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 Even when such consent is given, it may be withdrawn without reason by that couple (or surviving member of the couple) as long as research has not begun.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.