Book I: Health protection for individuals

When a person mentioned in 1° or 2° of Article L. 147-2 of the Code de l’action sociale et des familles is diagnosed with a genetic anomaly that may be responsible for a serious condition justifying preventive measures, including genetic counselling, or care, the prescribing doctor shall refer the matter to the Conseil national pour l’accès aux origines personnelles (National Council for Access to Personal Origins) mentioned in Article L….

I.- By way of derogation from the second paragraph ofArticle L. 1111-2 andArticle L. 1111-7, only the doctor prescribing the examination of genetic characteristics is authorised to communicate the results of this examination to the person concerned or, in the case of an adult subject to a legal protection measure with representation of the person, to the person in charge of the protection measure. II – By way of derogation…

An order by the Minister for Health, issued on a proposal from the Agence de la biomédecine and the Haute Autorité de santé, defines the rules of good practice applicable to the prescription and performance of an examination of a person’s genetic characteristics and identification by genetic fingerprinting for medical purposes. This order also defines the rules of good practice applicable, where applicable, to the medical follow-up of the person.

Examination of a person’s genetic characteristics or identification by genetic fingerprinting for medical purposes may only be carried out in medical biology laboratories authorised for this purpose under the conditions laid down in Chapter II of Title II of Book I of Part Six and accredited under the conditions laid down in Chapter I of Title II of Book II of the same Part. Where the laboratory is part of…

Any breach, observed in an establishment, a health cooperation group or a laboratory, of the legislative and regulatory requirements applicable to the examination of genetic characteristics for medical purposes or to the identification of a person by genetic fingerprinting shall result in the suspension or withdrawal of the authorisation provided for inArticle L. 1131-2-1, under the conditions laid down inArticle L. 6122-13. The authorisation may also be withdrawn in the…

Subject to the provisions of the last paragraph of Article L. 1131-2-1, only practitioners approved for this purpose by the Biomedicine Agency referred to in Article L. 1418-1 under conditions laid down by regulation may carry out examinations of a person’s genetic characteristics or their identification by genetic fingerprinting for medical purposes. Persons who carry out examinations of a person’s genetic characteristics or identification by genetic fingerprinting for scientific research…

The preservation and processing of elements and products of the human body, including the constitution and use of collections of human biological samples for genetic research purposes, are governed by the provisions of articles L. 1243-3 and L. 1243-4.

Analyses enabling identification by genetic fingerprint in the context of the legal proceedings referred to inarticle 16-11 of the Civil Code must be subject to quality control organised by the National Agency for the Safety of Medicines and Health Products, in accordance with the procedures laid down by the decree provided for inarticle 16-12 of the Civil Code.

The following shall be determined by decree of the Conseil d’Etat : 1° The conditions under which, in the interests of patients and their relatives, examinations of a person’s genetic characteristics or their identification by genetic fingerprinting for medical purposes may be prescribed and carried out, as well as the conditions under which the examinations of somatic genetic characteristics referred to in Article L. 1130-2 may be prescribed; 2° The…

The provisions of this chapter do not apply to examinations to check tissue or blood compatibility, carried out in the context of the donation of human body parts and products, which are subject to the provisions of Book II of Part One.