Advances in medical science and technology are rapidly changing and as we saw with the pandemic, diagnostic tests play a pivotal role in health care decision making. They inform treatment decisions, save costs and, most importantly, deliver better outcomes for patients. Unfortunately, these life-changing innovations are all too often not available to many of the people who need them most. Currently, 47 percent of the global population and 81 percent of people in low and lower-middle income countries have little or no access to life-saving diagnostics.
If you’re following the policy trend at large — or even if you’re not — this is where we inevitably turn to discussions of the role of Universal Health Coverage (UHC) in the pursuit of better access to screening and diagnosis. Population health is not only in the best interest of individual countries, but as evidenced by a global pandemic, it is important to global health as well. UHC — ensuring people can access the health care they need, when they need it, without financial hardship — is foundational to improving world health care.
Currently, 47 percent of the global population and 81 percent of people in low and lower-middle income countries have little or no access to life-saving diagnostics.
So, where do we start? With better access to diagnostics.
After the world faced a global pandemic and pulled together, we all learned vital lessons which must not be forgotten. First and foremost, we saw that by working together and sharing information early, we could develop diagnostics and vaccines faster. This learning must extend beyond times of crisis.
We also saw that health systems with well-developed diagnostics infrastructure were more effective at containing and controlling the pandemic. And they were better able to continue providing essential diagnostic tests and treatment monitoring for patients with other diseases such as cancer.
Normally, it would take years to bring a new test to market. Here — through focus and collaboration — we managed to do so in months.
As the world responded to urgent calls for better access to COVID-19 tests, hopes were also expressed that this would spark innovation leading to widespread testing, vaccines and treatments, which ultimately would reduce the spread of the pandemic.
After the World Health Organization (WHO) declared COVID-19 as a public health concern, the urgency galvanized companies to work at full speed. The first Polymerase Chain Reaction (PCR) tests for SARS-CoV-2 were available for limited laboratory use within eight days. Only 64 days later PCR tests were authorized for use and available for scaled-up testing in major health centers.[1]
Normally, it would take years to bring a new test to market. Here — through focus and collaboration — we managed to do so in months.
As reported by the Lancet Commission, investing in diagnostic capabilities has been shown to lead to fewer misdiagnoses, better use of resources, and better patient care.
Driven by necessity, countries invested in diagnostics capabilities to fight the virus and, as reported by The Lancet, real change was seen at a pace that would previously have seemed impossible.
Why stop there?
The recommended WHO Resolution on strengthening diagnostics capacity represents an important step toward recognizing access to diagnostics as a policy priority as well as establishing concrete policy measures, to ensure equitable and timely access. It would pave the way for a considerable shift in strengthening our health care systems, driving progress toward global health equity and global health security.
As reported by the Lancet Commission[2], investing in diagnostic capabilities has been shown to lead to fewer misdiagnoses, better use of resources, and better patient care.
Early diagnosis is the cornerstone of sustainable, efficient and resilient health care systems. This in turn would reduce late-stage health care expenditures, including long-term costs of chronic disease management and disability, and better manage costs for patients, payors and governments.
Increasing access to diagnostics is crucial to controlling and potentially even eradicating certain diseases like cervical cancer, HIV, tuberculosis, viral hepatitis and malaria.
Laboratories are an essential component of a sustainable, efficient and resilient health system. But only if there’s enough of them and trained staff to run them.
The crux of the matter is that staff shortages in both high-income countries and low- and middle-income countries continue to create a barrier to diagnostic services.
How short-staffed are we? Well, to put a number on it, an estimated shortage in diagnostic workforce capacity saw a need for an additional 480,000-576,000 staff to support diagnostic testing.[2] And who loses when we don’t have enough skilled laboratory professionals? Patients.
Investment in diagnostics such as improving laboratory infrastructure and workforce development must also be supported by smart local regulatory approaches. This will ensure that patients, regardless of where they live, have timely access to innovation and safe, effective diagnostics.
Health care could enter a new golden age, shifting our focus from primarily treating disease to preserving health through prevention and by helping people live longer, more healthy lives.
This can be through adherence to international best practices, such as those created by International Medical Device Regulators Forum and implementation of regulatory reliance models — where one regulatory body (or the WHO) relies on the decisions, such as marketing authorizations, inspections and product changes, already made by trusted authorities and recognized institutions.
Governments should prioritize expansion of professionals with expertise in pathology and laboratory medicine[3] and introduce laboratory personnel as a key component of workforce initiatives to address the needs of currently over-burdened health care systems.
A new golden age for health care?
Roche is building partnerships to increase access to diagnostic solutions in low- and middle-income countries and to strengthen targeted laboratory systems through workforce training classes. In May 2022, Roche entered a partnership with the Global Fund to support low- and middle-income countries in strengthening critical diagnostics infrastructure. The aim is building local capacity to tackle infrastructure challenges to improve diagnostic results and manage health care waste. This is in line with Roche’s ambition to double patient access to innovative, high-medical-value diagnostics for people around the world.
Health care could enter a new golden age, shifting our focus from primarily treating disease to preserving health through prevention and by helping people live longer, more healthy lives.
To achieve the golden age we need to learn from the past. All public and private stakeholders have a duty to work together to ensure diagnostics continue to improve health outcomes around the world by bringing this important resolution to life.
Where a person lives should no longer be the key determining factor in their health. We have a tremendous opportunity here, let’s take it.
[1] Accelerating diagnostic tests to prevent a future pandemic. Bill Rodriguez. Cepi. Available at: https://100days.cepi.net/100-days-mission-diagnostic-test-future-pandemic/ (Accessed 04.04.2023)
[2] The Lancet Commission on diagnostics: transforming access to diagnostics. Fleming, Kenneth A et al.The Lancet, Volume 398, Issue 10315, 1997 – 2050. https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(21)00673-5.pdf
[3] https://www.ihe.net/ihe_domains/ihe_pathology_and_laboratory_medicine/ (Accessed: 04.04.2023)