Key facts of the case:

Appeal — Access to documents of EU institutions, bodies, offices or agencies — Regulation (EC) No 1049/2001 — First indent of Article 4(2) — Exception relating to the protection of commercial interests — Article 4(3) — Protection of the decision-making process — Documents submitted to the European Medicines Agency in the context of a marketing authorisation application for a medicinal product for human use — Decision to grant a third party access to the documents — General presumption of confidentiality — No obligation for an EU institution, body, office or agency to apply a general presumption of confidentiality.

Outcome of the case:

On those grounds, the Court (Fourth Chamber) hereby:

1. Dismisses the appeal;
2. Orders PTC Therapeutics International Ltd to bear its own costs and to pay those incurred by the European Medicines Agency (EMA);
3. Orders the European Confederation of Pharmaceutical Entrepreneurs to bear its own costs.