Injunctions blocking the European Medicines Agency from releasing clinical-trial data from AbbVie Inc. (ABBV) and InterMune Inc. must be reexamined, according to the European Union’s highest court.
A lower EU tribunal “erred in law” on some points when it imposed provisional injunctions blocking the EMA from releasing the data pending the outcome of appeals on the issue by AbbVie and InterMune, the EU Court of Justice said in a decision published today.
“We’re back in the situation now where the court has to look again at the applications of AbbVie and InterMune,” Martin Harvey-Allchurch, a spokesman for the EMA, said by phone today. “Pending the outcome, as a courtesy to the court, we have said we will not disclose the documents in those cases,” Harvey-Allchurch said. “We continue to consider to release documents to other applicants in other cases.”
The EU regulator promised in 2010 to bolster its transparency by disclosing, on demand, clinical trial data for every drug reviewed. Drug safety activists pressed for the move amid concerns over suicide risks linked to Sanofi’s failed diet pill Acomplia.
A spokeswoman for AbbVie said the Court of Justice hadn’t made a final judgment in referring the matter back to the General Court for further consideration.
“Until the conclusion of this additional assessment by the General Court, there can be no final outcome,” Fiona Olivier, the spokeswoman, said in an e-mail. “AbbVie remains confident that the General Court will rule in favor of upholding the provisional injunction.”
A spokesman for Brisbane, California-based InterMune didn’t immediately respond to a request for comment.
AbbVie argued in court that companies could suffer “serious and irreparable” harm from the publication of the data.
The lower court was wrong to decide that “the alleged infringement of the AbbVie companies’ fundamental right to the protection of their business secrets” and their right to an effective remedy “was sufficient in itself to establish” the risk of such harm, the EU’s top court said in the decision, dated Nov. 28.
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