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1 Green Light Committee Initiative

Role of theGreen Light Committee Initiative in MDR-TB Treatment Scale-up

SALMAAN KESHAVJEE, MD, PHD

CHAIR GREEN LIGHT COMMITTEE

BEIJING, PEOPLE’S REPUBLIC OF CHINAAPRIL 3, 2009

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PURPOSE OF THE GLCPURPOSE OF THE GLC

Created in 2000 by the WHO and the Stop TB Partnership to ensure:

Access to quality assured second line drugs at affordable prices

Monitoring and evaluation of second-line drug use in approved projects

Promotion of technical assistance for MDR-TB projects

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Green Light Committee – 2000 to 2009Green Light Committee – 2000 to 2009

Members: • WHO, CDC, IUATLD, Latvian National TB Programme,

Partners In Health/Harvard Medical School, Médecins Sans Frontières, KNCV, Hospital F.J. Muniz – Argentina, World Care Council.

• Former members include: Medical Research Council (South Africa), Estonian National TB Programme and the Peru National TB Programme.

Role:• A legal advisory body of the WHO• A sub-group of the Working Group on MDR-TB in the Stop TB Partnership

Tasks: 1. Provide policy advice on drug-resistant TB to the WHO.2. Review project applications for countries entering the GLC mechanism. 3. Promote technical assistance to countries/programs through WHO and

its partners. 4. Provide access to reduced-priced 2nd line anti-TB drugs through GDF.5. Provide access to independent monitoring and evaluation through WHO and

its partners.

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GLC Initiative: 8 years (2000 to 2008)GLC Initiative: 8 years (2000 to 2008)

0

10000

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2000 2001 2002 2003 2004 2005 2006 2007 2008

Pat

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s ap

prov

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20

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licat

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GLC approved (cumulative)

Cumulative number of applications

~ 50'000 ~ 50'000 patients patients

approved for approved for enrolmentenrolment

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GLC approved projects as of December 2008GLC approved projects as of December 2008134 applications in 61 countries 134 applications in 61 countries

~ 50'000 patients approved for enrolment~ 50'000 patients approved for enrolment

1. Bangladesh2. India3. Indonesia4. Myanmar5. Nepal6. Timor-Leste

1. Burkina Faso2. Cameroon3. DR Congo4. Ethiopia5. Guinea6. Kenya 7. Lesotho8. Mozambique9. Rwanda10. Uganda11. Tanzania

1. Belize2. Bolivia3. Costa Rica4. Dominican Republic5. Ecuador6. El Salvador 7. Guatemala8. Haiti9. Honduras10. Mexico11. Nicaragua12. Paraguay13. Peru14. Uruguay

1. Egypt2. Jordan 3. Lebanon4. Pakistan5. Syria6. Tunisia

1. Armenia2. Azerbaijan3. Belarus4. Bulgaria5. Estonia 6. Georgia7. Kazakhstan8. Kyrgyzstan9. Latvia 10. Lithuania11. Moldova 12. Romania13. Russia14. Serbia 15. Tajikistan16. Ukraine17. Uzbekistan

1. Cambodia2. China3. Micronesia4. Mongolia5. Philippines6. Samoa 7. Vietnam

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Successful collaboration with donorsSuccessful collaboration with donors

"To help contain resistance to second-line anti-TB drugs and consistent with the policies of other international funding sources, all procurement of medications to treat MDR-TB must be conducted through the Green Light Committee (GLC)"

Third Board Meeting, 10-11 October, 2002

Second-line drugs for low and lower-middle income countries; thousands of patients to be enrolled in 2007-2011; creation of a Global Buffer Stock of SLDs and a Revolving Fund

Funds for Technical Assistance and

Monitoring/Evaluation

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Technical DocumentsTechnical Documents

Source: http://whqlibdoc.who.int/publications/2008/9789241547581_eng.pdf

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Contribution to MDGsContribution to MDGs

The GLC mechanism contributes to the following Millennium Development Goals:

Meeting the global tuberculosis control targets and prevent development of almost incurable forms of TB (XDR-TB) (MDG 6, target 8)

Increase access to quality-assured, affordable second-line drugs for the treatment of drug-resistant TB (DR-TB) among well-performing TB control programs in developing countries (MDG 8, target 17, WHA 60.19);

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Green Light Committee Initiative: ComponentsGreen Light Committee Initiative: Components

Green Light Committee

Green Light Committee Secretariat

(housed in the WHO)

WHOStop TB Dept

Global DrugFacility

• Policy advice

• Application review

• GLC administration • Technical Assistance • Drug Procurement

High-level expertise on the management of MDR-TB programmes based on best available evidence and collective experience.

Peer support and knowledge sharing in communication with other GLC-approved programmes.

Technical assistance through a wide network of technical partners.

Independent external monitoring and evaluation of approved programmes.

Quality-assured second-line drugs to treat MDR-TB at concessionary prices.

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General strategy for MDR-TB Scale-upGeneral strategy for MDR-TB Scale-up

Development of a GLC-approved pilot project

Expansion of the pilot project

Integration into the national TB control strategy

Nationwide scale-up/universal access

GLC mechanism can provide coordinated TA at every stage of this process

Countries Need to Drive Process

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GDFProcurement Agent

GLCExpert committee

The GLC Initiative: Understanding the ProcessThe GLC Initiative: Understanding the Process

GLC Secretariat GDF:Procurement

Country/Project

WHO:Technical

Support / M&E

2 months

Country/Project

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1. Need to treat all DR-TB patients as early as possible with quality assured drugs and under sound programmatic conditions in order to prevent transmission of DR-TB.

2. MDR-TB management through the GLC strengthens basic TB control, helps to improve the quality of DOTS, and contributes to health systems strengthening

3. Integrating MDR-TB treatment into national programs can be difficult in many settings due to the fact that it is demanding,complex and costly.

Challenges:• Implementing pilot projects• Integrating DR-TB treatment within national TB control

strategies• Expanding treatment to provide universal access in rural

and urban areas

Lessons Learnt from Current GLC Projects & WHO DRS DataLessons Learnt from Current GLC Projects & WHO DRS Data

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Areas of MDR-TB Management: Main ObstaclesAreas of MDR-TB Management: Main Obstacles

Uninterrupted access to

quality-assured second-line drugs

DRUGS

Appropriate and timely diagnostics

DIAGNOSIS

Delivery of care for two years with

appropriate management of adverse events

CARE DELIVERY

Programs need help to build laboratory capacity for diagnosis of patients

and monitoring of treatment. This includes the implementation of

available new diagnostics (GLI and

partners).

Programs need help in the area of drug supply management (TB and ancillary drugs) and

forecasting

Global supplies of drugs and procurement

mechanisms need to be strengthened

Programs need help with pilot program

implementation, DR-TB treatment integration into

national TB control strategies, capacity building

(HR), and scale-up

Monitoring & Evaluation

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Green Light Committee Initiative: Enhancing the mechanism for scale-upGreen Light Committee Initiative: Enhancing the mechanism for scale-up

Green Light Committee

Green Light Committee Secretariat

(housed in the WHO)

WHOStop TB Dept

Global DrugFacility

• Policy advice

• Application review

• GLC administration (includes Training and coordination of GLC consultants)

• Provides technical assistance to programs (pre- and post-application) through the MDR-TB team and partners

• Drug Procurement

GLC MDR-TB Support Unit• data collection from internal and

external sources

• data analysis

• coordinate TA (long-term; on-site) to countries (GLC and non-GLCcountries) working with TB Teamand partners

• provide assistance on drugmanagement

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The GLC mechanism and the future…The GLC mechanism and the future…

The GLC mechanism is working with projects and countries to facilitate scale-up of DR-TB treatment.

The success of the mechanism depends on: • Push from countries themselves for integrated DR-TB

treatment/management

• Reliable supply of QA drugs at concessionary prices

• Newer models of technical assistance stressinglong-term, on-site approaches that build local capacity

• Sufficient funding for countries to implement programs

• Sufficient staffing and financial resources at the level of the GLC mechanism to ensure its functions – WHO member countries have a direct stake in this

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THANK YOU