The Legal Landscape for Advanced Therapies: Material and Institutional Implementation of European Union Rules in France and the United Kingdom

Aurélie Mahalatchimy (1) , Emmanuelle Rial-Sebbag (2) , Virginie Tournay (3) , Alex Faulkner

1 PACTE - Pacte, Laboratoire de sciences sociales
2 INSERM - Institut National de la Santé et de la Recherche Médicale
3 CEVIPOF - Centre de recherches politiques de Sciences Po (Sciences Po, CNRS)

In 2007, the European Union adopted a lex specialis, Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regime across the European Union but have to respect national laws. This article describes the recent EU laws, and contrasts two national regimes, asking how France and the United Kingdom regulate ATMPs which do and do not fall under the scope of Regulation (EC) No. 1394/2007. What are the different legal categories and their enforceable regimes, and how does the evolution of these highly complex regimes interact with the material world of regenerative medicine and the regulatory bodies and socioeconomic actors participating in it?

Mots clés: Regenerative medicine; Regulatory bodies; Advanced therapies; Institutional implementation

Domaines: Sociologie; Science politique

Aurélie Mahalatchimy, Emmanuelle Rial-Sebbag, Virginie Tournay, Alex Faulkner. The Legal Landscape for Advanced Therapies: Material and Institutional Implementation of European Union Rules in France and the United Kingdom. Journal of Law and Society, 2012, 39 (1), pp.131 - 149. ⟨hal-01560611v1⟩