Dear Andrzej, dear
, dear
,
Thank you again for our exchange of views of 2 October. We very much appreciated the
opportunity to meet virtually, knowing how busy these times are.
The COVID-19 crisis has shown the importance of having a strong R&D innovation ecosystem
and industrial assets in Europe enabling our region to immediately participate in the research and
development of vaccines as well as ensure medicines' supply. We applaud the European
Commission's considerable efforts to secure the provision of COVID-19 vaccines to Europe and
we know that we must also consider how to build the sustainable capacity to fund R&D and
infrastructure projects, capable of rapidly developing and manufacturing countermeasures to
health emergencies from vaccines, to treatments to diagnostics. A public-private approach such
as was necessary in effectively facing the COVID-19 crisis, seems to be the most appropriate
approach.
In relation to the ongoing review of the Paediatric and Orphan Regulations, and as mentioned
during our discussion, we wanted to inform you that EFPIA will soon release a public report
which directly addresses two questions:
1. How do companies and their investors make decisions on whether to develop an OMP?
2. How would decisions to develop today’s authorised OMPs have been affected if the
incentives provided by the OMP Regulation had not been there?
We believe that this report will provide a useful complement to the Technopolis analysis that
your services published on 11 August. We would like to invite you to join a public discussion
scheduled on 30 October and intended to discuss the two questions above.
As per your suggestion, we have also followed-up with Mr. Ryan to have a dedicated call about
future EU action to tackle antimicrobial resistance, as well as industry’s efforts to stimulate R&D
of new antimicrobials, via the newly launched AMR Action Fund. We are looking forward to
that discussion.
Please don't hesitate to contact us should you need any additional information and thank you
again very much indeed for your time. We look forward to hearing back from you regarding your
participation in the EFPIA event on 30 October.
Best wishes,
EFPIA - European Federation of Pharmaceutical Industries and Associations
+3226262555
Dear Andrzej,
Thank you so much and I look forward to hearing from you.
Very best,
EFPIA - European Federation of Pharmaceutical Industries and Associations
+3226262555
On Mon, 21 Sep 2020 at 19:05,
@ec.europa.eu> wrote:
Dear Andrzej,
I hope this message finds you well.
We noted that in her recent State of the Union speech, the Commission President called for a stronger
“European health union” and more competences for health at European level. At the same time we
understand that the Pharmaceutical Strategy could be adopted on 24 November. Following the
publication of the Commissions Roadmap and Public Consultation on the Pharmaceutical Strategy, we
have requested a meeting with Commissioner Kyriakides in October.
Prior to a meeting with the Commissioner, we would like to request a meeting with you and your
colleagues, to understand the potential consequences of the State of the Union proposals for the
upcoming Pharmaceutical Strategy. The discussion on the Pharmaceutical Strategy highlights the
relevance of activities that were already planned and that could address many of the real or perceived
shortcomings of the European medicines regulatory framework in the short term. We see many of
these areas as highlighted in the regulatory (science) strategies published by EMA or jointly by
EMA/HMA, and we would be very to exchange views on how these are seen in the context and in
support of the eventual implementation of the Pharmaceutical Strategy as well as the Staff Working
Document on OMPs and Paediatrics.
I would be very grateful for the opportunity to meet with you and your colleagues either via digital
means or in person to discuss these proposals in more detail and very much look forward to hearing
from you.
Many thanks and best wishes,
EFPIA - European Federation of Pharmaceutical Industries and Associations
+3226262555