23 December 2022

Switzerland revises its rules for genetic testing

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The revised Law on Human Genetic Testing (GUMG), the Ordinance on Human Genetic Testing (GUMV) and the Ordinance on DNA Profiling in the Civil and Administrative Field (VDZV) entered into force on 1st of December 2022. These regulations include new categories as well as additional provisions for genetic testing.

  • Dr. Jonatan Baier

    Legal Partner

Due to the major progress in the field of genetic research and medical diagnostics, more and more genetic tests are being developed not just in the medical field, but also outside of it. The latter are mostly offered commercially and were hardly regulated until now. In order to take these developments into account and to prevent abuses, the GUMG, the GUMV and the VDZV were revised and the revision entered into force on the 1st of December 2022.

What are genetic tests?

Genetic tests examine the human genome and are usually carried out to answer health-related questions (e.g. hereditary diseases or predispositions for diseases) or to clarify relationships (e.g. paternity). They can be helpful for the diagnosis, treatment or prevention of certain diseases and may provide answers to the following questions: How well does my body react to a certain medicine? Does my unborn child have a hereditary disease or a chromosomal disorder?

In this context, sensitive social, ethical and psychological issues can arise before or after genetic testing. The importance and use of genetic tests is not only growing in the medical field. Rather, an increasing number of these tests are also being developed outside of the medical field and subsequently used without the prescription of a doctor. For example, there are genetic tests to determine athletic dispositions or to help optimize nutrition. These are so-called ""direct-to-consumer"" tests (DTC tests)which are regularly offered on the internet as self-test kits without personal or professional support. The results are then made available online. This can be problematic because not all DTC tests 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 companies outside of Switzerland can be found on the internet.

Before the revision of the GUMG, the scope of the law was limited to genetic testing in the medical field. It was therefore unclear whether genetic tests outside the medical field, which were therefore not regulated by the GUMG, were permitted at all. With the revision, the scope of application was extended. This makes it possible to prevent abuses and to guarantee the protection of personal rights.

What are the new regulations for genetic testing within the medical field?

Since genetic tests may examine different genetic characteristics, they are also regulated to different degrees. It is understandable, for instance, that there is a big difference between using genetic tests to rule out a hereditary disease and to determine the appropriate diet. This also means that some information is more sensitive and therefore more worthy of protection. Stricter rules therefore apply to the former. In addition, the law restricts the testing of young children or other persons incapable of judgement by only allowing such test to be carried out if there exists medically necessary. The highest requirements apply to the use of genetic tests for DNA profiling and in the medical field.

With the revision, the group of persons who may order genetic tests in the medical field has been enlarged. Previously, genetic tests could only be ordered by doctors. Now dentists, pharmacists and chiropractors can also order selected medical genetic tests in their respective fields. Furthermore, an additional accreditation obligation now applies to genetic laboratories in the medical field. The revised law also establishes regulations in the area of prenatal diagnostics, i.e. with the examinations of an unborn child. Such genetic tests may only be carried out if they concern the unborn’s health. Tests that merely clarify the gender may not be carried out if it is not in relation to the diagnosis of a disease. In addition, the revision stipulates that the parents of an unborn child may only be informed of its sex after the 12th week of pregnancy.

The new GUMG also prohibits manufacturers and suppliers from advertising genetic tests for medical purposes and prenatal examinations to the public. This does not apply to advertisements by manufacturers and providers that are directed towards professionals who are authorized to arrange such genetic tests (i.e. doctors, dentists, chiropractors and pharmacists).

What new regulations apply to genetic testing outside the medical field?

As already mentioned, there are more and more genetic tests in a non-medical context, which are now also regulated. The law distinguishes between two categories of genetic tests outside the medical field. The first category includes genetic tests for which the protection of personality must be ensured due to the sensitive data. This category includes, for example, tests on ethnic origin, dietary behavior, athleticism or traits such as intelligence, aptitude or character. Such genetic tests must now be ordered by one of the following health professionals: doctors, pharmacists, nutritionists, psychologists, physiotherapists, druggists, chiropractors or osteopaths. Persons with recognized foreign qualifications are also included. Laboratories that carry out such tests must now have a corresponding license. 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 – as a result – also produce less information worthy of protection. An example of this would be genetic analysis of hair color or taste sensation. Their inducement is not restricted by the law and they can be offered directly to users. The only central rule that applies to all genetic tests is that there must always be consent from the person concerned. This general requirement prohibits secret genetic tests for third parties.

Excess information

By taking a genetic test for medical purposes, the person concerned hopes to get answers to their specific questions. However, the person may only want some information but not other. For this reason, the patient has the right to determine before the genetic test begins whether and to what extent he or she may be given excess information. Thus, he or she has the right to know, but also the right to not know. In the case of genetic tests outside the medical field, the rule is that no excess information may be communicated. This regulation also makes sense because the scope of the results often cannot be individualized in the beginning and subsequently there is no professional support.

Our health law experts will be happy to assist you with questions on this and other health law topics.
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