In March 2024, the World Health Organization, in collaboration with Africa CDC, brought together stakeholders from across Africa to discuss the role of technology transfer in supporting local manufacturing.

Taking place in Gaborone, Botswana, much of the conversation and presentations focused on vaccine manufacturing and the benefits of technology transfer to build scientific and technical capabilities, supply security and facilitate entry of new health products into the continent. Issues around Intellectual Property (IP), both as a barrier and an enabler, and finding the balance between innovation and access, were key discussion points, with an emphasis on fostering a balanced IP system that supports innovation while ensuring access to innovations, especially in Africa.

The part of the workshop that caught my attention was Active Pharmaceutical Ingredient (API) manufacturing in Africa. The API is the key drug substance that is added to medicines when the Finished Pharmaceutical Product (FPP) is manufactured. Not only is the cost of the API typically between 60-80% of the FPP, but it stands to reason that if the API is imported, then focussing only on manufacturing the FPP does not adequately address supply chain issues. 

Furthermore, with the cost of the API being the key determinant of the cost of the FPP,  we have to find innovative ways to manufacture the API to allow local producers to be cost competitive. However, there is limited recognition of the potential of local API manufacturing to address key challenges for the continent, as evidenced by the limited number of local API manufacturers. During discussions at the meeting, there was strong consensus that process chemistry innovation can offer significant opportunities to reduce cost for local API manufacturing, thereby increasing competitiveness to address niche and regional markets.

The issue with traditional tech transfer for an API manufacturer is that typically any process improvements would belong to the technology owner. The technology owner will also provide strict criteria for suppliers of raw materials, quality standards and process controls, which leaves limited scope for the tech recipient to innovate and identify areas for cost reduction. In essence, the technology transfer benefits the donor by opening access to new markets but is of limited benefit to the recipient. If we want to have game changing opportunities, then we need to promote local innovation around process chemistry and identify cost competitive manufacturing options that will serve the local, regional and global markets. 

We also need to work to create a supportive environment for API manufacturing, which could be achieved by enhancing collaboration and coordination among stakeholders, advocating for local production and access to essential health products in policy groups, and addressing challenges related to regulatory frameworks, funding, and skill development.

While this is still a formidable challenge, the H3D Foundation and our partners at CPT Pharma believe that by starting small, with project-based capacity-building initiatives, we can demonstrate the potential of local innovation to support cost competitive API manufacturing and capitalize on the opportunity to strengthen local production in Africa, enhance access to health products, and promote economic growth.

By Dr Susan Winks, H3D Foundation COO