Global, neglected and most neglected diseases (WHO & MSF) 6 World pharmaceutical market (>$600 bn in 2005) Most neglected diseases (e.g. dengue, Chagas) Neglected diseases (e.g. malaria, tuberculosis) Global diseases (e.g. measles, diabetes)
Understanding global inequalities Private health spendingMalaria cases Dorling D (2007) Worldmapper: The Human Anatomy of a Small Planet. PLoS Medicine 4(1)13-18 7
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)
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 Hotez et al, Control of Neglected Tropical Diseases. N Engl J Med 2007, 357:1018-1027
11 Hotez et al, Control of Neglected Tropical Diseases. N Engl J Med 2007, 357:1018-1027
Relationships between science, technology and production 12 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… 13 Scientometrics 72(1):93-103, 2007
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 ” Scientometrics 72(1):93-103, 2007
… and in Brazil 15 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 16
Entrepreneurship as ‘Conceptual Orphan’ 17 Hine and Kapeleris (2006) Edward Elgar Publishing Ltd, UK, 259 pp. ISBN-10 1 84376 584 4
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 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 20 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 21 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 22 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 23 Jensen MB, Johnson B, Lorenz E, Lundvall BA: Forms of knowledge and modes of innovation. Research Policy 2007, 36:680-693.
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 28
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
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 30
A “health failures / innovations needed / country actions” matrix 31
A “health failures / innovations needed / country actions” matrix 32
Innovative Developing Countries, IDCs (*) Morel et al (2005) Innovation Strategy Today 1(1):1-15 http://www.biodevelopments.org/innovation/index.htm 43
44 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 45 (*) Morel et al (2005) Innovation Strategy Today 1(1):1-15 http://www.biodevelopments.org/innovation/index.htm 6 components or determinants LDCs IDCs OECD
Morel et al (2005) Science 309:401-404, 2005 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
Parasite Genome Network Planning Meeting Morel et al (2005) Science 309:401-404, 2005 49
50 National Health Innovation System Morel et al (2005) Science 309:401-404, 2005
Collaborative research network on leprosy involving Brazilian researchers 51 Morel et al (2007) The road to recovery. Nature 449, in press
Health technology innovation: Major historical periods Era of the public sector 1850-early 1900s’: Era of the public sector Epitomized by the work of Pasteur Era of the private sector 1900s’-1970s’: Era of the private sector Emerged in Germany & chemical companies Era of public sector reawakening 1970s’-2000: Era of public sector reawakening United Nations: WHO Special Programmes (HRP, TDR) USA: Bayh-Dole Act; NIH budget increase Era of public-private partnerships (PPPs) 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 54
product product-development 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
Mary Moran’s Pharmaceutical R&D Policy Project 58
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
Mary Moran’s Pharmaceutical R&D Policy Project 60
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
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 (*) 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 63
A spectrum of global health PPPs Nature of PPPs’ visions and mandates Focus on financial risk reduction Focus on capacity building and public health 64 DCVR (Developing Countries' Vaccine Regulators) Network
Mary Moran’s Pharmaceutical R&D Policy Project: PPP timelines 65
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
Intellectual property rights and innovation in developing countries 68 IP not protected IP strongly 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 69 IP protection due to external pressure IP protection by country decision IP policy in transition
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/ 73
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
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/ http://www.who.int/phi/en/ What next? May 2008 is approaching rapidly
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
Financing for what kind of innovation? 78 Hine and Kapeleris (2006) Edward Elgar Publishing Ltd, UK, 259 pp. ISBN-10 1 84376 584 4
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 IAVI Policy Research Working Paper #14 - R&D Models: Lesson from Vaccine History
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 $2,880,000 Mahoney et al, Vaccine 18:2625-2635, 2000
Commercial trade of pharmaceuticals in Brazil 81 Morel et al (2007) The road to recovery. Nature 449, in press
Brazil: Health expenditures, per capita (US$) 83
Brazil: Health expenditures, per capita (US$) 84 2002-05: 59.5% up
Public expenditure in health for selected countries (US$ per capita, 2003) 85 CountryUS$ USA2,548 Germany2,506 France2,273 UK2,081 Japan1,997 Canada1,886 Australia1,699 Cuba183 Mexico172 Brazil153 Argentina148 Chile137
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
Financing for what kind of innovation? 87 Gardner et al, Health Affairs 2007, 26(4):1052-1061.