Framework maintains a symbolic prohibition and coherence with the principle of respect for human beings enshrined in article 16 of the French Civil Code. [© CLIPAREA.com - Fotolia.com]
France passed a law on bioethics on July 7 called Loi du 7 juillet 2011. The law, which addresses several major areas of bioethics, above all confronts the question of what legal framework applies to research on human embryos and embryonic stem cells. Lawmakers had to balance the desire to avoid treating the embryo as laboratory material or an object but rather as a potential human life and, on the other hand, the necessity of meeting medical research needs.
The first bioethics law, Loi No. 2004-800 enacted on August 6, 2004, put in place a system of exemptions providing for the possibility of conducting research on human embryos exceptionally and under very strict conditions. That system of exemptions expired on February 6, 2011. The law and the legislative process that produced the Loi du 7 Juillet 2011 are specific to France, but the questions surrounding its enactment and development are universal to professionals in the pharmaceutical and biotech fields.
The development of this law exposed the gulf that exists between France’s Assemblée nationale (national assembly) and the Sénat (senate) when it comes to the legal framework best suited to research on human embryos: either a prohibition in principle accompanied by exemptions or a limited authorization system. In the end, the former solution was retained, thus maintaining both a strong symbolic prohibition and coherence with the principle of respect for human beings from the very outset of life enshrined in article 16 of the French Civil Code.
While the economic issues associated with human embryonic research, particularly for the pharmaceutical industry, were raised during the parliamentary discussions, they did not constitute a major concern in what was essentially an ethical debate. Thus, the report established by the commission in charge of examining the bill at the Assemblée nationale states that: “While they should not be ignored, the pharmaceutical industry’s economic considerations and the fear of experiencing a brain drain to foreign countries or falling behind as a nation in the sciences did not constitute a strong enough argument to override the well-founded ethical principles and legitimize all types of embryonic research.”
Prohibition on Creating Transgenic Embryos and Chimeras
Included in Loi du 7 juillet 2011 are two series of prohibitions with respect to embryos to ban procedures that breach the fundamental prohibitions placed on the manipulation of living organism.
The first, which results from a senate amendment to article L2151-2 of the Code de la santé publique (public health code), completely prohibits, with no possible exemption, the creation of transgenic embryos (by manipulation of genetic stock) and chimeras (mixing human and animal cells).
The French are not alone in having enacted legislation in this area; other nations have already explicitly prohibited the creation of chimeras. In Canada, this falls under the April 22, 2004 Assisted Human Reproduction Act, which, in section 5, prohibits creating or transplanting a chimera, defined in section 3 as an embryo into which a cell of any nonhuman life form has been introduced.
The U.K., on the other hand, has authorized the creation of chimeras for research purposes. The legal framework applicable to these chimeras, also known as hybrids, is the Human Fertilization and Embryology Act 1990, as amended by the Human Fertilization and Embryology Act 2008, enacted on November 13, 2008. The British legislation allows chimeras to be used exclusively for research during a period of 14 days as of the day on which the process of creating the chimera began. It also provides safeguards by expressly prohibiting the transplantation of any chimera into a woman.
Establishing a Legal Framework
The two series of prohibitions set up in France establish a distinct set of criteria for the granting of research on embryos, embryonic stem cells, and stem cell lines. The first series of conditions provided in article L2151-5 II of the public health code states that those contemplating such research must establish that the project, if scientifically relevant, will likely lead to major medical advances, would be impossible to achieve without the use of human embryos, and is in line with the ethical principles relating to embryonic research. Furthermore, it is also stipulated, not as a true legal criteria but rather as an article of faith, that “ethical research alternatives to those using human embryos should be privileged.”
The second series of conditions addresses the origin of human embryos and the circumstances under which the informed consent of their donors must be obtained. Under this series of conditions, only embryos that were conceived in vitro as part of medically assisted reproduction but that are no longer part of a parental project may be used in a research project. In addition, the couple (or surviving member of the couple) from whom the extra embryos originate must provide written consent to the contemplated research after being informed of the possibility that another couple might want the embryos or that the embryos will no longer be preserved. Even when such consent is given, it may be withdrawn without reason by that couple (or surviving member of the couple) as long as research has not begun.
France’s regulating authority in this area is the Agence de la biomédecine (biomedical agency), which authorizes the applicable research protocols after verifying that they meet the aforementioned conditions (article L2151-5 IV of the public health code). The agency’s decisions, however, may be revoked by health and research ministers, who hold a true veto right and may choose to prohibit or suspend a research protocol authorized by the agency if they believe that the legal conditions have not been fulfilled.
Furthermore, article L2151-5 V of the public health code states that embryos on which research is being conducted may not later be used for gestation. In addition, a conscience clause is explicitly provided in article L2151-7-1 of the public health code, according to which “no researcher, engineer, technician, or research assistant whomsoever, nor any doctor or medical assistant is required to participate in any manner whatsoever in research on human embryos.”
Loi du 7 juillet 2011 addresses key concerns related to bioethics, striking out its 2004 counterpart. Recognizing that this issue would evolve over time in response to scientific progress, the lawmakers provided that all of the areas addressed by the new legislation must be re-examined no later than seven years after the current law comes into force. Lawmakers allowed seven years to think about a debate that is not likely to be settled given the continuing improvement in medical and scientific techniques. It is this consistent re-examination that will be so critical to ensuring that medical research remains ethical.