The Legal Landscape for Advanced Therapies
Material and Institutional Implementation of European Union Rules in France and the United Kingdom
Bibliographic Data
| ID | 11449185 |
|---|---|
| Authors | Aurélie Mahalatchimy (0000-0002-4365-2143, Laboratoire Pacte, corresponding author), Emmanuelle Rial‐Sebbag (0009-0005-3818-0101, Laboratoire Epidémiologie et Analyses en Santé Publique : Risques, Maladies Chroniques et Handicaps), Virginie Tournay (0000-0003-2740-5262, Centre de Recherches Politiques de Sciences Po), Alex Faulkner (0000-0002-0492-6316, King's College London) |
| Year | 2012 |
| Volume | 39 |
| Issue | 1 |
| Pages | 131-149 |
| Publication date | 2012-03-01 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Journal of Law and Society (JOURNAL) |
| Journal identifiers | ISSN: 0263-323X • E-ISSN: 1467-6478 |
| Publisher | Wiley (PUBLISHER • GB) |
| DOI | 10.1111/j.1467-6478.2012.00574.x |
| PMID | 22530249 |
| OpenAlex | W2093864830 |
| Language | EN |
| Citations received | 5 |
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
Business · European union · International trade · Political science · Process (computing · Product (mathematics · Scope (computer science · Biomedical Ethics and Regulation · Computer Science · Law · Medical and Health Sciences Research · Pluripotent Stem Cells Research · Public Administration
Stretching and Challenging the Boundaries of Law
Governing new global health-care markets
Special Treatment? Flexibilities in the Politics of Regenerative Medicine’s Gatekeeping Regimes in the UK
Comparing national home-keeping and the regulation of translational stem cell applications
Promissory identities
| Citations per year | 0.5 |
|---|---|
| Citation span | 2016 - 2017 (2) |
| Highly cited | No |