Over the last 18 years, MMV has built a successful track record of helping pharmaceutical partners in Asia, North America and Europe achieve regulatory approval or WHO Prequalification for their antimalarial products.
In line with its mission to promote equitable access to malaria medicines, MMV has been working in partnership with African manufacturers to support them to meet the World Health Organization’s (WHO) standards of Good Manufacturing Practice (GMP) and Prequalification, 12 addressing a range of issues related to cost, packaging, distribution, continuity of supply, regional supply chain autonomy, training of healthcare workers and sustainability in many malaria-endemic countries.
Photo: Universal Corporation Ltd
This publication provides an overview of how MMV has been supporting African manufacturers to produce quality-assured antimalarial therapies.
SMC and the RTS,S vaccine in combination provide significant added protection against malaria in young children during the malaria season, as compared to either intervention alone.
First African-manufactured combination therapy for seasonal malaria chemoprevention receives WHO prequalification
7 MMV funded scholars will start their training at the Malaria Research and Training Center, Mali
The production of quality-assured malaria drugs in Africa, the continent that accounts for 95% of global cases and deaths, falls short of demand. As a result, the continent is heavily reliant on importation of these essential medicines. A broad range of factors have impeded coverage with malaria prevention and treatment medicines in Africa. These include gaps in coordination, policy, regulations, human resources and service delivery. 5 Deficits in the supply 6 and quality 7 of malaria medicines have persisted due to the following factors:
Supporting African pharmaceutical manufacturers to meet quality standards is therefore critical to safeguard the supply of quality antimalarial medicines in the region. This in turn, can boost uptake of lifesaving tools, meet the needs of Africa’s rapidly growing population and displace products of substandard or unknown quality. The production of quality-assured medicines in Africa will also help diversify sources of global medicine production.
MMV also works with international procurement and funding agencies to support the entry of these drugs into the market. This, in turn, has improved access to vital, quality-assured antimalarial therapies.
The COVID-19 pandemic shone a light on this problem, as supply-chain disruptions led to stockouts of many essential medicines, the impact going beyond the direct effect of the pandemic itself. 10 Since then, many African countries have underscored their intention to move towards greater self-sufficiency in the production of quality medicines and other therapies.
Treatment: Fast access to malaria treatment is crucial to reduce the impact of this disease that can kill in a matter of hours. Artemisinin-based combination therapies (ACTs) are the mainstay of malaria treatment against the deadliest form of the parasite. A locally available, reliable source of ACTs, close to the patients who need them most, will save lives; this can also help displace products of substandard or unknown quality, which are known to contribute to resistance.
Prevention: Malaria chemoprevention involves administering antimalarial medicines to populations at heightened risk if infected. Over the past decade, the use of chemoprevention strategies has grown. In June 2022, WHO expanded its guidance to support the administration of sulfadoxine-pyrimethamine (SP)-based chemoprevention interventions to broader groups of people living in malaria-endemic areas in Africa: eligible populations now include infants aged 0-24 months, school-aged children and increasing numbers of pregnant women. 11 Demand for this medicine is therefore expected to grow even more in the years to come.
Photo: Omotayo Tajudeen
Title: Kenya manufacturer is first in Africa to get WHO approval for malaria drug
Pre-qualification seen as significant step towards self-sufficiency in healthcare in continent where more than 70% of drugs are imported'
Building an African pharmaceutical manufacturing sector that meets international quality standards will require pan-African and international collaboration and leadership bolstered by political will and far-sighted investors. 13 It will also require guidance and commitment from normative bodies as well as private-sector cooperation.
MMV has worked closely with international stakeholders to ensure alignment and complementarity of this initiative with related strategies and activities. For instance, MMV and Africa CDC recently signed a Memorandum of Understanding to support strengthening of African pharmaceutical manufacturing capacity, in line with Africa CDC’s Strategic Plan for 2023-2027.
Funders, governments, regional bodies, procurement agencies and health regulators have also shown commitment to Africa’s drive to make its own medicines. This is key for progress. For example, health regulators in Africa are working towards the regional harmonization of drug development and prequalification. In addition, Africa’s Continental Free Trade Area (AfCFTA) will create a large free trade area, develop regional value chains, and is expected to alleviate Africa’s reliance on external economies. 14
It is essential that governments using domestic funds prioritize quality-approved sources of antimalarial medicines; for example, by procuring medicines from local manufacturers compliant with WHO GMP. Governments can also create a favorable and competitive environment for manufacturers of quality-approved essential medicines by removing import tariffs on the needed starting materials or by strengthening export rebates.
Achieving progress towards Universal Health Coverage is heavily dependent on access to affordable and high-quality essential medicines, vaccines and diagnostics. Local production should therefore be integrated as a key component of functional health systems. The regional manufacture and equitable distribution of antimalarial therapies and interventions will speed progress towards the elimination of malaria. As the capacity and skills of drug manufacturers grow, they will be able to leverage their experience with malaria medicines and expand into products for other diseases with increased collaboration from pan-African policymakers. The implementation and financing of these strategies are worthy of full global support.
1. World Malaria Report, 2022
2. World Economic Forum Report, AfCFTA: A New Era for Global Business and Investment in Africa
3. ‘How PEPFAR aims to spur medical manufacturing in Africa’. Devex Pro. December 2022
4. Universal Corporation Ltd (UCL) received WHO prequalification for sulfadoxine-pyrimethamine in August 2023 and sulfadoxine-pyrimethamine + amodiaquine (SPAQ) in October 2023
5. Roman et al. ‘Determinants of uptake of intermittent preventive treatment during pregnancy: a review.’ Malaria Journal. 2019; 18:372
6. Anne Fitzpatrick. “The impact of public health sector stockouts on private sector prices and access to healthcare: Evidence from the anti-malarial drug market.” Journal of Health Economics. January 2022
7. Walker et al. Are we doing enough to prevent poor-quality antimalarial medicines in the developing world? BMC Public Health. 2018
8. ‘How PEPFAR aims to spur medical manufacturing in Africa’. Devex Pro. December 2022
9. ‘Inside Africa’s Push to Make its Own Medicines’. International Finance Corporation. World Bank Group
10. ‘Inside Africa’s Push to Make its Own Medicines’. International Finance Corporation, World Bank Group
11. WHO Guidelines for Malaria, 2023
12. WHO Prequalification is a certification issued by the World Health Organization that ensures medicines adhere to global standards of quality, safety and efficacy. This is done by assessing the quality, safety and efficacy of medicinal products. Certifications for WHO Prequalification of pharmaceutical products and Good Manufacturing Practice (GMP) are an international endorsement of quality drugs
13. ‘Five ways to prepare for the next pandemic’. Nature. October 2022
14. ‘In Africa’s free trade area, investment in pharmaceuticals means impact and profit’. World Economic Forum. March 2023
