CJEU Case C-175/18 P / Judgment

PTC Therapeutics International Ltd v European Medicines Agency
Deciding body type
Court of Justice of the European Union
Deciding body
Court (Fourth Chamber)
Decision date
ECLI (European case law identifier)
  • CJEU Case C-175/18 P / Judgment

    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.
  • Paragraphs referring to EU Charter

    52) That core EU objective is also reflected in Article 15(1) TFEU, which provides that the institutions, bodies, offices and agencies of the European Union are to conduct their work as openly as possible, that principle of openness also being expressed in Article 10(3) TEU and in Article 298(1) TFEU, and in the enshrining of the right of access to documents in Article 42 of the Charter of Fundamental Rights of the European Union (judgment of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 74 and the case-law cited).