Rupilia Martínez is 48-years-old and lives in San Miguel, about 30 minutes from San Vicente clinic. She works in agriculture and has had malaria three times. Photograph by Maria Fernada Pérez Rincones
Photograph by Maria Fernada Pérez Rincones

An earlier version of this brief contained inaccuracies regarding the funding and scope of a FIND/Unitaid initiative. This has been corrected to note that this is a jointly funded initiative supporting both technology transfer and local production in low- and middle-income countries for long-term impact and manufacturing expansion.

The COVID-19 pandemic has uncovered what has long been appreciated in the field of diagnostics: the need to improve production and supply capacity of diagnostic tests through local research, development and manufacturing in low- and middle-income countries (LMICs). Expansion and diversification of local production is particularly needed in LMICs where there is currently limited local manufacturing capacity. We cannot rely only on manufacturers primarily in high-income countries (HICs) if global needs are to be met. 

As an international medical humanitarian organisation, Médecins Sans Frontières (MSF) relies on diagnostic tests daily as an entry point for appropriate clinical care in our medical projects in more than 70 countries. MSF teams have seen first-hand how insufficient access to diagnostics hinders effective medical care and can lead to worse outcomes for people’s health.

In light of growing recognition of LMIC needs and accompanying efforts to increase access to diagnostics in these countries through improved local production, this brief (available in English, French and Korean) offers an analysis of local production of diagnostics in LMICs with limited capacity and makes recommendations for improvement in four key areas:. 

  1. Creating an enabling funding and procurement environment to promote local production; 
  2. Promoting open IP, technology transfer and access-oriented research and development for local manufacturers;
  3. Ensuring that local production is sustainable and meets local health needs; and 
  4. Strengthening regulatory mechanisms and public trust in locally manufactured products.