in a nutshell
On December 1, 2022, Switzerland’s new Human Genetic Testing Act (HGTA) will come into force.
The new HGTA will provide a comprehensive legal framework for all types of genetic testing (including consumer and lifestyle genetic testing) to protect privacy rights, prevent misuse of genetic data, implement stronger measures to ensure the quality of Interpretation of results.
As part of the comprehensive revision of the HGTA, the Human Genetic Testing Ordinance and the Ordinance on DNA Profiling for Civil and Administrative Purposes have been amended accordingly.
- important point
- Status of the old HGTA and expansion of the scope of application of the new HGTA
- New categories of genetic testing and additional prerequisites
- Handling surplus information
- Advertisement for genetic testing
- Enhanced protection of data privacy and individual rights
The main features of the amendment are:
- Expanding HGTA coverage from genetic testing for medical purposes only to all genetic testing for medical and non-medical purposes
- Introduction of clear rules by which persons (medical professionals and/or others) can initiate various categories of genetic testing and the acceptability of self-test kits for genetic testing
- Establishing clear requirements for laboratories performing different categories of genetic testing
- Establishing Comprehensive Rules for Advertisement of Genetic Tests
- Enhancing individual rights (such as informed consent) and data privacy related to genetic testing, including the introduction of clear rules for handling surplus information
The old HGTA was introduced in 2008 to be replaced by the new HGTA. Prior to the adoption of the new HGTA, the scope of HGTA was limited to genetic testing for medical purposes only. Because of this limited scope, most consumer genetic testing and self-testing kits that have become widespread in recent years have not been subject to the general requirements laid down by the HGTA. In fact, it was unclear whether genetic testing not covered by the HGTA would be tolerated at all. The increasing availability of genetic testing kits and self-testing kits for consumers led to a reassessment of the HGTA, during which existing legislation proved to be inadequate in its safety measures. Did. As part of the revision, the scope of the HGTA was expanded to cover genetic testing for medical purposes and genetic testing for non-medical purposes.
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 has strict requirements for prenatal testing permits and DNA profiling.
1) Medical genetic testing
Genetic testing for medical purposes includes diagnostic, presymptomatic and other genetic testing performed for medical purposes (e.g. testing for inherited diseases or predispositions, to reveal potential drug intolerance). genetic testing, etc.). Under the old law, genetic testing for medical purposes could only be initiated by a doctor. Under the new HGTA, physicians, dentists, pharmacists, and chiropractors are also allowed to initiate select genetic tests for medical purposes in their respective fields. The same applies to persons with qualifications recognized in foreign countries. Genetic testing for medical purposes can only be performed by accredited laboratories.
2) Non-medical genetic testing
Non-medical genetic testing includes all genetic testing not performed for medical purposes.
- Sensitive personality traits include (i) physiological traits that may influence a subject’s lifestyle, (ii) personal traits such as personality, behavior, intelligence, preferences or talents, and (iii) ethnicity. or any other characteristics related to origin. Non-medical genetic testing for such sensitive personality traits may only be initiated by physicians, and to the extent the genetic testing chosen is relevant to their respective disciplines, dentists, pharmacists, and chiropractors. Laboratories performing such genetic testing require approval from the Federal Public Health Service (FOPH).
- Non-medical genetic tests for less sensitive personality traits (e.g., taste tests) do not need to be initiated by a medical professional, but instead are freely available to end customers as part of so-called direct-to-consumer genetic testing. can provide. Tests and self-test kits. There are no accreditation requirements for laboratories performing such genetic tests. However, laboratories must implement a quality management system that complies 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 an additional prerequisite, prenatal testing may only be performed to reveal features that directly affect the health of the embryo or fetus (e.g. Down syndrome). Finally, the HGTA stipulates that parents will only be informed of the gender of the fetus after 12 weeks’ gestation.
4) Creation of DNA profile
DNA profiling under the HGTA is only permitted for purposes of establishing parentage or confirming identity. A data subject’s informed consent is required to create a DNA profile outside of civil and administrative court proceedings. If DNA profiling yields redundant information, such information must not be disclosed to data subjects and must not be included in audit reports. Creating a deceased girlfriend’s DNA profile is subject to additional requirements under the HGTA.
DNA profiling according to the HGTA is subject to accreditation by the Federal Department of Justice and police.
The new HGTA introduces clear rules on how surplus information collected in genetic testing should be handled.
Before initiating genetic testing for medical purposes, patients should be informed of the potential extra information associated with the genetic testing being initiated. Patients have the right to decide how much of their surplus information they are willing to share (“right to know” and “right not to know”) before starting genetic testing.
Extraneous information collected in non-medical genetic testing (for analysis of both sensitive and non-sensitive personality traits) should not be communicated to patients.
Genetic testing for medical purposes and prenatal genetic testing must not be advertised to the general public. This does not apply to medical professionals who are authorized to initiate such genetic testing pursuant to HGTA provisions. Such advertising must be objective and meet public needs. It should not be misleading or intrusive.
Non-medical genetic testing is subject to advertisements containing sufficient information regarding informed consent, prohibition of dissemination of redundant information, requirements for initiation of genetic testing under HGTA Articles 31-34, and limitations on its conduct. can be advertised to the general public as Prenatal testing and genetic testing in the context of incompetent persons. Misleading information is prohibited.
Public advertisements for DNA profiling must include information about legal requirements for DNA profiling and informed consent as set forth in the HGTA. Misleading representations are prohibited.
The new HGTA clearly states that all genetic testing requires informed consent, which can be withdrawn at any time. In addition, it details what information must be disclosed to the patient prior to initiation of genetic testing in order to obtain legally valid informed consent.
From a data protection perspective, the HGTA states that the creation of redundant information should be avoided whenever possible. Furthermore, those who handle samples or process genetic data are required by law to take appropriate technical and organizational measures to protect such samples and data. Furthermore, the HGTA states that Swiss data protection law and cantonal data protection law apply.
Any use of genetic data for other (secondary) purposes always requires the consent of the data subject. In the case of anonymized data, it is sufficient to notify the data subject in advance of any secondary use of the anonymized data, and such use is not permitted unless the data subject objects to the anonymization. increase.
Thanks to Matteo Ritzinger for helping prepare this alert.