Criticism of the Genetic Diagnostics Act 

In February 2013, the German Medical Association (GMA) published a joint statement with medical and scientific associations in which she called for an amendment of the Genetic Diagnostics Act. According to the associations, experience has shown that the law complicates the daily routines of doctors and patients with a multitude of regulations. The broad scope of application of the law is seen as especially problematic since it encompasses both diagnostic and predictive genetic examinations. The German Medical Association (Bundesärztekammer) and other scientific associations also criticise the cooperation with the Genetic Diagnostics Commission (GEKO) because some of the directives developed by the GEKO were not possible to implement. 

In 2012, the German Society of Human Genetics also identified a need to amend the law. In its opinion it recommends inter alia to extend the scope of application to direct-to-consumer genetic tests (lifestyle tests) and to complement the law with further regulations regarding genetic counselling, the destruction of genetic samples and prenatal genetic examination.

Previously, a group of academies (consisting of the German National Academy of Sciences (Leopoldina), the German Academy of Science and Engineering (acatech) and the Berlin-Brandenburg Academy of Sciences and Humanities) published the opinion “Predictive Genetic Diagnostics as an Instrument of Disease Prevention" in 2010 on behalf of the Union of German Academies of Sciences and Humanities (Union der deutschen Akademien der Wissenschaften). In the opinion, the academies criticise that essential parts of the German Genetic Diagnostics Act do not correspond to the current state of technology, that they are hardly applicable in medical practice or that they have negative effects on the success of recognised screening examinations (for instance on the new-born screening). In a joint paper, the academies formulate 22 recommendations on how the Genetic Diagnostics Act should be amended and discuss aspects of genetic testing on healthy people to prevent diseases.

Joint Declaration of the German Medical Association and the scientific assocations on the necessity of amending the Genetic Diagnostics Act. Online Version (German)

Opinion of the German Society of Human Genetics on the need of amendment of the German Genetic Diagnostics Act. Online Version (German) 

Opinion of the German National Academy of Sciences (Leopoldina): "Predictive Genetic Diagnosis as an Instrument of Disease Prevention". Online Version (German)

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