Switzerland: The new Human Genetics Testing Act and related ordinances
Shortly
On December 1, 2022, the new Human Genetic Examination Act (HGTG) in Switzerland will come into force.
The new HGTA provides a comprehensive legal framework for all types of genetic testing (including direct-to-consumer and lifestyle genetic testing) and implements stricter measures to protect privacy rights, prevent misuse of genetic data, and ensure the quality of genetic testing and the interpretation of results .
As part of the comprehensive revision of the HGTA, the human genetic examination ordinance and the ordinance on the creation of DNA profiles for civil and administrative purposes were amended accordingly.
contents
- The central theses
- Situation according to the old HGTA and extension of the scope of application according to the new HGTA
- New categories and additional requirements for genetic testing
- Dealing with Excess Information
- Advertisement for genetic testing
- Stronger protection of data protection and personal rights
The central theses
The main features of the change include the following:
- Extension of the scope of the HGTA from genetic testing for medical purposes only to all genetic testing for medical and non-medical purposes
- Introducing clear rules on how people (healthcare professionals and/or others) can order different categories of genetic testing and allowing self-testing kits for genetic testing
- Setting clear requirements for laboratories performing different categories of genetic testing
- Introduce comprehensive rules on the advertising of genetic tests
- Strengthen privacy rights (e.g. informed consent) and data protection in the context of genetic testing, including the introduction of clear rules on how to deal with excess information
Situation according to the old HGTA and extension of the scope of application according to the new HGTA
The old HGTA, which is now being replaced by the new HGTA, was introduced in 2008. Before the new HGTA was passed, the scope of the HGTA was limited to genetic testing for medical purposes. Due to this limited scope, most of the genetic testing and self-testing kits for direct consumers that have been widely used in recent years have not been subject to the general requirements of the HGTA. In fact, it was unclear whether genetic tests that are not subject to the HGTA are permitted at all. The ever-increasing availability of direct consumer genetic testing and self-test kits led to a re-evaluation of the HGTA, which found that the existing legislation offered insufficient safeguards. As part of the revision, the scope of the HGTA was expanded to include genetic testing for medical purposes and genetic testing for non-medical purposes.
New categories and additional requirements 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. In addition, the HGTA places strict requirements on the admissibility of prenatal examinations and the creation of DNA profiles.
1) Medical genetic testing
Genetic testing for medical purposes includes diagnostic, pre-symptomatic and other genetic tests performed for medical purposes (e.g. tests for hereditary diseases or predispositions; genetic tests to clarify possible drug intolerance, etc.). According to the old law, genetic tests for medical purposes could only be carried out by doctors. According to the new HGTA, in addition to doctors, dentists, pharmacists and chiropractors may arrange for selected genetic tests for medical purposes in their respective fields. The same applies to people with recognized foreign qualifications. Genetic testing for medical purposes may only be performed by accredited laboratories.
2) Non-medical genetic testing
Non-medical genetic testing includes all genetic testing that is not performed for medical purposes.
- Sensitive personality characteristics include any information about (i) physiological characteristics, knowledge of which could affect the person’s way of life, (ii) personal characteristics such as character, behavior, intelligence, preferences or aptitudes, and (iii) ethnicity or other characteristics related to origin. Non-physician genetic tests for such sensitive personality traits may only be ordered by physicians and, insofar as selected genetic tests relate to their respective specialty, by dentists, pharmacists and chiropractors. Laboratories that carry out such genetic tests require approval from the Federal Office of Public Health (BAG).
- Non-medical genetic testing for non-sensitive personality traits (e.g. testing for taste sensations, etc.) does not have to be initiated by healthcare professionals, but can be offered free of charge to end customers as part of what are known as direct-to-consumer genetics test and self-test kits. Laboratories that carry out such genetic tests do not require a license. However, the laboratories must implement a quality management system in accordance with applicable national and international standards.
3) Prenatal genetic testing
The general requirements for genetic testing for medical purposes also apply to prenatal genetic testing. As a further requirement, prenatal examinations may only be carried out to clarify characteristics that directly affect the health of the embryo or fetus (e.g. Down syndrome). Finally, the HGTA stipulates that parents may only be informed of the sex of the unborn child after the 12th week of pregnancy.
4) DNA profiling
DNA profiling under the HGTA is only permitted for parentage or identification purposes. The creation of DNA profiles outside of civil and administrative court proceedings requires the informed consent of the person concerned. If surplus information is obtained through DNA profiling, this information must not be passed on to the data subject and must not be included in the investigation report. The creation of DNA profiles of deceased persons is subject to additional requirements under the HGTA.
The creation of DNA profiles according to the HGTA is subject to accreditation by the Federal Department of Justice and Police.
Dealing with Excess Information
The new HGTA introduces clear rules for dealing with excess information collected from genetic testing. Before initiating a genetic test for medical purposes, the patient must be informed that additional information may arise in connection with the genetic test to be carried out. The patient has the right, before the start of the genetic examination, to determine whether and to what extent superfluous information may be communicated to him (“right to know” and “right not to know”).
Excess information from non-medical genetic tests (to analyze sensitive and non-sensitive personality traits) must not be communicated to the patient.
Advertisement for genetic testing
Genetic testing for medical purposes and for prenatal genetic testing may not be publicly advertised. This does not apply to members of the health professions, who are allowed to arrange for such genetic tests according to the provisions of the HGTA. This advertising must be objective and meet public needs. It must not be misleading or intrusive.
Non-medical genetic tests may be publicly advertised if the advertisement contains sufficient information on the declaration of consent, the ban on passing on additional information and the requirements for carrying out genetic tests according to §§ 31-34 HGTA as well as the performance restrictions Persons. Misleading information is prohibited.
Public advertising for DNA profiling must include information about the legal requirements for DNA profiling and informed consent under the HGTA. Misleading information is prohibited.
Stronger protection of data protection and personal rights
The new HGTA makes it clear that all genetic tests require informed consent, which can be revoked at any time. It also specifies in detail which information must be disclosed to the patient before the start of the genetic test in order to obtain legally valid informed consent.
With regard to data protection, the HGTA states that the creation of additional information should be avoided as far as possible. In addition, anyone who handles samples or processes genetic data is legally obliged to take appropriate technical and organizational measures to protect these samples and data. In addition, the HGTA states that the Swiss data protection law and the data protection laws of the cantons apply.
The use of genetic data for all other (secondary) purposes always requires the consent of the person concerned. In the case of anonymized data, it is sufficient to inform the data subject in advance about the secondary use of the anonymized data, and such use is permissible provided that the data subject does not object to the anonymization.
Thanks to Matteo Ritzinger for helping to prepare this warning.
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