Assisted reproduction procedures and techniques

In accordance with the provisions of the decree of March 14, 2012, the order issued by the Minister of Health on June 18, 2012 set out the list of biological MPA procedures in regular use as of July 9, 2011. These procedures have already been implemented for many years in healthcare establishments and medical biology laboratories, and are established by usage. They are assessed on an annual basis through annual activity reports submitted by MPA centers.

The Agence de la biomédecine, consulted on the list established by decree, has compiled a technical file for each process, including :

• A description of the techniques regularly used for these processes,
• Characterization or nature of the process,
• The procedures and operating methods involved, and identification of the critical stages,
• Where applicable, the impact of the process on the number of embryos conserved,
• A summary of relevant data from the monitoring of biological MPA activities and the existing vigilance system. This document was the subject of an opinion by the Agency's Policy Board on May 4, 2012 and was forwarded to the Minister on May 11, 2012, in accordance with the provisions of article R. 2141-1-1 et seq. and article 3 of the decree of March 14, 2012. The list was amended on November 6, 2013.

A new procedure may only be included on the list if its implementation does not contravene the principles set out in articles 16 to 16-8 of the French Civil Code⁽²⁾

and articles L. 2151-2 and 3 of the French Public Health Code⁽³⁾

, if it is compatible with the objective of limiting the number of embryos stored, and if its efficacy, reproducibility and, in the current state of knowledge, the safety of its use for the health of the woman and the unborn child are sufficiently established. Any modification that introduces an additional critical step or additional manipulation of gametes, germinal tissue or embryos, in relation to the existing procedure, thus constitutes a new procedure. The inclusion of a new procedure on the list is made by the Minister of Health, on his or her own initiative or at the request of an establishment, laboratory or organization authorized to perform PGM activities, after consultation with the Agence de la biomédecine. The Agency sends its opinion within 4 to 6 months, together with the reasoned opinion of its advisory board and a technical file. This file must include scientific evidence available in France or abroad, based on scientific literature (studies, epidemiological surveys, biomedical research), and animal or in vitro test reports.

Listed processes are periodically assessed by the Agency on the basis of data submitted by healthcare establishments, laboratories and organizations in their annual activity reports. If it appears that a process does not meet the conditions or presents a risk to public health, the Director General of the Agency proposes to the Minister that it be withdrawn from the list.

A process may also be withdrawn, temporarily or permanently, if the conditions laid down are no longer met, or for any public health reason. Withdrawal is decided by reasoned order of the Minister of Health.

Any technique designed to improve an existing process must be authorized by the Director General of the Agence de la biomédecine (after receiving the reasoned opinion of its Orientation Council). The technique is authorized if, without constituting a new process, it improves the efficacy, reproducibility and safety of the process it modifies.

The Agence de la biomédecine, which was consulted on the list of processes set by the order of June 18, 2012, has compiled a list of MPA techniques regularly implemented for the purpose of using biological processes, in conjunction with healthcare professionals. This list of techniques is accompanied, for each technique, by a file including:

• A description of the techniques regularly used for these processes,
• Characterization or nature of the process,
• The procedures and operating methods involved, and identification of critical stages,
• Where applicable, the impact of the process on the number of embryos conserved,
• A summary of relevant data from the monitoring of biological MPA activities and existing vigilance systems.

This document was the subject of an opinion by the Agency's Policy Board on May 4, 2012 and was forwarded to the Minister on May 11, 2012, in accordance with the provisions of article R. 2141-1-1 et seq. and article 3 of the decree of March 14, 2012. The list was amended on November 6, 2013.

The application is submitted by any establishment, laboratory or organization authorized to practice medically assisted procreation. It is processed within 4 months of the application being declared complete.

All applications are submitted to the Agency's Steering Committee for its opinion. The Board assesses the nature and merits of the proposed modification, in particular whether it is an improvement to an existing process or a new process. A new process is any modification that introduces an additional critical step or additional manipulation of gametes, germinal tissue or embryos, taking into account the existing process.

(2) Principles of primacy of the person and prohibition of any violation of his or her dignity, inviolability of the human body, consent of the person, prohibition of any violation of the integrity of the human species, non-ownership of the human body and free donation, prohibition of surrogacy and respect for anonymity... (3) Prohibition of in vitro conception, cloning or use of embryos for research, commercial or industrial purposes.