European Ombudsman ramps up action against European Medicines Agency over data transparency plans

The European Ombudsman has toughened her stance on the European Medicines Agency (EMA), after the agency failed to provide satisfactory answers on how it planned to ensure transparency about clinical trial reports.

The ombudsman, Emily O’Reilly, told the EMA that she was “disappointed” by its approach and would now ask the European Commission formally for its view. The EMA needs the commission’s agreement before its policy can be adopted.

O’Reilly also planned to consult “concerned members of the European parliament” and has launched an investigation into how the EMA handles requests for access to clinical trial reports about the approval of the drug Humira. Humira is produced by AbbVie, which took legal action against the EMA last year to prevent access to documents related to its products.1

O’Reilly first …