Many countries also struggle with the complicated Global Fund procedural and financial requirements, increasing lead times in procurement and causing drug stock-outs, which suggests that the processes need to be harmonized and simplified. On the manufacturing side, limited production of QA API and FPP SLDs is caused by a lack of incentives for suppliers and a lack of competitiveness in the SLD supplier market, which yields higher prices.
Vincent described USAID’s three-pronged approach for making affordable, quality SLDs available around the world. The first approach is to improve and expand the global SLD supply chain, which mainly involves
• coordinating with GDF4 and other partners on SLD SCM at the global level;
• improving procurement procedures;
• harmonizing treatment regimens; and
• improving the data on SLD needs.
The second approach is to encourage the quality of QA SLDs by taking the following steps:
• supporting GDF in the market development of quality SLDs;
• providing technical assistance to FPP and API manufacturers to become PQ;
• developing public pharmacopeia standards; and
• improving diagnostic technology.
The third approach, technical assistance at the country level, involves
• reducing bottlenecks through better quantification and stock-out early warning systems;
• in-country and regional technical assistance in pharmaceutical management for MDR TB (SLDs and ancillary medicines);
• development of new training platforms and information systems for SLD management; and
• promoting active indicator-based surveillance of use of SLDs, the formularies, and co-medication safety.
4 USAID is a major donor to GDF, providing 31 percent ($14.97 million) of GDF’s budget in 2011.