Legal | Tax | Compliance
Legal | Tax | Compliance
What is permissible in promoting medical advancement? New laws regulating genetic testing in humans, including medical and non-medical tests and their advertising, have been in effect since December 1, 2022.
The revised federal Act on Human Genetic Testing (HGTA) came into force on 1st December 2022. The corresponding implementation law – such as the ordinance on human genetic testing (HGTO) and the executive order on creating DNA profiles in civil and administrative areas (VDZV) – were also revised at the same time and adopted simultaneously.
The new statutory provisions apply to almost all cyto- and molecular genetic examinations that are required for the diagnostic clarification of genetic heritage or characteristics acquired during the embryonic stage of the human genome. Moreover, they govern all other laboratory experiments that are directly geared toward obtaining this type of information about the genome (cf. Art. 2 paragraph. 1 and Art. 3 lit. a HGTA). For the first time, not only the medical field, but also the non-medical sector is addressed. The regulations contain, inter alia, guidelines on whether and how such screenings might be advertised.
Advertising for genetic screening
Advertising genetic screening in humans is only partially permitted if certain requirements are met. Advertising intends to influence people in a deliberate and wilful manner, mostly for commercial purposes and to control (consumer) behaviour. Consequently, all measures that promote the demand for genetic screening, or the distribution and sale of products to carry out such screenings, are classified as advertising for genetic screening. In addition to brochures, posters and circulars or advertisements in newspapers, magazines, and books, this also includes advertising on objects, as well as by means of electronic media or at information events. Furthermore, and similar to advertising for pharmaceuticals, a distinction must be made concerning the target group, namely advertising tailored towards health care specialists and to the public.
“Specialist advertising” refers to measures that are directed exclusively at persons who are authorised to prescribe and perform genetic screenings (also in the medical field). In contrast, “public advertising" refers to advertising that is addressed to the public or to an indefinite number of recipients and is available to everyone. This differentiation between a limited group of people and an undefined mass of people is based on the diverging levels of education and the differing wealth of experience of the addressees. In order to guarantee consumer protection, public advertising is more restrictive than specialist advertising.
Swiss legislation governs advertising for genetic screening in particular in Art. 4 HGTO.
Requirements for specialist advertising
Advertising measures that are directed exclusively at individuals who are authorised to prescribe and perform genetic screenings (also in the medical field) are in principle not subject to any restrictions, as specified in the HGTA or the HGTO. However, such advertising measures must comply with the general requirements for advertising. In particular, the legal parameters according to competition law, medical profession and health profession law or, if applicable, medicine products law must be observed.
Requirements for public advertising
As a matter of principle, public advertising for examinations in the medical field is prohibited. However, specialists and professionals (e.g., physicians) who are authorised to prescribe and perform such examinations may advertise their services within a limited scope. This type of advertising must be objective and meet public needs; it must neither be deceptive nor intrusive (cf. Art. 4 paragraph. 1 HGTO).
For genetic screenings that cover aspects outside the medical field (e.g., for nutritional optimisation) and for the creation of DNA profiles (e.g., paternity tests), public advertising is permitted to a limited extent. Advertising must refer to legal requirements (e.g., the prerequisite that such screenings must be performed by a specialist, or the prohibition of performing these screenings on children) and must not contain deceptive information of any kind (cf. Art. 4 paragraph. 2 HGTO).
Final recommendation
Providers of genetic screenings should take the new legal requirements for advertising into consideration. Although penal sanctions are not intended by the legislator, in case of violation the license to perform cyto- or molecular genetic examinations may be revoked (cf. Art. 8 HGTA).
Therefore, we recommend that you have all information and advertising measures legally reviewed in advance by a legal expert. For further advice on this topic, please contact our health law experts.
Interested in our checklist for DTC tests?
