Court of Justice confirms that there is no general presumption of confidentiality over documents submitted to regulators (PTC Therapeutics v EMA and MSD Animal Health Innovation, Intervet v EMA)

Table of contents

• What are the practical implications of these cases?
• What was the background?
• What did the court decide?
• Case details

Article summary

Life Sciences analysis: The Court of Justice landmark decision did not follow the Advocate General’s opinion but instead maintained the General Court’s ruling and dismissed the appeals in the related access to documents judgments. This upholds a string of judgments on third party access to documents maintaining that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency to support a marketing authorisation application. Certain commercially confidential information may be protected by exception if the interested party can show that the disclosure will cause it harm. The decision strengthens Regulation 1049/2001 (the Transparency Regulation) and prepares for the incoming new clinical trials regulatory regime.