WHO's Essential Diagnostics List Could Help Countries Assess True Burden of Disease

The World Health Organization (WHO) is expanding its essential guidance to include diagnostic equipment and other vital technologies, following years of lobbying from clinicians, researchers, and industry groups alike.

The World Health Organization (WHO) has been releasing its essential medicines list (EML), every 2 years, since 1977, providing a roadmap for clinicians and advocates seeking to ensure populations have access to needed drugs in anticipation of public health crises.

Now, the international agency is expanding its guidance to include diagnostic equipment and other vital technologies, following years of lobbying from clinicians, researchers, and industry groups alike. The so-called “essential diagnostics list” (EDL) will be released later this year.

“It’s clear that treatment of an illness will not be effective if it is not diagnosed correctly,” Suzanne Hill, PhD, Director of Essential Medicines and Health Products, WHO, said in a statement announcing the initiative. “The EDL will be another useful tool to help countries address their disease burden by focusing on evidence-based diagnostic tools.”

According to WHO, the EDL will be similar to the EML—of which the most recent edition was released June 6, 2017—in that it is “intended to provide evidence-based guidance to countries to create their own national lists of essential diagnostic tests and tools.” Such lists, the organization reports, have in the past helped countries, particularly those in the developing world, “facilitate[e] access to treatment and promot[e] affordable prices” by setting priorities in assessing drug needs. “It is expected that national essential diagnostics lists will provide the same benefits for diagnostic tests,” the WHO statement adds.

As a first step, the organization is forming a Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD), which will serve in an advisory capacity and make recommendations as to the diagnostic equipment to be included on the EDL. As the title of the advisory panel indicates, the first EDL will focus on in vitro diagnostics (IVDs) for tuberculosis (TB), malaria, HIV and hepatitis B and C. However, WHO plans to expand the list “as soon as possible” to include other “communicable diseases.”

One organization that is pleased with the new initiative on the part of the WHO is the Global Health Technologies Coalition (GHTC), a coalition of 27 nonprofits that advocates for public policy designed to speed the creation of new healthcare technologies, including drugs, vaccines, and diagnostic tools. According to director Jamie Bay Nishi, GHTC has been pushing for the creation of the EDL for more than a year, and the organization attended the WHO’s 70th World Health Assembly in May 2017 as part of this effort.

“We first became aware of the EDL idea after reading an article in the New England Journal of Medicine that proposed [it]; we thought it would be a smart, cost-effective way to encourage access to diagnostic tools and encourage development of new technologies,” Bay Nishi, who took over as GHTC director in March, told Contagion® in an exclusive interview. “We see this as a complement to EML, and believe that it will work hand-in-hand with that [document]. There are a number of people being treated for malaria, for example, even though they may not have been properly diagnosed.” The EDL likely would help align diagnosis and treatment in at-risk areas in order streamline the provision of proper care, she added.

Now that the EDL project has been initiated, GHTC has directed its advocacy efforts toward getting representation of its membership on to WHO’s SAGE IVD, so that they can have input into its content. However, Bay Nishi is quick to emphasize that her organization has no say in the composition of the advisory group.

“This initial phase is focusing on HIV, TB, malaria, and hepatitis B and C,” she added. “I’ve heard some folks out there saying, ‘What about this [disease]?’ Our view is that WHO has to be able to walk before they can run and that this is a good starting point. Obviously, as an organization, we’re looking to encourage sustained investment in this effort and help it move to an expanded list of diseases over time.”

Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous healthcare-related publications. He is the former editor of Infectious Disease Special Edition.