HIV self-tests may be sold in Switzerland from 19th June 2018. In the interest of public health and based on the recommendation of the Swiss Federal Commission on Sexual Health (FCSH) and the Federal Office of Public Health (FOPH), Swissmedic has approved the delivery for use to the general public of HIV self-tests, provided that they comply with the statutory requirements. In order to minimise the risk of purchasing counterfeit products tests should be distributed by professional outlets such as pharmacies or druggists, where personal advice can also be given.
In Switzerland, up until now, HIV tests could only be requested and performed in professional settings. Distribution to the public was prohibited (Medical Devices Ordinance, MedDO, SR 812.213 Article 17, 3rd paragraph). From June 19th, 2018 onwards, anyone can use a so-called self-test at home to see if he or she may have been infected with HIV. This is in line with several other countries and follows the World Health Organization (WHO) and European Centre for Disease Prevention and Control (ECDC) recommendations to allow the use of HIV self-tests, as an additional test option to the public. The goal is to reach individuals that would not otherwise undergo testing, not all people affected by HIV know that they have become infected and are HIV-positive, and thus ultimately improve the access to prevention, care and treatment.
HIV self-tests are considered compliant with the statutory requirements when they have demonstrated conformity to the EU requirements set forth in the IVD Directive 98/79/EC applicable to HIV self-tests, and thus bear the CE marking on the package and in the Instructions For Use. Each self-test must be accompanied by the appropriate information. The information must state, among other things, that a reactive (positive) test result indicates a probable infection with HIV. Patients with a positive result must be advised to contact a doctor as soon as possible to have the result of the self-test verified by a laboratory test.
What does this mean to you?
If you are currently placing compliant HIV self-tests on the European market you can now also access the Swiss market.
According to Swiss AIDS1, in June 2017 around 20,000 people in Switzerland were living with HIV. 542 new cases of HIV were diagnosed in Switzerland in 2016. This represented an increase of 1% over the previous year (2015). The introduction of HIV self-tests can be seen as a possible method for increasing HIV status awareness in Switzerland, where almost 20% of HIV-infected individuals are unaware of their seropositivity. By decreasing the threshold to getting tested, it is believed that the HIV self-tests can lead to increases in HIV testing rates and in the number of people who receive their test results.
1 Statistics on HIV/AIDS – Swiss AIDS – https://www.aids.ch/en/faq/hiv-test/statistics.php