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

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

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

1st Round Table

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)

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

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

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 “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, 357:1018-1027

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

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, 2004. 151 pages

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

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

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

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-10 1 84376 584 4

Entrepreneurship as ‘Conceptual Orphan’ Hine and Kapeleris (2006) Edward Elgar Publishing Ltd, UK, 259 pp. ISBN-10 1 84376 584 4

2nd Round Table

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, 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, 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 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, 36:680-693.

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 Systems

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

GDP per capita Korea x Brazil, 1975-2004

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

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

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)

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

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

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

Fighting science failures (knowledge gaps)

Fighting science failures (knowledge gaps)

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

Fighting market failures (resources gap)

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

Fighting public health failures (best practices gap)

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

3rd Round Table

Components of health innovation

Components of health innovation

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 http://www.biodevelopments.org/innovation/index.htm

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 http://www.biodevelopments.org/innovation/index.htm

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 http://www.biodevelopments.org/innovation/index.htm

The power of the emerging... IDCs!

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

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 309:401-404, 2005

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 309:401-404, 2005

National Health Innovation System C M Morel - Aula Inaugural, ENSP/FIOCRUZ 09 março 2006 National Health Innovation System Morel et al (2005) Science 309:401-404, 2005

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

4th Round Table

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

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

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

Mary Moran’s Pharmaceutical R&D Policy Project

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

Mary Moran’s Pharmaceutical R&D Policy Project

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

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

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

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

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

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

5th Round Table

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 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 and compulsory licences

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

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/

Public Health, Innovation and IP 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 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) 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

6th Round Table

Financing for what kind of innovation? Hine and Kapeleris (2006) Edward Elgar Publishing Ltd, UK, 259 pp. ISBN-10 1 84376 584 4

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

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 18:2625-2635, 2000

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

Evolution of Latin America’s economies

Brazil: Health expenditures, per capita (US$)

Brazil: Health expenditures, per capita (US$) 2002-05: 59.5% up

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

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”

Financing for what kind of innovation? Gardner et al, Health Affairs 2007, 26(4):1052-1061.

Science 317:482-487, 27/July/2007

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