The new law on gene diagnostics in Germany--an overview about the main principles

On the 1st of February, 2010--more than 20 years after the first considerations and after several drafts of laws have been submitted to the German Lower House of Parliament, the law on gene diagnostics dated on 31.7.2009, get in to force. The law rules on genetic testing for purposes of health, parentage and descent in case of the law concerning refugees and foreigners, insurance and employment. It creates no independent basis for authorizing the performance of genetic tests. It regulates the application in which they are forbidden and mandatory conditions which must be followed in the conduct of lawful genetic investigations. Like many German laws in the field of biomedicine, it has gaps and rating contradictions. It is based on the political minimum consensus and not on the current state of medical research. For this reason, there are gaps rules, where political consensus was not possible, such as rules on genetic investigation for research (biobank) or PID. In any case the GenDG brings more security in the field of genetic diagnostics. In interaction with the general provisions the GenDG regulates genetic investigation to a sufficient extent.