Timo Minssen is Professor of Biotechnology Law at the University of Copenhagen’s Center for Information & Innovation Law. His research focuses in particular on Biomedical Innovation Law and he has published extensively in this area. He leads four major interdisciplinary research projects concerning biobanks, synthetic biology, systems biology, precision medicine and large research infrastructures. He has been a Visiting Research Fellow at the Universities of Cambridge & Oxford, Harvard Law School, the Chicago-Kent College of Law and the Max Planck Institute.
Recent initiatives and new legislation will considerably increase public access to clinical trials data (CTD) in both Europe and in the US. Greater CTD transparency entails enormous benefits, inter alia for the enhancement of precision medicine. Yet, the costs and concerns associated with increased transparency are also substantial. They include worries over patient privacy and misuses of clinical trial data in poor-quality analyses. Moreover, the drug industry has expressed concerns over fewer incentives to invest in innovative R&D and increased exposure to litigation owing to trolling of these data by class-action tort lawyers. Focusing on recent EU legislation and experiences, this presentation will describe the genesis of the regulatory transparency requirements, as well as the incidents, developments and policy concerns that have shaped them. Special emphasis will be laid on the model for increased transparency recently adopted in the EU with Regulation 536/2014 and the alleged conflicts between actual practices, policy goals and the EU’s new legislation on personal data protection and trade secrets. This presentation will argue that these clashes are real and must be swiftly addressed to reap the full benefits of CTD transparency.