In the recent cases of PTC Therapeutics International v. EMA (C-175/18 P) and MSD Animal Health Innovation and Intervet International v. EMA (C-178/18 P), the Court of Justice of the European Union (CJEU) for the first time considered the question of access to European Union documents submitted - in this instance - to the European Medicines Agency (EMA) as part of a marketing authorisation (MA) application to third parties.
EU Regulation No 1049/2001 regulates public access to European Parliament, Council and Commission documents, and defines when grounds of public or private interest governing the right of access to such documents can prevail over the broad EU principle that there should be "the widest possible access to documents". Specifically, under article 4, access shall be refused to a document "where disclosure would undermine the protection of … commercial interests of a natural or legal person, including intellectual property".
However, in these judgments the CJEU dismissed the appeals brought by PTC Therapeutics and MSD Animal Health Innovation and Intervet International and upheld the EMA decisions to allow third-party access to documents contained in the file of MA applications, including toxicology and clinical study reports.
The two cases raised identical issues concerning the legality of the EMA's decision to grant, under Regulation No. 1049/2001, access to a number of documents submitted as part of MA applications. Both appellants claimed that the toxicology and clinical study reports should benefit from a general presumption of confidentiality and should not be disclosed to third parties.