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Right to Informed Consent as a Basic Requirement| 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 |
| An examination of the genetic characteristics of a patient who presents a symptom of a genetic disease or of a person who is asymptomatic but has precedents in the family, may only be prescribed in the framework of an individual medical consultation. When the patient is asymptomatic, the consultation has to be carried out by a doctor working within a multidisciplinary team gathering clinical and genetic competences. As the principle of informed consent is endorsed by the Convention, this is also the case in the French legislation regarding the examination of the genetic characteristics of a person. Carrying on the work started with the Act of 4 March 2002 on the rights of patients and the quality of the health system, which endorsed the patient’s right to consent as a general patient right in article L 1111-4 of the Public Health Code, the legislator of 2004 also placed from now on the individual with regard to genetic services in the forefront. The principle of informed consent was specifically endorsed regarding an examination of the genetic characteristics of a person by article 16-10 of the Civil Code. The phrasing of the principle was refined by the Act of 6 August 2004. The new formulation of article 16-10 is more precise than the previous one, which just stated that the consent had to be obtained prior to the examination. In accordance with article 16-10 of the Civil Code the explicit consent of the person also has to be obtained in writing prior to the examination, after he or she has been appropriately informed of its nature and its finality. The consent has to specify the purpose of the test. It can be revoked at any moment without any requirements regarding the form. As stipulated in article 16-10 of the Civil Code a person has to be appropriately informed of the nature and the finality of the examination of his or her genetic characteristics. This general principle established by the Civil Code is elaborated in the Public Health Code. As the Decree of 4 April 2008 attaches a lot of importance to the communication of information and the obtaining the consent of the examined person , it ads article R 1131-4 to the regulatory part of the Public Health Code. This article elaborates the content of the information that has to be provided prior to the consent. Prior to the written expression of his consent, the person has to be informed of the characteristics of the examined disease, of the means of detecting it, the degree of reliability of the analyses as well as the possibilities of prevention and treatment. Moreover, he or she has to be informed of the methods of genetic transmission of the examined disease and its possible consequences among other member of his family. |