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

The European Ombudsman, P. Nikiforos Diamandouros, called on 10 May 2010 on the European Medicines Agency (EMEA) 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. EMEA 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 EMEA.

• Primary Source

European Medicines Agency: Transparency policy http://www.ema.europa.eu/htms/human/transparency/transparency.htm

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