STAT Plus: EMA warns that its clinical trial transparency efforts may be jeopardized
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.
