European Ombudsman Emily O’Reilly has raised transparency concerns in two areas, announcing an investigation May 14 into the composition and transparency of the Commission’s expert groups, and asking on May 16 about clinical trial data transparency.
On expert groups, she asked interested persons and organizations for feedback “on how balanced the representation of relevant areas of expertise and interest is in different groups, how transparent the groups are and how well the application procedures work,” according to a press release (Text available in EN, DE, FR).
O’Reilly explained: “The Commission relies heavily on the advice of hundreds of expert groups to draw up legislation and policy, covering areas from tax and banking services, to road safety and pharmaceuticals. It is of utmost importance for these groups to be balanced and to work as transparently as possible so that the public can trust and scrutinise their work.”
The invitation to the public consultation is available here.
Clinical Trial Transparency
In a letter to the European Medicines Agency (EMA), O’Reilly expressed concern about “what appears to be a significant change of policy concerning clinical trial data transparency,” according to a press release. “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.”
The ombudsman 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.
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