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

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Bridging the gap in global health innovation from needs to access

Bridging the Gap in Global Health Innovation: Global HealthFrom Needs to Access

9-13 September 2007


Health innovation the neglected capacity of developing countries to address neglected diseases

Health Innovation: Global HealthThe neglected capacity of developing countries to address neglected diseases

Carlos Morel

Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil


Plenary lecture
Plenary lecture Global Health

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


1 st round table
1 Global Healthst Round Table


Global neglected and most neglected diseases who msf
Global, neglected and most neglected diseases (WHO & MSF) Global Health

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)


Understanding global inequalities
Understanding global inequalities Global Health

Private health spending

Malaria cases

Dorling D (2007) Worldmapper: The Human Anatomy of a Small Planet. PLoS Medicine 4(1)13-18



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


Neglected tropical diseases
Neglected tropical diseases care seems to vary among countries (e.g. Uganda x Mali)

“The neglected tropical diseases are a group of 13 major disablingconditions that are among the most common chronic infectionsin the world's poorest people”

Hotez et al, Control of Neglected Tropical Diseases. N Engl J Med 2007, 357:1018-1027


Hotez et al, Control of Neglected Tropical Diseases. care seems to vary among countries (e.g. Uganda x Mali)N Engl J Med 2007, 357:1018-1027


Relationships between science technology and production
Relationships between science, technology and production care seems to vary among countries (e.g. Uganda x Mali)

Francisco Sagasti. Knowledge and innovation for development. The Sisyphus challenge of the 21st century, Cheltenham, UK; Northampton, USA:Edward Elgar, 2004. 151 pages


The sisyphus challenge in chile
The Sisyphus challenge in Chile… care seems to vary among countries (e.g. Uganda x Mali)

Scientometrics72(1):93-103, 2007


The sisyphus challenge in chile1
The Sisyphus challenge in Chile… care seems to vary among countries (e.g. Uganda x Mali)

“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”

Scientometrics72(1):93-103, 2007


And in brazil
… and in Brazil care seems to vary among countries (e.g. Uganda x Mali)

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


Entrepreneurship as conceptual orphan
Entrepreneurship as ‘Conceptual Orphan’ care seems to vary among countries (e.g. Uganda x Mali)

“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-10 1 84376 584 4


Entrepreneurship as conceptual orphan1
Entrepreneurship as ‘Conceptual Orphan’ care seems to vary among countries (e.g. Uganda x Mali)

Hine and Kapeleris (2006) Edward Elgar Publishing Ltd, UK, 259 pp. ISBN-10 1 84376 584 4


2 nd round table
2 care seems to vary among countries (e.g. Uganda x Mali)nd Round Table


Forms of knowledge and modes of innovation jensen et al 2007
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, 36:680-693.


Forms of knowledge and modes of innovation jensen et al 20071
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, 36:680-693.


Forms of knowledge and modes of innovation jensen et al 20072
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, 36:680-693.


Forms of knowledge and modes of innovation jensen et al 2007 situations
Forms of knowledge and modes of innovation (Jensen et al, 2007): Situations

  • Situation IOrganizations 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, 36:680-693.


Forms of knowledge and modes of innovation jensen et al 2007 indicators
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, 36:680-693.



National innovation learning systems1
National Innovation & Learning Systems 2007): Indicators

ACTIVENIS (Korea)

PASSIVE NLS (Brazil)


Gdp per capita korea x brazil 1975 2004
GDP per capita 2007): IndicatorsKorea x Brazil, 1975-2004

2004

Brazil: 7.531

Korea: 18.840

1975

Brazil: 5.502

Korea: 3.722


Science failures
Science failures 2007): Indicators

  • 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


Market failures
Market failures 2007): Indicators

  • 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)


Public health failures
Public health failures 2007): Indicators

  • 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




Fighting science failures knowledge gaps
Fighting actions” matrix science failures(knowledge gaps)


Fighting science failures knowledge gaps1
Fighting actions” matrix science failures(knowledge gaps)



Fighting market failures resources gap
Fighting actions” matrix market failures (resources gap)



Fighting public health failures best practices gap
Fighting actions” matrix public health failures(best practices gap)



3 rd round table
3 actions” matrix rd Round Table




Innovative developing countries idcs
Innovative Developing Countries, IDCs actions” matrix

(*) Morel et al (2005) Innovation Strategy Today 1(1):1-15http://www.biodevelopments.org/innovation/index.htm


Innovative developing countries idcs1
Innovative Developing Countries, IDCs actions” matrix

(*) Morel et al (2005) Innovation Strategy Today 1(1):1-15http://www.biodevelopments.org/innovation/index.htm


Ldcs idcs oecd and the six components of health innovation
LDCs actions” matrix  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):1-15http://www.biodevelopments.org/innovation/index.htm



Health innovation networks
Health Innovation Networks actions” matrix


  • Developing Country Vaccine Manufactures’ Network actions” matrix

    • 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 309:401-404, 2005


National health innovation system
National Health Innovation System actions” matrix

Morel et al (2005) Science 309:401-404, 2005


Collaborative research network on leprosy involving brazilian researchers
Collaborative research network on leprosy involving Brazilian researchers

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


4 th round table
4 Brazilian researchersth Round Table


Health technology innovation major historical periods
Health technology innovation: Major historical periods Brazilian researchers

  • 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


Global health ppps product based and product development based
Global health PPPs: Brazilian researchersproduct-based and product-developmentbased

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



Mary moran s pharmaceutical r d policy project1
Mary Moran’s Pharmaceutical R&D Policy Project Brazilian researchers

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



Types of global health partnerships
Types of global health partnerships Brazilian researchers

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


Health pdps broad range of mandates
Health PDPs: Broad range of mandates Brazilian researchers

“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


A spectrum of global health ppps
A spectrum of global health PPPs Brazilian researchers

Nature of PPPs’visions and mandates

Focus on financial risk reduction

Focus on increasing capacity and public health


A spectrum of global health ppps1
A spectrum of global health PPPs Brazilian researchers

Nature of PPPs’visions and mandates

Focus on financial risk reduction

Focus on capacity building and public health

DCVR (Developing Countries' Vaccine Regulators) Network



Mary moran s pharmaceutical r d policy project performance metrics
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


5 th round table
5 Performance metricsth Round Table


Intellectual property rights and innovation in developing countries
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, 78:474-493.


Intellectual property rights and innovation in developing countries1
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, 78:474-493.



Ip management in health
IP management in health countries

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


Public health innovation and ip
Public Health, Innovation and IP countries

Resolution of the World Health Assembly

Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)

http://www.who.int/phi/documents/en/


Public health innovation and ip1
Public Health, Innovation and IP countries

  • 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


Resolution wha 59 24 igwg
Resolution WHA 59.24 & IGWG countries

  • 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


Intergovernmental working group igwg
Intergovernmental Working Group (IGWG) countries

  • 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


6 th round table
6 countriesth Round Table


Financing for what kind of innovation
Financing for what kind of innovation? countries

Hine and Kapeleris (2006) Edward Elgar Publishing Ltd, UK, 259 pp. ISBN-10 1 84376 584 4


The challenge of financing technological innovation vaccines
The challenge of financing technological innovation countries: 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


The challenge of financing technological innovation vaccines1
The challenge of financing technological innovation countries: 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, Vaccine18:2625-2635, 2000


Commercial trade of pharmaceuticals in brazil
Commercial trade of pharmaceuticals in Brazil countries

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






Financing it is not only money that counts
Financing: It is not only money that counts capita, 2003)

“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”


Financing for what kind of innovation1
Financing for what kind of innovation? capita, 2003)

Gardner et al, Health Affairs 2007, 26(4):1052-1061.



Thank you morel@fiocruz br

Thank you capita, 2003)[email protected]

Carlos Morel

Oswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, Brazil


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