On December 1, 2022, the new Swiss Human Genetic Testing Act (HGTA) will come into force.
The new HGTA provides a comprehensive legal framework for all types of genetic testing (including direct-to-consumer genetic testing and lifestyle genetic testing) and implements stronger measures to protect the right to life privacy, preventing the misuse of genetic data and guaranteeing the quality of genetic testing and the interpretation of results.
As part of the HGTA’s comprehensive review, the Human Genetic Testing Ordinance and the Civil and Administrative DNA Profiling Ordinance have been amended accordingly.
- Key points to remember
- Situation under the old HGTA and extension of scope under the new HGTA
- New categories and additional prerequisites for genetic testing
- 1) Medical genetic testing
- 2) Non-medical genetic tests
- 3) Prenatal genetic test
- 4) Creation of DNA profiles
- Treatment of excess information
- Advertisement of genetic tests
- Enhanced protection of data privacy and human rights
Key points to remember
The main features of the amendment are as follows:
- Expanding HGTA Scope of Genetic Testing for Medical Purposes Only to All Genetic Testing for Medical and Non-Medical Purposes
- Introduction of clear rules under which persons (medical professionals and/or others) can initiate different categories of genetic testing and the eligibility of self-testing kits for genetic testing
- Establishing clear requirements for laboratories performing different categories of genetic testing
- Establishment of comprehensive rules on the advertising of genetic tests
- Strengthening of individual rights (e.g. informed consent) and data privacy in the context of genetic testing, including the introduction of clear rules on handling excess information
Situation under the old HGTA and extension of scope under the new HGTA
The old HGTA, which will now be replaced by the new HGTA, was introduced in 2008. Prior to the adoption of the new HGTA, the scope of the HGTA was limited to genetic testing for medical purposes only. Because of this limited scope, most of the direct-to-consumer genetic testing and self-testing kits that have become very popular in recent years were not subject to the general requirements stipulated by the HGTA. In fact, it was unclear whether non-HGTA genetic testing was permitted. The ever-increasing availability of direct-to-consumer genetic testing and self-testing kits prompted a reassessment of the HGTA, during which existing legislation was found to provide insufficient safeguards. As part of the revision, the scope of the HGTA was expanded to cover genetic testing for medical purposes, as well as genetic testing for non-medical purposes.
New categories and additional prerequisites for genetic testing
The new HGTA introduces a distinction between genetic testing for medical purposes and non-medical genetic testing for the analysis of sensitive and non-sensitive personality traits. Additionally, the HGTA sets strict requirements for the eligibility of prenatal testing and the creation of DNA profiles.
1) Medical genetic testing
Genetic testing for medical purposes includes diagnostic, presymptomatic and other genetic examinations carried out for medical purposes (e.g. testing for diseases or hereditary predispositions; genetic testing to clarify potential drug intolerances, etc.). Under the old law, genetic testing for medical purposes could only be initiated by doctors. Under the new HGTA, besides doctors, dentists, pharmacists, and chiropractors are also allowed to initiate certain genetic tests for medical purposes in their respective fields. The same applies to persons holding a recognized foreign diploma. Genetic testing for medical purposes can only be performed by accredited laboratories.
2) Non-medical genetic tests
Non-medical genetic testing includes all genetic testing that is not done for medical purposes.
- Sensitive personality traits include all information concerning (i) physiological traits knowledge of which may influence the subject’s lifestyle, (ii) personal characteristics such as character, behavior, intelligence, preferences or talents and (iii) ethnicity or other origin-related characteristics. Non-medical genetic testing for these sensitive personality traits can only be initiated by physicians and, to the extent that certain genetic tests relate to their respective fields, by dentists, pharmacists and chiropractors. Laboratories carrying out such genetic tests must obtain authorization from the Federal Office of Public Health (OFSP).
- Non-medical genetic testing for non-sensitive personality traits (e.g. taste sensation testing, etc.) does not need to be initiated by medical professionals, but may be offered free of charge to end customers in so-called direct-to-consumer genetic testing. test and self-test kits. There is no licensing requirement for laboratories performing such genetic testing. However, laboratories must implement a quality management system in accordance with applicable national and international standards.
3) Prenatal genetic test
The general requirements for genetic testing for medical purposes also apply to prenatal genetic testing. As an additional prerequisite, prenatal examinations can only be performed to clarify features that directly affect the health of the embryo or fetus (eg, Down syndrome). Finally, the HGTA states that parents cannot be informed of the sex of the unborn child until after the 12th week of pregnancy.
4) Creation of DNA profiles
DNA profiling under the HGTA is only permitted to establish parentage or for identification purposes. The creation of DNA profiles outside of civil and administrative legal proceedings requires the informed consent of the person concerned. If additional information is obtained through DNA profiling, this information should not be disclosed to the data subject and should not be included in the examination report. The creation of DNA profiles of deceased persons is subject to additional requirements under the HGTA.
The creation of DNA profiles in accordance with the HGTA is subject to the approval of the Federal Department of Justice and Police.
Treatment of excess information
The new HGTA introduces clear rules on how to handle excess information gathered during genetic testing. Before initiating a genetic test for medical purposes, the patient should be informed that additional information may result in relation to the genetic test about to be initiated. The patient has the right to determine before the start of the genetic test whether and to what extent excess information can be communicated to him (“right to know” and “right not to know”).
Excess information collected during non-medical genetic testing (for analysis of sensitive and non-sensitive personality traits) should not be released to the patient.
Advertisement of genetic tests
Genetic testing for medical purposes and for prenatal genetic testing should not be advertised to the general public. This does not apply to healthcare professionals who are authorized to undertake such genetic testing under the provisions of the HGTA. This advertising must be objective and meet the needs of the public. It should not be misleading or intrusive.
Non-medical genetic tests may be advertised to the general public, provided that the advertisement contains sufficient information on informed consent, the prohibition on disclosing excess information and the requirements for the initiation of genetic testing pursuant to HGTA 31-34, as well as restrictions on the performance of genetic testing in prenatal examinations and persons incapable of judgment. Misleading information is prohibited.
Public advertising for DNA profiling must include information about the legal requirements for the creation of DNA profiles and informed consent as stipulated in the HGTA. Misleading statements are prohibited.
Enhanced protection of data privacy and human rights
The new HGTA clearly states that all genetic testing requires informed consent, which can be revoked at any time. It further specifies in detail what information must be disclosed to the patient before the start of the genetic test to obtain legally valid informed consent.
In terms of data protection, the HGTA states that the creation of excess information should be avoided where possible. In addition, anyone handling samples or processing genetic data is required by law to protect these samples and data by taking appropriate technical and organizational measures. In addition, the HGTA states that Swiss data protection law and the data protection laws of the cantons apply.
The use of genetic data for any other (secondary) purpose always requires the consent of the data subject. In the case of anonymised data, it is sufficient to inform the data subject in advance of the secondary use of the anonymised data and such use is permitted provided that the data subject does not object to the anonymisation.
Thanks to Matteo Ritzinger for supporting us in preparing this alert.
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