The Genetic Diagnostics Act

Parties requesting human genetic analyses have been obliged since 1 February 2010 to comply with the new German Genetic Diagnostics Act (Gendiagnostikgesetz – GenDG).

The Act regulates genetic tests for medical purposes, for establishing parentage, in insurance and at work.

You can find the wording of the Act here.


The Genetic Diagnostics Act requires all genetic analyses to be accompanied by a detailed statement of the nature, significance and scope of the test, as well as written patient consent.

Supplemental genetic counselling must be recommended in case of prenatal and predictive analyses. The patient may waive this in writing.

The Act covers both classical human genetic tests, as well as polymorphisms with relatively low genetic penetration (e.g. Factor V Leiden for assessment in cases of thrombophilia). There may be controversial discussion of whether this is what the legislature and patients wish to see happen.

The legislature has established a Genetic Diagnostic Commission at the Robert Koch Institute in order to ascertain the “generally-recognised state of science and technology”. It can be presumed that the Commission will also address the following problems:

 

  • all HLA typing
  • alpha 1-antitrypsin genotype
  • apolipoprotein E genotype
  • factor V Leiden/prothrombin mutation
  • haemochromatosis (HFE gene)
  • IL28B genotype
  • lactose intolerance genotype
  • MTHFR
  • PAI
  • human genetics


IMPORTANT: The laboratory may not act until it has been provided with written consent (section 8 subsection (1), sentence 3).

Simply stating that “consent has been given” is not sufficient according to today’s legal view!

You can request or download consent forms by faxing +49 6221 3432-8179. You need to send them in when requesting a genetic test so that we may act.

We would recommend that you retain a copy in your patients’ records.

Laboratory tests for acquired genetic defects, e.g. in patients with leukaemia, do not fall under the Genetic Diagnostics Act.

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