Switzerland Omics overview of federal law about genetic investigations in humans

Latest source version: https://lex.weblaw.ch/lex.php?norm_id=810.12&source=sr&lex_id=104375

Switzerland’s Federal Act on Human Genetic Testing (GUMG/LAGH) is built to protect dignity and privacy while ensuring genetic tests are high-quality and clinically sound [1,2]. It requires explicit, revocable consent and guarantees rights both to know and not to know results, while limiting “excess information” and placing strict guardrails on confidentiality, storage, and advertising [2].

In medicine, only qualified physicians may initiate testing, and non-directive genetic counselling is mandatory for presymptomatic, prenatal, and family-planning contexts [3]. Prenatal rules are especially strict—for example, fetal sex may not be disclosed before 12 weeks unless medically relevant [3]. Laboratories need FOPH authorisation, quality systems, and are subject to inspections; any large-scale population screening requires prior federal approval with a demonstrable pathway to patient benefit [3,4].

Outside medicine, results may only be reported for the stated purpose, with additional protections for sensitive traits such as personality or origin [5]. Employers cannot demand non-medical tests or irrelevant genetic data; presymptomatic testing is explicitly banned at work, with only narrow SUVA-approved exceptions for serious occupational safety risks where residual risk remains [6].

Insurers are tightly constrained. They cannot require presymptomatic, prenatal, or family-planning tests [7]. They also cannot use presymptomatic genetic data for social insurance, occupational pensions, wage-continuation, life ≤ CHF 400,000, or disability ≤ CHF 40,000/year [7]. For larger private policies above these thresholds, limited physician-gated use is possible only if tests are reliable, relevant, and known to the applicant; prenatal or family-planning data may never be used [7].

Liability law is similarly restrictive: genetic testing and data cannot be used for compensation/damages assessment, except when the person themselves uses results to claim genetic injury [8]. DNA profiling for ancestry or identification is handled under a separate, tightly controlled regime that explicitly excludes medically relevant traits [9]. Oversight comes from the independent Federal Commission for Genetic Testing, and enforcement includes penalties up to three years’ imprisonment or major fines [10,11].

Practically, the law reinforces that genetics must remain patient-centred and clinic-contained: basic health insurance is genetics-blind by design, and even supplementary insurance use is either banned or heavily constrained. Models where insurers subsidise access to clinical precision medicine but never access raw genomic data sit fully within the law and avoid indirect pressure to disclose [12].

Citations

English: Federal Act on Human Genetic Testing (GUMG/LAGH, SR 810.12). In force version as of 1 August 2025.Deutsch: Bundesgesetz über genetische Untersuchungen beim Menschen (GUMG, SR 810.12). Systematische Sammlung, Stand 1 August 2025.Official source: Fedlex (SR 810.12)

  1. Purpose & Scope — dignity, misuse prevention, quality; regulates genetic/prenatal testing in medicine, outside medicine, employment, insurance, liability, and DNA profiling (Art. 1–2).
  2. Principles — no genetic discrimination (Art. 4); explicit consent; rights to know/not know (Arts. 5, 7–8); minimise excess information; confidentiality, data protection, storage limits, secondary use (Arts. 6, 9–12); no public advertising (Art. 14); tests must meet science/tech standards (Art. 15).
  3. Medical Testing — initiation by qualified physicians (Art. 20); mandatory counselling for presymptomatic, prenatal, family-planning (Arts. 21–22); prenatal restrictions incl. sex disclosure ban < 12 weeks (Art. 17); results by physician/specialist, controlled disclosure to relatives (Art. 26); labs require FOPH permit, quality system, inspections; controlled outsourcing (Arts. 28–29).
  4. Population Screening — systemic programmes require FOPH-approved concept with benefit, reliability, counselling, durability (Art. 30).
  5. Outside Medical Field — results must match stated purpose; sensitive categories (lifestyle, personality, origin) protected; qualified initiators; FOPH lab permits (Arts. 31–36).
  6. Employment — no forced non-medical testing/irrelevant data (Art. 37); job-related exams only, employer sees fit/unfit (Art. 38); presymptomatic testing banned except SUVA-approved cases with proven risk (Arts. 39–41).
  7. Insurance — no presymptomatic/prenatal/family-planning requirements (Art. 42); bans presymptomatic data use for social insurances, pensions, wage-continuation, life ≤ CHF 400k, disability ≤ CHF 40k/year (Art. 43); above thresholds: limited physician-gated use (Art. 44); prenatal/family-planning data excluded (Art. 43(3)).
  8. Liability — prohibits presymptomatic/prenatal/family-planning testing/data for compensation except when initiated by claimant (Arts. 45–46).
  9. DNA Profiles — distinct ancestry/ID regime; excludes medical traits; strict consent, sampling, retention, court/authority rules (Arts. 47–53).
  10. Oversight — independent Federal Commission; Act mandates evaluation (Arts. 54–55).
  11. Enforcement — Cantonal prosecution; penalties up to 3 years imprisonment or fines; administrative fines for advertising/procedural breaches (Arts. 56–58).
  12. Practical Insurance Implications — LAMal is genetics-blind; GUMG blocks insurer access below thresholds; above thresholds, handling is narrow and physician-gated; subsidy models without insurer access comply (Arts. 42–44).
Consolidated version in force since 1 Aug 2025 (major revision active from 1 Dec 2022).
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