|
Art. 10 Genetic testing of individuals
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.
|
Art. 11 Prenatal tests
It is forbidden to perform prenatal tests whose purpose is:
- a.
- to determine characteristics of the embryo or foetus which do not directly impair its health; or
- b.
- to determine the sex of the embryo or foetus for a purpose other than diagnostic.
|
Art. 12 Screening
1Screening may only be performed if the programme has been authorised by the competent federal authority.
2Authorisation can be granted if:
- a.
- early treatment or prophylaxis is possible;
- b.
- the test method has been shown to produce reliable results; and
- c.
- appropriate genetic counselling is provided.
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.
|
Art. 13 Right to prescribe genetic tests
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.
|
Art. 14 Genetic counselling in general
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:
- a.
- the purpose, nature and significance of the test and of any complementary measures;
- b.
- any risks which may be associated with the test and the frequency and nature of the disorder being diagnosed;
- c.
- the possibility of an unexpected test result;
- d.
- the possible physical and psychological burden;
- e.
- third-party payment options for the cost of the test and of subsequent measures;
- f.
- support available in connection with the test result;
- g.
- the severity of the anomalies which may be detected and the possible therapeutic and prophylactic measures.
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.
|
Art. 15 Genetic counselling for prenatal genetic tests
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.
|
Art. 16 Information in connection with prenatal risk assessment
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:
- a.
- the purpose and significance of the test;
- b.
- the possibility of unexpected test results;
- c.
- the possible complementary tests and interventions; and
- d.
- information and counselling centres as defined in Article 17.
|
Art. 17 Information and counselling centres for prenatal testing
1 The cantons shall ensure that there are independent information and counselling centres for prenatal testing, with personnel with the required competency.
2 They may set up centres of this kind jointly or delegate their tasks to the recognised pregnancy advisory centres (Federal Act of 9 October 19811 on Pregnancy Advisory Centres).
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.
|
Art. 18 Right to self-determination
1Having been provided with adequate information, the person concerned is free to decide:
- a.
- whether to undergo a genetic or prenatal test and, where appropriate, a subsequent test;
- b.
- whether to know the result of the test; and
- c.
- what conclusions he or she wishes to draw from the test result.
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.
|
Art. 19 Disclosure of genetic data
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.
|
Art. 20 Further use of biological material
1A sample may only be used for further purposes to which the person concerned has consented.
2and 3 …1
1 Repealed by Annex No 3 of the Human Research Act of 30 Sept. 2011, with effect from 1 Jan. 2014 (AS 2013 3215; BBl 2009 8045).
|