Legal | Tax | Compliance
Legal | Tax | Compliance
In connection with the revision of the Federal Act on Human Genetic Testing (HGTA), which came into force on December 1, 2022, the scope of application was extended to genetic tests in the non-medical field. Thus, a large number of genetic tests offered on the internet are now subject to clear rules and requirements. The following article provides an overview of the most important changes in this context.
Due to the great progress in the field of genetic research and medical diagnostics, more and more genetic tests are being developed in the medical field, but also outside medicine. The latter are not intended to answer any medical questions. Rather, they are often so-called "lifestyle genetic tests" aimed at self-optimisation. These can usually be easily ordered on the internet, are inexpensive, and the results are quickly available. Against this background, the revised HGTA and other legal provisions offer solutions to prevent abuses and ensure the protection of personality.
What are genetic tests?
Genetic tests examine the human genome and are often performed to answer health questions or to clarify relationships. These are genetic tests within the medical field. Genetic tests outside the medical field, on the other hand, are aimed at people who want to learn more about their body, their talents or their origins on the basis of their DNA. Thus, they are not intended to provide medical diagnoses.
There are non-medical genetic tests that are meant to determine athletic disposition or help optimise nutrition. These are so-called "direct-to-consumer" tests (DTC tests). They are offered on the internet as self-test kits without personal or professional support, and the results are then made available online. This can be problematic because not all DTC tests offered provide reliable results and a worrying test result regularly generates follow-up questions. In most cases, DTC genetic tests are prohibited in Switzerland, but regardless of this, many offers from foreign companies can be found on the internet.
Before the revision of the HGTA, the scope of the law was limited to genetic testing in the medical field. Therefore, it was unclear whether genetic tests outside the medical field, which were therefore not regulated by the HGTA, were allowed at all. With the revision, the scope has been extended and clear rules have been established. This makes it possible to prevent abuses and to ensure the protection of personality.
How to distinguish between genetic testing within and outside the medical field?
Genetic examinations that provide information about current or future health impairments or concern other medically relevant characteristics fall into the medical field. This includes, for example, examinations concerning chromosomal disorders such as trisomy 21 or hereditary diseases such as cystic fibrosis.
On the other hand, genetic tests whose results do not provide any information on diseases, disease risks or other medically relevant characteristics are assigned to the non-medical area.
In order to distinguish between genetic examinations within and outside the medical field, it is first necessary to examine the nature of the medical property to be examined. In other words, the question is whether the property to be examined provides information about current or future possible health impairments or other medically relevant characteristics of the person concerned. If this is the case, it is a genetic examination in the medical field. Furthermore, the purpose of the examination is also relevant. If the examination is performed for medical reasons or on the basis of a medical indication, it is also a genetic examination in the medical field.
What are the new regulations for genetic testing outside the medical field?
The HGTA distinguishes between two categories of genetic tests outside the medical field. The first category comprises genetic tests for which the protection of personality must be observed due to their sensitive data. This category includes, for example, tests on ethnic origin, dietary behaviour, athleticism, or traits such as intelligence, aptitude, or character. Now such genetic tests must be ordered by one of the following health professionals: physicians, pharmacists, nutritionists, psychologists, physiotherapists, druggists, chiropractors or osteopaths. Also included are persons with recognised foreign degrees. Here, the sample for the genetic test must be taken in the presence of the specialist. This ensures that no clandestine tests are carried out on third parties or unauthorised tests on young children. Laboratories that perform such tests must now have the appropriate authorisation. However, they do not have to go through an accreditation procedure as in the medical field.
The second category includes genetic tests that involve less sensitive data and thus produce less information worthy of protection. An example of this would be genetic analyses of hair colour or taste sensation (e.g., assessing the ability to perceive bitter taste). Their inducement is not fundamentally restricted by the law and thus they can be offered as DTC tests directly to users via the Internet. Nevertheless, the general rules regarding information, consent and advertising must also be observed here. These prohibit, among other things, secret genetic tests for third parties.
It should be noted at this point that the law merely sets out the general conditions for carrying out a genetic test. However, it does not determine how meaningful or useful the test must be.
What happens when lifestyle genetic tests or similar are used without a specialist?
Companies from abroad offer many genetic tests outside the medical field, which, according to the new regulations, must be performed by a specialist. Private individuals who order such a lifestyle genetic test from abroad for themselves and then carry it out without a specialist are not liable to prosecution. On the other hand, persons can be prosecuted who, among other things, intentionally order genetic testing for third parties without their consent or provide DTC tests to affected persons for examinations in the medical field, for the clarification of personality traits that are particularly worthy of protection outside the medical field or for the creation of DNA profiles.
Are there criminal penalties for violations of the regulations?
The HGTA provides for prison sentences of up to three years or penalties for offences as well as fines for violations (Art. 56 and 57 HGTA).
Our health law experts will be happy to assist you with questions on this and other health law topics.
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