German genetic testing policy report strikes conservative note

15 November 2010

Germany's national academy of sciences Leopoldina has published a new report on predictive genetic testing.
Predictive genetic diagnostics as an instrument of disease prevention is the output from a working group of experts from Leopoldina, the Berlin-Brandenburg Academy of Sciences and Humanities and the German Academy of Science and Engineering Acatech. It considers not only medical but also ethical, economic and legal issues related to predictive genetic testing of healthy individuals, and sets out a range of recommendations.
There is an express rejection of eugenic principles such as wanting to eliminate certain genes from all individual genomes of a population’. Recommendations include planning for the wider uptake of genetic testing within health services for patients with or at risk of ‘genetically determined and essentially treatable diseases’, including production of evidence relating to effectiveness and cost-effectiveness, development of medical guidelines for predictive genetic diagnostics, training for medical professionals, and expansion of newborn screening programmes. The report also calls for more basic and translational research into genetic contributions to complex diseases, and societal education about the ‘possibilities and limits of genetic medicine’, especially in schools.
Perhaps the most significant recommendations relate to a new German law on genetic testing (the Gendiagnostikgesetz) intended to protect against abuse of genetic information, which stipulates that the results of genetic testing and analysis should be expunged from medical records after ten years. Conversely, the report says that there should not be a set deadline, and that data should be stored for longer as it may be relevant to the future health of the patient or family members. Similarly, the report calls for amendment of the law’s definition of newborn screening as universal genetic screening, since this means that only doctors (not nurses or midwives) can obtain parental permission for testing, a situation thought not to be in the best interests of the newborns since it limits uptake (see press release).
In other respects the recommendations are highly conservative, calling for a ban on direct-to-consumer (DTC) services on that grounds that such tests ‘do not fulfil the requirements of medical and ethically acceptable predictive genetic diagnostics’ due to a questionable scientific basis and the lack of associated formal genetic counselling – despite the fact that this sort of counselling is not really required for tests with very low predictive ability such as those for common diseases. They also propose that genetic investigation of healthy individuals with no family history of serious disease should be confined to the research setting until the ethical and social implications have been more fully investigated.
Comment: In seeking to ensure that the benefits of genetic testing for individuals and families with serious inherited forms of disease are not limited, the report is a very positive step for German health policy. Vehement rejection of genetic testing for other situations may in some ways also be beneficial, in focusing attention on those with significant medical needs. However, in other respects it could be an over-reaction to perceived harms that are, in reality, highly improbable.


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