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

被引:21
作者
Mahalatchimy, Aurelie [1 ,2 ,3 ]
Rial-Sebbag, Emmanuelle [1 ,2 ]
Tournay, Virginie [3 ]
Faulkner, Alex [4 ]
机构
[1] INSERM, UMRS 1027, F-31073 Toulouse, France
[2] Univ Toulouse 3, Fac Med, F-31073 Toulouse, France
[3] Inst Etud Polit, PACTE Polit Org, UMR 5194, F-38040 Grenoble, France
[4] Kings Coll London, Dept Polit Econ, London WC2R 2LS, England
关键词
D O I
10.1111/j.1467-6478.2012.00574.x
中图分类号
D9 [法律]; DF [法律];
学科分类号
030101 [法学理论]; 030111 [法律史学];
摘要
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?
引用
收藏
页码:131 / 149
页数:19
相关论文
共 30 条
[1]
[Anonymous], THEORIES CONCEPTS IN
[2]
[Anonymous], 2006, OJ L, VL38
[3]
[Anonymous], 2000, SORTING THINGS OUT C
[4]
[Anonymous], 2001, OJ L, VL121, P34
[5]
[Anonymous], GUID QUAL SAF ASS HU
[6]
[Anonymous], 2004, OJ L, VL102
[7]
[Anonymous], CM6989
[8]
[Anonymous], 2006, OJ L, VL294, P32
[9]
[Anonymous], 2005, OJ L, VL91, P13
[10]
Barry Andrew., 2006, European Journal of Social Theory, V9, P239, DOI DOI 10.1177/1368431006063343