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France: New Bioethics Law

(July 18, 2011) Law 2011-814 of July 7, 2011, on bioethics was finally adopted by the French Parliament after months of debate and published in the JOURNAL OFFICIEL, France's official gazette, of July 8, 2011. (Loi n° 2011-814 du 7 juillet 2011 relative à la bioéthique, LEGIFRANCE (last visited July 14, 2011)). The new Law updates the 2004 Bioethics Law to take into account recent scientific discoveries and progress or new techniques in the fields of biology and medicine. A summary of its main provisions follows.

In its first article, the Law authorizes the ratification of the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, signed at Oviedo, Spain, on April 4, 1997 (Council of Europe website (last visited July 14, 2011)).

The Law now requires that close family members be informed when genetic testing of the tested individual reveals a high risk of his or her developing a serious genetically transmitted illness and only if preventive measures and treatment can be envisaged. It sets forth the procedures to be followed in order to inform these relatives. (Loi n° 2011-814, art. 2).

In the matter of organ donation, the Law authorizes organ-swapping between two unrelated families if the organ of the respective willing donor relatives is found medically incompatible with that of the intended recipients (id. art. 7). Education programs on organ donation will be organized in high schools and higher education establishments to promote such donations (id. art. 8).

The Law prescribes that doctors must clearly inform all expectant mothers of their right to be tested for prenatal defects (id. art. 20). Anonymous sperm and egg donations by adults are allowed (id. art. 27). Assisted reproduction is available to couples, married or not, and they will no longer be required to have been together for two years, as was previously the case. However, it is only authorized in cases of medical infertility (thus excluding homosexual couples) or to avoid the transmission to the child or to one member of the couple of a particularly grave illness. Infertility must be medically diagnosed (id. art. 33). During the legislative debate, legislators held that for homosexual couples assisted reproduction should not be authorized because infertility in such cases is social, not medical, infertility. Surrogate motherhood has from the beginning of the consideration of lawful means of assisted reproduction in France been rejected as an option, in the interest of both mothers and children; therefore, legislators rejected it as an option under the new Law and it remains prohibited.

The Law maintains the principle of prohibition of research on embryos and embryonic stem cells, which is only permitted in exceptional cases, subject to approval by the Biomedicine Agency. The following conditions must be met for the research to be authorized: (1) the scientific importance of the research project must be established; (2) the research is likely to lead to a major medical breakthrough; (3) it is expressly established that the result hoped for cannot be achieved by any other means of research; and (4) the research project and its implementation respect all the ethical principles on research on embryos and embryonic stem cells. In conducting their experiments, researchers may use only surplus embryos from IVF treatments. (Id. arts. 40-44.)

The Law contains a “conscience clause” for research personnel stating that no researcher, engineer, technician, or research assistant, nor any physician or medical assistant is obligated to participate in any capacity whatsoever in research on embryos and embryonic stem cells where exceptionally authorized (id. art. 53).

The Law is to be reviewed within a timeframe of at most seven years (id. art. 47).