Pharmacogenetics guide

Law: who may offer pharmacogenetics? Germany, Austria and Switzerland compared

Reviewed by Dr. Daniel Wallerstorfer, molecular biologist and founder of Novogenia · Updated: 13 October 2026 · Reading time: 11 min

In short

In Germany, pharmacogenetics is a diagnostic genetic examination (Section 3 No. 7(c) GenDG): only physicians perform it, with information and written consent. In Austria, the Gene Technology Act does not require a medical specialist to order purely pharmacogenetic analyses; according to the Gentechnikbuch, they are not predictive analyses under Section 65(1) Nos. 3 and 4 GTG. Switzerland places pharmacogenetics in the medical context but, besides physicians, also lets pharmacists and – within their field – dentists and chiropractors order it, each under conditions (Arts. 5–8 GUMV). In all three countries, decisions about medication are made by the treating physician.

When the medicine is the trigger: why pharmacogenetics challenges the law

On 4 December 2009, the Austrian Gene Technology Commission put a remarkable idea on record: in pharmacogenetics, the trigger is not the gene but the medicine. A variant that slows an enzyme makes no one ill on its own – only a specific drug at an unsuitable dose can cause problems. The Commission’s example: a heart attack in clopidogrel resistance, because the body does not adequately activate the prodrug clopidogrel (Gentechnikbuch, chapter 5).

Is pharmacogenetics diagnostics, then? Here the laws part ways. Picture a door with a lock. In Germany, only the physician holds the key. In Switzerland, a whole key ring hangs on the hook: for physicians, pharmacists, dentists and chiropractors, each with conditions. In Austria, the Gene Technology Act leaves the door to purely pharmacogenetic testing unlocked. One thing is the same in all three countries: decisions about medication are made by the treating physician. This article gives orientation, not legal advice for your individual case.

Germany: pharmacogenetics is diagnostics – with a physician reservation

The Genetic Diagnostics Act (Gendiagnostikgesetz, GenDG) leaves no doubt. Under Section 3 No. 7(c) GenDG, a diagnostic genetic examination includes an examination that aims to clarify whether genetic traits are present that can influence the effect of a medicinal product. Pharmacogenetics is written into the law – as diagnostics. Clear obligations follow:

Physician reservation: Only physicians may perform diagnostic genetic examinations (Section 7(1) GenDG). A specialist qualification in human genetics is required only for predictive examinations.
Lab on assignment: The lab analyzes the sample only on behalf of the responsible physician (Section 7(2)) and only if it has proof of consent (Section 8(1)).
Consent: explicit and in writing, given to the responsible physician. It also covers whether the result is disclosed or destroyed (Section 8(1)).
Information beforehand: purpose, type, scope and informative value, with adequate time to reflect (Section 9).
Counseling afterward: Once the result is in, the responsible physician should offer genetic counseling (Section 10(1)).
Result via the physician: The lab discloses the result only to the commissioning physician (Section 11(2)), who discloses it to the person examined (Section 11(1)).

For pharmacies: A pharmacogenetic examination under their own responsibility is not possible in Germany, but pharmacists can work with the responsible physician. More in Pharmacogenetics in the pharmacy and Pharmacogenetics in medical practice.

Austria: purely pharmacogenetic testing fits none of the four drawers

The Austrian Gene Technology Act (Gentechnikgesetz, GTG) sorts genetic analyses in humans for medical purposes into four types (Section 65(1) GTG). The strict obligations depend on the type:

Type	What it is for (Section 65(1))	What else applies
Type 1	Determining an existing disease, preparing a therapy or monitoring its course – based on acquired (somatic) changes	no obligations under Sections 68 and 69
Type 2	Determining an existing disease based on a germline mutation	specialist information and counseling, consent confirmed in writing (Section 69)
Type 3	Determining a predisposition to a disease or carrier status where prophylaxis or therapy is possible	only in approved facilities and when ordered by a specialist (Section 68(1)), plus Section 69
Type 4	like type 3, but with no possible prophylaxis or therapy	like type 3

Purely pharmacogenetic testing fits none of these drawers: it looks at inherited genes, not acquired changes, and determines neither a disease nor a predisposition. The Gene Technology Commission sees it the same way in the Gentechnikbuch (chapter 5): pharmacogenetic examinations are generally not to be regarded as predictive analyses within the meaning of Section 65(1) Nos. 3 and 4 GTG. Adverse reactions triggered by a medicine are not diseases within the meaning of the GTG.

In practice: For purely pharmacogenetic analyses, the GTG requires neither a specialist order (Section 68(1)) nor specialist information with written confirmation (Section 69). As a principle for genetic analyses for medical purposes, Section 65(1) names the state of science and technology.

Watch out for genes with a double role: If a trait also allows statements about the predisposition to a future hereditary disease, its examination is subject to the rules for predictive analyses, the Gentechnikbuch notes. A 2024 expert opinion for the health ministry (“Neue Entwicklungen bei der Anwendung genetischer Analysen”) gives examples: a pharmacogenetic analysis of the G6PD gene is at the same time an analysis for hereditary G6PD deficiency. And a pharmacogenetically relevant loss-of-function variant in DPYD also means carrier status for hereditary dihydropyrimidine dehydrogenase deficiency. For a panel, this means: check every gene individually.

What could change: The same opinion finds purely pharmacogenetic testing not adequately covered by the GTG. It proposes treating it like type 1 – without specific information and written documentation of consent – and letting every physician who needs the information for therapy order it. This has not been adopted: Sections 65, 68 and 69 GTG are unchanged in the version in force.

And medication? In Austria, prescribing remedies (Heilmittel) is part of practicing medicine (Section 2(2) No. 7 Physicians Act 1998), and independent medical practice is reserved for physicians (Section 3(1)). Anyone offering a pharmacogenetic analysis without a medical license therefore does not recommend stopping, switching or re-dosing a drug, but refers to the treating physician.

Switzerland: medical – but with a whole key ring

Switzerland regulates genetic testing in the Federal Act on Human Genetic Testing (GUMG) and the Ordinance on Human Genetic Testing (GUMV). Pharmacogenetics is clearly medical: Art. 19 GUMG expressly includes tests “to determine the effects of a possible therapy.” The GUMV defines pharmacogenetic tests as genetic tests of characteristics that influence the effect of medicinal products (Art. 2(a)).

As a rule, physicians with a federal qualification in the relevant specialty or in human genetics order tests (“prescribe” in the official translation; Art. 20(1) GUMG). For tests without particular requirements, the Federal Council may widen the circle (Art. 20(3)) – and for pharmacogenetics, it has:

Who may order	What the GUMV allows	Special features
Physicians, even without a specialist qualification in the field	pharmacogenetic tests (Art. 5(1)(a))	conditions of Art. 5(2)
Dentists	pharmacogenetic tests in dentistry (Art. 6)	the dentist discloses the result
Pharmacists	pharmacogenetic tests (Art. 7)	prior consultation with the prescribing professional for prescription-only medicines; separate consultation area
Chiropractors	pharmacogenetic tests in chiropractic (Art. 8)	the chiropractor discloses the result

All of them must be authorized to practice under their own professional responsibility, and three conditions apply to all (Art. 5(2) GUMV): a specific selection of genetic variants is tested, results of known clinical significance are expected, and preventive or therapeutic measures are available according to current science and practice.

The general rules apply too: free and express consent after adequate information (Arts. 5 and 6 GUMG); the result is communicated by a physician or a specialist the physician authorizes (Art. 26(1)). If a pharmacy orders the test, the pharmacist discloses the result personally – only what relates to its purpose (Art. 7(4) GUMV).

What Switzerland does differently from Germany, Austria and the EU

More professions than in Germany: There, only the physician performs the examination (Section 7 GenDG); in Switzerland, pharmacists, dentists and chiropractors may order tests too.
A defined circle instead of an open door: The GTG names no authorized group for purely pharmacogenetic testing. In Switzerland, only the professionals listed in Art. 20 GUMG and Arts. 5 to 8 GUMV may order; everyone else needs such a professional.
No self-tests: Ready-to-use genetic tests for self-testing may only be supplied for “other” tests outside the medical context (Art. 13 with Art. 31(2) GUMG). Pharmacogenetics is not one of them.
Advertising with limits: Public advertising for medical genetic tests is banned, except by persons authorized to order them – and theirs must be objective (Art. 14 GUMG, Art. 4(1) GUMV).
Lab abroad: Prescribing physicians and laboratories may delegate testing to a lab abroad that works to the state of the art, has a quality management system and is authorized in its own country, if the person has consented in writing (Art. 29 GUMG). Clarify your samples’ route to the lab in advance.

Three countries at a glance

Question	Germany	Austria	Switzerland
Classification	diagnostic genetic examination (Section 3 No. 7(c) GenDG)	per the Gentechnikbuch, not a predictive analysis under Section 65(1) Nos. 3 and 4 GTG	medical context (Art. 19 GUMG)
Who orders	physicians only (Section 7(1))	no specialist order required (Section 68 covers types 3 and 4)	physicians, pharmacists, dentists and chiropractors under conditions (Arts. 5–8 GUMV)
Before the analysis	information from the physician, written consent (Sections 8, 9)	Section 69 covers types 2 to 4, not purely pharmacogenetic testing	information, free and express consent (Arts. 5, 6 GUMG)
Role of the pharmacy	cooperation with the responsible physician	GTG requires no medical order for purely pharmacogenetic testing; medication stays with the physician (Physicians Act)	may order; prior consultation for prescription-only medicines (Art. 7 GUMV)

And the EU? The test itself is a medical device

In the EU, a test that the manufacturer intends to provide information to predict treatment response or reactions, or to define or monitor therapeutic measures, is an in vitro diagnostic medical device under Regulation (EU) 2017/746 (Art. 2(2)(e) and (f)). When a genetic test is used in healthcare to improve treatment, member states ensure that the person tested receives relevant information on the nature, significance and implications of the test (Art. 4(1)). Stricter national rules such as the GenDG remain possible (Art. 4(4)).

One rule applies everywhere: medication stays in the physician’s hands

Three countries, three routes – one person at the finish line. A pharmacogenetic result can support a treatment decision. The decision itself – stopping, switching, changing the dose – is made by the treating physician. Switzerland even writes this into its ordinance: if a pharmacy tests the effect of a prescription-only medicine prescribed by another professional, it consults that professional beforehand (Art. 7(2) GUMV). How to explain results clearly is covered in Understanding and communicating results.

Checklist: before you offer pharmacogenetics

Germany: a physician performs the examination, provides the information, obtains written consent and receives the result.
Austria: you check every gene in the panel to see whether it also says something about a hereditary disease or carrier status – if so, the rules for predictive analyses apply.
Switzerland: you are one of the professionals authorized to order tests under Arts. 5 to 8 GUMV, and the conditions of Art. 5(2) are met.
Swiss pharmacy: prior consultation for prescription-only medicines, separate consultation area.
Every change to medication goes through the treating physician.
Consent and data protection are in place – more in Data protection and consent.

How we do it at Novogenia

How we classify pharmacogenetics:

Our own lab in Austria: We analyze every saliva sample in our lab in Eugendorf near Salzburg. We hold the Austrian license for medical genetic analyses, are CLIA-certified and work according to ISO 15189.
Part of our medical spectrum: Pharmacogenetics belongs to our Therapy area – pharmacogenetics & therapy optimization.
The right route for each country: Where national law requires it, we provide medical analyses only through the professionals authorized to order them – in Germany, through physicians. In Austria, all our partners can offer purely pharmacogenetic analyses.
Two kinds of sample kits: as a medical device for medical analyses and as a non-medical device for lifestyle analyses.
Medication stays with the physician: Any change to medication is made only by the treating physician.

Frequently asked questions

Can a pharmacy in Germany offer a pharmacogenetic test?

Not under its own responsibility. Under Section 3 No. 7(c) GenDG, pharmacogenetics is a diagnostic genetic examination, and only physicians may perform those (Section 7(1)). The responsible physician provides the information, obtains written consent and receives the result from the lab (Sections 8, 9 and 11(2)). A pharmacy can work with that physician, for example in a medication review.

Does a purely pharmacogenetic analysis in Austria need a physician's referral?

The Gene Technology Act requires a medical specialist to order an analysis only for types 3 and 4 (Section 68(1) GTG), and specialist information with written confirmation only for types 2 to 4 (Section 69). According to the Gentechnikbuch (chapter 5), pharmacogenetic examinations are not predictive analyses under Section 65(1) Nos. 3 and 4 – unless a trait also says something about the predisposition to a future hereditary disease. Decisions about medication are still always made by the treating physician.

May pharmacists in Switzerland order pharmacogenetic tests?

Yes, if they are authorized to practice under their own professional responsibility and the conditions of Art. 5(2) GUMV are met (Art. 7 GUMV). If the test concerns a prescription-only medicine prescribed by another professional, they consult that professional beforehand. Information and disclosure of the result take place in a separate consultation area, and only results relating to the purpose of the test are disclosed.

Is a pharmacogenetic test a medical device?

In the EU, yes, if the manufacturer intends it to provide information to predict treatment response or reactions, or to define or monitor therapeutic measures. It is then an in vitro diagnostic medical device under Art. 2(2) of Regulation (EU) 2017/746. Ask your lab how it classifies its tests.

May I advertise pharmacogenetics to the public in Switzerland?

Advertising to the public for genetic testing in a medical context is prohibited (Art. 14(1) GUMG). The ban does not apply to persons authorized to order such tests under Art. 20 GUMG (Art. 14(2)). Their advertising must be objective, meet a public need and be neither misleading nor intrusive (Art. 4(1) GUMV). Information addressed exclusively to professionals authorized to order tests does not count as advertising to the public (Art. 4(4) GUMV).

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Note: 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. Pharmacogenetic results do not replace a medical decision: any change to medication is made only by the treating physician. Regulations can change; errors and changes excepted.