Adoption of revised laws on human genetic testing

23 September 2022 – Today, genetic testing can be carried out easily and cheaply. While raising delicate ethical, psychological, and social issues, genetic testing has become widely available to the general public. Interested individuals can order so-called “direct-to-consumer genetic tests” (DTC-GT) online from numerous foreign suppliers for both medical and non-medical purposes. The current Law on Human Genetic Testing (GUMG) came into force in 2007 and naturally does not reflect the technological progress made since. Parliament has therefore instructed the Federal Council to review the law and close legal loopholes.

On June 15, 2018, Parliament passed the revised GUMG which has been unanimously approved by the National Council and Council of States. Following the adoption of the revised GUMG, the implementing legislation has been under revision as well. This concerns in particular the Ordinance on Human Genetic Testing (GUMV) and the Ordinance on DNA Profiling in Civil and Administrative Matters (VDZV). The Federal Council has published the revised ordinances on September 23, 2022. The revised GUMG and its ordinances are scheduled to enter into force on December 1, 2022.

The revised law delivers on the demanded clarification regarding the scope of application. Comprehensive prohibitions have been waived; instead, the revised GUMG foresees minimum requirements for genetic testing that apply to all areas. The regulation of genetic testing for the clarification of hereditary characteristics in the medical field undergoes only minor changes. While the initiation of such genetic testing in the medical field was previously reserved for physicians, this has now been extended to selected health professionals. In future, dentists in the field of dentistry, pharmacists in the field of pharmacy and chiropractors in the field of chiropractic will be able to initiate selected medical genetic tests, for example to clarify drug intolerance. New is the regulation of genetic testing outside the medical field. For testing on physiological or personal traits and ethnic origins, although outside the medical field, initiation by health professionals, these include doctors, pharmacists, druggists, nutritionists, physiotherapists, psychologists, chiropractors and osteopaths, and licenses for laboratories are required. For other genetic testing, the results of which are comparatively insignificant on a person’s lifestyle or behaviour, only basic principles apply. Such tests can be given directly to customers, also via the Internet. In addition, the revised laws newly regulate the handling of surplus information from genetic testing, advertising requirements, requirements for dispensing DTC-GT, prenatal examinations as well as the performance of genetic testing on the deceased.

The Federal Council has made use of its authority to adapt individual requirements at the ordinance level. The revised GUMV inter alia includes the definition of health professionals who may initiate genetic testing outside the medical field, guidelines on the licensing system for genetic laboratories in and outside the medical field, guidelines for genetic testing of non-heritable traits and typing of blood groups, blood and tissue characteristics. As before, the creation of DNA profiles to clarify parentage or for identification purposes is subject to strict requirements, which are regulated in more detail in the VDZV. For example, the identity of the persons examined must be checked and their consent must be obtained. Laboratories require accreditation.

To highlight one point of discussion, non-invasive prenatal testing was the subject of much debate in the run-up to the revision for its ethic and social issues. Organizations for the disabled raised strong reservations about widespread prenatal testing, because it could lead to selection in certain cases. Albeit otherwise placing a great deal of emphasis on self-determination while adhering to certain minimum standards, in the case of prenatal genetic testing the legislator opted for a ban on sex determination before the twelfth week of pregnancy as well as on all prenatal genetic testing outside the medical field.

Whether the revised law will do justice to technological progress and social change remains to be seen. Andreas Wildi and Lucina Herzog will shortly publish on the topic of human genetic testing with a more in-depth review of the revised provisions and their implications in practice.