Table 2

Key stakeholders involved in introducing diagnostic products to low-resource settings

Stakeholder categoryKey roleExamples
RegulatorsEvaluate the quality, safety and efficacy of products and approve themNational regulatory authorities, WHO DxPQ*
Policy makersDevelop policies and guidelines to guide how products are usedMinistries of health, WHO
FundersFund programme activitiesMinistries of finance, global funders, for example, the Global Fund, PEPFAR/USAID†, UNITAID‡, World Bank, DFID§ and other bilateral funders
ProcurersNegotiate contracts and purchase products for use in-countryNational procurement authorities, global funders (eg, the Global Fund), UN agencies
SuppliersDevelop, manufacture and distribute products and support the end user on ongoing basesDiagnostics developers, manufacturers
ImplementersWork with developer and/or distributor to implement new diagnostic tools as part of disease programme activitiesMinistries of health, local government health programme, implementing partners (eg, local and international NGOs)
End usersUse the product on ongoing bases and provide feedback for continuous improvements and insights into the design of future productsHealthcare providers (clinicians, clinical officers, nurses, laboratorians, community health workers), patients
Technical expertsProvide insights into the problem, evaluate interventions, support creation of policyAcademic researchers, local and international NGOs, WHO
Advocacy groupsAdvocate for improved diagnostic, treatment and preventive efforts to effectively address the disease burden in low-resource settingsTAG, ASLM
  • *WHO Prequalification of In-Vitro Diagnostics Programme.

  • †President’s Emergency Plan for AIDS Relief/United States Agency for International Development.

  • ‡Global health organisation under WHO that largely funds interventions to address HIV/AIDS, hepatitis, tuberculosis, malaria and reproductive, maternal, newborn and child health.

  • §Department for International Development.

  • ASLM, African Society for Laboratory Medicine; NGOs, non-governmental organisations; TAG, Treatment Action Group.