In a letter to the EMA, the European Ombudsman, Emily O'Reilly, has expressed concern about a significant change of policy concerning clinical trial data transparency. The European Ombudsman investigates complaints about maladministration in the E.U. institutions and bodies.
Any E.U. citizen, resident or an enterprise or association in a member state can lodge a complaint with the Ombudsman. The Ombudsman has reviewed documents showing the EMA plans to limit access to clinical trial data by imposing strict confidentiality requirements and by allowing data only to be seen on screen using an interface provided by EMA, as well as imposing wide restrictions on the use of such data.
O'Reilly said, "We were pleased when EMA announced, in 2012, a new pro-active transparency policy, giving the broadest possible public access to clinical trial data. I now am concerned about what appears to be a significant change in EMA's policy, which could undermine the fundamental right of public access to documents established by E.U. law. European citizens, doctors and researchers need maximum information about the medicines they take, prescribe and analyze. "
In the last five years, the Ombudsman has conducted over a dozen inquiries into the EMA. Many concerned refusals to make public documents regarding the authorization and regulation of medicines by the agency, including medicines for treating multiple sclerosis, acne, bacterial infections and obesity. In response to the Ombudsman's intervention in these cases, EMA appeared ready to adopt a pro-active approach towards transparency.
On April 2, the European Parliament voted in favor of legislative proposal to make clinical trial data public. As a consequence, the results of all future clinical trials in Europe should eventually be made publicly accessible online.
The Ombudsman has asked EMA's director, Guido Rasi, to inform her by May 31 how EMA intends to deal with requests for public access to existing clinical trial data. She also asked him to list the reasons and the legal basis for what appears to be a significant change of policy.
