Ethical and legal frameworks for embryonic stem-cell based research in France and in Europe: a challenge for biotechnology

Anne-Marie Duguet (1) , Emmanuelle Rial-Sebbag (1) , Aurélie Mahalatchimy (2, 3) , Mou Li , Anne Cambon-Thomsen (1)

1 LEASP - Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps
2 DICE - Droits International, Comparé et Européen
3 DICE / CERIC - Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC)

Developing research based on the use of biological material raises the question of the sources of the cells. Should we use human stem cells or embryonic stem cells? For human stem cells, since 1994, the French law considers the human body is inviolable and cannot be subject of property (Art 16-1 of the Civil Code) that means no trade and no patent. Focusing on embryos, the Oviedo convention (Council of Europe) on Human rights and biomedicine (1997) says in Art 18: it is up to each country to authorize or not the embryo research. There are differences among countries in Europe, from a total ban to an approval of the research with nuclear transfer. In France, several opinions of the French National Ethics committee (CCNE) claimed for the protection of the embryo. Regarding commercialization of cells and patentability, the European Directive 98/44.CE on legal protection of biological inventions says: Biotechnology inventions are essential for the development of the community; only adequate protection can make them profitable and facilitate trade. The national patent law remains the reference. In France, in 2006 research on embryo and embryonic stem cells was organized by the decree of April 27 th , 2006 under the control of the French National biomedicine Agency. Even if the research on embryo was not permitted it could have been conducted under exceptions.. In 2010 the French National Ethics committee changed his position in the opinion 112 and the Act 2013-715 of August 6, 2013 is now allowing research on embryo and on embryonic Stem cells under conditions.

Mots clés: Embryo; Embryonic stem cells; Ethics; Regulatory framework; France; Europe

Domaines: Droit

Anne-Marie Duguet, Emmanuelle Rial-Sebbag, Aurélie Mahalatchimy, Mou Li, Anne Cambon-Thomsen. Ethical and legal frameworks for embryonic stem-cell based research in France and in Europe: a challenge for biotechnology. CUPL. Biotechnology Medicine and Law, 2018, 978-7-5620-8420-4. ⟨halshs-01938427⟩