Mahalatchimy Aurélie, Rial-Sebbag Emmanuelle, Tournay Virginie, Faulkner Alex
Université de Toulouse.
J Law Soc. 2012;39(1):131-49. doi: 10.1111/j.1467-6478.2012.00574.x.
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?
2007年，欧盟通过了一项特别法，即关于高级治疗用医药产品（ATMPs）的（欧盟）第1394/2007号法规，这是再生医学领域一种新的医疗产品法律类别。该法规适用于通过工业方式制备或采用涉及工业流程的方法生产的ATMPs。它还提供了一项医院豁免规定，这意味着不受欧盟法律监管的医药产品无法受益于整个欧盟的统一制度，而是必须遵守各国法律。本文介绍了欧盟近期的法律，并对比了两个国家的制度，探讨法国和英国如何对属于和不属于（欧盟）第1394/2007号法规范围的ATMPs进行监管。不同的法律类别及其可执行制度是什么，以及这些高度复杂的制度的演变如何与再生医学的物质世界以及参与其中的监管机构和社会经济行为者相互作用？
