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Decision on own-initiative inquiry OI/3/2014/FOR concerning the partial refusal of the European Medicines Agency to give public access to studies related to the approval of a medicinal product

This inquiry is concerned with how the European Medicines Agency (EMA) should deal with requests for public access to documents containing information on the safety and efficacy of medicines. The specific focus is on the right of public access to three clinical study reports on Humira, a widely sold anti-inflammatory drug.

In 2013 EMA decided to grant public access to these reports. However, the pharmaceutical company that sells the drug (AbbVie) took court proceedings against EMA which had the effect of blocking the proposed release of the reports. In 2014, before the conclusion of the court proceedings, EMA and AbbVie made an out-of-court agreement by which EMA would grant public access to redacted versions of the reports. The Ombudsman contacted EMA to check whether the redactions were justified. Following this check, the Ombudsman was not convinced that all of the redactions were in fact justified. The Ombudsman then began an inquiry, on her own initiative and in the public interest, into EMA's approach to the granting of public access.

In the course of the inquiry it emerged that EMA, in response to other public access requests for the same reports, had released much fuller versions of them. Nevertheless, certain redactions remained.

The Ombudsman accepted that some of these redactions were justified (because of the need to protect personal data). But she was not convinced that other redactions, made to protect commercial interests, were justified. In these latter instances, the Ombudsman took the view that there was likely to be an overriding public interest in disclosure. As a general observation the Ombudsman noted that, where the information in a document has implications for the health of individuals (such as information on the efficacy of a medicine), the public interest in disclosure will generally defeat any claim of commercial sensitivity. Public health should always trump commercial interests.

In closing the inquiry, the Ombudsman recognised that EMA has now made very significant progress with its proactive transparency policy, effective since January 2015. However, in relation to some specific portions of the reports, the Ombudsman questioned EMA's continued reliance on the protection of commercial interests. With a view to promoting systemic improvements, the Ombudsman made several suggestions to EMA as to its future practice in this ar