From:
Sent:
mardi 15 septembre 2020 17:59
To:
(SANTE)
Cc:
Subject:
BTO: Meeting with EUCOPE on O/P revision and Pharma strategy - 14
September 2020
Dear
Please see our BTO from the meeting with EUCOPE yesterday.
It was quite a fruitful meeting, a lot of homework for EUCOPE!
They will come back to us in October with the outcomes of their brainstorming on
the possible solutions for the O&P revision.
Thank you,
O&P and Pharma Strategy Teams
Meeting with EUCOPE on O/P revision and Pharma strategy - 14 September
2020
EUCOPE:
(Alexion)
SANTE
T :
Evaluation of orphan and paediatric legislation
EUCOPE
Follow-up to the Evaluation of the Orphan Regulation will be followed closely
within EUCOPE.
The Orphan Regulation has delivered concrete results. A follow-up should build
on this positive result and on the objectives of the legislation.
Main finding: 95% of rare diseases have no treatment
Leveraging real world evidence is important. Regulatory flexibilities are also
needed.
Collaboration around European Reference Networks has been a success story.
Affordability: changing the Orphan Regulation will have no impact on this.
Complementary measures are needed outside the scope of the Orphan
Regulation (pricing being a national competence).
Current level of pharmaceutical incentives should be maintained.
Working group has been set up, with external (multiple) stakeholders.
disciplinary, joint reflection process, approx. 30 participants in this group. Expert
group will have (smaller) focus groups.
Three main topics for this group: 1) optimisation of incentives framework (what
kind of incentives most valuable); 2) looking into regulatory pathway (increased
accessibility also in view of developments in science); 3) bring tools and
incentives to Europe that are not here yet (e.g. in US) for development of
orphan medicinal products.
Expert group should come up with recommendations by the end of this year.
More convergence needed as regards risk-benefit assessment and more
alignment between evidence generation at EMA level and national decisions
(including use of Real World Evidence between HTA bodies).
Action: EUCOPE will come back to SANTE with the preliminary results of the work of
the Expert group on orphan drug incentives already in October.
Pharmaceutical strategy
SANTE analysed the objectives of the strategy and thanked EUCOPE for their
comments to the Roadma and asked EUCOPE what actions they would like to see in
the Commination in terms of the objectives mentioned.
EUCOPE
Lessons learned from Covid should be taken into account.
Include actions that look into the root causes for shortages not just in crisis.
Look into ways of integrating in the authorisation process the value of post
launch evidence generation.
Give emphasis on Europe as part of the word that innovation in pharma takes
place.
Reduce dependency on generics manufactured in China/India
Joint procurement is not a cost containment tool in itself
Build on the positive effect of ERNs (extrapolate lessons from O/P to other
meds)
EUCOPE mentioned that the trans-border healthcare directive will help European
patients travel to centres of excellence for care. They also mentioned that an Expert
group on RWE for regulatory decisions is established by the Belgian INAMI.
Recommendation from that group will be presented on 10 November in a
conference on the European Health Data space which is organised in collaboration
with the DE presidency. (EUCOPE will send more information). EUCOPE also
enquired on the interlinkage of strategy and O/P revision and asked to maintain the
current level of incentives, and find a way to define with all stakeholders unmet
needs innovation and value.