On Wednesday, 22 January, the Court of Justice of the European Union dismissed the actions of the company PTC Therapeutics International (Case C-175/18 P) and the companies MSD Animal Health Innovation and Intervet International (Case C-178/18 P) against judgments of the General Court of the European Union of February 2018; the latter court had ruled in favour of the European Medicines Agency (EMA), which had authorised partial access to their respective marketing authorisation application files for a medicinal product for human use in the first case and for veterinary use in the second case.
According to the court, EMA was not required to apply a general presumption of confidentiality in deciding whether the reports concerned are protected by one or more exceptions under the regulation (1049/2001) on public access to documents. The European agency was entitled to carry out a concrete and individual examination of these reports, which had led it to redact certain passages in them.
On the matter of harm to the complainants’ commercial interests, the European judge considers that the risk of misuse of data must be established and not merely alleged. He judges that any application to set aside access to a marketing authorisation application file for a medicinal product must therefore provide explanations of the nature, purpose, and scope of the data whose disclosure would harm commercial interests.
See the judgment in Case C-175/18: http://bit.ly/2sNqgWK
See the judgment in Case C-178/18: http://bit.ly/2REE26A (Original version in French by Mathieu Bion)