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Law, bioethics and practice in France: forging a new legislative pact

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Abstract

In France, bioethics norms have emerged in close interaction with medical practices. The first bioethics laws were adopted in 1994, with provisions for updates in 2004 and most recently, in 2011. As in other countries, bioethics laws indirectly refer to certain fundamental values. The purpose of this paper is threefold. First, I shall briefly describe the construction of the French bioethics laws and the values they are meant to protect. Secondly, I will show that the practice of clinical ethics, as reported in a few studies on ART, living organ donation and PGD, challenge the role attributed to doctors as “gatekeepers” of those fundamental values. Thirdly, I will suggest that the quality of medical practices would improve if the law focused on strengthening the tacit pact between doctors and patients, rather than putting doctors in charge of enforcing societal values. Doctors, for their part, would limit their role to what they can do best: provide sufficient patient support and safe care. Against those who argue that we should dispense with bioethics laws altogether, I hold that the laws are useful in order to limit the development of abusive practices. However, a new legislative approach should be adopted which would a positive presumption in favor of patients’ requests.

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Notes

  1. Law no. 94-654 voted July 29, 1994, relative to the donation and use of elements and products of the human body, to medically-assisted procreation, and to prenatal diagnosis (published in the official record, Le Journal Officiel, (henceforth abbreviated JO) dated 30/07/1994, page 11060); Law no. 94-653 voted July 29, 1994 relative to respect for the human body (Journal Officiel dated 30/07/1994, p 11056).

  2. Law no. 2004-800 voted August 6, 2004, relative to bioethics (JO dated 07/08/2004, text 1).

  3. Law no. 2011-814 voted July 7, 2011, relative to bioethics (JO dated 08/07/2011, text 1).

  4. See the various opinions handed down on these questions by the Comité Consultatif National d’Ethique (National Consultative Committee on Ethics) since its founding.

  5. Example of the law voted December 22, 1976, relative to organ harvesting, known as the “Caillavet law.”

  6. The 1994 law was to be updated in 5 years. The 2011 law provides for its revision in 7 years.

  7. On the relationship between ethics committees and the legislative framework, cf. Monnier (1986).

  8. According to French law, ART is defined as “clinical and biological processes facilitating in vitro conception; the storage of gametes, germinal tissue, and embryos; embryo transfer; and artificial insemination” (article L 2141-1 of the French Public Health Code (Code de la Santé Publique, hereinafter referred to as the CSP).

  9. For example, third-party gestation was prohibited by a ruling handed down on May 31, 1999 by the Plenary Assembly of the Court of Cassation (France’s highest court) prior to being explicitly prohibited by the 1994 law. Cf. article 16-7 of the Code civil “toute convention portent sur la procreation ou la gestation pour le compte d’autrui est nulle”. Bulletin 1991 of the Cassation Assemblée Plenière, 31 May 1991, A.P. No. 4 p. 5.

  10. The prohibition on cloning, for example (art. L 2163-1 of the CSP). The blanket ban instituted by the law is regularly challenged for the purposes of permitting therapeutic cloning.

  11. See infra the legislation demonstrating these three principles. Successive French administrations have defended the French position on the question of these values, even if it is sometimes opposed to that in neighboring countries. For example, during the 2011 debate on revising bioethics law, Health Minister Xavier Bertrand was able to say, “Our future and the conception of the human condition are at stake in this bill, and we want to preserve them. Sometimes values clash: certain plead for the independence of free will, granting the right to every individual to dispose of his or her body as he or she sees fit; others believe that without denying these principles, the top priority is respect for human dignity, threatened by the commercialization of the human body (…) France continues to offer and promote a better ethical bargain.” (Speech to the Assemblée Nationale, Tuesday, February 8, 2011).

  12. See the article in this volume by Brunet, L. and Kunstmann, J.M. Gamete donation in France: The future of the anonymity doctrine.

  13. Protocol completed in 2010. The study focused on evaluating requests for access to reproductive technologies in “borderline” cases, in ethical terms, due either to age, serious chronic or transmissible disease, or the need to resort to a technique that is illegal at the moment (surrogate motherhood, for example). See the article in this volume by Fournier, Véronique; Berthiau, Denis; d’Haussy, Julie; and Bataille, Philippe: Access to assisted reproductive technologies in France: The emergence of the patients' voice. See also the brochure published July 2011 by the Centre d’Ethique Clinique, Quand la demande d’enfant derange l’éthique, reporting the findings.

  14. The protocol initiated in May 2003, consisted of meeting with a parent donating a liver graft to his or her child, within the framework of the pre-donation consultation. See Fournier et al. (2008).

  15. Protocol completed in 2010. We conducted telephone interviews with donor candidates to find out how they evaluated the procedure ex-post, thereby collecting additional data for ethical reflection on living donor liver transplant.

  16. Gaille, Marie and Viot, Géraldine. Prenatal diagnosis as a tool and a support for eugenics: Myth or reality in contemporary French society? in this volume.

  17. Many essays and books also provide grounds for reflection: for example, Feuillet-Liger, Brigitte, ed., 2009: Procréation médicalement assistée et anonymat, panorama international, Bruylant. See also Brunet, Laurence and Kunstmann, Jean-Marie: Gamete donation in France: The future of the anonymity doctrine, in this volume.

  18. Art. L 1241-2 al. 3 du CSP:  “The man and woman forming the couple must be alive, of reproductive age, and either married or capable of proving they have lived together for at least 2 years. They must give prior informed consent to embryo transfer or insemination. They will be disqualified from embryo transfer or insemination if one of them dies, files for divorce or separation, or moves out of the house they share, or if either the man or woman addresses a written revocation of consent to the doctor in charge of performing the ART procedure.”

  19. Art. L 2141-10 du CSP : ART  “cannot be performed by the doctor unless the applicants meet the requirements set forth by the present law. After conferring with the multidisciplinary clinico-biological team, the doctor may rule that in the interest of the future child, the applicants for the procedure should think it through more.”

  20. Art. L 1231-1, L 1231-3 et L 1231-4 of the French CSP. The Expert Committee instituted by the law on August 6, 2004 is made up of two five-member boards appointed for 3 years by the Minister of Health. Three of these board members, two of whom are doctors and one a person qualified in the field of the humanities, serve on both boards (art. L 1231-1). Permission to harvest an organ must be granted by a County Court Judge (Président du Tribunal de Grande Instance) after the Expert Committee certifies that the donor consent is free and informed.

  21. Supra.

  22. See Fournier et al. (2008).

  23. Gaille, Marie and Viot, Géraldine. Prenatal diagnosis as a tool and a support for eugenics: Myth or reality in contemporary French society? in this volume.

  24. See article by Fournier, V.; Berthiau, D.; Bataille, P.; Dhaussy, J. in this volume: Access to reproductive technologies in France: Revising the limits.

  25. See footnote 24.

  26. For example, the law on parental relationships no longer makes a distinction between a “legitimate” parental relationship (within marriage) and an “illegitimate” parental relationship (outside marriage): order dated July 6, 2005 and law dated January 20, 2010. Divorce legislation was liberalized by the law of April 26, 2004. Likewise, the law dated November 16, 1999 provides a legal definition of common-law marriage, and makes it possible for either heterosexual or homosexual couples to sign a PACS civil-union agreement. However, it is true that marriage is still forbidden to same-sex couples (deduced from article 144 of the Code civil), as is adoption.

  27. See article by Spranzi, M. in this volume, Clinical ethics and values: How do norms evolve from practice?

  28. See article by Fournier, V.; Berthiau, D.; Bataille, P.; Dhaussy, J. in this volume, op. cit.

References

  • Fournier, Véronique, Emma Beetlestone, Florence Plainguet, Sophie Branchereau, Emmanuel Jacquemin, Olivier Scatton, and Olivier Soubrane. 2008. Le consentement dans le don vivant d’organes: Un alibi éthique? Bioethica Forum 1(2): 115–120.

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  • Monnier, S. 1986. Les comités d’éthique et le droit: éléments d’analyse sur le système normatif de la bioéthique. Paris: L’Harmattan.

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Berthiau, D. Law, bioethics and practice in France: forging a new legislative pact. Med Health Care and Philos 16, 105–113 (2013). https://doi.org/10.1007/s11019-012-9406-8

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