WHO and Medicines Patent Pool Announce License Agreement to Manufacture Rapid Diagnostic Tests
The World Health Organization (WHO) and the Medicines Patent Pool (MPP) have announced a license agreement with SD Biosensor Inc., a global in-vitro diagnostic company, to provide sublicensees with the right, know-how, and material to manufacture SD Biosensor’s rapid diagnostic testing (RDT) technology. This license agreement, negotiated under the COVID-19 Technology Access Pool (C-TAP), represents a significant milestone in the initiative’s evolution as it enables the manufacture of diagnostics for COVID-19, as well as other diseases such as HIV, malaria, and syphilis.
Features of the License Agreement
The technology offered through the license is ideal for low and middle-income countries, as it is easy to use and requires no equipment. It also has high sensitivity and has been prequalified and emergency use listed by WHO. The broad scope of the license extends beyond COVID-19, increasing its public health value. This allows sublicensed manufacturers to tap into greater market opportunities and achieve financial sustainability in the inter-pandemic period. The comprehensive know-how and support provided to sublicensees aim to develop manufacturing capabilities, enabling them to achieve quality production at competitive prices.
Boosting Local and Regional Production
The license agreement promotes local and regional production of rapid diagnostic tests, particularly in Africa. This complements the effort made by the Global Fund, PEPFAR, and Unitaid to accelerate the manufacturing of RDTs on the African continent, initially focusing on HIV RDTs. The agreement enhances the ability of African-based sublicensees to take advantage of SD Biosensor’s technology transfer support.
Aligned with WHO’s Objectives
The technology transfer support aligns well with the objectives of WHA Resolution 76.5 on strengthening diagnostics capacity. It urges countries to commit resources to invest in research and product development and to promote local production capacity for diagnostics, mainly in developing countries. Access to diagnostics remains a core priority for WHO and its partners in managing diseases and implementing test and treatment strategies.
Feedback from WHO and MPP
Dr. Yukiko Nakatani, Assistant Director-General of Access to Medicines and Health Products at WHO, commended SD Biosensor for sharing its RDT technology under the C-TAP platform. The license serves as a model for addressing other public health needs beyond COVID-19. Charles Gore, Executive Director of the Medicines Patent Pool, expressed excitement about the agreement, as rapid and sensitive diagnostics are essential for access to treatment. The license allows SD Biosensor to provide the material and know-how for diagnosing various diseases, including HIV and malaria.
The Technology and C-TAP
SD Biosensor’s COVID-19 antigen test is a rapid chromatographic immunoassay that can detect proteins specific to a particular pathogen. It can be applied to other communicable pathogens such as HIV, malaria, and syphilis. This technology transfer agreement expands the access opportunities created by C-TAP’s multilateral technology-sharing mechanism to include other public health diseases. WHO is also announcing the development of a new business model, the Health Technology Access Pool (HTAP), which builds on the foundation of C-TAP to promote access to priority health technologies.
In conclusion, the license agreement between WHO, MPP, and SD Biosensor represents a significant step in expanding access to rapid diagnostic tests for various diseases. The agreement’s scope, support for sublicensees, and alignment with WHO’s objectives prioritize the development of local and regional manufacturing capabilities. This initiative is crucial for low and middle-income countries, particularly in Africa, and emphasizes the importance of diagnostics in managing diseases effectively.
Analyst comment
Positive news. The license agreement to manufacture rapid diagnostic tests, negotiated under the COVID-19 Technology Access Pool, allows for the production of diagnostics for COVID-19 and other diseases. It promotes local and regional production, aligns with WHO’s objectives, and provides support for sublicensees. This initiative expands access to rapid diagnostic tests, prioritizes manufacturing capabilities in low and middle-income countries, and emphasizes the importance of diagnostics in disease management. Expect increased availability of affordable and accessible diagnostic tests in the market.
