Global Funds and International Collaboration

1. Global Funds and International Collaboration Essential Drugs and Medicines Policy World Health Organization October 2003 with thanks to: Stop TB Partnership Global Fund to Fight AID, Tuberculosis, and Malaria

2. Millennium Development Goals Global Fund to Fight A,T,M Global Medicines Facilities

3. United Nations Millennium Declaration(18 September 2000) Goal 1: Eradicate extreme poverty and hunger Goal 2: Achieve universal primary education Goal 3: Promote gender equality and empower women Goal 4: Reduce child mortality Target 5: Reduce by two-thirds, between 1990 and 2015, the under-five mortality rate Goal 5: Improve maternal health Target 6: Reduce by three-quarters the maternal mortality ratio Goal 6: Combat HIV/AIDS, malaria and other diseases Target 7: Halt by 2015 and begin to reverse the spread of HIV/AIDS Target 8: Halt and begin to reverse incidence of malaria, other major diseases Goal 7: Ensure environmental sustainability Goal 8: Develop a Global Partnership for Development

4. MDG Target 17: In cooperation with pharmaceutical companies provide access to affordable essential drugs in developing countries • Indicator 46: Proportion of population with access to affordable essential drugs on a sustainable basis • How to measure? • Informed expert opinion • Household survey • Facility survey • How to improve access • Millennium Development Project Task Force

5. Millennium Development Goals Global Fund to Fight A,T,M Global Medicines Facilities

6. HIV/AIDS, TB and Malaria are among the world's great killers. In 2002... • 3.1 million people died of AIDS • Tuberculosis accounted for 2 million deaths • Malaria killed more than 1 million people, mostly children in Africa

7. Commitments and Disbursements of Approved Proposals, Rounds 1 and 2 over 2002 – 2005(assuming renewal) Medicines  30% of projected expenditures Figures refer to Rounds 1 and 2 only. Inflection in commitments in Q4 in 2003 is due to the completed signing of all initial agreements; inflection in Q4 of 2004 is due to the approval of funding for Years 3-5 of these programs. Approval of additional rounds during 2003-2005 will greatly increase these projections.

8. What is The Global Fund? The purpose is to: • attract, manage and disburse additional resources • work through a new partnership of public and private stakeholders • reduce infections, illness and death from HIV/AIDS, tuberculosis and malaria in countries in need • contribute to poverty reduction as part of the Millennium Development Goals

9. Main global fund activities Proposal development Proposal review Agreement of grants Programme implement–ation Monitoring & evaluation The Global Fund mantra is: …raise it(£$€..) …spend it(£$€..) … prove it(…had an impact)

10. Global Fund administrative arrangements- receives, reviews, funds, monitors proposals The Primary Recipient(s) is the legally accountable party in country which will disburse to subrecipients and ensure M&E reporting to GF – can be a public, NGO or private (or multilateral) party in the CCM Instruction to disburse Secretariat Trustee Global Funds Fund Advice Primary recipient Local Fund Agent Reporting Country Funds Coordinating Mechanism Reporting The Local Fund Agent is the "eyes and ears" of the GF in country, assessing PR and advising the Secretariat on ongoing performance – can be local office of int'l audit/ accounting firm, regional bank, etc. Sub recipient

11. HAART recipients in developing countries (000s) Global Fund support should substantially increase the number of people on HAART* in developing countries 3x Increase over current recipients +270 790 2x +220 All other developing countries 300 Sub-Saharan Africa All other developing countries 6x Sub-Saharan Africa HAART recipients supported by Round 1 Funds* HAART recipients supported by Round 2 Funds* Total HAART recipients after 2 Rounds* Current HAART recipients** HAART = highly active anti-retroviral therapy (ARV therapy) * Based on proposed figures by the end of 5 years or the end of the proposal period

12. Estimated number of Arteminisin-Based treatments available per year* (000s) The Fund will significantly increase the availability of Arteminisin-Based Derivative Treatments in Africa +3250 4050 Increase over current treatments ~300x +770 15 Current number of treatments available Additional treatments made available through Round 1 Additional treatments made available through Round 2 Total treatments available with Rounds 1 and 2 * Based on estimated average cost of $1.50 per treatment * Based on an estimated average cost of $1.50 per treatment

13. PSM-TF: Critical elements for procurement and supply management A. Selection and rational use – selection of medicines, diagnostics, other products - adherence, resistance, safety B. Quality assurance – compliance to quality standards, drug registration, monitoring product quality C. Procurement and pricing – procurement responsibilities, procurement principles, monitoring suppliers, achieving lowest possible price, international/national law, (domestic production) D. Supply chain management – supply chain management, forecasting, preventing shortages, preventing diversion E. Budgeting and finance – (direct payment), discourage duties/taxes, ensuring additionality, )in-kind donations) F. Monitoring and evaluation – indicators and methods

14. Global Fund - Procurement and Supply Management* Policies 1. Procurement practices • Interagency Pharmaceutical Procurement Principles 2. Procurement responsibilities • Recipient responsible for all procurement if capable • Regional/global procurement encouraged if lowers prices 3. Monitoring supplier performance • Recipient must monitor and report 4. Quality assurance • Supplier qualification – WHO or PIC/S standards after 2004 • Routine product quality monitoring See official records of Global Fund to Fight AIDS, Tuberculosis and Malaria for precise information on policies ( www.theglobalfund.org)

15. Global Fund - Procurement and Supply Management* Policies 5. Lowest possible price • Competitive purchasing from qualified manufacturers • Recipients to apply national laws to achieve lowest price • Encourages differential pricing • Information on prices paid by Recipients to be made public 6. International and national law • Encourages Recipients to use the provisions of the TRIPS and Doha Declaration, including the flexibilities • Fund to defer to appropriate dispute resolution mechanisms

16. Expected outcomes for Rounds 1 and 2 after five years • More than 500,000 people on antiretrovirals – x3 current • 30 million reached with HIV voluntary counseling & testing • 500,000+ orphans receiving health, education, community care • 2 million additional tuberculosis cases treated with DOTS • Over 7,000 new treatments of multi-drug resistant TB – x3 • 20 million combination drug treatments for malaria delivered • 40 million bed nets to protect African families from malaria

17. www.globalfundatm.org

18. Millennium Development Goals Global Fund to Fight A,T,M Global Medicines Facilities

19. The need for a Global Drug Facility

20. W O R K I N G G R O U P S New TB Diagnostics DOTS-Plus MDR-TB New TB Vaccines New TB Drugs DOTS expansion TB/HIV Coordinating Board Partnership Secretariat WHO Technical Advisory Group Global TB Drug Facility Cross-cutting: Advocacy & Communications/ Financing Global Partners Forum Global Partnership to Stop TB

21. What does the GDF offer? • Grants of first line drugs, to support DOTS expansion • A direct procurement mechanism for countries and NGOs, for use in DOTS programmes • A web-based tool for placing orders and tracking shipments • Support for in-country supply management

22. Application Eligibility criteria Specific conditions Standard form Supporting documents Monitoring Quarterly reports Existing monitoring Independent verification Results based Review Independent Committee 12-15 members meets 3x/year Country visit Supply Pooled procurement Standard products High quality Low cost GDF Operations

23. Activity streams for GDF - lessons for others?

24. GDF Products and Prices GDF Catalogue: www.stoptb.unwebbuy.org

25. Performance Monitoring

26. GDF Lessons • Establish a partnership of agencies • For political, technical, and financial support • Ensure total supply chain management • Link demand, supply and monitoring to increase access and rational use • Create a ‘virtual supply agency’ • Each critical function is carried out by organization best-placed to handle • Use product packaging to simplify logistics, promote rational use, enhance patient acceptability and compliance • Standard list of TB drugs, fixed dose combinations, patient packs • Grants of drugs used to catalyse improvements in quality of health care • Develop a diverse funding base • Donor grants to GDF • Direct procurement - countries and NGOs use own resources • Donors/lending agencies (eg WB/GFATM) for support to countries

27. www.stoptb.unwebbuy.org

28. What about HIV-AIDS and malaria?…current thinking and planning… • “GMS” = a “trio of disease-partnership efforts” with a common co-ordination mechanism within WHO: • GDF continues for TB – new facility for malaria • AIDS care facilities for medicines and diagnostics (ACF? ADDF?) • Improve supply management and care through the supply of core commodities for HIV/AIDS, TB and Malaria • To facilitate a wide range of functions: • forecasting needs  selection • quality assurance  procurement • market stimulation  resource mobilisation • IPR issues  technical assistance

29. Options for procurement of medicines, diagnostics, other health products within a global facility • Informed buying • sharing information on prices and supplier, individual purchase • Coordinated informed buying • joint market research, sharing supplier information and price monitoring • individual contracting and purchasing • Group contracting • joint supplier selection and price negotiation, agreement to purchase • actual purchasing still between buyer (government, NGO) and supplier • Virtual supply agency • central tendering and contracting with global procurement agent • like GDF for TB • International supply agency – UNICEF, IDA Adapted in part from: Options For Procurement Of Antimalarial Drugs, RBM-IOM Expert Consultation on Procurement and Financing Of Antimalarial Treatment, Washington, September 15, 2003, A. Edward Elmendorf See Details in Handout

30. Millennium Development Goals Global Fund to Fight A,T,M Global Medicines Facilities