AFRICA – The Global Funds to Fight AIDS, Tuberculosis and Malaria (The Global Fund), with support from the World Health Organisation (WHO), the U.S. Presidents Emergency Plan for AIDS Relief (PEPFAR), and WHO’s UNITAID, have partnered to deliver a plan on HIV/AIDS test kits manufacturing in Africa.
Essentially, the partnership will seek to accelerate the manufacturing of health products in Africa, with HIV rapid diagnostic tests (RDTs) as the initial focused product category.
Led by the Global Fund, which is launching a pilot, open Expert Review Panel for Diagnostic Products (ERPD) call for Expression of Interest (EOI) for African manufacturers of HIV RDTs to accelerate the availability of quality-assured RDTs in Africa.
Consequently, the Global Fund has invited manufacturers of HIV in-vitro diagnostic products conducting some, or all, of the manufacturing steps in Africa to submit their product information for review.
Once a submission is accepted by the Global Fund, the ERPD – an independent panel of technical experts convened by WHO – will conduct an assessment of the potential risks linked to the procurement and use of such diagnostic products that have not yet been prequalified by WHO or authorized for use through a stringent regulatory review.
Peter Sands, Executive Director of the Global Fund appreciated that promoting capacity building for regional manufacturing is important, particularly in Africa, to contribute to building resilient health systems and driving equitable access to quality-assured products.
“As a global health partnership, the Global Fund is poised to support this work, recognizing that it is owned and led by the continent,” said Sands on behalf of the Global Funds.
The ERPD makes recommendations to the Global Fund for procurement and the outcomes of the ERPD assessment will be shared with partners to enable wider distribution of the assessed products.
Moreover, the products considered by the ERPD to have an acceptable risk-benefit profile for procurement will need to continue working towards compliance with quality standards through prequalification or another stringent regulatory review with lifecycle regulatory oversight.
Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO welcomed the move adding that the important initiative would address two key priorities i.e., the need for a reliable supply of rapid HIV test kits so that everyone with HIV in Africa can access lifesaving treatment, and the need for enhanced local manufacturing of medical products in Africa, to build capacities and reduce reliance on imports.
“This is a pivotal milestone in the organizations’ joint efforts to accelerate the supply diversification agenda, which contributes to more equitable access to quality-assured health products, more resilient supply chains, and supply security,” emphasized WHO Director General.
Philippe Duneton, Executive Director of UNITAID further pointed out the organization’s firm commitment to strengthening the manufacturing capacity of health products in Africa.
“We join hands with global health partners to take this critical step towards greater access to health products, including diagnostics. Investing in and supporting a robust regulatory framework,” Duneton said.
Changing the paradigm to focus HIV tools production in areas of most need
The WHO notes that currently many health products, including HIV tests, are manufactured far from where they are used, compromising their equitable and timely supply.
Unfortunately, this reality became glaringly apparent during the COVID-19 pandemic, when global supply chain disruption had a disproportionate impact on regions that were net importers of health products.
Ambassador Dr. John Nkengasong, U.S. Global AIDS Coordinator and Senior Bureau Official for Global Health Security and Diplomacy at the U.S. Department of State noted that strengthening regional manufacturing of quality-assured diagnostics and other critical health commodities on the African continent was a key priority for PEPFAR.
“Supporting African-based manufacturing of HIV rapid tests will build a strong foundation for longer-term capacity of diagnostic manufacturing for all health threats, and will ensure supply security, patient access, and contribute to global health security, ” Dr. Nkengasong specified.
Through its NextGen market-shaping approach, the Global Fund is working closely with partners to implement interventions that accelerate new product introduction, support capacity building for regional manufacturing and procurement, and promote sustainable supply chains and country capacity strengthening at global, national, and community levels.
Moreover, the efforts will also see more technical, procurement, and demand generation support to manufacturers, which will help ensure the quality and safety of the tests, expedite their deployment, and expand access for all
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