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Selling genetic tests online: Germany, Austria and Switzerland
In an online shop, the purpose of a genetic analysis decides which rules apply. You can sell lifestyle analyses on nutrition, sport or well-being online in Germany and Austria as long as they serve no medical purpose (Section 2(1) GenDG; Section 4 No. 23 GTG). Medical analyses go through physicians wherever the law requires it (Section 7 GenDG; Section 68 GTG). Switzerland also regulates lifestyle analyses: only certain health professionals order them, the sample is collected in their presence, home tests are ruled out, and the written information names the lab (Arts. 13, 32 and 34 GUMG). Mailing a saliva kit to a customer in Switzerland is therefore not an option for these analyses.
One kit, three countries – and one switch
Picture your shop selling an analysis on nutrition and sport. One customer orders from Munich, one from Linz, one from Zurich. The saliva kit is the same, and so is the lab. Yet only two parcels go out: mailing a kit to a customer in Switzerland is not an option for these analyses.
The reason is a railroad switch that sits in the same place in all three countries: the purpose of the analysis. The same saliva sample can run on the “lifestyle” track or the “medical” track – depending on the question the analysis is meant to answer and how the report describes the result. Germany and Austria mainly regulate the medical track; Switzerland regulates both. Here is what that means for your online shop. The full legal picture for your own genetic-test brand is in Law: offering genetic tests under your own brand. This article is orientation, not legal advice for your specific case.
The first question: lifestyle or medical?
Before a genetic test goes into your shop, you classify it. At Novogenia, the line is clear: partners offer only non-medical analyses – lifestyle, nutrition, beauty and sport. Medical genetic analyses are only available through physicians (lab and partner rules). For your shop, that means:
- In the range: analyses that show how your body handles nutrients, exercise, stress or skin care.
- Not in the range: analyses of disease risks, diagnoses or drug effects.
- Words count too: Product copy that turns a nutrition question into a disease risk moves the analysis onto the medical track.
Germany: the GenDG governs the medical side
The Genetic Diagnostics Act (Gendiagnostikgesetz, GenDG) applies to genetic examinations for medical purposes, for clarifying parentage, and in insurance and employment (Section 2(1)). A power-versus-endurance analysis is not listed. There is one boundary you should know: clarifying whether genetic traits are present that can trigger a disease or health disorder together with certain external factors also counts as diagnostic (Section 3 No. 7(b)). Only physicians may perform diagnostic examinations; only specialists in human genetics or suitably qualified physicians may perform predictive ones (Section 7(1) GenDG).
For your shop, this means: describe lifestyle analyses as what they are – insights into how your body handles nutrition, exercise or skin care. Phrases like “risk of …” or “disorder” do not belong on the product page.
Austria: the GTG asks about disease
Under the Gene Technology Act (Gentechnikgesetz, GTG), a genetic analysis is a lab analysis that allows statements about carrier status, a disease risk, an existing disease or the course of a disease or therapy (Section 4 No. 23). Analyses that allow none of these statements fall outside this definition. For medical analyses, Section 65(1) distinguishes four types. Analyses of a predisposition to a disease or of carrier status (types 3 and 4) may only be performed in approved facilities and when ordered by a specialist (Section 68(1) GTG).
The consequence for your shop is the same as in Germany: lifestyle analyses stay lifestyle. As soon as a report or product copy makes statements about disease risks, you are in physician territory.
Switzerland: lifestyle analyses need a professional too
The Federal Act on Human Genetic Testing (GUMG) explicitly regulates testing outside medicine as well. Physiological characteristics which, if known, may influence a person’s lifestyle count as sensitive characteristics (Art. 31(1)(a) GUMG) – according to the GUMV ordinance, in particular eating behavior, physical activity and general well-being (Art. 37(1)). That is exactly where typical lifestyle analyses sit. For them:
- Only health professionals order them (Art. 34 GUMG, Art. 40 GUMV): physicians, pharmacists, psychologists, druggists HF and – for physiological characteristics – nutritionists FH, physiotherapists FH, chiropractors and osteopaths.
- Sample in their presence: The sample is collected in the presence of the person ordering the test (Art. 34(3) GUMG).
- No home tests: Self-tests may only be supplied for other tests (Art. 13 GUMG), such as hair color or sense of taste (Art. 37(3) GUMV).
- The lab is named: The written information names the performing lab, companies and labs abroad involved, and the contact details of a specialist for questions and of the person responsible for data processing (Art. 32 GUMG).
- Lab abroad: allowed, among other conditions, with the written consent of the person concerned (Art. 36 with Art. 29 GUMG).
- Advertising with mandatory information: Public advertising for these analyses must explain the rules on ordering, information and communication of results and must not mislead (Art. 14(3) GUMG). Advertising via electronic media explicitly counts (Art. 4(3) GUMV) – so your product page does too.
What counts as medical in Switzerland is spelled out: among others, analyses of food intolerances, metabolic disorders or an increased risk of sports injuries (Art. 37(2) GUMV). Physicians order these tests (Art. 20 GUMG), and advertising them to the public is prohibited (Art. 14(1) GUMG).
For your shop, this means: you do not mail lifestyle kits to consumers in Switzerland. A model in which, for example, pharmacists or druggists HF order the analysis and collect the sample in their presence, on the other hand, fits the structure of the law – more on the shelf model in Drugstores and supermarkets: test kits on the shelf.
Three countries in a shop comparison
| Question | Germany | Austria | Switzerland |
|---|---|---|---|
| Lifestyle analysis in an online shop | possible; not listed in the scope of the GenDG (Section 2(1)) | possible as long as it allows no statements under Section 4 No. 23 GTG | only via health professionals listed in Art. 40 GUMV |
| Kit mailed to the home | yes | yes | no, for lifestyle analyses (Art. 13, Art. 34(3) GUMG) |
| Medical analyses | physicians only (Section 7) | types 3 and 4: approved facility, ordered by a specialist (Section 68) | ordered by physicians (Art. 20) |
| Naming the lab | recipients in the privacy notice (Art. 13 GDPR) | recipients in the privacy notice (Art. 13 GDPR) | in the written information (Art. 32 GUMG) |
| Advertising | describe, don’t promise | describe, don’t promise | mandatory information (Art. 14(3) GUMG); no public advertising for medical tests |
What your shop needs for genetic tests
The rules translate into clear building blocks for your checkout. How the stations fit together in detail is shown in The customer journey: from kit to subscription.
- Describe the product honestly: The rule of thumb: describe what the analysis shows – don’t promise results. The result is a report, not a medical finding, and not a diagnosis (more in Advertising genetic tests and Marketing personalized products).
- Set your shipping countries: Lifestyle kits do not go to consumers in Switzerland.
- Plan for adults: At Novogenia, customers confirm that they are of legal age.
- Consent before the sample: Consent belongs before the sample, not after it. Before the sample, your customer registers and gives consent; how that works technically is something you set up with Novogenia.
- A kit that fits the purpose: For lifestyle analyses, kits come as a non-medical device; we clarify the classification at the start (more in Saliva kits: medical device or not?).
- Clear assignment: The unique label in the kit links the sample to exactly one person (more in Sample logistics).
- Settle withdrawal and data protection: The kit and the analysis follow their own withdrawal rules (Distance selling and withdrawal); genetic data are specially protected (Shop data protection).
Checklist: genetic tests in your online shop
- Every analysis is classified as lifestyle or medical – for every country you ship to.
- Your shop lists only non-medical analyses; medical ones go through physicians.
- Product copy describes what the analysis shows and makes no statements about disease risks.
- Shipping addresses in Switzerland are excluded for lifestyle kits.
- The checkout is designed for adults.
- Information and consent come before the sample and can be proven.
- The kit’s classification fits the purpose of the analysis.
- For Swiss offers via professionals: sample in their presence, written information under Art. 32 GUMG, mandatory information in advertising.
- When in doubt, ask a specialized lawyer or the competent authority.
Frequently asked questions
Do I need a physician to sell lifestyle genetic tests online in Germany?
Can I mail saliva kits to Switzerland?
Which topics count as medical in Switzerland?
Does my shop have to name the lab?
Can I sell genetic tests to minors?
Related: Law: offering genetic tests in DE, AT and CH · Advertising genetic tests · Shop data protection: health and genetic data
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Request a project →Offer for e-commerceNote: This guide is general information for businesses and 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 derived from them are logical conclusions, not scientifically proven. Regulations can change; errors and changes excepted.
