The European Medicines Agency release adverse reaction reports on acne drug

In August 2010, the European Medicines Agency (EMA) accepted the Ombudsman’s recommendation to give access to documents related to a drug used to treat severe forms of acne. In June the European Ombudsman, P. Nikiforos Diamandouros, recommended that EMA release adverse reaction reports for an acne drug. EMA had initially denied access, arguing that EU transparency rules did not apply to adverse reaction reports. EMA accepted the Ombudsman’s recommendation and announced the release of the reports.

The complaint originated in April 2008, when an Irish citizen asked EMA for access to documents containing details of all suspected serious adverse reactions relating to an anti-acne drug. After taking the drug, his son had committed suicide.

After looking into the complaint, the Ombudsman concluded that the EU rules on access to documents apply to all documents held by EMA. Therefore, the Ombudsman recommended that EMA review its refusal to grant access to the adverse reaction reports.

The Ombudsman further suggested that, as part of a wider proactive information policy, EMA could provide additional clarifications to make it easier for the public to understand such data and their significance. EMA accepted the Ombudsman’s recommendation to give access to the documents by announcing the release of the adverse reaction reports. Mr Diamandouros said: "I commend EMA’s constructive approach in this important case. EMA’s work has a direct impact on the health of European citizens. It is, therefore, crucial to give the widest possible access to documents and to pursue a pro-active information policy for the benefit of citizens."

For Further Information:

 The Ombudsman’s full recommendation is available here.:

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