EMA transparency criticised

pharmafile | May 11, 2010 | News story | Sales and Marketing EMA, Roaccutane, patient information 

The European Medicines Agency (EMA) has been given a rap over the knuckles by the European Ombudsman for a perceived lack of transparency.

The ombudsman, P. Nikiforos Diamandouros, investigates complaints about EU bodies – in this case from an Irish person in 2008 after the EMA turned down their request for information on adverse drug reactions for Roche’s acne medicine Roaccutane.

Diamandouros wants the EMA to do a u-turn on its refusal to give access to the relevant documents, which include reactions giving rise to suicidal tendencies.

EMA says EU Regulation 1049/2001 on access to documents does not cover such reports, but Diamandouros argues it applies to all documents that EMA holds.

“EMA plays a crucial role in the approval and monitoring of medicines placed on the market,” he argues.

“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 proactive information policy for the benefit of citizens.”

The EMA has responded by saying that broadening access “is in line with the Agency’s transparency initiative” and that it will respond on this specific issue by the end of July.

Its argument against disclosure was founded on the notion that this could result in people seeing data that was misleading or unreliable.

But the ombudsman has not said that adverse reaction reports must “automatically” be available – and he suggests the EMA could provide additional explanations to help the public understand such disclosures.

The rebuke clearly rankles with the EMA, which points out it has launched several initiatives to increase the transparency of its operations.

These include public consultations on access to EudraVigilance, the EU database on adverse drug reactions, and on its general policy on document access.

Since last December it has also been as been proactively publishing regular information about the safety of pandemic vaccines, it adds.

Adam Hill

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