Type
Article
Titre
The Legal Landscape for Advanced Therapies: Material and Institutional Implementation of European Union Rules in France and the United Kingdom
Dans
Journal of Law and Society
Auteur(s)
MAHALATCHIMY Aurélie - Politiques publiques, ACtion politique, TErritoires (Auteur)
RIAL-SEBBAG Emmanuelle - Institut National de la Santé et de la Recherche Médicale (Auteur)
TOURNAY Virginie - (Auteur)
FAULKNER Alex - (Auteur)
Éditeur
GB : Blackwell Publishing
Volume
39
Numéro
1
Pages
131 - 149 p.
ISSN
0263323X
DOI
10.1111/j.1467-6478.2012.00574.x
Mots clés
Regenerative medicine, Regulatory bodies, Advanced therapies, Institutional implementation
Résumé
EN
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?

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