International legal issues surrounding genetic testing

27 November 2008

France’s Biomedicine Agency (Agence de la Biomédecine) has submitted evidence to the French government which is undertaking an inquiry into the 2004 Bioethics Act. As part of this evidence, the agency has called for better guidance on how genetic information is passed onto relatives of patients diagnosed with a genetic condition [Benkimoun P (2008) BMJ 337:a2610. doi: 10.1136/bmj.a2610]. Under the current Act, doctors are not allowed to disclose any genetic information to relatives without consent from the patient and it is up to the patient to contact relatives if he/she wishes. Patients can either do this directly or via the Biomedicine Agency, however, the process through which this occurs still requires clarification and the agency has called for better legislation to guide it. In the UK, the general presumption is that the consent of the patient should be sought prior to disclosure of genetic information if it is to be used for purposes other than clinical use for the patient. However, if consent is refused, confidentiality can be breached legitimately under certain circumstances, if the disclosure can be justified, such as where it is in the public interest. The General Medical Council provides guidance on this matter and their draft guidelines on confidentiality, which have recently been released for consultation contains a section relating to genetic information.

Issues concerning peoples’ rights in relation to their genetic information are becoming increasingly important not least due to the burgeoning market for direct-to-consumer genetic tests. The Australian government is considering banning these products due to concerns about the interpretation of test results, especially for serious genetic conditions and feel that they would cause more harm than benefit [Finkel E (2008) Science 322 (5905): 1177]. Others might argue that individuals should have the right to decide if they would like to obtain genetic information directly or not, especially since the harms and/or benefits of such information will vary on an individual basis.

Regardless of what an individual patient may consider is reasonable, professional groups such as medical professionals or researchers may additionally be required to comply with sector specific guidance as to who may have access to genetic information or how best to balance their obligations to individuals and other interested parties (e.g. relatives). Some of these issues have been addressed by the UK’s Human Genetics Commission in its report on genetic information, where it makes recommendations on the use of genetic information in clinical practice and medical research, and for non-clinical purposes such as insurance, employment, forensic databases and family relationship testing (see previous news).


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