Industry responds to European clinical trials regulation revision
There is an increasing international competition in clinical trials because clinical research creates jobs, drives academic excellence and delivers innovative medicines for patients. Improving the attractiveness and competitiveness of Europe as a prime location for clinical research was a key driver for the revision of the E.U. clinical trial legislation, which aimed to reduce unnecessary red tape whilst preserving the quality and safety of clinical trials.
European legislators are expected to reach a compromise on the clinical trials regulation before Christmas. EFPIA (European Federation of Pharmaceutical Industries and Associations), EuropaBio, ACRO and Cancer Research U.K. call on all parties to bear the drivers of this legislative revision in mind and take the steps needed to grow E.U. clinical research.
The longer the regulatory process takes to approve a clinical trial or process regulatory procedures around it, the greater the cost of the trial. Higher costs can result in fewer trials being run, reducing the ability to understand treatments better. EFPIA believes harmonized and streamlined approaches are needed in the future.
Richard Bergstrom, EFPIA director general, said, “The timelines set out by the Commission are achievable. We can look to Belgium and the U.K. as examples for best practice. Where adjustments to national regulatory systems are required, these should be regarded as investment in the future. My member companies invest around $27.1 billion every year on clinical research in Europe, and clinical trials contribute to economic growth, attract high-skilled jobs and foster an innovative European research community.”
Alastair Kent OBE, president of EGAN, said, “It is important for European patients that research happens here in Europe. We want to see a proportionate approach to regulating clinical trials that will foster the innovation that is necessary to solve our unmet health needs. Keeping medical research in Europe will allow European patients to continue to be partners in the research that so many of us desperately need.”
Miriam Gargesi, director of healthcare at EuropaBio, said, “EuropaBio recognizes the need for competitive assessment timelines to ensure an attractive regulatory environment for clinical research. We believe that there is no scientific justification for longer assessment timelines if we want to continue to deliver new and innovative medicinal products to patients.”
“The CROs of ACRO conduct clinical trials throughout the world, and we would deeply regret any retreat from efforts to establish consistent and attainable timelines for the approval of trial applications in Europe,” said Douglas Peddicord, Ph.D., ACRO executive director. “Any reduction in the scientific and economic competitiveness of the E.U. will hurt patients, whose access to new therapies will be delayed.”
Sara Osborne, head of policy at Cancer Research U.K., said, “Clinical research is crucial to improve our understanding of existing treatments as well as developing new ones. We’re pleased with the suggested Clinical Trials Regulation and believe that it will provide a much needed improvement for the clinical research environment.”