EFPIA notes the decision by the Court of Justice of the European Union (CJEU) in the case of PTC Therapeutics International v EMA (C-175/18 P) and MSD Animal Health Innovation and Intervet International v EMA (C-178/18 P), delivered on 22 January 2020.
The biopharmaceutical industry believes that the disclosure of clinical trial results and responsible sharing of clinical trial data is in the best interests of patients, clinicians, medical research and the biopharmaceutical industry. The industry is now widely-recognised as leading the way in clinical trial data sharing, adhering to the principles set out in joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing including sharing patient level data.
Responsible data sharing means supporting enhanced data sharing, while safeguarding patient privacy, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research. As an industry we are committed to continuing to work with partners across the research and regulatory community to develop a shared understanding and vision of where that balance lies.
We will further analyse the decision of the CJEU and its implications of potential further improvements needed in current transparency policies.