Europe – EU Court of Justice Rules in Favor of EMA in Transparency Case

The Court of Justice of the EU on Wednesday ruled that the European Medicines Agency (EMA) acted lawfully when it released certain toxicology reports and a clinical study report from two sponsors that wanted to keep that information confidential.

The cases centered around New Jersey-based PTC Therapeutics and MSD Animal Health (part of Merck), which claimed that EMA’s disclosure of a clinical study report, in the case of PTC, and five toxicology reports from MSD Animal Health would undermine their commercial interests.

But the Court of Justice concluded, siding with the General Court ruling from February 2018, that the passages in the reports at issue “did not constitute information capable of falling within the exception relating to the protection of commercial interests.”…