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European Court may yet force AbbVie and InterMune to release data

Orders rethink on EMA's Humira and Esbriet injunction

European Medicines Agency (EMA)The European Court of Justice has ordered a re-examination of an earlier decision preventing the European Medicines Agency (EMA) from releasing clinical trial data against the will of two pharma companies.

The case revolves around an injunction granted in April to AbbVie and InterMune that blocked the release of information under the EMA's access-to-documents programme, set up by the agency in 2010.

In its latest ruling, the ECJ has concluded that the EU's General Court tribunal "erred in law" when it prevented the EMA from releasing the data, and has ordered it to reconsider its verdict.

AbbVie is trying to block the release of individual patient-level data on its big-selling arthritis drug Humira (adalimumab), while InterMune is trying to block a request from academic researchers for information on its only marketed product, idiopathic pulmonary fibrosis (IPF) drug Esbriet (pirfenidone).

The EMA said it will not go ahead with disclosing the documents related to the case until the General Court has reached a conclusion on the case, while the companies limited themselves to saying they were confident that the lower court would rule in favour of upholding the injunction. At the moment there is no indication when a decision may be reached.

AbbVie and InterMune are backed by the European Federation of Pharmaceutical Industries and Associations (EFPIA) which has warned that the interests of drug developers could be suffer significant commercial harm if data is released indiscriminately.

The legal dispute strikes at the heart of the increasingly acrimonious debate between industry and the EU regulator on the topic of clinical trial transparency, which is approaching a conclusion as the EMA sifts through hundreds of comments on proposals that were due to come into force on January 1 but have now been delayed.

In October, the senior figures at the EMA hit back at industry's reluctance to make de-identified patient-level data and full clinical study reports (CSRs) more widely available, saying its fears about giving up trade secrets were unfounded and block important health research.

Article by
Phil Taylor

6th December 2013

From: Research, Regulatory



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