Equitable access to affordable, quality assured health products is an essential part of sustainable health systems. But with the majority of the world’s health products produced in just a few mainly high-income countries, most low- and middle-income countries do not have stable, affordable access to the tests, treatments and tools they need.
For example, while Africa shoulders 25% of the world’s disease burden – including major infectious diseases like HIV, TB and malaria – more than 95% of the active pharmaceutical ingredients and 70% of the pharmaceuticals consumed on the continent are imported. This leaves countries vulnerable to price volatility, supply chain disruptions or unavailability of essential health products, particular during periods of supply scarcity in the face of surges in regional or global demand or after climate-related shocks or extreme weather events. This vulnerability became clear during the COVID-19 pandemic, when global lockdowns, increased demand and interruptions to supply meant countries without local manufacturing did not have access not only to COVID-19 tools, but routine medical supplies as well.
To ensure countries are better prepared to prevent and respond to new global health emergencies, people have continued access to the health commodities they need, and to build resilience to climate change, we must strengthen regional manufacturing of health products.
How we contribute to strengthening regional manufacturing
At Unitaid, we save lives by making new health products available, adapted, and affordable for people in low- and middle-income countries. We identify challenges that are slowing progress towards global health goals, find and invest in innovative products and solutions, then work with countries and partners to take them to scale so people everywhere can benefit.
Key challenges to strengthening regional manufacturing include the cost and complexity of achieving quality and regulatory compliance, unstable economies, poor access to finance, suboptimal infrastructure, and unpredictable public sector demand. Our regional manufacturing strategy draws on our unique role of identifying and investing in new health products and approaches, our experience of market shaping and our extensive network of partners – from manufacturers to procurers.
We are focusing first on Africa, where countries rely the most on imported health products and where increased local capacity would greatly improve sustainability and access to products addressing regional needs. The goal is to transition to a sustainable African manufacturing industry that delivers a range of health products at scale, meeting the required quality standards and priced competitively. We will, in parallel, seek to identify opportunities for impact in Latin America and other underserved regions of the world.
Identifying high-potential health products and local manufacturers: In the first phase of our strategy, we are identifying a priority set of health product categories that could contribute to regional sustainability and preparedness if made at the regional level, such as: antiretroviral therapy for people with HIV; drugs to treat mothers with post-partum hemorrhage; antimalarials; rapid diagnostic tests; and oxygen. Our analysis of the manufacturing landscape is identifying and engaging with several African-owned manufacturers capable of producing these products at the scale.
Market shaping: On their own, very few countries are able to meet the minimum quantity for orders at reduced bulk prices. In our role as a connector, Unitaid is working to bring together the partners needed to help countries move toward supporting regional economic zones to pool demand. Regional and national leadership from the African Union, the Africa Centres for Disease Control and Prevention (Africa CDC) and national ministries will be key to building regional markets large enough to benefit from economies of scale and bulk pricing.
Connecting relevant partners: To build the capacity of these manufacturers and identify procurement partners and platforms for their products, we are leveraging new and existing partnerships such as with the Africa CDC, African Pharmaceutical Technology Foundation, African Society for Laboratory Medicine, African Union Development Agency-NEPAD (AUDA-NEPAD), the European Commission, the Foundation for Innovative New Diagnostics (FIND), the Global Fund to Fight AIDS, Tuberculosis and Malaria, Medicines Patent Pool, Pan American Health Organization (PAHO), the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), Regional Economic Communities, and the WHO Department of Regulation and Prequalification. We are also connecting with existing manufacturers in other regions that could provide technology transfer – training, equipment, quality control guidance – to local producers to boost their capacity and meet required regulations.
Our new regional manufacturing strategy builds on our existing work. For example, to strengthen diagnostics manufacturing during the COVID-19 pandemic, together with FIND we spearheaded the transfer of rapid diagnostic testing technology across three continents, ensuring supply security and contributing to a lower global price for these tests.
In Senegal, we partnered with FIND to support diaTROPIX, a nonprofit manufacturer that is part of Institut Pasteur Dakar. Bionote and Mologic, two diagnostics developers, provided technology transfer – the instructions, raw materials, equipment and quality control needed to create the tests – to diaTROPIX, enabling the production of high-quality tests in Senegal. As the world transitions from the COVID-19 pandemic, we are supporting diaTROPIX to produce a portfolio of tests needed in the region, including for HIV. This strengthens regional manufacturing capacity both for products needed today and keeps the facility functioning and ready to expand to make tests for other diseases when another local outbreak or global pandemic occurs.
Together with the Medicines for Malaria Venture, we also supported Universal Corporation Ltd in Kenya to become the first African manufacturer to gain WHO prequalification of sulfadoxine-pyrimethamine, an effective and affordable medicine used to prevent malaria in pregnant women and infants, and for SP-AQ, the combination treatment for seasonal malaria chemoprevention to protect children under 5.
Strengthening regional manufacturing is critical to meet the health-related Sustainable Development Goals and to support climate targets by reducing transport costs and carbon emissions. Regional manufacturing is therefore a key part of our new Climate and Health Strategy, which calls for a move to climate-smart health products that are not harmful to the environment, are resilient, responsive to climate change, locally adapted and regionally produced.
In November 2023 at the World Local Production Forum, Unitaid together with global and regional partners launched one of the first new initiatives under its regional manufacturing strategy: the Health Products Manufacturing Support Platform (HMSP). The HMSP aims to address the challenge of technical capacity for regional manufacturers in Africa. It will do so by matching opportunities for technical assistance related to technology, management, and operational skills, specific projects and skill sets, linkages to capital, and regulatory compliance.
Moving forward, we will work with Africa CDC, AUDA-NEPAD, WHO and other partners to implement the HMSP. We will also support other strategic initiatives in Africa and Latin America to help build demand and to contribute to an enabling environment for a more sustainable, regional manufacturing sector to ensure affordable access to quality health products for people in low- and middle-income countries.
- Issue Brief: Regional Manufacturing
- Meeting Report: Strengthening cooperation to enable sustainable development and manufacturing of effective, quality and affordable diagnostic countermeasures (FIND and Unitaid)
- Report: Building for sustainability: Accelerating regional manufacturing for diagnostics (FIND and Unitaid)
- Expression of Interest: Enabling regional supply of diagnostic tests in LMICs expression of interest: strengthening the regional supply of in vitro diagnostics in LMICs (FIND and Unitaid)
- Opinion Paper: Enabling a market-based approach to manufacturing quality-assured health products in Africa: A differentiated coordination approach
- Global Fund, PEPFAR and Unitaid Collaboration Paves Way to Accelerate Approval of African-Manufactured HIV Rapid Tests