A few weeks ago, two drugmakers filed requests for an injunction to prevent the European Medicines Agency from releasing detailed patient-level data from studies about their drugs. The moves by AbbVie and Intermune are the first such challenges to a three-year-old agency policy to provide access to documents and were made in response to a pair of Freedom of Information requests made to the EMA last year to release “raw data” on safety and efficacy. AbbVie, for instance, is trying to prevent rivals from obtaining data about its best-selling Humira treatment for rheumatoid arthritis.
Today, the General Court of the European Union ordered the EMA not to provide any documents to the drugmakers that filed the Freedom of Informatoin requests, at least until a final ruling is given. In a statement, the EMA says it is considering whether to file an appeal. Nonetheless, the agency plans to continue releasing documents on a case-by-case basis, depending upon the outcome of these challenges. Since November 2010, the EMA says more than 1.9 million pages of documents have been released in response to access requests.
Since the challenges were filed, the EMA claims to have received more than 30 statements of support from the European Ombudsman, members of the European Parliament, academic institutions, non-governmental organizations and scientific journals, among others (here is the EMA statement). Conversely, US and European pharmaceutical industry trade groups have filed papers supporting the drugmakers.
As noted previously, the challenges occurred amid an ongoing controversy over the disclosure of clinical trial data, which most drugmakers are fighting over concerns that confidential information could be unfairly obtained by rivals. On the other side of the debate are researchers who argue that results cannot be independently verified unless patient-level data and case-study reports are fully disclosed.
There are, however, cracks showing in the stance taken by the pharmaceutical industry. Last year, GlaxoSmithKline (GSK) agreed to make patient-level data available to independent researchers, a step that came after the drugmaker paid a $3 billion settlement to settle civil and criminal charges that included a failure to release trial data (see this). However, the drugmaker has not yet launched its effort.
And earlier this month, Roche has agreed to make available data from all 74 clinical trials for its treatment to a team of Cochrane Collaboration researchers. The move comes after the the drugmaker recently agreed to widen access more generally for clincal trial information for its medicines in response to increased pressure from academics and a widely publicized online petition (back story).
STORY ENDS HERE