May 26, 2014
There has been an apparent volte-face by the European Medicines Agency on its earlier promise of a pro-active transparency policy that was about “establishing trust and confidence and enabling independent re-analysis of the evidence used by the EMA scientific committees to determine the benefits and risks of medicines “
See here for a critique of the apparent changes.
The reasons behind the change of policy are not clear. The following is pure speculation on my part:
TTIP/Pressure from the Commission?
Elements within the Commission, including DG Trade and DG Enterprise, and perhaps some in DG Sanco, argued against the transparency provisions finally agreed in the regulation revising the Clinical Trials Directives, on the grounds that they would adversely affect TTIP negotiations or damage the industry. Did the Commission seek to influence the agency’s transparency policy here?
Settlement to Legal Challenge?
The agency reached an agreed settlement to the legal challenge by AbbVie to […]