BREAKTHROUGHS BLOG

February 01, 2017

WHO begins process to establish an essential diagnostics list following calls by GHTC and partners

Matthew Robinson, MA
Policy and Advocacy Officer
GHTC
A researcher holds onchocerciasis (river blindness) diagnostic tests. Photo: PATH/Patrick McKern
A researcher holds onchocerciasis (river blindness) diagnostic tests. Photo: PATH/Patrick McKern

Last Thursday, the World Health Organization (WHO) took the first step toward establishing an essential diagnostics list (EDL), releasing a proposal outlining how it intends to develop and operationalize the list by early 2019. This move follows calls by GHTC and other partners for the agency to establish an EDL to provide guidance to countries on the vital diagnostics that should be made available through health systems to complement WHO’s existing Model List of Essential Medicines (EML).

As GHTC has previously noted, the need for an EDL to complement the EML is clear and has been compellingly demonstrated. An essential diagnostics list would not only help health care providers, particularly in low- and middle-income countries, improve diagnostic capacity and access, and thus improve patient care, it also holds potential to catalyze research and development (R&D) for new diagnostics by exposing health areas where we today lack appropriate and effective tools. GHTC is pleased to see WHO heed this call from advocates and scientists and begin the process to establish an EDL.

The proposal released by WHO lays out the broad principles the agency will follow in standing up an initial version of the diagnostics list. This includes:

    A child is tested for malaria. Photo: PATH/Gena Morgan
    A child is tested for malaria. Photo: PATH/Gena Morgan
  1. Focusing on in vitro diagnostics (IVDs): Given the large number of diagnostic tools, WHO believes that it will be most feasible to focus the first version of the list on IVDs—which are tests on samples derived from the human body—before considering expanding the list at a later date to include other diagnostic methods like radiological tests or x-rays.

  2. Targeting the list to support and complement the existing EML: Even limiting the list to IVDs leaves a wide breadth of potential diagnostics to be considered. Therefore, WHO proposes to start with identifying the diagnostics needed to enable appropriate use of medicines on the EML.

  3. Making an allowance for IVDs to address outbreak identification and response: While the EDL would be designed initially to complement medicines on the EML, WHO acknowledges that there is a clear need to help countries identify diagnostics necessary to address disease outbreaks with pandemic potential. As such, the EDL could include initially or be expanded later to include these technologies as well.

  4. Including diagnostics for various levels of the health care system: Different levels of health care facilities have different capacities and diagnostic needs within clinical care. Therefore, WHO will ensure the EDL includes diagnostics to meet the needs of these different providers and contexts.

  5. Designing for ease of use: WHO will focus on presenting the EDL in a format that is easy-to-use and accessible for countries, to facilitate use of the information and uptake of the suggested technologies. WHO is considering a variety of methods to support this goal. 

Moving forward, WHO’s essential medicines staff will consult with the Expert Committee on the Selection and Use of Essential Medicines at its meeting in March to gather technical input on how to best operationalize the principles outlined above. Based on this feedback, a pilot group of diagnostics will be evaluated based on existing evidence of programmatic impact, with the goal of completing the development of an initial version of the EDL by early 2019.

GHTC will continue to follow this issue closely and work with our members to ensure that the first version of the EDL is solidly grounded in our decades of combined experience with diagnostics and that the process of establishing the list moves forward efficiently. Keep watching this space for updates.

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