Chapter I: Antenatal diagnostics: prenatal diagnosis and pre-implantation diagnosis.

I.- Foetal medicine refers to medical practices, in particular clinical, biological and imaging practices, aimed at the diagnosis and prognostic evaluation and, where appropriate, the treatment, including surgery, of a particularly serious condition or one likely to have an impact on the future of the foetus or unborn child. II-Any pregnant woman receives, during a medical consultation, fair, clear and appropriate information about the possibility of having recourse, at her…

The Minister responsible for health shall determine: 1° By order issued on a proposal from the Agence de la biomédecine, the recommendations of good practice relating to the methods of access, care for pregnant women and couples, organisation and operation of the multidisciplinary centres for prenatal diagnosis mentioned in VIII ofArticle L. 2131-1 and the recommendations of good practice relating to prenatal diagnosis and pre-implantation diagnosis as well as the…

Any establishment or laboratory authorised to carry out medical biology examinations intended to establish a prenatal diagnosis, and any multidisciplinary prenatal diagnosis centre is required to submit an annual activity report to the regional health agency and the Agence de la biomédecine instituted in article L. 1418-1, in accordance with the procedures determined by order of the Minister for Health.

Any breach of the legislative and regulatory requirements applicable to prenatal diagnosis observed in an establishment or laboratory, and caused by it, shall result in the temporary or permanent withdrawal of the authorisations provided for in Article L. 2131-1. The authorisation of an establishment or laboratory may also be withdrawn in the event of a breach of the requirements laid down in the authorisation or if the volume of activity…

Preimplantation diagnosis is the biological diagnosis carried out using cells taken from the embryo in vitro. Preimplantation diagnosis is only authorised in exceptional cases under the following conditions: A doctor practising in a multidisciplinary prenatal diagnosis centre as defined by article L. 2131-1 must certify that the couple or the unmarried woman, due to her family situation, has a high probability of giving birth to a child suffering from a…

By way of derogation from the sixth paragraph ofArticle L. 2131-4, and subject to having exhausted all the possibilities offered by Articles L. 1241-1 to L. 1241-7, pre-implantation diagnosis may also be authorised when the following conditions are met: -the couple or the unmarried woman has given birth to a child suffering from a genetic disease causing death in the first years of life and recognised as incurable at the…

Only practitioners who have been approved for this purpose by the Agence de la biomédecine mentioned in Article L. 1418-1 under conditions laid down by regulation may carry out biological diagnosis using cells taken from the in vitro embryo.

Unless otherwise provided, the terms and conditions for the application of this chapter shall be determined by decree in the Conseil d’Etat, and in particular : 1° The missions, the role of the other parties involved in prenatal diagnosis and the conditions for the creation and authorisation of the multidisciplinary centres for prenatal diagnosis provided for in Article L. 2131-1; 2° The nature of the medical biology tests intended to…