Global Forum Update onResearch for HealthVolume 5
InnovaƟ on for health is a vital driver of development. Drawing new ideas and discoveries from research, it may cross many sectors and disciplines involved in the development and applicaƟ on of a novel product or process.
The Global Forum for Health Research focuses on promoƟ ng an environment that fosters innovaƟ ve soluƟ ons for the health of poor populaƟ ons. In doing so, Fostering innovaƟ on it places parƟ cular emphasis on health equity as the central goal, i.e. reducing health dispariƟ es within and between populaƟ ons.
The fi Ō h volume of the Global Forum Update on Research for Health provides insights into the newest thinking on innovaƟ on for global health. Some 30 for global health leading insƟ tuƟ ons and professionals from around the world refl ect on how policy, social, technological and corporate innovaƟ ons can be fostered for global health. Global Forum Update on This volume is produced to coincide with the Global Ministerial Forum on Research for Health, Bamako, which is co-organized by the Global Forum for Research for Health Volume 5 Health Research.
Editors
Monika Gehner, Susan Jupp and Stephen A Matlin, Global Forum for Health Research
Editorial Advisory Board
Luis Gabriel Cuervo Pan American Health OrganizaƟ on Andrés de Francisco The Partnership for Maternal, Newborn and Child Health Nirmal Kumar Ganguly NaƟ onal InsƟ tute of Immunology, India Stuart Gillespie Plaƞ orm on Agriculture and Health Research Odile Leroy European Malaria Vaccine IniƟ aƟ ve Judith Sutz Universidad de la República, Uruguay Alfred Watkins World Bank Pro-Brook Derek Yach PepsiCo, Inc.
ISBN: 978-2-940401-12-3 www.globalforumhealth.org
Cover - Final_layout.indd 1 22/10/08 16:30:41 00-08 Contents GF5:GF5 23/10/08 09:37 Page 1
Fostering innovaƟ on for global health
Global Forum Update on Research for Health Volume 5
www.globalforumhealth.org Pro-Brook
Title page.indd 1 23/10/08 09:34:53 00-08 Contents GF5:GF5 23/10/08 09:15 Page 3
Contents
Editorial Advisory Board: Luis Gabriel Cuervo Pan American Health Organization Andrés de Francisco The Partnership for Maternal, Newborn and Child Health Nirmal Kumar Ganguly National Institute of Immunology, India Stuart Gillespie Platform on Agriculture and Health Research Odile Leroy European Malaria Vaccine Initiative Judith Sutz Universidad de la República, Uruguay Alfred Watkins World Bank Derek Yach PepsiCo, Inc.
Editorial Team: Monika Gehner, Global Forum for Health Research Susan Jupp, Global Forum for Health Research Stephen A Matlin, Global Forum for Health Research
Production Team: Julia Federico, Global Forum for Health Research Monika Gehner, Global Forum for Health Research Oana Penea, Global Forum for Health Research
Pro-Brook Publishing Team: Trevor Brooker, Pro-Brook Publishing Tim Probart, Pro-Brook Publishing Stephen Kemp-King, Pro-Brook Publishing Simon Marriott, Art Direction Jude Ledger, Copy Editor Pr Photo credits: WHO/PAHO/Carlos Gaggero WHO/TDR/Andy CraggsWyndeham Grang
The Global Forum Update on Research for Health Volume 5 is published for the Global Forum for Health Research by Pro-Brook Publishing Limited
Pro-Brook Publishing, 13 Church Street, Woodbridge, IP12 1DS, United Kingdom
Copyright Text © the Global Forum for Health Research 2008 Volume © Pro-Brook Publishing Limited 2008
All rights are reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photo-copying, recording or otherwise without the permission of the Publisher.
The information contained in this publication is believed to be accurate at the time of manufacture. Whilst every care has been taken to ensure that the information is accurate, the Publisher and Global Forum for Health Research can accept no responsibility, legal or otherwise, for any errors or omissions or for changes to details given to the text or sponsored material. The views expressed in this publication are not necessarily those of the Publisher or of the Global Forum for Health Research.
Application for reproduction should be made in writing to the Publisher.
ISBN 978-2-940401-12-3 First published 2008
Acknowledgements: The Publishers hereby acknowledge the assistance of all the contributors who have helped in the production of the publication and the advertisers who have made the publication possible.
e, Southwick, UK Global Forum Update on Research for Health Volume 5 3 00-08 Contents GF5:GF5 22/10/08 14:06 Page 5
Contents
Contents 009 Foreword/Préface Gill Samuels
013 The scope and potential of innovation for health and health equity Stephen A Matlin
innovating for health and development 024 Research and innovation in Brazil: the institutional role of the Ministry of Health Suzanne Jacob Serruya with Reinaldo Guimarães, Itajai Oliveira de Albuquerque and Carlos Medicis Morel
030 Health markets and future health systems: innovation for equity Gerald Bloom with Claire Champion, Henry Lucas, M Hafizur Rahman, Abbas Bhuiya, Oladimeji Oladepo and David Peters
036 Strengthening the base: innovation and convergence in climate change and public health Saqib Shahab with Abdul Ghaffar
041 Global health diplomacy – a bridge to innovative collaborative action Thomas E Novotny and Ilona Kickbusch with Hannah Leslie and Vincanne Adams
048 Hideyo Noguchi Africa Prize Kiyoshi Kurokawa with Tamaki Tsukada and Eri Maeda
054 Health research and innovation: recent Spanish policies Flora de Pablo with Isabel Noguer moting healt 059 The changing landscape of research for health Kirsten Havemann with introduction by Ulla Tørnæs
066 Global health and the foreign policy agenda Jonas Gahr Støre
072 “Policies for innovation”: evidence-based policy innovation – transforming constraints into opportunities Miguel Angel González Block
Social innovations 076 Interactions between populations, health workers and health programmes for prevention of malaria: teachings of an analysis “from below” Yannick Jaffré
082 Ethical aspects of innovation in health José Geraldo de Freitas Drumond
088 Ethics, evidence and innovation Kenneth W Goodman
091 Seeding a global movement on neglected diseases Sandeep P Kishore with Pius Mulamira
096 Supporting implementation research partnerships for health systems strengthening: one foundation’s approach in sub-Saharan Africa Elaine K Gallin
099 The practical impact of research in South-East Asia funded by the Wellcome Trust Jimmy Whitworth with Ruth Branston and Michael Chew
Global Forum Update on Research for Health Volume 5 5 00-08 Contents GF5:GF5 22/10/08 14:06 Page 7
Contents
104 Independence and innovation: looking beyond the magic of words Xavier Crombéddressing global challenges
107 Creating incentives to induce behavioural change and improve health: success and limitations of conditional cash transfer programmes Mylene Lagarde with Andy Haines and Natasha Palmer
Technological innovations 114 Innovation and access: medicines for the poor – the IGWG strategy and plan of action Bart Wijnberg and Marleen Monster
120 The Noordwijk Medicines Agenda: a model for changing innovation for neglected and emerging infectious diseases Bénédicte Callan with Susanne L Huttner, Iain Gillespie and Barbara Slater
124 Health dynamics, innovation and the slow race to make technology work for the poor Melissa Leach with Ian Scoones H ealth research institutions and g 130 Leapfrog technologies for health and development Harry McConnell with Prita Chathoth, Ashley Pardy, Camille Boostrom, Eugene Boostrom, Koos Louw, Luis Gabriel Cuervo and Sumiko Ogawa
138 The IVI’s innovative approach to closing the gap between vaccines for industrialized and developing countries Denise DeRoeck with Anna Lena Lopez, Rodney Carbis and John D Clemens
143 Commercializing African health research: building life science convergence platforms Peter A Singer and Abdallah S Daar with Sara Al-Bader, Ronak Shah, Ken Simiyu, Ryan E Wiley, Pamela Kanellis, Menaka Pulandiran and Marilyn Heymann
Corporate sector-related innovations 152 Making drugs accessible to poor populations: a funding model Paul L Herrling
157 Public-private partnerships drive innovation to improve the health of poor populations Christopher J Elias with Yvette Gerrans and F Marc LaForce
161 Innovations and incentives: why pharmaceutical companies are becoming interested in neglected tropical diseases Arianne Matlin
166 Vision for a venturing ecosystem to generate global health innovation William Rosenzweig
171 Beyond product: the private sector drive to perform with the purpose of alleviating global under-nutrition Dondeena Bradley
174 Innovating against hunger and under-nutrition Josette Sheeran
177 Riders for Health: an award-winning social enterprise ensuring health care delivery across Africa Ngwarati Mashonga
182 UNITAID: innovative financing to scale up access to medicines Jorge Bermudez
186 Threshold of evidence needed for health claims on functional foods Peter J Jones with Stephanie Jew
190 The Lilly MDR-TB Partnership: innovation to fight a disease Patrizia Carlevaro
Global Forum Update on Research for Health Volume 5 7
236837a1.indd 1 10/9/08 9:40:12 PM Foreword
Foreword Gill Samuels, Chair of the Foundation Council, Global Forum for Health Research, Switzerland
nnovation is a vital driver of development. It involves the between policies and actions of global players and national creation of novel ideas, processes and products and their forces shaping country research and innovation systems. Iapplication to deliver practical solutions. In the health Some LMICs are now showing greater commitment to field, it encompasses not only technological inventions of investing in research for health and to developing systematic products such as drugs, vaccines and diagnostics, but also and equitable approaches to the creation and use of innovations in the environmental, economic, political and knowledge and innovation. These “innovative developing social fields that can impact on the capacity to deliver health countries” have the potential to contribute significantly to the products and services and health protection and promotion production of health-related products, services and processes messages and that can influence the broader determinants of for low-income countries and to south-south capacity health. building. To do so, they will require policy and legal The Global Forum for Health Research especially focuses frameworks that need to be set nationally and globally, as well on promoting an environment that fosters innovative solutions as significant levels of public sector investment to ensure that to health problems that are relevant to resource-poor settings the system delivers products that are accessible and or adapted to different social and cultural contexts in low- and affordable to the poor and contribute to a reduction in health middle-income countries (LMICs). In doing do, it places disparities. particular emphasis on health equity as the central goal and The Global Ministerial Forum on Research for Health on the importance of bringing innovation to bear on the (Bamako, 17-19 November 2008) brings together a wide health problems of the poorest and most disadvantaged range of stakeholders in research and innovation for health. It people. affords a unique opportunity for a multi-sectoral dialogue to While increasing attention is now being given to the role of give impetus to this global agenda, to address the high-income countries in contributing to research and environment for innovation to accelerate achievement of the innovation for global health or the health of populations in Millennium Development Goals and tackle some of the LMICs, these countries need their own capacity to conduct world’s major health challenges. and utilize research to solve their immediate health problems. As a contribution to this dialogue, the Global Forum for They too need to strengthen their systems of innovation as Health Research has commissioned this collection of writings important drivers of development. by a range of experts and leaders in the fields of development, The global agenda must encompass how to (a) strengthen innovation and research. We are extremely grateful to the health research systems and innovation systems in LMICs; writers for providing cogent summaries, fresh insights and (b) strengthen systems incentives to create relevant products challenging messages to inform the dialogue. J accessible to poor populations; and (c) enhance coherence
Global Forum Update on Research for Health Volume 5 09 Préface
Préface
Gill Samuels, Présidente du Conseil de Fondation, Global Forum for Health Research, Suisse
'innovation est un moteur essentiel du développement. la cohérence entre les politiques et les actions des acteurs Cela comprend la création d’idées, de procédés et de globaux et des forces nationales qui configurent les systèmes Lproduits nouveaux et leur application pour fournir des de recherche et d'innovation des pays. solutions pratiques. Dans le domaine de la santé, cela Certains pays à faibles et moyens revenus s’engagent englobe non seulement les inventions technologiques de maintenant à investir dans la recherche pour la santé et à produits, tels que médicaments, vaccins et diagnostics, mais développer des approches systématiques et équitables pour aussi l’innovation dans tous les domaines environnemental, susciter et utiliser la connaissance et l’innovation. Ces 'pays économique, politique et social qui peuvent avoir un impact en développement innovants' ont le pouvoir de contribuer sur la capacité d'offrir des produits et des services de santé et significativement à la production de services, de processus et sur les messages de protection et de promotion de la santé de produits pour la santé à destination des pays à faible qui peuvent influencer les déterminants de la santé. revenu, et de renforcer les capacités entre pays du Sud. Pour Le Forum mondial pour la recherche en santé a pour objet, ce faire, ils auront besoin d’un cadre politique et juridique en particulier, de promouvoir un environnement qui favorise qu'il faudra établir à différents niveaux, nationaux et mondial, des solutions novatrices aux problèmes de santé spécifiques ainsi que d'investissements conséquents du secteur public aux milieux défavorisés ou adaptés aux contextes sociaux et pour s'assurer que le système fournit des produits accessibles culturels variés des pays à faibles et moyens revenus. Pour ce et abordables pour les pauvres, contribuant à une réduction faire, il se donne tout particulièrement comme objet des disparités en santé. d’atteindre l'équité en santé et de faire porter l'innovation sur Le Forum ministériel mondial sur la recherche pour la santé les problèmes de santé des plus pauvres et des plus (Bamako, 17-19 novembre 2008) rassemble un large défavorisés. éventail de personnes concernées par la recherche et Alors que l’on accorde une attention accrue à la l'innovation pour la santé. Il offre une occasion unique de contribution des pays à revenu élevé à la recherche et à dialogue multi-sectoriel en vue de dynamiser cet ordre du jour l'innovation pour la santé globale ou la santé des populations mondial, de s'intéresser à l'environnement pour l'innovation des pays à faibles et moyens revenus, ces pays ont besoin de pour accélérer la réalisation des objectifs du Millénaire pour leur propre capacité d’effectuer et d'utiliser la recherche pour le développement et s'atteler à certains des plus grands défis résoudre leurs problèmes de santé immédiats. Ils doivent en matière de santé dans le monde. aussi renforcer leurs systèmes d'innovation, en tant que En tant que contribution à ce dialogue, le Forum mondial facteurs importants du développement. pour la recherche en santé a commandé ces contributions de L'ordre du jour global doit inclure les moyens de (a) nombreux experts et chefs de file dans les domaines du renforcer les systèmes de recherche en santé et les systèmes développement, de l'innovation et de la recherche. Nous d'innovation dans les pays à faibles et moyens revenus ; (b) sommes extrêmement reconnaissants aux auteurs d’avoir renforcer les systèmes d'incitation pour créer des produits fourni des récapitulations pertinentes, des éclairages nouveaux adaptés accessibles aux populations pauvres, et (c) améliorer et des messages stimulants pour contribuer au dialogue. J
10 Global Forum Update on Research for Health Volume 5 13-20 Matlin Stephen:GF5 23/10/08 09:46 Page 13
Introduction
The scope and potential of innovation for health and health equity
Article by Stephen A Matlin, Executive Director, Global Forum for Health Research, Switzerland
nnovation encompasses not only the birth of an idea or a Box 2: Capturing the benefits of innovation for development goals discovery, but its application in practice – taking the … if the development community turns its back on the Ioutputs of research and invention and using them to put explosion of technological innovation in food, medicine new goods, services or processes into use. and information, it risks marginalizing itself and The products of innovation in science and technology are denying developing countries opportunities that, if usually tangible (e.g. machines, equipment, devices, harnessed effectively, could transform the lives of poor materials) and their value is clearly visible as they often people and offer breakthrough development greatly contribute to the wealth of individuals, corporations opportunities to poor countries. and countries. But innovation in other fields – such as … economic, political and social spheres – is also of great importance and can also contribute, in sometimes less In short, the challenge the world faces is to match the tangible but nevertheless highly valued, ways to the pace of technological innovation with real policy conditions in which people live and their quality of life. innovation both nationally and globally. And if we can The Global Forum for Health Research1 espouses this broad do that successfully, we can dramatically improve the view of innovation (see Box 1) and seeks to promote prospects for developing countries of meeting the key innovation in all fields that will improve the health of poor development goals… populations and reduce health inequities.
Box 1: Innovation for health and health equity MARK MALLOCH BROWN, ADMINISTRATOR, UNDP 2 Innovation for health and health equity is an initiative in FOREWORD TO HUMAN DEVELOPMENT REPORT 2001 any sector or combination of sectors that takes up novel ideas, inventions or processes and applies them to economic, environmental, political and social determinants – achieving improved health and greater health equity. that need to be better understood and managed to improve health and reduce health disparities within and between The importance of capturing the benefits of innovation to populations. This enlarged domain of relevant research is achieve the Millennium Development Goals, including those referred to as “research for health”6,7 and is attracting for health, has been emphasized (see Box 2)2. increasing attention. The newly published report8 of the Commission on Social Research and innovation for health: Determinants of Health provides a wealth of evidence on the dimensions and sectors and elements important influences of social factors and highlights the need needed for more research to understand the “causes of the causes” of Research for health ill-health. The Global Ministerial Forum on Research for The role of research in contributing to better health in low- Health (Bamako, 17–19 November 2008) is the first meeting and middle-income countries (LMICs) has been stressed at this level to address the complex array of cross-sectoral repeatedly in the last two decades,3-5 placing emphasis on the issues involved in addressing some of the world’s major range of health research that is relevant – including basic health challenges through a broad and multidisciplinary sciences and biomedical research, health policy and systems approach9. research and social, behavioural and operational research. The Global Forum for Health Research10 defines “research However, in the last few years there have been efforts to for health” as research undertaken in any discipline or direct attention to a wider range of determinants of health combination of disciplines that seeks to: beyond biological and health system factors – including understand the impact on health of policies,
Global Forum Update on Research for Health Volume 5 13 GF5 advert - plain.eps 17/10/08 14:10:02 13-20 Matlin Stephen:GF5 23/10/08 09:46 Page 15
Introduction
programmes, processes, actions or events originating in many different fields, including the arts and humanities. any sector – including, but not limited to the health The innovation system crosses many sectors and sector itself and encompassing biological, economic, disciplines involved in the development and application environmental, political, social and other determinants of of a new product or process – for example, including health; legal, financial and commercial aspects. assist in developing interventions that will help prevent or Both research and innovation take place in a national mitigate that impact; environment whose characteristics (e.g. political, legal, contribute to the achievement of health equity and better economic, social, cultural) can have a major influence – health for all. determining the extent to which innovation is fostered and how well it succeeds. This is further impacted on by Innovation for health the global environment which again can strongly Taking this broad view of research for health, innovation for influence the likelihood of innovative ideas being health and health equity can be defined as shown in Box 1 developed, translated into practice and effectively applied. and the systemic relationship between research and innovation for health can be depicted schematically as in Elements for successful research and innovation Figure 1: The conduct of research requires a set of specific knowledge The system which encompasses research for health in a and skills, as well as an institutional environment in which country is only partly in the health sector, since; (1) it the researcher can function. Considerable effort and also involves many other sectors that help to determine resources have been expended in recent decades in the eventual health status of individuals. These include strengthening individual and institutional research capacities sectors concerned with education, employment, the in LMICs11. environment, transport, the law, etc; (2) it includes many Innovation also requires both skilled human resources and kinds of researchers in different disciplines, often not an enabling environment. One element that is crucial for employed within the health sector or dedicated research successful innovation is entrepreneurship – a set of attributes institutes such as Medical Research Councils or National that collectively add up to the capacity to practically exploit a Institutes of Health but working within higher education novel idea or product and to ensure its successful application or other research institutions, nongovernmental in practice. Some of the attributes of successful organizations or the community. entrepreneurship may be innate – drive and flair for Research for health can therefore be seen as a commercialization and interpersonal skills are often seen in component of the wider research system which includes this light – but, in fact, the key skills of entrepreneurship that all the researchers, institutions and funders in the public contribute to success can be learned from well-designed and private sectors that make up a nation’s total courses. Many entrepreneurship courses are provided in research effort. high-income countries (HICs)12 and on the Internet13 – often The innovation system partly overlaps with the research linked with business schools – and such courses are system, from which it draws new ideas and discoveries. increasingly being taught in LMICs14. It does not include the entire research system, however, since not all research is directed towards eventually Technological innovation producing new products, services or processes but may Technological innovation for health includes the development be aimed at expanding knowledge and understanding in and use of drugs, vaccines and diagnostics. Since the invention of aspirin in the late 19th century, this field has been largely driven by the private sector, which created a thriving industry based in HICs that has provided thousands of new drugs and generates a market currently worth more than US$ 0.5 trillion 15 Health Other sectors per year – predicted to double to around US$ 1.3 sector trillion by 2020. ResearchResearccch systemsystem Global However, despite this impressive record, three environment Health research factors are at work that presage major changes system ahead: Innovationnovation systemsystem The pharmaceutical industry is becoming increasingly unwieldy and unproductive and will need to change its business model. The report16 of
National environment the Commission on Intellectual Property Rights, Innovation and Public Health observed that, following a decade of concentration in the global pharmaceutical industry, many large pharmaceutical companies moved towards a more focused role. Figure 1: Relationships between the research and innovation systems for health They license more potential products in from
Global Forum Update on Research for Health Volume 5 15 13-20 Matlin Stephen:GF5 23/10/08 09:46 Page 16
Introduction
biotech and other small companies and increasingly countries, the largest emerging market economies outsource clinical research to specialist research (Brazil, China, India, Indonesia, Mexico, Russia and organizations, with an increasing emphasis in recent Turkey), are also becoming much more prosperous, with years on trials in developing countries such as India and real gross domestic product (GDP) projected to triple by China. It was estimated that 35% of drugs in Phase III 2020, when they could account for as much as one fifth trials in 2001 were either licensed in or the product of of global pharmaceutical sales. collaborative research, and two thirds of clinical trials involved contract research organizations. The As well as providing increasingly important markets for Commission noted that developing country R&D health products, these and other innovative developing expertise, in both the public and the private sector, was countries22 are also increasingly engaged in the creation of being used increasingly at all stages of the innovation new products and have considerable potential in the cycle, with foreign collaborations increasing in Brazil, biotechnology field. An analysis23 of responses from 232 China, India and other innovative developing countries. developing world experts from 58 countries, asked how best The rise of a biotechnology industry, often comprising to harness biotechnology to improve health in their regions, companies spunoff from university laboratories, has divided their recommendations into four categories: offered additional opportunities for the discovery of new classes of drugs and is resulting in significant changes in Science: the structure of the industry. Collaborate through national, regional and international According to a PricewaterhouseCoopers report17, the networks; current business model of the pharmaceutical industry is Survey and build capacity based on proven models both economically unsustainable and operationally through education, training and needs assessments. incapable of acting quickly enough to produce the types of innovative treatments that will be demanded by global Finance: markets. Pharmaceutical companies are facing a dearth Develop regulatory and intellectual property frameworks of new compounds in the pipeline, poor share value for commercialization of biotechnology; performance, rising sales and marketing expenditures, Enhance funding and affordability of biotechnology; increased legal and regulatory constraints and tarnished Improve the academic-industry interface and the role of reputations. The report considers that “The core small- and medium-sized enterprises. challenge is a lack of innovation. The industry is investing twice as much in R&D as it was a decade ago Ethics, society, culture: to produce two fifths of the new medicines it then Develop public engagement strategies to inform and produced. It is simply an unsustainable business model. educate the public about developments in genomics and Over the next decade, the industry must shift its biotechnology; investment focus more towards research and less on Develop capacity to address ethical, social and cultural sales and marketing.… It must focus on the issues; development of medicines that prevent, treat or cure. Improve accessibility and equity. These must demonstrate tangible benefits and tackle unmet medical needs. Governments and payers must Politics: play their part and ensure the industry is rewarded for Strengthen understanding, leadership and support at the these efforts”. political level for biotechnology; Develop policies outlining national biotechnology strategy. The market-driven model has provided enormous health benefits for people in HICs, but has done The Commission on Intellectual Property Rights, relatively little to address the health problems of Innovation and Public Health (CIPIH) has emphasized the LMICs. As an illustration of the market failure, of 1393 “innovation cycle” (see Box 3) as a framework of particular new chemical entities marketed between 1975 and relevance to LMICs24. 1999, only 16 were for tropical diseases and tuberculosis, while tropical communicable diseases were Innovation for health in social and other responsible for well over 10 million deaths per year, sectors 90% of which occurred in LMICs18-20. Mahoney and It has been emphasized that, to maximize the potential for Morel have argued that this failure, along with science improving global health afforded by the growing capacity for and public health failures, need to be addressed by innovation in some developing countries, both countries and paying attention to the global health innovation system21. donors need to link two disparate schools of thought: (1) a search for technological solutions exemplified by global New markets and new innovative actors in LMICs are public-private product development partnerships, and (2) a causing a shift in the centre of gravity of the focus on systemic solutions exemplified by health policy and pharmaceutical industry. Markets are changing and the systems research. According to Gardner et al25, strong recent PricewaterhouseCoopers report17 notes that the E7 capacity for both technological and social innovation in
16 Global Forum Update on Research for Health Volume 5 13-20 Matlin Stephen:GF5 23/10/08 09:46 Page 17
Introduction
developing countries represents the only truly sustainable protection and conditional cash transfer means of improving the effectiveness of health systems. Local schemes in Latin America and elsewhere have public-private research and development partnerships, demonstrated significant improvements in a variety of health implementation research and individual leadership are indicators26-29. needed to achieve this goal. Innovative models of health-care delivery that have been Recognizing the importance of socioeconomic factors in field-tested include microfranchising of community health determining health status, a number of initiatives have clinics30 and other community-based clinic approaches31, focused on linking welfare, work and microfinancing schemes social franchising as a strategy for expanding access with health. A range of innovative family welfare, social to reproductive health services for adults32 and youths33 and
Box 3: The innovation cycle
The scientific and technical Translational research components of the discovery and development process represent only one aspect. Whether the whole process DISCOVERY actually delivers products needed by • Lead identification/ poor patients in developing countries optimization • Basic research at prices that are potentially affordable depends on a host of political, economic, social and cultural factors. “3D” DEVELOPMENT Demand for INNOVATION • New/improved new/improved tools We prefer to consider innovation as a tools and post- CYCLE • Preclinical cycle. This cycle depicted in right marketing research and clinical represents a schema that applies development principally to developed countries and the diseases which predominantly DELIVERY affect them, where effective demand • Getting products and the population’s health needs to patients Market approval most closely coincide. For conditions and manufacture such as cancer and asthma, incremental improvements are commonplace, and companies have a reasonable assurance that health-care providers and patients will purchase their products. That provides the basic economic and financial incentive for innovation. Whatever the various problems encountered in the innovation cycle, either technical or in terms of the policy framework (…), it broadly works for the developed world and sustains biomedical innovation directed at the improvement of public health.
For developing countries, where the demand is weak – but not the need – there is little incentive to develop new or modified interventions appropriate to the disease burden and conditions of the country. This economic reality introduces an important gap in the innovation cycle: either no products exist in the first place, or if they do, then there is often disproportionately small effort, globally, to make them more effective and affordable in poorer communities. Broadly speaking, the innovation cycle does not work well, or even at all, for most developing countries.
Making the innovation cycle work in developing countries depends on improving the efficiency of the innovation process by addressing both technical and policy challenges at each stage of the cycle (discovery, development and delivery). Special issues arise at the interfaces between the stages of the process, and within each stage. For example, improved research tools and platform technologies could go a long way towards streamlining innovation, both leading up to and within the discovery stage. Many of the approaches used in the development stage have not changed significantly in decades. The regulatory framework poses specific challenges in the process of development and in facilitating delivery.
Our concept of innovation sees the process as a cycle consisting of three major phases that feed into each other: discovery, development and delivery. This is in contrast to conceiving of innovation as an entirely linear process that culminates in the launch of a new product. Within the innovation cycle, public health need creates a demand for products of a particular kind, suited for the particular medical, practical or social context of the group in question, and feeds into efforts to develop new or improved products.
Commission on Intellectual Property Rights, Innovation and Public Health24
Global Forum Update on Research for Health Volume 5 17 13-20 Matlin Stephen:GF5 23/10/08 09:46 Page 18
Introduction
Technological achievement index
Leaders Potential leaders Dynamic adopters Marginalized Data not available
Technological Hubs innovation score 16 (maximum)
4 (minimum)
Figure 2: Technology Achievement Index: the geography of technological innovation and achievement
linking microfinance with gender and HIV/AIDS awareness34. It should not be taken for granted that LMICs will The agriculture sector is of critical importance to necessarily take the best and most speedy advantage of the livelihoods, basic health and nutrition, with enormous new opportunities afforded by innovation. For example, a benefits having been reaped from the green revolution35 of recent commentary questions the pace at which innovative the 20th century. The need for a second such revolution to companies are appearing in India, as evidenced by the slow cope with population increases and climate change impacts growth in home-produced patents filed in the country. It in the present century highlights the importance of notes, however, that one out of ten US patents in 2006 had understanding and addressing barriers to technological an owner or co-owner with an Indian name, showing that innovation and transfer36,37. Indians can be exceptionally innovative when given the opportunity in an environment that supports risk-taking Global innovation capacity for better health and innovation39. and health equity While science and innovation in much of Africa has long United Nations Development Programme (UNDP) has lagged behind, new approaches are now being seen, as developed a Technology Achievement Index which focuses reflected in the Tshwane Consensus40. The emergence is now on four dimensions of technological capacity that are being foreshadowed of a more socially responsive innovation important for reaping the benefits of the network age. The system that will ensure that scientific priorities are selected indicators selected relate to important technology policy according to social and economic priorities (e.g. using objectives for all countries, regardless of their level of “technology foresight” exercises to determine the allocation of development: research resources)41. As noted by the Science and Creation of technology; Technology Adviser for Africa’s New Partnership for Africa’s Diffusion of recent innovations; Development (NEPAD), it is important that scientific and Diffusion of old innovations; technological capacity for health is not reduced to focusing Human skills. on equipment, funding and the numbers of health scientists and technicians. It requires attention to the configuration of In 2001, estimates were prepared for 72 countries for skills, policies, organizations, non-human resources, and which data were available and of acceptable quality. The overall context to generate, procure and apply scientific results (Figure 2) show three trends: a map of great knowledge and related technological innovation to identify disparities among countries, diversity and dynamism in and solve specific health problems42. technological progress among developing countries and a As innovation theory and practice evolve, valuable new map of technology hubs superimposed on countries at insights are emerging of direct relevance to the advance of different levels of development. The 30 leading exporters of innovation in developing countries. For example, one recent high-tech products included (with rankings) Malaysia (9), report43 argues that we are witnessing forces in play which are China (10), Mexico (11), Thailand (18), Philippines (22), transforming the industrial landscape and that can be Brazil (27), Indonesia (28) and Costa Rica (30). Within the understood within the umbrella concept of “global open top 30 group, China, Mexico, Philippines, Indonesia and innovation”. Open innovation, while not a new phenomenon, Costa Rica showed rates of increase during the 1990s that is importantly being given fresh impetus by globalization, far exceeded those of any other countries in the rankings.38 linked to the interplay between subtle organizational
18 Global Forum Update on Research for Health Volume 5 13-20 Matlin Stephen:GF5 23/10/08 19:31 Page 19
Introduction
processes and interorganizational linkages and networks. The along the value chain (i.e. vertical collaboration) is report examines the role of globalized innovation networks for significantly positively correlated with superior innovation innovation performance and concludes that, among a number performance of firms in all analysed countries. of different types of innovation collaboration – vertical For the goals of achieving improved health and health (collaboration with suppliers and customers), horizontal (with equity, this analysis supports the idea, referred to above, competitors) and science-based (with universities and of closer engagement with the end-user in a socially government research institutions) – innovation collaboration responsive mode; and it also helps frame observations on the expanding roles of innovative offshoring44 and global Key messages knowledge networks45. The Global Forum for Health Research will work to: Historically, HICs have contributed most to research generate informed debate on innovation for health in and innovation for global health and to the health of LMICs, including social as well as technological populations in LMICs. However, LMICs are increasingly innovation; developing their own capacities to conduct and utilize promote the development and study of health innovation research and to apply innovative solutions to their systems at global and country levels, with a particular immediate health problems, as well as to strengthen emphasis on innovations to enhance health equity. their systems of innovation as vital drivers of development. Stephen A Matlin has been Executive Director of the Global The global agenda must encompass how to: Forum for Health Research since January 2004. Educated as an strengthen health research systems and innovation organic chemist, he worked in academia for over 20 years, with systems in LMICs; research, teaching and consultancy interests in medicinal, incentivize the systems to create relevant products biological and analytical chemistry. This was followed by periods as accessible to poor populations; Director of the Health and Education Division in the enhance coherence between policies and actions of Commonwealth Secretariat, Chief Education Advisor at the UK global players and national forces shaping country Department for International Development and as a freelance research and innovation systems. consultant in health, education and development.
References
1. The Global Forum for Health Research was established in 1998 with a available in the UK, at: mission to focus more health research on the needs of the poor. See: http://www.hotcourses.com/uk-courses/postgraduate-Entrepreneurship- www.globalforumhealth.org. courses/hc2_browse.pg_loc_tree/16180339/90904/p_type_id/3/p_bcat_id 2. United Nations Development Programme. Human Development Report /2084/page.htm 2001: Making new technologies work for human development. Oxford 13 Wilson K. 1987–2007: 20 years of promoting entrepreneurship University Press, Oxford, 2001. education in Europe. European Foundation for Entrepreneurship http://hdr.undp.org/en/reports/global/hdr2001/ Research, 2007. 3. Commission on Health Research for Development. Health research: http://ieec.co.uk/2007/proceedings/wed/Wilson%20- essential link to equity in development. Oxford University Press, New %20Session%20H%20-%20Building%20the%20Evidence%20Base% York, 1990. 20FINAL.ppt#285,3,The Importance of Building the Evidence Base 4. Ad Hoc Committee on Health Research Relating to Future Intervention 14. See, for example, the Entrepreneurship Course of the Africa Technology Options, Investing in Health Research and Development. World Health Development Forum’s Entrepreneurship Hub based in Lusaka, Zambia. Organization, Geneva, 1996. The primary goal of the Hub is to promote entrepreneurship and 5. Report of the Commission on Macroeconomics and Health. innovation as a way of creating wealth and jobs and reducing poverty. Macroeconomics and health: investing in health for economic http://www.atdforum.org/spip.php?article230 development. World Health Organization, Geneva, 2001. 15. Global pharmaceutical market estimated to double to $1.3 trillion by 6. Global Forum Update on Research for Health 2005. Health research to 2020. PharmaManufacturing.com, 2007. achieve the Millennium Development Goals, Pro-Brook Publishing, www.pharmamanufacturing.com/industrynews/2007/198.html London, 2004. www.globalforumhealth.org. 16. Report of the Commission on Intellectual Property Rights, Innovation and 7. Monitoring financial flows for health research: volume 2. Global Forum Public Health. Public health, innovation and intellectual property rights. for Health Research, Geneva, 2004. www.globalforumhealth.org. Geneva, World Health Organization, 2006. 8. Commission on Social Determinants of Health: Final Report. Closing the www.who.int/intellectualproperty/documents/thereport/en/index.html gap in a generation: health equity through action on the social 17. Pharma 2020: The vision – which path will you take? determinants of health. WHO, Geneva, 2008 PricewaterhouseCoopers, 2007. www.who.int/entity/social_determinants/final_report/csdh_finalreport_200 www.pwc.com/extweb/pwcpublications.nsf/docid/ 8.pdf 91BF330647FFA402852572F2005ECC22 9. Global Ministerial Forum on Research for Health, Bamako, 16–19 18. Trouiller P, Olliaro P. Drug development output from 1975 to 1996: what November 2008. http://bamako2008.org proportion for tropical diseases? International Journal of Infectious 10. See www.globalforumhealth.org. Diseases, 1999, 3, 61-3. 11 Nuyens Y. No development without research: a challenge for research www.dndi.org/cms/public_html/images/article/229/JAMA.pdf capacity strengthening. Global Forum for Health Research, Geneva, 19. Trouiller P et al. Drugs for neglected diseases: a failure of the market and 2005. www.globalforumhealth.org. a public health failure? Tropical Medicine and International Health, 12 See, for example, a list of postgraduate entrepreneurship courses 2001, 6(11) 945-51.
Global Forum Update on Research for Health Volume 5 19 13-20 Matlin Stephen:GF5 23/10/08 09:46 Page 20
Introduction
References continued
http://econ.tu.ac.th/archan/chalotorn/on%20mkt%20failure 2003. www.fhi.org/NR/rdonlyres /troullier%20et%20al.pdf /etdpo24ma6cu2bvuewr73oldfpm4icnnxakmuw3u36wb4iim7jzm5ejefnm 20.Trouiller P et al. Drug development for neglected diseases: a deficient jjn3jknd37m7kgswnif/YI2final3.pdf market and a public-health policy failure. Lancet, 2002, 34. Pronyk PM et al. The Intervention with Microfinance for AIDS & Gender 359(9324):2188-94. Equity (IMAGE). A structural intervention for HIV prevention in rural www.dndi.org/cms/public_html/images/article/228/lancet%20r&d.pdf South Africa: early results from a community randomised trial. 21. Mahoney RT, Morel CM. A global health innovation system (GHIS). International AIDS Conference, 11–16 July 2004; 15: abstract no. Innovation Strategy Today, 2006, 2(1):1-12. ThPeC7538. www.biodevelopments.org/innovation/ist4.pdf http://gateway.nlm.nih.gov/MeetingAbstracts/ma?f=102281315.html 22. Morel C et al. Health innovation in developing countries to address 35. Borlaug N. Biotechnology and the green revolution: An diseases of the poor. Innovation Strategy Today, 2005, 1(1) 1-15. ActionBioscience.org interview. American Institute of Biological Sciences, www.biodevelopments.org/innovation/index.htm 2002. 23. Daar AS, Berndtson K, Persad DL, Singer PA. How can developing www.actionbioscience.org/biotech/borlaug.html countries harness biotechnology to improve health? BMC Public Health, 36. Paarlberg R. Starved for science: how biotechnology is being kept out of 2007, 7:346. Africa. Harvard University Press, Boston, 2008. www.biomedcentral.com/1471-2458/7/346 www.wellesley.edu/PublicAffairs/Releases/2008/020108.html 24. Public health, innovation and intellectual property rights. Report of the 37.Spielman DJ, Birner R. How innovative is your agriculture? Using Commission on Intellectual Property Rights, Innovation and Public Health, innovation indicators and benchmarks to strengthen national agricultural WHO, Geneva, 2006. www.who.int/intellectualproperty/documents/ innovation systems. ARD Discussion Paper no. 41. World Bank, thereport/ENPublicHealthReport.pdf Washington, DC, 2008. 25. Gardner CA, Acharya T, Yach D. Technological and social innovation: a http://siteresources.worldbank.org/INTARD/Resources/InnovationIndicators unifying new paradigm for global health. Health Affairs, 2007, 26(4) Web.pdf 1052–61. Reprinted in: Matlin SA et al (eds.). Health partnerships 38. United Nations Development Programme, Human Development Report review. Global Forum for Health Research, Geneva, 2008, 22-27. 2001: Making new technologies work for human development. Oxford www.globalforumhealth.org. University Press, Oxford, 2001, p.42. 26. Pan American Health Organization. Social protection in health schemes 39. Mark Fidelman M. Where are India’s innovative companies, products for mother and child population: lessons learned from the Latin and solutions? Seeking Apha Website, posted 9 May 2008. American Region. PAHO/WHO, Washington DC, 2008. http://seekingalpha.com/article/76511-where-are-indias-innovative- www.paho.org/english/AD/THS/OS/SPHS-eng.pdf companies-products-and-solutions 27. Conditional cash transfers: what’s in it for health? Technical briefs for 40. The Tshwane Consensus on Science and Development – the emergence of policy-makers: number 1/2008, World Health Organization, Geneva. innovative developing countries. Science in Africa, November 2005. www.who.int/health_financing/documents/pb_e_08_1-cct.pdf www.scienceinafrica.co.za/2005/ november/tshwane.htm 28. Glassman A, Todd, Gaarder M. Performance-based incentives for health: 41. Dickson D. Can Africa pioneer a new way of doing science? SciDev.Net, conditional cash transfer programs in Latin America and the Caribbean. 24 January 2005. www.scidev.net/editorials/index.cfm?fuseaction= Center for Global Development, Washington, DC, 2007. printarticle&itemid=144&language=1 www.cgdev.org/files/13542_file_CCT_LatinAmerica.pdf 42. Mugabe J. Health innovation systems in developing countries. Strategies 29. Department of Social Welfare, Zambia. Research on cash transfers. for building scientific and technological capacities. CIPIH study paper, www.socialcashtransfers-zambia.org/pageID_2466947.html Geneva, 2005. 30. Increasing access to life-saving medicines through business format www.who.int/intellectualproperty/studies/Health_Innovation_Systems.pdf franchising. The HealthStore Foundation, Minneapolis, 2008. 43. Herstad SJ, Bloch C, Ebersberger B, van de Velde E. Open innovation http://www.cfwshops.org/HealthStore%20Foundation%2004-09-2008.pdf and globalisation: theory, evidence and implications. Vison Era-Net, 31. Amin AM. Getting health to rural communities in Bangladesh. World Ministry of Employment and the Economy, Finland, 2008. Health Organization, Geneva, 2008. www.visioneranet.org/files/391/openING_report_final.pdf www.who.int/bulletin/volumes/86/2/08-010208/en/print.html 44. Ernst D. Innovation offshoring and Asia’s “upgrading through innovation” 32. Mcbride J, Ahmed R. Social franchising as a strategy for expanding strategies. East-West Center Working Papers, Economics Series, No. 95. access to reproductive health services – a case study of the Green Star www.eastwestcenter.org/pubs/2670 service delivery network in Pakistan. Commercial Market Strategies 45. Ernst D. Can Chinese IT firms develop innovative capabilities within Project, USAID, 2001. http://psp-one.com/files/ global knowledge networks? East-West Center Working Papers, Economics 900_file_01_Social_Franchising_As_a_Strategy.pdf Series, No. 94. 33. LaVake SD, YouthNet Program. Applying Social Franchising Techniques to www.eastwestcenter.org/pubs/2669 Youth Reproductive Health/HIV Services. Family Health International,
20 Global Forum Update on Research for Health Volume 5 23 Title page:GF5 22/10/08 14:04 Page 23
Innovating for health and development
024 Research and innovation in Brazil: the institutional role of the Ministry of Health Suzanne Jacob Serruya with Reinaldo Guimarães, Itajai Oliveira de Albuquerque and Carlos Medicis Morel
030 Health markets and future health systems: innovation for equity Gerald Bloom with Claire Champion, Henry Lucas, M Hafizur Rahman, Abbas Bhuiya, Oladimeji Oladepo and David Peters
036 Strengthening the base: innovation and convergence in climate change and public health Saqib Shahab with Abdul Ghaffar
041 Global health diplomacy – a bridge to innovative collaborative action Thomas E Novotny and Ilona Kickbusch with Hannah Leslie and Vincanne Adams
048 Hideyo Noguchi Africa Prize Kiyoshi Kurokawa with Tamaki Tsukada and Eri Maeda
054 Health research and innovation: recent Spanish policies Flora de Pablo with Isabel Noguer
059 The changing landscape of research for health Kirsten Havemann with introduction by Ulla Tørnæs
066 Global health and the foreign policy agenda Jonas Gahr Støre
072 “Policies for innovation”: evidence-based policy innovation – transforming constraints into opportunities Miguel Angel González Block
Global Forum Update on Research for Health Volume 5 023 24-27 Serruya:GF5 23/10/08 12:19 Page 24
Innovating for health and development
Research and innovation in Brazil: the institutional role of the Ministry of Health
Article by Suzanne Jacob Serruya1 (pictured), Director, Department of Science and Technology, Ministry of Health, Brazil with Reinaldo Guimarães1, Itajai Oliveira de Albuquerque1 and Carlos Medicis Morel2
uring the course of the last century, public policies Scientific and Technological Development (CNPq), the with a focus on technological innovation have shown Studies and Projects Funding Body (FINEP) and the Dthe importance of this issue for the governmental Coordination for the Improvement of Higher Education agenda of several countries. Technological innovation Personnel (CAPES). acquires more importance to the extent that the countries’ As a consequence of the constitutional acknowledgement markets are strengthened, and reach, in the last two decades that health is a citizen’s right and the State’s obligation of the 20th century, an increasing strategic weight in (1988) and, particularly, after publication in 1990 of Law proportion that the international inequality scenario of 8080, which regulates the Brazilian Unified Health System economic globalization is characterized by the interplay of the (SUS; 1990), it established the legal landmarks which following actors: (i) economically wealthy and innovative allowed the Ministry of Health to incorporate the mission to countries; (ii) poor countries situated on the boundaries of develop a vertical fomat to technological research, world consumption of goods and services; (iii) countries at an development and innovation, in compliance with the intermediate development stage, such as the “BRICs” (Brazil, prerequisites of Brazilian sanitary reform and the political Russia, India, China) or, as they are also denominated, the atmosphere resulting from, at that time, recent Innovative Developing Countries (IDCs)1. redemocratization of the political institutions. According to the World Health Organization’s records, in its Therefore, it was in the light of the principles of universality, World Health Report 1998, at the beginning of this new equity, integrality and decentralization related to the attention millennium we live a unique moment of accelerated given to health, which guided the SUS management, that the technological evolution that has never been seen in the 1st National Conference of Science and Technology in Health history of health care. To that effect, the Swedish Council on (1st CNCTS; 1994) established that the National Policy of Technology Assessment in Health Care (SBU) emphasizes Science and Technology in Health (PNCTS) cannot be that at least 50% of all therapeutic methods in use, were not separated from a National Health Policy, having as a goal the available ten years ago. generation of knowledge and material goods to strengthen Regarding biomedical sciences, it has been observed, a Brazilian social policies. It must be pointed out that PNCTS, trend by the knowledge production international centres of due to the nature of its constitutional object, is a sectorial ignoring the diseases of major prevalence in humanity, component of the National Innovation System, since “it providing substantial funds for research and development of searches for a complementarity between agents and systems products that generate greater economic earnings, clearly in a new and more strategic context and contemplates all described by the so called 10/90 Gap and its effects on the relevant processes: basic research, strategic research, financing of researches related to neglected diseases and, as directed research, applied research, operational research, a consequence, on national health care of the poor and disclosure of results, technological development and developing countries, where such diseases constitute a factor management, pilot and industrial scale production, quality which defines the epidemic challenges to be faced. guarantee, marketing, technological regulation and evaluation Although the Brazilian C&T system is the most solid in and patent protection. It shall further contemplate a wide Latin America, the Ministry of Health, since its foundation in range of development of human resources. The parameters the 1950s, was of less importance in the development of shall be applied to health technologies, such as: health technological research and innovation of interest to public processes and products, health organization, control and health issues. Traditionally, science and technology policy management, environment and health information”. and management have been conducted by the Ministers of The recommendations of the 1st CNCTS however, were not Science & Technology and Education, responsible for the very effective, due to the prevailing influence, at that time, of horizontal promotion of research and personnel training neoliberal ideas in the economy of the peripheric countries, through their agencies, namely: the National Council of based on the forecasts of the so-called Washington
24 Global Forum Update on Research for Health Volume 5 24-27 Serruya:GF5 23/10/08 12:19 Page 25
Innovating for health and development
Consensus (1989). Concerning sector C, T, & I policies, according to Guimarães2, the 1980s in Brazil: The other action of great impact on the National Innovation System is the conclusion of Hemobrás, a “did not represent a radical breaking up, in relation to state-owned company that will allow Brazil’s self- models, political proposals or system development. It sufficiency in blood by-products, complying with 100% began in a period of economic recession, and, due to of SUS demand for Factor IX, immunoglobulin and one of these dramatic ironies, it was also the time of the human albumin and 30% of the demand for Factor VIII country’s redemocratization associated with a rebound of the neoliberals against the developing model and destruction of the public sector. To the C & T system, this represented a continuous limitation of the previous R$ 160 million (US$ 102 million). As per 2007, for the decade’s achievements, that was only discontinued from purpose of promoting economic growth, the Brazilian 1985 through 1988, when it pursued a return to the government launched the Growth Acceleration Programme situation existing in the 1970s, a vain attempt due to the (PAC) – 2007–2010. PAC gathers a set of institutional tax crisis and the impasse with foreign creditors which actions representing a larger public investment in respectively, hindered the increase of National Treasury infrastructure, credit and financing incentives, improvement funds and raised difficulties to the negotiation of new of investments and tax system in the medium and long term. agreements with multilateral organizations”. It is expected the application of funds amounting to approximately R$ 503.9 billion (US$ 320.5 billion), for A revisiting of the project has occurred during the two investments in social and urban infrastructure, transport governments of President Luiz Inácio Lula da Silva. As from logistics and energy. 2003, the Ministry of Health redefined its structure and a The “More Health” Programme (Mais Saúde), an integral new strategy was set forth for the purpose of strengthening part of PAC, is a mobilizing programme, under the the managing role of the institution concerning the supervision of the Ministry of Health, which has the development of scientific knowledge and technological challenge of reducing the vulnerability of the National Health innovation significant for the Brazilian health system3. The Policy, from a strategic point of view, including the national most important institutional event of this period was the production chain into the health industrial complex, by second National Conference of Science, Technology and means of major investments in innovation, modernization Innovation in Health (2nd CNTIS), based on 300 municipal and development of a public laboratory network, export conferences and 24 state conferences, therefore further, expansion and diversification and by attracting more extending the debate on science and technology to the technologically advanced foreign companies to produce in interests of the academic community. the Brazilian market. Within a macro-organizational structure, over the last five As a productive system structuring programme, the “More years, the following may be pointed out: the establishment of Health” Programme (Mais Saúde), will invest R$ 5.1 billion the Secretary of Science, Technology and Innovation in (US$ 3.3 billion) in (i) the consolidation of a more Health (SCTIE), encompassing the following departments: competitive Brazilian industry in the production of medical Pharmaceutical Assistance, Science and Technology and the equipment, materials, reagents and diagnosis devices, blood Industrial Complex and Innovation in Health; signature of a by-products, immunobiologics, chemical intermediates and Technical Cooperation Agreement between the Ministries of vegetable extracts for therapeutic purposes, active principles Health and Science and Technology (MCT); establishment of and drugs for human use and (ii) in strategic areas of the the Science, Technology and Innovation Council of the field of scientific-technologic knowledge for the purpose of Ministry of Health; representation of the Ministry of Health in reducing the vulnerability of the National Health System. It is the Forum of Competitiveness in a Pharmaceutical and expected that 80% of the needs of the National Biotechnological Productive Chain organized by the Ministry Immunization Programme (PNI) will come from local of Development, Industry and Foreign Trade and, chiefly, the production, including the incorporation of new vaccines: “More Health” Programme (Programa Mais Saúde). pneumococcus, meningococcus AC, double viral and The health production chain, marked by a strong reliance quinquivalent (DPT & HiB & Hepatitis B virus). The purpose on imports and a high trade deficit (US$ 5.5 billion in 2007) of Mais Saúde is to replace the import of 20% of the demand accounts for 7–8% of the GDP, using funds of approximately for pacemakers, ultrasonography and mammography equipment for the Brazilian National Health System (SUS). The other action of great impact on the National Innovation System is the conclusion of Hemobrás, a state-owned Health production chain, marked by a strong reliance company that will allow Brazil’s self-sufficiency in blood by- on imports and a high trade deficit (US$ 5.5 billion in products, complying with 100% of SUS demand for Factor 2007) accounts for 7–8% of the GDP, using funds of IX, immunoglobulin and human albumin and 30% of the approximately R$ 160 million (US$ 102 million) demand for Factor VIII. The funds necessary for expansion of the production capacity will be provided by the Brazilian Development Bank (BNDES), by means of the Novo
Global Forum Update on Research for Health Volume 5 25 24-27 Serruya:GF5 23/10/08 12:19 Page 26
Innovating for health and development
Sub-area Number of Total of Sub-area Number of Total of projects resources (US$)* projects resources (US$)* Pharmaceutical care 19 18 432 362 Malaria 2 367 821 Nontransmissible diseases 8 7 579 845 Leishmaniasis 5 1 076 487 Transmissible diseases 19 6 085 187 Leptospirose 1 25 189 Clinical research 1 27 128 Dengue 3 123 769 Elderly health 1 447 572 Tuberculosis 1 30 628 Health of individuals with special needs 1 254 492 Total 12 1 623 894 Oral health 1 8 281 Violence, accidents and trauma 13 699 962 Source: Brazil, Ministry of Health, Department of Science and Technology – Decit. Others areas 44 36 498 330 Managerial Database. Captured on 7 May 2008 Total: 4 Sub-agenda(s) 107 70 033 160 *US$ conversion rate August 2008: US$ 1 = R$ 1.56
Source: Source: Brazil, Ministry of Health, Department of Science and Technology – Table 2: Numbers of projects and resources by neglected Decit. Managerial Database. Captured on 7 May 2008 diseases *US$ conversion rate August 2008: US$ 1 = R$ 1.56 Search criteria: sub-agenda and transversality Health Productive Complex in Health Table 1: Total investments applied to innovation projects by the 1500 100,00 National Agenda of Priorities Sub-agendas 80,00 1000 60,00 40,00 Profarma (Programme to Support the Development of the 500 Health Industrial Complex). Development of Mais Saúde is 20,00 0 0,00 pointed out as a fundamental factor to reach the proposed 2002/2003 2004/2005 2006/2007 objectives, Brazilian integration with Latin American, Caribbean and African markets, as a strategic space to Number of projects US$ (million)
expand the local industry scale and productivity, integrate Source: Brazil, Ministry of Health, Department of Science and Technology – Decit. local and regional production chains and establish technical Managerial Database. Captured on 7 May 2008 cooperation for technical and scientific abilities4. Figure 1: Evolution of the department of science and technology’s In addition to provisions for Mais Saúde, considering the support the health research 2002–2007 period, the Secretary of Science, Technology and Strategic Supplies (SCTIE) has been guaranteeing increasing “Mode II” of knowledge production5. funds to comply with the guidelines provided by the Health Upon evaluating the present stage of the Science, Research Priority National Agenda Funds for the selected Technology and Innovation Policies in Health, we observe projects have been guaranteed through resources from SCTIE, that there has been progress concerning a definition of the MCT and state governments. The total investment applied to priorities of research topics and corresponding funding, by innovation projects (see Table 1), during the 2002–2007 means of public calls. The Mais Saúde Programme period, was approximately R$ 109 251 729 (US$ 70 033 constitutes a powerful strategy to implement and strengthen 160), or up to 40% of all funds intended for the 25 sub- the National Innovation System, through investments in agendas of ANPPS (see Figure 1). infrastructure which will enable Brazilian public and private Research and development on neglected diseases is an companies to incorporate adequate programmes to introduce example of a key strategic area that only now is receiving the new health technologies into the local and foreign markets. high priority it deserves. Through open competition and peer- However, since it is a medium- and long-term structuring review processes the Ministry of Health and the Ministry of project, it is necessary to take into consideration scenarios Science and Technology, through their funding agencies which may, if existing, jeopardize, the success of these DECIT and CNPq, invested in 2006–2007 R$ 20 million public policies. (US$ 12 million) in six diseases that disproportionately hit At first, among a possible combination of events, we may poor and marginalized populations in Brazil: Dengue, Chagas consider non-accomplishment of funding within the disease, leishmaniases, leprosy, malaria and tuberculosis. In deadlines and amounts necessary to implement the policy, a radical departure from traditional national or international due to a need to increase the primary surplus, which means initiatives in this area that are usually academic and just the economy of budget resources intended for payment of curiosity-driven, the DECIT/CNPq Neglected Diseases R&D government debt charges. Although Brazil is now enjoying a Programme is based on a Call for Applications that better situation regarding economic turbulence in the simultaneously require the proposals to have high scientific international market, Brazilian interests have recently merit and to address critical health priorities. In addition, returned to an increasing trend and additional resources from efforts are made to invest at least 30% of the R&D funds in the federal budget may be requested to pay the government groups located in the three Brazilian geographic regions debt, therefore jeopardizing the funds intended for the Mais where these diseases are highly prevalent – the Centre West, Saúde Programme. The increase of interest and shortage of the North East and the North, particularly the Amazon offers from other funding sources may also be reflected on the (see Table 2). access to credit lines offered by the BNDES, leading to a This example should not be perceived as an isolated case, redefinition of priorities. On the other hand, Mais Saúde, but as representing the paradigmatic shift occurring in Brazil’s pointed out as a structuring programme for developing the science, technology and innovation policies in health, Health Industrial Complex, requires a commitment for traditionally limited to “Mode I” and now also addressing continuation beyond the government of President Lula, a
26 Global Forum Update on Research for Health Volume 5 24-27 Serruya:GF5 23/10/08 12:19 Page 27
Innovating for health and development
practice that is not usual in terms of the political culture in result of this adversity, to sell their assets in these countries. Brazil, particularly if, the Programme deadlines do not Innovation policies are important instruments to foster include strict regulatory limits to account for the current national economies. When well executed they should sectorial needs. Finally, reliance on foreign resources and originate a favourable socioeconomic ambience that technologies may constitute another difficulty, intensified by positively influences the internal economic market and the the current international financial crisis. Foreign companies national balance of trade. Besides, the scientific development have been cautious concerning new investments in can potentially promote social inclusion. developing countries and they have shown a trend, as a Suzanne Jacob Serruya MD, PhD is director of the Department Key messages of Science and Technology, Secretariat of Science, Technology and Strategic Inputs of the Brazilian Ministry of Health. Innovation policies are important instruments to foster national economies and they should originate Reinaldo Guimarães MD, MSc is chairman of the Secretariat of a favourable socioeconomic ambience that Science, Technology and Strategic Inputs of the Brazilian Ministry positively influences the internal market and the of Health. national balance of trade. In Brazil, the “More Health” Programme (Mais Itajai Oliveira de Albuquerque MD, MSc is assessor for Health Saúde) constitutes a powerful strategy to strengthen Technology Assessment in the Department of Science and the National Innovation System by means of major Technology, Secretariat of Science, Technology and Strategic investments in innovation, modernization and Inputs of the Brazilian Ministry of Health. development of public laboratory work, export expansion and by attracting more technologically Carlos Medicis Morel MD, PhD is director of the Centre for advanced foreign companies in Brazilian Market. Technological Development in Health, Oswaldo Cruz Foundation.
References
1. Morel CM, Acharya T, Broun D, Dang AJ, Elias C, Ganguly NK, Gardner 3. Morel CM, Carvalheiro JR, Romero CNP, Costa EA, Buss PM: The road to CA, Gupta RK, Haycock J, Heher AD, Hotez PJ, Kettler HE, Keusch GT, recovery. Nature 2007, 449:180-182. Krattiger AF, Kreutz FT, Lall S, Lee K, Mahoney R, Martinez-Palomo A, 4. Ministério da Saúde: Mais saúde: direito de todos: 2008-2011. Brasília: Mashelkar RA, Matlin SA, Mzimba M, Oehler J, Ridley RG, Pramilla S, Editora do Ministério da Saúde; 2008. Singer P, Yun MY: Health innovation networks to help developing countries 5. Gibbons M, Limoges C, Nowotny H, Schwartzman S, Scott P, Trow M: The address neglected diseases. Science 2005, 309:401-404. new production of knowledge: the dynamics of science and research in 2. Guimarães R. FNDCT: Uma nova missão. contemporary societies. London; Thousand Oaks; New Delhi: SAGE "http://www.schwartzman.org.br/simon/scipol/pdf/fndct.pdf" Publications; 1994. http://www.schwartzman.org.br/simon/scipol/pdf/fndct.pdf , 1-35. 2008.
Global Forum Update on Research for Health Volume 5 27 30-33 Bloom:GF5 22/10/08 14:04 Page 30
Innovating for health and development
Health markets and future health systems: innovation for equity
Article by Gerald Bloom (pictured), Heath policy analyst, Institute of Development Studies, UK with Claire Champion, Henry Lucas, M Hafizur Rahman, Abbas Bhuiya, Oladimeji Oladepo and David Peters
any low- and low-middle income countries have incentives and improving the performance of these markets. pluralistic health systems, characterized by There is less agreement on what those roles should be in Mwidespread and often highly segmented markets different development contexts and how health systems can offering a diverse range of health-related goods and construct the institutional arrangements for them to play services1,2,3. Out-of-pocket payment for health care averages these roles effectively. more than 50% of all health spending in these countries4, The spread of market relationships has advanced so far in with non-state providers, both private and not-for-profit, many countries that official policies often have limited typically providing the majority of outpatient curative care5,6. relevance to the realities that poor people face when coping If health services are to benefit the poor, it is essential to gain with health problems. We propose an approach which a detailed understanding of such markets that can both explores the operation of health markets in order to help inform attitudes towards them and guide innovations that explain how health systems are changing, identify potential attempt to engage with them to improve health outcomes. opportunities for intervention and innovation, and guide the The spread of market relationships in the provision of design of monitoring systems that can track and learn from health services has coincided with the growth of markets in both the intended and unintended consequences of such other sectors. In some countries this has been associated with innovations. We then examine different types of emerging economic liberalization and economic growth. In others, its innovations, and focus on two in Nigeria and Bangladesh. emergence is linked to economic decline and the failure of state-provided services to meet popular expectations. In many Conceptual framework circumstances the spread of markets has been much faster This section describes an approach for analysing and than the capacity of the state and other key actors to establish understanding health markets in low- and middle-income regulatory arrangements to influence their performance. A countries. It draws on the framework for understanding large proportion of market transactions now take place markets that poor people use presented in a recent paper by outside a legal regulatory framework or in settings where Elliot et al10 and summarized in Figure 1. The authors of that regulatory regimes are poorly implemented, particularly for paper place at the centre the relationship between providers the poor. In addition, the boundaries between public and and consumers, that is in our case, the relationship between private sectors have become blurred. In many countries users health service providers and patients. Those relationships are routinely make informal payments for services or drugs at greatly influenced by a multi-dimensional and complex public facilities, or consult government health workers environment made of formal and informal rules and of privately7. In others, public providers are officially encouraged agencies that undertake a number of supporting functions. to generate income in order to supplement often very limited Strategies for change need to take into account the diverse government subsidies8. components of this context as well as ways to improve the The marketization of health services has created both management of a single organization or intervention. They opportunities and challenges for poor people. They may have also need to acknowledge the importance of conflicts of greater choice about where to seek drugs and medical advice, interest and the degree to which power relationships but cost is often a barrier to access. There are examples of influence the organization and functioning of relevant excellent services but, as Das et al9 document, the quality of markets. For example, many health-related markets are services that both public and private health workers provide segmented, with well-regulated components used mostly by is often flawed, partly in response to perverse incentives. the better off and unregulated ones used by the poor2. Such incentives also result in an emphasis on medical care at An important aspect of the relationship between providers the expense of prevention and health promotion. It is widely and patients concerns the transfer of the benefits of medical recognized that both government and other intermediary expert knowledge to the latter. This transaction is organizations can play important roles in altering these characterized by varying degrees of asymmetry of information
30 Global Forum Update on Research for Health Volume 5 30-33 Bloom:GF5 22/10/08 14:04 Page 31
Innovating for health and development
Market players Informal networks
Government SUPPORTING Private sector FUNCTIONS
Informing and Infrastructure communicating Related services
Supply Demand
Informal Laws Setting and rules and enforcing rules norms Sector -specific regulations and Non-statutory standards regulations Not-for-profit Membership sector Rules organisations
Representive bodies
Figure 1: Conceptualizing market systems
and a consequent imbalance in power, which possessors of middle-income countries have shown a willingness to pay expertise can use to their advantage. Societies have evolved more for the services of providers whose competence they mechanisms to address this problem through a combination trust and many providers have adopted strategies to build of regulation by the state, different forms of self-regulation and maintain a reputation for high expertise and ethics 14, 15, and organizations that build and maintain a reputation for 16, 17. Trust and reputation may be based on a variety of factors competent and ethical behaviour. The relevant actors include including directly experienced quality of services (e.g., the regulatory arms of central and local government, availability of drugs, cleanliness, courteous staff), perceived professional and trade associations, large service provision status of providers (e.g., professional title, advertised organizations, and a variety of civil society organizations and qualifications and experience) and brand recognition (e.g., consumer associations. widely known franchise, accreditation or licensing authority). Current rules and regulations often do not take into Less formal arrangements are often important at the account the importance and diversity of health markets in community level, where providers operate within local trust developing countries, and thus many actors operate outside networks. Word of mouth is an important medium for the a legal framework. Barriers to appropriate regulations are establishment and maintenance of a facility’s reputation18. often linked to a lack of government capacity to enforce them Another important aspect of the performance of health- or incentives to do so11. Many government regulatory related markets relates to information flows. Providers and agencies focus on the services used by the better off and shy users of health services get information from many sources. away from attempts to regulate the informal sector which is In Bangladesh, for example, the primary source of of paramount importance for the poor. This has led to the information for informal providers is from sales emergence of a variety of partnerships between governments representatives or wholesalers who are associated with and other actors to co-produce rules and improve market generic manufacturers. Other sources include the diverse performance12, 13. communications media that national and international Where regulation is limited and information asymmetries advocacy groups, government agencies and commercial are large, trust is a key dimension in the relationships advertising agencies increasingly use to deliver messages to between providers and consumers. Patients in low- and both providers and the general population. New
Global Forum Update on Research for Health Volume 5 31 30-33 Bloom:GF5 22/10/08 14:04 Page 32
Innovating for health and development
Key messages communication tools, such as mobile telephones and the Internet, are significantly increasing the options and capacity Given the pervasiveness of markets for health-related for information dissemination, even in some of the poorest goods and services and the great degree to which the countries. This increasing volume of circulating information poor obtain medical care in these markets, it is time for creates an urgent need for trusted knowledge brokers. health policy-makers to take action to improve their performance, based on a systematic understanding of Health market innovations in developing how these markets operate. In doing so, they need to countries take account of the following: Innovations aimed at improving health services have taken Attempts to achieve long-lasting change through the place in both informal and formal sectors. Those happening efforts of a single organization or a particularly in organized markets have taken various forms, ranging from innovative individual tend to be unsuccessful; it is commercial models (mostly found in Asia and Latin America) important to understand and address market to highly subsidized but market-oriented interventions systems as a whole in order to achieve sustainable such as the establishment of provider networks, social change. franchises or accreditation schemes (mainly run by Reforms should begin with markets in which poor nongovernmental organizations or faith-based organizations). people are already engaged and will often involve Notwithstanding the innovations described above, many informal providers, who operate outside formal legal health transactions involving poor people still take place in and regulatory frameworks, and local agencies such the informal sector, where there are minimal quality as provider associations, citizen groups and local standards and no reporting requirements. To examine ways of accountability structures. addressing these constraints, two initiatives that involve Interventions intended to benefit the poor need to partnerships between informal providers, policy-makers and acknowledge and take into account the influence of the public to shape better health markets for the poor are power and conflicts of interest on their outcome and discussed below. this should be anticipated in a detailed stakeholder In Bangladesh, informal providers (village doctors, analysis. medicine vendors) are the major source of health care for Interventions that focus solely on providers of health rural people. A recent formative study conducted in one services are unlikely to have a great impact on the southeastern sub-district (560 000 people) of Bangladesh by poor unless they are linked to measures that provide ICDDR,B found that 96% of health-care providers were more equitable access to government funding and informal including village doctors, traditional healers donor financial flows (Kabiraj), traditional birth attendants and spiritual healers. The study found many instances of inappropriate and even dangerous prescribing. The consortium has launched a three- Acknowledgement pronged intervention of training informal providers, This paper is an output of the DFID-funded Future Health establishing an association of these providers to implement a Systems Consortium (http://www.futurehealthsystems.org/). degree of quality control and the involvement of the The opinions expressed do not necessarily reflect the views Bangladesh Health Watch in monitoring the performance of of DFID. It also draws on a soon-to-be published informal providers. background paper for an initiative of the Rockefeller In Nigeria where malaria is a major cause of illness and Foundation on the role of the private sector in health death, most people depend on patent medicine vendors systems. This initiative applies a broad health systems lens (PMVs) as a source of anti-malarial medication. PMVs and is undertaking exploratory work in three broad areas: operate in poorly markets. A scoping study by the School of attitudes of key stakeholders, analysis of five functional Public Health at Ibadan University found that PMVs were the areas (risk-sharing, regulation, logistics, contracting and major source of malaria treatment (39%) followed by self- provider performance) and identification of country level treatment (26%)19. It also indicated that PMVs often programmes and organizations that show a strong potential recommend inappropriate products that are inexpensive but for replication and/or scaling up. It is expected that the also ineffective. In this complex and unregulated market Rockefeller Foundation and additional partners will launch environment, local PMV associations were identified as a programme in the near future. institutions with the potential to play an important role in providing information, influencing PMV behaviour, and procuring drugs. Also, a large proportion of PMVs (92%) said Gerald Bloom is a health policy analyst at the Institute of that community involvement in drug regulation would be Development Studies (IDS) in the UK, whose work has focused on highly desirable to complement the relatively weak the management of health system change in societies undergoing government system. For example, they could use relatively rapid transition. He has worked in a number of African countries inexpensive equipment to test the efficacy of anti-malarial and in China. He is presently the coordinator of a multi-institute drugs. Recent consultations with stakeholders found study of poverty and illness in China, Cambodia and Laos, a overwhelming support for an intervention that would involve senior researcher in the Future Health Systems research a partnership between public and private sectors. J programme consortium and health domain convener of the STEPS
32 Global Forum Update on Research for Health Volume 5 30-33 Bloom:GF5 22/10/08 14:04 Page 33
Innovating for health and development
Centre. He is co-Chair of the China Health Development Forum. research with special focus on equity issues, behaviour change, and community development-oriented action research for the Claire Champion is a doctoral student at Johns Hopkins School improvement of health of the poor and reduction of social of Public Health (International Health). Prior to her doctorate disparity in health. He is the country coordinator of the Future programme, Ms Champion managed various health private sector Health Systems: Innovations for Equity research programme strengthening programmes in Africa and Asia. She has an MBA consortium in Bangladesh. from Harvard Business School and an MPH from Johns Hopkins University. Oladimeji Oladepo is a health promotion specialist with extensive experience in evaluating public health interventions in Henry Lucas is an expert in management information systems Nigeria. He has a special interest in social, behavioural and and on methodologies for monitoring and evaluation at the educational research in the control of tropical diseases, Institute of Development Studies (IDS). He has long experience reproductive health, planning and evaluation of primary health- of work in many countries in Africa, Asia and the Pacific in a care services, and policy development. He is head of the variety of studies focusing on different aspects of poverty Department of Health Promotion and Education at the University reduction and on health systems. of Ibadan, and the country coordinator of the Future Health Systems: Innovations for Equity research programme consortium M Hafizur Rahman is a public health physician with years of in Nigeria. experience in directing health research programmes in several countries in South Asia, Africa and the United States. He has David Peters is a public health physician and associate particular interests in reproductive health, equity of health professor in the Health Systems Program in the Department of services and research methodologies. He is the manager for the International Health at Johns Hopkins Bloomberg School of Future Health Systems research consortium, and a faculty Public Health, and is a senior public health specialist at the member at the Johns Hopkins University Bloomberg School of World Bank. He has an interest in the performance of health Public Health. systems in developing countries, and has worked as a researcher, policy advisor, bureaucrat and manager of health systems in Abbas Bhuiya is the head of the Social and Behavioural Canada, Africa and South Asia. He is director of Future Health Science Unit and Poverty and Health Programme of the Center Systems: Innovations for Equity, a consortium of researchers for Health and Population Research (ICDDR,B). For the last 25 from Uganda, Nigeria, India, China, Bangladesh, Afghanistan years, Dr Bhuiya has been engaged in community health and the United Kingdom and United States.
References
1. Mackintosh M and Koivusalo M. Health systems and commercialization: rationale and practice. Enterprise Development and Microfinance, 2008, in search of good sense. In: Mackintosh M and Koivusalo M, eds. 19(2):101-119. Commercialization of Health Care, 2005, Basingstoke: Palgrave 11. Ensor T and Weinzierl S. A review of regulation in the health sector in MacMillan. low and middle income countries. Signposts to more effective states, 2. Bloom G, Standing H. Pluralism and marketisation in the health sector: 2006, Brighton: Institute of Development Studies. meeting health needs in contexts of social change in low and middle 12. Joshi A and Moore M. Institutionalized co-production: unorthodox public income countries. IDS Working Paper 136, 2001, Sussex: Institute of service delivery in challenging environments. Journal of Development Development Studies. Studies, 2004, 40(4):31-49. 3. Berman P, Rose L. The role of private providers in maternal and child 13. Peters DH and Muraleedharan V. Regulating India’s health services: to health and family planning services in developing countries. Health Policy what end? What future? Social Science & Medicine, 2008, 66:2133- Plan, 1996, 11:142-155. 2144. 4. World Health Organization. Data on national health accounts, 2008. 14. Montagu D. Franchising of health services in low-income countries. http://www.who.int/nha/country/Regional_Averages_by_WB_Income_group Health Policy and Planning, 2002, 17(2), 121-130. -En.xls 15. Montagu D. Accreditation and other external quality assessment systems 5. Hanson K, Berman P. Private health care provision in developing for health care, DFID Health Systems Resource Centre Working Paper, countries: a preliminary analysis of levels and composition. Health Policy 2003. Plan, 1998, 13:195-211. 16. Mills A, Brugha R, Hanson K and McPake B. What can be done about 6. Peters DH, Marchandani G, Hansen PM. Strategies for engaging the the private health sector in low-income countries? Bulletin of the World private sector in sexual and reproductive health: how effective are they? Health Organization, 2002, 80(4):325-330. Health Policy and Planning, 2004, 19(Suppl.1):5-20. 17. Prata N, Montagu D and Jeffeys. Private sector, human resources and 7. Das Gupta M, Gauri V and Khemani S. Decentralized delivery of primary health franchising in Africa. Bulletin of the World Health Organization, health services in Nigeria: survey evidence from the states of Lagos and 2005, 83:274-279. Kogi. Development Research Group, Human Development Sector, Africa 18. Leonard K. Learning in health care: evidence of learning about clinician Region, World Bank, 2004. quality in Tanzania. Economic Development and Cultural Change, 2007, 8. Bloom G, Kanjilal B and Peters D. Regulating health care markets in 55(3):533-555. China and India. Health Affairs, 2008, 27.4:952-63. 19. Oladepo O et al. Malaria treatment and policy in three regions in Nigeria: 9. Das J, Hammer J and Leonard K. The quality of medical advice in low- the role of patent medicine vendors. Future Health Systems Working income countries. Journal of Economic Perspectives, 2008, 22(2):93-114. Paper No. 1, 2008. 10. Elliot D, Gibson A and Hitchins R. Making markets work for the poor:
Global Forum Update on Research for Health Volume 5 33 36-40 Shahab:GF5 22/10/08 14:03 Page 36
Innovating for health and development
Strengthening the base: innovation and convergence in climate change and public health
Article by Saqib Shahab (pictured), President, Canadian Public Health Association with Abdul Ghaffar
his short paper briefly highlights the “10/90 gap” The 10/90 gap in research and intervention between high-income and low-income countries for in public health Tboth climate change as well as public health research. Many of the successes of public health that are now taken for The term “10/90 gap” as used here is broadly reflective of the granted in high-income countries remain unattainable for the disequilibrium between high- and low-income countries in majority of the population in low-income countries. research and other investments in health interventions. The There have been notable successes in public health paper then goes on to discuss the significant overlaps and achievements in low-income countries, such as childhood commonalities in terms of climate change impacts as well as immunization programmes, resulting in reduction of solutions when considered against the broad unfinished childhood deaths from vaccine-preventable infectious public health agenda. Through the use of a few selected diseases. However preventable illnesses due to issues such examples, readers are encouraged to think about how they as unsafe water, malnutrition and vector-borne diseases such can foster a holistic, comprehensive approach to address as malaria remain unacceptably high. It is pertinent to note both climate change as well as public health within that many of the existing gaps in public health in low-income their jurisdictions. regions continue to have a major environmental, nutritional or infectious disease component. These are the very issues that The 10/90 gap in research and intervention will be further negatively impacted by global climate change. in climate change Research gaps are not limited to technical issues. They are There is now irrefutable proof that climate change due to also in governance, funding and operationalization. Therefore human activity is occurring, and will accelerate in the coming research should not only be on causes of morbidity and decades unless significant mitigation to reduce greenhouse mortality due to climate change and surveillance of health gas emissions occurs1. Empirical data from meteorology, effects, but also on feasibility of applying cost-effective agriculture, hydrology, ecology and other natural sciences interventions and evaluating their impact. is demonstrating the ecological impact of anthropogenic climate change. Opportunities for convergence in climate Direct and indirect, short- and long-term effects of climate change and public health research and action change on human health are being recognized. Data at the There is considerable overlap between research needs for global and high-income country level is good. Data from low- public health and climate change when one considers income countries is improving. Researchers, policy-makers protecting human populations form the adverse effects of and civil society now need to use established knowledge climate change, especially for the worlds’ most vulnerable translation tools and approaches to ensure that research populations. For these populations, the greatest impact of informs practice and vise versa. Expanding empirical research climate change will not be some novel disease or other only from high-income to low-income regions in itself will not environmental stress; it will be an accentuation of existing be sufficient or timely to bring about change. This is challenges including vector-borne diseases such as malaria especially true because some of the modelling exercises are complex and the impacts not easily generalizable to the Level of implementation Key tools Individual Education local context. Household Empowerment Health, environmental, ecological and social sciences Community Information, resilience, facilitation researchers have learnt a great deal about the value of linking Region/country Policy, regulation, financing, equity Global Collaboration, equity, financing researchers with civil society and policy-makers. These lessons learnt need to be applied broadly to the climate Table 1: Key tools for application of climate change research and interventions by level of implementation change and health agenda.
36 Global Forum Update on Research for Health Volume 5 36-40 Shahab:GF5 22/10/08 14:03 Page 37
Innovating for health and development
Issue Do technical Are technical solutions Barriers Opportunities for research, knowledge solutions exist? successfully implemented in to implementation translation, implementation and evaluation low-income countries?
Vector-borne diseases Yes Somewhat Climate, geography, economy, Solutions need to be appropriate, acceptable governance and sustainable
Disasters: hurricanes, Limited Limited Populations already vulnerable Increase state and community capacity and cyclones resiliency to predict and respond to natural disasters
Water stress Limited Limited Loss of local control over water Resource poor communities have always resources. Powerful competing traditionally conserved water; local interests on decreasing fresh knowledge and empowerment has to be water supplies linked to new technologies for water conservation
Safe water supply Yes Not uniformly Macroeconomic limitations; lack National fiscal transfers to public health; of local training and infrastructure investment in infrastructure and point of use capacity
Changing agricultural Historically strong Significant experience in Some areas may have peaked in Understanding fundamental changes that yield capacity to translating research into their capacity to sustain may be required in crop types increase improved agricultural yields increasing yields agricultural yields
Poverty and inequity Limited Significant successes related Continuing unmet needs in Demonstrating how addressing poverty and to micro credit, literacy and female literacy and gender equity inequity can increase community capacity empowerment and social capital
Conflict Limited Non conflict based dispute Perceived national self interest. Demonstration of non conflict based resolution as advocated by Historical rivalries solutions as ultimately more sustainable intergovernmental organizations and local and global civil societies
Source: Shahab S, Ghaffar A, Stearns BP, Woodward A: Strengthening the base: preparing health research for climate change. Global Forum for Health Research, April 2008
Table 2: Approach to application of technical knowledge in low-income settings
and dengue; poor water quality and quantity; hunger and malnutrition; hot and unpredictable weather patterns; and Investments made in research in public health more frequent storms and natural disasters2. programmes and interventions that are impacted by The direct effects of climate change such as thermal stress climate change now and into the future are also, in have been well quantified for high-income countries and are many instances, issues that are or should also beginning to be modelled for low-income countries. Similarly, currently be high priority in terms of preventable the indirect but early effects of climate change such as public health disease burden increase in water- and vector-borne diseases are also now beginning to be estimated. Long-term effects however, such as impact of ecological changes on food security, water accessibility and extreme weather events such as hurricanes achieving the Millennium Development Goals (especially as and storms is harder to estimate globally3. they relate to hunger, universal primary education, gender There is some debate about what the microclimatic impacts equality, child mortality, malaria, environmental sustainability of climate change at the local level will be. It is a fair and a global partnership for development) will increase the assumption that they will be predominantly negative for the resilience and adaptive capacity of the most vulnerable majority of people living in low-income countries. They may populations to the known and potential negative consequences be initially climate neutral or positive for a few people living of climate change, in addition to being a demonstrated public in low-income countries and some in high-income countries. health goal in their own right5. However, over time, the global impacts on health, economy, The “new public health” stresses not just the direct, and ecology are now considered to be profoundly negative4. proximate causes of ill-health, but also the more distal, Investments made in research in public health programmes broadly defined “determinants of health”. Application of these and interventions that are impacted by climate change now public health principles would foster a more holistic and into the future are also, in many instances, issues that understanding of the approach to health protection and are or should also currently be a high priority in terms of health promotion in the face of climate change6,7. Health preventable public health disease burden. This convergence should, after all, be “a state of complete physical, mental ensures that limited resources are used ethically, equitably and social well-being and not merely the absence of disease and efficiently. So, for example, comprehensive steps towards or infirmity”8.
Global Forum Update on Research for Health Volume 5 37 36-40 Shahab:GF5 22/10/08 14:03 Page 38
Innovating for health and development
Health impacts of climate change
Adaptation to x x x x climate change Research Evidence Policy Action Impact of mitigation on health What Can it be applied to What Who will put works other settings: incentives in place these - Translation exist for measures? - Generalization reducing May not - Cost the impact always be the on health health or public sector
Figure 1: Framework for conceptual map of research areas and domains
The synergistic, catalytic power of this convergence has anthropogenic activity contributing to climate change. great potential. It can protect vulnerable populations from Adaptation is adjusting to current and future impacts of current known public health threats that are also being climate change. The health sector needs to engage with and potentiated by climate change; and also make vulnerable support research in both the mitigation as well as the populations more resilient to cope with future potentially adaptation sector. unknown threats. Not seeking convergence of the climate While research in mitigation is primarily seen as a change and public health research and intervention agenda, responsibility of the energy sector. There are substantial however, runs the risk of potentially undoing many of the potential co-benefits to health beyond reversal of climate public health gains of the recent past. change if health-centric approaches to mitigation are adopted. These include: Innovative strategies for research in climate Improved air quality with reduction of fossil fuel use and change and public health greater use of cleaner alternative energy sources. Mitigation is preventing climate change in the first place, Reduction in injuries due to road traffic accidents with primarily by reducing greenhouse gas emissions and other increased reliance on public transport and better urban,
100% Research and development to identify new Unavertable with existing interventions interventions
x – population coverage with z current mix of interventions Averted with Avertable with Avertable with Research and development to y – maximum achievable coverage current mix of improved existing but non- interventions and efficiency cost-effective reduce the cost with a mix of available cost-effective of existing interventions population interventions coverage interventions z – combined efficacy of a mix of all intervention of mix efficacy Combined available interventions 0% x y 100% Source: Ghaffar A, de Francisco A, Matlin S. The Combined Approach Effective coverage in population Matrix: a priority-setting tool for health research. Global Forum for Health Research, 2004. Adapted from Ad Hoc Committee on Health Research on health Research, Investing in Health systems and policies Research and Development. WHO, 1996.
Figure 2: An approach to analysing the burden of a health problem to identify research needs. Relative shares of the burden that can and cannot be averted with existing needs
38 Global Forum Update on Research for Health Volume 5 36-40 Shahab:GF5 22/10/08 14:03 Page 39
Innovating for health and development
community and work life planning. Key messages Prevention of chronic diseases such as diabetes, stroke and heart disease by promoting active transport such as Incorporation of climate change health impacts into walking and cycling and healthier diets. public health planning: a) Estimate current and future impacts of climate As the benefits for mitigation are global, for both high- change when planning public health interventions. income as well as low-income countries, momentum is b) For each public health intervention assess if building globally for a concerted effort to mitigate the health there will be an impact of climate change, and adjust impacts of climate change. It is important to continue to for that. document the health impacts of climate change as well as c) Climate change should be one of the variables mitigation by enhanced surveillance systems to continue to when estimating the impact and outcomes of public provide evidence and impetus for climate change mitigation. health interventions. Meanwhile, it is essential that populations globally prepare Partnering with all stakeholders: to adapt to some of the inevitable adverse consequences of a) Partner with other stakeholders outside the climate change until such time that mitigation efforts start to health sector for climate change adaptation have a stabilizing effect9. strategies. The application of research for adaptation, while of global b) Continue to advocate for mitigation as the significance and import, has to be rooted in local contexts of ultimate goal to address climate change. geography, economics and culture. c) Maximize the diffusion of innovations through It is important to have a conceptual map of what research civil society and the Internet. is required (see Figure 1)10. It is also important to ensure that d) Incorporate climate change mitigation and resources for research are used most efficiently to maximize adaptation impacts in intra- and intersectoral the public good. Many of the most urgent impacts of climate planning. Should include all possible sectors such can be countered with existing knowledge and a more as transportation, housing, energy policy, cost-effective way of leveraging proven public health education, health, agriculture, land use, interventions for vulnerable populations in sustainable ways environment, industries, trade etc. (see Figure 2)11. Supporting innovation, collaboration and Research approaches need to be empirical but also knowledge translation in research: ecological. The translation and application of existing and a) Include climate change as an element to consider new research findings needs to act both at the community for trans-disciplinary research funding. level in terms of empowerment as well as at a global/regional b) Make knowledge translation and collaboration level in terms of policy and funding. Many public health with low-income countries a prerequisite for interventions that will also protect vulnerable populations research funding approval in high-income countries. against progressive climate change act at a variety of levels c) Support the establishment of public health including individual, household, community, national and surveillance systems that monitor the impact of regional (see Table 1)12. climate change as an integral part of health status Examples of successful interventions include: and assessment measures. Household uptake of long-lasting insecticide-treated bed d) Ensure research is translated into locally relevant, nets when combined with other more standard vector cost-effective and sustainable interventions. control programmes. Provision of effective, affordable, locally manufactured point-of-use water filters. Innovative approaches from regional “second generation” assessments of the impacts of and adaptation to climate For each example of a successful or promising intervention, change done primarily in agriculture and water resources it is not sufficient just to know whether a technical solution need to be replicated and expanded to include direct and exists. Research on cost-effective and sustainable indirect health impact and adaptation assessments13. implementation also needs to occur (see Table 2)10. Civil society is well prepared to engage with governments and researchers to advocate for and adopt contextually Conclusions appropriate local interventions to mitigate and adapt to While the challenges are significant, so are the opportunities. climate change. There is unprecedented open access for Climate change seems to have acted as a catalyst promoting most if not all stakeholders to information thorough the World trans-disciplinary, holistic, global partnerships in research, Wide Web. knowledge generation, translation and action. Along with the expected increase in funding for climate Many initiatives are currently underway especially in the change research and interventions, it is vital that this spirit of environmental, agricultural and water resources sectors to openness and collaboration is maintained. Innovation in assess impacts to and adaptation from a developing country climate change research and interventions potentially has the perspective. The issue of health should be one of the explicit promise to address many existing and long-standing public foci of these initiatives. health issues as well as prepare for future risks.
Global Forum Update on Research for Health Volume 5 39 36-40 Shahab:GF5 22/10/08 14:03 Page 40
Innovating for health and development
Saqib Shahab is a physician specializing in public health and at the Regional Office for the Eastern Mediterranean Region, World preventive medicine. He has trained and worked internationally, Health Organization. including in Pakistan, the UK, US and Canada. Within public He has a long history of working internationally in global public health, Saqib has a special interest in environmental and health, including with the Global Forum for Health Research, with occupational health, communicable and noncommunicable a special interest and expertise in enhancing health systems disease control, and surveillance systems. His current interests capacity to participate in and apply research, especially in include incorporating climate change research and interventions as developing country and resource poor settings. His recent focus an integral part of public health practice. has been emphasizing research not just on technical and biomedical issues, but also health system organization, policy, Abdul Ghaffar is a physician and public health specialist who is capacity and cost effectiveness. currently the Regional Adviser for Research Policy and Cooperation,
References
1. Confalonieri U et al. Human health. Climate change 2007: impacts, 8. Preamble to the Constitution of the World Health Organization as adopted adaptation and vulnerability. Contribution of Working Group II to the by the International Health Conference, New York, 19–22 June 1946; Fourth Assessment Report of the Intergovernmental Panel on Climate signed on 22 July 1946 by the representatives of 61 States (Official Change. Parry ML et al, eds. Cambridge University Press, Cambridge, UK, Records of the World Health Organization, no. 2, p.100) and entered into 2007, 391-431. force on 7 April 1948. 2. Cambell-Lendrum D, Corvalan C, Neira M. Global climate change: PK:64167702~piPK:64167676~theSitePK:4503324,00.html implications for international public health policy. Bulletin of the World 9. MEbi KL, Kovats RS, Menne B. An approach for assessing human health Health Organization, March 2007, vol.85, no.3, p.235-237. vulnerability and public health interventions to adapt to climate change. 3. McMichael AJ et al, eds. Climate change and human health: risks and Environmental Health Perspectives, December 2006, 114(12):1930-4. responses. WHO 2003. 10. Shahab S, Ghaffar A, Stearns BP, Woodward A. Strengthening the base: 4. Stern Review on the Economics of Climate Change. HM Treasury, UK, preparing health research for climate change. Global Forum for Health 2006. Research, April 2008. 5. McMichael AJ, Butler CD. Emerging health issues: the widening challenge 11. Ghaffar A, de Francisco A, Matlin S. The Combined Approach Matrix: A for population health promotion. Health Promotion International, priority-setting tool for health research. Global Forum for Health December 2006, 21 Suppl 1:15-24. Research, 2004. 6. Few R. Health and climatic hazards: framing social research on 12. McMichael AJ, Kjellstrom T, Smith KR. Environmental health. In: Merson vulnerability, response and adaptation. Global Environmental Change, MH, Black RE, Mills AJ, eds. International public health: diseases, 2007, 17 (2), pp.281-295. programs, systems and policies, 2nd Ed. Jones and Bartlett, 2006. 7. Hanlon P, Carlisle S. Do we face a third revolution in human history? 13. Leary N, Kulkarni J. Climate Change Vulnerability and Adaptation in If so, how will public health respond? Journal of Public Health, 21 July Developing Country Regions. Draft Final Report of the AIACC Project, 2008, Oxford. April 2007. GEF/START/ UNEP.
40 Global Forum Update on Research for Health Volume 5 41-45 kichbusch:GF5 23/10/08 09:17 Page 41
Innovating for health and development
Global health diplomacy – a bridge to innovative collaborative action
Article by Thomas E Novotny (pictured left), Director, International Programs, UCSF School of Medicine and Ilona Kickbusch (pictured right), Director, Global Health Program, Graduate Institute of International and Development Studies, Geneva with Hannah Leslie, Vincanne Adams
“Medicine is a social science, and politics health may perpetuate the imbalance of power between the nothing but medicine on a grand scale.” developed and the developing world. However, we now see a power shift in the role of the emerging economies, as in the RUDOLF VIRCHOW, 1858 recent Doha rounds of World Trade Organization negotiations. From the mid 1850s, countries have dealt with the lobal health diplomacy may be thought of as a increasing risk of disease from beyond their borders as a political activity that meets the dual goals of improving national and economic security issue3. These national Ghealth while maintaining and strengthening interests now mandate that countries engage internationally international relations. As diplomacy is frequently referred to as a responsibility to protect against imported health threats as the art and practice of conducting negotiations, the term or to help stabilize conflicts abroad so that they do not disrupt “global health diplomacy” aims to capture the multi-level and global security or commerce. Concerns for health security multi-actor negotiation processes that shape the global policy include the threat of bioweapons (accidental or purposeful) as environment for health. It bridges the commitment to well as both infectious diseases and noncommunicable development and the need to define collective action in an diseases that can wreak havoc on global economies. It is the interdependent world. This emerging field draws on a broad careful balancing of sometimes competing global health range of disciplines including international relations, medical priorities, playing out both nationally and globally, that make anthropology, political science, history and public health. partnership across disciplines essential in raising the profile Therefore it is important to understand some of the historical of health as a foreign policy concern. Global health efforts will and conceptual underpinnings of this emerging field. founder unless and until nation states cooperate in combining Academic rigour applied to global health diplomacy is a their national interests with the global public good. critical leaven in a chaotic global health environment. This paper presents a brief review of the issues that provide a Contributing concepts possible focus for future training, research and service in Humanitarian assistance global health diplomacy. The notion of humanitarian assistance as part of foreign policy was described in a 1974 editorial in Preventive Historical roots Medicine, wherein Cahill advocated using medicine as a tool A historical perspective may help illustrate an emerging of modern diplomacy4. His more recent work suggests that tension surrounding health cooperation and diplomacy. In health is a common ground for understanding and fact, international public health agreements were originally cooperation among peoples and nations with differing created to protect against the importation of foreign-born traditions and values5. This is especially true in nations that diseases and as a defence for national commercial and are shattered by war, civil conflicts and ethnic violence. Over trading interests, going as far back as the Middle Ages the next 25 years, humanitarianism rather than foreign policy in Europe. per se was the focus for health diplomacy. However, We may also find some roots of health diplomacy in early humanitarian assistance provided by the United States and missionary work, which adopted medical treatment as part of others to disaster areas such as Sudan fulfilled broader evangelical activities. For example in India, Fitzgerald political and economic objectives rather than just described the emergence of medical assistance as a tool for beneficence6. Aligning aid organizations with dysfunctional religious conversion among British colonial subjects1. There is governments may enable these governments to be thus a need to consider the normative foundations of global unresponsive to their own national crises7. These examples health diplomacy, such as in the humanitarian activities of suggest that aid organizations must be politically and ethically the Red Cross Movement, with equity and social justice being more savvy in order to assure justice-based approaches to key components2. The current structures of global public international health assistance8. Health diplomacy attempts
Global Forum Update on Research for Health Volume 5 41 41-45 kichbusch:GF5 22/10/08 14:03 Page 42
Innovating for health and development
to prioritize the health outcomes of humanitarian aid as a in trade, transport, medicine and society have created ideal route to negotiations in the political sphere. conditions for emerging infections with potentially A critical new development in global health is the devastating impacts15. However, deficiencies in public health proliferation of private sector and government donations in infrastructure argue for greater public health preparedness to international aid; these have been largely disease-specific prevent global pandemics16. enterprises (such as the Global Fund for AIDS, TB and Globalization has also expanded the threat of Malaria). A 2004 estimate suggested that international noncommunicable disease to populations and economies funding for global health reached US$ 14 billion in that year, worldwide17. This latter set of threats (tobacco-related due largely to contributions from the Bill & Melinda Gates diseases, obesity, injuries, mental health problems, cancers, Foundation and the US government’s Presidential Emergency stroke and cardiovascular disease) are much less attention- Plan for AIDS Relief (PEPFAR)9. The proliferation of smaller grabbing as global health problems compared with the high- nongovernmental organizations (NGOs), privately funded profile infectious diseases that are now so well funded; and focused on single communities, specific health nevertheless, they are the largest contributors to the global outcomes or specific medical interventions is also burden of disease11. Noncommunicable diseases have emerged unprecedented in history. Along with this bonanza, there is as global threats, no longer considered a condition of only increasing convergence of thought on the evidence of affluent populations18. These conditions may contribute to effectiveness for global health interventions10. This evidence developmental stagnation in emerging economies, and they has been thoroughly reported in the hallmark publication, may lead to inordinate demands on health systems that Disease control priorities in developing countries11. What disrupt production and trade capacities of these economies. may be missing from these discussions, however, is a sense of the absorptive capacities and global governance needs Enlightened self-interest that are necessary for both recipients and donors to manage Improvements in health status globally – especially in these resources12. developing countries – promote economic and security interests for both donor countries and the larger global Human rights community19. In 1997, the Institute of Medicine (IOM) The emergence of human rights as a global movement published a volume of evidence supporting the United States’ clearly sparked challenges and debates within the field of critical need to address global health as a vital national humanitarian assistance that have yet to be resolved. The priority20; following this, infectious diseases were recognized notion of human rights and health assistance has emerged in the National Intelligence Estimate as a significant threat to as a basis for cooperative action across nations, the private national security, with an emphasis placed on the sector and NGOs. The right to health became a key element importance of HIV/AIDS21. Recently, some have even of this discourse, but its importance remained largely suggested that the avian influenza threat presents potential understated until the world acknowledged the enormous for cooperation between the militaries of, for example, the impact of HIV/AIDS. Health and human rights emerged as a United States and China. They may be encouraged to pool their distinct movement and was made concrete with the 1994 resources in order to address a common threat such as this22. founding of the Journal of health and human rights by Given the potential for new commitments to global health Jonathan Mann, head of the WHO HIV/AIDS programme at diplomacy in a changing global political environment, the the time. He clarified this union of human rights and health, IOM’s Board on Global Health is now organizing a 14-month stating “that the human rights framework provides a more consensus study to examine and articulate the case for why useful approach for analyzing and responding to modern multiple agencies from government and the private sector in public health challenges than any framework thus far the United States should make a deeper commitment to available within the biomedical tradition”13. Building on this global health. This study will greatly expand on the 1997 foundation, Paul Farmer’s written works and leadership have IOM report to consider the diplomatic agenda, expanded dramatically advanced the human rights agenda in health global research cooperation and perhaps new ways of diplomacy, arguing that the international public health and addressing the global health workforce crisis (see foreign policy communities both fail to recognize the needs of www.iom.edu/CMS/3783/51303.aspx). the world’s poor and neglect to address the structural inequalities that lead to illness among them14. Given a Multinational cooperation decade since health and human rights emerged as a In December 2004, the United Nations issued an important movement, health diplomacy must now incorporate both a report, A more secure world: our shared responsibility: report concern for resource equity and a concern for social justice of the high-level panel on threats, challenges and change23, in health assistance. It must also consider the political and a follow-up to the 2000 UN Millennium Summit, where economic landscape in which these standards must commitments to global cooperation were made in response be defended. to several major health and development challenges. The 2004 report emphasized the need to achieve the Millennium Globalization Development Goals (MDGs; see Table 1), with a focus on During the 20th century, researchers have recognized the health and biological security. spread of both communicable and noncommunicable The focus of the UN report also extends to the social diseases as a consequence of globalization. Global changes determinants of health (especially poverty and economic
42 Global Forum Update on Research for Health Volume 5 41-45 kichbusch:GF5 22/10/08 14:03 Page 43
Innovating for health and development
1. Eradicate extreme poverty and hunger; disparate, uncoordinated efforts within global health call for 2. Achieve universal primary education; a more systematic global cooperative effort30,31. However, 3. Promote gender equality and empower women; 4. Reduce child mortality; neither the traditional state actors nor the modern nonstate 5. Improve maternal health; actors are likely32 to accept either centralization under a 6. Combat HIV/AIDS, malaria and other diseases; 7. Ensure environmental sustainability; and ruling global authority or harmonization of goals, practices 8. Develop a global partnership for development. and procedures across organizations. Nonetheless, the Table 1: The United Nations Millennium Development Goals acceptance and integration of health as a global public good for 2015 has crossed a variety of thresholds, including trade, security, inequities), infectious diseases and environmental bioethics, international relations and economics. This degradation. Although sovereign states are the front line in suggests that the principles and policies of global health dealing with health threats, the report emphasized that no governance, what Fidler terms the “source code”, have state can stand wholly alone and that collective strategies, functioned independently of centralized efforts. Instead of collective institutions and a sense of collective responsibility developing a new governance structure, global health actors are indispensable in addressing the global health challenges should consider how successful applications of this source of the 21st century. The WHO has flexed its muscle in this code will look in the 21st century. A range of proposals that arena with new instruments, such as the Framework build on network governance and aim to bring together the Convention on Tobacco Control (see below). Additionally, many actors in this new political space have since been put governments have begun to align themselves in new forward33. A growing international consensus on what works arrangements, such as in the 2007 Oslo Declaration, and what does not work in global health, and the growth of wherein the Ministers of Foreign Affairs (not of Health) of the new academic global health programmes and Brazil, France, Indonesia, Norway, Senegal, South Africa and philanthropic structures will redefine global health Thailand recognized the need for new forms of cooperation governance in the years to come. to support development, equity, peace and security24. The What should also be evident is the need for new public UN MDGs are a framework for multinational health health instruments to support collective health efforts. Fidler diplomacy, monitored and promoted by the member states of calls for further examination of new efforts in global health the United Nations, and some have called for codifying them governance such as the Framework Convention on Tobacco in a Framework Convention on Global Health25. Today’s Control (FCTC) and the revised International Health health diplomats must understand how global health Regulations (IHR). The FCTC was the first treaty governance has and must change. implemented under the WHO’s constitutions, Article 19. It has now been ratified by 155 countries and will call for Global health governance national policies to assure full participation in the Conference The shifting role of nation states and the growing insecurity of the Parties, the supervising entity for the treaty34. In in global public health has generated tremendous discussion addition, there are challenges posed by the new IHR as a concerning global health governance, particularly given the consensus agreement within the WHO for countries to rise of new actors within the field. Cohen drew attention to support global responses to critical public health problems the increasing role of private philanthropy, illustrating the and to share information and responses to these problems35. nearly unfettered influence and unintended consequences of efforts by wealthy individuals and organizations now active Emergence of health diplomacy in the in the field26. United States Further, sovereign nations may lose their power to set In 2001, the Council on Foreign Relations36 made a strong other priorities if they must adhere to donor priorities for case that the US government had a critical responsibility to disease-specific activities (such as in the first version of make health a priority in foreign policy. US global health PEPFAR). In fact, the World Bank has suggested a moral policy today is rooted in both national security concerns and hazard argument regarding external funding such as that a worldwide desire for social justice and equity37. Health which is now proliferating: if upwards of 50% of government diplomacy offers the potential for breaking free of the spending comes from external sources, a country may lose governance dilemma by bringing together health and foreign control of its priorities, programmes and strategies, yielding policy based on a concept of human security that embraces all control to the donors27. In this context, what should be the rights and well-being rather than only enlightened national global health governance structure and what should be the self-interest. role of multinational membership organizations in governing Recently several US government officials have discussed global health? Without systematic attention to the medical diplomacy as an element of foreign policy, often governance needs and social justice issues of health focusing on the delivery of health care within low-resource assistance, global health financiers will fall short of their settings and the distribution of medical technology38,39. In intended humanitarian goals. 2005, the IOM reviewed a number of international models The role of nonstate actors, including private for increasing humanitarian assistance within the HIV/AIDS philanthropies, private individuals and private industry, has epidemic with the suggestion for development of a Global emerged as a concern from both political28 and social science Health Corps that would provide for improved global health perspectives29. These new global networks are clearly a capacity through elective service by US health 21st century humanitarian assistance phenomenon. The professionals40. This programme would actually emulate
Global Forum Update on Research for Health Volume 5 43 41-45 kichbusch:GF5 22/10/08 14:03 Page 44
Innovating for health and development
efforts such as those provided by Cuba over recent decades41 Thomas E Novotny is a Professor of Epidemiology and and that China has recently adopted42. Biostatistics at the University of California, San Francisco, and co- director with Professor Kickbusch of an executive training course Conclusions on global health diplomacy conducted with support from the This brief review provides an overview of the history, Centers for Disease Control and Prevention and the Fulbright conceptual basis and new inputs into the growing field of Senior Specialists Program. He is director-designate of the Joint health diplomacy, and it provides some perspectives that Degree Program in Global Health at San Diego State University we may include as elements of professional education and and the University of California San Diego. research in the coming years. Health diplomacy is a field in the making43, and there is ample material in the history of Ilona Kickbusch is the Director of the Global Health Programme international relations, humanitarian aid and medical at the Graduate Institute of International and Development assistance with which to begin serious analytic work as Studies, Geneva Switzerland with a focus on global health well as to develop pedagogy within the academic governance and global health diplomacy. She is a political environment. Today, there are literally dozens of global scientist with a PhD from the University of Konstanz, Germany, health educational programmes in the United States and and she is recognized for her contributions to innovation in public Europe, and many of these were described in a recent health, health promotion and global health. (January 2008) special issue of Academic medicine. Yet there are few educational initiatives that focus specifically Hannah Leslie is a Program Analyst with the University of on the interface between international relations, diplomacy California, San Francisco Global Health Sciences Program and an and public health (Personal Communication, I Kickbusch MPH candidate at the University of California, Berkeley, School of and C Erk, A survey of training programmes and courses, Public Health. 11 August 2008). With so many new educational programmes involving multiple disciplinary approaches to Vincanne Adams is Professor of Anthropology, History and global health education, it is clear that health diplomacy will Social Medicine at the University of California, San Francisco. She be an exciting new academic pursuit within these directs the joint (with UC Berkeley) medical anthropology program programmes in the coming decades. J in the San Francisco Bay Area.
References
1. Fitzgerald R. “Clinical Christianity”: the emergence of medical work as a 13.Mann JM. Health and human rights. British Medical Journal (Clinical missionary strategy in colonial India, 1800–1914. In: Health, medicine research ed.), 1996, 312(7036), 924-5. and empire: perspectives on colonial India. Hyderabad: Orient Longma, 14.Farmer P. Pathologies of power: health, human rights, and the new war 2001, pp.88-136. on the poor. Berkeley, CA: University of California Press, 2003. 2. Aginam O. The nineteenth century colonial fingerprints on public health 15.Garrett L. The coming plague: newly emerging diseases in a world out of diplomacy: a postcolonial view, 2003. Retrieved 14 January 2008 from balance. New York: Farrar, Straus and Giroux, 1994. HYPERLINK "http://www2.warwick.ac.uk/fac/soc/law/elj/ 16.Garrett L, Fidler DP. Sharing H5N1 viruses to stop a global influenza lgd/2003_1/aginam" pandemic. PLoS Medicine, 2007, 4(11):e330. http://www2.warwick.ac.uk/fac/soc/law/elj/lgd/2003_1/aginam. 17.Beaglehole R, Yach D. Globalisation and the prevention and control of 3. Fidler D. The globalization of public health: the first 100 years of non-communicable disease: the neglected chronic diseases of adults. international health diplomacy, 2001. Retrieved 14 January 2008 from Lancet, 2003, 362(9387):903-8. HYPERLINK 18.Novotny TE. Why we need to rethink the diseases of affluence. PLoS http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042- Medicine, 2005, 2(5), e104. 96862001000900009. 19.Fox DM, Kassalow JS. Making health a priority of US foreign policy. 4. Cahill KM. Editorial: medicine and diplomacy. Preventive Medicine, American Journal of Public Health, 2001, Oct;91(10):1554-6. 1974, 3(2),187-92. 20.Institute of Medicine. America’s vital interest in global health. 5. Cahill K.M. Health and foreign policy: an American view. Annals of Washington DC: Institute of Medicine, 1997. Tropical Medicine and Parasitology, 1997, vol. 91, no.7, pp.735-41. 21.Central Intelligence Agency. The global infectious disease threat and its 6. Autesserre S. United States “humanitarian diplomacy” in South Sudan implications for the United States. Washington, DC: NIE 99-17D, [1]. Journal of Humanitarian Assistance, 2002. Retrieved 7 August January 2000. 2008 from http://www.jha.ac/articles/a085.htm 22.Erickson A. Combating a collective threat: prospects for Sino-American 7. Rieff D. A bed for the night: humanitarianism in crisis. Simon & cooperation against avian influenza, 2007. Retrieved 17 January 2008, Schuster, 2003. from http://www.ghgj.org/Erickson_1.1_Combating.ht 8. De Waal A. Famine crimes: politics & the disaster relief industry in 23. Report of the Secretary-General’s high-level panel on threats, challenges Africa. Indiana University Press, 1997. and change, UN. A more secure world: our shared responsibility. Doc. 9. Kates J, Morrison JS, Lief E. Global health funding: a glass half full? A/59/565 (2 December 2004) http:// HYPERLINK Lancet, 2006, 368(9531):187-8. “http://www.un.org/secureworld” www.un.org/secureworld/report.pdf. 10. Buekens P, Keusch G, Belizan J, Bhutta ZA. Evidence-based global 24.Ministers of Foreign Affairs of Brazil, France, Indonesia, Norway, Senegal, health. Journal of the American Medical Association, 2004, South Africa and Thailand. Oslo Ministerial Declaration – global health: a 291(21):2639-2641. pressing foreign policy issue of our time. Lancet, 2007, 369:1373-78. 11.Jamison D. World Bank, Disease Control Priorities Project. Disease 25.Gostin LO. A proposal for a Framework Convention on Global Health. Control Priorities in Developing Countries, 2nd ed. Washington, DC: Journal of International Economic Law, 2007, 10(4), 989–1008. Oxford University Press on behalf of the World Bank, 2006. 26.Cohen J. The new world of global health. Science, 2006, 311(5758), 12.Novotny TE. Global governance and public health security in the 21st 162-167. doi: 10.1126/science.311.5758.162. century. California Western International Law Journal, 2007, 38:19-40. 27.Sridhar D, Batniji R. Misfinancing global health: the case for
44 Global Forum Update on Research for Health Volume 5 41-45 kichbusch:GF5 22/10/08 14:03 Page 45
Innovating for health and development
References continued
transparency in disbursements and decision-making. Oxford, UK: Global 23(2), 265-282. Economic Governance Programme, University of Oxford, (2008). 35.Fidler DP, Calain P. XDR Tuberculosis, the New International Health 28.Garrett L, Fidler DP. Sharing H5N1 viruses to stop a global influenza Regulations, and Human Rights. Global Health Governance, 2007. pandemic. PLoS Medicine, 2007, 4(11):e330. Retrieved 17 January 2008, from http://www.ghgj.org/Fidler_1.1. 29.Wehrenfennig D. Beyond diplomacy: conflict management in a diverse XDRTuberculosis.htm world. Paper presented at the annual meeting of the Western Political 36.Fox DM, Kassalow JS. Making health a priority of US foreign policy. Science Association, Hyatt Regency Albuquerque, Albuquerque, New American Journal of Public Health, 2001, 91(10):1554-6. Mexico, 17 March 2006. Online
Global Forum Update on Research for Health Volume 5 45 48-52 Kurokawa:GF5 23/10/08 19:30 Page 48
Innovating for health and development
Hideyo Noguchi Africa Prize
Article by Kiyoshi Kurokawa (pictured), Chair, Hideyo Noguchi African Prize and
PHOTO BY Special Advisor to the Cabinet of the Japanese Government with Tamaki Tsukada and Eri Maeda TETSUO SAKUMA
n 28 May 2008 Brian Greenwood, of London School creation of wealth and social stability are some of the of Hygiene and Tropical Medicine, and Miriam Were requirements for us, the people of Africa, to get out of the Oof National AIDS Control Council of Kenya, were indignity in which most of us live. We, the people of awarded the First Hideyo Noguchi Africa Prize. Africa, believe that through this forum (TICAD) and The presentation ceremony hosted by Prime Minister Yasuo the prize outcomes will be positive for Africa”, Fukuda was attended by their Majesties the Emperor and (Miriam Were)2. Empress of Japan and hundreds of international dignitaries, The creation of the prize came out as a typical Koizumi- including more than 40 heads of state and government of the style coup de main during his visit to Africa in May 20063. It African countries participating in the Fourth Tokyo was literally a top-down initiative. Nobody at the time actually International Conference on African Development (TICAD IV). thought about the meaning, let alone the consequence, of The presentation ceremony marked the first day of the TICAD creating yet another prize in the already over-crowded IV held in Yokohama. The day happened to coincide with the international prize market. However, it turned out that this “80th anniversary plus one week” of Noguchi’s death in particular field of science – tropical medicine, public health, Ghana, 21 May 1928. or so-called translational research – lacked a proper system of The best description of the ideals of the Hideyo Noguchi reward which commanded substantial international outreach Africa Prize is perhaps the acceptance speeches of the two and legitimacy. It was precisely this area of science and laureates (excerpts as follows): research which warranted particular attention of the “Forty-three years ago, as a young man, I set off on my first international science community if we were to defeat the visit to Africa to take up an appointment at University College global health challenges. Hospital, Ibadan in Western Nigeria. At that time, this was Why do we have to constrain ourselves on a specific considered rather a strange thing to do. I had up to that point continent when a global issue like health and medicine is at done well in my medical career in England and some of my issue? Because Africa is the continent most in need of seniors in the UK considered that going to work in Africa was resources, financial or otherwise, in order to achieve the bizarre, almost a form of professional suicide for a young United Nation’s Millennium Development Goals (MDGs). physician. This evening is the occasion on which I have These were the founding principles and parameters which finally proved them wrong. The concept underlying the determined the framework of the new prize. The prize has set Noguchi Prize is an extremely important one as it establishes itself a totally different and radical approach on how to the point that what is sometimes considered as rather soft, recognize, inspire and shape research in a globalizing world. that is applied or field, research, is as intellectually rigorous Before going into the prize further, let us briefly review and demanding as the high technology laboratory research Hideyo Noguchi, a figure who captivated Koizumi’s that, in the past, has usually attracted the international prizes. imagination to conceive this prize. The establishment of the Noguchi Prize will help to redress this balance and the Japanese Government is to be Who is Noguchi? commended on taking this initiative”, (Brian Greenwood)1. Hideyo Noguchi (1876–1928) was a prominent Japanese “Reduction of the disease burden on the people of Africa bacteriologist in the early 20th century, internationally and improvement of health is crucial for the creation of wealth acclaimed for his contribution to the understanding of and improvement of the overall socioeconomic situation in infectious diseases4. Noguchi eventually died in Accra, Gold Africa. People who live in poverty and who are frequently sick Coast (now Ghana) of yellow fever while working in search of cannot be productive enough to improve the situation. Africa’s its pathogen5. It is said that the death of his close Rockefeller history that includes the massive transatlantic slave trade that colleague Dr Adrian Stokes of yellow fever made Noguchi disorganized the continent for nearly 500 years followed by decide to travel to Africa. It was still a decade before the virus colonialism and apartheid for a further 100 years laid the was discovered by mankind and ascertained as the pathogen. roots of poverty and disempowerment in Africa that casts a Noguchi was born in a very poor family in the long shadow into the present and future. Healthy people, impoverished rural village of Fukushima. He had a physical
48 Global Forum Update on Research for Health Volume 5 48-52 Kurokawa:GF5 23/10/08 19:30 Page 49
Innovating for health and development
handicap, a deformity on his left hand due to a burn that he suffered during his early childhood. Nothwithstanding these The latter part of 2006 was consecrated to handicaps, he managed to obtain, through extraordinary establishing a truly effective business model or hard work, a licence to practise medicine in Japan. He did process in order for this prize to be competitive and exceptionally well in school but in those days, obtaining attractive in the science community as well as higher education, especially in medicine, was expensive and pertinent to the global (i.e. African) health needs exclusive. The professional horizon of a medical student from a lowly family background without a degree from the Imperial University, could not extend much further than a provincial practitioner. Noguchi was not content to remain in obscurity. In 1901, at the age of 23, Noguchi moved to the United States and made his way to the laboratory of Simon Flexner Business model or process of the prize at the University of Pennsylvania. In 1904, Flexner was It is not possible to make a simple comparison between the invited to head the newly founded Rockefeller Institute for style of research in the days of Noguchi, when researchers Medical Research (now Rockefeller University), and brought were honoured simply by discovering or isolating agents from Noguchi, his most trusted protégé, with him. In the early patients, and that of the contemporary scene where years in the institute, Noguchi earned the epithet “human conditions and requirements have become much more dynamo”, not without a racist hue. But by the 1910s he was complex. However, the field-based research style of Noguchi one of the top researchers leading the institute to world fame is increasing in its value in combating diseases in Africa. comparable to its European counterparts. In those days in There is an atavistic call for simple but high quality research the field of medicine (and to a large extent science in based on practical needs on the ground combined with a general), the United States had been playing the second deep understanding of the ecological and human factors fiddle to Europe. indigenous to Africa. His extraordinary appetite for research and zeal to conquer In May 2006, Prime Minister Koizumi announced the the cause of diseases, brought him to various places in the establishment of the prize in the joint press conference with western hemisphere in Central and South America where the President Kufuor of Ghana. After returning to Japan, Koizumi rate of death from yellow fever was particularly high. The instructed the ministries of foreign affairs, health and welfare, Rockefeller Institute for Medical Research had formed a and science and education to elaborate on the concept. The special task force for South America and appointed Noguchi Cabinet Office was designated as the coordinating agency as one of its leaders. In 1918, Noguchi landed on Guayaquil, and in July 2006, in the Japan-African Union (AU) summit, Ecuador, the epicentre of this disease; his battle against the prize became the main agenda. In the joint press yellow fever thus began. In just nine days, he isolated the conference by Prime Minister Koizumi and AU Chairperson pathogen (Leptospira icteroides) and produced a vaccine and Konare it was announced that the prize will be awarded antiserum, successfully lowering the death rate. Noguchi every five years and that the first will be awarded in 2008 was worshipped as a crusader against yellow fever in places within TICAD IV. A cabinet decision was made to that effect. where he visited: Mexico, Brazil and Peru. However, it was The latter part of 2006 was consecrated to establishing a not possible at that time to identify a virus; it did not exist truly effective business model or process in order for this even in people’s imagination. However, Noguchi harboured prize to be competitive and attractive in the science some doubts about the veracity of his findings and he did community as well as pertinent to the global (i.e. African) record certain observations to this effect true to his academic health needs. conscience. That was what motivated Noguchi to set sail The first demand was to ensure diversity and for Africa. inclusiveness. Nominations will be sought from around the A prominent Rockefeller scientist travelling all the way to globe including all the 53 countries in Africa. Africa has often Africa, notwithstanding various prejudices against a non- been a non-entity in the science community. By white, physically handicapped upstart had a tremendous inclusiveness, we do not mean affirmative action. What is impact worldwide. It is this courage and passion combined needed is a truly fair and equitable playing ground to with his belief in field-based research that makes Noguchi encourage research of Africa, for Africa, by Africa. The and his contribution remarkable. And this is the nexus composition of the three selection committees will between Noguchi and the newly created prize. be international with a balanced representation from various continents6. The second demand was to ensure fairness and academic Hideyo Noguchi (1876–1928) was a prominent rigour of the selection process. Not only the outcome but also Japanese bacteriologist in the early 20th century, the process through which the laureate is elected should be internationally acclaimed for his contribution to the superlative, that is worthy of the substantial amount of understanding of infectious diseases. Noguchi honorarium attached to the prize. Prestige and appeal of a eventually died in Accra, Gold Coast (now Ghana) of prize is not something which could be bought but only yellow fever while working in search of its pathogen earned by example. For this purpose, two sub-committees were set up to conduct the expert level screening in respect
Global Forum Update on Research for Health Volume 5 49 48-52 Kurokawa:GF5 23/10/08 19:30 Page 50
Innovating for health and development
of medical research and medical services. The Hideyo Noguchi Africa Prize Committee, the parent body presiding The prize will first and foremost vigorously encourage over the two sub-committees, will finalize the candidates research on the major and most relevant medical and to be recommended to the Prime Minister of Japan for health issues in Africa final decision. The third demand was to ensure relevance of the prize to the health/medical reality on the ground. The “connectivity” of the prize with the people and society of Africa is the core uncontrollably across the African continent claiming more value of the prize. The connectivity is embodied in the than 1 million lives a year, Greenwood contributed to the financial mechanism too. One half of the honorarium will be creation and designing of effective strategies to control financed by the Government of Japan and the other half by malaria. His crucial contributions in malaria research greatly donations from the public which will be administered by the helped developing the tools and knowledge that are essential Japan International Cooperation Agency (JICA). in turning the tide on this devastating disease. His work What are the main target areas of the prize? The prize will brings hope where very recently only despair existed. first and foremost vigorously encourage research on the major Greenwood has spent more than 30 years on site in Africa and most relevant medical and heath issues in Africa. including 15 years as Director of the MRC Laboratories in The Although dramatic achievements have been made in recent Gambia where he pioneered landmark research contributing decades in this area, there is still an absolute shortage of to the understanding of the immunology, pathogenesis and awareness beyond the expert community. The prize, by its epidemiology of malaria, a major killer in Africa, and other institutional linkage to the TICAD process and its strong infectious diseases such as meningitis and pneumonia, all resonance with global health policy, aspires to be a key major contributors to mortality among children in Africa. His instrument in addressing the medical as well as public health research and translational clinical studies, involving simple challenges in this area. but high quality methods as well as field trials of drugs and The prize values not only the advancement of our vaccines, have provided the scientific underpinning to a wide understanding of African diseases in terms of biomedical range of influential public health policies at national and research in its conventional sense, but also our understanding international levels. His important contributions include: of the bigger picture in terms of human and environmental Demonstration of the effectiveness of insecticide-treated ecology surrounding these diseases. bed-nets for control of malaria, which is now the The prize will also give more emphasis on the human and cornerstone of malaria interventions throughout the societal aspect of the research or health activities in concern. continent, supported and financed by many donor We do not believe that such an approach will compromise the agencies; disciplinary rigour of research or health activities. If anything, Primary studies on artemisinin-based combination this kind of emphasis will lead to a bigger impact in terms of therapies (ACTs), now widely adapted as first-line achieving the MDGs more effectively. treatment for malaria; Demonstration that malaria chemoprevention reduces Achievements of the two laureates child mortality. This is now being applied for intermittent Nomination requests together with the nomination guidelines preventive treatment in infants, children and in pregnancy; were sent out to more than 2000 individuals and institutions, Substantial contributions to trials of malaria vaccines, and slightly more than 100 nominations were received. including the efficacious RTS,S vaccine. From February to December 2007, the Medical Research Sub-Committee selected three among 57 candidates. Another important aspect of Greenwood’s achievements is Meanwhile, from June to December 2007, the Medical his reinvention of field research in tropical medicine – Services Sub-Committee selected three among 23 changing it from an ancillary colonial or military activity candidates. These six candidates were referred to the Hideyo focusing on hygiene to a multi-partite, multi-disciplinary Noguchi Africa Prize Committee for final consideration. In endeavour, wherein holistic solutions are required – based on February 2008, the Hideyo Noguchi Africa Prize Committee cutting-edge science and a genuine understanding of the unanimously recommended Brian Greenwood and Miriam complex eco-system as well as real-life challenges unique to Were as the candidates for the first prize. This was duly Africa. Thus laboratory and clinical research, preventive and approved and announced on 26 March 2008 by the curative medicine, epidemiology, anthropology, and Prime Minister. behavioural research were all brought together. These modern Reactions from the international health and research approaches which we now take for granted came from community were cordial and encouraging. The WHO, Greenwood’s prescience and leadership. the World Bank, the Gates Foundation, the Rockefeller Over the years, Greenwood has made capacity building – Foundation and the Rockefeller University were among another lasting legacy of his research based on African soil – those who issued genial statements congratulating a central objective including the training and support of young the laureates7. African scientists. A cohort of students, doctors and clinicians Brian Greenwood was honoured for his bold and innovative who developed their careers under Greenwood’s inspirational work on malaria. At a time when malaria was spreading mentorship has immensely contributed to the increase in
50 Global Forum Update on Research for Health Volume 5 48-52 Kurokawa:GF5 23/10/08 19:30 Page 51
Innovating for health and development
stature of medical research in Africa amongst the scientific issues on Africa. community in general. Japan as Chair of G8 this year, which is incidentally the Under the medical services category, the inaugural award year of TICAD, is leading the efforts to harness the surging went to Miriam K Were, whose efforts to bring basic medical enthusiasm of the international community on the health services and health rights to women and children in the agenda10. The Japanese government considers the Hideyo villages of East Africa has been a beacon of hope for millions Noguchi Africa Prize mechanism to be an integral part of this of people in Africa and the world. Through her work with policy context. African Medical and Research Foundation (AMREF)8 and Health and medical interventions tend to be subject to the UZIMA Foundation9, Were has been a source of inspiration whim of pity. Of course, health matters are by nature for all people on the African continent. humanitarian. However, we need to conscientize the public For the past 40 years, Were has dedicated her life to that charity is not sufficient to roll back the overwhelming advancing the health and welfare of the people of Africa health challenge in Africa. We need to encourage robust through a focus on the practicalities of delivering service at a science and research in Africa. Science should not be a local level. She has united communities to develop and monopoly of the developed world. Research on African implement innovative solutions to quotidian health problems. health cannot be truly meaningful or sustainable unless it is The most illustrious example of her community-based owned by Africans. approach is her ongoing work to build public toilet facilities The following excerpt from an article by Professor in local communities, improving hygiene and overcoming Makgoba, Vice-Chancellor of KwaZulu Natal University, longstanding taboos. She also drastically raised the infant perhaps best captures the African hope and expectations. vaccination rate by organizing children into small groups to “Major international prizes that have shaped modern visit local clinics. Her innovation and systemic precedents medical scientific advancements such as the Nobel Prize, have had enduring impacts not only in Kenya but throughout have the thrust on individualistic scientific achievements the East African region and across the entire continent, without a direct link to society or a focus on global health through her engagement with the African Union and as a key burden. For these reasons they have advanced science and health adviser to the African Heads of State on AIDS, health research in a particular, esoteric way; have become tuberculosis and malaria. prizes of the elite and advantaged science and scientists of Her style of work through the direct engagement of the the developed world; and have been detached from real youth, sex workers, intravenous drug users, homosexuals global health problems. As a result, while prestigious, in and others to encourage openness and frank discussion on reality they have been exclusive and insensitive to the sexuality and HIV/AIDS has galvanized communities in health realities of the developing world. Often the processes Kenya and contributed to the reduction of stigma and and structures of their decision-making have been discrimination against people living with HIV/AIDS. She is a shrouded in secrecy and have lacked diversity and dedicated advocate for vulnerable populations, especially the internationalism. It will be interesting to see how these poor and the marginalized. She is also committed to the established awards rise to the challenges of the modern empowerment and development of all voices across lines of world and in particular to the impact of this newly launched sex, tribe, and age and class background. Widows and Hideyo Noguchi Africa Prize.” orphans severely affected by HIV/AIDS are amongst those We wish to acknowledge our indebtedness to each and all most positively touched by her contribution to expanding of the three selection committees in particular the three access to medical services. chairpersons for their intellectual and moral support We would also like to pay tribute to the families, throughout the process. We must also record our deep particularly the spouses, of the two laureates whose gratitude and almost thunderstruck admiration for Junichiro continuing support and understanding for the harsh working Koizumi for his sense of mission which constantly motivated environment of medical profession/career in Africa has been and inspired us to make this concept a reality*. J instrumental to realise these achievements. The importance of these familial ties came home to all of us during the flower *The opinions contained herein do not necessarily presentation ceremony by the children of the alma mater of represent the views or policies of the Government of Japan. Hideyo Noguchi in Fukushima when Alice Greenwood (wife of Brian Greenwood) and Humphreys Were (husband of Kiyoshi Kurokawa MD is Chair of the Hideyo Noguchi Africa Miriam Were) hugged each other in tears congratulating each Prize Committee and Special Advisor to the Cabinet of the other’s enduring assistance over the years. Japanese Government. See www.kiyoshikurokawa.com11
Conclusion Tamaki Tsukada is Director of the Hideyo Noguchi Africa Prize The prize is a unique call to marshal the multitude of Unit, Cabinet Office (currently Director of Economic Security activities on research and service delivery in the field of Division, Ministry of Foreign Affairs). health transpiring on the African continent – a continent most in need of resources and care but often marginalized and Eri Maeda is Officer of the Hideyo Noguchi Africa Prize Unit, neglected – and eventually to transform the way in which the Cabinet Office (currently South-East Asia Division, Ministry of international community addresses medical and health Foreign Affairs).
Global Forum Update on Research for Health Volume 5 51 48-52 Kurokawa:GF5 23/10/08 19:30 Page 52
Innovating for health and development
References
1. See acceptance speech by Brian Greenwood at the Presentation Ceremony, following for details: http://www.cao.go.jp/noguchisho/iinkai/iinmember- 28 May 2008 (http://www.cao.go.jp/noguchisho/jyusyousiki-sikisidai- e.html e/greenwood-e.pdf). The nationality of the members of the Sub-Committee for Medical 2. See acceptance speech by Miriam Were at the Presentation Ceremony, Research is as follows: 19 Japan, 1 France, 1 Mexico, 1 USA, 1 Ghana 28 May 2008 (http://www.cao.go.jp/noguchisho/jyusyousiki-sikisidai- and 1 Australia. See the following for details: e/were-e.pdf). http://www.cao.go.jp/noguchisho/iinkai/medicalresearch-e.html 3. See address by Junichiro Koizumi to the Nippon Keidanren (Confederation The nationality of the members of the Sub-Committee for Medical Services of Japanese Business), 4 July 2007 is as follows: 3 Japan, 7 African (Mali, Nigeria, Gambia, South Africa, (http://www.cao.go.jp/noguchisho/bokin/aisatsu-e.pdf). Côte d’Ivoire, Zambia and Mozambique), 1 Mexico and 1 USA. See the 4. Noguchi’s major research achievements could be summarized as follows: following for details: 1. Discovery of Treponema pallidum, the causative agent of syphilis, in http://www.cao.go.jp/noguchisho/iinkai/medicalservice-e.html the brains of progressive paralysis patients (1913). 7. See for example the following statements and press releases: 2. Success in growing pure culture of Syphilis spirochete (1911), WHO: http://www.who.int/mediacentre/news/releases/2008/pr10/en/ however, no one has succeeded ever since in the replication of pure World Bank: http://web.worldbank.org/WBSITE/EXTERNAL/ culture of Syphilis spirochete. NEWS/0,,contentMDK:21701357~pagePK:34370~piPK:34424~theSit 3. Proves that both Oroya fever and Verruga peruana are caused by a ePK:4607,00.html single pathogen Bartonella bacilliformis by verifying that Bartonella Rockefeller University: http://newswire.rockefeller.edu/ bacilliformis invades red blood cells in both cases (1926). ?page=engine&id=736 4. Observation of Leptospira icteroides from patients of yellow fever Gates Foundation: (1919). (Leptospira, which was then identified as the cause of yellow http://65.117.201.112/GlobalHealth/Announcements/Announce- fever by Noguchi, was later disproved and proved to be in fact the 080326.htm spirochete of Weil’s disease. His name is remembered in the binomial 8. Professor Were serves as a Chairman, International Board of Directors of leptospira noguchi in the classification of spirochetes.) the African Medical and Research, Foundation, AMREF from February The number of research papers written by him reached almost 200 and 2003 to date (www.amref.org). various kinds of infectious diseases came under the scope of his interest, 9. Professor Were was Founding Chairperson up to 2001 and is a Member of varying from study of pathogens and immunology to development of the Board of Trustees of the UZIMA Foundation to date. The Foundation is vaccine and experimental technique. Noguchi was three times nominated a charitable trust registered in Kenya (http://uzimafoundation.org/main/). as a Nobel-Prize candidate in the period 1914–1920. 10. See for example the following report by the G8 health experts group: 5. The Noguchi Memorial Institute for Medical Research was established in http://www.g8summit.go.jp/doc/pdf/0708_09_en.pdf 1979 and named after Hideyo Noguchi who died from yellow fever in 11. See following commentaries and reports by the author Kiyoshi Kurokawa: 1928, the very same disease he was researching into http://www.bdafrica.com/index.php?option=com_content&task=view&id= (http://www.noguchimedres.org/). 1726&Itemid=5821 6. The nationality of the members of the Hideyo Noguchi Africa Prize http://www.kiyoshikurokawa.com/en/2008/04/announcement-of.html Committee is as follows: 8 Japan, 1 UK, 1 USA and 1 Senegal. See the http://www.kiyoshikurokawa.com/en/2008/05/hideyo-noguchi.html
52 Global Forum Update on Research for Health Volume 5 54-57 DePablo:GF5 23/10/08 09:19 Page 54
Innovating for health and development
Health research and innovation: recent Spanish policies
Article by Flora de Pablo (pictured), Director-General, Instituto de Salud Carlos III, University of Salamanca, Spain with Isabel Noguer
nnovation is a complex concept referring to the creation of provides modern regulation for the most advanced tools something new, normally through study and in biomedicine, i.e. human stem cell and embryonic Iexperimentation. In the context of public health, tissue use, genetic analysis, biobanks, etc. The Act also innovation usually results from research and may include addresses the recognition of health research as a career new medicines, medical devices, diagnostic methods, clinical for health professionals and provides incentives for practices or means of health care delivery1. pursuing it. This new law was fostered by the Ministry of Economic development is associated with a progressive Health and Consumer Affairs and many of its aspects will increase and improvement in the production of goods and be implemented by the Instituto de Salud Carlos III services, however, social development is associated with the (ISCIII). level of cohesion and distribution of wealth2. The Index of The Research and Development and Innovation (R&D&I) Human Development is an approximation to the degree of 2008–11 National Plan, including all areas of public social development, and is a weighted measure of the GDP central government funded research, came into effect in per capita, life expectancy and literacy level3. In this context, September 2007. The three guiding principles of this the Millennium Development Goals have galvanized plan for scientific and technological policy in Spain are: i) unprecedented efforts to meet the needs of the world’s to serve the citizens, increasing social well-being and poorest and range from halving extreme poverty to halting the sustainable development with complete and equal spread of HIV/AIDS and providing universal primary incorporation of women; ii) to contribute to improving education, all by the target date of 2015. These estimates competitiveness in the private business sector; iii) to make evident a tendency towards the globalization of health recognize and promote R&D as an essential element for problems4, sharing risks, disability and moral consequences, the generation of new knowledge. The health component all of which require uniting efforts to combat these threats. pursues the following goals: 1) to generate knowledge in Within the broad context of health and innovation and its order to improve health; 2) to foster innovation; and 3) outlook in the context of world health we will briefly comment technology transfer and translational research “from the on the recent advances in defining objectives and policy bench to the bed side”. The budget allocated to this instruments in research and development in health-related initiative has greatly increased and new initiatives have areas in Spain, and some of the challenges still facing us. been set up such as research networks, training and technology transfer. Main lines of research include: 1) The Spanish framework of research, cellular and molecular technologies; 2) translational development and innovation research; 3) public health, environment and occupational The general aim of biomedical research is still the prevention, health; 4) pharmaceutical research; and 5) scientific and improvement or cure of human diseases. Spain has one of technical research. the best national health systems in the world; it provides The recently created Ministry of Science and Innovation essentially free medical and hospital health care coverage to (April 2008) will manage the majority of central all residents of Spain, including immigrants, as well as high government funds earmarked for R&D&I and will standards of diagnosis and treatment. Although biomedical cooperate with the 17 autonomous regions, each of research has increased significantly in Spain in the last which have independent budgets for health and R&D&I. decade, it is still not among the ten most productive countries in the EU, keeping in mind a number of indicators and According to the 2008 edition of Science, Technology and corrected for population. We have, therefore, developed a Innovation in Europe published by EUROSTAT, analysing the new framework to try to close this gap, based on: data of 2006, Spain spent 1.16% (6546 million euros) of its The Biomedical Research Act (of July 2007), which GDP in R&D, whereas the EU27 devoted 1.84% of their GDP
54 Global Forum Update on Research for Health Volume 5 54-57 DePablo:GF5 22/10/08 14:02 Page 55
Innovating for health and development
(210 000 million euros). The range is broad among different Rank Disease or injury % of total deaths
countries, with Sweden and Finland reaching 3.82% and 1 Ischaemic heart disease 13.4 3.45% respectively, whereas Romania, Bulgaria and 2 Cerebrovascular disease 10.6 Slovenia do not reach 0.5%. With a rather limited 3 HIV/AIDS 8.9 4 Chronic obstructive pulmonary disease 7.8 investment, however, Spanish scientists have markedly 5 Lower respiratory infections 3.5 increased the number of publications included in 6 Trachea, bronchus, lung cancers 3.1 international databases (Web of Science): they represented 7 Diabetes mellitus 3.0 8 Road traffic accidents 2.9 1.9% of the world’s total in 1999, and 3.1% in 2006. This 9 Perinatal condition 2.2 places Spain in tenth position in the world based on number 10 Stomach cancer 1.9 of articles, but in position 36 based on citations per document. More than 50% of these publications in the last Table 1: Ten leading causes of death, 2030 decade correspond to biomedical disciplines and health sciences. Rank Diseases Science moves fast in a global world context and 1 HIV/AIDS continuous support is required to obtain valuable results. We 2 Unipolar depressive disorders still face many challenges and pending tasks in biomedical 3 Ischaemic heart disease research that need to be tackled: 4 Road traffic accidents 5 Perinatal conditions The modern hospital where clinical care, research and 6 Cerebrovascular disease teaching are intrinsic synergistic daily activities is not 7 Chronic obstructive pulmonary disease widespread in the country, although a group of excellent 8 Lower respiratory infections 9 Hearing loss, adult onset centres have, or soon will have, achieved accreditation 10 Cataracts as “Institutes of Health Research”, recognizing their qualification at the highest standards level. Table 2: Estimated leading causes of DALYs in 2030 The transfer of knowledge to the productive system is very slow. We have to promote and facilitate the infectious diseases will decrease while that caused by registration of patents and the creation of “spin off” noncommunicable diseases will rise. Ischaemic heart technologically based companies to levels comparable to disease and cerebrovascular disease will be the two leading those of countries in our economic sphere. For that to causes of mortality in the world (see Table 1). happen, the main task is to build trust among public Although deaths due to HIV/AIDS are still on the rise , they and private partners for fruitful collaborations. will be overtaken by deaths due to the consumption of Participation in the most innovative EU programmes, as tobacco. Vascular diseases are the first cause of mortality in well as in the Seventh European Framework Programme all regions, with major differences based on the classification (7FP) has to increase. In this context the Spanish of countries according to their income. In general, these government has launched EUROINGENIO 2010 in order forecasts place the world on an equal footing with regard to to increase Spanish participation and funding from the the definition of research priorities and the benefits of whole of health related programmes and tools offered by possible results. the 7FP. Spain is one of the most important contributors The three leading causes of Disability Adjusted Life Years to European Development Clinical Trials Partnerships (DALYs) are projected to be HIV/AIDS, unipolar depressive (EDCTP) or Ambient Assisted Living (AAL), both ruled by disorders and ischaemic heart disease. In this case, there are article 169 of the European Union Treaty. also significant differences based on the level of income of countries (see Table 2). In summary, we are beginning a most exciting time for Infectious diseases have not yet been overcome. In this biomedical research growth in quality and impact in context, aside from the potential benefits of a global strategy innovation in Spain. The target of the new Ministry of for more efficient development cooperation, synergy and Science and Innovation is to make Spain one of the world’s wealth generation, greater investment in health is needed6. ten most productive countries in the field of science, On the other hand, forecasts for HIV/AIDS growth create new technology and innovation by 2015. We already have the challenges for cooperation and R&D&I policies. This human potential, we just need to be successful in the epidemic, as well as other infectious diseases, on account of management of economical resources, and to keep their relationships with the adoption of behaviour patterns, increasing these resources with public and, in higher offers areas for cross research with chronic diseases, so very proportion than now, private participation. widespread in developed countries. Strategies like “Multiple Health Behaviour”7 could benefit developing countries in The Spanish contribution to some world their fight against HIV. Evidence-based medicine and rational health challenges use of antibiotics still suffer from large gaps in their A recent study on Global Burden of Disease (GBD) application, extension and potential benefits both in projections from 2002 to 20305 predicts significant changes developing and developed countries8, 9, 10. with regard to mortality and disabilty in the world. Life As for future threats to health, Spain is contributing in a expectancy in all continents will increase, mortality due to variety of ways. The National Plan for R&D&I 2008–2011,
Global Forum Update on Research for Health Volume 5 55 54-57 DePablo:GF5 22/10/08 14:02 Page 56
Innovating for health and development
prioritizes translational research in those diseases that create Key messages the highest mortality and burden of disease in the world. Public health, environmental health and occupational health Global burden of disease makes evident a tendency are common to the entire set of prioritized diseases. towards the globalization of health problems, International cooperation is present in the National Plan sharing risks, disability and moral consequences, and other solidarity-based government initiatives. The all of which require uniting efforts to combat Iberoamerican Program for Science and Technology (CYTEC) these threats. endowed with US$ 6 million (70% donated by Spain) Spain is beginning a most exciting time for strengthens all areas of knowledge and technology, financing biomedical research growth in quality and impact in projects, research networks or technological innovation innovation. The target of the new Ministry of Science consortia. The Interuniversity Cooperation Program with and Innovation is to make Spain one of the world’s Iberoamerican and Mediterranean countries was endowed ten most productive countries in the field of science, with 21.5 million euros in 2008. technology and innovation by 2015. We already have Within the framework of the World AIDS Conference for the human potential; we just need to be successful 2008, the Spanish government has just announced a in the management of economical resources, and to contribution of 10.2 million euros to the UNAIDS Programme keep increasing these resources with public and, in giving priority to research on vaccines and microbiocides. As higher proportion than now, private participation. far as other infectious diseases are concerned, in 2008, New and innovative initiatives of public-private Spain contributed 16.3 million euros to the International partnership are underway, especially in vaccines. Union against Tuberculosis and 12.9 million euros to the fight The results of such programmes may create a against zoonosis in the Mediterranean. precedent for R&D&I at the service of the In the Iberoamerican context, the Spanish government neediest populations. supports the Pan American Health Organization’s programmes with a total of 14 million euros to fight the main health problems in Iberoamerica especially communicable 17 and the results of such programmes will create a precedent diseases. Lastly, the ISCIII contributes to the Tropical Diseases for R&D&I at the service of the neediest populations. Research Programme of the WHO and other multilateral partners, focused on research and development of Flora de Pablo is Director-General of the Instituto de Salud programmes to fight neglected diseases, as well as others Carlos III (National Health Institute Carlos III). An MD and PhD led by the WHO within the field of infectious and from the University of Salamanca, she worked at the National chronic diseases. Institutes of Health in Bethesda (USA) for nine years until 1991, The most important benefit of progress in understanding and in the California Institute of Technology in Pasadena (USA) in the human genome may be for common chronic diseases 1996. Until 2007 she was Professor at the Center for Biological such as cardiovascular disease, diabetes mellitus and cancer. Investigation (CSIC) in Madrid, where her group studied growth However the integration of such knowledge into clinical factors in embryonic development. practice is still in its early stages. Therefore many questions surround the current state of this translation. Some Isabel Noguer MD, MPH, PhD Isabel Noguer is currently working researchers have found gaps in knowledge about medical for the Instituto de Salud Carlos III, as a Deputy Director-General organization, clinical behaviour and practice, and patient of International Research Programmes, and mainly devoted to needs that should be addressed to translate scientific promoting the participation of the ISCIII and National Health advances of chronic diseases into practice11. It is estimated System centres in international research programmes, especially that it takes on average 17 years for proven medical advances 7FP of the EU. to be incorporated into common practice, with the exception She is an epidemiologist and public health expert. She worked of new technologies and pharmaceuticals12. for the Spanish Ministry of Health for 15 years in different fields, We have not found estimates applicable to developing particularly HIV/AIDS. She conducted a wide range of technical countries, including technologies that are already widespread and operational studies for international and multilateral agencies in the developed world. However, new and innovative (World Bank, PAHO, UNAIDS, WHO), has several international initiatives of public private partnership are underway13, 14, 15, 16, publications and led different European and international projects.
56 Global Forum Update on Research for Health Volume 5 54-57 DePablo:GF5 22/10/08 14:02 Page 57
Innovating for health and development
References
1. Report of the intergovernmental working group on public health, 9. Finch R. Innovation – drugs and diagnostics. Journal of Antimicrobial innovation and intellectual property. 61st World Health Assembly actions. Chemotherapy, 2007, 60 Suppl 1:i79-82. www.who.int/mediacentre/events/2008/wha61. Consulted on 30 July 10.Owen N, Glanz K, Sallis JF, Kelder SH. Evidence-based approaches to 2008. dissemination and diffusion of physical activity interventions. American 2. Accountability in poverty reduction strategies: the role of empowerment Journal of Preventative Medicine, 2006, 31(4 Suppl):S35-44. and participation. Social development papers. Participation and civil 11.Scheuner MT, Sieverding P, Shekelle PG. Delivery of genomic medicine for engagement. Paper 104, May 2007. common chronic adult diseases: a systematic review. Journal of the 3. United Nations Development Programme (UNDP). Human Development American Medical Association, 2008, 19;299:1320-34. Report 2006, UNDP 2007. http://www.undp.org.cn. Consulted on 1 12.Liang L. The gap between evidence and practice. Health Affairs August 2008 (Millwood), 2007, 26:w119-21. 4. Murray CJL, Lopez AD. Alternative projections of mortality and disability 13.Mahoney RT, Krattiger A, Clemens JD, Curtiss R 3rd. The introduction of by cause 1990–2020: global burden of disease study. Lancet, 1997 new vaccines into developing countries. IV: Global Access Strategies. 349:1498–1504. Vaccine 2007, 16;25:4003-11. 5. Mathers CD, Loncar D. Projections of global mortality and burden of 14.Graham WJ et al. Measuring maternal mortality: an overview of disease from 2002 to 2030. PLoS Medicine, 2006, 3(11):e442. doi:10. opportunities and options for developing countries. BMC Medicine, 2008, 1371/journal.pmed.0030442. 26;6:12. 6. Macroeconomics and health: investing in health for economic 15.Ryman TK, Dietz V, Cairns KL. Too little but not too late: results of a development. Report of the Commission on Macroeconomics and Health. literature review to improve routine immunization programs in developing World Health Organization, 20 December 2001. countries. BMC Health Services Research, 2008, Jun 21;8:134. 7. Prochaska JO. Multiple health behavior research represents the future of 16.Lawes CM, Vander Hoorn S, Rodgers A. Global burden of blood-pressure- preventive medicine. Preventative Medicine, 2008, 46:281-5. related disease, 2001. Lancet, 2008, 3;371:1513-8. 8. Howland RH. Limitations of evidence in the practice of evidence-based 17.Manzi F et al. From strategy development to routine implementation: the medicine. Journal of Psychosocical Nursing and Mental Health Services, cost of Intermittent Preventive Treatment in Infants for malaria control. 2007, 45:13-6. BMC Health Services Research, 2008;31;8(1):165.
Global Forum Update on Research for Health Volume 5 57 59-63 haverman:GF5 22/10/08 14:02 Page 59
Innovating for health and development
The changing landscape of research for health
Article by Kirsten Havemann, Senior Technical Adviser, Ministry of Foreign Affairs, Denmark
Introduction: policies for innovation – the Danish perspective and experiences
It is my pleasure to present the article, “The changing landscape of research for health” below, which describes more than 30 years of Danish experiences in funding research as part of development cooperation. The article demonstrates a deep commitment to the ultimate goal of equal partnership based on a new paradigm, through the process of research for health. The Danish Government is committed to ensuring that the support to research is demand driven and adheres to the Paris Declaration. It is also important to emphasize that the research results are an essential element of poverty reduction efforts. I find it important to stress that the developing countries together with their development partners will need to work together and broaden the scope of research to extend beyond academic institutions. In an environment of globalization, urbanization and rapid technological innovation there is an urgent need for innovation and rethinking of the role of research and the knowledge that it generates. In particular, it needs to become integrated as part of development co-operation. It is my hope that the article on the Danish perspectives and experiences can contribute to the rethinking and innovation needed in the area of research and health.
Ulla Tørnæs, Minister for Development, Ministry of Foreign Affairs, Denmark
here is a need to rethink the role of research in research. Thus, traditional biomedical models and systems of development assistance and move beyond health health research are giving way to a more holistic paradigm3 Tresearch to a new paradigm, called “research for based on equity and inclusion in order to impact and health”. The Danish Government considers research for improve global health. This new emphasis, along with greater health the tipping point in building good governance and focus on quality of the research processes, will require democratic processes that are important for health. It is major attention to capacity development, most notably through such progress that long-term change on indicators of for governments and civil society organizations in health and overall well-being can be accomplished. Health developing countries. indicators, in particular, have come increasingly into focus as Through case studies emerging from Denmark’s support of the world aims to achieve the Millennium Development Goals research cooperation, and from global experience, this article (MDGs) by 2015. However, it is also becoming evident that will demonstrate how traditional research can be capacity to undertake research is as important as the strengthened and complemented through the emerging research itself. Without a mass of qualified personnel able to paradigm and utilized in an effort to positively impact global think and act critically at all levels of the health system, core health and well-being. More specifically, the article indicators of maternal and infant mortality, nutrition, malaria progresses as follows: it details the requirements of the new and tuberculosis will not reach the targets set by the paradigm, and subsequently touches upon the road towards international community, especially in Africa1. new standards, attitudes and behaviours as well as tools and The Council on Research for Development (COHRED) has methods within the framework of research for health. It ends defined this new paradigm, research for health, as “the wider with key challenges and recommendations based on the range of activities and strategies that take health research one Danish experience. step further, and make it an essential input into both human and economic development”2. Research for health demands Shifting paradigm multidimensional knowledge which takes into account social, The World Health Organization states that three out of eight political, economic, ecological and environmental MDGs, eight of the 16 targets to achieve the MDGs and 18 determinants of health, while simultaneously redefining of the 48 indicators for success of the MDGs relate directly to “who” has the power to lead, fund, implement and use health4. Health is an important contributor not only to the
Global Forum Update on Research for Health Volume 5 59 59-63 haverman:GF5 22/10/08 14:02 Page 60
Innovating for health and development
MDGs, but is also the basis for effective social and economic relevant fields (for example: social, environmental, political, progress. In order to achieve the MDGs, a focus on better economic) and levels (for example: individuals, civil society, health for all – regardless of status – is very much needed. local communities, academia at national level) of society are In addition, research and the knowledge it generates is in considered in health research policies and practices. This is demand. The emerging research paradigm requires building further complicated by the changing burden of disease where a broad based public health and research system5. This noncommunicable diseases now have overtaken requirement demands a shift in the culture and practice of communicable diseases worldwide. These diseases are the health research to “reach beyond academic institutions and primary cause of death in the 21st century – and will laboratories”6 for providing a comprehensive evidence base demand a very different approach to knowledge. In addition, for rights-based approaches to health policy7 that will include other key challenges in bridging the know-do gap include the political and socioeconomic determinants that influence diversity of communication styles between the various actors, health and well-being8. Policy-makers, implementers of health the tendency to develop research in isolation, competing sector reforms, health promoters and researchers need to agendas, time conflicts, and a difference in the expand their understanding of what constitutes “legitimate” understanding of “new” and “relevant” knowledge and evidence in this new paradigm, research for health, with the research methods11. Approaching these challenges and aim of more positively impacting inequities, and for the creating appropriate research conditions will require the creation of conditions that create better research environments. establishment of new standards with a stronger focus Take for example the Danish funded ENRECA on capacity strengthening, collaboration, and the (Enhancement of Research Capacity in Developing creation/management of knowledge through networks Countries) which had the goals of enhancing local research and partnerships. capacity and partnership through cooperation on equal terms Effective application of research implies that Denmark and between Southern and Northern partners. ENRECA began our partner countries have the capacity to integrate new 15 years ago and spearheaded an increased focus on knowledge for policy-making and sustainable development. capacity building as a more integrated part of research Thus, capacity building (or strengthening) must be an projects. The researchers from the South who have integral part of research programmes in the Danish participated in the ENRECA programme have been able to development co-operation. share their knowledge with other local co-researchers, and Capacity strengthening is not only intended to provide they have often been called upon as advisers by local technical skills to our partner countries in the South. It authorities and by donor countries, such as Denmark. Within provides a learning environment where multiple actors and Denmark, ENRECA has been supportive in building a stakeholders can engage in a process of producing and network of researchers for health. These programmes were sharing knowledge from research which promotes social the basis for what is now the Danish Research Network for mobilization for accountability, inclusion, cohesion and International Health (DRNIH) (see Table 1). participation. In doing so, it strengthens the demand side of governance, giving an impetus to local knowledge What are the standards in the new research production, management, and partnership as well as for health paradigm? narrowing the know-do gap. It is important here to Central to the notion of Essential National Health Research differentiate between networks and partnership. Networks Systems (ENRH) is the reference to “creating the conditions exist as a “loose form of cooperation”, whereas partnerships for health”9 and therefore the conditions for research for are “highly structured forms of cooperation”12. Partnerships health. This not only implies that local communities, demand multisectoral actions and the setting of new sociologists, development practitioners, economists, urban standards on research for health which was stressed by the planners and public health specialists may inform the health Pearson Commission on International Development. agenda at the national level. It also increases the North-South and South-South research networks and responsibility of the policy-makers in ensuring that they have partnerships can serve mutual benefits when they promote the evidence needed to make appropriate policy and support equal participation of Southern partners. This recommendations for the health of their populations. This approach has been promoted through support to the Danish responsibility is amplified when considering civil society’s Research Network for International Health (DRNIH) with a increasing role in research and “evidence-based advocacy,” view to create synergy between research and policy13. In and the trends towards a rights-based perspective in addition, they contribute to the evidence base on which health internationally. informed action can be taken. While these types of networks In the sphere of health and development, the gap between and partnerships are not new in the research/policy those who “know” (research community), those who “rule” paradigm, Denmark has observed that the emerging (policy-makers) and those who “implement” (health paradigm is shifting away from the traditional definitions of a technicians) has often been cited as a reason for political “researcher” to include actors ranging from national failure and the rise of the global burden of disease. A growing governments and the private sector to institutions of higher body of literature refers to this as the “know-do” gap10. The education and civil society organizations. These actors are now trend towards research for health introduces more domains taking an active part in networking or partnerships around of knowledge into the landscape aiming to ensure that all research for health14.
60 Global Forum Update on Research for Health Volume 5 59-63 haverman:GF5 22/10/08 14:02 Page 61
Innovating for health and development
Global Forum for Health Research (1998-present)18 History Mission and objectives Activities • Established as an • Reduce inequities in health research and in the • Bring together influential stakeholders in health research for independent international distribution of health research expenditures for development to: foundation addressing health problems of the poor • Initiate research • Build networks • Correct the 10/90 gap through health research in: • Stimulate use of research findings • Biomedical and behavioural sciences • Health systems and health policy • The above is accomplished through: • Socioeconomic, sociopolitical and cultural • An annual conference dimensions of health • Other related forums • Disseminating up-to-date information about global research initiatives on the web
African Health Research Forum (AfHRF) (2002-present)19 History Mission and objectives Activities
• Emerged from • Ensure that Africa’s voice on health research is • Organizes regional health research forums to enhance communication consultation process within recognized. and collaborative efforts, and training for both researchers and community Africa on health research, members concluding limited research • Emphasizes the importance of ethical analysis in input from countries in research • Publishes Africa Health Research Review and sponsors the Africa Health Africa due to lack of Research Fellowship to train research leaders and managers conducive research environments and • Considers itself a “network of networks” (COHRED 2004) leadership to build stronger health research systems • In conjunction with WHO Regional Office for Africa and African Advisory (CCGHR 2006) Committee for Health Research and Development (AACHRD), provides technical support to African nations on developing their respective health research systems to meet local priorities (CCGHR 2006)
Danish Research Network for International Health (DRNIH) (1996-present) History Mission and objectives Activities • An amalgamation of • Strengthen dialogue and interaction between • Provides unique set-up for different actors to work hand-in-hand in ENRECA programmes with research and development assistance in defining needs for further research in the area of international health as emphasis on capacity- international health as a means of improving health well as consolidating new knowledge building in the South and in low-income societies, in line with the principles of the North Danish Development Assistance (DRNIH, 2007) • Funds projects in thematic areas such as vaccine development, nutrition, neglected tropical diseases, noncommunicable diseases, environmental • An informal network • Encourage collaborative approaches to research in health, sociocultural aspects of illness and medicine, the use of funded by Danida until interdisciplinary settings pharmaceuticals and drug resistance, capacity development for research November 2004. Thereafter and research networks a general assembly was • Generate new knowledge in areas that span held which changed the traditional disciplinary boundaries Project examples: course of the network, • Bandim Health Project in Guinea Bissau assessing the effect of vaccination making it a formalized • University of Copenhagen to work on skills development of Africa entity Universities • Tororo Community Health project in Uganda to focus on capacity • Members include: Danish enhancement. Together with district health teams are researching change research institutions, processes in health systems to improve intersectoral collaboration consultancy firms, NGOs, • Jointly with Danish Water Forum, supported Ghanaian partners in advisers and research conducting workshop on water, health and sanitation. Forum advocated for partner-institutions in low- new knowledge, exchange of international experiences, identifying income countries effective methods to improve conditions, and gathering financial support for relevant research. The forum used to identify specific research projects and proposals that could be undertaken through a consultative process with all stakeholders involved
The South Africa-Netherlands Research Program on Alternatives in Development (SANPAD) (1997-present)20 History Mission and objectives Activities
• A collaborative research • Promote dialogue between Dutch and South • Subsidize and foster research projects that are social development or programme between African researchers policy oriented through annual call for proposals South African and the Netherlands • Advance more conducive research environment, • Organize Research Capacity Initiative (RCI), an intensive research particularly in historically disadvantaged methodology course intended to enhance research capacity of communities, for quality research disadvantaged/inexperienced researchers
• Adheres to joint committee governance structure with North and South representation aiming to highlight policy relevance of research (Baud, 2002)
Table 1: Networking towards partnerships
Global Forum Update on Research for Health Volume 5 61 59-63 haverman:GF5 22/10/08 14:02 Page 62
Innovating for health and development
In considering the conditional and contractual aspects of start “at home” with recognition of the need to adapt to the partnerships, Maxwell and Riddell argue that actors in the new environment, as well as to develop our institutional current development environment have yet to reach true capacity. This was the first step in ensuring equity and equality partnerships, which requires more than information sharing in the health sector. and policy dialogue15. Characteristics of a true partnership include jointly agreed country programmes and multi-annual Which tools and methods are used for financial agreements. Using these guidelines, a recent research for health? collaboration between the Danish Water Forum and the Crucial to the process of innovation in research for health are DRNIH to support practitioners in Ghana around issues of the different types, methods and tools of research. Types of water, health and sanitation demonstrates an early stage of research are for example biomedical research, health policy such partnership (see Table 1). and systems research, social science and behavioural The growing international research for health landscape also research, operational research and participatory action boasts a range of networks that progressively show the research. While the spectrum of the research landscape varies emergence of true partnerships. Table 1 lists case examples, from the controlled clinical trials in the biomedical sphere to starting from the more global network, the Global Forum for the analysis of power in the participatory action research Health Research, the regional African Health Research Forum sphere, each of the two spectra has their own strengths and (AfHRF), the national DRNIH and lastly to an institutionalized weaknesses. While quantitative research often contributes to North and South linkage, the South Africa-Netherlands the understanding of the biological nature of diseases and Research Program on Alternatives in Development (SANPAD). assists in developing the products for treating ill health, In its trajectory to partnership, Denmark has been an active qualitative research adds to the understanding of the “how, participant in the international dialogue for developing global who, why, what when and where” of health. Qualitative research norms and has provided funding for specific research research also informs the products and interventions of health programmes. Furthermore, numerous thematic areas have systems and planning and provides the relevant knowledge of been addressed with Danish research funding (see Table 1). A scaling up efforts that have the greatest potential of benefiting conscious choice is thus made to ensure that the research communities. How different methods and tools are selected becomes demand driven, adheres to the Paris Declaration16, and merged will depend on the researchers and the relevant and focuses on the research results to be used and stakeholders involved, as well as the context in which research implemented as a contribution to poverty reduction. In this is being implemented. It is important to remember that while way the know-do gap that currently exists can be bridged. methods and tools are scientifically developed, the choice of which is needed must remain context-specific. What are the attitudes and behaviours needed in the research for health paradigm? Key challenges in research for health There is growing recognition globally that simply channelling The key challenges ahead for development research include the additional funds into traditional health-care services (such as growing impact of globalization, technological innovations and clinical medicine) and health research cannot be equated with urbanization, which will make it increasingly difficult to separate “good health” and “good research” particularly when research relevant for poverty reduction and research relevant for considering the rise of noncommunicable diseases. In order to technological advances. Furthermore, 42% of global spending truly impact the global burden of disease and reach the MDGs, on health research and development is made by the the vision for research for health must not be limited to the pharmaceutical sector. Adjusting research funding to the national research/policy regime. It needs to be expanded changing aid modalities means that networking and locally and globally in order to ensure that knowledge is shared partnerships in the future will be increasingly important. Having equally and capacity is enhanced in the research and policy effective and efficient research structures and systems built into regimes of countries which have limited resources to build up the local level planning systems, and having sufficient and and sustain their research communities. This does not imply qualified human resources to undertake research, add to the that the “North” defines its technical assistance in this regard challenges emerging in the research for health paradigm. This to funding a handful of doctoral candidates from the “South”. fact will not only impact the funding and financing of research Rather, research for health should be considered a learning but will also impact the priorities of research as adjustments are process for all partners involved, and this requires collaborative made to the contingencies of this new reality. While this process networking (horizontal South-South, vertical North-South and needs to be addressed in donor countries such as Denmark, South-North, as well as diagonal across sectors and levels) the importance of system strengthening and capacity building between partners, and a balancing of health care between of our partner countries and us cannot be overlooked. The long- micro (immediate) and macro (long-term) needs. It should be term aim is to ensure that qualified researchers will based on the principles of the Ottawa Charter17 and include contribute to the global knowledge base as well as be able to considerations beyond funding/financing. Understanding the develop their own countries. diversity of the landscape and considering issues related to sustainability, relevancy and power relationships are a few of Conclusion the requirements of this attitude shift. One important lesson Denmark’s lessons learnt from funding, implementing and learnt for Denmark has been that the shift in attitude had to supporting research, have been two-fold. First of all, capacity
62 Global Forum Update on Research for Health Volume 5 59-63 haverman:GF5 23/10/08 10:04 Page 63
Innovating for health and development
building must be an inherent part of the development and and the creation of effective research environments. research process. This does not simply mean funding PhD research students from the South to study in the Northern The Global Ministerial Forum for Research for Health in countries. Capacity building implies that both the South and Bamako, November 2008 will be an opportunity to discuss the North are engaged in a “learning process.” This means common challenges and to develop genuine partnerships on recognizing that the Northern countries have just as much to research for better health. J learn as their Southern partners about process and collaboration. Investing more into higher education Kirsten Havemann is a social and public health specialist with collaboration, which is fundamental for having qualified interest and expertise in health and social sector analysis, design and researchers in the first place, could be one option to be systems development. She has extensive knowledge and skills in considered. Secondly, that establishing networks is only the participatory and action-oriented research and operations. After her beginning and not an end goal. The ultimate goal in the process more than 20 years of field experience in Africa and Asia where she of research for health is equal partnership. This process is ever- held substantive posts, such as Senior Adviser for the Danish advancing and “mistakes” become stepping stones and Government, she moved to the World Bank’s Social Development opportunities for consultation and reflection in order to change Department working on social accountability, the WHO as standards, behaviours and/or tools necessary for good research. governance research officer and now for the Danish Government as Drawing from these points on the Danish experiences and Senior Adviser for Health. the core messages of the new paradigm, three important future steps include: Ulla Tørnæs has been Minister for Development Cooperation in Consensus on redefinitions and rearrangements of who is Denmark’s Ministry of Foreign Affairs since February 2005. involved in research, how it is conducted and a common Following studies at the University of Chambéry, France (1984–85), understanding of what principles laid the foundation of the Copenhagen Business School (1985–88) and Copenhagen research within each local and national setting for the University (from 1991), she worked in the Secretariat of the Liberal evolution of a new landscape of research for health. Parliamentary Party from 1986 to 1994. She sat on the Party Risk taking and synergy building between development Committee and the Executive Body of the Liberal Party in Østre partners such as funders, researchers and implementers of Storkreds (a Copenhagen constituency) from 1988 to 1991. health leading to good governance and based on ideals of Following several roles within the Liberal Party, Ulla Tørnæs partnership. became its Political Spokesman in the Folketing (Danish Parliament) Global health research priority setting to support the in 1998. She was Minister of Education from November 2001 to strengthening of essential national health research systems February 2005.
References
1. United Nations Development Program. Millennium Development Goals Paradigm. The European Journal of Public Health, 2008, 18 (3): 217-219. Report. New York, UNDP, 2006. 10. World Health Organization. “Bridging the Know-Do Gap”. Meeting on 2. Council on Health Research for Development (COHRED). Supporting Health Knowledge Translation in Global Health. Geneva, WHO, 2006. Research Systems Development in Latin America, Results of Latin America 11. Academy for Educational Development (AED) Center for Health Regional Think Tank. Presented at Latin America Regional Think Tank, Communication. Bridging the Gap between Public Health Research and Antigua, August 2006, Record Paper 6. (Quoting p. 4.) Practice: Lessons from the Field. Washington, D.C., AED, 2005. 3. A paradigm is what members of a scientific community, and they alone, 12. Baud, I. North-South Partnerships in Development Research: An share. See Kuhn, T.S. The Essential Tension. Chicago, University of Chicago Institutional Approach. International Journal of Technology Management and Press, 1977. A paradigm shift is therefore a major change in thinking Sustainable Development, 2002, 1 (3): 153-170. (Quoting pp. 154-155) towards a new set of standards and behaviors for which practioners may be 13. Tostensen, A. Bridging Research and Development Assistance: A Review of accountable. The degree of success can be measured by the ability of these Danish Research Networks. Bergen, Chr.Michelsen Institute, 2006/7. paradigms to solve increasingly difficult questions. See Barker, J.A. 14. Baud, I. North-South Partnerships in Development Research: An Paradigms: The Business of Discovering the Future. In: Pierce, J.L. & Institutional Approach. International Journal of Technology Management Newstrom, J.W., eds. The Manager’s Bookshelf. A Mosaic of Contemporary and Sustainable Development, 2002, 1 (3): 153-170. Views. New York, HarperCollins College, 1996. 15. Maxwell, S. & Riddell, R. Conditionality or Contract: Perspectives on 4. World Health Organization. Health in the Millennium Development Goals. Partnership for Development. Journal of International Development, 1998, Online: http://www.who.int/mdg/goals/en/ (date accessed 31 July 2008). 10 (2): 257-268. 5. Hunter, D.J. Health Needs More Than Health Care: The Need for a New 16. Organization for Economic Co-operation and Development (OECD). The Paradigm. The European Journal of Public Health, 2008, 18 (3): 217-219. Paris Declaration. Online: http://www.oecd.org/document/18/0,2340, 6. World Health Organization. World Report on Knowledge for Better Health: en_2649_3236398_35401554_1_1_1_1,00.html (date accessed 31 July Strengthening Health Systems. Geneva, WHO, 2004. pp. XVI. 2008). 7. Johnstone, P. Evidence for Evidence-Based Policy. Presented at 6th 17. This Charter supports the building of healthy public policies, creating International Cochrane Colloquium, Baltimore, Maryland., 1998. supportive environments, strengthening community action, developing 8. Bryant, T. Role of Knowledge in Public Health and Health Promotion Policy personal skills and re-orienting health services. Change. International Health Promotion, 2002, 17 (1): 89-98. Citing: 18. Global Forum for Health Research. Online: http://globalforumhealth.org Tesh, S. Hidden Arguments: Political Ideology and Disease Prevention Policy. (date accessed 26 July 2008). New Brunswick, NJ, Rutgers University Press, 1990Raphael, D. The 19. African Health Research Forum. Online: http://www.afhrf.org (date accessed Question of Evidence in Health Promotion. Health Promotion International, 26 July 2008). 2000, 15 (4): 355-367. 20. South Africa-Netherlands Research Program on Alternatives in 9. Hunter, D.J. Health Needs More Than Health Care: The Need for a New Development. Online: www.sanpad.org.za (date accessed 26 July 2008).
Global Forum Update on Research for Health Volume 5 63 66-69 Norway Minister:GF5 23/10/08 09:22 Page 66
Innovating for health and development
Global health and the foreign policy agenda
Article by Jonas Gahr Støre, Minister of Foreign Affairs, Norway
his article is based on the transcript of a speech mothers and fathers? delivered at the State of the Planet Conference on Then we went on to Angola, which had a seat on the board T27 March 2008, held by the Earth Institute at Columbia of WHO and was going to cast its vote. There we met University in New York, United States.1 with the Health Minister, and I discovered that the Minister was not in the Angolan cabinet, not in the inner circle This afternoon I would like to share with you what I would of government. call a personal journey, which has meant a great deal to me I then developed my own thesis that there is a negative and helped to shape some of the key ideas that we are correlation between the weight of the health challenge and working on now. the influence of the health minister. You might ask why a foreign minister has been invited here In my country, as in other developed countries with good to talk about health. Surely we have health ministers for that. health status, you win or lose an election because of health I will try to answer this question. policy. Whereas in the poorest countries, health is all too I was brought into the field of global health in 1997, when often simply given low priority. Dr Brundtland, the outgoing Norwegian Prime Minister, When Dr Brundtland was elected and took up her post in decided to run for Director-General of the World Health Geneva, one of the first things she said was that our main Organization. And I was invited in on her team. challenge is not to deal with health ministers – because they In the autumn of 1997, we campaigned in Africa. During know the problems. It is to try to get through to presidents, these travels with Dr Brundtland, I saw things that I had prime ministers and finance ministers, and give them this never really seen before. I saw that health issues had simple message: you too are health ministers. important implications extending far beyond the health sector. We need to find new ways of portraying health And how incredibly important human health, national health expenditures as more than costs, but also as an investment. and global health were to so many of the dimensions And we need to develop a new language and a new mindset of society. that will enable us to reach and communicate with the real I remember when we arrived in Botswana, a country that circles of power. Health professionals are too focused on their Norway has worked closely with for many years. We had just own field and have a limited ability to communicate with concluded our development cooperation with Botswana people in other sectors. because the country had made so much progress. Life This is really an extension of the conclusion of the expectancy had risen to 70, which is quite sensational in an Brundtland report, Our Common Future. We need to get to African context. the core of the economic dimension and speak a language But while we were there, researchers from the University of that people with power really understand. Harare published new figures that readjusted average life We need to establish a link between investing in health and expectancy in Botswana to 35 years. This was in 1997, improving the health status of the population – of the when the first AIDS figures really started to make an impact. productive fabric of society. We need to convince political And we could literally see and feel the consequences for the leaders that if we do these things, there will be more to share. population, for the integrity of the state. What would happen If they fail they will be wasting their opportunity as to the teachers, the police, the army, the civil servants, the political leaders. This is in fact what brought us to Jeffrey Sachs. We wanted someone who could convene some of the world’s leading We need to establish a link between investing in health economists with experience in these areas to work on and improving the health status of the population – of documenting what everybody could see – that if you are poor, the productive fabric of society. We need to convince you are more likely to have poor health. But it is less well political leaders that if we do these things, there will be documented that poor health in itself breeds poverty, creating more to share a vicious spiral. So we were convinced that we had to get this down on paper and document it and its implications.
66 Global Forum Update on Research for Health Volume 5 66-69 Norway Minister:GF5 23/10/08 09:22 Page 67
Innovating for health and development
Jeffrey Sachs’ commission presented the report at the end and UNICEF in the 1990s had brought coverage up to 80%. of the year 2000. I am certain that the process we launched A very high level. But since 1990, there has been stagnation then contributed to the methodology used in devising the and almost status quo. How do we mobilize a new campaign Millennium Development Goals (MDGs). The study for vaccines? How do we create new markets for malaria documented how appropriate, timely action can save 8 to 10 medicine? million lives a year. That in itself would be a real When the first Stoltenberg government took office in March humanitarian gain. But such action would also help to 2000, the Prime Minister decided that Norway would take increase life spans, productivity and economic well-being, on responsibility for providing vaccines for every child in the especially of the poor. world. So this was a “Norway–Gates coalition” in a way. But the study also documented that this will not happen Gates in the private sector and Norway in the public sector by itself. There has been a prevailing idea that as long as – investing in a specific alliance: GAVI, the Global Alliance for countries continue to develop, health will simply follow. This Vaccines and Immunization. is not the case. I remember discussing this with Prime Minister So there is a need to scale up the spending on health, by Stoltenberg, and how easy it was to bring him on board – for the poor countries themselves, and by better targeting three reasons. First, because he was a father and he had had development assistance for health. The report is particularly his children vaccinated. It is something you do for free valuable because it demonstrated how affordable this in Norway. You don’t have to think about paying for it, operation could be. It documented the difference it would you take it for granted. Because it is part of what the welfare make if rich countries devoted one tenth or 1% of their gross state offers. Secondly, he is an economist, and he saw that national income to health-targeted development assistance vaccination is by far the most cost-effective intervention you for specific interventions. can make. You can prevent disease with two shots at a very That would be an investment that would be repaid many early stage in life. And, finally, he was a politician. So he times and save millions of lives every year, and it would could bring this into the realm of political action. provide economic development and global security. I believe that what happened around 2000, with the There were many who criticized this approach and argued launching of the MDGs, was a response to the heightened that there are too many vertical interventions, such as bed awareness of all politicians, not just health ministers, of the nets and vaccines. And that the approach to health care link between health and development. should be much more horizontal. I would like to touch briefly on a few of the changes that But these approaches can be combined. Unless we have have taken place since then. Ten years ago, world a massive focus on what is literally on our own doorstep, we investments in health aid totalled US$ 4 billion a year. This can forget about the horizontal process, and about making has more than tripled to US$ 15 billion today. tangible differences in health. Around 2000 AIDS treatment was out of reach, and when Another conclusion of the report was the importance of drugs came on the market, it was at a cost of US$ 40–100 partnership – which I believe is really a key lesson. a day. A cost that neither poor people nor donors Partnership is a simple word, but a very complex thing to could afford. Now it costs 4 cents a day to treat AIDS, and practise. The Sachs Commission concluded that more more than 2 million people are receiving treatment. That is development assistance should be targeted towards health, far too few, but it is a beginning. while poor countries should allocate more money for health Malaria was and is the top priority of every African health over their budgets. minister. Today, tens of millions of bed nets have been It is only if this works together that it will make a distributed and new drugs have been made available on a difference. Partnerships between rich and poor, partnerships broad scale. Where the majority of children sleep under nets, between the private and the public sectors. malaria wards stay empty. Some said that this was going to be a great challenge for As I said, there was great frustration about vaccination, the UN. Why are we inviting the private sector in? Isn’t it the with coverage stagnating and new vaccines not being UN that has the mandate to do these kinds of things? introduced. This situation has now been turned around, and You have to remember that the idea of public-private for example measles mortality has dropped by 90% in Africa. partnerships still was quite new as it first emerged as an idea Additional hundreds of millions of children are being in the 1990s. We felt that in the WHO, working with Dr vaccinated. The GAVI Alliance has saved between two and Brundtland, the way she reached out to the private sector, three million children from dying every year since it began was being criticized by those who said “it says in our its work. Tobacco was another serious world health problem. mandate that we are the leaders in health”. Around 2000, it was predicted that tobacco would be the But let’s not forget that it was Kofi Annan himself who leading cause of death by 2020. That might still happen, but invited other sectors to join the global fund to fight AIDS, TB it is likely – thanks to the framework convention on tobacco and malaria. To mobilize US$ 10 billion every year to make control – that this prediction will not come true. a difference. So if the UN had not embarked on that course, The process of developing the convention is quite another I think the idea would have been marginalized. story, and I will not spend time on it here. But work on the There were a number of other areas that started to attract convention started two months after Dr Brundtland took attention. Vaccines for example. A major effort by the WHO office, and was concluded two months before she left the
Global Forum Update on Research for Health Volume 5 67 66-69 Norway Minister:GF5 23/10/08 09:22 Page 68
Innovating for health and development
WHO. It is modelled on the Kyoto Protocol. So it is another health implications. Are health concerns being given the example of lessons learned across sectors. necessary priority? Are we applying the foreign policy tools at These approaches gave rise to an ethics of politics. It is our disposal to get to grips with them? about engagement, it is about the political will to seize Against the backdrop of an evolving health and opportunities, it is about partnership, and it is about development agenda, I believe we have something new burden sharing. And I believe that these approaches can be emerging here. At the UN General Assembly last September, used to combat climate change, to promote health, not only we were 30 foreign ministers who came together to discuss in a number of development areas, but also in dealing with these fields. international conflict. And it coincides closely with what we In order for us to make these ideas workable, we need to are trying to achieve in Norwegian foreign policy. continue take a broader view and work out new perspectives. In 2005, Jens Stoltenberg returned as Prime Minister and We still take a very traditional approach in the debate on I became his Foreign Minister. And we scaled up our national and global health security. We discuss our own approach to health. Stoltenberg took the vaccine initiative one country’s perspective – with the main focus on protecting our step further, and Norway pledged to make a real difference, own population. That is our responsibility as governments. not only in vaccinating every child, but also in fulfilling MDGs Even the threats of pandemic flu can be seen in this light. 4 and 5 – reducing child and maternal mortality. We buy drugs for our populations. But as we all know, viruses And we are now investing 100 million dollars a year and bacteria know no borders. So if we include the specifically for interventions in this area, not alone, but in perspective of interdependence and shared vulnerability partnership with the private sector and with specific across nations and regions, we need to add a broader governments. Having worked with and been inspired by my dimension to this debate. More than anything, it calls countryman Jan Egeland and his work in the UN and for solutions in which the benefits of preparedness are elsewhere, and with Jeffrey Sachs, I saw that as Foreign equitably distributed. Minister, I could deal with health differently than has been the Because my insecurity does not depend on the Norwegian case in the past. health system, it depends on systems far beyond Norway. All I realized that health was not just the province of health of this has to influence our development policy, our UN policy ministers, finance ministers, presidents, prime ministers, but and also our Norwegian foreign policy. also of foreign ministers. Because health disasters are also a As a final observation, one important insight of this group cause of conflict. They are a cause of environmental of experts is that health security cannot be interpreted degradation and of collapsing and failing states. narrowly. What we need is an understanding of the We all know that threats to health do not respect national determinants of health. Poverty is of course intuitively borders. So this is clearly a challenge for foreign policy. We recognized as a core determinant even though we have failed know that developing countries carry the heaviest burden as to address it fully. regards disease, but have the lowest capacity for prevention, Two more direct determinants of health that are often treatment and control. So global health security is only as overlooked are trade and intellectual property rights. In many strong as the weakest link. countries, HIV and AIDS are overloading already weak health Are we prepared, as foreign ministers, to face a global systems and having impacts on capacity, preparedness, health crisis? Norway closed its border with Sweden for the human rights and movement across borders. This has foreign first time in modern history during the outbreak of mouth and policy implications. foot disease in 2000. And we were completely puzzled by the We also have to address how fragile states might collapse question “how do we reopen borders? When are you certain under what we call “the double burden of disease”. Poor that the epidemic is over and we can do so safely?” This is a countries struggling with the burden of infectious diseases are foreign policy issue. It is easy to deal with Sweden, our increasingly being burdened with non-infectious diseases – neighbour, in such cases. But there can be other settings which often cripple a poor health system. were this is more complicated. As foreign ministers, we need Another dimension is that rich countries are recruiting to review government structures and systems and adapt them health workers from poor countries to take care of an ageing to better respond to global interdependence. population. This gives rise to a number of very serious, ethical When I became Foreign Minister, I called six of my and economic issues. These, too, must be brought into the colleagues in different corners of the world and asked them to foreign policy agenda. join me in an informal setting to address this issue. And to try I would like to conclude by mentioning a concrete example to highlight what it means to be a foreign minister in an era that I never thought I would deal with as foreign minister – where health problems are global. I approached France, the issue of virus sharing. Thailand, Indonesia, South Africa, Senegal and Brazil. And Indonesia has been hard hit by avian influenza. Bird flu they all responded favourably. We met at the UN in 2006 and is widely considered to be one of the most likely sources of appointed experts to work out an agenda, identify the the next global pandemic. And global preparedness relies problems and to advise us on a plan of action. We came heavily on monitoring the outbreaks, particularly those together in Oslo in March last year to adopt the Oslo Agenda, which affect humans. A year ago, Indonesia felt that it was the Oslo Declaration and a plan of action. We singled out ten being short-changed by the international community and foreign policy areas where we need to take a look at the asked bluntly why it should contribute to the production of
68 Global Forum Update on Research for Health Volume 5 66-69 Norway Minister:GF5 24/10/08 09:18 Page 69
Innovating for health and development
a vaccine it will not be able to afford and would be unlikely What this all adds up to is that this is a matter of political to ever have access to by sharing its virus – good question. will, of knowledge and of partnership. I disagree with Indonesia’s decision to stop sharing the Thank you for accompanying me on this personal virus from local outbreaks, because I believe that Indonesia journey. J and all other countries should contribute fully to global preparedness. But I also understand and agree that we must Jonas Gahr Støre is Minister for Foreign Affairs of Norway. He make sure that the benefits of preparedness are shared has a degree in political science from the Institut d’Etudes equitably and sustainably. Politiques de Paris, and has held a teaching position at Harvard One of the most shocking observations I was met with Law School. His first introduction into public life was as Special when I got to the WHO was that there is no opportunity to Advisor to the Prime Minister, followed by a three-year tenure as prepare malaria drugs, because where there is no money Director-General of the Prime Minister’s International Department. there is no market for these drugs. But for a disease that In 1998, Mr. Støre was appointed Ambassador of Norway’s strikes somewhere between a half and one billion people Permanent Mission at the United Nations in Geneva, but served each year, how can we say there is no market? only briefly as he was asked by former Prime Minister of Norway And if we accept that there is no market for malaria and then Secretary-General of the World Health Organization, Gro medicine simply because people can’t afford to buy it, that is Harlem Brundtland, to become her Chief of Staff. also a market failure.
References
1. The sppech has been made public formerly at www.regieringen.no and as an audio file at http://www.earth.columbia.edu/sop2008/ index.php?id=agenda
Global Forum Update on Research for Health Volume 5 69 72-74 Block:GF5 22/10/08 14:33 Page 72
Innovating for health and development
“Policies for innovation”: evidence-based policy innovation – transforming constraints into opportunities Article by Miguel Angel González Block, Executive Director, Centre for Health Systems Research, National Institute of Public Health, Mexico
of medical care, growing competitiveness from international markets, and the growth of the informal sector. Innovative Man has created new worlds – of language, of music, of social protection models are thus being designed and poetry, of science; and the most important of these is the implemented to reduce catastrophic family health world of the moral demands, for equality, for freedom, and expenditure, channel national and state subsidies and to for helping the weak. encourage family prepaid contributions2. Mexico’s System of Social Protection in Health was thus KARL POPPER.1 established in 2003 through a Constitutional amendment with the aim of reaching universal coverage of pre-paid health care for 20103. Seguro Popular was established to implement ealth policy in developing countries is increasingly the programme through payments to state health authorities committed to the worlds of science and equity. based on strengthening infrastructure, meeting federal HEvidence-based policy-making can thus be conceived standards and promoting the voluntary and in most cases as an innovation process integrating, within politics, the contributory affiliation by families to the insurance scheme. values of healthy life, objective truth and fairness. Innovation Yet reaching this goal may not be easy, particularly in poor becomes particularly important to support the political states where the proportion of the uninsured is highest and processes of decentralization, poverty reduction and regional the health system capacity gap also the greatest. integration. Health metrics are increasingly focusing on Furthermore, health expenditure is currently being channelled inequities and therefore on the potential as well as on the through out-of-pocket private health care for about half of the urgency for improvement. Comparative sociology, economics total, involving families across the social spectrum. and health system sciences are responding through Adding to this complexity is the fact that 11.8 million innovative social and policy arrangements as well as through Mexicans work as migrant labour in the United States of improved evaluation methods. America, accounting for 10% of the population. They also This article presents case studies in innovation at the two leave behind close to 4 million relatives, and have 4 million health system poles of decentralization and regionalization. US-born children with them, for a total of close to 20 million Attention is given to the role of evidence-based financial of population that rely to different extents on institutions both protection policy implementation by local health authorities. sides of the border4. Up to one third of financing for private Two case studies are presented to illuminate evidence-based care in Mexico could be resourced from the remittances sent policy-making at the regional level: Salud Migrante, a pilot by migrants. These families face a complex scenario for health project to develop binational health insurance for Mexican insurance. They express health needs in both countries, they migrants in the United States, and the Mesoamerican Health face highly differentiated service and insurance demand and System, a multi-national effort to address disease control and supply factors across them, including insurmountable barriers health system strengthening. These examples suggest that for comprehensive health insurance in the United States. The research can be an invaluable tool to transform what question is whether Seguro Popular will be able to insure are political constraints for policy-making at local and health needs in Mexico and to reduce private expenditure. regional levels into opportunities to move towards new Another question is whether Seguro Popular can provide a organizational frontiers. backbone of services to support returning migrants and to provide health care for needs that cannot be insured abroad. Health system vulnerability Looking South, Mexico shares an ecology with its Central Middle-income countries, particularly in Latin America, are American neighbours and needs to address health issues finding it increasingly difficult to extend health care through such as malaria, dengue and HIV-AIDS from a regional traditional social security institutions due to increasing costs standpoint. Mexico also has an important number of
72 Global Forum Update on Research for Health Volume 5 72-74 Block:GF5 22/10/08 14:33 Page 73
Innovating for health and development
Guatemalan migrants and is a pass-through country for institutions or private providers, in spite the fact that they migrants to the United States. Mexico and Guatemala have operate with very different resource bases. This suggests the just established a Binational Health Commission, while importance that the socioeconomic context plays in Central American countries have kept a common health determining research utilization patterns and capacities. agenda for decades. Thanks to long-standing research on Much is being said about the importance of developing health and migration, Mexico is now leading a Global Fund knowledge brokers as a bridge between researchers and financed project to pilot strategies to promote migrant HIV- users. To put this idea to the test, the National Institute of AIDS prevention and promotion in border-crossing points Public Health (INSP) developed State Centers for Health throughout Central America and Mexico. More recently, Systems Development (CEDESS) as a franchise-like presidents of Central American countries plus Mexico and arrangement for operation by interested nongovernment Colombia agreed to develop the Mesoamerican Health organizations working in health systems. Agreements are System, an evidence-based policy development platform signed between INSP and the NGO, enabling them to offer, led by the National Institute of Public Health (INSP). adapt and execute existing training courses and applied research protocols with state health agencies. CEDESS also Strengthening local capacities and disseminate research results through executive summaries knowledge brokering and liaise INSP researchers with local projects and To address the need to strengthen research capacity at state development programmes. Importantly, CEDESS do their level in Mexico a number of research and policy institutions work as far as possible with local academic and consulting joined forces to establish the consortium Health Systems agencies, thus strengthening local capacity. Activities have Research for State Sector Development (INDESES). This included the evaluation of the state immunization effort is being supported through national and international programmes, support for the development of a range of funding and collaboration, including Mexico’s Science and model innovations in selected municipalities, and training in Technology Institute (CONACYT), the Canadian Health evidence-based health promotion. Services Research Foundation (CHSRF), IDRC and the Alliance for Health Policy and Systems Research. INDESES South-North collaboration for binational aimed to strengthen specially the demand of health systems health insurance innovations research by state policy-makers and managers through INSP established a collaboration between US and Mexico assessing and intervening along the four “A”s of research – health providers, authorities and academics to develop Salud acquisition, assessment, adaptation and application. Migrante, an evidence-based binational health insurance for INDESES developed a curriculum originally structured by migrants. Innovation design were based on evidence coming CHSRF’s EXTRA training programme, aiming to strengthen from a wide range of intersectoral issues: the effects of evidence-based policy-making through increasing capacity to remittances on private health spending in Mexico, utilize research5. The focus has been on multi-institutional catastrophic health spending in the US, lack of access to managerial teams to address their coordination issues health services due to distrust, forced repatriation of migrants through research-based interventions. Specific tools to to Mexico due to unmanageable health conditions, the strengthen the interface between researchers and users were political pressure for regularization of migrants in the US as also developed. Literature synthesis methods were developed well as willingness to pay studies for highlighting the on the basis of international experience focusing on potential of cross-border health services. interventions for vulnerable groups. On this basis a listening Innovation design focuses on integrating the private not- exercise was developed to identify policy-maker and for-profit health providers and insurance agencies in the US managerial concerns. CHSRF’s 1:3:25 executive summary with the public health system in Mexico, with the aim of format was also implemented to provide an effective means integrating as far as possible financing and referrals. A to divulge research results. coalition of partners has been established and pilots are Policy-makers and mangers were provided with a tool also being prepared across two US and two Mexican states. The developed initially by CHSRF’s to assess their capacity to Mexican federal government has made critical commitments utilize research and to plan strategies to strengthen it to support binational health insurance. On this basis, a accordingly6,7. Results of a first wave of application were package of essential primary care services is being designed collated to test the tool and to obtain a diagnosis of utilization for universal access by migrants in the United States, to be capacity at the aggregate level. Not surprisingly, results provided mostly by community health centres and insured demonstrated widely differing capacities and strengthening through non-profit health plans. A key provision is that needs according to level of development. Less evident were funding for services in the US should come from migrant findings suggesting that research acquisition is a higher contributions and other private or public sources. Migrants priority above analysis, adaptation and application. In richer will be supported to access Seguro Popular in their states states it was recommended to strengthen acquisition mainly particularly to access secondary care services and to insure through increasing the skill levels of mangers. In poorer their dependents’ integral care in Mexico. To this end, Seguro states preference was given to strengthening the importance Popular promotion and affiliation will be made available in accorded to research by top decision-makers. No major the United States through web-based facilities and with the differences were detected across the various public support of community agencies.
Global Forum Update on Research for Health Volume 5 73 72-74 Block:GF5 22/10/08 14:33 Page 74
Innovating for health and development
The main challenge of Salud Migrante includes organizing implement a range of programmes to strengthen health the insurance scheme in such a way that it gains the system capacity through applied research and training, thus migrants’ trust to cross the border for secondary care and to ensuring that the vertical programmes at the core of the reunite with a public service in Mexico that has not always Mesoamerican system lead to a diagonal effort widely responded to their needs. A key component to surmount this benefiting national health systems. barrier will be the design and implementation of Salud Migrante, an agency in Mexico capable of articulating health Lessons service providers and insurers within each country and across Middle-income countries in Latin America and other regions the border. have the capacity and indeed the imperative of promoting Research is being undertaken to develop the operational innovations for health systems integration through national- platforms required for the sound operation of Salud Migrante. local, South-South and South-North collaboration. These This involves a coalition of research and service provider efforts should be accompanied by North-South selective partners and is being led by INSP. This effort represents funding efforts and technology transfer to empower their a historic South-North collaboration in research and Southern partners with the capacity to develop large-scale, innovation. INSP is well prepared to assume this task given international projects based on their proven technical and its full accreditation with the Council on Education for Public political leadership. Health, the US body accrediting most schools of public health Research institutions can play a critical role to bridge across in the US. bureaucratic and international boundaries through mission- oriented research. Projects of sufficient scale and scope can South-South collaboration for regional lead innovation design, enable the incubation of new integration institutional arrangements and undertake piloting and INSP is collaborating with efforts to establish the evaluation. Research institutions in middle-income countries Mesoamerican Health System, an initiative recently have in many cases developed sufficient networking, trust announced by the presidents of Central America, Colombia and accreditation by partners North and South to support this and Mexico as part of their ongoing regional integration. With important role for innovation. the international funding from partner countries, foundation Innovations should also be supported through knowledge and bilateral agencies, such a system aims to eradicate brokering and research capacity building efforts. Research malaria and undernutrition, the control of dengue, lowering institutions can play a key role to help in the assessment of the costs of medicines and strengthening capacity to address the capacity to utilize research by programme managers and emerging epidemiological risks. CISS is now leading a policy-makers, to train knowledge brokers based on such regional effort to assess research and epidemiological assessments, to facilitate the uptake of research by policy- surveillance capacity by public health institutions in makers through specific tools and methods, and to develop participating countries, an initiative funded by the research and innovation priorities in critical health system International Association of National Public Health Institutes. development areas. J Based on this assessment, a Mesoamerican Public Health Institute is being developed as a consortium to provide the Miguel Angel González Block is Executive Director, Center for secretariat and technical support coordination functions for Health Systems Research, National Institute of Public Health, the Mesoamerican Public Health System. This effort will Mexico.
References
1. Popper, Karl. The Open Society and its Enemies. Plato, Volume I: Hegel Canadian Health Services Research Foundation, Executive Training for & Marx, Routledge & Kegan Paul, London, 1945. Research Application EXTRA. Ottawa: http://www.chsrf.ca. 2. Tokman V. Inserción laboral, mercado de trabajo y protección social. 6. González Block MA et al. Utilización de Investigación por gestores de Documento de proyecto. CEPAL 2006. salud. Desarrollo y validación de una herramienta de autodiagnóstico para 3. Frenk J et al. Reforma integral para mejorar el desempeño del sistema de países de habla hispana. Salud Pública de México 2008a. Aceptado para salud en México. Salud Pública Mex 2007, 49 supl I:S23-S36. publicación. 4. González Block MA et al. Salud Migrante. Propuesta de un Seguro 7. González Block MA et al. Utilización de investigación por gestores de Binacional de Salud. Perspectivas en Salud Pública, Sistemas de Salud, salud. Desarrollo y validación de una herramienta de autodiagnóstico. Instituto Nacional de Salud Pública, 2008. ISBN 978-970-9874-81-5. Enviado a Publicación. Salud Pública de México 2008b. 5. CHSRF Extra Canadian Health Services Research Foundation CHSRF
74 Global Forum Update on Research for Health Volume 5 75 Title page:GF5 23/10/08 14:06 Page 75
Social innovations
076 Interactions between populations, health workers and health programmes for prevention of malaria: teachings of an analysis “from below” Yannick Jaffré
082 Ethical aspects of innovation in health José Geraldo de Freitas Drumond
088 Ethics, evidence and innovation Kenneth W Goodman
091 Seeding a global movement on neglected diseases Sandeep P Kishore with Pius Mulamira
096 Supporting implementation research partnerships for health systems strengthening: one foundation’s approach in sub-Saharan Africa Elaine K Gallin
099 The practical impact of research in South-East Asia funded by the Wellcome Trust Jimmy Whitworth with Ruth Branston and Michael Chew
104 Independence and innovation: looking beyond the magic of words Xavier Crombé
107 Creating incentives to induce behavioural change and improve health: success and limitations of conditional cash transfer programmes Mylene Lagarde with Andy Haines and Natasha Palmer
Global Forum Update on Research for Health Volume 5 75 76-79 jaffe:GF5 22/10/08 10:10 Page 76
Social innovations
Interactions between populations, health workers and health programmes for prevention of malaria: teachings of an analysis “from below”
Article by Yannick Jaffré, Research Director, French National Centre for Scientific Research (CNRS)
ne of the most accurate ways of qualitatively corresponds to several theoretical models that emphasize the evaluating a health situation consists of analysing it links between “sociological reasoning” and its socio-historical Ofrom the point of view of diverse social groups who are environment2. It is sufficient here to mention “thick supposed to benefit from the development programmes description” that aims at describing and analysing the links and who also physically feel the difficulties of their situation between actions and the meanings given to them by their each day. authors3 or micro-history that identifies invisible structures Of course, one must beware of succumbing to a “populist” according to which the actors’ experiences are articulated4. approach or confusing the “actors oriented” position with a Concretely, in the framework of the application of health naive approval of what could be considered as “traditional” or programmes, this position enables two vital processes. It first unanimously shared homogeneous “communitarian” permits the comparison of words used by “developers” and opinions. Populations everywhere are pluralist and always the realities they are supposed to designate. In short, it manifest economic inequalities, contradictory cultural options permits us to know if the notions used to define health and political conflicts1. To put it simply, nothing is ever strategies have a “real” reference or if they are mere “paper “communitary” or “traditional”: everything is always words” designating only the rhetorical universe of “projects” “political” and “historical”. and “seminars”5. Consequently, this position permits us to Besides, if various “laymen” behaviours are socially analyse the applicability of theoretically conceived health explicable, this cannot mean that they are coherent and measures in real situations – more precisely, in their “contexts”. commonplace from the health angle. Having reasons for acting in a certain way cannot be synonymous to right action, Proposals and difficulties of malaria and a good number of causes of infantile and maternal prevention programmes mortality find their explanation in harmful popular Let us briefly recapitulate the situation. Globally, various behaviours. But once these precautions are taken, the preventive strategies for limiting the morbid effects of malaria approach “from below” is indispensable because it permits – besides vaccine research – have three objectives that imply the shift from “global” to “local” and allows the study in situ broad fields of activities, with unfortunately as many specific of how big strategies conceived by international institutions difficulties6. come to install themselves in the ordinary course of lives and (1) To begin with, establishing an early diagnosis can in social practices that impact on health. permit a rapid and satisfactory management of the disease These ordinary dimensions of daily life are often ignored by and the necessary observation of the treatment. However, research or development programmes. And if the technical forms of resistance to antimalarial measures that have been goals of “projects” benefit from a lot of attention, these social observed give the impression that the treatment is not always dimensions are evoked only very erratically under the appropriate to the complaint as would be desired. term “context”. The error here is obvious, since this term in Questions of quality of health offer and mutual fact designates a set of essential variables: how one eats, understanding between populations and health personnel are lives, sleeps or washes…in short, the “context” that we have essential here. not yet taken the time to study is simply “all that is social”, The exchange of health information always implies a and that nevertheless determines and explains the essentials translation of the doctor’s technical medical vocabulary into of the actors’ behaviours. the laymen’s representations of the illness. This difference Methodologically, this qualitative approach “from below” between reference systems explains the great number of
76 Global Forum Update on Research for Health Volume 5 76-79 jaffe:GF5 22/10/08 10:10 Page 77
Social innovations
difficulties of mutual understanding between health teams like the constant transfer of health personnel towards more and populations. This is accentuated by the fact that in a “profitable” programmes. number of countries, the scientific language used (most often An economy of “projects” is in evidence everywhere English or French) is different from the language ordinarily (bonus, daily allowance, transport) along with a employed by people to express themselves. In this case, misappropriation of health personnel towards public health when local languages do not possess a true scientific lexicon that is considered more advantageous8. and medical terms, the health dialogue requires multiple Thanks to various health education campaigns, there has interpretations and adaptations of the terms used. Health been a real improvement of knowledge about the role of the dialogue can then be described as a confrontation between mosquito in particular and the advantage of bednets. But this two semantic systems bringing about different classifications new knowledge does not “automatically” lead to new of the pathologies. practices. Unfortunately, it must be admitted that little Several “distortions” will then result. Some diseases like change has been noted in the presence of malaria in the malaria, distinguished by the medical discourse, can be zones of highest transmission. This is particularly so in Africa conceived by populations as constituting a single morbid unit where the appearance of new resistances and new “urban” (“diseases of fever”) and hence interpreted wrongly as forms of the disease has been noted9. benign. Reciprocally, several clinical signals defining a single medical syndrome can be distinguished by populations as New trails? many different illnesses. Naturally, programmes once begun must be continued and Lack of scientific analysis of these laymen interpretations attempts made to diffuse these health proposals that are of the disease and its treatments have made confusions really new body practices10. But, if one agrees with what has between health teams and populations more of a norm than been affirmed here, three other broader paths that can only an exception. Yet, populations can only adhere to the be briefly mentioned here must also be considered. prevention of what they can label and understand. Very broadly, these constant divergences prevent the (1) A political ecology: between public and private spaces: establishment of a true health dialogue and encourage constructing a healthy city populations to have recourse to popular remedies or Several dimensions are interlinked and must therefore be “informal chemists”7 – economically more costly than treated together. The rapid growth of urban population11, the judicious medical treatments, but culturally closer to transformation of malaria features, the great social the populations. inequalities as well as the common presence of other To put it plainly, following the treatment and resistance to pathologies (dengue, chikungunya, schistosomiasis, new molecules is largely a matter of communication and trachoma, etc.) give a global dimension to parasitical and quality of the health offer. infectious risks in new urban spaces. (2) Preventive measures must then be planned and In other words, although the rural world cannot be implemented particularly for “risk” groups, such as pregnant abandoned, a large number of new health questions are women. Bednets and insecticide-treated curtains used for linked to the specificities of contemporary megapoles12 some years seem to constitute an effective means. However, where 72% of the population of Africa lives in they are still little used in Africa outside “pilot” programmes. unsanitary conditions13. This is simply because “bed manners” defined according to In short, it is obvious that no progress in malaria kinship, the status of the child or ill-adapted architecture, prevention will occur without conducting a solid reflection gradually deconstruct and dilute the theoretical coherence of involving urbanists, architects, doctors and specialists in health “messages”. social sciences on the various ways of constructing “healthy Thus, preventive proposals are remodelled by the ordinary cities” rather than “pathogeneous complexes”. Several fields course of things: bednets are torn during children’s games, need to be examined here. intense heat prevents people from sleeping under the net, Public spaces must be analysed and their general sexual intimacy leads to children being kept at a distance, management improved14, 15, 16, 17. It is necessary to understand mosquitoes breed in beds with boards, the status of elders the various ways in which public policies and occupation reserves bednets for seniors. of “lived spaces” are articulated depending on These ordinary norms and daily actions construct the territories18, 19, 20. Once again, to put it simply: it is references for a way of living. This is why impregnated ridiculous to ask the poor and destitute to protect themselves bednets are used in the frame of restricted programmes – when open drains run across the cities. when “the project” plays the role of a reminder for the new Simultaneously, in private spaces, more adapted norms proposed. But their effectiveness diminishes when architectures could be developed. Indeed, the diffusion of new actions imposed by this innovation are eroded or architectural models – use of tin and cement – particularly demolished by the routines of daily behaviours. unsuited to the extreme heat of tropical climates, besides (3) Finally, from an administrative point of view, the being an ecological absurdity, renders the regular use of multiplicity and “verticalization” of programmes makes bednets illusory. their harmonization difficult. It often leads to confusion As was the case for tuberculosis or all water-borne among populations and provokes iatrogenic effects diseases, the struggle against malaria is thus linked to a
Global Forum Update on Research for Health Volume 5 77 76-79 jaffe:GF5 22/10/08 10:10 Page 78
Social innovations
policy of habitat. Although this cannot be detailed here, two (3) Intitate better coordination of development policies and essential points must be mentioned that encourage help clinicians remain at their posts populations to take care of their environment. The following three observations counteract the First of all, access to property must be developed. This “verticalization” of health programmes and would thwart alone can guarantee the time required for planning and iatrogenic effects of health development projects. impart a desire to improve one’s environment. First of all, it is culturally of little relevance to treat History also teaches us that transformations of space owe “nuisances felt” requiring similar “defensive barriers” more to aesthetic reasons than to health guidelines. (malaria, dengue, chikungunya) separately. Therefore, new norms combining beauty and function must Next, work on the causes of parasitic infections would be diffused21, 22. permit action on common initial causes largely linked to Globally, these multiple dimensions, mainly economic, water and hygiene. sanitary and urban, must orient a real reflection on the Finally, clinicians could be helped to remain in their political ecology of the disease23. departments rather than encouraged to join different, more or less temporary, specific programmes of “public health”. (2) University and continuing education concerned with The struggle against malaria depends largely on how aid contexts of healing practices and development policies are conducted. A better More specifically, the dialogue between health personnel and coordination of programmes, the pooling of means, populations must be improved. But if this dimension is enhancing actions and grants of research subsidies granted to recognized as essential in the texts, practically no teaching – practitioners who despite their low salaries and difficulties initial training – dealing with the complex links between continue to work with sick people, would be an essential aid. languages and popular behaviours versus sanitary proposals To conclude, at different levels all authorities interact with is proposed in faculties of medicine or paramedical schools. various health programmes. Consequently, helping local Ehnolinguistic works on the body and on disease24, 25 authorities comes down largely to thinking about ways of should be used – not as a “curiosity” or a social “plus” – but promoting an offer of quality health. J in order to initiate a real reflection on conditions of future healing practices in a specific environment. Let us put this Yannick Jaffré worked as an anthropologist in West Africa for even more simply: is good medical advice if not understood 20 years. He collaborated with public health teams, conducted or applicable by patients “good advice”? many anthropological research projects focused on health priority The most common practices refute the precepts taught, and taught in many African and French medical faculties. thus reducing teaching to a purely rhetorical exercise. For He is now Research Director at the French National Centre for example, practically no hospital in sub-Saharan Africa uses Scientific Research (CNRS – UMR 6578) and responsible for bednets despite recommending their use. If requirement PhD teaching in health anthropology in SHADYC (Sociology, levels shouldn’t be lowered, nonetheless concrete questions History and Anthropology of Cultural Dynamics) in a French social must be raised about the suitability of “basic material” for sciences high school (EHESS). Yannick Jaffré has written many local conditions of practice (linguistic uses, specific forms of books and articles about disease in West Africa and the organization of work, etc.). relationships between health-care providers and users.
78 Global Forum Update on Research for Health Volume 5 76-79 jaffe:GF5 22/10/08 10:10 Page 79
Social innovations
References
1. Olivier de Sardan JP. Anthropology and development. Understanding 13. Davis M. Le pire des mondes possibles. De l’explosion urbaine au contemporary social change. London, Zed Press, 2005. bidonville global, Paris, La Découverte, 2006, p.205. 2. Passeron JC. Le raisonnement sociologique. Paris, Albin Michel, 2006. 14. Onibokun AG (dir.). La gestion des déchets urbains. Des solutions pour 3. Geertz C. La description dense. Vers une théorie interprétative de la l'Afrique. Paris, CRDI/Éditions Karthala, 2002. culture. EHESS/Eds Parenthèses, 1998, Enquête N°6, 73-105. 15. Enten F. L’hygiène et les pratiques populaires de propreté. Le cas de la 4. Lévi G. Le pouvoir au village. Histoire d’un exorciste dans le Piémont du collecte des déchets à Thiès (Sénégal). In: Bonnet D and Jaffré Y (sous la XVIIe siècle. Paris, Gallimard NRF, 1989 (1st edition 1985). direction). Les maladies de passage. Paris, Karthala, 2003, 375-402. 5. Jaffré Y. Quand la santé fait l’article. Presse, connivences élitaires et 16. Blundo G. La question des déchets et de l’assainissement à globalisation sanitaire à Bamako, Mali. Revue de Pathologie Exotique, Dogondoutchi. Niamey, Lasdel. Etudes et Travaux, N°10, 2003. 2007, 100 (3), 207-215. 17. Hahounou E. La question des déchets et de l’assainissement à Tillabéri. 6. Jaffré Y. Contributions of social anthropology to malaria control. In: Niamey, Lasdel. Etudes et Travaux, N°9, 2003. Tibayrenc M (ed.). Encyclopedia of Infectious Diseases: Modern 18. Frémont A. La région, espace vécu, Paris, Flammarion, 1999. Methodologies, New York, Wiley, 2008, 591-602. 19. Ingold T. The perception of the environment. Essays in livelihood, 7. Jaffré Y. Farmacie cittadine, farmacie “per terra”. Africa e Mediterraneo, dwelling and skill, Routeledge, London, 2000. 1999, 1, 31-36. 20. Choay F. Pour une anthropologie de l’espace, Paris, Seuil, 2006. 8. Jaffré Y and Olivier de Sardan JP. La construction sociale des maladies. 21. Vigarello G. Le propre et le sale. L’hygiène du corps depuis le moyen- Paris, PUF, 1999. âge. Paris, Seuil, 1985, p.286. 9. Gonzalez JP et al. Fundamentals, domains, and diffusion of disease 22. Goubert, 1986. emergence: tools and stategies for a new paradigm. In: Tibayrenc M (ed.). 23. Baer HA. Toward a political ecology of health in medical anthropology. Encyclopedia of Infectious Diseases: Modern Methodologies. New York, Medical Anthropology Quarterly, 1996, New Series, Vol. 10, No. 4, Wiley, 2008, 525-568. Critical and Biocultural Approaches in Medical Anthropology: A Dialogue, 10. Corbin A, Courtine JL and Vigarello G. Histoire du corps. Vol. 2. Paris, 451-454. Seuil, 2005. 24. Jaffré Y. Une médecine inhospitalière. Paris, Karthala, 2003. 11. Antoine P. L’urbanisation en Afrique et ses perspectives. Archives des 25. Tourneux H et al. Dictionnaire peul du corps et de la santé (Diamaré, documents de la FAO. 1997, p.21. Cameroun), Paris, Karthala, 2007. 12. Harpham T. Urban health in developing countries: a review. Progress in Development Studies, 2001, Vol. 1, No. 2, Sage Publications, 113-137.
Global Forum Update on Research for Health Volume 5 79 82-85 DeFreitas:GF5 22/10/08 10:10 Page 82
Social innovations
Ethical aspects of innovation in health
Article by José Geraldo de Freitas Drumond, Professor of Bioethics and Medical Ethics, State University of Montes Claros (UNIMONTES), Brazil
he health sector comprises the activities of which consisted in valuing the contribution of biomedical hospitals, ambulatories and medical attention that research regarding the “production of health”, in the period Thave a strong relationship with science and 1900–1978. It came to a conclusion that the increase of 1% technology, which is why it requires a deeper discussion in the effort of research in this area implied a drop of 0.10% in order to address its complexity. According to in the rate of mortality, varying between 23% and 48% in the Albuquerque, the scientific infrastructure of this sector is magnitude of the contribution of this research in the reduction “a result of flow of information that supports the advent of of the rate of mortality. innovations which in turn affects medical practice and The second study, which was carried out by Lichtenberg3, health”1. valued the impact of expenditure on research and Recent times have seen a continuous development development (R&D) in the pharmaceutical industry on the of new technology, resulting from advancements in biological reduction of the rate of mortality. It comprised the period and medical sciences. Most of these appeared after the between 1970 and 1990 and came to the conclusion that middle of the 20th century, materializing in the form of new there was an obvious relation between an increase in lifespan equipment, new clinical proceedings and new preventive and the introduction of new drugs approved by the American measures composed of vast quantities of new information, Food and Drug Administration (FDA), whose drugs increased which, in turn, promote health. As a result, health care has lifespan from 0.75% to 1% a year. become one of the fastest growing sectors of the world The Report on Human Development4, which established economy in recent years. the link between technological development and human The health sector simultaneously shows two special development, states “medical advancements such as characteristics. First and foremost, technological-scientific immunizations and antibiotics resulted, during the 20th development has produced important benefits to welfare, century, in faster improvements in Latin America and East impacting on the economy and on society as a whole. On the Asia than those achieved in Europe during the 19th century other hand, the implications involved in implementing these through better nutrition and sanitation”. And it concludes: innovations in national health systems have been costly “(...) During the 70s the lifespan in two mentioned regions and questions have been raised as far as ethical aspects are (LA and EA) exceeded 60 years, getting in four decades what concerned. in Europe, beginning in 1800, took 150 years to achieve ”. In short, the health sector must find the balance between Campos and Albuquerque5 support the argument with costs and benefits for society, taking into account ethical three situations: 1) the non-existence, in the health sector, of procedures. In the health sector, innovation must have the a consumer’s capability to decide which products he should purpose of improving the quality of life by means of using acquire, given that he does not have the necessary products and procedures which avoid the appearance of new information to take such a decision. For instance, it would diseases, while at the same time trying to eradicate the not be possible for a patient to decide between radiotherapy existing ones. and chemotherapy in the event of there being resources for only one of these therapies. This fact, by itself, already Research, technology and innovation in determines the breaking of one of the rules of the market for health the allocation of appropriate resources, which is the The impact of investment in research in the health sector with symmetry of information. 2) there is no medical assistance, regard to the improvement of the quality of life of populations as it happens in other economical sectors, “limits to has been assessed by several studies, of which two are rationalize the production”. For instance, it is enough to frequently quoted. remark that any emergency service is compelled to offer The first one refers to the statistical study of Vehorn et al2, specialists (such as a neurosurgeon). This is mandatory even
82 Global Forum Update on Research for Health Volume 5 82-85 DeFreitas:GF5 22/10/08 10:10 Page 83
Social innovations
if, statistically, this kind of trauma does not often demand his (R&D) resources. intervention, given that it is not possible to admit denying To the Global Forum for Health Research9, only 10% of such a service as a result of statistics. A similar situation worldwide expenditure on health research concerns diseases takes place with the necessity of providing units with and conditions that affect the poorest 90% of the world’s antiophidian serums for the occasional case of a patient population, hence the title “10/90 gap”. bitten by snake. The professional responsible for each unit Albuquerque et al10 analyse the theme of innovation in must assume the onus of the rigorous maintenance of the health from the point of view of the economics of technology quality and validity of the product. 3) In contrast to industrial and suggest that this discussion takes place over two issues: processes, which are generally standardized and show the first, the necessity of health being understood as a worldwide same pattern of production, in the health sector, one cannot phenomenon and, as result, comes the importance of standardize inputs and processes, for the simple fact that initiatives for the creation of international cooperatives with patients attended by different health agents or different the intention of joint efforts in research and the support to set medical teams might be submitted to different approaches. It up health systems that should guarantee the effective is possible to exemplify from the treatment of a single worm diffusion of worldwide scientific and technological disease carried out with a treatment of magnify specter and achievements. Another issue refers to the importance of the without prior examinations up to the submission of the national scientific endeavour of developing countries, for patient to a battery of exams, for the same therapeutics. This which no country in the world should avoid taking part in the results from the predominant subjectivity of the process of international networks of research and diffusion of innovations. work in health, which is basically craft, in spite of the The ethical perplexity caused by contemporary “techno objectivity of some background. science” is consequent to the fact that the world, in spite of These and others observations are enough to confirm the the amount of progress made, is in a frontier of serious moral peculiarity of medical assistance when compared to any responsibilities, determined by the process of intervention other economical category5. more and more aggressive of the man in the biosphere, Experts in the innovation economy have pointed to a accelerating its deterioration, and the intervention of the narrow relation between science and technology in the health man in his own essence, through the manipulation of his sector6. The development of the health sector has favoured genetic identity. improvement not only in the quantity but also in the quality The technological innovations might not just benefit of treatments and in the methods of diagnosis, although such humanity, but also be used against it, having become certain a relation, concurrently, is responsible for the increased costs that the last battle for human dignity is being fought in of medical assistance. molecular genetics laboratories, where human DNA The explanation for this equation – technological is manipulated. innovation and an increase of expenses – is a result of the The worst situation for humanity – that obtained through specificity of the health sector in so far as, in contrast with science the demystification of natural phenomena – is exactly other sectors of production in which the introduction of a new the loss of the spiritual values provoked by the corrosive technology brings the substitution of the old ones, in the power of technology on human values, specially due to the health sector this phenomenon is cumulative. For instance, unequal struggle between the speed of scientific discoveries the evolution of the cardiovascular propaedeutic and the and the capacity for moral reflection upon them. propaedeutics methods favoured by the technology of the If the progress of science is, in fact, much faster than the electrocardiogram, shear ultrasound scan and for the time needed to think about its effects on the biosphere and Doppler, did not succeed in replacing the classic method of human life, the discussion about the intervention of medical cardiac listening or even in substituting among themselves. technology in human life is made more distressing and pressing. Ethics aspects of medical technology If there is no more doubt that science and technology are There is a known disparity between the degree of the disease fundamental processes to the development of societies – and the investments in research in the worldwide scenario, creating a gap between the countries that are knowledge- as described by the World Health Organization7, in a context based and those that depend on them to obtain it – the of unequal distribution, especially in case of the “load of the developed countries cannot use their knowledge power to avoidable disease ”. subjugate others. According to the WHO8, low- and medium-income Due to being simultaneously a public and a private property countries are responsible for only 2.2% of the global funds (on account of its double financing), technology has a huge cost invested in health research and this is mostly due to the that limits its development in most countries. Therefore, the absence of complete innovation systems in such countries. creation of an international cooperation policy for the There is in the health sector “a huge gap” between the degree development or enhancement of national technology innovation of the disease and the expenditures in research and systems should be stimulated. This would, consequently, have development: pneumonia and diarrhoea which are, for an international insertion, especially if it is built in the form of example, responsible for 15.4% of the degree of the disease research and technology cooperatives. Therefore, it could be and, at the same time, the two biggest causes of death in the expected that the gap between nations, that means a small whole world, receive only 0.2% of research and development hiatus between life and death for millions of human beings
Global Forum Update on Research for Health Volume 5 83 82-85 DeFreitas:GF5 22/10/08 10:10 Page 84
Social innovations
when the matter is human health, can be diminished. only to individual health, but, also, to the policies of public There must be developed an ethic responsibility health in general. conscience, in the individual plan, so much as in institutional International literature, specialized in the economics of and government levels, since the development of science and technology, while focusing on the health subsystem, has technology must be used only with the purpose of demonstrated a narrow relation between the improvement of contributing to individual and collective progress, in other sanitary indicators and investments in research and words, to the happiness of mankind. innovation in health. Medicine has been, for a long time, based on empirical In the meantime, questions are controversial and still not knowledge, many times mysterious and transcendental, as it answered, such as the relation of the costs of innovation and has been demonstrated in its history from ancient Greece to their benefits to the population, which leads to whether recent times. Scientific development began in the 19th technology is a factor that increases the costs of health care, century. Up to that time, the medicine practised was based is it part of the problem, or both. on symptomatic demonstrations and on objective data, On the other hand, the distribution of scientific knowledge focused on the care of the patient and with searching to and information in health is accumulated in the central reduce his suffering. countries, on account of the concentration of investments in Today the competence acquired through scientific the sector (around 98%) compared with developing countries knowledge can place the medical professional in front of or peripherals ones. This has caused a massive difference countless ethical dilemmas, mostly concerning the classic regarding the nosological predominance in the poorest occupation of medicine regarding the improvement of the regions of the globe, as highlighted by the “10/90 gap”, conditions of health and quality of life of the population. designated by the Global Forum of Health Research. It is not possible to agree with those who, on the excuse of Therefore, there is a need to establish policies and using the most recent medical technology, have the purpose strategies to support the development of national systems of to cure diseases or to maintain the life of a patient at any cost innovation in health for those countries that still do not have after running out of all the biological possibilities for a developed technological and scientific system (or have it in maintaining a dignified quality of life. an incomplete way), and to favour international links Although they increase the cost of medical attention, between the developed, or complete, systems and the modern technologies will be fully justified if they lead to an underdeveloped countries. effective improvement of human health. The tendency to From the point of view of the medical praxis, be it scientific ideology and submission to the market logic ambulatory or nosocomial, its close relation with contributes to the enlargement of health industry profits, technological innovations has caused an increase in ethical while evaluation of the relation between cost, risk and dilemmas. Medicine, in the early 21st century, has become possible benefits to the patient are forgotten. the instrument of a new human utopia, that is, the utopia of health and the perfect body. Concusion As a result of this modern context, based on the advances The development of science and technology in the last of technology, it might induce the development of a new quarter of century has been responsible for the extraordinary medical culture, which is transforming the medical doctor progress achieved by the different sectors of modern society into more of a life manipulator than a health promoter. J to the extent that, at present, technology permeates practically all segments of the human life. José Geraldo de Freitas Drumond is a medical doctor and More recently, the development of biotechnology has made Professor of Bioethics and Medical Ethics at the State University an enormous contribution to the health sector, carrying most of Montes Claros (UNIMONTES), Minas Gerais (Brazil). He is also of the investments in research and development (R&D) in the President of the Minas Gerais State Agency For Research public and private sectors. Examples of this progress, such as Development (FAPEMIG), a member of the International Council the genomic and the pharmaceutical genomic flourished, of “Acta Bioethica”, PAHO/WHO, Chile and President of the creating a predictive medicine, which brought benefits not Sociedad Iberoamericana de Derecho Médico (SIDEME).
84 Global Forum Update on Research for Health Volume 5 82-85 DeFreitas:GF5 22/10/08 10:10 Page 85
Social innovations
References
1. Albuquerque EM, Souza SGA and Baessa AR. Pesquisa e inovação em saúde. Brasília/Natal, OPAS/OMS, NESC, UFRN, 1998. saúde: uma discussão a partir da literatura sobre economia da tecnologia. 6. Nelson R. The intertwining of public and proprietary in medical Ciência & Saúde Coletiva, 2004, 9 (8):277-294, 2004. technology. In: Rosenberg N et al. Sources for medical technology: 2. Verhorn C, Landefeld J and Wagner D. Measuring the contribution of universities and industry (Medical Innovation at the Crossroads, Vol. 5). biomedical research to the production of health. Research Policy, 1982, Washington, National Academy, 1995. 11 (1) 3-13. 7. World Health Report: Making a difference. World Health Organization, 3. Lichtenberg F. Pharmaceutical innovation, mortality reduction, and Geneva, 1999. http://www.who.org economic growth. National Bureau of Economic Research. Cambridge 8. Investing in health research and development. World Health Organization, (Working Paper 6569), 1998. TDR/Gen/96.1. http://www.who.org 4. UNDP (United Nations Development Program). Human Development 9. The 10/90 report on health research 2001–2002. Global Forum for Report: making new technologies work for human development. Nova Health Research (GFHR), Geneva, 2002. York, 2001. http://www.undp.org 10. Albuquerque EM and Cassiolato JE. As especificidades do Sistema de 5. Campos FE and Albuquerque E. As especificidades do trabalho no setor Inovação no Setor Saúde. Revista de Economia Política, Vol. 22, nº 4 saúde. In: Castro J, Santana JP. Negociação coletiva do trabalho em (88), October–December 2002.
Global Forum Update on Research for Health Volume 5 85 88-90 goodman:GF5 23/10/08 10:08 Page 88
Social innovations
Ethics, evidence and innovation*
Article by Kenneth W Goodman, Professor of Medicine, Director of Bioethics Program and co-Director of Ethics Programs, University of Miami, United States
t should be uncontroversial to state that the world’s development of powerful antiretroviral drugs is an example of greatest overarching moral challenge – and duty – is scientific creativity; the failure to make these drugs widely Ireducing disparities in nutrition, shelter, health and available to the world’s poor is an example of political opportunities for a creative and fulfilling life. Yet while the sclerosis and misadventure. Political innovation by leaders in moral charge is uncontroversial, great controversy surrounds developed countries would – and still could – ensure that efforts to meet this challenge. One could even argue that, but more people around the world enjoy the benefits of for such controversy and disagreement, there would be fewer biomedical science. disparities and they would be smaller. For our purposes, “innovation” is a value-laden term. It If this is right, it means there is even greater urgency embeds the concepts of “good” and “progress” and “public.” to identify points of agreement beyond the mere imperative To be sure, one might be innovative in degrading the to reduce disparities. The need for innovation is a source of environment, spreading disease and widening oppression, such agreement. but these are evil and perverse goals. Innovation for the Now, everyone rightly admits that current disparities are project here is ethical innovation: intentional, creative change unacceptable; and that traditional methods to reduce them aimed at reducing global disparities. At the intersection of have often been inadequate, at least so far; and that change science and policy, ethical innovation celebrates shared of some sort is required. So our goal here is to suggest ways values and goals, and it imposes on scientists and policy- in which ethically optimized innovation can serve us in doing makers the duty to use their creative energies in the pursuit our duty to reduce disparity. There are at least two parts to of goods that align with those values. this project: foster and encourage innovation (construed We can go further: failure to attempt such a pursuit is itself broadly) and demand evidence in support of creative change. a wrong, a blameworthy abnegation of duty. Indeed, it is From conception through action, ethics is the brightest thread irrational to have the ability to change the world for the better in the fabric of disparity reduction. – and then fail to try. (Among other things, this means that scientists cannot escape at least some moral responsibility for Foster innovation their work.) “Change” and “innovation” are not synonymous. The world It follows that the first part of our project – the injunction to often changes as a result of human action but without human foster innovation – is morally obligatory. Moreover, the intention. Some changes are for the worse. “Innovation”, obligation applies to scientists and policy-makers in equal however, implies both intention and progress. Moreover, measure. It becomes a collective obligation for those societies innovation tends to have a good track record, especially in the in a position to make innovative change – those which enjoy health sciences. The world’s scientific community has often adequate nutrition, housing and health, say – to help those risen to the occasion and helped provide the tools needed to who do not enjoy these rights. prevent and treat a broad range of maladies. Scientific While good intentions are necessary, they are insufficient. innovation has been fostered by governments, professional Something more is needed. societies, nongovernmental organizations and others who had at their disposal the curiosity and creativity of the Evidence-based innovation world’s researchers. There are several reasons why good intentions alone are not But scientific discovery needs a partner for the benefits of adequate to the task. The strongest reason is that the poverty research to be realized, and this requires innovation by the we find on earth today is sustained and complex. If mere world’s policy-makers. When the former succeed and the good intentions were adequate, one would only need to send latter fail, progress is impeded. The discovery and a donation and infer that such largesse would somehow discharge one’s duty to attempt to reduce disparity. Further, * Work on this chapter was supported in part by the Jay Weiss Center for Social Medicine and Health Equity at the University of Miami and by the we know too well that the research engines of North America, Arsht Initiatives, a series of gifts from philanthropist Adrienne Arsht. Europe and Japan are marvels of scientific innovation, but
88 Global Forum Update on Research for Health Volume 5 88-90 goodman:GF5 23/10/08 10:08 Page 89
Social innovations
they are too often undergirded by intentions that have little or Ethics, evidence and disparity reduction nothing to do with the reduction of global disparity. What is The duty to reduce disparities is, as above, complex and wanted is ethically optimized innovation coupled with some daunting. Many people around the world need clean water grounding, warrant or evidence that actions inspired by good as much as costly pharmaceuticals; vector-borne disease intentions will be effective. control more than hospitals; education at the same time as Some missteps aside, health research in developing vaccinations, birth control or visits by foreign physicians. One countries has improved over the past quarter century – at could say that development and disparity reduction are least insofar as research sponsors and investigators now wedded in such a way that neither can be achieved without must adhere to any of a suite of national or international rules the other. Enter an experiment in disparity-reducing for the protection of human subjects. Such rules may be seen innovation – The Millennium Villages project. Commissioned in part as attempts to ensure that good (or at least not bad) by the United Nations Secretary-General in 2002, the consequences result from projects whose intentions are or Millennium Villages link sustainable infrastructure might be questionable. And we have learned along the way, development to public health surveillance and research: for instance, that international health research must address problems that inhere in the population being studied1. Do not Simple solutions like providing high-yield seeds, study Alzheimer’s disease, say, in a country where few fertilizers, medicines, drinking wells, and materials to people live long enough to get it. build school rooms and clinics are effectively combating The relationships among science, ethics and policy are extreme poverty and nourishing communities into a new complex. Some years ago in meetings of a philosopher, age of health and opportunity. Improved science and scientist and physician from the University of the West Indies technology such as agroforestry, insecticide-treated bed in Jamaica and the University of Miami in the United States, nets, antiretroviral drugs, the Internet, remote sensing there was extended discussion about the nature of these and geographic information systems enrich this relationships. It was agreed that ethics is essential for progress. Over a five-year period, community building trust in the developing world; that ethics and trust committees and local governments build capacity to are required for a successful research programme; that the continue these initiatives and develop a solid foundation health of communities depends on more and better research; for sustainable growth4. and that such research is necessary for reducing disparities. We arrived at the following motto: What is innovative here combines good intentions and No ethics, no trust; sound science. Part of what is meant by “sound science” is no trust, no research; that researchers and those who fund them have clear goals no research, no health; for reducing disparity. Continued evaluation and assessment no health, no development2. will determine if evidence-based standards help foster success for such a morally-driven initiative. More than charm, a good motto has content. If there is Note how little has been said here about the administrative substance here it is shorthand or elliptical for several ideas, engines established for overseeing human-subjects research. including that research must be effective if it is to improve the health of populations, and that such efficacy is not born of Key messages good intentions or warm thoughts. Effective research takes into account the needs of populations; marshals the best Humans are, generally, creative creatures. The methods for achieving success; communicates this research history of civilization demonstrates a series of to public health practitioners, clinicians and policy-makers; innovations that have improved life and fostered and supports them in the application of the research. If, as progress. Humans are also, generally, beneficent. above, “ethics is the brightest thread in the fabric of disparity But some changes have been destructive, neglectful reduction”, then it is also the brightest thread in formulating or impotent. And humans have reason, at least and carrying out a research programme. generally, which is why the success of science is so In both cases, though, ethics must be intertwined with often taken for granted. What is needed, we have evidence if it is to have any success in disparity reduction. argued here, is an ethically optimized, evidence- Innovation without evidence is mere novelty; evidence based view of innovation. Taken ensemble, such a without innovation is a shallow and vulgar empiricism. view counsels us thus: The history of the evidence-based medicine and evidence- There is an uncontroversial moral imperative to based public health movements has helped focus our reduce global disparity, and this can be undertaken attention on the mutually supportive role ethics and evidence creatively. play3. What is noteworthy for our purposes is that evidence- Evidence-based science can help ensure that based practice is innovative, despite its apparent obviousness. disparity-reducing initiatives are just and effective. It is innovative in that it has led to a large, creative international It would be blameworthy not to deploy ethically effort to harmonize the collection and communication of optimized, evidence-based tools in the pursuit of research results. It is not without flaws, and has even disparity reduction. occasioned some controversy. Innovation is often like that.
Global Forum Update on Research for Health Volume 5 89 88-90 goodman:GF5 23/10/08 10:08 Page 90
Social innovations
This is because what has been called the “regulatory ethics Kenneth W Goodman is Professor of Medicine at the University paradigm” is too narrow in the kinds of innovations it regards of Miami, with appointments in Philosophy, Epidemiology and as worthy5. Public Health and Nursing and Health Studies. He directs the Ethics is never so challenged and tested as when it is university’s Bioethics Program and is co-Director of its Ethics invoked in the name of public policy. Our economic and Programs, which have been designated a World Health political shortcomings and failures too often make it seem Organization Collaborating Center in Ethics and Global Health that the demands of a universal ethic – human rights, for Policy – one of three in the world. His research has focused on instance – are beside the point or too difficult to achieve. This ethics in epidemiology and public health, in health informatics is a mistake. The ability to reduce disparity, which ability and in clinical and research ethics, including translational no one seriously doubts humanity enjoys, confers on us research or evidence-based applications of research in public the duty to set about such reductions. Put differently, morality health and clinical practice. demands this effort, science makes it effective, and, with these, innovation promises the future will be better than the past. J References
1. Ethical and Policy Issues in International Research: Clinical Trials in Press, 2003. Developing Countries, Vol. 1. Bethesda, Maryland, National Bioethics 4. Millennium Villages, background and history, 2008 Advisory Commission, 2001. (http://www.millenniumvillages.org/aboutmv/index.htm, accessed 10 2. In addition to the author, participants included Drs Anthony Mullings August 2008). (Kingston) and Paul Braunschweiger (Miami). 5. Agich GJ. Ethics and innovation in medicine. Journal of Medical Ethics, 3. Goodman KW. Ethics and evidence-based medicine: Fallibility and 2001, 27:295-296. responsibility in clinical science. Cambridge: Cambridge University
90 Global Forum Update on Research for Health Volume 5 91-93 Kishore:GF5 23/10/08 14:09 Page 91
Social innovations
Seeding a global movement on neglected diseases
Article by Sandeep P Kishore (pictured), Weill Cornell Medical College, United States with Pius Mulamira
niversities Allied for Essential Medicines (UAEM) is a Ugandan lists, it remains out of reach for thousands of coalition of student-led chapters at more than 40 villagers. The students find that even when the drug is Uuniversities in North America and is increasingly available there are inappropriate dispensing practices. As a recognized as a credible and important partner in the result, local community members turn to traditional innovation and access to essential medicines movement1. medicines and healers, which are relatively cheap. However, we are keenly aware of the inherent risks involved To address the paucity of Coartem we have adopted a two- when students in the industrialized world try to imagine the pronged approach. First, we have alerted the WHO Essential needs of resource-poor populations. Thus, UAEM seeks new Medicines programme of this crisis. To our surprise, we partnerships with students globally. The partnership serves a found that such notifications of local drug availability are dual purpose: to first identify the most pressing local needs rare. We are devising new research tools with Makerere and and secondly, to mobilize resources North–South to address the WHO to identify the barriers to Coartem access. the needs. Secondly, we have brought the issue to the forefront of our Here, we describe the seeding of our movement in Africa chapters in the global “North” in hopes of addressing the and partnership with the first UAEM chapter in Africa barriers to access head-on. Our successes include reaching (Makerere University, Kampala, Uganda) on three discrete the first price concession on an antiretroviral (d4T) in 20012 projects including community-based service, developing new and successfully petitioning the WHO to include a new class training instruments on neglected diseases and building a of drugs (statins)3 as essential medicines. However, new credible voice for young scientists throughout Africa. linkages with colleagues in local settings provide bidirectional perspectives on whether the “essential Partnering with student-led community- medicines” concept is being actualized. If medicines on the based programmes Essential Medicines list continue to face price and trade Community-based education and service (COBES) is a new barriers, we hope to document and address these in turn. discipline introduced in the Makerere University medical Hence, these linkages generate research questions that yield school and public health curriculum where students learn crucial data to improve health. about diseases affecting the people in their communities. Groups of 8–10 medical and public health students report to Assembling the first open-access neglected different villages all over the country with questionnaires to be disease curriculum completed in interview style by members of local Interest in neglected diseases is growing globally but there are communities (see Figure 1). Questions include queries on the few publicly available resources for community and self- most important problem the community faces, potential education. To address this gap we are jointly assembling a solutions and current coping strategies. Surveillance of neglected disease curriculum for use in universities globally. community clinics reveals the community-specific disease The course will initially be modelled after a student-led course burden as well as discrete information on essential drug initiated by students in Cornell University (New York, USA). availability and treatment practices. Critically, though these In this course, we aim to show how concepts from the basic reports contain fresh data, they are merely handed in for a sciences, clinical medicine, economics and population health grade and forgotten. We decided to use the reports to (nutrition) inform each other as they are brought to bear on nucleate a movement on access to essential drugs. an important issue in global health – malaria. We centred the The COBES reports provided the unsurprising finding that course on the current, highly touted intervention – malaria remains the predominant concern in northern and insecticide-treated bednets. An initial economic and political eastern Ugandan villages, comprising up to 70% of paediatric discussion gives context to the pertinent issues in biology, visits. However, despite the high prevalence of malaria, first- medicine and population health that will help us form an line anti-malarial drugs (Coartem) remain in short supply. informed opinion on the potential for bednets as a way to Despite being an essential drug on international and “eradicate malaria in our lifetime” (WHO and Gates
Global Forum Update on Research for Health Volume 5 91 91-93 Kishore:GF5 22/10/08 09:37 Page 92
Social innovations
Age: Sex: certificate of support from the Ministry of Justice of Ethiopia, Education level: a) Primary b) Secondary c) Tertiary d) Other e) None substantiating their mandate. The group provides a mouthpiece to Marital Status: young, struggling scientists to bring a) Single b) Married c) Divorced d) Widow e) Widower issues to the forefront. The model is emblematic of a more general 2. Is there a way in which the above mentioned problems could be solved? movement, coined the Young 3. If so, could you suggest the possible solutions? 4. In your own view, what do you consider the most important of the problems mentioned? African Scientist Network based in 5. Why do you consider this problem the most important? Dar-es-Salaam, Tanzania, that 6. What do you think is the main cause of the problem mentioned above? 7. As an individual, how are you trying to cope with the problem? seeks to represent African scientists. Across the globe, the World 9. What challenges do you meet when trying to solve the most important problem you face? Association of Young Scientists 10. Do you consider disease to be one of the problems people face in this community? 11. If so, what are the most common diseases you encounter in this community? (WAYS; http://ways.org) provides 12. What do you think are the causes of the diseases mentioned above? resources and advice for researchers seeking guidance, Figure 1: Needs-based community questionnaire used by Makerere University medical and public equipment, training opportunities health students and subsidies to attend international research conferences. One third of WAYS’ 4000 members Foundation challenge). The full syllabus complete with are African-based scientists. To assist these young scientists, specified lecture objectives, key review papers and critical new groups like AuthorAID (www.authoraid.info) are case-studies is freely available here: http://skishore. emerging to help young scientists overcome barriers in wikispaces.com/NDCurriculum. publishing, including one-to-one guidance on editing and Expanding or adapting the course is easily done. English. Students and local faculty members can simply add on new A student-led campaign can be of great help in addressing modules that incorporate the four perspectives. Thus, a 4- neglected disease awareness in the tropics because that’s week course on malaria can become a 12-week course that where diseases actually are. One campaign, Loose Change includes modules on, say, maternal and child mortality and for a Worm-Free World (http://sabin.convio.net/site/Page HIV/AIDS. We aim to deploy the course in five universities Navigator/LooseChange) seeks to educate the general public in Africa and five in the United States by the summer of about possible preventive measures, while actively engaging 2010, with a goal of integrating the course into standard youth on neglected disease control. To be sure, we medical curricula. We aim to do so by working with medical acknowledge the limitations in trainees’ impacting research school curricula directors at institutions with UAEM budgets in the short-term. Our vision, however, concerns chapters. The digital repository, Health Sciences Online building a pipeline of trainees and young researchers with (HSO; www.hso.info), also offers more than 50 000 access to resources, insights and thought leaders globally. courses in a diverse range of health topics in English Our embryonic collaborations will grow, spurring future social medium for anyone seeking them. innovations that will yield biomedical innovations in the long term. Equally importantly, our linkages ensure that we are Seedling a global movement on neglected aligning our desire to help with where the needs lie. These diseases partnerships should help provide more rigorous evidence on We believe a bottom-up approach driven by students and the most pressing gaps when matching up disease burden to young researchers across disciplines is an under-utilized current R&D priorities. method to impact research priorities. A recent example is Join us in our movement on neglected diseases. worth highlighting. Garemew Guma, a malaria researcher in Addis Ababa, Ethiopia has formed the Young Ethiopian Key messages Scientist Network for health research and development (YENet). The idea is that the scientific enterprise should align with society’s needs (and vice versa). The group received a University-sponsored and student-led community- based programmes in resource-poor settings provide new mechanisms to ensure resources are mobilized and coordinated meaningfully; New training instruments, including interdisciplinary neglected diseases curricula, provide capture and We believe a bottom-up approach driven by students mature interest in neglected diseases; and young researchers across disciplines is an under- Young scientist networks are emerging globally utilized method to impact research priorities to help align society’s needs with science (and vice versa).
92 Global Forum Update on Research for Health Volume 5 91-93 Kishore:GF5 22/10/08 09:37 Page 93
Social innovations
Sandeep P Kishore is enrolled in the Weill Cornell Medical Essential Medicines. He completed his BS in Biology at Duke College/Sloan-Kettering Institute/Rockefeller University University and his MSc in Immunology at Oxford University. Tri-Institutional MD-PhD programme. His scientific research concerns characterizing gene activation in the parasite Pius Mulamira is a second-year medical student at Makerere responsible for malaria. He has been involved in student-led University in Kampala, Uganda. He is interested in a career in global health efforts through assembling a Forum on Neglected biomedical research on neglected diseases and, along with Diseases, integrating global health into medical school curricula, student leaders at Makerere University, has initiated the first and successfully advocating for the inclusion of a cholesterol- UAEM chapter in Africa at his university. lowering statin on the World Health Organization's Model List of
References
1. Chokshi DA & Rajkumar R (2007) Leveraging university research to Secondary Prevention of Cardiovascular Diseases in the WHO Model List advance global health. JAMA 298, 1934-1936. of Essential Medicines 2. Kapczynski A, Crone ET, & Merson M (2003) Global health and university http://mednet3.who.int/EML/expcom/expcom15/applications/newmed/stati patents. Science 301, 1629. ns/Statins.pdf. 3. Magrini N KS (2007) Proposal for the Inclusion of a Statin for the
Global Forum Update on Research for Health Volume 5 93 96-98 gallin:GF5 22/10/08 09:37 Page 96
Social innovations
Supporting implementation research partnerships for health systems strengthening: one foundation’s approach in sub-Saharan Africa
Article by Elaine K Gallin, Program Director for Medical Research, Doris Duke Charitable Foundation, United States
verburdened by poor health, sub-Saharan Africa (MDGs) by 2015 will require a renewed focus on accounts for more than 50% of the world’s under-five strengthening health systems so that they can provide Omortality but has just 15% of the world’s under-five integrated primary health care thereby reducing maternal and population. Similarly, approximately 920 women per 100 child mortality4. A particularly notable effort in this regard has 000 die from pregnancy-related causes each year in sub- been the International Health Partnership Plus, which Saharan Africa. In developed countries, the figure is just consists of nine international organizations and ten donors eight1. Most other health indicators tell a similar story. The who came together in 2007 to focus on health outcomes region’s health systems, which have been weakened by related to the health MDGs5. Some of these funders are decades of under-investment, are struggling to deliver simple redirecting a portion of their resources to help bolster the interventions such as insecticide-treated bed nets, capacity of regional health systems6. rehydration therapy to treat diarrhoea and de-worming medications. It has been estimated that “full access to and The implementation knowledge gap utilization of proven, effective interventions would avert two Whether the focus is on care for individual diseases or the thirds of child deaths and three quarters of maternal deaths”2. provision of integrated primary health care, the gap between But this is unlikely to occur unless the severe shortages in existing therapies and prevention of human diseases and the health workers, the inadequate health infrastructure and translation of that knowledge into measurable improvements inefficient procurement delivery, and information systems in in population health in low-resource regions is often sub-Saharan Africa are addressed. daunting. Strong evidence about what works most effectively in different settings where there are multiple disease burdens Shifting the focus back to primary health and limited resources is often lacking7. Moreover, even if care and systems improvements there is evidence about effectiveness on a small scale, large- Much of the unprecedented investment in global health scale delivery can present additional challenges8. As noted in occurring in the last two decades has been directed towards a recent commentary in Science, there is a critical need to single-disease or intervention programmes, which are support implementation science which “creates generalizable sometimes referred to as vertical programmes. Investments in knowledge than can be applied across settings and contexts these vertical programmes have resulted in significant to answer central questions”9. Filling the knowledge progress, but they also have negative effects in severely implementation gap requires a strong foundation of metrics resource-constrained areas because they compete with each and evaluation10. It also will require interdisciplinary teams other for scarce health workers and other limited resources3. that include experts in health services delivery, economics Achieving the health-related Millennium Development Goals and management sciences, among other areas. Unfortunately, when compared to the infusion of funds for health services, little has been invested in health The Doris Duke Charitable Foundation (DDCF) has launched systems research11. a new initiative, described here, to increase the knowledge As demonstrated by the Mexican health insurance reform available for evidence-based health systems planning and known as Segura Popular, which rigorously documented stimulate innovations in scaling-up health services delivery systems changes that increased uptake of existing health services by the previously uninsured, high quality measurements of a health system’s performance not only
96 Global Forum Update on Research for Health Volume 5 96-98 gallin:GF5 22/10/08 09:37 Page 97
Social innovations
enable local policy-makers to make informed decisions, but expectations is likely to require that PHIT partnership teams it can empower them to overcome political obstacles12. While employ a variety of innovative approaches. similar large-scale projects aimed at improving health PHIT partnership grants will be awarded through a multi- systems in measureable ways have yet to be conducted in stage competitive peer-reviewed process, which will result in sub-Saharan Africa, smaller projects in the region have a maximum of six successful teams each receiving support reported significant health outcomes attributable to systems ranging from US$ 8 million to US$ 15 million for a period of improvements. For example, the Community Health and five to seven years. Figure 1 outlines the three-stage selection Family Planning Project in Ghana found that posting nurses process that began with a solicitation for letters of interest who worked with volunteer community health workers to from potential partnership teams working in one of nine sub- rural communities reduced child mortality by half in three Saharan African countries16. Applicants were requested to years13. Similarly, various health systems strengthening identify health systems bottlenecks, weaknesses and funding efforts between 2000 and 2004 were associated with a gaps that limit the provision of large-scale primary health 24% decrease in under-five child mortality in Tanzania14. In care in a specific region and work with African institutions, order to both maximize the current investments in global regional governments and other sectors to develop a health health and to encourage additional investments, more service delivery plan that builds on existing health attention needs to be paid to filling the knowledge programmes and coordinates with national health plans. implementation gap so that policy-makers have the tools A total of 137 letters of interest were received with multiple available to make evidence-based decisions. teams applying from all of the nine targeted countries. The initiative’s Advisory Council and other experts recommended DDCF’s initiative: population health that 29 teams be invited to submit proposals to receive six- implementation and training partnerships month planning grants. The 29 PHIT planning grant With these needs in mind and after consultations with many applications proposed many different approaches to address experts15, DDCF has committed up to US$ 100 million to health systems bottlenecks and deficiencies including help catalyze a shift from a focus on single-disease workforce task shifting, building on school-based programmes to an emphasis on strengthening health programmes, developing youth-centred training projects, and systems to effectively deliver integrated primary health care creating quality assurance teams. Criteria for awarding to underserved populations in sub-Saharan Africa. planning grants included: (1) the local experience and Announced in September 2007, the initiative is part of quality of the team; (2) the potential for impact in the region; DDCF’s commitment to support clinical research that (3) the implementation research plan; and (4) alignment advances the translation of biomedical discoveries into with local and national health plans. It is expected that at improved human health. The initiative aims to (1) provide least nine teams will receive six-month grants in early integrated primary health care and achieve significant, autumn 2008 to support their efforts in developing measurable health improvements in up to six communities/ comprehensive milestone-driven five- to seven-year work districts in sub-Saharan Africa; (2) strengthen health systems plans. It is anticipated that the last stage of the selection in the selected communities/districts so local and national process will be completed in June 2009 when the governments can sustain these improvements beyond the comprehensive work plans developed during the planning grant period; and (3) increase the knowledge available for phase are reviewed, and up to six teams selected to receive evidence-based health systems planning by supporting PHIT partnership awards. implementation research. The Institute of Health Metrics and Evaluation has created The initiative will centre on funding a small portfolio of a PHIT Partnership Implementation Research Framework17 to large-scale projects referred to as Population Health and define the terminology used by applicants, review study Implementation Training (PHIT) Partnerships for five to seven design issues, and provide a list of the health systems years. Each PHIT partnership is expected to provide indicators commonly used in implementation research on integrated health services delivery to a population of at least 250 000 and to link these activities to rigorous implementation research. Implementation research is September 2007: call for letters of interest defined broadly to include all aspects of monitoring and evaluation as well as operations research that enhances the knowledge base about the efficient delivery of health care to January 2008: 29 teams invited to submit planning grant proposals resource-constrained populations. PHIT partnerships are not expected to create stand alone health service delivery projects. Rather, whenever possible, they are expected to October 2008: award six-month planning grants to 9 or more teams build upon already funded programmes, coordinate with national health plans and strengthen existing databases and processes. PHIT partnerships are also expected to harmonize June 2009: award PHIT implementatin grants to up to six teams with and link to other programmes using common indicators and measurement tools, as well as to build local capacity to Figure 1: PHIT partnership selection process carry out rigorous implementation research. Meeting these
Global Forum Update on Research for Health Volume 5 97 96-98 gallin:GF5 23/10/08 10:10 Page 98
Social innovations
health service delivery. While it is anticipated that the Key messages partnerships will employ different approaches in designing their research, it is expected that there will be a set of core Strengthening health systems to efficiently provide data collected by all partnerships. PHIT partnership teams integrated primary health services in sub-Saharan will also participate in a grantee network, contribute a shared Africa requires not only more resources but database, and attend annual meetings. implementation research to determine what works In conclusion, implementation research is needed to and how to efficiently and rapidly scale up those increase the knowledge base on how to strengthen health interventions that do work. systems and efficiently provide integrated primary health care The Doris Duke Charitable Foundation (DDCF) has in severely resource constrained regions of sub-Saharan launched a new initiative, described here, to Africa. While there are no easy or quick solutions, the Doris increase the knowledge available for evidence- Duke Charitable Foundation’s African Health Initiative based health systems planning and stimulate provides one approach to addressing this issue. By funding a innovations in scaling-up health services delivery. few large-scale projects that build on existing programmes in The initiative will support a portfolio of large-scale specific regions, rigorously monitor and test different health service delivery projects – referred to as approaches, and share data, it is hoped that health will be Population Health Implementation and Training improved, health systems will be strengthened and new Partnerships – that provide integrated primary knowledge will be gained. J health care linked to rigorous implementation research. Elaine K Gallin is Program Director for Medical Research at the Doris Duke Charitable Foundation (DDCF) and helped design and manage a grant portfolio which aims to support and strengthen this paper. Before joining DDCF, Dr Gallin spent 20 years working clinical research. While the focus of those programmes had been for the US government as a researcher, congressional science in the United States, they have also included operations research fellow and lastly as Deputy Director of the Office of International in Africa, as well as the new African Health Initiative described in Health Programs in the US Department of Energy.
References
1. UNICEF. State of the children’s world 2008: child survival. New York, 10. Murray CJL, Frenk, J. Health metrics and evaluation: strengthening the 2008. science. Lancet, 2008, 371:1191–1199. 2. UN Millennium Project 2005, Who’s got the power. Taskforce on Child 11. Sanders D and Haines A. Implementation research is needed to achieve Health and Maternal Health, New York. international health goals. PLOS Medicine, 2005, 3:720-721. 3. Reich, MR et al. Global action on health systems: a proposal for the 12. Frenk J. Bridging the divide: global lessons from evidence-based health Toyako G8 summit. Lancet, 2008, 371: 865-869. policy in Mexico. Lancet, 2006, 368:954-961. 4. Murray CJL, Frenk J, Evans T. The global campaign for the health MDGs: 13. Binka B et al. Rapid achievement of the child survival millennium challenges, opportunities, and the imperative of shared learning. Lancet, development goal: evidence from the Navrongo experiment in Northern 2007, 370:1018–1020. Ghana. Tropical Medicine and International Health, 2007, 12:578. 5. Scaling up for better health. Work plan for the International Health 14. Masanja H et al. Child survival gains in Tanzania: analysis of data from Partnership and related Initiatives (IHP+), September 2007 to March demographic and health surveys. Lancet, 2008, 371:1276-1283. 2009. 15. The DDCF African Health Initiative Advisory Council includes the 6. Lazzari S. Maximizing positive synergies between health systems and following members: Marian Jacobs, Roger Glass, Demisse Habte, Barry global health initiatives. The Global Fund, WHO expert consultation on Bloom, Francis Omaswa, Adetokunbo Lucas and Miriam Were. However positive synergies between health systems and global health initiatives, many other experts have reviewed proposals and contributed to this 2008. initiative. More information on the initiative can be found at 7. Buekens P et al. Evidence-based global health. Journal of the American ddcf.org/mrp-ahi. Medical Association, 2004, 291:2641. 16. The nine focus countries are: Ghana, Lesotho, Kenya, Madagascar, 8. McCannon CJ et al. The science of large-scale change in global health. Malawi, Mozambique, Rwanda, Tanzania and Zambia. Journal of the American Medical Association, 2007, 298:1937–1939. 17. Ravishankar N et al. Doris Duke Charitable Foundation PHIT Partnership 9. Madon T et al. Implementation Science. Science, 2007, Implementation Research Framework, 2008. Obtained online at 318:5857–5859. http://www.ddcf.org/mrp-ahi.
98 Global Forum Update on Research for Health Volume 5 99-102 Whitworth:GF5 22/10/08 09:36 Page 99
Social innovations
The practical impact of research in South-East Asia funded by the Wellcome Trust
Article by Jimmy Whitworth (pictured), Head of International Activities, Wellcome Trust, United Kingdom with Ruth Branston and Michael Chew
he Wellcome Trust South-East Asia Major Overseas The Wellcome Trust South-East Asia Programme Programme began in 1979 as a collaboration between established clinical research groups with laboratory support Tscientists from Oxford University in the UK and Mahidol across Thailand to conduct clinical research on illnesses of University in Bangkok, Thailand, to undertake tropical major public health importance. In the case of malaria this medicine research, and has now grown into a major network meant initially working on the Thai-Cambodia border, where that today enjoys an international reputation for excellence in there was the highest incidence of malaria and the parasite clinical research in many important tropical diseases. What strains were highly resistant to therapies of the day. Much of started as a small unit headed by Professor David Warrell to the subsequent work on malaria treatment has been study snake bites and severe malaria has now evolved into a conducted on the Thai-Burmese border at the Shoklo Malaria major contributor to global tropical medicine research efforts Research Unit established in1986. With a keen eye for in infectious diseases of global and regional significance, collaborative research opportunities outside Thailand, links including: malaria, melioidosis, rickettsial diseases, were forged with the Hospital for Tropical Diseases, Ho Chi leptospirosis, dengue, typhoid, tuberculosis, tetanus, bird flu, Minh City, Vietnam, in 1991, and Mahosot Hospital, meningitis and encephalitis. Vientiane, Lao PDR, in 1999 to bring a regional dimension to This trajectory has been in keeping with the Wellcome the work. Trust’s policy of identifying promising scientists with The network is now firmly established with operationally important questions and being prepared to support them in independent teams across South-East Asia at two hubs in the long term. We usually award junior level fellowships or Bangkok and Ho Chi Minh City and at major centres in Mae project grants initially, and then provide incrementally larger Sot and Vientiane. The Thailand unit has spread its network grants over time as these individuals demonstrate their ability extensively through research collaborations in many countries to conduct excellent scientific research to answer the across Asia and even into Africa, where partnerships have questions they have set themselves. Over time successful been set up for antimalarial artesunate therapy trials researchers will attract teams of scientists around themselves, (registered as AQUAMAT), for an international effort with eventually forming a critical mass in the form of a centre or Interpol to tackle counterfeit drugs1 and, more recently, for a unit. These centres over time can expand further through the worldwide antimalarial resistance surveillance network development of satellite units, or through hub-and-spoke (WARN)2. Work on melioidosis, cryptococcal infection, mechanisms leading to the establishment of region-wide leptospirosis and the rickettsial diseases is based in rural networks. In the case of the South-East Asia Major Overseas hospitals at Udon Thani and Ubon Ratchathani near the Lao Programme, the network stretches from India to Indonesia and Cambodian borders respectively. The unit in Vietnam has and provides a platform of research-experienced collaborative also evolved gradually and has itself a satellite unit in Hanoi, centres for the conduct of major trials and studies (see Figure and networking sites in several Asian countries, focusing on 1). This region is densely populated with half of the world’s research in typhoid, tetanus, dengue, malaria, meningitis, human population living within 3200 kilometres (2000 encephalitis, tuberculosis and avian influenza. The latter miles) of Bangkok, often in close proximity to domestic and potential global threat precipitated the establishment of a wild animals. regional research network – the South-East Asia Influenza Right from the beginning, the strategy in South-East Asia Clinical Research Network – which is co-ordinated by the incorporated several key principles: close integration with Vietnam unit and involves other partner institutions in local institutions, attracting high-calibre staff both nationally Vietnam, Thailand and Indonesia, including the Thailand and internationally, identifying and responding rapidly to Unit. International partners include Oxford University, the diseases of public health relevance, formulating studies of the National Institutes of Allergy and Infectious Disease, the highest quality to understand and tackle the diseases, Wellcome Trust and the World Health Organization (WHO)3. developing research and institutional capacity, and translating Inseparable from the research activities, the trust’s South- the evidence of research into policy and practice. East Asia Programme has been actively engaged in capacity
Global Forum Update on Research for Health Volume 5 99 99-102 Whitworth:GF5 22/10/08 09:36 Page 100
Social innovations
strengthening through training of clinical scientists from across the region and building world-class clinical research infrastructure. Global health is an international endeavour and the Thailand unit staff, which now numbers 370, represent 15 different nationalities, although host country staff make up more than 90% of the workforce. Dozens of Thai, Laotian and Vietnamese scientists and clinicians have completed degrees from undergraduate BSc theses through masters and PhDs to post- doctoral fellowships. Significant investments primarily from the Wellcome Trust in project grants, fellowships and core funding for research in modern research offices and laboratories have underpinned the programme’s current standing as a global leader in tropical medicine research. A very close integration with local institutional partners has meant that research strategies have always been formulated around local health priorities, and as a result, outputs are quickly translated into policy and practice both nationally and internationally for maximum impact.
Impact of research From the outset, the work of the programme has focused on clinical research relevant to improved patient health4. This has involved the close integration between clinicians working at the bedside of patients in hospitals and health centres, with public health and laboratory Figure 1: Location of the Wellcome Trust South-East Asia Programme and scientists working on basic science including collaborating centres microbiology, pharmacology, genetics, immunology and allied disciplines. had been the treatment of choice for more than 350 years5. Malaria The programme has developed methods of assessment of Work done at the Thai unit in the 1980s provided antimalarial drugs, including the introduction of genotyping comprehensive clinicopathological descriptions of severe which allowed for the first time large trials to be conducted malaria which influenced international policy by forming the in endemic areas, and has used pharmacological techniques basis for the first WHO severe malaria management to establish the optimal regimens of artemether-lumefantrine, guidelines. These together with the identification and artesunate-mefloquine6 and dihydroartemisinin-piperaquine, characterization of low blood sugar as a major manifestation which are the main antimalarial drug combinations in of severe malaria, and pioneering work on the development use today. of dose regimens for chloroquine injections and the The research group has also demonstrated the adverse introduction of loading doses of quinine had a major impact effects of malaria in pregnancy. Even in low transmission on the mortality from severe malaria, particularly in the first settings there are reductions in birth weight and infant 24 hours after admission. survival associated with both falciparum and vivax malaria. Subsequent work by the programme which started in the They have also shown through pharmacological studies that 1990s has pioneered the development, evaluation, and women in late pregnancy are systematically underdosed with introduction of artemisinin combination treatment (ACT) current antimalarial treatment regimens, and through clinical which is now the first-line treatment for falciparum malaria studies that artemisinins in pregnancy are safe, leading throughout the world (see Figure 2). The effects of ACTs on to the lifting of prescribing restrictions in the second and transmission and incidence of malaria have been third trimesters. characterized and the largest ever-randomized trial in severe malaria, using the established network of clinical research Other infections collaborating sites, showed a reduction in mortality Dengue, a viral infection spread by mosquitoes, is a of 35% with artesunate compared to quinine, which perennial problem in South-East Asia, and in many cities is
100 Global Forum Update on Research for Health Volume 5 99-102 Whitworth:GF5 22/10/08 09:36 Page 101
Social innovations
treatment and this is now recommended by WHO. For cases with multiply-resistant infections, which can be identified by a simple clinical algorithm, the Vietnam unit has shown that the macrolide antibiotic azithromycin or the new fluoroquinolones are the best drugs to use. Several lines of research have focused on various causes of meningitis of public health importance in the region. One common cause of meningitis, cryptococcal infection, is seen in patients with severe immunosuppression associated with advanced HIV disease. Current recommendations for combination antifungal therapy for this condition are based on pharmacological studies conducted in Thailand. For patients with tuberculous meningitis, adding steroids to standard antibiotic treatment reduces mortality by 35%7. This has led to changes in treatment guidelines not only in Vietnam but also in the UK. Other work in Vietnam has highlighted the importance of Streptococcus suis as a cause of meningitis in Asia. Indeed in 2007 an outbreak in China killed at least 100 Figure 2: Artemisia annua (sweet wormwood) plants in pots. The source of artemisinin for the treatment of malaria people. This has implications for diagnosis and treatment in terms of choice of antibiotic and the use of steroids. It the main cause of paediatric hospital admission in the rainy also highlights the need for closer communications season. Dengue may lead to haemorrhage or shock, causing between experts in human and animal health as this serious illness and death in children. Clinical studies of bacterium is associated with pork butchery. dengue in Vietnam have led to improved patient care and outcome through the development of diagnostic tests for early Conclusions identification of infection, the only recent randomized The South-East Asia Programme has focused particularly on controlled trials of patient care such as fluid replacement specific pathogens of importance in the region but has in management, and the use of new antiviral drugs for the first recent years also widened its scope to syndromic approaches time in this disease. This has led to a significant fall in (such as studying causes of fever) and important non- mortality for hospitalized patients with severe dengue to less infectious diseases. For example the network has conducted than 1% in hospitals in Ho Chi Minh City. studies in parts of Thailand, Laos and Vietnam to identify the Despite the existence of a highly effective vaccine for the common causes of patients presenting to hospitals or health prevention of tetanus, clinical cases do still occur throughout units with fever, highlighting the importance of often-forgotten South-East Asia. Studies of patient care in Vietnam have led diseases such as leptospirosis (Weil’s disease) and scrub to a reduction in mortality for patients with tetanus from 40% typhus (tsutsugamushi fever), thereby improving diagnostic to 6% through the development of standardized guidelines for protocols and leading to more rational prescribing8, 9. It has the use of artificial ventilation, improved nursing practices, also identified infantile beri-beri (vitamin B1 deficiency) as reduction of hospital-acquired infections, and the use of the major cause of infant death in the Karen refugee magnesium to reduce the need for muscle relaxants. population and in Laos10. This condition used to kill 10% of Meliodosis is a serious bacterial infection common in all babies, but now that it is recognized, prevented and South-East Asia, probably acquired from stagnant water or treated with thiamine, it is no longer a recognized cause infected soil. Studies on meliodoisis in the 1980s showed of death. that treatment with ceftazidime, a third-generation The South-East Asia Programme, has, through long-term cephalosporin antibiotic, could halve mortality from 80% to sustained funding from the Wellcome Trust, been able to 40%, and this drug immediately became the treatment of contribute greatly to increasing the knowledge base of choice. A continued interest in this infection has made the important infectious diseases in the region and globally. unit the leading meliodosis research unit in the world, This has provided a strong international base for training having conducted 75% of all trials. Current treatment in clinical research. recommendations are based on their evidence on This clinical research with a centre of gravity in South- maintenance combination regimens for eradication treatment. East Asia undertaken in rural, refugee and displaced Over the years the unit has also improved laboratory methods persons populations, as well as in major urban for the diagnosis of melioidosis which are now generally conurbations, has influenced national treatment policies adopted throughout the world. directly. Typhoid is a common cause of fever wherever sanitary It has also provided an evidence base that donors, conditions are poor. A series of randomized controlled trials of governments and the WHO have used to justify their patients with typhoid have demonstrated that the support and to develop their policies for many of the fluoroquinolone class of antibiotic should be used as first-line world’s most important diseases.
Global Forum Update on Research for Health Volume 5 101 99-102 Whitworth:GF5 22/10/08 09:36 Page 102
Social innovations
Research into health is increasingly recognized as critically London School of Hygiene and Tropical Medicine, where he was important in the struggle against death and disease in poor Professor of International Public Health from 1999 to 2004. populations11. The Wellcome Trust-funded South-East Asia Programme is a model for successful and sustainable Ruth Branston joined the Wellcome Trust in 2005 and is a tropical medicine research. Similar Wellcome Trust-funded Science Portfolio Adviser in the Immunology and Infectious programmes are located in Kenya, Malawi and South Africa. J Disease Funding Stream. She oversees the trust’s research portfolio in Asia including the trust’s major research programmes Acknowledgements in Thailand, Laos and Vietnam. She graduated from Bath We are grateful for the inputs and suggestions for this article University in 1997 with a degree in biochemistry and completed a from Nick White (Bangkok) and Jeremy Farrar (Vietnam). PhD in molecular pathology in 2001 at University College We are also indebted for all dedicated work conducted by London. Subsequent to her PhD, she worked for Biovex, a themselves and their teams over the years. For more biotechnology company and also for Defra (UK Department of information about the South-East Asia Programme please Environment Food and Rural Affairs) managing the portfolio of visit: http://www.wellcome.ac.uk/Achievements-and-Impact/ research on bovine TB. Initiatives/International-biomedical-science/Major-Overseas- Programmes/South-east-Asia-programme/WTD003485.htm Michael Chew is a Science Portfolio Adviser at the Wellcome Trust’s Science Funding division and works in the Pathogens, Jimmy Whitworth has been Head of International Activities at Immunology and Population Health department. The department the Wellcome Trust since 2004. He oversees strategy and policy manages the trust’s funding and strategic portfolio in infectious for research in developing and restructuring countries of the world, and noncommunicable diseases, especially in the context of including fellowships, project and programme grants, networks tropical medicine and public health both in the UK and in low- and partnerships. He qualified in medicine in 1979 and has and middle-income countries. Before joining the trust, he worked in The Gambia for Save the Children Fund, and in Sierra undertook research for a PhD in parasitology at Imperial College Leone and Uganda for the Medical Research Council. He has London, followed by postdoctoral work at the Institute of Child worked at the Liverpool School of Tropical Medicine and the Health, London, and Imperial College for 16 years.
References
1. Newton PN et al. A collaborative epidemiological investigation into the malaria with 3-day artesunate-mefloquine combination. Journal of criminal fake artesunate trade in South East Asia. PLoS Medicine, 2008, Infectious Diseases, 1994; 170:971-977. 5:e32. 7. Thwaites GE et al. Dexamethasone for the treatment of tuberculous 2. Sibley CH, Barnes KI, Plowe CV. The rationale and plan for creating a meningitis in adolescents and adults. New England Journal of Medicine, World Antimalarial Resistance Network (WARN). Malaria Journal, 2007, 2004, 351:1741-51. 6:118. 8. Phetsouvanh R et al. Causes of community-acquired bacteremia and 3. South-East Asia Influenza Clinical Research Network. patterns of antimicrobial resistance in Vientiane, Laos. American Journal http://www.seaclinicalresearch.org/ of Tropical Medicine and Hygiene, 2006, 75:978-85. 4. Farrar J. Global health science: a threat and an opportunity for 9. Phongmany S et al. Rickettsial infections and fever, Vientiane, Laos. collaborative clinical science. Nature Immunology, 2007, doi Emerging Infectious Diseases, 2006, 12:256-62. 10.1038/ni532. 10. Luxemburger C et al. Beri-beri: the major cause of infant mortality in 5. Dondorp A et al; South East Asian Quinine Artesunate Malaria Trial Karen refugees. Transactions of the Royal Society for Tropical Medicine (SEAQUAMAT) group. Artesunate versus quinine for treatment of severe and Hygiene, 2003, 97:251-5. falciparum malaria: a randomised trial. Lancet, 2005, 366:717-725. 11. Keusch GT and Medlin CA. Tapping the power of small institutions. 6. Nosten F et al. Treatment of multi-drug resistant Plasmodium falciparum Nature, 2003, 422; 561.
102 Global Forum Update on Research for Health Volume 5 104-106 Xavier Crombe:GF5 22/10/08 09:36 Page 104
Social innovations
Independence and innovation: looking beyond the magic of words
Article by Xavier Crombé, Research Director, Fondation Médecins Sans Frontières, Paris
ndependence and innovation have at least one thing in asked whether humanitarian action is even meant to be an common – they are both highly valued concepts. This is innovative sector? The stated purpose of development aid is Icertainly true for the field of humanitarian action but may to introduce innovation (whether in farming techniques, also apply more generally to modern states and societies. marketing practices, medical know-how or some other field) Which public or private institution, political or social group in order to bring about economic, social or political change, would nowadays claim to oppose innovation and to cherish but humanitarian aid, strictly defined, is about alleviating subordination? In an apparent paradox, however, these two suffering in times of crisis. While development offers a set of nearly universal values of the “modern world” are commonly innovations for a better future, humanitarian action is about held to be under constant threat. Many states claim their right the provision of means of survival in the here and now. Hence to sovereign independence and oppose interference in their the very different attitudes development and humanitarian internal affairs from other independence-conscious states or NGOs have, in principle, towards independence: dev- nongovernmental organizations (NGOs), while post 9/11 elopment professionals usually insist on “partnerships” with humanitarian NGOs have been staging an ever-increasing existing authorities, administrations and “communities”; number of roundtable discussions, workshops and humanitarians, on the other hand, see themselves as filling conferences around the theme “independence under threat”. voids and acting as temporary substitutes for local institutions In a similar vein many NGOs, in public or private, resent in disarray and for uncaring, reluctant or incapacitated donors’ overwhelming demands for reports and paperwork authorities, whether legitimate or de facto. that they think stifle innovation, while donors have been vowing to bring innovative practices to an aid community Lessons from Niger1 lacking adequate accountability procedures. This very distinction lies at the heart of the controversies that One important reason for this trend is that, much like divided the various aid-related institutions in Niger in the concepts of “good governance”, “sustainable development” or course of the 2005 food crisis. To development advocates, “responsibility to protect”, independence and innovation “emergency” humanitarian agencies were guilty of arrogance, produce an easy consensus as long as they remain abstract disrespect for the sovereignty of the Niger government and notions or undefined goals or principles. As soon as they start ignorance of the local context. They emphasized the need for to become concrete, however, one organization’s claim of long-term policies and stable market practices to fix what, to independence is often seen by others as arrogant and self- them, was not an emergency but a chronic crisis. As a result serving opposition to coordinated action, while the they opposed emergency responses, especially free food groundbreaking innovation heralded by one is dismissed by distributions. They argued that this failed to address the another as mindless adventurism or a mere smokescreen. structural causes of the problem and would jeopardize efforts If I bring this measure of relativism to the debate from the made over the previous 20 years to foster sustained outset it is because the possible interactions (and sometimes development, instead trapping Niger’s rural communities in a contradictions) between independence and innovation cannot vicious circle of dependence. Humanitarian “emergency” be addressed if they are thought of as positive in and of NGOs such as MSF counter-attacked by arguing that the themselves, as is so often the case. Independence from ongoing food crisis was evidence of the failure of past policies whom, and for what purpose? These questions are worth based on market deregulation to ensure food security for the asking, especially in the humanitarian field where poorest families. They further criticized development policy- independence is so often unquestioningly presented as a makers for turning a blind eye to the present suffering of the “core principle”, with little elaboration. The same applies to population, in particular ignoring the deaths of tens of innovation, whether technical, scientific, organizational or thousands of malnourished children, all in the name of food some other form. Innovation from what? For what goal? For security improvements and individual producers’ autonomy at whose benefit? In fact the question might legitimately be some distant point in the future.
104 Global Forum Update on Research for Health Volume 5 104-106 Xavier Crombe:GF5 22/10/08 09:36 Page 105
Social innovations
This protracted debate along the all-too-familiar lines of feasible; its results would also be useful for more “classical” emergency versus development aid actually served to emergency situations in war zones. MSF was soon running a obscure the more complex reasoning and interactions that private therapeutic centre in Maradi, financed with its own shaped the 2005 crisis in Niger. Innovation and private funding. Yet, independence in this case bordered on independence had a role in these, but not necessarily in the isolation – while not opposed to it, neither Niger’s Ministry of ways that might have been expected. Health nor the aid community showed any interest in this To all its stakeholders the food security system put in place nutritional project. In contrast, the MSF team’s efforts to have in Niger at the end of the 1990s was highly innovative. It a new and more effective protocol for malaria treatment relied for data collection on state-of-the-art technology for registered at national level met with strong resistance from monitoring food crops, including satellite images provided by the medical authorities, who saw it as impinging on the NASA, and was meant to break away from former state’s sovereignty. Within MSF, the Niger nutritional bureaucratic control by emphasizing market deregulation and programme also received little attention or support. Niger’s monitoring. It was also innovative in that its “core principles” peaceful context meant that it was not a priority for the MSF were partnership and consensus among its stakeholders (the operations department while many doctors, both at government of Niger, the European Union, several bilateral headquarters and field level, remained sceptical about a donor countries and the World Food Programme [WFP]). programme that reduced medical supervision of the These partners in the new approach to food security also had treatment of children with severe conditions. To overcome independence in mind – Niger’s independence from food this internal resistance external expertise (a nutritionist, aid, although donors were responsible for funding grain a psycho-anthropologis) was sought and dispatched reserves to cover possible shortages before that ultimate goal to the field. could be achieved. In 2004 the programme started to show impressive Contrary to an accusation commonly made by results, with 10 000 children treated, more than 80% of development agencies, not all the organizations ringing the them cured. It also began to receive increasing interest: the emergency bell in 2005 were newcomers in Niger. Nor were WFP representative in Niamey was willing for the agency to they necessarily emergency-oriented in their programming reinvest in severe malnutrition in Niger and to purchase prior to that year. Following a series of interventions in the Plumpy’nut from the local production MSF had helped to set country since the mid-1980s addressing either nutritional up in an attempt to lower its cost. This encouraged MSF to needs or epidemics, MSF France had settled down in the push for donors and medical authorities to recognize the Maradi region in early 2002 and embarked on a medium- scale of malnutrition in Niger and to include adoption of the term nutritional programme. The driver behind this decision, innovative therapeutic protocol in their strategic objectives for quite debated at the time, was innovation, both scientific and 2005. Indeed central to MSF’s operational choices, public organizational. The scientific (and technical) innovation was statements and overall role in the 2005 food crisis in Niger Plumpy’nut, a ready-to-use therapeutic food (RUTF) was the goal, set prior to the crisis, of diffusing this tested available in a sachet and the result of progress in nutritional innovation for the treatment of severe malnutrition. The research that had identified the cause of malnutrition as controversies that subsequently erupted reflected resistance micronutrient deficiency rather than lack of protein, a long- from donors and local authorities to this process, notably time creed of nutritionists. Plumpy’nut was the product of because the images of starving children filmed in MSF cooperation between the nutrition department of the French feeding centres were used as evidence of the failing of the public research unit IRD (Institute for Development food security apparatus and were undermining the culture of Research) and a private small-scale food company, Nutriset. consensus upon which it was built. The MSF programme It was not MSF but the nutritional consultancy Valid was marked by both independence and dependence. International that first saw the potential of RUTF. Its Financial independence allowed the organization to carry out members developed a new protocol called Community its nutritional programme on an unprecedented scale, with Therapeutic Care (CTC) which was designed to increase the 40 000 children treated in 2005. At the same time MSF reach of existing feeding centres by allowing most severely remained dependent on a number of other factors: on media malnourished children to be treated at home with the use of coverage of the food crisis, which contributed to a blurring of RUTF. It was this combination of innovations that convinced its message; on the capacity of other NGOs to adapt to the two members of MSF, a nutritionist from the medical- situation; on the ambivalent position of WFP, torn between its technical department and the medical doctor heading the role as donor representative in the food security system and emergency department, to try and implement this new that of emergency food agency; on political infighting within protocol in Niger in 2002. the Niger government; and on local understanding of the The programme they established was about filling a void: crisis and the belated international response to it. with the attention and funding of donors focused on What did the food crisis and the way it was reported do for preventing food crises through crop monitoring and food the diffusion of the nutritional innovation promoted by MSF? market liberalization, therapeutic treatment of severe The use of RUTF for severe malnutrition was registered as malnutrition was no longer available in Niger’s health the national protocol in Niger; nutritional surveys, rare prior system. In addition, Niger was a stable country in which to the crisis, are now routinely undertaken by UN agencies progressive experimentation with this new approach was and NGOs to monitor the situation; and therapeutic feeding
Global Forum Update on Research for Health Volume 5 105 104-106 Xavier Crombe:GF5 22/10/08 09:36 Page 106
Social innovations
centres funded by international donors have flourished. At the standards. With consultants and employees from these global level, WHO, UNICEF and WFP published a joint press sectors being sought by NGOs to bring new expertise to communiqué calling for the international community to humanitarian action, this process of professionalization mobilize to treat severe malnutrition worldwide and reflects a more general evolution in the concept of recommending the use of RUTF combined with the CTC “professionalism” in Western societies. Increasingly method. The Niger crisis certainly had an accelerating effect professionalized NGOs in turn witnessed a change in their on the renewed interest of international health institutions in working environment, one in which they had played an a more medical approach to malnutrition, although this was important part, willingly or not. The successive reforms of also part of a more general trend following a decade of USAID and the creation of DfID in the UK reflected the way exclusive public health focus on infectious diseases. Finally, it in which donors were adapting to the evolution of NGOs. This is also worth noting that this process of adoption, process was accompanied by new requirements and implementation and diffusion of innovation by MSF in Niger channels of control, in much the same way as local and the dynamics of the 2005 crisis have resulted in authorities and communities in the field were adjusting and important changes in MSF’s outlook. MSF’s historical increasing their demands towards better resourced approach to nutrition was limited to emergency situations; aid organizations. having only reluctantly engaged in a medium-term As the work of sociologists and anthropologists shows2, programme in Niger’s context of chronic malnutrition, the innovation and its diffusion can only be understood with organization has now launched an international campaign to reference to the societal context in which they occur. Existing promote increased use of ready-to-use food not only to treat political, economic or symbolic conflicts largely determine the but also to prevent malnutrition in endemic areas. acceptance or rejection of a given innovation, as any innovation inevitably serves some interests while running Social and political processes counter to others. As the Niger case illustrates, this may be As this lengthy account of MSF’s experience with nutrition in the case within a single NGO, between the various Niger has attempted to show, there is no simple equation departments, professions and individuals of which it is made between independence and innovation. Interdependence is up, in the broader aid community or in the local societies more often than not the modus operandi of humanitarian receiving international assistance. The political stakes may of NGOs in the field. It is not their invocation of a “core course differ depending on the aim of innovation – to raise principle”, but their readiness to oppose, when necessary, the “humanitarian standards”, change public health policies or culture of consensus, allied to the weight and credibility their improve the living conditions of local communities, for voice has acquired through years of effective relief action, that example – but these various objectives and the type of enables them (albeit not always) to avoid being tied to the resistance they may encounter are often interconnected. agendas of others. Historically the humanitarian sector has Hence, questioning the links between independence and developed through a series of innovations, usually referred to innovation in humanitarian action is to reflect upon the many as professionalization. This process began in the 1980s, unexpected ways in which our own evolution has changed when NGOs were faced with the daunting task of meeting the the social and political environment in which we now work, needs of populations living in refugee camps. The purpose of for better or for worse. J professionalization was to develop the means of delivering effective assistance to large groups of people, but it also Xavier Crombé is currently a research director at the Fondation increased humanitarian agencies’ autonomy of decision MSF and teaches humanitarian affairs at the Institut d’Etudes and action. In the Cold War context, however, aid provided Politiques in Paris has been working for the humanitarian by primarily Western NGOs was hardly perceived organization Médecins Sans Frontières (Doctors Without as independent. Borders/MSF) since 2000 and has completed several field Medical kits, new logistics tools and water engineering are missions, including in China (Tibet), Afghanistan and Darfur. He the most obvious innovations of this period. But joined the Fondation MSF, a research unit in the Paris office of professionalization subsequently incorporated other forms of Médecins Sans Frontières in 2004. He has recently co-edited with innovation, including some borrowed from the commercial Jean-Hervé Jezequel a book on the 2005 food crisis in Niger: Niger and other sectors like new means of communication, 2005, Une Catastrophe Si Naturelle, Paris, MSF/Karthala, 2007. standardized recruitment techniques and accounting
References
1 The following section is derived from various contributions in Xavier 2 For a useful synthesis, see Jean-Pierre Olivier de Sardan, Anthropology and Crombe & Jean-Herve Jezequel (eds.) Niger 2005, une catastrophe si development, understanding contemporary social change. Zed Books, naturelle. Paris Karthala/MSF, 2007 (English version forthcoming 2008). London, 2005.
106 Global Forum Update on Research for Health Volume 5 107-111 Mylene Lagarde:GF5 22/10/08 15:53 Page 107
Social innovations
Creating incentives to induce behavioural change and improve health: success and limitations of conditional cash transfer programmes Article by Mylene Lagarde, (pictured), Research Fellow, Health Economics and Financing Programme, London School of Hygiene and Tropical Medicine with Andy Haines and Natasha Palmer
he debut of the first conditional cash transfer Finally, these programmes are also justified by the need to (CCT) Programme, called Progresa (subsequently address more entrenched demand-side obstacles, such as TOportunidades), in Mexico, was paradoxically rooted in the cultural barriers or the failure to perceive the benefits of willingness to cut social spending. As the Mexican economy was preventive health interventions. seriously hit by the Peso crisis, the Ministry of Finance decided to replace the traditional in-kind transfers to the poor by an Characteristics of experiences to date innovative experiment that would target fewer, more needy Following the success and promotion of the original Mexican households, and offer them cash on the condition that they programme, many Latin American countries have implemented comply with a set of requirements, intended to break the vicious similar conditional Cash Transfer Programmes (see Table 1). circle of poverty1. Initially implemented on a relatively small- CCT programmes have been less common in other parts of the scale, Progresa was found to be an effective mechanism world, although recent experiences with health components particularly for improving uptake of preventive interventions have been launched in Turkey3, Nepal4, India5, Kenya6 and at a for children by 2001, and subsequently scaled-up at the small scale in Malawi7. It is worth noting that the majority of national level in Mexico. Its principles were soon replicated in CCT interventions have occurred in middle-income countries. other Latin American countries, and more than 10 years later, This is likely to be due to their relatively high cost, and the dozens of other CCT schemes have now flourished from fact that they often rely on complex information and Honduras to Ecuador or Nepal, with one of the most recent management systems8. implemented in the city of New York. Inspired by the original example of Progresa, many countries Conditional cash transfers have been categorized as a have introduced CCT programmes where the compliance with particular form of performance-based payments2, which health conditionalities is only one dimension of a broader make cash payments to households contingent on a set of intervention (see Table 1). This is justified by the overall behavioural requirements, such as attending regular health objective of those interventions which is to provide support to check-ups or sending one’s children to school. The ultimate families dwelling in extreme poverty, in order to develop the objective of CCT is twofold. In addition to a short-term poverty potential of the household members in the long run. reduction created by the increase in income, CCTs are A more limited number of programmes have had much designed to act as powerful incentives for households to narrower objectives, typically focusing on improving particular adopt a behaviour that will positively impact on their well- preventive health behaviour. Examples include the use of CCT being, and break the cycle of poverty in the long run. to incentivize the participation in testing for HIV status7 and This particular feature is based on the recognition that there provide incentives for mothers to deliver in health facilities in might be a series of demand-side barriers restraining Nepal4 and India5. individuals from using preventive and basic curative health Most programmes implemented in Latin American countries services. The first demand-side obstacle consists of the have targeted the poorest groups of the population. As poor financial cost individuals must bear when they decide to use people usually face the greatest barriers to access, CCT health services. This cost can be the direct cost of using mechanisms thereby act as transfer mechanisms that health services (when they are not completely free), the redistribute resources to reduce health inequities. Other CCT indirect cost (in particular the cost of transport can create programmes, in particular in lower-income settings, have not major obstacles), and the opportunity cost (for example the targeted specific groups, either because the information loss of revenue incurred by the use of health services instead systems did not allow them to, or to maximize the effects when of spending that time on income-generating activities). initial overall uptake rates were very low in the population4, 5.
Global Forum Update on Research for Health Volume 5 107 107-111 Mylene Lagarde:GF5 22/10/08 15:53 Page 108
Social innovations
Country, programme name and reference Target population Transfer size Conditionalities Parallel intervention(s) Brazil – Bolsa Poorest households from Up to maximum of US$ 18.25. US$ 6.25 per For pregnant and lactating women: attending educational Children received nutrition Alimentação22 selected municipalities (chosen person beneficiary in the household (pregnant workshops, regular check-ups and vaccinations up-to-date. For supplements according to infant malnutrition women or children under 7) children under 7: maintaining vaccinations up-to-date and growth prevalence) monitoring
Colombia – Poorest households from US$ 50 on average US$ 20 per family; US$ 6 For children under 7: attending health and nutrition check-ups. For Familias en selected municipalities (also per primary school child; US$ 12 per secondary children aged 8–18 year old: attending school. For mothers: Acción 13, 33 chosen on poverty criteria) school child. Approximately 30% of household attending health education workshops consumption
Ecuador – Bono Children under 16 and house- US$ 15 per month per household; senior and For children aged 6–16 year old: attending school regularly (more Institutional strengthening de Desarollo holds belonging to the first and disabled heads of household receive US$ 11.50 than 80%). For children under 5: regular health post visits for activities (strengthening the Humano34 second quintile of income per month growth and development checkups and immunizations beneficiary selection system (SelBen) for social programmes)
El Salvador – Red Children under 15 and expectant US$ 15 if eligible for health component only, For women: participating to training courses, and complying with Strengthening of the education Solidaria35 women from families living in US$ 20 if eligible for both health and education basic protocol concerning preventative health. For children aged system (improving facilities and extreme poverty within priority components, US$ 10 if eligible for education 6–14 years old: attending school teaching material availability), municipalities component only (between 15% and 18% of the and a US$ 19 million programme minimum rural salary, bimonthly) of contracting out NGOs to ensure the provision of basic health and Honduras – Children and women from poor US$ 17 on average (US$ 4 per family, US$ 5 per Attending primary school and regular health visits nutrition services Programa de households, living in designated child). Approximately 10% of household Asignación beneficiary municipalities consumption - Familiar 11 (chosen on socioeconomic criteria)
India – Janani Pregnant women belonging to Rs 700 in rural areas and Rs 600 in urban areas Attending at least 3 antenatal and post-birth check-ups and In low-performing States (with low Suraksha Yojana5 poorest households, aged older delivering in a public health facility (programme benefits are institutional delivery rates), an than 19 years, and for up to 2 supposed to be extended to women delivering in private incentive is paid to the accredited live births (extended after the facilities too) health worker for each delivery (Rs third live birth if the mother 600 in rural areas and Rs 200 in chooses to undergo sterilization urban areas) immediately after the delivery)
Jamaica – Children under 17 years old, US$ 9 per month per child eligible for For children aged 6–17 years old: attending school. For other Programme for pregnant and lactating women, education component, US$ 9 per month per beneficiaries: complying with required health visits per year Advancement elderly over 65 years, destitute household member eligible for the health (number depends on beneficiary age and status) Through Health adults under 65 years component and Education15
Kenya6 Poor households having Orphan Ksh 1000 (US$ 13.86) for households with up For children aged 6–17 years old: attending school. For children and Vulnerable Children (OVC) to 2 OVC, Ksh 2000 (US$ 22.72) with 3–4 OVCs, under 5: regular health centre visits for immunizations. For children aged 0–17 years old as and Ksh 3000 (US$ 42.58) with 5 or more OVCs 0–1 year and for growth monitoring and vitamin A supplement for permanent members children 1–5 years
Malawi7 Individuals doing an HIV test, in US$ 1.04 on average – vouchers of values Collecting HIV test result rural areas between US$ 0–3 per individual were randomly assigned
Mexico – Progresa Eligible households (selected on US$ 20 on average; US$ 13 per family; US$ For children: attending primary and secondary school attendance; Children received nutrition (renamed poverty criteria) among selected 8–17 per primary school child; US$ 25–32 per and complying with regular health visits and immunization supplements – allocation was not Oportunidades) 10, 16, communities (selected on secondary school child; US$ 12–22 grant once schedule. For pregnant women: complying with regular health visits random and children in “control” 18-21, 36 poverty criteria) a year for school supplies – approximately 25% and attending health education workshops areas could also have received of household consumption them
Nepal – Safe Pregnant women with no more 1500 NRs in mountain areas, 1000 NRs in hill Giving birth in a public health facility Trained health workers receive an Delivery Incentive than 2 living children or an areas, 500 NRs in the lowlands (30–50% of the incentive of NRs 300 for each Programme4 obstetric complication mean transport cost to the health facility) delivery, and facilities are reimbursed NRs 1000 per delivery to recover the cost (as deliveries are Nicaragua – Red de 42 municipalities chosen to US$ 25 on average US$ 18 per family; US$ 9 For mothers of children under 5: attending educational workshops free of charge for women). The Protección Social12 participate in the pilot phase: per family with school-age child; US$ 20 once a and bringing children to preventive health programmes programme trained and contracted 50% randomly selected for year for supplies. Approximately 20% of For children aged 7–13 years old: attending school private providers to deliver the intervention household consumption health services required.
Paraguay – Red Children aged 0–14 (including Health and education transfer of US$ 5 per For children aged 25–60 months: attending educational centres (early stimulation). For children de Protección y street children), and pregnant child aged 0–14 years old (up to 4 children per aged 5–14 years: attending basic schooling. For children aged 0–24 months: visits to health centre Promoción Social37 women in extreme poverty household) plus an additional US$ 10 per for growth/development monitoring. For children aged 25–60 months: visits for growth monitoring. household. For children aged 5–14 years: medical check-ups and preventative dental care. For pregnant and lactating women: visits to health facility for pregnancy check-ups and post-partum control
Peru – Juntos38 Children and pregnant or US$ 33 For children under 5: preventative health care visits for children 0–5 years. For pregnant and lactating women from poorest lactating women: complying with pre- and postnatal care visits, attending nutrition training households in rural sessions. For children aged 6–14 years old: attending school. For all: obtaining birth certificates communities or ID cards (for individuals older than 18 years)
Turkey – Social Risk Poor families with children and Bimonthly transfers of education: primary US$ For school age children: attending school. For children aged 0–6 years: complying with regular Management pregnant women 13 for boys, US$ 16 for girls; secondary US$ 20 visits to health clinics. For pregnant women: regular attendance to prenatal and postnatal check- Project3 for boys, US$ 28 for girls. ups and giving birth at hospitals Bimonthly transfers of health: US$ 12 per month per child, US$ 12 per month during pregnancy, US$ 39 for birth at health centre Table 1: Description of CCT programmes with health components
108 Global Forum Update on Research for Health Volume 5 107-111 Mylene Lagarde:GF5 22/10/08 15:54 Page 109
Social innovations
Finally, it should be underlined that many of the early CCT groups should also noted, although the reasons behind these programmes have been carefully designed and implemented in differences in findings are unclear, except in one case where a fashion that has allowed a robust evaluation of their impact9. contamination in control groups might have hidden a positive This is an innovative trait for such large-scale social effect12. Some of the apparent differences in different interventions, which seems to have originated from the initial age groups may also be spurious and related to multiple sub- commitment to rigorous design of the evaluation of Progresa. group analyses. Even when randomized evaluations have not been possible for Finally, some of these mechanisms have been linked to political or logistical reasons, close monitoring and meticulous improved health outcomes. The Colombian programme data collection have usually allowed independent researchers Familias en Acción, improved the nutritional status of newborns to carry out good impact evaluations9. In this respect CCT and infants13, although not that of children older than 24 programmes have set an example to be emulated by other months old. Progresa was found to have improved the policy-makers and demonstrated that it is politically and nutritional status and growth of children17-20 and was associated administratively feasible to randomize access to potentially with lower prevalence of obesity and hypertension amongst beneficial interventions when their benefits have not yet adults21. The proportion of under-weight and stunted children been shown. had been reduced amongst the beneficiaries of the Nicaraguan Overall CCTs display several innovative features. Their CCT programme12. However, the Brazilian programme Bolsa requirements intend to go beyond the traditional wealth effect Alimentação programme was found to have a negative impact of simple cash transfers, by incentivizing households to adopt on weight-for-age for children under 7 years old, which seems beneficial behaviours while at the same time addressing to have been caused by a misunderstanding of eligibility criteria demand-side obstacles to accessing health services. for the programme by participating mothers22. The potential positive effects of CCTs on anaemia are more Evidence of effectiveness subject to debate, as the positive effects found for the Mexican A series of positive effects of CCT programmes on health-related programme17, 19 might have been biased9, 20, while the outcomes have been demonstrated. Nicaraguan intervention was probably not12. Finally, two CCTs have been found to improve significantly the uptake of programmes demonstrated some positive effects on children’s preventive services. A small scale project in Malawi7 found that health as reported by their mothers13, 17. monetary incentives increased the percentage of individuals In addition to their direct benefits on health outcomes, CCTs collecting HIV test results, and that the effect was increasing have proved effective at increasing investments in what with the amount of the cash transfer. In Mexico, families economists call “human capital”, thereby potentially improving benefiting from Progresa visited health facilities twice as much long-term opportunities and living standards of beneficiaries. as non-beneficiary families10. In Honduras, the PRAF First, several CCT programmes have increased enrolment rates programme significantly increased health service utilization for of children from beneficiary households at school8, which is pre-school children11, the uptake of routine child check-ups and widely recognized as critical for the improvement of children’s growth monitoring visits, and the use of antenatal care, even if future opportunities. A study of the Mexican programme also no effect was found on the uptake of post-delivery check-ups. showed positive effects on cognitive development for children18. In Nicaragua, the Red de Protección Social scheme improved Second, CCT programmes have demonstrated a positive effect the proportion of disadvantaged infants (0–3 years old) taken on household food consumption. Two studies, one on the to health centres in the past six months, both one and two Colombian experience23 and the other on the Mexican years after it had started12. Finally, in Colombia, CCTs were programme24, have shown that receiving cash transfers was found to increase the uptake of preventive health care visits for associated with an increase in quantity and quality of food children aged less than 4 years old13, 14. The PATH programme consumed, which would undoubtedly be beneficial for the in Jamaica was recently found to be effective at increasing the health of beneficiaries. Third, some findings suggest that CCT use of preventive health care for children in recipient families15. can provide opportunities to poor households to break the Lastly, the Safe Delivery Incentive Programme in Nepal was vicious circle of poverty. For example, investments in income- found to be effective in increasing use of skilled attendance generating activities have been associated with CCTs in at delivery and reducing the probability of a woman delivering Colombia23 and Mexico25. at home4. Overall, despite some methodological concerns9 there is a Conditional cash transfer programmes have also sometimes broad and reasonably robust body of evidence suggesting that proved to be an effective intervention to increase immunization CCTs are powerful instruments to improve directly or indirectly rates among children. Positive effects were found in Mexico on the health of beneficiaries, or increase the uptake of preventive measles and TB vaccination rates16, in Honduras on the health measures. coverage of the first dose DTP/pentavalent vaccine and in Colombia on the probability that children aged 24 months old Limitations had complied with the DPT vaccination schedule. The absence Despite these successes, a series of issues should be kept in of long-term effects of Progresa on immunization rates suggest mind to apprehend the replicability of CCT programmes to other that CCTs are less effective in further improving rates where settings, in particular in low-income countries, or to consider these have reached a high level9. The lack of impact of these their extension to new areas. programmes on vaccination coverage among particular age To start with, most CCT programmes have been imple-
Global Forum Update on Research for Health Volume 5 109 107-111 Mylene Lagarde:GF5 22/10/08 15:54 Page 110
Social innovations
mented in middle-income countries where they have benefited groups. In particular, the ethics of some programmes using from the existence of adequate basic infrastructure (banks, monetary incentives to encourage irreversible contraceptive roads and health facility network) and information systems that methods5, 31 should be questioned. Similarly, one can wonder have contributed to the success of their targeting strategies. whether it is ethical to use monetary donations as an incentive Some programmes have in fact been complemented by for individuals not to contract sexually transmitted infections, supply-side interventions (see Table 1) to ensure the provision and stop providing them when they are found to be sick32. of good quality health or education services. The lack of reliable infrastructure in lower-income settings might mitigate Conclusion the success of CCTs. Preliminary findings in Nepal suggest that The introduction of conditional cash transfers represents a new failure to provide good quality care and referral transportation and potentially valuable financing tool at the disposal of policy- means might compromise the success of the programme4. makers to tackle health issues. These programmes have been Besides, the actual implementation of CCT programmes found particularly successful at decreasing demand-side requires substantial human and technical capacity, which barriers to access for poorest populations, and incentivize them might be more difficult to find in low-income settings. Recent to increase the use of health services. It is also hoped that their reports from the Nepali and Jamaican schemes4, 15 show that effects might carry over beyond their existence, by initiating lack of communication around the scheme, failure to provide behavioural changes among beneficiaries, although to date clear guidelines to health workers, and financial there is a lack of evidence on that aspect. mismanagement resulting in payment delays can jeopardize its Despite a series of limitations that should be kept in mind success. regarding their implementation in low-resource settings, the Moreover, there are a number of unresolved questions early experiences in Latin America are generally promising and concerning the costs of such programmes. First, as for many further investigation should be made into the desirability and social safety net mechanisms where the proportion of feasibility of such schemes in lower-income countries. In that administrative costs can constitute an important part of the regard, the lessons learnt from a recent intervention in Nepal programme budget26, the cost efficiency of CCTs can be will be very useful to inform further experiences. challenged. Indeed, Caldes and Maluccio27 show that two key Yet, as for any innovative scheme, there is still scope for components in most CCT programmes, targeting and improvement to understand how they should be designed to conditionality, are important driving factors for costs. For the avoid unexpected adverse effects or to maximize their impact Colombian CCT programme, administrative costs represented in low-income settings. Public debate on the ethical aspects of half of the value of actual benefits delivered to beneficiaries27. such schemes should also be encouraged, particularly where Second, given that the entire eligible population satisfying the they are designed to incentivize procedures that may be conditionality receives monetary transfers, regardless of irreversible or may have unintended adverse consequences. whether or not they were meeting the conditionality before the Key messages implementation of the programme, the cost per marginal visit induced to access a health service can be very high28, thereby questioning the cost-effectiveness of the scheme. The Conditional cash transfers have proved to be expansion of CCT programmes to countries where means effective demand-side incentives to increase the testing is too costly or not effective15, 29, makes this issue even uptake of health services and even sometimes more critical. Indeed, not targeting the poorest groups will improved health outcomes. increase the marginal costs of the programmes since utilization When effective targeting mechanisms have been of health services are usually higher among the better-off. This available, CCT programmes have increased access raises the issue of the benefit incidence of such non-targeted of poorest populations to health services. incentive schemes where a disproportionate share of the The presence of adequate infrastructures, political budget might be spent on wealthier groups. The Nepali CCT commitment and technical capacity have often scheme provides a direct illustration of this concern, as existing contributed to the successful implementation of inequalities in use of delivery care services resulted in a greater CCT interventions. proportion of beneficiaries amongst the richer groups4. Thirdly, Further investigation should be made into the the cost-effectiveness of CCT should also be measured against feasibility and cost-effectiveness of Conditional that of other traditional approaches to improve the uptake of Cash Transfers in low-income settings. health services. Typically in low-income settings, increasing the coverage of health infrastructures and strengthening the health system is likely to be more cost-effective than Mylene Lagarde is an economist by training and joined the Health introducing conditional cash transfer mechanisms. Economics and Financing Programme of the London School of Finally, the expansion of CCT interventions might raise Hygiene & Tropical Medicine as a Research Fellow in Health ethical issues. On the one hand, existing programmes have Economics in 2005. She is involved in projects on health financing shown that perverse or unanticipated effects could occur, mechanisms, and health workers’ career choices and motivation in when individuals might seek to become or stay eligible to low- and middle-income countries. She had previously worked as a benefits22, 30. On the other hand, due consideration should be Health Economist in the Ministry of Health in Cameroon, and was in given to the ethical implications of a policy tool that can be charge of the analysis of a KABP survey on HIV/AIDS in France. powerful enough to change the behaviour of poor or vulnerable
110 Global Forum Update on Research for Health Volume 5 107-111 Mylene Lagarde:GF5 22/10/08 15:54 Page 111
Social innovations
Andy Haines became Director of the London School of Hygiene & Natasha Palmer is a Lecturer in Health Economics & Policy with Tropical Medicine in 2001. He was previously Professor of Primary 15 years of experience in policy and research in the health sector in Health Care and Director of the Department of Primary Care & low- and middle-income countries. Her research interests include Population Sciences, at Royal Free and University College Medical health system financing, scaling up HIV treatment and care services, School, and worked part-time as a general practitioner. His research contracting services to nongovernmental organizations, human interests are health services research and epidemiology. He has resources and motivation. She is involved in teaching and research undertaken major intervention trials in primary care settings and degree training at the London School of Hygiene & Tropical Medicine, studied the impacts of climatic factors on health. He sits on many and has collaborative research linkages with institutions in a variety national and international committees. He was knighted in the 2005 of developing countries. She received her doctorate from the New Years Honours list for services to medicine. University of London.
References
1. Grimes C. Do the right things. Financial Times, 24 May 2008, London. Association, 2004, 291(21): p.2563-2570. 2. Oxman AD and Fretheim A. An overview of research on the effects of results- 20. Behrman JR and Hoddinott J. Programme evaluation with unobserved based financing. Report Nr 16-2008, 2008, Nasjonalt kunnskapssenter for heterogeneity and selective implementation: the Mexican PROGRESA impact helsetjenesten, Oslo. on child nutrition. Oxford Bulletin of Economics and Statistics, 2005, 67(4): 3. World Bank, Turkey – conditional cash transfer, in Profile prepared for the p.547-569. Third International Conference on Conditional Cash Transfers (Istanbul, 21. Fernald LC, Hou X and Gertler P. Oportunidades program participation and Turkey, 26–30 June 2006). World Bank: Washington, DC, 2006. body mass index, blood pressure, and self-reported health in Mexican adults. 4. Powell-Jackson T et al. Evaluation of the Safe Delivery Incentive Preventing Chronic Disease, 2008, 5(3): p.2-12. Programme: final report of the evaluation. Support to Safe Motherhood 22. Morris SS et al. Conditional cash transfers are associated with a small Programme, Nepal. Kathmandu, 2008. reduction in the rate of weight gain of preschool children in Northeast Brazil. 5. Ministry of Health and Family Welfare, Janani Suraksha Yojana: Guidelines Journal of Nutrition, 2004, 134(9): p.2336-2341. for implementation. Government of India: New Delhi, 2005. 23. Attanasio O and Mesnard A. The impact of a conditional cash transfer 6. World Bank, Kenya – cash transfer programme for orphan and vulnerable programme on consumption in Colombia. The Institute of Fiscal Studies: children, in Profile prepared for the Third International Conference on London, 2005. Conditional Cash Transfers (Istanbul, Turkey, 26–30 June 2006). World 24. Hoddinott J and Skoufias E. The impact of PROGRESA on food consumption. Bank: Washington, DC, 2006. Economic Development and Cultural Change, 2004, 53: p.37-61. 7. Thornton R. The demand for and impact of learning HIV status: evidence 25. Gertler P, Martinez S and Rubio-Codina M. Investing cash transfers to raise from a field experiment. Harvard University, 2006. long-term living standards. In: World Bank Policy Research Paper 3994. The 8. Rawlings LB and Rubio GM. Evaluating the impact of conditional cash World Bank: Washington, DC, 2006. transfer programs: lessons from Latin America. World Bank Research 26. Grosh M. Administering targeted social programs in Latin America: from Observer, 2005 (20): p.29-55. platitude to practice. The World Bank: Washington, DC, 1994. 9. Lagarde M, Haines A and Palmer N. Conditional cash transfers for improving 27. Caldes N and Maluccio J. The cost of conditional cash transfers. In: uptake of health interventions in low- and middle-income countries – a Economic and Sector Study Series RE2-04-014. Inter-American Development systematic review. Journal of the American Medical Association, 2007, Bank: Washington, DC, 2004. 298(16): p.1900-1910. 28. de Janvry A et al. Can conditional cash transfers serve as safety nets in 10. Gertler P. Final report: the impact of PROGESA on health. International Food keeping children at school and from working when exposed to shocks? Policy Research Institute, 2000. Journal of Development Economics, 2006, 79(2): p.349-373. 11. Morris SS, Flores R, Olinto P and Medina JM. Monetary incentives in primary 29. Jalan J and Murgai R. An effective “targeting shortcut”? An assessment of health care and effects on use and coverage of preventive health care the 2002 below-poverty line census method. Centre for Studies in Social interventions in rural Honduras: cluster randomised trial. Lancet, 2004, Sciences, Calcutta and the World Bank, India, 2006. 364(9450): p.2030-37. 30. Stecklov G et al. Demographic externalities from poverty programs in 12. Maluccio J and Flores R. Impact evaluation of a conditional cash transfer developing countries: experimental evidence from Latin America. program: the Nicaraguan Red de Protección Social. In: Food Consumption Department of Economics, American University, Washington DC, 2006. and Nutrition Division discussion paper No 184. International Food Policy 31. Weeden D et al. Community-based incentives: increasing contraceptive Research Institute: Washington, DC, 2004. prevalence and economic opportunity. Asia-Pacific Population Journal, 13. Attanasio O et al. The short-term impact of a conditional cash subsidy on 1986, 1(3): p.31-46. child health and nutrition in Colombia. The Institute of Fiscal Studies: 32. Jack A. World Bank backs anti-AIDS experiment. Financial Times, 25 April London, 2005, p.15pp. 2008: London. 14. Attanasio O et al. Baseline report on the evaluation of Familias en Accion. 33. Attanasio O et al. How effective are conditional cash transfers? Evidence The Institute of Fiscal Studies: London, 2004, p.168pp. from Colombia. Institute for Fiscal Studies Briefing Notes, 2005. 15. Levy D and Ohls J. Evaluation of Jamaica’s PATH program: final report. 34. World Bank, Ecuador – Bono de Desarrollo Humano (BDH), in Profile Mathematica Policy Research: Washington, DC, 2007. prepared for the Third International Conference on Conditional Cash Transfers, 16. Barham T. The impact of the Mexican conditional cash transfer on Istanbul, Turkey, 26–30 June 2006. World Bank: Washington, DC, 2006. immunization rates. Department of Agriculture and Resource Economics, UC 35. Support for the solidarity network program loan proposal. Inter-American Berkeley, 2005. Development Bank: Washington, DC, 2005. 17. Gertler P. Do conditional cash transfers improve child health? Evidence from 36. Gertler P and Fernald L. The medium term impact of Oportunidades on child PROGRESA’s control randomized experiment. American Economic Review, development in rural areas, 2004. 2004, 94(2): p.336-341. 37. World Bank, Paraguay – Red de Protección y Promoción Social, in Profile 18. Fernald LC, Gertle PJ and Neufeld LM. Role of cash in conditional cash prepared for the Third International Conference on Conditional Cash Transfers, transfer programmes for child health, growth, and development: an analysis Istanbul, Turkey, 26–30 June 2006. World Bank: Washington, DC, 2006. of Mexico’s Oportunidades. Lancet, 2008, 371(9615): p.828-37. 38. World Bank, Peru – Programa Nacional de Apoyo Directo a los más Pobres 19. Rivera JA et al. Impact of the Mexican program for education, health, and “Juntos” in Profile prepared for the Third International Conference on nutrition (Progresa) on rates of growth and anaemia in infants and young Conditional Cash Transfers, Istanbul, Turkey, 26–30 June 2006. World Bank: children: a randomized effectiveness study. Journal of the American Medical Washington, DC, 2006.
Global Forum Update on Research for Health Volume 5 111 113 Title page:GF5 23/10/08 10:18 Page 113
Technological innovations
114 Innovation and access: medicines for the poor – the IGWG strategy and plan of action Bart Wijnberg and Marleen Monster
120 The Noordwijk Medicines Agenda: a model for changing innovation for neglected and emerging infectious diseases Bénédicte Callan with Susanne L Huttner, Iain Gillespie and Barbara Slater
124 Health dynamics, innovation and the slow race to make technology work for the poor Melissa Leach with Ian Scoones
130 Leapfrog technologies for health and development Harry McConnell with Prita Chathoth, Ashley Pardy, Camille Boostrom, Eugene Boostrom, Koos Louw, Luis Gabriel Cuervo and Sumiko Ogawa
138 The IVI’s innovative approach to closing the gap between vaccines for industrialized and developing countries Denise DeRoeck with Anna Lena Lopez, Rodney Carbis and John D Clemens
143 Commercializing African health research: building life science convergence platforms Peter A Singer and Abdallah S Daar with Sara Al-Bader, Ronak Shah, Ken Simiyu, Ryan E Wiley, Pamela Kanellis, Menaka Pulandiran and Marilyn Heymann
Global Forum Update on Research for Health Volume 5 113 114-118 Wijnberg:GF5 22/10/08 09:35 Page 114
Technological innovations
Innovation and access: medicines for the poor – the IGWG strategy and plan of action
Article by Bart Wijnberg (pictured left), Vice-Chair for the European region, WHO Inter-Governmental Working Groupon Public Health, Innovation and Intellectual Property andMarleen Monster (pictured right), Senior Policy Advisor, Directorate General for International Cooperation’s Coherence Unit, Ministry of Foreign Affairs, The Netherlands
his paper will examine why it was urgent for WHO to a reasonable return on investment. In general, both the public establish an inter-governmental working group (IGWG) and private sectors lacked the resources to invest in research. Tthat could draft a multilateral strategy on public health, As a result, the products of innovation that developing innovation and intellectual property rights. We will reflect on countries had to rely on were designed principally to meet the the outcome of the IGWG process and present some ideas on health-care needs of developed countries with well-organized how best to put the strategy into practice. health-care systems6. In most developing countries, patent protection did not bring greater innovation as the market was Background too small, and scientific and technological capabilities were Today 4.8 billion people live in developing countries and 2.7 inadequate7. Furthermore, the monopoly costs associated billion of them live on less than US$ 2 a day. Half of all with patents impacted the affordability of patented health- diseases in these countries are communicable. Governments, care products8. As a consequence, developing countries still the pharmaceutical industry, foundations, nongovernmental face problems related to access – medicines are often very organizations (NGOs) and others recognize that poverty is a expensive, difficult to obtain and ineffective within the health- major factor in preventing access to medicines in the care systems that are in place – and to innovation: for some developing world and are working to encourage the diseases, no treatment, vaccine or cure exist. development of new or adapted medicines and to improve Over the years this traditional system to develop medicines access to them2. has started to crack. Public health-care funding (including medicines) in developed countries has become an The urgency of a new multilateral strategy: increasingly difficult issue because costs have risen due to developing countries are missing out on demographic changes. What is more, climate change and innovation and access globalization have altered the traditional map of diseases. In the 20th century medicines were developed according to Those diseases that historically occurred only in developing an established pattern: pharmaceutical companies would countries are now taking root in developed countries and vice develop a vaccine or medicine though trial and error, versa: the prevalence of noncommunicable diseases such as investing enormous amounts of time and resources in the cancer and cardiovascular disease has rapidly increased in process. Once a vaccine or medicine had been developed, it developing countries. Drug-resistant bacteria and pandemic was patented, creating a monopoly position for the developer, influenza are major threats to global public health, in both the who could then recover high research-and-development costs developed and developing worlds. Until now, it has been by setting a high monopoly price. Provided they were applied difficult, if not impossible, for pharmaceutical companies to appropriately, patents were assumed to encourage innovation2. respond adequately to this complex situation. And the patent The search for the “blockbuster” – a top-selling, often one- system has had difficulties of its own: low standards of size-fits-all medicine – has always been the basis for the big patentability and shortcomings in patent clearance have led pharmaceutical companies’ R&D strategies4. The innovation to patents of poor quality or dubious validity9. cycle in developed countries has to a large extent been A new, more complex system of innovation has now relatively sustainable over the years5. emerged: active campaigns by NGOs have increased public What was this strategy’s effect on health care in developing awareness of the lack of accessible and affordable medicines countries? Where innovation was concerned, the traditional in developing countries and the issue is now receiving more approach to developing medicines failed. There was no attention. Pharmaceutical companies have started to invest significant market demand due to a lack of (collective) more in research on diseases that affect developing countries, purchasing power and inadequate health systems in setting up specific programmes to this end. Large private developing countries. Pharmaceutical companies were not funds have donated resources aimed at finding cures for inclined to develop new medicines for diseases in resource- diseases like malaria, HIV/AIDS and tuberculosis. Some poor countries without a clear market demand that promised companies have introduced tier-pricing systems for
114 Global Forum Update on Research for Health Volume 5 114-118 Wijnberg:GF5 22/10/08 09:35 Page 115
Technological innovations
13 differentiating medicine prices in developing countries. Key elements of the IGWG Global Strategy and Plan of Action Public-private partnerships have been set up to counter the 1. Prioritizing R&D needs market’s failure to develop sufficient products for diseases 2. Promoting R&D that affect the poor. And in researching and developing 3. Building and improving capacity medicines, there is now more consideration for local 4. Transfer of technologies circumstances and resource-poor environments. In the 5. Application and management of intellectual property TRIPS9 Agreement, all World Trade Organization (WTO) (IP) contribute to innovation and promote public health members have adopted a framework of minimum standards 6. Improving delivery and access for intellectual property rights protection, though Least 7. Promoting sustainable financing mechanisms Developed Countries have been allowed to delay 8. Establishing monitoring and reporting mechanisms implementing them until 2016 at the latest11. The 2003 Doha Declaration on the TRIPS Agreement and public health to the multilateral agreements on TRIPS. There is now a was very important in balancing commercial interests against more common understanding of the need to be careful public health interests where intellectual property rights are when adopting public health-related legislation that goes concerned. The 2003 Declaration facilitated access to beyond the TRIPS Agreement. affordable medicines for developing countries by allowing The means for increasing developing countries’ access to flexibility on intellectual property rights. Progress was under medicines, as provided for in the TRIPS Agreement, way, but more needed to be done. have been made more explicit. In addition, the WHO member states have reaffirmed that developing countries The outcome of the IGWG process can use the TRIPs flexibilities to the full. A more structured effort was needed to better understand the New mechanisms for fostering research and barriers to innovation in, and access to, medicines, and how development on neglected diseases have been identified, the situation might be improved. For this reason, a WHO which allow intellectual property rights to be applied in a Commission on Intellectual Property, Innovation and Public flexible, non-traditional way. Health was asked to draft a report with recommendations on b) Inclusion of Type I diseases the relationship between public health, innovation and The strategy will promote R&D focusing on Type II and Type intellectual property rights. When the report was completed, III diseases and the specific R&D needs of developing Resolution WHA 5925 established an intergovernmental countries in relation to Type I diseases14. The strategy does working group to draw up a global strategy and plan of action not therefore place limitations on which diseases warrant in order to “provide a medium-term framework based on the most focus. The inclusion of Type I diseases in the strategy recommendations of the Commission and to secure, inter acknowledges their rapidly growing significance in alia, an enhanced and sustainable basis for needs-driven, developing countries. This is a positive outcome. Developing essential health research and development relevant to countries can prioritize Type I diseases in their health diseases that disproportionally affect developing countries research strategies if they consider them to be a threat to and to propose clear objectives for research and public health. development, and estimating funding needs in this area”12. c) An expert working group on financing and R&D After complex negotiations lasting two years, the Global coordination Strategy and Plan of Action on Public Health, Innovation The strategy gives developing countries an opportunity to and Intellectual Property Rights, prepared by the raise the profile of alternative R&D mechanisms and, in the Intergovernmental Working Group of Experts on Public longer term, mobilize financial and technical support for Health, Innovation and Intellectual Property (IGWG), was programmes, whether existing or new15. An expert WHO approved at the 61st World Health Assembly in May 2008 working group is to be established to examine current (see WHA 6122). financing and coordination of research and development, as The result is a broader palette of policy options, for well as to propose new and innovative sources of funding. example in terms of securing funding, stimulating new types of R&D and R&D cooperation, and implementing the TRIPS Process flexibilities where they relate to public health. These have a) The inter-sectoral aspect of the negotiations been described in the strategy and fleshed out in the (partly This was one of the most interesting features of the IGWG unfinished) plan of action (PoA). Policy choices have been process. Because such a broad range of topics were made more explicit and the various stakeholders identified. discussed, many of the member states’ delegations were The following results are especially noteworthy and will larger than usual. In the Netherlands’ case, representatives of be useful for the Global Forum’s 2008 meeting in Bamako the Ministry of Health, Welfare and Sport, the Ministry of in November. Foreign Affairs and the Ministry of Economic Affairs formed part of the official delegation. Although we were like-minded Content in many areas, it took some time to achieve consensus, even a) The role of intellectual property rights where they relate at national, interministerial level. The three ministries to public health has been put into perspective concerned held broad national consultations with industry Intellectual property rights should be applied according representatives and NGOs. This helped us to focus and reach
Global Forum Update on Research for Health Volume 5 115 114-118 Wijnberg:GF5 22/10/08 09:35 Page 116
Technological innovations
a common position. result that needs consolidating. Member states themselves The same was true for the multilateral organizations have an important role to play in coordinating their WHO, involved in the process. The IGWG evolved in the interfaces WTO and WIPO policies at national level. between the mandates of the WHO, WTO and WIPO and others16. While implementing the strategy will require a Putting the IGWG Strategy and Plan of greater level of coordination between these organizations, we Action into practice: some ideas are cautiously optimistic that this collaboration will bear fruit, We left Geneva exhausted but in high spirits, with a given the generally positive atmosphere during the completed strategy, and ready to embark on an urgent IGWG negotiations17. priority: implementing the strategy in our respective countries. The initial culture clash between health and trade/IP So where do we go from here? professionals during the negotiations eventually led to a Firstly, a broad range of innovations is required. Research positive outcome: there is now greater understanding and efforts may focus on diverse forms of creative thinking and awareness on both sides of how public health relates to result in equally diverse discoveries: not only new drugs, new intellectual property rights and trade issues. Health vaccines, new diagnostics, but also new strategies for professionals in particular can benefit further by re-examining utilizing them and new social or economic policies that can national intellectual property rights policies and engaging reinforce their use or create a supportive environment for actively in international trade negotiations. their application. These, of course, were not the only stakeholders. The IGWG process revealed the interfaces between public Companies, NGOs and PPPs all tried to influence the health, innovation and intellectual property. The actions that proceedings and the outcome. Some were better organized have been identified are all interconnected. It is important than others, but it was fascinating to be a part of a multi- that policy-makers are aware of the links between the three stakeholder environment in which global interests were areas and take a coherent approach to the issue. If the goal at stake. is to increase access to, and innovation in, medicine, it would b) The interplay of forces be unwise for policy-makers to focus on only one element. During the negotiations we had the sense that IGWG was one Isolated policy interventions will create more, rather than of the first processes within WHO in which lower- and fewer, problems. middle-income countries strongly voiced their opinions. The The complexity of this policy area may require a networked traditional North-South divide made way for a more approach in which innovators attempt to create a forum, a multidimensional dynamic. The European Union partners, central network in which all the actors agree that the network including the European Commission, were notable for the is worth building and defending21. Learning capacity is crucial: mediating role they played in the negotiations. policy-makers, researchers and industry which operate in the c) The duration of the process international system should learn from one another’s Reaching agreement on this complex issue is quite an initiatives, ideas and achievements. The process as started in achievement. But to have done so in such a short time is IGWG is arguably a good example of such a network. It is a remarkable. During the negotiations the differences between hybrid structure, technical as well as social in nature, in which countries’ positions were clear and it sometimes felt as the interests of the stakeholders, while different, converge. though a consensus would never be reached18. Everyone By leading the overall process, the World Health involved felt the urgency to act, however, and agreement was Organization played a crucial role in the IGWG. Hopefully, reached by all parties in a relatively short period. WHO will be equally significant in promoting the d) The complexity of the strategy implementation of the strategy. WHO should encourage The strategy identifies a complex set of actions that link public governments to act on what they have promised, stimulate health with innovation and intellectual property rights. It also the business community and NGOs to work more closely names stakeholders, and sets out the required timetable and together and encourage the UN institutions and the WTO to a rudimentary budget. The principal merit of the strategy and play an active role in the network. Another important task for plan of action lies in its breadth of policy choices rather than WHO is to promote the exchange of information and thus its prioritization of required actions. The budget still needs to increase learning capacity throughout the network, and be fleshed out – no small task! monitor the performance and the progress being made e) The role and mandate of WHO with implementation. Much of the debate (especially during the final hours of discussion on the PoA) was devoted to the role of WHO. What next? Where should WHO take the lead, where should it be just one a) Public health and innovation: setting a decentralized of the actors, and where should it not be involved? We feel agenda on innovation that ultimately, despite some unresolved points in the PoA, It is possible that decentralizing the agenda on innovation in the “spirit of Geneva”19 prevailed and WHO’s role was both developing and developed countries might offer a confirmed. Director-General Margaret Chan’s personal solution to the innovation problem. The current agenda commitment, charisma and ability to build bridges with the sometimes seems too prescriptive, cumbersome and WTO and the World Intellectual Property Organization (WIPO) centralized to effectively tackle the problems of the poor. Too certainly contributed to this result20, but it is nonetheless a often there is a tendency to define diseases in fixed terms,
116 Global Forum Update on Research for Health Volume 5 114-118 Wijnberg:GF5 22/10/08 09:35 Page 117
Technological innovations
Examples of networks that may fall under the umbrella of the overall IGWG strategy funded research; supporting the creation of voluntary open databases and An interesting new European initiative, which could compound libraries; promote innovation and the implementation of the encouraging the use of appropriate licensing, including decentralized innovation agenda in developing but not limited to open licensing; and countries, is the European Solutions Enterprise on considering, where appropriate, the use of the “research Neglected Diseases (euSEND). This public-private exception” on patents for innovation purposes24. partnership’s innovative approach could result in a sustainable model to alleviate the burden of most, if not In each of these innovation mechanisms, intellectual all, neglected tropical diseases – in terms not only of property rights are applied in a flexible, non-traditional way. new drugs and/or treatments, but also of new Policy-makers involved in public-private partnerships are technologies and practical methods for local delivery encouraged to take a stance on IP that maximizes public 22 and support . availability of the results of innovation. This may mean that a public entity is obliged to become co-owner of the The “Yaoundé Agenda” is another example. One of the intervention to ensure public access. And when clinical trials 23 outcomes of the OECD High Level Forum on Medicines are paid for with public funds, data exclusivity should ideally for Neglected and Emerging Infectious Diseases: be reduced to a minimum25. Policy Coherence to Enhance their Availability which c) Including alternative models in policy options and took place in Noordwijk in the Netherlands in June 2007, generating firm commitments was an offer, by the Minister of Public Health of The results of the IGWG open the door to exploring Cameroon, to host a meeting to develop a alternative financing mechanisms. While this outcome has complementary agenda. The Noordwijk Agenda reflected yet to be confirmed by an expert working group “to examine mostly on the coherent policies, incentives and current financing and coordination of research and partnerships needed in OECD countries to foster development, as well as proposals for new and innovative innovation and scale up research on neglected and sources of funding”26, now is the time to act. Industry, PPPs emerging infectious diseases that disproportionately and NGOs should seek out neutral ground and deliver affect developing countries. It was felt that a common proposals to carry this forwards. Initial thoughts complementary Yaoundé Agenda was needed to and ideas have been mooted from several sides27 and have specifically address African needs and incentives in already sparked the first concrete activities in this area28. terms of health innovation and drug development, production and regulation. The meeting is expected to Conclusion take place after the Bamako Global Forum. The Dutch The goal of the IGWG process was to increase poor people’s Government is taking an active interest in this meeting access to medicines by optimizing the interfaces between and will provide financial assistance. Key messages without taking into account local or other variations or indeed the problem of resistance. The search tends to be for the cure The goal of the IGWG process was to increase poor rather than a cure. Incremental innovation could be crucial to people’s access to medicines by optimising the developing countries seeking to adjust Westernized products interfaces between public health, innovation and to the local situation. The ability to respond to local intellectual property rights. circumstances and needs requires flexibility. Equally important, the innovation agenda should be set in the public To achieve that ambition: we needed a broader domain, with the widest possible range of stakeholders palette of policy options: on securing funding, for involved by means of networks and platform technologies. example, promoting new kinds of R&D and R&D This is one way to achieve creative outputs that are relevant cooperation, implementing TRIPS in a public health to the health needs of developing countries. oriented, non-traditional, manner, and b) Innovation and intellectual property rights: improving acknowledging the significance of Type I diseases access to research data and knowledge for developing countries. Decentralizing the agenda and boosting innovation rely Implementing the strategy is both important and heavily on the accessibility of research data and knowledge. urgent. Maintaining the strategy’s coherence and Without access to information that is already available, synergy will be vital. innovation will be severely hampered. The IGWG strategy The strategy should be implemented flexibly, using identifies a number of alternative innovation mechanisms hybrid (decentralised) networks and innovation that could ensure that research results are made agendas. At the same time, WHO should maintain publicly accessible: close oversight of implementation, measure promoting the creation and development of accessible progress and promote greater cooperation between public health libraries; stakeholders and the various networks. promoting public access to the results of government-
Global Forum Update on Research for Health Volume 5 117 114-118 Wijnberg:GF5 22/10/08 09:35 Page 118
Technological innovations
public health, innovation and intellectual property rights. To same time, WHO should maintain close oversight achieve that ambition, we needed a broader palette of policy of implementation, measure progress and promote greater options: on securing funding, for example, promoting new cooperation between stakeholders and the various kinds of R&D and R&D cooperation, and implementing TRIPS networks. in a public health oriented manner. A further result of the negotiations was the acknowledgement of the significance of Bart Wijnberg is an adviser at the Pharmaceutical Affairs and Type I diseases for developing countries. And the IGWG Medical Technology Department of the Ministry of Health, Welfare process established that intellectual property rights should be and Sport of the Kingdom of the Netherlands. He was Vice-Chair, applied in a flexible, non-traditional manner if we want to on behalf of the Euro region, of the WHO Inter-Governmental improve new innovation mechanisms and increase access to Working Group on Public Health, Innovation and Intellectual research data and knowledge. Property (IGWG). Until now, many features of this broader palette are still only ideas on paper. Implementing the strategy is both Marleen Monster is a senior policy adviser at the important and urgent. Maintaining the strategy’s coherence Directorate General for International Cooperation’s Coherence and synergy will be vital. Unit at the Ministry of Foreign Affairs of the Kingdom of the The strategy should be implemented flexibly, using hybrid Netherlands. (decentralized) networks and innovation agendas. At the
References
1. The authors would like to thank Ms Gerda Vrielink, at the Netherlands’ Plan of Action on Public Health, Innovation and Intellectual Property Permanent Mission to the UN in Geneva, Ms Marja Esveld and Mr Theo Rights (http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf) van de Sande of the Dutch Ministry of Foreign Affairs (Development p.7). Cooperation) and Mr Frank van der Zwan of the Dutch Ministry of 15. Fink C. Intellectual property and public health: an overview of the debate Economic Affairs for their valuable comments on an earlier draft of this with a focus on US policy. Center for Global Development, 2008, p.26. paper. 16. Notably the OECD. 2. http://www.who.int/mediacentre/events/2008/wha61/issues_paper1/en/ 17. Notwithstanding the failure of recent WTO negotiations. 3. Report of the Commission on Intellectual Property Rights, Innovation and 18. We had the feeling that we were negotiating a treaty text, which, of Public Health, hereafter cited as CIPIH report, (2006): Public Health, course, was not the objective. Attempts to open negotiations on the Innovation and Intellectual Property Rights, p.32 content of existing IP rules further extended the process. 4. www.wikipedia.org 19. A term used frequently during the negotiating process to try and achieve 5. CIPIH report, p.193. a cooperative sprit. William Safire’s Political Dictionary, 2008, traces the 6. CIPIH report, p.193. use of this term to 1955 when President Eisenhower first used it. 7. CIPIH report, p.35. 20. The constant, positive presence of WTO and WIPO representatives during 8. CIPIH report, p.32. the IGWG and the World Health Assembly also contributed to the end 9. CIPIH report, p.34. result. 10. Trade-related aspects of Intellectual Property Rights. 21. See Latour B. Reassembling the social: an introduction to actor-network- 11. CIPIH report, p.34. theory. Oxford, Oxford University Press, 2005. 12. Global Strategy and Plan of Action on Public Health, Innovation and 22. www.tipharma.com Intellectual Property Rights (http://www.who.int/gb/ebwha/pdf_files/A61/ 23. Organisation for Economic Cooperation and Development. A61_R21-en.pdf). 24. For further details see IGWG strategy, under 2.4 13. Ibid. (http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf). 14. “For the purpose of this strategy, the definitions of Type I, II and III 25. Differences may exist between PPPs which could make tailor-made diseases, are as referred to by the Commission on Macroeconomics and solutions necessary. Health and as further elaborated in the CIPIH report: Type I diseases are 26. WHA 61.21, paragraph 4(7). incident in both rich and poor countries, with large numbers of vulnerable 27. One such proposal was made by Paul Herrling from Novartis. Others populations in each. Type II diseases are incident in both rich and poor have been put forward by James Love of Knowledge Ecology International. countries, but with a substantial proportion of the cases in poor countries. 28. UNITAID decision of 2–3 July 2008 to create a “patent pool” Type III diseases are those that are overwhelmingly or exclusively incident (http://www.unitaid.eu/en/Eighth-Board-Meeting-Geneva-2-3-July- in developing countries. The prevalence of diseases and thereby their 2008.html). categorization in the typology can evolve over time” – Global Strategy and
118 Global Forum Update on Research for Health Volume 5 120-123 Callan:GF5 23/10/08 15:09 Page 120
Technological innovations
The Noordwijk Medicines Agenda: a model for changing innovation for neglected and emerging infectious diseases
Article by Bénédicte Callan (pictured), Principle Administrator, Biotechnology Division, Organisation for Economic Co-operation and Development with Susanne L Huttner, Iain Gillespie and Barbara Slater
ver the last century health care innovation has Box 1: The OECD transformed the way medicine is practised and has The Organisation for Economic Co-operation and Obrought substantial benefits in the prevention, diagnosis Development (OECD) was born after the Second World and treatment of diseases. But the innovation system has failed to War in order to coordinate and implement the “Marshall deliver new medicines, vaccines and diagnostics to address Plan” for the reconstruction of Europe. The OECD today infectious diseases that primarily affect the developing world. has 30 member countries in North America, Europe and Our understanding of the ecosystem for innovation, from Asia-Pacific as well as 100 observer/partner countries. basic research through to delivery to the patient, needs to be The OECD focuses on economic, social and brought up to date and new ways of networking research and technological issues and contributes to economic development (R&D) need to be found to: growth and globalization. The OCED is a forum for make the process of innovation more efficient so that more discussion among governments and provides products are developed more quickly and at lower costs; governments with peer reviews, guidelines, best change the incentives faced by innovators, so as to practices and policy recommendations as well as data, encourage more firms and researchers to become involved statistics and indicators. in R&D; improve the commercial viability of small market products; and, The Noordwijk Medicines Agenda (NMA) create more capacity, especially in disease endemic This is the context for the OECD, in collaboration with the countries. government of the Netherlands organizing a High Level Forum on Availability of Medicines for Neglected and Emerging Why the OECD? Infectious Diseases (HLF) which took place 20–21 June 2007 OECD countries (see Box 1) have many reasons to be involved in Noordwijk-aan-Zee, Netherlands. The HLF was attended by in this issue. Besides ethical and humanitarian imperatives, high level officials from OECD and developing countries, there are strong economic reasons driving involvement. New industry, research and funding organizations, academia, and emerging infectious diseases can spread rapidly and affect philanthropic foundations, and international and health, the economy and security in all countries, including nongovernmental organizations who came together with a those of the OECD. common goal of building a coherent open agenda for action to Meantime, if the productivity decline across mainstream stimulate innovation and radically accelerate the availability of health innovation (especially for new medicines) is to be turned new medicines, vaccines and diagnostics for neglected around substantial efficiency gain will be necessary. Greater infectious diseases. competition, shorter product life-cycles and shorter time to The Noordwijk Medicines Agenda (NMA) represents a broad market, coupled with growing costs and risks put the traditional consensus reached at the HLF among the participants about approach to innovation under rising pressure and with it the the problems, goals, and work ahead in order to improve the block-buster model of drug development we have seen in availability of medicines for neglected infectious diseases. It recent decades. In fact, many of the policies and practices sets out a number of specific actions to bring about change in being put in place or considered to enhance the availability of the way we innovate in this area, calling for improved efficiency drugs, vaccines and diagnostics for neglected infectious and coherence and strengthened collaborative efforts among diseases may also be relevant to markets for health innovation innovators and other stakeholders, in particular the WHO in advanced industrialized countries. Thus the innovation (see Box 2). system itself needs a thorough health check and some much Many of the actions contained in the NMA can only be overdue medicines. achieved by partnerships between many players across many
120 Global Forum Update on Research for Health Volume 5 120-123 Callan:GF5 22/10/08 09:34 Page 121
Technological innovations
Box 2: The Noordwijk Medicines Agenda Box 3: The importance of the OECD Recognizing that it is important to scale up and expand The added value that the OECD brings to the issue of new for-profit and non-profit models of innovation for improving the availability of medicines for neglected tackling neglected infectious diseases in the developing and emerging infectious diseases is its: world, the Noordwijk Medicines Agenda calls for several • Capacity for sound economic analysis and evidence- changes to the present health-innovation system (for based policy advice on the different policy options for full details, see www.oecd.org/sti/biotechnology/nma). action, including the scale up of R&D networks and the incentives necessary for bringing new products to Innovation system efficiency market; 1. Prioritise research and development needs and align • Understanding of the innovation system and research to a common purpose. groundbreaking work on new research models that 2. Facilitate the development and operation of a could improve the efficiency of the discovery, sustainable architecture for sharing and exchange of development and delivery of new medicines by knowledge, data and research tools. removing disincentives to sharing data and material 3. Explore collaborative mechanisms for IP and opening up innovation; management. • Ability to broker whole of government buy-in and 4. Promote the transfer of technology, knowledge and build coherent policies, by virtue of the OECD technical skills to strengthen innovation systems in organizational structure which includes cross developing countries. ministry representation (i.e. Health, Development and 5. Support developing country led efforts to provide Aid, Finance, Innovation, Economic Development and their own health, local production and research Industry). systems.
Changing incentives to build capacity makers in harnessing innovation to achieve sustainable growth 6. Create incentives for R&D through alternative policy and development in a way that takes account of the growing mechanisms to reward innovation. complexities – and some of the exciting experimentation – in 7. Explore for-profit and not-for-profit models to promote the practice of innovation. In a sense, it provides the key actors and stimulate development of drugs, vaccines and with a laboratory to test out the workings and impacts of some diagnostics. of these new directions in innovation. The focus is broad, well beyond health innovation, but the scope and ambition of the What can the OECD bring to this issue? work overlaps substantially with that of the NMA. 8. Pursue the viability of a global virtual collaborative Some of the key elements from the perspective of the drug development network that scales up existing NMA are: initiatives and is more open. Knowledge markets 9. Identify infrastructure needs to underpin a global The concept of knowledge markets is one that supposes that virtual collaborative network. knowledge has value and that if that value can be captured to the full then not just utility but efficiency will be maximized. We know there needs to be greater transparency in the flow of sectors. The OECD can bring some very unique skills and knowledge as well as new kinds of markets through which abilities to these partnerships. In particular we can provide a knowledge can be valued and exchanged. Knowledge markets strong foundation for evidence-based policy-making through attempt to address the inefficiencies in knowledge processes that involve actors from across government, management especially in the underuse and undersharing of industry, and other parts of civil society (including public the large amounts of data and information created throughout research organizations, NGOs and philanthropies). the life science innovation cycle. The concept of knowledge markets thus encompasses a Advancing the NMA at the OECD number of different mechanisms or marketplaces where At present, we have a wide range of work going forward across buyers and sellers trade a variety of knowledge intensive goods the Organisation that directly or indirectly addresses the issues and services. Mechanisms such as intellectual property raised in the NMA. The indirectly relevant work is too broad exchanges, patent pools, consortia, matching or brokering ranging to present here, but a major themes of OECD work is services, as well as knowledge “warehouses” are all examples especially pertinent – namely our work on improving the of new ways of deriving value from knowledge assets. In the efficiency of the system of health innovation, mainly brigaded life sciences, examples of tradable assets could be scientific under a major new OECD-wide project known as the data such as outcomes of clinical trials and toxicology data. Innovation Strategy. Achieving greater access and exploitation of existing The NMA puts forward several actions which focus on knowledge, by facilitating the trading and sharing thereof, developing new models for innovation. Our newly launched would increase the efficiency of the health innovation cycle OECD Innovation Strategy focuses on improving economic and potentially deliver a number of positive health and performance and social welfare. Its aim is to assist policy- economic outcomes.
Global Forum Update on Research for Health Volume 5 121 120-123 Callan:GF5 22/10/08 09:34 Page 122
Technological innovations
There are real challenges of course in identifying which knowledge assets it makes economic sense to trade as well as Some examples of collaborative mechanisms include in articulating and developing the kinds of market platforms clearinghouses, IP exchanges/auctions, patent pools, that would need to be created to support this. cross-licensing schemes and intellectual property The first step is to understand what kind of knowledge is sharing agreements being underused and under-developed in the life sciences and what sorts of new institutions, organizational mechanisms and infrastructures for creating value are required to exploit this knowledge in order to improve health innovation. Collaborative Intellectual Property (IP) mechanisms diseases. We in the OECD do substantial work on how policies One of the actions in the NMA is to explore “collaborative (subsidies, tax breaks, orphan drug act, patents) influence firm mechanisms” for IP management. These are mechanisms that or country innovation. For infectious diseases, and other small, rights holders voluntarily enter into (often, though not uncertain markets for drugs, other policies of course have been exclusively, explicitly for-profit) to ease access to patented mooted and sometimes used, such as patent extensions, inventions that allow more open innovation and collaborative AMCs, prizes, global funds etc. But we do not have the kind of research as well as more rapid and less costly (mainly through analytical work for these new mechanisms that we have for diminished transaction costs) access to knowledge. Some more “traditional” interventions. Work therefore needs to be examples of collaborative mechanisms include clearinghouses, done to look at these specific policies in terms of identifying IP exchanges/auctions, patent pools, cross-licensing schemes, their strengths and limitations, evaluating their effectiveness and intellectual property sharing agreements. Our focus on and understanding what mix of mechanisms is necessary to these collaborative mechanisms so far has been to try address different types of disease or situations. to document what practices are beginning to emerge, Innovative finance mechanisms determine their impact and consider what normative action – Finally, it has been recognized that reliance on philanthropic
if any – may be necessary to enable maximal positive impacts and public funding is not sustainable for R&D into neglected Pub_Global_final(r)300-SM.ai 21/10/08 10:47:07 on innovation. infectious diseases as these sources could be endangered by a New models for pharma-business innovation shift in priorities. To that end, new and innovative funding As I mentioned above, the current block-buster model for mechanisms have been put forward to help generate more developing new medicines is creaking at the seams. Many new sustainable and longer-term resources. A Global Forum, models have been articulated in recent years, some have been Lessons for Development Finance from Innovative Financing in tried and fewer have been successful – at least in some cases. Health, was held on 7 October 2008, organized by the Meantime, the advent of genomics as well as evidence-based Development Cluster of the OECD. The Forum considered medicines and targeted therapy has demonstrated that donor and recipient governments’ views on the issues and efficiencies in terms of the health benefits to patients from new opportunities created by recent innovative financing innovations are possible – but only in smaller, more discrete mechanisms. In particular, the Forum looked at lessons learned markets. In many ways, this shift shares a number of from the International Finance Facility for Immunization similarities with the challenges facing drug discovery and Company (IFFIm), the costs and benefits of new approaches, delivery for infectious diseases. The key question is how how to leverage private sector investment and future innovation in drug development can continue to remain an developments in the innovative financing mechanisms as well attractive proposition for mobile capital when markets may be as the opportunities, and adaptability of these mechanisms smaller, competition higher, and public expenditure on health across sectors. care under continual pressure. On the face of it, pulling all these strands together into a Our focus here is on how policies around the use of coherent picture could be one of the greatest challenges we pharmacogenetics and genomics, as well as biomarkers more could face from the policy perspective. But this is where our generally, can be developed that improve innovation efficiency innovation strategy approach is really different. We advocated and that support the servicing of smaller markets. Some of the new ways of working in the NMA. We pushed for collaboration questions therefore are around what is required in terms of and new ways of working. We decided that if we were asking changes in the regulatory systems and clinical trials, and what others to work this way then we in the OECD had to show that is required in terms of drug evaluation systems. this could be done. So that is precisely what we are doing – There needs to be more work done in this area as to how can bringing together government actors from science, industry, we identify which of the proposed new models can continue to competition, education, development, investment, employment attract capital in the long term, that can meet the identified and many other ministries to work together on changing the health need and that will not unnecessarily distort markets in face of innovation. so doing. This is the challenge for the OECD – and it remains the Evaluating the policy mix challenge laid at the feet of us all by the NMA. The HLF also recognized the need to look at what the best The effort needed to make such collaboration work is high; mix of mechanisms (push and pull) might be to encourage but the rewards are potentially much higher. companies and researchers to work on neglected infectious
122 Global Forum Update on Research for Health Volume 5 Technological innovations
from the University of California, Berkeley and a BA in biology Key messages from Yale University.
The way we look at innovation needs to change – Susanne Huttner is Director of the OECD Science, Technology from a linear model to an iterative, complex and Industry Directorate. Previously she was Associate Vice- interactive cycle. In this new model there is a need Provost for Research for the University of California System, for new tools, new actors and a collaborative, Executive Director of the Industry-University Cooperative multidisciplinary, horizontal approach. Research Programme, and Director of the Biotechnology There is a need for new models of innovation that Programme. She holds a PhD in neuroscience. are more open and global. In order to support this more open model, we need new infrastructures to Iain Gillespie has been Head of OECD’s Biotechnology Division support them including governance models, since 2001. Previously he worked in academia and in the regulatory frameworks, guidelines and tools. biotechnology industry before joining government service in No one can do this alone, more partnerships, 1991, holding policy posts in four different UK government networks and policy coherence are needed to drive a departments. He holds a BSc and PhD (microbiology), an MA health innovation strategy that is more efficient and (international relations and European politics) and an MBA. reactive to global public health needs. Barbara Slater is a consultant focused primarily on strategic health policy (population health, infectious diseases, Bénédicte Callan is Principal Administrator in the biotechnology and innovation). She has wide experience at the Biotechnology Division of the OECD where she leads work on provincial and national level in Canada as well as internationally. health-related biotechnology, with a primary focus on technology, Ms Slater is adjunct professor in the Faculty of Medicine, innovation and intellectual property rights policies. She was Department of Health Policy, Management and Evaluation at the previously Fellow for Political Economy at the Council on Foreign University of Toronto, Canada. Relations in New York. Dr Callan has a PhD in political science
Global Forum Update on Research for Health Volume 5 123 124-127 Leach, mel:GF5 22/10/08 09:34 Page 124
Technological innovations
Health dynamics, innovation and the slow race to make technology work for the poor
Article by Melissa Leach (pictured), Director, Social, Technological and Environmental Pathways to Sustainability (STEPS) Centre, United Kingdom with Ian Scoones
he science, technology and development races are oni. of outbreaks at source, aimed at eradication – as for example Nowhere is this clearer than in international health, in responses to human pandemic and avian influenza, and to Twhere a new generation of donor, philanthropic and haemorrhagic fevers such as Ebola. The emphasis is on a public-private initiatives is emerging and attracting increasing plethora of technological and infrastructural initiatives funding. These hold out promises of new drugs, vaccines and focused on early warning, risk assessment, surveillance, infrastructure applications, with some claiming major rapid response teams, treatment and vaccination. In both technological breakthroughs that could solve longstanding cases, the nature of the health problem is assumed to be health problems and tackle emerging disease outbreaks in the broadly similar across vast areas, so that technological and developing world. This “race to universal fixes” for health and associated institutional solutions are unproblematically development problems is valuable. It is an important counter transferred, and can be applied “at scale”. to innovation approaches aimed simply at a race to the top in Alongside the obvious merits of these approaches, the global economy, assuming that health and poverty-related however, lie many telling examples of failure. These include problems will be solved by trickle down. Yet as this article potentially good health technologies left sitting on laboratory argues, it risks missing the finishing line if a complementary benches because they failed to fit local circumstances. They – and slower – race is not pursued. This “slow race” include examples of disease eradication programmes emphasizes pathways to tackling ill-health and disease which thwarted by unexpected microbial resistance to the drugs are specific to diverse and dynamic local contexts; creates involved, or by public resistance to programmes perceived as hybrids between local and external knowledge and inappropriate – as in the cases of the global polio eradication perspectives for appropriate solutions; recognizes that initiative in Nigeria in 2003–042, or tetanus toxoid technological fixes are not enough and that social, cultural campaigns in Uganda and Cameroon. In Gabon in 1995–96, and institutional dimensions are key, requiring a systems for example, American and French Ebola control measures approach to health and innovation, and embraces uncertainty were perceived as so inappropriate and offensive by villagers and unpredictable change through adaptation and learning. that they aroused deep suspicion, and international responses In this view, innovation for health and development is part of to a further outbreak there in 2001 met with fierce local a bottom-up, participatory process in which citizens in armed resistance3. Avoiding such problems requires resource-poor settings must take centre stage. complementary approaches to understanding and policy, with In the race to the universal fix, much current investment is four key elements contributing to the necessary slow race. justified by the prospect of “big hit” technologies with the First is to recognize the diversity of interlocking dynamics potential for global scope and applicability, and the capacity that shape health problems, and must inform responses to to deliver these on a large scale. This is exemplified by the 14 them. Challenges to human health have always involved “grand challenges” for research in global health identified by intimate relationships between social, political and economic the Bill and Melinda Gates Foundation, which range from processes, ecosystems and potential pathogens. The new and improved (e.g. needle-free, non-refrigerated) acceleration of population growth, mobility and urbanization, vaccines, to genetic and chemical technologies to control human-animal interactions, change in industrial, livelihood disease vectors, and enriched crops to improve nutrition. and food production systems, and technological and Another, and growing, strand of investment focuses on environmental processes has in many instances brought new responses to outbreaks and pandemic threats. Here, as in the challenges4, such as the emergence of new infectious approaches of the World Health Organization and others, the diseases and zoonoses5. Yet these dynamics play out in focus is on universalized, generic emergency-oriented control specific ways in diverse local settings, varying across regions, localities and sometimes even within communities, producing
i. The title, race metaphor and central arguments in this article are drawn multiple patterns and multiple needs. Thus a one-size-fits-all from Leach and Scoones, 20061. solution is often inappropriate. And given that problems of
124 Global Forum Update on Research for Health Volume 5 124-127 Leach, mel:GF5 22/10/08 09:34 Page 125
Technological innovations
disease and ill-health are not just the result of technical “kill”. Overall, there is a need for responses to be attuned to matters, a focus on technology as a separate domain carries local knowledge and circumstances. Context matters, and many dangers, leaving important social and political causes technologies and practices suited to one place might be unaddressed. A more context-specific and integrated rejected in another. approach to linking technologies, health and development is Third, the slow race implies a different approach to therefore needed. thinking about innovation. Rather than assume – as in the Second, different people and groups in society tend to “universal fix” view – that technologies can be developed understand and experience these dynamics in very different “upstream”, often in international centres, and then ways. The scientific perspectives of biomedical doctors or transferred in a linear way to the resource-poor settings that epidemiologists offer only some among multiple “framings” of need them, a more participatory and systemic approach is health problems and possible solutions. Other framings required. This can helpfully draw lessons into the health emerge from, for instance, local cultural understandings, sector from participatory technology development knowledge and experiential expertise. Such cultural framings approaches – as pioneered in agriculture and natural can be crucial to understanding both why technologies work resource management, for instance – that put local users at and are acceptable in particular settings – and why they are the centre of the innovation process, working in collaboration sometimes rejected. For example childhood vaccines are with scientists both to design new technologies and to adapt high on global policy agendas. In The Gambia, mothers go to existing ones to local circumstances. These approaches great lengths to build and protect their own and their recognize the value of local knowledge, moving away from children’s strength, which they see as dependent on proper the image of people as passive recipients of externally- quantity and flow of blood and body fluids. They value derived health technology, to involve them as active, creative immunizations in these terms, as introducing a powerful partners in technology development processes. substance that, going into the blood, either builds its strength Yet such participatory interactions raise many questions or builds in the blood defences against disease: “The about who controls the innovation process, and whose injection strengthens the health of the child. It gives the child perspectives drive it. Too often, participation has meant good body”. Within this logic, many feel that vaccinations are simply co-option of local people into pre-set technological effective against illness in general. 29% of urban and 48% agendas. The huge imbalances in the power, reach and of rural mothers could name no biomedically “correct” resources of people living in resource-poor settings and vaccinable diseases, yet were actively seeking immunization research agencies has contributed to this. Even where true – reflected in national coverage rates of 90% in 2003. Such collaborative arrangements have been established, these ideas about strength, fluid and substance do not conform to have often been isolated and dependent on the interest of biomedical notions of an immune system, disease-specific key individuals and on temporary project funds, rather than vaccines and strong distinctions between prevention and being fully institutionalized in national and international cure. Yet they ground strong appreciation of immunization in innovation systems. areas across The Gambia, Guinea, Sierra Leone and beyond. Rather than isolated project examples, an innovation Yet the same framing can also underlie anxiety: in a social systems approach emphasises the networked interaction of context in which mothers often miss clinic sessions due to multiple actors, both public and private, local and national, workloads and problems at home, they often worry greatly in processes which initiate, import, modify and diffuse that a backlog of such vaccinations will have “stacked up” technologies7. It emphasizes the links between these actors and that nurses will give their child several at once. This can that enable them to operate as an effective system, involving be seen as too much substance for the blood and body to issues of funding, marketing and the encompassing policy cope with6. Thus understanding why people accept (and why and legal framework. This involves not just building the they sometimes reject) technologies such as vaccines “hardware” of research and development (R&D) requires engaging with local cultural framings that may differ infrastructure and capacity, but fundamentally, considering strongly from those of mainstream scientists and policy-makers. the “software” of social and political relations among the Local knowledge and cultural logics can similarly inform many actors that are now involved, and the question of who and be integrated into epidemic response strategies, helping controls science and technology agendas in whose interests. to make these more context-specific, locally appropriate and The development of the International AIDS Vaccine Initiative acceptable. In Uganda, for example, local cultural categories (IAVI) illustrates many aspects of this approach8. The around Ebola outbreaks were linked to elaborate social initiative aims to further HIV vaccine research worldwide, protocols to control the disease, and from 2001 these were including the search for candidate molecules, the funding of successfully integrated into responses by the World Health clinical trials, work on delivery issues and wider policy and Organization3. Attention to local cultural logics also offers advocacy efforts, working towards an effective and cheap ways to understand local resistance to top-down external vaccine for resource-poor settings. Vaccine development interventions and adapt accordingly. Thus, understanding partnerships have been created between developing country local categories and fears would assist with several current organizations and northern research agencies, both public challenges in dealing with haemorrhagic fevers: encouraging and private. The initiative spreads its funding across a more cases to be identified early and brought to hospital, and diversity of players, and focuses on vaccine development and addressing prevalent anxieties that treatments themselves delivery issues rather than upstream research. It currently
Global Forum Update on Research for Health Volume 5 125 124-127 Leach, mel:GF5 22/10/08 09:34 Page 126
Technological innovations
operates in 22 countries, and is increasingly decentralized in and development. This will require new institutional and its operation, responding to early accusations of top-down, administrative arrangements which can embrace surprise, central control. The existence of regional offices and growing deal with uncertainty and accept ignorance, along with links with nongovernmental organizations (NGOs) and civil appropriate bureaucratic and other procedures. There are as society means the initiative is broad based and attuned to yet few examples in the health sector, but this is a frontier social and political issues. Nevertheless despite its scale it area for future development. still remains a small player in the overall HIV/AIDS technology Running the slow race to make health technologies work innovation and delivery network, dwarfed by larger funds for the poor therefore requires an embracing of dynamics and spent on more conventional upstream research. diversity; of multiple forms of knowledge and framing; of an Furthermore, innovation should focus not just on the innovation and health systems approach, and of adaptation technology, but also on the social, cultural and institutional and learning to cope with uncertainty. This in turn carries relationships that make it work. There are numerous major implications for the organization of research, funding examples where technologies already exist that could have and policy. major impacts on health and poverty problems, yet they An overarching challenge is to foster more, and more remain out of reach. To make existing technologies – effective, interdisciplinary, user-oriented and participatory sometimes everyday, old technologies – accessible to people research of various kinds. This involves creating research and living in poverty often means linking the technical with the innovation partnerships between scientists and potential social. For example in parts of South Asia, a revolution in users, especially poor people themselves, remembering and “community-led total sanitation” has occurred as community recapturing longstanding experiences in participatory organization, empowerment and learning has facilitated the technology development that have been overshadowed of late widespread building of extremely low-tech, low-cost latrines – by today’s new global technology-transfer hype. It involves in contexts where adoption of existing sanitation technologies linking natural science and biomedical disciplines with the in the past had been very low9. To enable people to make use social science that can illuminate how technologies might of technologies that may be available, but are poorly engage with society. It involves linking different sectors – and understood often requires culturally-appropriate communication the social and technical debates within each – so as to strategies, improving people’s knowledgeability, capacity and generate, for instance, lesson-learning from the agricultural power to make technology choices. and natural resource management fields across to health, and In other cases, institutional innovations – for instance in the vice versa. This carries implications for research funding, ways that health services are financed, delivered and much of which – whether from development donor agencies, relationships between people and providers negotiated – can foundations or research councils, is still strongly divided by be crucial in enabling people to access technologies and their natural science – social science boundaries, or split into benefits, as part of building health systems that work for the sectoral silos. The last few years have seen the take-off of poor. For example many health systems in Nigeria have some exciting and important funding initiatives which do become increasingly pluralistic and poor people are faced promise support for the kind of interdisciplinary and with a confusing myriad of health providers and drug sellers. international partnership work which is needed, but these Old barriers between private and public, modern and remain drops in the ocean of the levels of funding devoted to traditional, and formal and informal health providers are disciplinary, technical research. The challenge is to breaking down. In this context innovative learning and mainstream the social into the technical and vice versa, regulatory arrangements are being developed to increase the through genuinely trans-disciplinary openness in funding knowledge of medicine vendors and local people about regimes focused on (health) problems and issues, appropriate drug treatment for malaria, and to address the not disciplines. problems of access to and use of low quality anti-malarial At the same time, new policy approaches and institutions drugs by the poor (http://www.futurehealthsystems.org/ are needed which bring together poor people, health country/nigeria.htm). providers, scientists, administrators and health policy-makers Fourth, the complex interaction of multiple dynamics in new ways that promote dialogue: about long-term futures involved with health issues today – biological, demographic, and technology options; about health problems; about ecological, economic, social, political, cultural – operating at technology adaptation to local contexts; and about risks and different scales and at different speeds – results in deep uncertainties and ways to understand and adapt to these. uncertainties – and often ignorance – about likely outcomes Such institutions would need to enable both more open- and their consequences4. Despite this, the design of ended dialogues which take their lead from peoples’ felt technological research and development, of health systems health and well-being needs and debate the technological and of approaches to epidemics frequently proceed as if the options that might help address these, and more focused world were stable, and as if uncertainties and possibilities of dialogues around particular problem areas (e.g. how to surprise could be reduced to risks which can be assessed and address child deaths from diarrhoea, or an emerging managed. In today’s world, in which deep uncertainty and zoonosis) or particular new technologies, their potentials, surprise are inevitable, this is, more than ever, a flawed benefits and risks (e.g. a new vaccine). While some such approach. It may be time to move towards more adaptive, institutions might operate at local scales, they would need to learning-process approaches in building pathways to health articulate with national, regional and global equivalents, in a
126 Global Forum Update on Research for Health Volume 5 124-127 Leach, mel:GF5 22/10/08 09:34 Page 127
Technological innovations
networked interaction. ESRC STEPS (Social, Technological and Environmental Pathways to This slow race may be less glamorous than the technology Sustainability) Centre, a global hub linking environmental breakthroughs that capture global headlines. It is not a sustainability and technology with poverty reduction and social substitute for these, but it is a vital complement in the justice. Her research focuses on science-society, health and ongoing, painstaking task of linking science and innovation environmental issues, especially in West Africa. to the complex, diverse needs of people in resource-poor settings, and in helping to ensure that, in a dynamic and Ian Scoones is an agricultural ecologist and Professorial Fellow uncertain world, investments in science and technology for of the Institute of Development Studies, Sussex. He co-directs the health are firmly enmeshed with inclusive debate about the ESRC STEPS Centre. His research links natural and social social and political values they serve. J sciences, focusing on relationships between science and technology, local knowledge and livelihoods and the politics of Melissa Leach is a social anthropologist and Professorial Fellow agricultural, environment, epidemic disease and development of the Institute of Development Studies, Sussex, where she leads policy processes. the Knowledge, Technology and Society Team. She is Director of the
References
1.Leach M, Scoones I. The slow race: making science and technology work society. London: Earthscan Publications, 2007. for the poor. London: Demos, 2006. 7.Hall A et al. Why research partnerships really matter: innovation theory, 2.Yahya M. Polio vaccines – no thank you! Barriers to polio eradication in institutional arrangements and implications for developing new technology Northern Nigeria. African Affairs, 2007, 106(423):185. for the poor. World Development, 2001, 29(5):783-797. 3.Hewlett B, Hewlett BL. Ebola, culture and politics: the anthropology of an 8.Chataway J, Smith J. The International AIDS Vaccine Initiative (IAVI): is it emerging disease. Thomson-Wadsworth, 2007. getting new science and technology to the world’s neglected majority? 4. Bloom G et al. Health in a dynamic world. STEPS Working Paper 5. World Development, 2006, 34(1):16-30. Brighton: STEPS Centre, 2007. 9.Kar K. Subsidy or self-respect: participatory total community sanitation 5.Jones Kate E et al. Global trends in emerging infectious diseases. Nature, in Bangladesh. IDS Working Paper 184, Brighton: Institute of 2007, 451, 990-993. Development Studies, 2003. 6.Leach M, Fairhead J. Vaccine anxieties: global science, child health and
Global Forum Update on Research for Health Volume 5 127 130-135 McConnell:GF5 22/10/08 09:33 Page 130
Technological innovations
Leapfrog technologies for health and development
Article by Harry McConnell (pictured), Professor of Neuropsychiatry, Griffith University, Australia with Prita Chathoth, Ashley Pardy, Camille Boostrom, Eugene Boostrom, Koos Louw, Luis Gabriel Cuervo and Sumiko Ogawa
nformation and communication technologies (ICTs) are as a potential tool to address the inequalities in health care increasingly being recognized as essential health between the low- and middle-income countries (LMICs) and Itechnology, giving individuals at all levels of the health high-income countries. We focus here on two current workforce and other stakeholders access to information that examples of leapfrogging which are already being helps them protect and improve health and save lives. Radio successfully implemented in many developing countries: and television are ever-present in many parts of the world, ePublishing and mobile phones. Other leapfrog technologies and their uses in health care, health education, and health and potential benefits and risks of their use for health in information dissemination and access continue to be invaluable. At the clinical and laboratory level, ICTs are Barrier Comment used to track and provide patient information, to Absorptive capacity Inadequate ability to recognize, place value upon, facilitate research, diagnosis and testing, and to deliver internalize and apply new knowledge (e.g., services through telemedicine despite distance and among IT support workers and system managers in LMICs) time barriers. Debate continues as to the roles and relative Attitudes and Acceptability, perceived needs based on a needs analysis, 1 perception attitudes towards technology, concepts of development and importance of ICTs in socioeconomic development aid, and focus on the problems to be solved (i.e. being people- including health development. Many people believe driven and problem-oriented not kit-driven) that ICTs are a necessary component of every facet of Cultural and Language, cultural views towards technology, sharing of development, ranging from infrastructure projects and community issues resources within the community, appropriateness of a specific technology within a given culture or community, literacy general economic development to community requirements, gender issues and access issues development, health care provision and education. On Legal and ethical Privacy, confidentiality, security, malpractice potential, the other hand, there are many barriers to Issues insurance, jurisdiction, copyright, patents for new technologies implementing ICTs and health technologies in and treatments, other intellectual property issues developing countries (see Table 1) and many argue Technical issues Access to electricity grid and alternative power supplies, power that clear precedence must be given to clean water, schedules and reliability, UPS back-ups, ongoing maintenance of computers. Inappropriate access devices and inappropriate sanitation and jobs. There have been many efforts to Internet technologies including low bandwidth. Insufficient use older ICTs for health and development in language and cultural adaptation of content and the digital divide developing countries. Radio and television networks Environmental Effects of weather, temperature, humidity and dust on equipment. can be powerful tools for widespread health education. issues Security and accessibility of equipment. Isolation, transport issues There have been many efforts to donate legacy systems and older computers to developing countries, Sustainability Ongoing upgrades of technology, ongoing costs, issues cost-effectiveness although some argue that this is more a means of dumping eWaste than a philanthropic effort. MIT Practical issues of Corruption, borders and customs in equipment transport, working internationally nationally-imposed barriers to information access or has recently announced it is developing a US $ 10 dissemination or to information privacy, donor-imposed computer using the older Apple II hardware and barriers, time zones and communication issues of working in remote geographical areas software in parallel with the One Laptop per Child (OLPC) initiative. Health care In health, insufficient means to implement health care and take infrastructure full advantage of leapfrog ICT technologies, e.g. lack of The concept of leapfrogging implies that developing treatment facilities, drug delivery systems, inadequate cold countries should be able to benefit from the most chain facilities for vaccines current technologies and bypass older legacy systems as a more efficient means of achieving technology Table 1: Potential barriers to implementing leapfrog technologies in developing countries transfer. This paper looks at leapfrogging technologies
130 Global Forum Update on Research for Health Volume 5 130-135 McConnell:GF5 22/10/08 09:33 Page 131
Technological innovations
Technology Examples of potential applications Examples of potential risks and in developing countries implementation problems in developing countries
Telemedicine technologies eRadiology, ePathology, teleSurgery, Store and Forward Differing cultural understandings of illness; Telemedicine can enable access to necessary expertise medico-legal implications; bandwidth issues and help in overcoming the “brain drain” of medical personnel in developing countries
Open access technologies Technologies such as Web Bibliometrics, Web 2.0 and wiki are Poor quality controls for information; making it possible to realize the principles of The Budapest Open misinformation becomes published as fact Access Initiative, The Berlin Declaration, the Open Source Initiative and Gnu License, as well as The Copy Left Movement. Projects such as The Public Knowledge Project, HINARE, The Open Archives Initiative and online journals such as the Public Library of Science, Biomedcentral are revolutionizing medical publishing with Open Peer Review and Commentary and free access to publications. This has resulted in a paradigm shift in why and how we publish scientific research
Collaborative technologies Advances such as Web 2.0 and wiki will mean that health professionals and Poor quality controls for information; and social networking patients in developing countries can effectively network with each other misinformation becomes published as fact and with the industrialized world and actively participate in knowledge development through projects such as medical wikis. This will also lead to patient empowerment and to better informed health care particularly for those suffering from chronic illness and disabilities
GRID technologies May deliver greater power at less cost by harnessing the capacity of Cost and limited bandwidth access limit utility many computers and increasing collaboration efforts
Internet2 Internet2 allows advanced centres of medicine to provide health education Risk of increasing digital divide as currently to hospitals and universities in developing countries through increased limited availability in developing countries bandwidth, improved security and collaboration potential
eLearning technologies and The creation of these new resources is both exciting and precarious as Lack of acceptance; technology transfer virtual patient simulation they can offer limitless possibilities to advance in areas like distance issues learning and interdisciplinary development. Facilitates capacity building and collaboration with other institutions through both real time and asynchronous delivery methods
Bioinformatics Identification of drug targets and understanding pathogen-host High development costs interactions
Alternative network technology 3G, 4G mobile phone networks and digital satellite radio offer the High establishment costs potential for access in remote areas
Eco-technologies Environmental sustainability, sanitation, clean water, bioremediation High development costs
Solar technology Power for computers, phones. A lesser known health sector application Reliability for solar technology is the application of solar ovens to dispose of hazardous medical waste
Genomics and recombinant Sequencing pathogen genomes to assist in development of antimicrobials; Intellectual property and patent issues technologies decreased costs of vaccine development; development of less expensive and more field-useable vaccines Reduced costs of drug development; development of more effective and appropriate and less expensive drugs for priority problems in LMICs
Nanotechnology Nanomedicine offers new methods of diagnostics and could completely Concerns over health effects of nanoparticles, displace certain classes of drugs and change the ways diseases like HIV, including potential for asbestos-like effects malaria and TB are treated
Genetically modified crops Increased nutrients to counter specific deficiencies Cross-contamination with other crops, international regulation issues
Combinatorial chemistry New drug discovery High development costs
Molecular technologies Affordable diagnosis of infectious disease High development costs
Table 2: Examples of leapfrog technologies
Global Forum Update on Research for Health Volume 5 131 130-135 McConnell:GF5 22/10/08 09:33 Page 132
Technological innovations
developing/LMIC countries are outlined in Table 2. Case studies have recently been published outlining eHealth activities and results in Peru, South Africa, Turkey, The UN hopes that if the very poor in Africa have mobile Vietnam and Rwanda2. The South African case study3 phones they will be able to use them effectively in confirmed that the needs of developing countries differ from medical emergencies and also to access appropriate and those of the developed world in some areas. Issues of useful health information interoperability, human resource development, broadband penetration and high cost of bandwidth are worth noting. Although several e-Governance projects have been implemented in South Africa and a draft e-Health White Paper Discussion Document has been developed, the doctor and one nurse in every hospital in developing implementation of eHealth policy remains a concern. countries, especially those in rural and peripheral areas, were The training of the workforce needed for successful eHealth to have access to (and effectively use) a mobile “smart” implementation is globally a common focus. Apart from phone with web capability, it could have a major impact on residential degree courses, online training opportunities are provision of health care. now also offered, such as Drexel University’s Certificate in The UN Millennium Villages Program has initiated a plan Healthcare Informatics4 and Certificate in Medical Billing and in which some of the world’s poorest people in several African Coding5. An important part of eHealth, albeit sometimes countries will be connected to cellular networks and be able viewed as on the periphery, is consumer health sites. Such to use mobile phones. This is expected to have a significant sites should preferably be accredited by the Health On the Net impact on health care and education. They will not have Foundation (HON), whose mission is to guide Internet users access to mobile web browsing yet, but that could be to reliable understandable accessible and trustworthy sources available to them within a few years. The UN hopes that if of medical and health information6. However, the apparent the very poor in Africa have mobile phones they will be able success of consumer health sites can result in – or unveil – to use them effectively in medical emergencies and also another problem for health-care consumers and providers. A to access appropriate and useful health information. A rural recent survey in the USA commissioned by Envision Solutions hospital would be able to make a call to the nearest found that more than 85 million adults in the USA – almost specialty hospital or specialist and thus help save lives 40% – have doubted their health-care providers’ opinions during emergencies. when the information did not match what they found online7. Mobile web browsing, at the very least, could provide A good example of technology leapfrogging is mobile instant access to the most relevant and up-to-date health phones, which have enabled low- and middle-income information to health practitioners, especially if the most countries to overcome the barriers of poor or insufficient relevant and appropriate information were available in easily telecom infrastructure and leapfrog into 21st century mobile accessible forms, and it would offer a private and personal technology. ICT leapfrogging also applies to digital form of learning experience. The mobile web can be a technologies whereby many low- and middle-income “knowledge repository” for both providers and consumers of countries have been able to leapfrog to the digital age without health care. Other mobile devices such as patient monitoring going through the analogue era technologies. This possibility devices, PDAs and wireless radios can all be used in public to leapfrog extends to eLearning and eHealth as well. health education, training and capacity enhancement. For Currently, most of the popular eLearning and eHealth example, they can be used in real-time monitoring of patient programs and applications require sophisticated hardware vital signs and in accessing important and useful and software, and in many cases access to high-speed health information. Internet. As a result, countries that need eLearning and One of the main constraints that prevents developing eHealth services the most are also the ones least able to countries from being fully part of the emerging global ICT access and use them. With the introduction of mobile infrastructure is the lack of resources, both financial and technologies and devices, it is possible to provide eLearning human, to acquire and apply the technologies. The latter is and eCapacity building programmes to public health true, especially in public health. Even if the government or providers, even in remote and isolated areas. By 2010, the donor agencies are prepared to invest in the required total number of mobile phone users is expected to grow to infrastructure, at present there are not enough skilled people 3.3 billion globally, or approximately half the world’s within the health sector, especially in the rural areas, who are population. Although the more affordable mobile phones in able or willing to use most ICTs effectively. Mobile phones and developing countries may not yet have sophisticated features some other hand-held wireless devices, however, do not found in Smart Phones, mobile phones are becoming seem to pose too much of a challenge to the users. ubiquitous in Asia, Africa and Latin America. This is expected Medical record-keeping is an area which begs for to result in an increase in mobile-enabled health systems and leapfrogging. In the tsunami-hit hospitals in Sri Lanka and services throughout the world. The recent development of other countries, for example, paper-based health records and “mobile web” is already turning web browsing into an “any patient records were washed away or destroyed. Having one’s time, any place” phenomenon. The mobile web will medical records available on a mobile phone would also help essentially function as “personal computers”. If at least one doctors, nurses and pharmacists make the right decisions,
132 Global Forum Update on Research for Health Volume 5 130-135 McConnell:GF5 22/10/08 09:33 Page 133
Technological innovations
based on a patient’s health history. developments in public health research. In many parts of the Electronic public health journals offer a very inexpensive developing world, unlimited Internet access is now available form of eLearning. They keep readers up-to-date on new on a monthly rate basis. Health personnel with such access can easily have individualized professional Initiative/organization Comment development by just going through these online journals. Many medical schools and colleges have AED SatelLife Uses ICTs, especially PDAs, in health and development. computer centres that allow students free time on the http://www.healthnet.org/whatwedo.php Internet. Many journals are available on a fully open- Development Gateway World Bank Initiative. Portal for development partners and access basis, e.g. BioMedCentral and PLOS Medicine, member countries. www.developmentgateway.org and in developing countries many journals are First Voice International Uses WorldSpace Digital Satellite Radio for broadcast of health available through HINARI and even some evidence- information. www.firstvoiceint.org/ based medicine websites such as dynamicmedical.com are available free of charge to Health InterNetwork Biomedical publishers, working closely with the World for Developing Nations Health Organization (WHO), allowing free or very low priced health professionals in many developing countries. (HINARI) online access to more than 2000 key biomedical research and Electronic journals also offer the convenience of taking healthcare journals. part in blogs, debates, webchats, and other forms of http://cat.inist.fr/?aModele=afficheN&cpsidt=14647338 eLearning and electronic participation. This has the Health on the Net Sets code of practice for health Internet sites to guide added advantage of peer learning and of being part of Foundation (HON) Internet users to reliable, understandable, accessible and communities of practice on a global scale. ePublishing trustworthy sources of medical and health information. www.hon.ch also stands to make major changes in the way we InfoDev World Bank Initiative. Sponsors ICT and development disseminate information. Success will be measured by programmes and framework documents. www.infodev.org web bibliometrics analysing one’s contribution to Interactive Health Nonprofit organizations dedicated to using online making a real impact, rather than merely by Network and Academy technologies to combat health inequities through stimulating counting peer review publications and citations. These for Health Equity and discussion regarding effective policies for public and private bibliometrics have the potential to replace the current Disability health programmes and practices affecting those most marginalized in society. Works in Africa and Asia-Pacific system of publish or perish merit system measured by predominantly on eLearning and ePolicy initiatives. Uses ICTs citations. The new system will allow an for eCapacity Building of health-care workers and for effective unprecedented transparency in research, making national and international policy development. www.ihn.info fraudulent research very difficult. Open access, open International Network Promotes access, use, dissemination and communication archives, open editorial review and open peer review for the Availability of of research information in developing countries will make possible access to original data and Scientific Publications http://www.inasp.info/file/434/inasp-health.html (INASP) collaboration in ways not yet envisioned. An open source approach to research dissemination will ensure International Sets standards in telecommunications and monitors eHealth true advancement in scientific acknowledge through Telecommunication programmes; Sponsor of the World Summit on the Union Information Society (WSIS). http://www.itu.int real paradigm shifts and important innovative advances8. IRDC Acacia Initiative Works in Africa with a focus on appropriate applications and This year’s Global Economic Prospects9 focuses on technologies, infrastructure, policy and governance. www.idrc.ca/acacia technology diffusion in developing countries and states that even the introduction of relatively simple PATH Nonprofit organization using health technologies designed for technologies can have far-reaching development low-resource settings, by the people who will use them; promoting health equity for women, among the world’s most impacts. “Technological advances do not need to be vulnerable – and influential – populations and vaccine extraordinarily complex or reliant on the most programmes. www.path.org sophisticated technology to have important Rockefeller Foundation Sponsors think tank meetings on E-health aimed at improving development impacts”. This holds true for health ICTs. and the global coalition health systems in the developing world. Includes BIREME/PAHO/ With the convergence of mobile phones and the web, for eHealth in WHO Latin American and Caribbean Center on Health Sciences we expect major impacts on the way health developing countries Information, the American Medical Informatics Association (AMIA), International Medical Informatics Association (IMIA), information is used and processed. More and more Health Level Seven (HL7), Health Metrics Network (HMN), health workers will be able to access web-based Partners in Health (PIH), Regenstrief Institute, Telemedicine health and hospital information using their mobile Society of India, United Nations Foundation (UNF) and Vodafone Group Foundation Technology Partnership, University of phones than their desk top or laptop computers, Washington’s Center for Public Health Informatics, and the which usually do not exist in many health care World Health Organization (WHO). http://www.rockfound.org; facilities. Ubiquitous, portable and personal http://www.ehealth-connection.org/ computing via affordable mobile phones will lead the WHO Essential Has eHealth branch focusing on applications in developing way in leapfrogging ICTs in many parts of the Technologies countries; collaborates with NGOs on programmes; sponsors developing world. ePublishing and Open Access make Programme many conferences on technology and health. www.who.int it possible to access essential health information at the Table 3: Examples of international initiatives promoting ICTs for health and point of care on these devices, and this is already development (modified from McConnell 2004, 2006) occurring in many areas.
Global Forum Update on Research for Health Volume 5 133 130-135 McConnell:GF5 22/10/08 09:33 Page 134
Technological innovations
Table 3 shows some examples of international efforts He has a keen interest in Open Access and innovative use of IT to toimplement Leapfrog technologies in developing countries make scientific publishing more available in developing countries. for health care. Professor McConnell has worked extensively with the WHO, World Bank and other international agencies on the implementation of Conclusion eHealth programmes in developing countries. He trained in the USA, In public health practice, ICTs enable the identification of Canada, New Zealand and the UK. Professor McConnell also has a disease and risk factor trends, analysis of social and keen interest in evidence-based policies for disability services and in demographic data, and increase access to publications and health and disability in developing countries. He is a Consultant databases. As free and open source software continues to Psychiatrist and Professor of Neuropsychiatry at Griffith University evolve, the uses of ICTs for health will expand School of Medicine. exponentially. ICTs can be used by medical professionals and community health workers to improve not only health Prita Chathoth PhD has more than 20 years of international services but also entire health-care systems, while experience in eLearning, eHealth and ICTs for development. She beneficiaries can use ICTs to access health information and worked at the World Bank in Washington, DC, from 1993 to 2007. make well-informed decisions regarding their own During this time, for more than seven years, she served as senior health. However, not all members of the health workforce or operations officer in the Global Development Learning Network the public have equal access to ICTs. The digital divide – the (GDLN). As Task Manager of the GDLN Global Dialogues Program, Dr gap between those with effective access to ICTs and those Chathoth worked extensively with all regions of the world. without it – contributes directly to the persistent health From July 2005 to December 2006, Dr Chathoth was on inequality both between and within countries. In health, assignment at the WHO Office in Sri Lanka as eCapacity Building lacking or limited access to ICTs impedes the provision of Coordinator and Project Manager of the Sri Lanka eHealth Project. health care and the effectiveness of public health work. Prior to joining the World Bank, she worked at INTELSAT, in Efforts to bridge the gap in access to ICTs have varied Washington, DC, as a training specialist. In 2007, Dr Chathoth dramatically in their effectiveness and their usefulness. worked as a consultant at the Pan American Health Organization Beyond the creation of systems for cell phone and Internet (PAHO). She has researched, written and produced more than 15 use, we need to ensure that access to ICTs for health will link broadcast quality documentaries. Dr. Chathoth currently works as an individuals to the health information and modes of independent eLearning/eHealth Consultant. communication that are most useful to them, and that the most necessary, valid and useful information is available in Ashley Pardy is the co-director of the Interactive Health Network the most acceptable and useable forms. (IHN) and project manager of the Academy for Sustainable Health Thomas Kuhn in The Structure of Scientific Revolutions in Equity and Development (AHEAD). Both are nongovernmental 1962 put forward that true scientific knowledge does not organizations dedicated to improving health and disability services in advance as a linear increase in understanding based on developing countries through the use of information communication logical models. He proposed that true advances occur technologies. Now a full-time PhD student at Griffith University in naturally as a series of revolutions, replacing the old Australia, Ashley started her university education at Queens paradigms and resulting in a “paradigm shift”: a new way of University in Canada, where she completed her BA and then thinking about a problem. Thus, to advance development, the continued on to Australia to do her masters in International use of leapfrog technologies must extend this process to Relations. She is currently focusing her dissertation on mental health include ecologically, financially and socially sustainable research in Ethiopia and is actively involved in development projects means of tackling poverty and heath inequalities. Examples in the Asia pacific region. Ashley has worked as a volunteer in Asia, of such paradigm shifts include very recently the effect of the Africa and South America. Internet on information retrieval, and earlier the discovery of penicillin and vaccines for combating infectious diseases. Camille Boostrom is a PhD candidate in public health at Griffith ICTs are already having an impact in health in developing University, Australia. Her research analyses the sector-wide approach countries through the rapidly growing use of mobiles and in Mozambique’s health sector and its impacts on the country’s through Open Access initiatives for ePublishing10. There is a HIV/AIDS prevention efforts, specifically on the negotiation and unique opportunity for developing countries to harness dissemination of HIV/AIDS communications. Camille is also a eHealth technologies in a way that will ensure a paradigm Research Associate with the Georgetown University Medical Center. shift in how we “deliver” or “support” development and how health is progressed in these regions. It offers the potential of Eugene Boostrom MD, DrPH is a public health specialist with greater transparency, improved governance and access to more than 30 years’ experience in the development of health essential tools and expertise, irrespective of geography or of systems and health personnel. He has worked in Africa, Latin financial or resource implications. J America and the Caribbean, the Middle East and South Asia with bilateral and multilateral agencies, universities, foundations and the Harry McConnell is a neuropsychiatrist specializing in disability private sector. He retired from the World Bank as Senior Public with more than 20 years’ experience in both the clinical and public Health Specialist in 2002 and now lives in Okinawa, Japan, where health aspects of health and disability. He has published five he is a Visiting Researcher at Meio University Research Institute. He textbooks and worked as a Clinical Editor at BMJ Clinical Evidence. also teaches public health, epidemiology, health project and human
134 Global Forum Update on Research for Health Volume 5 130-135 McConnell:GF5 22/10/08 09:33 Page 135
Technological innovations
resources planning and management, and sustainable development knowledge management including summarizing evidence and related topics for the Japan International Cooperation Agency (JICA), developing strategies to systematically inform policy and practice Japan’s National Institute of Public Health, and Hokkaido University with research evidence. From his position as Clinical Editor at BMJ Medical School. Clinical Evidence he emphasized evidence-based programmes and access to developing countries and worked closely with the World Koos Louw is an eHealth consultant living in Cape Town, South Health Organization and International NGOs including the Cochrane Africa. He served for many years in the top management of the Collaboration and INCLEN. More recently he has coordinated the South African Medical Research Council as Executive Director: response of the Pan American Health Organization (PAHO/WHO) to Informatics and Knowledge Management. He is an acclaimed role the 2004 Mexico Declaration on Health Research. player in the area of health informatics and knowledge management, nationally and internationally, and has a track record Sumiko Ogawa, MS in Medical Sciences, MPH, PhD, is Associate of various successful large multi-institutional eHealth projects. He Professor at Meio University, Okinawa, Japan, where she teaches holds a PhD from Stellenbosch University, South Africa. This Public Health. Her successful work with WHO and JICA in university appointed him in the honorary position of Visiting developing Primary Health Care and Village Drug Revolving Funds Professor: Information Science (Knowledge Management) and as an and improving water supplies in the Lao PDR’s remote Khammouane Associate of its Centre for Knowledge Dynamics and Decision Province from 1992 to 1996 led the Government of Laos to award Making. her its Labor Medal, and the Japan Chamber of Commerce named her Japan’s Outstanding Young Person of 1997. With support from Luis Gabriel Cuervo is a Medical Doctor with an MSc in Clinical Japan’s Ministry of Education and JICA, she documented the post- Epidemiology & Biostatistics from the Universidad Javeriana, and World War Two recovery and development of health systems and qualified as a Specialist in Family Medicine at the Universidad del human resources for health in war-ravaged Okinawa. She is Valle, Colombia. He brings first hand experience as producer and President of Okinawa’s Association of Former Overseas JICA Experts user of evidence for health care in the clinical, academic, and and a member of the board of Japan’s Association for Overseas research fields working in various communities in rural and urban Volunteer Studies. She continues her work with the Lao PDR MOH environments in Colombia. He has developed a career around and also teaches and consults for JICA.
References
1 Dzenowagis J. Bridging the digital divide in health: the role of free and divide. Health Affairs, 2000, 19(6):255. open source software. World Health Organization Expert Meeting on Free Dzenowagis J. Bridging the digital divide in health: the role of free and open & Open Source Software UNCTAD, Geneva, 2004. Available at: source software. World Health Organization Expert Meeting on Free & http://r0.unctad.org/ecommerce/event_docs/fossem/dzenowagis.pdf Open Source Software UNCTAD, Geneva, 2004. Available at: 2 Refer: www.ehealth-connection.org/content/country-case-studies http://r0.unctad.org/ecommerce/event_docs/fossem/dzenowagis.pdf 3 Refer: www.ehealth- Improving health, connecting people: the role of ICTs in the health sector of connection.org/files/resources/County%20Case%20Study%20for%20eHeal developing countries. A Framework Paper, InfoDev, 2008. th%20South%20Africa.pdf http://www.infodev.org/en/Project.38.html 4 Refer: www.drexel.com/online-degrees/information-sciences-degrees/cert- McConell H. Pardy Medical Publishing in Snyder et al. Medicine and the hci/index.aspx media (in press), 2008. 5 Refer: www.drexel.com/online-degrees/nursing-degrees/medical-billing- McConnell H, Shields T and Drury P. Leadership in Global Health coding/index.aspx Technology Update. World Hospitals and Health Services, 2006. 6 Refer: www.hon.ch/ McConnell H and Marchibroda J. Leadership in Global Health Technology 7 Monegain B (ed). Online info has patients doubting doctors, survey founds. (LIGHT): an international dialogue towards cooperation in medical In: Healthcare IT News, 30 July 2008 education, clinical, and research initiatives in healthcare. World Hospitals http://www.healthcareitnews.com/story.cms?id=9654 and Health Services, March, 2004. 8 McConell H. Pardy Medical Publishing in Snyder et al. Medicine and the Salamanca-Buentello F et al. Nanotechnology and the developing world. media (in press), 2008. PLoS Medicine, 2005, 2(5): e97 doi:10.1371/journal.pmed.0020097. 9 http://econ.worldbank.org/WBSITE/EXTERNAL/EXTDEC/ Singh JP. Leapfrogging development? The political economy of EXTDECPROSPECTS/GEPEXT/EXTGEP2008/0,,menuPK:4503385~page telecommunications restructuring. SUNY Press, NY, 1999. PK:64167702~piPK:64167676~theSitePK:4503324,00.html Steinmueller E. ICTs and the possibilities for leapfrogging by developing 10 McConell H. Pardy Medical Publishing in Snyder et al. Medicine and the countries. International Labour Review, 2001, 140(2):193-210. media (in press), 2008. Tan-Torres Edejer T. Disseminating health information in developing countries: the role of the internet. British Medical Journal, 2000, Furthur reading 321(7264):797-800. Berger M. Nanotechnology patents and the future of the pharma industry. Warschauer M. Reconceptualizing the digital divide. First Monday, 2002, Nanowerk LLC, 2007. 7(7). Available at: http://www.nanowerk.com/spotlight/spotid=2912.php http://firstmonday.org/issues/issue7_7/warschauer/index.html Bernhardt JM. Health education and the digital divide: building bridges and Global Economic Prospects 2008: Technology Diffusion in the Developing filling chasms. Health Education Research, 2000, 15(5):527-531. World. World Bank, 2008. Brodie A et al. Health information, the internet, and the digital
Global Forum Update on Research for Health Volume 5 135 138-142 de Roeck:GF5 22/10/08 16:12 Page 138
Technological Innovations
The IVI’s innovative approach to closing the gap between vaccines for industrialized and developing countries
Article by Denise DeRoeck (pictured), Coordinator, Social Science Research and Institutional Development, International Vaccine Institution, South Korea with Anna Lena Lopez, Rodney Carbis and John D Clemens
xperience in the past three decades has shown that Because populations can differ in their immune response to a getting a new childhood vaccine introduced into a particular vaccine, national policy-makers are increasingly Edeveloping country is more than simply a matter of demanding local or at least regional data on a vaccine’s obtaining good results from clinical trials, getting it licensed efficacy or field effectiveness. and introduced into immunization programmes in Finally, country policy-makers may be uncertain of their industrialized countries, and expecting developing countries population’s demand for or acceptance of the new vaccine. to follow suit. A large number of obstacles stand in the way. This is perhaps less of an issue for vaccines introduced into First, country policy-makers, as well as donors, may consider the infant immunization schedule, such as the new rotavirus the new vaccine unaffordable, especially compared to the and pneumococcal conjugate vaccines, since children are pennies-per-dose basic childhood vaccines, such as DPT and simply given the additional vaccine during their regular oral polio. Second, a number of countries, especially large immunization sessions. However, it can be an important Asian countries, such as China, Vietnam, India and issue for vaccines provided outside of the infant schedule, Indonesia, have a policy of self-reliance in vaccine such as the new human papillomavirus (HPV) vaccine (given production, requiring them to produce or at least fill/finish and to pre-adolescent girls), and vaccines against cholera and package locally any vaccine used by the national typhoid fever – which are not licensed for use in children immunization programme. The new vaccine may be patent- under the age of one or two years. These vaccines require protected, too complex or too expensive to produce locally. special efforts to administer – such as school- or community- One way to deal with both of these issues is to develop based vaccination campaigns – thus increasing the potential technologies for vaccine manufacture and testing that can be for resistance or disinterest on the part of health authorities transferred to qualified vaccine producers in developing and the community. Conducting sociobehavioural studies and countries so that they can manufacture high quality vaccines private demand surveys concerning the particular disease at affordable prices. and vaccine in target populations can help predict demand for Another common obstacle to introducing a new or the vaccine, as well as preempt possible negative reactions or underutilized vaccine into developing countries is that local lack of interest (e.g., by using commonly-held beliefs or policy-makers may not be convinced of the need for the attitudes to inform social mobilization activities and messages), vaccine in their country. This may be because the disease is and inform the design of effective vaccination strategies. part of a syndrome or group of diseases and not recognized A number of product development partnerships (PDPs) as a distinct disease (e.g., diarrhoea caused by rotavirus virus have been established in recent years – primarily with other enteric pathogens); the disease is not well diagnosed, funding from the Bill & Melinda Gates Foundation – to due in part to a lack of specific, accurate or low-cost undertake the complex, multi-faceted and coordinated set of diagnostic tests, and thus is under-reported (e.g., typhoid activities that are required to address the above issues in fever); or the disease mainly affects poor, marginalized or order to accelerate the development and introduction of rural populations and is therefore not on the radar screen in specific vaccines into developing countries. Examples are the urban areas where policy-makers and the media are Malaria Vaccine Initiative, the International AIDS Vaccine concentrated (e.g., cholera, Japanese encephalitis). Initiative (IAVI), the Rotavirus Vaccine Project, the Aeras Estimates of the burden of the specific disease are therefore Global TB Vaccine Foundation and the PneumoADIP. While required, which may include conducting prospective disease most PDPs use a model that combines in-house activities and surveillance studies. The vaccine’s effectiveness in local expertise with those that are out-sourced to diverse partner populations may also be questioned, especially when the organizations, the approach of the International Vaccine trials for licensure have been conducted solely in Institute, an independent international organization founded industrialized countries or only in certain parts of the world1. in 1997 and based in Seoul, Korea, has been to build
138 Global Forum Update on Research for Health Volume 5 138-142 de Roeck:GF5 22/10/08 16:12 Page 139
Technological Innovations
development of Shigella vaccines, since natural immunity against Vaccine Research for Vaccine discovery development: vaccine shigellosis is believed to be and design: introduction: species- and serotype-specific. An effective vaccine would likely • Genotyping have to contain antigens from a • Laboratory process • Collection of large number of species and (pathogen detection) development epidemiological, serotypes and would need to be • Novel antigens • Assays develop- economic and • Novel adjuvants ment (immuno- socio-behavioral modified each year, based on • New routes of monitoring) data circulating serotypes, making the administration • Technology • Studies of vaccine development of such a vaccine (e.g., sublingual) transfer for large- feasibility, accept- scientifically challenging and the • Reformulation and scale production ance and field ultimate production logistically improvement of • Clinical trials effectiveness complex and expensive. These existing or proto- • Data synthesis findings from the field led the IVI’s type vaccines (cost-effectiveness laboratory scientists to go back to and impact the drawing board and to use an analyses) and innovative genomic search dissemination strategy to analyse whole genome sequences from the four Shigella Figure 1: In-house capabilities and activities of the IVI along the vaccine continuum species, using specimens obtained from the field surveillance studies. in-house capacity in all three major areas along the “vaccine This research led to the discovery of proteins common to all continuum” – namely vaccine discovery and design; vaccine species and serotypes that can potentially serve as antigens development and field testing; and vaccine introduction. for a cross-protective Shigella vaccine. Such a vaccine is These in-house capabilities “from bench to community” (see currently in development at the IVI’s laboratories and initial Figure 1) have been built through the Institute’s Laboratory tests in animals have been positive. Sciences and Translational Research divisions and its In the remainder of this paper, we describe how the IVI’s Product Development and Technology Transfer unit. in-house capabilities have been put to work to accelerate the Having in-house capacities in all or most of the areas use of new-generation cholera vaccines in cholera-endemic required for getting a vaccine introduced into developing countries. These activities are depicted in Figure 2. countries has a number of advantages. Conducting most of the activities and research in- Vaccine Research to house can quicken the pace of development: vaccine introduction: progress, as well as save costs by reducing the need to hire ReformulationRefformullattiion anandd iimimprovementprovement iin IVIVI’sI’s • Prospective disease surveillance subcontractors with additional laboratories of a low-cost oral killed studies in several sites administrative fees and overhead whole-cell (WC) cholera vaccine produced • Cost-of-illness and vaccine demand in Vietnam costs. It also enhances flexibility, surveys by more easily and rapidly • Socio-behavioral surveys Testing of the safety and Immunogenicity • Demonstration of mass vaccination allowing the researchers to switch of the improved oral killed WC vaccine for using Dukoral in Mozambique and gears and move into the direction licensure in Vietnam and India assessment of its protective impact that the data take them without Phase III trial of TechnologyTechnology ttransferransfer involving multiple layers of improved WC of improved WC Analysis of herd effects and overall bureaucracy. For example, vaccine in Kolkata vaccine to high- impact of oral killed WC-based vaccines for licensure and prospective surveillance of quality developing WHO pre- shigellosis (bacterial dysentery) country producers qualification Site-specific impact and cost- conducted by the Translational effectiveness analysis of different Development of new immuno-assays Research Division in six Asian cholera vaccination program options for cholera countries, revealed that the diversity in the distribution of FieldFi ld ttestingtiflilild of a live oral, single-dose Analysis, synthesis and dissemination species and serotypes of Shigella Peru-15 vaccine in Bangladesh and India of global and country-specific data to from country to country and even inform decisions about use of cholera vaccines from year to year within the same country was greater than commonly believed. These Figure 2: The IVI’s Cholera Vaccine Programme to accelerate the use of low-cost oral cholera vaccines for endemic populations findings greatly complicate the
Global Forum Update on Research for Health Volume 5 139 138-142 de Roeck:GF5 22/10/08 16:12 Page 140
Technological Innovations
The IVI’s programme to accelerate the use of The first challenge that the programme undertook was to new-generation oral cholera vaccines in develop a source of low-cost cholera vaccine that met WHO endemic populations requirements for safety and quality for use in public health At the time the IVI began its Cholera Vaccine Program in programmes throughout the cholera-endemic world. The 2000, there were two internationally licensed new-generation Product Development and Technology Transfer unit of the IVI oral cholera vaccines. One was Dukoral™, produced by worked with the local Vietnamese producer, VaBiotech, to Swedish Bacteriology Laboratories (SBL), and consisting of improve the Vietnamese WC vaccine so that it complied with killed whole cells Vibrio cholerae O1 strains with a purified WHO guidelines. This involved reformulating the vaccine by recombinant B-subunit of cholera toxin (rBS-WC). The replacing a high toxin-producing strain with a low toxin- vaccine, which requires the administration of two doses given producing strain, changing the antigen content of other one to six weeks apart, was found in field trials in Bangladesh strains, and developing new lot release assays that both to confer around 50% protection after three years2. It is provide greater consistency in the formulation of the product licensed for persons two years and older, costs several dollars and that better detect the removal of cholera toxin. These per dose, and thus its use has been largely limited to efforts resulted in a vaccine that meets quality standards, is travellers from industrialized countries traveling to cholera- safe and yet remains affordable in cholera-endemic settings. endemic areas. The second was a live, attenuated vaccine The next challenge was to achieve licensure of this (CVD 103HgR or Orochol™), manufactured by Berna Biotech improved cholera vaccine in Vietnam, as well as in other of Switzerland. This vaccine had been licensed for travellers potential countries of manufacture. The IVI’s Translational in several industrialized countries, but was not found to be Research Division conducted Phase II clinical trials, with the protective in cholera-endemic populations and is no longer National Institute of Hygiene and Epidemiology (NIHE), being produced3. among adults in Sonla, Vietnam and found a greater increase Despite recommendations from the World Health in serum vibriocidal antibodies and higher rates of Organization (WHO) for the use of new-generation cholera seroconversion than those seen after receipt of the original vaccines in 1999, no country has yet introduced cholera Vietnamese vaccine7. The improved WC vaccine is in the vaccines into its immunization programme, with the process of being licensed in Vietnam, based on these results. exception of Vietnam. As a result of technology transfer from Internationalizing the use of this vaccine required that it be Sweden, Vietnam manufactures an oral killed whole-cell produced by vaccine manufacturers in countries with NRAs (WC) vaccine, which does not contain the purified B-subunit approved by WHO. Following a due diligence process, the IVI of the cholera toxin and is consequently less expensive to chose Shantha Biotechnics of Hyderabad, India, as the first produce (<$0.50/dose). The vaccine was found in field trials company to receive the production technology for the new in Vietnam to provide 66% efficacy during a cholera outbreak WC vaccine. Before the vaccine could be licensed and 8–10 months after vaccination in a trial in Hue, Vietnam4. produced in India, a series of clinical trials was also required After reports of cholera epidemics caused by the O139 strain in that country. First, the Translational Research Division, in occurring in South Asia, this strain was added to make a collaboration with the National Institute for Cholera and bivalent (O1/O139) vaccine. Long-term effectiveness studies Enteric Diseases (NICED), conducted Phase II trials first showed that the bivalent vaccine conferred similar protection among adults and then children in Kolkata, India. More than as Dukoral™ (~50% protection 3–5 years after vaccination)5. half of adults and 80% of children developed four-fold or The vaccine is used in Vietnam by the national immunization greater increases in serum vibriocidal antibodies to V. programme in high-risk areas of the Mekong Delta, central cholerae O1, indicating a strong immune response in this coastal areas and some provinces in Northern Vietnam, cholera-endemic population. Next, bulk vaccine from especially during floods. VaBiotech in Vietnam was shipped to Shantha, where it was This vaccine could not be used outside of Vietnam, filled and finished for use in a Phase III randomized, placebo- however, because the country’s national regulatory authority controlled trial involving more than 67 000 children and (NRA) does not meet WHO requirements. The vaccine also adults. This trial, conducted jointly by NICED and the IVI, did not conform to the WHO guidelines for the production of began in 2006 and will continue with disease surveillance for killed oral cholera vaccines – specifically, in the way the three years following vaccination to estimate the new antigen content was determined and in the presence of low vaccine’s efficacy. but detectable levels of cholera toxin6. At the same time, the IVI’s Product Development and Therefore, at the inception of the IVI’s Cholera Vaccine Technology Transfer unit completed the development of Program there was the need for a low-cost, safe and effective quality control assays and showed that the new process cholera vaccine for use in endemic countries and the only worked at laboratory scale. The production technology for this available new-generation vaccines were either ineffective in vaccine will be transferred to Shantha, which will enable the endemic populations, too expensive for public sector use in company to produce the vaccine from scratch under strict developing countries, or did not meet international standards. good manufacturing practice (GMP) conditions. Licensure in There was also a need to demonstrate to the global health India and the subsequent production of the vaccine by community and to skeptical policy-makers in cholera- Shantha can begin after the Phase III clinical trial in Kolkata endemic countries the need for, feasibility and effectiveness of is completed, if the results are shown to be favourable. The vaccination to prevent cholera using new-generation vaccines. ultimate goal is for this vaccine to be pre-qualified by WHO to
140 Global Forum Update on Research for Health Volume 5 138-142 de Roeck:GF5 22/10/08 16:12 Page 141
Technological Innovations
enable its use by UN agencies and by the GAVI Alliance, if cholera vaccination, the Translational Research Division, in and when the alliance decides to support the introduction of collaboration with the University of Washington, performed cholera vaccines into GAVI-eligible countries where cholera analyses of the herd effects of killed WC-based oral cholera still poses a public health threat. vaccines (both DukoralTM and the WC vaccine without the B- Seeing the need for additional oral cholera vaccines, subunit), using surveillance data from the original clinical especially ones that require only a single dose and could trials of these vaccines in Bangladesh conducted in the mid- therefore be used to control currently-occurring outbreaks, 1980s15. The herd effects of these vaccines were found to be the Cholera Vaccine Program has also worked on the clinical substantial; stochastic (probability) modelling estimated that development of a promising live attenuated oral vaccine vaccinating only 50% of the population in a cholera-endemic (Peru-15), developed at Harvard University and licensed to area would result in an estimated 93% overall reduction of Avant Immunotherapeutics in the United States. The vaccine disease incidence in the entire population16. These herd also has the promise of being effective in infants. The IVI’s effects, along with country-specific incidence rates, cost-of- Translational Research Division collaborated with the illness and private demand results from the cholera field ICDDR,B in Bangladesh to evaluate the safety and studies were incorporated into a model, developed by UNC immunogencity of Peru-15 in adults, toddlers and infants8,9. and the IVI, to estimate the impact and cost-effectiveness of The trial results were positive and have led to plans for different programme options for cholera vaccination in four further Phase II and Phase III trials of the vaccine in cholera-endemic settings (Matlab, Bangladesh; Kolkata, Bangladesh and India. As with the oral killed WC vaccine, India; North Jakarta, Indonesia and Beira, Mozambique). the aim is to have the vaccine produced by a qualified Using these and further analyses of the global impact and vaccine manufacturer in a cholera-endemic country – cost-effectiveness of cholera vaccination, the IVI will work following technology transfer from Avant – and for its pre- with policy-makers at the country and international levels to qualification by WHO, so that it can be an important, inform decisions about whether to invest in cholera vaccine affordable tool for the control of both epidemic and endemic introduction in endemic countries. Already, the IVI’s research cholera throughout the cholera-endemic world. has had an impact on global vaccine policy, as the Board of In parallel with these efforts in the laboratory and in the the GAVI Alliance recently prioritized cholera vaccines for field to develop and test low-cost new-generation cholera future support. vaccines for global use, the Cholera Vaccine Program Key messages embarked on a comprehensive research programme to build the case for cholera vaccination where it is needed for both the global health community and for individual cholera- The development and introduction of a new vaccine endemic countries. This programme of translational research in developing countries requires a complex and began with prospective laboratory-confirmed cholera coordinated set of activities encompassing vaccine surveillance studies in two field sites in Asia (slum areas in discovery and design, vaccine development and North Jakarta, Indonesia and Kolkata, India) and one in testing, and research to inform decisions regarding Africa (Beira, Mozambique)10. Nested into these studies were vaccine introduction. studies of the cost-of-illness from cholera, conducted in The IVI’s in-house capabilities in all three areas collaboration with the University of North Carolina (UNC) creates synergies between its laboratory, School of Public Health, which tracked the treatment and translational research and product development other costs of cases identified by the disease surveillance sections and enhances flexibility to resolve studies. Sociobehavioural surveys to determine the beliefs, problems and change direction in response to knowledge, attitudes and practices of these cholera-plagued research findings. communities regarding the disease and preventive measures Using its in-house capabilities, the IVI’s Cholera were also conducted at these field sites, as were household Vaccine Program has developed a new low-cost oral surveys to estimate private demand for new-generation cholera vaccine, coordinated the technology transfer cholera vaccines, both in these impoverished communities and clinical testing of this vaccine for production by and in nearby middle-class neighborhoods11,12. a high-quality developing country producer, To provide additional information on the population coordinated field trials of an oral live attenuated demand, feasibility and effectiveness of mass cholera vaccine candidate, and generated multi-faceted data vaccination, the Translational Research Division conducted a to inform decisions to introduce cholera vaccines in demonstration of the DukoralTM vaccine in Beira, affected countries. Mozambique in collaboration with the Ministry of Health in 2003/4, in which more than 11 000 children and adults received the full two doses of the vaccine13. A case-control Denise DeRoeck serves as the Coordinator for Social Science study conducted during a subsequent cholera outbreak Research and Institutional Development at the International provided further data on the vaccine’s effectiveness – found Vaccine Institute, based in Seoul, Korea. She has a Masters in to be 78–84% over at least five months – in a population Public Health degree and more than 10 years of experience in the with a high prevalence of HIV infection14. areas of immunization financing, policy analysis and data As one step in determining the overall potential impact of synthesis regarding the introduction of new vaccines in developing
Global Forum Update on Research for Health Volume 5 141 138-142 de Roeck:GF5 23/10/08 10:22 Page 142
Technological Innovations
countries, as well as 20 years of experience overall in the field of development and technology transfer, with a focus on vaccines global public health. against cholera and typhoid fever.
Anna Lena Lopez, MD, is a paediatric infectious diseases John D Clemens, MD, Director-General of the International specialist by training. She is presently a senior scientist Vaccine Institute, is an international expert on the evaluation of and epidemiologist at the IVI where she heads the Cholera vaccines in developing countries. He served as Chief of the Vaccine Program. Epidemiology Branch of the National Institute of Child Health and Human Development, US National Institutes of Health (NIH) and Rodney Carbis worked at CSL in Australia, where he was as Director of the first WHO Collaborating Centre for Vaccine responsible for developing and implementing changes in the Evaluation in Developing Countries. His research has focused on manufacturing process of influenza vaccines as well as developing innovative methodological approaches to evaluating vaccines in high yielding influenza seed lots. He then joined Sartorius developing country populations. He has conducted clinical studies (Australia) and assisted pharmaceutical companies in developing of vaccines against cholera, enterotoxigenic Escherichia coli, downstream processes and optimizing filtration systems. He joined typhoid fever, pneumococcus, tuberculosis, Haemophilus the IVI in 2003, where he leads a team involved in vaccine process influenzae type b, measles and Japanese encephalitis.
References
1. This has been the case of new oral rotavirus vaccines, which, because 9. Qadri F et al. The PXV Study Group. Peru-15, a live attenuated oral they had only been tested in the Americas and Europe, have not yet been cholera vaccine, is safe and immunogenic in Bangladeshi toddlers and recommended by WHO for use in Africa or Asia. infants. Vaccine, 2007, 25(2):231-8. 2. Clemens JD et al. Field trial of oral cholera vaccines in Bangladesh: results 10.Deen JL et al. The high burden of cholera in children: comparison of from three-year follow-up. Lancet, 1990, 335:270-273. incidence from endemic areas in Asia and Africa, PLoS Neglected Tropical 3. Cite Jakarta study paper. Diseases, 2008, 2(2):e173. 4. Trach DD et al. Field trial of a locally produced, killed, oral cholera vaccine 11.Lucas ME et al. Private demand for cholera vaccines in Beira, in Vietnam. Lancet, 1997, 349:231-235. Mozambique. Vaccine, 2007, 25(14):2599-609. 5. Thiem VC et al. Long-term effectiveness against cholera of oral killed 12.Kim D et al. Private demand for cholera vaccines in Hue, Vietnam. Value whole-cell vaccine produced in Vietnam. Vaccine, 2006, 24:4297-4303. in Health, Jan–Feb 2008, 11(1):119-128. 6. WHO Expert Committee on Biological Standardization: fifty-second report. 13.Cavailler P et al. Feasibility of a mass vaccination campaign using a two- Geneva, Switzerland, 2006. dose oral cholera vaccine in an urban cholera-endemic setting in 7. Anh DD et al. Safety and immunogenicity of a reformulated Vietnamese Mozambique. Vaccine, May 2006, 24(22):4890-5. bivalent killed, whole-cell, oral cholera vaccine in adults. Vaccine, 2007, 14.Lucas ME et al. Effectiveness of mass oral cholera vaccination in Beira, 25:1149-1155. Mozambique. New England Journal of Medicine, 2005, 352(8):757-67. 8. Qadri F et al. Peru-15 Study Group. Randomized, controlled study of the 15.Ali M et al. Herd immunity conferred by killed oral cholera vaccines in safety and immunogenicity of peru-15, a live attenuated oral vaccine Bangladesh: a reanalysis. Lancet, 2005, 366: 44-49. candidate for cholera, in adult volunteers in Bangladesh. Journal of 16.Longini IM et al. Controlling endemic cholera with oral vaccines. PLoS Infectious Diseases, August 2005, 192(4):573-9. Medicine, 2007; 4(11): e336.
142 Global Forum Update on Research for Health Volume 5 143-150 singer:GF5 23/10/08 10:23 Page 143
Technological Innovations
Commercializing African health research: building life science convergence platforms
Article by Peter A Singer (pictured left), Interim Director, McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, Canada and Abdallah S Daar (pictured right), senior scientist, McLaughlin- Rotman Centre for Global Health, University Health Network and University of Toronto, Canada with Sara Al-Bader, Ronak Shah, Ken Simiyu, Ryan E Wiley, Pamela Kanellis, Menaka Pulandiran and Marilyn Heymann
In this article, we propose that African innovation – and in The application of science and technology is particular African life sciences innovation – could and should fundamental, and indeed indispensable, to the social become a prime driver for health and economic development and economic transformation of our countries… We in on the continent. We consider a model to catalyse life Africa must either begin to build up our scientific and sciences innovation and commercialization in Africa through technological training capabilities or remain an “convergence innovation”, which overcomes the problem of impoverished appendage to the global economy... missing links between science, business and capital, and There is no reason to believe that Africa cannot provides a specific focus on product development. Our main achieve what others have achieved in these fields. focus is life sciences innovation for health but with an HE PAUL KAGAME, PRESIDENT OF RWANDA understanding that applications in agriculture and energy could also benefit from convergence innovation. In a previous essay Accelerating health product innovation in sub-Saharan to Z Textile Mills, a company in Arusha, Tanzania, in a Africa we set out our initial ideas1. Here we review the joint venture with the Japanese company Sumitomo, is concept of convergence innovation, elaborate on our real- Athe largest manufacturer of long-lasting insecticide world experiences in three African countries, and set out impregnated bednets in Africa. Pellets containing insecticide opportunities and proposals for the future. While our initial are shipped from Japan to Arusha, where they are melted, focus has been on Ghana, Rwanda and Tanzania, our vision turned into long strings, which are rolled onto spools, and is a continent where many countries are capturing the health then formed into nets, cut, packaged and shipped using and economic benefits of their own domestic health research. company owned trucks to points of distribution in many African countries particularly in East and Central Africa. A to Vital role of science, technology and Z currently manufactures about 12 million bednets a year, innovation in African development which are WHO-certified and reasonably priced. Moreover, The Global Forum for Health Research has long advocated A to Z has created more than 5000 jobs for Tanzanians, the importance of domestic health research, sufficient supporting at least 20 000 people. As an example of resources and capacity strengthening in the developing world, manufacturing a science-based health product for one of highlighting in its most recent report the continuing under- Africa’s most burdensome diseases, A to Z is a huge success. resourcing of research applied to the needs of developing Now imagine a company like A to Z that relied not on countries2. Similarly, a UN task force has emphasized the imported technology but on domestic African health research. importance of science, technology and innovation for Over the same time period that A to Z was manufacturing reaching the UN Millennium Development Goals (MDGs)3. malaria bednets, distinguished East African researchers like In 2007 African Union Heads of State strongly urged Wen Kilama of the National Institute for Medical Research in member states to promote research, development and Tanzania and Onesmo Ole Moi Yoi of ICIPE in Kenya were innovation by allocating at least 1% of Gross Domestic studying and publishing on the malaria parasite and Product (GDP) of national economies to this area by 20104, mosquito vector. Imagine if this domestic East African with the aim of improving local technological and human research was the source of the technology for innovations in capacity to address local problems. The involvement of the long lasting insecticide-treated bednets! Unfortunately, the private sector as critical enabler of innovation, economic linkages between African researchers and research development and social welfare has also become better institutions, and companies – even those that are understood and emphasized5. domestically based – historically has been weak. Life sciences – with applications as diverse as health,
Global Forum Update on Research for Health Volume 5 143 143-150 singer:GF5 23/10/08 10:23 Page 144
Technological Innovations
Box 1: Stagnant technologies infrastructure to commercialize R&D, turning it into products Schistosomiasis dipstick test and services for local benefit and, ultimately, regional and Professor Kwabena Bosompem of the Noguchi Memorial global export. Included under this umbrella are a vibrant Institute for Medical Research, Ghana, has developed a private sector, flexible financing mechanisms for small dipstick assay for schistosomiasis disease, an endemic businesses, support structures for small business problem in Ghana caused by parasites which are development and expertise in management, technology present in infected water. Although it has a low transfer, intellectual property and regulation7. Most mortality rate, schistosomiasis often is a chronic illness importantly, as we shall argue below, the disparate elements that can damage internal organs and, in children, impair of science, business and capital need to be brought together growth and cognitive development. Schistosomiasis is and collectively energized. the second-most socioeconomically devastating disease Other developing countries, now known as “emerging after malaria (Danso-Appiah et al, 2008). Despite having economies” – with India and China as leading examples – are developed a prototype test for the disease several years beginning to commercialize innovative health products8 ,9, 10. ago, the commercial potential of the test has not been Will African countries also begin to turn their domestic health exploited due to a lack of technology transfer capacity research into products and services that address their local or support for product development, field trials or health problems? market assessment. MRC research in Ghana, Tanzania and Artemisia annua Rwanda Artemisia annua grows in the highlands in Arusha, The McLaughlin-Rotman Centre for Global Health (MRC), Tanzania, with 2–10 times higher yield than anywhere based at the University Health Network and University of else in the world (transcripts from participant Toronto, Canada, has built expertise in the use of life sciences interviews, Tanzania). At the National Institute for in the developing world, with an emphasis on health Medical Research, scientists developed an innovative technologies. In 2002, we published our study on the Top process to enhance the production of Artemisia, which Ten Biotechnologies for improving health in developing is not being locally applied. Once grown, however, all countries within the next 5 to 10 years11 conducted in Tanzanian Artemisia is farmed, dried and exported to partnership with scientists from around the world. In 2004, Kenya, where extraction occurs, before being shipped to we published a series of seven case studies which explored Switzerland where it is further processed for use in the the national health biotechnology innovation systems in the antimalarial Coartem ® produced by Novartis. Little developing world, primarily in emerging economies, and set commercial value is captured locally, and though there out policy recommendations12. Current activities include a are efforts to commercialize Artemisia locally using project on biotechnology firms in a number of emerging innovative processes these remain uncoordinated economies, including India, China, Brazil and South Africa, across the private sector, government and universities. which seeks to raise the profile of indigenous innovation and understand the challenges and opportunities facing these Agricultural research firms.8, 9, 13 MRC is also involved in technology-specific This included a fertilizer formulated at the Institute of projects, such as the role of human genomic variation Research into Science and Technology in Rwanda by a projects and regenerative medicine technologies in improving scientist who refused to disclose its formula. Due to lack public health in developing countries14, 15. of awareness of the innovation process and support Since early 2007, we have been working with three African structures to protect inventions, the potential value of governments to explore ways to strengthen their life sciences this discovery was untapped. In another example, seed innovation, and accelerate the commercialization of science- varieties developed at Rwanda’s Institute of Agriculture based health products based on domestic African health and Scientific Research are being marketed in Malawi – research. So far more than 100 stakeholders from academia, no royalties are flowing back to the Institute, hence no private sector, government and civil society have been local value has been captured. interviewed face-to-face in Ghana, Tanzania and Rwanda, with the aim of gaining understanding of the obstacles to agriculture and environment – have found special attention innovation and product development and commercialization from national governments and policy-making bodies such as and exploring potential solutions. Several hundred the African Union6 and United Nations. Countries are being stakeholders have been engaged through workshops where encouraged by pan-African and multilateral bodies to see life we reported back results and discussed health product sciences as a route through which innovative, entrepreneurial commercialization in these countries. In each country, activity can be channelled to produce local solutions to local we have sought to identify the areas of local strength which problems, in time helping to diversify economies, capitalize offer the greatest promise of commercialization and ways on local talent and reduce dependency on outside sources for in which this process could be catalysed through needed technologies. “convergence innovation”. Realizing this goal will require not only increased The first country we began working in was Ghana, where investment in R&D, but also in the tools, skills and we were hosted by the Ministry of Health and Honourable
144 Global Forum Update on Research for Health Volume 5 143-150 singer:GF5 23/10/08 10:23 Page 145
Technological Innovations
Old Results = Science x Capital x Business x = approach • slower process Linear • increased risk
Business
New Results = = approach • Demand based, outward Science Capital focused innovation • Increased speed • Improved scope • Scalability • Multi dimensional innovation Synergistic
Figure 1: Old and new approaches to innovation
Minister Courage Quashigah. Through our interviews, we and intellectual property protection, were found to require found many of the key elements of innovation to be in place attention, however the key limitation in the product – a strong regulatory body for food and drug products; development pathway was the lack of inter-sectoral linkages. pockets of innovative research; a relatively strong Connections between researchers and the private sector, pharmaceutical sector accounting for the production of between government and end users, and between all other 30% of Ghana’s health products (including La Gray entities in the innovation system, need to be built. Pharmaceuticals, a facility focusing on the production of In Tanzania, we conducted a case study at the invitation of Active Pharmaceutical Ingredients); the existence of the Minister of Communications, Science and Technology. financing mechanisms for science-based businesses (for Here, we found a strong research and tertiary education base example the Government’s Venture Capital Trust Fund); and both in the private and public sector, with a number of an entrepreneurial mindset among Ghanaians, reflected in universities running biotechnology programmes. Again, the the number of business schools and the growing success of regulatory system is strong and there is government the IT industry. Particular knowledge areas that were commitment to building innovative economic sectors and considered to be of most promise were traditional medicine diversifying Tanzania’s economy. As in Ghana, traditional and tools for diagnosis of local diseases. Some elements of medicine and diagnostics were the leading contenders for innovation policy and practice, such as technology transfer commercialization, given the right support, but the
Internal/external life science stakeholders Physical Centre • Research institutes • Entrepreneurs • Research groups • Entrepreneurs • Private sector • Manufacturing • Capital providers/investors • Capital providers • Distribution centres • Private sector • Government/NGOs • Professional services • Technology transfer groups • Policy makers/government • NGOs • Other Incubators/research parks Virtual platform • International organizations life science stakeholders
Figure 2: Life science convergence platform
Global Forum Update on Research for Health Volume 5 145 143-150 singer:GF5 23/10/08 10:23 Page 146
Technological Innovations
entrepreneurial mindset was not evident among the research The traditional view of innovation has seen it as a linear community. A number of institutes for traditional medicine are process, starting with investment in fundamental science, producing products for local consumption; however, these then seeking capital to further develop applications, leading could be significantly improved with the application of to the formation of a business or uptake of the technology by business rigour. There were some very interesting efforts to the private sector and then to distribution (see Figure 1). This create clusters and SME clubs, but these were relatively is a slow process, often not directed by market and consumer small-scale in any particular focus area. Again, there was need, and as such subject to increased risk and uncertainty. enormous scope for increasing linkages between researchers “Convergence innovation” embodies a new approach to and entrepreneurs. innovation, and involves the bringing together of science, In Rwanda, our host was the Minister in the President’s business and capital – three key elements of innovation – to Office in Charge of Science, Technology, Scientific Research, create a dynamic environment where scientific knowledge, and Information Communication Technologies. The Rwandan the demands of the marketplace and the realities of funders case presents a different though exciting model since, exist together. This model aims to increase speed of product compared to the other two countries, the life sciences development and relevance of products to the population, research base is less well developed and, sadly, there is a and reduce risk to investors. smaller base of highly trained science professionals. The Support structures are needed to create this type of government is actively seeking to build capacity with a view environment including both virtual and physical platforms for to transforming its current agriculture-based economy to a stimulating innovation, encouraging cross-sectoral learning knowledge-based economy by year 2020, and to use and nurturing technologies. Examples of such structures science, technology and ICT as a key enabler of this include science parks, technopoles and clusters, each of transformation. An important building block, in the shape of which differ slightly in approach but for our purposes will be the Science and Technology master plan, is already in place16. treated as variations on the theme of convergence innovation. As yet there is no framework to harness health and Our model is of a “convergence platform” that offers services biotechnology inventions but the government is keen to necessary to grow nascent scientific and entrepreneurial develop one – for example, the Pharmacy Task Force in the capacity into an organized and fully realized cluster. Acting as Ministry of Health is working with Tanzania to establish a the focal point for science, business and capital stakeholders, food and drugs regulatory agency; a patent office is being the platform will provide a forum to effectively integrate formed in the Ministry of Commerce and a recent patent law diverse expertise and interests and facilitate partnerships. has been passed. There are no major links between scientists Additionally, a convergence platform will be involved in public in Rwanda and Rwandan scientists abroad and little advocacy, provide training and offer entrepreneurial support awareness of scientific investment opportunities by and awareness, providing a balanced approach to bridging Rwandan entrepreneurs. business and science. We define a convergence platform as a One phenomenon that we came across in all three physical or virtual place that: countries was “stagnant technologies”: technologies at early attracts a breadth of talent and resources from science, stages of development, in need of product development business, and capital communities across the innovation support and expertise, but lacking the means (both resources value-chain to a single point; and experience) to realize their true value (see Box 1). offers entrepreneurial support and services to facilitate The main finding from our research in all three countries business planning, business development and was a need for improved linkages among different elements partnership formation; in the innovation system – science, business, and capital – to provides opportunities for knowledge exchange and enhance knowledge flow and to stimulate the “innovation shared learning opportunities – entrepreneurial training, culture” necessary to underpin future growth of a knowledge- special programmes and events, mentorship and peer-to- based economy. Currently, limited contact between sectors peer learning; and a lack of awareness of the tools to stimulate innovative provides a focal point for the attraction of risk capital; performance is resulting in the failure to harness the creativity is adaptable to local circumstances and markets – one of African scientists, as illustrated by stagnant technologies size does not fit all; and an overall lack of examples of locally-driven innovative facilitates connections to related platforms and other activity coming from these three countries. In short, Africa is institutions locally and internationally. more successful at health research than at commercializing that research into health products aimed at local and regional A concrete example of a convergence platform is the MaRS health problems. Centre in Toronto, created with the explicit goal of realizing benefits from the wealth of life sciences research in the Convergence innovation and convergence Toronto region. By mingling talent across the functional platforms innovation system – from basic scientists to venture Having seen that little African health research is translated capitalists – MaRS provides research and business incubation into health products, what can be done about this? What facilities, co-located with professional services firms and approach to innovation can help catalyze new approaches investors, technology transfer offices and venture capital that are more socially and economically productive? groups. MaRS has connected science, technology and
146 Global Forum Update on Research for Health Volume 5 143-150 singer:GF5 23/10/08 10:23 Page 147
Technological Innovations
entrepreneurs with business skills, networks and capital to pre-commercial technologies identified locally to the point of stimulate innovation and accelerate the creation and growth market readiness. Technologies or ideas selected for the PDP of successful Canadian enterprises by building a community are co-developed with the platform’s expert team and given in which innovators, entrepreneurs, scientists, professionals initial seed funding to take them past the proof-of-concept and investors can meet to establish linkages and exchange stage and make them attractive to risk capital investors – knowledge17. thus taking technologies across the so-called “valley of death”. The PDP will therefore play a key role in facilitating Key elements of the proposed convergence partnerships with local and global risk capital investors and platforms in Africa receptors capable of taking the technology to a viable Ghana, Tanzania and Rwanda are three African countries commercial stage. Initially, the PDP will develop pilot seeking to capture the value of local life sciences research. projects, focused on areas with potential to realize short-term MRC has been working with these countries, and with SHI gains to generate revenue. Anchored by rigorous scientific Consulting, a strategy consulting firm based in Canada which and business criteria that select only the most promising pre- serves the innovative life sciences sector, to develop business commercial technologies for further development, the PDP plans for convergence platforms which will enable will build a reputation as a consolidator of investor-grade life accelerated health product commercialization and improve sciences assets. innovation capacity. Though each platform has subtly Over time, each convergence platform will be networked different features, in essence they all consist of three main into its counterparts in other countries, leveraging elements which, together, create a dynamic environment for experience, skills and lessons learned across the continent. product commercialization: Some of these platforms are in the same African region (e.g. Physical centre: this is a physical building which co- Tanzania and Rwanda), in which case the platforms could locates tenant space for research, companies of all sizes, work together to become hubs for regional innovative activity business advisors, investors, office space and professional and attract promising projects from the entire region. Other services. The aim of the physical centre is both to provide regional and international incubators and science park physical infrastructure (Internet access, laboratory services, networks and associations such as the Africa Incubator conferencing facilities, scientific equipment) and to house Network (AIN), as well as convergence platforms outside activities for networking, entrepreneurial services and Africa, will also be potential partners for collaboration. training which would lead to increased local product development. Activities that would occur in the centre Financing convergence platforms and include hands-on advisory services in commercialization and resulting companies business development, entrepreneurial programming and The convergence platforms (consisting of physical, virtual networking sessions. The location of the physical centre must and product development elements) are structured as not-for- be well-chosen, ideally within a major city as the “hub” of profit entities with an independent board of directors. The research, government organizations and private sector platforms have the opportunity to become sustainable in the activity. It must also be located in a neutral space with mid-term through fees for services or rent. Reaching accessibility to a critical mass of stakeholders. sustainability, however, requires an infusion of start-up Virtual network: the virtual network links together higher capital in the millions of dollars, for which several potential education, public and private research institutions, funding sources exist. Generally, according to our financial government and other stakeholders, through, for example, models, the platforms should break even within five years, events, email listings and site visits. It also manages the pre- although they will continue to pay off debt resulting from the incubation and development of promising technologies to initial capital investment for a longer period of time. support the technology transfer process. Examples of Initial funding for the platforms could come from a range activities include a “technology audit” to identify promising of public sources, structured as loans or grants. African technologies in each country ripe for commercialization, and governments themselves could be direct funders of an annual Venture Forum which will draw out innovative convergence platforms, seeing them as promising ideas from the research community for further business mechanisms to address a number of economic, health and support and development. The virtual network helps to wider societal goals and to leverage the benefit of R&D ensure a national effort – and serves the crucial function of investments already being made. scoping promising technologies, which could later represent The public sector window of the African Development “deal flow”, as widely as possible. The virtual network also Bank (AfDB), with its mandate to promote economic and enhances various functions of the physical centre by social development through loans, equity investments and supporting formation of linkages, deal flow between technical assistance, is another potential sponsor. Indeed, a partners, inter-sector and cross-institutional communication recent ADB High Level Panel Report, Investing in Africa’s and collaboration, and entrepreneurship/commercialization future – the AfDB in the 21st century outlines a new role training. and strategic plan for the AfDB. It highlights the need to Product development programme: the product foster innovation in Africa and recommends that “the Bank development programme (PDP) acts as a specialized support the development of national and regional centres of “technology development accelerator programme” to develop excellence in the health sciences and in energy and
Global Forum Update on Research for Health Volume 5 147 143-150 singer:GF5 23/10/08 10:23 Page 148
Technological Innovations
environmental technologies. There are significant potential together stakeholders through events, activities and other benefits from linkages between life science and the private virtual means; a central secretariat will coordinate this sector”18. Like the traditional infrastructure investment of a approach but, at this stage, no physical centre is being bridge joining two sides of a river, a convergence platform is proposed. In contrast, the Tanzanian stakeholders are an infrastructure investment for joining science and capital for pursuing an integrated physical and virtual model to better social and economic benefits to the host country and leverage local capacities and existing institutions. In Rwanda, its people. again there is likely to be a physical and virtual component, The World Bank, with its interest in capacity-building in the with emphasis on both scientific and entrepreneurial capacity crucial areas of science, technology and innovation, is building, and a focus on both health and agriculture. another potential sponsor for the virtual component of these Second, local champions to spearhead these platforms are platforms, as are a wide variety of donor agencies for whom vital. Throughout our work in Africa, we have encountered a science, technology and innovation play a central role in good deal of local enthusiasm for the convergence innovation future economic development. concept from those eager to capitalize on the opportunity and By contrast to the platforms themselves, financing for the catalyze a different approach to health and economic technologies which have reached the point of proof of development. Involvement of local partners is the only way to principle or market readiness should come from private ensure that these platforms are realistic in scope, responsive investments in the form of equity or debt. In terms of private to local needs and financially sustainable. This is occurring in capital providers for technologies and spin-out companies, Ghana, where a Task Force on Life Science there are a number of entities with potential interest in Commercialization and Convergence was established by the making investments in Africa, including the private sector Honourable Minister of Health and mandated to advise him window of the ADB and the International Finance Corporation on next steps. Led by an eminent academic Professor Francis (IFC), the private sector arm of the World Bank. In December Nkrumah, the task force meets on a monthly basis and is in 2007, the IFC, with support from the Bill & Melinda Gates the process of further developing a business plan for the Foundation, released a report entitled The Business of Health platform, appointing a secretariat and sourcing funding for the in Africa, on opportunities for private-sector approaches to first one or two years of operations. In Tanzania the business health in sub-Saharan Africa. The report covers health plan for its convergence platform has been presented to the services provision, medical and nursing education, risk Minister and the next step is to appoint a local steering pooling arrangements, distribution and retail of health committee to develop and deliver the plan. In Rwanda, the products, and also life sciences manufacturing and business plan has been presented to the Minister and local innovation19. In a promising development, the accompanying champions are being identified. announcement states that there are plans to mobilize up to Third, the role of the local private sector is critical. US$ 1 billion in investment and advisory services support Ultimately, it is the private sector which has the skills and over the 2008–2012 time frame, including an equity expertise to commercialize technologies. Prominently investment vehicle starting with US$ 100 million (growing to included in the local champions mentioned above must be up to US$ 300–350 million over this time frame). leading entrepreneurs. Venture capital firms both within and outside Africa are The potential benefits, and metrics of success, of another potential source of risk funding. Two examples are a convergence platform include: increased product South-African Bioventures, the only wholly life sciences- commercialization in Africa; increased formation of life focused VC firm in sub-Saharan Africa, which has made a science enterprises and growth of support industries and number of successful investments in that country, particularly therefore increased high value employment; enhanced life in the medical device area; and Bridgeworks, a Kenya-based science-based entrepreneurial culture; increased formation of VC, which also has a special focus on health technologies sustainable public-private partnerships, linkages and and over the last few years has gained extensive experience knowledge flow among science, business and capital in the requisite measures to identify, develop, support and stakeholders in Africa; increased inward investment and risk finance small science-based ventures in Africa. These capital; increased exports, initially regionally but ultimately investments would also be appealing for social investors, who globally, of health products; and lastly, and most importantly, will tolerate lower returns in exchange for social benefits. improved health, social and economic outcomes for Africa. Of course, there are also risks. Convergence platforms are Lessons learned and next steps complex endeavours highly dependent on the mobilization of Having begun to operationalize convergence innovation on sufficient critical mass. Commercialization of innovation is a the ground through working with local governments and other high-stakes game that fails much of the time. Innovation stakeholders, including writing business plans and sourcing requires a long-term commitment. To be successful, potential funders, a number of lessons have been learned governments must also simultaneously address gaps across which will improve the likelihood of success. the functional innovation system. First, flexibility is key. One size does not fit all across Africa How can this model of convergence innovation, facilitated and each platform is being developed with sensitivity to local through convergence platforms, be extended to other circumstances, goals and capacities. In Ghana, for example, countries in Africa and suitably networked so as to gain emphasis is being placed on a virtual model that links maximum leverage within and across regions? The first step
148 Global Forum Update on Research for Health Volume 5 143-150 singer:GF5 23/10/08 10:23 Page 149
Technological Innovations
is to engage the wider audience of African Health Ministers, and of Surgery at the University of Toronto. He is a fellow of the both to raise the profile of what has been done so far and to Royal Society of Canada, the Canadian Academy of Health consider how this model of innovation might help them to Sciences, and of the Academy of Sciences for the Developing achieve their public health goals by enabling the growth of World (TWAS). He won the UNESCO Avicenna Prize for Ethics indigenous health innovation. Ministers of Science and and Science in 2005. Technology and of Finance should be interested in these initiatives for what convergence innovation can mean for Sara Al-Bader is studying for her Masters/PhD at the Institute of their countries’ social and economic development. A few Medical Sciences, University of Toronto. After a BSc in Physics examples of successfully commercialized products based on and an MSc in the History and Philosophy of Science from the African health research will go a long way to building the University of London, Sara worked as a science communicator in confidence of African and international investors. If one were several science museums in the UK and US. She then worked in a private investor, one would have no idea how to scope the UK government’s Department of Trade and Industry, promoting promising technologies against health, agricultural, the involvement of women in science at all levels. In 2001 Sara environmental or energy problems in Africa. The convergence joined the policy section at the UK’s Academy of Science, the platform provides one-stop shopping for investors, greatly Royal Society. Her role there was to coordinate and supply decreasing the complexity and cost of identifying promising scientific advice to policy-makers nationally and internationally, in technologies. a range of areas. Sara is part of the commercialization team, Given the ingenuity, creativity and entrepreneurialism in researching the state of life sciences commercialization in South Africa, it is inevitable that the continent will move towards a Africa and Ghana. more diversified economy through increased knowledge- based activities. What is not at all inevitable is that this Ronak Shah is a research project coordinator at the process will be as quick and efficient as possible. Failures of McLaughlin-Rotman Centre for Global Health. He joined the group both individual technologies and models will pave the path in May 2007 after finishing his Masters in Bioscience enterprise to ultimate success, and mechanisms to leverage learning at the University of Cambridge, UK. He did his undergraduate will be highly desirable. By focusing explicitly on degree in Microbiology from the University of Guelph in Ontario, commercialization of domestic African health research, and Canada. His interests lie in product development and translation learning how best to translate this research into commercial of life science research to products in low-resource settings. products and services, convergence platforms pave a path for African countries towards accelerating social and economic Ken Simiyu is studying for his PhD at the Institute of Medical development. As noted by President Kagame, the alternative Sciences, University of Toronto. He received a Bachelor’s degree paths are much less desirable. J in Veterinary Medicine and Masters degrees in Veterinary Public Health and Business Administration from the University of Acknowledgments Nairobi, Kenya and completed a Masters in Public Health degree Helpful comments and suggestions were received from at George Washington University, Washington DC. In Nairobi, He Hassan Masum. This study was funded by Genome Canada provided marketing research and business development expertise through the Ontario Genomics Institute and the Canadian to the Kenyan government, the Kenyan Trypanosomiasis Research Institutes of Health Research through a Michael Smith Institute and international pharmaceutical companies based in award to Dr Singer. The McLaughlin-Rotman Centre for Nairobi. In Washington, he worked with the International Global Health, Program on Life Sciences, Ethics and Policy Organization for Migration (IOM) as a health policy consultant. His is also supported by the Bill & Melinda Gates Foundation current area of focus is health research commercialization in and other partners listed at www.mrcglobal.org. ASD and Africa. PAS are supported by the McLaughlin Centre for Molecular Medicine. Ryan E Wiley is Managing Director of SHI Consulting. He has successfully worked with industry, governments, academic Peter A Singer is Interim Director of the McLaughlin-Rotman institutions and nonprofit organizations throughout the Americas Centre for Global Health, University Health Network and University and in Asia. In addition to his work with SHI Consulting, He is an of Toronto, and Professor of Medicine at the University of Toronto. adjunct professor in McMaster University’s Faculty of Health He is also a fellow of the Royal Society of Canada and the Sciences, past Chair of New Leaders of Sunnybrook Foundation, Canadian Academy of Health Sciences, and a member of the Director of Women’s College Hospital Foundation and founding Scientific Advisory Board of the Bill & Melinda Gates Foundation Co-chair of Newchapter at Women’s College Hospital Foundation. Grand Challenges in Global Health initiative. In 2007 he received He holds a PhD in immunology from McMaster University and has the Michael Smith Prize, as Canada’s “Health Researcher of the published extensively in the areas of asthma/allergy, immunology, Year” in Population Health and Health Services, from the pharmacology and gene therapy. Canadian Institutes of Health Research. Pamela Kanellis is an analyst with SHI Consulting. She has Abdallah S Daar is a senior scientist at the McLaughlin-Rotman expertise in the areas of economic development and business Centre for Global Health, University Health Network and planning, working with clients from industry and academia. Most University of Toronto, and Professor of Public Health Sciences recently, she performed an inventory assessment for the region of
Global Forum Update on Research for Health Volume 5 149 143-150 singer:GF5 23/10/08 10:23 Page 150
Technological Innovations
Waterloo and the province of Prince Edward Island in Canada, India. She was also involved with the Centre for International providing a foundation for strategy development. Prior to joining Health where she researched cost-effective, community-based SHI Consulting, she earned a PhD in Medical Genetics from the health promotion strategies to address the concerning issue of University of Toronto, where she focused her studies in the area of China’s rapidly ageing population. She is a summer student at the oncology. She also brings her knowledge of high-throughput McLaughlin-Rotman Centre for Global Health. functional genomics, DNA repair and bacterial genetics. Her work has been published in several top-tier peer reviewed journals. Marilyn Heymann is entering her fourth year at the University of Toronto to complete a major in Political Science and Health Menaka Pulandiran graduated from the University of Toronto Studies. She has spent two years working with the University of with a Human Biology Major and with double Minors in Zoology and Toronto’s Center for International Health working on an African Classical Civilization. In the past she has worked with an AIDS Initiative and also travelled to Cambodia with the Center for international health organization known as Child Family Health International Health. She is a summer student at the McLaughlin- International on their Infectious Diseases programme in Mumbai, Rotman Centre for Global Health.
References
1 Masum H et al. Accelerating health product innovation in sub-Saharan biotechnology industries: potential champions of global health? Health Africa. MIT Innovations, 2007, 2:129-149. Affairs, 2008, 27:1029-1041. 2 Burke EM, Francisco A and Matlin S. Monitoring financial flows for health 11 Daar AS et al. Top ten biotechnologies for improving health in developing research: behind the global numbers, 2008. countries. Nature Genetics, 2002, 32:229-232. 3 Juma C and Yee-Cheong L. Innovation: applying knowledge in 12 Thorsteinsdottir et al. Introduction: promoting global health through development. UK & US: Earthscan, 2005. biotechnology. Nature Biotechnology, 2004, 22:DC3-DC7. 4 Assembly of the African Union. Eighth Ordinary Session 29–30 January 13 Rezie et al. Brazilian health biotech – fostering crosstalk between public 2007. Addis Ababa, Ethiopia. Decisions and Declarations. and private sectors. Nature Biotechnology, 2008, 26:627-644. 5 Unleashing entrepreneurship: making business work for the poor. United 14 Seguin et al. Genomic medicine and developing countries creating a room Nations Development Programme, 2004. of their own. Nature Reviews, 2008, 9:487-93. 6 Freedom to innovate: biotechnology in Africa’s development. Report of the 15 Greenwood L et al. Regenerative medicine: new opportunities for High-Level African Panel on Modern Biotechnology. Addis Ababa, Ethiopia: developing countries. International Journal of Biotechnology. African Union and Pretoria, South Africa: New Partnership for Africa’s 16 Government of Rwanda. National science, technology, scientific research Development, 2007. and innovation policy. Conference draft. Kigali, Rwanda, 2005. 7 Gardner et al. Health Affairs, 2007, 26:1052-1061. 17 Cooksey D. A review of UK health research funding. UK Treasury Report, 8 Frew et al. India’s health biotech sector at a crossroads. Nature 2006, 97–98, London. Biotechnology, 2007, 25: 403-417. 18 African Development Bank. Investing in Africa’s guture – the ADP in the 9 Frew et al. Chinese health biotech and the billion-patient market. Nature 21st century. High Level Panel Report, 2007. Biotechnology, 2008, 26: 37-53. 19 International Finance Corporation. The business of health in Africa: 10 Frew SE, Kettler HE and Singer PA. The Indian and Chinese health partnering with the private sector to improve people’s lives, 2007.
150 Global Forum Update on Research for Health Volume 5 151 Title page:GF5 23/10/08 09:28 Page 151
Corporate sector-related innovations
152 Making drugs accessible to poor populations: a funding model Paul L Herrling
157 Public-private partnerships drive innovation to improve the health of poor populations Christopher J Elias with Yvette Gerrans and F Marc LaForce
161 Innovations and incentives: why pharmaceutical companies are becoming interested in neglected tropical diseases Arianne Matlin
166 Vision for a venturing ecosystem to generate global health innovation William Rosenzweig
171 Beyond product: the private sector drive to perform with the purpose of alleviating global under-nutrition Dondeena Bradley
174 Innovating against hunger and under-nutrition Josette Sheeran
177 Riders for Health: an award-winning social enterprise ensuring health care delivery across Africa Ngwarati Mashonga
182 UNITAID: innovative financing to scale up access to medicines Jorge Bermudez
186 Threshold of evidence needed for health claims on functional foods Peter J Jones with Stephanie Jew
190 The Lilly MDR-TB Partnership: innovation to fight a disease Patrizia Carlevaro
Global Forum Update on Research for Health Volume 5 151 152-155 Herling:GF5 22/10/08 09:31 Page 152
Corporate sector-related innovations
Making drugs accessible to poor populations: a funding model
Article by Paul L Herrling, Head of Corporate Research, Novartis International, Switzerland
ccording to a recent publication by Mary Moran 20051, several of which are in early clinical testing. A more et al1, public-private partnerships (PPPs) or product recent survey is shown in Figure 1. Adevelopment partnerships (PDPs) involving non- Despite the high attrition rate it is to expected that several governmental organizations (NGOs), academia and the of these projects will approach full development towards pharmaceutical/biotech industry have generated a growing registration with costs of several hundred million US dollars early pipeline of new drug therapies for neglected diseases per project. A study by Dalberg, commissioned by the such as malaria, tuberculosis, Dengue and parasitic diseases International Federation of Pharmaceutical Manufacturers & such as Leishmaniasis, human African trypanosomiasis and Associations (IFPMA) and Novartis2 estimates that US$ 6–10 Chagas disease. This activity resulted in about 63 projects in billion will be needed for that purpose in the next 10 years.
Historic funding has built a portfolio that is moving towards clinical trials
Historic funding... … has created the pipeline of today
R &D F unding R eceived – PDP s (USD M) PDP Compounds by Disease – including industry ** 447 Private 12 450 Chagas 12 HAT Entities VL Malaria 3% 11 TB 400 Gov 21% 10 VL 350 5 9 HAT 9 TB Chagas 8 300 8 C linical Other funding 7 needs 250 6 2 6 4 200 5 5 Private 5 76% Non Profits 4 4 150 4 2 3 1 Malaria 3 4 2 2 100 1 2 50 3 1 3 1 1 1 1 2 2 * 1 1 1 0 0 1999–2007 1996–2005 Early Lead id Lead PrecliniPhase 1Phase 2Phase 3 Reg Phase 4 –by stage op cal disease D0/1 D2 D3 D4
*Chagas, HAT & VL are sourced from DNDi through 2006; Does not include IOWH **Some projects have not been included in graph due to uncertainty of stage in pipeline Sources: DNDi Business Plan, "Independent Review MMV" DIFID, MMV Annual Report 2006, Focus on Finances MMV.org; The New Landscape of Neglected Disease Drug Development, Wellcome Trust (2005); "TB DRUGS: Where We Are Today, The Vision For Tomorrow" CEO GATB (Jan 2007); WHO Draft “Global plan of action on public health innovation and intellectual property” (August 2007)
Figure 1: An emerging pipeline for neglected diseases, from (2)
152 Global Forum Update on Research for Health Volume 5 152-155 Herling:GF5 23/10/08 14:28 Page 153
Corporate sector-related innovations
Fund for R&D in neglected diseases
Board: strategy, diseases, tools Funders:current & new i.e. BMGF , W T etc. plus governments from Developed countries and Developing world
fundsfunds
Portfolio management Team: medical, scientific, technical professionals (fund only to next go/no go decision) projectsprojects aandnd ffundsunds forfor exclusivel i licensesli tot ddevelopmentl t neglectedg disease to the next stageg
IP Academia PPPs Industry royalties,roya mmilestonesile In case of profits made using data paid by the fund:
Figure 2: A funding model for R&D for neglected diseases
In comparison, in the same study the estimated cost of nations will have to contribute. Representatives of the donors building this early pipeline was around US$ 0.5 billion, would constitute the Board of the fund in which the disease allocated by a variety of private and public donors to PDPs. scope, product scope (e.g. medicines/vaccines only, or to There is no indication that the current donors could generate include diagnostic methods etc.) and the strategy would be sufficient funds for full development of the neglected diseases defined. The Board would not be involved directly in the pipeline. There is a danger that a very unfortunate situation portfolio management within the strategy. The mission of the will arise where innovative compounds for neglected diseases fund must include the obligation to make available the in the pipeline that show a promising proof of concept in early therapies it funds to poor patients in the developing world for human studies will stall in further development for lack of free or at an affordable price, or at least at no profit (if a profit funding. can be made, then the normal market mechanisms will be The model proposed (see Figure 2) describes a possible applicable). FRIND would only finance the R&D component way to address this situation that attempts to take into and would need partners/other donors for manufacturing account the needs of all stakeholders. It has been discussed and distribution. with several pharmaceutical companies and representatives Potential applicants. Any entity, academic, biotech/ of NGOs such as Médecins Sans Frontières, Oxfam and the pharmaceutical company or PDP with a therapeutic/ World Health Organization, who have all indicated that they diagnostic project fulfilling a medical need for a neglected had no have fundamental objections and encouraged us to disease within the scope of FRIND can apply to the fund. further develop it. The model is complementary to others Portfolio management team/scientific advisory board. such as Advanced Marketing Commitments and Prizes and The members of the portfolio management team should have the differences will be discussed. the same profile and skills found in large pharmaceutical A model to fund R&D for neglected diseases (Fund for companies’ portfolio decision teams, i.e. scientific-, medical, R&D in Neglected Diseases, FRIND). The model (Figure 3) technical-R&D, regulatory-, economics- experts familiar both is designed to apply only to disease areas with large medical with the therapeutic area and the environment in which the need but where no commercial returns can be expected and new drugs should be applied (field experts). where normal market mechanisms therefore do not apply and Prioritization and allocation principles. The portfolio where pharmaceutical and biotech companies can only invest decisions should be made exclusively on scientific, medical, very limited R&D funds. Examples are the 10 diseases on the technical and economic criteria excluding political factors as TDR list3. much as possible. To reduce potential waste of resources it is Funding and governance. The fund can be financed by the essential to apply a fund allocation rule where having estimated current donors to PDPs but in view of the magnitude the totality of funds required for the entire development of the envisaged governments of both developed and developing product, the portfolio team would then only allocate the funds
Global Forum Update on Research for Health Volume 5 153 152-155 Herling:GF5 22/10/08 09:31 Page 154
Corporate sector-related innovations
Portfolios are fragmented across players – even in key diseases
39 54 5 16 12 3 3 Public 100% Novartis Public 90% GSK 1 Public Public Public 80% Public Sanofi-aventis 5 2 24 TDR 1 70% Pfizer 1 GSK 1 TDR 2 TDR 1 •Fragmentation 60% between industry Sanofi-aventis publicand Pfizer 1 PDPs for 50% 1 Astrazeneca 3 malaria and TB
40% MMV 24 •Fragmentation Other 12 DNDi 11 DNDi 6 between public 30% DNDi 3 and PDPs for smaller diseases 20% TDR 1 IOW H 1 10% GATB 11 DNDi 2 IO W H 1 Public only IOW H 1 0% Industry only Malaria TB Chagas HAT VL Other PDPs Dengue
Notes: Number of public projects is estimated based on interviews and research; Surface area does not depict size of projects, which vary significantly by stage of discovery and development Source: The New Landscape of Neglected Disease Drug Development,Wellcome Trust (2005); TB Alliance Portfolio.ppt (October 2007); (www.ifpma.org/clinicaltrials); Industry R&D for Diseases Primarily Affecting Developing Countries (company response to IFPMA survey); Working Group on New TB Drugs (Oct 2006)
Figure 3: The current pipeline for neglected diseases is fragmented. From (2)
needed to reach the next decision point. At this stage the new return would allocate an exclusive licence to the fund for the results would be evaluated and a new decision to continue particular neglected disease within the mission of FRIND. funding to the next stage or stop would be made. The inventors would retain the rights for all other applications. Overcoming the fragmentation of the neglected disease This is important because nature does not distinguish portfolio. An analysis of the current neglected disease between diseases of the rich and poor. For instance, a portfolio2 indicates that even within single diseases there are compound developed for Dengue fever, a neglected disease of several actors working in parallel and with limited increasing impact, might very well show useful activity in communication between them (Figure 3). hepatitis C, an indication with commercial blockbuster It is expected that the fund under discussion would become potential, because both the Dengue virus and the hepatitis C the major source of funds for R&D for neglected diseases and virus (HCV) are genetically close because both belong to the one consequence would be that the portfolio management genus Flaviridae. The inventor might very well want to team would eventually see most projects within a disease develop the commercial application (HCV) using their own area which would allow them to compare them, invest in the funds to later sell it with profit where a commercial market best ones or combine them. exists. If, however, the entity marketing such a therapy uses Intellectual property protection. Intellectual property data that has been elaborated in a FRIND funded activity, protection is essential for fostering investments in research for royalties and/or milestones should be due to the fund to new medicines worldwide and should not be an impediment reimburse their expenses for the data generation. to access to medicines in the developing world4. In the context of FRIND, intellectual property could be handled Discussion as follows: There are several alternative models in discussion to The inventors of the new product to be funded by FRIND stimulate R&D in neglected diseases, e.g. Advance Market (academic institutions, biotech companies, PDPs or Commitments (AMC) 5 or Prize mechanisms as proposed by pharmaceutical companies) would usually patent their James Love6. The current FRIND proposal overcomes a major inventions and retain ownership. If any of the entities above drawback of the two models discussed above. Any entity that apply to FRIND for funding of their project in R or D they in wants to access either AMC or Prize money needs to invest at
154 Global Forum Update on Research for Health Volume 5 152-155 Herling:GF5 23/10/08 15:33 Page 155
Corporate sector-related innovations
risk in the full development of its product for neglected from NGOs such as MSF, representatives from WHO, Oxfam disease and as about 7 out of 10 projects in clinical phase and other pharmaceutical companies and is currently being one fail before registration all that investment would be lost. presented to national governments. If sufficient support for This is a major disincentive not only for pharmaceutical this concept can be generated a more detailed model will be companies but is outright unaffordable for many PDPs, elaborated in a second phase. J academic institutions or small biotech firms. In addition since many advances in the treatment of disease are Acknowledgements incremental, the concept of a “prize” for the first successful The author would like to thank Stephanie Meredith, Tido von product is inappropriate and might be a disincentive to Schoen-Angerer and Lee Wells for constructive discussions. parallel activities. In contrast the current FRIND model would fund the individual R&D phases upfront and would bear the Paul L Herrling is Head of Corporate Research at Novartis. He is risk. An additional benefit is that through FRIND a portfolio also Chairman of the Board of the Novartis Institute for Tropical management approach across different players might be Diseases (NITD) in Singapore, a long-term endeavour to advance established that allows more optimal allocation of (scarce) medical research in tropical infectious diseases. In addition, he donor resources to the most promsing R&D projects. oversees the Friedrich Miescher Institute (FMI) in Basel, The model proposed here and AMCs or Prizes are not Switzerland, the Genomics Institute of the Novartis Research mutually exclusive but rather complementary to increase the Foundation (GNF) in California, USA and the Novartis Vaccines probability of the creation of urgently needed new therapies Institute for Global Health (NVGH) in Siena, Italy. for neglected diseases. The brief description of the model in He is also a Professor of Drug Discovery Science at the this paper is intended to stimulate discussion and to evaluate University of Basel, Switzerland. In addition to scientific editing its acceptance from the main stakeholders and potential activities, he also served on several boards. donors. It has already received constructive contributions
References and abbreviations
1. Moran M. A breakthrough in R&D for neglected diseases: New ways to get 4. Herrling P. Patent sense. Nature, 2007, 449:174-175 (2007). the drugs we need. PLoS Medicine 2005, 2:828-831. 5. http://www.vaccineamc.org/mechanism.html 2. Feasibility study for a fund for R&D for neglected diseases. Dalberg Global 6. Love J. The big idea: prizes to stimulate R&D for new medicines. Development Advisors. Commissioned by IFPMA and Novartis International Knowledge Ecology International, Tim Hubbard, Wellcome Trust Sanger AG, 2008. Institute. Revised March 2007. 3. http://www.who.int/tdr/diseases/default.htm
Abbreviations HAT: human African trypanosomiasis AMC: advanced market commitments HCV: hepatitis virus C BMGF: Bill & Melinda Gates Foundation IFPMA: International Federation of Pharmaceutical Manufacturers & D0: drug discovery phase 0, target finding Associations D1: drug discovery phase 1, high throughput assay formatting IOWH: Institute for One World Health D2: drug discovery phase 2, high throughput screening, hit finding MMV: Medicines for Malaria Venture D3: drug discovery phase 3, lead optimization, medicinal chemistry NGO: nongovernmental organization for small molecules R&D: research and development D4: drug discovery phase 4, late preclinical phase TB: tuberculosis DNDi: Drugs for Neglected Diseases Initiative TDR: WHO special programme for research and training in tropical FRIND: Funding Model for R&D in Neglected Diseases diseases GATB: Global Alliance for Tb Drug Development, Tb Alliance VL: Visceral Leishmaniasis GSK: GlaxoSmithKline WT: Wellcome Trust
Global Forum Update on Research for Health Volume 5 155 157-160 elias:GF5 22/10/08 09:31 Page 157
Corporate sector-related innovations
Public-private partnerships drive innovation to improve the health of poor populations
Article by Christopher J Elias (pictured), President and CEO of PATH with Yvette Gerrans and F Marc LaForce
lthough technology has been increasingly used to Unfortunately, the drive to pursue projects with the highest improve health in high-income countries, its potential profit means that private companies usually do not Aapplication has been more challenging in developing consider developing products tailored to the needs of poor nations. Low-income settings usually do not offer large countries because markets in those countries are often financial incentives to drive commercial investment in unstable and perceived risks diminish projected return technology development. In addition, local research, on investment. development and manufacturing capacity are often limited in The public sector, by contrast, often lacks the capability poorer countries. and experience to design, develop, produce and distribute Program for Appropriate Technology in Health (PATH) is an novel technologies on its own. Thus, the challenge for the international, nonprofit organization that creates sustainable, public sector is to harness the innovation capability of the culturally relevant solutions that enable communities private sector to produce global public goods. This can be worldwide to break longstanding cycles of poor health. By accomplished by shifting market forces enough to attract collaborating with diverse public- and private-sector partners, private sector involvement in developing appropriate, cost- we help advance affordable and culturally appropriate health effective health care technologies – and then making those technologies. PATH’s experience over the past 30 years technologies broadly available in low-income settings. suggests that one of the best ways to ensure that effective To accomplish this task, the public sector must co-invest in health technologies are developed and made available in necessary and suitable technologies. By underwriting some of developing countries is through public-private partnerships the costs of research and development, sharing risk, and (PPPs). PATH helps to bridge the gap between public health supporting the infrastructure to test products in poor countries needs and commercial interests. It negotiates solutions that with high rates of endemic disease, it is possible to leverage are mutually beneficial for the public and private sectors by commercial interest and investment in technological solutions guiding technology development towards the priority health for otherwise neglected diseases. PPPs are primarily needs of poor populations. Acting as an intermediary between supported by funds from private foundations and industry and the public sector, PATH has successfully governments and, while offering private companies the advanced and facilitated the commercial introduction of more potential for a reasonable commercial return on their than 50 new technologies for improving public health in investment in product development, they insist on developing countries1. commitments to supply, pricing and intellectual property Globally, most new health technologies come from the rights that help ensure the affordability and accessibility of research and development efforts of private industry. these innovations. Commercial enterprises not only have the expertise and In addition to these up-front investments to “push” the resources to carry a product forwards through the complex development of needed technologies, public sector and expensive testing and regulatory approval process, but organizations also can help to ensure larger and more also have strong market-driven incentives to do so. predictable markets for health products through a variety of “pull” mechanisms. Perhaps the strongest pull mechanism is to greatly expand the use of currently existing, proven health PATH helps to bridge the gap between public health needs products through the strengthening of health delivery and commercial interests. It negotiates solutions that are systems in poor countries. Growing demand for effective mutually beneficial for the public and private sectors by health products, combined with efficient and regular guiding technology development towards the priority delivery, sends a strong market signal to product innovators. health needs of poor populations Currently, a variety of innovative financing mechanisms – such as advanced market commitments – are being piloted
Global Forum Update on Research for Health Volume 5 157 157-160 elias:GF5 23/10/08 15:33 Page 158
Corporate sector-related innovations
as pull mechanisms to further incentivize commercial three meningococcal C conjugate vaccines were developed research and development investment in health technologies for use in the United Kingdom to control an increased for poor countries. incidence of meningococcal C cases. It is worth noting that Much of PATH’s experience with PPPs has involved work to the epidemic disease burden in Africa was more than 1000 improve immunization in developing countries, especially in times higher that that noted in the United Kingdom. Africa. We have been especially active in forging partnerships By the 1990s the components to develop a group A to develop new vaccines against malaria and meningitis. This meningococcal conjugate vaccine already existed. paper summarizes our work related to the Meningitis Vaccine Technology was available for conjugating, or chemically Project as an example of how PPPs can be used effectively to linking, the meningitis A polysaccharide to a protein carrier, address health issues in low-income settings2. which makes the vaccine highly immunogenic and effective in young children, provides long-lasting protection, and Case study: reducing the burden of decreases carriage and transmission rates. Two meningitis meningitis in Africa A/C conjugate vaccines were tested in clinical trials in Africa, Meningococcal meningitis is a serious and potentially lethal but these projects were dropped by their commercial bacterial infection in the membranes that surround the brain sponsors. The challenge was to develop a programme that and spinal cord. Despite prompt treatment with antibiotics, would motivate a vaccine producer to take a risk on a market often difficult in remote areas of Africa, about 10% of unable to pay high prices for this vaccine. affected individuals die, and up to 25% of survivors are left In 2000, the World Health Organization (WHO) with permanent disabilities, such as deafness or mental commissioned an independent assessment of existing retardation3. Sub-Saharan Africa is particularly prone to intellectual property on conjugation technology and of the relatively small annual epidemics of meningococcal costs for product development and production for a group A meningitis, which expand to catastrophic proportions every or group A/C meningococcal conjugate vaccine intended for 10 to 12 years. Most of these epidemics are caused by a Africa. The assessment showed that development of an single meningococcal strain, group A. The group A epidemic affordable vaccine was feasible. Soon after, the Bill & in 1996–1997 caused more than 280 000 cases and Melinda Gates Foundation awarded PATH a ten-year grant to 25 000 deaths4. These meningitis epidemics have plagued establish the Meningitis Vaccine Project (MVP), a partnership Africa for 100 years. between PATH and WHO, to develop, test, license and To deal with these recurrent epidemics, countries in introduce meningococcal A vaccines for Africa. Africa’s “meningitis belt”, have relied on a “reactive” strategy One of the first actions of MVP was to convene a that focuses on first detecting outbreaks and then mounting consultation with health officials from the African meningitis reactive immunization campaigns using meningococcal belt. These early consultations with African leaders and polysaccharide vaccine. The polysaccharide vaccine is health officials quickly revealed what they wanted in a affordable, but it doesn’t work very well. Although it may vaccine. Hassane Adamou, the secretary general for Niger’s prevent those carrying the bacterium from getting sick, it Ministry of Health, said: “Please don’t give us a vaccine we does not stop them from passing it on to others. Immunity can’t afford. That is worse than no vaccine”2. African leaders lasts only a few years, and the vaccine has minimal felt that a vaccine that was priced at US$ 0.50 per dose or protective effect on children under two years of age5. Moreover, these reactive immunization campaigns are expensive and disruptive Serum Institute since they redirect resources from other public health activities. of India During the epidemic season, scarce human resources are redirected to reactive immunization campaigns, thereby further weakening the health system. Clearly, a better and more powerful conjugate meningococcal A vaccine is needed for Africa. SynCo US Food and Drug Despite the obvious public health Biopartners need, manufacturers have not Administration been interested in committing the LLC resources to develop such a vaccine when the returns have been at best poorly defined. Figure 1: Public-private partnership developed for the Meningitis Vaccine Project, an effort led collaboratively by PATH and the World Health Organization By contrast, during the 1990s,
158 Global Forum Update on Research for Health Volume 5 157-160 elias:GF5 22/10/08 09:31 Page 159
Corporate sector-related innovations
less would be affordable and sustainable. MVP began its development work with that goal in mind. Over the course of The Meningitis Vaccine Project provides an illustrative the project, MVP has been informed by a Project Advisory example through its facilitation of the development of an Group entirely composed of African health leaders, as well as affordable group A conjugate vaccine for use in Africa’s an Expert Advisory Group of leading vaccine and meningitis belt, including countries such as Mali, Senegal, meningococcal research scientists. northern Nigeria, Sudan, Ethiopia, The Gambia, Senegal, Niger and Burkina Faso The role of public-private partnership in developing a meningitis vaccine MVP brought three critical partners to the table: SynCo Bio Partners BV in Amsterdam, which supplied meningococcal A factors enabled successful creation of this PPP for developing polysaccharide (one of the two main components of the a new meningitis vaccine for Africa? vaccine); the Serum Institute of India Limited (SIIL) in Pune, First, the scientific base required to make a conjugate India, which agreed to supply tetanus toxoid (the second Meningitis A vaccine was reasonably well known. The main component of the vaccine) and to scale-up the independent assessment commissioned by WHO in 2000 manufacturing processes for the final vaccine; and the Center established that it was feasible to develop an affordable for Biologics Evaluation and Research at the US Food and Meningitis A conjugate vaccine, indicating that the risks of Drug Administration (FDA) in Bethesda, Maryland, which innovation were manageable. agreed to transfer a conjugation technology (see Figure 1). Second, the geographic market and likely financing for the This consortium formed a new model for vaccine product was clear because the vaccine was targeted for sub- development: a key raw material came from one source, the Saharan Africa’s meningitis belt. Through the Project Advisory technology from another and the final scale-up for production Group, African public health officials in the affected nations from another. Moreover, it included a North-to-South transfer indicated that sustained use of this vaccine was possible. of technology and capacity. Controlling meningitis epidemics in the belt was a major PATH first negotiated a nonexclusive licence for the public health priority, and if the vaccine was priced at less conjugation technology from the US National Institutes of than $US 0.50 per dose, leaders indicated that they could Health Office of Technology Transfer (on behalf of the FDA), likely purchase the vaccine within the donor consortia that which PATH then sublicensed to SIIL. To protect the are the basis for much of the existing vaccine purchasing in charitable mission of the project, PATH and SIIL agreed that these countries. if SIIL were to cease developing or producing the vaccine, Third, the intellectual property ownership was relatively SIIL would transfer to PATH the manufacturing know-how straightforward and the cost of the ingredients and developed during their collaboration to enable another conjugation method were known with reasonable certainty, manufacturer to make the vaccine. In addition, the PATH-SIIL and were inexpensive. SIIL already manufactured the tetanus agreement set out an explicit initial pricing of US$ 0.40 per toxoid protein carrier. SynCo had a well established dose for sales to the public sector in Africa, with SIIL having polysaccharide manufacturing process. The FDA owned the the freedom to sell the vaccine in the private sector at higher critical intellectual property, which was quickly transferred to prices. PATH’s agreement with SIIL also includes explicit SIIL via PATH. Both SynCo and the FDA agreed to participate procedures and remedies should SIIL not meet public sector in technology transfer activities supported by MVP. demand or charge the public sector more for the vaccine than Fourth, the manageable technical risks, priority of the maximum agreed-upon price. meningitis control in the African region, and secure and The pivotal phase II trial of the Meningitis A conjugate straightforward intellectual property landscape justified an vaccine, which included 600 healthy toddlers aged 12–23 approach where the project could underwrite most of the months in Mali and The Gambia, showed that the conjugate capital costs for product development and, consequently, vaccine produced antibody titers almost 20-fold higher than exert significant leverage in determining the supply and the current polysaccharide vaccine5. Phase II and II/III clinical public-sector pricing arrangements. trials of MVP’s Meningitis A vaccine candidate are currently This set of circumstances led MVP to explore a specific yet under way in Mali, The Gambia, Senegal and India. Barring strategic approach to PPP development. The manageable any delays, the vaccine will be introduced at public health technology risk made the meningococcal A vaccine an ideal scale in Burkina Faso in late 2009, with other countries product for technology transfer to a developing country to follow. manufacturer. In addition, the need to keep costs low fit well with the strengths of a developing country manufacturer Key factors driving partnership development such as SIIL. It is important to recognize that unique circumstances inform Greater uncertainty – whether around the science, the the design of each partnership between the public and private markets or the intellectual property – would pose greater risk sector. Different degrees of scientific uncertainty, technical for all involved and make it more difficult for the public sector risks and relative co-investment to meet capital requirements to underwrite such a large proportion of the research and determine what conditions can be negotiated regarding development costs and, thereby, to achieve such firm supply, pricing and intellectual property rights. What key commitments to specific supply and pricing arrangements.
Global Forum Update on Research for Health Volume 5 159 157-160 elias:GF5 23/10/08 15:31 Page 160
Corporate sector-related innovations
Key messages northern Nigeria, Sudan, Ethiopia, The Gambia, Senegal, Niger and Burkina Faso. When developing health technologies for poor populations, commercial partners can often provide Acknowledgments essential technical expertise and innovation, and The authors wish to thank PATH staff member John Ballenot public partners can reduce risk through developing for his contributions to this article. The Meningitis Vaccine unique partnerships, clarifying the market and Project has received funding from the Bill & Melinda strengthening delivery systems. For example, WHO Gates Foundation. played a key role in enhancing surveillance activities, facilitating links with African ministries of Christopher J Elias MD MPH is President and CEO of PATH, an health and providing a sound introductory platform international nonprofit organization dedicated to improving the for the Meningitis A conjugate vaccine. health of people around the world by advancing technologies, A public sector nonprofit organization, such as PATH, strengthening systems and encouraging health behaviours. PATH can help to successfully bridge gaps between public works in more than 70 countries in the areas of health health needs and commercial interests through technologies, maternal and child health, reproductive health, public-private partnership. vaccines and immunization, and emerging and epidemic Developing effective public-private partnerships diseases. Dr Elias was honoured as the Schwab Foundation’s requires attention to many factors such as the state Social Entrepreneur of the Year for the United States in of the science, the identified market for the product, 2005. He received his MD from Creighton University and his and the complexity of intellectual property issues. MPH from the University of Washington. Effective partnerships must solicit and follow guidance from developing country leaders on a Yvette Gerrans MBA, MS, RN is the Strategy and Policy variety of issues such as product presentation, cost, Analyst at PATH, where her work focuses on special initiatives communication and introduction strategies. under the president’s office. Ms Gerrans has more than 11 years’ experience in both domestic and global health. Before coming to PATH in 2005, Ms Gerrans worked in health care strategy While the MVP partnership model could and should be consulting with Deloitte & Touche and she has lived and worked applied to other new vaccine products where the underlying abroad, primarily in East Africa and South-East Asia. She has an science and manufacturing costs are well established, it will MS in public policy and management from Carnegie Mellon be less applicable for novel products where the science, University and an MBA from the University of Pittsburgh, as well product formulation, and manufacturing process as a BS in nursing from Duquesne University. development are still to be discovered. Successful PPPs must be designed strategically to match the circumstances of the F Marc LaForce MD is the Director of the Meningitis Vaccine particular products they are pursuing. Project, which is a partnership between PATH and the World Health Organization aimed at developing, testing, licensing and Summary introducing conjugate meningococcal vaccines in sub-Saharan Over the past 30 years, PATH’s work has demonstrated the Africa. During a long and distinguished career in disease value of public-private partnerships for developing prevention, vaccinology and international health, he has also technologies to address health issues in poor populations. held positions with the US Centers for Disease Control and The Meningitis Vaccine Project provides an illustrative Prevention, the University of Colorado School of Medicine and example through its facilitation of the development of an the University of Rochester School of Medicine and Dentistry. Dr affordable group A conjugate vaccine for use in Africa’s LaForce earned his MD from the Seton Hall College of Medicine meningitis belt, including countries such as Mali, Senegal, and Dentistry.
References
1. Brooke S, Harner-Jay CM, Lasher H, Jacoby E. How public-private 4. World Health Organization. Enhanced surveillance of epidemic partnerships handle intellectual property: the PATH experience. In: meningococcal meningitis in Africa: a three-year experience. The Weekly Krattiger A, Mahoney RT, Nelson L et al, eds. Intellectual Property Epidemiological Record, 2007, 82:34-40. Management in Health and Agricultural Innovation: A Handbook of Best 5. Sow S, Okoko B, Preziosi MP et al. A Phase II, observer-blind, Practices. Oxford, UK: MIHR and Davis, USA: PIPRA, 2007, randomized study to evaluate the safety and immunogenicity of a new 1755–1763. Available online at www.ipHandbook.org. meningococcal group, a conjugate vaccine, in healthy African toddlers 2. Roberts L. An ill wind, bringing meningitis. Science. 2008, residing in the meningitis belt. Presented at: Royal Society of Tropical 320:1710–1715. Medicine and Hygiene Centenary Conference, 14 September 2007, 3. Oostenbrink R, Maas M, Moons KG, Moll HA. Sequelae after bacterial London, UK. meningitis in childhood. Scandinavian Journal of Infectious Diseases, 2002, 34:379-82.
160 Global Forum Update on Research for Health Volume 5 161-163 Arianne Matlin:GF5 23/10/08 09:30 Page 161
Corporate sector-related innovations
Innovations and incentives: why pharmaceutical companies are becoming interested in neglected tropical diseases
Article by Arianne Matlin, researcher and writer
lmost 1 billion people, a sixth of the world’s only increased funding but also enhanced strategies for population, are afflicted with neglected tropical developing new products that will be accessible to the poor in Adiseases1. Between 1984 and 1994 in southern developing countries6. Sudan, 100 000 of a population of 280 000 died from Multinational pharmaceutical companies are often best visceral leishmaniasis (VL) during famine and civil war2. Why, placed in terms of compound libraries, financial resources then, are such diseases “neglected”? To most people in and facilities to carry out R&D into NTDs. Indeed several, developed countries, VL, onchocerciasis, schistosomiasis and including GlaxoSmithKline and Novartis, have dedicated NTD other illnesses on the World Health Organization’s list of research divisions7. However, the traditional patent-based neglected tropical diseases (NTDs)3 are unknown or remote. model of financial reward is not conducive to targeting the Even in developing countries where they are endemic, they cash-strapped and unstable markets of developing countries8. often receive little attention from governments. Returns are derived from exclusive intellectual property rights Sufferers become trapped in a vicious cycle of poverty and to a drug for a fixed period, after which cheaper “generics” disease. Disability and disfigurement caused by NTDs lead to may be produced. To recover the cost of bringing a drug to stigma and social isolation, with devastating impact on market and generate profit, companies must charge a economic productivity and quality of life. Health care in most relatively high price for the branded product. A 1999 report developing nations is not free at the point of use and the cost in the Journal of the American Medical Association found of treatment, when available, pushes patients deeper into that since 1975, only 13 of 1233 new drugs reaching the debt and destitution. market worldwide had been developed for NTDs9. Mortality rates of many individual NTDs are lower than for Now fresh hope for NTD research is emerging from innovative some “less neglected” tropical diseases such as malaria, and models designed to encourage pharmaceutical companies to while the combined burden of disease for NTDs is target markets that would otherwise be economically unattractive. substantial, the populations affected are usually the poorest, living in remote rural areas, urban slums or conflict zones1. Prizes These factors have long conspired to maintain a low profile of Large cash prizes, offered by governments, charities or WHO, NTDs on national and international agendas, according to could be used to stimulate research into NTDs. In January WHO Director General Margaret Chan4. Even in the UN’s 2008, experts in drug development, public health, Millennium Development Goals, which aim to tackle by 2015 economics and intellectual property gathered at an some of the most pressing issues relating to global poverty, international workshop in Maastricht, Netherlands to discuss NTDs are given little direct attention5. Goal 6 is to “Combat this possibility10. Such a scheme could potentially bypass HIV/AIDS, malaria and other diseases”. patents, or their use to control the manufacturing and sale of How can interest in NTDs be raised? What can be done to new therapies. Prizes could prove particularly beneficial in bridge the inequality in research and development (R&D) the area of vaccines, which are disfavoured by the current funding between diseases affecting rich and poor? patenting system as they are used by patients on a one-off or Mahoney and Morel have discussed the evolution of a short-term basis. In the USA, this idea has already been “global health innovation system”. They identified three types proposed in a bill introduced by Senator Bernie Sanders. The of “health failure” that justify attention to such a system: Medical Innovation Prize Fund Act of 2007 aims to “de- science failures, market failures and public health failures. couple the reward for product research development from the They noted that, to address globally the science and market price of the product”, reducing treatment costs. An award failures that have resulted in the absence of safe and effective would be made for every new FDA-registered therapy, drugs or vaccines against a range of infectious diseases, we depending on its health impact. Government funding would need more basic and applied research, which requires not begin at US$ 80 billion per year (tied to GDP), with 4%
Global Forum Update on Research for Health Volume 5 161 161-163 Arianne Matlin:GF5 22/10/08 16:21 Page 162
Corporate sector-related innovations
allocated specifically to NTDs11. Precedents for medical reduce the timescale of FDA assessment from an average of prizes include a US$ 1 million award announced by the 18 to perhaps 6 months. Economists estimate that this time charity Prize4Life in 2006 for a biomarker to track the saving could be worth more than US$ 300 million for a progression of amyotrophic lateral sclerosis12. Some concerns “blockbuster’ treatment”18, compared with an average cost of about the details of prize schemes remain to be addressed, US$ 400 million for development of a new chemical entity. including the difficulty in gauging in advance an appropriate “Thus, a voucher could enable a company to recoup a amount for the reward. significant portion of the cost of developing a new drug”, states a report by the International AIDS Vaccine Initiative19. Advance Market Commitments Enhanced dialogue between a company and the FDA Advance Market Commitments (AMCs) are an alternative throughout development also increases the early attrition rate specifically targeted towards vaccine development. They for drugs that will never reach the market, allowing resources guarantee a market to support this long, costly and otherwise to be diverted to those most likely to succeed. risky process, which is normally driven by high predicted FTO vouchers for NTDs were approved by the US congress return when the product is marketed. 25% of global child in September 2007, based on a precedent for success from deaths result from diseases preventable by vaccination13. The the Orphan Drug Act of 1983. There is potential to extend prophylactic nature of vaccine interventions could produce a the scheme to Europe, now that a legal framework exists dramatic health impact, but their introduction to developing within the European Medicines Agency17. Provisions are countries is often hindered by a lack of infrastructure and made to ensure that time savings are made only in the guaranteed finance and by uncertain demand among affected efficiency of the review process for the commercial drug, and populations (problems of penetrance and patient compliance). no shortcuts are taken in safety or efficacy trials. The scheme The premise of an AMC is that, during the agreement’s is not limited to vaccines, and addresses some of the specified lifetime, donor governments commit to support a problems associated with prizes and AMCs, particularly developing country market at a pre-agreed price, sufficient to those relating to prediction of markets and health benefits. provide the incentive driving R&D. The recipient country also However, as the IAVI review points out19, the FTO does not contributes a determined, affordable proportion and guarantee that the R&D funding will ultimately generate an continues to purchase the vaccine at this price after the AMC adequate supply of an affordable new treatment to expires14. Following a consultation by the UK Department for developing countries. International Development, in February 2007 the UK Treasury announced a commitment of US$ 485 million at Conclusion the launch of a pilot AMC for vaccines against pneumococcal Prizes, AMCs and FTOs represent innovative responses to the disease, with further contributions from Italy, Russia, current reality that the market fails poor people suffering from Canada, Norway and the Gates Foundation15. Details of economically unattractive diseases. However, it is still too AMCs must still be optimized, in particular how to set pricing early to assess their effectiveness. To have a real impact on levels several years in advance of a product launch and how NTDs, these schemes must be implemented together with to ensure that research activity and funding are not distracted synergistic efforts by governments and international from second generation products16. However, then-UK organizations to create supporting health infrastructures and Chancellor Gordon Brown welcomed the initiative for high adequate surveillance and reporting in developing countries. volume, low cost drug production, which he said will “ensure Pharmaceutical companies can then develop and distribute that the many will not be denied the medical advances affordable new NTD therapies to affected populations. available to the few”. Eradicating NTDs would benefit developing country economies and societies in ways far beyond the implied Fast Track Option scope of the “other diseases” mentioned in the Millennium The Fast Track Option (FTO) is a third scheme designed to Development Goals. Perhaps in the foreseeable future we will promote NTD research. This is a mechanism to raise funds, be able to drop the epithet “neglected”. J without public sponsorship, through the auction of a voucher to a pharmaceutical company. Proceeds from the sale are Arianne Matlin holds a PhD in Biochemistry/Molecular Biology dedicated to R&D for NTDs17. The voucher entitles the bearer from the University of Cambridge, UK. She has carried out post- to nominate a commercial drug for expedited review by the doctoral research in Cambridge and at Brandeis University, USA, US Food and Drug Administration (FDA). FTO vouchers can into the control of eukaryotic gene expression. She currently works be sold on to another company, or used by the purchaser to in science publishing.
162 Global Forum Update on Research for Health Volume 5 161-163 Arianne Matlin:GF5 22/10/08 16:21 Page 163
Corporate sector-related innovations
References
1. Savioli, L. WHO/CDS/NTD/2006.2. WHO Neglected Tropical Diseaes 713. brochure http://www.who.int/neglected_diseases/ director/en/index.html 11. http://www.keionline.org/index.php?option=com_content&task= 2. Seaman, J., Mercer, A.J. and Sondorp, E. (1996) The epidemic of visceral view&id=150 leishmaniasis in western Upper Nile, southern Sudan: course and impact 12. http://www.prize4life.com/page/about_us from 1984 to 1994. Int. J. Epidemiol., 25, 862-871. 13. Affolder, R., Rizzo, I., Burgess, C., Bchir, A. and Lob-Levyt, J. (2007) A 3. WHO Global Plan to combat Neglected Tropical Diseases, 2008-2015. prescription for drug delivery. Nature, 449, 170-172. 4. http://www.who.int/dg/speeches/2007/190407_ntds/en/index.html 14. Hollis, A. (2007) Prize, Advance Market Commitments and 5. Boutayeb, A. (2007) Developing countries and neglected diseases: pharmaceuticals for developing countries. New ICTSD series on new challenges and perspectives. Int. J. Equity Health, 6: 20. opportunities through innovation fostering R&D and promoting access to 6. Mahoney, R.T. and Morel, C.M. (2006) A global health innovation system medicines. (GHIS). Innovation Strategy Today, 2, 1-12. 15. http://www.hm-treasury.gov.uk/newsroom_and_speeches/ 7. Moran, M., Ropars, A.-L., Guzman, J., Diaz, J. And Garrison, C. (2005) press/2007/press_18_07.cfm The new landscape of neglected disease drug development. 16. http://www.dfid.gov.uk/Pubs/files/amc-consultation-report.pdf Pharmaceutical R&D Policy Project. 17. http://www.who.int/intellectualproperty/submissions/Mary.Moran2.pdf 8. http://www.yale.edu/macmillan/igh/index.html 18. DiMasi, J., Hansen, R. and Grabowski, J. (2003) The price of innovation: 9. Pecoul, B., Chirac, P., Trouiller, P. and Pinel, J. (1999) Access to essential new estimated of drug development costs. J. Health Econ., 22, 151-185. drugs in poor countries: a lost battle? JAMA, 281, 361-367. 19. https://www.iavi.org/file.cfm?fid=47963 10. Travis, J. (2008) Prizes eyed to spur medical inovation. Science, 319,
Global Forum Update on Research for Health Volume 5 163 166-170 Rosenzweig:GF5 23/10/08 14:38 Page 166
Corporate sector-related innovations
Vision for a venturing ecosystem to generate global health innovation
Article by William Rosenzweig, Managing Director, Physic Ventures
dvances in collaborative innovation models in the clinical research and patents) to unmet health needs of an United States involving entrepreneurs, academic ageing baby boomer population. Ainstitutions, venture capital investors and corporate We began by researching six major health issues affecting partners have created successful start-up businesses that large populations that could be addressed through nutrition: deliver science-based functional food products to the US heart health, weight management, cognitive development, market in a speedy, capital-efficient manner. These bone health, sleep and stress and immune system health. companies and their products provide preventive wellness Simultaneously, we identified and inventoried the latest solutions to personal and public health concerns including science-based ingredient technologies at leading academic weight management and obesity, cardiovascular health, institutions. Our creative team then generated 75 new immune system and digestive health, and sleep and stress product concepts that delivered the most scientifically discomforts. Each of these areas has a large and well- credible active ingredients in convenient and attractive food established US market for costly prescription drugs to treat forms. These preliminary product ideas, illustrated only as a related ailments and chronic diseases; these food-based name, product description and a drawing of a package were solutions are intended to offer an alternative approach to tested on early-adopter “healthy-food” consumers for their keeping people healthy. conceptual appeal using an Internet-based market research Concurrently, advances in progressive entrepreneurial and tool. The market for the products was defined as “The investment models in developing countries such as India, Worried-Well” – educated consumers with discretionary Pakistan and Africa are receiving increased attention and financial resources who cared about, and believed in capital. A broad range of nongovernmental stakeholders preventive health practices. including foundations, private investors, entrepreneurial We then sourced samples of the appropriate food intermediaries and multinational corporations are beginning ingredients and began discussions with university tech to pursue product-driven, market-based solutions to pressing transfer and licensing offices about proprietary use. The 12 health issues related to nutrition, hygiene and disease most promising concepts (as determined by the research) prevention. were developed into prototype products on the bench at Both efforts flourish when diverse stakeholders with Mattson and Associates, a leading culinary design firm. The complementary capabilities and resources collaborate to form chefs and food technologists at Mattson were able to assess a common vision and embrace an open innovation ecosystem which novel ingredients could be practically incorporated into model for venture formation and implementation. The product forms that were great tasting, convenient and multinational corporation is a key actor and stakeholder affordable while delivering efficacious amounts of the active common to both endeavours, and as such is in a unique ingredients (as determined by existing clinical studies). The position to provide initiative, capital and business group of 12 prototypes was culled to seven that had a strong resources necessary to catalyze and accelerate global chance of becoming high-growth business platforms. During health innovation. the ensuing months, entrepreneurial teams of experienced business leaders, food developers and marketing experts Brand new brands: case study of a were recruited to evolve the prototypes into commercial collaborative innovation model products and brand-driven businesses and launch them in In April 2004 my partners and I organized a venture-capital the market. backed incubator called Brand New Brands (BNB) to create The expectation of the entrepreneurs and investors was that next generation functional food products and launch them as these new ventures could grow quickly (four years or less new platform companies in the United States healthy foods from launch) and cost-efficiently (spending a fraction of what market. Our team developed a rapid and cost-effective large companies do) in the market, attract loyal customers innovation process that linked academic-based scientific and achieve a substantive sales velocity that would be research about novel food ingredients (with accompanying indicative of future scale and potential to become leading
166 Global Forum Update on Research for Health Volume 5 166-170 Rosenzweig:GF5 23/10/08 14:38 Page 167
Corporate sector-related innovations
Brand New Brands’ products and companies were Venture investors developedal venture ispecificallyntermed for a fast growing US market Soci iary Social venture intermediary enabled by a mature grocery retail distribution channel and large numbers of health-conscious consumers accustomed to paying a premium for healthy, organic, natural and functional foods products
Entrepreneurial leadership the BNB businesses. The intellectual capital of Unilever’s executives was offered as part of their “value-add” and was Academic a natural extension of the company’s recent commitment to research Corporate 3 centres investors an “open innovation” strategy.) Unilever was willing and eager to participate in an external innovation effort of this nature because these new products and markets were considered strategic to their long-term business, but too nascent, risky and small-scaled to be pursued or integrated Figure 1: Venture ecosystem for a US based business incubator into the company’s core efforts. designed to launch new functional food brands Brand New Brands’ products and companies were developed specifically for a fast growing US market enabled brands – US$ 50 million or greater in sales. At that point, the by a mature grocery retail distribution channel and large BNB businesses could be sold to larger food companies numbers of health-conscious consumers accustomed to looking for opportunities to extend and expand their business paying a premium for healthy, organic, natural and functional into high-growth healthy food segments. foods products. However, the principles of using rapid Brand New Brands was financed by a consortium of life- innovation processes with a consortium of partners who science and consumer-focused venture capital funds and the share a common vision about value creation could venture capital group of a multinational corporation. With be implemented to address global health issues in US$ 6 million in capital and in less than 24 months, the developing markets. BNB incubator launched four new businesses, complete with their own dedicated entrepreneurial teams and product The venturing ecosystem lines.1 The incubator was able to attract the capital of these Brand New Brands was a carefully designed enterprise investors because of the potential to achieve sizeable where all of the stakeholders – entrepreneurs, investors, financial returns as established by a pattern of high-value corporate and academic collaborators – had aligned interests acquisitions by large food companies of emerging healthy and incentives and shared a commitment to a core purpose. food brands during the prior decade2. These guiding principles were memorialized in a The collaboration of the cohort exemplified the potential for “constitution” by the stakeholders4. An incubator model was diverse partners to contribute effectively to a creative chosen, despite a history of mixed success, because of its innovation effort. Experienced food entrepreneurs with links appropriateness for rapid screening of manifold opportunities to leading academic researchers, backed by venture capital and the need for swift product commercialization. The US investors (several of whom had strong relationships with was identified as the focal market for many reasons: the research institutions and ingredient manufacturers) were experiences of the leadership team, growth dynamics of the able to generate significant competitive advantage in terms of consumer market, existence of an established distribution product innovation and speed to market over traditional large system, the availability of venture capital financing and the food companies. The BNB incubator was enhanced by the precedence of successful financial exits. active participation of Unilever, one of the world’s leading BNB’s incubator model had several unique structural food and personal care companies, which not only attributes. It was not owned or controlled by any one party, contributed capital through its venture capital group, but also and as such it functioned independently under motivated made several executives readily available to BNB’s entrepreneurial leadership. This is distinct from corporate entrepreneurial leadership on an ongoing basis. These and academic incubators that often have flat institutional scientific and business resources provided insights and compensation structures and cultures that are burdened by assistance about ingredient technologies, competition, the bureaucratic nature of large organizations. All of the markets and supply chain considerations. Additionally, entrepreneurs involved in BNB received meaningful equity Unilever dedicated a senior business executive with expertise incentives and were motivated by success in the in brand management, business development and M&A to marketplace. As such BNB was able to develop a distinct assist the companies as a board observer after they were culture as a rapid-learning organization where entrepreneurs spun-out from the incubator. (It is worth noting that Unilever cooperated and competed in a resource- and time- invested its capital on the same terms as the venture capital constrained environment. investors without any preferential rights to acquire or control It was also agreed that all of the new products should be
Global Forum Update on Research for Health Volume 5 167 166-170 Rosenzweig:GF5 23/10/08 14:38 Page 168
Corporate sector-related innovations
and food delivery technologies that had market potential in At Unilever, the company manages a diversified other parts of the world. This would be a simple and cost- portfolio of investments in a global cadre of leading effective way to leverage the scouting level efforts that were venture capital and private equity funds undertaken as part of the basic incubator model but would require local market expertise and additional scientific and medical expertise. able to be made by contract manufactured by established Similarly, we could look to identify opportunities to transfer food co-packers. This would also enable speed to market and technologies and fully developed products through licences to avoid costly investment in facilities and equipment. Another existing entrepreneurial teams or companies on the ground in innovative design feature was that BNB had a formal “end- developing countries. With the appropriate financing and date” and fixed budget when it would cease inventing and distribution partners, these teams could launch new incubating ideas. This forced the teams to make decisions businesses intent on rapid distribution of appropriate within a constrained timeframe and push their ideas to products into underserved markets. This venture ecosystem market. This structure reinforced a sharp focus on product might benefit from participation by foundations or other innovation and market success. Open-ended incubators funders intent on financing or underwriting costs that would attract talented product development resources but can lack make products immediately affordable and accessible to the an orientation to take the innovations to market. poor, while also providing necessary educational and technical support for market development. Expanding the collaborative cohort to create a global venturing ecosystem Leadership roles for the multinational Subsequent to the launch of four new functional food corporation and social venture intermediary companies, the BNB team had been approached by several While the overall effort is best orchestrated by experienced multinational companies seeking to explore ways to stimulate entrepreneurial leadership, a key partner in a global health innovation and entrepreneurial models that address unmet innovation ecosystem is likely to be a multinational needs in developing country populations, particularly in the corporation that has relevant product and domain areas of nutrition, hydration and hygiene. This has inspired us experience, local market and distribution expertise, a to think about how we could leverage our venture ecosystem proclivity for strategic venturing and growth strategy that model to spur innovation in developing markets. embraces open innovation. In the past several years a By expanding the stakeholder base in the cohort to include number of Fortune 50 companies have announced strategic entrepreneurs, intermediaries and investors working in commitments to developing markets and are beginning to developing markets, the team at BNB, with its global consider ways of replicating or adapting venturing models academic partners, could simultaneously evaluate ingredient and best practices developed through US and Europe
Venture Global investor venture investors
al venture intermed Soci iary Social venture intermediary
US Local entrepreneurial entrepreneurial leadership leadership
Academic Corporate partner partner Foundation
Figure 2: Expanded venture ecosystem linking US incubator to local developing country effort for global health innovation
168 Global Forum Update on Research for Health Volume 5 166-170 Rosenzweig:GF5 23/10/08 14:49 Page 169
Corporate sector-related innovations
experiences. A committed multinational corporation can micro-nutrition, hygiene or disease prevention, a social provide myriad resources while helping to mitigate risks for venture intermediary might be in the best position to identify all members of the cohort. and align the interests of appropriate entrepreneurial, The first valuable resource is risk capital that may be financial and corporate stakeholders for a successful global committed as part of a larger portfolio of strategic venturing venturing ecosystem. activities. At Unilever, the company manages a diversified portfolio of investments in a global cadre of leading venture Key messages capital and private equity funds. The scope and activities of these funds match Unilever’s strategic interests and A venturing ecosystem can flourish when a diverse geographic focus. With the appropriate co-investors, limited stakeholder cohort shares a common vision and partners and fund managers, a corporate investor might join commits to an open innovation model for new an investment fund focused on starting and growing business creation. This approach seems well suited businesses in relevant developing markets. One related for transferring health product innovations related example is Acumen Fundi, a non-profit global investment to nutrition, hygiene and clean water from the US to vehicle that converts philanthropic contributions into developing markets. investment capital to deploy in market-based innovations to Best practices developed and proven in the US could solve the problems of poverty. be linked and leveraged through partnerships with The multinational corporation can also contribute valuable multinational corporations and social venture market research and insight, and executive talent that can intermediaries to extend a venturing ecosystem from inform strategy. In some cases, the corporate partner may be developed countries into developing markets. in a position to structure distribution relationships or joint- A successful multistakeholder open innovation effort venture partnership that could accelerate access or success requires entrepreneurial leadership, creativity, and a of a new venture in market. (There are some positive shared design ethic intent on aligning the interests, precedents for this approach between large corporations and incentives and outcomes for all stakeholders in the entrepreneurial start-ups in the US food sector.) venturing ecosystem. A successful global venturing ecosystem may also need a social intermediary partner to bridge the innovation ecosystem from the developed world to the developing William Rosenzweig is Managing Director of Physic Ventures, a world. International intermediaries that support venture capital firm based in San Francisco that invests in entrepreneurship in developing countries such as Endeavor keeping people healthy. He was a founder and CEO of Brand and Volans Ventures2 might be ideal partners to steward the New Brands, CEO and Minister of Progress for The Republic of creation of a linked and parallel venturing ecosystem. These Tea and co-author of the best-selling book The republic of tea: groups are set up to help for-profit and socially focuesed how an idea becomes a business. Since 1999 he has been a entrepreneurs scale innovations to enhance overall impact. faculty member at the Haas School of Business at UC Berkeley, By taking a comprehensive design approach to an issue like where he originated and taught the MBA course in Social Entrepreneurship. www.physicventures.com References
1. The websites of the four Brand New Brands provide details about the Approach companies and their products. See www.lightfullfoods.com; Brand New Brands uses a portfolio-based incubator model to develop and www.corozonasfoods.com; www.attunefoods.com; and market the highest potential new functional food business opportunities www.dreamerz.com for the US marketplace. Core to our approach is the commitment to 2. Phil Howard, assistant professor at Michigan State University in the create food and beverage products that are efficacious (by medical department of Community, Agriculture, Recreation and Resource Studies, standards) honest and transparent in their claims, and satisfying to eat or has written extensively about the rapidly evolving industry structure of the drink. By vetting and assessing the potential of scores of new product organic foods sector. He has produced a series of intriguing diagrams that concepts, we take the most promising opportunities and fuse them with illustrate a web of relationships connecting entrepreneurial enterprises talented, passionate and proven entrepreneurial teams who turn ideas into with multinational corporations. His papers and illustrations are available thriving new ventures. at http://www.msu.edu/%7Ehowardp/. See Figure 3. 3. “Open innovation” describes a new paradigm for the management of We focus our efforts and resources by innovating “category-creating” industrial innovation in the 21st century, in which firms work with brand platforms that are capable of crossing over from niche markets to external partners to both commercialize their internal innovations and to the mainstream in three to five years. We only pursue opportunities where obtain a source of external innovations that can be commercialized. The we can claim distinct competitive advantages over large food companies term was coined by Henry Chesbrough, based on his research on the through IP, brand creation or non-traditional distribution. Our strategy is to innovation practices of large multinational companies. take the most promising new nutritional technologies and deliver them to www.openinnovation.net the marketplace through great-tasting products with engaging “lifestyle” 4. Brand New Brands: core purpose and values statement brands that educate and attract loyal customers and progressive retail Core purpose partners. We take opportunities to market that are likely to scale quickly We aspire to improve and enhance the lives of adults and children by due to the convergence of scientific advances, consumer readiness and introducing the next generation of foods designed specifically to promote media attention. health and support the prevention of disease.
Global Forum Update on Research for Health Volume 5 169 166-170 Rosenzweig:GF5 23/10/08 14:38 Page 170
Corporate sector-related innovations
References continued enture interm Social v ediary We define success by 1) thrilling our customers while serving their health benefits. Brands exude creativity and charisma. We guarantee the safety Social venture intermediary needs and, 2) creating and capturing value by rapidly growing high and integrity of everything we do and are forthright and accurate in performance businesses that offer long-term potential to strategic buyers. our claims.
Core values Entrepreneurial leadership – we are highly resourceful and strive for Impact and Innovation – our products delight our customers and fulfill the leverage, scale and speed to market. We pursue ambitious visions unmet health needs of large and expanding populations. creatively, with rigorous execution.
High performance teams – we foster a communicative, coordinated and 5. Acumen Fund is a non-profit global venture fund that uses entrepreneurial collaborative “green light” culture that values initiative, personal approaches to solve the problems of global poverty. We seek to prove that responsibility and mutual respect. small amounts of philanthropic capital, combined with large doses of business acumen, can build thriving enterprises that serve vast numbers Ownership – we initiate and act with the passion, commitment and of the poor. Our investments focus on delivering affordable, critical goods accountability of owners. We strive to create value for all of our and services – like health, water, housing and energy – through stakeholders by creating valuable, profitable new businesses. innovative, market-oriented approaches. www.acumenfund.org 6. www.endeavor.org and www.volans.org are global venture development Product excellence – Brand New Brands develops breakthrough products intermediaries which provide capital and technical assistance to help for- of the highest quality, taste, convenience and efficacy. Product platforms profit and socially oriented entrepreneurs leverage their impact. are backed by scientific rigour, intellectual property and tangible health
Green & Jul y 2008 Black's Seeds of Organic Industry Change Lightlife 2002, 5% Equity July 2000 Structure: May 2005, 100% Equity 1997 Acquisitions by the Top 30 Food M&M December Processors in North America Mars ConAgra General 1999 #9 July 2007 Cadbury #1 6 Schweppes Alexia Mills Cascadian #6 Farm #1 0 Foods March 1998 Boca Frutti di Millina's June 2008 Foods Bosco Finest Earth's Best Muir Glen Larabar June 2001 February 2000 September 1999 From Heinz Walnut French Acres Heinz Nile Spice Kraft Meadow Back to #1 #27 Rich October 2001 June December Products Nature Mountain 2003 1998 Spectrum Corp. ShariAnn's Organics May January September 2003 Sun 2002 2007 September 1999 August $100 M 2005 $33 M Garden of MaraNatha SunSpire 19.5% Equity; Eatin' White December 2005 DeBole's Wave/Silk March 0% Equity Arrowhead May 2002 2008 April 1998 Mills $189 M $80 M Cargill TofuTown Hain June 2007 #18 From Dean Celestial August 2003 Dean #85 April 1999 Alta Dena May 1999 #7 Westbrae October 1997 $80 M $23.5 M Health Valley Bearitos Westsoy March 2000 December Breadshop $390 M 2002 Casbah July 1998 Little Bear March Horizon 13% Equity 2008 January 2004 Celestial Imagine/Rice 100% Equity April 1999 SunSpire Seasonings Dream/Soy $216 M Dream MaraNatha The Organic Cow of Food Vermont Hershey Processors# Bear Foods Naked Kellogg #23 #1 2 Coca-Cola Pepsi November 2007 Organic #1 5 #3 $122 M Brand Acquistions October 2006 Wholesome Dagoba February & Hearty June Strategic 2008 October 2000 November 2006 November 1999 Alliances 40% Equity 2001 $307 M $43M $181 M # Numbers refer to Phil Howard, Assistant Professor Naked Kashi rank in North Honest Morningstar Dept. of Community , Agriculture, Odwalla Juice American food sales Tea Farms/Natural according to Food Recreation and Resource Studies Touch Processing, August, Michigan State University 2007
Figure 3: Organic industry structure
170 Global Forum Update on Research for Health Volume 5 171-173 Bradley:GF5 22/10/08 09:28 Page 171
Corporate sector-related innovations
Beyond product: the private sector drive to perform with the purpose of alleviating global under-nutrition
Article by Dondeena Bradley, Vice-President, Nutrition, PepsiCo
n a day and age when so much of the world’s population economies? How will the private and public sectors build has more than it possibly needs, it is painful to envision mutual trust, so that programmes can be created to provide Ithat most of the world does not have nearly enough to measurable results for those most in need? survive. It is widely accepted that proper nutrition is the backbone for overall health. However, obtaining food for Building trust and creating partnerships survival far outweighs obtaining optimal nutrition in countries between the public and private sectors where the economic reality is harsh. In fact, in an unstable Creating trust and building relationships is at the heart of good financial atmosphere, making sound and affordable business. Industry, government, non-government organizations, nutritional decisions is a luxury many cannot afford. and academia each provide unique expertise. Working together Therefore, it is no surprise that under- and over-nutrition, to harness knowledge from all angles can provide the highest along with diet-related chronic disease, account for more than possible rate of success. Distrust regarding both intentions and half of the worldwide disease burden1. Under-nutrition is capabilities present roadblocks that must be addressed. defined as a diet that does not provide adequate calories Partnerships built on a foundation of trust, shared values and and/or micronutrients for growth and maintenance, whereas common aspirations seem to be the most productive way to over-nutrition is defined by a diet that includes too many reach realistic, measurable goals. In fact, as Rosabeth Kanter calories. More than one third of child deaths worldwide are Moss of the Harvard Business Review4 notes, “When giants attributed to under-nutrition2. In poorer nations, under- transform themselves from impersonal machines into human nutrition affects one out of four preschool-aged children, and, communities, they gain the ability to transform the world among pregnant women, leads to one out of six infants born around them in very positive ways… Values turn out to be the with low birth weight. Micronutrient deficiencies affect 2 key ingredient in the most vibrant and successful multinational billion people worldwide and contribute to infections, birth (corporations). I refer … to the serious nurturing of values in defects and impaired physical and mental development. hearts and minds.” Stunting, a key indicator of chronic malnutrition, affects about At PepsiCo*, for instance, our company’s value system 178 million children globally3. emphasizes that we should seek to combine financial Increases in chronic diseases, such as cardiovascular performance with the explicit purpose of addressing complex disease, certain cancers and diabetes, are directly linked to the social problems… performance with purpose5. In fact, we have increasing prevalence of obesity caused by poor diet and a developed a comprehensive agenda of sustainability with sedentary lifestyle1. Two out of three overweight and obese respect to nurturing internal talent, protecting natural people now live in emerging and transitional markets. The environmental resources, and nourishing individuals with outwardly visible signs of obesity are often misleading and can healthful products through human nutrition. cause individuals to search for a “quick fix” to the most visible Partnerships that have the greatest chance of succeeding will symptoms of over-nutrition. Beneath the surface of this be those that are formed with a strong understanding of the epidemic are malnourished overweight and obese populations practical challenges to be overcome in the communities they who suffer from substantial micronutrient deficiencies. hope to help. Business practices, cultural nuances and the The world nutrition crisis has reached a level of such presence or absence of distribution systems and infrastructure magnitude that to not explicitly focus on it would be
unconscionable. With a challenge so significant, how can the * Given the prominence of the Pepsi brand in our corporate name, we private sector, and specifically the food industry, share its recognize the perception that soft drinks are at the heart of our business. business resources and expertise? Can the industry’s insight However, soft drinks account for only 15% of our revenue. We are constantly working to reformulate and develop new healthier offerings for into consumer behaviour in developed countries unlock new our consumers. The evolution of our portfolio into nutritionally sound approaches to escalating problems for consumers in emerging products demonstrates commitment to our values.
Global Forum Update on Research for Health Volume 5 171 171-173 Bradley:GF5 22/10/08 09:28 Page 172
Corporate sector-related innovations
affect the daily reality of bringing products and solutions to consumers in regions where nutrition information is not individuals. Even with excellent global policy, translation into required. the language of local needs is necessary. Through dialogue Globalize individual company and regional measures to regarding capabilities and shared values, public-private ensure responsible marketing and advertising of foods and partnerships have the potential to effectively deal with non-alcoholic beverages to children, bringing increasing these issues. proportions of the industry into the fold. Target individual company communications and forge The compelling role of the private sector public-private partnerships to cultivate awareness and There is a compelling role for the private sector, and specifically adoption of healthier lifestyles worldwide. the food industry, to continue to play in addressing the global Commit our time, expertise and resources to support nutrition crisis. PepsiCo has a comprehensive approach to public-private partnerships to accomplish the objectives of engaging individuals and organizations from a variety of the WHO Strategy. disciplines, with success even in these early stages. The greatest asset that PepsiCo brings to bear in these relationships This global, coordinated, private sector commitment comes and efforts is our drive to perform with purpose. at the halfway mark of the United Nations Millennium PepsiCo’s goal is to put nutritionally sound products within Development Goals’ (MDGs’) target of 2015. While extensive the reach of every consumer. We do this through a uniquely global effort has been targeted to MDG 1 (eradicating extreme acquired understanding of, and adaptation to, consumer poverty and hunger), the specific roles of private and public needs. We have experience in building the infrastructure to sector partnerships in supporting this has been missing. deliver products and solutions where they are needed, as well In those countries where progress on the MDG 1 goals is as in maximizing benefits related to cost, scale, distribution waning, therefore, PepsiCo is developing a more orchestrated and agriculture. approach to its core business capabilities in consumer The public sector brings particular strength in identifying fundamentals, health policy, nutrition, product and food global and national priorities based on broad health needs, production research and development, distribution systems abilities and the mandate to development norms and and marketing. standards to guide how products should be developed and One specific effort is to develop affordable and nutritious marketed. Together, the public and private sectors must products for mothers and families at the base of the economic collaborate to co-author the “playbook” or strategic action plan. pyramid in India, Nigeria and South Africa. The level of iron Governments recently recognized this when they endorsed the and zinc deficiencies and stunting in these populations is Global Strategy on Diet and Physical Activity at the May 2008 staggering; health professionals agree that such deficiencies World Health Assembly. Only if both parties write the action lead to a multitude of lifelong physical and intellectual plan will the unique capabilities of each be maximized. problems that undermine national competitiveness. PepsiCo is partnering with both governments and leading academic Our commitment researchers in these three countries, as well as with key NGOs, The world’s leading food and beverage companies believe it is such as the Global Alliance for Improved Nutrition. Consistent our responsibility to provide affordable, accessible and with our sustainability agenda, we are giving a great deal of nutritionally sound food and beverages to our consumers in attention to crafting sustainable business models to offer developing countries. Evidence of this commitment was affordable, nutritious foods and beverages to consumers recently contained in an unprecedented approach taken by in these areas. leading food companies. On 13 May 2008, the CEOs from The PepsiCo Foundation has a proven track record of seven multinational food and non-alcoholic beverage supporting successful community interventions on a local companies (Kellogg Company, Kraft Foods Inc, Mars level. For example, in collaboration with the Centers for Incorporated, Nestlé SA, PepsiCo Inc, The Coca-Cola Company Disease Control and Prevention and The Friedman School of and Unilever) signed a Global Commitment to Action in Nutrition Science and Policy at Tufts University, PepsiCo support of implementing the World Health Organization’s Foundation co-funded Shape Up Somerville, a three-year, Strategy on Diet, Physical Activity and Health. Set forth groundbreaking intervention designed to help prevent obesity originally in 2004, the WHO Strategy acknowledges that an in high-risk, elementary school children using environmental effort to help people improve their health and nutrition requires changes in the community, in schools and at home that affect actions by all stakeholders, including the private sector. behaviour6. Citywide policy changes were made that directly Through this coalition, five key global commitments will be affected the behaviours of children and their families. Tufts is carried out over the next five years. currently working to scale-up the initial success of Shape Up Innovate product composition and availability to provide Somerville. Internationally, the PepsiCo Foundation has healthier product options that address both excess and started to fund four major community-based interventions in deficient consumption of specific nutrients and calories. Mexico, India, China and the UK. Initial baseline results are Clearly, micronutrient deficiencies are a pressing need in expected within six months, but already the investment has developing nations and could be addressed in part led to enhanced local capacity-building research and through functional foods. advocacy skills required to tackle chronic diseases. Provide clear nutrition information to consumers, including
172 Global Forum Update on Research for Health Volume 5 171-173 Bradley:GF5 22/10/08 09:28 Page 173
Corporate sector-related innovations
Nutrition science: the missing elements who have too much to those who have too little. required for sustained progress This type of approach to breaking down the larger problem PepsiCo itself and many other food companies are stepping up into deliberately simple concepts not only would address the their investments in research so that future food products will over-nutrition crisis in developed countries, but also offer direct increasingly address epidemiologically determined nutrition and measurable results to those in an under-nutrition crisis. needs. These needs range from macro- and micronutrients so As this concept moves from idea to reality, we have the desperately needed if we are to reduce the levels of acute and opportunity to bring together the current network of social chronic under-nutrition. We bring more than technical entrepreneurs who are dedicated to solving problems at knowledge about the nutrient needs and possible solutions – the local level. we also bring a deep understanding of how to ensure that we meet consumers’ sensory needs and desires in a fun way. A Key messages problem we face – and one that bests the public sector as well – is that nutritional science in many developing countries It is paramount to the success of impacting the global remains trapped in a 20th century paradigm of what is nutrition crisis that we create a platform of trust possible. We need to learn from other sectors about how best between the public and private sectors through to stimulate innovation. Further, we need to work together to acknowledgment invest in building the much-needed capacity in nutrition of our common values and shared goals, especially science that is critical/essential for the public and private those that transcend cultural, regional or socio- sectors in emerging markets. economic differences. The recent review of governance in nutrition, part of the It is the responsibility of the private sector to develop landmark Lancet series on nutrition, highlighted how most innovative strategies that utilize and share business research in nutrition globally focused on overweight and know-how with partners in the government, obesity; and even the work on under-nutrition and academic, research and non-governmental arenas. micronutrients was dominated by researchers from a handful of The same comprehensive performance with purpose developed countries. The Global Forum is to be commended for approach that is employed to reach corporate goals having played a key role in facilitating the development of must be applied to the urgent purpose of alleviating pharmaceutical research capacity development in many the global nutrition crisis. developing countries. Now is the time to do the same for It is our in-depth knowledge of the individual nutrition science. PepsiCo and leading food companies are consumer that puts us in a unique position to solve ready to join forces in such efforts. problems in practical ways. As a food industry leader, we can reach individuals in communities, bringing the The future: redistributing caloric wealth promise of The global nutrition crisis magnifies the chasm between the global nutrition policy into the daily lives of those “haves” and the “have-nots”. Economic disparity is closely who need it most. associated with nutritional disparities. To close these gaps, the Invest together in nutrition science. type of “transformative innovation” described by Tadataka Yamada, MD, President of the Global Health Program of the Bill & Melinda Gates Foundation7 will be needed. Both public and Dondeena Bradley PhD is Vice President of Nutrition at PepsiCo private sectors must discard traditional thinking and invent and therefore responsible for delivering global nutrition science programmes that transfer business know-how to and from strategies and education platforms for its principal businesses. She emerging and developed countries. was previously Director of Strategic Marketing at McNeil We believe turning caloric wealth into social currency Nutritionals, accountable for development of new technology through a unique collaboration with micro-lending institutions platforms and strategic planning of new health platforms. Dr could be just such an innovative programme. Although Bradley received a Doctorate of Philosophy in Food Science from currently in the embryonic stage, it is our hope to fine-tune an The Ohio State University and a Master of Science in Food and innovative transfer of resources – a “social will” – from those Nutrition from Purdue University.
References
1. World Health Organization. Nutrition for Health and Development Review, 2008. Programme. Internet: http://www.who.int/nutrition/en/index.html. 5. PepsiCo 2007 Annual Report: Performance With Purpose. Internet: Accessed on 1 August 2008. http://media.corporate-ir.net/media_files/irol/78/78265/2007_AR.pdf. 2. Horton, R. Maternal and child undernutrition: an urgent opportunity. The Accessed on 1 August 2008. Lancet, 2008, 371:9608, 179-85. 6. Economos, CD et al. A community intervention reduces BMI z-score in 3. Lawn, JE, Cousens, S & Zupan, J. 4 million neonatal deaths: When? children: Shape Up Somerville first year results. Obesity, 15, 2007, Where? Why? The Lancet, 2005, 365:9462, 891-900. 1325-36. 4. Moss, RK. Transforming giants: what kind of company makes it its 7. Yamada, T. In search of new ideas for global health. New England Journal business to make the world a better place? Harvard Business of Medicine, 2008, 358, 1324-5.
Global Forum Update on Research for Health Volume 5 173 174-176 Sheeran:GF5 22/10/08 09:28 Page 174
Corporate sector-related innovations
Innovating against hunger and under- nutrition
Article by Josette Sheeran, Executive Director, United Nations World Food Programme
The United Nations World Food Programme reaches In Senegal, where iodine-deficiency disorders including more than 90 million people a year with a life-saving goitre are a health concern due to lack of iodized salt, WFP food intervention. The vital question we are now purchases salt for its assistance programmes from 7000 asking is whether that intervention is the smartest, village salt producers and works with the partnering most powerful and targeted nutritional intervention nongovernmental organization (NGO), the Micronutrient possible? That will be the leading edge of our work Initiative, to provide them with the equipment and technical for the years to come training they need on how to iodize salt8. The guaranteed income and technical capacity provided to salt producers – mostly women – helps break the cycle of hunger at its root he numbers of hungry and undernourished in the world while providing a sustainable and local health solution. today are staggering – one in seven people or 854 Today, WFP is launching a set of pilot projects in 18 Tmillion go to bed hungry each night1. And just in the developing nations (in Africa, Asia and Latin America) to past year alone, the global food crisis has thrown another examine how it can better use its large purchasing power in 100–130 million into the ranks of the urgently hungry, developing countries to support the sustainable development threatening to unravel progress on the Millenium of food security which can ultimately improve the livelihoods, Development Goal of halving the proportion of hungry in the health and well-being of these populations. The programme, world2, 3). Despite overwhelming advances in medicine, which is supported by the Bill and Melinda Gates Foundation science and technology in the past few decades, every day and the Howard G Buffett Foundation, is called Purchase for 25 000 people die from hunger and related causes, 14 000 Progress (P4P). It builds on WFP’s decades-long operational of them children4. Beyond health indicators, the direct cost of experience, its extensive deep-field presence and its strong child and maternal under-nutrition in developing countries is food procurement background. an estimated US$ 30 billion per year5. The implications for WFP has been procuring food locally for decades and spent the future prosperity of developing economies are serious and over US$ 1.2 billion buying food in Africa alone from 2001 the need for action is crucial considering one in four children to 20077. In 2007, 80% of WFP’s food purchases were are under weight and 40–60% of children in developing made in developing countries, totalling US$ 612 million – countries suffer from iron-deficiency anaemia, which impairs 56% of the total quantity purchased was procured in least mental development6. developed and low-income countries, while 24% was The United Nations World Food Programme (WFP) – the procured in middle-income developing countries. In 2008, world’s largest humanitarian organization with the mandate food purchases in the developing world are expected to reach to combat global hunger – is transforming food aid to create nearly US$ 1 billion7. By using innovations in WFP’s local a new paradigm for affordable and accessible nutrition for the food procurement strategy that will strengthen sustainable world’s poor. We call this a shift from being a food aid agency local agricultural markets and enhance production, P4P will to a food assistance agency. In this, WFP is examining how provide more cash to smallholder and low-income farmers in innovative programmes for providing food and food- developing countries, thereby boosting rural livelihoods and assistance can be used to break the cycle of hunger at its root ultimately reducing the level of poverty in local populations. and so be a part of a long-term solution. For example, today A key element of the programme is outcomes monitoring, half of WFP’s budget is cash, and 80% of this cash is used measuring the impact on agricultural production, livelihoods, to purchase food from small low-income farmers in 69 food security, food consumption and coping strategies will be developing nations7. This is a win-win solution which helps to assessed. Integral to P4P is support by partners including reduce malnutrition and poverty by promoting the livelihoods national governments, UN agencies, the World Bank, as well of local farmers through assured incomes and, consequently, as NGOs and research-based institutions. National the economic development of local communities. governments develop the overall strategy for the agricultural
174 Global Forum Update on Research for Health Volume 5 174-176 Sheeran:GF5 22/10/08 09:28 Page 175
Corporate sector-related innovations
sector while leading the investment drive to improve compared with fortified blended foods. Drawing upon agricultural production, marketing and rural infrastructure, decades of experience helping countries and local industry to while the cash for food procurement comes from donor produce low-cost micronutrient-fortified blended foods, WFP countries contributing towards WFP’s global operations. is moving forwards to innovatively develop locally adapted WFP has entered a new paradigm in tackling malnutrition and produced RUSF at the country level. This is another win- by increasing its efforts and attention on the right types of win solution which minimizes purchase costs and also fosters food it provides to beneficiaries, particularly children. The the development and growth of local industry. For example, Lancet series on under-nutrition found that a key to reducing the WFP Country Office in India, in partnership with local undernutrition is to focus effective interventions on vulnerable industry and with guidance from food technologists, has groups including children less than 24 months of age9. While developed a micronutrient-fortified spread based on fortified blended foods such as Corn Soya Blend (CSB) have chickpeas which was designed according to currently long been used in food assistance programmes, their available knowledge on the nutritional composition of foods composition has largely remained unchanged for 30 years required for the prevention and treatment of moderate despite increased knowledge on how to best meet the malnutrition. The product is affordable, acceptable to the nutritional needs of young children. population and produced using inputs from Indian Ready-to-use foods are energy- and nutrient-dense foods agricultural producers. It will ultimately be used within the that come in the form of spreads or pastes, do not require context of India’s Integrated Child Development Services water, and are designed to meet the specific nutritional needs Programme and, with further development, in WFP’s food of children. Ready-to-use therapeutic foods (RUTF) such as assistance response to the Myanmar Cyclone. Encouraged by Plumpy Nut®, have revolutionized the treatment of severe this success and with the objective of providing affordable, acute malnutrition among children greater than six months of accessible and nutritionally beneficial food, WFP is exploring age by enabling a new type of programming – Community similar efforts in Ethiopia, Egypt and Liberia. Therapeutic Care (CTC)10. Due to the antibacterial properties The future sustainability and success of RUSF in large- of RUTFs, which are based on peanuts or other groundnuts scale operations requires concurrent research by the scientific rather than water, children can be more quickly discharged and research community – not only on the efficacy of RUSF from clinics to complete their nutritional recovery at home, – but implementation and delivery science research that fed by their parents rather than clinic staff. By increasing the will provide nutrition programme designers and field- number of children who can be treated, reducing exposure to operations staff with readily-usable information on the most disease and reducing drop-out rates, the CTC approach is far appropriate delivery modalities, age-groups to target, as well more effective than conventional centre-based care with as nutrition education that is needed at the household and therapeutic milk11. community level. While approximately 3.5% of children less than five years The world has a moral, ethical and economic imperative to of age in developing country populations suffer from severe develop and support innovations that will end child under- acute malnutrition, moderate acute malnutrition and chronic nutrition. Organizations involved in the prevention and malnutrition typically affect about 10–30% of under-fives9. treatment of malnutrition such as the World Food Programme Both conditions, though less severe than acute malnutrition, have an obligation to ensure that people are not only fed, but significantly increase children’s risk of death9. The that they are fed with foods of the right nutritional conventional approach to treating these conditions is to composition to ensure that they can be healthy and thrive provide fortified blended foods through supplementary or nutritionally. While effective tools now exist for the treatment maternal and child health nutrition programmes. However, of severe acute malnutrition where it arises, it is much less concerns about the nutritional adequacy of fortified blended expensive to treat child malnutrition before it progresses to the foods for young children (6–24 months) and children with stage where it is life-threatening. In fact, a study from Haiti malnutrition have led many in the nutrition community to call released this year found that focusing efforts on preventing for improved food commodities to prevent and treat malnutrition among children of less than two years of age was malnutrition12, 13. more effective than treating cases of malnutrition among Ready-to-use supplementary foods (RUSFs), used in under-fives where they emerged14. limited capacity to-date, are currently in development and testing as a potential way to improve the way chronic and moderate acute malnutrition are prevented and treated. The world has a moral, ethical and economic Though only one of several potential options to address imperative to develop and support innovations that malnutrition, RUSFs represent a promising nutrition will end child under-nutrition. Organizations involved opportunity that could improve the nutritional status, well- in the prevention and treatment of malnutrition such being and future productivity of children in developing as the World Food Programme have an obligation to countries. With further research, RUSFs may also have a role ensure that people are not only fed, but that they are in the nutritional rehabilitation of adults, particularly among fed with foods of the right nutritional composition to HIV/AIDS and tuberculosis-affected beneficiaries. ensure that they can be healthy and thrive nutritionally One of the greatest challenges to wide-scale adoption of RUSFs by WFP and other agencies is the increased cost
Global Forum Update on Research for Health Volume 5 175 174-176 Sheeran:GF5 22/10/08 09:28 Page 176
Corporate sector-related innovations
We know today that investing in child nutrition pays long- communities, such global innovations can improve the future term dividends that greatly outweigh the short-term costs. A livelihoods of generations of children living at risk today. J study in Guatemala undertaken over a span of nearly 40 years found that children who had received a nutritious food Josette Sheeran became the eleventh Executive Director of the supplement when they were less than three years old earned United Nations World Food Programme in April 2007. As leader of more than 46% more as adults than their counterparts who WFP, Ms Sheeran oversees the world’s largest humanitarian agency. had not received the same supplement15. Furthermore, Ms Sheeran comes to the post after serving as Under Secretary for micronutrient supplementation and fortification both ranked Economic, Energy and Agricultural Affairs at the United States in the top three most cost-effective interventions in the 2008 Department of State. She has developed several important US Copenhagen Consensus16. initiatives and aided development of critical multilateral projects to At the heart of the World Food Programme’s transformation aid reconstruction in Afghanistan, in Pakistan after the 2005 from a food-aid to a food-assistance agency is the ability to earthquake, and in Lebanon after the 2006 war. In 2006, she was innovatively re-think, develop and implement food and food appointed by Secretary-General Annan to the High-level UN Panel assistance interventions that can ultimately break the root on System-wide Coherence in the areas of development, causes of hunger that afflict millions of poor. In partnership humanitarian assistance and the environment. Ms Sheeran has with scientific research, policy and field operations received numerous awards.
References
1. Food and Agriculture Organization (FAO), United Nations. State of Food exposures and health consequences. Lancet, 2008, 371. Insecurity in the World, 2006. 10. Collins S. Changing the way we address severe malnutrition during 2. World Food Programme (WFP), United Nations. Programme Design and famine. Lancet, 2001, 358. Support Division, 2008a. 11. Collins S et al. Management of severe acute malnutrition in children. 3. World Bank, News and Broadcasts “Food Price Crisis Imperils 100 Million Lancet, 10, 2006. in Poor Countries, Zoellick Says”, 2008. 12. Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends 4. Food and Agriculture Organization (FAO), United Nations. State of Food improve the nutrient density of traditional complementary foods in Haiti, Insecurity in the World, 2002. but iron and zinc gaps remain for infants. Food and Nutrition Bulletin, 5. Food and Agriculture Organization (FAO), United Nations. State of Food 25, 2004. Insecurity in the World, 2004 13. Lutter CK, Dewey KG. Proposed nutrient composition for fortified (http://web.worldbank.org/WBSITE/EXTERNAL/NEWS/). complementary foods. Journal of Nutrition, 133, 2003. 6. UNICEF and Micronutrient Initiative (MI). Vitamin and Mineral 14. Ruel MT et al. Age-based preventive targeting of food assistance and Deficiencies: A global progress report. Micronutrient Initiative, 2004. behaviour change and communication for reduction of childhood 7. World Food Programme (WFP), United Nations. Food Procurement undernutrition in Haiti: a cluster randomised trial. Lancet, 71, 2008. Services, 2008b. 15. Hoddinott J et al. Effect of a nutrition intervention during early childhood 8. Micronutrient Initiative (MI). 2006–2007 Annual Report, Canada, 2008. on economic productivity in Guatemalan adults. Lancet, 371, 2008. 9. Black RE et al. Maternal and child undernutrition: global and regional 16. Copenhagen Consensus, 2008. (http://www.copenhagenconsensus.com).
176 Global Forum Update on Research for Health Volume 5 177-180 Ngwarati:GF5 22/10/08 09:27 Page 177
Corporate sector-related innovations
Riders for Health: an award-winning social enterprise ensuring health care delivery across Africa
Article by Ngwarati Mashonga, Acting Operations Director, Riders for Health
Gambian Department of State for Health has been losing on “I’d stand by and watch children die of treatable diseases average 50 employees a year3. because there was no means of getting them to treatment or treatment to them”.1 Children are dying of treatable diseases SHERIFF SENGHORE, COMMUNITY HEALTH NURSE IN THE GAMBIA because they can’t be reached This alarming trend is not specific to The Gambia. Across Africa, rural communities continue to suffer chronically from heriff Senghore has worked as a Community Health Nurse treatable diseases simply because they are isolated by (CHN) in The Gambia for more than 20 years. He is distance, harsh terrains, lack of transport and poverty. And Sresponsible for preventive and basic health care, ranging across the continent, health workers are giving up the battle from advice about sanitation and hygiene to treatment for minor and leaving in search of less frustrating employment. ailments. His first posting was in the remote Basse region The billions of dollars spent on developing new vaccines, where he served a catchment area of approximately donating mosquito nets, producing condoms or providing 34 000 people. Initially he was lucky enough to be given an food supplies will have no effect unless these measures reach ambulance to get around, but the vehicle was in such poor their destinations. In countries where more than half of the condition that he had to push start it every morning. The population resides in rural communities, health care delivery ambulance eventually broke down completely, forcing Sheriff depends on reliable outreach systems. Health workers, like to resort to using a bicycle to visit his communities. As the Sheriff in The Gambia, who travel out to communities and roads in the region are so bad, he spent more time pushing focus on basic preventive health care, are Africa’s best hope and carrying the bike than riding it. Eventually he stopped for reducing its huge mortality rates. using the bike altogether and simply walked. These health workers must travel vast distances to reach One of the villages within Sheriff’s catchment area was their patients, bringing with them as much as possible as they 18 km from his home. He would start walking at 6.30am, are unlikely to return to the community for another fortnight. carrying all his equipment. If he found any sick children in There is little or no public transportation, the best roads are the villages, he had to track down a horse cart to refer them little better than dirt tracks and, without the infrastructure for to hospital. Long, bumpy journeys under the hot sun seldom maintenance, the few vehicles available rapidly break down helped his patients but there were no other options. In a for want of replacement parts or basic servicing. A breakdown region where malaria causes 29% of under five mortality2, can mean that a health worker will miss seeing as many as regular health care visits to educate and monitor are vital if 200 people in a day, with fatal consequences for those left the Millennium Development Goal (MDG) of reducing infant unreached. Not one of the MDGs mentions transport, yet the mortality is ever to be achieved. achievement of each one is dependent on reliable access to Over the years, Sheriff was given a number of vehicles by rural communities. various humanitarian agencies, all of which broke down within a short space of time because there was no Riders’ solution: the planned preventive maintenance infrastructure in place and no replacement parts maintenance system were supplied. Time and again, Sheriff was left to walk to the For Andrea and Barry Coleman, founders of Riders for Health communities in his care. (Riders), this situation was wholly unacceptable, and they set With these ongoing challenges faced by all medical staff about finding a practical solution to the isolation of rural tackling rural health issues, it is hardly surprising that The communities. Drawing on their knowledge and experience
Global Forum Update on Research for Health Volume 5 177 177-180 Ngwarati:GF5 22/10/08 09:27 Page 178
Corporate sector-related innovations
from the world of motorcycle racing, they founded Riders on one basic principle: to find a way to get 100 000 reliable Riders at a glance kilometres out of a motorcycle, or any other motorized Operates more than 1000 vehicles across sub-Saharan vehicle, no matter how harsh the conditions. Riders now Africa, enabling health workers to reach more than 10 works to ensure that health care delivery in the areas in million people reliably and predictably. which it works is never undermined by vehicles failing – no matter how harsh the conditions. Operates on a national scale in Zimbabwe, Lesotho and From the outset, Riders worked in support of health- The Gambia in partnership with Ministries of Health and focused organizations, providing them with the transport works with partner agencies (NGOs, UN agencies or infrastructure to deliver their own services on a predictable community-based organizations) in Kenya and Nigeria. and cost-effective basis. Riders’ innovation was the design of an appropriate, sustainable infrastructure in which to Employs more than 200 staff in Africa. manage vehicles used in the harshest of conditions in Africa. The system, known as Transport Resource Management Has the ability to calculate accurate cost-per-kilometre (TRM), focuses on preventive maintenance and involves the budgets for clients. management of viable vehicles (assessed according to age, mileage and condition) owned by the partner agency. It has Provides sophisticated, tried and tested economic been tried, tested and costed, and has the potential to be models to suit the needs of each client/partner. replicated across Africa. Central to the effectiveness of the TRM system are several key elements. The first is the practice known as outreach build up the capital costs for replacing a vehicle at the end of maintenance, or in other words, “taking the service to the its life. This enables ministries of health and other agencies customer”. In some countries, ministries of health and other to know the precise cost of each kilometre travelled by the humanitarian agencies sometimes attempt to bring vehicles health workers to which they have allocated vehicles. into capital and provincial cities for servicing. Even when Accurate budgets can then be produced bringing clarity (rarely) this results in appropriate servicing, the cost (in for planning and accountability to the process of health money and in time) is unacceptably high. In contrast, Riders’ care delivery. technicians meet health workers in the field to service the Riders’ values and systems are specifically designed for vehicles regularly. This removes the danger of vehicles developing country markets and enable them to provide not- missing services and breaking down as a result, and means for-profit, cost-effective services which meet a pressing need that valuable resources are not wasted on travelling to in the market, providing rates that allow clients and partners central workshops. to relocate valued resources to others areas of need. TRM The second element is high-quality training of the vehicle proves that communities need no longer be excluded from users. The quality of driving and riding is possibly the largest access to health care because of distance or harsh terrain factor in the longevity and cost-effectiveness of any vehicle. and illustrates to ministries of health and other health Riders’ training is highly successful at instilling a culture of agencies that they can save money and also streamline pride and preventive maintenance in drivers and riders, who effectiveness by adopting this model. are trained to conduct daily checks on their vehicles to identify potential issues before they cause damage, extending Impact the vehicle life and ensuring correct performance until the Riders employs 200 people across Africa, running more than next service. 1500 vehicles and keeping health and community workers The third element and crucial benefit offered by TRM is from a variety of organizations “on the road”. Riders run that it is based on the true costs of running a vehicle in harsh national programmes in Zimbabwe, Nigeria, Lesotho and conditions. Ministries of health and many indigenous The Gambia, and have smaller community-focused nongovernmental organizations (NGOs) have no experience programmes in Kenya and Tanzania. in vehicle management and yet vehicles are vital to meet their health goals. High costs, unreasonable “down time” and Improving health often the loss of relatively new vehicles through negligence In 2002, the Gambian government handed over the running are common consequences, with negative outcomes on the of its entire health fleet to Riders. Since the programme health of the people served and a demoralizing effect on began, the number of health workers using motorcycles has agencies’ and governments’ health workers. increased by 110%. These health workers are now seeing Rather than simply charging for fuel and parts on an ad- five times more people and will see all of the people they hoc basis, Riders’ unique cost-per-kilometre (CPK) serve within any given month. One such health worker is calculation takes into account the costs of regular Manyo Gibba, who cares for more than 15 000 people in 14 maintenance as well as management and logistics costs. villages. “Before I had the motorcycle I had to walk or hire a This enables vehicle management to be based on a precise donkey,” she says. “Many of the communities would not see understanding of how much money vehicles are using in me for a month or more. Now I see them once a week.” terms of management, fuel and parts. The CPK also provides This effective mobilization has led to a rise in infant for a replacement fund, giving organizations the chance to immunization rates from 62% to 73%, as well as a 261%
178 Global Forum Update on Research for Health Volume 5 177-180 Ngwarati:GF5 22/10/08 09:27 Page 179
Corporate sector-related innovations
increase in the diagnoses of diarrhoea, a 75% increase in the Gambian Department of State for Health5. diagnoses of acute respiratory infection and a 55% increase Furthermore, Riders’ work contributes to the empowerment in diagnoses of malaria for the period 2001–20024. of women by proving that women can learn to drive and Many of these diseases are preventable through provision maintain motorcycles and four-wheeled vehicles as well as of education in health and hygiene. In Zimbabwe, men. In Zimbabwe, around 15% of health professionals Environmental Health Technicians (EHTs) play an important trained to ride motorcycles by Riders have been women. role in disease control, disseminating of health information, “We have a culture where men do some things and women implementing sanitation programmes, protecting water do other things”, commented the Deputy Director of the Farm sources, controlling disease outbreaks, and avoiding water, Community Trust of Zimbabwe. “Now here we have a air and land pollution. programme for children. The men will not work with the Michael Marime is an EHT in the Ministry of Health and children and the women can’t get to the children. The training Child Welfare in Zimbabwe. The coverage of the area he puts women on bikes and gets them there”.6 serves could not be done on foot or bicycle. He was trained Riders also encourages the hiring and training of female for three weeks in riding and efficient operation of his Yamaha technicians. These new skills increase women’s earning AG100 motorcycle and has since covered more than 90 000 capacities and raise their status in the community, as well as km without a single breakdown. challenging notions of women’s roles in primarily patriarchal “In 1999 there was a cholera epidemic in my area with 99 societies. Women across Africa are now not only the “natural recorded cases”, recounts Michael. “The motorcycle enabled caregivers” of the community; they are also the local mechanics. me to effect follow-up visits that saved lives, where death “Some people they find it funny to see a female riding a would have been inevitable. I have assisted in malaria control motorcycle”, says Manyo Gibba. “Even my mother, she was and flood disease prevention where, truly, motorcycles have complaining that I shouldn’t ride a motorcycle. I told her it, saved lives”. well, it’s part of my job. I have to do it”.
Empowerment and changing perceptions “Whenever there is a problem we can get Not only is Riders helping to access remote communities, but there quickly.” the locally-managed systems also empower the health Sheriff Senghore now manages a health centre at Albreda, a workers and technicians, thereby building local capacity. With large village 20 km from the nearest hospital on the north bank a well-maintained motorcycle, health workers can see more of the river Gambia. Albreda health centre is responsible for the people, more frequently and for longer periods. Health welfare of approximately 15 000 men, women and children. workers’ job satisfaction improves as faster travel means more The centre has an ambulance managed and maintained by time doing what they were trained to do and being able to go Riders for Health which, despite being two years old, still looks home to their own families every night. Additionally, without brand new and has never yet had a breakdown. The the strain of walking for miles each day, the health workers ambulance is used for both outreach visits to neighbouring themselves are healthier too. villages and the referral of emergency cases to Banjul Hospital. Increasing confidence and self-reliance, and changing It has been particularly useful in the recent national programme attitudes, are important objectives for Riders, with its systems for malaria control, in which all the communities in the regions being adapted by local people to suit national conditions and were visited and 2700 mosquito-nets distributed to pregnant to simultaneously bring about change in traditional practices. women and mothers of under-fives. The indigenous knowledge that comes with local staff and the “Riders taught us how to maintain it properly to ensure it ability to interact effectively with rural communities ensures will run for a long time without breaking down”, reported that Riders’ programmes are sustainable. In exchange, Riders Sheriff. “We can now provide reliable services in roadworthy contributes to community development by instilling a culture vehicles which means that whenever there is a problem we of preventive maintenance, developing management and can get there quickly. This has helped to immensely reduce transparent accounting skills and promoting gender equality. our mortality rate”. By working closely with Riders, local communities have Key messages found that, contrary to their previous experience, the life and performance of a vehicle can be extended through basic Managed transport is essential to the success of any preventive maintenance. As other agencies had not trained health intervention or other development initiative local people in vehicle maintenance, the only option was to in Africa. use the equipment until it broke and then discard it. Locally-managed infrastructure, based on the Following their collaboration with Riders, communities now principles of preventive maintenance, is key to understand that daily maintenance procedures will guarantee building the necessary capacity and creating them a reliable transport service that never breaks down. sustainable models for effective development. Instilling this culture of preventive maintenance is crucial to Well-managed transportation has a huge impact building sustainable infrastructure in Africa. on the cost-effectiveness of health-focused “We have had vehicles just stop working after one year. organizations and the ability to reach their One year and that’s it. Under TRM they keep working for health goals. three years or more”, observes the Director of Planning in the
Global Forum Update on Research for Health Volume 5 179 177-180 Ngwarati:GF5 22/10/08 09:27 Page 180
Corporate sector-related innovations
Ngwarati Mashonga, now Acting Operations Director of Riders Bachelor of Commerce degree (specializing in Transport for Health, joined Riders in his native Zimbabwe in 1996 after Economics) by distance learning. In 2007, Mr Mashonga was qualifying as a motorcycle mechanic. He became programme appointed to the post of Field Programme Coordinator, to oversee director in 2001, overseeing a team of 41 staff and the the replication of Riders’ programmes into new countries. management of nearly 600 vehicles. He also completed a
References
1. Malaria and motorcycle maintenance. The Times, 5 January 2008, p.33. 4. OC&C. Due diligence report on Riders’ operations in Africa, 2005 p.3. 2. Countdown to 2015. Maternal, newborn and child survival. 2008 Report. 5. OC&C. Due diligence report on Riders’ operations in Africa, 2005, p.5. The United Nations Children’s Fund (UNICEF), 2008. 6. OC&C. Due diligence report on Riders’ operations in Africa, 2005, p.38. 3. Figures taken from an interview with Sehou Omar Toure, Planning Director for the Department of State Health, 25 July 2008.
180 Global Forum Update on Research for Health Volume 5 182-185 Bermudez:GF5 22/10/08 09:27 Page 182
Corporate sector-related innovations UNITAID: innovative financing to scale up access to medicines
Article by Jorge Bermudez, Executive Secretary, UNITAID WHO/C BLACK
urely, we all agree that we are confronting what could estimated number of deaths is approximately 20 000. This is be called a “global state of emergency”. This complex an expanding worldwide problem. Ssituation is affected and worsened by the impact of With regards to malaria, which is endemic in many regions inequity in global health. of the world, particularly low- and middle-income countries, more than 500 million people are infected each year which The global context: challenges and responses converts into a range of between 1 and 1.5 million deaths in Currently there are nearly 6.5 billion people worldwide, of more than 100 countries. Resistance to commonly used which 84% live in low- and middle-income countries. medicines is posing new challenges. There is now a real need However, these people consume less than 11% of global to introduce artemisine combination treatments (ACT) on a health expenditure and are responsible for more than 93% of much larger scale. The cost of this medicine is several times the global burden of disease. If we consider the more than what is traditionally available. pharmaceutical market whose current value is estimated at Of course, we can acknowledge that the world has secured nearly US$ 650 billion and forecasted to reach near US$ a global response to this global challenge. The right to health 900 billion by 2011, we note that 85% of this budget is is included in the Universal Declaration of Human Rights consumed mainly in the USA, Europe and Japan. In other established in 1948. The Millennium Development Goals, words, medicines are on the north; patients are on the south. which carry defined targets and goals, five of which are In addition to this, nearly 10 million children die every year directly linked to health, represents a worldwide commitment worldwide. The fact remains that half of all these deaths are by the United Nations Member States, setting the objectives avoidable if access to vaccines and treatment were more to be reached by 2015. Other commitments and widely available. achievements could also be mentioned, but there remains an When considering human immnodeficiency virus/acquired unaddressed gap when it comes to the resources currently immunodeficency syndrome (HIV/AIDS), there are currently being made available for global health. more than 2 million deaths each year caused by the disease and an estimated 33.2 million people worldwide are living Why UNITAID? with HIV. The antiretroviral treatment coverage levels are on The natural question one could ask might be: when average as low as 31% of what is needed. Surely increase combining all elements of a coordinated and comprehensive treatment coverage is imperative. global response, is there really a need for an additional Let us now look at the burden of tuberculosis (TB). Most initiative? What was envisaged by UNITAID establishment in recent estimates according to WHO show that almost 2 September 2006? million people died from TB in 2006, including 231 000 The answer to this is that there are unaddressed issues at people with HIV. Globally there were 9.2 million new TB stake, including adequate medicines for children, as well as cases in 2006, which included 709 000 cases among second- and third-line treatments. In addition, UNITAID is a people living with HIV. Latest global TB estimates show that “plus” to existing initiatives, offering support to the worst the estimated number of multidrug resistant TB (MDR-TB) affected and most vulnerable countries. It is a new innovative cases is 489 000 and the estimated number of deaths to be mechanism for financing treatment, originally instigated on 130 000. For extensively drug resistant TB (XDR-TB), the the basis of a solidarity air ticket levy, UNITAID ensures sustainable, predictable and long-term financing and is therefore manufacturer-attractive. Global forecasting will ensure supply and its comprehensive approach addresses When considering HIV/AIDS, there are currently more both demand and supply factors. UNITAID is building solid than 2 million deaths each year caused by the and strong partnerships with current initiatives that deal with disease and an estimated 33.2 million people access to medicines and it represents a multi-dimensional worldwide are living with HIV approach, addressing quality, regulation, intellectual property rights, pricing and in-country support for supply systems. It surely is influencing the current health agenda.
182 Global Forum Update on Research for Health Volume 5 182-185 Bermudez:GF5 22/10/08 09:27 Page 183
Corporate sector-related innovations
UNITAID’s mission and overarching principles are very accordingly. For domestic and intra-European flights, the clear and they aim especially at scaling up access to contribution is 1 euro per passenger flying in economy class treatment of HIV/AIDS, malaria and tuberculosis for the and 10 euros for business and first class flights. For the poorest people in low- and middle-income countries by other international flights, the contribution rises to 4 euros lowering the prices of quality-ensured medicines and in economy class and 40 euros in business and first class. accelerating availability of new products. Overarching There are currently eight countries implementing this levy – principles include predictability, sustainability, partnership France, Chile, Côte d’Ivoire, Democratic Republic of Congo, and additionality, solidarity and aid effectiveness, adaptability, Republic of Korea, Madagascar, Mauritius, and Niger – independence, transparency and accountability. which makes up 70% of UNITAID’s funds. UNITAID added value is based on the facts that with a It is interesting to note the relevance of this type of stable, predictable and innovative form of financing, contribution – as little as 1 euro can provide treatment for associated with strong mobilization of its partners, it is possible two children with malaria and 40 euros is enough to to support long-term, sustainable programmes which will: maintain the treatment of an HIV-positive child for one year. Impact market dynamics and reduce current prices of The contribution raised by passengers on board a full available medicines, therefore allowing for more airplane from Paris to New York will cover the treatment of treatments with the same budget. This has been 60 HIV-positive children or one case of MDR-TB for a achieved with reductions of prices for ARVs (paediatric whole year. and second line by up to 60%). Initially proposed by five countries (Brazil, Chile, France, Allow for availability of manufactured medicines that are Norway and the United Kingdom), during the United better adapted to patient needs, such as fixed-dose Nations General Assembly in September 2006, UNITAID is combinations for paediatric ARVs. currently supported by 27 countries, most of them are on Contribute to address and ensure quality of products, by their way to implementing the innovative financing supporting WHO Prequalification Programme and speed mechanisms. Other countries, as well as the Bill and up the pace in which priority medicines are assessed. Melinda Gates Foundation, have pledged multi-year support Deliver medicines and other commodities more rapidly in to UNITAID, subject to annual reviews and assessment of the countries in need, by decreasing initial delivery lead key performance indicators. This unique solidarity has time, as has been achieved for ARVs, TB and malaria broken the barriers between North and South, as both products in several countries. contribute within their respective possibilities. As a concrete example, 19 African countries joined the pledge to support In the two years since UNITAID’s launch it has become a UNITAID in 2007 and Mauritius and Niger already have central actor in the fight against pandemics and has taken the lead and have made contributions in 2007. established the necessary partnerships with major UNITAID has implemented a very specific business stakeholders. Its capacity of budgeting with a stable, model. The main decision-making body is the Executive predictable and innovative form of funding is mobilizing both Board, composed currently of 11 members including: the members and partners, responding to crucial and strategic five founding countries, Brazil, Chile, France, Norway and issues that were previously not being adequately addressed, the United Kingdom; the Republic of Korea representing the in particular the focus on specific niches. Asian countries; the African Union; NGO representatives; communities living with the diseases; the World Health What is UNITAID? Organization; and private foundations represented by the UNITAID is an innovative mechanism of financing and Bill and Melinda Gates Foundation. Within a hosting scaling-up access to medicines and diagnostics for agreement, UNITAID (the Secretariat and Trust Fund) is HIV/AIDS, TB and malaria. It was launched in the context hosted by the World Health Organization. Therefore, in of the Global Action against Hunger and Poverty, in support addition to the hosting arrangements, UNITAID relies on the to the achievement of the health-related Millennium technical expertise of WHO. Development Goals. For many years the international UNITAID funds are utilized for medicines and diagnostics community has searched for adequate tools to ensure stable and all our activities are implemented by means of financing for development. Mainly based around the idea of partnership agreements, therefore countries are not directly a solidarity air ticket levy or tax, the main advantage of this financed by UNITAID. It is important for me to stress that all is its ability to be implemented on a national scale, clearly our projects are approved by the Executive Board and without any negative impact on the countries. implemented in the field by partner organizations under The idea of a solidarity contribution on air tickets is close coordination and monitoring by UNITAID. Current simple, equitable and an economically adequate tool. It can actions funded by UNITAID include support to more than be easily implemented and is based on a tax payment 80 countries worldwide in activities related to scaling-up structure on departing flights in the country where the access to medicines and diagnostics for HIV/AIDS, TB and tickets are issued. malaria. Let us take the example of France and how this levy works. The solidarity contribution on air tickets has been in Main achievements to date force since July 2006. France has chosen a progressive In the two years since its inception, UNITAID has mechanism based on the flight distances and the class demonstrated major achievements related to approved niches choice of the traveller so that the contribution varies and has contributed to making these solutions accessible to
Global Forum Update on Research for Health Volume 5 183 182-185 Bermudez:GF5 22/10/08 09:27 Page 184
Corporate sector-related innovations
most low- and middle-income countries. lowest possible price to diagnostic instruments, reagents and With regards to HIV/AIDS and in partnership with the supplies through UNITAID support. Clinton HIV/AIDS Initiative, UNITAID is contributing to Strong support for the WHO Prequalification Programme increase the number of children receiving HIV treatment. A ensures high-quality new products being introduced more baseline of 135 000 children in treatment was established rapidly on the international market. This support has enabled for early 2008, the aim is to reach 235 000 by the end of a streamlined process to be developed between receiving the this year and to continue this increase by 100 000 a year manufacturer’s dossiers and the assessment or inspection of in 2009 and 2010. The cost of an HIV child treatment for their manufacturing sites; doubling the number of training a year has decreased from US$ 200 two years ago to just workshops for capacity building; organization of technical US$ 60 today. In addition to this dramatic price reduction, assistance missions to support improvements in the quality the drugs offered on the market have improved and new of products; and the development of guidelines and and better-adapted formulations are now available. With standards to facilitate global quality assurance activities. the same partnership, UNITAID is also addressing second- Besides prequalifying 21 additional products in 2007, line ARVs for adults; this project has allowed 70 000 including five products for TB and three for malaria, the patients to benefit in 2007 and an additional 140 000 planning and implementation of a field sampling and testing more will benefit in 2008 in 26 countries. The project has programme has been developed within this framework of also achieved relevant market impact with a 30% cooperation. WHO has been able to restart the decrease in prices. prequalification of laboratories in low- and middle-income In partnership with UNICEF and WHO, the acceleration countries thanks to UNITAID support. of the global scale-up of national PMTCT (Prevention of mother-to-child transmission) programmes is being Forward challenges insured. An initial project targeted eight countries and The priorities that drive UNITAID are ever present in the aims to reduce the cost of diagnostics as well as test 1.2 health agenda worldwide. For the reasons appointed, million pregnant women and subsequently treat 340 000 UNITAID has a clear mandate and an added value, which of them. In addition, treatment of any infected infants will will bring a positive impact on market dynamics and access be insured by linking them to our ongoing programmes for to medicines globally. Certainly the progress reports made by paediatric ARVs. Increased access to primary prevention the World Health Assemblies over the next coming years will and family planning services will also be secured in these include the impact UNITAID has had with regards to better countries with the improved integration of these PMTCT medicines for children and the impact on the drugs and services into prenatal care with a stronger link to health diagnostics market. It is essential to deliver both hope and services. quality of life to vulnerable populations in need. A total of 51 countries are currently benefiting from UNITAID’s Executive Board will be examining the current UNITAID funding related to HIV/AIDS. scope of action and niches in the near future, as the innovative Scaling-up Artemisinin-based combination therapies way of funding and delivering results is being taken as a (ACT) is a part of UNITAID’s contribution to malaria control concrete example of results-driven initiatives. The recent calls in endemic countries. In partnership with UNICEF and for proposals and innovative concept notes have uncovered WHO, more than 1.4 million treatments were delivered in potential new initiatives and may broaden potential partnerships. Burundi and Liberia as they faced the risk of disruption of Additional innovative mechanisms for funding in treatments in 2007. With UNICEF and the Global Fund to conjunction with air ticket levy may also ensure sustainability Fight AIDS, TB and Malaria (GFATM), the support to the and long-term predictability. An international solidarity GFATM Round methodology has meant 55 million citizenship programme could raise the levels of revenues, treatments in 20 countries have been delivered, impacting therefore justifying the approach of UNITAID as a laboratory delivery time, prices of products and avoiding “stock-outs” for innovative financing, while scaling up access to medicines. of these products. The principle of establishing a patent pool as a platform for Current UNITAID TB programmes include support negotiation and ensuring a win-win situation with patent for 740 000 first-line treatments (in 19 countries) and holders and potential patent grantees may also represent a the establishment of a strategic rotating stockpile to reduce pioneering way to ensure market stability and expand access lead times and overall treatment costs, in addition to to high-quality and low-priced new products for low- and achieving cost containment in the short term and opening middle-income countries. the prospect for price reductions in the medium term. Other Building and maintaining solid partnerships is crucial in projects support paediatric TB covering over 750 175 searching for additionality among the stakeholders which are children and ensure the development of new child-friendly responsible for ensuring a global response to this “global formulations for infants under four years in at least 58 state of emergency” that the world is confronted with. countries and supporting the purchase of 5757 treatments UNITAID is helping to tackle the imbalance and inequities for MDR-TB in 17 countries with an objective to achieve that are hampering the achievement of better health price reductions of up to 20% for second-line anti-TB drugs conditions and quality of life for all those in need. It is a by 2011. More recently UNITAID has financed MDR-TB collective mission for all. diagnostics with the objective of securing access at the
184 Global Forum Update on Research for Health Volume 5 182-185 Bermudez:GF5 22/10/08 09:27 Page 185
Corporate sector-related innovations
Key messages Jorge Bermudez, a Brazilian Medical Doctor with an MSc in Tropical Medicine and a PhD in Public Health has been UNITAID’s Although low- and middle-income countries face a Executive Secretary since July 2007. Originally a Senior global state of emergency in HIV/AIDS, TB and Researcher at the Brazilian National School of Public Health and malaria, the international community has responded responsible for the establishment of the Nucleus for with the creation of UNITAID and several initiatives Pharmaceutical Policies at that school, he was also Unit Chief for which are reducing the inequities and addressing Essential Medicines, Vaccines and Health Technologies at the Pan the gaps to ensure access to medicines as a American Health Organization (PAHO/WHO) in Washington DC fundamental human right. (2004–2007) and Director of the Brazilian National School of Innovative financing mechanisms are a way to Public Health, Rio de Janeiro (2001–2004). Other previous posts ensure the scale-up of access to medicines and were held within the Brazilian health system. He is the author of diagnostics as they are a sustainable and several books, book chapters and papers dealing with access to predictable way of enabling long-term commitments medicines and medicines policies within public health. with different stakeholders. Acting in specific niches, with solid partnerships, with regards to HIV/AIDS, TB and malaria is a means through which UNITAID promotes additionality and seeks to avoid the overlap of activity with national governments and other donors. Achieving price reductions, new and better- adapted formulations and quality-assured products while promoting stable markets, are UNITAID’s key targets, so as to make quality products available to all people in need in low- and middle income countries.
Global Forum Update on Research for Health Volume 5 185 186-188 Jones:GF5 22/10/08 09:27 Page 186
Corporate sector-related innovations
Threshold of evidence needed for health claims on functional foods
Article by Peter J Jones (pictured), Director, Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, Canada with Stephanie Jew
he nutritional sciences discipline has for several consumers profit from guidance on functional foods decades faced challenges in promoting consistency possessing the potential to ward off degenerative disease and Tregarding the action of multiple dietary constituents on extend longevity. Secondly, health care systems benefit from health risk indicators. Whether for carotenoids, sodium, reduced operating costs due to a healthier population with dietary cholesterol or fatty acid composition, or most recently reduced dependency on pharmaceutical agents. Thirdly, for long chain fatty acid alcohols, nutritional and food scientists regulatory bodies, health claims provide a means of have often failed to achieve consensus in delivering a united protecting the public from misleading or unsubstantiated message concerning the ability of these dietary ingredients to information on product labels. Furthermore, food companies improve disease risk. Notwithstanding, consumers, as well as realize an improved market share subsequent to increased marketers of foods and food ingredients have been eager to acceptance and sales of products bearing health claims in the use health claims, even when supported by such marketplace. Lastly, food producers and farmers enjoy higher controversial data. The lack of consistency in positioning of commodity prices from these food constituents possessing health messages concerning efficacy of food-based bioactives added health value. In addition, research activity in the has, however, resulted in a confidence gap on the part of agriculture-food-health continuum remains vibrant to ensure consumers. Notwithstanding, over the past several years both continued livelihood of scientists and technologists which in our ability to design human feeding trials of superior quality, turn stimulates the biotechnology sector. as well as to analytically assess the nature of the bioactive A recent supplement has delved into the topic of how much constituents, have advanced considerably. As a result of such evidence is required to substantiate a health claim1. This advances, legislation originating largely in Japan began to cross-jurisdictional review presented examples of current surface in the 1980s. It started to systematize the question models for establishing health claim legislative policies. While as to how much scientific information is required to not providing a comprehensive coverage of all territories substantiate a health claim for any given dietary agent which globally, the range of examples included spans from Japan might modify a physiological process in a manner consistent representing a jurisdiction in which health claim legislation is with disease risk reduction. Through the advancements made well advanced, along to the cases of countries such as in Japan, many countries globally have now developed Canada which has demonstrated a more conservative health precise and systematic approaches for evaluating scientific claims development history over past decades. The second data making linkages between food ingredients and disease half of the aforementioned supplement seeks to deal with risk reduction. These approaches share common objectives of cases where specific functional ingredients are defined under identifying and defining the threshold of published evidence the more general global pattern of health claim legislation. required to substantiate authoritative statements to the public Using category specific examples, this section looks at the at large as label claims for a given marketed food product. complex scientific issues to be addressed for ascertaining The process of developing a formal assessment of scientific health claims. Various bioactive categories are discussed from data connecting functional ingredients with health attributes the standpoint of the level of substantiation of current benefits multiple stakeholders within this field. First, evidence identified as being required to support a claim approved by various regulatory authorities. Currently, various organizations are also in the midst of These approaches share common objectives of identifying reviewing and revising existing health claims standards. In and defining the threshold of published evidence required 2007, the European Regulation on nutrition and health to substantiate authoritative statements to the public at claims was established, thus the European Union (EU) is large as label claims for a given marketed food product now governed under a common regulation for health claims on food. This common legislative process has become a template of sorts for other regions, with the Association of
186 Global Forum Update on Research for Health Volume 5 186-188 Jones:GF5 23/10/08 14:56 Page 187
Corporate sector-related innovations
South East Asian Nations developing regulations close to EU claims on foods are likely to be resolved within the nearer standards with EU support2. Similarly, Codex Alimentarius, a future due to the continuing development of superior commission created by the Food and Agriculture technologies. Advances in emerging areas such as Organization and World Health Organization to develop nutrigenomics and metabolomics are certain to enhance our global food standards and guidelines, has been working to understanding of interactions that exist between nutrition and create a document on how health claims are substantiated. genes, nutrient utilization and trafficking at the molecular The guidelines of just how much and what type of evidence level, as well as the influence of these entities on overall is required to substantiate a health claim has been brought function will improve future understanding of relationships up recently, as some members of the scientific community between diet and disease. Such advances are likely to feel that the draft document presented by Codex had too improve the possibility of not only identifying precise much emphasis on clinical trials3. It has been noted that nutritional needs of specific groups and individuals with although Codex is not a regulatory body, its decisions are shared genetic and metabolic characteristics, but provide used as an international benchmark; and even though Codex additional means of meeting those needs in a novel manner does not have the same force of law as do regulations by using foods with individual-specific nutrient content. This stemming from a national legislation, it is used as a reference knowledge should lead to innovative approaches in arriving point for countries that are looking at revising or creating at solutions to diet-related diseases such as diabetes, health claim legislation4. cardiovascular disease and cancer. When the potential Despite their purported health benefits, foods with health economic importance of this area is considered, together claims should always be considered within the context of with current global sales in nutritional products approaching healthy diet eating practices. Augmenting a conventional diet US$ 200 billion, it is understandable that a strong interest with functional foods should not be taken as correcting an exists from both industry and governments to capitalize on otherwise inadequate intake. It is important that foods these opportunities. By the same token, consumers should possessing health claims be efficacious in terms of their benefit from improved access to foods with health benefits as ability to improve physiological performance, overall well- well as the enhanced availability of authoritative scientific being and disease risk reduction. However, these foods need statements in the form of health claims permitting them an to also possess a high safety profile at elevated levels of informed choice. J intake. Regarding safety issues, the general principle that foods must be safe, of course applies to foods with health Key messages claims. The messages contained in health claims can promote over-consumption of foods to which they may be Health claims on foods can be beneficial to many affixed as consumers can often regard these positive stakeholders including consumers, health-care messages as invitations to ingest higher than usual amounts systems, regulatory bodies, the food industry, food of these foods. As such, reassurances must be provided producers and research scientists. within existing health claim frameworks that safety issues Currently, there is no universal consensus on how have been given thorough consideration. Global jurisdictions much and what type of evidence is required to that appear to exercise greater caution in permitting health substantiate a health claim. However, recently, claims may do so to increase the assurance of public safety, organizations such as the European Union, particularly given the possibility of higher consumption Association of South East Asians and Codex patterns among a sub-set of consumers who may over- Alimentarius are implementing and/or developing respond to health claim messages. As a rule, nutrition region-wide common regulations. profiles must always be discussed in terms of “nutritional safety” implying that functional foods cannot counteract the Peter J Jones, the Canada Research Chair in Functional Foods general guiding principles for a balanced and complete diet. and Nutrition, joined the University of Manitoba in 2005 as The ultimate criterion of success for a given functional food Director of the Richardson Centre for Functional Foods and in terms of benefiting the chief stakeholders identified above Nutraceuticals. Before 2005 he was professor at McGill University depends on the general consumers’ understanding of, as well serving as Director of the School of Dietetics and Human Nutrition as confidence in, health claim messages. The multiple from 1994–1999. groups holding a key interest in this area, including Dr Jones serves as President of the Danone Institute for government regulators, industrial partners as well as Nutrition in Canada and is also Chairman of the Functional Foods the scientific community must unite to find reasonable and Nutraceuticals Board of the Vancouver-based Forbes Medi- compromises between issues of simplicity and tech group. Dr Jones also has sat on the Food and Agriculture understandability of claims for consumers versus the Organization of the United Nations, World Health Organization, scientific rigor needed to ensure that food-related health and United Nations University (FAO/WHO/UNU) Expert Consultant claims corresponds to their scientific background. It is Panel for Energy and Protein Requirements in Human Nutrition. essential that health claim messages be kept straightforward Dr Jones has published many articles and reviews in and simple in order to sustain the confidence of consumers. international journals, as well as chapters in leading nutrition It is also important to identify that some of the current textbooks. He received the Young Investigator Award for issues and vagaries surrounding the validity and benefits of Excellence in Nutrition Research in 1997.
Global Forum Update on Research for Health Volume 5 187 186-188 Jones:GF5 22/10/08 09:27 Page 188
Corporate sector-related innovations
Stephanie Jew graduated as a Registered Dietitian in 2004 workshops focused on functional foods and nutraceuticals. She before working in the School of Dietetics and Human Nutrition at currently works for Agriculture and Agri-Food Canada as a Special McGill University as a Research Assistant. During this period she Project Assistant focusing on food health claims. was involved in co-authoring publications and organizing
References
1. Evidence for health claims on food: how much is enough. Journal of claims. (http://www.nutraingredients.com/Regulation/IADSA-keeps- Nutrition (supplement), June 2008. pressure-on-Codex-over-science-for-health-claims, accessed 4 September 2. Sterling S. EU regulations attract global attention. 2008). (http://www.nutraingredients.com/Regulation/EU-regulations-attract-global- 4. McNally A. Codex will look again at health claims science. attention, accessed 4 September 2008). (http://www.nutraingredients.com/Regulation/Codex-will-look-again-at- 3. Daniells S. IADSA keeps pressure on Codex over science for health health-claims-science, accessed 4 September 2008).
188 Global Forum Update on Research for Health Volume 5 190-192 Carlevaro:GF5 22/10/08 09:26 Page 190
Corporate sector-related innovations
The Lilly MDR-TB Partnership: innovation to fight a disease
Article by Patrizia Carlevaro, Head, International Aid Unit, Eli Lilly and Company
e have the ability to communicate instantly from any manufacturing expertise to improve local availability of point in the world through hand-held devices. We essential drugs in the developing world in the late 1990s. TB Wcan bake a potato in six minutes. Our cars tell us strains that are resistant to first-line drugs can be treated with directions to our destination. We listen to hours of music stored a combination of various drugs, including two of Lilly’s older in a gadget smaller than a human hand. antibiotics. Their patents had expired, but the market for them From smart phones to GPS devices, corporations are was too small to attract generic manufacturers. While making countless innovations in an effort to make life easier. transferring local technology to partners, we began this At Eli Lilly and Company, we are employing innovation in an initiative by supplying our medicines at concessionary prices to effort to make life possible. resource-constrained countries facing outbreaks. In 1882, Dr Robert Koch announced his discovery of We recognized, however, that the spread of MDR-TB cannot Mycobacterium tuberculosis, the bacteria causing tuberculosis be halted by medicine alone. In 2003, we officially created the (TB). Tuberculosis is an airborne bacterium that can spread to Lilly MDR-TB Partnership, a public-private initiative now any organ of the body, most often the lungs. Symptoms may mobilizing 18 partners on five continents. It is important to include severe and prolonged coughing, fever, weight loss, realize that Lilly has no commercial interest in TB as the chest pain and night sweats. At the time of Dr Koch’s discovery, company has transitioned out of the anti-infective market. The TB killed one in seven people in Europe and the United Lilly MDR-TB Partnership is strictly a humanitarian initiative States of America. and is Lilly’s signature corporate social responsibility programme. Today, TB remains a vicious and deadly disease. Of the nine Each Lilly partner is a global leader in its respective function. million people diagnosed with TB each year, nearly two million Together, the partners comprise the five main components of will die of the disease. By the end today, close to 5000 people the Partnership: transferring manufacturing technology to local will have lost their lives to TB. Yet, these are more than mere pharmaceutical companies and continuing to supply medicines statistics – these are someone’s father, son, mother, daughter… at concessionary prices; implementing MDR-TB health care people whose lives mean everything to their loved ones. treatment and training programmes and strengthening Equally worrisome is the fact that each year, multidrug- surveillance of drug resistance; promoting community support resistant tuberculosis (MDR-TB) strikes nearly half a million and patient advocacy; working with policymakers to raise people around the world. MDR-TB can develop from first-line awareness and prevent the spread of MDR-TB. And, recently, TB, or be contracted by patients without their knowledge. It we started conducting research for new drug discovery. occurs when medicines used to treat TB are misused or From the start, one of our primary goals was to increase the mismanaged, resulting in a more virulent strain. MDR-TB, like supply of high-quality, affordable medicines to the people who TB, is airborne and contagious, but treatment is more complex need them most. To do so, Lilly devised a strategy for and longer in duration. It is highly contagious, and the hardest transferring technology and expertise so that these medicines hit are often the most vulnerable and least able to fight. could be manufactured in hard-hit countries where MDR-TB is The good news, however, is that given adequate health care most prevalent. We share the formula, trademarks and infrastructure and adherence to proper medication regimens, technologies for our two MDR-TB-fighting antibiotics with MDR-TB is treatable and curable. People infected with this manufacturing partners in the four countries with the most disease now have the chance to go on to lead productive and MDR-TB cases – Aspen Pharmacare in South Africa, Shasun fulfilling lives. Lilly has invested US$ 135 million in Chemicals and Drugs in India, Hisun Pharmaceutical in China, programmes to make this chance a reality for thousands of and SIA/Biocom International in Russia. In addition to MDR-TB patients. transferring technology, Lilly provides financial assistance to A global health innovator for more than 130 years, Eli Lilly purchase the equipment necessary to manufacture the and Company saw an opportunity to use its pharmaceutical medications. This approach not only enables access to
190 Global Forum Update on Research for Health Volume 5 190-192 Carlevaro:GF5 22/10/08 09:26 Page 191
Corporate sector-related innovations
medicines at lower prices for MDR-TB patients, but also supports local economies and the manufacturing of high- Scientific innovation will always remain a key component quality medicines. Purdue University, in the United States, to fighting disease and restoring health. MDR-TB can be shares its Good Manufacturing Practices programme with treated with existing medicines, but the regimen is time these facilities and is also helping in raising overall standards intensive and requires isolation from family and friends for safety and environmental stewardship. A major challenge in controlling and treating MDR-TB is the shortage of health-care professionals, including doctors, nurses, hospital administrators and community health-care workers, trained in proper MDR-TB treatment protocol. At the Project/Advocacy Partnership, and the World Economic Forum core of this Partnership is a deep-rooted conviction that having design and implement community support and patient trained and motivated health-care professionals is advocacy programmes locally. Those infected with MDR-TB indispensable in the effective delivery of life-saving treatments are encouraged to seek and complete treatment, and and prevention strategies, especially at the grassroots level. educational programmes are conducted in workplaces to For this reason, Lilly made training, treatment and surveillance reduce the stigma associated with TB. As feelings of a cornerstone of its multi-pronged corporate social depression and isolation are common among MDR-TB responsibility effort. Having worked in Africa and for UNICEF, patients, the opportunity for patients and former patients to I know first-hand of the pivotal role that nurses, midwives and connect via one-to-one patient mentoring through the TB primary caregivers have in providing good health care. Lilly has Survival Project website is invaluable. Our partners have been instrumental in ensuring that front-line health workers established community outreach, psychological support and have the necessary knowledge and skills to provide the best food aid programmes serving tens of thousands of patients and possible treatment, care and support for people living with carers throughout the world. TB and MDR-TB. In addition, Lilly works with RESULTS Education Fund, the Lilly supports Harvard Medical School and Partners in Stop TB Partnership and the WHO to raise awareness and Health, the International Council of Nurses, the International prevent the spread of this global pandemic. Developed country Hospital Federation, and the World Medical Association in the governments have played a crucial role in fighting the TB creation of global training courses for nurses, doctors and pandemic by creating such multilateral organizations as the hospital administrators worldwide. The Partnership is Global Fund for HIV/AIDS, TB and Malaria, and UNAIDS. educating health-care workers to recognize and treat MDR-TB, Through its bilateral efforts, including the US government’s and also empowering them to transfer their knowledge by PEPFAR programme, the Partnership advocates for increased training others. resources and policy action to stop the spread of TB. We also Our partners understand that meaningful changes must encourage the media to help disseminate our message: Lilly occur in the communities where MDR-TB patients live and and the Stop TB Partnership created an Award for Excellence work. Lilly and the International Federation of the Red Cross in Journalism on TB to recognize outstanding reporting in print and Red Crescent Societies, TB Alert, TB Survival that increases public understanding of TB and MDR-TB.
Figure 1: The Lilly MDR-TB Partnership has active programmes in nearly 60 countries
Global Forum Update on Research for Health Volume 5 191 190-192 Carlevaro:GF5 22/10/08 09:26 Page 192
Corporate sector-related innovations
A final challenge for all regions in defeating MDR-TB is research. Scientific innovation will always remain a key As leading international policy makers, attendees of the component to fighting disease and restoring health. MDR-TB Global Ministerial Forum on Research for Health play a can be treated with existing medicines, but the regimen is time critical role in setting the global health agenda. This intensive and requires isolation from family and friends. In responsibility includes identifying and dedicating addition, other deadly strains of TB, known as extensively drug resources to the pandemics afflicting the world’s most resistant tuberculosis (XDR-TB) have emerged, resulting in an vulnerable people even greater urgency to discover and develop new drugs. Lilly has established a nonprofit early phase drug discovery initiative in collaboration with the Infectious Disease Research Institute in Seattle and the National Institute of Allergy and Infectious Disease of the National Institutes of Health and other groups in does best – from manufacturing life-saving pharmaceuticals, to the United States. The goal of the initiative is to tightly integrate training health-care workers, to advocating for supportive medicinal chemistry expertise from the pharmaceutical policies and resources. The lesson for private sector responses industry with academic expertise in chemistry, microbiology to disease and poverty is that the battle must be waged on and TB, particularly basic biology genetics and molecular many fronts. biology. People involved in the initiative will scour millions of Lilly is moving aggressively to realize the WHO goal of molecules in medicinal libraries donated by Lilly and another treating 1.7 million MDR-TB patients by 2015. We have a manufacturer and work with other collaborators to identify and great deal of work ahead of us, and look forward to working develop promising new drug candidates. with governments and private sector providers to develop As leading international policy makers, attendees of the sustainable strategies against TB for better health in countries Global Ministerial Forum on Research for Health play a critical with limited resources. With the help of our partners and your role in setting the global health agenda. This responsibility leadership, we will continue to fight MDR-TB in 2008 includes identifying and dedicating resources to the pandemics and beyond. J afflicting the world’s most vulnerable people. We encourage you to support new thinking on programmes Patrizia Carlevaro, Head of the International Aid Unit and Team designed to curb the spread of MDR-TB. We also urge Leader of Lilly’s MDR-TB Partnership, has worked in global public your countries to comply with WHO standards of treatment, health and international development for the past 20 years. Prior because compliance with this effective regimen saves lives and to joining Lilly, Patrizia was Head of the Essential Drugs Unit at slows the evolution of multidrug-resistant strains. The UNICEF where she was responsible for global pharmaceutical Partnership fully supports TB activities as an entry-point to policies and programmes. Patrizia lived and worked in West strengthen health-care systems and place patients under the Africa, where in partnership with the United Nations Industrial supervision of a health-care worker to ensure appropriate and Development Organization (UNIDO), she established a national complete treatment. generic-drug manufacturing plant in the Republic of Guinea. She The Lilly MDR-TB Partnership is proof that public-private serves on the advisory board of various health-care industry partnerships can work in confronting disease on a global scale. committees and is on the Board of Directors of the Florence Our Partnership works because each member does what it Nightingale International Foundation.
192 Global Forum Update on Research for Health Volume 5 Global Forum Update onResearch for HealthVolume 5
InnovaƟ on for health is a vital driver of development. Drawing new ideas and discoveries from research, it may cross many sectors and disciplines involved in the development and applicaƟ on of a novel product or process.
The Global Forum for Health Research focuses on promoƟ ng an environment that fosters innovaƟ ve soluƟ ons for the health of poor populaƟ ons. In doing so, Fostering innovaƟ on it places parƟ cular emphasis on health equity as the central goal, i.e. reducing health dispariƟ es within and between populaƟ ons.
The fi Ō h volume of the Global Forum Update on Research for Health provides insights into the newest thinking on innovaƟ on for global health. Some 30 for global health leading insƟ tuƟ ons and professionals from around the world refl ect on how policy, social, technological and corporate innovaƟ ons can be fostered for global health. Global Forum Update on This volume is produced to coincide with the Global Ministerial Forum on Research for Health, Bamako, which is co-organized by the Global Forum for Research for Health Volume 5 Health Research.
Editors
Monika Gehner, Susan Jupp and Stephen A Matlin, Global Forum for Health Research
Editorial Advisory Board
Luis Gabriel Cuervo Pan American Health OrganizaƟ on Andrés de Francisco The Partnership for Maternal, Newborn and Child Health Nirmal Kumar Ganguly NaƟ onal InsƟ tute of Immunology, India Stuart Gillespie Plaƞ orm on Agriculture and Health Research Odile Leroy European Malaria Vaccine IniƟ aƟ ve Judith Sutz Universidad de la República, Uruguay Alfred Watkins World Bank Pro-Brook Derek Yach PepsiCo, Inc.
ISBN: 978-2-940401-12-3 www.globalforumhealth.org
Cover - Final_layout.indd 1 22/10/08 16:30:41