As discussions on the European Biotech Act continue, BioMed Alliance has published a position statement calling for stronger recognition and support for academic clinical research as a key contributor to Europe’s biotechnology ecosystem. Academic clinical research generates independent evidence, addresses unmet medical needs and advances scientific and clinical innovation, yet academic researchers continue to face regulatory and financial barriers that can hinder the translation of promising research into clinical applications.
BioMed Alliance calls for academic and non-commercial research organisations to be recognised as strategic contributors to Europe’s biotechnology ecosystem and for dedicated EU support for academic biotechnology development, including late-stage clinical research and pivotal trials. A key priority is to ensure that low-intervention clinical trials (LICTs) are supported by proportionate, risk-based requirements. Our recommendations also address the need to harmonise informed consent requirements, strengthen regulatory support for academic developers through the EU Health Biotechnology Support Network, and ensure that publicly funded biotechnology innovation delivers a public return, including through affordability and equitable patient access.
