International Fund, PEPFAR and Unitaid Collaboration Paves Strategy to Speed up Approval of African-Manufactured HIV Fast Exams
08 August 2023
Geneva – The International Fund to Struggle AIDS, Tuberculosis and Malaria (the International Fund), the U.S. President’s Emergency Plan for AIDS Aid (PEPFAR) and Unitaid are partnering to speed up the manufacturing of well being merchandise in Africa, with HIV fast diagnostic exams (RDTs) because the preliminary centered product class.
With help from the World Well being Group (WHO), the International Fund, in partnership with PEPFAR and Unitaid, is launching a pilot, open Skilled Overview Panel for Diagnostic Merchandise (ERPD) name for Expression of Curiosity (EOI) for African producers of HIV RDTs to speed up the supply of high quality assured RDTs in Africa.
By issuing this name for EOI [ download in English | Français ] , the International Fund is inviting producers of HIV in-vitro diagnostic merchandise conducting some, or all, of the manufacturing steps in Africa to submit their product info for overview. As soon as a submission is accepted by the International Fund, the ERPD – an unbiased panel of technical consultants convened by WHO – will conduct an evaluation of the potential dangers linked to the procurement and use of such diagnostic merchandise that haven’t but been prequalified by WHO or licensed to be used by a stringent regulatory overview.
“Selling capability constructing for regional manufacturing is vital, notably in Africa, to contribute to constructing resilient well being techniques and driving equitable entry to quality-assured merchandise,” stated Peter Sands, Govt Director of the International Fund. “As a world well being partnership, the International Fund is poised to help this work, recognizing that it’s owned and led by the continent.”
The ERPD makes suggestions to the International Fund for procurement. The end result of the ERPD evaluation might be shared with companions to allow wider distribution of the assessed merchandise. Merchandise thought of by the ERPD to have a suitable risk-benefit profile for procurement might want to proceed working in the direction of compliance with high quality requirements by prequalification or one other stringent regulatory overview with lifecycle regulatory oversight. Extra particulars on the ERPD, which is hosted by the WHO Regulation and Prequalification division, can be found right here.
“WHO welcomes this vital initiative, which addresses two key priorities: the necessity for a dependable provide of fast HIV check kits so that everybody with HIV in Africa can entry lifesaving therapy; and the necessity for enhanced native manufacturing of medical merchandise in Africa, to construct capacities and scale back reliance on imports,” stated Dr Tedros Adhanom Ghebreyesus, Director-Basic of WHO.
This can be a pivotal milestone within the organizations’ joint efforts to speed up the availability diversification agenda, which contributes to extra equitable entry to quality-assured well being merchandise, extra resilient provide chains and provide safety. Producers and companions are invited to hitch an info session on the Name for EOI on 10 August at 14:00 Central European Summer season Time (CEST).
At this time, many well being merchandise – together with HIV exams – are manufactured removed from the place they’re used, compromising their equitable and well timed provide. This actuality grew to become obviously obvious through the COVID-19 pandemic, when world provide chain disruption had a disproportionate affect on areas that had been internet importers of well being merchandise.
“Strengthening regional manufacturing of quality-assured diagnostics and different vital well being commodities on the African continent is a key precedence for PEPFAR,” stated Ambassador Dr. John Nkengasong, U.S. International AIDS Coordinator and Senior Bureau Official for International Well being Safety and Diplomacy on the U.S. Division of State. “Supporting African-based manufacturing of HIV fast exams will construct a robust basis for long term capability of diagnostic manufacturing for all well being threats, and can guarantee provide safety, affected person entry, and contribute to world well being safety.”
“Unitaid is firmly dedicated to strengthening manufacturing capability of well being merchandise in Africa,” stated Philippe Duneton, Govt Director of Unitaid. “We be part of palms with world well being companions to take this vital step in the direction of better entry to well being merchandise, together with diagnostics. Investing in and supporting a strong regulatory framework, alongside technical, procurement and demand technology help to producers, will assist guarantee the standard and security of those exams, expedite their deployment and broaden entry for all.”
The International Fund continues to drive equitable entry to quality-assured well being merchandise. Via its NextGen market-shaping method, the International Fund is working carefully with companions to implement interventions that speed up new product introduction, help capability constructing for regional manufacturing and procurement, and promote sustainable provide chains and nation capability strengthening at world, nationwide and group ranges.
