EUU, Alm.del - 2020-21 - Bilag 490: Høringssvar vedr. revision af den generelle lægemiddellovgivning

Europaudvalget 2020-21
EUU Alm.del Bilag 490
Offentligt

Holbergsgade 6

DK-1057 Copenhagen K

P +45 7226 9000

F +45 7226 9001

M [email protected]

W sum.dk

Minister for Health

European Commission

Date: 27-04-2021

Section: MEDINT

Case Officer: DEPKLN

Case: 2106758

Doc.: 1704240

Pharmaceutical strategy for Europe: Combined evaluation

roadmap/inception impact assessment

Denmark would like to use this opportunity to thank the European Commission (EC)

for all the efforts made in terms of the highly important work on the pharmaceutical

strategy for Europe. We agree on the need for an ambitious, long-term project in

order to make the system patient-centered, future-proof and crisis-resistant while

ensuring safe medicines of high quality. Of equal importance is the focus on the

se tor’s glo al o petiti e ess a d thus ai tai i g the EU as a attra ti e hu for

research, development and investment. Last, but not least the possibilities offered by

the increasing use of data for regulatory purposes should be further explored in order

for the legislative framework to be better equipped to respond to the scientific and

technological developments (including in a timely fashion for the benefit of patients

in particular and society in general).

From a Danish perspective, all of the objectives listed in the roadmap are key in order

to ensure the above. At the same time, Denmark acknowledges that there are many

different possible policy options to choose from in order to reach these objectives.

Denmark also shares the challenges pointed out by the EC that the strategy needs to

tackle. However, we believe that overall, the work with the pharmaceutical strategy

is on track.

The pharmaceutical strategy for Europe is multifaceted as it covers many aspects. A

substantial number of details, dependencies and interfaces between the various

objectives will inevitably be revealed over time as the work progresses. We would,

however, like to highlight some reflections for the purpose of the on-going work. We

consider that the areas outlined are vital in order to ensure a strengthened

pharmaceutical agenda within the EU.

Security of supply and APIs

APIs are a necessity in order to produce pharmaceuticals. Due to lower production

osts, a su sta tial u er of API’s for ge eri s a d iosi ilars i parti ular are

produ ed outside the EU a d so e API’s are a ufa tured o ly at a ery li ited

number of sites world-wide. Obviously, this makes the EU vulnerable, in particular

when demand increases as we have seen it happen during the pandemic.

It is vital that these challenges are not only addressed through the pharmaceutical

strategy, as the handling of the matter needs a multi-sectoral approach. Various

means may be considered in order to strengthen the supply chain. Potential

initiatives could include:



Strengthened role for the EU, including in crisis situations;

EUU, Alm.del - 2020-21 - Bilag 490: Høringssvar vedr. revision af den generelle lægemiddellovgivning



Strengthened resilience in the production stage, i.e. more diversity and

increased incentives to produce off-patent pharmaceuticals, including

antibiotics;

Registration requirements, i.e. registration of API as well as indication of

production capacity for the API registered.

Increased transparency in terms of production

–

and distribution pathways

would equally contribute positively as would the competence for member

states to act accordingly if the production of essential API is deemed too

fragile. Increased transparency would also make it easier to track and trace

the entire supply chain. The registration of APIs to improve transparency is

going to have to be supported by a robust database and changes in law to

oblige manufacturers to update information regularly.

Real world data and big data

The use of real-world data and big data provide for a substantial potential of

strengthening the entire life cycle of a pharmaceutical. National competent

authorities need to match the (data driven) development in this field. From a

regulatory perspective, it is critical to map the challenges that this (also) provides,

including evidence requirements.

That said, technological possibilities lead to a shift in paradigms where data may

provide for the following:



Compensate for lack of evidence, i.e. in relation to orphan drugs where small

patient populations make gold-standard clinical trials more difficult;

Strengthened pre-marketing phase as products may be authorized at an

earlier point in time and strengthened scientific advice;

Strengthened post-marketing phase;

Strengthening of the compiled set of decisions, including those to be made

by authorities as real-world data may lead to a more multifaceted dataset

for decision makers;

Strengthened basis for HTA-decisions to ensure timely access;

Strengthened possibilities to identify fraudulent data, e.g. in relation to

clinical trials



A strengthened digital agenda

From a Danish perspective, a strengthened digital agenda is vital in order for the EU

to remain an attractive region for research, development and production of

pharmaceuticals.

Increased digitalization will also facilitate overview and integration of data for the

benefit of data analysis. Overview of data will indeed strengthen decision making by

both competent authorities and industry as well as the public more generally and will

contribute positively in terms of e.g. the accessibility agenda.

Another aspect stemming from digitalization is the potential of reducing

(administrative) burdens and increasing the involvement of patients in order to

etter apture patie ts’ ie s, prefere es et . i relatio to their treat e t.

A strengthened digital agenda can not be achieved solely through the pharmaceutical

strategy. It requires attention in other strategies such as the strategies on

digitalization and on industry.

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EUU, Alm.del - 2020-21 - Bilag 490: Høringssvar vedr. revision af den generelle lægemiddellovgivning

At the same time, health data contain sensitive information so it is important to

e sure that data is used i a la ful a d se ure a er ith respe t for EU’s a d

Member States’

data prote tio regulatio a d pri iples.

Increased integration between innovation and technology in the development of

pharmaceuticals and focus on innovation throughout the life cycle of a pharma-

ceutical

The technological development indeed also contributes significantly to the

development of new medicines, e.g. within advanced therapy (ATMP).

Precision medicine, nano technology, 3D print, in-situ manufacturing etc. in many

aspects have positive implications on the patient. Therefore, it obviously also

prompts attention from national competent authorities as regards awareness on

public health and patient safety through regulatory means.

In view of the above, Denmark considers it appropriate to evaluate if the existing

regulatory processes are up to date as well as future-proof, including in terms of

authorization of medicines.

In view of the fast development in science and technology, we also find it advisable

to promote a more adaptive legislative framework. This work also needs to be

continuously coordinated with associated legislative fields, e.g. medical devices,

where the rapid technological development increasingly blurs the lines between

medicinal products and medical devices.

A balanced approach as regards incentives in order to ensure innovation within the

EU and continuous development of generics and biosimilar products

Denmark considers it

ital to e sure the regio ’s attra tiveness

in terms of financial

investments, research and development within the life science sector. Therefore, a

well thought out and balanced approach to incentives as well as an up-to-date and

future proof regulatory framework is key, taking into account the financial

sustainability of national health systems and the relationship with intellectual

property rights. The pursuit of affordable medicines must not counter vital incentives

to innovate, as this will undermine the long-term positive effects of having a strong

innovative pharmaceutical industry, whose importance to the EU has been amplified

in the current COVID-19 crisis.

In this regard, it is vital that the objective of establishing a tailored system of

incentives does not cause a destabilisation of the existing structures, bearing in mind

that predictability is key for investments in R&D. In addition, incentives should be

considered in a broader perspective, taking into account that other key factors such

as digitalization, a sound competitive environment, education, access to highly

qualified skills also form part of this agenda.

Disse i atio of est pra ti e glo ally a d fo us o the e viro e t

Production and distribution of medicines, science and technology all have global

dimensions, which accentuates the need for dialogue and knowledge sharing

between competent authorities at global level.

Therefore, it is key that the EU maintains and further increases our collaboration

globally. The current Covid-19 crisis has also amplified the need for international

engagement, including harmonization and knowledge and information sharing on

(quality) standards, collaboration and cohesion of regulatory frameworks.

Side 3

EUU, Alm.del - 2020-21 - Bilag 490: Høringssvar vedr. revision af den generelle lægemiddellovgivning

Along the same lines, Denmark would like to stress the need for a green approach

across the entire pharmaceutical value chain, and that such an approach must

equally be promoted by the EU at international level.

Yours sincerely,

Magnus Heunicke

Side 4