry into children’s heart surgery at the Bristol Royal Infirmary 1984-
1995: Learning from Bristol July 2001 p465, p447 DHSC5030766. Professor Kennedy hoped that the
changes he was recommending would lead to a change in the culture: “Perhaps
the most significant
change we call for is one which does not attract a specific Recommendation. This is the change
which is needed in the culture of the NHS. We see changes to that culture as being a product of the
Recommendations as a whole. If the Recommendations are implemented, changes in the culture will
follow.”
His steps included a duty of candour, regulation, assurance and a national reporting system:
matters which are reflected in these recommendations too. These remain important. Now, some of
those most centrally involved with patient safety in England are exploring the contribution that a safety
management system could bring in addition (see the discussion in the text): it would add significantly
to the “whole” which Professor Kennedy envisaged.
Written Statement of Dr Aidan Fowler para 18, paras 32-42 WITN7717001. The devolved
administrations are observers on an external stakeholder panel when National Patient Safety Alerts
are issued and have access to the data and analysis generated in support of an Alert.
Written Statement of Judith Paget para 9 WITN5712002
Written Statement of Peter May para 3.1 WITN7461007
Written Statement of Lynsey Cleland para 19, para 23 WITN7671001
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improving safety. It should be considered a serious disciplinary matter on the part of the person
in authority to whom a report of a sentinel event is reported not to consider it adequately.
The need to ensure that people in leadership roles have a duty resting upon them individually
as leaders is further underpinned by observations of the Independent Neurology Inquiry in
Northern Ireland in 2022, which became a statutory inquiry during the course of proceedings
and reported (in respect of doctors who exercised leadership roles, as well as administrators)
that: “Medical
professionals were ... apprehensive in raising a concern about the practice
of a colleague or querying discrepancies that arose, which did not directly touch upon the
welfare of their own patient. It was clear that senior managers were too often reluctant to
manage doctors and were easily deflected by the raising of any clinical dimension to an
issue of concern. Correspondingly, many doctors who took on a management role were
accustomed to operating collegially and consensually and found the responsibilities of
management did not easily fit into that extant culture.”
128
In short, this would make whistleblowing an obligation: but more than that, it would make
the person to whom a report of a sentinel event is made, accountable for what is then
done in response to it. It entrenches the principle that safety is the responsibility of all.
It makes patient safety a hallmark of quality care. In effect, it gives teeth to the duty of
candour in healthcare.
Accountability of leadership
On several occasions during the course of the Inquiry witnesses were asked what could be
done to change the culture of the NHS. Many inquiries had suggested a culture change was
needed. None had achieved this.
The answer given by Professor Sir Jonathan van Tam was “leadership”. The exchange
went like this:
“Q: … how do you best incentivise candour and openness in the organisations
which you lead and, for that matter, in the NHS?
A: ... it boils down to a set of personal values and it boils down to me as a leader,
in whatever position I am in an organisation, insisting of the people who report to
me, and who are also in leadership positions, insisting on certain standards and
insisting upon responsibility and accountability. And insisting, in their reports, on
the same and building from the very top to the bottom an insistence on quality ...
I don’t think this is something that can be created by a mission statement or a set
of wonderful principles that are ... framed in every office in the building. I think it
has to be about lived relationships and about, if you’re in a position of leadership,
your expectation directly of the people who report to you, and your insistence that
they have the right to expect the same all the way down the system. Of course
at different levels with different things that they are responsible for at different
128
242
Independent Neurology Inquiry Report June 2022 p21 RLIT0002449
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levels in the system, but that kind of built-in ownership and accountability for
what they do.”
129
Lord Evans of Weardale, then chair of the Committee on Standards in Public Life,
emphasised the central importance of leadership in his foreword to a report in January
2023:
Leading in Practice: A review by the Committee on Standards in Public Life.
130
Rob Behrens identified a “cover-up
culture”
from his experience as Parliamentary and
Health Services Ombudsman over the last seven years. Asked how such a culture can be
ended he is quoted as saying that: “First
of all, you have to recognise that it
[a cover-up
culture]
exists and secondly you have to make leaders accountable for how the culture
operates”.
He added that ministers, NHS bosses and the boards of NHS Trusts need to be
much more proactive.
131
Since culture is identified by seeing the way in which people behave and react, it is not
something that can necessarily be directed from the top. However, it is generally true
that leadership sets the tone for an organisation. It can establish the parameters within
which those who work for the organisation operate. It can indicate the approach which it is
acceptable to take to those whom the organisation serves, fellow workers, and third parties.
The seven principles of public life identified by Lord Nolan 30 years ago include leadership.
132
Accountability is another. Rob Behren’s words encapsulate four more – objectivity, and
integrity, in recognising the problems with an existing culture; openness and honesty in
admitting to it. The first principle – selflessness – may also have a part to play, by not
seeking to retreat into defensiveness, which is another way of describing actions which put
self-interest ahead of those of others.
The importance of leadership and the possibility it can make a difference is real. An individual
duty of candour, and a duty to record, and give proper consideration to reports of concerns
made by healthcare staff to those in leadership roles should be provided for, enforceable
first as a requirement of the job, and second underpinned by secondary legislation.
129
130
131
132
Professor Sir Jonathan Van-Tam Transcript 18 November 2022 pp67-68 INQY1000265
He said: “Senior
leaders must ensure that values are understood and embedded into all aspects of
how their organisations operate – from the way leaders communicate with employees, to the priority
given to developing good decision-making, to the approach taken to recruitment and performance
management. While the tone from the top is critical, leadership matters throughout an organisation.
Leaders at all levels have a fundamental role in exemplifying and helping their teams live up to the
Principles in their day-to-day behaviours.”
He did however caution that “From
the evidence we have
heard, it is clear that there is no single right way to embed an ethical culture in organisations, but a
range of possible approaches and measures”,
although it was clear that an ethical culture did not
happen by accident. Committee on Standards in Public Life
Leading in Practice: A review by the
Committee on Standards in Public Life
January 2023 p4 RLIT0002399
The Guardian
NHS ombudsman Rob Behrens: ‘There are serious issues of concern’
17 March 2024
RLIT0002366. He told the Inquiry: “Defensive
cultures are a product of defensive leadership, so the
behaviour of senior leaders is critical in creating an open, transparent environment where patient
safety is prioritised.”
Written Statement of Rob Behrens para 19 WITN7706001
Lord Nolan
Standards in Public Life: First Report of the Committee on Standards in Public Life
May
1995 p18 RLIT0001795
243
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Organisation of a safety management system
The steps identified above require a body (preferable to one person,
133
since safety
requires team effort; though having an individual in every healthcare organisation who
has a designated responsibility for safety
134
can be part of the system) to oversee a safety
management system, to collate reports and build a picture of the challenges to safety within
the health services across the UK and the measures that are needed to meet them.
Why is the status quo not enough? The answer is that despite the focus on patient safety,
there are still recurring safety risks and serious incidents in healthcare. This can be seen in
repeated concerns in the last decade such as in the Morecambe Bay Investigation (Kirkup,
2015),
135
First Do No Harm: The report of the Independent Medicines and Medical Devices
Safety Review
(The Independent Medicine and Medical Devices Safety Review, 2020),
136
the Ockenden review of maternity services at Shrewsbury and Telford Hospital NHS Trust
(Ockenden, 2020);
137
and
Reading the signals: Maternity and Neonatal Services in East Kent
Report
(Kirkup, 2022).
138
These investigations and reports have identified similar problems
to those which this Inquiry has laid bare: not only a problematic culture, which does not put
patient safety first; but too many bodies, with no one having an overall role with executive
power or central influence; too much fragmentation leading to a confusion of approach and
paralysis of decision-making.
Dr Henrietta Hughes, the Patient Safety Commissioner for England, gave evidence that
“Overall,
the patient safety landscape has arguably become too cluttered and is too
confusing from the point of view of patients … Reorganisations also inherently present short
term inefficiencies and delay.”
139
In
First Do No Harm,
Baroness Cumberlege wrote in the opening letter to the
Secretary of State:
“We
have found that the healthcare system – in which I include the NHS, private
providers, the regulators and professional bodies, pharmaceutical and device
manufacturers, and policymakers – is disjointed, siloed, unresponsive and
133
134
135
136
137
138
139
244
The Professional Standards Authority suggested that coordination be achieved by a commissioner with
an overarching role focussed on ensuring that the various bodies charged with protecting the public
work together as an effective system. Though I am not averse to this, it might be better that there be a
commission with one head. Professional Standards Authority for Health and Social Care
Safer care for
all: solutions from professional regulation and beyond
September 2022 pp84-87 RLIT0001837
Provided that care is taken that this does not lead to other health professionals thinking that safety is
not their problem too.
Kirkup
The Report of the Morecambe Bay Investigation
March 2015 WITN7523007
First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review
8 July 2020 RLIT0001379
Ockenden Report – Findings, Conclusions and Essential Actions From the Independent Review of
Maternity Services at the Shrewsbury and Telford Hospital NHS Trust 30 March 2022 WITN7523009
Kirkup
Reading the signals: Maternity and neonatal services in East Kent – the Report of the
Independent Investigation
October 2022 WITN7523008
Written statement of Dr Henrietta Hughes para 36 WITN7328004
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defensive … The system is not good enough at spotting trends in practice and
outcomes that give rise to safety concerns.”
140
In mid October 2023 the Health Services Safety Investigations Body (“HSSIB”) published a
report about safety management systems for healthcare. The report said:
“An
overall systems approach is needed – that is, one that encompasses all
aspects of healthcare including non-clinical services, which can have a significant
impact on patient safety. For example, a whole-system approach should consider
auxiliary services such as decontamination services, facilities management or
healthcare engineering. Currently, this may not be the case in healthcare. HSSIB
[Health Services Safety Investigations Body]
highlighted the importance of other
services and parts of the healthcare system that may have a significant impact
on patient safety and will need to be included in an overall systems approach.”
141
The report described the essentials of safety management systems: “An
SMS
[safety
management system]
is a proactive and integrated approach to managing safety. It sets
out the necessary organisational structures and accountabilities and will continuously be
improved. It requires safety management to be integrated into an organisation’s day-to-day
activities. There is no one-size-fits-all SMS”.
The report detailed that it involves:
(a)
“safety
policy
– establishes
senior management’s commitment
to improve
safety and outlines responsibilities; defining the way the organisation needs to be
structured to meet safety goals
safety risk management
–
which includes the identification of hazards (things
that could cause harm) and risks
(the likelihood of a hazard causing harm) and
the assessment and mitigation of risks
safety assurance
–
which involves the monitoring and measuring of
safety performance
(eg how effectively an organisation is managing risks), the
continuous improvement of the SMS, and evaluating the continued effectiveness of
implemented risk controls
safety promotion – which includes
training, communication and other actions to
support a positive safety culture
within all levels of the workforce.”
142
(b)
(c)
(d)
In summary:
“The
purpose of an SMS is to ensure that an industry achieves its business and
operational objectives in a safe way and complies with the safety obligations that
apply to it. However, it is not just a paper-based or electronic system specifically
140
141
142
First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review
8 July 2020 pp3-4 RLIT0001379
Health Services Safety Investigations Body
Investigation report: Safety management systems – an
introduction for healthcare
18 October 2023 p11 RLIT0002398
Health Services Safety Investigations Body
Investigation report: Safety management systems – an
introduction for healthcare
18 October 2023 p3 RLIT0002398. Emphasis added.
245
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developed for demonstrating compliance with regulatory frameworks. Instead,
an SMS should be a dynamic set of arrangements which grows in maturity and
develops as the industry evolves.”
143
The HSSIB recommended that “NHS
England explores, and if appropriate, supports the
development and implementation of safety management systems (SMSs) through an SMS
co-ordination group. This should be in collaboration with regulators, relevant arm’s length
bodies and national organisations, academics, patient representatives and safety leaders
from other safety-critical industries.”
144
This is consistent with Andrew Bragg’s submission discussed above that there should be a
systemised approach to safety, as there is in other safety critical industries.
The Patient Safety Commissioner for England is strongly supportive of the work the HSSIB
is leading, looking at how recommendations are made to the healthcare system and moving
towards an agreed set of principles that national organisations and office holders (such as
the Patient Safety Commissioner) with the power to make safety recommendations can
sign up to – but cautions that it has to start from a detailed “gap
analysis of the current
landscape”,
and a danger that one body might be a recreated National Patient Safety
Agency which, as noted, was absorbed into NHS England in 2012, and might be seen as
the preserve of “highly
specialised ‘experts’ … in contrast to high reliability organisations in
other sectors with SMSs, where safety is seen as the responsibility of everyone from the
CEO downwards.”
145
The National Director of Patient Safety for NHS England told the Inquiry that “it
is right to
ask what more the NHS could do in this space and what more we could learn from other
industries … Understanding how SMSs might be conceived and applied in a healthcare
setting is an integral step for informing further policy developments.”
146
The Professional Standards Authority for Health and Social Care also agrees with Andrew
Bragg’s view that there is a need for a body to check that the healthcare safety system is
operating effectively, and that serious review findings are implemented.
147
In summary, a powerful consensus has been building over the last three years that
an appropriate safety management system is needed for healthcare in England.
143
144
145
146
147
Health Services Safety Investigations Body
Investigation report: Safety management systems – an
introduction for healthcare
18 October 2023 p3 RLIT0002398
Health Services Safety Investigations Body
Investigation report: Safety management systems – an
introduction for healthcare
18 October 2023 p5 RLIT0002398
Written Statement of Dr Henrietta Hughes para 28, paras 30-31, para 35 WITN7328004
Written Statement of Dr Aidan Fowler para 18, paras 48-49 WITN7717001
Written Statement of Christine Braithwaite para 13 WITN7523012. The statement does, though,
draw attention to some of the differences between aviation safety, where for instance planes can
be grounded, and the NHS which has variable staffing, less predictable demand, where critical
decisions need to be made fast, conditions may vary from shift to shift and there are multiple variables
in the nature of diseases and conditions. Written Statement of Christine Braithwaite paras 11-12
WITN7523012. See also Andrew Bragg’s submission: Andrew Bragg Transcript 17 January 2023
pp167-170 INQY1000266
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Dr Rosie Benneyworth of the HSSIB has set out the next steps towards this – first, investigating
accountabilities for patient safety across organisational boundaries,
148
then considering how
NHS staff and patients could be involved in an integrated safety management system.
In Scotland, Healthcare Improvement Scotland scrutinises and assures the quality of NHS
services in Scotland but does not regulate them.
149
There is no equivalent organisation
elsewhere in the UK.
150
It recognises “the
combined strength of the respective skills and
expertise that each of the organisations with a role to play in safety and quality of care in
Scotland currently bring, but also understand the vital importance of these organisations
working together to share, consider and respond to intelligence about health and care
systems, as demonstrated by our membership of the Sharing Intelligence for Health & Care
Group (SIHCG) and the secretariat support we provide for this.”
151
The NHS Wales Executive has developed a National Quality Management System that
integrates quality and safety intelligence with performance to provide “a
rounded picture of
organisations which can be used as an early warning”.
152
In Northern Ireland it is the Department of Health that manages the Serious Adverse Incident
process, working jointly with the Public Health Agency.
153
Patient records
Because moves are already under way to give patients greater access to their own records,
that development in itself needs no recommendation from this Inquiry. However, the digital
initiatives in England, Scotland, Wales and Northern Ireland are still works in progress,
and this Inquiry is in a position to provide a unique perspective on aspects of process
and outcome which may assist in achieving what patients will value most about the new
landscape which is being formed. A repeated lesson from the Inquiry has been a sidelining
of what patients have had to say.
148
149
150
151
152
153
A report is due for publication in October 2024. Written Statement of Dr Rosie Benneyworth
WITN7689012
Established in 2011 as a Health Body, constituted by the National Health Service (Scotland) Act 1978,
as amended by the Public Service Reform Scotland Act 2010 and the Public Bodies (Joint Working)
Act 2014. While Healthcare Improvement Scotland is not a special health board, it may be grouped
with NHS special health boards in terms of Scottish Government initiatives such as shared services.
Written Statement of Lynsey Cleland paras 5-6, WITN7671001. The approach of the NHS Wales
Executive is described by their chief executive. Written Statement of Judith Paget para 4, paras
14-15 WITN5712002. The position in Northern Ireland is set out by the Permanent Secretary in the
Department of Health. Written Statement of Peter May paras 3.1-3.3 WITN7461007
The position of Healthcare Improvement Scotland is: “We
would have a strong interest in any
proposals to further strengthen the safety of the health and care system in Scotland, but believe that
detailed consideration needs to be given to the existing landscape, including the proposals for a
Patient Safety Commissioner, in order to ensure that any new arrangements are evidence-based and
do not inadvertently duplicate, complicate or dilute existing provisions.”
Written Statement of Lynsey
Cleland paras 30-31 WITN7671001
Written Statement of Judith Paget para 14 WITN5712002
Written Statement of Peter May paras 3.1-3.3 WITN7461007
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The message delivered generally to the Inquiry is one of deep concern about the failings
of NHS record keeping to date. It is important for there to be faith in the new system. There
should accordingly be a formal audit of the success of the system, as operated in each of
the four health administrations, by the end of 2027, which reports in a public forum as to its
level of success in the percentage of the population who are (a) able to access their medical
records online; (b) able to identify any corrections that need to be made to the data which
has been recorded in their records, and can succeed in any reasonable case in securing
those corrections; and (c) satisfied that they have sufficient control over the use of their
data for purposes beyond their immediate treatment such as for research. It should also
measure and report the degree of confidence which health professionals have in the degree
of detail, accuracy and timeliness of any record they enter, and be able to assess that little
material which should be recorded has been omitted. It should evaluate how far the savings
in time which are identified in the Government strategy have been achieved in England, and
whether all the national governments’ digital initiatives have met their objectives and can be
shown (on balance) to have improved the safety of patient care.
Because so many people who were infected trace their infections back to events which
happened some time before they were diagnosed, the destruction policies of many health
bodies have meant they are no longer are able to see, by looking back through their records,
what was recorded as having happened, and be able to show to others (if necessary) what it
led to in earlier years. Patients have a medical past which may help to inform diagnosis and
treatment options today: where diseases may incubate over long periods, and attendances
at medical centres may be sporadic, this may be important to them. Destruction policies
should therefore be kept under review.
Professor David Armstrong drew attention in his evidence to problems caused because of
a lack of interoperability of the digital systems currently in use in hospitals, both as between
many hospitals, and as between hospitals and GPs.
154
There is plainly a danger that the
systems to be adopted in England, Scotland, Wales and Northern Ireland may not be
capable of interoperability, which could affect patient care given the regular movements of
populations within the UK, and the resultant risks of gaps in personal health records (and
the consequences of those risks).
The above analysis, considered in the light of all the material the Inquiry has reviewed,
leads me to make the following recommendations:
4. Preventing future harm to patients: achieving a safety culture
(a)
Duty of candour
(i)
A statutory duty of candour in healthcare should be introduced in
Northern Ireland.
154
Professor David Armstrong Transcript 14 September 2022 pp141-145 INQY1000240. Professor David
Armstrong is professor of medicine and sociology at King’s College London.
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(ii)
The operation of the duties of candour in healthcare in Scotland and
in Wales should be reviewed, as it is being in England, to assess how
effective its operation has been in practice. Since the duty was introduced
in 2023 in Wales, the review there need not be immediate, but should be
no later than the end of 2026.
(iii) The review of the duty of candour currently under way in England should
be completed as soon as practicable.
(iv) The statutory duties of candour in England, Scotland, Wales (and
Northern Ireland, when introduced) should be extended to cover those
individuals in leadership positions in the National Health Service, in
particular in executive positions and board members.
(v)
Individuals in leadership positions should be required by the terms of
their appointment and by secondary legislation to record, consider and
respond to any concern about the healthcare being provided, or the way
it is being provided, where there reasonably appears to be a risk that
a patient might suffer harm, or has done so. Any person in authority
to whom such a report is made should be personally accountable for a
failure to consider it adequately.
Success in implementation will be measured by the extent to which there is an
increase in the number of reports made of near miss incidents to the designated data
collector; and a decline in the number of widespread or significant healthcare failures.
(b)
Cultural change
(i)
That a culture of defensiveness, lack of openness, failure to be
forthcoming, and being dismissive of concerns about patient safety be
addressed both by taking the steps set out in (a) above, and also by
making leaders accountable for how the culture operates in their part of
the system, and for the way in which it involves patients.
(c)
Regulation
(i)
That external regulation of safety in healthcare be simplified. As a
first step towards this, there should be a UK wide review by the four
health departments of the systems of external regulation, with the aim
of addressing all the points made earlier in this Report and in other
reports since 2000.
That the national healthcare administrations in England, Northern Ireland,
Scotland and Wales explore, and if appropriate, support the development
and implementation of safety management systems (“SMS”s) through
SMS coordination groups (as recommended by the HSSIB), and do so as
a matter of priority.
249
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Success in implementation will be measured by the percentage of patients who
know to whom they can express any concerns they may have about safety, who will
take up their cause, and what they can expect from them. At the same time, it will
be measured by the extent to which those who are busy working within the system,
especially those in leadership roles, have clarity as to what, precisely, is expected
of them, from whom. It should also be measured by a reduction in avoidable harm
from both errors and systemic issues.
(d)
Patient records
(i)
Before the end of 2027 there should be a formal audit, publicly reported,
of the extent of success of digitisation of patient records in each of the
four health jurisdictions of the UK, measuring at least the levels of patient
access to their personal records, their ability to identify and correct
apparent errors in them, their interoperability, and the confidence of
health professionals in the detail, accuracy and timeliness of any record
they enter, and that little material which should be recorded has been
omitted. Next steps should be identified.
(e)
Consideration should be given by the national healthcare administrations
in England, Scotland, Wales and Northern Ireland, to further coordination of
their approaches particularly to ensure that patterns of harm, or trends, are
identified and any response which for the sake of patient safety would be better
coordinated than left to each individual administration can collaboratively be
agreed and implemented.
5. Ending the defensive culture in the Civil Service and
government
A duty of candour on civil servants and ministers
The Inquiry has a particular perspective to bring to the debate about whether to extend
the duty of candour, on which the Lord Chancellor Alex Chalk said the Government was
keeping related duties and obligations under review: “we
will not rule out taking further
action if it is needed.”
155
The chapter on
Lines to Take
lays out clearly the consequences
of civil servants and ministers adopting lines to take without sufficient reflection, when they
were inaccurate, partial when they should have been qualified, had no proper evidential
foundation, ignored findings made by courts which were inconsistent (or flatly contradictory
of) the lines adopted, or made unrealistic claims that treatment had been the best it could
be. The commentary to that chapter reflects how:
155
Hansard parliamentary statement on Hillsborough: Bishop James Jones Report 6 December
2023 p3 RLIT0002396
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“In
relation to Hepatitis C, Ministers took on faith what civil servants said; civil
servants took on faith what the files said. No one stood back and reflected. No
one asked questions – could this really be right? How could the best treatment
available lead to the infection of so many?”
156
It records how a “line,
which was wrong from the very outset, then became entrenched
for around twenty years: a dogma became a mantra. It was enshrined. It was never
questioned.”
157
“Lines” are particularly important because they are set out to express
underlying policy and, especially when in place over many years, then affect or hinder the
development of new policies.
In respect of three of the “lines to take”, the consequences are described as cruel:
“The
cruelty, for those infected and affected, of hearing, over and over, that they
had received the best treatment available, that testing had been introduced
as soon as possible, that they had been inadvertently infected, should not be
underestimated.”
The use of the lines contributed to delay in there being a public inquiry; it almost certainly
meant that those infected and affected did not get the financial and psychological support
they would otherwise have received; it contributed to a loss of trust in the health service and
in the ability of government to understand and respond to genuine concerns and complaints.
In the light of findings such as are concentrated in the chapter on
Lines to Take,
the Inquiry
has a particular perspective on how the existence of a clearer, more emphatic, duty of
candour among civil servants might have altered the nature of the government response. It
might have avoided compounding the suffering which had already occurred.
I doubt that the last word has yet been said on whether a statutory personal duty of candour
should be introduced across the Civil Service. No one can sensibly dispute that people
in public life should observe basic moral principles: they are as applicable to government
ministers and officials as they are to clinicians.
158
The principles of public life may have
156
157
158
See the chapter on
Lines to Take.
See the chapter on
Lines to Take.
As was clear from the evidence of the expert group on Public Health and Administration, the attributes
of integrity, honesty, objectivity and impartiality form the bedrock upon which the Civil Service was
built; and ministers were expected to behave with objectivity, openness and honesty, even before Lord
Michael Nolan articulated those principles as part of the seven principles of public life. Public Health
and Administration Expert Panel Transcript 3 October 2022 pp6-9 INQY1000251. Expert Report to
the Infected Blood Inquiry: Public Health and Administration August 2022 pp8-12 EXPG0000048. The
Seven Principles of Public Life are:
1. Selflessness (requiring holders of public office to act solely in the public interest)
2. Integrity
3. Objectivity
4. Accountability
5. Openness
6. Honesty
7. Leadership
251
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become known as the Nolan Principles in 1995,
159
but they articulate what was already well
understood, and went beyond the “basic
moral principle of our society that we should tell the
truth.”
160
Yet they did not prevent what the chapters on the government response describe. I
said in the chapter
Lines to Take
that it is ironic that these Nolan principles were articulated
in their present form at a time when for six years an over-confident line with no proper
evidential foundation had been repeated by civil servants, adopted by them as having the
status of a “given” through a form of groupthink, and was to go on being used repeatedly. It
is more than ironic: it shows that without statutory underpinning the principles of Lord Nolan
and the Civil Service Code are not in themselves sufficient to prevent this happening.
It must be a concern that unless a duty of candour “has teeth” it might similarly be broken in
future; and it is my concern that unless I draw attention to this I shall not be fulfilling my duty
of making appropriate recommendations to the Government.
In addressing how best patient safety in future can be ensured in healthcare, and what “teeth”
might be effective in achieving the long sought-after change of culture, I have proposed that
leaders should be made accountable for failures of candour in their organisations; that no
blame should fall on those who admit to making honest mistakes, or to a “near miss”, but
instead on those who hide them (either in themselves or others), and that reliable data
will enable a proper record so that leaders and the public are informed accurately about
progress towards safer care.
Though the Civil Service does not itself deal directly with patient care, its actions, and those
of the ministers it supports can compound any failures of care, especially where they do so by
expressing mistaken, inadequate, or ill-considered views of the facts, or simply by delaying
responses to concerns or fresh information. Taking a wider view, there is a duty to the public
served by civil servants: citizens deserve honesty rather than ill-placed defensiveness.
Dame Una O’Brien, who was formerly Secretary to the Bristol Inquiry and later Permanent
Secretary at the Department of Health and Social Care, and thus worked in a part of the
Civil Service closely linked to the issues arising in this Inquiry, wrote an article in April 2023,
entitled “Silence
is not golden: The civil service must enable a ‘speak-up’ environment”.
In it she described the problem which led to the title of the article – “will
I be heard
respectfully without negative consequences? The policies and procedures might look
polished and inviting, but sometimes, especially in the civil service, a culture of hierarchy
and dismissiveness can cause us to hold back.”
She pointed to the examples of “Sue
Gray’s
report regarding No.10:
‘Some
staff had witnessed or been subjected to behaviours at work
which they had felt concerned about but at times felt unable to raise properly’”
and to “the
Foreign Affairs Committee’s report on the withdrawal from Afghanistan, where they point to
the absence of an adequate process for officials to express concerns about policy without
fear of damaging their careers.”
Both showed that (despite the Civil Service Code and Nolan
159
160
Lord Nolan
Standards in Public Life: First Report of the Committee on Standards in Public Life
May
1995 RLIT0001795
The words of Professor Kennedy in his 1980 Reith Lectures
Unmasking Medicine
Transcript
26 November 1980 p3 RLIT0000620
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Principles) people found it difficult to express concerns. She then turned to the “mature
good
practice”
of the nuclear and airline industries for inspiration as to the best way of addressing
this. Her solution was, as it had been in those industries, to develop “systems
that counter
deference and encourage staff at all levels to speak up with concerns.”
She thought that
part of achieving this was “leadership”, and a culture of trust and respect.
161
What she says echoes what the Inquiry has found of the period leading up to today; and the
solutions she suggests for the Civil Service are consistent with mine for healthcare: ensure
the accountability of leadership, and put blame not on those who raise concerns, but on
those who knowing of a matter of concern do not then raise it or who ignore concerns raised.
In the House of Lords debate on whether to accept an amendment to the Victims and
Prisoners Bill which proposed a statutory duty of candour, the following exchange took
place. Baroness Brinton asked the Parliamentary Under-Secretary of State, Lord Bellamy,
“there
is an issue about the personal duty of candour that changes behaviour. Does he
recognise that?”
His answer was: “Yes,
the Government recognise that up to a point. What
we are discussing is the right way to get there. The Government are not convinced that this
statutory amendment is the right way.”
162
It is plain that the objective of those who support a statutory duty is the same as those in
government who do not – that there needs to be a change of culture to one which values
personal candour and rejects defensiveness. The question is what best achieves this.
Part of the view of the Government has been that the introduction of an independent
advocate for victims of major incidents will go a considerable way in addressing what
might otherwise be achieved by enacting a statutory duty of candour. The addition of an
independent advocate to support victims of a major incident is indeed valuable. The Bill
regarding the role of independent advocates has, at the time of writing, not yet reached
the statute book. As currently drafted, it is very much a supportive one, in effect to act as a
knowledgeable intermediary, in response to a “major
incident”.
The independent advocates
will have no powers themselves to investigate; nor powers to require the provision of, or even
to see, documents. It is difficult to see that the role would have made a material difference
to the way in which governments reacted to what had happened to infect people through
blood and blood products. It is not at all easy to see that it would have encouraged a more
reflective approach within the Civil Service, or a more curious approach from ministers.
It is unlikely that the role, important and valuable though it is, will have any significant part in
achieving the culture change which is needed to prevent a future recurrence of the apparent
deafness and defensiveness of government to concerns about what had happened to cause
infections by blood and blood products.
161
162
Civil Service World
Silence is not golden: The civil service must enable a ‘speak up’ environment
6 April 2023 RLIT0002432
Hansard debate on Victims and Prisoners Bill 26 February 2024 pp5-6 RLIT0002433
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I well understand that a duty of candour cannot be drafted so widely as to oblige each
individual civil servant of whatever rank to consider separately in the aftermath of a major
incident whether they need to disclose a document they have seen or information of which
they are aware. This would, as Lord Bellamy suggests, be unworkable.
163
Government is
entitled to formulate its policy in a “safe space” if it is to work effectively. However, those
in a leadership role (as opposed to more junior civil servants) are well placed to know
what documents and information may and should be disclosed without encroaching on
such a safe space.
Equally, a duty should not be so limited as to apply only when concerns have developed so
far as to lead to an inquiry, or to a claim by way of judicial review, or a court case.
If and when, however, serious concerns are raised with or come to the attention of government
departments (as they were in relation to infected blood) there is a very real place for a
statutory requirement of candour to bite. This will first and foremost place requirements
on those who lead – for they should be accountable by statute for the honesty, objectivity
and completeness of what is said by them, or given to ministers to say. They should be
responsible too for ensuring that a candid response is forthcoming, which should draw
attention to any document or reliable information reasonably to be regarded as relevant to
the concern being raised telling not just the truth, but
the whole truth,
and nothing but the
truth. Those in a department who are not themselves in a leadership role should be obliged
to tell those to whom they report of any concern they have that a response (or proposed
response) is lacking or inaccurate – and to record that they have done so.
I have recommended that those in leadership positions in the health service, who would
not otherwise be within the scope of a statutory duty of candour, should be made subject
to it, and made accountable for their personal handling of concerns about the safety of
healthcare amongst those they lead. Recognition of a corresponding duty of leaders in the
Civil Service is also recommended.
The duty of ministers is to be properly reflective, curious and prepared if need be to be
critical of advice. What they say should, of course, be candid (subject to overriding issues
of public interest) but they also have a role in helping to ensure that Government as a
whole is candid.
It follows that I recommend that:
5. Ending a defensive culture in the Civil Service and government
(a)
The Government should reconsider whether, in the light of the facts revealed
by this Inquiry, it is sufficient to continue to rely on the current non-statutory
duties in the Civil Service and Ministerial Codes, coupled with those legal
duties which occur on the occasions when civil servants and ministers
interact with courts, inquests and inquiries, as securing candour.
163
254
Hansard debate on Victims and Prisoners Bill 26 February 2024 p5 RLIT0002433
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(b)
If, on review, the Government considers that it is sufficient to rely on the
current non-statutory duties in the Civil Service Code, it should nonetheless
introduce a statutory duty of accountability on senior civil servants for the
candour and completeness of advice given to Permanent Secretaries and
Ministers, and the candour and completeness of their response to concerns
raised by members of the public and staff.
The Government should consider the extent to which Ministers should
be subject to a duty beyond their current duty to Parliament under the
Ministerial Code.
(c)
6. Monitoring liver damage for people who were infected with
Hepatitis C
In February 2020 at the end of the hearings with the expert groups I said:
“I
would like to draw the attention publicly now of NHS England and hospital
trusts and boards throughout the country to the fact that the need for specialist
treatment by professionals who have a special understanding of infected blood
and blood products has not gone away, now that there is greater success in
treatment of the underlying conditions, that there is a need to ensure that the
standards of follow-up of those who have cleared Hepatitis C but have been left
with a compromised liver are maintained in accordance with what the experts
have set out this week”.
164
One of the most important issues to participants in relation to their treatment is their ability to
access monitoring and follow up care for Hepatitis C (and related symptoms and conditions)
after they achieve sustained virological response (“SVR”). This arises because of their very
reasonable anxieties about the harm long-untreated Hepatitis C may have done to their
bodies. Even if “cured”, in the sense that the disease process itself is no longer active,
it has left an increased risk of developing end-stage liver disease or liver cancer if they
had developed fibrosis or cirrhosis before treatment.
165
Witnesses told the Inquiry that they
had simply been discharged from any ongoing care or monitoring following achievement
of SVR. Currently there is no consistent clinical practice, and some patients receive no
clinical surveillance.
The prognosis and progression to cirrhosis and hepatocellular cancer is variable as between
patients,
166
with the major factor determining any long-term impact being the degree of liver
fibrosis at the time the person’s Hepatitis C PCR test became negative.
167
That has treatment
and monitoring implications. Although there is evidence that treatment intervention, even at
164
165
166
167
Sir Brian Langstaff Transcript 28 February 2020 pp177-178 INQY1000054
Hepatitis Expert Panel Transcript 26 February 2020 pp173-181 INQY1000052, Expert Report to the
Infected Blood Inquiry: Hepatitis January 2020 p58, pp67-68 EXPG0000001
Expert Report to the Infected Blood Inquiry: Hepatitis January 2020 p30 EXPG0000001
Expert Report to the Infected Blood Inquiry: Hepatitis January 2020 p58 EXPG0000001
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late stages of fibrosis, will change the risk of liver failure dramatically, successfully treated
patients still carry risks of progressing to cirrhosis.
168
Further, evidence from Scotland has
shown that after successful treatment, the risk of cancer fell but did
not
return to normal after
a three year period.
169
The extent to which SVR is associated with a reduction in the risk of
Hepatitis C-related damage (note, this is a reduction, not an eradication) depends on the
time Hepatitis C has been left to progress untreated and to what extent fibrosis or cirrhosis
has already occurred. There is thus a long term risk of those infected by NHS treatment
– the vast majority of whom were left untreated for years or even decades – developing
liver cancer even for those who have not reached liver failure.
170
Liver cancer is such that
surveillance is crucial for identifying it at an early stage. The tumour is “very
variable … and
some patients despite screening may be diagnosed at a late stage, even though they’ve
been undergoing tests.”
171
It is possible in theory for HCV to “reactivate” following immunosuppression, for example
associated with cancer treatment, if the assumed SVR did not in fact amount to full clearance
of the virus. “You
can think you have got rid of a virus infection in a human host and then
you do something to them and if there is any residual virus it may reactivate.”
172
Though
confirmed as a theoretical possibility in the Expert Report to the Infected Blood Inquiry:
Virology (Hepatitis Supplementary), which also confirms that there is “no
perfect test to
establish
[complete eradication]” of Hepatitis C it should be noted that the Expert Group
says that rates of recurrence are very low (if it has not occurred within 12 weeks of finishing
therapy) and it is rare after 24 weeks.
173
In the chapter on
Access to Treatment,
I recorded the recommendations of Professor
Michael Makris. These relate to people with an inherited bleeding disorder infected with
Hepatitis C, but they are equally applicable to those who have been infected by transfusion.
He recommends that those who are infected, including those who have successfully cleared
the virus, should be reviewed by a liver specialist at least once. He explains that many of
the patients with bleeding disorders treated over the last 35 years, especially prior to the last
decade, will have been treated through haemophilia centres rather than by an hepatologist.
Studies have shown that successful Hepatitis C treatment does not eliminate the risk of liver-
related complications in persons with infected bleeding disorders. Due to higher baseline
risk, incidence was higher after direct-acting antivirals than interferon-based SVR – since
people were being treated later.
174
168
169
170
171
172
173
174
Hepatitis Expert Panel Transcript 26 February 2020 pp96-97 INQY1000052
Hepatitis Expert Panel Transcript 26 February 2020 pp96-97 INQY1000052
Expert Report to the Infected Blood Inquiry: Hepatitis January 2020 p56 EXPG0000001, Hepatitis
Expert Panel Transcript 26 February 2020 pp170-171 INQY1000052
Hepatitis Expert Panel Transcript 26 February 2020 p119 INQY1000052
Professor Richard Tedder Transcript 14 October 2022 p75 INQY1000256
Only 1 out of 384 patients suffered a recurrence 60 weeks after completing therapy. Expert Report to
the Infected Blood Inquiry: Virology (Hepatitis Supplementary) December 2022 pp8-9 EXPG0000131
Written Statement of Professor Michael Makris WITN4033023. See the chapter on
Access to Treatment.
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He recommends that patients with advanced fibrosis or cirrhosis are entered into an hepato-
cellular screening programme, with six-monthly ultrasound scans and regular hepatology
follow-up to detect early signs of liver failure because “The
chances of success in the
treatment of hepatocellular carcinoma depends on how early it is diagnosed, so every
attempt should be made for early identification.”
He notes that “If
surveillance is required,
there should be a named doctor/team responsible for making sure it takes place on time”
and that those with an inherited bleeding disorder who have had Hepatitis C should be seen
by a consultant hepatologist, rather than a more junior member of staff.
175
I said in the course of the hearings, and repeat here, that given the particular complexities
infected people with inherited bleeding disorders present, and a need to have some
understanding of the historical context, I agreed with what Professor Makris was saying.
In respect principally of people infected with Hepatitis C as a result of transfusion, the
participants represented by Leigh Day
176
recommended in essence what Professor Makris
had set out. Since I consider their recommendations to be justified by the evidence, my
recommendations use their words as my own, with the addition of two further points.
The first is point (v) to accord with Professor Makris’ recommendations in respect of the
involvement of a consultant hepatologist.
The second reflects the commentary at the conclusion of the section on
Treatment of
Hepatitis C
in the chapter on
Access to Treatment,
where I said that: “The
consistent delivery
of appropriate follow-up monitoring is a legitimate concern. For this reason, I recommend
that those bodies responsible for commissioning hepatology services in each of the home
nations should publish the steps they have taken to satisfy themselves that the services
they are commissioning meet the particular needs of this group of people harmed by NHS
treatment, including those with bleeding disorders whose treatment for Hepatitis C was not
managed by hepatologists.”
I therefore recommend:
6. Monitoring liver damage for people who were infected with Hepatitis C
(a)
All patients who have contracted hepatitis via a blood transfusion or blood
products should receive the following care:
(i)
those who have been diagnosed with cirrhosis at any point should
receive lifetime monitoring by way of six-monthly fibroscans and annual
clinical review, either nurse-led, consultant-led or, where appropriate, by
a GP with a specialist interest in hepatitis
175
176
Written Statement of Professor Michael Makris p4 WITN4033023. See the chapter on
Access to Treatment.
This was a group which consisted largely of those who had been infected by transfusion, the
majority of whom were infected by Hepatitis C. Final Submissions on behalf of Leigh Day
Participants 16 December 2022 pp202-203 SUBS0000059. This is consistent with the advice of
the expert group on hepatitis. Expert Report to the Infected Blood Inquiry: Hepatitis January 2020
pp67-68 EXPG0000001
257
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(ii)
those who have fibrosis should receive the same care
(iii) where there is any uncertainty about whether a patient has fibrosis they
should receive the same care
(iv) fibroscan technology should be used for liver imaging, rather
than alternatives
(v)
those who have had Hepatitis C which is attributable to infected blood or
blood products should be seen by a consultant hepatologist, rather than
a more junior member of staff, wherever practicable
(vi) those bodies responsible for commissioning hepatology services in
each of the home nations should publish the steps they have taken to
satisfy themselves that the services they are commissioning meet the
particular needs of the group of people harmed by NHS treatment
7. Patient Safety: Blood transfusions
The measures taken to reduce the risk of transmission of infection by the blood services
have greatly changed the risk-profile of blood transfusion. The majority (>80%) of reports to
the Serious Hazards of Transfusion scheme (“SHOT”) are now due to errors or mistakes in
the clinical transfusion process. The biggest risks are receiving the wrong blood (either the
wrong component is transfused or specific requirements are not met), receiving too much
blood too quickly and developing transfusion associated circulatory overload (“TACO”), or
not receiving blood quickly enough (blood delays).
Shared decision making and consent in clinical transfusion practice was recommended by
the Advisory Committee on the Safety of Blood, Tissue and Organs (“SaBTO”), by NICE
in their blood transfusion guidance (and supported, in Scotland, by Realistic Medicine)
yet successive audits, including a recent audit against the NICE Quality Standards, has
demonstrated less than universal compliance.
Though NHS hospitals and staff continue to be under exceptional pressure, perhaps
never more so than over the past few years, most of these are systems errors preventable
with the right processes, knowledge and training as well as implementation of enhanced
electronic clinical systems which promote and support best practice in the laboratory and
at the bedside.
Professor Cheng-Hock Toh, chair of the National Blood Transfusion Committee, asked
readers of the
British Medical Journal
the question “How
can we ensure that the right patient
gets the right blood at the right time?”
He summed up his answer by saying “Preventing
... avoidable harm is not difficult – it needs clear leadership and resolve to make the right
decisions to use blood effectively and for the right blood to be transfused in a timely manner.”
177
177
Cheng-Hock Toh
How can we ensure that the right patient gets the right blood at the right time?
British
Medical Journal 23 October 2023 RLIT0002235
Recommendations
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What he says resonates with the evidence there has been before the Inquiry, and leads to
six improvements which will help to avoid harm.
The first is in respect of how best to avoid blood transfusions which though very safe indeed
(nowadays) nonetheless always come with risks, some of which, as of now, may be unknown.
Tranexamic acid
There is a substantial body of evidence which shows that patients who receive tranexamic
acid
178
have significantly less life-threatening bleeding, major bleeding or bleeding into
a critical organ within the 30 days after treatment. There is no difference in the risk of
unwanted thrombosis. Large surgical trials have shown that tranexamic acid resulted in
a lower incidence of postpartum haemorrhage amongst patients undergoing caesarean
section, and a lower incidence of haemorrhage resulting in re-operation among patients
undergoing cardiac surgery.
179
Its use is supported by NICE. In 2015 NICE issued a guideline recommending that tranexamic
acid be offered to adults undergoing surgery who are expected to have at least moderate
blood loss; and that tranexamic acid be offered to children undergoing surgery as well, if
they are expected to have at least moderate blood loss (ie greater than 10% blood volume).
Tranexamic acid is not expensive. There is strong evidence that it is clinically effective and
that its use will reduce mortality and costs. Yet it was noted that clinical opinion was that
usage might have been as low as 10%-20% at that point.
180
It became a NICE quality standard in December 2016.
181
By 2021 a national comparative
audit showed that 67.5% of eligible surgical patients were given tranexamic acid, though
potentially all were eligible to receive it.
182
It appears there is a NICE quality standard that is
not being well implemented.
Patients at risk of a blood transfusion could have been offered it too, and in Professor Roberts’
view should have been. He said: “if
I had surgery and woke up to find I’d received blood
and I hadn’t been given tranexamic acid, I’d be really annoyed
…”
183
So he and Professor
Mike Murphy (of NHSBT and professor of blood transfusion medicine at the University of
Oxford) formed an ad-hoc group with representation from the Royal College of Surgeons
of England, the Royal College of Anaesthetists and the Royal College of Physicians, and
“we
wrote an editorial and said ... the status quo isn’t adequate and we’re going to try and
178
179
180
181
182
183
Tranexamic acid prevents the natural process of clot breakdown, allowing the clot to stay in place. The
body is therefore more likely to clot successfully, to stem bleeding.
Devereaux et al
Tranexamic Acid in Patients Undergoing Noncardiac Surgery
New England
Journal of Medicine April 2022 RLIT0001825, Professor Ian Roberts Transcript 10 November 2022
pp70-79 INQY1000259
NICE Guideline on Blood Transfusion 18 November 2015 p10, p22 RLIT0001793
NICE Quality standard on Blood Transfusion 15 December 2016 RLIT0001794
NHS Blood and Transplant
2021 National Comparative Audit of NICE Quality Standard
QS138
February 2022 p9 WITN7001061
Professor Ian Roberts Transcript 10 November 2022 p86 INQY1000259. Professor Roberts is a
professor of epidemiology at the London School of Hygiene and Tropical Medicine.
259
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change things, and we made some suggestions of what we think needed to be done and we
are still in the process of trying to carry those things out.”
184
They have recently pointed out that the 2023 audit of the NICE Quality Standards for Blood
Transfusion produced nearly identical results to the 2021 audit.
185
The actions thus far taken
have been ineffective, despite the Royal College of Surgeons (England) and the Royal
College of Anaesthetists having highlighted its use, and aimed to ensure that “consideration
of tranexamic acid use”
is included in the safe surgery checklist of all NHS hospitals.
186
The National Medical Director of NHS England, Stephen Powis, wrote in 2022 to Trust medical
directors recommending the wider use of tranexamic acid to reduce bleeding in surgery.
187
Professor Toh, wrote in the
British Medical Journal
as chair of the National Blood
Transfusion Committee:
“The
number of deaths related to blood transfusions has more than doubled since
the covid-19 pandemic and the Serious Hazards of Transfusion group reports
that these numbers have not returned to pre-pandemic levels, remaining at or
above 35 deaths per annum since 2020.
This is deeply concerning but not entirely surprising in an overstretched NHS,
yet immediate and sustainable improvements are achievable. Firstly, we must
effectively reduce blood loss and unnecessary use of blood. A huge body of
evidence supports use of tranexamic acid to reduce major surgical bleeding by
25%, thus avoiding unnecessary blood use. Tranexamic acid is an inexpensive
drug championed by UK Medical Royal Colleges”.
188
He also said: “leadership
by integrated care boards in standardising and benchmarking
transfusion performance between hospitals could deliver better patient blood management.
This would save lives and avoid disastrous ‘never events’ in transfusion.”
189
184
185
186
187
188
189
Professor Ian Roberts Transcript 10 November 2022 pp87-88 INQY1000259
Letter from Professor Murphy, Professor Roberts and Professor Toh to Sir Brian Langstaff 1 November
2023 p2 WITN7310003, NHS Blood and Transplant
2023 National Comparative Audit of NICE Quality
Standard QS138
February 2024 p14 RLIT0002421
Letter from Professor Murphy and Professor Roberts to Sir Brian Langstaff 16 November
2022 p2 WITN7310002
Cheng-Hock Toh
How can we ensure that the right patient gets the right blood at the right time?
British
Medical Journal 23 October 2023 p1 RLIT0002235
Cheng-Hock Toh
How can we ensure that the right patient gets the right blood at the right time?
British
Medical Journal 23 October 2023 RLIT0002235
Cheng-Hock Toh
How can we ensure that the right patient gets the right blood at the right time?
British
Medical Journal 23 October 2023 RLIT0002235
Recommendations
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I recommend that:
7. Patient Safety: Blood transfusions
(a)
Tranexamic acid
(i)
In England Hospital Transfusion Committees and transfusion practitioners
take steps to ensure that consideration of tranexamic acid be on every
hospital surgical checklist; that hospital medical directors be required
to report to their boards and the chief executive of their Trust as to the
extent of its use; and that the board report annually to NHS England as
to the percentage of eligible operations which have involved its use. If
the percentage is below 80% or has dropped since the previous year,
this report should be accompanied with an explanation for the failure to
use more tranexamic acid and thereby reduce the risk to patient safety
that comes with using a transfusion of blood or red blood cells.
In Scotland, Wales and Northern Ireland offering the use of tranexamic
acid should be considered a treatment of preference in respect of all
eligible surgery.
(ii)
(iii) Consideration be given to standardising and benchmarking transfusion
performance between hospitals in order to deliver better patient
blood management.
The recommendations which follow closely follow recommendations suggested by the
NHSBT in their closing submissions. Though in the way they are formulated, they relate
(necessarily) to England, I note that the Welsh Blood Service “agrees
and endorses
the comprehensive submissions and recommendations now advanced to the Inquiry by
NSHBT ... in Wales, headways is already being made in areas which overlap some of the
recommended actions, as a result of the Welsh-specific NHS Wales Blood Plan ... WBS will
consider with care whatever recommendations the Inquiry makes, with a view to building on
those improvements which have already started.”
190
The Northern Ireland Blood Transfusion
Service “earnestly
awaits Sir Brian’s recommendations to explore further ways in which to
deliver improved and enhanced care to its service users.”
191
The Scottish National Blood
Transfusion Service has developed its own similar approach. In 2021 it set out a 5-year
plan. The strategy comprises three main strategic goals: Education, Communication and
Data & Quality Improvement.
192
190
191
192
Closing submissions of the Welsh Blood Service 15 December 2022 p2 SUBS0000049
Closing submissions of the Northern Ireland Blood Transfusion Service 16 December 2022
p23 SUBS0000051
In overview, these are:
Education:
to continue to educate and develop a workforce to deliver person centred care with the
key focus on the safe, effective and appropriate use of blood for patients in Scotland
Communication:
between team members and the transfusion network to promote and share
initiatives in clinical transfusion practice
261
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Review of progress towards the Transfusion 2024 recommendations
In 2019 in England a plan –
Transfusion 2024 –
set out key priorities for clinical and
laboratory transfusion practice for safe patient care across the NHS for the next five years.
It was based on the outcomes of a symposium in March 2019, organised by the National
Blood Transfusion Committee and supported by NHS England and NHS Improvement. The
key priorities were set out under four headings in a table – Patient Blood Management,
Transfusion Laboratory Safety, Information Technology, and Recommendations for further
research and development – each with a number of specific actions to be taken.
193
Progress
needs to be maintained – first by publicly assessing progress across the first five years,
and determining what the next steps should be, including whether a further five year
plan is merited.
I recommend:
(b)
Progress in implementation of the
Transfusion 2024
recommendations
be reviewed, and next steps be determined and promulgated; and that
in Scotland the 5 year plan is reviewed in or before 2027 with a view to
determining next steps.
The responsibility for this in England is that of NHS England, shared
with the National Blood Transfusion Committee, the Royal Colleges (as
appropriate), and NHSBT.
Transfusion laboratories
Transfusion laboratory safety is one of the key priorities expressed in
Transfusion 2024.
Though transfusion is in general conducted very safely, there are still hazards, to which
SHOT draws attention in its annual reports. Most transfusion-related complications arise
from mistakes in hospital transfusion laboratories.
194
Thus in 2020, 323 such complications
were reported; in 2021, 266; and in 2022, the latest year for which there is a report, 296.
195
Clinical and laboratory teams can function optimally only if adequately staffed and resourced.
Inadequate staffing levels have been a common feature to which other inquiries into NHS
incidents have drawn attention. They include the Mid Staffordshire Inquiry;
196
the Paterson
193
194
195
196
262
Data and quality improvement:
to use the unique opportunity of Account for Blood (AfB) and the
Scottish Transfusion Epidemiology Database (STED) along with other healthcare datasets and
dashboard capabilities to set and monitor key performance indicators and care quality indicators which
continually improve clinical transfusion practice.
SNBTS Transfusion Team 5-year Strategy pp27-28 March 2021 WITN7300016
Allard et al
Transfusion 2024: A 5-year plan for clinical and laboratory transfusion in England
Transfusion Medicine 2021 pp2-4 WITN7001031. The seminar in March 2019 is discussed in the
chapter
Blood Transfusion: Clinical Practice.
Annual SHOT Report 2021 p77 SHOT0000032
Annual SHOT Report 2020 p73 SHOT0000031, Annual SHOT Report 2021 p77 SHOT0000032,
Annual SHOT Report 2022 p73 SHOT0000033
Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry February 2013 RLIT0001925
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Inquiry;
197
the Ockenden Review;
198
and an inquiry into avoidable deaths and failures of care
in sickle cell patients (No
One’s Listening).
199
Compliance with UK Transfusion Laboratory
Collaborative (“UKTLC”) standards has been accepted by the MHRA, and UK Accreditation
Service as evidence to support their inspections for laboratories: the UKTLC has concluded
that a significant proportion of the errors were most probably related to issues of information
technology, staff education, staffing levels, skill mix, training and competency issues.
200
This material leads me to recommend, as the NHSBT suggests that I should, that:
(c)
Transfusion laboratories should be staffed (and resourced) adequately to
meet the requirements of their functions.
Training in Transfusion Medicine
The Inquiry has heard evidence that clinicians, particularly those without expertise in the
blood transfusion field, lack sufficient training. Historically, this has led to inappropriate use
of transfusion; most notably transfusion where it is unnecessary.
201
In a context where risks inherent in blood and blood components can never be nil, it is
important that inappropriate use of transfusion is avoided. In addition, avoidable errors in
relation to blood transfusion remain.
202
All staff likely to be involved in blood transfusions
need to have basic knowledge of blood components, indications for use, alternative options
where available, risks, benefits, possible reactions, and management. In addition, such staff
need to have the skills to improve patient outcomes in respect of transfusion and reduce
health inequalities by involving patients in their own care and ensuring that any care takes
into account the needs of patients as individuals.
NHSBT recommends that reducing risks to patients’ safety in this respect involves haematology
training, transfusion training, and education on the Better Blood Transfusion initiative.
203
SNBTS says that the LearnBloodTransfusion e-learning programme started in 2004, and
until recently was used throughout the UK. In Scotland it is mandated that all those in clinical
197
198
199
200
Report of the Independent Inquiry into the Issues raised by Paterson February 2020 RLIT0001926
Ockenden review summary of findings, conclusions and essential actions 30 March
2022 RLIT0001927
No One’s Listening: An Inquiry Into The Avoidable Deaths and Failures of Care for Sickle Cell Patients
in Secondary Care RLIT0001928
Chaffe et al
UK Transfusion Laboratory Collaborative: minimum standards for staff qualifications,
training, competency and the use of information technology in hospital transfusion laboratories
2014
Official Journal of the British Blood Transfusion Society 29 October 2014 RLIT0002437. The
UK Transfusion Laboratory Collaborative was formed in 2006 in response to 30-40% of all wrong
blood events reported to SHOT originating in hospital transfusion laboratories. It involves all major
transfusion organisations in the UK.
See the chapter
Blood Transfusion: Clinical Practice.
For example, see the 2022 SHOT report:
Annual SHOT Report 2022
SHOT0000033
In her Written Statement Dr Miflin described some of the work that NHSBT already does in respect
of training in blood transfusion at the postgraduate level. Written Statement of Dr Gail Miflin paras
1480-1488 WITN0672006. See also Closing Submissions of NHSBT 16 December 2022 para
17.43 SUBS0000062
263
201
202
203
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transfusion practice complete the Safe Transfusion Practice module within the first few
weeks of starting work in a Scottish hospital and compliance is monitored by the hospital
transfusion committee. The SNBTS transfusion team signpost the modules to be completed
by each staff group. NHSBT has now developed an alternative e-learning programme Blood
Transfusion Training.
204
I recognise that the content of training is carefully considered by those bodies whose
principal concern it is. However I recommend (as invited to do by NHSBT):
205
(d)
That those bodies concerned with undergraduate and postgraduate training
across the UK of those people who are, or intend to be, working in the NHS
ensure that they are adequately trained in transfusion, that the standards by
which sufficiency of training is measured are defined, and accountability for
training in transfusion be defined.
Implementing SHOT reports
Acting on reports of near-misses and serious events is part of the tapestry of haemovigilance.
The MHRA, SHOT and the National Blood Transfusion Committee now between them
provide a complete picture on haemovigilance in the UK. The role and work of SHOT has
been set out in evidence by Professor Bellamy.
206
He said, in compelling evidence, that
mandating reporting to SHOT would help, because:
“we
know that there is a large level of underreporting … It simply isn’t credible that
years go by when no hospital has a near miss … I think for near misses, there is
a tendency not to report things. But if you want a system which is robust, which is
going to stop the real harm from taking place, you’re not going to do that by waiting
until that real harm occurs. You need to recognise the patterns beforehand. You
need to recognise the behaviours, the practices, the systems errors, which lead
to those near misses because it’s only if you get rid of all the near misses that
you’re going to stop the eventual actual event from happening.”
207
In his statement he explained that “reporting
… to the MHRA is mandatory for actual
serious adverse events and reactions, but reporting to SHOT, for example, near-misses, is
‘professionally mandated’ but not legally mandatory, but forms part of clinical governance
204
para 241 SUBS0000044. SNBTS also worked with the territorial health boards through the
Scottish National Blood Transfusion Committee (“SNBTC”) and Haematology and Transfusion
Scotland Network to develop a Scottish National Transfusion Record (“NTR”) in July 2022, which
guides clinicians through the consent process with a Transfusion Associated Circulatory Overload
(“TACO”) checklist.
NHS Lothian Transfusion Education and Training: Blood Transfusion procedure outlines the
transfusion education and training requirements of staff members involved in any stage of the
transfusion process. (November 2023)
Closing Submissions of NHSBT 16 December 2022 paras 17.41-17.43 SUBS0000062
Written Statement of Professor Mark Bellamy WITN7312001, Professor Mark Bellamy Transcript
16 November 2022 p182 INQY1000263. Professor Bellamy is chair of the SHOT steering group.
Professor Mark Bellamy Transcript 16 November 2022 pp64-65 INQY1000263
Recommendations
205
206
207
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arrangements for Trusts and Health Boards … although SHOT and MHRA use an integrated
reporting portal”.
208
He thought that mandating NHS trusts and health boards to have a designated person in
place to report haemovigilance matters might be possible. If such a post were not mandated,
he feared that what would then be an optional position could be an early victim of cuts.
209
Professor James Neuberger was “very
much in favour”
of legally mandating reporting, and
said that having someone statutorily responsible would be a “very
useful start.”
210
As I comment in the chapter on
Blood Transfusion: Clinical Practice:
“all
three of Professor Bellamy, Professor Neuberger and Dr Cave thought more
reporting should be encouraged; all agreed that near-misses should be identified
(indeed, the reasoning articulated for this by Professor Bellamy is compelling),
and differed only on whether the effect of mandating a ‘responsible person’ to
ensure proper haemovigilance reporting would be to incentivise others to think
of reporting or lead to them thinking that it was someone else’s responsibility …
for my part I think that mandating trusts and health boards to have a responsible
person in place, as a first step, together with a regularly audited professional
requirement on doctors who are responsible for giving transfusions to include
in their report not only that a transfusion was given (recording the identifiers of
the unit(s)) but stating why it was given would be more likely to underpin the
importance of haemovigilance than water it down.”
SHOT is a professionally independent body making recommendations to improve blood
safety to all organisations involved in blood transfusion. Reporting to SHOT is “professionally
mandated’’.
Thus, among other mechanisms, the regulatory framework operating around
implementation of SHOT report recommendations should similarly be professionally
mandated and monitored by healthcare regulators. This will produce a requirement for
implementation within a system which has an in-built monitoring framework. This must
not absolve healthcare providers of a separate obligation to monitor the implementation of
the recommendations. In the submission of NHSBT it nonetheless retains an appropriate
flexibility for good reasons and an appropriate risk assessment.
211
I recommend:
(e)
That all NHS organisations across the UK have a mechanism in place
for implementing recommendations of SHOT reports, which should be
professionally mandated, and for monitoring such implementation.
208
209
210
211
Written Statement of Professor Mark Bellamy para 33 WITN7312001. He said “the
existing regulations
are a little bit too flimsy and nebulous, whereas what is laid out for the MHRA reporting scheme
and the BSQR
[Blood Safety and Quality Regulations]
is absolutely clear.”
Professor Mark Bellamy
Transcript 16 November 2022 pp65-66 INQY1000263
Professor Mark Bellamy Transcript 16 November 2022 pp66-67 INQY1000263
Professor James Neuberger Transcript 16 November 2022 pp66-67 INQY1000263
Closing Submissions of NHSBT 16 December 2022 para 17.34 SUBS0000062
265
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Establishing the outcome of every transfusion
It is likely to be of significant importance to establish the outcome of every transfusion. If
this had been achieved at the time of the principal events described in the Report, it seems
likely that alarm bells would have rung sooner; that infections would have been detected
(clinically, if they could not be established by existing tests) and advice to patients have
been better informed, more quickly.
Scotland started developing the system “Account for Blood” in 2008 and it was in use from
2010. The database now covers 95-98% of blood transfusions in Scotland. The Scottish
Transfusion Epidemiology Database uses the patient data from the Account for Blood
system and links it with hospital inpatient records.
212
SNBTS worked with the territorial health
boards through the Scottish National Blood Transfusion Committee and Haematology and
Transfusion Scotland Network to develop a Scottish National Transfusion Record in July
2022, which guides clinicians through the consent process with a Transfusion Associated
Circulatory Overload (TACO) checklist. The current aim, as part of a 5 year plan is to better
understand the demand for blood components and how demand changes over time.
Outside Scotland the outcomes for recipients of blood components are not easily known
without a national or clinical audit.
Transfusion 2024
has been mentioned above. It includes
development of a system of “vein-to-vein” tracking. The plan notes that implementation of
these significant schemes would be subject to finding the funds to do so.
213
However, NHSBT
submits that having robust systems to understand the outcomes of people undergoing
transfusion of blood components, coupled with one that allows clinical audit and research,
should be an aim of the NHS. This is likely to be best achieved using the IT systems
currently being developed, which have appropriate interfaces between existing systems.
214
Furthermore, if it is done correctly it should allow NHSBT to manage the blood stocks
throughout the system and for experts to audit the appropriate use of blood components
using simple tools of analysis rather than large complex time-taking audits, thus in itself
leading to a greater likelihood of a better use of blood.
215
I am told that the recording of, and access to, information concerning transfusion is currently
difficult in the NHS in England. The lack of integration between various records is an
important limitation which hampers patient access to information, and limits the ability of
the blood service to undertake tracing, audit and root cause analysis.
216
Thus, a framework
within existing systems should be established for proper recording of outcomes for recipients
of blood components.
212
213
214
215
216
266
Closing Submissions of SNBTS 16 December 2022 paras 242-245 SUBS0000044
Allard et al
Transfusion 2024: A 5-year plan for clinical and laboratory transfusion in England
Transfusion Medicine 2021 p3 WITN7001031
Simply trying to take data out of many existing systems into a new registry would be fraught with data
transfer risks and potential errors and would be extremely difficult to set up and costly to maintain.
Closing Submissions of NHSBT 16 December 2022 para 17.57 SUBS0000062
Closing Submissions of NHSBT 16 December 2022 para 17.58 SUBS0000062
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Though this recommendation is focused on the blood services in England, the outcomes
which are reported should be of interest to the WBS, NIBTS and SNBTS. The latter
recommends the implementation of enhanced electronic clinical systems which promote
and support best practice at the bedside as a major plank in preventing avoidable systems
errors from harming patients. It is important that resources continue to be allocated to
improve these further – and to ensure that insofar as those systems provide information on
outcomes from transfusion the detail is shared, possibly through SHOT, with the other blood
services of the UK.
I recommend:
(f)
Establishing the outcome of every transfusion
(i)
That a framework be established for recording outcomes for recipients
of blood components. That those records be used by NHS bodies to
improve transfusion practice (including by providing such information
to haemovigilance bodies).
Success in achieving this will be measured by the extent to which the SHOT
reports for the previous three years show a progressive reduction in incidents
of incorrect blood component transfusions measured as a proportion of the
number of transfusions given.
(ii)
To the extent that the funding for digital transformation does not already
cover the setting up and operation of this framework, bespoke funding
should be provided.
(iii) That funding for the provision of enhanced electronic clinical systems
in relation to blood transfusion be regarded as a priority across the UK.
8. Finding the undiagnosed
When doctors become aware that patients received a blood transfusion prior to 1996
217
they should immediately be offered a test for Hepatitis C (if they have not already had one).
There may be limited opportunities in the usual interactions between patients and their GPs
for it to be found out in normal practice that a given patient had ever had a transfusion in
the past, if it is not already known. However, the opportunity arises when a new patient is
registered at a practice. They should then be asked, as a matter of routine, if they had a
transfusion before 1996 and, if they say they have, should be offered the opportunity of a
precautionary blood test. There need be no alarm for the patient about this: rather, the offer
should instil confidence that their safety is being protected by the doctor, and a substantial
majority of previously untested patients may expect the reassurance of a negative test.
However, if the test is positive (as it is likely it will be in some cases) then treatment with
217
The reasons for picking this date are that it is reasonably possible that some infections may have
occurred from blood transfusions after universal screening was introduced in September 1991, and it
was in 1996 that SHOT effectively began.
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direct acting antivirals may follow.
218
This requirement would also have the effect of raising
awareness in general practice about Hepatitis C and thereby reduce the number of people
diagnosed very late, some of whom have given evidence to this Inquiry.
I recommend:
8. Finding the undiagnosed
(a)
(b)
When doctors become aware that a patient has had a blood transfusion prior
to 1996, that patient should be offered a blood test for Hepatitis C.
As a matter of routine, new patients registering at a practice should be asked
if they have had such a transfusion.
9. Protecting the safety of haemophilia care
Peer review of haemophilia centres
Audits of practice are more often than not conducted internally in hospital Trusts and health
boards: if shortcomings are identified, that leads to discussions and agreement as to the
steps necessary to overcome them; these steps are then implemented; and then whether
and how far those steps have been successful in remedying the original shortcomings is
assessed. Audit of a specialist centre which is not conducted internally, but by a clinical
team from other centres is probably better described as “peer review”.
A practice of peer review of haemophilia centres by haemophilia consultants from other
centres has grown up since 1991 (in Northern Ireland and Scotland) and in England and
Wales (1992/93), and has been refined over time. Consultant specialists help to identify
service gaps against the service specification adopted at the time. Over the years since
then, this too has evolved. A national service specification for haemophilia and related
conditions has been developed and published.
219
Peer review not only helps a centre to be better assured it is adopting “best practice”, or
identifies where it may be falling short, but it can highlight matters of growing concern across
the country. Thus, the last peer review reported inequity in the quality of care provided
218
219
The Statistics Expert Group compared the age-sex bands for EIBSS claimants in England against
their statistical estimates for the number of people infected with Hepatitis C through transfusions and
identified three groups who appear to be underrepresented:
• people born 1975-1984 who had a transfusion as a child (at best a quarter of the number estimated
feature as claimants)
• people born 1965-1974 who had a transfusion (only a third of the number estimated
feature as a claimant)
• women born 1945-1964 who had a transfusion around childbirth (just over half the number
estimated feature as claimants)
Expert Report to the Infected Blood Inquiry: Statistics (Supplementary) July 2023 p9 EXPG0000132
The Haemophilia Alliance
A National Service Specification for Haemophilia and other Inherited
Bleeding Disorders
February 2006 HSOC0020872
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because of inconsistency in the provision of key staff groups especially in physiotherapy
and psychosocial care.
220
Three institutional core participants (UKHCDO, the Scottish Territorial Health Boards, and
the Belfast Health and Social Care Trust) support auditing and peer review: technically, the
professional assessment, against standards, of the organisation of healthcare processes
and quality of work, with the objective of facilitating its improvement. The primary aim is
to ensure the care provided is both safe, and of the highest quality, and that shortfalls in
provision are identified. In particular, in a small specialty such as haemophilia, this enables
best practice to be maintained across the UK.
However, peer review is defeated if the recommendations made as a consequence of the
review are not implemented. Accordingly, I recommend:
9. Protecting the safety of haemophilia care
(a)
That peer review of haemophilia care should continue to occur as presently
practised, with any necessary support being provided by NHS Trusts and
Health Boards; and
That NHS Trusts and Health Boards should be required to deliberate on
peer review findings and give favourable consideration to implementing the
changes identified with a view to ensuring comprehensive, safe, care.
A peer review of each centre should take place not less than once
every five years.
(b)
(c)
Networks for haemophilia care
Most haemophilia centres only have a small number of dedicated specialists, since bleeding
disorders are relatively rare. It can be all too easy for these small numbers to lead to a
degree of isolation amongst specialists, or to create difficulties in facilitating discussion of
haemophilia care during the course of busy practices, especially since these often involve
other aspects of haematology. The Scottish Territorial Health Boards have found it particularly
useful for there to be regional networks of clinicians providing regular forums for case and
policy discussions. These networks are arranged so that they include patient involvement in
policy discussions.
221
At the moment, Scottish haemophilia centre directors meet every two months, and constitute
such a network: patient input to the forums comes via the Scottish Inherited Bleeding
Disorder Network.
222
220
221
222
Overview Report of the Inherited and Acquired Haemophilia and other Bleeding Disorders Peer
Review Programme
May 2020 p5 RLIT0001937
Closing submissions of the NHS Scotland Territorial Health Boards pp112-113 SUBS0000058
Closing submissions of the NHS Scotland Territorial Health Boards p113 SUBS0000058
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To an extent, such networks already exist informally elsewhere, and with some support
from the Haemophilia Society and UKHCDO. However, discussion in a multidisciplinary
format, involving patients, would help to prevent one or two voices having a disproportionate
influence on care over others. As the history revealed by the Inquiry has shown, the influence
of one or two voices can (and did in 1983/84) have a damaging effect on the safety of
patient care: the moderating effect of wider discussion, the involvement of patients, and of
other clinical disciplines should help to avoid this being repeated in future.
Accordingly, I recommend that:
(d)
The necessary administrative and clinical resources should be provided by
hospital trusts and boards, integrated care boards, and service commissioners
to facilitate multi-disciplinary regional networks to discuss policy and practice
in haemophilia and other inherited bleeding disorders care, provided they
involve patients in their discussions.
Recombinant factor products
In the submissions made by participants represented by Collins solicitors
223
it is indicated
that people with severe von Willebrand disorder are still being treated with plasma-based
factor products. I recommend (adopting wording used by the Scottish Territorial Health
Boards, who also favour this proposal)
224
that, across the UK:
(e)
recombinant coagulation factor products should be offered in place of
plasma-derived ones where clinically appropriate. Service commissioners
should ensure that such treatment decisions are funded accordingly.
National haemophilia database
There is no doubt that a database of the type which the National Haemophilia Database
(“NHD”) constitutes should be maintained. It helps to track the occurrence of disease, its
prevalence, and clinical outcomes (in particular, mortality over time). It helps to identify needs
as yet unmet in order to plan future therapeutic and organisational arrangements. Such a
registry was recommended by the European Association of Haemophilia and Associated
Disorders in 2008;
225
and is thought to be especially important for pharmacovigilance and
planning of care including budget allocation.
It has been of considerable benefit to the Inquiry to have seen the figures and been supplied
with data kept and collated by the NHD. Though there have historically been uncertainties
about some of the data, and concerns about the way in which the data was collected, it has
223
224
225
270
Submissions on behalf of the core participants represented by Collins Solicitors p202,
p222 SUBS0000063
Submissions on Recommendations of the NHS Scotland Territorial Health Boards p7 SUBS0000006
Colvin et al
European principles of haemophilia
Haemophilia 21 November 2007 HSOC0021039
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nonetheless represented a reliable means of showing trends in care and outcome in some
detail. It is thus useful for historical research where that is needed.
Individuals may opt out of their data being used for research should they wish to do so:
those who do
not
opt out are included in the UK National Haemophilia Research Registry,
which may be used for observational research (the identity of patients is not disclosed
for this purpose).
The UKHCDO, which runs the NHD, is a charity. Its members are NHS consultants who
work in NHS hospitals treating NHS patients. Its objectives are to preserve, protect and
relieve persons suffering from haemophilia and other inherited bleeding disorders; to
advance the education of the medical profession, the nursing profession, professions allied
to medicine and the general public in the knowledge of haemophilia and other inherited
bleeding disorders and their treatment; and to promote or assist in the promotion of audit
and research into the causes, prevention, alleviation and management of haemophilia and
other inherited bleeding disorders and to disseminate the useful results of such research.
226
Currently the NHD is funded, through the UKHCDO, by a mixture of NHS, charitable and
pharmaceutical money. There is a need for additional funding if it is to become a better tool
for patient-centred care, and to be enabled to encourage equity of access by generating
comparative reports. Additional funding would also support additional expert statistical input
(for instance, enabling a mutually beneficial collaboration with universities), and enable a
review of the database structure and its migration to more up-to-date technology.
UKHCDO and the Scottish Territorial Health Boards propose that further resource should be
provided to enable these steps to be taken.
227
If more public money is to be spent in enabling these improvements to the NHD, it might be
thought that the NHD should be brought within the NHS, rather than remaining technically
independent of it though entirely dependent on clinicians employed in the NHS and patients
treated by it agreeing to provide it with the data on which its operation entirely depends.
I consider that there would be little advantage in this: it would expose the NHS to greater
expense (at the moment, it contributes about half the cost of running the NHD: if the NHD
were incorporated fully within the NHS the cost would all then fall upon its shoulders). If the
NHD were formally made a part of the NHS itself it would inevitably be subject to the natural
fluctuations of the health budget, and the uncertainties that come with that.
I have been persuaded that, at least for the foreseeable future (though matters should be
kept under review) the NHD should continue to be run by the UKHCDO, funded as is currently
the case, but that additional resource as indicated above should be made from public funds.
226
227
United Kingdom Haemophilia Centre Doctors’ Organisation
Constitution
November
2013 p1 WITN4031004
Submissions on Recommendations on behalf of UKHCDO 16 December 2022 para 290
SUBS0000050, Submissions on Recommendations on behalf of NHS Scotland Territorial Health
Boards 14 June 2022 para 14 SUBS0000006
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I therefore recommend:
(f)
that the National Haemophilia Database, run by the UKHCDO, merits the
support of additional central funding.
10. Giving patients a voice
One of the most striking aspects of the evidence has been a failure adequately to listen to
patients and to hear what they wanted, rather than assume the “listener” already knew.
There is no easy way of ensuring that medical authorities, and government, become less
defensive when patients tell them that their care could have been better, or has failed in
certain respects. The recommendations made already in this Report should go some way
towards meeting that challenge. However, without enabling the patient voice to be heard
better those improvements will be incomplete.
Accordingly, I recommend that steps be taken to help the patient voice to be both heard and
taken into account in developing clinical policies, and healthcare policies in future.
There are a number of steps which it is desirable to take to achieve this. Some may seem
minor, but they are, taken together, part of a composite picture of how patients can be
enabled to play a full part in what is best seen as a patient-doctor partnership in care.
The first follows on from my recommendation that multidisciplinary regional network meetings
to discuss policy and practice in future haemophilia care and treatment be facilitated. It is
important that they involve patients, as they already do in the Scottish regional network
system. That recommendation looks to give a stronger voice to people with bleeding
disorders. It therefore does not apply in the same way to the far greater number of people
who were infected with Hepatitis C as a consequence of transfusion when treated for
conditions other than haemophilia.
Elisabeth Buggins has the perspective of a parent of children infected at children’s hospitals,
as well as experience of management within the NHS. Her view is that in more recent
years the policy of the NHS internal market, intended to promote healthcare competition
for patients’ benefit, has led to a focus on performance management concentrating on
NHS institutions rather than on the clinical benefits of decisions to individuals and to the
health and happiness of communities. A cultural shift from focus on the institution to the
individual needs, in her view, to be systemically supported by the way in which healthcare
is organised. She argues that as part of this patient-reported outcomes and experiences
should be measured in the process of clinical audit: too little of (otherwise very useful)
clinical audit which is currently performed in hospitals routinely includes patient-reported
outcomes or experience measures. She says that:
“The
picture cannot be complete without it. Instead, the system relies on patients
feeling strongly enough to write in with thanks or complaints and much useful
insight is lost. Where patients are not routinely seen, such as those with milder
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conditions, the incentive to write diminishes rapidly and should problems
occur some distance from treatment, the treating hospital is unlikely to be
informed about it.”
228
A number of submissions have recognised the importance to patients of organisations or
bodies which can speak for them, or lobby for them. Organisations can give people voice:
the evidence of campaigners speaking for various different interest groups in the Inquiry has
demonstrated that. Some organisations have charitable status, often now of some pedigree.
The Hepatitis C Trust operates on a truly UK-national basis. It has earned plaudits for
the information it has been able to supply, the support it has been able to give, and the
signposts by which it has directed individuals to find the support that they have needed.
It has been able to speak for people infected with Hepatitis C in an undemonstrative but
effective manner. Its ability to help people to understand that they are not alone, to help
them access support and treatment and to understand it, and to speak for them has drawn
almost unanimous unstinting praise across, and for the duration of, the Inquiry.
For people with haemophilia, the Haemophilia Society has been long established. The
chapter about it describes some of its past history.
229
For the future, it can continue (as it
has in recent years) to realise its potential as a fully effective voice ensuring that the patient
view is made known not only at national but also, because of its organisation, at regional
levels. In Scotland, there is a separate charity – Haemophilia Scotland. In Scotland there
is also the Infected Blood Forum (“SIBF”), focused on giving patients a voice; in Wales,
Haemophilia Wales; in Northern Ireland, Haemophilia Northern Ireland. In Northern Ireland,
there is an allied organisation, Families and Friends of Haemophilia Northern Ireland, which
is not itself a registered charity.
Organisations which are campaign or mutual interest groups, rather than charities, have also
played a very valuable role, helping to give a collective voice to different strands of opinion
amongst those who were infected, or affected. They have campaigned indefatigably; have
enabled people to share a collective comfort in mutual support; have kept their members
informed; and have developed close connections amongst their members that have not
only preceded the Inquiry but seem likely to outlive it by quite a while. The end of a six
year Inquiry following years of struggle to have their views heard and considered will bring
personal and emotional challenges which the continuation of these groups would help to
meet, particularly in the short term. The end of the Inquiry gives an opportunity for the
Government to go some way to facilitate this. To do so would underscore the sincerity of the
apology that I hope and expect will be forthcoming, and would show that the government is
not dismissive of the prospect that these groups will have more to offer as a compensation
scheme takes shape, and would enable the patient voice to continue to be heard on the
issues reflected in this Report.
228
229
Closing Submission of Elisabeth Buggins 16 December 2022 para 2, para 4, para 18 SUBS0000054
See the chapter on the
Haemophilia Society.
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One of the weaknesses of the evidence before the Inquiry has come from the relatively
low numbers of people with thalassaemia or sickle cell disease being prepared to speak to
the Inquiry about their experiences. Proportionately, they must have suffered at least the
same likelihood of blood-borne disease as others – indeed, given their need for regular
transfusion, it is to be expected that people with thalassaemia or sickle cell disease will
have a significantly higher proportion of blood-borne disease than do most people who have
had a transfusion of only a few units.
The Thalassaemia Society (“UKTS”) said in its final submissions:
“It
was disappointing yet understandable for the
[current team at the UKTS]
that
despite their best efforts of trying to encourage their membership and families
affected to come forward and testify, many chose not to due to the trauma of
the diagnosis, the rigorous and horrific treatment regimes, experiences, stigma
and fatalities … In most communities in which thalassaemia is prevalent, there
is an enormous amount of social stigma associated with living with an inherited
condition affecting the production of red ‘blood’ cells. Within some communities,
the idea of someone living with thalassaemia was inaccurately categorised as
them having ‘bad blood’. As a consequence of this, individuals would wrongly be
considered as a ‘burden’, ‘less than’ and not ‘marriage material’ … Unfortunately,
the stigma and belief is still present today … The feelings attributed to
psychosocial burden due to thalassaemia were then further reinforced by the
stigma associated with Hepatitis C.”
230
One of the recommendations which the UKTS urged upon me was public funding for the
UKTS and other charities “who
supported and continue to support individuals who were
infected or affected to provide advice, education and advocacy services. Public funding
would help UKTS and other charities provide ongoing assistance and campaigning to
ensure horrific events like these do not occur.”
231
It is in my view of particular importance that where it is known (as is beyond doubt here)
that there is a voice to be heard, but that it is currently speaking in a very quiet whisper,
steps must be taken, as best can be done, to enable those who should listen to it to hear it
far more loudly.
Patient feedback
The MHRA makes an online Yellow Card system available through the gov.uk website, in
order to notify it of any adverse reaction from drugs or medicines.
232
The existence of this
online opportunity to provide feedback is not well known. It deserves greater publicity. It
is part of listening to what patients have to say. One way of drawing attention to it would
be for a yellow banner to be put across patient data information sheets which accompany
230
231
232
274
Closing Submissions of UKTS paras 6-8 SUBS0000067
Closing Submissions of UKTS para 11 SUBS0000067
yellowcard.mhra.gov.uk
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medicines advising people, to say that if they feel that they have an adverse reaction, even if
(and perhaps especially if) the reaction is a delayed one, they should use the online portal to
report it. The action required for this would simply be to mandate it – the product data sheet
is paid for by manufacturers, and this would simply be additional but mandatory content.
This – or some similar way of drawing attention to the online Yellow Card scheme – applies
only to those taking pharmaceutical medication. Where patients are told, or know, that they
have had a transfusion of blood or a blood component, they should as a matter of practice
be told that if they have any adverse reaction as a consequence they too can, and should,
report it; and that although their principal point of contact to describe an adverse reaction
is likely to be the treating clinician or body, they can in addition make a report of it through
the Yellow Card online scheme if they wish to do so – and it is important that they take up
this opportunity.
233
Drawing these threads together, I recommend:
10. Giving patients a voice
(a)
That the patient voice be enabled and empowered by the following measures:
(i)
clinical audit should as a matter of routine include measures of patient
satisfaction or concern, and these should be reported to the board of the
body concerned.
Success in this will be measured by comparing the measure of satisfaction
from one year to the next, such that the reports to the board concerned
demonstrate a trend of improvement by comparing this year’s outcomes with
the similar outcomes from at least the two previous years.
(ii)
that the following charities receive funding specifically for patient
advocacy: the UK Haemophilia Society; the Hepatitis C Trust;
Haemophilia Scotland; the Scottish Infected Blood Forum; Haemophilia
Wales; Haemophilia Northern Ireland; and the UK Thalassaemia Society.
(iii) that favourable consideration be given to other charities and
organisations supporting people infected and affected that were granted
core participant status (as listed on the Inquiry website) to continue to
provide support for at least the next 18 months. Further support should
be reviewed at that stage with a view to it continuing as appropriate.
(iv) particular consideration be given, together with the UK Thalassaemia
Society and the Sickle Cell Society, to how the needs of patients with
thalassaemia or sickle cell disease can best holistically be addressed.
233
Dr Alison Cave is Chief Safety Officer at the MHRA and told the Inquiry that patients with adverse
reactions to a transfusion could report through the Yellow Card scheme using the option “Report
something not on our list”
at yellowcard.mhra.gov.uk. Dr Alison Cave Transcript 16 November 2022
pp76-77 INQY1000263
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(v)
steps be taken to give greater prominence to the online Yellow Card
system to those receiving drugs or biological products, or who are being
transfused with blood components.
11. Responding to calls for a public inquiry
Rationale
By 1986 the Government can have been under no illusion about the scale of what had
happened to people with haemophilia – many had been infected with HIV, a virus with an
exceptionally high mortality rate for which there was no known treatment. Sufferers of HIV
experienced public hostility and stigma. In addition, over the five years which followed it
became apparent beyond question that the non-A non-B Hepatitis with which most had also
been infected was far more serious than some clinicians would have wished to believe in
the early 1980s.
Calls were raised suggesting that the root cause of the problem was a failure to plan for, and
achieve, self-sufficiency in the supply of blood products. The decision by the regulator not to
ban imports of commercial concentrate from the United States, recognised as being in the
throes of an AIDS epidemic, was controversial.
Yet more people – many more – were known to be suffering from hepatitis transmitted
by blood transfusion, and some more again had been infected by AIDS as a result of
blood transfusion.
The sources of blood products and blood were said to be rife with disease, that insufficient
precautions had been taken, and that the risks had never been spelt out to patients receiving
blood and blood products
Yet as the chapter in relation to a
Delay in Holding a Public Inquiry
records that:
“there
is no documentary evidence to show that it occurred to anyone within
Government before 1989
234
either that there might be an important public interest
in investigating and understanding precisely how this had occurred
[ie the fact
that so many people had gone into hospital for treatment and come out infected
by HIV or Hepatitis B or C],
or that those whose lives had been devastated in
this way might deserve answers as to how and why it had happened. It ought to
have been clear that there were lessons to be learned for the future if something
similar were not to recur.”
234
It should be noted that Lord Norman Fowler, who was in office as Secretary of State for Health and
Social Services prior to June 1987, has urged that it took far too long for this Inquiry to be held, and
has himself criticised the prevarication over it being held.
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Reasons for not holding a public inquiry, as recorded in that chapter, were generally defensive
and uninformative. The chapter does not bear repetition here: but it is worth reflecting that
there were lessons to be learned from what had happened.
235
A number of participants have called for the adoption of a recognised process in deciding
whether or not there should be a public inquiry into a matter which is potentially of public
concern, or from which lessons might be learned, or both. Given the background in the
present case, they are right to do so.
The question involves resolving the circumstances in which an inquiry should be held, and
who should have power to determine that the criteria for holding one have been met. The
Inquiries Act provides, appropriately (but with a very broad level of generality) that:
“A
Minister may cause an inquiry to be held under this Act in relation to a case
where it appears to him that–
(a) particular events have caused, or are capable of causing, public concern, or
(b) there is public concern that particular events may have occurred.”
236
This means that the minister has a discretion. It is sufficient if it “appears
to him”
that there
is, has been, or might well be public concern, and that there should be an inquiry. Equally, if
the opposite appears to her or him, there will be no inquiry. For matters of UK-wide concern
this is in practice the Prime Minister’s decision.
The facts considered by this Inquiry indicate two shortcomings in this. First, the minister
most likely to understand whether there is public concern may very well be the minister for
the department of state which is most concerned with the subject matter. Where the inquiry
is into the performance of (for instance) a particular hospital trust, poisoning by a hostile
state, or murder by a healthcare professional, the minister of the department concerned
237
may well be inclined to think that public concern merits an inquiry. By contrast, they may
be less inclined to hold an inquiry if the public concern is directed more toward the way
in which their department discharged its responsibilities. It would be only human for civil
servants in that department to be defensive – indeed, they may already have been, when
concerns were first raised; and it may be also be understandable if a minister is worried in
some cases that they, the minister, might be thought unsupportive of their department if they
asked for there to be an Inquiry into it, and this might make it more difficult to lead it.
In short, the first weakness of Section 1 of the 2005 Act is that it provides a discretion liable
to be exercised by someone in whose interests and inclination it may be to be defensive of
their own department, who may well be assured by their own department that all the facts
are known and that no harm was done, such that there is nothing to be concerned about and
thus nothing to be inquired into – or nothing that an inquiry might add – and thus reject calls
for there to be one. Further, if an inquiry is called, sponsored by and therefore paid by or
235
236
237
See the chapter
Lessons to be Learned.
s1 The Inquiries Act 2005 p1 RLIT0002405
In the examples chosen, the health minister, or the Home Office minister.
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through a departmental budget, there are inevitably concerns that the independence of the
inquiry may be compromised. The examples in the context of this Inquiry of the way in which
the report about
Self-Sufficiency in Blood Products in England and Wales: a Chronology
from 1973 to 1991
was handled, or the Scottish Executive report was unsatisfactory,
238
show that there can be good reason for worrying about the ability of an internal investigation
to reveal the truth.
A further problem with the wording of the power is that it arises where there is “public
concern”.
This is a very flexible concept. It must, practically, be linked to some concept of
sufficiency. Is there enough public concern to justify holding one? How is this to be judged?
Is it truly of interest to a wider public than a group with a particular sectional interest? If the
bar is set too low, then inquiries risk becoming more common at great expense. If they do,
the force that their recommendations might otherwise have is lost. There may be evidence
of significant numbers of people who appear to share a particular concern, without there
being an objective evaluation of whether that concern might actually be justified.
These concerns suggest there might be a need to amend the Act, to set out further criteria.
However, that is a process which might take some time, and the flexibility the Act provides
may be valuable. In the alternative, I propose an interim measure to provide the public with
reassurance that widespread calls for an inquiry, or particular focussed concerns which
justify one, have been properly considered by a body independent of the government
department(s) of state most centrally concerned.
My recommendation is that the same body as I recommend should review progress towards
responding to, and if accepted, implementing the recommendations of this Inquiry – the
Public Administration and Constitutional Affairs Committee (“PACAC”) – should have the
more general function of considering whether to recommend to an appropriate minister that
there be an inquiry. It should exercise this when there is sufficient support in Parliament
for such a course.
This mechanism allows for significant flexibility to be retained as to the precise circumstances
in which there should be an inquiry – inquiries take many forms, from those which consider
a one-off incident, to those which involve considering the effectiveness of systemic controls,
to those which consider historic practices which have recently come to light (eg the Inquiry
into organ retention), to those which consider practices at a single institution (Strangeways;
Mid Staffordshire), and those which consider the appropriateness of, or lack of, provision for
certain groups. Each inquiry is unique: the procedure in each will differ. There is no room for
a “one size fits all” approach. The Act remains in force, and the minister continues to have
discretion as to ordering one, and if so whether it should be statutory.
The mechanism I propose ensures proper respect for the democratic process – the power to
call an Inquiry remains ultimately within the hands of a minister (not necessarily the minister
whose department is most centrally concerned), and the process is open to all the scrutiny,
238
278
See the chapters on the
Self-Sufficiency Report
and
Scotland.
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and transparency, of the select committee process. It gives more confidence that if calls
for an Inquiry are rejected there are good reasons for this, capable of being examined by a
cross-party body; but it also provides a safeguard against inquiries being held too readily, as
might be the case if more prescriptive criteria were to be set.
An inquiry hub has now been established within the Cabinet Office. In my view it is appropriate
that in any case in which the department concerned is potentially subject to criticism at the
conclusion of the investigation, the inquiry should be sponsored and supported by the Cabinet
Office
239
(unless the Cabinet Office is itself the subject of inquiry; and with the exception of
those inquiries where it appears to the minister that the department concerned is likely
neither to be a core participant itself nor potentially subject to criticism at the conclusion
of the Inquiry).
240
This leads me to recommend:
11. Responding to calls for a public inquiry
(a)
that a minister should retain the power to call an inquiry as the minister sees
fit, in accordance with the Inquiries Act 2005 – but where a minister does not
choose to do so, then:
if there is sufficient support from within Parliament for there to be an inquiry,
the question whether there should be one should be referred to PACAC for it
to consider the question.
If it appears to PACAC that there is sufficient concern to justify a public
inquiry, either because what happened and why has caused concern (as
the committee sees it) or there are likely to be lessons learned which may
prevent similar concerns arising in future, the committee may recommend to
an appropriate minister that there be an inquiry.
If the minister disagrees with the recommendation, they must set out in detail
and publish reasons for this disagreement which are sufficient to satisfy
PACAC that the matter has been carefully and properly considered.
(b)
(c)
(d)
239
240
The present Inquiry is a case in point. An initial proposal was that the Department of Health and Social
Care should sponsor the Inquiry. Since many of those likely to be participants in the Inquiry considered
the department to have played a significant part in the failings which led to their suffering, and the
reaction of the government in response, they rightly objected to this. The sponsoring minister became
the Chancellor of the Duchy of Lancaster. I have been grateful for the support given by the Cabinet
Office to this Inquiry, and also that at no stage has anyone from that Department sought to interfere
with the inquiry process.
If, for instance, the Inquiry is into the behaviour of a single medical professional, or the performance of
a particular hospital trust or board, it is unlikely to be necessary for public confidence that the DHSC
stand aside from sponsoring the inquiry.
279
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12. Giving effect to Recommendations of this Inquiry
Part of the history of the Inquiry has been (a) delay on the part of successive governments;
(b) the failure to account for inaction; and in consequence (c) a consequent loss of trust in
authority by those who have been infected, and those in turn affected by the harm that had
happened to people who were important to them.
As a public inquiry, it is being held in the public interest. That interest is essentially in
three respects:
• what happened to lead to treatment causing so many serious infections, and why;
• how authorities reacted to what had happened, and why they did so; and
• the lessons to be learned from that and recommendations to be made so that the
future is better, and past mistakes are not repeated.
It is important in the public interest, therefore, that recommendations are fully and properly
considered. If they are to be rejected, then that should be for good reason, and the public (in
whose interest an Inquiry is conducted) should be told clearly what the reason or reasons are.
Accountability is one of the seven principles of public life which Lord Nolan recognised and
articulated.
241
The first question, therefore, is how government should be held accountable
for the way in which it deals with the recommendations made both here, and those that have
already been made over a year ago, in the Second Interim Report of the Inquiry and have so
far resulted in little tangible result for people infected and affected by this tragedy.
I propose two mechanisms. They run together.
First, a number of the submissions made by core participants endorse a submission made
on behalf of those core participants represented by Milners solicitors:
“In
our submission, Parliament’s intention in passing the Inquiries Act 2005
was to give the chair of a statutory inquiry the power to scrutinise the actions of
Government in accordance with its terms of reference, and to do so in a flexible
and more expansive way than is available to a court considering a judicial review
challenge. Indeed, it could be argued that the primary purpose of the Act and of
many inquiries, is to scrutinise the decisions and actions of the Executive.”
242
241
242
Lord Nolan
Standards in Public Life: First Report of the Committee on Standards in Public Life
May
1995 p18 RLIT0001795
Submissions on behalf of the core participants represented by Milners Solicitors August 2023 p3
SUBS0000070. In my view, this is critically dependent upon the terms of reference: many statutory
inquiries may consider the actions of public bodies such as individual NHS trusts, the police services,
local authority actions, and general disasters which require scrutiny across many fields: not every
inquiry is of an Arms to Iraq nature.
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Section 14(1)(a) of the Act provides: “For
the purposes of this Act an inquiry comes to an
end – on the date, after the delivery of the report of the inquiry, on which the chairman
notifies the Minister that the inquiry has fulfilled its terms of reference”.
243
Focussing on the wording of this, it is said to me that an inquiry does not end with the
delivery of the report, but with the chair’s notification to the Minister.
There is a precedent, to show that the report of the Inquiry is not necessarily the last word.
Thus, when Sir Michael Bichard presented his report to the Home Secretary on 14 June
2004 into the deaths of two children in Soham he wrote in a covering letter “I
look forward
to the Government’s response to my findings and to the recommendations which I make.
As you know, I aim to reconvene my Inquiry in six months’ time to assess progress on
those recommendations which the Government chooses to accept. I am confident, as I
acknowledge in my report, of the spirit in which my recommendations will be received and
taken forward.”
244
Six months later he was sent a progress report, and provided an update
himself on 15 March 2005, in which he said “I
am also clear that the fact that this public
review was known to be taking place has concentrated minds
”.
245
In an accompanying press
release it was said “He
asked for preparatory work on these schemes to be completed by
Spring 2006 and suggested that the Home Secretary should commit to publishing reviews
of progress in September this year and March 2006. Sir Michael also said he hoped such
reviews of Inquiries would occur as a matter of course in the future.”
246
Though his findings
and recommendations were contained entirely within his June 2004 report, his actions
after June 2004 were concerned solely with the implementation of the recommendations
which he had made.
The Inquiry’s terms of reference cover an unusually wide period: they began at the start of the
NHS. There is no specific end date. That is because the Inquiry is charged, amongst other
matters, with examining the nature, adequacy and timeliness of the response of government
(in particular the Department of Health and Social Care), NHS bodies, other public bodies
and officials, the medical profession, the UK Haemophilia Centre Doctors Organisation, the
pharmaceutical industry and other organisations (including the Haemophilia Society) to the
use of infected blood or infected blood products to treat NHS patients; and “To
consider the
nature and the adequacy of the treatment, care and support (including financial assistance)
provided to people who were infected and affected (including the bereaved)”.
247
Though this
Report (together with the Second Report which says all I have to say as to compensation)
is a full report and I do not anticipate that it should be necessary to add any more to it, the
Inquiry has a function to consider the appropriateness, and timeliness, of the response to
the recommendations it makes.
243
244
245
246
247
s14(1)(a) Inquiries Act 2005 RLIT0002407
The Bichard Inquiry Report 22 June 2004 p4 RLIT0002389, The Bichard Inquiry Final Report 15 March
2005 p6 RLIT0002390
The Bichard Inquiry Final Report 15 March 2005 p6 RLIT0002390
Submissions on behalf of the core participants represented by Milners Solicitors August
2023 p4 SUBS0000070
Infected Blood Inquiry Terms of Reference para 5a, para 8 INQY0000458
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There has been some concern, as anyone who has followed the proceedings of the House
of Lords Statutory Inquiries Committee will be aware, as to the follow up of progress
towards considering and, if accepted, implementing the recommendations of public
Inquiries. The penultimate chapter in this Report considers the response of government to
the recommendations made to it by Sir Robert Francis, and the recommendations made to
it by this Inquiry in its Second Interim Report which followed. It has shown that assurances
have been given, and not kept. It has demonstrated that the reasons for this have not been
revealed in full to the public. It has led to a real and understandable fear that without a clear
process or timetable there may be a dragging of feet. As I have said repeatedly in public,
delay not only causes frustration, but compounds the harm and suffering many of those
infected and affected have endured. In the context of this Inquiry, perhaps beyond all other,
it is unconscionable to allow a state of affairs to exist in which these fears are realised.
I am satisfied that I must do what I properly can within my powers to try to ensure this
does not happen.
As to the timetable, I anticipate that
within
the next 12 months the Government will have
considered and either committed to implementing the recommendations which I make, or has
given sufficient reason, in sufficient detail for others to understand, why it is not considered
appropriate to implement any one or more of them. During that period, and
before
the end
of this year, the Government should report back to Parliament as to the progress made on
considering and implementing the recommendations. I anticipate that at that stage I should
be able to tell the Minister that the Inquiry has fulfilled its terms of reference. But I shall do
so only if I am satisfied that there is no further role I can usefully play in preventing delay.
I also recommend that the Public Administration and Constitutional Affairs Committee
(“PACAC”) should review both the progress towards responding to the recommendations,
and, if they are accepted, towards implementing them. Though the recommendations are
capable of covering the work of different select committees (health, home affairs to name
but two) it is essential that the response be viewed as a whole. The rationale for there being
a select committee which should have these tasks is:
• The reputation for independence which select committees have, especially in recent
times with the live broadcast of many of their proceedings. They are part of the
Parliamentary process. The Inquiry reports to a Minister; the Minister is answerable
to Parliament; select committees have the ability to scrutinise the actions (or
inaction) of the Minister.
• A 2017 Institute for Government report suggested that select committees could
examine annual progress updates from government on the state of implementation
of inquiry recommendations;
248
248
282
Institute for Government
How public inquiries can lead to change
December 2017 p6 WITN7523003
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• INQUEST proposed that there should be a National Oversight Mechanism which is
structurally and operationally independent;
249
• Dame Diana Johnson MP (herself chair of a select committee) has argued that
select committees are well equipped to carry out “detailed
scrutiny”
on the adequacy
of the government’s proposed response to inquiry recommendations, and feels that
this approach should become the norm;
250
• The House of Commons Health and Social Care Select Committee has set
up a new independent expert panel, which appears to be the first committee
linked arrangement, to evaluate “progress
the Government has made against its
own commitments”.
251
– Advice to ministers from civil servants may well be tempered by knowing that a
body likely to command respect will potentially examine the outcome, apparent
logic and timeliness of that advice – and will do so in public.
– Such a process is within the general scope of Parliamentary powers, and also
generally open to press and media comment. The history set out in the chapters
of this Report which record the Government response to what had happened
show that on a number of occasions action appears to have been prompted by
impending publicity.
The rationale for recommending that, of the select committees that might have been
suggested, PACAC take on this function is that its role includes the scrutiny of government
operation. The committee is experienced in high profile matters of public interest. Government
generally provides responses to committee recommendations, and often there are further
reports and responses. PACAC is appointed by the House of Commons to examine the reports
of the Parliamentary and Health Service Ombudsman which are laid before the House, and
matters in connection therewith; to consider matters relating to the quality and standards
of the administration provided by Civil Service departments and other matters relating to
the Civil Service; and to consider constitutional issues. The members of the committee are
drawn from the three largest political parties, and the committee itself publishes its results
through reports and making its recommendations known to the government.
PACAC also has some experience in providing post-inquiry scrutiny of government.
Following controversy over the Iraq Inquiry PACAC launched a short inquiry into the conduct
of public inquiries and the machinery of government. The committee’s report recommended
that the government must assess, as a matter of urgency, how the Iraq Inquiry could have
been carried out more quickly, and must report its findings to Parliament. In that connection
249
250
251
Inquest
No More Deaths: Learning, action, and accountability: the case for a National Oversight
Mechanism
June 2023 p4 RLIT0002401
Johnson
How to hold the government to account on public inquiries
The Guardian 30 May
2023 RLIT0002397
House of Commons Health and Social Care Committee
Expert Panel: Evaluation of the Government’s
progress on meeting patient safety recommendations
19 March 2024 p5 RLIT0002393
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it wrote “We
remain concerned about the lack of mechanisms for meaningful Parliamentary
oversight over the establishment of both statutory and non statutory inquiries.”
252
The state and capabilities of the Civil Service has been a long running concern for the
Committee.
253
It has considered and reported on propriety of governance in the wake of the
collapse of financial services firm Greensill Capital and revelations about its closeness to
government and its lobbying activities.
254
These considerations lead me to recommend:
12. Giving effect to Recommendations of this Inquiry
(a)
Within the next 12 months, the Government should consider and either
commit to implementing the recommendations which I make, or give sufficient
reason, in sufficient detail for others to understand, why it is not considered
appropriate to implement any one or more of them.
During that period, and
before
the end of this year – the Government should
report back to Parliament as to the progress made on considering and
implementing the recommendations.
This timetable should not interfere with earlier consideration and response to
the Recommendations of the Second Interim Report of the Inquiry
The Public Administration and Constitutional Affairs Committee (“PACAC”)
should review both the progress towards responding to the Inquiry’s
recommendations and, to the extent that they are accepted, implementing
those recommendations
PACAC should accept the role in respect of any future statutory inquiry of
reviewing government’s timetable for consideration of recommendations, and
of its progress towards implementation of that inquiry’s recommendations.
(b)
(c)
(d)
(e)
The Recommendations
1. Compensation
My principal recommendation remains that a compensation scheme should be set up now.
252
253
254
Public Administration and Constitutional Affairs Committee
Lessons still to be learned from the Chilcot
Inquiry
27 February 2017 p16 RLIT0002400
Public Administration and Constitutional Affairs Committee
Developing Civil Service Skills: a unified
approach
30 November 2015 RLIT0002395
Public Administration and Constitutional Affairs Committee
Propriety of Governance in Light of
Greensill
29 November 2022 RLIT0002402
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2. Recognising and remembering what happened to people
(a)
A permanent memorial be established in the UK and consideration be given
to memorials in each of Northern Ireland, Wales and Scotland. The nature of
the memorial(s), their design and location should be determined by a memorial
committee consisting of people infected and affected and representatives of the
governments. It should be funded by the UK government.
A memorial be established at public expense, dedicated specifically to the children
infected at Treloar’s school. The memorial should be such as is agreed with those
who were pupils at Treloar’s.
There should be at least three events, approximately six months apart, drawing
together those infected and affected, the nature and timing of which should
be determined by a working party as described above, facilitated by some
central funding.
(b)
(c)
3. Learning from the Inquiry
(a)
The General Medical Council, and NHS Education for Scotland, Health Education
and Improvement Wales, Northern Ireland Medical and Dental Training Agency and
NHS England, should take steps to ensure that those “lessons to be learned” which
relate to clinical practice should be incorporated in every doctor’s training.
They should look favourably upon putting together a package of training materials,
with excerpts from oral and written testimony, to underpin what can happen in
healthcare, and must be avoided in future.
The Inquiry website is maintained online.
(b)
(c)
4. Preventing future harm to patients: achieving a safety culture
(a)
Duty of candour
(i)
(ii)
A statutory duty of candour in healthcare should be introduced in
Northern Ireland.
The operation of the duties of candour in healthcare in Scotland and in
Wales should be reviewed, as it is being in England, to assess how effective
its operation has been in practice. Since the duty was introduced in 2023 in
Wales, the review there need not be immediate, but should be no later than
the end of 2026.
The review of the duty of candour currently under way in England should be
completed as soon as practicable.
(iii)
(iv) The statutory duties of candour in England, Scotland, Wales (and Northern
Ireland, when introduced) should be extended to cover those individuals in
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leadership positions in the National Health Service, in particular in executive
positions and board members.
(v)
Individuals in leadership positions should be required by the terms of their
appointment and by secondary legislation to record, consider and respond
to any concern about the healthcare being provided, or the way it is being
provided, where there reasonably appears to be a risk that a patient might
suffer harm, or has done so. Any person in authority to whom such a report is
made should be personally accountable for a failure to consider it adequately.
Success in implementation will be measured by the extent to which there is an
increase in the number of reports made of near miss incidents to the designated data
collector; and a decline in the number of widespread or significant healthcare failures.
(b)
Cultural change
(i)
That a culture of defensiveness, lack of openness, failure to be forthcoming,
and being dismissive of concerns about patient safety be addressed both by
taking the steps set out in (a) above, and also by making leaders accountable
for how the culture operates in their part of the system, and for the way in
which it involves patients.
(c)
Regulation
(i)
That external regulation of safety in healthcare be simplified. As a first step
towards this, there should be a UK wide review by the four health departments
of the systems of external regulation, with the aim of addressing all the points
made earlier in this Report and in other reports since 2000.
That the national healthcare administrations in England, Northern Ireland,
Scotland and Wales explore, and if appropriate, support the development
and implementation of safety management systems (“SMS”s) through SMS
coordination groups (as recommended by the HSSIB), and do so as a
matter of priority.
(ii)
Success in implementation will be measured by the percentage of patients who
know to whom they can express any concerns they may have about safety, who will
take up their cause, and what they can expect from them. At the same time, it will
be measured by the extent to which those who are busy working within the system,
especially those in leadership roles, have clarity as to what, precisely, is expected
of them, from whom. It should also be measured by a reduction in avoidable harm
from both errors and systemic issues.
(d)
Patient records
(i)
Before the end of 2027 there should be a formal audit, publicly reported, of the
extent of success of digitisation of patient records in each of the four health
jurisdictions of the UK, measuring at least the levels of patient access to their
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personal records, their ability to identify and correct apparent errors in them,
their interoperability, and the confidence of health professionals in the detail,
accuracy and timeliness of any record they enter, and that little material which
should be recorded has been omitted. Next steps should be identified.
(e)
 Consideration should be given by the national healthcare administrations in
England, Scotland, Wales and Northern Ireland, to further coordination of their
approaches particularly to ensure that patterns of harm, or trends, are identified and
any response which for the sake of patient safety would be better coordinated than
left to each individual administration can collaboratively be agreed and implemented.
5. Ending a defensive culture in the Civil Service and government
(a)
The Government should reconsider whether, in the light of the facts revealed by this
Inquiry, it is sufficient to continue to rely on the current non-statutory duties in the
Civil Service and Ministerial Codes, coupled with those legal duties which occur on
the occasions when civil servants and ministers interact with courts, inquests and
inquiries, as securing candour.
If, on review, the Government considers that it is sufficient to rely on the current
non-statutory duties in the Civil Service Code, it should nonetheless introduce
a statutory duty of accountability on senior civil servants for the candour and
completeness of advice given to Permanent Secretaries and Ministers, and the
candour and completeness of their response to concerns raised by members of the
public and staff.
The Government should consider the extent to which Ministers should be subject to
a duty beyond their current duty to Parliament under the Ministerial Code.
(b)
(c)
6. Monitoring liver damage for people who were infected with Hepatitis C.
(a)
All patients who have contracted hepatitis via a blood transfusion or blood products
should receive the following care:
(i)
those who have been diagnosed with cirrhosis at any point should receive
lifetime monitoring by way of six-monthly fibroscans and annual clinical review,
either nurse-led, consultant-led or, where appropriate, by a GP with a specialist
interest in hepatitis
those who have fibrosis should receive the same care
where there is any uncertainty about whether a patient has fibrosis they should
receive the same care
(ii)
(iii)
(iv) fibroscan technology should be used for liver imaging, rather than alternatives
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(v)
those who have had Hepatitis C which is attributable to infected blood or blood
products should be seen by a consultant hepatologist, rather than a more
junior member of staff, wherever practicable
(vi) those bodies responsible for commissioning hepatology services in each of the
home nations should publish the steps they have taken to satisfy themselves
that the services they are commissioning meet the particular needs of the
group of people harmed by NHS treatment
7. Patient Safety: Blood transfusions
(a)
Tranexamic acid
(i)
In England Hospital Transfusion Committees and transfusion practitioners
take steps to ensure that consideration of tranexamic acid be on every hospital
surgical checklist; that hospital medical directors be required to report to their
boards and the chief executive of their Trust as to the extent of its use; and
that the board report annually to NHS England as to the percentage of eligible
operations which have involved its use. If the percentage is below 80% or
has dropped since the previous year, this report should be accompanied
with an explanation for the failure to use more tranexamic acid and thereby
reduce the risk to patient safety that comes with using a transfusion of blood
or red blood cells.
In Scotland, Wales and Northern Ireland offering the use of tranexamic acid
should be considered a treatment of preference in respect of all eligible surgery.
Consideration be given to standardising and benchmarking transfusion
performance between hospitals in order to deliver better patient
blood management.
(ii)
(iii)
(b)
Progress in implementation of the
Transfusion 2024
recommendations be reviewed,
and next steps be determined and promulgated; and that in Scotland the 5 year
plan is reviewed in or before 2027 with a view to determining next steps.
The responsibility for this in England is that of the NHS, shared with NBTC, the
Royal Colleges (as appropriate), and NHSBT.
(c)
(d)
Transfusion laboratories should be staffed (and resourced) adequately to meet the
requirements of their functions.
That those bodies concerned with undergraduate and postgraduate training
across the UK of those people who are, or intend to be, working in the NHS
ensure that they are adequately trained in transfusion, that the standards by which
sufficiency of training is measured are defined, and accountability for training in
transfusion be defined.
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(e)
That all NHS organisations across the UK have a mechanism in place for
implementing recommendations of SHOT reports, which should be professionally
mandated, and for monitoring such implementation.
Establishing the outcome of every transfusion
(i)
That a framework be established for recording outcomes for recipients of blood
components. That those records be used by NHS bodies to improve transfusion
practice (including by providing such information to haemovigilance bodies).
Success in achieving this will be measured by the extent to which the SHOT
reports for the previous three years show a progressive reduction in incidents
of incorrect blood component transfusions measured as a proportion of the
number of transfusions given.
(ii)
To the extent that the funding for digital transformation does not already
cover the setting up and operation of this framework, bespoke funding
should be provided.
That funding for the provision of enhanced electronic clinical systems in
relation to blood transfusion be regarded as a priority across the UK.
(f)
(iii)
8. Finding the undiagnosed
(a)
(b)
When doctors become aware that a patient has had a blood transfusion prior to
1996, that patient should be offered a blood test for Hepatitis C.
As a matter of routine, new patients registering at a practice should be asked if they
have had such a transfusion.
9. Protecting the safety of haemophilia care
(a)
(b)
That peer review of haemophilia care should continue to occur as presently practised,
with any necessary support being provided by NHS Trusts and Health Boards; and
That NHS Trusts and Health Boards should be required to deliberate on peer review
findings and give favourable consideration to implementing the changes identified
with a view to ensuring comprehensive, safe, care.
A peer review of each centre should take place not less than once every five years.
The necessary administrative and clinical resources should be provided by hospital
trusts and boards, integrated care boards, and service commissioners to facilitate
multi-disciplinary regional networks to discuss policy and practice in haemophilia
and other inherited bleeding disorders care, provided they involve patients in
their discussions.
(c)
(d)
Recommendations
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(e)
recombinant coagulation factor products should be offered in place of plasma-
derived ones where clinically appropriate. Service commissioners should ensure
that such treatment decisions are funded accordingly.
that the National Haemophilia Database, run by the UKHCDO, merits the support of
additional central funding.
Giving patients a voice
That the patient voice be enabled and empowered by the following measures:
(i)
clinical audit should as a matter of routine include measures of patient
satisfaction or concern, and these should be reported to the board of the
body concerned.
Success in this will be measured by comparing the measure of satisfaction
from one year to the next, such that the reports to the board concerned
demonstrate a trend of improvement by comparing this year’s outcomes with
the similar outcomes from at least the two previous years.
(ii)
that the following charities receive funding specifically for patient advocacy:
the UK Haemophilia Society; the Hepatitis C Trust; Haemophilia Scotland; the
Scottish Infected Blood Forum; Haemophilia Wales, Haemophilia Northern
Ireland, and the UK Thalassaemia Society.
that favourable consideration be given to other charities and organisations
supporting people infected and affected that were granted core participant
status (as listed on the Inquiry website) to continue to provide support for at
least the next 18 months. Further support should be reviewed at that stage
with a view to it continuing as appropriate.
(f)
10.
(a)
(iii)
(iv) particular consideration be given, together with the UK Thalassaemia Society
and the Sickle Cell Society, to how the needs of patients with thalassaemia or
sickle cell disease can best holistically be addressed.
(v)
steps be taken to give greater prominence to the online Yellow Card system to
those receiving drugs or biological products, or who are being transfused with
blood components.
11.
(a)
Responding to calls for a public inquiry
that a minister should retain the power to call an inquiry as the minister sees fit,
in accordance with the Inquiries Act 2005 – but where a minister does not choose
to do so, then:
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(b)
if there is sufficient support from within Parliament for there to be an inquiry,
the question whether there should be one should be referred to PACAC for it to
consider the question.
If it appears to PACAC that there is sufficient concern to justify a public inquiry,
either because what happened and why has caused concern (as the committee
sees it) or there are likely to be lessons learned which may prevent similar concerns
arising in future, the committee may recommend to an appropriate minister that
there be an inquiry.
If the minister disagrees with the recommendation, they must set out in detail and
publish reasons for this disagreement which are sufficient to satisfy PACAC that the
matter has been carefully and properly considered.
Giving effect to Recommendations of this Inquiry
Within the next 12 months, the Government should consider and either commit
to implementing the recommendations which I make, or give sufficient reason, in
sufficient detail for others to understand, why it is not considered appropriate to
implement any one or more of them.
During that period, and
before
the end of this year – the Government should report
back to Parliament as to the progress made on considering and implementing the
recommendations.
This timetable should not interfere with earlier consideration and response to the
Recommendations of the Second Interim Report of the Inquiry
The Public Administration and Constitutional Affairs Committee (“PACAC”) should
review both the progress towards responding to the Inquiry’s recommendations
and, to the extent that they are accepted, implementing those recommendations
PACAC should accept the role in respect of any future statutory inquiry of reviewing
government’s timetable for consideration of recommendations, and of its progress
towards implementation of that inquiry’s recommendations.
(c)
(d)
12.
(a)
(b)
(c)
(d)
(e)
Recommendations
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