EQUITY AND QUALITY FOR ALL
As part of its remit, the Agence de la biomédecine strives to improve the management and impartial supervision of couples who turn to assisted reproductive technology.
As a reference authority on these issues, it relies on the medical, scientific, legal and ethical expertise of the professionals it works with to develop high-performance monitoring tools and to determine good medical practices to be adopted by all players. Its role is constantly changing ; it varies according to technical progress, advances in scientific knowledge, regulatory changes and social issues.
THE ROLE OF THE AGENCE DE LA BIOMÉDECINE
The Agence is responsible for the regular publication of every ART centre’s results, provides support and consultancy when necessary, and in some cases recommends quantified indicators to some centres.
The Agence also makes its expertise concerning the geographical organisation of ART activities and conservation (of eggs and sperm, embryos and germinal tissue) available to regional health authorities. In this capacity, it expresses an opinion on all requests emanating from healthcare institutions, medical laboratories and public and private organisations wishing to carry out clinical and biological activities relating to assisted reproductive technology.
The Agence issues transport permits for embryos and import and export permits for eggs and sperm and germinal tissue to medical teams in order to meet the individual needs of a couple wishing to pursue a parental project following a change of residence.
The French law 2011-814 of 7 July 2011 introduced a new legal framework with respect to biological procedures for assisted reproductive technology. They must be authorised in order to be implemented in healthcare institutions and medical laboratories. The procedures listed in a decree by the Minister of Health are subject to periodic evaluation by the Agence de la biomédecine on the basis of data supplied by healthcare institutions, laboratories and organisations in the context of their annual reports of operations. If it appears that a procedure does not fulfil its conditions or poses a public health risk, the Director general of the Agence recommends its removal from the list to the Minister.
Therefore, all techniques seeking to improve an existing procedure must be authorised by the Director general of the Agence de la biomédecine (following a reasoned opinion from the Advisory Board). Techniques are authorised if, without constituting a new procedure, they improve the efficiency, reproducibility and safety of the procedure that they are modifying.
As far as vigilance and the monitoring of patients is concerned, the Agence is tasked with applying the vigilance system on clinical and biological activities relating to assisted reproductive technology (ART Vigilance). The aim of ART Vigilance is to perform a surveillance of incidents relating to eggs and sperm, embryos and germinal tissue used for therapeutic purposes, as well as adverse effects suffered by egg and sperm donors or people who are using ART. The aim of the system is to assemble and analyse adverse effects in order to improve practices and optimise the safety of treatment.
In addition to this, it monitors the health of people who have used assisted reproductive technology and children resulting from it, as well as egg donors.
It also publishes information on egg and sperm donation and works to promote egg and sperm donation.