The result of an intense moral and ethical debate

France's Loi No. 211-814 du 7 juillet 2011 relative à la bioéthique (law no. 211-814 of July 7, 2011 on bioethics) has just being enacted[1] following a swift and intense legislative process.[2]

The legislation addresses several major areas of bioethics, a concept generally defined as anything associated with the relationship between the human body and science, and to medicine in particular.

The law sets forth conditions governing:

  • the information that must be disclosed to the family of a person who has been diagnosed with a serious genetic anomaly;
  • paired organ donation;
  • the collection of umbilical cord blood and placenta blood during childbirth and the possibility of dedicating such donations to the newborn in question or his or her siblings where therapeutic necessity is established;
  • the implementation of a minimum reflection period of one week before deciding to voluntarily terminate a pregnancy in the context of a termination performed for medical reasons, i.e. after the legal period of the twelfth week of pregnancy;
  • the various medically-assisted procreation techniques with a view to ensuring their effectiveness and safety for the woman and the unborn child and the possibility of transferring embryos from one couple to another.  

Above all, this law addresses the question of what legal framework should apply to research on human embryos and embryonic stem cells, which is a very sensitive bioethical topic as it concerns the origin of life.

The parliamentary debates give an understanding of the moral and ethical principles on which lawmakers based their reasoning, with, on one hand, the desire to not treat the embryo merely as laboratory material or an object, but rather as a potential human life and, on the other hand, the necessity of meeting the needs of medical research.

They also revealed 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, it was the prohibition in principle on human embryonic research with a system of permanent exemptions that was the solution 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.

There was an urgent need to enact legislation in this area. Indeed, 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, but that system of exemptions  expired on February 6, 2011.

Finally, while the economic issues associated with human embryonic research, particularly for the pharmaceutical industry, were raised during the parliamentary discussions, they were far from constituting 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[3] states that: "[TRANSLATION] 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."

Tightly controlled research

Absolute prohibition on creating transgenic embryos and chimeras

The Loi du 7 juillet 2011 sets forth two series of prohibitions with respect to embryos.

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 idea here, according to French lawmakers, is to ban procedures that breach the fundamental prohibitions placed on the manipulation of living organisms.

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 non-human life form has been introduced.

The United Kingdom, on the other hand, has authorized the creation of chimeras for research purposes, namely cybrids (embryos created by introducing the nucleus of a human cell into an animal oocyte, then using a chemical or electric shock to instigate embryonic development). 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 for research exclusively 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.  

The conditions governing human embryonic research

After stating the principle that research on "[TRANSLATION] the human embryo, embryonic stem cells and stem cell lines" is prohibited, article L2151-5 of the public health code sets forth two cumulative series of conditions that must be present for such research to be authorized on an exceptional basis.

The first series of conditions provided in article L2151-5 II of the public health code states that the scientific and medical nature of the research being contemplated must meet the following criteria:

  • the scientific relevance of the research project has been established;
  • the research will likely lead to major medical advances;
  • it has been explicitly established that it would be impossible to achieve the desired results through research that does not use human embryos;
  • the research project and the implementation conditions of the protocol are 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 "[TRANSLATION] ethical research alternatives to those using human embryos should be privileged."

The second series of conditions provided for in article L2151-5 III of the public health code deals with the origin of human embryos and the circumstances under which the informed consent of their donors must be obtained.

Thus:

  • 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;
  • 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 above conditions (article L2151-5 IV of the public health code). The agency's decisions, however, may be revoked by the 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 statesthat embryos on which research is being conducted may not later be used for gestation.

In conclusion, a conscience clause is explicitly provided for in article L2151-7-1 of the public health code, according to which "[TRANSLATION] 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.

Importing and exporting embyronic stem cells

Under article L2151-6 of the public health code, both importing and exporting embryonic stem cells for research purposes are subject to the prior authorization of the Agence de la biomédecine.

Loi du 7 juillet 2011 is innovative in that it strikes out the condition that existed under its 2004 counterpart, which made authorization to export embryonic stem cells conditional on the participation of the French research organization at issue in an international research program.

The conditions set forth by the Loi du 7 juillet 2001 [sic] for granting import or export authorization, however, are not sufficiently detailed. Article L2151-6 of the public health code simply states that such authorization will only be granted if the stem cells were obtained in compliance with the fundamental principles provided for in articles 16 to 16-8 of the French Civil Code.

These provisions list a whole series of rules intended to guarantee respect of the human body; they specifically serve as a reminder that the human body, its elements and its products are and should remain outside of the commercial sphere, as reflected in article 16-1 of the Civil Code, which states that, "[UNOFFICIAL TRANSLATION] the human body, its elements and its products may not form the subject of a patrimonial right," as well as in article 16-5 of the same Code, which provides that "[UNOFFICIAL TRANSLATION] agreements that have the effect of bestowing a patrimonial value to the human body, its elements or products are void." 

Hopefully, these conditions will be further clarified by the law's implementing decree, which has not yet been published.

The Loi du 7 juillet 2011 establishes a coherent legal framework for the thorny issue of human embryonic research.

Recognizing that this issue would itself evolve over time in response to scientific progress, the lawmakers provided that all of the areas addressed by the legislation must be re-examined no later than seven years after the law comes into force.

They thereby gave themselves seven years to think about a debate that is not likely to be settled given the continuing improvement in medical and scientific techniques.