Posted by Michael Wonder on 29 Jan 2020
Documents disclosed to the EMA as part of an MA application process are not presumed to be confidential
28 January 2020 - On 22 January 2020 the CJEU handed down two decisions in which it decided that the EMA was entitled to disclose to third parties the study reports submitted to it by applicants for marketing authorisations, despite the applicants claiming confidentiality over the reports.
The PTC v EMA (C-175/18 P) and MSD v EMA (C-178/18 P) decisions both grappled with the tension between the principle of transparency of EU institutions and the desire to incentivise pharmaceutical companies by preventing competitors from gaining access to documents submitted during the marketing authorisation application process.
