The Study Commission (Enquete-Kommission) on "Law and Ethics in Modern Medicine" of the 14th Federal Parliament recommended in 2002 that genetic tests conducted on human subjects should be governed in Germany by extensive legislation on genetic diagnostic testing. In its final report of 14 May, 2002, it stresses the right of the individual to informational self-determination. Together with federal and state data protection officers, it called for an explicit ban on the carrying out of predictive genetic tests without the consent of the patient. In addition, the Study Commission urged legislation covering how such tests should be conducted as well as the procedures to be observed, inter alia, for screening purposes.

In Germany, the adoption of the German Genetic Diagnostics Act was preceded by a series of political initiatives. Further information on this process can be found in: Damm 2004. For a comment on the 2005 draft for discussion, see: Henn 2005; Wiesing / Schmitz 2005 and Hasskarl / Ostertag 2005.