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. Carlos Morel Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil
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
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

6. Global, neglected and most neglected diseases (WHO & MSF)
Most neglected diseases (e.g. dengue, Chagas)
World pharmaceutical market (>$600 bn in 2005)
Neglected diseases (e.g. malaria, tuberculosis)
Global diseases (e.g. measles, diabetes)

7. Understanding global inequalities
Private health spending
Malaria cases
Dorling D (2007) Worldmapper: The Human Anatomy of a Small Planet. PLoS Medicine 4(1)13-18

8. Public opinion sees illegal drugs as a major problem all over Africa

9. On the other hand the need to pay for medical and health care seems to vary among countries (e.g. Uganda x Mali)

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”
Hotez et al, Control of Neglected Tropical Diseases. N Engl J Med 2007, 357:

11. Hotez et al, Control of Neglected Tropical Diseases
Hotez et al, Control of Neglected Tropical Diseases. N Engl J Med 2007, 357:

12. Relationships between science, technology and production
C M Morel - Aula Inaugural, ENSP/FIOCRUZ
09 março 2006
Relationships between science, technology and production
Francisco Sagasti. Knowledge and innovation for development. The Sisyphus challenge of the 21st century, Cheltenham, UK; Northampton, USA:Edward Elgar, pages

13. The Sisyphus challenge in Chile…
Scientometrics 72(1):93-103, 2007

14. The Sisyphus challenge in Chile…
“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”
Scientometrics 72(1):93-103, 2007

15. Morel et al (2007) The road to recovery. Nature 449, in press
… and in Brazil
Morel et al (2007) The road to recovery. Nature 449, in press

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”…
Hine and Kapeleris (2006) Edward Elgar Publishing Ltd, UK, 259 pp. ISBN

17. Entrepreneurship as ‘Conceptual Orphan’
Hine and Kapeleris (2006) Edward Elgar Publishing Ltd, UK, 259 pp. ISBN

18. 2nd Round Table

19. Forms of knowledge and modes of innovation (Jensen et al, 2007)
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
Jensen MB, Johnson B, Lorenz E, Lundvall BA: Forms of knowledge and modes of innovation. Research Policy 2007, 36:

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
Jensen MB, Johnson B, Lorenz E, Lundvall BA: Forms of knowledge and modes of innovation. Research Policy 2007, 36:

21. Forms of knowledge and modes of innovation (Jensen et al, 2007)
Know-what
Know-why
Know-how
Know-who
Emphasis on STI mode
Emphasis on DUI mode
Jensen MB, Johnson B, Lorenz E, Lundvall BA: Forms of knowledge and modes of innovation. Research Policy 2007, 36:

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
STI
DUI
STI
DUI
Jensen MB, Johnson B, Lorenz E, Lundvall BA: Forms of knowledge and modes of innovation. Research Policy 2007, 36:

23. Forms of knowledge and modes of innovation (Jensen et al, 2007): Indicators
Jensen MB, Johnson B, Lorenz E, Lundvall BA: Forms of knowledge and modes of innovation. Research Policy 2007, 36:

24. National Innovation & Learning Systems

25. National Innovation & Learning Systems
ACTIVE NIS (Korea)
PASSIVE NLS (Brazil)

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

27. C M Morel - Aula Inaugural, ENSP/FIOCRUZ
09 março 2006

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)
(*) Gibbons M, Limoges C, Nowotny H, Schwartzman S, Scott P, Trow M: The new production of knowledge: the dynamics of science and research in contemporary societies. London; Thousand Oaks; New Delhi: SAGE Publications; 1994

29. Market failures New methods/processes of production
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)

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 (*)
(*) Savigny, Kasale, Mbuya, and Reid (2004) Fixing Health Systems

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

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

33. Fighting science failures (knowledge gaps)

34. Fighting science failures (knowledge gaps)

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

36. Fighting market failures (resources gap)

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

38. Fighting public health failures (best practices gap)

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

40. 3rd Round Table

41. Components of health innovation

42. Components of health innovation

43. Innovative Developing Countries, IDCs
C M Morel - Aula Inaugural, ENSP/FIOCRUZ
09 março 2006
Innovative Developing Countries, IDCs
(*) Morel et al (2005) Innovation Strategy Today 1(1):1-15

44. Innovative Developing Countries, IDCs
C M Morel - Aula Inaugural, ENSP/FIOCRUZ
09 março 2006
Innovative Developing Countries, IDCs
(*) Morel et al (2005) Innovation Strategy Today 1(1):1-15

45. LDCs  IDCs  OECD and the six components of health innovation
6 components or determinants
LDCs  IDCs  OECD
(*) Morel et al (2005) Innovation Strategy Today 1(1):1-15

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

47. Health Innovation Networks
C M Morel - Aula Inaugural, ENSP/FIOCRUZ
09 março 2006
Health Innovation Networks

48. C M Morel - Aula Inaugural, ENSP/FIOCRUZ
09 março 2006
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
Morel et al (2005) Science 309: , 2005

49. Parasite Genome Network Planning Meeting
C M Morel - Aula Inaugural, ENSP/FIOCRUZ
09 março 2006
Parasite Genome Network Planning Meeting
Morel et al (2005) Science 309: , 2005

50. National Health Innovation System
C M Morel - Aula Inaugural, ENSP/FIOCRUZ
09 março 2006
National Health Innovation System
Morel et al (2005) Science 309: , 2005

51. Morel et al (2007) The road to recovery. Nature 449, in press
Collaborative research network on leprosy involving Brazilian researchers
Morel et al (2007) The road to recovery. Nature 449, in press

52. 4th Round Table

53. C M Morel - Aula Inaugural, ENSP/FIOCRUZ
09 março 2006

54. Health technology innovation: Major historical periods
Paris, 16 November 2005
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
Mahoney, R & Morel, C. (2006) A Global Health Innovation System (GHIS). Innovation Strategy Today 2(1):1-12
FIOCRUZ-Institut Pasteur Workshop

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): & 78(5):

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

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

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

61. Types of global health partnerships
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
“Development as Growth” (*)
“Development as Freedom” (A. Sen)(*)
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
(*) Personal communication - Margaret Chon, Seattle University School of Law

63. A spectrum of global health PPPs
Nature of PPPs’ visions and mandates
Focus on financial risk reduction
Focus on increasing capacity and public health

64. A spectrum of global health PPPs
Nature of PPPs’ visions and mandates
Focus on financial risk reduction
Focus on capacity building and public health
DCVR (Developing Countries' Vaccine Regulators) Network

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

66. Mary Moran’s Pharmaceutical R&D Policy Project: Performance metrics
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

67. 5th Round Table

68. Intellectual property rights and innovation in developing countries
IP strongly protected
IP not protected
Chen Y, Puttitanun T: Intellectual property rights and innovation in developing countries. Journal of Development Economics 2005, 78:

69. Intellectual property rights and innovation in developing countries
IP protection due to external pressure
IP protection by country decision
IP policy in transition
Chen Y, Puttitanun T: Intellectual property rights and innovation in developing countries. Journal of Development Economics 2005, 78:

70. IP and compulsory licences

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)

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

75. Resolution WHA 59.24 & IGWG 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
What next? May 2008 is approaching rapidly

76. Intergovernmental Working Group (IGWG)
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

78. Financing for what kind of innovation?
Hine and Kapeleris (2006) Edward Elgar Publishing Ltd, UK, 259 pp. ISBN

79. The challenge of financing technological innovation: Vaccines
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
IAVI Policy Research Working Paper #14 - R&D Models: Lesson from Vaccine History

80. The challenge of financing technological innovation: Vaccines
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
Mahoney et al, Vaccine 18: , 2000

81. Commercial trade of pharmaceuticals in Brazil
Morel et al (2007) The road to recovery. Nature 449, in press

82. Evolution of Latin America’s economies

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

84. Brazil: Health expenditures, per capita (US$)
: 59.5% up

85. Public expenditure in health for selected countries (US$ per capita, 2003)
Country
US$
USA
2,548
Germany
2,506
France
2,273 UK
2,081
Japan
1,997
Canada
1,886
Australia
1,699
Cuba
183
Mexico
172
Brazil
153
Argentina
148
Chile
137

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”

87. Financing for what kind of innovation?
Gardner et al, Health Affairs 2007, 26(4):

89. Science 317: , 27/July/2007

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