EFPIA welcomes the agreement on the EU Clinical Trials Regulation concluded by the legislators today. EFPIA believes this new legislative framework will allow for a more harmonised approach with a single submission, streamlined assessment and reduction of red tape. EFPIA sees this as a positive step towards restoring European competitiveness in clinical research in an increasingly competitive global market.

Clinical research drives a healthy economy by creating jobs, supporting academia, and attracting investment. More importantly, it supports a healthy society by supporting innovation, which brings new and improved medicines to patients. Towards this end, EFPIA has repeatedly called for competitive clinical trial authorisation timelines. Timelines that are too long contribute to higher clinical trials cost, which can lead to fewer clinical trials being run. While EFPIA and its membership strongly support the timelines put forth by the Commission in its initial proposal, EFPIA recognises the difficulties faced by some Member States in implementation. The legislation agreed upon today remains a positive step towards a more streamlined scientific and ethical process for clinical trials approval.  

EFPIA welcomes that the legislators’ approach on transparency respects the need to protect personal patient data and commercially-sensitive information. As an industry we support enhanced transparency around clinical trials and the result today reflects the EFPIA-PhRMA commitments towards responsible data sharing with researchers, patients and the general public. The Commitments establish a common baseline for responsible transparency that protects both patients and innovation. 

“When we think about the regulatory framework around clinical trials, we always need to keep in mind the aim of those clinical trials – ultimately, that is to promote innovation; protect patient safety and integrity, and improve patient outcomes,” noted EFPIA Director General Richard Bergstrom. “Legislation needs to take this into account, whether it concerns the timelines surrounding clinical trials authorisation or the measures for sharing clinical trials data. Shorter, more competitive timelines and responsible data sharing measures are both in the interests of patients. This is what we have asked for and what we will continue to ask for.”