NEW YORK – Citing inadequate access to medical testing that leads to serious illnesses and premature deaths in remote and low-income homes worldwide, the World Health Organization is calling on member countries to invest in tools and policies that could close those gaps, including adding diagnostics strategies within their national health plans.
While most of the change will have to come from actions by the affected countries, the WHO said it will provide expertise and technical guidance to help them close such gaps.
The World Health Assembly, the decision-making body of WHO, said in a resolution that diagnostic services, including in vitro laboratory tests and in vivo services such as imaging and blood pressure monitoring, are vital for human health. The resolution, issued May 27, builds on the WHO's advocacy efforts for member countries to invest in enabling timely and lifesaving diagnoses, as well as the organization's model list of essential in vitro diagnostic tests, first published in 2018 and subsequently updated since.
Francis Moussy, team lead for the WHO model list of essential diagnostics, said the main outcome of the resolution so far has been increased awareness about the need for better access to medical testing, especially in low- and middle-income countries. Awareness will help national authorities push for more funding and policies that could expand the reach of diagnostic technologies, he said, adding that diagnostic development firms have expressed interest in how they could use the resolution to become more involved in global health.
Moussy said the WHO already provided guidance for essential medicines and vaccines but "diagnostics and other medical devices have been more or less ignored." Even so, the resolution builds on some existing but siloed work within the WHO to bring testing to vulnerable populations.
Adriana Velazquez Berumen, a biomedical engineer and WHO medical devices team leader, said the WHO will provide model policies, technical documents, training materials, regulatory guidance, and procurement guides, "but it is really up to member states to use them." Those members, with support from non-governmental organizations, will be the ones buying the medical equipment and diagnostic tools, but can point to the resolution to help convince their parliaments to fund their efforts and justify spending proposals.
She noted that the WHO already has experts and budgets for projects to provide diagnostics for diseases such as tuberculosis, HIV, malaria, and cervical cancer, as well as efforts to expand medical testing for pregnant women and use of telehealth.
"This resolution is really like an overarching tool that says 'All diagnostics are important, we need to work together towards increasing access to all diagnostics,'" she said.
That prior work has included guidelines published in recent years on infectious disease tests including rapid tuberculosis tests and hepatitis C virus self-testing. In 2020, the WHO also signed a series of agreements to provide 120 million rapid COVID-19 tests in low- and middle-income countries.
Global non-profit diagnostics advocacy group FIND called the passage of the resolution a "historic milestone on the path to health for all, enabling countries to prioritize the systems and resources needed to ensure everyone who needs a test can get one." The organization said the resolution builds on recommendations published in 2021 by the Lancet Commission on Diagnostics, negotiations led by the southern African nation of Eswatini on behalf of the WHO's Africa Region, and advocacy by Indonesia, which committed this year to improving access to essential diagnostic tests.
In an announcement, FIND officials praised the assembly's resolution for its promise to deliver testing to hospitals, clinics, and homes for infectious and noncommunicable diseases and health conditions as well as to help countries with pandemic preparation and prevention and their efforts to reduce selection pressure for antimicrobial resistance.
In its 2021 report, the Lancet Commissions said it found that about 47 percent of the world's population had little access to medical diagnostics despite the early lesson from the pandemic that timely, accurate diagnosis is crucial to delivering healthcare. The reach of pathology and laboratory medicine was poor and inequitable, and the available data suggested similar or worse access to diagnostic imaging.
"Diagnostics are not explicitly mentioned in proposals for universal health coverage and are largely missing from national strategic plans for health, and the focus on diagnostics in the National Action Plans for Health Security is limited primarily to epidemic infectious diseases," the commission wrote. Corruption, gaps in physical infrastructure, and shortfalls of diagnostics staff contribute to the problem.
The National Action Plans are WHO-supported and state-implemented processes to build national healthcare capacities and plan for public health threats.
Velazquez Berumen said the Lancet Commission's work supported the resolution but WHO member states were the catalysts for the change. For example, Eswatini, formerly called Swaziland, and other African countries identified the shortfall in access to accessible, affordable, high-quality diagnostics, she said, while the broader collection of member countries worked on the proposal that each nation fund access to affordable laboratory tests, stethoscopes, and EKG instruments alike. Meanwhile, the WHO will develop guidance those countries could use to identify their shortcomings.
Sue Horton, corresponding author for the October 2021 Lancet article and emeritus professor at the University of Waterloo in Ontario, said she and her coauthors had promoted their findings for 18 months and pushed for the World Health Assembly to take up the cause. The resolution passed by the assembly embodies many of the Commission's key recommendations even if it did not include every subject, she said.
Horton said the resolution is an excellent first step toward expanding global access to diagnostics. It keeps in mind the lessons learned from COVID-19 about the importance of testing, while giving national governments and patients alike an advocacy tool they can use to point out shortfalls and push for changes.
The Lancet Commission members found it important to include both in vitro and in vivo diagnostics because delivering the correct medical decisions often require both. Combining spending figures for both types of tests also helps draw more attention to diagnostics even if that total remains dwarfed by spending on pharmaceuticals, Horton said.
The Lancet Commission members examined access to testing for six key conditions and found that most patients with four of the conditions go undiagnosed. An estimated 35 percent of people with tuberculosis are undiagnosed, as are 46 percent of people with HIV, 56 percent with diabetes, 61 percent with hypertension, and, in pregnant women, 62 percent with hepatitis B and 62 percent with syphilis. Reducing those gaps across the board to 10 percent underdiagnosed would prevent about 1.1 million premature deaths in low- and middle-income countries, the authors wrote.
"Global access to high-quality diagnostics is poor, and even when diagnostics are available, they are often of variable quality," the authors wrote. "Access is also inequitable, with diagnostics often being more readily available in larger urban areas and for people of higher socioeconomic status."
The commission recommended national strategies for diagnostics that include key point-of-care testing and ultrasound access at primary healthcare centers. They also suggested efforts including education and telehealth access to expand the size and capacity of countries' healthcare workforces, safety regulations for diagnostics, and methods to ensure diagnostic testing is affordable, available, and accessible.
Horton noted that the Lancet Commission also called for the creation of a global alliance that could coordinate work among national and international agencies as they make investments and policy changes that could help increase access to diagnostic testing. The commission continues advocating for the creation of such a body and is in talks with FIND and the Clinton Health Access Initiative about the potential launch this fall of an alliance organization that could become the focal point of these advocacy efforts.
Moussy said the WHO is in discussions with organizers of the proposed global diagnostics alliance and supports the concept but noted that organization is early in development.
Velazquez Berumen said the WHO now needs to continue development of its essential diagnostic and priority medical device lists, support collaboration among members, and support regulatory changes aligned with the resolution. It will use funding from member states, development agencies, and NGOs to make those changes. The required actions from the WHO also include collecting data on the affordability and availability of essential diagnostics, giving member countries technical advice on diagnostics, and developing guidance for diagnostic needs during emergencies.
Joanna Sickler, vice president of health policy and external affairs for Roche, said the assembly's resolution is well timed to take advantage of the recent lessons from the pandemic about the importance of diagnostics for responding to public health threats and the results of inequities in testing. Memories are short, she said, and applying those lessons now could help cement the importance of diagnostics in public health and national health strategies, she said.
"Diagnostics have huge potential to enable universal health care, to enable prevention, to enable us to move to a healthcare system that's focused on preventing disease instead of just treating it," she said.
In response to the resolution, Roche sees a chance to advise national governments as they draft their testing strategies and work with laboratory experts to maintain and apply the testing capacity they built in response to the pandemic, Sickler noted.
"The high-volume instruments that were used for COVID-19 testing and are used for molecular respiratory testing across diseases are the same instruments that are used for HPV screening, for STI screening, for tuberculosis," she said. "So, if we build that lab system today to improve screening and prevention, we're then set up for tomorrow for pandemic preparedness.
But Sickler said the resolution is the beginning of the journey toward improving diagnostics capacity and each country will have its own trajectory. She also noted that high-income countries, too, can take advantage of the same opportunity to consider how to make their healthcare systems more effective and cost effective for all populations.