EU Court Maintains Suspension of EMA Document Release

March 23, 2017

The EU Court of Justice has denied European Medicines Agency appeals to allow the agency to release documents as part of its transparency efforts.

PTC Therapeutics and Intervet filed suit in December 2015 seeking to block the EMA’s release of industry documents requested by third parties. The EU Court of Justice responded by suspending the release of three documents and EMA appealed the ruling.

The documents relate to PTC’s Duchenne muscular dystrophy treatment Translarna and three toxicity studies on a veterinary medicine manufactured by Intervet. PTC and Intervet argued that releasing the documents would violate their right to withhold commercially confidential information.

In addition to upholding the suspension, the court ordered EMA to pay court costs incurred by PTC Therapeutics. The EMA said it will abide by the order but will continue processing document-access requests on drugs under the transparency rule.

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