Europaudvalget 2019-20
EUU Alm.del Bilag 854
Offentligt
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Holbergsgade 6
DK-1057 Copenhagen K
P +45 7226 9000
F +45 7226 9001
M [email protected]
W sum.dk
Minister for Health and Senior Citizens
European Commission
DG Health and Food Safety
Date: 07-07-2020
Section: MEDINT
Case Officer: DEPKLN
Case: 2008770
Doc.: 1270791
Consultation on Road Map for the Pharmaceutical Strategy
–
timely access to affordable medicines
The Danish Government welcomes this opportunity to put forward our response to
the Road Map for the Pharmaceutical Strategy launched by the European
Commission in June.
The Road Map describes four categories of objectives that each contains a range of
sub-topics, which will be pursued through legislative and non-legislative actions.
From a Danish perspective, these objectives seem to capture the essence of the
broad range of issues that appear to require attention at European level.
The Danish Government supports the Commission
s
emphasis on the need to build a
holistic, patient-centred, forward-looking Pharmaceutical Strategy that covers the
whole life-cycle of pharmaceutical products from scientific discovery to authorization
and patient access. The Danish Government also supports a strategy that emphasises
the sound functioning of the internal market and the sustainability of public finances.
The European pharmaceutical industry contributes significantly to the European
trade surplus, and is a major contributor to the EU economy where it creates
economic growth and employment.
Shortages of medicines are a potential threat to patient safety in the European
Union. Access to and availability of medicines is essential to our health and our
confidence in the health system. It is therefore important that the European citizens
can trust that they have access to both existing and new medicines of high quality
and safety.
The covid19 crisis has amplified many of the objectives set out in the Road Map. The
indisputable fact that the pharmaceutical sector is vital for the Union and its citizens
in order to safeguard public health and pave the way for research and innovation has
become increasingly evident. The crisis has equally underlined the fact that the sector
operates in a global setting with many complex dependencies on other actors. Thus,
we fully endorse the view that attention shall also be given to the international
di e sio a d the se tor s glo al o petitiveness.
The pharmaceutical sector is a knowledge-intensive sector where a strong IP
framework and incentives structure contribute to innovation and development of
new therapies.
 EUU, Alm.del - 2019-20 - Bilag 854: Høringssvar på Kommissionens roadmap vedr. kommende lægemiddelstrategi
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Overall, the Danish Government finds it important that the future EU Pharmaceutical
Strategy aims at striking a balance between availability and access to medicines on
the o e ha d, a d i ovatio a d the se tor s glo al o petitive ess o the other.
The current pandemic has highlighted the need to address the ongoing concerns on
shortages of medicines. We believe that the strategy should consider if and how we
can make use of strategic stockpiling of critical medicines and medical products in
combination with ensuring supply by diversifying supply lines and upholding a level
playing field globally with the aim to decrease the dependence of EU countries on the
manufacturing capacity of single suppliers from third countries to mitigate these
concerns.
The pharmaceutical sector is indeed data driven and we therefore highly welcome
the Co
issio s
statement that the artificial intelligence (AI) agenda and
opportunities for the sector within data analysis will be part of the future work with
the strategy.
We further agree that synergies with other EU policies in areas, such as
Europe s
beating cancer plan, research, innovation, intellectual property rights and the EU
Green Deal must be considered. In this regard, we find it important to ensure that the
Pharmaceutical Strategy and the EU4Health programme work in the same direction.
The Road Map takes a very broad approach to all of these topics and the Danish Gov-
ernment would like to stress the importance of the final strategy being action-ori-
ented, setting out clear priorities for further work at European level.
./.
In addition, please find attached a common non-paper from BE, DE, DK, ES, FR and PL
outlining some aspects that could be useful to consider in the coming strategy.
In summary, the Danish Government finds that the Road Map sets a good overall
direction for the future strategy. We look forward to the political and technical
discussions that lie ahead in order to make the EU a strong global player within this
highly important sector.
Yours sincerely,
Magnus Heunicke
Side 2
 EUU, Alm.del - 2019-20 - Bilag 854: Høringssvar på Kommissionens roadmap vedr. kommende lægemiddelstrategi
How to ensure EU's preparedness for pandemics
The corona virus has taken a heavy toll in terms of human lives and let to an unprecedented economic
downturn. The present situation has
raised questions about Europe’s preparedness for pandemics
and
underlined the need for a common European approach, so that the EU and its member states find
themselves better prepared for a second outbreak of the virus and future pandemic crises. The stakes are
high and a solution will require a holistic approach that draws on a wide range of instruments in the EU
toolbox including industrial policy, research, digitization and EU funding.
This paper will attempt to zoom in on some of the key parameters for
ensuring the EU’s
long-term
resilience in case of future public health crises in the EU. These include a sufficient supply of personal
protective equipment (PPE), medical devices, critical medicines, and vaccines. Understanding the
shortcomings is essential, as was also pointed out in the Spanish non-paper previously circulated
regarding the need for stress testing of national health systems.
The
backdrop for an initiative to ensure the EU’s preparedness for future pandemics
is Member
States’
experiences of varying degrees of shortages during the current COVID-19 crisis. A key goal is therefore
to identify ways to ensure stronger long-term European resilience to withstand future crisis. A broader,
holistic EU strategy could be more efficient than each member state attempting to enhance preparedness
on their own, as also emphasized by the BENELUX-countries in their letter to the Commission of 16
April 2020 on joint procurement.
As an initial step, a comprehensive diagnosis is needed in order to get a clear picture of the magnitude,
the character and the believed causes of the supply deficiencies and challenges observed during the first
stage of the COVID-19 crisis. An EU strategy on availability of critical medicines, medical devices, PPE
and vaccines to prepare for potential future health crises should address: (i) efficient monitoring and
possibility of data sharing, (ii) coordination of supplies, (iii) research and innovation, (iv) the regulatory
framework, (v) global value and supply chains, and (vi) production facilities. Below are some preliminary
considerations on these issues.
1. Efficient monitoring and data sharing
In order to boost resilience and preparedness, efficient surveillance, sharing, analysing and comparing
data will be key. With respect to privacy and use of personal data, an EU strategy that aims to enhance
preparedness for future pandemics should look into how the EU could significantly increase its ability to
track pandemic development in order to help identify health emergencies on the rise, and to increase
situational awareness across the EU. Key considerations in this respect would be:
-
Central data points should be identified
in order to ensure monitoring and thereby obtain a
common baseline and understanding of key measurements in the prelude to a crisis. Key
measurements could include the spread of a given pandemic, but also available stock etc. The
potential for establishing common European standards or harmonised methodology for health data
interoperability and key figures of future epidemics should also be explored.
Continuous monitoring, comparing, sharing and analysis
of such data is necessary in order to
be able to have a shared and up-to-date understanding of the situation and identify the right actions
in order to respond firmly and swiftly.
-
 EUU, Alm.del - 2019-20 - Bilag 854: Høringssvar på Kommissionens roadmap vedr. kommende lægemiddelstrategi
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A strengthened mandate for
The European Centre for Disease Prevention and Control
(ECDC)
to coordinate, with national health authorities, prevention and reaction plans against future
epidemics within a future EU health task force.
2. Coordination of supplies
To ensure better distribution and coordination of supplies, the strategy should look into:
-
Efficient division of labour within the EU
in order to optimize European production, drawing on
national and regional expertise in existing life science clusters and production facilities. A key feature
of the division of labour could be cooperation agreements and legal commitments on a voluntary
basis from Member States towards common EU goals and targets. Experiences from shared
responsibilities and management in cohesion policy could be considered as inspiration for the
working methods. Such an approach would allow for the use of smart specialisation and place based
mechanisms.
Size of the stocks,
where Member States could seek to agree on dynamic criteria ensuring flexibility
in terms of the crisis to be addressed, resulting in:
i.
Lists of critical medicines, critical protective equipment, critical medical devices, and critical
vaccines that need to be stocked as a minimum;
ii.
Size of the stocks - e.g. 3 months of supplies for the entire EU.
Common goals should reflect the responsibilities of each Member State to secure its own resilience,
and how quickly the industry can be expected to restructure their production. It is to be expected
that it will be more time-consuming and economically burdensome to switch production to advanced
pharmaceuticals than to PPE such as masks.
-
The EU should establish
common strategic stocks of critical medicines and medical products
(protective equipment, testing kits etc.). In this respect,
The European Civil Protection
Mechanism's rescEU-program
should be evaluated with a view to ensure that it is being used
adequately to build (relevant) stocks of critical medicines, medical devices, PPE, and vaccines.
As a supplement to national crisis management,
the capacity of the European Civil Protection
Mechanism,
to coordinate distribution across Member States, including whether Member States
need to play a greater role in the distribution based on common criteria for access and cooperation
between member states.
-
-
As these programs and mechanisms are meant to be utilised in a time of crisis, further consideration
should be given to more long-term solutions, which would allow time for capacity building. Joint
Procurement Actions could hold considerable potential and be deployed more broadly, notably with a
view to encourage EU capability build-up.
3. Research and innovation
Strong investments in fundamental research and alignment of research and innovation efforts and better
linking of these to European manufacturing of products and medicines are essential in order to be better
prepared for the next pandemic, in terms of both vaccine development, diagnostics, treatment, sharing
research data and the understanding of public behaviour. It is vital to increase European capacities on
research and development for vaccines and treatments, as well as to coordinate at the international level
 EUU, Alm.del - 2019-20 - Bilag 854: Høringssvar på Kommissionens roadmap vedr. kommende lægemiddelstrategi
(ACT-A initiative) in order to ensure capacity to develop and produce vaccines. Drawing on expertise
from all Member States, the following initiatives could be considered:
-
Joint vaccine development.
Developing a vaccine is a huge and expensive task, and a unified
European strategy holds great European added value; in this regard, it is necessary to ensure
coordinated dialogue with the pharmaceutical industry as regards critical components and
procedures. This includes a coherent, transparent, and coordinated approach towards the selection
of vaccine candidates, support mechanisms, possibly including financial support via EU funds. Fast
track procedures, mapping the most promising candidates with manufacturing capacity in close
dialogue with industry for instance on how to limit the liability in engaging in such production can
play a role. It should be considered, whether funds should be allocated at EU level specifically for
the establishment of a clinical preparedness platform, as this would accommodate the urgent need
of enabling EU to speed up the time from the outbreak of a future pandemic to the successful
deployment of a vaccine. Decreasing liability of producing vaccines through guaranteed public
purchase could make such efforts more attractive to engage in and EU-level contracts in order to
scale up the production of developed vaccines could be explored.
Diagnostics.
A coordinated European approach and more precise diagnostic tools, test reliability,
and better knowledge of the impact of different test strategies is needed. Establishing networks of
laboratories that can be activated when the need occurs, i.e. in case of a pandemic, could be explored.
Treatment.
The development of innovative medicines is essential for progress in preventing and
treating new diseases. This calls for long-term, continuous R&I investments e.g. in the fields of
virology end epidemiology
,
and the implementation of large-scale clinical trials in order to obtain
robust results in a timely manner. It should be examined whether EU should aim to scale up
innovation capacity by strengthening the framework conditions for conducting medical research and
medical trials and how EU-funds could to a greater extent finance large-scale clinical trials and getting
medical products ready for the market.
Sharing research data.
Swift dissemination of research results throughout the EU will increase
chances of breakthroughs. To realise the objectives of the European Open Science Cloud (EOSC),
initial deployment of a new European COVID-19 Research Data Platform Pilot should be a priority.
The value of social sciences and humanity (SSH).
A key aspect in a pandemic is the regulation
of public behaviour. Research in the effects of public communication, (mis)information campaigns,
the role of social media, and other IT communication, including tailor-made apps for tracking and
information sharing, will be highly relevant.
-
-
-
-
4. Regulatory framework
In order to support cooperation between public and private partners there might also be a need to look
further to the regulatory framework, building on the EU’s
own
strengths and principles:
-
Ensure resilience through a
strategically strengthened Single Market
as this is one of our greatest
assets and a key element in building resilience. The free flow of trade across borders, common rules
and standards can accelerate the development of optimal solutions to future crisis.
Examine the option of more permanent antitrust guidelines relevant in times of crisis
concerning limited and temporary cooperation among businesses in response to urgent situations
related to pandemics. In the current situation, the
‘Temporary
Framework Communication’ has been
-
 EUU, Alm.del - 2019-20 - Bilag 854: Høringssvar på Kommissionens roadmap vedr. kommende lægemiddelstrategi
valuable to companies willing to temporarily cooperate and coordinate activities in order to increase
production.
-
Examine the effectiveness of the public procurement procedures and Joint Procurement
Agreement (JPA).
The
‘guidance
for public buyers’ has helped to ensure rapid and efficient
purchases of necessary equipment, but evaluations of national and European level procurement
processes should be conducted to examine how the practical modalities, speed of the implementation
etc. could be improved .
5. Global value and supply chains
As commodities from international trading partners are essential, the following should be considered:
-
Ensure open, fair and flexible global value chains.
A key part of ensuring affordable supply of
commodities and critical products involves diversifying supply lines and upholding a level playing
field globally. This includes identifying new trading partners with the aim to decrease the
dependency of EU countries on single suppliers.
The EU should also strengthen EU and national
investment screening towards non-EU investments in the EU in strategic sectors (including health,
pharmaceuticals, biotech etc.), while at the same time encouraging investments (re)located in the EU.
-
While making value chains more robust it is important to consider the
need for sourcing certain
critical input.
This requires openness in terms of ensuring continued access, but also points to the
possible further potential in circular models, which could improve access to relevant materials. Also
in this area resilience of supply chains is important and it could be also necessary for companies to
diversify their sourcing regarding critical medicines in order to have more than one active substance
supplier.
Amidst growing global trade tensions,
preventing protectionism will be key
when considering
temporary measures. There is a real risk of the current situation leading to withdrawal from global
markets, which should be tempered through a focus on flexible and robust value chains within and
outside the EU as well as drawing on expertise from global markets. Consideration should be given
to important trading partners and in particular developing countries, who depend on imports from
the EU and are vulnerable because of weak capacity and health systems.
Ensure flow of trade by transport.
During the COVID-19 pandemic open European supply lines
has been essential in ensuring the regular flow of trade by sea, land and air and the operation of
supply chains. Therefore, it should be considered how the EU in the future could facilitate regular
flow of trade for the undisrupted availability of critical commodities to e.g. the life science industry.
Any trade measures should be
compliant with WTO-rules, IPR regulation
and
support the
multilateral trading system,
minimizing the risk of retaliation or dispersion of measures in other
sectors than health.
-
-
-
6. Production facilities
In order to ensure supplies, looking into increasing the production facilities in the EU, could be relevant.
Here, the following could be considered:
- A
public commitment to buy a certain number of specific products
could ensure the incentive
to increase production facilities in the EU and alleviate insecurity of companies in terms of whom
 EUU, Alm.del - 2019-20 - Bilag 854: Høringssvar på Kommissionens roadmap vedr. kommende lægemiddelstrategi
to sell the products in times of low supply. Consideration could be given to guidelines, the current
state aid rules, the principle of equitable global access, distribution keys and how to best ensure
smooth operations, transparency and trust
–
through EU-level decisions or bottom-up
cooperation.
- The European Commission should
allow incentives to develop and invest in production
capacity
for select and critical active ingredients, raw materials and medicines in the EU including
support for innovation and more efficient production technologies as well as reduction of
regulatory burden.
-
Encouraging adaptability as an economically efficient way of strengthening resilience.
During the current crisis, many European businesses have shown excellent adaptability and been
able to produce i.e. hand sanitizer and face shields to cope with the increasing demand and to shift
production depending on different suppliers. The particular Danish experience shows that
digitization and public-private partnerships can help build resilience. Based on this, the
Commission could study similar experiences across the EU to explore to what extent
adaptability
- based on modern and digitalized production
- could be an economically efficient way to
ensure self-sufficiency and resilience without initiating large-scale production with risks of
overproduction etc. Such adaptability could furthermore be underpinned by
collaboration
agreements between Member States and larger companies
where these agree to produce a
number of specific products in times of crisis against expected sales to governments and national
health care systems and thus not jeopardizing businesses normal production with limited or no
benefit. The role of Small and Medium-sized companies should also be taking into account in these
consideration (e.g. by open calls to participate in collaborations agreements). Finally, a broader
focus on digitalization and automation could be explored to strengthen the structural capacity of
our industry to quickly adjust production processes.
-
Exploring the potential of fostering industrial ecosystems and structuring them within
European projects,
for critical medicines, medical devices, PPE and vaccines, maintaining an
innovative and competitive life-science sector in the EU through solid IPR protection, favourable
framework conditions for conducting medical research and clinical trials, and sharing of data and
coordination of R&D. We should consider the creation of
Important Projects of Common
European Interest
for the production of active substances, vaccines, medical equipment and for
e-health, health data and biotechnologies, where appropriate to address specific market failures
.
A
special focus could be on removing regulatory barriers in order to allow for innovation and greater
control of supply lines of critical products and also the role of Small and Medium-sized companies.