20 May 2008
On Wednesday 7 May, the Council of Ministers of the Council of Europe approved the final version of an Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Genetic Testing for Health Purposes (see press release), the fourth in a series of protocols added to the Convention on Human Rights and Biomedicine since its adoption by the Committee of Ministers in 1996. Shortly after the CHRB came into effect, the Steering Committee on Bioethics (CDBI) was called upon to establish a Working Party to prepare a Protocol concerning the problems relating to human genetics and questions surrounding the results of predictive genetic tests for purposes other than health or scientific research linked to health.
In February 2003, the Working Party released a working document presenting the outcome of its discussions, for public consultation on the applications of genetics for health purposes (see previous news story). Following the 2003 draft, the work on the Protocol progressed slowly, and in 2004 it was decided to reduce the scope of the Protocol to focus on genetic testing, excluding biomedical research, gene therapy and other applications of genetics for health purposes.
The scope of the Protocol was narrowed even further by the express exclusion of genetic testing on the human embryo and foetus – which the Council is considering for independent attention - genetic testing for purposes of identification, and testing for employment and insurance purposes. In 2006, the Working Party decided to pursue two separate instruments, dealing first with genetic testing for health purposes, resulting in the current Protocol, and secondly with genetic testing for employment and insurance purposes.
‘Genetic test’ as defined in the Protocol refers to the analysis of chromosomes, DNA or RNA and other sources of information equivalent to that provided by genetic material. The Protocol reinforces the OECD Guidelines for Quality Assurance in Genetic Testing, and includes further provisions on clinical utility, medical supervision and genetic counselling. Extensive consideration is given to issues related to consent, and genetic screening programmes have also been addressed. The Protocol is expected to be opened for signature about mid-November.