1. Treating MDR-TB A Challenge Throughout ECA Public Health Practice II

2. The Historical Setting Why is there growing DRUG RESISTANCE in TB… - Long treatment course - Drug side effects - Inappropriate drug use and poor surveillance  POOR COMPLIANCE or BAD DOTS vs. - Poor quality drugs - HIV - War  economic, social and political strife - Poverty

3. The Historical Setting (cont.) One Side… MDR-TB is too expensive to treat in poor countries and it distracts attention and resources from drug susceptible cases DOTS alone will stop outbreaks MDR is not as contagious or virulent as drug susceptible TB Treatment is expensive and lab work difficult

4. Historical Setting (cont.) The Other Side… There is a moral imperative to provide care to individual patients It is essential to control MDR-TB for fear of its growth DOTS can amplify resistance If we have the technology (ie Second-line drugs) we should treat the sick patients

5. The Vicious Cycle No international consensus on how to treat MDR-TB Allows high drug prices Primary reason to not start projects

6. Working Group for DOTS-PLUS Need to generate political will Need to show manufactuers there is high demand - …So they can still profit? Need lower prices Need to avoid making the drugs too widely available - Concern for black market that would breed resistance

7. Strategy One: Perform a Market Analysis Who are the manufacturers? - Monopoly w/ EXPENSIVE patents - Monopoly wo/patents - Multiple Prioritize most expensive drugs Check for Quality Assurance

8. Strategy Two: Unified Approach to Big Pharma Create single negotiating body Medecins Sans Frontieres represented ALL buyers for the initial 2000 patients Plans for the International Dispensary Association to continue

9. Strategy Three: Establish A Market Problem = Lack of Competition Added to Essential Drugs List - Facilitates in-country registration - Under “reserve anti-infective agents” Stimulate excitement in the generic drug industry Two Markets: (1) Countries with programs and $$$ (2) Estimated # of global cases (growing!)

10. Strategy Four: Negotiation The “Tiered-Tender” System - Biggest contract to manufacturer with lowest price and highest quality - Then smaller proportions to select companies Long term outcome goals: - Low prices - High quality - More competition

11. Range of decrease in prices is 38.3% to 98.45%

12. Strategy Five: Advantages to Suppliers Ex 1: Monopoly with small second-line TB sales - Humanitarian commitment Ex 2: Generic drug maker - Involvement in high profile int’l opportunity Also… - Creation of Green Light Committee - Registration of Drugs - Plan long term continuous production

13. Green Light Committee Guarantee low price access to sound pilot projects and also monitors ongoing projects Minimize black market  further resistance Requires countries to: - Need functional DOTS program - Government commitment AND funding - Coordinated organization and management - Case-finding strategies - Laboratory diagnosis techniques - Treatment and follow-up strategies - Information Systems

14. Green Light Committee Two NGOs - MSF - Royal Netherlands TB Association Two NTP (National TB Programs) - Estonia - CDC Academic Institution - Harvard Medical School WHO 2 replaced q3yrs Each with 1 vote

15. Additional Strategies: Research and Development for NEW drugs (Its been 30 yrs!) Diagnostics for Chest xray neg or extrapulmonary TB? - Serology or PCR? - Goal of 85% case detection Vaccine Development - BCG with more immunogenicity - Listeria monocytogenes “actin-rocket”

16. 3 by 5 Create AIDS Medicine and Diagnostics (AMDS) - Coordinator - No direct purchasing - Information clearinghouse for manufacturers, procurement agents and treatment programs - “Technical” tools to help supply cycle such as expert teams and improve security - Eventual plan to establish buyer networks Create WHO Procurement, Quality, Sourcing Project - Pre-qualification board to assess manufacturers and products to assure high quality