African Pharmaceutical Technology Foundation, others: Opportunities local African pharmas should not let go
COVID-19 laid bare Africa’s huge reliance on imported pharmaceuticals, with the continent importing as much as 90 percent of its drugs at an annual cost of about $16 billion. This overreliance of Africa’s pharmaceutical sector on other countries has resulted in gross medicine insecurity and challenges in the medicine supply chain within Africa, as well as the continuous proliferation of substandard and falsified medicines on the continent.
The pharma sector in Africa cannot meet the enormous demand for medicines due to its poor local manufacturing capacity.
The high cost of pharmaceutical manufacturing with limited access to reasonable funding, lack of supportive infrastructure for the regulatory compliance of pharmaceutical manufacturing companies, poor regulatory policies, and lack of negotiation capacity to engage with global pharmaceutical companies are some challenges confronting local African pharma manufacturers.
This critical situation has in the last decade and more urgently in the last few years, drawn significant attention from the World Health Organisation and the African Development Bank, among others, and emphasised their need to provide sustainable interventions for Africa’s pharma sector to produce medicines locally.
Given the tremendous benefits that these interventions provide for Africa’s pharma sector, local pharma manufacturers on the continent must be prepared to leverage these opportunities to increase their manufacturing capacity…
Opportunities local African pharma manufacturers should not let go
A new determination to provide medicines locally has led to the development of various interventions and initiatives to support local pharmaceutical manufacturing on the continent and increase the capacity of Africa’s pharma sector to compete globally. Some of these key interventions and the opportunities they provide include:
1. The establishment of the African Pharmaceutical Technology Foundation
The African Development Bank has approved the establishment of the African Pharmaceutical Technology Foundation, an innovative institution that will strengthen Africa’s access to the technologies that support the manufacturing of medicines, vaccines, and other pharmaceutical products.
Hosted by Rwanda, the APTF will serve as a transparent intermediator, advancing and brokering the interests of Africa’s pharma sector with global pharmaceutical companies to share IP-protected technologies, know-how, and patented processes. Hence, local African pharma manufacturers will engage in local production initiatives with systematic technology learning and technology upgrading at the plant level. African pharma manufacturers will also benefit from the expertise of the APTF’s world-class experts.
2. The establishment of the African Medicines Agency
The value of the AMA in harmonizing regulatory systems for pharmaceutical products and increasing the capacity of national regulatory authorities across Africa holds tremendous benefits for local African pharma manufacturers.
The AMA will provide clear, efficient, science-based regulatory pathways that will encourage pharmaceutical companies to pursue approvals of medical products, by reducing the time, money, and effort required to register the same medical product in different countries.
By providing guidance on the marketing authorization process, the AMA will strengthen efforts for the control of a growing cross-border market of unregulated and fake medicines in circulation on the continent. This will significantly reduce the competition faced by genuine local pharma manufacturers in marketing their products.
The AMA will also strengthen local manufacturing capacity by expediting the reviews of clinical trial applications for vaccines and assessment of “highly complex” product dossiers and coordinating joint inspections of Active Pharmaceutical Ingredients (API) manufacturing sites.
3. The WHO mRNA technology transfer initiative
The WHO and its partners have established a global technology transfer hub for mRNA vaccines in Afrigen, Cape Town, South Africa. The goal of this initiative is for manufacturers from low-and-middle-income countries (LMICs) to receive the training and licenses to manufacture vaccines locally and for technology transfer.
The WHO has announced that the first six African countries that will receive technology from the technology transfer hub to produce their own mRNA vaccines are Kenya, Nigeria, Egypt, Senegal, South Africa and Tunisia.
This will provide the necessary know-how and human capital training to enable these countries to build capacity for rapid production of vaccines and biological products. African countries and local pharma manufacturers should therefore leverage this project to secure a pipeline of talents for vaccine manufacturing in Africa.
4. The WHO prequalification of medicines programme
Pharmaceutical manufacturers that attain WHO PQ of their product establish their capability to produce medicines that consistently meet stringent standards of quality in line with WHO specifications and global standards.
This provides opportunities for increased sales and market access by conferring eligibility for international, donor-sponsored tenders for medicines; improved capacity to manufacture products for entry into stringently regulated markets; increased potential to compete successfully for contract manufacture for local markets; and faster registration.
African governments must therefore see the critical need for investment in the WHO PQ of local pharmaceutical companies as a non-negotiable pathway to strengthening Africa’s pharma sector. It is worth mentioning that in a World Bank-funded program, Nigeria’s National Institute for Pharmaceutical Research and Development (NIPRD) and its technical partner, Bloom Public Health, will begin support of selected Nigerian pharmaceutical manufacturers through the process of WHO PQ. This will be the biggest pharmaceutical intervention in the country and an outstanding model for other African countries.
Given the tremendous benefits that these interventions provide for Africa’s pharma sector, local pharma manufacturers on the continent must be prepared to leverage these opportunities to increase their manufacturing capacity and position themselves as global competitors in the pharmaceutical industry.
Anyakora is the CEO of Bloom Public Health and a public health expert &
Odibeli is a pharmacist and the regional communications manager at Bloom Public Health