Today, the General Court delivered three landmark judgments relating to transparency of clinical trial data in the EU. The long-awaited rulings clarify the scope of commercial confidentiality with regard to data pertaining to centrally approved medicinal products and included in the MA application dossier. The three rulings uphold the European Medicines Agency (EMA)’s decisions to release documents requested in accordance with the so-called “Transparency Regulation” and EMA’s policy 0043 on access to documents.
The judgments concern Case T-235/15, Pari Pharma v EMA, regarding the disclosure of CHMP similarity and superiority reports on an orphan medicine; Case T-718/15, PTC Therapeutics International v EMA, on the disclosure of a clinical study report; and Case T-729/15, MSD Animal Health Innovation and Intervet international, concerning toxicology study reports for a veterinary medicine.
According to an EMA press release, the General Court noted that the companies failed to give any concrete evidence of how the release of the contested documents would undermine their commercial interests, and therefore rejected their claims. This is the first time in which the General Court pronounced itself on the merits with respect to the Transparency Regulation and EMA’s Policy 0043.