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Ombudsman: European Medicines Agency should review refusal to release reports on adverse drug reactions

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Press release no. 11/2010

10 May 2010

The European Ombudsman, P. Nikiforos Diamandouros, has called on the European Medicines Agency (EMA) to reconsider its refusal to give access to documents related to a drug used to treat severe forms of acne. The complainant, an Irish citizen, specifically asked for reports on suspected adverse reactions to the drug, such as reactions giving rise to suicidal tendencies. EMA refused access, arguing that EU transparency rules do not apply to adverse reaction reports. The Ombudsman did not agree. In his view, the EU transparency rules apply to all documents held by EMA.

Mr Diamandouros commented: "EMA plays a crucial role in the approval and monitoring of medicines placed on the market. Since its work has a direct impact on the health of European citizens, it is of utmost importance for EMA to give the widest possible access to documents and also to pursue a pro-active information policy for the benefit of citizens."

Adverse reaction reports related to anti-acne medication

The European Medicines Agency evaluates and supervises medicinal products 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 drug 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. EMA refused this request. In September 2008, the complainant turned to the Ombudsman.

In its opinion, EMA argued that the EU transparency rules (Regulation 1049/2001 on access to documents) did not apply to the suspected serious adverse reaction reports. The Agency stressed that their release would not benefit citizens because it could result in the circulation of data that could prove to be misleading or unreliable.

Following his investigation, the Ombudsman concluded that the EU rules on access to documents apply to all documents held by EMA. In his view, this does not mean that adverse reaction reports must automatically be accessible, given that certain exceptions contained in the transparency rules might apply. He, therefore, recommended that EMA review its refusal to grant access to the adverse reaction reports.

As regards EMA's concerns about the circulation of data that could prove to be misleading or unreliable, the Ombudsman suggested that, as part of a proactive information policy, EMA could provide additional explanations designed to render such data and their significance more readily understandable by the public.

EMA is invited to submit a detailed opinion by 31 July 2010.

The Ombudsman's full recommendation is available at:

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

For press inquiries: Ms Rosita Agnew, Head of the Media, Enterprise and Civil Society Unit, tel: +32 2 2842542

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: www.ombudsman.europa.eu

For press inquiries: Ms Gundi Gadesmann, Deputy Head of the Communication Unit, tel.: +32 2 284 26 09, Twitter: @EUombudsman

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