Promulgation of the law of August 2, 2021 on bioethics: new missions for the Biomedicine Agency

The Agence de la biomédecine, a public body under the authority of the French Ministry of Solidarity and Health, is responsible for overseeing assisted reproduction, prenatal diagnosis and genetics, organ, tissue and cell transplants, and embryo and embryonic stem cell research. The entry into force of the new law on bioethics has changed the scope of the Agency's missions and the way it operates. The Agence de la biomédecine has been anticipating these changes for many months, working with the French Ministry of Health and Solidarity to ensure that the practical arrangements for implementing the changes introduced by the new law are put in place as quickly as possible.

Developments in medically assisted procreation

The new law on bioethics introduces major changes, particularly in the field of medically assisted procreation. The law extends access to MAP to couples and unmarried women, with health insurance covering all beneficiaries. It also prohibits any discrimination in access to AMP, notably with regard to the marital status or sexual orientation of applicants. The new law also authorizes the double donation of gametes and introduces age criteria for access to AMP, which will be set by decree by the Conseil d'Etat, after consulting the Agence de la biomédecine.

The Agence de la biomédecine is responsible for proposing rules for the allocation of gametes and embryos, which will be laid down by decree of the Ministry of Health.

In addition, new rules authorize children born of third-party donor AMP to access, if they so wish, at the age of majority, the non-identifying data and identity of the donor who enabled their conception. At the same time, the legal framework for gamete (oocyte and sperm) donation is evolving, with the donor's consent to access this data becoming a condition of donation. People who donated before this new legal framework came into force may, if they wish, agree to reveal their identity or non-identifying data concerning them by contacting an ad hoc commission set up by the Ministry of Solidarity and Health. People born of a MAP before the new provisions of the law come into force will be able to refer to this new commission for access to non-identifying data and the identity of the third-party donor, which will contact the former donor to ask whether or not he or she consents to the disclosure of his or her identity or non-identifying data concerning him or her.

In order to make the right of access to origins effective, the new law provides for the creation of a national registry of gamete and embryo donors by the Agence de la biomédecine. This register, which will be kept by the Agence de la biomédecine, will store the data needed to respond to requests for information from children born of gamete- or embryo-donor MPA, under conditions that strictly guarantee their security, integrity and confidentiality, for a limited and appropriate period of time. In order to be ready and able to rapidly implement the changes introduced by the law on bioethics, the Agence de la biomédecine has anticipated the creation of this register, which should be operational one year after the law's promulgation.

The text also authorizes, but does not encourage, the self-preservation of gametes for non-medical reasons, subject to age conditions set by decree by the Conseil d'Etat, after consulting the Agence de la biomédecine.

** Induced changes for organ, tissue and cell donation** The new law on bioethics is a major step forward.

The new law on bioethics introduces a number of changes for organ, tissue and cell donation. It increases the number of pairs for cross-donation of organs from living donors, to increase the possibility of matching, and allows the use of an organ from a deceased donor to replace one of the living donors in cross-donation programs.

Under certain conditions, it authorizes the harvesting of hematopoietic stem cells (HSC) from minors or adults under legal protection for the benefit of one of their parents.

The Agence de la biomédecine's mission to monitor the health status of organ and oocyte donors has been extended to that of related and unrelated HSC donors.

Developments in embryo and stem cell research

The text maintains the current authorization system for embryo research, but simplifies the system for research on human embryonic stem cells by introducing a system of declaration to the Agence de la biomédecine. It maintains the ban on modifying a human embryo by adding cells from other species. In addition, a 14-day limit has been set for the in vitro culture of human embryos included in a research protocol.

Research protocols on induced pluripotent stem cells involving the differentiation of these cells into gametes, the aggregation of these cells with extra-embryonic tissue precursor cells, and the insertion of these cells into an animal embryo with the aim of transferring it to a female are now subject to prior declaration to the Agence de la biomédecine.

The Agence de la biomédecine has been entrusted with the management and control of HESC and IPS research declarations.

The new law clarifies the possibilities already open within the framework of embryo research protocols, by confirming the right to use new mutagenesis techniques, notably "molecular scissors". Thanks to this research, it is possible to hope to cure or, at any rate, to gain a better understanding of many genetic diseases. This possibility, which the bill makes explicit, is only open for the exclusive purposes of in vitro scientific research, and with all the guarantees provided by the legal framework for embryo research in France. Furthermore, the prohibition of modifications that could be transmitted to descendants remains unavoidable.

** Induced changes in medical genetics

With regard to over-the-counter genetic tests, the new law on bioethics reinforces the ban on all canvassing for advertising purposes.

The Agence de la biomédecine (Biomedicine Agency) is no longer responsible for drawing up quality standards for open-access genetic tests.

It is now possible to carry out genetic character tests on people who are unable to express their wishes, in their own interest or in the interest of their family members, as well as on deceased people when a doctor suspects a genetic anomaly that could be responsible, for family members, for a serious condition justifying preventive or curative measures.

Lastly, the new law completes the system for informing relatives in the context of a medical genetic characteristics examination for :

• children born from gamete or embryo donation (AMP)
• children born under X and women who have given birth under X.

The Agence de la biomédecine is responsible for proposing modifications to the good practice decree concerning the provision of information to relatives in the context of a genetic characteristics examination for medical purposes.

Press contacts: Agence TBWACorporate Violaine Bourquin - violaine.bourquin@tbwa-corporate.com - 06 07 46 34 89 Blanche Bobin Parra - blanche.bobin-parra@tbwa-corporate.com - 06 48 40 75 16

Agence de la biomédecine Hélène Duguet - presse@biomedecine.fr - 06 16 35 91 80