Genetic Testing in a Medical Context(10 - 20)
Criminal Provisions(36 - 41)
Final Provisions(42 - 44)
The Federal Assembly of the Swiss Confederation,
in accordance with Article 98 paragraph 3, 110 paragraph 1, 113 paragraph 1, 117 paragraph 1, 119 paragraph 2 f, 122 paragraph 1 and 123 paragraph 1 of the Federal Constitution1,
and having considered the Dispatch of the Federal Council dated 11 September 20022,
1This Act stipulates the conditions under which human genetic testing may be performed:
2It also regulates the creation of DNA profiles for the purpose of determining the filiation or identity of an individual. The DNA Profiling Act of 20 June 20031 applies to the use of DNA profiles in criminal proceedings and for the purpose of identifying unknown or missing persons.
This Act aims:
In this Act:
No one may be discriminated against on grounds of his or her genetic material.
1Genetic and prenatal testing, including screening, may not be performed unless the person concerned has been provided with adequate information about the testing and has given his or her voluntary consent. This shall not apply to exceptions stipulated in a federal law.
2If the person concerned is incapable of judgement, that person's legal representative shall provide consent on his or her behalf. In the medical context the limitations of Article 10 paragraph 2 must be observed.
3Consent may be withdrawn at any time.
Every person has the right to refuse to receive information about his or her genetic status subject to Article 18 paragraph 2.
The processing of genetic data is subject to:
1Any person who wishes to perform cytogenetic or molecular genetic tests requires authorisation from the competent federal authority.
2The Federal Council:
3The Federal Council may, having consulted the Expert Commission for Human Genetic Testing (Art. 35):
4DNA profiles within the meaning of this Act may only be created by laboratories recognised by the federal government. The Federal Council regulates the requirements and the procedure for recognising such laboratories and for oversight.
1It is forbidden to supply genetic in vitro diagnostic medical devices to individuals for a purpose which cannot be considered part of those individuals' professional or commercial activities.
2The Federal Council may, having consulted the Expert Commission for Human Genetic Testing, make provision for exceptions to this prohibition provided the products are used under medical supervision and misinterpretation of the test result is not possible.
1Genetic tests may only be performed on individuals if they serve a medical purpose and the right to self-determination according to Article 18 is ensured.
2A genetic test may only performed on a person incapable of judgement if the test is necessary to protect that person's health. Exceptionally, a test of this kind is permissible if there is no other way of identifying a severe hereditary disorder in the family or a corresponding predisposition and the burden on the person concerned is minimal.
It is forbidden to perform prenatal tests whose purpose is:
1Screening may only be performed if the programme has been authorised by the competent federal authority.
2Authorisation can be granted if:
3Before the competent federal authority issues the authorisation, it consults the Expert Commission for Human Genetic Testing and, where necessary, the Swiss National Advisory Commission on Biomedical Ethics.
4The Federal Council may make provision for further conditions. It designates the competent federal authority and regulates the procedure for issuing authorisations, oversight and fees.
1Genetic tests may only be prescribed by medical doctors who are authorised to practice their profession independently or under the supervision of such.
2Presymptomatic and prenatal genetic tests and tests for the purpose of family planning may only be prescribed by doctors who have received appropriate post-graduate training or who, during their post-graduate training, work under the supervision of doctors who have received appropriate post-graduate training.
3The doctor who prescribes a genetic test under the terms of paragraph 2 ensures that the person concerned receives genetic counselling.
1Presymptomatic and prenatal genetic tests and tests for the purpose of family planning must be preceded and followed by non-directive genetic counselling provided by a qualified person. The counselling session must be documented.
2Counselling must address only the individual and family situation of the person concerned; it must not take public interest into consideration. It must take into account the possible psychological and social impact of the test results on the person concerned and his or her family.
3The person concerned or, if he or she is not capable of judgement, his or her legal representative must be informed specifically of:
4A sufficient period of time for reflection must be allowed between the counselling session and the test.
5In screening testing the counselling must be adapted to the circumstances.
1The pregnant woman must be informed expressly about her right to self-determination both before and after a prenatal genetic test.
2The woman must be made aware if there is a high probability that the proposed test will not lead to any therapeutic or prophylactic options; she must also be informed of the opportunity to contact an information and counselling centre for prenatal testing.
3If a severe, incurable disorder is detected, the woman must also be informed about alternatives to termination of the pregnancy and made aware of the existence of associations of parents of disabled children and self-help groups.
4The woman's husband or partner should be involved in the genetic counselling if possible.
Before a laboratory test which provides information about the risk of the embryo or foetus having a genetic anomaly, and before investigations of the embryo or foetus using imaging techniques, the pregnant woman must be informed of the following:
1 The cantons shall ensure that there are independent information and counselling centres for prenatal testing, with personnel with the required competency.
3The centres provide general information and counselling on prenatal testing and, if requested to do so, put clients in touch with associations of parents of disabled children or self-help groups.
1Having been provided with adequate information, the person concerned is free to decide:
2The doctor must immediately inform the person concerned of the test result if there is an immediate physical danger to the person, to the embryo or to the foetus, which could be averted.
3Consent for presymptomatic or prenatal genetic testing and for tests for the purpose of family planning must be obtained in writing, with the exception of screening tests.
4If the person concerned is incapable of judgement, his or her legal representative shall decide.
1The doctor may disclose genetic test results only to the person concerned or, if he or she is incapable of judgement, to his or her legal representative.
2If the person concerned gives his or her express consent, the doctor may disclose the test result to the person's family members, spouse or partner.
3If consent is denied, the doctor may apply to the competent cantonal authority as stipulated in Article 321 number 2 of the Swiss Criminal Code1 to be released from his or her duty of professional secrecy, should the protection of the overriding interests of the family members, spouse or partner require that they receive this information. The authority may request an opinion from the Expert Commission for Human Genetic Testing.
At hiring and during a professional relationship, the employer and his or her medical consultant may not:
At hiring and during a professional relationship, the occupational health or designated doctor may prescribe a presymptomatic genetic test if the following conditions are met:
1The test can only address the genetic predisposition relevant to the particular post. Attempting to acquire other genetic data is forbidden.
2Genetic counselling as stipulated in Article 14 must be provided before and after the test.
3The sample must be destroyed on completion of the test.
1The doctor transmits the result of the test to the person concerned. The employer is only informed whether the person concerned can or cannot be considered for the intended activity.
2If the occupational health examination is mandated by Suva, this body pays for the test; in other cases the employer bears the costs.
If the executive bodies designated by the Employment Act of 13 March 19641 or the Federal Act of 20 March 19812 on Accident Insurance observe violations of Articles 21-24, they are bound by virtue of their office to intervene.
Insurance providers may not require either presymptomatic or prenatal genetic tests prior to providing insurance.
1Insurance providers may neither require the disclosure of, nor utilize, results of prior presymptomatic or prenatal genetic tests or tests for family planning purposes, from applicants for the following:
2If an individual takes out several life or invalidity insurance policies, the maximum amount stipulated in para. 1 d or e is valid for the sum of the policies. The applicant must provide the insurance provider with the relevant information.
1Before a private insurance policy not covered by Article 27 is taken out, insurance providers may only require the applicant to disclose the results of prior presymptomatic genetic tests to the designated doctor if:
2The designated doctor may inform the insurance provider only of the risk group to which the applicant must be assigned.
3The designated doctor may only retain the results of the test if they are relevant for the conclusion of the contract.
4The test results must be used solely for the purpose for which they were obtained from the applicant.
1 Performing presymptomatic genetic tests for the purpose of calculating claims or determining compensation is forbidden, except in cases involving a genetic anomaly acquired during the embryonic phase and for which compensation or restitution is being claimed.
2 Requesting or utilizing the results of prior presymptomatic or prenatal genetic tests or tests for family planning purposes, for the purpose of calculating claims or determining compensation, is forbidden.
1 When creating DNA profiles to determine filiation or for identification purposes it is not permitted to seek information concerning health or other personal characteristics, with the exception of the sex of the person concerned.
2 The sample must be taken by the laboratory which will perform the DNA profiling or by a doctor mandated by the laboratory. The person concerned must provide proof of his or her identity.
3 The samples may not be used for other purposes.
1 In civil proceedings, DNA profiling of parties or third parties may only be performed by order of the court or with the written consent of the person concerned.
2 The laboratory must retain the samples obtained in the course of the proceedings. The court which ordered the test ensures that the samples are destroyed immediately after the implementation of the final judgment, unless a person concerned has requested in writing that his or her samples be retained for a further period.
1 If in administrative proceedings there are justified doubts about the filiation or the identity of a person which cannot be dispelled in any other way, the competent authority may make the granting of authorisation or benefits conditional to DNA profiling.
2 DNA profiling may only be performed with the written consent of the persons concerned.
3 The samples must be retained by the laboratory. The authority ensures that the samples are destroyed immediately after the implementation of the decision.
1 Outside the context of administrative proceedings, DNA profiling to determine filiation may be performed only with the written consent of the persons concerned; a child incapable of judgement and whose filiation with a certain person must be determined, may not be represented by that person.
2 The laboratory that performs the DNA profiling must, before undertaking the test, inform the persons concerned in writing about the provisions of the Civil Code1 concerning the determination of filiation and draw their attention to the possible psychological and social impact of the test.
3 The person concerned or, if he or she is incapable of judgement, his or her legal representative, shall decide whether his or her sample shall be retained or destroyed.
4 Prenatal DNA profiling to establish paternity may not be prescribed by a doctor unless the pregnant woman has previously had a thorough discussion addressing in particular, her reasons for wanting to perform the test, the risks associated with obtaining the sample, the psychological, social and legal aspects associated with the pregnancy, any subsequent measures that may be taken following the result and the possibility of obtaining support. The counselling session must be documented.
1The Federal Council shall appoint an Expert Commission for Human Genetic Testing.
2The Expert Commission shall have the following tasks in particular:
3The Commission shall fulfil its tasks independently.
Any person who wilfully prescribes or performs a genetic test without obtaining the consent of the person being tested, as required by this Act, shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.1
Any person who wilfully performs a genetic test on a third party without the authorisation stipulated in Article 8 shall be liable to a fine.1
1 Any person who, in contravention of Article 9 paragraph 1, wilfully supplies genetic in vitro diagnostic medical devices to individuals for a purpose which cannot be considered part of those individuals' professional or commercial activities shall be liable to a fine. 1
1 Amended by Art. 333 of the Swiss Criminal Code (SR 311.0) in its version in the Federal Act of 13 Dec. 2002, in force since 1 Jan. 2007 (AS 2006 3459).
2 Amended by Art. 333 of the Swiss Criminal Code (SR 311.0) in its version in the Federal Act of 13 Dec. 2002, in force since 1 Jan. 2007 (AS 2006 3459).
Any person who, in contravention of Article 21 and in the context of employment, wilfully:
shall be liable to a custodial sentence not exceeding three years or to a monetary penalty.1
Any person who, in the context of insurance, wilfully:
shall be liable to a custodial sentence not exceeding three years or to a monetary penalty. 1
1The cantons shall be responsible for the prosecution and assessment of criminal acts under the terms of this Act.
2Articles 6 and 7 (offences committed within a company) and 15 (forgery, obtaining a false certificate by fraud) of the Federal Act of 22 March 19741 on Administrative Criminal Law apply.
1 Any person who requires an authorisation as stipulated in Article 8 must submit the request to the competent federal authority within three months of this Act coming into force.
2 Any person who does not submit the request within the deadline must cease his or her activity.
Screening programmes which have already been implemented by the time this Act comes into force do not require authorisation.