Crucial Development on the Presumption of Confidentiality in the Access to Document Saga (PTC Therapeutics v EMA and MSD Animal Health Innovation, Intervet v EMA)

The saga of access to documents (ATD) cases in the European pharmaceutical legal landscape continues, this time with two promising opinions of Advocate-General Hogan. In summary AG Hogan found that the General Court had erred in law in its conclusions that (a) there was no general presumption of confidentiality and (b) access to the study reports submitted in a marketing authorisation application dossier at issue would not compromise the applicants’ commercial interests.

This article has been originally published on LexisPSL.