Is there a legal concept of biomedical innovations in EU binding law?
Résumé
European Union law plays a great role in regulating “biomedical innovations” such as gene therapy, regenerative medicine or nanomedicine. Yet, the expression has been increasingly used in the literature and has emerged as a concept of science although not being homogenous. Considering it as a concept of legal science, we are defining biomedical innovation as an innovative product, procedure or technique based on biological elements of human or animal origin which entails high or unknown risks, and which serves a medical goal as well as economic competitiveness. Focusing on the biological component of biomedical innovations, and building on the characteristics of legally defined advanced therapy medicinal products, this paper explores if the biomedical innovation’s concept of legal science exists as a legal concept in applicable EU binding law, i.e. if EU law is considering, and/or defining biomedical innovations beyond the legal categories it embeds on the basis of identified and shared characteristics that would deserve to be regulated according to the EU legislator. Although it concludes that the expression “biomedical technologies” would better correspond to the EU legislator’s use, the analysis of EU binding law confirms the relevance of our definition of the biomedical innovation’s concept of legal science.
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