WHO Member States are increasingly stepping up to increase human resources and manufacturing capacities for local production. Many rapid diagnostic tests for HIV are manufactured far away from where they are used, which can compromise the equitable and timely supply of products where they are most needed. A strong appetite for diagnostics manufacturing capacity in Africa has been identified and has led to opportunities for African-based manufacturers to obtain support for the local production of HIV rapid diagnostic tests.
In response to the urgent need for substantial action required to achieve the relevant Sustainable Development Goals, the Africa CDC, AUDA-NEPAD, FIND, Global Fund, PATH, Unitaid, PEPFAR/USAID and the World Health Organization (WHO) are working towards scaling up the access to key health commodities, including quality-assured HIV RDTs, in the African region. A workshop took place on 1-3 July in Kigali, Rwanda, bringing together key partners to provide manufacturers of HIV RDTs based in Africa with a comprehensive set of information on WHO prequalification and the Expert Review Panel, new product introduction implications on national testing algorithms, donors’ perspectives on manufacturing in the African region, support projects available to manufacturers and experience from local manufacturers.
Manufacturers from 16 different countries attended the workshop and learnt about quality assurance through prequalification and the ERPD, ongoing support projects that manufacturers can leverage and current procurement mechanisms. A very lively audience contributed to an animated discussion during the two-day program and individual meetings with manufacturers were held on the third day. Our sincere thanks to all speakers who contributed to the workshop agenda: Philippe Boeuf, Susie Braniff, Boniface Dongmo, Fatima Gruszka, Aziz Jafarov, Theopista Kabuteni, David Karenye, Céline Lastrucci, Faith Mangwanya, Fasika Mekete, Clarisse Morris, Cheleka Mpande, Anne-Laure Page, Roger Peck, Jérémie Piton, Irena Prat, Ute Ströher, Eric Takang, Duncan Thela and David Woo as well as to Virgie Largado Ferri (PQT), the WHO Regional office for Africa and the WHO Country Office in Rwanda for their support to this event.
WHO is committed in its efforts to strengthen the global health ecosystem and foster stakeholder collaboration. To work towards these goals, we will continue advocating for compliance with international standards for quality, safety and performance for all health commodities, including IVDs. We will also further advance the regulatory agenda to support the growth of a strong regulatory capacity in Africa, including the emerging systems for IVDs. We count on manufacturers across the world, including those based on the African continent, to help us build a sustainable and equitable market, as a vital element for achieving universal health coverage and reaching the triple billion target.