Blood establishments are central to biotech innovation

EBA welcomes the European Commission’s proposal for a European Biotech Act. Public and non-profit blood establishments are the original precursors of personalised medicine and have played an historic and central role in the development of many ground-breaking biotechnological therapies, including advanced therapy medicinal products (ATMPs). Blood establishments continue to play a fundamental role in these and other advanced treatments, and any effort to boost Europe’s biotech sector must ensure it leverages the expertise, knowledge, and capacity of public and non-profit blood establishments.

EBA members agree that the proposal includes interesting measures to support research, development, and innovation across several health biotechnology sectors, including blood and blood components and other Substances of Human Origin (SoHO). The proposed measures to support strategic projects, as well as the new EU Health Biotechnology Support Network, will be valuable additions to the European biotech ecosystem. To be successful, these efforts must involve blood establishments and other scientific experts in their design and development.

EBA also welcomes, but advises caution over, the overall effort to simplify certain procedures in existing legislation and to introduce regulatory sandboxes to facilitate innovation, notably regarding SOHO donor protection.

Finally, EBA welcomes the proposal to establish a Union regulatory status repository. Given the increasing number of innovative therapies combining substances of human origin with medical devices, medicinal products or advanced therapy medicinal products, early regulatory clarification and transparent access to regulatory status decisions will be essential to avoid inconsistencies and ensure legal certainty for developers and competent authorities.

EBA’s full position paper and suggestions for improvements to the proposal can be downloaded below.