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

Volumn 39, Issue 1, 2012, Pages 131-149

  Mahalatchimy, Aurélie ^a,b   Rial Sebbag, Emmanuelle ^a   Tournay, Virginie ^b   Faulkner, Alex ^c  

^a Faculté de Médecine Centre Hospitalo universitaire   (France)

^b Laboratoire PACTE   (France)

^c KING'S COLLEGE LONDON   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; ECONOMICS; EDUCATION; ETHNOLOGY; EUROPEAN UNION; FRANCE; GOVERNMENT REGULATION; HISTORY; JURISPRUDENCE; LEGAL ASPECT; PRESCRIPTION; REGENERATIVE MEDICINE; UNITED KINGDOM;

EUROPEAN UNION; FRANCE; GOVERNMENT REGULATION; GREAT BRITAIN; HISTORY, 21ST CENTURY; JURISPRUDENCE; PRESCRIPTIONS; REGENERATIVE MEDICINE;

EID: 84857303007     PISSN: 0263323X     EISSN: 14676478     Source Type: Journal    
DOI: 10.1111/j.1467-6478.2012.00574.x     Document Type: Article

References (57)

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4. We use the term 'regenerative medicine' to refer broadly to the field under discussion even though it is not equivalent to 'advanced therapy medicinal products'. We do so because it has become a widely used term, especially amongst participating scientists and industry, and is also known to the public, rather than because it has a legal definition. As used here, it may refer to a range of therapeutic applications such as prevention and repair as well as strictly 'regeneration'.
5. In this paper, we consider that the English 'non-commodification' corresponds to the French principle of 'non-patrimonialité' of the human body and its elements, which means that the human body and its elements cannot be the object of a financial agreement.
6. Gene therapy medicinal products means: a biological medicinal product which has the following characteristics: it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view of regulating, repairing, replacing adding or deleting a genetic sequence; its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or the product of genetic expression of this sequence. Gene therapy medicinal products shall not include vaccines against infectious diseases. Annex, Part IV, 2.1 of /120/EC. Directive 2009
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