The European Ombudsman has urged the European Medicines Agency (EMA) to reconsider its refusal to provide access to documents relating to suspected adverse drug reactions (ADRs), stating that its failure to do so “constitutes an instance of maladministration.”

The case concerns an Irish citizen who in April 2008 had asked the EMA for reports on suspected ADRs relating to a nationally-authorised drug used in the treatment of severe forms of acne, such as those reactions which give rise to suicidal tendencies. The EMA refused such access, arguing that European Union (EU) transparency rules do not apply to ADR reports.

In September 2008 the complainant brought his case before the European Ombudsman, Nikiforos Diamandouros, who yesterday announced that he disagreed with the EMA’s argument and that, in his view, EU transparency rules apply to all documents held by the Agency.

Given that the EMA’s work has a direct impact on the health of European citizens, it is “of the utmost importance” for the EMA to give “the widest possible access to documents and also to pursue a pro-active information policy for the benefit of citizens,” said Mr Diamandouros.

Following his investigation, the Ombudsman concluded that EU rules on access to documents do in fact apply to all documents held by EMA, but added that this does not mean ADR reports must automatically be accessible, given that certain exceptions contained in the transparency rules (Regulation 1049/2001 on access to documents) might apply. Therefore, he called on the Agency to review its decision.

The EMA had also argued that the release of reports relating to suspected serious ADRs would not benefit citizens because it could result in the circulation of data that could prove to be misleading or unreliable. In his response to these concerns, the Ombudsman has suggested that, “as part of a proactive information policy, EMA could provide additional explanations designed to render such data and their significance more readily understandable by the public.”

Mr Diamandouros has invited the EMA to submit a detailed opinion by July 31. Also, in a draft recommendation, he suggests that the Agency should carry out a full analysis of the possibilities under Regulation 1049/2001 of granting access to the reports requested by the complainant, covering documents which it holds in any form, and also consider providing public access to the requested reports in any form, including electronic.

Yesterday the EMA issued a response to the Ombudsman’s findings, pointing out that since the complaint was made it has launched a number of major initiatives aimed at increasing the transparency of its operations. These have included public consultations on: - an access policy regarding data held in the EU’s ADR database, EudraVigilance; - the Agency’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.

In addition, since December 2009 the Agency has been proactively publishing regular information about the safety of pandemic vaccines, it says, adding that the experience gained in this pilot project will be taken into account in the finalisation of EMA transparency initiatives, which are currently under review.