The quest for Africa’s diagnostic self-sufficiency

By guest contributor Zibusiso Ndlovu

Despite the undeniable public health progress in recent decades, the African continent continues to face significant health challenges, especially from rising rates of non-communicable diseases (NCDs), emerging and resurging infections (Ebola, cholera, COVID19, polio, yellow fever, mpox), endemic diseases (HIV, TB, malaria) and rising prevalence of antimicrobial resistance (AMR), among other challenges. Africa has major diagnostic gaps, including suboptimal public health preparedness and it has continued to lag-behind in some health outcomes.

By the year 2050, Africa’s population is expected to double to two billion inhabitants, and this growth, combined with climatic and ecological changes, is likely to lead to perennial disease outbreaks. Reimagining diagnostic self-sufficiency of the future is an important discourse for Africa and this post explores the readiness of Africa to pursue diagnostic self-sufficiency.

Re-imagining diagnostic capacity in Africa

In the midst of COVID-19, Africa learned how fragile global cooperation could be during a crisis and the diagnostics market exposed how international solidarity can easily collapse. Lately, manufactures of CD4 point-of-care (POC) instruments exited the low and middle income market, yet CD4 cell count testing is critical for identifying advanced HIV disease, which killed 630,000 people living-with-HIV in 2022 (majority in Africa). Global health has colonial origins together with stark structural inequities that depict a “saviourship character” and the re-imagination of the 21^st century global health, gives opportunity to improve diagnostic efficiencies and regional diagnostic manufacturing.

Local diagnostic manufacturing is an existential priority for public health resilience in the African continent and self-sufficiency in diagnostics for Africa should enable economic growth. It is untenable that basic rapid diagnostic tests (RDTs) used to diagnose HIV are still being imported from global north (mostly through global north donor funding); leaving no value-add to Africa’s economies. Similarly, importations for basic lateral flow assays (LFA) for other diseases and conditions (urinalysis sticks, pregnancy tests) including RDTs for malaria, COVID-19, hepatitis, cholera, syphilis, etc are happening. Whilst partners have been crucial in the support of national programs, this should not come at the expense of a “colonization saviourship”, but strategic and collaborative partnerships that can enable trickle-down to enhance Africa’s economic growth. Basic LFAs and RDTs, most of which are already being produced in Africa (from companies like MAScIR (Morocco), Medical Diagnostech (South Africa), Revital Healthcare (Kenya), Diatropix (Senegal) and some already pre-qualified by WHO, should be procured and used Africa-wide, if they meet quality standards. These and other companies have demonstrated manufacturability of diagnostics in Africa, however, they have limited visibility. India supports locally produced diagnostics, which now compete internationally. Business as usual for diagnostics in Africa will not do. The idea of supporting African manufacturing should go hand-in-hand with decolonizing this space as funders still choose diagnostic products from global north. Procuring African-based manufacturing of diagnostic tests can help build a strong foundation for future capacity of diagnostic manufacturing for many health threats. The high disease burden in the continent constitutes a great incentive and a significant market for the diagnostic manufacturing industry.

However, re-imagining this diagnostic self-sufficiency requires effective support and collaboration from all stakeholders, including funders, governments, non-governmental agencies, private industry, academia and professionals.

Opportunities and areas of improvement

The African Union’s (AU) 2063 agenda sets Africa’s blueprint for transforming Africa into the global powerhouse and endorses health as a cornerstone agenda. Self-sufficiency in diagnostics will be critical to supporting this vision. As Africa CDC solidifies its autonomy as the leading regional health body of AU (together with African Medicines Agency, AMA), they should help to:

• Spotlight continental efforts to diagnostic manufacturing,
• Operationalize and harmonize regulatory structures,
• Support creation of an African waiver diagnostic list for use by donors and countries,
• Support/explore continental supply chain frameworks

The recent partnership between Global Fund, UNITAID and PEPFAR to accelerate the manufacturing of HIV RDTs in Africa is commendable as it contains the ‘seeds’ of a large-scale re-imagination of Africa’s diagnostic manufacturing. With support from WHO, this partnership is launching a pilot, open Expert Review Panel for Diagnostic Products (ERPD) call for expression of interest from African manufacturers. However, other disease tests should be included in the near future. Another commendable initiative is PEPFAR’s aim to procure 15 million HIV tests produced by African manufacturers by 2025.

Global health in Africa has largely been donor led and many countries have struggled to improve domestic health financing. This continued under-investment in domestic finance represents an important threat. Investments in diagnostics must be part of the strategic and trade priorities for African governments. Innovative financing mechanisms through public-private partnerships (PPP) for emerging manufactures should be expedited and governments should facilitate easier importation of raw materials (waiver import duty).

The COVID-19 pandemic improved collaborations between private and public diagnostic laboratories. To enhance diagnostic self-sufficiency, public health sector laboratories can harness expertise of private diagnostic laboratories in areas of laboratory management, sample and result transport, systems digitization, supply-chain and logistics including outsourced testing. These partnerships should be strengthened and have mutual benefit.

Research-and-development in some African institutions is scarcely linked to commercialization. However, it is commendable that some universities (like Witwatersrand and Stellenbosch in South Africa) have entrepreneurial subsidiaries (Wits Health Consortium and InnovUS, respectively) that pursue technology transfer and commercial interests from their R&D, whereas the Pasteur institute in Senegal launched Diatropix.

Africa now has a considerable laboratory workforce ‘fit-for-purpose’ and has over 1025 accredited laboratories across 29 countries and the depth of the transformative continental collaboration and sharing of best-practices among the scientific community (steered by ASLM and partners) has been exceptional. This is fundamental to the journey of Africa’s diagnostic self-sufficiency.

Other commendable initiatives include the Global Frugal Diagnostic Network which aims to support and stimulate equitable innovation in diagnostic development in resource-limited settings. Also, the Africa Collaborative Initiative to Advance Diagnostics (AFCAD) which seeks to support efforts that will enable member states to achieve equitable access of up to 80% coverage to the essential package of health.

Efforts are needed to explore and collate a tracking-list of African manufactured diagnostic products, including their diagnostic performance data and-or regulatory status. Data on the potential regional market size can be included.

However, community-based organizations (CBO), should be included to increase their literacy around diagnostics and for their input in; exploring potential diagnostic use-cases, scoping potential market size and advocating for geo-equitable laboratory access (as most laboratories are in urban settings yet 52% of population lives in rural areas). Equally, conferences for diagnostics should have CBO representatives. Similarly, politicians are proponents for most of these ideas and keeping them involved can give potency.

Conclusion

The future of diagnostics in Africa is promising. Africa’s quest for diagnostic self-reliance is not self-isolation, but a commitment (beyond the rhetorical nod) to revise its global health diagnostic security and economic growth. However, there will be challenges, which may be far greater than conventional wisdom allows; but Africa must engage actively.

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About the author:

Zibusiso ‘Zee’ Ndlovu is a diagnostics advisor and epidemiologist with Medecins Sans Frontieres/Doctors Without Borders (MSF). He provides strategic and technical diagnostic support to MSF programs in Africa, Asia and Middle East.  He tweets at @okaNdlovini; Contact: ndlovinizee@gmail.com

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