Legal provisions for the performance of genetic analyses
In Germany, Austria and Switzerland, the performance of genetic analyses is regulated by law to protect the patient. The German Gene Diagnostics Act, the Austrian Gene Technology Act and the Swiss Gene Diagnostics Act are very similar in this respect, while most other countries do not regulate gene analyses by law. All three laws classify genetic analyses as either nonmedical (“lifestyle”) or medical. For example, the German Genetic Diagnostics Act distinguishes among the following three categories of genetic tests:
Country list
Germany
Genetic examination (lifestyle genetic test) (§3 GenDG)
Product group
TOXO SENSOR
Definition: (§3 GenDG)
A test that identifies genetic traits that does not identify disease.
Applicable from:
Each. There is no physician proviso or other restriction. These analyses may be offered in fitness studios, on the Internet and through doctors and alternative practitioners. (§7 GenDG)
Genetic examination for medical purposes (Diagnostic) (§3 GenDG)
Product group
With the exception of the TOXO SENSOR, which is a lifestyle analysis.
Definition: (§3 GenDG)
- detects existing diseases
- recognizes genetic characteristics that can lead to disease in connection with environmental influences (disease risks / precautionary analyses)
- Detects potential drug intolerances
- detects whether a person is resistant to the development of a disease
Applicable from:
Excluding physicians. These analyses may NOT be distributed by alternative practitioners, nutritionists, fitness trainers or via the Internet. (§7 GenDG)
Genetic testing for medical purposes (predictive)
Product group:
Specialized gene analysis available from novogenia.com
Definition:(§3 GenDG)
- Foresees a disease (not the risk) arising in the future
- determines the carrier of a mutation that could lead to a disease in offspring
Applicable from:
Exclusively specially trained doctors. This includes specialists in human genetics or other physicians who have qualified for genetic testing within their specialty when they acquired a specialist, focus or additional designation. (§7 GenDG)
Source: http://www.gesetze-im-internet.de/gendg/
Thus, all medical genetic analyses in Germany are reserved exclusively for physicians, while non-medical genetic analyses may also be offered by fitness trainers, nutritionists, alternative practitioners and the general population.
Who is now legally allowed to offer what?
Alternative practitioners, nutritionists, fitness trainers and individuals:
- DNAnutriControl analyses
- Weight Sensor
- Nutrition Sensor (Home)
- Performance sensor
- Toxo Sensor
- Toxo Sensor (only in Austria)
Doctors
- All DNAnutriControl analyses
- All DNAhealthControl analyses