A Working Party on Human Genetics, under the auspices of the Council of Europe, has produced a draft version of a proposed Additional Protocol to the Convention on Human Rights and Biomedicine, and is requesting comments on it. The draft text (see also explanatory notes) deals with “applications of genetics for health purposes”, though the intention is that the final Protocol will also cover non-medical applications of genetics. The Council’s Steering Group on Bioethics has not yet examined the draft text.
The proposed Protocol covers “applications of genetics in the field of health including research, as well as in the fields of employment and insurance, which involve an intervention concerning the human genome, carried out on living persons or on the body of deceased persons”. It also covers such “interventions” carried out on “identified or identifiable human biological material, or the collection, processing or communication of personal genetic data”, but research use is excluded in this case. The Protocol does not apply to human embryos or fetuses.
The draft text includes general provisions on information, consent and authorisation, and on the conduct of genetic services. Services should, for example, have quality assurance programmes, ensure equitable access, and provide “genetic counselling and support appropriate to the … implications for the person concerned or the members of the person’s family”. Further sections deal with individual genetic tests on living people, tests on deceased people, genetic screening for health purposes, and “research”, which appears to be concerned mostly with somatic gene therapy. The sections on genetic tests cover not just diagnostics and predictive tests but also tests that may reveal a genetic predisposition or susceptibility to a disease: such tests, says the draft, should be performed “only for health purposes or for scientific research linked to health purposes”. Provisions on the consent that should be obtained include the statement that “appropriate information and consent or authorisation procedures” are necessary for tests carried out on biological material previously removed from a human body. Interestingly, another Article in this section, dealing with tests sold directly to the public, has three alternative texts, ranging from a flat prohibition of such tests to a requirement for adequate regulation and provision of information.
The UK has not adopted the Convention on Human Rights on Biomedicine because some aspects of it conflict with current law and practice in the UK. Similar difficulties may apply to the proposed Additional Protocol. For example, the prohibition on “discrimination” on the basis of genetic heritage would presumably preclude the use of any genetic test information in insurance, whereas tests approved by the Genetics and Insurance Committee in the UK can currently be used by insurers considering applications for high levels of life insurance and some other types of insurance cover. Some provisions of the Protocol might be interpreted as imposing quite draconian restrictions on the way research projects such as Biobank could operate, perhaps mandating individual feedback of all genotyping results. A weakness of the Protocol is that does not appear to make a clear distinction between predictive tests for highly-penetrant single-gene diseases, and tests that may reveal weaker predisposition to multifactorial disease. It is arguable that tests of the latter type do not need special regulation beyond that imposed on other, non-genetic types of medical test. The consultation closes on 30 April 2003.