Geneva, 13 December, 2005 Fabienne Jouberton Ernesto Jaramillo World Health Organization

1. Drug Management of Second-line anti-TB drugs through the Green Light Committee mechanism for programmes funded by the Global Fund to Fight Against AIDS, tuberculosis and malaria Geneva, 13 December, 2005 Fabienne Jouberton Ernesto Jaramillo World Health Organization

2. Green Light Committee mechanism:Linking independent concepts RATIONAL USE ACCESS GLC POLICY

3. Advantages of applying to the GLC mechanism • Access to quality-assured drugs following international accepted standards (including WHO) • Access to low-cost drugs • Access to a continuous drug supply, essential for treatment success • Access to technical assistance to ensure rational drug use

4. Advantages of applying to the GLC mechanism • Access to an external monitoring mechanism • Creation of wide evidence base for national policy development • Ensures consolidation of DOTS as the strategy to control TB

5. Collaboration agreed with the GFATM “to help contain resistance to second-lineanti-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 The Global Fund to Fight AIDS, Tuberculosis and Malaria

6. Collaboration agreed between the GLC and GFATM “Specific funding for DOTS-Plus and support to purchasing second-line drugs for the management of MDR-TB will be granted upon submission, review, and approval of an application to the GLC. GFATM will provide a GLC application form to the countries approved for funding by the Board; and will make this form part of the GFTAM form for the next rounds. “GLC will monitor DOTS-Plus and the use of second-line drugs throughout the entire period of funding by GFATM. If case monitoring visits reveal the (potential) misuse of second line drugs the GLC will communicate the findings to the GFATM and the procurement of preferentially priced drugs may be interrupted”

7. Drug management cycle of second-line anti-TB drugs Drug selection; Assurance of drug quality; Quantitative assessment of drug requirements; Management of procurement and distribution; Ensuring rational drug use.

8. Main variables in the drug procurement of second-line anti-TB drugs Drug registration status of products selected Customs regulations for importing drugs Drug forecast based on treatment regimen, cohort size and pace of patient enrolment Shelf-life of the products

9. Main variables in the drug procurement of second-line anti-TB drugs Lead time for delivery of the drugs Estimated size of buffer stock (two to three times the delivery delay) Drug labelling

10. Procurement for GLC-approved projects • Approved pilot project signs a contract with WHO • WHO-GLC Secretariat introduce the approved project to the procurement agency • Procurement agency sends a quotation to the project under request

11. Procurement for GLC-approved projects • The project sends a firm order to procurement agency • Procurement agency starts procuring the project after pre-payment • Delivery delay after pre-payment, between 2-4 months • Any change in the project’s drug request that exceeds 10% of what was originally GLC approved has to be reviewed and approved by the GLC

12. Procurement for GLC-approved projects • Current suppliers were selected and pre-qualified by the PA and endorsed by WHO (meeting WHO GMP or approved by a stringent national drug regulatory authority) in line with the GFATM procurement policy • Forecasting is made for each pilot project according to the treatment regimen (buffer stock 10%) • GLC monitors drug storage procedures and facilities at the project sites • Rational use is guaranteed by the stringent review procedures to applications, period monitoring, site visits and tracking down of the drugs procured to the project

13. Procurement for GLC-approved projects • Important facts to take into account: • Most countries require drugs to be registered before importation • The PA does not keep any stock for these drugs • Manufacturers produce on demand (in India, US, Europe)

14. Procurement for GLC-approved projects • Important facts to take into account: • Market size (small, particularly for Cycloserin, Capreomycin and PAS) • Labelling (Russian and English are the ones widely used in the GLC projects) • Short shelf lives (Capreomycin and PASER: 24 months, Cycloserin: 18 months) and one product in cold chain

15. Experience in drug management with GLC-approved projects • Bad practices: • Waiting for the drugs without placing an order (Manual of procurement for GLC approved projects available on the web site) • Looking at the payment modalities only at the time to purchase the drugs • Negociating exemption to registration only at the time to import the drugs

16. Experience in drug management with GLC-approved projects • Bad practices: - Forecasting the needs without taking in consideration all variables presented • Storing the drugs in a inadequate place • Neglecting communication between the project, the NTP, the PR and WHO procurement officer (Ms Fabienne Jouberton <joubertonf @ who.int >)

17. How to improve drug management of second-line anti-TB drugs • Good practices: Please suggest recommendations on how to use the GF grant to ensure proper drug management of second-line TB drugs