In a little-noticed statement, the European Medicines Agency warned that its hard-fought efforts to provide access to clinical trial data would be damaged if the European Union Court of Justice adopts a pair of recent rulings by one of the court’s advocate generals.
The rulings were made last month in response to a February 2018 court decision supporting the EMA in its quest for greater transparency. In related cases involving two different drug makers, the regulator maintained certain trial data should be made available in the public interest and that disclosure would not violate commercially confidential information, unless a company could justify withholding data.
The Court of Justice agreed, but PTC Therapeutics (PTCT) and Merck (MRK) filed appeals arguing the EMA did not have the right to release certain information because it would expose their trade secrets. On Sept. 11, Advocate General Gerard Hogan agreed with the companies that disclosure would, indeed, harm their interests, adding that there was also no presumption of confidentiality for clinical study reports.