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Germany introduces new law to control genetic testing

3 May 2009
Appeared in BioNews 506

The German parliament has approved legislation severely restricting the use of genetic testing. Under the new laws, which have been debated for more than seven years, genetic tests may only be carried out under specific circumstances, and only then after professional medical consultation and with the consent of all individuals involved. This effectively implements a total ban on the use of commercial enterprises offering 'direct-to-consumer' genetic tests in Germany.

The new legislation strictly defines the situations in which the analysis of genetic material is legal and covers paternity tests; pre-implantation testing on IVF embryos; and the use of genetic testing on adults to identify predispositions to medical disorders by employers or health insurance companies. Germany's Health Minister, Ulla Schmidt, called the move 'a crucial step in protecting the rights of patients...[and preventing] the abuse of sensitive personal data'. However, the laws have been criticised by the German opposition parties, the Green Party, the Free Democratic Party and the Left Party, for not being stringent enough and containing too many loopholes.

Paternity testing during pregnancy will now only be permitted in Germany in cases of sexual abuse or rape. Post-natal paternity tests may only be carried out with the consent of both the man and woman involved. Falling foul of this law will incur a fine of up to €5000. Earlier this year, a report by the science magazine, New Scientist, highlighted the growing number of US-based companies offering so-called 'discreet' paternity tests on bodily material collected without the knowledge of the father or child, and the social and ethical problems associated with this. The UK was the world leader in implementing laws to ban such practices in 2006. Most countries, including the US, do not have any legislation in place to prevent surreptitious genetic testing, and the German Medical Association has raised concerns that the new laws will result in a trend of 'medical tourism', with individuals seeking genetic tests abroad.

The new laws in Germany also restrict the genetic tests that can be performed on fetuses. Only medical conditions can be tested for, and these are limited to those that will affect the child early in life. Genes that predispose an individual to conditions with a later onset, such as breast cancer or Alzheimer's, may not be tested for. Tests to determine the sex of the child or other desired characteristics are also prohibited.

German employers are now banned from requesting genetic tests from their employees to identify potential medical problems unless the job imposes particular risks to the individual's health, for example in the chemical industry. Likewise, insurance companies are no longer able to ask for genetic tests from their clients. There are exceptions, however, when the insurance pay out sum is particularly large.

Ban on direct-to-consumer genetic tests in Germany
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