Federal Act on Human Genetic Testing (HGTA) (HGTA)

By Steph2
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In The Matter OfFederal Act on Human Genetic Testing (HGTA) (HGTA)
Exhibit A
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English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

Section 1 Purpose, Subject Matter, Scope and Defin

Art. 1 Purpose and subject matter

1 This Act aims, in connection with genetic and prenatal testing on humans: a. to protect human dignity and privacy; b. to prevent the abuse of genetic testing and of genetic data; c. to ensure the quality of genetic tests and the way their results are interpreted. 2 It stipulates the conditions under which human genetic and prenatal testing may be performed: a. in a medical context; b. in a non-medical context; c. in employment and insurance matters and in civil liability cases; d. for the creation of DNA profiles for the purpose of determining the filiation or identity of an individual.

Art. 2 Limitations of the scope and relationship to other legislation

1 Articles 3–15, 27, 33 and 56–58 apply to genetic testing to determine characteristics of the genetic material which are not transmitted to descendants. After consulting the Federal Commission for Human Genetic Testing in accordance with Article 54 («the Commission»), the Federal Council may: a. exclude such tests from the scope of this Act, if when performed in a medical context, they provide no surplus information on characteristics which are transmitted to descendants; b. specify alternative arrangements for providing information in accordance with Article 6; c. declare further provisions applicable, in particular for the right to prescribe genetic tests and for authorisation obligations. 2 Genetic tests for typing blood groups or blood or tissue characteristics which are performed in connection with blood transfusions and the transplantation of organs, tissue and cells fall under Articles 3–12, 16 paragraph 2 letter b, 17 paragraphs 1 letters b and c, 2 letter b and 3 and Articles

Para. 1 let. a — Amended by Annex No 3 of the FA of 29 Sept. 2023, in force since 1 Aug. 2025 (AS 2025 421; BBl 2023 721). Para. 2 — Amended by Annex No 3 of the FA of 29 Sept. 2023, in force since 1 Aug. 2025 (AS 2025 421; BBl 2023 721). Para. 3 — SR 363 Para. 4 — SR 810.30

Art. 3 Definitions

In this Act: a. genetic tests means cytogenetic and molecular genetic tests to determine characteristics of human genetic material, and all other laboratory tests whose immediate purpose is to provide such information about human genetic material; b. cytogenetic tests means tests to determine the number and structure of chromosomes; c. molecular genetic tests means tests to determine the molecular structure of deoxyribonucleic acid (DNA), ribonucleic acid and the immediate gene product; d. diagnostic genetic tests means genetic tests to determine those characteristics of human genetic material which are responsible for existing clinical symptoms; e. presymptomatic genetic tests means genetic tests to determine a predisposition to disease before clinical symptoms emerge; f. prenatal tests means prenatal genetic testing and prenatal risk assessment; g. prenatal genetic tests means genetic tests during pregnancy to determine characteristics of the genetic material of the embryo or foetus;

Section 2 Principles

Art. 4 Non-discrimination

No one may be discriminated against on grounds of his or her genetic material.

Art. 5 Consent

1 Genetic and prenatal tests may only be performed when the person concerned has been provided with adequate information about the testing and has freely and expressly consented. 2 The person concerned may withdraw his or her consent at any time. 3 If the person concerned is incapable of judgement, then the consent is required from his or her legal representative. 4 Persons incapable of judgement are to be included as far as possible in the information, counselling and consent procedures.

Art. 6 Information with regard to genetic tests

In particular, the person concerned must be provided with information on the following in a comprehensible form: a. the purpose, nature and informative value of the test; b. risks and physical or psychological stress which are associated with the test; c. how the sample and the genetic data are handled during and after testing, in particular with regard to quality assurance and storage; d. the possibility that surplus information may be obtained; e. the cases in which surplus information must not be communicated (Art. 17 para 2, 27 and 33); f. the possible significance of the test result for family members and their right not to know; g. their rights, particularly concerning consent, information and not knowing.

Art. 7 Right to receive information

1 The person concerned is entitled to receive the information that results from a genetic or prenatal test. 2 The information resulting from a genetic or prenatal test shall not be disclosed to any other person unless the person concerned has given his or her consent.

Art. 8 Right not to know

A person is entitled to refuse to be informed in whole or in part of information on their genetic material.

Art. 9 Avoidance of surplus information

When performing genetic tests, the generation of surplus information must be avoided as far as possible.

Art. 10 Protection of samples and genetic data

1 Anyone who handles samples or processes genetic data must protect them by taking suitable technical and organisational measures against unauthorised handling and processing. The Federal Council may define the requirements, particularly concerning storage. 2 The processing of genetic data is otherwise governed by the federal and cantonal data protection provisions.

Art. 11 Duration of storage of samples and genetic data

1 Samples and genetic data may be stored only as long as is necessary for: a. performing the test, including quality assurance; b. use for another purpose; c. fulfilling cantonal regulations, in particular concerning the management of patient dossiers. 2 For testing in accordance with Article 31 paragraph 2, the samples and data shall be destroyed two years at the latest after the testing, unless the person concerned has consented to their use for another purpose or has not objected to anonymisation.

Art. 12 Use of samples and genetic data for another purpose

1 Samples and genetic data may be used in unencrypted or encrypted form only for another purpose when the person concerned, after receiving sufficient information, has freely and expressly consented. 2 They may be used in anonymised form for another purpose when the person concerned has been informed in advance and has not objected to anonymisation.

Art. 13 Genetic tests for self-testing

Ready-to-use genetic tests that are intended by the manufacturer for use by the person concerned may be supplied only for genetic tests in accordance with Article 31 paragraph 2.

Art. 14 Advertising to the public

1 Advertising to the public for the following genetic testing is prohibited: a. genetic testing in a medical context; b. prenatal genetic testing and genetic testing for persons incapable of judgement. 2 This ban does not apply to persons who, in accordance with Article 20, are authorised to prescribe the tests specified in paragraph 1. 3 Advertising to the public for the genetic tests specified in Article 31 must indicate the requirements of this Act for their prescription, for providing information, and for disclosing the results, as well as on the ban on their use in the context of prenatal tests and on persons incapable of judgement. Misleading information is prohibited.

Art. 15 State of the art in science and technology

Genetic and prenatal tests shall be performed according to the state of the art of science and technology.

Section 3 Permissibility of Testing in Specific Ca

Art. 16 Genetic testing on persons incapable of judgement

1 Genetic testing on persons incapable of judgement may only be performed when testing is necessary to protect their health. 2 In derogation from paragraph 1, a genetic test may be performed when the risk and stress for the person incapable of judgement are insignificant, the person concerned does not recognisably object to the test verbally or through their behaviour and when: a. a serious genetic disorder in the family or related carrier status cannot be determined in any other way and the result of the test is either of great benefit for the health of the family members or provides essential information for family planning; or b. the test is required in connection with a transplant or transfusion permitted under the Transplantation Act of 8 October 2004 or the Therapeutic Products Act of 15 December 2000.

Para. 2 let. b — Amended by Annex No 3 of the FA of 29 Sept. 2023, in force since 1 Aug. 2025 (AS 2025 421; BBl 2023 721). Para. 2 let. b — SR 810.21 Para. 2 let. b — SR 812.21

Art. 17 Prenatal testing

1 Prenatal testing may only be performed in order to: a. determine characteristics that directly impair the health of the embryo or the foetus; b. determine blood groups or characteristics of the blood in order to prevent complications that stem from a pertinent incompatibility between mother and foetus or to be able to treat the consequences of the complications; or c. determine whether the umbilical cord blood of the embryo or foetus is suitable, on the basis of its tissue characteristics, for transplantation into a parent or a sibling. 2 Prior to the end of the twelfth week from the beginning of her last period, a pregnant woman may not be informed of the following: a. the gender of the embryo or foetus in a test under paragraph 1 letter a, unless an impairment to health is linked to the gender; b. the result of a test under paragraph 1 letter c. 3 Moreover, the foregoing information may not be provided after the end of the twelfth week if the physician considers that there is a ris

Art. 18 Genetic tests involving deceased persons, embryos or foetuses from induced abortions, from spontaneous abortions or stillbirths

1 Genetic tests may only be performed on a deceased person if: a. they are needed to determine a genetic disorder or related carrier status; b. this is requested by a relative of the deceased person; c. the tested characteristic concerns the health or the family planning of the relative; and d. the characteristic in question cannot be determined in any other way. 2 Genetic tests involving embryos or foetuses from induced abortions and from spontaneous abortions or stillbirths may only be performed with the consent of the woman concerned. 3 Genetic tests involving deceased persons, embryos or foetuses from induced abortions and from spontaneous abortions or stillbirths may also be performed when a postmortem is permitted under federal or cantonal law, and the genetic test serves to determine the cause of death.