New foundation is ready to help African pharmaceutical manufacturers

A year after its soft launch, the African Pharmaceutical Technology Foundation is ready to formally start work this month. The failures of the global health systems during the COVID-19 pandemic — when export restrictions, lockdowns, and hoarding sent supply chains into frantic disarray — made local manufacturing of pharmaceutical supplies a top priority for African leaders. But it's not been an easy path forward. A variety of barriers exist that hinder the growth of pharmaceutical research and development in African countries, and this means that intellectual property is often held overseas. This makes licensing and technology transfer a crucial part of expanding the manufacturing sector across the continent. But international manufacturers have in many cases refused to transfer the knowledge on how to create their products to African manufacturers. For example, in South Africa, Moderna and Pfizer declined to provide the technical know-how on how to replicate their COVID-19 vaccines to the world's first vaccine messenger RNA vaccines technology transfer hub, which pushed the hub to develop its own. In 2022, the African Development Bank launched the African Pharmaceutical Technology Foundation as a first-of-its-kind institution to work toward systematically overhauling this situation by ensuring more technology and know-how transfers happen. It serves as a Pan-African agency to bring both African and international firms to the table to make deals for the expansion of domestic manufacturing in Africa. The foundation plans to help guide negotiations in areas such as royalties, lump sum payments, and the geographical scope in which licenses are valid. It also aims to help enable companies and public sector institutions to build their own capacities to innovate. Since its launch, the foundation’s team has been busy building its structure, which has included setting up its board, advisory council, operational procedures, and office in Kigali. The foundation signed a host country agreement with Rwanda in December. “Technology and knowledge transfer are central. The new African Pharmaceutical Technology Foundation will help Africa gain rapid access to the latest pharmaceutical breakthroughs,” said Dr. Vincent Biruta, Rwanda’s minister for foreign affairs and international cooperation, at the ceremony. And starting this month, they’re ready to get to work. Professor Padmashree Gehl Sampath is leading the charge as the chief executive officer and will initially be accompanied by five staff members. “We anticipate that we will grow considerably over the course of [the] year,” Sampath said. The foundation will work with pharmaceutical companies, institutions, and governments and is starting off by launching four main programs as part of its five-year plan. “These programs have been chosen bearing in mind what's already going on in the region and where we can intervene to have a lot of impact,” Sampath said. The 4 programs • Helping African firms achieve “Good Manufacturing Practice” certification — a compliance with World Health Organization standards that indicates a manufacturer has built into its operations quality assurances that reach international standards, commonly known as WHO prequalification process. One of the most challenging aspects of participation in the pharmaceutical market involves companies working to comply with stringent regulatory processes for the approval and registration of medicines, and the continuous redesign and oversight of production facilities to reach this level of compliance, Sampath said. Some companies don't have the committed staff, technology, or resources to do this but the foundation aims to assist in this area. It will help local manufacturers with designing their plant and equipment, as well as helping them prepare dossiers that are submitted to WHO — the process in which manufacturers provide the global agency with the necessary documents to prove their product reaches a high enough quality. According to Sampath, for companies aspiring to supply both the regional African market and internationally, this “Good Manufacturing Practice” compliance with WHO standards for their products “will be critical.” • Using TRIPS flexibilities in the African region — leeways in the World Trade Organization’s agreement on trade-related aspects of intellectual property rights which allow the legal space to produce generic medicines. The foundation will work with countries to assess what types of intellectual property they need, identify what sort of TRIPS flexibilities they can use to locally produce, and train patent offices on how to examine patent applications that contain the use of these flexibilities. It will also work with countries on market shaping to help ensure that when manufacturing companies invest in the production of a product, there’s enough local demand to ensure the product will be purchased. "An overarching objective of the foundation is to match technologies with financing and markets. This is where the market shaping work will fall," Sampath said. • Building a biosimilars industry in Africa. Biogenerics, which are created when a pharmaceutical patent on biological drugs expires, are heavily undersupplied in the region because they are complex to produce, she said. The foundation will work to foster their production in order to improve access to these drugs which can be used for diseases ranging from cancer to diabetes. • Building “regional centers of excellence” for pharmaceutical production. The foundation will work to forge partnerships with universities and the manufacturing sector to encourage knowledge-sharing and ensure they are linked in similar ways that “have been instrumental for the blossoming of the pharmaceutical sector in industrialized countries,” Sampath said. “We are already in touch with many manufacturers both in Africa and outside — and [now], they can start approaching us,” Sampath said, adding that they can reach out to them through their new website. She noted that the foundation also aims to create an African technology pharmaceutical marketplace to serve as a forum where firms can form partnerships, based on the pharmaceutical technology areas in which they work. She said this marketplace will be in place starting in April. This month, the board of Gavi, the Vaccine Alliance, approved the creation of the African Vaccine Manufacturing Accelerator, which will make up to $1 billion available over 10 years to support vaccine manufacturing on the continent. Sampath said she’s in discussion with Gavi about this new accelerator and how the foundation can support that process, as well as working to ensure the local manufacturers the foundation works with can upgrade their operations to be of “Good Manufacturing Practice” standards so they can then receive funds from the new accelerator. The foundation is also in dialogue with the Coalition for Epidemic Preparedness Innovations, the AU’s Partnerships for African Vaccine Manufacturing, PATH, the Africa Centres for Disease Control and Prevention, and AfDB. And it expects to work closely with the secretariat of the African Continental Free Trade Area moving forward. The foundation’s host, Rwanda, also hosts the new African Medicines Agency, which is yet to officially launch. Sampath said the AMA will be a sister agency for the foundation. “We're going to work very closely with them because technology is a very important part of being able to achieve regulatory compliance. We anticipate that they will be a natural ally in growing an institutional ecosystem in Africa to support the pharmaceutical sector,” she said. Key funders of the foundation include Germany’s Federal Ministry for Economic Cooperation and Development and AfDB. The foundation also signed a memorandum of understanding with the European Investment Bank to co-finance projects this week. "We have ongoing discussions with several other funding agencies, which will develop and mature over the course of the next few months,” Sampath said.