Ref. Ares(2020)3434487 - 30/06/2020
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/
Subject:
BTO - Pharmaceutical Strategy meeting - Meeting with European
Patients Forum (EPF) 26 July 2020
Pharma strategy overview
Commissioner Kyriakides mentioned that the Commission intends to publish the
strategy by end of 2020. The Commissioner also presented the strategy’s objectives,
timeline and process and urged CPME to participate in the ongoing public consultation
(roadmap and questionnaire). She also invited CPME to take part in the online
stakeholder workshop on 14-15 July.
EPF Welcomes the published roadmap (especially equal access to medicines) and that
the strategy takes into consideration whole lifecycle of medicines and mentioned it will
respond to the consultation. EPF input will engage on 3 out of 4 objectives of the
roadmap (not manufacturing as this is more technical and not the primary focus of patient
advocacy activities).
Covid, vaccines, APIs and shortages The
Commissioner noted that the pandemic has amplified the challenges that needed to
be addressed in the new Strategy. The Commissioner outlined the elements of the
EU4Health initiative and its different strands which indicate a paradigm shift in EU
Health policy which is now more ambitious than ever. The crisis accentuated the
challenges and highlighted that we’re not out of the woods yet, we need more Europe in
health and EU4Health is a testament to that. The Commissioner asked EPF if they have
feedback from their survey on Covid-19 on patients and expressed her concern about
patients not following their treatments due to the crisis, an issue the Commission is
following closely. The Commissioner also mentioned plans to diversify in APIs, study on
shortages and called the EPF to help the Commission in identifying critical APIs for
patients.
EPF agreed that the Covid-19 pandemic is far from over and that a more European
approach is indeed needed. This is why it welcomes the EC focus on healthcare which
relates to Europe’s future itself and believes that it’s an opportunity for the EU to prove
its value to citizens. The EPF congress of 2020 focuses on shortages (especially for
antibiotics and cancer medicines) and it is good to see that Commission took this priority
on-board. EPF is ready to be contacted by Commission contractor on the shortages study
to provide input.
Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111
Innovation, Access, affordability
Commissioner Kyriakides mentioned that the strategy will focus on affordability
related to health systems and look for better ways to coordinate actions at national level
and EU level. The Commissioner welcomed the EPF paper on value on pricing of
innovative medicines and confirmed her participation to the EPF launch event scheduled
on 1/7. The Commissioner also welcomed EPF support on the HTA proposal on which
the Commission will work together with DE presidency. The Commissioner also called
for EPF input on the Orphan and Paediatric legislation evaluation which will be
published in the summer. The DG asked EPF to think about how they see the digital
perspective and how to not alienate patients that are not digital savvy.
EPF supports access to medicines for all patients (in 2016 it developed a definition of
access based on Availability, Affordability, Adequacy Appropriateness, Accessibility).
The strategy will remove some of the barriers to access and EPF welcomes the
recognition of challenges on affordability (which is not a problem for all medicines). EPF
mentioned that granting access to life saving medication should not be the privilege of
rich only countries alone. EPF supports the review of incentives-obligations and believes
that finding the right balance is key (balance does not lie at the same place for all
products). EPF supports achieving more transparency and reaching definitions for
“unmet medical need”, “added therapeutic value” where a patients perspectives is a must.
Innovation for unmet needs means better products that make difference in patients life.
We should upstream patient involvement in research (Eg using IMI) including in early
stages in clinical trials (which today don’t measure quality of life and patient endpoints
we should fix that before we come to the regulatory assessment stage). On affordability,
EPF supports a better value assessment cost effectiveness P&R procurement. Innovative
procurement (EU procurement for EU products is a big step – hand in hand with EU
level HTA). As innovation is not always aligned to the needs of patients the solution is to
involve patients early on to understand real value of innovation. Pricing is important as
EPF recognises that a fair price is needed (which doesn’t necessarily mean
cheap). Getting the right medicine at right moment important, too late means financial
waste, and that therapy is not as useful. Lack of access has complex reasons (market
failures, marketing strategies), small countries are particularly vulnerable. EPF believes
that the mechanism of parallel import is concerning and creates many problems. MS
should move away from increasing patient co-payments to decrease costs. They support
patient involvement in defining prices.
EU State of health companion report is positive and data needed (EPF is available to
help).
Closing the Commissioner mentioned that we want to have a dialogue with EPF and also
want the mental health aspect taken into account. Regular engagement with stakeholders
and in online event. We shouldn’t be talking about patients but with patients.
ENDS.
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Participants:
EPF:
Commission: Commissioner Kyriakides, Giorgos Rossides,
(CAB Kyriakides).
(DG SANTE).
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