Interesting facts

Who may legally offer which services?



GERMANY

AUSTRIA

SWITZERLAND

Legal Requirements for Performing Genetic Analysis

In Germany, Austria and Switzerland, performing genetic analysis is legally regulated for the protection of the patient. The German Genetic Diagnosis Law, Austrian Genetic Technology Law and the Swiss Genetic Diagnosis Law are very similar in this respect, while most other countries do not legally regulate genetic analyses. All three regulations classify genetic analysis as either non-medicinal (“lifestyle”) or medicinal. The German Genetic Diagnosis Law distinguishes between the following three categories of genetic tests:

GERMANY


Genetic Examination (Lifestyle Genetics Test) (§ GenDG) (§3 GenDG)

Product group

TOXO SENSOR


Definition (§3 GenDG): (§3 GenDG)

An examination of genetic traits that makes no medical diagnosis.


May be performed by:

Anyone. Testing privileges are not restricted to doctors or any other professionals. This type of analysis can be carried out in the gym, on the Internet and by both doctors and practitioners of alternative medicine. (§7 GenDG)(§7 GenDG)



Genetic Examination for Medicinal Purposes (Diagnostic) (§3 GenDG) (§3 GenDG)

Product group

With the exception of TOXO SENSOR, which is a lifestyle analysis.


Definition: (§3 GenDG) (§3 GenDG)

  • recognises existing diseases
  • recognises genetic traits which can lead to diseases when combined with certain environmental factors (risk of disease / preventative analysis)
  • recognises potential medication allergies
  • recognises whether someone is resistant against a certain disease

May be performed by:

Doctors only. This type of analysis may NOT be performed by alternative medicine practitioners, nutritionists, fitness trainers or on the Internet. (§7 GenDG) (§7 GenDG)


Genetic Examination for Medical Purposes (Predictive)


Product Group:

Medical genetic analysis available at novogenia.com


Definition: (§3 GenDG)(§3 GenDG)

  • can predict a disease which will develop in the future (not the risk of this occurring)
  • identifies the gene carrying a mutation which could lead to diseases in offspring

May be performed by:

Specially trained doctors only. This includes specialists in human genetics as well as other doctors who have received qualifications for genetic examination as part of their medical training. (§7 GenDG) (§7 GenDG)

Source: http://www.gesetze-im-internet.de/gendg/

This means that all medical genetic analyses in Germany may only be performed by doctors, while non-medical genetic analyses can be done by fitness trainers, nutritionists, practitioners of alternative medicine and other members of the general populace.


In Austria, the situation is similar, but there are a few small differences:


Austria


Genetic Analysis for Medical Purposes (§65 Section 2&3 GTG)


Product group:

With the exception of TOXO SENSOR and the PHARMACO SENSOR, which are lifestyle analyses.


Definition:

  • recognises existing diseases
  • recognises genetic traits that can cause disease when combined with certain environmental factors (risks of disease / predictive analysis)
  • recognises diseases that can arise in the future
  • recognises the genes carrying a disease that could arise in offspring

May be performed by:

Doctors only. This type of analysis may NOT be performed by alternative medicine practitioners, nutritionists or fitness trainers, and may not be sold on the Internet. (§68 GTG)


Genetic Examination (Lifestyle Genetics Test) (§65 Abs. 2&3 GTG)


Product group:


TOXO SENSOR, PHARMACO SENSOR


Definition:

An examination that determines genetic traits but makes no medical diagnosis.


May be performed by:

Anyone. It is not restricted to doctors or other professionals. These analyses can be performed in the gym, on the Internet and by both doctors or practitioners of alternative medicine. (§68 GTG)


Source:https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10010826&ShowPrintPreview=True



SWITZERLAND



Swiss law is exclusively applicable to the following areas: (GUMG Art. 1)

  • in the medical sector
  • in the labour sector
  • in the insurance sector
  • in the legal liability sector

It therefore excludes analyses without medical significance and those that have not been ordered by either the examinee’s employer or insurance provider. This makes them available to anyone. This produces the following categories:

Genetic Analysis for Medicinal Purposes (GUMG Art. 3)


Product group:


With the exception of TOXO SENSOR, which is a lifestyle analysis.


Definition:

Any form of genetic analysis that is performed for a medical purpose.


May be performed by:

Only doctors. This type of analysis may NOT be performed by alternative medicine practitioners, nutritionists or fitness trainers, and may not be sold on the Internet. (GUMG Art. 13)


Genetic Examination (Lifestyle Genetics Test) (GUMG Art. 1)


Product group:


TOXO SENSOR

Definition:

An examination that determines genetic traits but does not make a medical diagnosis.


May be performed by:

Anyone. It is not restricted to doctors or other professionals. These analyses can be performed in the gym, on the Internet and by both doctors or practitioners of alternative medicine. (GUMG Art. 1)


Source: https://www.admin.ch/opc/de/classified-compilation/20011087/index.html

In summary, this means that in all three countries, as well as in most other European countries, non-medical lifestyle genetic analysis is not restricted to doctors and can be offered by anyone. Medical genetic analysis, on the other hand, is exclusively restricted to doctors in Austria, Germany and Switzerland. The only difference is that medical allergy analysis (“pharmacogenetics”) is not considered a form of medical genetic analysis in Austria, while it is classified as such in Germany and Switzerland.



Who may legally offer which services?


Alternative medicine practitioners, nutritionists, fitness trainers and private persons:

  • DNAnutriControl analysis
    • Weight Sensor
    • Nutrition Sensor (Home)
    • Sport Sensor
    • TOXO SENSOR
    • PHARMACO SENSOR (only in Austria)

Doctors

  • All DNAnutriControl analyses
  • All DNAhealthControl analyses