Expanding regional pharmaceutical manufacturing, a critical component of Africa’s health security agenda and the New Public Health Order, has been a major focus of efforts to build resilient health systems and supply chains in Africa to enable more effective responses to health emergencies. The topic was showcased at multiple events, roundtables, and side sessions at the 77th World Health Assembly (WHA) which highlighted the need for continued support for production of medicines and medical products in Africa, for Africans.
From sessions on market shaping and pooled procurement, to creating enabling regulatory environments and developing a robust workforce, one message continues to be clear: fostering a strong pharmaceutical manufacturing sector requires multi-disciplinary, locally led, and ecosystem-level approaches that support the sector from end to end.
"For the local production of vaccines to be realized, an enabling ecosystem needs to be developed. This includes consistent political support […], technology transfer, policy coherence, incentives, access to financing, regulatory harmonization, market shaping, and a well-trained health workforce."
- Tedros Adhanom Ghebreyesus, Director-General, World Health Organization
The breadth of conversations around regional manufacturing highlighted the diversity of actors involved and the rapidly evolving pace at which efforts are moving forward. Amid the sessions and discussions, four key themes to progress emerged.
Shaping regional markets
Sustainably expanding pharmaceutical manufacturing relies not only on building manufacturing capabilities but also, critically, creating predictable demand. Establishing predictable demand is a challenge, in part, due to lack of clear buyer commitments and demand signals.
In the areas of vaccines, a concerted effort is being made to mitigate these challenges through the establishment of market shaping instruments to address demand-related challenges for manufacturers, including the African Vaccine Manufacturing Accelerator (AVMA), designed by Gavi in collaboration with Africa CDC, which will offer incentive milestone payments to vaccine manufacturers. AVMA’s goal is to support at least four African vaccine manufacturers to win Gavi/UNICEF tenders to produce over 800 million vaccine doses over 10 years.
“Market shaping activities will be focused on increased demand creation, product prioritization, and aggregating supply. We are approaching market shaping end-to-end and covering all health products to cover the full value chain.”
- Dr Abebe Genetu Bayih, Acting Coordinator, Partnerships for African Vaccine Manufacturing
At WHA, a key announcement came at the Africa CDC-hosted high-level meeting, “Ministerial Consultations on Local Manufacturing,” where AU member states committed to purchasing vaccines manufactured in Africa. This commitment, together with other market shaping instruments, has the potential to help incentivize regional production by creating greater predictability in demand.
Creating enabling regulatory environments
Regulatory capacity at national and regional levels affect the time it takes for medical products to reach patients. Regulatory harmonization is often seen as a key option to streamline regulatory processes and get products to market faster through joint inspections and reviews, information sharing, and mutual recognition. But, for countries to realize the benefits of regulatory harmonization, additional work needs to happen to ensure national level policies, guidelines, and procedures all allow and enable national regulators to accept regional level decisions in a timely and effective manner.
“We cannot forward move with pharmaceutical manufacturing in Africa unless we address the regulatory hurdles, because we need everyone to have confidence in the products that come out of the continent.”
– Chimwemwe Chamdimba, African Medicines Regulation Harmonization Program Head, AUDA-NEPAD
The African Medicines Agency (AMA), is also expected to help advance local manufacturing across the continent, strengthening the regulatory ecosystem at the continental level in complement to growing capacity at regional and national levels.
Toward this end, important strides are being made through the African Medicines Regulatory Harmonization (AMRH) programme, the precursor to AMA. AMRH is developing a series of frameworks for reliance to assure the quality of African-produced vaccines, biologics, and other medical products and to foster wider adoption of reliance mechanisms across the continent.
Strengthening medicines regulatory systems
Bolstering national and regional authorities to improve access to medicines.
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Consolidating demand through pooled procurement
To strengthen Africa’s purchasing power and influence, representatives from the African Union and Africa CDC also elaborated on recently announced efforts to develop pooled procurement mechanisms and reduce trade barriers through the African Continental Free Trade Area (AfCFTA). Africa CDC is developing the African Pooled Procurement Mechanism (APPM) in collaboration with Afrexim Bank and others to build upon the African Medical Supplies Platform established during the COVID-19 pandemic to enable volume aggregation and direct access to quality medicines and medical products for African governments.
The initiative will initially focus on pooling procurement for 10 priority products used for reproductive, maternal, neonatal and child health and will be piloted in 10 countries. The initiative aims to improve access to these commodities through managed pooled procurement and incentivize regional production.
A comprehensive report on the finalized design for APPM will be presented to the AU assembly in February 2025.
Pooled procurement of medicines in Africa
Ten African countries develop a procurement framework to secure quality-assured, low-cost essential medicines.
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Procuring HIV/AID medicines from African producers
Expanding regional manufacturing of HIV tests and AIDS medicines will increase supply and improve health security across the continent.
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Prioritizing a robust workforce
Achieving Africa’s goals of health security through, in part, a strong pharmaceutical manufacturing sector on the continent requires an increase in skilled professionals across the medicine manufacturing ecosystem.
“We must train for an ecosystem on the African continent. Local manufacturing cannot be capacitated in isolation, let's train for an ecosystem across all sectors including regulatory, logistics, and supply chain.”
– Petro Terblanche, CEO, Afrigen Biologics PTY Ltd
Creating a resilient workforce includes informed regulators to grant market authorization, well-trained laboratory staff to conduct quality control tests, and skilled logistics managers to manage the supply chain and ensure timely delivery of goods.
During the WHA side event “Developing Africa’s Workforce for Health Product Manufacturing” speakers emphasized that building a strong health workforce requires sustainable financing and operating models for training initiatives, competency-based training program curricula, including hands on training, and localization of training initiatives.
“Through collaboration and agreements across countries, sectors, and industries, we can collectively work together to build a fit-for-purpose pharmaceutical workforce in Africa.”
Laura B. Martin, Vaccines Program Director, Global Health Technical Programs, USP
One effort to address workforce gaps on the continent and localize training initiatives is through Africa CDC’s call for proposals to establish Regional Capability and Capacity Networks (RCCNs) for Biomanufacturing Workforce Development. The RCCNs will establish sustainable training programs to develop a workforce for the vaccine manufacturing ecosystem, including biomanufacturing, R&D, and regulatory affairs.
Improving access to vaccines
Building regulatory, laboratory, and manufacturing capabilities to improve health equity.
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Manufacturing maternal health supplies in Africa
We analyzed five maternal health products across eight countries in Africa to assess supply and demand.
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Beyond WHA77
Global commitment to increasing regional manufacturing in Africa remains strong. From the African Union’s continental vision of producing 60% of vaccines, therapeutics, and other medical products by 2040, to the multiple Africa CDC initiatives and other partnerships aimed at building manufacturing capacities, the message is clear: regional manufacturing is not an option, it is a must.
“As we navigate the ever-evolving global health landscape one thing remains clear, Africa's self-sufficiency in health security is very important. And the time is not tomorrow, the time is now.
- H.E. Minata Samate Cessouma, AU Commissioner for Health, Humanitarian Affairs, and Social Development
