Ref. Ares(2017)802454 - 14/02/2017
From:
CAB JUNCKER PRESIDENT
Sent:
14 February 2017 09:10
To:
CAB JUNCKER ARCHIVES
Subject:
FW: Comitology Reform
Categories:
Orange Category
From: xxxxx.xxxxxxxx@xxxxx.xx [mailto:xxxxx.xxxxxxxx@xxxxx.xx]
On Behalf Of Eric Cornut
Sent: Tuesday, February 14, 2017 8:49 AM
To: CAB JUNCKER PRESIDENT; CAB TIMMERMANS CONTACT
Cc: Elizabeth Kuiper
Subject: Comitology Reform
Dear President Juncker,
Dear First Vice-President Timmermans,
As your College is discussing the options regarding Comitology Reform again this week, EFPIA, the trade
association representing the research-based pharmaceutical industry in Europe, would like to underline the
importance of fair and science-based decision-making at EU level.
The process for obtaining market authorisation of innovative products defines the degree of predictability, which
business operators require when taking decisions in terms of investment, jobs and growth in and for the EU.
Additional uncertainty puts Europe at a competitive disadvantage globally and is also of grave concern to all
industries that are subject to product authorisations.
We urge the Commission to guard its independence as prescribed by the EU Treaties and to correctly implement
the existing comitology system while discussing the different options. This must be done in full respect for the
fundamental principles of EU law, such as non-discrimination, legal certainty and protection of legitimate
expectations, the conferral of powers, the right to good administration set out in Article 41 of the European
Charter of Fundamental Rights, and the EU’s international trade obligations.
In its present form, the comitology process that governs market authorisations, is designed to approve products
assessed as safe by Europe’s independent safety assessment authorities.
The Commission and its risk assessing agencies should strengthen risk communication to build trust - especially
where unfounded concerns persist and avoid fueling any unfounded concerns about new technologies.
In light of the aforementioned concerns and with a view to the foreseen discussion and adoption in the College of
Commissioners this week, we call on the Commission to respect the principles for fair and science-based
decision-making in accordance with existing law.
We are at your disposal for further information, and hope you will take our concerns into account while adopting
your final position.
Yours faithfully,
Eric Cornut
Director General EFPIA
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