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Oxford Conference on Innovation and Technology Transfer for Global Health

Bridging the Gap in Global Health Innovation: From Needs to Access. 9-13 September 2007. Health Innovation: The neglected capacity of developing countries to address neglected diseases. Carlos MorelOswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil. Plenary lecture. 4. PURPOSE: To address a

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Oxford Conference on Innovation and Technology Transfer for Global Health

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    1. Oxford Conference on Innovation and Technology Transfer for Global Health University of Oxford

    2. Bridging the Gap in Global Health Innovation: From Needs to Access 9-13 September 2007

    3. Health Innovation: The neglected capacity of developing countries to address neglected diseases Carlos Morel Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil

    4. Plenary lecture 4 PURPOSE: To address all round tables of this Oxford Conference through the biased lens of a developing country citizen, researcher and decision-maker

    5. 1st Round Table 5

    6. Global, neglected and most neglected diseases (WHO & MSF) 6

    7. Understanding global inequalities Private health spending Malaria cases 7

    8. 8

    9. 9

    10. Neglected tropical diseases “The neglected tropical diseases are a group of 13 major disabling conditions that are among the most common chronic infections in the world's poorest people” 10

    11. 11

    12. Relationships between science, technology and production 12

    13. The Sisyphus challenge in Chile… 13

    14. The Sisyphus challenge in Chile… 14 “Developing countries share disbelief about the benefits of the endogenous production of science as a tool for economical growth. Hence, public policies to strengthen science and technology and promote the culture of innovation are, in general, weak and sometimes incoherent”

    15. … and in Brazil 15

    16. Entrepreneurship as ‘Conceptual Orphan’ “While the role of entrepreneurs and entrepreneurship has never been denied, its most debilitating facet is its limited, often cursory, coverage by the great thinkers on economics and business”… 16

    17. Entrepreneurship as ‘Conceptual Orphan’ 17

    18. 2nd Round Table 18

    19. Forms of knowledge and modes of innovation (Jensen et al, 2007) 19 I. Science, Technology and Innovation - STI Based on the production and use of codified scientific and technical knowledge (“explicit knowledge”) High priority to the production of “know-why” Emphasis on the use of information and communication technology as tools for codifying and sharing knowledge “Global” knowledge

    20. Forms of knowledge and modes of innovation (Jensen et al, 2007) II. Doing, Using and Interacting - DUI Relies on informal processes of learning and experience-based know how High priority to the production of “know how” and “know who” Strategies emphasizing the role played by informal communication and communities of practice in mobilizing tacit knowledge for problem-solving and learning “Local” knowledge 20

    21. Forms of knowledge and modes of innovation (Jensen et al, 2007) Know-what Know-why Know-how Know-who 21

    22. Forms of knowledge and modes of innovation (Jensen et al, 2007): Situations Situation I Organizations are specialized in one of the two modes Situation II Organizations try to manage the two modes 22

    23. Forms of knowledge and modes of innovation (Jensen et al, 2007): Indicators 23

    24. National Innovation & Learning Systems 24

    25. 25 National Innovation & Learning Systems

    26. GDP per capita Korea x Brazil, 1975-2004 26

    27. 27

    28. Science failures Why: Insufficient knowledge Example: Unknown vaccines Viral: Dengue, avian flu Bacterial: Leprosy, TB Parasitic: Malaria, leishmaniases, trypanosomiases Need: Basic or “user-inspired” research; “Mode 2” of knowledge production (*) Innovation modality New or improved products New R&D strategies: PDPs; PPPs (Brazil: Innovation Law) 28

    29. Market failures Why: High costs prevent access to existing interventions or the development and production of cheaper ones Example: antiretrovirals; combination therapies; new TB drugs Need: Cheaper production processes; new funding strategies Innovation modalities New methods/processes of production New funding policies (Push: PDPs; Pull: Global Funds) New budgeting policies Increasing health budget (e.g. Brazilian taxation on financial transactions) Decreasing health expenses (e.g. antiretrovirals IPR negotiations between Governments and private sector) 29

    30. Public health failures Why: Lack of good governance or sound priorities; corruption; crises/war; cultural or religious factors; etc., prevent the access to cheap and readily available interventions Examples Infectious diseases: polio vaccination (Religious or cultural factors); leprosy chemotherapy (Brazil: wrong policy, lack of priority) Chronic diseases: obesity, tobacco (lobbying by multinational companies) Needs: Education, civil society mobilization, human rights approach Innovation modality: Process, strategy innovation National Vaccination Days; WHO Tobacco Convention; educational TV campaigns (e.g. Brazilian soap operas with health messages); Tanzania’s experience in priority-setting in health systems (*) 30

    31. A “health failures / innovations needed / country actions” matrix 31

    32. A “health failures / innovations needed / country actions” matrix 32

    33. 33 Fighting science failures (knowledge gaps)

    34. Fighting science failures (knowledge gaps) 34

    35. A “health failures / innovations needed / country actions” matrix 35

    36. Fighting market failures (resources gap) 36

    37. A “health failures / innovations needed / country actions” matrix 37

    38. Fighting public health failures (best practices gap) 38

    39. A “health failures / innovations needed / country actions” matrix 39

    40. 3rd Round Table 40

    41. Components of health innovation 41

    42. Components of health innovation 42

    43. Innovative Developing Countries, IDCs 43

    44. 44 Innovative Developing Countries, IDCs

    45. LDCs ? IDCs ? OECD and the six components of health innovation 45

    46. The power of the emerging... IDCs! 46

    47. Health Innovation Networks 47

    48. Developing Country Vaccine Manufactures’ Network Brazil, Cuba, China, India, Indonesia, Mexico WHO Developing Countries’ Vaccine Regulators Network Brazil, China, Cuba, India, Indonesia, Russia, South Africa, South Korea, Thailand 48

    49. Parasite Genome Network Planning Meeting 49

    50. 50 National Health Innovation System

    51. Collaborative research network on leprosy involving Brazilian researchers 51

    52. 4th Round Table 52

    53. 53

    54. Health technology innovation: Major historical periods 1850-early 1900s’: Era of the public sector Epitomized by the work of Pasteur 1900s’-1970s’: Era of the private sector Emerged in Germany & chemical companies 1970s’-2000: Era of public sector reawakening United Nations: WHO Special Programmes (HRP, TDR) USA: Bayh-Dole Act; NIH budget increase 2000- : Era of public-private partnerships (PPPs) Product Development Partnerships (PDPs) Innovative Developing Countries (IDCs) Health Innovation Networks 54

    55. Global health PPPs: product-based and product-development based Buse K, Walt G (2000) Global public-private partnerships: parts I & II Bull.World Health Organ. 78(4): 549-561 & 78(5): 699-709 55

    56. 56

    57. 57

    58. Mary Moran’s Pharmaceutical R&D Policy Project 58

    59. Mary Moran’s Pharmaceutical R&D Policy Project Mary Moran’s team identified three categories of major players in drug development for neglected and most neglected diseases Multinational drug companies 32 projects Working with PPPs or alone on a non-commercial basis Smaller scale commercial firms 60-plus projects Working with PPPs on a commercial basis Drug development PPPs 47 projects Working with large and small companies 59

    60. Mary Moran’s Pharmaceutical R&D Policy Project 60

    61. Types of global health partnerships 61 There is today a large number of global health PPPs focusing on neglected and most neglected diseases. They are quite different in terms of vision and goals. Partnerships focusing at reducing financial risks of drug development MMV; TB Alliance Partnerships focusing on public health and capacity building of endemic countries UN Special Programmes (HRP; TDR) Developing Country Vaccine Manufactures’ Network WHO Developing Countries’ Vaccine Regulators Network Partnerships addressing both goals DNDi

    62. Health PDPs: Broad range of mandates Partnership focuses on product development and registration; minimal or no involvement of developing countries Most PDPs involving multinational drug companies Partnership’s mandate includes issues such as capacity building; training; involvement of endemic country institutions and public health WHO/country networks UN Special Programmes “Development as Growth” (*) “Development as Freedom” (A. Sen)(*) 62

    63. A spectrum of global health PPPs 63

    64. A spectrum of global health PPPs 64

    65. Mary Moran’s Pharmaceutical R&D Policy Project: PPP timelines 65

    66. 66 Standard industry metrics, as used by Moran’s project, should be regarded as just one component of a broader set of metrics when analyzing Global PPPs of different nature Involvement of developing country partners National Innovation Systems GLP, GCP, GMP Regulatory agencies Strengthening local health systems & services Mary Moran’s Pharmaceutical R&D Policy Project: Performance metrics

    67. 5th Round Table 67

    68. Intellectual property rights and innovation in developing countries 68

    69. Intellectual property rights and innovation in developing countries 69

    70. IP and compulsory licences 70

    72. IP management in health To address IP management and licensing, one of the six components of health innovation, developing countries need to train human resources and strengthen their institutions in this critical area

    73. Public Health, Innovation and IP Resolution of the World Health Assembly Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) http://www.who.int/phi/documents/en/ 73

    74. Public Health, Innovation and IP 74 Secretariat for Public Health, Innovation and Intellectual Property (PHI) Established in September 2006 Mandate Facilitate implementation of Resolution WHA 59.24 Follow-up to the report of the Commission on Intellectual Property Rights, Innovation and Public Health

    75. Resolution WHA 59.24 & IGWG 75 Intergovernmental Working Group (IGWG) Mandate Global Strategy and Plan of Action “Securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries” Submission to the Sixty-first World Health Assembly in May 2008 http://www.who.int/phi/en/ What next? May 2008 is approaching rapidly

    76. Intergovernmental Working Group (IGWG) 76 Final product should go beyond a WHA resolution The “Global Strategy and Plan of Action” will need to be institutionalized / hosted at a suitable home or platform Expertise in neglected diseases R&D Good interface with industry and PDPs Balanced governance involving developed and developing countries Proven record of implementation capacity Long term vision and strategic thinking

    77. 6th Round Table 77

    78. Financing for what kind of innovation? 78

    79. The challenge of financing technological innovation: Vaccines 79 Historical models of vaccine development Predominantly private sector development Hepatitis B (HBV) vaccine: Merck Public (or nonprofit) sector vaccine design, with handover to the private sector for trials and manufacturing Human papillomavirus (HPV) vaccine Predominantly public-sector development Influenza vaccine: US Army Coordination by a nonprofit entity Salk polio vaccine

    80. The challenge of financing technological innovation: Vaccines 80 Expanded Program for Immunization (EPI) vaccines $0.25 per dose; $1.50 total cost/child New, non-EPI vaccines can cost 10x more $13.50 per fully immunized child The example of Dominican Republic Budget of current national immunization program: $658,190 Addition of hepatitis b vaccine: additional $590,040 Addition of Hib vaccine: additional $2,880,000

    81. Commercial trade of pharmaceuticals in Brazil 81

    82. 82

    83. Brazil: Health expenditures, per capita (US$) 83

    84. Brazil: Health expenditures, per capita (US$) 84

    85. Public expenditure in health for selected countries (US$ per capita, 2003) 85

    86. Financing: It is not only money that counts “Brazil’s approach to the HIV/AIDS epidemic has been characterized by an early public sector response, strong civil society participation, multisectoral mobilization of efforts and resources, a balanced and comprehensive approach to prevention and treatment and the inclusion of a human rights perspective in all strategies” 86

    87. Financing for what kind of innovation? 87

    88. 88

    89. 89

    90. Thank you morel@fiocruz.br Carlos Morel Oswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, Brazil

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