Ombudsman concerned about change of policy at Medicines Agency
16 May 2014 10:44 AM
In a letter to the European
Medicines Agency (EMA), the European Ombudsman, Emily
O'Reilly, has expressed concern about what appears to be a
significant change of policy concerning clinical trial data transparency.
According to documents the Ombudsman has seen, EMA is planning to limit access
to clinical trial data by imposing strict confidentiality requirements and by
allowing data only to be seen on screen using an interface provided by EMA, as
well as imposing wide restrictions on the use of such
data."
Emily O'Reilly commented:
"We were pleased when EMA announced, in 2012, a new pro-active
transparency policy, giving the broadest possible public access to clinical
trial data. I am now concerned about what appears to be a significant change in
EMA's policy, which could undermine the fundamental right of public access
to documents established by EU law. European citizens, doctors and
researchers need maximum information about the medicines they take, prescribe
and analyse. "
Change from pro-active
transparency to a very restrictive policy?
In the last five years, the
Ombudsman has conducted over a dozen inquiries into the EMA. Many concerned
refusals to make public documents regarding the authorisation and regulation of
medicines by the Agency, including medicines for treating multiple sclerosis,
acne, bacterial infections, and obesity. In response to the Ombudsman's
intervention in these cases, EMA appeared ready to adopt a pro-active approach
towards transparency.
Furthermore, on 2 April 2014,
the European Parliament voted in favour of legislative proposal to make
clinical trial data public. As a consequence, the results of all future
clinical trials in Europe should eventually be made publicly accessible
online.
Against this backdrop, the
Ombudsman has asked EMA's Director, Guido Rasi, to inform her by 31 May
2014 how EMA intends to deal with requests for public access to existing
clinical trial data. She also asked him to list the reasons and the legal basis
for what appears to be a significant change of policy.
The letter to EMA's Director
is available at:http://www.ombudsman.europa.eu/en/resources/otherdocument.faces/en/54347/
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The European Ombudsman
investigates complaints about maladministration in the EU institutions and
bodies. Any EU citizen, resident, or an enterprise or association in a Member
State, can lodge a complaint with the Ombudsman. The Ombudsman offers a fast,
flexible, and free means of solving problems with the EU administration. For
more information: http://www.ombudsman.europa.eu
For press inquiries:
Ms Gundi Gadesmann, Deputy Head of the Communication Unit, tel.: +32
2 284 26 09, Twitter @EUombudsman