Ban on direct-to-consumer genetic tests in Germany

28 April 2009

Germany has passed a new law significantly limiting the use of genetic tests, according to recent reports in the media (see Deutsche Welle and Associated Press).
Under this new legislation, genetic tests can only be carried out by a licensed doctor following the patient’s consent, making it an offence to conduct direct-to-consumer (DTC) genetic tests. Additionally, paternity tests will only be legal if both the man and woman agree, and individuals risk a fine of 5,000 Euros for carrying out tests in secret. Moreover, the law limits the use of genetic tests on fetuses to purely medical purposes (see recent work) , and specifically prohibits the use of genetic testing of fetuses for indications of a predisposition to illnesses that appear only later in life.
Following ongoing controversy regarding the obligatory use of genetic tests as a condition for employment in Germany (see previous news), the legislation also address discrimination using genetic information, preventing employers and insurance companies from demanding genetic tests in a similar manner to the Genetic Non-discrimination Act recently passed in the US (see previous news).
The law has been welcomed by Health Minister Ulla Schmidt who sees it as “a crucial step in protecting the rights of patients” and “prevent[ing] the abuse of sensitive personal data”. However, the German Medical Association has warned that the law might lead to “medical tourism”, with people trying to get genetic testing done abroad.
Comment: This law represents essentially a complete ban on DTC genetic tests, a regressive and paternalistic approach that takes genetic exceptionalism to an extreme not seen in other jurisdictions. It is unclear upon what grounds this special treatment of genetic tests is justified, or indeed what exactly constitutes a ‘genetic test’ – if it is simply a test that uses DNA (or RNA) as the analyte, there can be no rational case made for treating it any differently from measurement of any other biomarker. On the other hand, if the definition relates specifically to a test for inherited monogenic disorders, where a case for special treatment is often made, then the legislation seems to have significantly overshot its remit, since the majority of genetic tests available DTC are for common complex diseases.
There is still extensive ongoing debate regarding the appropriate level of regulation of DTC genetic tests – see, for example, two recent contrasting articles in the European Journal of Human Genetics [Guwitz D & Bregman-Eschet Y (2009) Eur J Hum Genet doi: 10.1038/ejhg.2008.254, and Patch C et al. (2009) Eur J Hum Genet doi: 10.1038/ejhg.2008.246] – and differing approaches are being considered across numerous countries. Moderate steps to protect the consumer from DTC genetic are being developed in the UK by the Human Genetics Commission (HGC). Outlined in two reports – Genes Direct in 2003 and the follow-up More Genes Direct in 2008 – its recommendations fall substantially short of an outright ban on DTC genetic tests (see previous news). Working with a small group of experts, the HGC is currently drafting a ‘Common Framework of Principles’, applicable to all jurisdictions, to which companies wishing to supply DTC genetic tests will be encouraged to sign up. These are expected include consideration of the clinical validity and utility of different tests, the level of information provided to consumers, quality assurance, data protection and consent.

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