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

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 Intervention Predicted Financing Financing GAP HIV/AIDS$10 Billion$8.1 Billion TB$2.5 Billion$3.1 Billion Malaria$0.7 Billion$2.5 Billion Total$13.2 Billion$13.7 Billion 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. Access to essential medicines in the developing world 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

8. Complicated supply chain Forecasting Security Quality

9. Bioavailability compromised for malaria drug Sulphadoxine/Pyrimethamine

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

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

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 As of January 2007 (billions) Contributions to Date Europe$3.562 USA$1.897 Japan & Others$0.995 Private Sector & Others$0.268 Total$6.722

19. What does $3.3 billion achieve? InterventionDec 2006Funding HIV: People on ARV treatment770,00058% TB: Cases treated under DOTS2 million24% Malaria: Insecticide-treated nets distributed18 million17% Funding % is for Rounds 1 through 5

20. Supply chain implications of scale-up Type of ExpenditureDistribution Commodities, products & drugs58% Human resources22% Administration11% Infrastructure & equipment11% Monitoring & evaluation2% Other6%

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

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

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. Very Dynamic Demand & Scale Up Challenges = 1.3 million patients = Approximately 30,000 pallets of ARV, OI, and STI drugs 1.3 million patients 90,000 pallets Treatment estimates at the end of 2005 5.2 million patients360,000 pallets Scaling up treatment by a multiple of 4 7.8 million patients540,000 pallets Scaling up treatment by a multiple of 6 Source : SCMS

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

51. GAMMA PHARMACEUTICALS LTD AMFA South Africa An African Solution to an African Problem

52. SCMS team operates seamlessly Affordable Medicines for Africa Johannesburg, South Africa AMFA Foundation St. Charles, Illinois, USA Booz Allen Hamilton McLean, Virginia USA Crown Agents Consultancy, Inc. Washington, DC, USA The Fuel Logistics Group (Pty) Ltd. Sandton, South Africa IDA Solutions Amsterdam, Netherlands JSI Research & Training Institute, Inc. Boston, Massachusetts, USA Management Sciences for Health, Inc. Boston, Massachusetts, USA The Manoff Group, Inc. Washington, DC, USA MAP International Brunswick, Georgia, USA The North-West University Potchefstroom, South Africa Northrop Grumman McLean, Virginia, USA Program for Appropriate Technology in Health Seattle, Washington, USA UPS Supply Chain Solutions SM Atlanta, Georgia, USA Voxiva, Inc. Washington, DC, USA 3i Infotech, Inc. Edison, New Jersey, USA

53. SCMS vision is transforming health care delivery Transforming health care delivery by ensuring that quality medicines reach people living with or affected by HIV and AIDS

54. Key SCMS strategies support efforts to serve more people Strengthen existing systems Aggregate procurement across many clients; longer-term supplier contracts Use world-class freight forwarding and inventory management; regional distribution centers Improve decision making through availability and use of logistics and supply chain data Coordinate efforts and global quantification with multiple partners Ensure sustainable solutions that will last beyond SCMS

55. Supply chain management

56. Forecasting – unappreciated critical step

57. Procurement – local & global implications Antiretrovirals Rapid HIV test kits Essential drugs to treat opportunistic and sexually transmitted infections Laboratory supplies and equipment Medical supplies

58. Increasing stock items at MEDS in scale up

59. Inventory – extraordinary demand, unprecedented response Smaller, regular shipments to protect local systems Timely, accurate and safe transport including cold chain Delivery of drugs and supplies door-to-door Security Shipment tracking from supplier to recipient Rapid response to emergency orders

60. Combating counterfeiting - Russian dolls strategy Active RFID Tag Passive, Semi- Passive, or Active RFID Tag Passive RFID &/or Barcode Nested Visibility (Russian Dolls)

61. Inside of Doors Savi Sentinel Inside of Container Monitoring product quality - Smart Container A “Smart Container” constantly monitors valuable goods Humidity Shock Tamper & Intrusion Temperature

62. Typically African drug supply chain Merck GSK CIPLA BMS Clinics Hospitals Pharmacies Wholesalers

63. PHD brings a South African business model that is transformational PHD Merck GSK CIPLA BMS Clinics Hospitals Pharmacies Wholesalers GSK Merck CIPLA BMS

64. Accra, Ghana Nairobi, Kenya Johannesburg, South Africa Regional distribution centers are sustainable Côte d’Ivoire Nigeria Ethiopia Uganda Tanzania Rwanda Mozambique Zambia Zimbabwe Namibia Botswana

65. Delivery – the last mile

66. SCMS strengthens existing supply chain systems through technical assistance Quantification and forecasting Assistance to manufacturers and suppliers Quality assurance/control Freight forwarding and inventory management Procurement Distribution Logistics MIS

67. Improving Availability and Use of Information Global supply chain visibility Product pedigree National/local supply chain visibility

68. Before and after - simple interventions

69. Selected highlights from year one Strengthening existing systems –Building capacity of Rwandan public sector procurement agency –Conducting facility level training in Haiti –Supporting procurement efforts of FBO in Uganda Ensuring an uninterrupted supply –Prevented stockouts in Botswana, Côte d’Ivoire, Haiti –Conducted national quantifications to improve forecasts (Côte d’Ivoire Guyana, Haiti, Zambia) Providing affordable, quality commodities –Declined $2.3M order for ARVs due to overstock –Saved $1.2M on $4.5M order through quantification, generic purchase, and price negotiations –30% cost savings in Vietnam for ARVs

70. SCMS collaboration highlights OGAC: procurement summary for COP05 WHO, UNAIDS: global ARV forecasting World Bank, Global Fund, USG: procurement working group FDA: harmonizing product registration requirements MEDS: East Africa Regional Distribution Center? Pfizer: Diflucan donation pilot project World Vision: leveraging logistics infrastructure CAMERWA (Rwanda): USG direct grantee status

71. Global Collaboration for Local Results Pooled Procurement

72. Essential principals of collaboration Monterey Accord –Country ownership –Good governance –Results focused –Utilize all resources - private, public, faith-based, & governments UNAIDS three ones is an embodiment for HIV/AIDS –One country strategy –One country coordinating mechanism –One monitoring and evaluating procedure

73. Pooled procurement a hot topic in collaboration Informed buying –Global Fund Price Reporting Mechanism Coordinated procurement –WB/GF/USG Coordinated Procurement initiative Centralized tendering and procurement –Rwanda/COMERWA joint tendering for Global Fund and USG Supply chain management –SCMS

74. Global Price Reporting Mechanism

75. Global Price Reporting Mechanism an example of informed buying Utilizing Global Fund electronic data to monitor & improve ARV medicine prices –Tool to improve efficiency, transparency, accountability of prices Potential for utility at many levels –donors –implementers –country programs –forecasters –pharmaceutical companies –academics –activist organizations Additional electronic data exists in mega funds for HIV/AIDS, TB, malaria, maybe more

76. PRM is a limited data set Data Set Contents GF (June 2006) GPRM (June 2006) Final* (Dec 2006) #Procurements 1,6325,501 5,418 #Countries 4193 90 Time period Jun 2003- Apr 2006 Nov 2002- Jun 2006 Nov 2002- Jun 2006 #ARVs15 #Dosage forms65 #Manufacturers29 Total Value$236,167,728

77. HIV/AIDS 65% spend on 11 products

78. 3 times difference in lead times Order Volume (000’s) Lead Time by Volume for NVP, 200mg Reported PRM Data Lead Time (days) Cipla Average = 158 Days Heterp Average = 49 Days Potential Lead Time Reduction 109 Days (69%)

79. Huge variance in pricing

80. High price outliers stavudine 15mg Guyana high outlier prices verified price per tablet volume nevirapine 200mg Russia 20x times more expensive than median price price per tablet volume

81. Rwanda paying 88% more than global median prices for oral solids CountryTotal # Procure- ments % prices > global median Total Volume (tabs) Total spent compared to global median price in $US* 7/05-6/067/04-6/05 Macedonia 3662.1%25,254,7965,877,6714,320,702 Zambia 8543.5%45,4137403,010,3951,484,232 Rwanda 2588%3,725,1782,896,996 Ethiopia 8349.4%64,997,6961,869,3763,397,352 Ukraine 2725.9%6,963,140922,09352,105 Viet Nam 2951.7%3,689,160501,950262 Sudan 17851.1%31,550,248354,817191,339 Guyana 1978.9%328,510347,861110,061

82. Kenya paying 54% less than global median prices for oral solids CountryTotal # Procure- ments % prices > global median Total Volume (tabs, ml) Total spent compared to global median price in $US* 7/05-6/067/04-6/05 Maldives 3641.7%35,061,090-1,681,933-520,151 Ghana 80%13,486,200-492,727-30,962 Haiti 819.9%16,048,110-273,736530,636 Kenya 1353.8%3,498,900-227,824807,153 Mauritania 1225%3,831,432-144,599 Togo 254%4,020,000-97,610 Cambodia 8444%7,272,057-72,009 Brundi 3138.7%2,523,040-64,978

83. WB/GF/USG Coordinated Procurement

84. Rwanda stimulated the initiative Leadership by the Rwandan Government Coordination between the government and donors Joint procurement of ARVs Building a system for monitoring, tracking, reporting and auditing ARV consumption and supply More patients on treatment Lower prices

85. With effective alignment/coordination, results will be seen at all levels Working group Accelerated grant implementation Elimination of duplication of effort Coordination of technical support In-country Reduced stock-outs Improved product quality Cost savings More patients served Enhanced local capacity (human resources and systems)

86. Challenges of global partnerships Resistance to a “new” initiative Explain phased approach in incorporating others Challenge Solution Concern about lack of participation by other key stakeholders Difficulty connecting all the players (time zones, email response, weak phone connections) Acknowledge the work already being done Highlight the working group’s role to provide resources to enhance existing efforts Over communicate, over coordinate, follow through, use alternative avenues of communication

87. Process established by working group to overcome challenges Utilization of a technical secretariat Small number of target countries spanning the easy to the difficult –Ethiopia, Guyana, Haiti, Mozambique, Rwanda, Vietnam Timeline (realistic expectations) Scale up from successful base Define success (agree on example of the ultimate objective)

88. The role of the technical secretariat Collect data HQ teleconference calls and discussion Meeting administration Reference documents Interview key stakeholders Analyze data Document status quo Identify impediments to coordination Propose solutions Develop alternatives Action/implementation plan

89. Overcoming challenges: Guyana Results Challenge Donor disbursement cycles do not align and often hinder efforts to coordinate effectively Completed national test kit quantification. Strengthened and expanded quantification coordination committee Limited sharing of supply chain information among the donors Fragmented procurement Approved SOW for joint initiative, including agreement to share work plans and develop mechanism for coordinated procurement MOH/WB/GF/USG agreed on specifications for warehouse management system

90. Foundation for success Clearly defined mission Coordination of global institutions with local implementation Concrete, tangible issues Strong leadership Resources are committed Strong, varied forms of communications Country-driven initiatives Flexibility

91. Overcoming challenges: Ethiopia Challenge Results Limited formalized communication among donors Separate procurement lifecycles Limited capacity at PHARMID to manage expanded procurement under the National Logistics Master Plan GFPR/MOH/USG signed MOU including coordinated quantification and procurement National ARV quantification to be completed in February Strategic plan completed, and partners coordinating implementation

92. Overcoming challenges: Mozambique Limited sharing of logistics information among the donors National quantification of ARVs completed Challenge Results Partners use different funding mechanisms (GF/SWAP, WB/MAP, and USG/PEPFAR) Human resources challenges at Ministry of Health MOH agreed on specifications for integrated logistics system for central medical stores Technical secretariat currently providing training on supply planning, and other trainings planned

93. Sustainability is About The Quality of Life Before treatment for HIV/AIDS /TB co-infection; March 2003 After treatment for HIV/AIDS /TB co-infection; September 2003

94. Questions Thanks! For more information: Website: scms.pfscm.org E-mail: scmsinfo@pfscm.orgscmsinfo@pfscm.org Main phone: +1.571.227.8600 Main fax: +1.703.310.5270