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

Abstract : 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?
Document type :
Journal articles
Liste complète des métadonnées

Cited literature [2 references]  Display  Hide  Download

https://hal.archives-ouvertes.fr/hal-01560611
Contributor : Spire Sciences Po Institutional Repository <>
Submitted on : Tuesday, November 7, 2017 - 6:25:02 PM
Last modification on : Friday, April 12, 2019 - 4:23:21 PM
Document(s) archivé(s) le : Thursday, February 8, 2018 - 2:31:43 PM

File

2012-tournay-the-legal-landsca...
Files produced by the author(s)

Identifiers

Collections

Citation

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, Wiley-Blackwell, 2012, 39 (1), pp.131-149. ⟨10.1111/j.1467-6478.2012.00574.x/full⟩. ⟨hal-01560611v2⟩

Share

Metrics

Record views

250

Files downloads

220