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Genetic Information and the Family Members| 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 |
| When a person accepts or refuses an examination of his or her genetic characteristics, he or she makes a decision that concerns his or her own health as well as the health of family members. Must the diagnosis of a genetic anomaly be made available to the potentially concerned members of the family? Every patient has the right to privacy and the right to medical secrecy. This principle was already for a long time stipulated in the French Penal Code (article 226-13) and was once again confirmed by the Act of 4 March 2002 on the rights of patients (article L 1110-4 of the Public Health Code). Members of the family are considered to be a third party in the French legislation. As a consequence, a tension may arise between the strict respect of the medical secrecy and the possible interest of other persons who may benefit from knowing the information. Convinced of the necessity of this information, when preventive measures or treatment may be possible, the French Parliament did however create a unique procedure of medical information concerning the family. According to the explanatory memorandum, the new provisions are justified by the conciliation of the respect for the privacy of the person concerned and the protection of the health of the family members. Also the Council of Orientation of the Agency of Biomedicine emphasizes that the choice of a person to inform his family by the specific procedure of medical information concerning the family does not result in the exemption from the obligation of the consulted physician to strictly respect the medical secret. The procedure of medical information concerning the family is considered to be one of the most important innovations of the Act of 6 August 2004 on bioethics. The new article L 1131-1 (subsections 3-5) of the Public Health Code stipulates that in case of the diagnosis of a serious genetic anomaly detected during the examination of the genetic characteristics of a person, the physician has to inform the person or his or her legal representative of the risk which his or her silence would pose to potentially concerned members of the family, since measures of prevention or care can be proposed to them. Since a typology of all serious genetic anomalies is difficult to draw up, the reference to the gravity may help the physician to qualify the situation, as they will have to decide if the anomaly can be considered as serious. As a consequence, the physician has a margin of appreciation to assess the situation in the context of the evolution of knowledge. This information has to be summarized in a document signed by the doctor and has to be given to the person concerned. In this case, the obligation of the physician to inform lies in the delivery of this document to the person or his legal representative, who has to confirm the handing-over. It may seem that the Act of 6 August 2004 on bioethics has implicitly changed article L 1111-2 of the Public Health Code which stipulates that the desire of a person to be kept in ignorance of a diagnosis or prognosis must be respected, unless third parties are exposed to a risk of contagion. The physician can not inform the person concerned or his or her legal representative of the risk which his or her silence would pose to potentially concerned members of the family without informing the patient him or herself of the diagnosed genetic anomaly. However, the phrasing of subsection 3 of article L 1131-1 of the Public Health Code which states “the physician has to inform the person or his or her legal representative of the risk which his or her silence would pose to potentially concerned member of the family” (italic by authors), implies that the person concerned is already informed of the results of the examination. Besides this linguistically counter-argument, the Council of Orientation of the Agency of Biomedicine also confirms that the right not to know is a fundamental right of a patient. The patient may choose to be kept in ignorance of the results of an examination of his or her genetic characteristics. As stipulated above (see 4.2), the risks that the potentially concerned members of the family may run can not be assimilated with a risk of contagion. The person concerned or his or her legal representative want to break the silence, they can choose to inform his family by the procedure of medical information concerning the family. He then indicates to the physician the names and addresses of the family members, of which he specifies the family tie which links them. This information is transmitted by the physician to the Agency of Biomedicine. The Agency informs, by the intermediary of a physician, the aforementioned members of the existence of medical information concerning the family that is likely to relate to them, and of the methods enabling them to access the information. The fact that the patient does not transmit the information concerning a serious genetic anomaly detected during the examination of his or her genetic characteristics which would pose risks to potentially concerned members of the family, since measures of prevention or care can be proposed to them, can not be used as a ground for liability (article L 1131-1, subsection 5). However, only the silence of the patient can not be seen as a ground for liability, since the procedure can be considered as a mode of informing the family that replaces the direct transmission of information by the patient. The patient may choose to remain silent but he or she may not obstruct the functioning of the procedure. As a consequence, his or her refusal to communicate the identity of the potentially concerned family members can constitute a fault that may engage liability. The methods of collection, transmission, conservation and access to this information have to be specified by a decree taken in the Council of Stake, after the opinion of the National Commission of Data Processing and Freedoms is obtained. At the day of writing, the procedure of medical information concerning the family has not yet became effective due to the lack of the publication of such a decree. |