Update: Partial revision of human research legislation

Numerous implementing provisions of the Human Research Act (HRA), which has been in force since 2014, are being revised. Specifically, the Human Research Ordinance (HRO), the Ordinances on Clinical Trials (ClinO and ClinO-Mep), the Organization Ordinance (OO-HRA) and the Stem Cell Research Ordinance (SCRO) are being amended. 

Although the evaluation conducted by the Federal Office of Public Health (FOPH) in 2017 and 2019 showed that the implementation of the HRA has generally proved successful, a need for action was identified with regard to the organization of implementation, research with health data and biological material, and transparency. Further need for revision arose in the area of genetic diagnostics and due to digitalization developments.

The strengthening of the right to self-determination of persons participating in human research projects and the explicit requirements for the selection of relevant groups of persons for clinical trials, in particular the inclusion of women, should be emphasized.

Finally, the revision brings the legislation into line with EU law in the area of medical devices and clinical trials. Since 2022, clinical trials in the EU have been uniformly regulated by Regulation No. 536/2014 on clinical trials on medicinal products for human use. This includes the creation of an electronic portal for the harmonized and central submission of trials (Clinical Trial Information System, CTIS).

The proposal was generally well received in the consultation process. However, some participants in the consultation feared an increased administrative burden. In addition, it was pointed out that the processing of health-related personal data for research purposes generally requires provisions at the legislative level, which is why a subsequent revision of the HRA is advisable.

The amendments will enter into force on November 1, 2024 (and those on transparency on March 1, 2025). 

The revision is part of the master plan "Federal measures to strengthen biomedical research and technology 2022-202

Update: New rules for laser treatments

Since 1 June 2019, the professional and commercial use of devices for cosmetic treatments with non-ionizing radiation (NIR) and sound has been regulated by the Federal Act on Protection against Hazards from Non-ionizing Radiation and Sound (NIRPA) and the associated Ordinance (V-NIRPA).

Since June 1, 2024, the treatment of acne, scars, couperose and the removal of hair using lasers, among other things, may only be carried out by persons who have a corresponding certificate of competence.

Certain lasers and light sources may only be used by doctors or appropriately trained healthcare professionals even after the end of this transitional period, provided they are class 4 lasers and high-energy pulsed non-coherent light sources that are marketed as medical devices.

We would like to thank our customers for the trust they have placed in us and for their valued cooperation!

Events