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Offering genetic tests in the pharmacy: what is allowed and how it works
Whether your pharmacy may offer a genetic test depends on the purpose of the analysis. You can offer lifestyle analyses on nutrition, weight, sport, stress and skin as a partner. Medical analyses belong in a physician’s hands wherever the law requires it – in Germany under Section 7 GenDG, in Austria for analyses of disease predispositions under Section 68 GTG. In Austria, pure pharmacogenetic analyses do not require a physician’s order. Switzerland also regulates lifestyle analyses: pharmacists are among the professions allowed to order them; the sample is taken in their presence, and home tests are not permitted for them.
Pharmacists are named in the law
Of all places, it is the strictest genetic testing law in the German-speaking world that names pharmacists explicitly. In Switzerland, genetic analyses on nutrition, sport and well-being may only be ordered by certain health professionals – and right after physicians, the list names pharmacists (Art. 40 GUMV). Germany and Austria do not mention lifestyle analyses explicitly in their laws at all; instead, they draw a clear line for medical analyses.
Picture your consultation counter with two doors. Through one – the lifestyle door – you walk with your customer yourself. The other – the medical door – leads to a physician. Which door is the right one is decided not by the lab technique but by the purpose of the analysis. This article shows where those doors are in Germany, Austria and Switzerland. It offers orientation but does not replace legal advice for your specific case.
Lifestyle or medical: the purpose decides
| Question | Lifestyle analysis | Medical analysis |
|---|---|---|
| What it clarifies | predispositions relevant to everyday life: how the body processes nutrients, responds to training or copes with stress | a disease, a disease risk or the effect of medications |
| Topics | nutrition, weight, sport and performance, stress, skin | for example, predispositions to cardiovascular disease or thrombosis |
| Who offers it | your pharmacy as a partner, within the rules of your country | wherever the law requires it, physicians only |
| Who interprets it | Novogenia | physicians |
| Sample kit | non-medical device | medical device |
Watch out for the gray zone: a nutrition question can quickly turn medical, for example when it comes to intolerances. In Switzerland, analyses on food intolerances are explicitly classed as medical (Art. 37(2) GUMV). So only offer analyses whose purpose and report you know.
Germany: physician reservation for medical purposes
The Gene Diagnostics Act (GenDG) applies to genetic examinations for medical purposes, for clarifying parentage, and in insurance and employment (Section 2(1)). An examination is medical if it is diagnostic or predictive (Section 3 No. 6). Diagnostic means, among other things, that it clarifies whether there are genetic traits that, together with external factors, can trigger a disease or health disorder (Section 3 No. 7(b)) or that can influence the effect of a medicinal product (point (c)).
These examinations are subject to the physician reservation: diagnostic examinations may only be performed by physicians, predictive ones only by specialists in human genetics or suitably qualified physicians (Section 7(1) GenDG). For your pharmacy, this means:
- Lifestyle analyses without a medical purpose are not listed in the scope of the GenDG. You can offer them as a partner.
- Pharmacogenetics is medical in Germany (Section 3 No. 7(c)) and therefore belongs in a physician’s hands.
- The line is drawn by purpose: if an analysis is meant to clarify whether a way of eating can trigger a health disorder, you are quickly in medical territory. What counts is what the analysis is meant to clarify and how the report describes the result.
Austria: four types in the Gene Technology Act
In Austria, the Gene Technology Act (GTG) governs genetic analyses in humans. A “genetic analysis” within the meaning of the act allows 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) distinguishes four types. The highest bar applies to types 3 and 4, which determine a predisposition to a disease: they may only be carried out in licensed facilities and only when ordered by a medical specialist (Section 68(1) GTG). For your pharmacy, this means:
- Lifestyle analyses do not fall under this definition as long as they do not allow any of the statements listed in Section 4 No. 23.
- Pharmacogenetics: Section 65 GTG does not list it as a separate type. Pure pharmacogenetic analyses that say nothing about a disease predisposition therefore do not require a physician’s order in Austria and may also be offered by partners. Decisions about medications still always rest with the treating physician. More in the Pharmacogenetics guide.
- Analyses of disease predispositions go through medical specialists.
Switzerland: a role of its own for pharmacies
Switzerland regulates genetic testing through the Federal Act on Human Genetic Testing (GUMG) and its ordinance (GUMV). Unlike Germany and Austria, it explicitly sets rules for analyses outside medicine as well. For analyses of physiological characteristics which, if known, may influence a person’s lifestyle (Art. 31(1)(a) GUMG) – according to Art. 37(1) GUMV, in particular eating behavior, physical activity and general well-being – the following applies:
- Who may order: only health professionals who are authorized to practice under their own professional responsibility and have acquired knowledge of human genetics in their education and training (Art. 34(1) GUMG). Art. 40 GUMV names, among others, physicians, pharmacists and druggists HF. They must work in the field the analysis belongs to (Art. 34(2) GUMG).
- Sample in their presence: The sample must be collected in the presence of the person ordering the test (Art. 34(3) GUMG). In other words, the saliva sample is taken at the consultation counter.
- No home tests: Self-tests may only be supplied for other tests, such as hair or eye color (Art. 13 GUMG, Art. 37(3) GUMV). A kit the customer uses alone at home is ruled out for lifestyle analyses.
- Some topics are always medical: Analyses that provide information on, in particular, food intolerances, metabolic disorders, an increased risk of sports injuries, or diseases, allergies and inflammation count as medical (Art. 37(2) GUMV) and are ordered by physicians (Art. 20 GUMG).
- Written information: It names the lab, any companies and labs abroad involved, and the contact details of a professional who can answer questions and of the person responsible for data processing (Art. 32 GUMG).
- Lab abroad: permitted if it works to the state of science and technology, has a suitable quality management system, is authorized in its own country, and the customer has consented in writing (Art. 36 in conjunction with Art. 29 GUMG).
- Only what fits the purpose: Only results that correspond to the purpose of the test may be communicated (Art. 33 GUMG).
And pharmacogenetics? In Switzerland, it is medical (Art. 19 GUMG). Under certain conditions, however, pharmacists may order pharmacogenetic tests themselves. If the test concerns a prescription-only medicine prescribed by another health professional, they consult that professional first; information and communication of results take place in a separate consultation area (Art. 7 GUMV).
What sets Switzerland apart: In Germany and Austria, almost everything hinges on one question: medical or not? Switzerland also asks who orders the analysis and how the sample reaches the lab. For pharmacies, this is more opportunity than obstacle: because home tests are ruled out for lifestyle analyses and the sample is taken in the presence of an authorized professional, your consultation counter is the natural place for it.
Three countries at a glance
| Question | Germany | Austria | Switzerland |
|---|---|---|---|
| Lifestyle analyses | not listed in the scope of the GenDG (Section 2); mind the line drawn by Section 3 No. 7 | not covered as long as they allow no statements under Section 4 No. 23 GTG | ordered by professionals under Art. 40 GUMV, including pharmacists |
| Medical analyses | physician reservation (Section 7 GenDG) | types 3 and 4: licensed facility, ordered by a specialist (Section 68 GTG) | ordered by physicians (Art. 20 GUMG) |
| Pharmacogenetics | diagnostic, so physician reservation (Section 3 No. 7(c)) | not listed as a type in Section 65 GTG; pure pharmacogenetics without a physician’s order | medical (Art. 19 GUMG); pharmacists under conditions (Art. 7 GUMV) |
| Sample and home test for lifestyle analyses | no specific rule in the GenDG | no specific rule in the GTG | sample in the professional’s presence (Art. 34(3) GUMG); no home tests (Art. 13 GUMG) |
Outside Germany, Austria and Switzerland, other rules apply – check them before you start. You will find the detailed country comparison in the nutrigenetics guide under Who may offer genetic tests?.
How a lifestyle analysis works in the pharmacy
- Choose the right analysis: What does your customer want to know? Nutrition, weight, sport, stress or skin.
- Inform and obtain consent: what the analysis shows and what it does not, who sees the report and how the data are protected. Record the consent in writing.
- Take the saliva sample: It takes just a few minutes and fits into a normal consultation. Sample kits for lifestyle analyses are non-medical devices, available in your design on request.
- Lab analysis: 4 days in the lab in Eugendorf near Salzburg, Austria, plus shipping.
- Report and consultation: The report arrives digitally via a secure portal, in up to 18 languages. Whether you see it is your decision – and your customer knows beforehand.
Every step in detail, through to product pickup, is described in The consultation process in the pharmacy. On data protection, read Genetic data and the GDPR.
When to refer to a physician
Good lifestyle advice knows its limits. Refer your customer onward if …
- they have symptoms or expect a diagnosis,
- they want to know whether they carry a predisposition to a disease,
- intolerances need to be clarified,
- the question is about stopping, switching or dosing medications – these decisions always rest with the treating physician,
- a pregnancy, an illness or an eating disorder is in the picture.
Novogenia keeps the two worlds clearly separate: Novogenia interprets lifestyle analyses itself; medical analyses are interpreted by physicians and, wherever national law requires it, offered only through them. How to advertise genetic tests correctly is covered in Advertising health services; the overall legal framework for your pharmacy is described in Law: what pharmacies must consider.
Frequently asked questions
May a pharmacy in Germany offer genetic tests?
May my pharmacy in Austria offer pharmacogenetic analyses?
Why are there no lifestyle genetic tests for home use in Switzerland?
How long does taking the saliva sample in the pharmacy take?
Does the pharmacy see its customers' reports?
Related: Who may offer genetic tests? · Pharmacogenetics guide · Novogenia’s laboratory
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Request a project →Offer for pharmaciesNote: 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.
