Bioethics laws

The term "bioethics" can be broken down into "bio", which means "life" in Greek, and "ethics", which refers to morals and behaviour. Bioethics is defined as the study of the moral issues raised by advances in biology and medicine. It questions basic foundations such as the dignity of human beings, independence and respect for the integrity of the human body.

Bioethics needs to be subject to a legal framework in order to be able to cope with the challenges posed by scientific advances. With the subject-matter becoming increasingly complex, the need to preserve ethical principles is now globally recognised. The law regulates potentially sensitive practices and prevents potential abuses. It seeks to ensure that medical and biological innovations are developed within a framework that respects human dignity and ethical values.

In order to support rapid developments in bioethics, the law contains a revision mechanism. In drafting a bill, the Government applies this public consultation mechanism, as well as the opinions of the Agence de la biomédecine, the Comité Consultatif National d’Éthique (the French National Ethics Advisory Committee - CCNE), the Conseil d’État, the appropriate parliamentary committees and the Office parlementaire d’évaluation des choix scientifiques et technologiques (Parliamentary Office for Evaluating Scientific and Technological Choices - OPESCT). The draft law is reviewed by the French Conseil d’État and presented to the Council of Ministers before being voted on by Parliament. Prior to being enacted, the draft law may be sent to the French Constitutional Council for its review.

France has been a pioneer in the field of bioethics and has been considering the issue in depth since the 1970s. Bioethics laws have regulated a number of different medical and research activities since 1994. They govern organ donations, medically assisted reproduction (MAR), genetics and research on human embryos, and lay down fundamental principles such as anonymity, the prohibition on payments for donations and the requirement to obtain consent. The first law also included rules on the use of personal health data.

The law has been revised on a number of occasions to adapt to scientific progress and societal expectations. The 2004 law introduced the regulation of cell therapy. In 2011, significant changes took place with the authorization of paired organ donations in the event of incompatibility between relatives and the oocyte vitrification, allowing for greater flexibility in parenting. The 2013 law established a strict framework for research on embryos and embryonic stem cells.

The most recent revisions were made by the law of 2 August 2021. It expanded access to MAR to female couples and unmarried women. It also introduced new rights for children born as a result of MAR with a donation, allowed a person’s own gametes to be harvested under certain conditions and clarified the laws on research on embryonic stem cells.

The Agence de la biomédecine, established by the 2004 Law, plays a central role in the application of bioethics laws. It ensures that practices, in its areas of expertise, comply with prevailing standards. As well as ensuring compliance with laws, the agency is actively involved in the process of reviewing laws by providing expert advice. Accordingly, it plays a crucial role in ensuring that regulatory adjustments meet contemporary needs and respect ethical values.