STAT Plus: European court upholds controversial EMA transparency rules for clinical trial data
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.
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