SLD market, despite its small size. However, it is currently facing a regulatory barrier, delay in WHO registration, and is seeking options to expedite the process. Lisa Hedman, Project Manager, WHO, commented that the Expert Review Panel process can grant a provisional prequalified (PQ) status while registration processes are pending. She noted that WHO is dealing with a “bandwidth” problem due to the large number of pending applications and inspections. This, compounded by the percentage of poor applications received from facilities deemed unacceptable (all of which must be processed and inspected), exhausts WHO resources and generates further delays.
Perspective of Providers and Collaborating Organizations
Challenges of Implementing a New MDR TB Program in a Country That Went Through the Proper GLC Mechanism31
Goldfeld related her experiences about how GHC initiated an MDR TB treatment in Ethiopia in 2009 in partnership with the Federal Ministry of Health. Ethiopia is a high TB- and MDR TB–burdened country. The GHC program employed a hospital and community-based MDR TB care model that GHC has pioneered in Cambodia, and in so doing overcame major obstacles, including the delay of WHO/GLC-approved SLDs from GDF and issues of diagnostic lab capacity, human resources, isolation beds, and access to traditional funding mechanisms such as the United States Agency for International Development (USAID).
Until this GHC program initiated treatment in February 2009, no MDR TB treatment was available in Ethiopia despite its large estimated burden and a successful application by the country for SLDs. Forty-five patients were approved for treatment, and the drugs had been anticipated for delivery in October 2008; however, they did not arrive until almost a year later. In this vacuum, by leveraging an initial donation of 18 doses of capreomycin from Eli Lilly, GHC, with the support of the Jolie-Pitt Foundation, purchased additional SLDs, provided funds for the inpatient and outpatient management of patients, and performed the first countrywide MDR training, including training personnel in its program in Cambodia. The South-to-South partnership that GHC established, with ongoing technical and program design input and funding for additional SLDs, ancillary medication, food baskets, social support, laboratory tests, and procedures, was supported by charitable contributions, including a grant from the Eli Lilly MDR-TB Partnership, continued support from the Jolie-Pitt Foundation,
31 This subsection is based on the presentation by Anne Goldfeld, Professor of Medicine, Harvard Medical School, and Co-founder, GHC.