E-DRUG: Access to documents at the EMA: going backwards rather than forward!
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Dear E-druggers
Prescrire has recently written to the Director of the European Medicines Agency after having been denied access to administrative documents. The EMA argues that the ongoing legal proceedings before the European Court of Justice are preventing the agency from implementing its policy on access to documents. Prescrire is appealing that decision.
In its refusal letter, the EMA cites the need to protect commercial interests. But our requests pertain to clinical data and to drug packaging, which are matters of public interest. If citizens in Europe are to enjoy the best healthcare possible, then the EMA access-to-documents policy must be ambitious.
Our letter is available here: http://english.prescrire.org/en/79/207/46302/2781/2506/SubReportDetails.aspx
At a recent meeting of The Dutch Medicines Evaluation Board, Ben Goldacre made a heartfelt plea for open access to clinical data from all pharmaceutical industry studies, including positive and negative results. MEB's Director Aginus Kalis supported Goldacre's argument. Will other regulatory agencies across Europe follow suit and put the EMA back on track? It remains to be seen.
Best wishes
Teresa Alves
Teresa Leonardo Alves
International Policy Adviser
Prescrire
talves@prescrire.org<mailto:talves@prescrire.org>