Implementation of the French Bioethics Act: Agence de la biomédecine presents the latest results of its surveys at the 3rd meeting of the Monitoring Committee

The Ministry of Solidarity and Health has presented the Order of April 14, 2022 setting the rules for the allocation of gametes and embryos, taken in application of the last paragraph of Article L. 2141-1 of the Public Health Code. As part of the implementation of the law of August 2, 2021, this order aims to harmonize and clarify the rules for the allocation, by medical teams, of gametes from donations or embryos offered for reception to people involved in a third-party donor AMP pathway.

With a view to the entry into force on September¹

, 2022 of the right of access to origins instituted by the law of August 2, 2021, the Agence de la biomédecine has presented the status of work in progress to create the national registry of gamete and embryo donors, which it will manage.

From September^1,

2022, this registry will store the identifying and non-identifying data of gamete and embryo donors, with a view to responding to requests that may be submitted, when they reach the age of majority, by people born from these donations. This register must offer strict guarantees in terms of the security, integrity and confidentiality of this data, for a limited and appropriate period of time.

Requests for access to data relating to origins will be processed by a commission reporting to the Minister of Health, which will be set up on the same date. Calls for applications from associations and qualified personalities to sit on this new commission are available on the Ministry of Solidarity and Health website.

To measure the impact of the new bioethics law on activity, the Agence de la biomédecine has conducted surveys of centers authorized to carry out gamete donation (sperm and oocytes) and gamete self-preservation outside a medical indication. The results observed between August 1 and December 31, 2021 were used to estimate the level of activity since implementation of the new law. Presented at the Monitoring Committee meetings of November 15, 2021 and February 14, 2022, these initial results have now been supplemented by data collected between January 1 and March 31, 2022, presented at the Committee's third meeting.

With regard to the extension of MPA to female couples and unmarried women, the survey of the 27 centers authorized to carry out sperm donation activities showed that, between January 1 and March 31 2022 :

• 185 sperm donors were registered in the 26 centers responding out of the 27, representing an upward trend compared with 2021.
• 5,126 requests for an initial consultation were recorded with a view to MPA with sperm donation for the benefit of female couples or unmarried women, including 47% from female couples and 53% from single women.
• 2,562 consultations were carried out for female couples or unmarried women, an average of 854 per month in 2022, compared with 653 per month between October 16 and December 31, 2021. The number of treatments is therefore accelerating sharply.
• 53 MPA attempts with sperm donation were carried out for these new patients.
• The turnaround time for MPA with sperm donation varies greatly from one center to another, with one center reporting a very different value from the others. Excluding this center, the average waiting time was 13.6 months on March 31, 2022, an increase of 1.6 months compared with the end of 2021. Taking all centers into account, the average waiting time was 14.8 months at the same date.

With regard to the possibility of gamete self-conservation outside a medical indication, the survey of 41 authorized centers (40 respondents) showed that, between January 1 and March 31, 2022 :

• 2,553 women requested an initial consultation for oocyte self-preservation (i.e. 851 per month) and 1,130 consultations were carried out (i.e. 377 each month). Interest is therefore growing compared with the period from October 15 to December 31, 2021, when 1,464 requests for initial consultation were recorded (or 587 per month). Of the women who embarked on such a course, 238 were able to complete it between January 1 and March 31, 2022.
• 47 men requested an initial consultation for sperm self-preservation (compared with 44 requests between October 15 and December 31, 2021), and 37 consultations were completed. A total of 28 men were able to complete their course and benefit from sperm self-preservation between January 1 and March 31, 2022.

Discussions with the various stakeholders addressed concrete concerns encountered in the field, notably concerning waiting times, the application of age limits, gamete stock management and the fight against discrimination.

*Stakeholders present at the May 16, 2022 follow-up committee meeting:

• Ministère des Solidarités et de la Santé - Direction Générale de la Santé
• Ministère des Solidarités et de la Santé - Direction Générale de l'Offre de Soins
• Agence technique de l'information sur l'hospitalisation (Technical agency for hospital information)
• Conférence des présidents des commissions médicales d'établissement des CHU (Conference of presidents of university hospital medical boards)
• Conférence des directeurs généraux de CHRU de France
• National Health Insurance Fund
• National Center for Care Abroad
• Association COLLECTIF BAMP!
• Association Mam'ensolo
• Association Les Enfants d'Arc en Ciel
• Association Don d'ovocytes, spermatozoïdes un espoir
• Association of gay and lesbian parents and future parents (APGL)
• Association Afrique Avenir
• Association Dons de gamètes solidaires
• Association PMAnonyme
• Association Les Cigognes de l'Espoir
• Ovocyte Donation Study Group (GEDO)
• Ovary and Testis Conservation Research and Study Group (GRECOT)
• Study Group on In Vitro Fertilization in France (GEFF)
• National College of Gynecologists and Obstetricians of France (CNGOF)
• National Federation of Medical Gynecology Colleges (FNCGM)
• Fédération nationale des biologistes des laboratoires d'étude de la fécondation et de la conservation de l'œuf (BLEFCO - national federation of fertilization and egg preservation laboratory biologists)
• Collective of French private AMP centers (CCP)
• Society for Reproductive Medicine (SMR)
• National Federation of Human Egg and Sperm Study and Conservation Centers (CECOS)
• Gamete donation centers

Press contacts: TBWACorporate Violaine Bourquin - violaine.bourquin@tbwa-corporate.com - 06 07 46 34 89 Tiffany Allenet - tiffany.allenet@tbwa-corporate.com - 06 08 16 14 07

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