Experts of the Partnership Network Association, within the framework of the regional SoS project, implemented by the consortium under the coordination of the Alliance for Public Health and under financial support from the Global Fund to Fight AIDS, Tuberculosis and Malaria, analyzed the legislation of Kyrgyzstan “On the possibility of introducing test systems for self-testing for HIV into medical products circulation”.
HIV self-testing (HIV-ST) is an innovative way to empower and reach more people living with HIV, and to help achieve the first of the United Nations’ 90-90-90 goals, which is to achieve by 2020 that 90% of all people with HIV knew their status. Increased use of HIV-ST can help achieve these global goals by reaching people who test for the first time, people with undiagnosed HIV, or people who need frequent retesting.
Currently, HIV-ST is carried out in many countries where there is no formal legal framework fully regulating the procedures for quality control, sale, distribution and use of HIV-ST kits. Test kits for HIV-STs are available online. The legislation of the Kyrgyz Republic does not contain norms regulating the use of test kits for HIV-ST, therefore it does not contain a direct prohibition on their use. For registration, import and sale of test systems for HIV-ST, it may be sufficient to complete the procedures in accordance with the requirements of the legislation on the circulation of medical devices. However, this regulatory path will not ensure the integration of HIV-ST into national strategies and algorithms for HIV testing, which will significantly complicate the activities of healthcare providers in this area and create conflicts in the interaction of HIV-ST consumers and healthcare providers. You can get acquainted with the analysis in our Resource Center at the link: Analysis of the legislation of the Kyrgyz Republic on the possibility of introducing HIV self-testing test systems into the circulation of medical devices