Are we on the verge of closing global gaps in diagnostics?

At this year’s World Health Assembly in May, delegates passed a resolution that could be the first step in dramatically scaling up access to the tests and equipment needed to accurately determine what is making people sick — particularly in low- and middle-income countries. Experts hope the resolution will jump-start national efforts to identify the gaps in diagnostic coverage, to harmonize regional regulations of the tests and to compel manufacturers to reduce prices so countries can actually make them available. The vote late last month was “a very important step toward implementation,” Stijn Deborggraeve, the diagnostics adviser for infectious diseases at Médecins Sans Frontières’ Access Campaign, told Devex. “It’s a political commitment from the member states to improve diagnostics capacity and access to diagnostics.” Now experts are watching if the commitment at the WHA will translate into the support — both political and financial — needed to improve the vast global gaps in access to diagnostics. As of 2015, nearly half of the world’s population had little to no access to the tests they need to accurately determine what is making them sick, according to a 2021 Lancet commission on diagnostics. That percentage rises to 81% in LMICs. And the commission estimated that improved access to diagnostic services for six conditions — HIV, tuberculosis, hypertension and diabetes in the general population, and syphilis and hepatitis B in pregnant people — could save 1.1 million lives each year. “If you’re going to have an effective or efficient health care system, you have to have a reasonably well functioning diagnostics component,” Kenneth Fleming, who chaired The Lancet commission, told Devex. “Otherwise, everything downstream is a bit of a loss.” It has long been a problem, but COVID-19 “really brought it home to people that you needed to know what the diagnosis was,” said Fleming. “Was it COVID or hay fever?” The commission ultimately issued 10 recommendations, including calling for the drafting and passage of a WHA resolution. With that step now accomplished, the focus will shift to the national level to see whether governments follow through on the commitments they made in Geneva — many of which capture the commission’s remaining recommendations. Countries committed to drafting national diagnostics strategies and developing essential diagnostics lists that address their specific needs. They also pledged to make diagnostics available at a primary health care level, to ensure more people have access to the tests. The need stretches beyond tests of samples taken from the body, like blood and tissue, which are known as in vitro diagnostics. It also includes imaging, X-ray, ultrasound and blood pressure testing, Fleming emphasized. That will come with a price tag and Fleming said one of the early and ongoing needs will be to convince ministries of finance to fund the plans that their counterparts in the ministries of health develop. He is already in the process of helping to establish an “alliance of interested parties to provide long-term leadership and advocacy, a convening forum to bring people together to share ideas of what works and what doesn’t work.” The idea is that the alliance can work with individual countries to develop strategies and think through issues like costs and savings that will accrue with more accurate diagnoses. The alliance can also coordinate with regional bodies to address issues like smoothing out regulatory policies. He pictures the coalition modeled an organization like Gavi, the Vaccine Alliance, or the Global Fund to Fight AIDS, Tuberculosis and Malaria, but without the grantmaking component — at least at the outset. Fleming said FIND, a global non-profit with a focus on diagnostics, and the Clinton Health Access Initiative have shown interest in spearheading such an alliance. They are already holding preliminary conversations with the Africa Centres for Disease Control and Prevention on initial steps. Improving access will also require the cooperation of another constituency that fell outside the bounds of the resolution, Deborggraeve said. “Industry and manufacturers need to make diagnostics affordable,” he said, particularly the handful of multinational companies that are responsible for producing the vast majority of diagnostics globally. Fleming said there was some early interest from those companies in thinking about how to address affordability issues. Deborggraeve is also looking to diversify manufacturing, including by encouraging more local production of the tests. He cautioned that this will raise a litany of intellectual property concerns and require producers to be willing not only to share patents but also trade secrets and know-how — something many companies were unwilling to do during the COVID-19 pandemic. Building local or regional manufacturing will take time, though, and the immediate focus is the initial steps to ensure broader access as quickly as possible. For his part, Fleming is hoping to help establish three or four pilot countries, where officials can chart the process and later guide other governments through it. He cautioned that it could take more than 20 years to systematically address the long-neglected gaps in access to diagnostics, but “a number of countries will lead the way, and more and more will follow.”