Federal Act on Human Genetic Testing (HGTA) (HGTA)
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 Scope
Art. 19
Genetic and prenatal tests in a medical context comprise diagnostic, presymptomatic and prenatal genetic tests, prenatal risk assessments, tests for family planning and additional genetic tests performed in a medical context, in particular to determine the effects of a possible therapy.
Section 2 Prescribing Tests, Counselling and Commu
Art. 20 Prescribing genetic tests
1 Genetic tests may only be prescribed by physicians who are authorised to practise under their own responsibility, and who: a. hold a federal qualification in the specialist field relevant to the test in question; o b. hold a specific qualification in the field of human genetics. 2 For genetic tests that have stricter requirements, particularly with regard to providing information, counselling or the interpretation of the results, the Federal Council, after consulting the Commission, may limit the right to prescribe to physicians who have a specific federal qualification or who have another specific qualification. 3 For genetic tests that do not set any particular requirements, the Federal Council, after consulting the Commission, may also grant the right to prescribe to the following persons: a. physicians who do not meet the requirements of paragraph 1; b. other specialists who are authorised to practise a medical, psychology or health profession under their own responsibility. 4 If
Art. 21 Genetic counselling in general
1 The prescribing physician shall ensure that the person concerned: a. is given the opportunity to receive counselling before and after a diagnostic genetic test; b. receives genetic counselling before and after a presymptomatic or prenatal genetic test or before and after a test for the purpose of family planning. 2 The counselling must be non-directive and be provided by a qualified person. Counselling must address only the individual and family situation of the person concerned; it may not take public interest into consideration. The counselling session must be documented. 3 In addition to the provision of information in terms of Article 6, the counselling must cover the following aspects in particular: a. the frequency and nature of the disorder being diagnosed; b. the medical, psychological and social effects related to testing or related to not undergoing testing; c. the cost of the test and of subsequent measures and the options for payment; d. the severity of the disorder which
Art. 22 Genetic counselling for prenatal genetic testing
1 A pregnant woman must be informed expressly about her right to self-determination in accordance with Articles 5, 7, 8 and 27 paragraph 1 both before and after a prenatal genetic test; in addition, she must be made aware of the existence of information and counselling centres in terms of Article 24. 2 The pregnant woman must be made aware beforehand if there is a high probability that there will be no therapeutic or prophylactic treatment available for the disorder to which the proposed test relates. 3 If, on receiving the test results, the pregnant woman is considering a termination of the pregnancy, she must be informed of the alternatives to termination and made aware of the existence of associations of parents of disabled children and self-help groups. 4 The pregnant woman's husband, wife or partner should be given the opportunity to be present when the genetic counselling is provided if possible.
Para. 4 — Amended by Annex No 3 of the FA of 29 Sept. 2023, in force since 1 Aug. 2025 (AS 2025 421; BBl 2023 721).
Art. 23 Provision of information in connection with prenatal risk assessments
Before a prenatal risk assessment is made, the pregnant woman must be informed of the following in particular: a. the purpose, nature and informative value of the test; b. the possibility of unexpected test results; c. the possible follow-up tests and procedures; d. the information and counselling centres in terms of Article 24; e. her rights, in particular concerning consent, the provision of information and her right not to know.
Art. 24 Information and counselling centres for prenatal testing
1 The cantons shall ensure that there are independent centres that provide information and counselling on prenatal testing. 2 The centres shall provide general information and counselling on prenatal testing and, if requested, provide contacts for associations of parents of disabled children or self-help groups. 3 The cantons may delegate their tasks in terms of paragraph 2 to the advisory centres in accordance with the Federal Act of 9 October 1981 on Pregnancy Advisory Centres.
Para. 3 — SR 857.5
Art. 25 Form of consent
Written consent must be given for presymptomatic and prenatal genetic testing and family planning testing.
Art. 26 Communication of the test results in general
1 The results of a genetic or prenatal test must be communicated to the person concerned by a physician or by a specialist authorised by the physician. 2 If the person concerned is incapable of judgement, the person’s legal representative may not refuse to be informed of the result of the test if knowledge of the result is necessary in order to protect the health of the person incapable of judgement. 3 If the communication of the results to family members or to other close persons is necessary to protect their interests, and in the absence of consent to this from the person concerned, then the physician may apply to the competent cantonal authority as specified in Article 321 paragraph 2 of the Swiss Criminal Code to be released from his or her duty of professional confidentiality. The authority may request an opinion from the Commission.
Para. 3 — SR 311.0
Art. 27 Communication of surplus information
1 The person concerned shall decide what surplus information he or she should receive. 2 If the person concerned is incapable of judgement, then the surplus information may only be disclosed to his or her legal representative if: a. this is necessary to protect the health of the person incapable of judgement, or b. the information concerns a serious genetic disorder in the family or to related carrier status. 3 Surplus information from prenatal genetic tests may only be disclosed if the information relates to: a. the direct impairment of the health of the embryo or foetus; or b. a serious genetic disorder in the family or related carrier status.
Section 3 Performing Genetic Testing
Art. 28 Authorisation
1 Any person who wishes to perform cytogenetic or molecular genetic tests in a medical context requires authorisation from the Federal Office for Public Health (FOPH). 2 The Federal Council, after consulting the Commission, may: a. make additional genetic tests or prenatal risk assessments subject to the authorisation requirement, if these tests or assessments must satisfy the same requirements as cytogenetic or molecular genetic tests with regard to quality assurance and the interpretation of results; b. waive the authorisation requirement for cytogenetic or molecular genetic tests that are not subject to special requirements with regard to their performance and the interpretation of the results; c. make individual steps in a process that are performed in facilities without authorisation in accordance with paragraph 1 subject to the authorisation requirement. 3 Authorisation shall be granted if: a. the required technical and operational criteria are met, and b. a suitable quality mana
Art. 29 Performing genetic testing abroad
Prescribing physicians and laboratories may delegate genetic testing, wholly or in part, to a laboratory abroad if: a. the laboratory guarantees the testing will be performed according to the state of the art in science and technology; b. the laboratory has a suitable quality management system; c. the laboratory is authorised in its country to perform such tests; and d. the person concerned has provided his or her written consent.
Section 4 Screening
Art. 30
1 Genetic testing that is systematically offered to the entire population or to specific groups of people, without there being any suspicion that the characteristics sought are present in the individuals tested (screening), may only be performed if a programme has been authorised by the FOPH. 2 The programme must show that: a. early treatment or prophylaxis is possible; b. the test method has been shown to produce reliable results; c. appropriate genetic counselling will be provided; and d. it is guaranteed that the screening is performed over a reasonable period of time. 3 It may provide that: a. the genetic testing may be prescribed by a health specialist who is not authorised in accordance with Article 20; b. the genetic counselling differs from the specifications of Article 21; c. consent in written form is not required. 4 Before the FOPH grants authorisation, it shall consult the Commission and, when necessary, the National Advisory Commission on Biomedical Ethics. 5 The Federal C