approved regulatory bodies (e.g., WHO PQ, SRA registration, U.S. FDA tentative approval, Global Fund/GDF Expert Review Panel) or evaluated following its own internal qualification scheme. Henkens also suggested that countries should commit to using only QA drugs, noting that given the relatively low efficacy of current treatment protocols and given the high rate of adverse reactions, patients have the right to be sure that at least the quality of drugs is not questionable.
A major challenge facing the supply chain for QA SLDs is that despite an increase in the number of QA manufacturers, the prices of QA products have not improved since 2001. Henkens suggested that the fact that Eli Lilly no longer subsidizes capreomycin and cycloserine could account for the increases in price of those drugs, noting that the prices for products that had the same manufacturers in 2001 and 2011 (ethionamide, prothionamide, and PAS) are the ones that have remained stable. Improved coordination among countries and producers could help ensure that increased competition does not lead to increased prices, given limited availability. Henkens suggested that “breaking the vicious cycle” would require strategies such as improved forecasting, transparent market allocation, and implementing a revolving fund and rotating stockpile.
Challenges for South Africa’s MDR TB Policy34
Decentralizing MDR TB care. The South African National Department of Health has announced that every facility treating MDR TB will have a GeneXpert® machine for diagnosing M.tb. and rifampicin resistance by the end of the 2012 financial year. Gray speculated that the expected significant increase in the number of diagnoses and the number of patients requiring MDR TB treatment will present a serious challenge to the current treatment capacity in the country. Only 2,500 beds are available in specialist TB hospitals in the country (for a population of 50 million). To address this problem, South Africa has developed a new policy aimed at decentralizing the management of MDR TB patient care. Gray expressed his concern that the policy also includes, in certain cases, treating patients on an ambulatory basis even in the intensive phase of treatment.
Challenges of public tendering. Most TB drugs in South Africa are procured on a competitive basis through the public sector, which generates a specific set of problems. First, there is a dearth of domestic producers, despite the tender system being geared toward nationally registered products. Second, many tenders for first- and second-line products go unawarded; for
34 This subsection is based on the presentation by Andrew Gray, Senior Lecturer, Pharmaceutical Sciences, School of Health Sciences, University of KwaZulu-Natal.