30-03-2012

The Hellenic National Bioethics Commission published an opinion on the issue of Direct-To-Consumer (DTC) genetic testing. The term DTC genetic test refers to any genetic examination that detects DNA changes and is available directly to the public as a kit. In general, the Commission supports the right to autonomy and the right to access information concerning a person's health, including genetic information. However, it is vital to maintain the balance between free access to health information and fortification of vulnerable people undergoing inappropriate or excessive genetic testing.

DTC genetic testing for health purposes, including tests that estimate disease risk, must be performed after genetic counseling with a liable doctor or geneticist, who will assess the feasibility of the test and will clarify the results, avoiding unnecessary tests and inaccurate evaluation of the findings. Exceptionally, DTC genetic testing for nutrigenomic or genealogy purposes may not demand genetic counseling. Regarding prenatal genetic testing, the Commission resumes its opinion that it is not allowed for eugenic purposes. DTC genetic testing concerning disclosure of a person's identity, such as paternity testing, presupposes consent from all involved parties. Otherwise, the matter must be brought to justice. To protect a child's right to ignorance, DTC genetic testing of asymptomatic children with no apparent medical need, is not justified, especially concerning late onset diseases. DTC genetic services must be based on accurate information about the actual prognostic or diagnostic value of the test. Misleading advertising about "prediction" of serious diseases, overlook the role of unidentified genetic factors or involved environmental factors. DTC genetic service providers must ensure protection of personal data which are collected and processed.

Finally, the Commission believes that an explicit legislation is required, which will include: a) recognition of the specialty of Clinical Genetics, b) quality accreditation/certification and c) rules of procedure for genetic centers offering DTC genetic testing, and d) use of biologic material or genetic data generated by DTC genetic testing for research purposes, with the subject's informed consent.

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