HAI Europe questions pharma commitment to clinical trial data transparency, claiming leaked documents suggest otherwise

29 July 2013

Consumer advocacy Health Action International (HAI) Europe says it welcomes any initiative that grants increased access to clinical trial data. However, the commitments made by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) in their joint “Principles for Responsible Clinical Trial Data Sharing” fall woefully short of the data transparency that is needed (The Pharma Letter July 24).

Moreover, it claims: “the overall commitment to transparency from EFPIA and PhRMA as such can be questioned, for while they claim to support greater access to clinical trial data we know from the recently leaked strategy document that they actually do the opposite. Indeed, the document shows that the pharmaceutical industry opposes many concrete steps towards greater data transparency under the EU Clinical Trials Regulation and the EMA’s recent move towards proactive publication of clinical trial data.”

Ancel la Santos Quintano of HAI Europe says: "Ironically industry claims to move towards increased access to clinical trial data, while we now know from this week's leaked EFPIA's internal strategy that at the same time they work to oppose concrete moves towards more transparency in EU regulations."

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