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February 1, 2023

GHTC Statement on the WHO Diagnostics Resolution

The COVID-19 pandemic has highlighted the centrality of access to diagnostics as a key component of detecting and controlling emerging infectious diseases. Early issues in developing accurate tests hampered the understanding of, and response to, the initial stages of the COVID-19 outbreak. This is the case for a broader range of health areas, including poverty-related neglected diseases.

Simply put, medicine cannot respond effectively without diagnostics. Yet despite diagnostics being an integral pillar to quality health care, a recent study from The Lancet highlighted that 47 percent of the global population has little to no access to diagnostics.

This resolution on diagnostics is a good first step in acknowledging and addressing the gap in political prioritization, and we urge the World Health Organization (WHO) and member states to consider the following: 

  1. Push for a special advisor to serve as a senior central point of contact at WHO for diagnostics to ensure internal alignment and push for greater strategic prioritization through a potential “International Diagnostics Alliance.” Likewise, the resolution should reaffirm the essential role played by civil society in defining, developing, and deploying better diagnostics. 
  2. Include provisions in the resolution to build, strengthen, and enforce national and regional regulatory frameworks covering the market for diagnostics and the registration, accreditation, and oversight of laboratories. 
  3. Coordinate national regulations concerning medical devices, and streamline and improve the WHO prequalification process to ensure greater access to diagnostics in lower- and middle-income countries. Mechanisms like collaborative registration should be strengthened to expedite the registration of new diagnostics in countries.
  4. Promote local and regional research and development, manufacturing, and distribution capacities for diagnostics. 
  5. Prioritize investment in the procurement of diagnostics for all health areas, in particular recognizing that significant gaps remain for poverty-related and neglected diseases. Funding for diagnostic procurement remains significantly underfunded, and improved coordination across stakeholders—including donors and procurement mechanisms—is needed to fill gaps and ensure populations, particularly those in low- and middle-income countries, have access to critical diagnostics.