Implementation of the French Bioethics Act: Agence de la biomédecine convenes the National Monitoring Committee for the second time

On September 28, 2021, the decree required to extend access to MAP to female couples and unmarried women was issued. On December 30, 2021, the decree required to make self-preservation of gametes possible outside any medical indication was issued. The right of access to one's origins, which will enable people born of third-party donor AMP to have access, when they reach the age of majority and if they so request, to the identity of the third-party donor as well as to information concerning him or her, will be open from September 1, 2022, in accordance with the law.

Against the backdrop of these rapid developments, the meeting of the Monitoring Committee provided an opportunity to review the steps already taken, to clarify forthcoming legislation, and to answer some of the questions raised by the new legal framework.

In order to monitor the quantitative impact of the implementation of the new bioethics law in the field, the Agence de la biomédecine has carried out 3 surveys of centers authorized to donate spermatozoa, centers authorized to donate oocytes and centers authorized to self-preserve gametes for non-medical purposes, who were asked about the activity recorded between October 16 and December 31, 2021. This work complements the results of the first survey, covering the period from August 1 to October 15, 2021, to provide an estimate of the level of activity linked to the implementation of the new law over the whole of 2021.

With regard to MPA with sperm donation, the survey data collected by the Agency from the 22 centers that responded (out of 26 authorized) means that, by extrapolation to all centers, we can consider that :

• almost 600 men* donated sperm in 2021. This is the highest recorded to date, the previous high being 404 donors in 2017.
• nearly 6,800 new requests for first consultations* from female couples and single women for PGM with sperm donation were recorded in 2021, 47% from female couples and 53% from single women.
• almost 2,300 consultations* were carried out in 2021 with a view to PGM with sperm donation by female couples and single women,
• 6 attempts at MPA with sperm donation by female couples and single women were made, and one pregnancy was in progress on December 31, 2021.
• the average waiting time for MPA with sperm donation is one year (between the first appointment and the first attempt), with disparities across the country.

As regards MPA with oocyte donation, survey data collected by the Agency from the 30 centers that responded (out of 31 authorized) allow us, by extrapolation to all centers, to consider that :

• almost 900 women* donated their oocytes in 2021. This is also the highest level ever recorded, the highest level previously recorded being 836 in 2019.

With regard to gamete self-preservation for non-medical purposes, survey data collected by the Agency from the 36 centers that responded (out of 40 authorized) make it possible, by extrapolation to all authorized centers, to consider that :

• almost 1,430 requests for consultations* with a view to non-medical oocyte self-preservation were registered, and 374 consultations were carried out in 2021.
• 45 requests for consultations with a view to non-medical self-preservation of spermatozoa were registered and 10 were carried out over the same period.

The Agence de la biomédecine has also carried out a survey on the resources of donation centers, in terms of human resources and equipment, in order to assess potential needs. This survey shows that some of the expected recruitments have already been made in 2021, on the basis of the funding granted to cope with the impact of the new anticipated pathways, but that there are still needs to be filled in 2022, as part of the management dialogues currently underway in the healthcare establishments concerned. New specific support credits will be allocated by the Ministry of Solidarity and Health in the spring of 2022 to enable healthcare facilities to continue to meet the needs of centers for MPA pathways initiated in 2022, particularly in terms of human resources. The data collected by the monitoring committee will be used to adapt the envelope to changes in activity over the rest of the year, as necessary.

The next meeting of the national monitoring committee will be held on Monday, May 16, 2022.

• Estimates based on results of center surveys.

**Stakeholders present at the February 14 Monitoring 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
• Les Enfants d'Arc en Ciel - l'asso !
• 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
• 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