At the U.S.-African Leaders Summit on December 13, Ambassador Dr. John Nkengasong announced the start of a new United States President’s Emergency Plan for AIDS Relief effort to accelerate regional manufacturing of critical health commodities on the continent. Building on existing capabilities and an analysis of future expansion potential, PEPFAR aims to procure 15 million HIV tests produced by African manufacturers in 2025 at an estimated cost of $20 million, alongside those purchased by other donors and partners. For antiretroviral treatments, by 2030, PEPFAR aims to work alongside other partners and buyers to shift at least two million clients on first-line ARV treatments to use African-made products.

The United States government purchases more than $1 billion of health commodities (diagnostics, therapeutics, vaccines, equipment) per year, the majority of which are consumed by people in Africa, but only a small fraction of which are produced in Africa. The PEFPAR program alone, currently spends roughly $750 million on HIV-related commodities such as HIV tests and anti-retroviral treatment every year but procures less than 1 percent of the value of these commodities from Africa due to the limited number of high-volume HIV product manufacturers on the continent today. Today, PEPFAR is seizing an opportunity to shape a more sustainable, resilient, and equitable future market for these products.

PEPFAR’s five-year strategy highlights regional HIV commodity production as a critical priority for sustaining the HIV/AIDS response. A strong regional manufacturing capability on the continent of Africa will have tremendous health, economic development and national security benefits. It will lead to a more diversified, resilient, and efficient supply chain that is more responsive to local needs. It can create significant job opportunities and attract investment. As demonstrated by COVID-19, this infrastructure will be critical to protecting against future health security threats- for Africa, the United States, and the world.

To reach these targets, PEPFAR will make key adjustments to its procurement policies to better support emerging African manufacturers to scale-up over time. PEPFAR will explore additional regulatory pathways to ensure proper approvals for quality-assured HIV products for purchasing, and over time, will contribute to strengthening of regional regulatory mechanisms on the continent such as the African Medicines Agency. PEPFAR will partner with others, including the President’s Malaria Initiative and Global Fund to Fight AIDS, TB and Malaria, to better align procurement efforts for African manufacturers of HIV, TB and malaria commodities. Lastly, PEPFAR will work with development finance partners to mobilize support for manufacturers with financing needs. PEPFAR is already collaborating with the United States Development Finance Corporation, which seeks to finance eligible private sector projects that build regional manufacturing capacity for therapeutics, diagnostics, and ancillary supplies in developing countries, with a focus on Africa.

In the coming months, PEPFAR will articulate a concrete roadmap outlining the critical steps it will be taking with partners, including key U.S. pharmaceutical companies and manufacturers, to accelerate a holistic U.S. approach to supporting regional manufacturing of HIV diagnostics and therapeutics and ultimately contribute toward a broader African market expansion effort for medical diagnostics, therapeutics and vaccines.

U.S. Department of State

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