Release of documents on two medicines temporarily halted

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14/03/2017

Release of documents on two medicines temporarily halted

EMA’s appeals against interim measures are dismissed by Court of Justice

The Vice-President of the Court of Justice of the European Union has dismissed two appeals by the European Medicines Agency (EMA) against interim orders of the President of the General Court, thus upholding the suspension of the release of certain documents requested by third parties under Regulation (EC) No 1049/2001, the so-called “Transparency Regulation”.

In December 2015, two court cases were brought against EMA by PTC Therapeutics and Intervet. The two companies challenged EMA’s decisions to release the requested documents in accordance with the Transparency Regulation and EMA’s 2010 policy on access to documents.

The first order in the interim measures proceedings had halted the release of a clinical study report for PTC Therapeutics’ Translarna (ataluren), a centrally authorised medicine for the treatment of Duchenne muscular dystrophy, until a judgment in the main case is delivered by the General Court. The second order had suspended the release of three toxicity studies for Intervet’s Bravecto (fluralaner), a veterinary medicine used to treat flea and tick infestations in dogs and cats.

Both companies argue that the release of the requested documents would infringe their right to protect commercially confidential information contained in their marketing authorisation applications.

The Agency respects the orders of the Vice-President of the Court of Justice received in early March 2017 and will not release the concerned documents until the General Court rules on the main cases.

The orders in the interim measures proceedings do not pre-empt the judicial decision on the two main cases. In the meantime, EMA will continue to process requests for access to documents concerning medicinal products in accordance with the Transparency Regulation and its 2010 policy on access to documents.

EMA’s policy on access to documents entered into force in 2010. It explains the rules that EMA applies when giving the public access to documents it holds under the terms of the Transparency Regulation. 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.

In October 2016, EMA launched its ground-breaking policy on the proactive publication of clinical study reports that support applications for marketing authorisation for medicines.

Note

The order related to the Translarna court case is available on the Court of Justice website. The second order will also be published on this website.

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