Ref. Ares(2020)5452150 - 13/10/2020
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Health systems, medical products and innovation
Medicines: policy, authorisation and monitoring
Brussels
SANTE.DDG1.B.5
/vt(2020)6212382
Subject:
BTO - Meeting with The European Consumer Organisation (BEUC)
on the Pharmaceutical Strategy – 8 October 2020
Participants: SANTE:
BEUC:
SANTE presented the objectives, state-of-play, and plans for implementation of the
strategy, stressing that it will include actions that will be initiated in the short and
medium term (next 3 years) but will aim to create a policy that is long-term and fit for
purpose for the next 20 years. There will be separate consultation process in the
implementation phase.
On funding BEUC emphasised the need for pull incentives for unmet need, noting that
more conditionality on funding is required linked to affordability (especially in case of
antibiotics, orphan medicines), and that regulators must pilot alternative approaches to
funding. Consumers/patients representatives should be involved more in the activities in
research and innovation, for example by being represented in the panels of the research
and innovation open days. Consensus is needed on basic concepts such as unmet needs.
On shortages:
BEUC asked if the expansion of EMA mandate will include powers on
shortages. They consider there is a need for the review of pharmaceutical legislation to
tackle availability (obligations for marketing authorization holders), prevention plans and
push for diversification.
SANTE mentioned that the strategy will focus on the root
causes and that information is needed before policy choices are made. The study on
shortages focuses on definitions and tools for monitoring shortages and it will inform
possible actions. On dependency the aim is to have a structured dialogue, to strike
balances with state aid, trade etc. More data is needed before actions can be brought
forward, but data availability and quality is improving.
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
Email: xxxxxxxxxxxxxxxxxxxxxxxx@xx.xxxxxx.xx
On affordability BEUC called for transparency of prices and medicines costs. They are
finalising a position paper on transparency of research costs. The EURIPID survey could
be expanded if there is interest in pricing transparency. BEUC asked about revision of the
transparency directive. SANTE mentioned we are aware of calls to revise the
transparency directive, actions are already ongoing on transparency on a voluntary basis.
There are already studies: IQVIA Study, shortages root causes study.
On health technology assessment BEUC is keen on having the proposal adopted and
had pressed DE Presidency on this. They asked what can be done to unblock the
situation.
SANTE: explained that it is a good proposal and that only links can be made,
but it is not in the Commission’s control, but remain optimistic for the outcome.
On the vaccine strategy BEUC considered that there is a need for quick compensation
scheme in case of adverse effects. They noted that some companies had requested the
product information with their vaccine be in one language across the EU but mentioned
these measures should be temporary/proportionate. There should always be a possibility
for access to information in the local language. They called for transparency of the
contracts and fair pricing. They stressed that the scientific assessment should be robust
because if there was a loss of confidence in COVID vaccination this could impact
attitudes to vaccination in general.
SANTE mentioned the Product Information flexibility
already exists, the waiver on printable information at moment of delivery is not total,
there will be no compromises on information for use. In any case the derogations are
made temporarily for the benefit of patients and to accelerate availability as much as
possible. The EMA Emergency Task Force for rolling review is in place to enable the
Commission accelerated procedure for authorisation on the basis of assessment /
evidence. Monitoring enhanced vaccines monitoring platform: we will not cut down on
evidence requirements for robust assessments.
BEUC asked about the interaction of the pharmaceutical strategy with the European
Health Data space.
SANTE explained that health data for secondary use by regulators
and industry for development and monitoring of medicines as well as regulatory
decision-making will include these issues and regulators’ access to the health data.
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