We contacted the BAG (Federal Office of Public Health) to clarify the legal situation regarding STI self-tests, understand why STI self tests are not permitted for home use, and identify regulatory hurdles that could affect our project’s future development.
Note: This summary reflects our interpretation of the Federal Office for Public Health's response. It does not constitute official guidance or endorsement.
The BAG highlighted Art. 61 IvDV (SR 812.219) stating that the dispensing of products for the detection of communicable human diseases to the public is prohibited. They confirmed that Swissmedic may grant exceptions in the interest of public health. Currently, the only exception applies to HIV self-tests.
So far, only HIV tests are permitted for home use. The BAG explained that the arguments for this exception are published on their website. These arguments can serve as reference points for how future exceptions might be justified.
The BAG pointed us to the ongoing revision of the Epidemics Act (EpG). The current ban on dispensing in vitro diagnostics directly to the public is planned to be lifted. However, a new Art. 49a EpG would give the Federal Council authority to restrict or prohibit certain diagnostic products if their use poses risks to public health.
The EpG revision process could fundamentally change the legal landscape for self-testing.
We integrated these insights by reframing our entrepreneurship vision into a two-step pathway - starting with a POC Syphilis test and in a second step focus on direct-to-consumer self-testing once this becomes possible under a modernized regulatory framework.