EU Court of Justice Denies EMA Appeal to Release Documents on Two Medicines

Regulatory NewsRegulatory News | 15 March 2017 |  By 

The Court of Justice of the EU earlier this month delivered a blow to transparency efforts at the European Medicines Agency (EMA), dismissing two appeals by the regulator.

The decision means the court has upheld the suspension of the release of clinical study report documents requested by a pharmaceutical company related to PTC Therapeutics’ Duchenne muscular dystrophy treatment Translarna (ataluren) and three toxicity studies for Intervet’s Bravecto (fluralaner), a veterinary medicine used to treat flea and tick infestations in dogs and cats.

The decision follows two court cases brought by PTC Therapeutics and Intervet in December 2015 in which the companies said that the release of the requested documents would infringe their right to protect commercially confidential information from their marketing authorisation applications. EMA appealed that decision in September 2016.

EMA says it will continue to process requests for access to documents concerning medicinal products in accordance with Regulation (EC) No 1049/2001, the so-called “Transparency Regulation,” and its 2010 policy on access to documents.

“The Regulation is the EU’s central instrument to achieve transparency, which is indispensable for increasing citizens’ understanding of EU decision-making and enhancing their confidence in the institutions,” EMA said in a press release.

EMA, in addition to bearing its own costs in the court proceedings, also was ordered to pay the costs incurred by PTC Therapeutics related to the appeal proceedings.


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