By Dr Ifedayo Adetifa, CEO, FIND
The 2026 African Union Summit has come and gone, along with numerous meetings and side events united by a common theme: health financing, local manufacturing, global health architecture reform, and advancing Africa’s health security and sovereignty. Having sat through enough high-level meetings, I know that the distance between a well-crafted declaration and a functioning diagnostic test at a primary health clinic in rural Gambia, Kenya, or northern Nigeria can feel infinite. We have all become good at articulating the problem and remarkably adept at the language of reform.
Five years ago, the 2021 Lancet Commission on Diagnostics reported that almost half the global population had little or no access to diagnostics, and that over a million premature deaths in low- and middle-income countries could be avoided annually by closing the diagnostic gap for just six priority conditions. The 2024 Commission update found that advancement was slowest on recommendations with substantial resource implications, specifically labour force, affordability, and diagnostics in fragile settings. The 2025 Global Diagnostics Gap Assessment, produced jointly by the International Pandemic Preparedness Secretariat, the Brown University Pandemic Centre, and FIND, identifies six major interconnected barriers across the diagnostics ecosystem, including underinvestment, delayed access to pathogen data, and the absence of clearly defined target product profiles. These are not technical puzzles but systemic failures.
Africa has not been silent. For seventeen years, the Maputo Declaration of 2008 made the moral case for quality-assured laboratory services as a pillar of health system strengthening. The Lusaka Agenda calls for transitioning out of donor dependency and places domestically financed primary health care as the cornerstone of health sovereignty. The 2025 Accra Compact and the 2026 Addis Reckoning both call for moving from resilience to reliance, including prioritising regional manufacturing of diagnostics. The 2023 WHA Resolution on diagnostics, the first of its kind, formally recognised diagnostics as essential to universal health coverage. Ministers, presidents, and commissioners have all spoken with clarity and conviction.
Yet every day, a mother presents at a primary health clinic (PHC) with a febrile child and there is no rapid diagnostic test available. A clinician makes a presumptive diagnosis and prescribes accordingly, often incorrectly. This is not a hypothetical but the lived reality of hundreds of millions of people that no communiqué can mask. In the WHO African Region, 40% of countries have no regulations for medical devices, and 60% lack national essential diagnostics lists that meet WHO recommendations. This is the backdrop against which we expect declarations to deliver change.
To move from rhetoric to action, we must acknowledge that a health system without a diagnostic backbone is not a system at all. The state of health in Africa is fundamentally a political decision. When a country allocates 4% of the national budget to health rather than the 15% pledged in Abuja, that is a choice. When a Ministry of Health has an essential diagnostics list that has never been operationalised at the facility level, that is also a choice. Sovereignty without adequate domestic financing is just a slogan. Health sovereignty cannot be donated, and it does not arrive with a declaration; it requires a budget line backed by law. So, what needs to be done?
National essential diagnostics lists must move from paper to practice. Too many countries have lists sitting in policy documents while primary health clinics operate without a single functioning rapid test. Implementation requires supply chain investment, training, quality assurance, and sustained procurement financing. Communities need integrated testing at the primary health level for fever syndromes, maternal and neonatal conditions, and non-communicable diseases. While the technology exists, the political and financial commitment to deploy it consistently is lacking.
Perhaps the most significant silent barrier is the fragmented regulatory landscape. The newly operationalised African Medicines Agency holds immense potential to transform access to quality-assured diagnostics across 55 member states. Compared to medicines, the regulatory landscape for in vitro diagnostics is considerably weaker, and the AMA must prioritise IVDs as a core workstream. The harmonised IVD registration pathways being built by Africa CDC’s Diagnostic Advisory Committee and AUDA-NEPAD’s AMRH initiative must also be accelerated, resourced, and politically protected.
Third, market fragmentation must be addressed as a structural problem. With 55 different procurement systems, African manufacturers face high entry costs and unpredictable demand. Pooled procurement, aligned with AfCFTA commitments and the Lusaka Agenda’s single-plan approach, can create the demand certainty that incentivises investment. Without viable markets, local diagnostics manufacturing will remain aspirational.
Fourth, health financing must be treated as the emergency it is. The contraction of donor financing has exposed the danger of aid-dependent health systems. African governments must urgently increase health budget allocations, protect diagnostic procurement specifically, and explore domestic financing mechanisms such as health levies, pooled insurance, debt swaps, and sovereign health funds capable of protecting essential services from external shocks.
The continental architecture, from the AMA to Africa CDC’s Diagnostic Advisory Committee to the Global Diagnostics Coalition, is more coherent now than at any point in the past two decades. As the 2024 Lancet Commission update rightly observed, greater progress has occurred where political will is aligned with industrial policy goals.
We are not just approaching a diagnostics crisis in Africa. Truth be told, Africa has been living through one for generations. The mother with the febrile child at the PHC is not waiting for the next summit. She is waiting for a test.
There is a need to support Africa’s continental aspirations and to work alongside governments, regulators, manufacturers, and communities to turn the ambitions of the Lusaka Agenda, the Accra Compact, and the WHA Resolution into diagnostics that reach patients. Africa has waited long enough.