The EU Court of Justice confirms the right of access to documents contained in the file of a marketing authorisation application for a medicinal product (PTC Therapeutics / MSD Animal Health)

The Court confirms the right of access to documents contained in the file of a marketing authorisation application for a medicinal product* An objection to such access must explain the nature, purpose and scope of the data whose disclosure would undermine commercial interests In the judgments in PTC Therapeutics International v EMA (C-175/18 P) and MSD Animal Health Innovation and Intervet International v EMA (C-178/18 P), delivered on 22 January 2020, the Court of Justice was required to examine, for the first time, the question of access to European Union documents submitted in the context of marketing authorisation (MA) applications. In this instance, it dismissed the appeals brought by, on the one hand, PTC Therapeutics International and, on the other, MSD Animal Health Innovation