Access to documents contained in a MA application file

By Anne-Florence Raducault, Celine Gasser


The ECJ confirms the right of third parties to have access to the documents contained in a Marketing Authorisation (MA) Application file for medicinal products.

ECJ, 22 janvier 2020, aff. C-175/18 P, PTC Therapeutics International Ltd / European Medicines Agency (EMA)

ECJ, 22 janvier 2020, aff. C-178/18 P, MSD Animal Health Innovation GmbH / European Medicines Agency (EMA) 

Judgments of the European Court of Justice

European Medicines Agency (EMA) had communicated to third parties (with some omissions), information contained in toxicological test reports and clinical trial reports obtained in a MA application file on the grounds that, apart from the information already omitted, the reports were not confidential and could therefore be disclosed.

The ECJ dismissed the applications of two companies selling medicinal products and who claimed that these reports should entirely benefit from a confidentiality presumption.

Two lessons can be drawn from these judgments

  • Absence of a general confidentiality presumption

An institution, body, office or agency of the European Union to which an application for access to documents has been submitted shall always retain the possibility of carrying out a concrete and individual examination of the documents in question in order to decide whether or not to disclose them in full or in part.

  • Obligation to demonstrate damages to commercial interests

Article 4 of Regulation 1049/2001 provides in particular for the refusal "of access to a document where disclosure would undermine the protection of the commercial interests of a natural or legal person, including intellectual property".

Explanations should be given as to the nature, purpose and scope of the data in question which made it possible to conclude that there was a risk of misuse of the data contained in the disputed reports and also to identify concretely and precisely the extracts in the disputed reports which could damage commercial interests in the event of disclosure.

A general risk is insufficient.