In the Swiss legal landscape, December 1, 2022 marked a significant milestone in the regulation of medical and non-medical tests providing genetic information.

The implementation of a revised version of the Federal Act on Human Genetic Analysis (LAGH) has garnered attention and raised crucial questions regarding privacy protection and ethics in the field of DNA testing.

DNA test in Switzerland

The main objective of this law is to protect human dignity and ensure the quality of human genetic and prenatal analyses. The law applies to both medical and non-medical genetic analyses, as well as those related to employment, insurance, and civil liability.

Key Principles:

It is prohibited to discriminate against a person based on their genetic heritage.
The free and informed consent of the individual concerned is required for any genetic or prenatal analysis.
The individual concerned must be properly informed about the details of the analysis.
Genetic samples and data must be protected against unauthorized use.
Storage periods are regulated, and use for other purposes requires explicit consent from the individual concerned.
Advertisement for certain analyses is prohibited.
Genetic analyses must adhere to scientific and technical advancements.

Purpose and Scope of the DNA Testing Law

The country has committed to maintaining a balanced approach in regulating DNA tests, whether they are related to medical diagnoses or the search for ancestral roots. Faced with an unprecedented proliferation of these tests, Switzerland felt the urgent need to adapt its legislation to prevent potential abuses and ensure the protection of its citizens' personal data.

In this context, it is imperative to delve into the details of this new Swiss law on DNA tests, understand its implications for citizens, and discuss the ethical and societal issues that accompany it.

Authorization for Conducting Analyses in Specific Cases

Genetic analyses on individuals lacking capacity for discernment are permitted in certain circumstances, primarily for health reasons or family benefit.
Prenatal analyses are permitted for health reasons or blood compatibility, with restrictions.
Genetic analyses on deceased individuals, embryos, fetuses, or stillborn children are allowed in certain circumstances, notably for detecting hereditary diseases, with appropriate consent.

Genetic Analyses in the Medical Field

Genetic and prenatal analyses in the medical field encompass genetic diagnostics, pre-symptomatic analyses, prenatal analyses to assess risks, analyses related to family planning, and other analyses for medical purposes, including evaluating the effects of therapy.

Only authorized medical professionals, such as doctors, can prescribe genetic analyses in the medical field.

Genetic counseling is mandatory before and after a genetic analysis. Information to be provided includes medical consequences, costs, possible measures, and rights related to the analysis.

Anyone conducting genetic analyses in the medical field must obtain authorization from the Federal Office of Public Health (OFSP), subject to specific conditions of professional qualifications and quality.

Medical Genetic Tests

Medical genetic tests could previously only be prescribed by doctors. Now, some of them may also be prescribed by dentists, pharmacists, and chiropractors within their respective areas of expertise, for example, to detect a medication intolerance. Additionally, medical genetic laboratories must now be accredited.

Genetic Analyses Outside the Medical Field

Genetic analyses conducted outside the medical field must still adhere to data protection and individual rights, as well as verify the qualifications of healthcare professionals and the quality of genetic analyses.

Genetic analyses outside the medical field are categorized into two groups:

Analyses aimed at determining sensitive personality characteristics.
Other genetic analyses that serve neither medical purposes nor the determination of sensitive characteristics.

In the case of genetic analysis outside the medical field, the individual concerned must be informed about the laboratory conducting the genetic analysis and the companies processing genetic data.

Only results relevant to the purpose of the analysis can be communicated to the individual.

Non-Medical Genetic Tests

For non-medical genetic tests, the law distinguishes two categories.

The first includes analyses requiring protection of personality, such as lifestyle tests, dietary behavior, sports abilities, ethnic origin, or other sensitive characteristics. These tests must be prescribed by a healthcare professional, and laboratories conducting these analyses must be authorized.

Additional Provisions for Genetic Analyses Aimed at Determining Sensitive Characteristics:

Genetic analyses intended to determine sensitive characteristics can only be prescribed by an authorized healthcare professional.

The sample collection must take place in the presence of the healthcare professional who prescribed the

analysis.

The provisions of the law regarding the conduct of genetic analyses abroad apply by analogy in the context of genetic analyses outside the medical field.

Sensitive Information:

The regulation of genetic tests varies depending on the sensitivity of genetic information. Some information is more sensitive than others and requires stricter protection against misuse.

Tests conducted on individuals lacking capacity for discernment, such as infants, are subject to stringent rules.

The strictest requirements apply to medical genetic analyses and the establishment of DNA profiles.

Employers, insurance institutions, and cases of civil liability are not permitted to require genetic analyses outside the medical field. They also cannot request or use genetically relevant data that is not medically pertinent.

Genetic analyses related to employment can only be conducted for the purpose of determining characteristics relevant to the job position.

The physician communicates the analysis results to the individual concerned and can only inform the employer whether the person is fit or unfit for the envisioned position.

No presymptomatic genetic analyses are allowed in connection with employment, except for preventive genetic analyses related to the prevention of occupational diseases or accidents.

Insurance institutions cannot demand genetic analyses.

It is prohibited to conduct genetic analyses for family planning purposes in cases involving civil liability unless they help establish a claim or seek damages.

Mandatory Consent:

A fundamental rule for all genetic tests is that the individual concerned must give their consent. No analysis can be performed on a third party without their consent.

Medically necessary tests can be conducted on individuals lacking capacity for discernment, such as infants.

Genetic Analyses in the Context of Employment, Insurance, and Civil Liability

DNA Profiles of Deceased Individuals:
When the person whose parentage needs to be determined has passed away, the analysis can be authorized under certain conditions, especially with the consent of close relatives.

In Civil Proceedings: In a civil proceeding, establishing a DNA profile can only be done by order of the judge or with the written consent of the individual concerned.

In Administrative Proceedings:
In an administrative proceeding, the competent authority can demand a DNA profile to establish the parentage or identity of an individual, but this requires the written consent of the individual concerned.

General Provisions on DNA Profiles Outside Legal Procedures:
Outside any legal procedure, a DNA profile can only be established with the written consent of the individual concerned. An incapacitated child whose parentage needs to be determined can only be represented in the context of examining that parentage.

Prenatal DNA Profiles to Determine Paternity:
Establishing a prenatal DNA profile to determine paternity can only be prescribed by a doctor after a thorough interview with the pregnant woman, covering various aspects related to pregnancy. The sex of the embryo or fetus can only be disclosed to the pregnant woman under certain conditions and within specific timeframes.

Paternity Tests:
Paternity tests are subject to strict rules. The person undergoing the test must prove their identity and give consent. Laboratories conducting these tests must also be accredited.

Prenatal Diagnosis:
The law also regulates prenatal diagnostics, which include all analyses conducted on unborn children. Only health tests are allowed before birth, and the sex of the child can only be determined if necessary for diagnosing a disease. Parents can only be informed of the child's sex after the end of the 12th week of pregnancy.

DNA Profiles to Determine Parentage or Identity of an Individual

Offenses: Individuals who intentionally:

Prescribe, commission, or conduct a genetic analysis or establish a DNA profile without the consent required by law are liable to imprisonment for up to three years or fines.
Communicate information about the genetic heritage of a person without their consent.
Prescribe or commission a genetic analysis unnecessary for health protection or not meeting specified legal conditions.
Demand genetic analyses outside the medical field in the context of employment or insurance, or request or use genetically irrelevant data.
Demand or prescribe presymptomatic genetic analyses in violation of legal conditions.
Demand prenatal genetic analyses, for family planning, or in the context of insurance.

Professionals intentionally acting without adhering to legal requirements regarding the destruction of genetic samples or data after two years are also liable to penalties.

Misdemeanors: Fines are imposed for those who intentionally:

Violate advertising rules or provide false information in advertising concerning genetic analyses.
Disclose the sex of the embryo or fetus before the twelfth week of pregnancy, in violation of the law.
Conduct a genetic analysis of a third party without authorization.
Establish a DNA profile of a third party without required recognition.

Criminal Provisions for Offenses Related to Genetic Analyses and DNA Profiles

Paternity test in Switzerland

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