[euopendata] Information released in spite of fears of misinterpretation

Thu Aug 12 09:12:45 UTC 2010

Dear access to information and open government data people, 

Here is important news about release of information from an EU agency. 

The EU medicines agency (EMA) had been reluctant to release data on adverse
reactions to an acne drug, with one of the arguments that people might
misunderstand the information. 

The EU Ombudsman argued that “as part of a proactive information policy, EMA
could provide additional clarifications to make it easier for the public to
understand such data and their significance.”

It is a common concern that information released might be “taken out of
context”. It is therefore positive that the EU Ombudsman is actively
proposing policy solutions which encourage access to raw data whilst ensuing
the public is sufficiently informed to be able to interpret the information.

Best, Helen 

_________________________

Helen Darbishire, Executive Director

Access Info Europe, www.access-info.org 

mobile tel: + 34 667 685 319

e-mail:  <mailto:helen at access-info.org> helen at access-info.org

Skype: helen_darbishire

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From: GADESMANN Gundi [mailto:gundi.gadesmann at ombudsman.europa.eu] 
Sent: 11 August 2010 10:01
To: GADESMANN Gundi
Subject: Ombudsman welcomes release of adverse reaction reports by the
European Medicines Agency 

Please find below a press release from the European Ombudsman. The English,
French and German versions are attached.   

PRESS RELEASE NO. 16/2010

Brussels, 11 August 2010

Ombudsman welcomes release of adverse reaction reports by the European
Medicines Agency 

The European Ombudsman, P. Nikiforos Diamandouros, has welcomed the
announcement of the European Medicines Agency (EMA) that it will release
documents related to a drug used to treat severe forms of acne. The
complainant, an Irish citizen, had asked for the release of reports
concerning suspected adverse reactions to the drug. EMA initially refused
access, arguing that EU transparency rules do not apply to adverse reaction
reports. The Ombudsman did not agree. He called on EMA to reconsider its
refusal to give access to the documents. EMA accepted the Ombudsman's
recommendation and announced the release of the reports.

Mr Diamandouros said: "I commend EMA's constructive approach in this
important case. EMA's work has a direct impact on the health of European
citizens. It is, therefore, crucial to give the widest possible access to
documents and to pursue a pro-active information policy for the benefit of
citizens." 

Adverse reaction reports related to anti-acne medication 

The London based European Medicines Agency approves and monitors medicines
placed on the EU market, with a view to protecting public health. In this
capacity, it receives from the competent authorities in the Member States
and from pharmaceutical companies information concerning suspected adverse
reactions to drugs.  

In April 2008, an Irish citizen asked EMA for access to documents containing
details of all suspected serious adverse reactions relating to an anti-acne
drug. His son had committed suicide after taking the drug. 

EMA refused his request, arguing that the EU rules on access to documents
did not apply to reports concerning suspected serious adverse reactions to
drugs. 

Following his investigation into the Irish citizen's complaint, the
Ombudsman concluded that the EU rules on access to documents apply to all
documents held by EMA. He, therefore, recommended that EMA review its
refusal to grant access to the adverse reaction reports. The Ombudsman also
suggested that, as part of a proactive information policy, EMA could provide
additional clarifications to make it easier for the public to understand
such data and their significance.

EMA accepted the Ombudsman's recommendation to give access to the documents
by announcing the release of the adverse reaction reports. The Ombudsman
will take account of EMA's announcement when drafting the decision closing
his investigation.

The Ombudsman's full recommendation is available at: 

<http://www.ombudsman.europa.eu/cases/draftrecommendation.faces/en/4810/html
.bookmark >
http://www.ombudsman.europa.eu/cases/draftrecommendation.faces/en/4810/html.
bookmark 

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/> http://www.ombudsman.europa.eu      

 For press inquiries: Ms Gundi Gadesmann, Media and External Relations
Officer, tel: +32 2 2842609 

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