Getting Medicines to People who Need Them: Donor Programs & Coordination

1. Getting Medicines to People who Need Them: Donor Programs & Coordination University of Iowa April 11, 2007

2. Agenda • Overview of the Issues • Some of the Donors • Multi-lateral • Bi-lateral • Foundations & FBOs • How to Get Drugs to People • Donor Collaboration

3. Issues

4. Global pharmaceutical market

5. Estimated 2007 Financing Gap UNITAID Initiative Slides, Michel D. Kazatchkine Ministère des Affaires Etrangères, France

6. The Tanzania pharmaceutical market ‘new money’ could overwhelm current supply chain systems

7. PROCESS R&D Clinical Trials Manufacturing Intellectual Property Registration Forecasting Security Shipping Customs Inventory In-country distribution Financing Market Competition ISSUES Fakes Quality Corruption Compliance Access to essential medicines in the developing world

8. Forecasting Security Quality Complicated supply chain

9. Bioavailability compromised for malaria drug Sulphadoxine/Pyrimethamine

10. Supplanting of Goods Quality Damage Theft Obsolescence Inappropriate Stock Noncompliance Fine Pick CHCF Delivery Warehouse Patient Facility Store Local Transport Customs Clearing Agent Shipping Agent Bulk Pick Bulk Transport Warehouse The Manufacturer The Spiral of Abuse

11. Fake DrugsMalaria (Chloroquine Tablets)

12. Convoluted framework for essential drugs in Kenya

13. Donors

14. At the beginning of 2000 there was NO: • GFATM - Global Fund to Fight AIDS, TB & Malaria • PEPFAR - President’s Emergency Program for AIDS Relief • GDF - Global Drug Facility for TB • PMI - President’s Malaria Initiative • UNITAID - International Drug Purchase Facility • Clinton Foundation – Clinton HIV/AIDS Initiative • Bill & Melinda Gates Foundation

15. Today: multiple mechanisms for medicines Bilateral Donors Private Sector GDF and GLC WHO (ACTs) $ or Drugs/Dx $ or Drugs/Dx UNITAID Drugs/Dx $ or Drugs/Dx US PMI Drugs/Dx $ or Drugs/Dx GFATM NGOs $ $ or Drugs/Dx PEPFAR FBO networks $ or Drugs/Dx $ or Drugs/Dx. World Bank Countries $ $ Country direct purchase Multiple Mechanisms of Countries Receiving Support for Drugs/Diagnostics For HIV, TB and Malaria

17. Global Fund created January 2002 • Innovative approach to international health financing. • Swiss non-profit foundation, not part of WHO • Double majority board decisions • Financial instrument, not an implementing entity • Support programs that reflect national ownership. • Leverage additional financial resources. • Country Coordinating Mechanism & Principal Recipients • $6.7 billion grants awarded through January 2007 • 6 proposal rounds • 450 grants • 136 countries • $3.3 billion disbursements

18. Significant capital from donors

19. What does $3.3 billion achieve? Funding % is for Rounds 1 through 5

20. Supply chain implications of scale-up

21. Implementation gap

22. Mechanisms promoting national sovereignty

23. Mozambique donor basket coordination

25. Stop TB Partnership & Global Drug Facility

26. GDF established to ensure availability of TB drugs

27. GDF performance over 5 years • 55 grants in 65 countries • 9 million patient treatment • $50 million annual procurement • Products • First-line adult anti-TB drugs • Second-line adult anti-TB drugs • First-line pediatric anti-TB drugs • Diagnostic kits • >200 monitoring and technical support missions

29. UNITAID – the airline ticket levy • Innovative funding mechanisms for development • $300 million projected for 2007 • Scale up access to treatment for HIV/AIDS, malaria and TB by: • Lowering the price of quality drugs and diagnostics • Accelerating the pace at which they are made available • Brazil, Chile, France, Norway and UK • Based on sustainable and predictable funding • Operate through existing partner institutions • Priority: • Pediatric ARVs • 2nd line ARVs • ACT • MDR TB drugs • Diagnostics

30. 45 countries currently engaged in financing

31. UNITAID strategy through collaboration • $34.8 M with Clinton Foundation • Paediatric ARVs against HIV/AIDS • Goal is 600,000 children • $5.7 M with Stop TB Partnership and GDF • Paediatric formulations against tuberculosis • Goal is 900,000 children • $79 M with UNICEF and the Global Fund • ACT (artemisinin-based combination therapy) against malaria • Goal is 12 million drugs in 19 countries

32. Faith-based Organizations

33. WHO: 30% to 70% of Africa health infrastructure owned by FBOs

34. 5 provinces studied in Zambia by Emory & Cape Town Universities

35. 87 religious entities providing HIV/AIDS care

36. MEDS in Kenya • Serves 40% of population • 13 million people • 1,000 customers • 110 employees • PEPFAR Participation • All ARVs; $30 million COP07

37. CHAN Medipharm in Nigeria • Serves 25% of population • 30 million people • 1,920 customers • 90 employees • PEPFAR Participation • 61 of 83 PEPFAR sites (26 Christian; 5 Muslim) • 70% of ARVs

38. Serves 40% of population 10 million people 1,171 customers 54 employees 55% of supplies are local source JMS in Uganda

39. FBOs and the global programs • FBOs provide much of the healthcare • FBOs often are not at the table • FBOs must be engaged to meet scale up requirements • FBOs are a key to sustainability • Faith-based Drug Supply Organizations are scared

40. EPN • Ecumenical Pharmaceutical Network is a thought leader and advocate in pharmaceutical distribution to developing world • 76 member organizations in 31 countries • Christian Health Associations (CHAs) • Drug Supply Organizations (DSOs) • WHO/EPN 2003 Survey of Sub-Saharan Africa • 16 Faith-based DSOs in 11 countries serving … • 8,269 hospitals and clinics • 112 million population • 43% of population on average in country

41. EPN/SCMS Taskforce • Provide a platform for continuous dialogue • Provide a formal mechanism for information sharing and feedback for all levels • Contribute to the SCMS supply chain strategy at a global level • Provide information on interventions in the EPN and PEPFAR countries • Identify specific issues of mutual concern and agree upon mechanisms to ensure they are addressed • Be a rapid response mechanism for concerns raised in country • Disseminate examples of best practice, lessons learned and success stories across countries • Introductions and access to other stakeholders of mutual interest

43. 5 years 15 focus countries $15 billion in funding ART for 2 million Prevent 7 million infections Care for 10 million affected President’s Emergency Plan for AIDS Relief

44. PEPFAR a new way of doing business • Department of State • U.S. Agency for International Development • Department of Defense • Department of Commerce • Department of Labor • Department of Health and Human Services (HHS) • Peace Corps

45. PEPFAR results through September 2006 • Prevention • 61.5 million people - reached through community outreach • 6 million pregnancies - supported prevention of mother-to-child transmission • Care • 2 million orphans and vulnerable children • 2.4 million people living with HIV/AIDS • 18.6 million counseling and testing sessions • Treatment • 822,000 people including 61% women and 9% children

46. What makes HIV medicines different? • Medical implications • Stock-out • Substandard or counterfeit product • High-value product • Size of scale-up effort • Need for sustainability beyond current funding situation

47. Track 1 & 1.5 partners launched ART scale up

48. Treatment estimates at the end of 2005 Scaling up treatment by a multiple of 4 Scaling up treatment by a multiple of 6 1.3 million patients 90,000 pallets 5.2 million patients 360,000 pallets 7.8 million patients 540,000 pallets = 1.3 million patients = Approximately 30,000 pallets of ARV, OI, and STI drugs Source: SCMS Very Dynamic Demand & Scale Up Challenges

49. Current supply chain challenges can impede program performance • Inadequate data for quantification/forecasting of needed commodities • Large, infrequent orders place burdens on local infrastructure leading to stockouts or product expiration • Overstretched country storage and delivery routes increase risk of theft, counterfeiting and spoilage resulting in health risks and product loss • Supply of HIV/AIDS commodities is determined by forecasts rather than demand

50. How to Get Drugs to People