• The Global Fund said manufacturers of HIV diagnostic products conducting some, or all, of the manufacturing steps in Africa, can now submit their product information for review.
• This is a pivotal milestone in the organisations’ joint efforts to accelerate the supply diversification agenda
More Kenyan manufacturers could be prequalified to sell HIV test kits to Pepfar and Global Fund.
The two said they will begin buying HIV rapid diagnostic kits from Africa to boost manufacturing capacity in the continent.
Currently, most HIV diagnostic products and drugs used locally are imported from India.
Kenya has one of Africa’s strongest industries of medical products but only two drug manufacturers are prequalified to supply ARVS.
On Wednesday, the Global Fund launched a pilot, Expert Review Panel for Diagnostic Products (ERPD).
This is an independent panel of technical experts convened by the World Health Organisation (WHO).
The pilot was launched in partnership with Pepfar and Unitaid, with support from WHO.
The Fund called for Expression of Interest for African manufacturers of HIV RDTs to accelerate the availability of quality assured test products in Africa.
It said manufacturers of HIV diagnostic products conducting some, or all, of the manufacturing steps in Africa can now submit their product information for review.
Once a submission is accepted by the Global Fund, the ERPD 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 authorised for use through a stringent regulatory review.
“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,” said Peter Sands, Executive Director of the Global Fund.
“As a global health partnership, the Global Fund is poised to support this work, recognising that it is owned and led by the continent.”
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 pre-qualification or another stringent regulatory review with lifecycle regulatory oversight.
More details on the ERPD, which is hosted by the WHO Regulation and Pre-qualification Department, are available here.
“WHO welcomes this important initiative, which addresses two key priorities," said Dr Tedros Adhanom Ghebreyesus, the director general of WHO.
He cited the need for a reliable supply of rapid HIV test kits so that everyone with HIV in Africa can access lifesaving treatment.
The other priority is 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 organisations’ 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.
Currently, many health products, including HIV tests, are manufactured far from where they are used, compromising their equitable and timely supply.
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.
"Strengthening regional manufacturing of quality-assured diagnostics and other critical health commodities on the African continent is a key priority for Pepfar,” said Amb Dr John Nkengasong, US Global Aids Coordinator and Senior Bureau Official for Global Health Security and Diplomacy at the US Department of State.
“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.”
"Unitaid is firmly committed to strengthening manufacturing capacity of health products in Africa,” said Philippe Duneton, executive director of Unitaid.
“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, alongside technical, procurement and demand generation support to manufacturers, will help ensure the quality and safety of these tests, expedite their deployment and expand access for all.”
The Global Fund said it is driving equitable access to quality-assured health products.
Through its NextGen market-shaping approach, the Global Fund is working closely with partners to implement interventions that accelerate new product introduction.
It also seeks to support capacity building for regional manufacturing and procurement and promote sustainable supply chains and capacity strengthening at global, national and community levels.