Press releases - Ombudsman concerned about change of policy at Medicines Agency as regards clinical trial data transparency»European Ombudsman

"In a letter to the European Medicines Agency (EMA), the European Ombudsman, Emily O'Reilly, has expressed concern about what appears to be a significant change of policy concerning clinical trial data transparency. According to documents the Ombudsman has seen, EMA is planning 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. Emily O'Reilly commented: '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 am now 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 EU law. European citizens, doctors and researchers need maximum information about the medicines they take, prescribe and analyse' ..."