Court of Justice of the European Union

PRESS RELEASE No6/20

Luxembourg, 22 January 2020

Judgments in Case C-175/18P

PTC Therapeutics International Ltd v European Medicines Agency(EMA),

And C-178/18P MSD Animal Health Innovation and Intervet International v European Medicines Agency(EMA)

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-175/18P) and MSD Animal Health Innovation and Intervet International v EMA(C-178/18P), 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 and Intervet International against thejudgments of the General Court1dismissing their actionsfor annulment of the decisions by which the European Medicines Agency (EMA) had granted access to documents containing information submitted in the context of the procedure relating to MA applications for medicinal products.

Full press release here: https://curia.europa.eu/jcms/upload/docs/application/pdf/2020-01/cp200006en.pdf