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European medicines agency: lack of transparency

The European Medicines Agency (EMEA) is reluctant to publish vital documents relating to drugs, in order to protect pharmaceutical companies' interests.

From 2005 to 2008, Prescrire sent 81 requests for documentation or additional information to the European Medicines Agency (EMEA).

Overall, Prescrire’s requests resulted in faster public access to numerous documents (drug assessment reports) or to their updates on the EMEA website, or to anomalies being rectified. These requests resulted in previously unpublished pharmacovigilance reports being made public. EMEA was forced to fulfil its obligations with regard to disclosing conflicts of interest affecting experts sitting on its committees.

Above all, the requests to EMEA revealed the agency's reluctance to supply comprehensive information, its slowness in replying, its refusal to pass on clinical data from reports by national agencies and from any document produced by pharmaceutical companies, such as periodic safety update reports.

EMEA censors some crucial sections of documents containing information of scientific interest. Prescrire has published a facsimile of a report on the adverse effects of rimonabant (formerly Acomplia°), in which the EMEA actually blacked out 65 of the 68 pages, purportedly to protect the company's commercial interests.

> Click here to download the facsimile of the blacked-out report (pdf, 670 Ko).

©Prescrire 24 September 2009

"Legal obligations for transparency at the European Medicines Agency: Prescrire's assessment over four years" Prescrire Int 2009; 18 (103): 228-231 (pdf, free).

> Click here for Prescrire's online Dossier "Medicines in Europe"

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