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

19 Pages Posted: 22 Feb 2012

See all articles by Aurélie Mahalatchimy

Aurélie Mahalatchimy

Faculté de Médecine Toulouse Cedex

Emmanuelle Rial‐Sebbag

Inserm, UMR 1027

Virginie Tournay

SciencesPo

Alex Faulkner

affiliation not provided to SSRN

Date Written: March 2012

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?

Suggested Citation

Mahalatchimy, Aurélie and Rial‐Sebbag, Emmanuelle and Tournay, Virginie and Faulkner, Alex, The Legal Landscape for Advanced Therapies: Material and Institutional Implementation of European Union Rules in France and the United Kingdom (March 2012). Journal of Law and Society, Vol. 39, Issue 1, pp. 131-149, 2012, Available at SSRN: https://ssrn.com/abstract=2009204 or http://dx.doi.org/10.1111/j.1467-6478.2012.00574.x

Aurélie Mahalatchimy (Contact Author)

Faculté de Médecine Toulouse Cedex ( email )

France

Emmanuelle Rial‐Sebbag

Inserm, UMR 1027

Toulouse
France

Virginie Tournay

SciencesPo

Rue de l'Université 13
Paris
France

Alex Faulkner

affiliation not provided to SSRN

No Address Available

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