After months of anticipation, the European Court of Justice has sided with the European Medicines Agency in its bid to provide access to clinical trial data and other types of information as part of a hotly contested transparency policy.
The court was reviewing appeals filed by two drug makers — Merck (MRK) and PTC Therapeutics (PTCT) — that claimed greater transparency would come at the expense of their commercial secrets. The cases have been closely watched as a test of EMA rules, as well as a policy that permits the agency to release certain clinical trial data, while also agreeing to select redactions negotiated with companies.
For its part, the regulator maintained certain trial data contained in marketing applications should be made available in the public interest and that disclosure would not violate commercially confidential information, unless a company could justify withholding data. But last fall, one Advocate General agreed with the companies that disclosure would harm their interests, triggering anxiety over a final decision.