EMA must release adverse reaction reports, says Ombudsman
Rules ‘apply to all documents held by EMA’
The European Medicines Agency (EMA) has come under pressure from the European Ombudsman to release information held on adverse reactions to drugs in trials.
The official, Nikiforos Diamandouros, has said EU rules on releasing information associated with its decision-making ‘apply to all documents held by EMA’. He noted: ‘EMA plays a crucial role in the approval and monitoring of medicines placed on the market. Since its work has a direct impact on the health of European citizens, it is of utmost importance for EMA to give the widest possible access to documents and also to pursue a pro-active information policy for the benefit of citizens.’
His conclusion came after an inquiry into complaints from an Irish citizen that EMA had refused to release documents detailing ‘all suspected serious adverse reactions relating to an anti-acne drug’ called Roaccutane, manufactured by Roche.
Diamandouros dismissed arguments from the agency that the documents’ release could publicise potentially ‘misleading or unreliable’ data.