The last few years since the onset of the COVID-19 pandemic have revealed the vulnerability of Africa’s pharmaceutical sector and the critical need for Africa to strengthen its local manufacturing capacity. With the growing burden of diseases on the continent, Africa must achieve self-reliance to cater for the increasing healthcare demands of its population.
Unfortunately, pharmaceutical manufacturing companies in Africa face immense challenges such as poor availability of sustainable financing (including market access), inadequate access to know-how, unreliable supply chains, and inexperienced regulatory authorities. The pharmaceutical industry in Africa is also severely constrained by intellectual property rights protection and patents on technologies, know-how, manufacturing processes, and trade secrets. This limits the negotiation capacity of African pharmaceutical companies to engage within the global pharmaceutical industry and take part in complex global pharmaceutical innovations.
In view of these challenges, the African Development Bank has approved the establishment of a ground-breaking institution, the African Pharmaceutical Technology Foundation (APTF) to strengthen the local capacity for manufacturing medicines, vaccines, and other pharmaceutical products. However, Africa’s capacity to leverage on the opportunities the APTF provides will depend strongly on the committed collaboration of African governments and the capacity of their National Medicines Regulatory Authorities (NMRAs). This is because NMRAs play a leading role in guaranteeing availability of quality-assured medicinal products in their respective countries, ensuring that medicines, including vaccines, medical devices, and other pharmaceutical products meet applicable standards of safety, quality and efficacy.
APTF and the impending boom in Africa’s pharma sector
Establishing the APTF will be a game-changer in Africa’s pharma sector. The foundation will serve as a transparent intermediator, advancing and brokering the interests of Africa’s pharmaceutical sector with global pharmaceutical companies to share IP-protected technologies, know-how, and patented processes. Hence, strengthening innovation in Africa’s pharmaceutical and vaccine ecosystem.
With this impending boom in Africa’s pharma sector, NMRAs must upgrade and strengthen their capacity in order to leverage on these opportunities to achieve a sustainable transformation in the pharmaceutical industry within their respective countries. The APTF must also support this improvement initiative with funding to maximize the impact of its investment.
NMRAs and their critical role in Africa’s pharma sector
NMRAs play an indispensable role in increasing patients’ access to quality-assured medicinal products. They are responsible for the registration and licensing of medicines; supporting initiatives for local manufacture of medicinal products; decision-making concerning the market authorization of medicinal products; supporting post-marketing surveillance; amongst others.
Unfortunately, although there are 54 NMRAs and quasi-NMRAs in Africa, most are incapable of performing the core functions expected of NMRAs.
Strategies to strengthen NMRAs in Africa
The WHO plays a pivotal role in supporting countries to strengthen their regulatory systems. The WHO Global Benchmarking Tool (GBT) is a significant part of the five-step program created by the WHO to increase the capacity of NMRAs. The GBT also incorporates the concept of ‘maturity level’ or ML, allowing WHO and regulatory authorities to assess the overall ‘maturity’ of the regulatory system on a scale of 1 to 4. Currently, only three NMRAs in Africa; Tanzania, Ghana, and Nigeria have achieved a maturity level 3 (ML3) rating. This means that only these three NMRAs have reached the level of a regulatory system operating as a stable, well-functioning, and integrated system.
Africa must leverage on the WHO GBT tool to strengthen its regulatory capacity. By using the GBT, NMRAs can identify where their strengths and weaknesses lie, and then collaborate with the WHO and other international experts to carry out a formal benchmarking process and create an effective institutional development plan that is tailored to their unique needs. The APTF should seriously consider catalysing this process by providing some necessary critical funding requirement to achieve this.
NMRAs will also benefit from strategic collaboration with stakeholders in the pharmaceutical and public health sector to provide expert guidance. There is a need to benchmark African NMRAs in a more transparent and objective manner, based on agreed criteria, to identify the different levels of capacities and performance. A good example of such strategic collaboration is the support provided by Bloom Public Health to African countries to establish a strategic plan and roadmap, which can lead to the migration of NMRAs to a high level of the WHO Global Benchmarking tool category.
It is also important that NMRAs on the continent take advantage of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) membership to build the capacity of its inspectors as promoted by the Africa-wide PIC/S Initiative. There is an urgent need for massive capacity building, not just for inspectors, but also for other regulatory functions.
The adoption of these strategies will ensure the preparedness of NMRAs to collaborate with the APTF for a sustainable transformation of Africa’s pharmaceutical industry.
Conclusion
Establishing the APTF is an innovative intervention in achieving an emergent, self-reliant pharmaceutical industry in Africa. African governments must therefore show a strong commitment to strengthen the capacity of their NMRAs and leverage on the possibility of funding from the APTF thereby building a resilient pharmaceutical industry on the continent.
Anyakora is the CEO of Bloom Public Health and a public health expert &
Odibeli is a pharmacist and the research and communications coordinator at Bloom Public Health
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