EU meds agency publishes adverse report for anti-acne drug after Ombudsman decision

In April 2008, an Irish citizen had asked EMA for access to documents containing details of all suspected serious adverse reactions relating to an anti-acne drug. His son had committed suicide after taking the drug. EMA had refused his request, claiming that EU rules on access to documents did not apply to reports concerning suspected serious adverse reactions to drugs.

Following his investigation into the Irish citizen's complaint, the EU Ombudsman had concluded that the EU rules on access to documents applied to all documents held by EMA.

He, therefore, had recommended that EMA review its refusal to grant access to the adverse reaction reports.

The EU Ombudsman had also suggested that, as part of a proactive information policy, EMA could provide additional clarifications to make it easier for the public to understand such data and their significance.

EMA had accepted the Ombudsman's recommendation to give access to the documents by announcing the release of the adverse reaction reports.

Diamandouros has welcomed the EMA’s decision in this respect. "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," he insisted.

The London based EMA approved and monitored medicines placed on the EU market, with a view to protecting public health.

In this capacity, it received from the competent authorities in the Member States and from pharmaceutical companies information concerning suspected adverse reactions to drugs.