EMA criticized over transparency rules

May 13, 2010

The European Ombudsman has recommended that the European Medicines Agency (EMA) review its refusal to grant public access to reports on adverse drug reactions.

The recommendation stems from 2008, when an Irish citizen asked the EMA for access to documents containing details of suspected serious adverse reactions relating to an anti-acne drug. The EMA refused, claiming that EU transparency rules do not apply to adverse reaction reports. According to the agency, such reports could result in the circulation of misleading or unreliable data.

But the Ombudsman, P. Nikiforos Diamandouros, does not agree; he believes that the EU transparency rules apply to all documents held by the EMA.

"The EMA plays a crucial role in the approval and monitoring of medicines placed on the market," said Diamandouros, in a press statement. "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."

However, this doesn't necessarily mean that the EMA will be handing out all its adverse reaction reports and even Diamandouros agreed that the reports should not be automatically accessible, as certain exceptions contained in the transparency rules might apply.

Regarding concerns about the circulation of data that may be misleading, Diamandouros suggested: "as part of a proactive information policy, the EMA could provide additional explanations designed to render such data and their significance more readily understandable by the public."

In defence, the EMA has pointed out that it has launched a number of major initiatives since 2008 to increase the transparency of its operations; for instance, the EMA has held public consultations regarding access to adverse drug reactions held in the EU database EudraVigilance; the EMA's policy on access to documents; and a new transparency policy setting out the EMA's vision on its level of openness towards its stakeholders. The EMA has also been publishing regular information about the safety of pandemic vaccines.

"The experience gained in this pilot project will be taken into account in the finalisation of the Agency’s transparency initiatives, which are currently under review," said the EMA on its website.

The Agency will submit its opinion on the issue raised by the Ombudsman by 31 July 2010.

www.ema.europa.eu