Major changes are now under way in the delivery and production systems for drugs needed to treat MDR TB, said Zintl. These changes will affect both the mechanisms and the patterns of supply for second-line drugs for MDR TB, and they represent a significant opportunity for national producers of reliable, high-quality anti-TB drugs.
The establishment of the GLC in 2000 represented a new paradigm in MDR TB care. As noted in Chapter 2, the WHO previously had counseled against treating patients with MDR TB in resource-limited settings. The fear at the time was that the effort to treat MDR TB patients would drain resources and distract attention from the more achievable goal of treating patients with drug-sensitive TB. The mandate for the GLC was to ensure that programmatic treatment was proper for MDR TB patients and that there was access to quality-assured second-line drugs at affordable prices. The GLC was also designed to enable, support, and monitor the Directly Observed Treatment Short course (DOTS)-Plus program. “The GLC was formed so that the new pilot projects did not increase the risk of MDR TB through poor-quality programs,” said Zintl. “The committee controlled access and provided discounted prices for relatively limited supplies of quality-assured drugs.” In 2006, WHO officially changed its policy to call for treatment of MDR TB patients in all countries with a significant MDR TB burden.
In the first 10 years of the GLC’s existence, only about 20,000 MDR TB patients were treated in GLC-approved projects—an average of 2,000 patients per year. As the incidence of MDR TB rose, the GDF, which works on behalf of the GLC to supply second-line drugs, struggled to secure adequate quantities of these drugs. In addition, it became clear that acquired drug resistance is an increasingly serious problem (see Chapter 4). In many countries with high burdens of MDR TB, moreover, patients can and do acquire second-line drugs on their own or through medical providers who do not deliver the drugs under proper programmatic conditions. Market data show that sales of second-line drugs have been rising rapidly in countries with high burdens of MDR TB, as would be expected given the increase in the disease.
Under these circumstances, the paradigm of the GLC’s approving projects one at a time for small numbers of patients began breaking down, said Zintl. This paradigm was leading to extensive delays and backlogs in the numbers of patients awaiting treatment because of a lack of drugs. It was posing a threat to multilateral funding for countries that could not access
1 This section is based on the presentation of Paul Zintl, Partners In Health.