The key issues discussed are presented below:
Role of European industry in the context of the Covid-19 crisis
EFPIA praised the good coordination by the Commission that al owed the industry to react appropriately
and ensure the medical needs during the crisis. However, at this point there is a clear need for more
on 10 August, is not appropriate and EFPIA is using its own projections which is not ideal. So far the
currently the situation is different as some Member States already made stocks; industry would not be
able to produce appropriately for a second wave if it is left in the dark on stocks and needs. There is a
clear need for a structured exchange of information on forecasting demand data.
Commission acknowledged a risk of complacency after the first wave and the importance to have
reliable data on needs. It wil continue to strongly advocate this vis-à-vis Member States. Commissioner
Breton is continuing the dialogue with relevant countries and the Clearing House established by the
Commission continues to work. In the short term Commission wil continue to raise awareness on these
issues. For the mid- term (November 2020), Commission is preparing a number of initiatives, including
the revision of the ECDC and EMA mandates, to address identified shortcomings and improve
preparedness and health crisis response. This push is also supported by the DE Presidency.
More EU in the health area (Health Union)
EFPIA inquired about the foreseen initiatives and whether the announced European BARDA wil be
limited to pandemics.
Commission explained that a first step wil be a package of proposals in November, based on current
provisions of the Treaties, aiming at improving the European response, especial y for health emergency.
health area at European level which could also lead to discussions on competence. As for the European
BARDA, which would not necessarily be limited to pandemics preparedness and response only, the idea
is to start discussing with al stakeholders, industry and Member States. The idea has been welcomed
but there is a need for a debate on scope and functions that add value before choosing options for
financing and structure. Lessons learned from the Covid-19 are the starting point and the discussion may
be launched in November as part of the same package of initiatives.
European Pharmaceutical Strategy/Intel ectual Property/Competition
EFPIA stressed the geographical diversity of the companies that they represent which is key to ensure a
good match with demands on the European market. The industry is a bit concerned about the re-shoring
message from the EU which could hurt EU competitiveness and affect the leading position as largest
exporter of medicines in the world and the strong European position in the international value chains.
The discussion at European level seems to focus exclusively on production and less on innovation (R&D).
EFPIA sees a need for re-balancing the two strands.
Commission stressed that the debate has just started and the upcoming European Council, postponed
for 1 October, wil also address the issue of strate
sovereignty, not producing everything in the EU but also not depending on very few supply sources. We
need to diversify supply chains. This approach goes hand in hand with the industrial eco-system and the
green and digital transitions. Given the strong political emphasis on this issue in Member States, which
expect credible proposals, it would be useful if EFPIA could provide concrete examples of how
sovereignty over supply chains can work in practice in order to make it more tangible for decision
In terms of initiatives to be announced in the pharma strategy, EFPIA raised a concern about changing
existing basic legislation, e.g. paediatric medicines acquis, which would send the wrong signal to
industry as opening a period of uncertainty. EFPIA also made the point that work on safety and greening
of pharmaceuticals continues and inquired about their idea to set up a platform on innovative
medicines.
Commission took note on the EFPIA position on the revision of pharma basic legislation and stressed
that many improvements can still be made via non-legislative actions. The idea is not to propose heavy
rules but to improve the current situation without a complete overhaul of the acquis. However, there is
an increased pressure for more transparency and affordable access. On the platform on innovative
medicines, the approach supported by the Commission is to bring together all relevant stakeholders
from various sectors, not only industry, and avoid mere talking shops. The upcoming European pharma
strategy may also address this issue.
EFPIA also touched on the issues of intellectual property (IP) and the upcoming IP action plan, which it
considered very important for the development of the pharma industry and its international
competitiveness. EFPIA also questioned the idea of compulsory licensing and inquired about changes in
the competition rules that wil affect the pharma industry. Commission stated that the IP importance is
well acknowledged and there is no hidden agenda with the upcoming action plan. At the same time,
there needs to make sure that there is no monopoly on knowledge. A good example is the recent
approach in the ACT-Accelerator where, although no obligation is put on companies to share IP,
companies benefitting from public funding are expected to contribute to facilitating universal and fair
access to new solutions. Compulsory licensing is already a legal possibility but it is seen as a last resort
not an instrument to be used upfront. On competition, there is a need to review various state aid
guidelines, e.g. on energy, and the idea is to see if current rules are fit for purpose in a post-Covid 19
context.
Brexit
Commission inquired about preparedness industry plans in the Brexit context. EFPIA mentioned that
discussions already started in 2019. However, the Covid-19 crisis led to the use by Member States of
stockpiles made for Brexit purpose. There is also an issue with supply for IE. EFPIA will send more
information on al these issues.
EU4Health programme
EFPIA inquired about on-going discussions and the financial envelope for the programme. Commission
explained the latest proposal agreed at the European Council, with a sizeable financial envelope as
compared to current programme. Commission will continue to support an ambitious programme. The
European Parliament indicated that EU4Health programme is part of the programmes for which they
would like to see an increase but there is the reality of negotiations and inter-play with other important
financing programmes.
Attendance:
EFPIA:
and other EFPIA
representatives
Commission: Kurt Vandenberghe (Cabinet of the President), Karolina Herbout-Borczak (Cabinet of
Commissioner Kyriakides),
General Secretariat of the Commission)
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European Commission
Secretariat General
Unit F4 Health, Education & Culture
BERL
B-1049 Brussels/Belgium
@ec.europa.eu