SUU, Alm.del - 2019-20 - Bilag 395: Kopi af brev til Europa-Kommissionen om European Health Union

Sundheds- og Ældreudvalget 2019-20
SUU Alm.del Bilag 395
Offentligt

12 May 2020

A EUROPEAN HEALTH UNION

- INCREASING EU COMPETENCE IN HEALTH -

COPING WITH COVID19 AND LOOKING TO THE FUTURE

The coronavirus has highlighted that the European Union does not have strong enough tools

to deal with an emergency such as the spread of a novel infectious disease, which by its nature

knows no borders. While the EU has significant competence in public health, healthcare

systems remain the responsibility of Member States, with minimal cooperation at EU level.

Article 168 of the Treaty stipulates that ‘a high level of human health protection shall be

ensured in the definition and implementation of all Community policies and activities’ and

the European Court of Justice has ruled on numerous occasions that the EU can pursue public

health objectives through internal market measures.

Currently the EU regulates pharmaceuticals, medical devices, tobacco, alcohol, food and

chemicals, amongst others. There are EU rules on clinical trials, and health research is

financed through Horizon 2020, the upcoming Horizon Europe, the Health Programme and

other EU funds. The European Medicines Agency, European Chemical Agency and European

Food Safety Authority are all executive agencies with important public health functions.

There is limited coordination of healthcare systems through voluntary measures, but also

through the Cross Border Healthcare Directive, and the Health Technology Assessment

Regulation, which is currently being negotiated, among others.

For emergency response there is the Union Civil Protection Mechanism, the Cross Border

Health Threats Decision (including joint procurement), and the European Centre for Disease

prevention and Control. All of these are being tested to their limits during the current crisis.

The right to physical and mental health is a fundamental human right. Every person, without

discrimination, has the right to access modern and comprehensive healthcare. We have to

safeguard citizens’ wellbeing not only during this current crisis but also in the aftermath.

Never again can we allow doctors and nurses to be exposed to such high risk and be forced

to make decisions on who can and cannot receive healthcare. Therefore, S&D calls for the

urgent creation of a European Health Union, which would encompass:



Stress-testing of EU healthcare systems

A new Directive for Minimum Standards for Quality Healthcare

A European Health Response Mechanism

Strengthened Joint Procurement Mechanism under a regulation

Revision of the Transparency Directive for pricing and reimbursement of medicines

Full implementation of Cross Border Healthcare Directive and Clinical Trials Regulation

Strengthened EU health agencies and strengthened civil protection capacities

Legislative action on antimicrobial resistance and vaccination

Robust Pharmaceutical Strategy and a European Resilience Strategy

European Health Data Space

A new approach to European health research

New legislation on health and safety in the workplace

SUU, Alm.del - 2019-20 - Bilag 395: Kopi af brev til Europa-Kommissionen om European Health Union

Stress Testing and Minimum Standards for Quality Healthcare

Ensuring everyone can use the health services they need without experiencing financial

hardship – universal health coverage – is a Sustainable Development Goal all countries have

committed to reach by 2030.

Health is an investment in human capital, social and economic

development, which contributes significantly to the protection of human rights and dignity.

Health systems are facing the most serious global pandemic in a century. The current crisis

exposes the difference in capacity between Member States’ healthcare capacities, and shows

that we are reliant on our neighbours having sufficiently resilient systems. Additionally some

Member States suffer significantly from brain drain, with highly qualified healthcare

professionals opting to work in Member States with better pay and conditions that their own.

In the face of different types of crises in recent years, the European Union has strengthened

the systems that have proven to be too weak. For example, the EU has carried out stress tests

in the energy sector and the banking system to assess the resilience of these sectors and their

potential needs.

In order to be prepared for future pandemic scenarios, Member States should carry out stress

tests on their healthcare systems to verify that they are prepared for the next health crisis.

These tests should be carried out according to parameters established by the Commission

and should help Member States detect the areas where their national healthcare systems

need improvements and financing. Member States should commit to carrying out these tests

as soon as possible.

Based on the findings of the stress tests the Commission should propose a Directive on

minimum standards for quality healthcare. This would encompass a set of common criteria

to be reported to the European Commission on a regular basis, using parameters such as

hospital beds per head, critical care capacities, numbers of doctors and nurses per head, rate

of health expenditure and access and affordability of healthcare for all, including for

vulnerable populations. It should contain a minimum permitted level of health coverage. A

European Healthcare Index summarising the relevant indicators would help track the progress

of healthcare systems in the EU. While the management, organisation and funding of

healthcare systems would remain Member State competences, European minimum

standards for quality healthcare would guarantee patient safety, decent working and

employment standards for healthcare workers and European resilience in the face of

pandemics and other public health crises.

Alongside this, healthcare indicators must be integral to the European Semester, part of our

agenda of reforming the Semester to reflect the SDGs.

S&D calls on the Member States to carry out stress testing of their healthcare systems, to

assess their preparedness for epidemics and ability to meet the SDG targets. Based on the

findings we call for an EU Directive for Minimum Standards for Quality Healthcare, which

would set the EU on a clear path to providing exceptional healthcare in all regions of Europe.

S&D Position Paper - A European Health Union

SUU, Alm.del - 2019-20 - Bilag 395: Kopi af brev til Europa-Kommissionen om European Health Union

European Health Response Mechanism

COVID19 has affected Member States at different times and in varying severity. Some

healthcare systems surpassed their capacities, while others still had critical care facilities

available. Many healthcare professionals expressed an interest in helping the most affected

areas. The Commission has produced guidelines to facilitate the treatment of patients, and

temporary deployment of doctors, in other Member States. The Union Civil Protection

Mechanism has also been used to mobilise doctors and nurses across Member States, and

the mechanism includes capacities such as emergency medical teams. The rescEU capacity

stockpiled key resources like masks, ventilators and laboratory equipment, to be deployed

where most needed. The Commission has set up a panel of experts, which is being regularly

consulted together with the ECDC and EMA on the COVID19 response.

While this work is to be commended, much of it came much too slowly, because the systems

were not in place or had not been used before on this scale. The EU has the power to adopt

measures to combat cross-border health threats under Article 168 paragraph 5.

S&D calls for these working methods to be formalised into a stronger legislative framework,

building on measures in the Cross Border Healthcare Directive, which has been poorly

implemented, and the Union Civil Protection Mechanism. This would allow patients and

healthcare professionals to move more easily between Member States as needed, and give

the Commission a greater role in identifying needs and surpluses. At its core would be a

health crisis management unit, coordinated by the ECDC and led by the Commissioner for

Health and the Commissioner for Crisis Management, together with the EMA and the expert

panel. This unit will be prepared with a pandemic emergency plan, in order to have a

coordinated response and the capacity to rapidly scale up the response to future heath crises,

based on standardised information. In its resolution on COVID19 the Parliament supported a

general call for a European Health Response Mechanism.

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As part of the response mechanism, the rescEU capacity should be reinforced, including the

stockpiling and emergency medical team capacity. A recent instrument, rescEU does not yet

have sufficient capacities and resources, and its functioning should be revised in light of the

experience gathered from COVID-19.

S&D calls for a European Health Response Mechanism to ensure the EU is ready to respond

immediately, with solidarity and unity, to a health threat. The Mechanism would be expert-

led, have its own medical resources under a strengthened Union Civil Protection Mechanism,

and facilitate the movement of patients and healthcare workers in the most efficient way.

Joint procurement and transparency

In the face of a crisis, some countries have been tempted to engage in export restrictions to

protect domestic supply of medicines and medical devices. We must avoid ‘me first’

behaviour when it comes to fighting a common enemy. For that reason we have the possibility

at EU level to procure treatments and vaccines jointly. Particularly regarding COVID19, S&D

will strongly advocate for rapid, fair, equal and affordable access to future vaccines and

treatments once they are available.

S&D Position Paper - A European Health Union

SUU, Alm.del - 2019-20 - Bilag 395: Kopi af brev til Europa-Kommissionen om European Health Union

More widely, there is a desperate need for new treatments for a number of conditions,

particularly new antibiotics in the face of rising antimicrobial resistance. No innovative

antibiotics have been developed in recent decades. Similarly, for other diseases only a small

number of truly curative medicines have been developed in recent years, with many newly

approved medicines designed to alleviate the symptoms of chronic diseases but not to cure

them. Therefore, when the breakthrough medicines come they are often unaffordable for

national healthcare systems, and EU Member States are competing against each other for

quick access and the best deal.

EU joint procurement is an excellent tool that we have at our disposal to avoid competing

against each other and secure equal access to important medicines and medical devices for

Member States. This should be more routinely used with new treatments and vaccines. We

should promote EU joint procurements for new innovative antibiotics, new vaccines and new

curative medicines, for example for hepatitis C. It should also be used for treatments of rare

diseases, which are not available in all Member States because of small patient populations

or high prices. It should be more centralised, allowing the Commission to react more swiftly

to needs. The Cross Border Health Threats Decision should be revised as a Regulation to

address all of these concerns.

We also urgently call on the Commission and Member States to revisit the idea of

transparency of net pricing and reimbursement of different treatments, to allow Member

States equal footing when negotiating with pharmaceutical companies for treatments that

are not jointly procured. This was blocked by the Council when it was last attempted nearly

a decade ago. We also need to secure the transparency of clinical trial results through the

swift implementation of the Clinical Trials Regulation, which has been heavily delayed.

S&D calls for the joint procurement procedure to be strengthened within a European

regulation, to allow it to become the norm for procuring certain treatments. Transparency

measures must also be improved. This will guarantee equal access to critical medicines and

medical devices as fast as possible whilst avoiding price speculation between Member States.

Guaranteeing EU supply of pharmaceuticals and medical devices

Many pharmaceutical supply chains are reliant on active pharmaceutical ingredients (APIs) or

generics that are manufactured in China or India, sometimes by only one factory globally. The

export bans put in place by India during the COVID19 crisis, and the fall in production caused

by the crisis in China, highlight the very real dangers of relying on these supply chains for

essential medicines. It has underlined the need to strengthen the European production of

key products, building a strong EU health industry capable of producing equipment for our

hospitals, including medical devices, active pharmaceutical ingredients and medicines.

We expect the Pharmaceutical Strategy, originally forecast for the end of this year, to address

this issue. This strategy must include legislative measures, policies and incentives to

encourage production of essential APIs and medicines here in Europe to guarantee supply at

all times and to set up an EU system for the monitoring of medicines shortages. In this respect,

mandatory national inventories of medicines and medical devices should be set up, with a

S&D Position Paper - A European Health Union

SUU, Alm.del - 2019-20 - Bilag 395: Kopi af brev til Europa-Kommissionen om European Health Union

focus on the most critical ones, to be held in each Member State and communicated with the

Commission and EMA to ensure any shortages can be foreseen and addressed.

Targeted guidelines for the pharmaceutical sector are needed in the Public Procurement

Directive. These guidelines should clarify recommendations for Member States on what to

consider specifically for the pharmaceutical sector whilst awarding bids. It should be based

on the principle of the ‘most economically advantageous tender’ (‘MEAT’ criteria), which aims

to ensure the best value for money rather than simply the cheapest product. Things to

consider should include the contribution to the security of EU supply and sufficient

manufacturing lead-time to guarantee the supply of medicines for patients.

S&D calls for the Commission to publish the Pharmaceutical Strategy as soon as possible to

increase EU security of supply and encourage the production of essential APIs and medicines

in Europe. We also call for the Commission to mandate national inventories of medicines and

medical devices to be shared at a European level. Public procurement should also work

towards these goals.

Strengthening EU agencies and guidance in health

S&D calls for the two main EU health agencies, the ECDC and EMA, to have substantially

strengthened competences, budget and staff to enable them to provide world-class public

health protection at all times, including during epidemics. This call has also been supported

in the Parliament resolution. Not only is their work invaluable at this current moment, but

also to face ongoing threats in the EU such as HIV, tuberculosis and hepatitis, antimicrobial

resistance, chronic diseases and future epidemics. The ECDC should have the capacity to run

laboratory work and coordinate testing for infectious diseases. EMA should play a key role in

the coordination of the design and approval of EU clinical trials during crises, including the

use of companion diagnostics, to provide researchers with fast advice and access to clinical

trial sites in the EU for the trials that are most needed.

The EU has no direct equivalent of the US Biomedical Advanced Research and Development

Authority (BARDA), which is responsible for procurement and development of

countermeasures against bioterrorism, chemical, nuclear and radiological threats as well as

pandemic influenza and emerging diseases. The creation of an EU BARDA should be

considered. The role of the European Agency for Safety and Health at Work (EU-OSHA) should

also be strengthened to ensure healthcare workers are not put at risk.

The agencies and the Commission facilitate a lot of exchange of best practice and produce

very relevant guidance and strategies. However, for the most part, following this guidance is

voluntary. For example, EU Action Plans on antimicrobial resistance and vaccination should

be reinforced with binding measures, including an EU vaccination card for citizens. Cancer

screening guidelines could be made mandatory. In the COVID19 crisis we have seen that

different Member States record deaths or recoveries related to COVID19 differently, which

makes EU-wide comparison of data difficult. ECDC may develop guidance on this, but it will

be up to Member States to follow it. Key guidance like this from the ECDC should be made

mandatory, along with common protocols for hospitalisation and discharge of patients with

infectious diseases. Standardisation, sharing of data and the adoption and promotion of

S&D Position Paper - A European Health Union

SUU, Alm.del - 2019-20 - Bilag 395: Kopi af brev til Europa-Kommissionen om European Health Union

international health data standards, should also be addressed by the Commission in the

creation of the European Health Data Space, while fully respecting European data protection

framework, including the GDPR, and in full consultation with civil society.

New tech solutions and innovations may make a difference when facing pandemics and health

crisis similar to COVID-19, and when exiting the current situation and restrictions. When new

solutions emerge, EU should always aim for a common approach between MS enhancing

cooperation and cross-border actions.

S&D calls for the budgets and competences of the ECDC and EMA to be increased, for the

creation of an EU BARDA to be considered, and for the role of EU-OSHA to be strengthened.

EU guidance and action plans should be made mandatory in some cases, and reinforced with

legislative measures. Data needs to be shared more routinely, while ensuring quality and

security standards, transparency about data access and control and fully respecting patients’

privacy and the GDPR. In this regard, S&D calls for a proposal on the creation of the European

Health Data Space.

One health

COVID19 has demonstrated the inter-dependencies between human health and the health of

our planet. The emergence of zoonosis, such as COVID19, that transfer from animals to

humans is exacerbated by climate change and environmental degradation. More attention

should be paid to the implications of unsustainable practices that lead to habitat and

biodiversity loss and antimicrobial resistance.

We must clearly highlight the connections between human health, animal health and

environmental protection, and explore ways to reinforce the application of ‘One Health’

approach in Europe, starting by taking action on the inappropriate and excessive use of

antibiotics in humans, as we have already done for animals. The European References

Networks (ERNs), which remotely join together European experts on specialist topics, should

be expanded to include infectious diseases and zoonosis. Member States could build centres

of excellence on these topics and other pressing health issues, which could join the ERNs.

The exacerbation of COVID19 by issues such as tobacco use, poor nutrition, air pollution and

health inequalities shows the importance of continuing our work in those fields in a holistic

approach.

S&D call for action on human, animal and environmental help to protect us against another

emerging disease. Legislative action should be taken on antibiotic use in humans in the EU

and an agreement should be reached at global level. S&D calls for the ERNs to be expanded

to look at more issues including infectious diseases and zoonosis.

S&D Position Paper - A European Health Union

SUU, Alm.del - 2019-20 - Bilag 395: Kopi af brev til Europa-Kommissionen om European Health Union

European Resilience

The COVID19 crisis highlighted the lack of resilience of our underfunded healthcare systems,

but also exposed weaknesses in our industries. S&D calls on the European Commission to

develop a strategy for a “Resilient Europe”, consisting of a risk assessment map and

intervention options to address, among other things, sound management and investments in

healthcare systems and pandemic response at European level, including a plan for resilient

supply chains in the EU. This is needed for the EU to regain its health sovereignty, as well as

boosting the European medical and surgical manufacturing industry as a high-tech and high

value-added sector. Health should be identified as a key Strategic Value Chain for the

European Union.

Interventions should be focused on protecting and secure citizens, managing critical

infrastructures and taking full advantage of digitalization and automation. Remote medical

diagnostics and treatment will help to ease pressure on Europe's healthcare systems,

providing specialised healthcare services over long distances, effectively eliminating the need

for the physician and patient to always be present in the same place, reducing costs and

limiting the possibility of transmitting infectious diseases between patients and healthcare

professionals where appropriate.

Needs and resources available at local and regional level

could be assessed in order to provide information which would be very useful to the

Commission in taking more centralised decisions in response to epidemics.

EU vision in Health Research

COVID-19 is clearly showing us that we need a coordinated, collaborative and open approach

in the field of research, especially research to help us prevent and recover from future

pandemics. While in terms of research output Europe is a leader in terms of both quality and

volume, better results will be achieved, including in the medical field, if this research is

translated into products such as medicines, vaccines, equipment or devices meant to save or

improve lives. The European Commission should be given a stronger role in coordinating

research carried out at national level. Currently decisions relating to research are made

primarily at the level of Member States. 'European research' is mainly considered to be

research funded by the European Union rather than research undertaken within the entire

European continent. While most scientific public health research publications (and abstracts)

are now in English, public health research is mainly undertaken in national languages, which

have to be translated for scientific reporting. Moreover, research projects through national

funding agencies are often limited, by law or regulation, to researchers within the funding

Member State, which means cross-border health research is still rare. The Health Programme

is designed to encourage cross-border health research and projects, but has a very small

budget. The European Commission, together with the Member States and the European

Parliament, can contribute to overcoming barriers, avoiding duplication and supporting valid

ideas in the best interests of patients and citizens. Open science will be crucial in this regard

and as the EU has been a pioneer in this field, we should use this strengthen to push this

leading position forward.

Horizon 2020 and Horizon Europe are meant to finance European collaborative projects in

fields like environmental safety, health information, health determinants and health services,

but Member States need to integrate these programmes and national programmes, which

S&D Position Paper - A European Health Union

SUU, Alm.del - 2019-20 - Bilag 395: Kopi af brev til Europa-Kommissionen om European Health Union

will allow the European Union to better perform in health research and innovation and

compete globally, avoiding the dependence from third countries. This will be key in the exit

and recovery from the crisis. In order to help us achieve that, we need strong financial backing

for research and innovation. When research is wholly or partially funded by European funding

and other public funds, the results need to stay within the public domain and have clear

affordability and accessibility conditions attached to them.

S&D calls for a new, more integrated approach to European research to ensure that it is fully

coordinated and we can make the most of our world-class research capacities in the field of

health. The budget of the Health Programme should be increased.

Health and Safety at Work

Every worker has the right to a healthy and safe workplace, no matter the size of the

employer, the contract or the place of employment. Safe workplaces are good for employees

but also for businesses and the economy – fewer workplace accidents and diseases mean

healthier and happier individuals, more work done in less time and more money saved for our

healthcare systems. That is why we are expecting the European Commission to continue

updating the Directive on the protection of workers from exposure to substances which cause

cancer and mutations in DNA and extend it to include substances harmful to reproduction, as

well as to cytotoxic substances.

The new Strategic Framework for Health and Safety has been long overdue and must reflect

the COVID-19 crisis in terms of ensuring health and safety at the workplace. The pandemic

has resulted in millions of employees working remotely, working under stressful conditions,

overworking and putting their own health at risk. We urgently need a number of legislative

measures to be put in place at the European level in this context.

S&D calls for legislation on the Right to Disconnect, a new Directive on Work-related

musculoskeletal disorders such as back, neck or shoulder pain, and a new Directive on Mental

Well-being at the Workplace aiming at recognising anxiety, depression and burn-out as

occupational diseases, establishing mechanisms for prevention and reintegration of affected

employees into the workforce, and protecting workers from mental illness in the workplace.

https://www.europarl.europa.eu/factsheets/en/sheet/49/public-health

https://www.un.org/sustainabledevelopment/health/

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https://www.europarl.europa.eu/doceo/document/RC-9-2020-0143_EN.html

S&D Position Paper - A European Health Union