| HOME | EUROPEAN ETHICAL-LEGAL PAPERS | CENTRE FOR BIOMEDICAL ETHICS AND LAW | EUROGENTEST |
|---|
Prenatal Diagnosis| FRANCE
| GENERAL OVERVIEW | BIOMEDICINE CONVENTION | EU MEMBER STATES | TYPES OF PATIENT RIGHTS LEGISLATION |
| Signed, not Ratified |
| Patient Rights in France |
| Rights of Users of Genetic Services |
| Right to Informed Consent |
| In case of minors and incapacitated adults |
| Right to information |
| Of the examined person |
| Genetic Information and the family members |
| Rights regarding the Medical File |
| Genetic Discrimination |
| Prenatal Diagnosis and Neonatal Screening |
| Prenatal diagnosis |
| Preimplantation Genetic Diagnosis |
| Neonatal Screening |
| Examinations of the genetic characteristics are not only performed on symptomatic or asymptomatic persons in the view of the diagnosis of a genetic disease, but they are also performed to achieve a prenatal diagnosis. The latter is regulated by different provisions than the examinations of the genetic characteristics of a person. Until the Act No. 94-654 of 29 July 1994 on the donation and use of elements and products of the human body, medically assisted reproduction and prenatal diagnosis, a specific regulation regarding the prenatal diagnosis did not exist in France. In addition to this Act, the Act of 6 August 2004 on bioethics and the Decree No. 2006-1661 of 22 December 2006 on prenatal diagnosis and preimplantation genetic diagnosis regulate the prenatal diagnosis and the preimplantation genetic diagnosis. Since the new codification of the Code in 2000 , the legal provisions concerning the prenatal diagnosis were regrouped under chapter I of title III (“actions of prevention regarding a child”) of the second part. The chapter is entitled “the prenatal diagnosis”. According to a prevailing definition in practice, narrower than the preceding one, the prenatal diagnosis is a diagnosis performed on the embryo or the fetus in vivo, performed to detect a morphological anomaly, an actual genetic disease or a chromosomical disease, or a predisposition to develop a disease in the future. This definition was the source of inspiration for article L 2131-1 of the Public Health Code, as it was formulated by the Act of 1994 and confirmed by the Act of 2004. In accordance to this article, a prenatal diagnosis can be described as the medical practices having for goal to detect in utero a disorder of a particular gravity of the embryo or the fetus. The medical practices contributing to a prenatal diagnosis, including the use of scanning techniques, are subjected to rules of good practices defined by a decree of the minister in charge of health, taken on the proposal of the general manager of the Agency of Biomedicine after the opinion of the French Agency of Medical Safety of Health Products was obtained. These rules of good practices have to hold account of the recommendations of the High Authority of Health (article R 2131-1-1). According to article L 2131-1 as well as article R 2131-2, a prenatal diagnosis has to be preceded by a medical consultation adapted to the examined disorder. In accordance to article R 2131-2, such a medical consultation has to allow the risk for the child to be born with a disease of a particular gravity to be evaluated, taking into account the family antecedents or the medical observations carried out during the pregnancy. Moreover, it has to allow the pregnant woman to be informed not only on the characteristics of the disease, the means of detecting it, the therapeutic possibilities, the results likely to be obtained during the analysis and on their possible consequences, but also on the inherent risk of the removal, its constraints and the possible consequences. It is the consulted physician who provides the pregnant woman of this information. He establishes a certificate, cosigned by the pregnant woman, certifying that this information was provided. When the pregnant woman agrees to the realization of the analyses, her consent is given conform to a model drawn up by a decree of the minister in charge of health, taken on the proposal of the general manager of the Agency of Biomedicine. The physician has to preserve the original copy of this certificate and of the written consent form. Another copy is given to the pregnant women and the expert who carries out the analyses. These documents have to be preserved by the publicly-owned establishments of health or the laboratories under the same conditions as the reports of the analyses of the medical biology (see 4.4). |