EMA's approach to transparency backed by European court

The European Union’s General Court today delivered three landmark rulings for the European Medicines Agency, upholding the EMA’s decisions to release documents requested in accordance with Regulation (EC) No 1049/2001, the so-called “Transparency Regulation.”

This is the first time that the EU Court of Justice has had the opportunity to pronounce itself on the application of the Transparency Regulation to documents held by the EMA. “We are very pleased that the General Court affirmed that the information contained in these documents cannot be considered commercially confidential in its entirety,” explained Stefano Marino, EMA’s head of Legal Department, adding: “We understand that with these rulings the General Court endorses our implementation of the Transparency Regulation that focuses on the interest of patients and public health.

The judgments concern Case  T-235/15 , Pari Pharma v EMA, in relation to the disclosure of similarity and superiority reports on an orphan medicine, prepared by the Committee for Medicinal Products for Human use (CHMP); 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 , regarding five toxicology study reports for a veterinary medicine. In all three cases, the pharmaceutical companies challenged EMA’s decision to release the concerned documents in accordance with the Transparency Regulation and EMA’s 2010 policy on access to documents ( Policy 0043 ).