Transcript The Green Light Committee An uphill battle for a noble goal…

Treating MDR-TB
A Challenge Throughout
ECA
Public Health Practice II
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
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
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
The Vicious Cycle
No international consensus on how to
treat MDR-TB
Allows high drug
prices
Primary
reason to not
start projects
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
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
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
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!)
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
Range of decrease in prices is 38.3% to 98.45%
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
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
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
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”
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