Unravelling Challenges of European Legal Approaches and Definitions of SoHO in Shaping Biomedical Innovation

This article seeks to examine the definition(s) of Substances of Human Origin (SoHO) and their impact on biomedical practices and innovation in Europe. It shows the challenges posed by the conceptual uncertainty surrounding SoHO, which could affect biomedical practices and social acceptability of SoHO activities. The first part examines constraints shaping regulatory approaches and demonstrates that theoretical and institutional approaches partially explain fragmentation and conflicting perspectives in delineating scope, complicating navigating various laws. The second part delves into definitions themselves, revealing that criteria recurrently lack clarity, leading to complexities in legal readability and interpretability when using nested concepts. The third and final part discusses how these elements may result in direct and indirect consequences on innovation. While uncertainties or lack of alignment of legal definitions can be seen as a compromise between conflicting perceptions, they may lead to issues in terms of acceptability of innovation.