Covid-19 has cast a harsh light on global health inequalities. Africa was last in line for all the life-saving tools needed to fight the new virus, including vaccines, tests, oxygen and personal protective equipment. However, this is not a new phenomenon. It was several years after antiretroviral drugs (ARVs) for HIV became widely available in high-income countries that the Global Fund to Fight AIDS, Tuberculosis and Malaria and the US President’s Emergency Relief Plan were created. AIDS (PEPFAR) to ensure wider access to these life-saving medicines in Africa. Almost all tests, drugs, vaccines and medical tools used in Africa are manufactured elsewhere. This means that when there is a global shortage or when supply chains are disrupted, it is those in need in Africa who suffer the most. In a global health emergency, national priorities emerge quickly, and those who can buy their way to the front of the queue do so.
African leaders have rightly concluded that ensuring better health security for their people means making more of the medical tools needed on the continent. Through the Partnership for African Vaccine Manufacturing and agreements with pharmaceutical companies, bilateral development partners and multilateral agencies such as Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness and Innovations (CEPI), many vaccine manufacturing facilities are now under construction in countries such as Senegal and South Africa.
Although most of the current focus is on vaccines, there is also real progress in diagnostic tests and drugs. The Global Fund already buys antimalarials, insecticide-treated malaria nets and essential medicines from African-based manufacturers. In August 2023, the Global Fund, in partnership with PEPFAR, Unitaid and the World Health Organization (WHO), issued a call for proposals for rapid HIV diagnostic tests manufactured in Africa. In October, the Global Fund, in collaboration with these same partners, as well as UNAIDS, the German Agency for International Cooperation (GIZ) and the African Centers for Disease Control and Prevention, hosted a public-private conference in Maputo, Mozambique to antiretroviral HIV infection with similar ambition.
As we move forward with these projects, it is important to address the immediate barriers while thinking about long-term sustainability, equitable access, and universal health coverage.
A key factor is market demand. Demand for medical products can change dramatically as diseases evolve and competing alternatives emerge. Without some confidence about who will buy the product and at what scale, private sector companies will not invest. Publicly funded manufacturing projects run the risk of becoming redundant if their sponsors were overly optimistic in their demand forecast.
This is why the Global Fund has focused on high-volume products for HIV and malaria, such as HIV tests and antiretroviral drugs, and insecticide-treated mosquito nets for malaria. In 2022, 51% of new HIV infections occurred in sub-Saharan Africa. In 2021, the WHO African Region accounted for 95% of malaria cases and 96% of malaria deaths. PEPFAR and the Global Fund are the world’s largest funders of HIV services and supplies. The Global Fund alone accounts for about half of the global market for insecticide-treated nets, and thus can guarantee continued demand for these products. In the long term, the success of African pharmaceutical manufacturing will depend on its ability to provide high-quality products to a much wider range of buyers across the region.
It is also extremely important that African-made products secure timely regulatory approvals so that multilateral agencies such as the Global Fund can procure them. This is an extremely complex area, as both products and manufacturing facilities must be approved globally by the WHO and nationally by national regulatory authorities. It is vital to ensure strict control of patient safety and product quality. However, these approval processes can be extremely cumbersome and expensive and may take a few years or more to secure approval. No investment case can tolerate a factory not being able to sell product for such a long time. Thus, for our call for proposals for rapid HIV diagnostic tests manufactured in Africa, the Global Fund is working with PEPFAR and Unitaid to pilot a rapid process based on an assessment conducted by an expert review team convened by the WHO.
The creation of the African Medical Association (AMA) could also make a huge difference. If AMA-approved products can be sold across the continent, this is much easier than securing 54 different national approvals. However, the AMA is still at a relatively early stage.
The sustainable development of regional manufacturing also requires investment in the wider ecosystem, including scientific and clinical research, regulatory capacity and equipment services. Above all, there is a strong need to invest in human capital, as the lack of specialized skills is a huge constraint. Development partners have a critical role to play in this context.
Finally, there is the issue of competitive pricing. Efficient production of medical products requires significant scale, so African drug manufacturers need to access regional markets, and for most product categories it will not be economically viable to have more than a few manufacturers serving the continent. The Global Fund takes a value-based approach for greater security of supply and has adopted a total delivery cost model, taking into account logistics costs. But it will be important for African manufacturers to demonstrate cost competitiveness. While local production is key to improving equitable access to medical products, so is low prices. When millions of people in Africa still lack access to life-saving medicines due to affordability, it is difficult to justify paying more than a very modest or transitional premium for African-made health products.
The history of local production of first-line tuberculosis (TB) treatments offers something of a cautionary tale. Although there are many successful examples, in several countries local manufacturers have used their political influence to secure national supply agreements at huge premiums to world prices, while gaps in quality assurance have contributed to the spread of drug-resistant TB. People with tuberculosis suffered as a result.
Such examples should not discourage us from accelerating the development of African production of medical products. It just means that we have to do this smartly, with the risks in mind. At the Global Fund we are committed to catalyzing the rapid development of regional manufacturing so that the people of Africa can benefit from a better, safer supply of high-quality, affordable tests, medicines and other medical tools. This is key to reducing global health inequalities.