Federal Act
on Human Genetic Testing
(HGTA)

This Act aims, in connection with genetic and prenatal testing on humans:

1. to protect human dignity and privacy;

2. to prevent the abuse of genetic testing and of genetic data;

3. to ensure the quality of genetic tests and the way their results are interpreted.

It stipulates the conditions under which human genetic and prenatal testing may be performed:

1. in a medical context;

2. in a non-medical context;

3. in employment and insurance matters and in civil liability cases;

4. for the creation of DNA profiles for the purpose of determining the filiation or identity of an individual.

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:

1. ³exclude 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;

2. specify alternative arrangements for providing information in accordance with Article 6;

3. declare further provisions applicable, in particular for the right to prescribe genetic tests and for authorisation obligations.

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 27, 33 and 56–58. The Federal Council may, after consulting the Commission:⁴

1. stipulate that only Articles 16 paragraph 2 letter b and 17 paragraphs 1 letters b and c, 2 letter b and 3 apply, if when performing such tests no surplus information on characteristics which are transmitted to descendants;

2. specify alternative arrangements for providing information in accordance with Article 6;

3. declare that the provisions applicable to tests for typing blood groups or blood or tissue characteristics also apply to genetic tests in the context of aftercare of a transplantation.

When creating DNA profiles to determine filiation or for identification purposes only Articles 3–5, 7–13, 15 and 56–58 apply besides Chapter 5. The use of DNA profiles in criminal proceedings or for the identification of unknown or missing persons is governed by the DNA Profile Act of 20 July 2003⁵.

Genetic and prenatal tests in the context of research on human diseases and on the structure and function of the human body are governed by the Human Research Act of 30 September 2011⁶.

In this Act:

1. 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;

2. cytogenetic tests means tests to determine the number and structure of chromosomes;

3. molecular genetic tests means tests to determine the molecular structure of deoxyribonucleic acid (DNA), ribonucleic acid and the immediate gene product;

4. diagnostic genetic tests means genetic tests to determine those characteristics of human genetic material which are responsible for existing clinical symptoms;

5. presymptomatic genetic tests means genetic tests to determine a predisposition to disease before clinical symptoms emerge;

6. prenatal tests means prenatal genetic testing and prenatal risk assessment;

7. prenatal genetic tests means genetic tests during pregnancy to determine characteristics of the genetic material of the embryo or foetus;

8. prenatal risk assessments means laboratory tests which provide information about the risk of the embryo or foetus having a genetic anomaly, but which are not genetic tests according to letter a, and investigations of the embryo or foetus using imaging techniques;

9. testing for family planning purposes means genetic tests to determine carrier status and the risk resulting therefrom of a genetic anomaly for future descendants;

10. DNA profile means specific characteristics of the genetic material of a person which are determined with a genetic test and are used to clarify their filiation or to identify this person;

11. genetic data means information about the genetic material of a person which is obtained from a genetic test, including their DNA profile;

12. sample: means biological material collected or used for a genetic test, including the preparation of a DNA Profile;

13. person concerned means a person whose genetic material is tested or from whom a DNA profile is created and from whom corresponding samples or genetic data exist; in the context of prenatal testing: the pregnant woman;

14. surplus information means a genetic test result that is not needed for the purpose of the test.

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

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.

The person concerned may withdraw his or her consent at any time.

If the person concerned is incapable of judgement, then the consent is required from his or her legal representative.

Persons incapable of judgement are to be included as far as possible in the information, counselling and consent procedures.

In particular, the person concerned must be provided with information on the following in a comprehensible form:

1. the purpose, nature and informative value of the test;

2. risks and physical or psychological stress which are associated with the test;

3. how the sample and the genetic data are handled during and after testing, in particular with regard to quality assurance and storage;

4. the possibility that surplus information may be obtained;

5. the cases in which surplus information must not be communicated (Art. 17 para 2, 27 and 33);

6. the possible significance of the test result for family members and their right not to know;

7. their rights, particularly concerning consent, information and not knowing.

The person concerned is entitled to receive the information that results from a genetic or prenatal test.

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.

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

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

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.

The processing of genetic data is otherwise governed by the federal and cantonal data protection provisions.

Samples and genetic data may be stored only as long as is necessary for:

1. performing the test, including quality assurance;

2. use for another purpose;

3. 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.

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.

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.

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.

Advertising to the public for the following genetic testing is prohibited:

1. genetic testing in a medical context;

2. prenatal genetic testing and genetic testing for persons incapable of judgement.

This ban does not apply to persons who, in accordance with Article 20, are authorised to prescribe the tests specified in paragraph 1.

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.

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

Genetic testing on persons incapable of judgement may only be performed when testing is necessary to protect their health.

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:

1. 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

2. ⁷the test is required in connection with a transplant or transfusion permitted under the Transplantation Act of 8 October 2004⁸ or the Therapeutic Products Act of 15 December 2000⁹.

Prenatal testing may only be performed in order to:

1. determine characteristics that directly impair the health of the embryo or the foetus;

2. 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

3. 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.

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:

1. 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;

2. the result of a test under paragraph 1 letter c.

Moreover, the foregoing information may not be provided after the end of the twelfth week if the physician considers that there is a risk that the pregnancy will be terminated because of gender or the suitability of the umbilical cord blood for transplantation.

Genetic tests may only be performed on a deceased person if:

1. they are needed to determine a genetic disorder or related carrier status;

2. this is requested by a relative of the deceased person;

3. the tested characteristic concerns the health or the family planning of the relative; and

4. the characteristic in question cannot be determined in any other way.

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.

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.

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.

Genetic tests may only be prescribed by physicians who are authorised to practise under their own responsibility, and who:

1. hold a federal qualification in the specialist field relevant to the test in question; o

2. hold a specific qualification in the field of human genetics.

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.

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:

1. physicians who do not meet the requirements of paragraph 1;

2. other specialists who are authorised to practise a medical, psychology or health profession under their own responsibility.

If the Federal Council allows genetic tests to be prescribed by specialists in terms of paragraph 3 letter b, then it may declare provisions on genetic tests to identify sensitive characteristics in terms of Article 31 paragraph 1 to be applicable.

The prescribing physician shall ensure that the person concerned:

1. is given the opportunity to receive counselling before and after a diagnostic genetic test;

2. receives genetic counselling before and after a presymptomatic or prenatal genetic test or before and after a test for the purpose of family planning.

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.

In addition to the provision of information in terms of Article 6, the counselling must cover the following aspects in particular:

1. the frequency and nature of the disorder being diagnosed;

2. the medical, psychological and social effects related to testing or related to not undergoing testing;

3. the cost of the test and of subsequent measures and the options for payment;

4. the severity of the disorder which may be detected and the possible therapeutic and prophylactic measures;

5. the support available in connection with the test result;

6. the circumstances in which insurance providers may require the disclosure of data from genetic testing.

A sufficient period of time for reflection must be allowed between the counselling session and testing.

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.

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.

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.

The pregnant woman's husband, wife or partner should be given the opportunity to be present when the genetic counselling is provided if possible.¹⁰

Before a prenatal risk assessment is made, the pregnant woman must be informed of the following in particular:

1. the purpose, nature and informative value of the test;

2. the possibility of unexpected test results;

3. the possible follow-up tests and procedures;

4. the information and counselling centres in terms of Article 24;

5. her rights, in particular concerning consent, the provision of information and her right not to know.

The cantons shall ensure that there are independent centres that provide information and counselling on prenatal testing.

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.

The cantons may delegate their tasks in terms of paragraph 2 to the advisory centres in accordance with the Federal Act of 9 October 1981¹¹ on Pregnancy Advisory Centres.

Written consent must be given for presymptomatic and prenatal genetic testing and family planning testing.

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.

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.

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 Code¹² to be released from his or her duty of professional confidentiality. The authority may request an opinion from the Commission.

The person concerned shall decide what surplus information he or she should receive.

If the person concerned is incapable of judgement, then the surplus information may only be disclosed to his or her legal representative if:

1. this is necessary to protect the health of the person incapable of judgement, or

2. the information concerns a serious genetic disorder in the family or to related carrier status.

Surplus information from prenatal genetic tests may only be disclosed if the information relates to:

1. the direct impairment of the health of the embryo or foetus; or

2. a serious genetic disorder in the family or related carrier status.

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).

The Federal Council, after consulting the Commission, may:

1. 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;

2. 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;

3. make individual steps in a process that are performed in facilities without authorisation in accordance with paragraph 1 subject to the authorisation requirement.

Authorisation shall be granted if:

1. the required technical and operational criteria are met, and

2. a suitable quality management system exists.

The Federal Council shall regulate:

1. the requirements placed on the laboratory manager and laboratory personnel and on the quality management system, and the operational criteria;

2. the duties of the holder of the authorisation;

3. the authorisation procedure;

4. the supervision, in particular the possibility of unannounced inspections; and

5. the information exchange between the relevant federal and cantonal bodies with regard to authorisations and supervisory activities.

Prescribing physicians and laboratories may delegate genetic testing, wholly or in part, to a laboratory abroad if:

1. the laboratory guarantees the testing will be performed according to the state of the art in science and technology;

2. the laboratory has a suitable quality management system;

3. the laboratory is authorised in its country to perform such tests; and

4. the person concerned has provided his or her written consent.

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.

The programme must show that:

1. early treatment or prophylaxis is possible;

2. the test method has been shown to produce reliable results;

3. appropriate genetic counselling will be provided; and

4. it is guaranteed that the screening is performed over a reasonable period of time.

It may provide that:

1. the genetic testing may be prescribed by a health specialist who is not authorised in accordance with Article 20;

2. the genetic counselling differs from the specifications of Article 21;

3. consent in written form is not required.

Before the FOPH grants authorisation, it shall consult the Commission and, when necessary, the National Advisory Commission on Biomedical Ethics.

The Federal Council, after consulting the Commission and having considered national and international regulations, may specify further conditions for screening.

Genetic tests to identify sensitive non-medical personality characteristics include tests performed in a non-medical context that concern the following:

1. physiological characteristics which, if known, may influence a person’s lifestyle;

2. personal characteristics such as character, behaviour, intelligence, preferences or talents; or

3. ethnic or other characteristics concerning origin.

Other non-medical genetic tests are tests that are performed neither in a medical context, nor to identify the sensitive characteristics in terms of paragraph 1, nor to create a DNA-profile.

The Federal Council may specify the genetic tests defined in paragraphs 1 and 2 in more detail.

In the case of non-medical genetic testing, the following information must be provided to the person concerned in addition to the matters specified in Article 6:

1. the laboratory that performs the genetic testing; and

2. the companies and laboratories abroad which are involved in the testing or which process the genetic data.

The information must be provided in writing and contain contact details for the following persons:

1. a specialist who is able to answer questions from the person concerned with regard to the genetic testing;

2. the person responsible for the data processing.

In the case of non-medical genetic testing, only the results that relate to the purpose of the testing may be disclosed to the person concerned.

Genetic testing in terms of Article 31 paragraph 1 may only be prescribed by health professionals who:

1. are authorised to practise under their own professional responsibility; and

2. have acquired knowledge of human genetics in their education and training.

Testing may only be prescribed by health professionals who work in the field relevant to the genetic test.

The sample must be collected in the presence of the prescribing person.

The Federal Council, after consulting the Commission, shall specify which health professionals may prescribe which genetic tests.

Any person who wishes to perform cytogenetic or molecular genetic tests to identify sensitive characteristics requires authorisation from the FOPH; authorisation shall be granted if the requirements of Article 28 paragraph 3 are met. Article 28 paragraph 4 applies mutatis mutandis.

The Federal Council may stipulate an authorisation requirement for further genetic testing, exempt individual cytogenetic or molecular genetic tests from the authorisation requirement or make individual steps in the process of performing a genetic test subject to an authorisation obligation. Article 28 paragraph 2 applies mutatis mutandis.

Article 29 applies mutatis mutandis to tests that are performed abroad.

Employers and insurance providers may neither require any non-medical genetic testing nor request any medically irrelevant genetic data, nor make use of any such data. The foregoing also applies in civil liability cases.

Genetic testing that is prescribed in connection with employment may only be performed to identify characteristics that are relevant in the workplace.

The physician shall inform the person concerned of the test result. The physician may only inform the employer whether the person concerned can be considered for the intended activity.

In connection with employment, neither an employer nor an associated physician may, subject to Article 40:

1. require presymptomatic genetic tests to be performed;

2. request data from prior presymptomatic genetic tests nor make use of such data.

In connection with employment, the physician engaged by the employer may prescribe a presymptomatic genetic test, when, in addition to complying with the provisions applicable to genetic tests in a medical context, the following requirements are met:

1. The Swiss Accident Insurance Fund (Suva) has ruled that the workplace is subject to occupational health monitoring, or other federal regulations require the employee to undergo a medical examination to ascertain his or her suitability for the job because there is a danger of an occupational disease or severe environmental contamination occurring or there is a serious risk of accident or health hazards for third parties.

2. Workplace-related measures in accordance with Article 82 of the Federal Act of 20 March 1981¹³ on Accident Insurance or other legal provisions are not sufficient to exclude a risk defined under letter a.

3. State-of-the-art scientific knowledge has established a link between a specific genetic predisposition and a form of occupational disease, danger of environmental contamination or risk of accident or health hazards to third parties; the Commission has confirmed the link and has deemed the type of test to be reliable in identifying the relevant genetic predisposition.

The agreement of SUVA is required in order to perform a genetic test to prevent an occupational disease.

The supervision of compliance by the employer with Articles 37-40 is governed by the provisions of the Employment Act of 13 March 1964¹⁴ and the Federal Act of 20 March 1981¹⁵ on Accident Insurance.

Insurance providers may not require either presymptomatic or prenatal genetic tests or tests for family planning purposes prior to providing insurance.

Insurance providers may neither request, nor make use of the results of prior presymptomatic tests on applicants for the following:

1. insurance governed in whole or in part by the Federal Act of 6 October 2000¹⁶ on General Aspects of Social Insurance Law;

2. mandatory occupational pensions insurance or occupational pensions insurance that goes beyond the scope of the mandatory insurance;

3. insurance relating to the obligation to continue paying the individual's salary during illness or maternity;

4. life insurance with an insured sum not exceeding CHF 400,000;

5. voluntary invalidity insurance with an annuity not exceeding CHF 40,000.

If an individual enters into two or more life or invalidity insurance contracts, the maximum amount specified in paragraph 1 letter d or e applies to the sum of the policies. The applicant must provide the insurance provider with the relevant information.

Insurance providers may neither request nor make use of the results of prior prenatal genetic tests or tests for family planning purposes.

Before entering into a private insurance contract not covered by Article 43, insurance providers may not request genetic data from prior presymptomatic genetic tests or make use of such data unless:

1. the test in question provides reliable results both technically and in practical medical terms;

2. the scientific value of the test for the calculation of premiums has been demonstrated and is relevant; and

3. the person to be insured has knowledge of the genetic data.

The insurance provider may only require that the data according to paragraph 1 be transmitted to the designated physician. The physician may inform the insurance provider only of the risk group to which the applicant must be assigned.

The genetic data and data on the risk group assigned may only be processed with a view to entering into a private insurance contract in accordance with paragraph 1.

In civil liability cases, it is prohibited, in particular for the purpose of calculating financial losses or measuring damages, to perform presymptomatic or prenatal genetic tests or tests for family planning, to request data from such tests or to make use of such data.

The foregoing does not apply if the tests assist the person concerned in claiming damages or satisfaction for genetic damage.

In medical negligence cases, particularly when calculating financial losses or measuring damages, the written consent of the person concerned is required for performing a diagnostic genetic test, requesting the data from such a test or for making use of such data.