“Diagnostics are a critical enabler of #HealthForAll”
Dr Tedros Adhanom Ghebreyesus, Director-General, World Health Organization
Outbreaks and emergencies have a way of exposing weaknesses in health systems and governance. Predictably, the COVID-19 outbreak has forced countries, laboratories and companies to scramble for rapid testing options. Quality of existing kits has come under scrutiny. There is unanimous agreement that early detection is critical for controlling this new pandemic.
Even when companies and donors invest in diagnostics during outbreaks, there is little interest in sustaining them, when the threat level declines. We saw this with the Ebola outbreak in West Africa, which led to a surge of R&D efforts around diagnostics. When the outbreak emerged in the Democratic Republic of the Congo, very few tests were accessible. There is the risk that this might play out again with the COVID-19 outbreak. While numerous research and product development efforts are now underway, will they disappear, once the scare and media interest vanish?
BROOMFIELD, CO – MAY 06: Matt Boisen, Corgenix program director-infectious diseases and emerging …[+] DENVER POST VIA GETTY IMAGES
The neglect of diagnostics
Undoubtedly, diagnostics are a fundamental component of a successful outbreak containment strategy, enabling evidence-based control strategies to be implemented without delay in order to contain the outbreak, minimize response costs and save lives. But why is diagnostic capacity discussed only during outbreaks and emergencies? The answer is neglect.
The global health community has neglected diagnostics for decades. Instead of investing in diagnostics and laboratory systems, undue emphasis was placed on empirical or syndromic management for many years. This explains why an Essential Medicines List was developed in the 1970s, but an Essential Diagnostics List was only developed in 2018.
When tests were promoted in low and middle-income countries (LMIC), the focus was on rapid tests for a few priority diseases (e.g. malaria, HIV). Rapid tests were perceived to be the only realistic option for poor countries, and no efforts were made to build or strengthen laboratory networks, with trained laboratory professionals.
Improvement of laboratories and strengthening health systems is still considered too expensive and difficult by many governments and donors. This explains why we struggle to manage conditions for which no simple rapid tests exist. This also explains why health systems with weak laboratory infrastructure cannot detect outbreaks early, nor offer comprehensive diagnostic services that cover a wider range of conditions, including antimicrobial resistance (AMR) and non-communicable diseases. To address AMR, in particular, diagnostics are crucial.
No UHC without diagnosis
The SDG goals require all countries to deliver on their pledge to ensure Universal Health Coverage (UHC) by 2030. As my colleagues and I have argued earlier, countries simply cannot achieve UHC if they are missing large numbers of people with treatable conditions. This is evident in a variety of studies that have constructed cascades of care, to assess gaps in health system performance. Cascade-of-care analyses for tuberculosis, diabetes, HIV, hepatitis C, malaria, and hypertension have each shown big gaps at the diagnosis stage. The consistency of diagnosis as a key gap across communicable and non-communicable diseases is quite remarkable and begs the question: how can any country deliver UHC with so many people failing to get diagnosed?
Diagnostics are also critical for many diseases that do not present as pandemics. That does not mean that we ignore them. For example, there are many neglected tropical diseases (e.g. leishmaniasis, sleeping sickness) where novel diagnostics are making a big difference, especially as elimination becomes a reality.
Blood tests are submitted to a reactive color test. The World Health Organization (WHO) has set up … [+] CORBIS VIA GETTY IMAGES
Medicines, undeniably, are crucial for disease management and prevention. But can we afford to continue emphasizing access to essential medicines, without access to essential diagnostics? As my colleagues and I have argued, all efficient and responsive health systems need both diagnostics and drugs. They are a package deal. Each needs the other, for optimal impact on patients and health systems.
When countries develop their UHC benefits packages, they must explicitly include and budget for essential tests, along with medicines. If this is not done, tests are not accessible to people who need them the most. Take the urine LAM test for TB among people living with HIV. Despite its simplicity, low cost, WHO endorsement, and potential to save lives among severely ill and hospitalized persons with HIV co-infection, its adoption and scale-up has been disappointing.
Country-led initiatives are key
In this context, it is critical for countries to develop their own national essential diagnostics lists, based on their national disease burden, felt needs, and priorities. Countries can also align their EDL with their national EML. The national EDL can then be used to guide the inclusion of tests within UHC benefits packages, inform procurement, and facilitate budgetary allocation.
Most countries routinely measure access to essential medicines. The national EDL can be a useful benchmark for measuring access to essential tests, which should become a key performance indicator for monitoring progress towards UHC.
India has shown leadership in this area. India has not only developed a National EDL, but also used the EDL to benchmark availability in the health system. India’s national EDL, in fact, is more comprehensive than the WHO EDL. India has also expanded access to testing via its Free Diagnostics Initiative, in an effort to reduce out-of-pocket expenditure on healthcare.
We need a strategic alliance of all stakeholders
We simply cannot continue to neglect diagnostics and laboratories. And we cannot afford to think about diagnostics only during outbreaks and emergencies. That is myopic, unsustainable, and, frankly, detrimental to the UHC agenda. After all, ‘shoe-leather public health and basic medical care’ is what stops outbreaks and ensures global health security. No basic medical care is complete without diagnosis.
What we need is a long-term, strategic, well-resourced alliance of all key stakeholders, to make sure essential diagnostics are available, affordable, and accessible in all LMICs, at all tiers of the health system, during all periods (not just during outbreaks). Stakeholders include country governments, WHO and other key UN agencies, donors, diagnostics industry, academics, NGOs, and civil society.
Alliances like GAVI have made a big difference in ensuring access to quality vaccine in even the remotest areas. Why can we not dream of something similar for diagnostics? With the rapid growth of the WHO Essential Diagnostics List, development of national EDLs by countries, renewed emphasis on primary healthcare and UHC, and exciting technological innovations (e.g. AI, digital health, point-of-care platforms), there is great opportunity to galvanize all key stakeholders to come together to solve the age-old diagnostic gap in global health.
While proposals for such a diagnostic alliance have been made in the past, little progress has been made, until now. Earlier this month, WHO and the Foundation for Innovative New Diagnostics (FIND) executed a memorandum of understanding to a strategic collaboration that will strengthen diagnosis in resource-poor countries by closing major diagnostic gaps at a country level and bolstering disease surveillance that will inform public health initiatives and enhance outbreak preparedness. Hopefully, such efforts will inspire a country-led diagnostics alliance.