Release of Drug Data Blocked

A court ruling that stops the European Medicines Agency from releasing data from two US companies calls into question the agency’s push for transparency.

By | May 2, 2013

FLICKR, CANDYThe European Medicines Agency’s (EMA) recent drive toward making preclinical and clinical data on experimental drugs more freely available was hampered this week after a European court ordered the agency not to release information from two US pharmaceutical companies, reported ScienceInsider.

The temporary injunction imposed by the General Court of the European Union backs Chicago-based AbbVie and California-based InterMune, which both filed complaints claiming that the release of information about their therapies would jeopardize their commercial interests.

The EMA began pushing for increased sharing of preclinical and clinical data on experimental drugs in 2010, after a European watchdog body ruled that it should release data in response to requests from a nonprofit organization. The agency has since responded to 613 requests for clinical data and released roughly 1.9 million pages of information, according to ScienceInsider.

The EMA has made it clear that it does not aim to aid competitors by allowing access to such information, however, and often redacts certain details. On the other hand, the agency’s head of communications Martin Harvey-Allchurch told ScienceInsider, “our position is that clinical trial data cannot, per say [sic], be considered confidential. There is a legitimate public interest to what we’re doing.”

Because the ruling only applies to these two particular cases, the agency plans to continue releasing data when individuals and companies request it and will proceed with the publication of released data on it website.

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