EU Court of Justice Confirms Access to Data in Marketing Authorization Applications

The Court of Justice of the European Union confirmed EMA’s right to release documents filed with marketing application for a medicinal product.

The decision stemmed from two lawsuits brought against the agency  —  by PTC Therapeutics and MSD Animal Health Innovation (owned by Merck) — for disclosing the contents of toxicology reports and a clinical study report the companies submitted as part of their marketing authorization applications for two products.

The EU’s highest court rejected the notion that the reports were covered by a “general presumption of confidentially.” It said the plaintiffs failed to explain how the released data would undermine their commercial interests.