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Who may offer genetic tests? The rules in Germany, Austria and Switzerland

Reviewed by Dr. Daniel Wallerstorfer, molecular biologist and founder of Novogenia · Updated: 12 October 2026 · Reading time: 11 min

Same saliva sample, two different worlds: the purpose sets the track

Picture two clients, two saliva samples, one lab. One client wants to know whether her body responds better to strength or endurance training. The other wants to know whether she carries a predisposition to a disease. For the lab, it is almost the same job. For the law, two different worlds.

The reason: the laws in Germany, Austria and Switzerland look not at the lab technique but at the purpose. Think of it as a railroad switch: it sends your analysis either onto the medical track, with a physician reservation and genetic counseling, or onto the lifestyle track with other rules. This article shows where the three countries draw the line – as orientation, not legal advice.

Germany: the Genetic Diagnostics Act draws the line at medical purposes

According to Section 2(1), the Genetic Diagnostics Act (Gendiagnostikgesetz, GenDG) applies to genetic examinations for medical purposes, for clarifying parentage, and in insurance and employment. For medical purposes, it distinguishes two types (Section 3 Nos. 6 to 8):

• Diagnostic: It clarifies an existing disease or health disorder – or whether genetic traits are present that, with external factors or foreign substances, can trigger a disease or health disorder, that influence the effect of a medicinal product, or that can fully or partly prevent a disease (Section 3 No. 7).
• Predictive: It clarifies a disease or health disorder that will only occur in the future, or a predisposition that can be passed on to children (Section 3 No. 8).

Both fall under the physician reservation (Section 7(1)): only physicians perform diagnostic examinations, only specialists in human genetics or suitably qualified physicians predictive ones. Add explicit written consent to the responsible physician (Section 8), information (Section 9) and counseling (Section 10).

In Germany, pharmacogenetics is explicitly medical: Section 3 No. 7(c) lists it as a diagnostic examination. So it belongs in medical hands.

And lifestyle analyses? The scope of the GenDG does not list analyses serving none of the purposes in Section 2(1), such as power versus endurance type. The physician reservation, consent and counseling sit in the part on medical purposes.

Mind the gray zone: Because Section 3 No. 7(b) also covers traits that only trigger a “health disorder” together with external factors, a nutrition question can quickly become medical – depending on what the analysis is meant to clarify and how the report words it. Guidelines on the state of science come from the Genetic Diagnostics Commission (Section 23 GenDG).

Austria: four drawers in the Gene Technology Act

In Austria, the Gene Technology Act (Gentechnikgesetz, GTG) regulates genetic analyses in humans. Its definition is narrow: a “genetic analysis” allows, according to the state of science and technology, statements about carrier status, a disease risk, an existing disease or the course of a disease or therapy (Section 4 No. 23).

For medical purposes, Section 65(1) sorts these analyses into four drawers, each with its own rules:

So Section 68(1) GTG requires a specialist order for types 3 and 4. Analyses allowing none of the statements in Section 4 No. 23 fall outside the definition; whether one does – on food tolerance, say – depends on its content.

And pharmacogenetics? Section 65 GTG does not explicitly name analyses of how the body processes medicines. “Preparing a therapy” appears only in type 1, which is based on somatic changes, not inherited genes. In the Gentechnikbuch (chapter 5, adopted on 4 December 2009), the Austrian Gene Technology Commission stated that pharmacogenetic examinations are not to be regarded as predictive analyses within the meaning of Section 65(1) Nos. 3 and 4 GTG – unless a trait also allows statements about the predisposition to a hereditary disease that may break out in the future. A 2024 expert opinion for the health ministry finds purely pharmacogenetic testing not adequately covered by the GTG and proposes a dedicated rule for its revision.

Regardless of the legal text: decisions about medication – stopping, switching or changing the dose – are made by the treating physician.

Switzerland: a traffic light with three colors

Since 1 December 2022, Switzerland has regulated genetic testing through the revised Federal Act on Human Genetic Testing (GUMG) and its ordinance (GUMV). Remember the system as a traffic light:

• Red – medical context: diagnostic, presymptomatic and prenatal tests and other tests for medical purposes, “in particular to determine the effects of a possible therapy” (Art. 19 GUMG). As a rule, physicians order them (Art. 20); for pharmacogenetics, other professions may too, under conditions (Arts. 5 to 8 GUMV).
• Yellow – sensitive characteristics: tests without a medical purpose, including tests of physiological characteristics which, if known, may influence a person’s lifestyle (Art. 31(1) GUMG) – according to Art. 37 GUMV, in particular eating behavior, physical activity and general well-being. This is where nutrigenetics sits.
• Green – other tests: for example hair and eye color or the senses of smell and taste (Art. 31(2) GUMG, Art. 37(3) GUMV).

What yellow means in practice follows after the comparison.

Three countries at a glance

What is different in Switzerland – and what it means for your practice

In Germany and Austria, almost everything hinges on one question: medical or not? Switzerland adds two: who orders the analysis, and how does the sample reach the lab? The practical consequences:

• Only certain professions may order: Analyses on nutrition, sport and well-being may only be ordered by health professionals under Art. 40 GUMV who are authorized to practice under their own professional responsibility: physicians, pharmacists, psychologists, druggists HF and – for physiological characteristics – nutritionists FH, physiotherapists FH, chiropractors and osteopaths. They must work in the field the test belongs to (Art. 34(2) GUMG). If you are not one of them, you need such a professional to order the analysis.
• Sample in their presence: The sample must be collected in the presence of the person ordering the test (Art. 34(3) GUMG). A kit mailed to the client and used alone at home is therefore ruled out for these analyses.
• Self-tests only for harmless topics: Self-tests may only be supplied for other tests, such as hair color or sense of taste (Art. 13 GUMG).
• Some topics are always medical: Analyses that give information on, among other things, food intolerances, metabolic disorders, an increased risk of sports injuries, or diseases, allergies and inflammation count as medical (Art. 37(2) GUMV). A physician orders them (Art. 20 GUMG). The GenDG and GTG have no such list of topics.
• Lab abroad: A lab abroad – in Austria, for example – may be used if it works to the state of science and technology, has a suitable quality management system, is authorized in its own country and the client has consented in writing (Art. 36 with Art. 29 GUMG). A Swiss lab needs authorization from the Federal Office of Public Health (Art. 35).
• Written information: It names the lab and any companies and labs abroad involved, with contact details of a specialist for questions and of the person responsible for data processing (Art. 32 GUMG).
• Advertising with mandatory information: Advertising to the public must explain the rules on prescription, information and disclosure of results and must not mislead (Art. 14(3) GUMG, Art. 4 GUMV) – more in Advertising genetic tests.

If you counsel clients in Switzerland:

• You belong to a professional group under Art. 40 GUMV and work in the relevant field – or you work with such a professional.
• The sample is collected in the presence of the person ordering the test.
• Topics under Art. 37(2) GUMV go through a physician.
• If the lab is abroad, the client’s written consent is in place.
• The written information contains everything required by Art. 32 GUMG.
• The report contains only results that relate to the purpose of the test (Art. 33 GUMG).
• Your advertising includes the mandatory information under Art. 14(3) GUMG and Art. 4 GUMV.

And outside Germany, Austria and Switzerland?

In the EU, a test the manufacturer intends to provide information on, say, a predisposition to disease or the likely response to a treatment is an in vitro diagnostic medical device under Regulation (EU) 2017/746 (Art. 2(2)); for medical genetic tests in healthcare, member states ensure the person tested is informed about their nature, significance and implications (Art. 4). Outside Europe – in the USA, for example – other rules apply; check them country by country. Data protection applies to all analyses: see Genetic data and the GDPR.

Checklist: before you add a genetic analysis to your services

• You know the purpose of every analysis and what the report says.
• If an analysis concerns a disease, a health disorder, a disease risk or the effect of medication, it belongs in medical hands wherever national law requires it.
• You know the rules in every country where your clients live.
• You mention medication only with a clear note that any change belongs in medical hands.
• Your lab can tell you how it classifies each analysis; when in doubt, you ask a specialized lawyer or the competent authority.

More on Germany: Who may perform what? and Gene Diagnostics Act.

Frequently asked questions

Related: Who may perform what? · Gene Diagnostics Act · Genetic data and the GDPR

Note: This guide is general information for professionals and does not replace medical or legal advice. The genetic traits determined in a genetic analysis are well documented (each gene included is backed by at least three independent studies); recommendations on nutrition, micronutrients and lifestyle derived from them are logical conclusions, not scientifically proven. Regulations can change; errors and changes excepted.