Court ruling favors EMA’s transparency policy

The Court of Justice of the European Union has ruled in favor of EMA in response to an appeal by PTC and Merck & Co.’s animal health unit, which were challenging the legality of agency decisions to grant public access to redacted toxicology and clinical study reports in 2015.

Wednesday’s decision upholds a 2018 ruling by the General Court of the European Union that no general presumption of confidentiality exists with respect to the study reports, and that such a disclosure of information would not compromise commercial interests. ...