Update5_FullDoc 2008

ideas and discoveries from research, it may cross many sectors and disciplines involved in the development and applicaƟon of a novel product or process.

The Global Forum for Health Research focuses on promoƟng an environment that fosters innovaƟve soluƟons for the health of poor populaƟons. In doing so, it places parƟcular emphasis on health equity as the central goal, i.e. reducing health dispariƟes within and between populaƟons.

Global Forum Update on Research for Health Volume 5

InnovaƟon for health is a vital driver of development. Drawing new

The fiŌh volume of the Global Forum Update on Research for Health provides insights into the newest thinking on innovaƟon for global health. Some 30 leading insƟtuƟons and professionals from around the world reflect on how policy, social, technological and corporate innovaƟons can be fostered for global health.

Fostering innovaƟon for global health Global Forum Update on Research for Health Volume 5

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 Health Research.

Editors Monika Gehner, Susan Jupp and Stephen A Matlin, Global Forum for Health Research

Editorial Advisory Board Pan American Health OrganizaƟon

Andrés de Francisco

The Partnership for Maternal, Newborn and Child Health

Nirmal Kumar Ganguly

NaƟonal InsƟtute of Immunology, India

Stuart Gillespie

Plaƞorm on Agriculture and Health Research

Odile Leroy

European Malaria Vaccine IniƟaƟve

Judith Sutz

Universidad de la República, Uruguay

Alfred Watkins

World Bank

Derek Yach

PepsiCo, Inc.

ISBN: 978-2-940401-12-3 Cover - Final_layout.indd 1

Pro-Brook

Luis Gabriel Cuervo

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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

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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

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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

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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 creation of novel ideas, processes and products and their application to deliver practical solutions. In the health field, it encompasses not only technological inventions of products such as drugs, vaccines and diagnostics, but also innovations in the environmental, economic, political and social fields that can impact on the capacity to deliver health products and services and health protection and promotion messages and that can influence the broader determinants of health.

The Global Forum for Health Research especially focuses on promoting an environment that fosters innovative solutions to health problems that are relevant to resource-poor settings or adapted to different social and cultural contexts in low- and middle-income countries (LMICs). In doing do, it places particular emphasis on health equity as the central goal and on the importance of bringing innovation to bear on the health problems of the poorest and most disadvantaged people.

While increasing attention is now being given to the role of high-income countries in contributing to research and innovation for global health or the health of populations in LMICs, these countries need their own capacity to conduct and utilize research to solve their immediate health problems.

They too need to strengthen their systems of innovation as important drivers of development.

The global agenda must encompass how to (a) strengthen health research systems and innovation systems in LMICs; (b) strengthen systems incentives to create relevant products accessible to poor populations; and (c) enhance coherence

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between policies and actions of global players and national forces shaping country research and innovation systems.

Some LMICs are now showing greater commitment to investing in research for health and to developing systematic and equitable approaches to the creation and use of knowledge and innovation. These “innovative developing countries� have the potential to contribute significantly to the production of health-related products, services and processes for low-income countries and to south-south capacity building. To do so, they will require policy and legal frameworks that need to be set nationally and globally, as well as significant levels of public sector investment to ensure that the system delivers products that are accessible and affordable to the poor and contribute to a reduction in health disparities.

The Global Ministerial Forum on Research for Health (Bamako, 17-19 November 2008) brings together a wide range of stakeholders in research and innovation for health. It affords a unique opportunity for a multi-sectoral dialogue to give impetus to this global agenda, to address the environment for innovation to accelerate achievement of the Millennium Development Goals and tackle some of the world’s major health challenges.

As a contribution to this dialogue, the Global Forum for Health Research has commissioned this collection of writings by a range of experts and leaders in the fields of development, innovation and research. We are extremely grateful to the writers for providing cogent summaries, fresh insights and challenging messages to inform the dialogue. J

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Préface

Préface Gill Samuels, Présidente du Conseil de Fondation, Global Forum for Health Research, Suisse

'innovation est un moteur essentiel du développement.

Cela comprend la création d’idées, de procédés et de produits nouveaux et leur application pour fournir des solutions pratiques. Dans le domaine de la santé, cela englobe non seulement les inventions technologiques de produits, tels que médicaments, vaccins et diagnostics, mais aussi l’innovation dans tous les domaines environnemental, économique, politique et social qui peuvent avoir un impact sur la capacité d'offrir des produits et des services de santé et sur les messages de protection et de promotion de la santé qui peuvent influencer les déterminants de la santé.

Le Forum mondial pour la recherche en santé a pour objet, en particulier, de promouvoir un environnement qui favorise des solutions novatrices aux problèmes de santé spécifiques aux milieux défavorisés ou adaptés aux contextes sociaux et culturels variés des pays à faibles et moyens revenus. Pour ce faire, il se donne tout particulièrement comme objet d’atteindre l'équité en santé et de faire porter l'innovation sur les problèmes de santé des plus pauvres et des plus défavorisés.

Alors que l’on accorde une attention accrue à la contribution des pays à revenu élevé à la recherche et à l'innovation pour la santé globale ou la santé des populations des pays à faibles et moyens revenus, ces pays ont besoin de leur propre capacité d’effectuer et d'utiliser la recherche pour résoudre leurs problèmes de santé immédiats. Ils doivent aussi renforcer leurs systèmes d'innovation, en tant que facteurs importants du développement.

L'ordre du jour global doit inclure les moyens de (a) renforcer les systèmes de recherche en santé et les systèmes d'innovation dans les pays à faibles et moyens revenus ; (b) renforcer les systèmes d'incitation pour créer des produits adaptés accessibles aux populations pauvres, et (c) améliorer

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la cohérence entre les politiques et les actions des acteurs globaux et des forces nationales qui configurent les systèmes de recherche et d'innovation des pays.

Certains pays à faibles et moyens revenus s’engagent maintenant à investir dans la recherche pour la santé et à développer des approches systématiques et équitables pour susciter et utiliser la connaissance et l’innovation. Ces 'pays en développement innovants' ont le pouvoir de contribuer significativement à la production de services, de processus et de produits pour la santé à destination des pays à faible revenu, et de renforcer les capacités entre pays du Sud. Pour ce faire, ils auront besoin d’un cadre politique et juridique qu'il faudra établir à différents niveaux, nationaux et mondial, ainsi que d'investissements conséquents du secteur public pour s'assurer que le système fournit des produits accessibles et abordables pour les pauvres, contribuant à une réduction des disparités en santé.

Le Forum ministériel mondial sur la recherche pour la santé (Bamako, 17-19 novembre 2008) rassemble un large éventail de personnes concernées par la recherche et l'innovation pour la santé. Il offre une occasion unique de dialogue multi-sectoriel en vue de dynamiser cet ordre du jour mondial, de s'intéresser à l'environnement pour l'innovation pour accélérer la réalisation des objectifs du Millénaire pour le développement et s'atteler à certains des plus grands défis en matière de santé dans le monde.

En tant que contribution à ce dialogue, le Forum mondial pour la recherche en santé a commandé ces contributions de nombreux experts et chefs de file dans les domaines du développement, de l'innovation et de la recherche. Nous sommes extrêmement reconnaissants aux auteurs d’avoir fourni des récapitulations pertinentes, des éclairages nouveaux et des messages stimulants pour contribuer au dialogue. J

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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 discovery, but its application in practice – taking the outputs of research and invention and using them to put new goods, services or processes into use.

The products of innovation in science and technology are usually tangible (e.g. machines, equipment, devices, materials) and their value is clearly visible as they often greatly contribute to the wealth of individuals, corporations 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 tangible but nevertheless highly valued, ways to the conditions in which people live and their quality of life.

The Global Forum for Health Research1 espouses this broad view of innovation (see Box 1) and seeks to promote innovation in all fields that will improve the health of poor populations and reduce health inequities.

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Box 1: Innovation for health and health equity

Innovation for health and health equity is an initiative in any sector or combination of sectors that takes up novel ideas, inventions or processes and applies them to achieving improved health and greater health equity.

The importance of capturing the benefits of innovation to achieve the Millennium Development Goals, including those for health, has been emphasized (see Box 2)2.

Research and innovation for health: dimensions and sectors and elements needed Research for health The role of research in contributing to better health in lowand middle-income countries (LMICs) has been stressed repeatedly in the last two decades,3-5 placing emphasis on the range of health research that is relevant – including basic sciences and biomedical research, health policy and systems research and social, behavioural and operational research.

However, in the last few years there have been efforts to direct attention to a wider range of determinants of health beyond biological and health system factors – including

Box 2: Capturing the benefits of innovation for development goals

… if the development community turns its back on the explosion of technological innovation in food, medicine and information, it risks marginalizing itself and denying developing countries opportunities that, if harnessed effectively, could transform the lives of poor people and offer breakthrough development opportunities to poor countries. …

In short, the challenge the world faces is to match the pace of technological innovation with real policy innovation both nationally and globally. And if we can do that successfully, we can dramatically improve the prospects for developing countries of meeting the key development goals…

MARK MALLOCH BROWN, ADMINISTRATOR, UNDP FOREWORD TO HUMAN DEVELOPMENT REPORT 20012 economic, environmental, political and social determinants – that need to be better understood and managed to improve health and reduce health disparities within and between populations. This enlarged domain of relevant research is referred to as “research for health”6,7 and is attracting increasing attention.

The newly published report8 of the Commission on Social Determinants of Health provides a wealth of evidence on the important influences of social factors and highlights the need for more research to understand the “causes of the causes” of ill-health. The Global Ministerial Forum on Research for Health (Bamako, 17–19 November 2008) is the first meeting at this level to address the complex array of cross-sectoral issues involved in addressing some of the world’s major health challenges through a broad and multidisciplinary approach9.

The Global Forum for Health Research10 defines “research for health” as research undertaken in any discipline or combination of disciplines that seeks to: understand the impact on health of policies,

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programmes, processes, actions or events originating in any sector – including, but not limited to the health sector itself and encompassing biological, economic, environmental, political, social and other determinants of health; assist in developing interventions that will help prevent or mitigate that impact; contribute to the achievement of health equity and better health for all.

Innovation for health Taking this broad view of research for health, innovation for health and health equity can be defined as shown in Box 1 and the systemic relationship between research and innovation for health can be depicted schematically as in Figure 1: The system which encompasses research for health in a country is only partly in the health sector, since; (1) it also involves many other sectors that help to determine the eventual health status of individuals. These include sectors concerned with education, employment, the environment, transport, the law, etc; (2) it includes many kinds of researchers in different disciplines, often not employed within the health sector or dedicated research institutes such as Medical Research Councils or National Institutes of Health but working within higher education or other research institutions, nongovernmental organizations or the community.

Research for health can therefore be seen as a component of the wider research system which includes all the researchers, institutions and funders in the public and private sectors that make up a nation’s total research effort.

The innovation system partly overlaps with the research system, from which it draws new ideas and discoveries.

It does not include the entire research system, however, since not all research is directed towards eventually producing new products, services or processes but may be aimed at expanding knowledge and understanding in

many different fields, including the arts and humanities.

The innovation system crosses many sectors and disciplines involved in the development and application of a new product or process – for example, including legal, financial and commercial aspects.

Both research and innovation take place in a national environment whose characteristics (e.g. political, legal, economic, social, cultural) can have a major influence – determining the extent to which innovation is fostered and how well it succeeds. This is further impacted on by the global environment which again can strongly influence the likelihood of innovative ideas being developed, translated into practice and effectively applied.

Elements for successful research and innovation The conduct of research requires a set of specific knowledge and skills, as well as an institutional environment in which the researcher can function. Considerable effort and resources have been expended in recent decades in strengthening individual and institutional research capacities in LMICs11.

Innovation also requires both skilled human resources and an enabling environment. One element that is crucial for successful innovation is entrepreneurship – a set of attributes that collectively add up to the capacity to practically exploit a novel idea or product and to ensure its successful application in practice. Some of the attributes of successful entrepreneurship may be innate – drive and flair for commercialization and interpersonal skills are often seen in this light – but, in fact, the key skills of entrepreneurship that contribute to success can be learned from well-designed courses. Many entrepreneurship courses are provided in high-income countries (HICs)12 and on the Internet13 – often linked with business schools – and such courses are increasingly being taught in LMICs14.

Technological innovation

Technological innovation for health includes the development 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 per year – predicted15 to double to around US$ 1.3 Other sectors Health sector trillion by 2020.

Research Researc ch system m However, despite this impressive record, three Global environment Health research factors are at work that presage major changes system ahead: The pharmaceutical industry is becoming novation system system Innovation increasingly unwieldy and unproductive and will need to change its business model. The report16 of the Commission on Intellectual Property Rights, National environment 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

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biotech and other small companies and increasingly outsource clinical research to specialist research organizations, with an increasing emphasis in recent years on trials in developing countries such as India and China. It was estimated that 35% of drugs in Phase III trials in 2001 were either licensed in or the product of collaborative research, and two thirds of clinical trials involved contract research organizations. The Commission noted that developing country R&D expertise, in both the public and the private sector, was being used increasingly at all stages of the innovation cycle, with foreign collaborations increasing in Brazil, China, India and other innovative developing countries.

The rise of a biotechnology industry, often comprising companies spunoff from university laboratories, has offered additional opportunities for the discovery of new classes of drugs and is resulting in significant changes in the structure of the industry.

According to a PricewaterhouseCoopers report17, the current business model of the pharmaceutical industry is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments that will be demanded by global markets. Pharmaceutical companies are facing a dearth of new compounds in the pipeline, poor share value performance, rising sales and marketing expenditures, increased legal and regulatory constraints and tarnished reputations. The report considers that “The core challenge is a lack of innovation. The industry is investing twice as much in R&D as it was a decade ago to produce two fifths of the new medicines it then produced. It is simply an unsustainable business model.

Over the next decade, the industry must shift its investment focus more towards research and less on sales and marketing.… It must focus on the development of medicines that prevent, treat or cure.

These must demonstrate tangible benefits and tackle unmet medical needs. Governments and payers must play their part and ensure the industry is rewarded for these efforts”.

The market-driven model has provided enormous health benefits for people in HICs, but has done relatively little to address the health problems of LMICs. As an illustration of the market failure, of 1393 new chemical entities marketed between 1975 and 1999, only 16 were for tropical diseases and tuberculosis, while tropical communicable diseases were responsible for well over 10 million deaths per year, 90% of which occurred in LMICs18-20. Mahoney and Morel have argued that this failure, along with science and public health failures, need to be addressed by paying attention to the global health innovation system21.

New markets and new innovative actors in LMICs are causing a shift in the centre of gravity of the pharmaceutical industry. Markets are changing and the recent PricewaterhouseCoopers report17 notes that the E7

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countries, the largest emerging market economies (Brazil, China, India, Indonesia, Mexico, Russia and Turkey), are also becoming much more prosperous, with real gross domestic product (GDP) projected to triple by 2020, when they could account for as much as one fifth of global pharmaceutical sales.

As well as providing increasingly important markets for health products, these and other innovative developing countries22 are also increasingly engaged in the creation of new products and have considerable potential in the biotechnology field. An analysis23 of responses from 232 developing world experts from 58 countries, asked how best to harness biotechnology to improve health in their regions, divided their recommendations into four categories: Science:

Collaborate through national, regional and international networks;

Survey and build capacity based on proven models through education, training and needs assessments.

Finance: Develop regulatory and intellectual property frameworks for commercialization of biotechnology; Enhance funding and affordability of biotechnology; Improve the academic-industry interface and the role of small- and medium-sized enterprises.

Ethics, society, culture: Develop public engagement strategies to inform and educate the public about developments in genomics and biotechnology; Develop capacity to address ethical, social and cultural issues; Improve accessibility and equity.

Politics: Strengthen understanding, leadership and support at the political level for biotechnology; Develop policies outlining national biotechnology strategy.

The Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) has emphasized the “innovation cycle” (see Box 3) as a framework of particular relevance to LMICs24.

Innovation for health in social and other sectors It has been emphasized that, to maximize the potential for improving global health afforded by the growing capacity for innovation in some developing countries, both countries and donors need to link two disparate schools of thought: (1) a search for technological solutions exemplified by global public-private product development partnerships, and (2) a focus on systemic solutions exemplified by health policy and systems research. According to Gardner et al25, strong capacity for both technological and social innovation in

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developing countries represents the only truly sustainable means of improving the effectiveness of health systems. Local public-private research and development partnerships, implementation research and individual leadership are needed to achieve this goal.

Recognizing the importance of socioeconomic factors in determining health status, a number of initiatives have focused on linking welfare, work and microfinancing schemes with health. A range of innovative family welfare, social

protection and conditional cash transfer schemes in Latin America and elsewhere have demonstrated significant improvements in a variety of health indicators26-29.

Innovative models of health-care delivery that have been field-tested include microfranchising of community health clinics30 and other community-based clinic approaches31, social franchising as a strategy for expanding access to reproductive health services for adults32 and youths33 and

Box 3: The innovation cycle

The scientific and technical components of the discovery and development process represent only one aspect. Whether the whole process actually delivers products needed by poor patients in developing countries at prices that are potentially affordable depends on a host of political, economic, social and cultural factors.

Translational research

DISCOVERY • Lead identification/ optimization • Basic research

Demand for new/improved tools and postmarketing research

“3D” INNOVATION CYCLE

DEVELOPMENT • New/improved tools • Preclinical and clinical development

We prefer to consider innovation as a cycle. This cycle depicted in right represents a schema that applies principally to developed countries and the diseases which predominantly DELIVERY • Getting products affect them, where effective demand to patients and the population’s health needs 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

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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.

The agriculture sector is of critical importance to livelihoods, basic health and nutrition, with enormous benefits having been reaped from the green revolution35 of the 20th century. The need for a second such revolution to cope with population increases and climate change impacts in the present century highlights the importance of understanding and addressing barriers to technological innovation and transfer36,37.

Global innovation capacity for better health and health equity United Nations Development Programme (UNDP) has developed a Technology Achievement Index which focuses on four dimensions of technological capacity that are important for reaping the benefits of the network age. The indicators selected relate to important technology policy objectives for all countries, regardless of their level of development: Creation of technology; Diffusion of recent innovations; Diffusion of old innovations; Human skills.

In 2001, estimates were prepared for 72 countries for which data were available and of acceptable quality. The results (Figure 2) show three trends: a map of great disparities among countries, diversity and dynamism in technological progress among developing countries and a map of technology hubs superimposed on countries at different levels of development. The 30 leading exporters of high-tech products included (with rankings) Malaysia (9), China (10), Mexico (11), Thailand (18), Philippines (22), Brazil (27), Indonesia (28) and Costa Rica (30). Within the top 30 group, China, Mexico, Philippines, Indonesia and Costa Rica showed rates of increase during the 1990s that far exceeded those of any other countries in the rankings.38

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It should not be taken for granted that LMICs will necessarily take the best and most speedy advantage of the new opportunities afforded by innovation. For example, a recent commentary questions the pace at which innovative companies are appearing in India, as evidenced by the slow growth in home-produced patents filed in the country. It notes, however, that one out of ten US patents in 2006 had an owner or co-owner with an Indian name, showing that Indians can be exceptionally innovative when given the opportunity in an environment that supports risk-taking and innovation39.

While science and innovation in much of Africa has long lagged behind, new approaches are now being seen, as reflected in the Tshwane Consensus40. The emergence is now being foreshadowed of a more socially responsive innovation system that will ensure that scientific priorities are selected according to social and economic priorities (e.g. using “technology foresight” exercises to determine the allocation of research resources)41. As noted by the Science and Technology Adviser for Africa’s New Partnership for Africa’s Development (NEPAD), it is important that scientific and technological capacity for health is not reduced to focusing on equipment, funding and the numbers of health scientists and technicians. It requires attention to the configuration of skills, policies, organizations, non-human resources, and overall context to generate, procure and apply scientific knowledge and related technological innovation to identify and solve specific health problems42.

As innovation theory and practice evolve, valuable new insights are emerging of direct relevance to the advance of innovation in developing countries. For example, one recent report43 argues that we are witnessing forces in play which are transforming the industrial landscape and that can be understood within the umbrella concept of “global open innovation”. Open innovation, while not a new phenomenon, is importantly being given fresh impetus by globalization, linked to the interplay between subtle organizational

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processes and interorganizational linkages and networks. The report examines the role of globalized innovation networks for innovation performance and concludes that, among a number of different types of innovation collaboration – vertical (collaboration with suppliers and customers), horizontal (with competitors) and science-based (with universities and government research institutions) – innovation collaboration Key messages

Historically, HICs have contributed most to research and innovation for global health and to the health of populations in LMICs. However, LMICs are increasingly developing their own capacities to conduct and utilize research and to apply innovative solutions to their immediate health problems, as well as to strengthen their systems of innovation as vital drivers of development.

The global agenda must encompass how to: strengthen health research systems and innovation systems in LMICs; incentivize the systems to create relevant products accessible to poor populations; enhance coherence between policies and actions of global players and national forces shaping country research and innovation systems.

along the value chain (i.e. vertical collaboration) is significantly positively correlated with superior innovation performance of firms in all analysed countries.

For the goals of achieving improved health and health equity, this analysis supports the idea, referred to above, of closer engagement with the end-user in a socially responsive mode; and it also helps frame observations on the expanding roles of innovative offshoring44 and global knowledge networks45.

The Global Forum for Health Research will work to: generate informed debate on innovation for health in LMICs, including social as well as technological innovation; promote the development and study of health innovation systems at global and country levels, with a particular emphasis on innovations to enhance health equity.

Stephen A Matlin has been Executive Director of the Global Forum for Health Research since January 2004. Educated as an organic chemist, he worked in academia for over 20 years, with research, teaching and consultancy interests in medicinal, biological and analytical chemistry. This was followed by periods as Director of the Health and Education Division in the Commonwealth Secretariat, Chief Education Advisor at the UK Department for International Development and as a freelance consultant in health, education and development.

References 1.

The Global Forum for Health Research was established in 1998 with a mission to focus more health research on the needs of the poor. See: www.globalforumhealth.org.

2.

United Nations Development Programme. Human Development Report 2001: Making new technologies work for human development. Oxford University Press, Oxford, 2001. http://hdr.undp.org/en/reports/global/hdr2001/ 3.

Commission on Health Research for Development. Health research: essential link to equity in development. Oxford University Press, New York, 1990.

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Ad Hoc Committee on Health Research Relating to Future Intervention Options, Investing in Health Research and Development. World Health Organization, Geneva, 1996.

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Report of the Commission on Macroeconomics and Health.

Macroeconomics and health: investing in health for economic development. World Health Organization, Geneva, 2001.

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Global Forum Update on Research for Health 2005. Health research to achieve the Millennium Development Goals, Pro-Brook Publishing, London, 2004. www.globalforumhealth.org.

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Monitoring financial flows for health research: volume 2. Global Forum for Health Research, Geneva, 2004. www.globalforumhealth.org.

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Commission on Social Determinants of Health: Final Report. Closing the gap in a generation: health equity through action on the social determinants of health. WHO, Geneva, 2008 www.who.int/entity/social_determinants/final_report/csdh_finalreport_200 8.pdf 9.

Global Ministerial Forum on Research for Health, Bamako, 16–19 November 2008. http://bamako2008.org 10.

See www.globalforumhealth.org.

11 Nuyens Y. No development without research: a challenge for research capacity strengthening. Global Forum for Health Research, Geneva, 2005. www.globalforumhealth.org.

12 See, for example, a list of postgraduate entrepreneurship courses

available in the UK, at: http://www.hotcourses.com/uk-courses/postgraduate-Entrepreneurshipcourses/hc2_browse.pg_loc_tree/16180339/90904/p_type_id/3/p_bcat_id /2084/page.htm 13 Wilson K. 1987–2007: 20 years of promoting entrepreneurship education in Europe. European Foundation for Entrepreneurship Research, 2007. http://ieec.co.uk/2007/proceedings/wed/Wilson%20%20Session%20H%20-%20Building%20the%20Evidence%20Base% 20FINAL.ppt#285,3,The Importance of Building the Evidence Base 14.

See, for example, the Entrepreneurship Course of the Africa Technology Development Forum’s Entrepreneurship Hub based in Lusaka, Zambia.

The primary goal of the Hub is to promote entrepreneurship and innovation as a way of creating wealth and jobs and reducing poverty. http://www.atdforum.org/spip.php?article230 15.

Global pharmaceutical market estimated to double to $1.3 trillion by 2020. PharmaManufacturing.com, 2007. www.pharmamanufacturing.com/industrynews/2007/198.html 16.

Report of the Commission on Intellectual Property Rights, Innovation and Public Health. Public health, innovation and intellectual property rights.

Geneva, World Health Organization, 2006. www.who.int/intellectualproperty/documents/thereport/en/index.html 17.

Pharma 2020: The vision – which path will you take?

PricewaterhouseCoopers, 2007. www.pwc.com/extweb/pwcpublications.nsf/docid/ 91BF330647FFA402852572F2005ECC22 18.

Trouiller P, Olliaro P. Drug development output from 1975 to 1996: what proportion for tropical diseases? International Journal of Infectious Diseases, 1999, 3, 61-3. www.dndi.org/cms/public_html/images/article/229/JAMA.pdf 19.

Trouiller P et al. Drugs for neglected diseases: a failure of the market and a public health failure? Tropical Medicine and International Health, 2001, 6(11) 945-51.

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References continued http://econ.tu.ac.th/archan/chalotorn/on%20mkt%20failure /troullier%20et%20al.pdf 20.

Trouiller P et al. Drug development for neglected diseases: a deficient market and a public-health policy failure. Lancet, 2002, 359(9324):2188-94. www.dndi.org/cms/public_html/images/article/228/lancet%20r&d.pdf 21.

Mahoney RT, Morel CM. A global health innovation system (GHIS).

Innovation Strategy Today, 2006, 2(1):1-12. www.biodevelopments.org/innovation/ist4.pdf 22.

Morel C et al. Health innovation in developing countries to address diseases of the poor. Innovation Strategy Today, 2005, 1(1) 1-15. www.biodevelopments.org/innovation/index.htm 23.

Daar AS, Berndtson K, Persad DL, Singer PA. How can developing countries harness biotechnology to improve health? BMC Public Health, 2007, 7:346. www.biomedcentral.com/1471-2458/7/346 24.

Public health, innovation and intellectual property rights. Report of the Commission on Intellectual Property Rights, Innovation and Public Health, WHO, Geneva, 2006. www.who.int/intellectualproperty/documents/ thereport/ENPublicHealthReport.pdf 25.

Gardner CA, Acharya T, Yach D. Technological and social innovation: a unifying new paradigm for global health. Health Affairs, 2007, 26(4) 1052–61. Reprinted in: Matlin SA et al (eds.). Health partnerships review. Global Forum for Health Research, Geneva, 2008, 22-27. www.globalforumhealth.org.

26.

Pan American Health Organization. Social protection in health schemes for mother and child population: lessons learned from the Latin American Region. PAHO/WHO, Washington DC, 2008. www.paho.org/english/AD/THS/OS/SPHS-eng.pdf 27.

Conditional cash transfers: what’s in it for health? Technical briefs for policy-makers: number 1/2008, World Health Organization, Geneva. www.who.int/health_financing/documents/pb_e_08_1-cct.pdf 28.

Glassman A, Todd, Gaarder M. Performance-based incentives for health: conditional cash transfer programs in Latin America and the Caribbean.

Center for Global Development, Washington, DC, 2007. www.cgdev.org/files/13542_file_CCT_LatinAmerica.pdf 29.

Department of Social Welfare, Zambia. Research on cash transfers. www.socialcashtransfers-zambia.org/pageID_2466947.html 30.

Increasing access to life-saving medicines through business format franchising. The HealthStore Foundation, Minneapolis, 2008. http://www.cfwshops.org/HealthStore%20Foundation%2004-09-2008.pdf 31.

Amin AM. Getting health to rural communities in Bangladesh. World Health Organization, Geneva, 2008. www.who.int/bulletin/volumes/86/2/08-010208/en/print.html 32.

Mcbride J, Ahmed R. Social franchising as a strategy for expanding access to reproductive health services – a case study of the Green Star service delivery network in Pakistan. Commercial Market Strategies Project, USAID, 2001. http://psp-one.com/files/ 900_file_01_Social_Franchising_As_a_Strategy.pdf 33.

LaVake SD, YouthNet Program. Applying Social Franchising Techniques to Youth Reproductive Health/HIV Services. Family Health International,

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2003. www.fhi.org/NR/rdonlyres /etdpo24ma6cu2bvuewr73oldfpm4icnnxakmuw3u36wb4iim7jzm5ejefnm jjn3jknd37m7kgswnif/YI2final3.pdf 34.

Pronyk PM et al. The Intervention with Microfinance for AIDS & Gender Equity (IMAGE). A structural intervention for HIV prevention in rural South Africa: early results from a community randomised trial.

International AIDS Conference, 11–16 July 2004; 15: abstract no.

ThPeC7538. http://gateway.nlm.nih.gov/MeetingAbstracts/ma?f=102281315.html 35.

Borlaug N. Biotechnology and the green revolution: An ActionBioscience.org interview. American Institute of Biological Sciences, 2002. www.actionbioscience.org/biotech/borlaug.html 36.

Paarlberg R. Starved for science: how biotechnology is being kept out of Africa. Harvard University Press, Boston, 2008. www.wellesley.edu/PublicAffairs/Releases/2008/020108.html 37.

Spielman DJ, Birner R. How innovative is your agriculture? Using innovation indicators and benchmarks to strengthen national agricultural innovation systems. ARD Discussion Paper no. 41. World Bank, Washington, DC, 2008. http://siteresources.worldbank.org/INTARD/Resources/InnovationIndicators Web.pdf 38.

United Nations Development Programme, Human Development Report 2001: Making new technologies work for human development. Oxford University Press, Oxford, 2001, p.42.

39.

Mark Fidelman M. Where are India’s innovative companies, products and solutions? Seeking Apha Website, posted 9 May 2008. http://seekingalpha.com/article/76511-where-are-indias-innovativecompanies-products-and-solutions 40.

The Tshwane Consensus on Science and Development – the emergence of innovative developing countries. Science in Africa, November 2005. www.scienceinafrica.co.za/2005/ november/tshwane.htm 41.

Dickson D. Can Africa pioneer a new way of doing science? SciDev.Net, 24 January 2005. www.scidev.net/editorials/index.cfm?fuseaction= printarticle&itemid=144&language=1 42.

Mugabe J. Health innovation systems in developing countries. Strategies for building scientific and technological capacities. CIPIH study paper, Geneva, 2005. www.who.int/intellectualproperty/studies/Health_Innovation_Systems.pdf 43.

Herstad SJ, Bloch C, Ebersberger B, van de Velde E. Open innovation and globalisation: theory, evidence and implications. Vison Era-Net, Ministry of Employment and the Economy, Finland, 2008. www.visioneranet.org/files/391/openING_report_final.pdf 44.

Ernst D. Innovation offshoring and Asia’s “upgrading through innovation” strategies. East-West Center Working Papers, Economics Series, No. 95. www.eastwestcenter.org/pubs/2670 45.

Ernst D. Can Chinese IT firms develop innovative capabilities within global knowledge networks? East-West Center Working Papers, Economics Series, No. 94. www.eastwestcenter.org/pubs/2669

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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

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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 with a focus on technological innovation have shown the importance of this issue for the governmental agenda of several countries. Technological innovation acquires more importance to the extent that the countries’ markets are strengthened, and reach, in the last two decades of the 20th century, an increasing strategic weight in proportion that the international inequality scenario of economic globalization is characterized by the interplay of the following actors: (i) economically wealthy and innovative countries; (ii) poor countries situated on the boundaries of world consumption of goods and services; (iii) countries at an intermediate development stage, such as the “BRICs” (Brazil, Russia, India, China) or, as they are also denominated, the Innovative Developing Countries (IDCs)1.

According to the World Health Organization’s records, in its World Health Report 1998, at the beginning of this new millennium we live a unique moment of accelerated technological evolution that has never been seen in the history of health care. To that effect, the Swedish Council on Technology Assessment in Health Care (SBU) emphasizes that at least 50% of all therapeutic methods in use, were not available ten years ago.

Regarding biomedical sciences, it has been observed, a trend by the knowledge production international centres of ignoring the diseases of major prevalence in humanity, providing substantial funds for research and development of products that generate greater economic earnings, clearly described by the so called 10/90 Gap and its effects on the financing of researches related to neglected diseases and, as a consequence, on national health care of the poor and developing countries, where such diseases constitute a factor which defines the epidemic challenges to be faced.

Although the Brazilian C&T system is the most solid in Latin America, the Ministry of Health, since its foundation in the 1950s, was of less importance in the development of technological research and innovation of interest to public health issues. Traditionally, science and technology policy and management have been conducted by the Ministers of Science & Technology and Education, responsible for the horizontal promotion of research and personnel training through their agencies, namely: the National Council of

D

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Scientific and Technological Development (CNPq), the Studies and Projects Funding Body (FINEP) and the Coordination for the Improvement of Higher Education Personnel (CAPES).

As a consequence of the constitutional acknowledgement that health is a citizen’s right and the State’s obligation (1988) and, particularly, after publication in 1990 of Law 8080, which regulates the Brazilian Unified Health System (SUS; 1990), it established the legal landmarks which allowed the Ministry of Health to incorporate the mission to develop a vertical fomat to technological research, development and innovation, in compliance with the prerequisites of Brazilian sanitary reform and the political atmosphere resulting from, at that time, recent redemocratization of the political institutions.

Therefore, it was in the light of the principles of universality, equity, integrality and decentralization related to the attention given to health, which guided the SUS management, that the 1st National Conference of Science and Technology in Health (1st CNCTS; 1994) established that the National Policy of Science and Technology in Health (PNCTS) cannot be separated from a National Health Policy, having as a goal the generation of knowledge and material goods to strengthen Brazilian social policies. It must be pointed out that PNCTS, due to the nature of its constitutional object, is a sectorial component of the National Innovation System, since “it searches for a complementarity between agents and systems in a new and more strategic context and contemplates all relevant processes: basic research, strategic research, directed research, applied research, operational research, disclosure of results, technological development and management, pilot and industrial scale production, quality guarantee, marketing, technological regulation and evaluation and patent protection. It shall further contemplate a wide range of development of human resources. The parameters shall be applied to health technologies, such as: health processes and products, health organization, control and management, environment and health information”.

The recommendations of the 1st CNCTS however, were not very effective, due to the prevailing influence, at that time, of neoliberal ideas in the economy of the peripheric countries, based on the forecasts of the so-called Washington

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Consensus (1989). Concerning sector C, T, & I policies, according to Guimarães2, the 1980s in Brazil: “did not represent a radical breaking up, in relation to models, political proposals or system development. It began in a period of economic recession, and, due to one of these dramatic ironies, it was also the time of the 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 decade’s achievements, that was only discontinued from 1985 through 1988, when it pursued a return to the situation existing in the 1970s, a vain attempt due to the tax crisis and the impasse with foreign creditors which respectively, hindered the increase of National Treasury funds and raised difficulties to the negotiation of new agreements with multilateral organizations”.

A revisiting of the project has occurred during the two governments of President Luiz Inácio Lula da Silva. As from 2003, the Ministry of Health redefined its structure and a new strategy was set forth for the purpose of strengthening the managing role of the institution concerning the development of scientific knowledge and technological innovation significant for the Brazilian health system3. The most important institutional event of this period was the second National Conference of Science, Technology and Innovation in Health (2nd CNTIS), based on 300 municipal conferences and 24 state conferences, therefore further, extending the debate on science and technology to the interests of the academic community.

Within a macro-organizational structure, over the last five years, the following may be pointed out: the establishment of the Secretary of Science, Technology and Innovation in Health (SCTIE), encompassing the following departments: Pharmaceutical Assistance, Science and Technology and the Industrial Complex and Innovation in Health; signature of a Technical Cooperation Agreement between the Ministries of Health and Science and Technology (MCT); establishment of the Science, Technology and Innovation Council of the Ministry of Health; representation of the Ministry of Health in the Forum of Competitiveness in a Pharmaceutical and Biotechnological Productive Chain organized by the Ministry of Development, Industry and Foreign Trade and, chiefly, the “More Health” Programme (Programa Mais Saúde).

The health production chain, marked by a strong reliance on imports and a high trade deficit (US$ 5.5 billion in 2007) accounts for 7–8% of the GDP, using funds of approximately

Health production chain, marked by a strong reliance on imports and a high trade deficit (US$ 5.5 billion in 2007) accounts for 7–8% of the GDP, using funds of approximately R$ 160 million (US$ 102 million)

The other action of great impact on the National Innovation System is the conclusion of Hemobrás, a state-owned company that will allow Brazil’s selfsufficiency in blood by-products, complying with 100% of SUS demand for Factor IX, immunoglobulin and human albumin and 30% of the demand for Factor VIII

R$ 160 million (US$ 102 million). As per 2007, for the purpose of promoting economic growth, the Brazilian government launched the Growth Acceleration Programme (PAC) – 2007–2010. PAC gathers a set of institutional actions representing a larger public investment in infrastructure, credit and financing incentives, improvement of investments and tax system in the medium and long term.

It is expected the application of funds amounting to approximately R$ 503.9 billion (US$ 320.5 billion), for investments in social and urban infrastructure, transport logistics and energy.

The “More Health” Programme (Mais Saúde), an integral part of PAC, is a mobilizing programme, under the supervision of the Ministry of Health, which has the challenge of reducing the vulnerability of the National Health Policy, from a strategic point of view, including the national production chain into the health industrial complex, by means of major investments in innovation, modernization and development of a public laboratory network, export expansion and diversification and by attracting more technologically advanced foreign companies to produce in the Brazilian market.

As a productive system structuring programme, the “More Health” Programme (Mais Saúde), will invest R$ 5.1 billion (US$ 3.3 billion) in (i) the consolidation of a more competitive Brazilian industry in the production of medical equipment, materials, reagents and diagnosis devices, blood by-products, immunobiologics, chemical intermediates and vegetable extracts for therapeutic purposes, active principles and drugs for human use and (ii) in strategic areas of the field of scientific-technologic knowledge for the purpose of reducing the vulnerability of the National Health System. It is expected that 80% of the needs of the National Immunization Programme (PNI) will come from local production, including the incorporation of new vaccines: pneumococcus, meningococcus AC, double viral and quinquivalent (DPT & HiB & Hepatitis B virus). The purpose of Mais Saúde is to replace the import of 20% of the demand 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 company that will allow Brazil’s self-sufficiency in blood byproducts, complying with 100% of SUS demand for Factor IX, immunoglobulin and human albumin and 30% of the 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

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Sub-area Pharmaceutical care Nontransmissible diseases Transmissible diseases Clinical research Elderly health Health of individuals with special needs Oral health Violence, accidents and trauma Others areas Total: 4 Sub-agenda(s)

Number of projects 19 8 19 1 1 1 1 13 44 107

Total of resources (US$)* 18 432 362 7 579 845 6 085 187 27 128 447 572 254 492 8 281 699 962 36 498 330 70 033 160

Source: Source: Brazil, Ministry of Health, Department of Science and Technology – Decit. Managerial Database. Captured on 7 May 2008 *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 National Agenda of Priorities Sub-agendas

Profarma (Programme to Support the Development of the Health Industrial Complex). Development of Mais Saúde is pointed out as a fundamental factor to reach the proposed objectives, Brazilian integration with Latin American, Caribbean and African markets, as a strategic space to expand the local industry scale and productivity, integrate local and regional production chains and establish technical cooperation for technical and scientific abilities4.

In addition to provisions for Mais Saúde, considering the 2002–2007 period, the Secretary of Science, Technology and Strategic Supplies (SCTIE) has been guaranteeing increasing funds to comply with the guidelines provided by the Health Research Priority National Agenda Funds for the selected projects have been guaranteed through resources from SCTIE, MCT and state governments. The total investment applied to innovation projects (see Table 1), during the 2002–2007 period, was approximately R$ 109 251 729 (US$ 70 033 160), or up to 40% of all funds intended for the 25 subagendas of ANPPS (see Figure 1).

Research and development on neglected diseases is an example of a key strategic area that only now is receiving the high priority it deserves. Through open competition and peerreview processes the Ministry of Health and the Ministry of Science and Technology, through their funding agencies DECIT and CNPq, invested in 2006–2007 R$ 20 million (US$ 12 million) in six diseases that disproportionately hit poor and marginalized populations in Brazil: Dengue, Chagas disease, leishmaniases, leprosy, malaria and tuberculosis. In a radical departure from traditional national or international initiatives in this area that are usually academic and just curiosity-driven, the DECIT/CNPq Neglected Diseases R&D Programme is based on a Call for Applications that simultaneously require the proposals to have high scientific merit and to address critical health priorities. In addition, efforts are made to invest at least 30% of the R&D funds in groups located in the three Brazilian geographic regions where these diseases are highly prevalent – the Centre West, the North East and the North, particularly the Amazon (see Table 2).

This example should not be perceived as an isolated case, but as representing the paradigmatic shift occurring in Brazil’s science, technology and innovation policies in health, traditionally limited to “Mode I” and now also addressing

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Sub-area

Number of projects 2 5 1 3 1 12

Malaria Leishmaniasis Leptospirose Dengue Tuberculosis Total

Total of resources (US$)* 367 821 1 076 487 25 189 123 769 30 628 1 623 894

Source: Brazil, Ministry of Health, Department of Science and Technology – Decit.

Managerial Database. Captured on 7 May 2008 *US$ conversion rate August 2008: US$ 1 = R$ 1.56

Table 2: Numbers of projects and resources by neglected diseases

1500

100,00 80,00

1000

60,00 40,00

500

20,00 0,00

0 2002/2003

2004/2005

Number of projects

2006/2007 US $ (million)

Source: Brazil, Ministry of Health, Department of Science and Technology – Decit.

Managerial Database. Captured on 7 May 2008

Figure 1: Evolution of the department of science and technology’s support the health research

“Mode II” of knowledge production5.

Upon evaluating the present stage of the Science, Technology and Innovation Policies in Health, we observe that there has been progress concerning a definition of the priorities of research topics and corresponding funding, by means of public calls. The Mais Saúde Programme constitutes a powerful strategy to implement and strengthen the National Innovation System, through investments in infrastructure which will enable Brazilian public and private companies to incorporate adequate programmes to introduce new health technologies into the local and foreign markets.

However, since it is a medium- and long-term structuring project, it is necessary to take into consideration scenarios which may, if existing, jeopardize, the success of these public policies.

At first, among a possible combination of events, we may consider non-accomplishment of funding within the deadlines and amounts necessary to implement the policy, due to a need to increase the primary surplus, which means the economy of budget resources intended for payment of government debt charges. Although Brazil is now enjoying a better situation regarding economic turbulence in the international market, Brazilian interests have recently returned to an increasing trend and additional resources from the federal budget may be requested to pay the government debt, therefore jeopardizing the funds intended for the Mais Saúde Programme. The increase of interest and shortage of offers from other funding sources may also be reflected on the access to credit lines offered by the BNDES, leading to a redefinition of priorities. On the other hand, Mais Saúde, pointed out as a structuring programme for developing the Health Industrial Complex, requires a commitment for continuation beyond the government of President Lula, a

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result of this adversity, to sell their assets in these countries.

Innovation policies are important instruments to foster national economies. When well executed they should originate a favourable socioeconomic ambience that positively influences the internal economic market and the national balance of trade. Besides, the scientific development can potentially promote social inclusion.

practice that is not usual in terms of the political culture in Brazil, particularly if, the Programme deadlines do not include strict regulatory limits to account for the current sectorial needs. Finally, reliance on foreign resources and technologies may constitute another difficulty, intensified by the current international financial crisis. Foreign companies have been cautious concerning new investments in developing countries and they have shown a trend, as a

Suzanne Jacob Serruya MD, PhD is director of the Department of Science and Technology, Secretariat of Science, Technology and Strategic Inputs of the Brazilian Ministry of Health.

Key messages

Innovation policies are important instruments to foster national economies and they should originate a favourable socioeconomic ambience that positively influences the internal market and the national balance of trade.

In Brazil, the “More Health” Programme (Mais Saúde) constitutes a powerful strategy to strengthen the National Innovation System by means of major investments in innovation, modernization and development of public laboratory work, export expansion and by attracting more technologically advanced foreign companies in Brazilian Market.

Reinaldo Guimarães MD, MSc is chairman of the Secretariat of Science, Technology and Strategic Inputs of the Brazilian Ministry of Health.

Itajai Oliveira de Albuquerque MD, MSc is assessor for Health Technology Assessment in the Department of Science and Technology, Secretariat of Science, Technology and Strategic Inputs of the Brazilian Ministry of Health.

Carlos Medicis Morel MD, PhD is director of the Centre for Technological Development in Health, Oswaldo Cruz Foundation.

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Ministério da Saúde: Mais saúde: direito de todos: 2008-2011. Brasília: Editora do Ministério da Saúde; 2008.

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

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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 pluralistic health systems, characterized by widespread and often highly segmented markets offering a diverse range of health-related goods and services1,2,3. Out-of-pocket payment for health care averages more than 50% of all health spending in these countries4, with non-state providers, both private and not-for-profit, typically providing the majority of outpatient curative care5,6.

If health services are to benefit the poor, it is essential to gain a detailed understanding of such markets that can both inform attitudes towards them and guide innovations that attempt to engage with them to improve health outcomes.

The spread of market relationships in the provision of health services has coincided with the growth of markets in other sectors. In some countries this has been associated with economic liberalization and economic growth. In others, its emergence is linked to economic decline and the failure of state-provided services to meet popular expectations. In many circumstances the spread of markets has been much faster than the capacity of the state and other key actors to establish regulatory arrangements to influence their performance. A large proportion of market transactions now take place outside a legal regulatory framework or in settings where regulatory regimes are poorly implemented, particularly for the poor. In addition, the boundaries between public and private sectors have become blurred. In many countries users routinely make informal payments for services or drugs at public facilities, or consult government health workers privately7. In others, public providers are officially encouraged to generate income in order to supplement often very limited government subsidies8.

The marketization of health services has created both opportunities and challenges for poor people. They may have greater choice about where to seek drugs and medical advice, but cost is often a barrier to access. There are examples of excellent services but, as Das et al9 document, the quality of services that both public and private health workers provide is often flawed, partly in response to perverse incentives.

Such incentives also result in an emphasis on medical care at the expense of prevention and health promotion. It is widely recognized that both government and other intermediary organizations can play important roles in altering these

M

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incentives and improving the performance of these markets.

There is less agreement on what those roles should be in different development contexts and how health systems can construct the institutional arrangements for them to play these roles effectively.

The spread of market relationships has advanced so far in many countries that official policies often have limited relevance to the realities that poor people face when coping with health problems. We propose an approach which explores the operation of health markets in order to help explain how health systems are changing, identify potential opportunities for intervention and innovation, and guide the design of monitoring systems that can track and learn from both the intended and unintended consequences of such innovations. We then examine different types of emerging innovations, and focus on two in Nigeria and Bangladesh.

Conceptual framework This section describes an approach for analysing and understanding health markets in low- and middle-income countries. It draws on the framework for understanding markets that poor people use presented in a recent paper by Elliot et al10 and summarized in Figure 1. The authors of that paper place at the centre the relationship between providers and consumers, that is in our case, the relationship between health service providers and patients. Those relationships are greatly influenced by a multi-dimensional and complex environment made of formal and informal rules and of agencies that undertake a number of supporting functions.

Strategies for change need to take into account the diverse components of this context as well as ways to improve the management of a single organization or intervention. They also need to acknowledge the importance of conflicts of interest and the degree to which power relationships influence the organization and functioning of relevant markets. For example, many health-related markets are segmented, with well-regulated components used mostly by the better off and unregulated ones used by the poor2.

An important aspect of the relationship between providers and patients concerns the transfer of the benefits of medical expert knowledge to the latter. This transaction is characterized by varying degrees of asymmetry of information

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Market players Informal networks Government

Infrastructure

SUPPORTING FUNCTIONS

Private sector

Informing and communicating

Related services

Supply

Laws

Demand

Setting and enforcing rules

Sector -specific regulations and standards Not-for-profit sector

Informal rules and norms Non-statutory regulations Membership organisations

Rules Representive bodies

Figure 1: Conceptualizing market systems

and a consequent imbalance in power, which possessors of expertise can use to their advantage. Societies have evolved mechanisms to address this problem through a combination of regulation by the state, different forms of self-regulation and organizations that build and maintain a reputation for competent and ethical behaviour. The relevant actors include the regulatory arms of central and local government, professional and trade associations, large service provision organizations, and a variety of civil society organizations and consumer associations.

Current rules and regulations often do not take into account the importance and diversity of health markets in developing countries, and thus many actors operate outside a legal framework. Barriers to appropriate regulations are often linked to a lack of government capacity to enforce them or incentives to do so11. Many government regulatory agencies focus on the services used by the better off and shy away from attempts to regulate the informal sector which is of paramount importance for the poor. This has led to the emergence of a variety of partnerships between governments and other actors to co-produce rules and improve market performance12, 13.

Where regulation is limited and information asymmetries are large, trust is a key dimension in the relationships between providers and consumers. Patients in low- and

middle-income countries have shown a willingness to pay more for the services of providers whose competence they trust and many providers have adopted strategies to build and maintain a reputation for high expertise and ethics 14, 15, 16, 17 . Trust and reputation may be based on a variety of factors including directly experienced quality of services (e.g., availability of drugs, cleanliness, courteous staff), perceived status of providers (e.g., professional title, advertised qualifications and experience) and brand recognition (e.g., widely known franchise, accreditation or licensing authority).

Less formal arrangements are often important at the community level, where providers operate within local trust networks. Word of mouth is an important medium for the establishment and maintenance of a facility’s reputation18.

Another important aspect of the performance of healthrelated markets relates to information flows. Providers and users of health services get information from many sources.

In Bangladesh, for example, the primary source of information for informal providers is from sales representatives or wholesalers who are associated with generic manufacturers. Other sources include the diverse communications media that national and international advocacy groups, government agencies and commercial advertising agencies increasingly use to deliver messages to both providers and the general population. New

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communication tools, such as mobile telephones and the Internet, are significantly increasing the options and capacity for information dissemination, even in some of the poorest countries. This increasing volume of circulating information creates an urgent need for trusted knowledge brokers.

Health market innovations in developing countries Innovations aimed at improving health services have taken place in both informal and formal sectors. Those happening in organized markets have taken various forms, ranging from commercial models (mostly found in Asia and Latin America) to highly subsidized but market-oriented interventions such as the establishment of provider networks, social franchises or accreditation schemes (mainly run by nongovernmental organizations or faith-based organizations).

Notwithstanding the innovations described above, many health transactions involving poor people still take place in the informal sector, where there are minimal quality standards and no reporting requirements. To examine ways of addressing these constraints, two initiatives that involve partnerships between informal providers, policy-makers and the public to shape better health markets for the poor are discussed below.

In Bangladesh, informal providers (village doctors, medicine vendors) are the major source of health care for rural people. A recent formative study conducted in one southeastern sub-district (560 000 people) of Bangladesh by ICDDR,B found that 96% of health-care providers were informal including village doctors, traditional healers (Kabiraj), traditional birth attendants and spiritual healers.

The study found many instances of inappropriate and even dangerous prescribing. The consortium has launched a threepronged intervention of training informal providers, establishing an association of these providers to implement a degree of quality control and the involvement of the Bangladesh Health Watch in monitoring the performance of informal providers.

In Nigeria where malaria is a major cause of illness and death, most people depend on patent medicine vendors (PMVs) as a source of anti-malarial medication. PMVs operate in poorly markets. A scoping study by the School of Public Health at Ibadan University found that PMVs were the major source of malaria treatment (39%) followed by selftreatment (26%)19. It also indicated that PMVs often recommend inappropriate products that are inexpensive but also ineffective. In this complex and unregulated market environment, local PMV associations were identified as 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 that community involvement in drug regulation would be highly desirable to complement the relatively weak government system. For example, they could use relatively inexpensive equipment to test the efficacy of anti-malarial drugs. Recent consultations with stakeholders found overwhelming support for an intervention that would involve a partnership between public and private sectors. J

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Key messages

Given the pervasiveness of markets for health-related goods and services and the great degree to which the poor obtain medical care in these markets, it is time for health policy-makers to take action to improve their performance, based on a systematic understanding of how these markets operate. In doing so, they need to take account of the following: Attempts to achieve long-lasting change through the efforts of a single organization or a particularly innovative individual tend to be unsuccessful; it is important to understand and address market systems as a whole in order to achieve sustainable change.

Reforms should begin with markets in which poor people are already engaged and will often involve informal providers, who operate outside formal legal and regulatory frameworks, and local agencies such as provider associations, citizen groups and local accountability structures.

Interventions intended to benefit the poor need to acknowledge and take into account the influence of power and conflicts of interest on their outcome and this should be anticipated in a detailed stakeholder analysis.

Interventions that focus solely on providers of health services are unlikely to have a great impact on the poor unless they are linked to measures that provide more equitable access to government funding and donor financial flows

Acknowledgement This paper is an output of the DFID-funded Future Health Systems Consortium (http://www.futurehealthsystems.org/).

The opinions expressed do not necessarily reflect the views of DFID. It also draws on a soon-to-be published background paper for an initiative of the Rockefeller Foundation on the role of the private sector in health systems. This initiative applies a broad health systems lens and is undertaking exploratory work in three broad areas: attitudes of key stakeholders, analysis of five functional areas (risk-sharing, regulation, logistics, contracting and provider performance) and identification of country level programmes and organizations that show a strong potential for replication and/or scaling up. It is expected that the Rockefeller Foundation and additional partners will launch a programme in the near future.

Gerald Bloom is a health policy analyst at the Institute of Development Studies (IDS) in the UK, whose work has focused on the management of health system change in societies undergoing rapid transition. He has worked in a number of African countries and in China. He is presently the coordinator of a multi-institute study of poverty and illness in China, Cambodia and Laos, a senior researcher in the Future Health Systems research programme consortium and health domain convener of the STEPS

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Centre. He is co-Chair of the China Health Development Forum.

Claire Champion is a doctoral student at Johns Hopkins School of Public Health (International Health). Prior to her doctorate programme, Ms Champion managed various health private sector strengthening programmes in Africa and Asia. She has an MBA from Harvard Business School and an MPH from Johns Hopkins University.

Henry Lucas is an expert in management information systems and on methodologies for monitoring and evaluation at the Institute of Development Studies (IDS). He has long experience of work in many countries in Africa, Asia and the Pacific in a variety of studies focusing on different aspects of poverty reduction and on health systems.

M Hafizur Rahman is a public health physician with years of experience in directing health research programmes in several countries in South Asia, Africa and the United States. He has particular interests in reproductive health, equity of health services and research methodologies. He is the manager for the Future Health Systems research consortium, and a faculty member at the Johns Hopkins University Bloomberg School of Public Health.

Abbas Bhuiya is the head of the Social and Behavioural Science Unit and Poverty and Health Programme of the Center for Health and Population Research (ICDDR,B). For the last 25 years, Dr Bhuiya has been engaged in community health

research with special focus on equity issues, behaviour change, and community development-oriented action research for the improvement of health of the poor and reduction of social disparity in health. He is the country coordinator of the Future Health Systems: Innovations for Equity research programme consortium in Bangladesh.

Oladimeji Oladepo is a health promotion specialist with extensive experience in evaluating public health interventions in Nigeria. He has a special interest in social, behavioural and educational research in the control of tropical diseases, reproductive health, planning and evaluation of primary healthcare services, and policy development. He is head of the Department of Health Promotion and Education at the University of Ibadan, and the country coordinator of the Future Health Systems: Innovations for Equity research programme consortium in Nigeria.

David Peters is a public health physician and associate professor in the Health Systems Program in the Department of International Health at Johns Hopkins Bloomberg School of Public Health, and is a senior public health specialist at the World Bank. He has an interest in the performance of health systems in developing countries, and has worked as a researcher, policy advisor, bureaucrat and manager of health systems in Canada, Africa and South Asia. He is director of Future Health Systems: Innovations for Equity, a consortium of researchers from Uganda, Nigeria, India, China, Bangladesh, Afghanistan and the United Kingdom and United States.

References 1.

Mackintosh M and Koivusalo M. Health systems and commercialization: in search of good sense. In: Mackintosh M and Koivusalo M, eds.

Commercialization of Health Care, 2005, Basingstoke: Palgrave MacMillan.

2.

Bloom G, Standing H. Pluralism and marketisation in the health sector: meeting health needs in contexts of social change in low and middle income countries. IDS Working Paper 136, 2001, Sussex: Institute of Development Studies.

3.

Berman P, Rose L. The role of private providers in maternal and child health and family planning services in developing countries. Health Policy Plan, 1996, 11:142-155.

4.

World Health Organization. Data on national health accounts, 2008. http://www.who.int/nha/country/Regional_Averages_by_WB_Income_group -En.xls 5.

Hanson K, Berman P. Private health care provision in developing countries: a preliminary analysis of levels and composition. Health Policy Plan, 1998, 13:195-211.

6.

Peters DH, Marchandani G, Hansen PM. Strategies for engaging the private sector in sexual and reproductive health: how effective are they?

Health Policy and Planning, 2004, 19(Suppl.1):5-20.

7.

Das Gupta M, Gauri V and Khemani S. Decentralized delivery of primary health services in Nigeria: survey evidence from the states of Lagos and Kogi. Development Research Group, Human Development Sector, Africa Region, World Bank, 2004.

8.

Bloom G, Kanjilal B and Peters D. Regulating health care markets in China and India. Health Affairs, 2008, 27.4:952-63.

9.

Das J, Hammer J and Leonard K. The quality of medical advice in lowincome countries. Journal of Economic Perspectives, 2008, 22(2):93-114.

10.

Elliot D, Gibson A and Hitchins R. Making markets work for the poor:

rationale and practice. Enterprise Development and Microfinance, 2008, 19(2):101-119.

11.

Ensor T and Weinzierl S. A review of regulation in the health sector in low and middle income countries. Signposts to more effective states, 2006, Brighton: Institute of Development Studies.

12.

Joshi A and Moore M. Institutionalized co-production: unorthodox public service delivery in challenging environments. Journal of Development Studies, 2004, 40(4):31-49.

13.

Peters DH and Muraleedharan V. Regulating India’s health services: to what end? What future? Social Science & Medicine, 2008, 66:21332144.

14.

Montagu D. Franchising of health services in low-income countries.

Health Policy and Planning, 2002, 17(2), 121-130.

15.

Montagu D. Accreditation and other external quality assessment systems for health care, DFID Health Systems Resource Centre Working Paper, 2003.

16.

Mills A, Brugha R, Hanson K and McPake B. What can be done about the private health sector in low-income countries? Bulletin of the World Health Organization, 2002, 80(4):325-330.

17.

Prata N, Montagu D and Jeffeys. Private sector, human resources and health franchising in Africa. Bulletin of the World Health Organization, 2005, 83:274-279.

18.

Leonard K. Learning in health care: evidence of learning about clinician quality in Tanzania. Economic Development and Cultural Change, 2007, 55(3):533-555.

19.

Oladepo O et al. Malaria treatment and policy in three regions in Nigeria: the role of patent medicine vendors. Future Health Systems Working Paper No. 1, 2008.

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Strengthening the base: innovation and convergence in climate change and public health Article by Saqib Shahab (pictured), University of Alberta with Abdul Ghaffar

his short paper briefly highlights the “10/90 gap” between high-income and low-income countries for both climate change as well as public health research.

The term “10/90 gap” as used here is broadly reflective of the disequilibrium between high- and low-income countries in research and other investments in health interventions. The paper then goes on to discuss the significant overlaps and commonalities in terms of climate change impacts as well as solutions when considered against the broad unfinished public health agenda. Through the use of a few selected examples, readers are encouraged to think about how they can foster a holistic, comprehensive approach to address both climate change as well as public health within their jurisdictions.

T

The 10/90 gap in research and intervention in climate change There is now irrefutable proof that climate change due to human activity is occurring, and will accelerate in the coming decades unless significant mitigation to reduce greenhouse gas emissions occurs1. Empirical data from meteorology, agriculture, hydrology, ecology and other natural sciences is demonstrating the ecological impact of anthropogenic climate change.

Direct and indirect, short- and long-term effects of climate change on human health are being recognized. Data at the global and high-income country level is good. Data from lowincome countries is improving. Researchers, policy-makers and civil society now need to use established knowledge translation tools and approaches to ensure that research informs practice and vise versa. Expanding empirical research only from high-income to low-income regions in itself will not be sufficient or timely to bring about change. This is especially true because some of the modelling exercises are complex and the impacts not easily generalizable to the local context.

Health, environmental, ecological and social sciences researchers have learnt a great deal about the value of linking researchers with civil society and policy-makers. These lessons learnt need to be applied broadly to the climate change and health agenda.

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The 10/90 gap in research and intervention in public health Many of the successes of public health that are now taken for granted in high-income countries remain unattainable for the majority of the population in low-income countries.

There have been notable successes in public health achievements in low-income countries, such as childhood immunization programmes, resulting in reduction of childhood deaths from vaccine-preventable infectious diseases. However preventable illnesses due to issues such as unsafe water, malnutrition and vector-borne diseases such as malaria remain unacceptably high. It is pertinent to note that many of the existing gaps in public health in low-income regions continue to have a major environmental, nutritional or infectious disease component. These are the very issues that will be further negatively impacted by global climate change.

Research gaps are not limited to technical issues. They are also in governance, funding and operationalization. Therefore research should not only be on causes of morbidity and mortality due to climate change and surveillance of health effects, but also on feasibility of applying cost-effective interventions and evaluating their impact.

Opportunities for convergence in climate change and public health research and action There is considerable overlap between research needs for public health and climate change when one considers protecting human populations form the adverse effects of climate change, especially for the worlds’ most vulnerable populations. For these populations, the greatest impact of climate change will not be some novel disease or other environmental stress; it will be an accentuation of existing challenges including vector-borne diseases such as malaria Level of implementation Individual Household Community Region/country Global

Key tools Education Empowerment Information, resilience, facilitation Policy, regulation, financing, equity Collaboration, equity, financing

Table 1: Key tools for application of climate change research and interventions by level of implementation

Innovating for health and development

Issue

Do technical solutions exist?

Barriers Are technical solutions successfully implemented in to implementation low-income countries?

Opportunities for research, knowledge translation, implementation and evaluation

Vector-borne diseases

Yes

Somewhat

Climate, geography, economy, governance

Solutions need to be appropriate, acceptable and sustainable

Disasters: hurricanes, cyclones

Limited

Limited

Populations already vulnerable

Increase state and community capacity and resiliency to predict and respond to natural disasters

Water stress

Limited

Limited

Loss of local control over water resources. Powerful competing interests on decreasing fresh water supplies

Resource poor communities have always traditionally conserved water; local knowledge and empowerment has to be 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 yield

Historically strong Significant experience in translating research into capacity to improved agricultural yields increase 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 resolution as advocated by intergovernmental organizations and local and global civil societies

Some areas may have peaked in their capacity to sustain increasing yields

Perceived national self interest.

Historical rivalries

Understanding fundamental changes that may be required in crop types

Demonstration of non conflict based solutions as ultimately more sustainable

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 more frequent storms and natural disasters2.

The direct effects of climate change such as thermal stress have been well quantified for high-income countries and are beginning to be modelled for low-income countries. Similarly, the indirect but early effects of climate change such as 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 and storms is harder to estimate globally3.

There is some debate about what the microclimatic impacts of climate change at the local level will be. It is a fair assumption that they will be predominantly negative for the majority of people living in low-income countries. They may be initially climate neutral or positive for a few people living in low-income countries and some in high-income countries.

However, over time, the global impacts on health, economy, and ecology are now considered to be profoundly negative4.

Investments made in research in public health programmes and interventions that are impacted by climate change now and into the future are also, in many instances, issues that are or should also currently be a high priority in terms of preventable public health disease burden. This convergence ensures that limited resources are used ethically, equitably and efficiently. So, for example, comprehensive steps towards

Investments made in research in public health programmes and interventions that are impacted by climate change now and into the future are also, in many instances, issues that are or should also currently be high priority in terms of preventable public health disease burden

achieving the Millennium Development Goals (especially as they relate to hunger, universal primary education, gender equality, child mortality, malaria, environmental sustainability and a global partnership for development) will increase the resilience and adaptive capacity of the most vulnerable populations to the known and potential negative consequences of climate change, in addition to being a demonstrated public health goal in their own right5.

The “new public health” stresses not just the direct, proximate causes of ill-health, but also the more distal, broadly defined “determinants of health”. Application of these public health principles would foster a more holistic understanding of the approach to health protection and health promotion in the face of climate change6,7. Health should, after all, be “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”8.

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Health impacts of climate change Adaptation to climate change

x Research x Evidence x Policy x Action

Impact of mitigation on health

Can it be applied to other settings: - Translation - Generalization - Cost

What works

What incentives exist for reducing the impact on health

Who will put in place these measures?

May not always be the health or public sector

Figure 1: Framework for conceptual map of research areas and domains

The synergistic, catalytic power of this convergence has great potential. It can protect vulnerable populations from current known public health threats that are also being potentiated by climate change; and also make vulnerable populations more resilient to cope with future potentially unknown threats. Not seeking convergence of the climate change and public health research and intervention agenda, however, runs the risk of potentially undoing many of the public health gains of the recent past.

Innovative strategies for research in climate change and public health

x – population coverage with current mix of interventions y – maximum achievable coverage with a mix of available cost-effective interventions z – combined efficacy of a mix of all available interventions Source: Ghaffar A, de Francisco A, Matlin S. The Combined Approach Matrix: a priority-setting tool for health research. Global Forum for Health Research, 2004. Adapted from Ad Hoc Committee on Health Research, Investing in Health Research and Development. WHO, 1996.

Combined efficacy of intervention mix

Mitigation is preventing climate change in the first place, primarily by reducing greenhouse gas emissions and other

anthropogenic activity contributing to climate change.

Adaptation is adjusting to current and future impacts of climate change. The health sector needs to engage with and support research in both the mitigation as well as the adaptation sector.

While research in mitigation is primarily seen as a responsibility of the energy sector. There are substantial potential co-benefits to health beyond reversal of climate change if health-centric approaches to mitigation are adopted. These include: Improved air quality with reduction of fossil fuel use and greater use of cleaner alternative energy sources.

Reduction in injuries due to road traffic accidents with increased reliance on public transport and better urban,

100%

Research and development to identify new interventions

Unavertable with existing interventions z

Avertable with improved efficiency

Averted with current mix of interventions and population coverage

0%

x

Avertable with existing but noncost-effective interventions

y

Research and development to reduce the cost of existing interventions

100%

Effective coverage in population

Research on health systems and policies

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

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community and work life planning.

Prevention of chronic diseases such as diabetes, stroke and heart disease by promoting active transport such as walking and cycling and healthier diets.

As the benefits for mitigation are global, for both highincome as well as low-income countries, momentum is building globally for a concerted effort to mitigate the health impacts of climate change. It is important to continue to document the health impacts of climate change as well as mitigation by enhanced surveillance systems to continue to provide evidence and impetus for climate change mitigation.

Meanwhile, it is essential that populations globally prepare to adapt to some of the inevitable adverse consequences of climate change until such time that mitigation efforts start to have a stabilizing effect9.

The application of research for adaptation, while of global significance and import, has to be rooted in local contexts of geography, economics and culture.

It is important to have a conceptual map of what research is required (see Figure 1)10. It is also important to ensure that resources for research are used most efficiently to maximize the public good. Many of the most urgent impacts of climate can be countered with existing knowledge and a more cost-effective way of leveraging proven public health interventions for vulnerable populations in sustainable ways (see Figure 2)11.

Research approaches need to be empirical but also ecological. The translation and application of existing and new research findings needs to act both at the community level in terms of empowerment as well as at a global/regional level in terms of policy and funding. Many public health interventions that will also protect vulnerable populations against progressive climate change act at a variety of levels including individual, household, community, national and regional (see Table 1)12.

Examples of successful interventions include: Household uptake of long-lasting insecticide-treated bed nets when combined with other more standard vector control programmes.

Provision of effective, affordable, locally manufactured point-of-use water filters.

For each example of a successful or promising intervention, it is not sufficient just to know whether a technical solution exists. Research on cost-effective and sustainable implementation also needs to occur (see Table 2)10.

Conclusions While the challenges are significant, so are the opportunities.

Climate change seems to have acted as a catalyst promoting trans-disciplinary, holistic, global partnerships in research, knowledge generation, translation and action.

Many initiatives are currently underway especially in the environmental, agricultural and water resources sectors to assess impacts to and adaptation from a developing country perspective. The issue of health should be one of the explicit foci of these initiatives.

Key messages

Incorporation of climate change health impacts into public health planning: a) Estimate current and future impacts of climate change when planning public health interventions. b) For each public health intervention assess if there will be an impact of climate change, and adjust for that. c) Climate change should be one of the variables when estimating the impact and outcomes of public health interventions.

Partnering with all stakeholders: a) Partner with other stakeholders outside the health sector for climate change adaptation strategies. b) Continue to advocate for mitigation as the ultimate goal to address climate change. c) Maximize the diffusion of innovations through civil society and the Internet. d) Incorporate climate change mitigation and adaptation impacts in intra- and intersectoral planning. Should include all possible sectors such as transportation, housing, energy policy, education, health, agriculture, land use, environment, industries, trade etc.

Supporting innovation, collaboration and knowledge translation in research: a) Include climate change as an element to consider for trans-disciplinary research funding. b) Make knowledge translation and collaboration with low-income countries a prerequisite for research funding approval in high-income countries. c) Support the establishment of public health surveillance systems that monitor the impact of climate change as an integral part of health status and assessment measures. d) Ensure research is translated into locally relevant, cost-effective and sustainable interventions.

Innovative approaches from regional “second generation� assessments of the impacts of and adaptation to climate change done primarily in agriculture and water resources need to be replicated and expanded to include direct and indirect health impact and adaptation assessments13.

Civil society is well prepared to engage with governments and researchers to advocate for and adopt contextually appropriate local interventions to mitigate and adapt to climate change. There is unprecedented open access for most if not all stakeholders to information thorough the World Wide Web. Along with the expected increase in funding for climate change research and interventions, it is vital that this spirit of openness and collaboration is maintained. Innovation in climate change research and interventions potentially has the promise to address many existing and long-standing public health issues as well as prepare for future risks.

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Saqib Shahab is a physician specializing in public health and preventive medicine. He has trained and worked internationally, including in Pakistan, the UK, US and Canada. Within public health, Saqib has a special interest in environmental and occupational health, communicable and noncommunicable disease control, and surveillance systems. His current interests include incorporating climate change research and interventions as an integral part of public health practice.

at the Regional Office for the Eastern Mediterranean Region, World Health Organization.

He has a long history of working internationally in global public health, including with the Global Forum for Health Research, with a special interest and expertise in enhancing health systems capacity to participate in and apply research, especially in developing country and resource poor settings. His recent focus has been emphasizing research not just on technical and biomedical issues, but also health system organization, policy, capacity and cost effectiveness.

Abdul Ghaffar is a physician and public health specialist who is currently the Regional Adviser for Research Policy and Cooperation,

References 1.

Confalonieri U et al. Human health. Climate change 2007: impacts, adaptation and vulnerability. Contribution of Working Group II to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change. Parry ML et al, eds. Cambridge University Press, Cambridge, UK, 2007, 391-431.

2.

Cambell-Lendrum D, Corvalan C, Neira M. Global climate change: implications for international public health policy. Bulletin of the World Health Organization, March 2007, vol.85, no.3, p.235-237.

3.

McMichael AJ et al, eds. Climate change and human health: risks and responses. WHO 2003.

4.

Stern Review on the Economics of Climate Change. HM Treasury, UK, 2006.

5.

McMichael AJ, Butler CD. Emerging health issues: the widening challenge for population health promotion. Health Promotion International, December 2006, 21 Suppl 1:15-24.

6.

Few R. Health and climatic hazards: framing social research on vulnerability, response and adaptation. Global Environmental Change, 2007, 17 (2), pp.281-295.

7.

Hanlon P, Carlisle S. Do we face a third revolution in human history?

If so, how will public health respond? Journal of Public Health, 21 July 2008, Oxford.

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8.

Preamble to the Constitution of the World Health Organization as adopted by the International Health Conference, New York, 19–22 June 1946; signed on 22 July 1946 by the representatives of 61 States (Official Records of the World Health Organization, no. 2, p.100) and entered into force on 7 April 1948.

PK:64167702~piPK:64167676~theSitePK:4503324,00.html 9.

MEbi KL, Kovats RS, Menne B. An approach for assessing human health vulnerability and public health interventions to adapt to climate change.

Environmental Health Perspectives, December 2006, 114(12):1930-4.

10.

Shahab S, Ghaffar A, Stearns BP, Woodward A. Strengthening the base: preparing health research for climate change. Global Forum for Health Research, April 2008.

11.

Ghaffar A, de Francisco A, Matlin S. The Combined Approach Matrix: A priority-setting tool for health research. Global Forum for Health Research, 2004.

12.

McMichael AJ, Kjellstrom T, Smith KR. Environmental health. In: Merson MH, Black RE, Mills AJ, eds. International public health: diseases, programs, systems and policies, 2nd Ed. Jones and Bartlett, 2006.

13.

Leary N, Kulkarni J. Climate Change Vulnerability and Adaptation in Developing Country Regions. Draft Final Report of the AIACC Project, April 2007. GEF/START/ UNEP.

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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 nothing but medicine on a grand scale.”

RUDOLF VIRCHOW, 1858

lobal health diplomacy may be thought of as a political activity that meets the dual goals of improving health while maintaining and strengthening international relations. As diplomacy is frequently referred to as the art and practice of conducting negotiations, the term “global health diplomacy” aims to capture the multi-level and multi-actor negotiation processes that shape the global policy environment for health. It bridges the commitment to development and the need to define collective action in an interdependent world. This emerging field draws on a broad range of disciplines including international relations, medical anthropology, political science, history and public health.

Therefore it is important to understand some of the historical and conceptual underpinnings of this emerging field.

Academic rigour applied to global health diplomacy is a critical leaven in a chaotic global health environment. This paper presents a brief review of the issues that provide a possible focus for future training, research and service in global health diplomacy.

G

Historical roots A historical perspective may help illustrate an emerging tension surrounding health cooperation and diplomacy. In fact, international public health agreements were originally created to protect against the importation of foreign-born diseases and as a defence for national commercial and trading interests, going as far back as the Middle Ages in Europe.

We may also find some roots of health diplomacy in early missionary work, which adopted medical treatment as part of evangelical activities. For example in India, Fitzgerald described the emergence of medical assistance as a tool for religious conversion among British colonial subjects1. There is thus a need to consider the normative foundations of global health diplomacy, such as in the humanitarian activities of the Red Cross Movement, with equity and social justice being key components2. The current structures of global public

health may perpetuate the imbalance of power between the developed and the developing world. However, we now see a power shift in the role of the emerging economies, as in the recent Doha rounds of World Trade Organization negotiations.

From the mid 1850s, countries have dealt with the increasing risk of disease from beyond their borders as a national and economic security issue3. These national interests now mandate that countries engage internationally as a responsibility to protect against imported health threats or to help stabilize conflicts abroad so that they do not disrupt global security or commerce. Concerns for health security include the threat of bioweapons (accidental or purposeful) as well as both infectious diseases and noncommunicable diseases that can wreak havoc on global economies. It is the careful balancing of sometimes competing global health priorities, playing out both nationally and globally, that make partnership across disciplines essential in raising the profile of health as a foreign policy concern. Global health efforts will founder unless and until nation states cooperate in combining their national interests with the global public good.

Contributing concepts Humanitarian assistance The notion of humanitarian assistance as part of foreign policy was described in a 1974 editorial in Preventive Medicine, wherein Cahill advocated using medicine as a tool of modern diplomacy4. His more recent work suggests that health is a common ground for understanding and cooperation among peoples and nations with differing traditions and values5. This is especially true in nations that are shattered by war, civil conflicts and ethnic violence. Over the next 25 years, humanitarianism rather than foreign policy per se was the focus for health diplomacy. However, humanitarian assistance provided by the United States and others to disaster areas such as Sudan fulfilled broader political and economic objectives rather than just beneficence6. Aligning aid organizations with dysfunctional governments may enable these governments to be unresponsive to their own national crises7. These examples suggest that aid organizations must be politically and ethically more savvy in order to assure justice-based approaches to international health assistance8. Health diplomacy attempts

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to prioritize the health outcomes of humanitarian aid as a route to negotiations in the political sphere.

A critical new development in global health is the proliferation of private sector and government donations in international aid; these have been largely disease-specific enterprises (such as the Global Fund for AIDS, TB and Malaria). A 2004 estimate suggested that international funding for global health reached US$ 14 billion in that year, due largely to contributions from the Bill & Melinda Gates Foundation and the US government’s Presidential Emergency Plan for AIDS Relief (PEPFAR)9. The proliferation of smaller nongovernmental organizations (NGOs), privately funded and focused on single communities, specific health outcomes or specific medical interventions is also unprecedented in history. Along with this bonanza, there is increasing convergence of thought on the evidence of effectiveness for global health interventions10. This evidence has been thoroughly reported in the hallmark publication, Disease control priorities in developing countries11. What may be missing from these discussions, however, is a sense of the absorptive capacities and global governance needs that are necessary for both recipients and donors to manage these resources12.

Human rights The emergence of human rights as a global movement clearly sparked challenges and debates within the field of humanitarian assistance that have yet to be resolved. The notion of human rights and health assistance has emerged as a basis for cooperative action across nations, the private sector and NGOs. The right to health became a key element of this discourse, but its importance remained largely understated until the world acknowledged the enormous impact of HIV/AIDS. Health and human rights emerged as a distinct movement and was made concrete with the 1994 founding of the Journal of health and human rights by Jonathan Mann, head of the WHO HIV/AIDS programme at the time. He clarified this union of human rights and health, stating “that the human rights framework provides a more useful approach for analyzing and responding to modern public health challenges than any framework thus far available within the biomedical tradition”13. Building on this foundation, Paul Farmer’s written works and leadership have dramatically advanced the human rights agenda in health diplomacy, arguing that the international public health and foreign policy communities both fail to recognize the needs of the world’s poor and neglect to address the structural inequalities that lead to illness among them14. Given a decade since health and human rights emerged as a movement, health diplomacy must now incorporate both a concern for resource equity and a concern for social justice in health assistance. It must also consider the political and economic landscape in which these standards must be defended.

Globalization During the 20th century, researchers have recognized the spread of both communicable and noncommunicable diseases as a consequence of globalization. Global changes

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in trade, transport, medicine and society have created ideal conditions for emerging infections with potentially devastating impacts15. However, deficiencies in public health infrastructure argue for greater public health preparedness to prevent global pandemics16.

Globalization has also expanded the threat of noncommunicable disease to populations and economies worldwide17. This latter set of threats (tobacco-related diseases, obesity, injuries, mental health problems, cancers, stroke and cardiovascular disease) are much less attentiongrabbing as global health problems compared with the highprofile infectious diseases that are now so well funded; nevertheless, they are the largest contributors to the global burden of disease11. Noncommunicable diseases have emerged as global threats, no longer considered a condition of only affluent populations18. These conditions may contribute to developmental stagnation in emerging economies, and they may lead to inordinate demands on health systems that disrupt production and trade capacities of these economies.

Enlightened self-interest Improvements in health status globally – especially in developing countries – promote economic and security interests for both donor countries and the larger global community19. In 1997, the Institute of Medicine (IOM) published a volume of evidence supporting the United States’ critical need to address global health as a vital national priority20; following this, infectious diseases were recognized in the National Intelligence Estimate as a significant threat to national security, with an emphasis placed on the importance of HIV/AIDS21. Recently, some have even suggested that the avian influenza threat presents potential for cooperation between the militaries of, for example, the United States and China. They may be encouraged to pool their resources in order to address a common threat such as this22.

Given the potential for new commitments to global health diplomacy in a changing global political environment, the IOM’s Board on Global Health is now organizing a 14-month consensus study to examine and articulate the case for why multiple agencies from government and the private sector in the United States should make a deeper commitment to global health. This study will greatly expand on the 1997 IOM report to consider the diplomatic agenda, expanded global research cooperation and perhaps new ways of addressing the global health workforce crisis (see www.iom.edu/CMS/3783/51303.aspx).

Multinational cooperation In December 2004, the United Nations issued an important report, A more secure world: our shared responsibility: report of the high-level panel on threats, challenges and change23, a follow-up to the 2000 UN Millennium Summit, where commitments to global cooperation were made in response to several major health and development challenges. The 2004 report emphasized the need to achieve the Millennium Development Goals (MDGs; see Table 1), with a focus on health and biological security.

The focus of the UN report also extends to the social determinants of health (especially poverty and economic

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1. Eradicate extreme poverty and hunger; 2. Achieve universal primary education; 3. Promote gender equality and empower women; 4. Reduce child mortality; 5. Improve maternal health; 6. Combat HIV/AIDS, malaria and other diseases; 7. Ensure environmental sustainability; and 8. Develop a global partnership for development.

Table 1: The United Nations Millennium Development Goals for 2015

inequities), infectious diseases and environmental degradation. Although sovereign states are the front line in dealing with health threats, the report emphasized that no state can stand wholly alone and that collective strategies, collective institutions and a sense of collective responsibility are indispensable in addressing the global health challenges of the 21st century. The WHO has flexed its muscle in this arena with new instruments, such as the Framework Convention on Tobacco Control (see below). Additionally, governments have begun to align themselves in new arrangements, such as in the 2007 Oslo Declaration, wherein the Ministers of Foreign Affairs (not of Health) of Brazil, France, Indonesia, Norway, Senegal, South Africa and Thailand recognized the need for new forms of cooperation to support development, equity, peace and security24. The UN MDGs are a framework for multinational health diplomacy, monitored and promoted by the member states of the United Nations, and some have called for codifying them in a Framework Convention on Global Health25. Today’s health diplomats must understand how global health governance has and must change.

Global health governance The shifting role of nation states and the growing insecurity in global public health has generated tremendous discussion concerning global health governance, particularly given the rise of new actors within the field. Cohen drew attention to the increasing role of private philanthropy, illustrating the nearly unfettered influence and unintended consequences of efforts by wealthy individuals and organizations now active in the field26.

Further, sovereign nations may lose their power to set other priorities if they must adhere to donor priorities for disease-specific activities (such as in the first version of PEPFAR). In fact, the World Bank has suggested a moral hazard argument regarding external funding such as that which is now proliferating: if upwards of 50% of government spending comes from external sources, a country may lose control of its priorities, programmes and strategies, yielding all control to the donors27. In this context, what should be the global health governance structure and what should be the role of multinational membership organizations in governing global health? Without systematic attention to the governance needs and social justice issues of health assistance, global health financiers will fall short of their intended humanitarian goals.

The role of nonstate actors, including private philanthropies, private individuals and private industry, has emerged as a concern from both political28 and social science perspectives29. These new global networks are clearly a 21st century humanitarian assistance phenomenon. The

disparate, uncoordinated efforts within global health call for a more systematic global cooperative effort30,31. However, neither the traditional state actors nor the modern nonstate actors are likely32 to accept either centralization under a ruling global authority or harmonization of goals, practices and procedures across organizations. Nonetheless, the acceptance and integration of health as a global public good has crossed a variety of thresholds, including trade, security, bioethics, international relations and economics. This suggests that the principles and policies of global health governance, what Fidler terms the “source code”, have functioned independently of centralized efforts. Instead of developing a new governance structure, global health actors should consider how successful applications of this source code will look in the 21st century. A range of proposals that build on network governance and aim to bring together the many actors in this new political space have since been put forward33. A growing international consensus on what works and what does not work in global health, and the growth of the new academic global health programmes and philanthropic structures will redefine global health governance in the years to come.

What should also be evident is the need for new public health instruments to support collective health efforts. Fidler calls for further examination of new efforts in global health governance such as the Framework Convention on Tobacco Control (FCTC) and the revised International Health Regulations (IHR). The FCTC was the first treaty implemented under the WHO’s constitutions, Article 19. It has now been ratified by 155 countries and will call for national policies to assure full participation in the Conference of the Parties, the supervising entity for the treaty34. In addition, there are challenges posed by the new IHR as a consensus agreement within the WHO for countries to support global responses to critical public health problems and to share information and responses to these problems35.

Emergence of health diplomacy in the United States In 2001, the Council on Foreign Relations36 made a strong case that the US government had a critical responsibility to make health a priority in foreign policy. US global health policy today is rooted in both national security concerns and a worldwide desire for social justice and equity37. Health diplomacy offers the potential for breaking free of the governance dilemma by bringing together health and foreign policy based on a concept of human security that embraces rights and well-being rather than only enlightened national self-interest.

Recently several US government officials have discussed medical diplomacy as an element of foreign policy, often focusing on the delivery of health care within low-resource settings and the distribution of medical technology38,39. In 2005, the IOM reviewed a number of international models for increasing humanitarian assistance within the HIV/AIDS epidemic with the suggestion for development of a Global Health Corps that would provide for improved global health capacity through elective service by US health professionals40. This programme would actually emulate

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efforts such as those provided by Cuba over recent decades41 and that China has recently adopted42.

Thomas E Novotny is a Professor of Epidemiology and Biostatistics at the University of California, San Francisco, and codirector with Professor Kickbusch of an executive training course on global health diplomacy conducted with support from the Centers for Disease Control and Prevention and the Fulbright Senior Specialists Program. He is director-designate of the Joint Degree Program in Global Health at San Diego State University and the University of California San Diego.

Conclusions This brief review provides an overview of the history, conceptual basis and new inputs into the growing field of health diplomacy, and it provides some perspectives that we may include as elements of professional education and research in the coming years. Health diplomacy is a field in the making43, and there is ample material in the history of international relations, humanitarian aid and medical assistance with which to begin serious analytic work as well as to develop pedagogy within the academic environment. Today, there are literally dozens of global health educational programmes in the United States and Europe, and many of these were described in a recent (January 2008) special issue of Academic medicine. Yet there are few educational initiatives that focus specifically on the interface between international relations, diplomacy and public health (Personal Communication, I Kickbusch and C Erk, A survey of training programmes and courses, 11 August 2008).

With so many new educational programmes involving multiple disciplinary approaches to global health education, it is clear that health diplomacy will be an exciting new academic pursuit within these programmes in the coming decades. J

Ilona Kickbusch is the Director of the Global Health Programme at the Graduate Institute of International and Development Studies, Geneva Switzerland with a focus on global health governance and global health diplomacy. She is a political scientist with a PhD from the University of Konstanz, Germany, and she is recognized for her contributions to innovation in public health, health promotion and global health.

Hannah Leslie is a Program Analyst with the University of California, San Francisco Global Health Sciences Program and an MPH candidate at the University of California, Berkeley, School of Public Health.

Vincanne Adams is Professor of Anthropology, History and Social Medicine at the University of California, San Francisco. She directs the joint (with UC Berkeley) medical anthropology program in the San Francisco Bay Area.

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Fidler D. The globalization of public health: the first 100 years of international health diplomacy, 2001. Retrieved 14 January 2008 from HYPERLINK http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S004296862001000900009.

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13.

Mann JM. Health and human rights. British Medical Journal (Clinical research ed.), 1996, 312(7036), 924-5.

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Farmer P. Pathologies of power: health, human rights, and the new war on the poor. Berkeley, CA: University of California Press, 2003.

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Garrett L. The coming plague: newly emerging diseases in a world out of balance. New York: Farrar, Straus and Giroux, 1994.

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Garrett L, Fidler DP. Sharing H5N1 viruses to stop a global influenza pandemic. PLoS Medicine, 2007, 4(11):e330.

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Beaglehole R, Yach D. Globalisation and the prevention and control of non-communicable disease: the neglected chronic diseases of adults.

Lancet, 2003, 362(9387):903-8.

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Novotny TE. Why we need to rethink the diseases of affluence. PLoS Medicine, 2005, 2(5), e104.

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Fox DM, Kassalow JS. Making health a priority of US foreign policy.

American Journal of Public Health, 2001, Oct;91(10):1554-6.

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Central Intelligence Agency. The global infectious disease threat and its implications for the United States. Washington, DC: NIE 99-17D, January 2000.

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Erickson A. Combating a collective threat: prospects for Sino-American cooperation against avian influenza, 2007. Retrieved 17 January 2008, from http://www.ghgj.org/Erickson_1.1_Combating.ht 23.

Report of the Secretary-General’s high-level panel on threats, challenges and change, UN. A more secure world: our shared responsibility. Doc. A/59/565 (2 December 2004) http:// HYPERLINK “http://www.un.org/secureworld” www.un.org/secureworld/report.pdf.

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Ministers of Foreign Affairs of Brazil, France, Indonesia, Norway, Senegal, South Africa and Thailand. Oslo Ministerial Declaration – global health: a pressing foreign policy issue of our time. Lancet, 2007, 369:1373-78.

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Gostin LO. A proposal for a Framework Convention on Global Health.

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Cohen J. The new world of global health. Science, 2006, 311(5758), 162-167. doi: 10.1126/science.311.5758.162.

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References continued transparency in disbursements and decision-making. Oxford, UK: Global Economic Governance Programme, University of Oxford, (2008).

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Wehrenfennig D. Beyond diplomacy: conflict management in a diverse world. Paper presented at the annual meeting of the Western Political Science Association, Hyatt Regency Albuquerque, Albuquerque, New Mexico, 17 March 2006. Online <PDF>. 2008-06-27, accessed 11 August 2008 at http://www.allacademic.com/meta/p97357_index.html.

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Retrieved from http://www.foreignaffairs.org/ 20070301faresponse86213/paul-farmer-laurie-garrett/from-marvelousmomentum-to-health-care-for-all-success-is-possible-with-the-rightprograms.html.

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Prescott EM. Politics of disease: governance and emerging infections, 2007. Retrieved January 17, 2008, from http://www.ghgj.org/Prescott_1.1_politicsDisease.htm 32.

Fidler D. Architecture amidst anarchy: global health’s quest for governance. Global Health Governance, 2007, 1(1):1-17. Accessed 11 August 2008 at http://diplomacy.shu.edu/academics/global_health/journal/PDF/Fidlerarticle.pdf.

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Silberschmidt G, Matheson D, Kickbusch I. Creating a committee C of the World Health Assembly, Lancet, 2009, 371 (9623):1483-6.

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23(2), 265-282.

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Novotny TE. US Department of Health and Human Services: a need for global health leadership in preparedness and health diplomacy. American Journal of Public Health, 2006), 96 (1):11-13.

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Frist B. History will judge us on fight against AIDS. Tennessean, 4 March 2008. Retrieved 10 March 2008, from http://www.tennessean.com/apps/pbcs.dll/article?AID=/20080304/OPINI ON01/803040332/1008 40.

Mullan F, Panosian C, Cuff PA. Healers abroad: Americans responding to the human resource crisis in HIV/AIDS. National Academy Press, 2005.

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PHOTO BY TETSUO SAKUMA

Hideyo Noguchi Africa Prize Article by Kiyoshi Kurokawa (pictured), Chair, Hideyo Noguchi African Prize and Special Advisor to the Cabinet of the Japanese Government with Tamaki Tsukada and Eri Maeda

n 28 May 2008 Brian Greenwood, of London School of Hygiene and Tropical Medicine, and Miriam Were of National AIDS Control Council of Kenya, were awarded the First Hideyo Noguchi Africa Prize.

The presentation ceremony hosted by Prime Minister Yasuo Fukuda was attended by their Majesties the Emperor and Empress of Japan and hundreds of international dignitaries, including more than 40 heads of state and government of the African countries participating in the Fourth Tokyo International Conference on African Development (TICAD IV).

The presentation ceremony marked the first day of the TICAD IV held in Yokohama. The day happened to coincide with the “80th anniversary plus one week” of Noguchi’s death in Ghana, 21 May 1928.

The best description of the ideals of the Hideyo Noguchi Africa Prize is perhaps the acceptance speeches of the two laureates (excerpts as follows): “Forty-three years ago, as a young man, I set off on my first visit to Africa to take up an appointment at University College Hospital, Ibadan in Western Nigeria. At that time, this was considered rather a strange thing to do. I had up to that point done well in my medical career in England and some of my seniors in the UK considered that going to work in Africa was bizarre, almost a form of professional suicide for a young physician. This evening is the occasion on which I have finally proved them wrong. The concept underlying the Noguchi Prize is an extremely important one as it establishes the point that what is sometimes considered as rather soft, that is applied or field, research, is as intellectually rigorous and demanding as the high technology laboratory research that, in the past, has usually attracted the international prizes.

The establishment of the Noguchi Prize will help to redress this balance and the Japanese Government is to be commended on taking this initiative”, (Brian Greenwood)1.

“Reduction of the disease burden on the people of Africa and improvement of health is crucial for the creation of wealth and improvement of the overall socioeconomic situation in Africa. People who live in poverty and who are frequently sick cannot be productive enough to improve the situation. Africa’s history that includes the massive transatlantic slave trade that disorganized the continent for nearly 500 years followed by colonialism and apartheid for a further 100 years laid the roots of poverty and disempowerment in Africa that casts a long shadow into the present and future. Healthy people,

O

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creation of wealth and social stability are some of the requirements for us, the people of Africa, to get out of the indignity in which most of us live. We, the people of Africa, believe that through this forum (TICAD) and the prize outcomes will be positive for Africa”, (Miriam Were)2.

The creation of the prize came out as a typical Koizumistyle coup de main during his visit to Africa in May 20063. It was literally a top-down initiative. Nobody at the time actually thought about the meaning, let alone the consequence, of creating yet another prize in the already over-crowded international prize market. However, it turned out that this particular field of science – tropical medicine, public health, or so-called translational research – lacked a proper system of reward which commanded substantial international outreach and legitimacy. It was precisely this area of science and research which warranted particular attention of the international science community if we were to defeat the global health challenges.

Why do we have to constrain ourselves on a specific continent when a global issue like health and medicine is at issue? Because Africa is the continent most in need of resources, financial or otherwise, in order to achieve the United Nation’s Millennium Development Goals (MDGs).

These were the founding principles and parameters which determined the framework of the new prize. The prize has set itself a totally different and radical approach on how to recognize, inspire and shape research in a globalizing world.

Before going into the prize further, let us briefly review Hideyo Noguchi, a figure who captivated Koizumi’s imagination to conceive this prize.

Who is Noguchi?

Hideyo Noguchi (1876–1928) was a prominent Japanese bacteriologist in the early 20th century, internationally acclaimed for his contribution to the understanding of infectious diseases4. Noguchi eventually died in Accra, Gold Coast (now Ghana) of yellow fever while working in search of its pathogen5. It is said that the death of his close Rockefeller colleague Dr Adrian Stokes of yellow fever made Noguchi decide to travel to Africa. It was still a decade before the virus was discovered by mankind and ascertained as the pathogen.

Noguchi was born in a very poor family in the impoverished rural village of Fukushima. He had a physical

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handicap, a deformity on his left hand due to a burn that he suffered during his early childhood. Nothwithstanding these handicaps, he managed to obtain, through extraordinary hard work, a licence to practise medicine in Japan. He did exceptionally well in school but in those days, obtaining higher education, especially in medicine, was expensive and 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 at the University of Pennsylvania. In 1904, Flexner was invited to head the newly founded Rockefeller Institute for Medical Research (now Rockefeller University), and brought Noguchi, his most trusted protégé, with him. In the early years in the institute, Noguchi earned the epithet “human dynamo”, not without a racist hue. But by the 1910s he was one of the top researchers leading the institute to world fame comparable to its European counterparts. In those days in the field of medicine (and to a large extent science in general), the United States had been playing the second fiddle to Europe.

His extraordinary appetite for research and zeal to conquer the cause of diseases, brought him to various places in the western hemisphere in Central and South America where the rate of death from yellow fever was particularly high. The Rockefeller Institute for Medical Research had formed a special task force for South America and appointed Noguchi as one of its leaders. In 1918, Noguchi landed on Guayaquil, Ecuador, the epicentre of this disease; his battle against yellow fever thus began. In just nine days, he isolated the pathogen (Leptospira icteroides) and produced a vaccine and antiserum, successfully lowering the death rate. Noguchi was worshipped as a crusader against yellow fever in places where he visited: Mexico, Brazil and Peru. However, it was not possible at that time to identify a virus; it did not exist even in people’s imagination. However, Noguchi harboured some doubts about the veracity of his findings and he did record certain observations to this effect true to his academic conscience. That was what motivated Noguchi to set sail for Africa.

A prominent Rockefeller scientist travelling all the way to Africa, notwithstanding various prejudices against a nonwhite, physically handicapped upstart had a tremendous impact worldwide. It is this courage and passion combined with his belief in field-based research that makes Noguchi and his contribution remarkable. And this is the nexus between Noguchi and the newly created prize.

Hideyo Noguchi (1876–1928) was a prominent Japanese bacteriologist in the early 20th century, internationally acclaimed for his contribution to the understanding of infectious diseases. Noguchi eventually died in Accra, Gold Coast (now Ghana) of yellow fever while working in search of its pathogen

The latter part of 2006 was consecrated to establishing a truly effective business model or process in order for this prize to be competitive and attractive in the science community as well as pertinent to the global (i.e. African) health needs

Business model or process of the prize It is not possible to make a simple comparison between the style of research in the days of Noguchi, when researchers were honoured simply by discovering or isolating agents from patients, and that of the contemporary scene where conditions and requirements have become much more complex. However, the field-based research style of Noguchi is increasing in its value in combating diseases in Africa.

There is an atavistic call for simple but high quality research based on practical needs on the ground combined with a deep understanding of the ecological and human factors indigenous to Africa.

In May 2006, Prime Minister Koizumi announced the establishment of the prize in the joint press conference with President Kufuor of Ghana. After returning to Japan, Koizumi instructed the ministries of foreign affairs, health and welfare, and science and education to elaborate on the concept. The Cabinet Office was designated as the coordinating agency and in July 2006, in the Japan-African Union (AU) summit, the prize became the main agenda. In the joint press conference by Prime Minister Koizumi and AU Chairperson Konare it was announced that the prize will be awarded every five years and that the first will be awarded in 2008 within TICAD IV. A cabinet decision was made to that effect.

The latter part of 2006 was consecrated to establishing a truly effective business model or process in order for this prize to be competitive and attractive in the science community as well as pertinent to the global (i.e. African) health needs.

The first demand was to ensure diversity and inclusiveness. Nominations will be sought from around the globe including all the 53 countries in Africa. Africa has often been a non-entity in the science community. By inclusiveness, we do not mean affirmative action. What is needed is a truly fair and equitable playing ground to encourage research of Africa, for Africa, by Africa. The composition of the three selection committees will be international with a balanced representation from various continents6.

The second demand was to ensure fairness and academic rigour of the selection process. Not only the outcome but also the process through which the laureate is elected should be superlative, that is worthy of the substantial amount of honorarium attached to the prize. Prestige and appeal of a prize is not something which could be bought but only earned by example. For this purpose, two sub-committees were set up to conduct the expert level screening in respect

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of medical research and medical services. The Hideyo Noguchi Africa Prize Committee, the parent body presiding over the two sub-committees, will finalize the candidates to be recommended to the Prime Minister of Japan for 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 value of the prize. The connectivity is embodied in the financial mechanism too. One half of the honorarium will be financed by the Government of Japan and the other half by donations from the public which will be administered by the Japan International Cooperation Agency (JICA).

What are the main target areas of the prize? The prize will first and foremost vigorously encourage research on the major and most relevant medical and heath issues in Africa.

Although dramatic achievements have been made in recent decades in this area, there is still an absolute shortage of awareness beyond the expert community. The prize, by its institutional linkage to the TICAD process and its strong resonance with global health policy, aspires to be a key instrument in addressing the medical as well as public health challenges in this area.

The prize values not only the advancement of our understanding of African diseases in terms of biomedical research in its conventional sense, but also our understanding of the bigger picture in terms of human and environmental ecology surrounding these diseases.

The prize will also give more emphasis on the human and societal aspect of the research or health activities in concern.

We do not believe that such an approach will compromise the disciplinary rigour of research or health activities. If anything, this kind of emphasis will lead to a bigger impact in terms of achieving the MDGs more effectively.

Achievements of the two laureates Nomination requests together with the nomination guidelines were sent out to more than 2000 individuals and institutions, and slightly more than 100 nominations were received.

From February to December 2007, the Medical Research Sub-Committee selected three among 57 candidates.

Meanwhile, from June to December 2007, the Medical Services Sub-Committee selected three among 23 candidates. These six candidates were referred to the Hideyo Noguchi Africa Prize Committee for final consideration. In February 2008, the Hideyo Noguchi Africa Prize Committee unanimously recommended Brian Greenwood and Miriam Were as the candidates for the first prize. This was duly approved and announced on 26 March 2008 by the Prime Minister.

Reactions from the international health and research community were cordial and encouraging. The WHO, the World Bank, the Gates Foundation, the Rockefeller Foundation and the Rockefeller University were among those who issued genial statements congratulating the laureates7.

Brian Greenwood was honoured for his bold and innovative work on malaria. At a time when malaria was spreading

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The prize will first and foremost vigorously encourage research on the major and most relevant medical and health issues in Africa

uncontrollably across the African continent claiming more than 1 million lives a year, Greenwood contributed to the creation and designing of effective strategies to control malaria. His crucial contributions in malaria research greatly helped developing the tools and knowledge that are essential in turning the tide on this devastating disease. His work brings hope where very recently only despair existed.

Greenwood has spent more than 30 years on site in Africa including 15 years as Director of the MRC Laboratories in The Gambia where he pioneered landmark research contributing to the understanding of the immunology, pathogenesis and epidemiology of malaria, a major killer in Africa, and other infectious diseases such as meningitis and pneumonia, all major contributors to mortality among children in Africa. His research and translational clinical studies, involving simple but high quality methods as well as field trials of drugs and vaccines, have provided the scientific underpinning to a wide range of influential public health policies at national and international levels. His important contributions include: Demonstration of the effectiveness of insecticide-treated bed-nets for control of malaria, which is now the cornerstone of malaria interventions throughout the continent, supported and financed by many donor agencies; Primary studies on artemisinin-based combination therapies (ACTs), now widely adapted as first-line treatment for malaria; Demonstration that malaria chemoprevention reduces child mortality. This is now being applied for intermittent preventive treatment in infants, children and in pregnancy; Substantial contributions to trials of malaria vaccines, including the efficacious RTS,S vaccine.

Another important aspect of Greenwood’s achievements is his reinvention of field research in tropical medicine – changing it from an ancillary colonial or military activity focusing on hygiene to a multi-partite, multi-disciplinary endeavour, wherein holistic solutions are required – based on cutting-edge science and a genuine understanding of the complex eco-system as well as real-life challenges unique to Africa. Thus laboratory and clinical research, preventive and curative medicine, epidemiology, anthropology, and behavioural research were all brought together. These modern approaches which we now take for granted came from Greenwood’s prescience and leadership.

Over the years, Greenwood has made capacity building – another lasting legacy of his research based on African soil – a central objective including the training and support of young African scientists. A cohort of students, doctors and clinicians who developed their careers under Greenwood’s inspirational mentorship has immensely contributed to the increase in

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stature of medical research in Africa amongst the scientific community in general.

Under the medical services category, the inaugural award went to Miriam K Were, whose efforts to bring basic medical services and health rights to women and children in the villages of East Africa has been a beacon of hope for millions of people in Africa and the world. Through her work with African Medical and Research Foundation (AMREF)8 and UZIMA Foundation9, Were has been a source of inspiration for all people on the African continent.

For the past 40 years, Were has dedicated her life to advancing the health and welfare of the people of Africa through a focus on the practicalities of delivering service at a local level. She has united communities to develop and implement innovative solutions to quotidian health problems.

The most illustrious example of her community-based approach is her ongoing work to build public toilet facilities in local communities, improving hygiene and overcoming longstanding taboos. She also drastically raised the infant vaccination rate by organizing children into small groups to visit local clinics. Her innovation and systemic precedents have had enduring impacts not only in Kenya but throughout the East African region and across the entire continent, through her engagement with the African Union and as a key health adviser to the African Heads of State on AIDS, tuberculosis and malaria.

Her style of work through the direct engagement of the youth, sex workers, intravenous drug users, homosexuals and others to encourage openness and frank discussion on sexuality and HIV/AIDS has galvanized communities in Kenya and contributed to the reduction of stigma and discrimination against people living with HIV/AIDS. She is a dedicated advocate for vulnerable populations, especially the poor and the marginalized. She is also committed to the empowerment and development of all voices across lines of sex, tribe, and age and class background. Widows and orphans severely affected by HIV/AIDS are amongst those most positively touched by her contribution to expanding access to medical services.

We would also like to pay tribute to the families, particularly the spouses, of the two laureates whose continuing support and understanding for the harsh working environment of medical profession/career in Africa has been instrumental to realise these achievements. The importance of these familial ties came home to all of us during the flower presentation ceremony by the children of the alma mater of Hideyo Noguchi in Fukushima when Alice Greenwood (wife of Brian Greenwood) and Humphreys Were (husband of Miriam Were) hugged each other in tears congratulating each other’s enduring assistance over the years.

issues on Africa.

Japan as Chair of G8 this year, which is incidentally the year of TICAD, is leading the efforts to harness the surging enthusiasm of the international community on the health agenda10. The Japanese government considers the Hideyo Noguchi Africa Prize mechanism to be an integral part of this policy context.

Health and medical interventions tend to be subject to the whim of pity. Of course, health matters are by nature humanitarian. However, we need to conscientize the public that charity is not sufficient to roll back the overwhelming health challenge in Africa. We need to encourage robust science and research in Africa. Science should not be a monopoly of the developed world. Research on African health cannot be truly meaningful or sustainable unless it is owned by Africans.

The following excerpt from an article by Professor Makgoba, Vice-Chancellor of KwaZulu Natal University, perhaps best captures the African hope and expectations.

“Major international prizes that have shaped modern medical scientific advancements such as the Nobel Prize, have the thrust on individualistic scientific achievements without a direct link to society or a focus on global health burden. For these reasons they have advanced science and health research in a particular, esoteric way; have become prizes of the elite and advantaged science and scientists of the developed world; and have been detached from real global health problems. As a result, while prestigious, in reality they have been exclusive and insensitive to the health realities of the developing world. Often the processes and structures of their decision-making have been shrouded in secrecy and have lacked diversity and internationalism. It will be interesting to see how these established awards rise to the challenges of the modern world and in particular to the impact of this newly launched Hideyo Noguchi Africa Prize.”

We wish to acknowledge our indebtedness to each and all of the three selection committees in particular the three chairpersons for their intellectual and moral support throughout the process. We must also record our deep gratitude and almost thunderstruck admiration for Junichiro Koizumi for his sense of mission which constantly motivated and inspired us to make this concept a reality*. J

Conclusion

Tamaki Tsukada is Director of the Hideyo Noguchi Africa Prize Unit, Cabinet Office (currently Director of Economic Security Division, Ministry of Foreign Affairs).

The prize is a unique call to marshal the multitude of activities on research and service delivery in the field of health transpiring on the African continent – a continent most in need of resources and care but often marginalized and neglected – and eventually to transform the way in which the international community addresses medical and health

*The opinions contained herein do not necessarily represent the views or policies of the Government of Japan.

Kiyoshi Kurokawa MD is Chair of the Hideyo Noguchi Africa Prize Committee and Special Advisor to the Cabinet of the Japanese Government. See www.kiyoshikurokawa.com11

Eri Maeda is Officer of the Hideyo Noguchi Africa Prize Unit, Cabinet Office (currently South-East Asia Division, Ministry of Foreign Affairs).

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References 1.

See acceptance speech by Brian Greenwood at the Presentation Ceremony, 28 May 2008 (http://www.cao.go.jp/noguchisho/jyusyousiki-sikisidaie/greenwood-e.pdf).

2.

See acceptance speech by Miriam Were at the Presentation Ceremony, 28 May 2008 (http://www.cao.go.jp/noguchisho/jyusyousiki-sikisidaie/were-e.pdf).

3.

See address by Junichiro Koizumi to the Nippon Keidanren (Confederation of Japanese Business), 4 July 2007 (http://www.cao.go.jp/noguchisho/bokin/aisatsu-e.pdf).

4.

Noguchi’s major research achievements could be summarized as follows: 1. Discovery of Treponema pallidum, the causative agent of syphilis, in the brains of progressive paralysis patients (1913).

2. Success in growing pure culture of Syphilis spirochete (1911), however, no one has succeeded ever since in the replication of pure culture of Syphilis spirochete.

3. Proves that both Oroya fever and Verruga peruana are caused by a single pathogen Bartonella bacilliformis by verifying that Bartonella bacilliformis invades red blood cells in both cases (1926).

4. Observation of Leptospira icteroides from patients of yellow fever (1919). (Leptospira, which was then identified as the cause of yellow fever by Noguchi, was later disproved and proved to be in fact the spirochete of Weil’s disease. His name is remembered in the binomial leptospira noguchi in the classification of spirochetes.)

The number of research papers written by him reached almost 200 and various kinds of infectious diseases came under the scope of his interest, varying from study of pathogens and immunology to development of vaccine and experimental technique. Noguchi was three times nominated as a Nobel-Prize candidate in the period 1914–1920.

5.

The Noguchi Memorial Institute for Medical Research was established in 1979 and named after Hideyo Noguchi who died from yellow fever in 1928, the very same disease he was researching into (http://www.noguchimedres.org/).

6.

The nationality of the members of the Hideyo Noguchi Africa Prize Committee is as follows: 8 Japan, 1 UK, 1 USA and 1 Senegal. See the

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following for details: http://www.cao.go.jp/noguchisho/iinkai/iinmembere.html The nationality of the members of the Sub-Committee for Medical Research is as follows: 19 Japan, 1 France, 1 Mexico, 1 USA, 1 Ghana and 1 Australia. See the following for details: http://www.cao.go.jp/noguchisho/iinkai/medicalresearch-e.html The nationality of the members of the Sub-Committee for Medical Services is as follows: 3 Japan, 7 African (Mali, Nigeria, Gambia, South Africa, Côte d’Ivoire, Zambia and Mozambique), 1 Mexico and 1 USA. See the following for details: http://www.cao.go.jp/noguchisho/iinkai/medicalservice-e.html 7.

See for example the following statements and press releases: WHO: http://www.who.int/mediacentre/news/releases/2008/pr10/en/ World Bank: http://web.worldbank.org/WBSITE/EXTERNAL/ NEWS/0,,contentMDK:21701357~pagePK:34370~piPK:34424~theSit ePK:4607,00.html Rockefeller University: http://newswire.rockefeller.edu/ ?page=engine&id=736 Gates Foundation: http://65.117.201.112/GlobalHealth/Announcements/Announce080326.htm 8.

Professor Were serves as a Chairman, International Board of Directors of the African Medical and Research, Foundation, AMREF from February 2003 to date (www.amref.org).

9.

Professor Were was Founding Chairperson up to 2001 and is a Member of the Board of Trustees of the UZIMA Foundation to date. The Foundation is a charitable trust registered in Kenya (http://uzimafoundation.org/main/).

10.

See for example the following report by the G8 health experts group: http://www.g8summit.go.jp/doc/pdf/0708_09_en.pdf 11.

See following commentaries and reports by the author Kiyoshi Kurokawa: http://www.bdafrica.com/index.php?option=com_content&task=view&id= 1726&Itemid=5821 http://www.kiyoshikurokawa.com/en/2008/04/announcement-of.html http://www.kiyoshikurokawa.com/en/2008/05/hideyo-noguchi.html

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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 something new, normally through study and experimentation. In the context of public health, innovation usually results from research and may include new medicines, medical devices, diagnostic methods, clinical practices or means of health care delivery1.

Economic development is associated with a progressive increase and improvement in the production of goods and services, however, social development is associated with the level of cohesion and distribution of wealth2. The Index of Human Development is an approximation to the degree of social development, and is a weighted measure of the GDP per capita, life expectancy and literacy level3. In this context, the Millennium Development Goals have galvanized unprecedented efforts to meet the needs of the world’s poorest and range from halving extreme poverty to halting the spread of HIV/AIDS and providing universal primary education, all by the target date of 2015. These estimates make evident a tendency towards the globalization of health problems4, sharing risks, disability and moral consequences, all of which require uniting efforts to combat these threats.

Within the broad context of health and innovation and its outlook in the context of world health we will briefly comment on the recent advances in defining objectives and policy instruments in research and development in health-related areas in Spain, and some of the challenges still facing us.

I

The Spanish framework of research, development and innovation The general aim of biomedical research is still the prevention, improvement or cure of human diseases. Spain has one of the best national health systems in the world; it provides essentially free medical and hospital health care coverage to all residents of Spain, including immigrants, as well as high standards of diagnosis and treatment. Although biomedical research has increased significantly in Spain in the last decade, it is still not among the ten most productive countries in the EU, keeping in mind a number of indicators and corrected for population. We have, therefore, developed a new framework to try to close this gap, based on: The Biomedical Research Act (of July 2007), which

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provides modern regulation for the most advanced tools in biomedicine, i.e. human stem cell and embryonic tissue use, genetic analysis, biobanks, etc. The Act also addresses the recognition of health research as a career for health professionals and provides incentives for pursuing it. This new law was fostered by the Ministry of Health and Consumer Affairs and many of its aspects will be implemented by the Instituto de Salud Carlos III (ISCIII).

The Research and Development and Innovation (R&D&I) 2008–11 National Plan, including all areas of public central government funded research, came into effect in September 2007. The three guiding principles of this plan for scientific and technological policy in Spain are: i) to serve the citizens, increasing social well-being and sustainable development with complete and equal incorporation of women; ii) to contribute to improving competitiveness in the private business sector; iii) to recognize and promote R&D as an essential element for the generation of new knowledge. The health component pursues the following goals: 1) to generate knowledge in order to improve health; 2) to foster innovation; and 3) technology transfer and translational research “from the bench to the bed side”. The budget allocated to this initiative has greatly increased and new initiatives have been set up such as research networks, training and technology transfer. Main lines of research include: 1) cellular and molecular technologies; 2) translational research; 3) public health, environment and occupational health; 4) pharmaceutical research; and 5) scientific and technical research.

The recently created Ministry of Science and Innovation (April 2008) will manage the majority of central government funds earmarked for R&D&I and will cooperate with the 17 autonomous regions, each of which have independent budgets for health and R&D&I. According to the 2008 edition of Science, Technology and Innovation in Europe published by EUROSTAT, analysing the data of 2006, Spain spent 1.16% (6546 million euros) of its GDP in R&D, whereas the EU27 devoted 1.84% of their GDP

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(210 000 million euros). The range is broad among different countries, with Sweden and Finland reaching 3.82% and 3.45% respectively, whereas Romania, Bulgaria and Slovenia do not reach 0.5%. With a rather limited investment, however, Spanish scientists have markedly increased the number of publications included in international databases (Web of Science): they represented 1.9% of the world’s total in 1999, and 3.1% in 2006. This places Spain in tenth position in the world based on number of articles, but in position 36 based on citations per document. More than 50% of these publications in the last decade correspond to biomedical disciplines and health sciences.

Science moves fast in a global world context and continuous support is required to obtain valuable results. We still face many challenges and pending tasks in biomedical research that need to be tackled: The modern hospital where clinical care, research and teaching are intrinsic synergistic daily activities is not widespread in the country, although a group of excellent centres have, or soon will have, achieved accreditation as “Institutes of Health Research”, recognizing their qualification at the highest standards level.

The transfer of knowledge to the productive system is very slow. We have to promote and facilitate the registration of patents and the creation of “spin off” technologically based companies to levels comparable to those of countries in our economic sphere. For that to happen, the main task is to build trust among public and private partners for fruitful collaborations.

Participation in the most innovative EU programmes, as well as in the Seventh European Framework Programme (7FP) has to increase. In this context the Spanish government has launched EUROINGENIO 2010 in order to increase Spanish participation and funding from the whole of health related programmes and tools offered by the 7FP. Spain is one of the most important contributors to European Development Clinical Trials Partnerships (EDCTP) or Ambient Assisted Living (AAL), both ruled by article 169 of the European Union Treaty.

In summary, we are beginning a most exciting time for biomedical research growth in quality and impact in innovation in Spain. The target of the new Ministry of Science and Innovation is to make Spain one of the world’s ten most productive countries in the field of science, technology and innovation by 2015. We already have the human potential, we just need to be successful in the management of economical resources, and to keep increasing these resources with public and, in higher proportion than now, private participation.

The Spanish contribution to some world health challenges A recent study on Global Burden of Disease (GBD) projections from 2002 to 20305 predicts significant changes with regard to mortality and disabilty in the world. Life expectancy in all continents will increase, mortality due to

Rank

Disease or injury

1 2 3 4 5 6 7 8 9 10

Ischaemic heart disease Cerebrovascular disease HIV/AIDS Chronic obstructive pulmonary disease Lower respiratory infections Trachea, bronchus, lung cancers Diabetes mellitus Road traffic accidents Perinatal condition Stomach cancer

% of total deaths 13.4 10.6 8.9 7.8 3.5 3.1 3.0 2.9 2.2 1.9

Table 1: Ten leading causes of death, 2030

Rank

Diseases

1 2 3 4 5 6 7 8 9 10

HIV/AIDS Unipolar depressive disorders Ischaemic heart disease Road traffic accidents Perinatal conditions Cerebrovascular disease Chronic obstructive pulmonary disease Lower respiratory infections Hearing loss, adult onset Cataracts

Table 2: Estimated leading causes of DALYs in 2030

infectious diseases will decrease while that caused by noncommunicable diseases will rise. Ischaemic heart disease and cerebrovascular disease will be the two leading causes of mortality in the world (see Table 1).

Although deaths due to HIV/AIDS are still on the rise , they will be overtaken by deaths due to the consumption of tobacco. Vascular diseases are the first cause of mortality in all regions, with major differences based on the classification of countries according to their income. In general, these forecasts place the world on an equal footing with regard to the definition of research priorities and the benefits of possible results.

The three leading causes of Disability Adjusted Life Years (DALYs) are projected to be HIV/AIDS, unipolar depressive disorders and ischaemic heart disease. In this case, there are also significant differences based on the level of income of countries (see Table 2).

Infectious diseases have not yet been overcome. In this context, aside from the potential benefits of a global strategy for more efficient development cooperation, synergy and wealth generation, greater investment in health is needed6.

On the other hand, forecasts for HIV/AIDS growth create new challenges for cooperation and R&D&I policies. This epidemic, as well as other infectious diseases, on account of their relationships with the adoption of behaviour patterns, offers areas for cross research with chronic diseases, so very widespread in developed countries. Strategies like “Multiple Health Behaviour”7 could benefit developing countries in their fight against HIV. Evidence-based medicine and rational use of antibiotics still suffer from large gaps in their application, extension and potential benefits both in developing and developed countries8, 9, 10.

As for future threats to health, Spain is contributing in a variety of ways. The National Plan for R&D&I 2008–2011,

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prioritizes translational research in those diseases that create the highest mortality and burden of disease in the world.

Public health, environmental health and occupational health are common to the entire set of prioritized diseases.

International cooperation is present in the National Plan and other solidarity-based government initiatives. The Iberoamerican Program for Science and Technology (CYTEC) endowed with US$ 6 million (70% donated by Spain) strengthens all areas of knowledge and technology, financing projects, research networks or technological innovation consortia. The Interuniversity Cooperation Program with Iberoamerican and Mediterranean countries was endowed with 21.5 million euros in 2008.

Within the framework of the World AIDS Conference for 2008, the Spanish government has just announced a contribution of 10.2 million euros to the UNAIDS Programme giving priority to research on vaccines and microbiocides. As far as other infectious diseases are concerned, in 2008, Spain contributed 16.3 million euros to the International Union against Tuberculosis and 12.9 million euros to the fight against zoonosis in the Mediterranean.

In the Iberoamerican context, the Spanish government supports the Pan American Health Organizationâ&#x20AC;&#x2122;s programmes with a total of 14 million euros to fight the main health problems in Iberoamerica especially communicable diseases. Lastly, the ISCIII contributes to the Tropical Diseases Research Programme of the WHO and other multilateral partners, focused on research and development of programmes to fight neglected diseases, as well as others led by the WHO within the field of infectious and chronic diseases.

The most important benefit of progress in understanding the human genome may be for common chronic diseases such as cardiovascular disease, diabetes mellitus and cancer.

However the integration of such knowledge into clinical practice is still in its early stages. Therefore many questions surround the current state of this translation. Some researchers have found gaps in knowledge about medical organization, clinical behaviour and practice, and patient needs that should be addressed to translate scientific advances of chronic diseases into practice11. It is estimated that it takes on average 17 years for proven medical advances to be incorporated into common practice, with the exception of new technologies and pharmaceuticals12.

We have not found estimates applicable to developing countries, including technologies that are already widespread in the developed world. However, new and innovative initiatives of public private partnership are underway13, 14, 15, 16,

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Key messages

Global burden of disease makes evident a tendency towards the globalization of health problems, sharing risks, disability and moral consequences, all of which require uniting efforts to combat these threats.

Spain is beginning a most exciting time for biomedical research growth in quality and impact in innovation. The target of the new Ministry of Science and Innovation is to make Spain one of the worldâ&#x20AC;&#x2122;s ten most productive countries in the field of science, technology and innovation by 2015. We already have the human potential; we just need to be successful in the management of economical resources, and to keep increasing these resources with public and, in higher proportion than now, private participation.

New and innovative initiatives of public-private partnership are underway, especially in vaccines.

The results of such programmes may create a precedent for R&D&I at the service of the neediest populations.

17

and the results of such programmes will create a precedent for R&D&I at the service of the neediest populations.

Flora de Pablo is Director-General of the Instituto de Salud Carlos III (National Health Institute Carlos III). An MD and PhD from the University of Salamanca, she worked at the National Institutes of Health in Bethesda (USA) for nine years until 1991, and in the California Institute of Technology in Pasadena (USA) in 1996. Until 2007 she was Professor at the Center for Biological Investigation (CSIC) in Madrid, where her group studied growth factors in embryonic development.

Isabel Noguer MD, MPH, PhD Isabel Noguer is currently working for the Instituto de Salud Carlos III, as a Deputy Director-General of International Research Programmes, and mainly devoted to promoting the participation of the ISCIII and National Health System centres in international research programmes, especially 7FP of the EU. She is an epidemiologist and public health expert. She worked for the Spanish Ministry of Health for 15 years in different fields, particularly HIV/AIDS. She conducted a wide range of technical and operational studies for international and multilateral agencies (World Bank, PAHO, UNAIDS, WHO), has several international publications and led different European and international projects.

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References 1.

Report of the intergovernmental working group on public health, innovation and intellectual property. 61st World Health Assembly actions. www.who.int/mediacentre/events/2008/wha61. Consulted on 30 July 2008.

2.

Accountability in poverty reduction strategies: the role of empowerment and participation. Social development papers. Participation and civil engagement. Paper 104, May 2007.

3.

United Nations Development Programme (UNDP). Human Development Report 2006, UNDP 2007. http://www.undp.org.cn. Consulted on 1 August 2008 4.

Murray CJL, Lopez AD. Alternative projections of mortality and disability by cause 1990–2020: global burden of disease study. Lancet, 1997 349:1498–1504.

5.

Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Medicine, 2006, 3(11):e442. doi:10.

1371/journal.pmed.0030442.

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Macroeconomics and health: investing in health for economic development. Report of the Commission on Macroeconomics and Health.

World Health Organization, 20 December 2001.

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Prochaska JO. Multiple health behavior research represents the future of preventive medicine. Preventative Medicine, 2008, 46:281-5.

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Howland RH. Limitations of evidence in the practice of evidence-based medicine. Journal of Psychosocical Nursing and Mental Health Services, 2007, 45:13-6.

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Finch R. Innovation – drugs and diagnostics. Journal of Antimicrobial Chemotherapy, 2007, 60 Suppl 1:i79-82.

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Owen N, Glanz K, Sallis JF, Kelder SH. Evidence-based approaches to dissemination and diffusion of physical activity interventions. American Journal of Preventative Medicine, 2006, 31(4 Suppl):S35-44.

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Scheuner MT, Sieverding P, Shekelle PG. Delivery of genomic medicine for common chronic adult diseases: a systematic review. Journal of the American Medical Association, 2008, 19;299:1320-34.

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Liang L. The gap between evidence and practice. Health Affairs (Millwood), 2007, 26:w119-21.

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Mahoney RT, Krattiger A, Clemens JD, Curtiss R 3rd. The introduction of new vaccines into developing countries. IV: Global Access Strategies.

Vaccine 2007, 16;25:4003-11.

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Graham WJ et al. Measuring maternal mortality: an overview of opportunities and options for developing countries. BMC Medicine, 2008, 26;6:12.

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Ryman TK, Dietz V, Cairns KL. Too little but not too late: results of a literature review to improve routine immunization programs in developing countries. BMC Health Services Research, 2008, Jun 21;8:134.

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Lawes CM, Vander Hoorn S, Rodgers A. Global burden of blood-pressurerelated disease, 2001. Lancet, 2008, 3;371:1513-8.

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Manzi F et al. From strategy development to routine implementation: the cost of Intermittent Preventive Treatment in Infants for malaria control.

BMC Health Services Research, 2008;31;8(1):165.

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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 development assistance and move beyond health research to a new paradigm, called “research for health”. The Danish Government considers research for health the tipping point in building good governance and democratic processes that are important for health. It is through such progress that long-term change on indicators of health and overall well-being can be accomplished. Health indicators, in particular, have come increasingly into focus as the world aims to achieve the Millennium Development Goals (MDGs) by 2015. However, it is also becoming evident that capacity to undertake research is as important as the research itself. Without a mass of qualified personnel able to think and act critically at all levels of the health system, core indicators of maternal and infant mortality, nutrition, malaria and tuberculosis will not reach the targets set by the international community, especially in Africa1.

The Council on Research for Development (COHRED) has defined this new paradigm, research for health, as “the wider range of activities and strategies that take health research one step further, and make it an essential input into both human and economic development”2. Research for health demands multidimensional knowledge which takes into account social, political, economic, ecological and environmental determinants of health, while simultaneously redefining “who” has the power to lead, fund, implement and use

T

research. Thus, traditional biomedical models and systems of health research are giving way to a more holistic paradigm3 based on equity and inclusion in order to impact and improve global health. This new emphasis, along with greater focus on quality of the research processes, will require major attention to capacity development, most notably for governments and civil society organizations in developing countries.

Through case studies emerging from Denmark’s support of research cooperation, and from global experience, this article will demonstrate how traditional research can be strengthened and complemented through the emerging paradigm and utilized in an effort to positively impact global health and well-being. More specifically, the article progresses as follows: it details the requirements of the new paradigm, and subsequently touches upon the road towards new standards, attitudes and behaviours as well as tools and methods within the framework of research for health. It ends with key challenges and recommendations based on the Danish experience.

Shifting paradigm The World Health Organization states that three out of eight MDGs, eight of the 16 targets to achieve the MDGs and 18 of the 48 indicators for success of the MDGs relate directly to health4. Health is an important contributor not only to the

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MDGs, but is also the basis for effective social and economic progress. In order to achieve the MDGs, a focus on better health for all – regardless of status – is very much needed.

In addition, research and the knowledge it generates is in demand. The emerging research paradigm requires building a broad based public health and research system5. This requirement demands a shift in the culture and practice of health research to “reach beyond academic institutions and laboratories”6 for providing a comprehensive evidence base for rights-based approaches to health policy7 that will include political and socioeconomic determinants that influence health and well-being8. Policy-makers, implementers of health sector reforms, health promoters and researchers need to expand their understanding of what constitutes “legitimate” evidence in this new paradigm, research for health, with the aim of more positively impacting inequities, and for the creation of conditions that create better research environments.

Take for example the Danish funded ENRECA (Enhancement of Research Capacity in Developing Countries) which had the goals of enhancing local research capacity and partnership through cooperation on equal terms between Southern and Northern partners. ENRECA began 15 years ago and spearheaded an increased focus on capacity building as a more integrated part of research projects. The researchers from the South who have participated in the ENRECA programme have been able to share their knowledge with other local co-researchers, and they have often been called upon as advisers by local authorities and by donor countries, such as Denmark. Within Denmark, ENRECA has been supportive in building a network of researchers for health. These programmes were the basis for what is now the Danish Research Network for International Health (DRNIH) (see Table 1).

What are the standards in the new research for health paradigm?

Central to the notion of Essential National Health Research Systems (ENRH) is the reference to “creating the conditions for health”9 and therefore the conditions for research for health. This not only implies that local communities, sociologists, development practitioners, economists, urban planners and public health specialists may inform the health agenda at the national level. It also increases the responsibility of the policy-makers in ensuring that they have the evidence needed to make appropriate policy recommendations for the health of their populations. This responsibility is amplified when considering civil society’s increasing role in research and “evidence-based advocacy,” and the trends towards a rights-based perspective in health internationally.

In the sphere of health and development, the gap between those who “know” (research community), those who “rule” (policy-makers) and those who “implement” (health technicians) has often been cited as a reason for political failure and the rise of the global burden of disease. A growing body of literature refers to this as the “know-do” gap10. The trend towards research for health introduces more domains of knowledge into the landscape aiming to ensure that all

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relevant fields (for example: social, environmental, political, economic) and levels (for example: individuals, civil society, local communities, academia at national level) of society are considered in health research policies and practices. This is further complicated by the changing burden of disease where noncommunicable diseases now have overtaken communicable diseases worldwide. These diseases are the primary cause of death in the 21st century – and will demand a very different approach to knowledge. In addition, other key challenges in bridging the know-do gap include the diversity of communication styles between the various actors, the tendency to develop research in isolation, competing agendas, time conflicts, and a difference in the understanding of “new” and “relevant” knowledge and research methods11. Approaching these challenges and creating appropriate research conditions will require the establishment of new standards with a stronger focus on capacity strengthening, collaboration, and the creation/management of knowledge through networks and partnerships.

Effective application of research implies that Denmark and our partner countries have the capacity to integrate new knowledge for policy-making and sustainable development.

Thus, capacity building (or strengthening) must be an integral part of research programmes in the Danish development co-operation.

Capacity strengthening is not only intended to provide technical skills to our partner countries in the South. It provides a learning environment where multiple actors and stakeholders can engage in a process of producing and sharing knowledge from research which promotes social mobilization for accountability, inclusion, cohesion and participation. In doing so, it strengthens the demand side of governance, giving an impetus to local knowledge production, management, and partnership as well as narrowing the know-do gap. It is important here to differentiate between networks and partnership. Networks exist as a “loose form of cooperation”, whereas partnerships are “highly structured forms of cooperation”12. Partnerships demand multisectoral actions and the setting of new standards on research for health which was stressed by the Pearson Commission on International Development.

North-South and South-South research networks and partnerships can serve mutual benefits when they promote and support equal participation of Southern partners. This approach has been promoted through support to the Danish Research Network for International Health (DRNIH) with a view to create synergy between research and policy13. In addition, they contribute to the evidence base on which informed action can be taken. While these types of networks and partnerships are not new in the research/policy paradigm, Denmark has observed that the emerging paradigm is shifting away from the traditional definitions of a “researcher” to include actors ranging from national governments and the private sector to institutions of higher education and civil society organizations. These actors are now taking an active part in networking or partnerships around research for health14.

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Global Forum for Health Research (1998-present)18 History Mission and objectives • Established as an independent international foundation

• Bring together influential stakeholders in health research for development to: • 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: • An annual conference • Socioeconomic, sociopolitical and cultural 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 • Emerged from consultation process within Africa on health research, concluding limited research input from countries in Africa due to lack of conducive research environments and leadership to build stronger health research systems (CCGHR 2006)

• Ensure that Africa’s voice on health research is recognized.

• Emphasizes the importance of ethical analysis in research

Activities • Organizes regional health research forums to enhance communication and collaborative efforts, and training for both researchers and community members • Publishes Africa Health Research Review and sponsors the Africa Health Research Fellowship to train research leaders and managers • Considers itself a “network of networks” (COHRED 2004) • In conjunction with WHO Regional Office for Africa and African Advisory 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 • An amalgamation of ENRECA programmes with emphasis on capacitybuilding in the South and the North

Activities

• Reduce inequities in health research and in the distribution of health research expenditures for addressing health problems of the poor

• Strengthen dialogue and interaction between research and development assistance in international health as a means of improving health in low-income societies, in line with the principles of Danish Development Assistance (DRNIH, 2007)

Activities • Provides unique set-up for different actors to work hand-in-hand in defining needs for further research in the area of international health as well as consolidating new knowledge

• 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 pharmaceuticals and drug resistance, capacity development for research interdisciplinary settings funded by Danida until and research networks November 2004. Thereafter • Generate new knowledge in areas that span a general assembly was Project examples: traditional disciplinary boundaries held which changed the • Bandim Health Project in Guinea Bissau assessing the effect of vaccination course of the network, • University of Copenhagen to work on skills development of Africa making it a formalized Universities entity • Tororo Community Health project in Uganda to focus on capacity enhancement. Together with district health teams are researching change • Members include: Danish processes in health systems to improve intersectoral collaboration research institutions, • Jointly with Danish Water Forum, supported Ghanaian partners in consultancy firms, NGOs, conducting workshop on water, health and sanitation. Forum advocated for advisers and research new knowledge, exchange of international experiences, identifying partner-institutions in loweffective methods to improve conditions, and gathering financial support income countries 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 programme between South African and the Netherlands

• Promote dialogue between Dutch and South African researchers

• Subsidize and foster research projects that are social development or policy oriented through annual call for proposals

• Advance more conducive research environment, particularly in historically disadvantaged communities, for quality research

• Organize Research Capacity Initiative (RCI), an intensive research methodology course intended to enhance research capacity of 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

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In considering the conditional and contractual aspects of partnerships, Maxwell and Riddell argue that actors in the current development environment have yet to reach true partnerships, which requires more than information sharing and policy dialogue15. Characteristics of a true partnership include jointly agreed country programmes and multi-annual financial agreements. Using these guidelines, a recent collaboration between the Danish Water Forum and the DRNIH to support practitioners in Ghana around issues of water, health and sanitation demonstrates an early stage of such partnership (see Table 1).

The growing international research for health landscape also boasts a range of networks that progressively show the emergence of true partnerships. Table 1 lists case examples, starting from the more global network, the Global Forum for Health Research, the regional African Health Research Forum (AfHRF), the national DRNIH and lastly to an institutionalized North and South linkage, the South Africa-Netherlands Research Program on Alternatives in Development (SANPAD).

In its trajectory to partnership, Denmark has been an active participant in the international dialogue for developing global research norms and has provided funding for specific research programmes. Furthermore, numerous thematic areas have been addressed with Danish research funding (see Table 1). A conscious choice is thus made to ensure that the research becomes demand driven, adheres to the Paris Declaration16, and focuses on the research results to be used and implemented as a contribution to poverty reduction. In this way the know-do gap that currently exists can be bridged.

What are the attitudes and behaviours needed in the research for health paradigm?

There is growing recognition globally that simply channelling additional funds into traditional health-care services (such as clinical medicine) and health research cannot be equated with “good health” and “good research” particularly when considering the rise of noncommunicable diseases. In order to truly impact the global burden of disease and reach the MDGs, the vision for research for health must not be limited to the national research/policy regime. It needs to be expanded locally and globally in order to ensure that knowledge is shared equally and capacity is enhanced in the research and policy regimes of countries which have limited resources to build up and sustain their research communities. This does not imply that the “North” defines its technical assistance in this regard to funding a handful of doctoral candidates from the “South”.

Rather, research for health should be considered a learning process for all partners involved, and this requires collaborative networking (horizontal South-South, vertical North-South and South-North, as well as diagonal across sectors and levels) between partners, and a balancing of health care between micro (immediate) and macro (long-term) needs. It should be based on the principles of the Ottawa Charter17 and include considerations beyond funding/financing. Understanding the diversity of the landscape and considering issues related to sustainability, relevancy and power relationships are a few of the requirements of this attitude shift. One important lesson learnt for Denmark has been that the shift in attitude had to

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start “at home” with recognition of the need to adapt to the new environment, as well as to develop our institutional capacity. This was the first step in ensuring equity and equality in the health sector.

Which tools and methods are used for research for health?

Crucial to the process of innovation in research for health are the different types, methods and tools of research. Types of research are for example biomedical research, health policy and systems research, social science and behavioural research, operational research and participatory action research. While the spectrum of the research landscape varies from the controlled clinical trials in the biomedical sphere to the analysis of power in the participatory action research sphere, each of the two spectra has their own strengths and weaknesses. While quantitative research often contributes to the understanding of the biological nature of diseases and assists in developing the products for treating ill health, qualitative research adds to the understanding of the “how, who, why, what when and where” of health. Qualitative research also informs the products and interventions of health systems and planning and provides the relevant knowledge of scaling up efforts that have the greatest potential of benefiting communities. How different methods and tools are selected and merged will depend on the researchers and the relevant stakeholders involved, as well as the context in which research is being implemented. It is important to remember that while methods and tools are scientifically developed, the choice of which is needed must remain context-specific.

Key challenges in research for health The key challenges ahead for development research include the growing impact of globalization, technological innovations and urbanization, which will make it increasingly difficult to separate research relevant for poverty reduction and research relevant for technological advances. Furthermore, 42% of global spending on health research and development is made by the pharmaceutical sector. Adjusting research funding to the changing aid modalities means that networking and partnerships in the future will be increasingly important. Having effective and efficient research structures and systems built into the local level planning systems, and having sufficient and qualified human resources to undertake research, add to the challenges emerging in the research for health paradigm. This fact will not only impact the funding and financing of research but will also impact the priorities of research as adjustments are made to the contingencies of this new reality. While this process needs to be addressed in donor countries such as Denmark, the importance of system strengthening and capacity building of our partner countries and us cannot be overlooked. The longterm aim is to ensure that qualified researchers will contribute to the global knowledge base as well as be able to develop their own countries.

Conclusion Denmark’s lessons learnt from funding, implementing and supporting research, have been two-fold. First of all, capacity

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and the creation of effective research environments.

building must be an inherent part of the development and research process. This does not simply mean funding PhD research students from the South to study in the Northern countries. Capacity building implies that both the South and the North are engaged in a “learning process.” This means recognizing that the Northern countries have just as much to learn as their Southern partners about process and collaboration. Investing more into higher education collaboration, which is fundamental for having qualified researchers in the first place, could be one option to be considered. Secondly, that establishing networks is only the beginning and not an end goal. The ultimate goal in the process of research for health is equal partnership. This process is everadvancing and “mistakes” become stepping stones and opportunities for consultation and reflection in order to change standards, behaviours and/or tools necessary for good research.

Drawing from these points on the Danish experiences and the core messages of the new paradigm, three important future steps include: Consensus on redefinitions and rearrangements of who is involved in research, how it is conducted and a common understanding of what principles laid the foundation of the research within each local and national setting for the evolution of a new landscape of research for health.

Risk taking and synergy building between development partners such as funders, researchers and implementers of health leading to good governance and based on ideals of partnership.

Global health research priority setting to support the strengthening of essential national health research systems

The Global Ministerial Forum for Research for Health in Bamako, November 2008 will be an opportunity to discuss common challenges and to develop genuine partnerships on research for better health. J Kirsten Havemann is a social and public health specialist with interest and expertise in health and social sector analysis, design and systems development. She has extensive knowledge and skills in participatory and action-oriented research and operations. After her more than 20 years of field experience in Africa and Asia where she held substantive posts, such as Senior Adviser for the Danish Government, she moved to the World Bank’s Social Development Department working on social accountability, the WHO as governance research officer and now for the Danish Government as Senior Adviser for Health.

Ulla Tørnæs has been Minister for Development Cooperation in Denmark’s Ministry of Foreign Affairs since February 2005.

Following studies at the University of Chambéry, France (1984–85), Copenhagen Business School (1985–88) and Copenhagen University (from 1991), she worked in the Secretariat of the Liberal Parliamentary Party from 1986 to 1994. She sat on the Party Committee and the Executive Body of the Liberal Party in Østre Storkreds (a Copenhagen constituency) from 1988 to 1991.

Following several roles within the Liberal Party, Ulla Tørnæs became its Political Spokesman in the Folketing (Danish Parliament) in 1998. She was Minister of Education from November 2001 to February 2005.

References 1.

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United Nations Development Program. Millennium Development Goals Report. New York, UNDP, 2006.

Council on Health Research for Development (COHRED). Supporting Health Research Systems Development in Latin America, Results of Latin America Regional Think Tank. Presented at Latin America Regional Think Tank, Antigua, August 2006, Record Paper 6. (Quoting p. 4.)

A paradigm is what members of a scientific community, and they alone, share. See Kuhn, T.S. The Essential Tension. Chicago, University of Chicago Press, 1977. A paradigm shift is therefore a major change in thinking towards a new set of standards and behaviors for which practioners may be accountable. The degree of success can be measured by the ability of these paradigms to solve increasingly difficult questions. See Barker, J.A. Paradigms: The Business of Discovering the Future. In: Pierce, J.L. & Newstrom, J.W., eds. The Manager’s Bookshelf. A Mosaic of Contemporary Views. New York, HarperCollins College, 1996.

World Health Organization. Health in the Millennium Development Goals.

Online: http://www.who.int/mdg/goals/en/ (date accessed 31 July 2008).

Hunter, D.J. Health Needs More Than Health Care: The Need for a New Paradigm. The European Journal of Public Health, 2008, 18 (3): 217-219.

World Health Organization. World Report on Knowledge for Better Health: Strengthening Health Systems. Geneva, WHO, 2004. pp. XVI. Johnstone, P. Evidence for Evidence-Based Policy. Presented at 6th International Cochrane Colloquium, Baltimore, Maryland., 1998.

Bryant, T. Role of Knowledge in Public Health and Health Promotion Policy Change. International Health Promotion, 2002, 17 (1): 89-98. Citing: Tesh, S. Hidden Arguments: Political Ideology and Disease Prevention Policy.

New Brunswick, NJ, Rutgers University Press, 1990Raphael, D. The Question of Evidence in Health Promotion. Health Promotion International, 2000, 15 (4): 355-367.

Hunter, D.J. Health Needs More Than Health Care: The Need for a New

Paradigm. The European Journal of Public Health, 2008, 18 (3): 217-219.

World Health Organization. “Bridging the Know-Do Gap”. Meeting on Knowledge Translation in Global Health. Geneva, WHO, 2006.

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Academy for Educational Development (AED) Center for Health Communication. Bridging the Gap between Public Health Research and Practice: Lessons from the Field. Washington, D.C., AED, 2005.

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Baud, I. North-South Partnerships in Development Research: An Institutional Approach. International Journal of Technology Management and Sustainable Development, 2002, 1 (3): 153-170. (Quoting pp. 154-155) 13.

Tostensen, A. Bridging Research and Development Assistance: A Review of Danish Research Networks. Bergen, Chr.Michelsen Institute, 2006/7.

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Baud, I. North-South Partnerships in Development Research: An Institutional Approach. International Journal of Technology Management and Sustainable Development, 2002, 1 (3): 153-170.

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Maxwell, S. & Riddell, R. Conditionality or Contract: Perspectives on Partnership for Development. Journal of International Development, 1998, 10 (2): 257-268.

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Organization for Economic Co-operation and Development (OECD). The Paris Declaration. Online: http://www.oecd.org/document/18/0,2340, en_2649_3236398_35401554_1_1_1_1,00.html (date accessed 31 July 2008).

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This Charter supports the building of healthy public policies, creating supportive environments, strengthening community action, developing personal skills and re-orienting health services.

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Global Forum for Health Research. Online: http://globalforumhealth.org (date accessed 26 July 2008).

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African Health Research Forum. Online: http://www.afhrf.org (date accessed 26 July 2008).

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South Africa-Netherlands Research Program on Alternatives in Development. Online: www.sanpad.org.za (date accessed 26 July 2008).

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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 delivered at the State of the Planet Conference on 27 March 2008, held by the Earth Institute at Columbia University in New York, United States.1

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This afternoon I would like to share with you what I would call a personal journey, which has meant a great deal to me and helped to shape some of the key ideas that we are working on now.

You might ask why a foreign minister has been invited here to talk about health. Surely we have health ministers for that.

I will try to answer this question.

I was brought into the field of global health in 1997, when Dr Brundtland, the outgoing Norwegian Prime Minister, decided to run for Director-General of the World Health Organization. And I was invited in on her team.

In the autumn of 1997, we campaigned in Africa. During these travels with Dr Brundtland, I saw things that I had never really seen before. I saw that health issues had important implications extending far beyond the health sector.

And how incredibly important human health, national health and global health were to so many of the dimensions of society.

I remember when we arrived in Botswana, a country that Norway has worked closely with for many years. We had just concluded our development cooperation with Botswana because the country had made so much progress. Life expectancy had risen to 70, which is quite sensational in an African context.

But while we were there, researchers from the University of Harare published new figures that readjusted average life expectancy in Botswana to 35 years. This was in 1997, when the first AIDS figures really started to make an impact.

And we could literally see and feel the consequences for the population, for the integrity of the state. What would happen to the teachers, the police, the army, the civil servants, the We need to establish a link between investing in health and improving the health status of the population – of the productive fabric of society. We need to convince political leaders that if we do these things, there will be more to share

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mothers and fathers?

Then we went on to Angola, which had a seat on the board of WHO and was going to cast its vote. There we met with the Health Minister, and I discovered that the Minister was not in the Angolan cabinet, not in the inner circle of government.

I then developed my own thesis that there is a negative correlation between the weight of the health challenge and the influence of the health minister.

In my country, as in other developed countries with good health status, you win or lose an election because of health policy. Whereas in the poorest countries, health is all too often simply given low priority.

When Dr Brundtland was elected and took up her post in Geneva, one of the first things she said was that our main challenge is not to deal with health ministers – because they know the problems. It is to try to get through to presidents, prime ministers and finance ministers, and give them this simple message: you too are health ministers.

We need to find new ways of portraying health expenditures as more than costs, but also as an investment.

And we need to develop a new language and a new mindset that will enable us to reach and communicate with the real circles of power. Health professionals are too focused on their own field and have a limited ability to communicate with people in other sectors.

This is really an extension of the conclusion of the Brundtland report, Our Common Future. We need to get to the core of the economic dimension and speak a language that people with power really understand.

We need to establish a link between investing in health and improving the health status of the population – of the productive fabric of society. We need to convince political leaders that if we do these things, there will be more to share.

If they fail they will be wasting their opportunity as political leaders.

This is in fact what brought us to Jeffrey Sachs. We wanted someone who could convene some of the world’s leading economists with experience in these areas to work on documenting what everybody could see – that if you are poor, you are more likely to have poor health. But it is less well documented that poor health in itself breeds poverty, creating a vicious spiral. So we were convinced that we had to get this down on paper and document it and its implications.

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Jeffrey Sachs’ commission presented the report at the end of the year 2000. I am certain that the process we launched then contributed to the methodology used in devising the Millennium Development Goals (MDGs). The study documented how appropriate, timely action can save 8 to 10 million lives a year. That in itself would be a real humanitarian gain. But such action would also help to increase life spans, productivity and economic well-being, especially of the poor.

But the study also documented that this will not happen by itself. There has been a prevailing idea that as long as countries continue to develop, health will simply follow. This is not the case.

So there is a need to scale up the spending on health, by the poor countries themselves, and by better targeting development assistance for health. The report is particularly valuable because it demonstrated how affordable this operation could be. It documented the difference it would make if rich countries devoted one tenth or 1% of their gross national income to health-targeted development assistance for specific interventions.

That would be an investment that would be repaid many times and save millions of lives every year, and it would provide economic development and global security.

There were many who criticized this approach and argued that there are too many vertical interventions, such as bed nets and vaccines. And that the approach to health care should be much more horizontal.

But these approaches can be combined. Unless we have a massive focus on what is literally on our own doorstep, we can forget about the horizontal process, and about making tangible differences in health.

Another conclusion of the report was the importance of partnership – which I believe is really a key lesson.

Partnership is a simple word, but a very complex thing to practise. The Sachs Commission concluded that more development assistance should be targeted towards health, while poor countries should allocate more money for health over their budgets.

It is only if this works together that it will make a difference. Partnerships between rich and poor, partnerships between the private and the public sectors.

Some said that this was going to be a great challenge for the UN. Why are we inviting the private sector in? Isn’t it the UN that has the mandate to do these kinds of things?

You have to remember that the idea of public-private partnerships still was quite new as it first emerged as an idea in the 1990s. We felt that in the WHO, working with Dr Brundtland, the way she reached out to the private sector, was being criticized by those who said “it says in our mandate that we are the leaders in health”.

But let’s not forget that it was Kofi Annan himself who invited other sectors to join the global fund to fight AIDS, TB and malaria. To mobilize US$ 10 billion every year to make a difference. So if the UN had not embarked on that course, I think the idea would have been marginalized.

There were a number of other areas that started to attract attention. Vaccines for example. A major effort by the WHO

and UNICEF in the 1990s had brought coverage up to 80%.

A very high level. But since 1990, there has been stagnation and almost status quo. How do we mobilize a new campaign for vaccines? How do we create new markets for malaria medicine?

When the first Stoltenberg government took office in March 2000, the Prime Minister decided that Norway would take on responsibility for providing vaccines for every child in the world. So this was a “Norway–Gates coalition” in a way.

Gates in the private sector and Norway in the public sector – investing in a specific alliance: GAVI, the Global Alliance for Vaccines and Immunization.

I remember discussing this with Prime Minister Stoltenberg, and how easy it was to bring him on board – for three reasons. First, because he was a father and he had had his children vaccinated. It is something you do for free in Norway. You don’t have to think about paying for it, you take it for granted. Because it is part of what the welfare state offers. Secondly, he is an economist, and he saw that vaccination is by far the most cost-effective intervention you can make. You can prevent disease with two shots at a very early stage in life. And, finally, he was a politician. So he could bring this into the realm of political action.

I believe that what happened around 2000, with the launching of the MDGs, was a response to the heightened awareness of all politicians, not just health ministers, of the link between health and development.

I would like to touch briefly on a few of the changes that have taken place since then. Ten years ago, world investments in health aid totalled US$ 4 billion a year. This has more than tripled to US$ 15 billion today.

Around 2000 AIDS treatment was out of reach, and when drugs came on the market, it was at a cost of US$ 40–100 a day. A cost that neither poor people nor donors could afford. Now it costs 4 cents a day to treat AIDS, and more than 2 million people are receiving treatment. That is far too few, but it is a beginning.

Malaria was and is the top priority of every African health minister. Today, tens of millions of bed nets have been distributed and new drugs have been made available on a broad scale. Where the majority of children sleep under nets, malaria wards stay empty.

As I said, there was great frustration about vaccination, with coverage stagnating and new vaccines not being introduced. This situation has now been turned around, and for example measles mortality has dropped by 90% in Africa.

Additional hundreds of millions of children are being vaccinated. The GAVI Alliance has saved between two and three million children from dying every year since it began its work. Tobacco was another serious world health problem.

Around 2000, it was predicted that tobacco would be the leading cause of death by 2020. That might still happen, but it is likely – thanks to the framework convention on tobacco control – that this prediction will not come true.

The process of developing the convention is quite another story, and I will not spend time on it here. But work on the convention started two months after Dr Brundtland took office, and was concluded two months before she left the

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WHO. It is modelled on the Kyoto Protocol. So it is another example of lessons learned across sectors.

These approaches gave rise to an ethics of politics. It is about engagement, it is about the political will to seize opportunities, it is about partnership, and it is about burden sharing. And I believe that these approaches can be used to combat climate change, to promote health, not only in a number of development areas, but also in dealing with international conflict. And it coincides closely with what we are trying to achieve in Norwegian foreign policy.

In 2005, Jens Stoltenberg returned as Prime Minister and I became his Foreign Minister. And we scaled up our approach to health. Stoltenberg took the vaccine initiative one step further, and Norway pledged to make a real difference, not only in vaccinating every child, but also in fulfilling MDGs 4 and 5 – reducing child and maternal mortality.

And we are now investing 100 million dollars a year specifically for interventions in this area, not alone, but in partnership with the private sector and with specific governments. Having worked with and been inspired by my countryman Jan Egeland and his work in the UN and elsewhere, and with Jeffrey Sachs, I saw that as Foreign Minister, I could deal with health differently than has been the case in the past.

I realized that health was not just the province of health ministers, finance ministers, presidents, prime ministers, but also of foreign ministers. Because health disasters are also a cause of conflict. They are a cause of environmental degradation and of collapsing and failing states.

We all know that threats to health do not respect national borders. So this is clearly a challenge for foreign policy. We know that developing countries carry the heaviest burden as regards disease, but have the lowest capacity for prevention, treatment and control. So global health security is only as strong as the weakest link.

Are we prepared, as foreign ministers, to face a global health crisis? Norway closed its border with Sweden for the first time in modern history during the outbreak of mouth and foot disease in 2000. And we were completely puzzled by the question “how do we reopen borders? When are you certain that the epidemic is over and we can do so safely?” This is a foreign policy issue. It is easy to deal with Sweden, our neighbour, in such cases. But there can be other settings were this is more complicated. As foreign ministers, we need to review government structures and systems and adapt them to better respond to global interdependence.

When I became Foreign Minister, I called six of my colleagues in different corners of the world and asked them to join me in an informal setting to address this issue. And to try to highlight what it means to be a foreign minister in an era where health problems are global. I approached France, Thailand, Indonesia, South Africa, Senegal and Brazil. And they all responded favourably. We met at the UN in 2006 and appointed experts to work out an agenda, identify the problems and to advise us on a plan of action. We came together in Oslo in March last year to adopt the Oslo Agenda, the Oslo Declaration and a plan of action. We singled out ten foreign policy areas where we need to take a look at the

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health implications. Are health concerns being given the necessary priority? Are we applying the foreign policy tools at our disposal to get to grips with them?

Against the backdrop of an evolving health and development agenda, I believe we have something new emerging here. At the UN General Assembly last September, we were 30 foreign ministers who came together to discuss these fields.

In order for us to make these ideas workable, we need to continue take a broader view and work out new perspectives.

We still take a very traditional approach in the debate on national and global health security. We discuss our own country’s perspective – with the main focus on protecting our own population. That is our responsibility as governments.

Even the threats of pandemic flu can be seen in this light.

We buy drugs for our populations. But as we all know, viruses and bacteria know no borders. So if we include the perspective of interdependence and shared vulnerability across nations and regions, we need to add a broader dimension to this debate. More than anything, it calls for solutions in which the benefits of preparedness are equitably distributed.

Because my insecurity does not depend on the Norwegian health system, it depends on systems far beyond Norway. All of this has to influence our development policy, our UN policy and also our Norwegian foreign policy.

As a final observation, one important insight of this group of experts is that health security cannot be interpreted narrowly. What we need is an understanding of the determinants of health. Poverty is of course intuitively recognized as a core determinant even though we have failed to address it fully.

Two more direct determinants of health that are often overlooked are trade and intellectual property rights. In many countries, HIV and AIDS are overloading already weak health systems and having impacts on capacity, preparedness, human rights and movement across borders. This has foreign policy implications.

We also have to address how fragile states might collapse under what we call “the double burden of disease”. Poor countries struggling with the burden of infectious diseases are increasingly being burdened with non-infectious diseases – which often cripple a poor health system.

Another dimension is that rich countries are recruiting health workers from poor countries to take care of an ageing population. This gives rise to a number of very serious, ethical and economic issues. These, too, must be brought into the foreign policy agenda.

I would like to conclude by mentioning a concrete example that I never thought I would deal with as foreign minister – the issue of virus sharing.

Indonesia has been hard hit by avian influenza. Bird flu is widely considered to be one of the most likely sources of the next global pandemic. And global preparedness relies heavily on monitoring the outbreaks, particularly those which affect humans. A year ago, Indonesia felt that it was being short-changed by the international community and asked bluntly why it should contribute to the production of

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a vaccine it will not be able to afford and would be unlikely to ever have access to by sharing its virus – good question.

I disagree with Indonesia’s decision to stop sharing the virus from local outbreaks, because I believe that Indonesia and all other countries should contribute fully to global preparedness. But I also understand and agree that we must make sure that the benefits of preparedness are shared equitably and sustainably.

One of the most shocking observations I was met with when I got to the WHO was that there is no opportunity to prepare malaria drugs, because where there is no money there is no market for these drugs. But for a disease that strikes somewhere between a half and one billion people each year, how can we say there is no market?

And if we accept that there is no market for malaria medicine simply because people can’t afford to buy it, that is also a market failure.

What this all adds up to is that this is a matter of political will, of knowledge and of partnership.

Thank you for accompanying me on this personal journey. J Jonas Gahr Støre is Minister for Foreign Affairs of Norway. He has a degree in political science from the Institut d’Etudes Politiques de Paris, and has held a teaching position at Harvard Law School. His first introduction into public life was as Special Advisor to the Prime Minister, followed by a three-year tenure as Director-General of the Prime Minister’s International Department.

In 1998, Mr. Støre was appointed Ambassador of Norway’s Permanent Mission at the United Nations in Geneva, but served only briefly as he was asked by former Prime Minister of Norway and then Secretary-General of the World Health Organization, Gro Harlem Brundtland, to become her Chief of Staff.

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

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“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

Man has created new worlds – of language, of music, of poetry, of science; and the most important of these is the world of the moral demands, for equality, for freedom, and for helping the weak.

KARL POPPER.1

ealth policy in developing countries is increasingly committed to the worlds of science and equity.

Evidence-based policy-making can thus be conceived as an innovation process integrating, within politics, the values of healthy life, objective truth and fairness. Innovation becomes particularly important to support the political processes of decentralization, poverty reduction and regional integration. Health metrics are increasingly focusing on inequities and therefore on the potential as well as on the urgency for improvement. Comparative sociology, economics and health system sciences are responding through innovative social and policy arrangements as well as through improved evaluation methods.

This article presents case studies in innovation at the two health system poles of decentralization and regionalization.

Attention is given to the role of evidence-based financial protection policy implementation by local health authorities.

Two case studies are presented to illuminate evidence-based policy-making at the regional level: Salud Migrante, a pilot project to develop binational health insurance for Mexican migrants in the United States, and the Mesoamerican Health System, a multi-national effort to address disease control and health system strengthening. These examples suggest that research can be an invaluable tool to transform what are political constraints for policy-making at local and regional levels into opportunities to move towards new organizational frontiers.

H

Health system vulnerability Middle-income countries, particularly in Latin America, are finding it increasingly difficult to extend health care through traditional social security institutions due to increasing costs

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of medical care, growing competitiveness from international markets, and the growth of the informal sector. Innovative social protection models are thus being designed and implemented to reduce catastrophic family health expenditure, channel national and state subsidies and to encourage family prepaid contributions2.

Mexico’s System of Social Protection in Health was thus 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 the programme through payments to state health authorities based on strengthening infrastructure, meeting federal standards and promoting the voluntary and in most cases contributory affiliation by families to the insurance scheme.

Yet reaching this goal may not be easy, particularly in poor states where the proportion of the uninsured is highest and the health system capacity gap also the greatest.

Furthermore, health expenditure is currently being channelled through out-of-pocket private health care for about half of the total, involving families across the social spectrum.

Adding to this complexity is the fact that 11.8 million Mexicans work as migrant labour in the United States of America, accounting for 10% of the population. They also leave behind close to 4 million relatives, and have 4 million US-born children with them, for a total of close to 20 million of population that rely to different extents on institutions both sides of the border4. Up to one third of financing for private care in Mexico could be resourced from the remittances sent by migrants. These families face a complex scenario for health insurance. They express health needs in both countries, they face highly differentiated service and insurance demand and supply factors across them, including insurmountable barriers for comprehensive health insurance in the United States. The question is whether Seguro Popular will be able to insure health needs in Mexico and to reduce private expenditure.

Another question is whether Seguro Popular can provide a backbone of services to support returning migrants and to provide health care for needs that cannot be insured abroad.

Looking South, Mexico shares an ecology with its Central American neighbours and needs to address health issues such as malaria, dengue and HIV-AIDS from a regional standpoint. Mexico also has an important number of

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Guatemalan migrants and is a pass-through country for migrants to the United States. Mexico and Guatemala have just established a Binational Health Commission, while Central American countries have kept a common health agenda for decades. Thanks to long-standing research on health and migration, Mexico is now leading a Global Fund financed project to pilot strategies to promote migrant HIVAIDS prevention and promotion in border-crossing points throughout Central America and Mexico. More recently, presidents of Central American countries plus Mexico and Colombia agreed to develop the Mesoamerican Health System, an evidence-based policy development platform led by the National Institute of Public Health (INSP).

Strengthening local capacities and knowledge brokering To address the need to strengthen research capacity at state level in Mexico a number of research and policy institutions joined forces to establish the consortium Health Systems Research for State Sector Development (INDESES). This effort is being supported through national and international funding and collaboration, including Mexico’s Science and Technology Institute (CONACYT), the Canadian Health Services Research Foundation (CHSRF), IDRC and the Alliance for Health Policy and Systems Research. INDESES aimed to strengthen specially the demand of health systems research by state policy-makers and managers through assessing and intervening along the four “A”s of research – acquisition, assessment, adaptation and application.

INDESES developed a curriculum originally structured by CHSRF’s EXTRA training programme, aiming to strengthen evidence-based policy-making through increasing capacity to utilize research5. The focus has been on multi-institutional managerial teams to address their coordination issues through research-based interventions. Specific tools to strengthen the interface between researchers and users were also developed. Literature synthesis methods were developed on the basis of international experience focusing on interventions for vulnerable groups. On this basis a listening exercise was developed to identify policy-maker and managerial concerns. CHSRF’s 1:3:25 executive summary format was also implemented to provide an effective means to divulge research results.

Policy-makers and mangers were provided with a tool also developed initially by CHSRF’s to assess their capacity to utilize research and to plan strategies to strengthen it accordingly6,7. Results of a first wave of application were collated to test the tool and to obtain a diagnosis of utilization capacity at the aggregate level. Not surprisingly, results demonstrated widely differing capacities and strengthening needs according to level of development. Less evident were findings suggesting that research acquisition is a higher priority above analysis, adaptation and application. In richer states it was recommended to strengthen acquisition mainly through increasing the skill levels of mangers. In poorer states preference was given to strengthening the importance accorded to research by top decision-makers. No major differences were detected across the various public

institutions or private providers, in spite the fact that they operate with very different resource bases. This suggests the importance that the socioeconomic context plays in determining research utilization patterns and capacities.

Much is being said about the importance of developing knowledge brokers as a bridge between researchers and users. To put this idea to the test, the National Institute of Public Health (INSP) developed State Centers for Health Systems Development (CEDESS) as a franchise-like arrangement for operation by interested nongovernment organizations working in health systems. Agreements are signed between INSP and the NGO, enabling them to offer, adapt and execute existing training courses and applied research protocols with state health agencies. CEDESS also disseminate research results through executive summaries and liaise INSP researchers with local projects and development programmes. Importantly, CEDESS do their work as far as possible with local academic and consulting agencies, thus strengthening local capacity. Activities have included the evaluation of the state immunization programmes, support for the development of a range of model innovations in selected municipalities, and training in evidence-based health promotion.

South-North collaboration for binational health insurance innovations INSP established a collaboration between US and Mexico health providers, authorities and academics to develop Salud Migrante, an evidence-based binational health insurance for migrants. Innovation design were based on evidence coming from a wide range of intersectoral issues: the effects of remittances on private health spending in Mexico, catastrophic health spending in the US, lack of access to health services due to distrust, forced repatriation of migrants to Mexico due to unmanageable health conditions, the political pressure for regularization of migrants in the US as well as willingness to pay studies for highlighting the potential of cross-border health services.

Innovation design focuses on integrating the private notfor-profit health providers and insurance agencies in the US with the public health system in Mexico, with the aim of integrating as far as possible financing and referrals. A coalition of partners has been established and pilots are being prepared across two US and two Mexican states. The Mexican federal government has made critical commitments to support binational health insurance. On this basis, a package of essential primary care services is being designed for universal access by migrants in the United States, to be provided mostly by community health centres and insured through non-profit health plans. A key provision is that funding for services in the US should come from migrant contributions and other private or public sources. Migrants will be supported to access Seguro Popular in their states particularly to access secondary care services and to insure their dependents’ integral care in Mexico. To this end, Seguro Popular promotion and affiliation will be made available in the United States through web-based facilities and with the support of community agencies.

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implement a range of programmes to strengthen health system capacity through applied research and training, thus ensuring that the vertical programmes at the core of the Mesoamerican system lead to a diagonal effort widely benefiting national health systems.

The main challenge of Salud Migrante includes organizing the insurance scheme in such a way that it gains the migrants’ trust to cross the border for secondary care and to reunite with a public service in Mexico that has not always responded to their needs. A key component to surmount this barrier will be the design and implementation of Salud Migrante, an agency in Mexico capable of articulating health service providers and insurers within each country and across the border.

Research is being undertaken to develop the operational platforms required for the sound operation of Salud Migrante.

This involves a coalition of research and service provider partners and is being led by INSP. This effort represents a historic South-North collaboration in research and innovation. INSP is well prepared to assume this task given its full accreditation with the Council on Education for Public Health, the US body accrediting most schools of public health in the US.

Lessons Middle-income countries in Latin America and other regions have the capacity and indeed the imperative of promoting innovations for health systems integration through nationallocal, South-South and South-North collaboration. These efforts should be accompanied by North-South selective funding efforts and technology transfer to empower their Southern partners with the capacity to develop large-scale, international projects based on their proven technical and political leadership.

Research institutions can play a critical role to bridge across bureaucratic and international boundaries through missionoriented research. Projects of sufficient scale and scope can lead innovation design, enable the incubation of new institutional arrangements and undertake piloting and evaluation. Research institutions in middle-income countries have in many cases developed sufficient networking, trust and accreditation by partners North and South to support this important role for innovation.

Innovations should also be supported through knowledge brokering and research capacity building efforts. Research institutions can play a key role to help in the assessment of the capacity to utilize research by programme managers and policy-makers, to train knowledge brokers based on such assessments, to facilitate the uptake of research by policymakers through specific tools and methods, and to develop research and innovation priorities in critical health system development areas. J

South-South collaboration for regional integration INSP is collaborating with efforts to establish the Mesoamerican Health System, an initiative recently announced by the presidents of Central America, Colombia and Mexico as part of their ongoing regional integration. With the international funding from partner countries, foundation and bilateral agencies, such a system aims to eradicate malaria and undernutrition, the control of dengue, lowering the costs of medicines and strengthening capacity to address emerging epidemiological risks. CISS is now leading a regional effort to assess research and epidemiological surveillance capacity by public health institutions in participating countries, an initiative funded by the International Association of National Public Health Institutes.

Based on this assessment, a Mesoamerican Public Health Institute is being developed as a consortium to provide the secretariat and technical support coordination functions for the Mesoamerican Public Health System. This effort will

Miguel Angel González Block is Executive Director, Center for Health Systems Research, National Institute of Public Health, Mexico.

References 1.

2.

3.

4.

5.

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Popper, Karl. The Open Society and its Enemies. Plato, Volume I: Hegel & Marx, Routledge & Kegan Paul, London, 1945.

Tokman V. Inserción laboral, mercado de trabajo y protección social.

Documento de proyecto. CEPAL 2006.

Frenk J et al. Reforma integral para mejorar el desempeño del sistema de salud en México. Salud Pública Mex 2007, 49 supl I:S23-S36.

González Block MA et al. Salud Migrante. Propuesta de un Seguro Binacional de Salud. Perspectivas en Salud Pública, Sistemas de Salud, Instituto Nacional de Salud Pública, 2008. ISBN 978-970-9874-81-5.

CHSRF Extra Canadian Health Services Research Foundation CHSRF

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6.

7.

Canadian Health Services Research Foundation, Executive Training for Research Application EXTRA. Ottawa: http://www.chsrf.ca.

González Block MA et al. Utilización de Investigación por gestores de salud. Desarrollo y validación de una herramienta de autodiagnóstico para países de habla hispana. Salud Pública de México 2008a. Aceptado para publicación.

González Block MA et al. Utilización de investigación por gestores de salud. Desarrollo y validación de una herramienta de autodiagnóstico.

Enviado a Publicación. Salud Pública de México 2008b.

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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

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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 evaluating a health situation consists of analysing it from the point of view of diverse social groups who are supposed to benefit from the development programmes and who also physically feel the difficulties of their situation each day.

Of course, one must beware of succumbing to a “populist” approach or confusing the “actors oriented” position with a naive approval of what could be considered as “traditional” or unanimously shared homogeneous “communitarian” opinions. Populations everywhere are pluralist and always manifest economic inequalities, contradictory cultural options and political conflicts1. To put it simply, nothing is ever “communitary” or “traditional”: everything is always “political” and “historical”.

Besides, if various “laymen” behaviours are socially explicable, this cannot mean that they are coherent and commonplace from the health angle. Having reasons for acting in a certain way cannot be synonymous to right action, and a good number of causes of infantile and maternal mortality find their explanation in harmful popular behaviours. But once these precautions are taken, the approach “from below” is indispensable because it permits the shift from “global” to “local” and allows the study in situ of how big strategies conceived by international institutions come to install themselves in the ordinary course of lives and in social practices that impact on health.

These ordinary dimensions of daily life are often ignored by research or development programmes. And if the technical goals of “projects” benefit from a lot of attention, these social dimensions are evoked only very erratically under the term “context”. The error here is obvious, since this term in fact designates a set of essential variables: how one eats, lives, sleeps or washes…in short, the “context” that we have not yet taken the time to study is simply “all that is social”, and that nevertheless determines and explains the essentials of the actors’ behaviours.

Methodologically, this qualitative approach “from below”

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corresponds to several theoretical models that emphasize the links between “sociological reasoning” and its socio-historical environment2. It is sufficient here to mention “thick description” that aims at describing and analysing the links between actions and the meanings given to them by their authors3 or micro-history that identifies invisible structures according to which the actors’ experiences are articulated4.

Concretely, in the framework of the application of health programmes, this position enables two vital processes. It first permits the comparison of words used by “developers” and the realities they are supposed to designate. In short, it permits us to know if the notions used to define health strategies have a “real” reference or if they are mere “paper words” designating only the rhetorical universe of “projects” and “seminars”5. Consequently, this position permits us to analyse the applicability of theoretically conceived health measures in real situations – more precisely, in their “contexts”.

Proposals and difficulties of malaria prevention programmes Let us briefly recapitulate the situation. Globally, various preventive strategies for limiting the morbid effects of malaria – besides vaccine research – have three objectives that imply broad fields of activities, with unfortunately as many specific difficulties6.

(1) To begin with, establishing an early diagnosis can permit a rapid and satisfactory management of the disease and the necessary observation of the treatment. However, forms of resistance to antimalarial measures that have been observed give the impression that the treatment is not always appropriate to the complaint as would be desired.

Questions of quality of health offer and mutual understanding between populations and health personnel are essential here.

The exchange of health information always implies a translation of the doctor’s technical medical vocabulary into the laymen’s representations of the illness. This difference between reference systems explains the great number of

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difficulties of mutual understanding between health teams and populations. This is accentuated by the fact that in a number of countries, the scientific language used (most often English or French) is different from the language ordinarily employed by people to express themselves. In this case, when local languages do not possess a true scientific lexicon and medical terms, the health dialogue requires multiple interpretations and adaptations of the terms used. Health dialogue can then be described as a confrontation between two semantic systems bringing about different classifications of the pathologies.

Several “distortions” will then result. Some diseases like malaria, distinguished by the medical discourse, can be conceived by populations as constituting a single morbid unit (“diseases of fever”) and hence interpreted wrongly as benign. Reciprocally, several clinical signals defining a single medical syndrome can be distinguished by populations as many different illnesses.

Lack of scientific analysis of these laymen interpretations of the disease and its treatments have made confusions between health teams and populations more of a norm than an exception. Yet, populations can only adhere to the prevention of what they can label and understand. Very broadly, these constant divergences prevent the establishment of a true health dialogue and encourage populations to have recourse to popular remedies or “informal chemists”7 – economically more costly than judicious medical treatments, but culturally closer to the populations.

To put it plainly, following the treatment and resistance to new molecules is largely a matter of communication and quality of the health offer.

(2) Preventive measures must then be planned and implemented particularly for “risk” groups, such as pregnant women. Bednets and insecticide-treated curtains used for some years seem to constitute an effective means. However, they are still little used in Africa outside “pilot” programmes.

This is simply because “bed manners” defined according to kinship, the status of the child or ill-adapted architecture, gradually deconstruct and dilute the theoretical coherence of health “messages”.

Thus, preventive proposals are remodelled by the ordinary course of things: bednets are torn during children’s games, intense heat prevents people from sleeping under the net, sexual intimacy leads to children being kept at a distance, mosquitoes breed in beds with boards, the status of elders reserves bednets for seniors.

These ordinary norms and daily actions construct references for a way of living. This is why impregnated bednets are used in the frame of restricted programmes – when “the project” plays the role of a reminder for the new norms proposed. But their effectiveness diminishes when new actions imposed by this innovation are eroded or demolished by the routines of daily behaviours.

(3) Finally, from an administrative point of view, the multiplicity and “verticalization” of programmes makes their harmonization difficult. It often leads to confusion among populations and provokes iatrogenic effects

like the constant transfer of health personnel towards more “profitable” programmes.

An economy of “projects” is in evidence everywhere (bonus, daily allowance, transport) along with a misappropriation of health personnel towards public health that is considered more advantageous8.

Thanks to various health education campaigns, there has been a real improvement of knowledge about the role of the mosquito in particular and the advantage of bednets. But this new knowledge does not “automatically” lead to new practices. Unfortunately, it must be admitted that little change has been noted in the presence of malaria in the zones of highest transmission. This is particularly so in Africa where the appearance of new resistances and new “urban” forms of the disease has been noted9.

New trails?

Naturally, programmes once begun must be continued and attempts made to diffuse these health proposals that are really new body practices10. But, if one agrees with what has been affirmed here, three other broader paths that can only be briefly mentioned here must also be considered.

(1) A political ecology: between public and private spaces: constructing a healthy city Several dimensions are interlinked and must therefore be treated together. The rapid growth of urban population11, the transformation of malaria features, the great social inequalities as well as the common presence of other pathologies (dengue, chikungunya, schistosomiasis, trachoma, etc.) give a global dimension to parasitical and infectious risks in new urban spaces.

In other words, although the rural world cannot be abandoned, a large number of new health questions are linked to the specificities of contemporary megapoles12 where 72% of the population of Africa lives in unsanitary conditions13.

In short, it is obvious that no progress in malaria prevention will occur without conducting a solid reflection involving urbanists, architects, doctors and specialists in social sciences on the various ways of constructing “healthy cities” rather than “pathogeneous complexes”. Several fields need to be examined here.

Public spaces must be analysed and their general management improved14, 15, 16, 17. It is necessary to understand the various ways in which public policies and occupation of “lived spaces” are articulated depending on the territories18, 19, 20. Once again, to put it simply: it is ridiculous to ask the poor and destitute to protect themselves when open drains run across the cities.

Simultaneously, in private spaces, more adapted architectures could be developed. Indeed, the diffusion of architectural models – use of tin and cement – particularly unsuited to the extreme heat of tropical climates, besides being an ecological absurdity, renders the regular use of bednets illusory.

As was the case for tuberculosis or all water-borne diseases, the struggle against malaria is thus linked to a

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policy of habitat. Although this cannot be detailed here, two essential points must be mentioned that encourage populations to take care of their environment.

First of all, access to property must be developed. This alone can guarantee the time required for planning and impart a desire to improve one’s environment.

History also teaches us that transformations of space owe more to aesthetic reasons than to health guidelines.

Therefore, new norms combining beauty and function must be diffused21, 22.

Globally, these multiple dimensions, mainly economic, sanitary and urban, must orient a real reflection on the political ecology of the disease23.

(2) University and continuing education concerned with contexts of healing practices More specifically, the dialogue between health personnel and populations must be improved. But if this dimension is recognized as essential in the texts, practically no teaching – initial training – dealing with the complex links between languages and popular behaviours versus sanitary proposals is proposed in faculties of medicine or paramedical schools.

Ehnolinguistic works on the body and on disease24, 25 should be used – not as a “curiosity” or a social “plus” – but in order to initiate a real reflection on conditions of future healing practices in a specific environment. Let us put this even more simply: is good medical advice if not understood or applicable by patients “good advice”?

The most common practices refute the precepts taught, thus reducing teaching to a purely rhetorical exercise. For example, practically no hospital in sub-Saharan Africa uses bednets despite recommending their use. If requirement levels shouldn’t be lowered, nonetheless concrete questions must be raised about the suitability of “basic material” for local conditions of practice (linguistic uses, specific forms of organization of work, etc.).

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(3) Intitate better coordination of development policies and help clinicians remain at their posts The following three observations counteract the “verticalization” of health programmes and would thwart iatrogenic effects of health development projects.

First of all, it is culturally of little relevance to treat “nuisances felt” requiring similar “defensive barriers” (malaria, dengue, chikungunya) separately.

Next, work on the causes of parasitic infections would permit action on common initial causes largely linked to water and hygiene.

Finally, clinicians could be helped to remain in their departments rather than encouraged to join different, more or less temporary, specific programmes of “public health”.

The struggle against malaria depends largely on how aid and development policies are conducted. A better coordination of programmes, the pooling of means, enhancing actions and grants of research subsidies granted to practitioners who despite their low salaries and difficulties continue to work with sick people, would be an essential aid.

To conclude, at different levels all authorities interact with various health programmes. Consequently, helping local authorities comes down largely to thinking about ways of promoting an offer of quality health. J Yannick Jaffré worked as an anthropologist in West Africa for 20 years. He collaborated with public health teams, conducted many anthropological research projects focused on health priority and taught in many African and French medical faculties.

He is now Research Director at the French National Centre for Scientific Research (CNRS – UMR 6578) and responsible for PhD teaching in health anthropology in SHADYC (Sociology, History and Anthropology of Cultural Dynamics) in a French social sciences high school (EHESS). Yannick Jaffré has written many books and articles about disease in West Africa and the relationships between health-care providers and users.

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References 1.

Olivier de Sardan JP. Anthropology and development. Understanding contemporary social change. London, Zed Press, 2005.

2.

Passeron JC. Le raisonnement sociologique. Paris, Albin Michel, 2006.

3.

Geertz C. La description dense. Vers une théorie interprétative de la culture. EHESS/Eds Parenthèses, 1998, Enquête N°6, 73-105.

4.

Lévi G. Le pouvoir au village. Histoire d’un exorciste dans le Piémont du XVIIe siècle. Paris, Gallimard NRF, 1989 (1st edition 1985).

5.

Jaffré Y. Quand la santé fait l’article. Presse, connivences élitaires et globalisation sanitaire à Bamako, Mali. Revue de Pathologie Exotique, 2007, 100 (3), 207-215.

6.

Jaffré Y. Contributions of social anthropology to malaria control. In: Tibayrenc M (ed.). Encyclopedia of Infectious Diseases: Modern Methodologies, New York, Wiley, 2008, 591-602.

7.

Jaffré Y. Farmacie cittadine, farmacie “per terra”. Africa e Mediterraneo, 1999, 1, 31-36.

8.

Jaffré Y and Olivier de Sardan JP. La construction sociale des maladies.

Paris, PUF, 1999.

9.

Gonzalez JP et al. Fundamentals, domains, and diffusion of disease emergence: tools and stategies for a new paradigm. In: Tibayrenc M (ed.).

Encyclopedia of Infectious Diseases: Modern Methodologies. New York, Wiley, 2008, 525-568.

10.

Corbin A, Courtine JL and Vigarello G. Histoire du corps. Vol. 2. Paris, Seuil, 2005.

11.

Antoine P. L’urbanisation en Afrique et ses perspectives. Archives des documents de la FAO. 1997, p.21.

12.

Harpham T. Urban health in developing countries: a review. Progress in Development Studies, 2001, Vol. 1, No. 2, Sage Publications, 113-137.

13.

Davis M. Le pire des mondes possibles. De l’explosion urbaine au bidonville global, Paris, La Découverte, 2006, p.205.

14.

Onibokun AG (dir.). La gestion des déchets urbains. Des solutions pour l'Afrique. Paris, CRDI/Éditions Karthala, 2002.

15.

Enten F. L’hygiène et les pratiques populaires de propreté. Le cas de la collecte des déchets à Thiès (Sénégal). In: Bonnet D and Jaffré Y (sous la direction). Les maladies de passage. Paris, Karthala, 2003, 375-402.

16.

Blundo G. La question des déchets et de l’assainissement à Dogondoutchi. Niamey, Lasdel. Etudes et Travaux, N°10, 2003.

17.

Hahounou E. La question des déchets et de l’assainissement à Tillabéri.

Niamey, Lasdel. Etudes et Travaux, N°9, 2003.

18.

Frémont A. La région, espace vécu, Paris, Flammarion, 1999.

19.

Ingold T. The perception of the environment. Essays in livelihood, dwelling and skill, Routeledge, London, 2000.

20.

Choay F. Pour une anthropologie de l’espace, Paris, Seuil, 2006.

21.

Vigarello G. Le propre et le sale. L’hygiène du corps depuis le moyenâge. Paris, Seuil, 1985, p.286.

22.

Goubert, 1986.

23.

Baer HA. Toward a political ecology of health in medical anthropology.

Medical Anthropology Quarterly, 1996, New Series, Vol. 10, No. 4, Critical and Biocultural Approaches in Medical Anthropology: A Dialogue, 451-454.

24.

Jaffré Y. Une médecine inhospitalière. Paris, Karthala, 2003.

25.

Tourneux H et al. Dictionnaire peul du corps et de la santé (Diamaré, Cameroun), Paris, Karthala, 2007.

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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 hospitals, ambulatories and medical attention that have a strong relationship with science and technology, which is why it requires a deeper discussion in order to address its complexity. According to Albuquerque, the scientific infrastructure of this sector is “a result of flow of information that supports the advent of innovations which in turn affects medical practice and health”1.

Recent times have seen a continuous development of new technology, resulting from advancements in biological and medical sciences. Most of these appeared after the middle of the 20th century, materializing in the form of new equipment, new clinical proceedings and new preventive measures composed of vast quantities of new information, which, in turn, promote health. As a result, health care has become one of the fastest growing sectors of the world economy in recent years.

The health sector simultaneously shows two special characteristics. First and foremost, technological-scientific development has produced important benefits to welfare, impacting on the economy and on society as a whole. On the other hand, the implications involved in implementing these innovations in national health systems have been costly and questions have been raised as far as ethical aspects are concerned.

In short, the health sector must find the balance between costs and benefits for society, taking into account ethical procedures. In the health sector, innovation must have the purpose of improving the quality of life by means of using products and procedures which avoid the appearance of new diseases, while at the same time trying to eradicate the existing ones.

T

Research, technology and innovation in health The impact of investment in research in the health sector with regard to the improvement of the quality of life of populations has been assessed by several studies, of which two are frequently quoted.

The first one refers to the statistical study of Vehorn et al2,

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which consisted in valuing the contribution of biomedical research regarding the “production of health”, in the period 1900–1978. It came to a conclusion that the increase of 1% in the effort of research in this area implied a drop of 0.10% in the rate of mortality, varying between 23% and 48% in the magnitude of the contribution of this research in the reduction of the rate of mortality.

The second study, which was carried out by Lichtenberg3, valued the impact of expenditure on research and development (R&D) in the pharmaceutical industry on the reduction of the rate of mortality. It comprised the period between 1970 and 1990 and came to the conclusion that there was an obvious relation between an increase in lifespan and the introduction of new drugs approved by the American Food and Drug Administration (FDA), whose drugs increased lifespan from 0.75% to 1% a year.

The Report on Human Development4, which established the link between technological development and human development, states “medical advancements such as immunizations and antibiotics resulted, during the 20th century, in faster improvements in Latin America and East Asia than those achieved in Europe during the 19th century through better nutrition and sanitation”. And it concludes: “(...) During the 70s the lifespan in two mentioned regions (LA and EA) exceeded 60 years, getting in four decades what in Europe, beginning in 1800, took 150 years to achieve ”.

Campos and Albuquerque5 support the argument with three situations: 1) the non-existence, in the health sector, of a consumer’s capability to decide which products he should acquire, given that he does not have the necessary information to take such a decision. For instance, it would not be possible for a patient to decide between radiotherapy and chemotherapy in the event of there being resources for only one of these therapies. This fact, by itself, already determines the breaking of one of the rules of the market for the allocation of appropriate resources, which is the symmetry of information. 2) there is no medical assistance, as it happens in other economical sectors, “limits to rationalize the production”. For instance, it is enough to remark that any emergency service is compelled to offer specialists (such as a neurosurgeon). This is mandatory even

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if, statistically, this kind of trauma does not often demand his intervention, given that it is not possible to admit denying such a service as a result of statistics. A similar situation takes place with the necessity of providing units with antiophidian serums for the occasional case of a patient bitten by snake. The professional responsible for each unit must assume the onus of the rigorous maintenance of the quality and validity of the product. 3) In contrast to industrial processes, which are generally standardized and show the same pattern of production, in the health sector, one cannot standardize inputs and processes, for the simple fact that patients attended by different health agents or different medical teams might be submitted to different approaches. It is possible to exemplify from the treatment of a single worm disease carried out with a treatment of magnify specter and without prior examinations up to the submission of the patient to a battery of exams, for the same therapeutics. This results from the predominant subjectivity of the process of work in health, which is basically craft, in spite of the objectivity of some background.

These and others observations are enough to confirm the peculiarity of medical assistance when compared to any other economical category5.

Experts in the innovation economy have pointed to a narrow relation between science and technology in the health sector6. The development of the health sector has favoured improvement not only in the quantity but also in the quality of treatments and in the methods of diagnosis, although such a relation, concurrently, is responsible for the increased costs of medical assistance.

The explanation for this equation – technological innovation and an increase of expenses – is a result of the specificity of the health sector in so far as, in contrast with other sectors of production in which the introduction of a new technology brings the substitution of the old ones, in the health sector this phenomenon is cumulative. For instance, the evolution of the cardiovascular propaedeutic and the propaedeutics methods favoured by the technology of the electrocardiogram, shear ultrasound scan and for the Doppler, did not succeed in replacing the classic method of cardiac listening or even in substituting among themselves.

Ethics aspects of medical technology There is a known disparity between the degree of the disease and the investments in research in the worldwide scenario, as described by the World Health Organization7, in a context of unequal distribution, especially in case of the “load of the avoidable disease ”.

According to the WHO8, low- and medium-income countries are responsible for only 2.2% of the global funds invested in health research and this is mostly due to the absence of complete innovation systems in such countries.

There is in the health sector “a huge gap” between the degree of the disease and the expenditures in research and development: pneumonia and diarrhoea which are, for example, responsible for 15.4% of the degree of the disease and, at the same time, the two biggest causes of death in the whole world, receive only 0.2% of research and development

(R&D) resources.

To the Global Forum for Health Research9, only 10% of worldwide expenditure on health research concerns diseases and conditions that affect the poorest 90% of the world’s population, hence the title “10/90 gap”.

Albuquerque et al10 analyse the theme of innovation in health from the point of view of the economics of technology and suggest that this discussion takes place over two issues: first, the necessity of health being understood as a worldwide phenomenon and, as result, comes the importance of initiatives for the creation of international cooperatives with the intention of joint efforts in research and the support to set up health systems that should guarantee the effective diffusion of worldwide scientific and technological achievements. Another issue refers to the importance of the national scientific endeavour of developing countries, for which no country in the world should avoid taking part in the international networks of research and diffusion of innovations.

The ethical perplexity caused by contemporary “techno science” is consequent to the fact that the world, in spite of the amount of progress made, is in a frontier of serious moral responsibilities, determined by the process of intervention more and more aggressive of the man in the biosphere, accelerating its deterioration, and the intervention of the man in his own essence, through the manipulation of his genetic identity.

The technological innovations might not just benefit humanity, but also be used against it, having become certain that the last battle for human dignity is being fought in molecular genetics laboratories, where human DNA is manipulated.

The worst situation for humanity – that obtained through science the demystification of natural phenomena – is exactly the loss of the spiritual values provoked by the corrosive power of technology on human values, specially due to the unequal struggle between the speed of scientific discoveries and the capacity for moral reflection upon them.

If the progress of science is, in fact, much faster than the time needed to think about its effects on the biosphere and human life, the discussion about the intervention of medical technology in human life is made more distressing and pressing.

If there is no more doubt that science and technology are fundamental processes to the development of societies – creating a gap between the countries that are knowledgebased and those that depend on them to obtain it – the developed countries cannot use their knowledge power to subjugate others.

Due to being simultaneously a public and a private property (on account of its double financing), technology has a huge cost that limits its development in most countries. Therefore, the creation of an international cooperation policy for the development or enhancement of national technology innovation systems should be stimulated. This would, consequently, have an international insertion, especially if it is built in the form of research and technology cooperatives. Therefore, it could be expected that the gap between nations, that means a small hiatus between life and death for millions of human beings

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when the matter is human health, can be diminished.

There must be developed an ethic responsibility conscience, in the individual plan, so much as in institutional and government levels, since the development of science and technology must be used only with the purpose of contributing to individual and collective progress, in other words, to the happiness of mankind.

Medicine has been, for a long time, based on empirical knowledge, many times mysterious and transcendental, as it has been demonstrated in its history from ancient Greece to recent times. Scientific development began in the 19th century. Up to that time, the medicine practised was based on symptomatic demonstrations and on objective data, focused on the care of the patient and with searching to reduce his suffering.

Today the competence acquired through scientific knowledge can place the medical professional in front of countless ethical dilemmas, mostly concerning the classic occupation of medicine regarding the improvement of the conditions of health and quality of life of the population.

It is not possible to agree with those who, on the excuse of using the most recent medical technology, have the purpose to cure diseases or to maintain the life of a patient at any cost after running out of all the biological possibilities for maintaining a dignified quality of life.

Although they increase the cost of medical attention, modern technologies will be fully justified if they lead to an effective improvement of human health. The tendency to scientific ideology and submission to the market logic contributes to the enlargement of health industry profits, while evaluation of the relation between cost, risk and possible benefits to the patient are forgotten.

Concusion The development of science and technology in the last quarter of century has been responsible for the extraordinary progress achieved by the different sectors of modern society to the extent that, at present, technology permeates practically all segments of the human life.

More recently, the development of biotechnology has made an enormous contribution to the health sector, carrying most of the investments in research and development (R&D) in the public and private sectors. Examples of this progress, such as the genomic and the pharmaceutical genomic flourished, creating a predictive medicine, which brought benefits not

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only to individual health, but, also, to the policies of public health in general.

International literature, specialized in the economics of technology, while focusing on the health subsystem, has demonstrated a narrow relation between the improvement of sanitary indicators and investments in research and innovation in health.

In the meantime, questions are controversial and still not answered, such as the relation of the costs of innovation and their benefits to the population, which leads to whether technology is a factor that increases the costs of health care, is it part of the problem, or both.

On the other hand, the distribution of scientific knowledge and information in health is accumulated in the central countries, on account of the concentration of investments in the sector (around 98%) compared with developing countries or peripherals ones. This has caused a massive difference regarding the nosological predominance in the poorest regions of the globe, as highlighted by the “10/90 gap”, designated by the Global Forum of Health Research.

Therefore, there is a need to establish policies and strategies to support the development of national systems of innovation in health for those countries that still do not have a developed technological and scientific system (or have it in an incomplete way), and to favour international links between the developed, or complete, systems and the underdeveloped countries.

From the point of view of the medical praxis, be it ambulatory or nosocomial, its close relation with technological innovations has caused an increase in ethical dilemmas. Medicine, in the early 21st century, has become the instrument of a new human utopia, that is, the utopia of health and the perfect body.

As a result of this modern context, based on the advances of technology, it might induce the development of a new medical culture, which is transforming the medical doctor into more of a life manipulator than a health promoter. J José Geraldo de Freitas Drumond is a medical doctor and Professor of Bioethics and Medical Ethics at the State University of Montes Claros (UNIMONTES), Minas Gerais (Brazil). He is also President of the Minas Gerais State Agency For Research Development (FAPEMIG), a member of the International Council of “Acta Bioethica”, PAHO/WHO, Chile and President of the Sociedad Iberoamericana de Derecho Médico (SIDEME).

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References 1.

Albuquerque EM, Souza SGA and Baessa AR. Pesquisa e inovação em saúde: uma discussão a partir da literatura sobre economia da tecnologia.

Ciência & Saúde Coletiva, 2004, 9 (8):277-294, 2004.

2.

Verhorn C, Landefeld J and Wagner D. Measuring the contribution of biomedical research to the production of health. Research Policy, 1982, 11 (1) 3-13.

3.

Lichtenberg F. Pharmaceutical innovation, mortality reduction, and economic growth. National Bureau of Economic Research. Cambridge (Working Paper 6569), 1998.

4.

UNDP (United Nations Development Program). Human Development Report: making new technologies work for human development. Nova York, 2001. http://www.undp.org 5.

Campos FE and Albuquerque E. As especificidades do trabalho no setor saúde. In: Castro J, Santana JP. Negociação coletiva do trabalho em

saúde. Brasília/Natal, OPAS/OMS, NESC, UFRN, 1998.

Nelson R. The intertwining of public and proprietary in medical technology. In: Rosenberg N et al. Sources for medical technology: universities and industry (Medical Innovation at the Crossroads, Vol. 5).

Washington, National Academy, 1995.

7.

World Health Report: Making a difference. World Health Organization, Geneva, 1999. http://www.who.org 8.

Investing in health research and development. World Health Organization, TDR/Gen/96.1. http://www.who.org 9.

The 10/90 report on health research 2001–2002. Global Forum for Health Research (GFHR), Geneva, 2002.

10.

Albuquerque EM and Cassiolato JE. As especificidades do Sistema de Inovação no Setor Saúde. Revista de Economia Política, Vol. 22, nº 4 (88), October–December 2002.

6.

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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 greatest overarching moral challenge – and duty – is reducing disparities in nutrition, shelter, health and opportunities for a creative and fulfilling life. Yet while the moral charge is uncontroversial, great controversy surrounds efforts to meet this challenge. One could even argue that, but for such controversy and disagreement, there would be fewer disparities and they would be smaller.

If this is right, it means there is even greater urgency to identify points of agreement beyond the mere imperative to reduce disparities. The need for innovation is a source of such agreement.

Now, everyone rightly admits that current disparities are unacceptable; and that traditional methods to reduce them have often been inadequate, at least so far; and that change of some sort is required. So our goal here is to suggest ways in which ethically optimized innovation can serve us in doing our duty to reduce disparity. There are at least two parts to this project: foster and encourage innovation (construed broadly) and demand evidence in support of creative change.

From conception through action, ethics is the brightest thread in the fabric of disparity reduction.

I

Foster innovation “Change” and “innovation” are not synonymous. The world often changes as a result of human action but without human intention. Some changes are for the worse. “Innovation”, however, implies both intention and progress. Moreover, innovation tends to have a good track record, especially in the health sciences. The world’s scientific community has often risen to the occasion and helped provide the tools needed to prevent and treat a broad range of maladies. Scientific innovation has been fostered by governments, professional societies, nongovernmental organizations and others who had at their disposal the curiosity and creativity of the world’s researchers.

But scientific discovery needs a partner for the benefits of research to be realized, and this requires innovation by the world’s policy-makers. When the former succeed and the latter fail, progress is impeded. The discovery and *

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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 Arsht Initiatives, a series of gifts from philanthropist Adrienne Arsht.

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development of powerful antiretroviral drugs is an example of scientific creativity; the failure to make these drugs widely available to the world’s poor is an example of political sclerosis and misadventure. Political innovation by leaders in developed countries would – and still could – ensure that more people around the world enjoy the benefits of biomedical science.

For our purposes, “innovation” is a value-laden term. It embeds the concepts of “good” and “progress” and “public.”

To be sure, one might be innovative in degrading the environment, spreading disease and widening oppression, but these are evil and perverse goals. Innovation for the project here is ethical innovation: intentional, creative change aimed at reducing global disparities. At the intersection of science and policy, ethical innovation celebrates shared values and goals, and it imposes on scientists and policymakers the duty to use their creative energies in the pursuit of goods that align with those values.

We can go further: failure to attempt such a pursuit is itself a wrong, a blameworthy abnegation of duty. Indeed, it is irrational to have the ability to change the world for the better – and then fail to try. (Among other things, this means that scientists cannot escape at least some moral responsibility for their work.)

It follows that the first part of our project – the injunction to foster innovation – is morally obligatory. Moreover, the obligation applies to scientists and policy-makers in equal measure. It becomes a collective obligation for those societies in a position to make innovative change – those which enjoy adequate nutrition, housing and health, say – to help those who do not enjoy these rights.

While good intentions are necessary, they are insufficient.

Something more is needed.

Evidence-based innovation There are several reasons why good intentions alone are not adequate to the task. The strongest reason is that the poverty we find on earth today is sustained and complex. If mere good intentions were adequate, one would only need to send a donation and infer that such largesse would somehow discharge one’s duty to attempt to reduce disparity. Further, we know too well that the research engines of North America, Europe and Japan are marvels of scientific innovation, but

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they are too often undergirded by intentions that have little or nothing to do with the reduction of global disparity. What is wanted is ethically optimized innovation coupled with some grounding, warrant or evidence that actions inspired by good intentions will be effective.

Some missteps aside, health research in developing countries has improved over the past quarter century – at least insofar as research sponsors and investigators now must adhere to any of a suite of national or international rules for the protection of human subjects. Such rules may be seen in part as attempts to ensure that good (or at least not bad) consequences result from projects whose intentions are or might be questionable. And we have learned along the way, for instance, that international health research must address problems that inhere in the population being studied1. Do not study Alzheimer’s disease, say, in a country where few people live long enough to get it.

The relationships among science, ethics and policy are complex. Some years ago in meetings of a philosopher, scientist and physician from the University of the West Indies in Jamaica and the University of Miami in the United States, there was extended discussion about the nature of these relationships. It was agreed that ethics is essential for building trust in the developing world; that ethics and trust are required for a successful research programme; that the health of communities depends on more and better research; and that such research is necessary for reducing disparities.

We arrived at the following motto: No ethics, no trust; no trust, no research; no research, no health; no health, no development2.

More than charm, a good motto has content. If there is substance here it is shorthand or elliptical for several ideas, including that research must be effective if it is to improve the health of populations, and that such efficacy is not born of good intentions or warm thoughts. Effective research takes into account the needs of populations; marshals the best methods for achieving success; communicates this research to public health practitioners, clinicians and policy-makers; and supports them in the application of the research. If, as above, “ethics is the brightest thread in the fabric of disparity reduction”, then it is also the brightest thread in formulating and carrying out a research programme.

In both cases, though, ethics must be intertwined with evidence if it is to have any success in disparity reduction.

Innovation without evidence is mere novelty; evidence without innovation is a shallow and vulgar empiricism.

The history of the evidence-based medicine and evidencebased public health movements has helped focus our attention on the mutually supportive role ethics and evidence play3. What is noteworthy for our purposes is that evidencebased practice is innovative, despite its apparent obviousness.

It is innovative in that it has led to a large, creative international effort to harmonize the collection and communication of research results. It is not without flaws, and has even occasioned some controversy. Innovation is often like that.

Ethics, evidence and disparity reduction The duty to reduce disparities is, as above, complex and daunting. Many people around the world need clean water as much as costly pharmaceuticals; vector-borne disease control more than hospitals; education at the same time as vaccinations, birth control or visits by foreign physicians. One could say that development and disparity reduction are wedded in such a way that neither can be achieved without the other. Enter an experiment in disparity-reducing innovation – The Millennium Villages project. Commissioned by the United Nations Secretary-General in 2002, the Millennium Villages link sustainable infrastructure development to public health surveillance and research: Simple solutions like providing high-yield seeds, fertilizers, medicines, drinking wells, and materials to build school rooms and clinics are effectively combating extreme poverty and nourishing communities into a new age of health and opportunity. Improved science and technology such as agroforestry, insecticide-treated bed nets, antiretroviral drugs, the Internet, remote sensing and geographic information systems enrich this progress. Over a five-year period, community committees and local governments build capacity to continue these initiatives and develop a solid foundation for sustainable growth4.

What is innovative here combines good intentions and sound science. Part of what is meant by “sound science” is that researchers and those who fund them have clear goals for reducing disparity. Continued evaluation and assessment will determine if evidence-based standards help foster success for such a morally-driven initiative.

Note how little has been said here about the administrative engines established for overseeing human-subjects research.

Key messages

Humans are, generally, creative creatures. The history of civilization demonstrates a series of innovations that have improved life and fostered progress. Humans are also, generally, beneficent.

But some changes have been destructive, neglectful or impotent. And humans have reason, at least generally, which is why the success of science is so often taken for granted. What is needed, we have argued here, is an ethically optimized, evidencebased view of innovation. Taken ensemble, such a view counsels us thus: There is an uncontroversial moral imperative to reduce global disparity, and this can be undertaken creatively.

Evidence-based science can help ensure that disparity-reducing initiatives are just and effective.

It would be blameworthy not to deploy ethically optimized, evidence-based tools in the pursuit of disparity reduction.

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This is because what has been called the “regulatory ethics paradigm” is too narrow in the kinds of innovations it regards as worthy5.

Ethics is never so challenged and tested as when it is invoked in the name of public policy. Our economic and political shortcomings and failures too often make it seem that the demands of a universal ethic – human rights, for instance – are beside the point or too difficult to achieve. This is a mistake. The ability to reduce disparity, which ability no one seriously doubts humanity enjoys, confers on us the duty to set about such reductions. Put differently, morality demands this effort, science makes it effective, and, with these, innovation promises the future will be better than the past. J

Kenneth W Goodman is Professor of Medicine at the University of Miami, with appointments in Philosophy, Epidemiology and Public Health and Nursing and Health Studies. He directs the university’s Bioethics Program and is co-Director of its Ethics Programs, which have been designated a World Health Organization Collaborating Center in Ethics and Global Health Policy – one of three in the world. His research has focused on ethics in epidemiology and public health, in health informatics and in clinical and research ethics, including translational research or evidence-based applications of research in public health and clinical practice.

References 1.

Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Vol. 1. Bethesda, Maryland, National Bioethics Advisory Commission, 2001.

2.

In addition to the author, participants included Drs Anthony Mullings (Kingston) and Paul Braunschweiger (Miami).

3.

Goodman KW. Ethics and evidence-based medicine: Fallibility and responsibility in clinical science. Cambridge: Cambridge University

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Press, 2003.

Millennium Villages, background and history, 2008 (http://www.millenniumvillages.org/aboutmv/index.htm, accessed 10 August 2008).

5.

Agich GJ. Ethics and innovation in medicine. Journal of Medical Ethics, 2001, 27:295-296.

4.

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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 coalition of student-led chapters at more than 40 universities in North America and is increasingly recognized as a credible and important partner in the innovation and access to essential medicines movement1.

However, we are keenly aware of the inherent risks involved when students in the industrialized world try to imagine the needs of resource-poor populations. Thus, UAEM seeks new partnerships with students globally. The partnership serves a dual purpose: to first identify the most pressing local needs and secondly, to mobilize resources North–South to address the needs.

Here, we describe the seeding of our movement in Africa and partnership with the first UAEM chapter in Africa (Makerere University, Kampala, Uganda) on three discrete projects including community-based service, developing new training instruments on neglected diseases and building a credible voice for young scientists throughout Africa.

U

Partnering with student-led communitybased programmes Community-based education and service (COBES) is a new discipline introduced in the Makerere University medical school and public health curriculum where students learn about diseases affecting the people in their communities.

Groups of 8–10 medical and public health students report to different villages all over the country with questionnaires to be completed in interview style by members of local communities (see Figure 1). Questions include queries on the most important problem the community faces, potential solutions and current coping strategies. Surveillance of community clinics reveals the community-specific disease burden as well as discrete information on essential drug availability and treatment practices. Critically, though these reports contain fresh data, they are merely handed in for a grade and forgotten. We decided to use the reports to nucleate a movement on access to essential drugs.

The COBES reports provided the unsurprising finding that malaria remains the predominant concern in northern and eastern Ugandan villages, comprising up to 70% of paediatric visits. However, despite the high prevalence of malaria, firstline anti-malarial drugs (Coartem) remain in short supply.

Despite being an essential drug on international and

Ugandan lists, it remains out of reach for thousands of villagers. The students find that even when the drug is available there are inappropriate dispensing practices. As a result, local community members turn to traditional medicines and healers, which are relatively cheap.

To address the paucity of Coartem we have adopted a twopronged approach. First, we have alerted the WHO Essential Medicines programme of this crisis. To our surprise, we found that such notifications of local drug availability are rare. We are devising new research tools with Makerere and the WHO to identify the barriers to Coartem access.

Secondly, we have brought the issue to the forefront of our chapters in the global “North” in hopes of addressing the barriers to access head-on. Our successes include reaching the first price concession on an antiretroviral (d4T) in 20012 and successfully petitioning the WHO to include a new class of drugs (statins)3 as essential medicines. However, new linkages with colleagues in local settings provide bidirectional perspectives on whether the “essential medicines” concept is being actualized. If medicines on the Essential Medicines list continue to face price and trade barriers, we hope to document and address these in turn.

Hence, these linkages generate research questions that yield crucial data to improve health.

Assembling the first open-access neglected disease curriculum Interest in neglected diseases is growing globally but there are few publicly available resources for community and selfeducation. To address this gap we are jointly assembling a neglected disease curriculum for use in universities globally.

The course will initially be modelled after a student-led course initiated by students in Cornell University (New York, USA).

In this course, we aim to show how concepts from the basic sciences, clinical medicine, economics and population health (nutrition) inform each other as they are brought to bear on an important issue in global health – malaria. We centred the course on the current, highly touted intervention – insecticide-treated bednets. An initial economic and political discussion gives context to the pertinent issues in biology, medicine and population health that will help us form an informed opinion on the potential for bednets as a way to “eradicate malaria in our lifetime” (WHO and Gates

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certificate of support from the Ministry of Justice of Ethiopia, Education level: substantiating their mandate. The a) Primary b) Secondary c) Tertiary d) Other e) None 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?

African Scientist Network based in 4.

In your own view, what do you consider the most important of the problems mentioned?

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? seeks to represent African scientists.

7.

As an individual, how are you trying to cope with the problem?

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?

(WAYS; http://ways.org) provides 11.

If so, what are the most common diseases you encounter in this community?

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 are African-based scientists. To assist these young scientists, Foundation challenge). The full syllabus complete with new groups like AuthorAID (www.authoraid.info) are specified lecture objectives, key review papers and critical emerging to help young scientists overcome barriers in case-studies is freely available here: http://skishore. publishing, including one-to-one guidance on editing and wikispaces.com/NDCurriculum.

English.

Expanding or adapting the course is easily done.

A student-led campaign can be of great help in addressing Students and local faculty members can simply add on new neglected disease awareness in the tropics because that’s modules that incorporate the four perspectives. Thus, a 4where diseases actually are. One campaign, Loose Change week course on malaria can become a 12-week course that for a Worm-Free World (http://sabin.convio.net/site/Page includes modules on, say, maternal and child mortality and Navigator/LooseChange) seeks to educate the general public HIV/AIDS. We aim to deploy the course in five universities about possible preventive measures, while actively engaging in Africa and five in the United States by the summer of youth on neglected disease control. To be sure, we 2010, with a goal of integrating the course into standard acknowledge the limitations in trainees’ impacting research medical curricula. We aim to do so by working with medical budgets in the short-term. Our vision, however, concerns school curricula directors at institutions with UAEM building a pipeline of trainees and young researchers with chapters. The digital repository, Health Sciences Online access to resources, insights and thought leaders globally.

(HSO; www.hso.info), also offers more than 50 000 Our embryonic collaborations will grow, spurring future social courses in a diverse range of health topics in English innovations that will yield biomedical innovations in the long medium for anyone seeking them. term. Equally importantly, our linkages ensure that we are aligning our desire to help with where the needs lie. These Seedling a global movement on neglected partnerships should help provide more rigorous evidence on diseases the most pressing gaps when matching up disease burden to We believe a bottom-up approach driven by students and current R&D priorities. young researchers across disciplines is an under-utilized Join us in our movement on neglected diseases. method to impact research priorities. A recent example is 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 communitybased 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).

Age:

92

Sex:

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Sandeep P Kishore is enrolled in the Weill Cornell Medical College/Sloan-Kettering Institute/Rockefeller University Tri-Institutional MD-PhD programme. His scientific research concerns characterizing gene activation in the parasite responsible for malaria. He has been involved in student-led global health efforts through assembling a Forum on Neglected Diseases, integrating global health into medical school curricula, and successfully advocating for the inclusion of a cholesterollowering statin on the World Health Organization's Model List of

Essential Medicines. He completed his BS in Biology at Duke University and his MSc in Immunology at Oxford University.

Pius Mulamira is a second-year medical student at Makerere University in Kampala, Uganda. He is interested in a career in biomedical research on neglected diseases and, along with student leaders at Makerere University, has initiated the first UAEM chapter in Africa at his university.

References 1.

2.

3.

Chokshi DA & Rajkumar R (2007) Leveraging university research to advance global health. JAMA 298, 1934-1936.

Kapczynski A, Crone ET, & Merson M (2003) Global health and university patents. Science 301, 1629.

Magrini N KS (2007) Proposal for the Inclusion of a Statin for the

Secondary Prevention of Cardiovascular Diseases in the WHO Model List of Essential Medicines http://mednet3.who.int/EML/expcom/expcom15/applications/newmed/stati ns/Statins.pdf.

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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 accounts for more than 50% of the world’s under-five mortality but has just 15% of the world’s under-five population. Similarly, approximately 920 women per 100 000 die from pregnancy-related causes each year in subSaharan Africa. In developed countries, the figure is just eight1. Most other health indicators tell a similar story. The region’s health systems, which have been weakened by decades of under-investment, are struggling to deliver simple interventions such as insecticide-treated bed nets, rehydration therapy to treat diarrhoea and de-worming medications. It has been estimated that “full access to and utilization of proven, effective interventions would avert two thirds of child deaths and three quarters of maternal deaths”2.

But this is unlikely to occur unless the severe shortages in health workers, the inadequate health infrastructure and inefficient procurement delivery, and information systems in sub-Saharan Africa are addressed.

O

Shifting the focus back to primary health care and systems improvements Much of the unprecedented investment in global health occurring in the last two decades has been directed towards single-disease or intervention programmes, which are sometimes referred to as vertical programmes. Investments in these vertical programmes have resulted in significant progress, but they also have negative effects in severely resource-constrained areas because they compete with each other for scarce health workers and other limited resources3.

Achieving the health-related Millennium Development Goals

The Doris Duke Charitable Foundation (DDCF) has launched a new initiative, described here, to increase the knowledge available for evidence-based health systems planning and stimulate innovations in scaling-up health services delivery

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(MDGs) by 2015 will require a renewed focus on strengthening health systems so that they can provide integrated primary health care thereby reducing maternal and child mortality4. A particularly notable effort in this regard has been the International Health Partnership Plus, which consists of nine international organizations and ten donors who came together in 2007 to focus on health outcomes related to the health MDGs5. Some of these funders are redirecting a portion of their resources to help bolster the capacity of regional health systems6.

The implementation knowledge gap Whether the focus is on care for individual diseases or the provision of integrated primary health care, the gap between existing therapies and prevention of human diseases and the translation of that knowledge into measurable improvements in population health in low-resource regions is often daunting. Strong evidence about what works most effectively in different settings where there are multiple disease burdens and limited resources is often lacking7. Moreover, even if there is evidence about effectiveness on a small scale, largescale delivery can present additional challenges8. As noted in a recent commentary in Science, there is a critical need to support implementation science which “creates generalizable knowledge than can be applied across settings and contexts to answer central questions”9. Filling the knowledge implementation gap requires a strong foundation of metrics and evaluation10. It also will require interdisciplinary teams that include experts in health services delivery, economics and management sciences, among other areas.

Unfortunately, when compared to the infusion of funds for health services, little has been invested in health systems research11.

As demonstrated by the Mexican health insurance reform known as Segura Popular, which rigorously documented systems changes that increased uptake of existing health services by the previously uninsured, high quality measurements of a health system’s performance not only

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enable local policy-makers to make informed decisions, but it can empower them to overcome political obstacles12. While similar large-scale projects aimed at improving health systems in measureable ways have yet to be conducted in sub-Saharan Africa, smaller projects in the region have reported significant health outcomes attributable to systems improvements. For example, the Community Health and Family Planning Project in Ghana found that posting nurses who worked with volunteer community health workers to rural communities reduced child mortality by half in three years13. Similarly, various health systems strengthening efforts between 2000 and 2004 were associated with a 24% decrease in under-five child mortality in Tanzania14. In order to both maximize the current investments in global health and to encourage additional investments, more attention needs to be paid to filling the knowledge implementation gap so that policy-makers have the tools available to make evidence-based decisions.

DDCFâ&#x20AC;&#x2122;s initiative: population health implementation and training partnerships With these needs in mind and after consultations with many experts15, DDCF has committed up to US$ 100 million to help catalyze a shift from a focus on single-disease programmes to an emphasis on strengthening health systems to effectively deliver integrated primary health care to underserved populations in sub-Saharan Africa.

Announced in September 2007, the initiative is part of DDCFâ&#x20AC;&#x2122;s commitment to support clinical research that advances the translation of biomedical discoveries into improved human health. The initiative aims to (1) provide integrated primary health care and achieve significant, measurable health improvements in up to six communities/ districts in sub-Saharan Africa; (2) strengthen health systems in the selected communities/districts so local and national governments can sustain these improvements beyond the grant period; and (3) increase the knowledge available for evidence-based health systems planning by supporting implementation research.

The initiative will centre on funding a small portfolio of large-scale projects referred to as Population Health and Implementation Training (PHIT) Partnerships for five to seven years. Each PHIT partnership is expected to provide integrated health services delivery to a population of at least 250 000 and to link these activities to rigorous implementation research. Implementation research is 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 resource-constrained populations. PHIT partnerships are not expected to create stand alone health service delivery projects. Rather, whenever possible, they are expected to build upon already funded programmes, coordinate with national health plans and strengthen existing databases and processes. PHIT partnerships are also expected to harmonize with and link to other programmes using common indicators and measurement tools, as well as to build local capacity to carry out rigorous implementation research. Meeting these

expectations is likely to require that PHIT partnership teams employ a variety of innovative approaches.

PHIT partnership grants will be awarded through a multistage competitive peer-reviewed process, which will result in a maximum of six successful teams each receiving support ranging from US$ 8 million to US$ 15 million for a period of five to seven years. Figure 1 outlines the three-stage selection process that began with a solicitation for letters of interest from potential partnership teams working in one of nine subSaharan African countries16. Applicants were requested to identify health systems bottlenecks, weaknesses and funding gaps that limit the provision of large-scale primary health care in a specific region and work with African institutions, regional governments and other sectors to develop a health service delivery plan that builds on existing health programmes and coordinates with national health plans.

A total of 137 letters of interest were received with multiple teams applying from all of the nine targeted countries. The initiativeâ&#x20AC;&#x2122;s Advisory Council and other experts recommended that 29 teams be invited to submit proposals to receive sixmonth planning grants. The 29 PHIT planning grant applications proposed many different approaches to address health systems bottlenecks and deficiencies including workforce task shifting, building on school-based programmes, developing youth-centred training projects, and creating quality assurance teams. Criteria for awarding planning grants included: (1) the local experience and quality of the team; (2) the potential for impact in the region; (3) the implementation research plan; and (4) alignment with local and national health plans. It is expected that at least nine teams will receive six-month grants in early autumn 2008 to support their efforts in developing comprehensive milestone-driven five- to seven-year work plans. It is anticipated that the last stage of the selection process will be completed in June 2009 when the comprehensive work plans developed during the planning phase are reviewed, and up to six teams selected to receive PHIT partnership awards.

The Institute of Health Metrics and Evaluation has created a PHIT Partnership Implementation Research Framework17 to define the terminology used by applicants, review study design issues, and provide a list of the health systems indicators commonly used in implementation research on

September 2007: call for letters of interest

January 2008: 29 teams invited to submit planning grant proposals

October 2008: award six-month planning grants to 9 or more teams

June 2009: award PHIT implementatin grants to up to six teams

Figure 1: PHIT partnership selection process

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Key messages

health service delivery. While it is anticipated that the partnerships will employ different approaches in designing their research, it is expected that there will be a set of core data collected by all partnerships. PHIT partnership teams will also participate in a grantee network, contribute a shared database, and attend annual meetings.

In conclusion, implementation research is needed to increase the knowledge base on how to strengthen health systems and efficiently provide integrated primary health care in severely resource constrained regions of sub-Saharan Africa. While there are no easy or quick solutions, the Doris Duke Charitable Foundation’s African Health Initiative provides one approach to addressing this issue. By funding a few large-scale projects that build on existing programmes in specific regions, rigorously monitor and test different approaches, and share data, it is hoped that health will be improved, health systems will be strengthened and new knowledge will be gained. J

Strengthening health systems to efficiently provide integrated primary health services in sub-Saharan Africa requires not only more resources but implementation research to determine what works and how to efficiently and rapidly scale up those interventions that do work.

The Doris Duke Charitable Foundation (DDCF) has launched a new initiative, described here, to increase the knowledge available for evidencebased health systems planning and stimulate innovations in scaling-up health services delivery.

The initiative will support a portfolio of large-scale health service delivery projects – referred to as Population Health Implementation and Training Partnerships – that provide integrated primary 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 clinical research. While the focus of those programmes had been in the United States, they have also included operations research in Africa, as well as the new African Health Initiative described in

this paper. Before joining DDCF, Dr Gallin spent 20 years working for the US government as a researcher, congressional science fellow and lastly as Deputy Director of the Office of International Health Programs in the US Department of Energy.

References 1.

UNICEF. State of the children’s world 2008: child survival. New York, 2008.

2.

UN Millennium Project 2005, Who’s got the power. Taskforce on Child Health and Maternal Health, New York.

3.

Reich, MR et al. Global action on health systems: a proposal for the Toyako G8 summit. Lancet, 2008, 371: 865-869.

4.

Murray CJL, Frenk J, Evans T. The global campaign for the health MDGs: challenges, opportunities, and the imperative of shared learning. Lancet, 2007, 370:1018–1020.

5.

Scaling up for better health. Work plan for the International Health Partnership and related Initiatives (IHP+), September 2007 to March 2009.

6.

Lazzari S. Maximizing positive synergies between health systems and global health initiatives. The Global Fund, WHO expert consultation on positive synergies between health systems and global health initiatives, 2008.

7.

Buekens P et al. Evidence-based global health. Journal of the American Medical Association, 2004, 291:2641.

8.

McCannon CJ et al. The science of large-scale change in global health.

Journal of the American Medical Association, 2007, 298:1937–1939.

9.

Madon T et al. Implementation Science. Science, 2007, 318:5857–5859.

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10.

Murray CJL, Frenk, J. Health metrics and evaluation: strengthening the science. Lancet, 2008, 371:1191–1199.

11.

Sanders D and Haines A. Implementation research is needed to achieve international health goals. PLOS Medicine, 2005, 3:720-721.

12.

Frenk J. Bridging the divide: global lessons from evidence-based health policy in Mexico. Lancet, 2006, 368:954-961.

13.

Binka B et al. Rapid achievement of the child survival millennium development goal: evidence from the Navrongo experiment in Northern Ghana. Tropical Medicine and International Health, 2007, 12:578.

14.

Masanja H et al. Child survival gains in Tanzania: analysis of data from demographic and health surveys. Lancet, 2008, 371:1276-1283.

15.

The DDCF African Health Initiative Advisory Council includes the following members: Marian Jacobs, Roger Glass, Demisse Habte, Barry Bloom, Francis Omaswa, Adetokunbo Lucas and Miriam Were. However many other experts have reviewed proposals and contributed to this initiative. More information on the initiative can be found at ddcf.org/mrp-ahi.

16.

The nine focus countries are: Ghana, Lesotho, Kenya, Madagascar, Malawi, Mozambique, Rwanda, Tanzania and Zambia.

17.

Ravishankar N et al. Doris Duke Charitable Foundation PHIT Partnership Implementation Research Framework, 2008. Obtained online at http://www.ddcf.org/mrp-ahi.

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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 Programme began in 1979 as a collaboration between scientists from Oxford University in the UK and Mahidol University in Bangkok, Thailand, to undertake tropical medicine research, and has now grown into a major network that today enjoys an international reputation for excellence in clinical research in many important tropical diseases. What started as a small unit headed by Professor David Warrell to study snake bites and severe malaria has now evolved into a major contributor to global tropical medicine research efforts in infectious diseases of global and regional significance, including: malaria, melioidosis, rickettsial diseases, leptospirosis, dengue, typhoid, tuberculosis, tetanus, bird flu, meningitis and encephalitis.

This trajectory has been in keeping with the Wellcome Trust’s policy of identifying promising scientists with important questions and being prepared to support them in the long term. We usually award junior level fellowships or project grants initially, and then provide incrementally larger grants over time as these individuals demonstrate their ability to conduct excellent scientific research to answer the questions they have set themselves. Over time successful researchers will attract teams of scientists around themselves, eventually forming a critical mass in the form of a centre or unit. These centres over time can expand further through the development of satellite units, or through hub-and-spoke mechanisms leading to the establishment of region-wide networks. In the case of the South-East Asia Major Overseas Programme, the network stretches from India to Indonesia and provides a platform of research-experienced collaborative centres for the conduct of major trials and studies (see Figure 1). This region is densely populated with half of the world’s human population living within 3200 kilometres (2000 miles) of Bangkok, often in close proximity to domestic and wild animals.

Right from the beginning, the strategy in South-East Asia incorporated several key principles: close integration with local institutions, attracting high-calibre staff both nationally and internationally, identifying and responding rapidly to diseases of public health relevance, formulating studies of the highest quality to understand and tackle the diseases, developing research and institutional capacity, and translating the evidence of research into policy and practice.

T

The Wellcome Trust South-East Asia Programme established clinical research groups with laboratory support across Thailand to conduct clinical research on illnesses of major public health importance. In the case of malaria this meant initially working on the Thai-Cambodia border, where there was the highest incidence of malaria and the parasite strains were highly resistant to therapies of the day. Much of the subsequent work on malaria treatment has been conducted on the Thai-Burmese border at the Shoklo Malaria Research Unit established in1986. With a keen eye for collaborative research opportunities outside Thailand, links were forged with the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, in 1991, and Mahosot Hospital, Vientiane, Lao PDR, in 1999 to bring a regional dimension to the work.

The network is now firmly established with operationally independent teams across South-East Asia at two hubs in Bangkok and Ho Chi Minh City and at major centres in Mae Sot and Vientiane. The Thailand unit has spread its network extensively through research collaborations in many countries across Asia and even into Africa, where partnerships have been set up for antimalarial artesunate therapy trials (registered as AQUAMAT), for an international effort with Interpol to tackle counterfeit drugs1 and, more recently, for a worldwide antimalarial resistance surveillance network (WARN)2. Work on melioidosis, cryptococcal infection, leptospirosis and the rickettsial diseases is based in rural hospitals at Udon Thani and Ubon Ratchathani near the Lao and Cambodian borders respectively. The unit in Vietnam has also evolved gradually and has itself a satellite unit in Hanoi, and networking sites in several Asian countries, focusing on research in typhoid, tetanus, dengue, malaria, meningitis, encephalitis, tuberculosis and avian influenza. The latter potential global threat precipitated the establishment of a regional research network – the South-East Asia Influenza Clinical Research Network – which is co-ordinated by the Vietnam unit and involves other partner institutions in Vietnam, Thailand and Indonesia, including the Thailand Unit. International partners include Oxford University, the National Institutes of Allergy and Infectious Disease, the Wellcome Trust and the World Health Organization (WHO)3.

Inseparable from the research activities, the trust’s SouthEast Asia Programme has been actively engaged in capacity

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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 postdoctoral 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 programmeâ&#x20AC;&#x2122;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 scientists working on basic science including microbiology, pharmacology, genetics, immunology and allied disciplines.

Figure 1: Location of the Wellcome Trust South-East Asia Programme and collaborating centres

Malaria Work done at the Thai unit in the 1980s provided comprehensive clinicopathological descriptions of severe malaria which influenced international policy by forming the basis for the first WHO severe malaria management guidelines. These together with the identification and characterization of low blood sugar as a major manifestation of severe malaria, and pioneering work on the development of dose regimens for chloroquine injections and the introduction of loading doses of quinine had a major impact on the mortality from severe malaria, particularly in the first 24 hours after admission.

Subsequent work by the programme which started in the 1990s has pioneered the development, evaluation, and introduction of artemisinin combination treatment (ACT) which is now the first-line treatment for falciparum malaria throughout the world (see Figure 2). The effects of ACTs on transmission and incidence of malaria have been characterized and the largest ever-randomized trial in severe malaria, using the established network of clinical research collaborating sites, showed a reduction in mortality of 35% with artesunate compared to quinine, which

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had been the treatment of choice for more than 350 years5.

The programme has developed methods of assessment of antimalarial drugs, including the introduction of genotyping which allowed for the first time large trials to be conducted in endemic areas, and has used pharmacological techniques to establish the optimal regimens of artemether-lumefantrine, artesunate-mefloquine6 and dihydroartemisinin-piperaquine, which are the main antimalarial drug combinations in use today.

The research group has also demonstrated the adverse effects of malaria in pregnancy. Even in low transmission settings there are reductions in birth weight and infant survival associated with both falciparum and vivax malaria.

They have also shown through pharmacological studies that women in late pregnancy are systematically underdosed with current antimalarial treatment regimens, and through clinical studies that artemisinins in pregnancy are safe, leading to the lifting of prescribing restrictions in the second and third trimesters.

Other infections Dengue, a viral infection spread by mosquitoes, is a perennial problem in South-East Asia, and in many cities is

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Figure 2: Artemisia annua (sweet wormwood) plants in pots. The source of artemisinin for the treatment of malaria

the main cause of paediatric hospital admission in the rainy season. Dengue may lead to haemorrhage or shock, causing serious illness and death in children. Clinical studies of dengue in Vietnam have led to improved patient care and outcome through the development of diagnostic tests for early identification of infection, the only recent randomized controlled trials of patient care such as fluid replacement management, and the use of new antiviral drugs for the first time in this disease. This has led to a significant fall in mortality for hospitalized patients with severe dengue to less than 1% in hospitals in Ho Chi Minh City.

Despite the existence of a highly effective vaccine for the prevention of tetanus, clinical cases do still occur throughout South-East Asia. Studies of patient care in Vietnam have led to a reduction in mortality for patients with tetanus from 40% to 6% through the development of standardized guidelines for the use of artificial ventilation, improved nursing practices, reduction of hospital-acquired infections, and the use of magnesium to reduce the need for muscle relaxants.

Meliodosis is a serious bacterial infection common in South-East Asia, probably acquired from stagnant water or infected soil. Studies on meliodoisis in the 1980s showed that treatment with ceftazidime, a third-generation cephalosporin antibiotic, could halve mortality from 80% to 40%, and this drug immediately became the treatment of choice. A continued interest in this infection has made the unit the leading meliodosis research unit in the world, having conducted 75% of all trials. Current treatment recommendations are based on their evidence on maintenance combination regimens for eradication treatment.

Over the years the unit has also improved laboratory methods for the diagnosis of melioidosis which are now generally adopted throughout the world.

Typhoid is a common cause of fever wherever sanitary conditions are poor. A series of randomized controlled trials of patients with typhoid have demonstrated that the fluoroquinolone class of antibiotic should be used as first-line

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 people. This has implications for diagnosis and treatment in terms of choice of antibiotic and the use of steroids. It also highlights the need for closer communications between experts in human and animal health as this bacterium is associated with pork butchery.

Conclusions The South-East Asia Programme has focused particularly on specific pathogens of importance in the region but has in recent years also widened its scope to syndromic approaches (such as studying causes of fever) and important noninfectious diseases. For example the network has conducted studies in parts of Thailand, Laos and Vietnam to identify the common causes of patients presenting to hospitals or health units with fever, highlighting the importance of often-forgotten diseases such as leptospirosis (Weilâ&#x20AC;&#x2122;s disease) and scrub typhus (tsutsugamushi fever), thereby improving diagnostic protocols and leading to more rational prescribing8, 9. It has also identified infantile beri-beri (vitamin B1 deficiency) as the major cause of infant death in the Karen refugee population and in Laos10. This condition used to kill 10% of all babies, but now that it is recognized, prevented and treated with thiamine, it is no longer a recognized cause of death.

The South-East Asia Programme, has, through long-term sustained funding from the Wellcome Trust, been able to contribute greatly to increasing the knowledge base of important infectious diseases in the region and globally.

This has provided a strong international base for training in clinical research.

This clinical research with a centre of gravity in SouthEast Asia undertaken in rural, refugee and displaced persons populations, as well as in major urban conurbations, has influenced national treatment policies directly.

It has also provided an evidence base that donors, governments and the WHO have used to justify their support and to develop their policies for many of the worldâ&#x20AC;&#x2122;s most important diseases.

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Research into health is increasingly recognized as critically important in the struggle against death and disease in poor populations11. The Wellcome Trust-funded South-East Asia Programme is a model for successful and sustainable tropical medicine research. Similar Wellcome Trust-funded programmes are located in Kenya, Malawi and South Africa. J Acknowledgements We are grateful for the inputs and suggestions for this article from Nick White (Bangkok) and Jeremy Farrar (Vietnam).

We are also indebted for all dedicated work conducted by themselves and their teams over the years. For more information about the South-East Asia Programme please visit: http://www.wellcome.ac.uk/Achievements-and-Impact/ Initiatives/International-biomedical-science/Major-OverseasProgrammes/South-east-Asia-programme/WTD003485.htm Jimmy Whitworth has been Head of International Activities at the Wellcome Trust since 2004. He oversees strategy and policy for research in developing and restructuring countries of the world, including fellowships, project and programme grants, networks and partnerships. He qualified in medicine in 1979 and has worked in The Gambia for Save the Children Fund, and in Sierra Leone and Uganda for the Medical Research Council. He has worked at the Liverpool School of Tropical Medicine and the

London School of Hygiene and Tropical Medicine, where he was Professor of International Public Health from 1999 to 2004.

Ruth Branston joined the Wellcome Trust in 2005 and is a Science Portfolio Adviser in the Immunology and Infectious Disease Funding Stream. She oversees the trust’s research portfolio in Asia including the trust’s major research programmes in Thailand, Laos and Vietnam. She graduated from Bath University in 1997 with a degree in biochemistry and completed a PhD in molecular pathology in 2001 at University College London. Subsequent to her PhD, she worked for Biovex, a biotechnology company and also for Defra (UK Department of Environment Food and Rural Affairs) managing the portfolio of research on bovine TB. Michael Chew is a Science Portfolio Adviser at the Wellcome Trust’s Science Funding division and works in the Pathogens, Immunology and Population Health department. The department manages the trust’s funding and strategic portfolio in infectious and noncommunicable diseases, especially in the context of tropical medicine and public health both in the UK and in lowand middle-income countries. Before joining the trust, he undertook research for a PhD in parasitology at Imperial College London, followed by postdoctoral work at the Institute of Child Health, London, and Imperial College for 16 years.

References 1.

Newton PN et al. A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia. PLoS Medicine, 2008, 5:e32.

2.

Sibley CH, Barnes KI, Plowe CV. The rationale and plan for creating a World Antimalarial Resistance Network (WARN). Malaria Journal, 2007, 6:118.

3.

South-East Asia Influenza Clinical Research Network. http://www.seaclinicalresearch.org/ 4.

Farrar J. Global health science: a threat and an opportunity for collaborative clinical science. Nature Immunology, 2007, doi 10.1038/ni532.

5.

Dondorp A et al; South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) group. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet, 2005, 366:717-725.

6.

Nosten F et al. Treatment of multi-drug resistant Plasmodium falciparum

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malaria with 3-day artesunate-mefloquine combination. Journal of Infectious Diseases, 1994; 170:971-977.

7.

Thwaites GE et al. Dexamethasone for the treatment of tuberculous meningitis in adolescents and adults. New England Journal of Medicine, 2004, 351:1741-51.

8.

Phetsouvanh R et al. Causes of community-acquired bacteremia and patterns of antimicrobial resistance in Vientiane, Laos. American Journal of Tropical Medicine and Hygiene, 2006, 75:978-85.

9.

Phongmany S et al. Rickettsial infections and fever, Vientiane, Laos.

Emerging Infectious Diseases, 2006, 12:256-62.

10.

Luxemburger C et al. Beri-beri: the major cause of infant mortality in Karen refugees. Transactions of the Royal Society for Tropical Medicine and Hygiene, 2003, 97:251-5.

11.

Keusch GT and Medlin CA. Tapping the power of small institutions.

Nature, 2003, 422; 561.

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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 common – they are both highly valued concepts. This is certainly true for the field of humanitarian action but may also apply more generally to modern states and societies.

Which public or private institution, political or social group would nowadays claim to oppose innovation and to cherish subordination? In an apparent paradox, however, these two nearly universal values of the “modern world” are commonly held to be under constant threat. Many states claim their right to sovereign independence and oppose interference in their internal affairs from other independence-conscious states or nongovernmental organizations (NGOs), while post 9/11 humanitarian NGOs have been staging an ever-increasing number of roundtable discussions, workshops and conferences around the theme “independence under threat”.

In a similar vein many NGOs, in public or private, resent donors’ overwhelming demands for reports and paperwork that they think stifle innovation, while donors have been vowing to bring innovative practices to an aid community lacking adequate accountability procedures.

One important reason for this trend is that, much like concepts of “good governance”, “sustainable development” or “responsibility to protect”, independence and innovation produce an easy consensus as long as they remain abstract notions or undefined goals or principles. As soon as they start to become concrete, however, one organization’s claim of independence is often seen by others as arrogant and selfserving opposition to coordinated action, while the groundbreaking innovation heralded by one is dismissed by another as mindless adventurism or a mere smokescreen.

If I bring this measure of relativism to the debate from the outset it is because the possible interactions (and sometimes contradictions) between independence and innovation cannot be addressed if they are thought of as positive in and of themselves, as is so often the case. Independence from whom, and for what purpose? These questions are worth asking, especially in the humanitarian field where independence is so often unquestioningly presented as a “core principle”, with little elaboration. The same applies to innovation, whether technical, scientific, organizational or some other form. Innovation from what? For what goal? For whose benefit? In fact the question might legitimately be

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asked whether humanitarian action is even meant to be an innovative sector? The stated purpose of development aid is to introduce innovation (whether in farming techniques, marketing practices, medical know-how or some other field) in order to bring about economic, social or political change, but humanitarian aid, strictly defined, is about alleviating suffering in times of crisis. While development offers a set of innovations for a better future, humanitarian action is about the provision of means of survival in the here and now. Hence the very different attitudes development and humanitarian NGOs have, in principle, towards independence: development professionals usually insist on “partnerships” with existing authorities, administrations and “communities”; humanitarians, on the other hand, see themselves as filling voids and acting as temporary substitutes for local institutions in disarray and for uncaring, reluctant or incapacitated authorities, whether legitimate or de facto.

Lessons from Niger

1

This very distinction lies at the heart of the controversies that divided the various aid-related institutions in Niger in the course of the 2005 food crisis. To development advocates, “emergency” humanitarian agencies were guilty of arrogance, disrespect for the sovereignty of the Niger government and ignorance of the local context. They emphasized the need for long-term policies and stable market practices to fix what, to them, was not an emergency but a chronic crisis. As a result they opposed emergency responses, especially free food distributions. They argued that this failed to address the structural causes of the problem and would jeopardize efforts made over the previous 20 years to foster sustained development, instead trapping Niger’s rural communities in a vicious circle of dependence. Humanitarian “emergency” NGOs such as MSF counter-attacked by arguing that the ongoing food crisis was evidence of the failure of past policies based on market deregulation to ensure food security for the poorest families. They further criticized development policymakers for turning a blind eye to the present suffering of the population, in particular ignoring the deaths of tens of thousands of malnourished children, all in the name of food security improvements and individual producers’ autonomy at some distant point in the future.

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This protracted debate along the all-too-familiar lines of emergency versus development aid actually served to obscure the more complex reasoning and interactions that shaped the 2005 crisis in Niger. Innovation and independence had a role in these, but not necessarily in the ways that might have been expected.

To all its stakeholders the food security system put in place in Niger at the end of the 1990s was highly innovative. It relied for data collection on state-of-the-art technology for monitoring food crops, including satellite images provided by NASA, and was meant to break away from former bureaucratic control by emphasizing market deregulation and monitoring. It was also innovative in that its “core principles” were partnership and consensus among its stakeholders (the government of Niger, the European Union, several bilateral donor countries and the World Food Programme [WFP]).

These partners in the new approach to food security also had independence in mind – Niger’s independence from food aid, although donors were responsible for funding grain reserves to cover possible shortages before that ultimate goal could be achieved.

Contrary to an accusation commonly made by development agencies, not all the organizations ringing the emergency bell in 2005 were newcomers in Niger. Nor were they necessarily emergency-oriented in their programming prior to that year. Following a series of interventions in the country since the mid-1980s addressing either nutritional needs or epidemics, MSF France had settled down in the Maradi region in early 2002 and embarked on a mediumterm nutritional programme. The driver behind this decision, quite debated at the time, was innovation, both scientific and organizational. The scientific (and technical) innovation was Plumpy’nut, a ready-to-use therapeutic food (RUTF) available in a sachet and the result of progress in nutritional research that had identified the cause of malnutrition as micronutrient deficiency rather than lack of protein, a longtime creed of nutritionists. Plumpy’nut was the product of cooperation between the nutrition department of the French public research unit IRD (Institute for Development Research) and a private small-scale food company, Nutriset.

It was not MSF but the nutritional consultancy Valid International that first saw the potential of RUTF. Its members developed a new protocol called Community Therapeutic Care (CTC) which was designed to increase the reach of existing feeding centres by allowing most severely malnourished children to be treated at home with the use of RUTF. It was this combination of innovations that convinced two members of MSF, a nutritionist from the medicaltechnical department and the medical doctor heading the emergency department, to try and implement this new protocol in Niger in 2002.

The programme they established was about filling a void: with the attention and funding of donors focused on preventing food crises through crop monitoring and food market liberalization, therapeutic treatment of severe malnutrition was no longer available in Niger’s health system. In addition, Niger was a stable country in which progressive experimentation with this new approach was

feasible; its results would also be useful for more “classical” emergency situations in war zones. MSF was soon running a private therapeutic centre in Maradi, financed with its own private funding. Yet, independence in this case bordered on isolation – while not opposed to it, neither Niger’s Ministry of Health nor the aid community showed any interest in this nutritional project. In contrast, the MSF team’s efforts to have a new and more effective protocol for malaria treatment registered at national level met with strong resistance from the medical authorities, who saw it as impinging on the state’s sovereignty. Within MSF, the Niger nutritional programme also received little attention or support. Niger’s peaceful context meant that it was not a priority for the MSF operations department while many doctors, both at headquarters and field level, remained sceptical about a programme that reduced medical supervision of the treatment of children with severe conditions. To overcome this internal resistance external expertise (a nutritionist, a psycho-anthropologis) was sought and dispatched to the field.

In 2004 the programme started to show impressive results, with 10 000 children treated, more than 80% of them cured. It also began to receive increasing interest: the WFP representative in Niamey was willing for the agency to reinvest in severe malnutrition in Niger and to purchase Plumpy’nut from the local production MSF had helped to set up in an attempt to lower its cost. This encouraged MSF to push for donors and medical authorities to recognize the scale of malnutrition in Niger and to include adoption of the innovative therapeutic protocol in their strategic objectives for 2005. Indeed central to MSF’s operational choices, public statements and overall role in the 2005 food crisis in Niger was the goal, set prior to the crisis, of diffusing this tested innovation for the treatment of severe malnutrition. The controversies that subsequently erupted reflected resistance from donors and local authorities to this process, notably because the images of starving children filmed in MSF feeding centres were used as evidence of the failing of the food security apparatus and were undermining the culture of consensus upon which it was built. The MSF programme was marked by both independence and dependence.

Financial independence allowed the organization to carry out its nutritional programme on an unprecedented scale, with 40 000 children treated in 2005. At the same time MSF remained dependent on a number of other factors: on media coverage of the food crisis, which contributed to a blurring of its message; on the capacity of other NGOs to adapt to the situation; on the ambivalent position of WFP, torn between its role as donor representative in the food security system and that of emergency food agency; on political infighting within the Niger government; and on local understanding of the crisis and the belated international response to it.

What did the food crisis and the way it was reported do for the diffusion of the nutritional innovation promoted by MSF? The use of RUTF for severe malnutrition was registered as the national protocol in Niger; nutritional surveys, rare prior to the crisis, are now routinely undertaken by UN agencies and NGOs to monitor the situation; and therapeutic feeding

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centres funded by international donors have flourished. At the global level, WHO, UNICEF and WFP published a joint press communiqué calling for the international community to mobilize to treat severe malnutrition worldwide and recommending the use of RUTF combined with the CTC method. The Niger crisis certainly had an accelerating effect on the renewed interest of international health institutions in a more medical approach to malnutrition, although this was also part of a more general trend following a decade of exclusive public health focus on infectious diseases. Finally, it is also worth noting that this process of adoption, implementation and diffusion of innovation by MSF in Niger and the dynamics of the 2005 crisis have resulted in important changes in MSF’s outlook. MSF’s historical approach to nutrition was limited to emergency situations; having only reluctantly engaged in a medium-term programme in Niger’s context of chronic malnutrition, the organization has now launched an international campaign to promote increased use of ready-to-use food not only to treat but also to prevent malnutrition in endemic areas.

standards. With consultants and employees from these sectors being sought by NGOs to bring new expertise to humanitarian action, this process of professionalization reflects a more general evolution in the concept of “professionalism” in Western societies. Increasingly professionalized NGOs in turn witnessed a change in their working environment, one in which they had played an important part, willingly or not. The successive reforms of USAID and the creation of DfID in the UK reflected the way in which donors were adapting to the evolution of NGOs. This process was accompanied by new requirements and channels of control, in much the same way as local authorities and communities in the field were adjusting and increasing their demands towards better resourced aid organizations.

As the work of sociologists and anthropologists shows2, innovation and its diffusion can only be understood with reference to the societal context in which they occur. Existing political, economic or symbolic conflicts largely determine the acceptance or rejection of a given innovation, as any innovation inevitably serves some interests while running counter to others. As the Niger case illustrates, this may be the case within a single NGO, between the various departments, professions and individuals of which it is made up, in the broader aid community or in the local societies receiving international assistance. The political stakes may of course differ depending on the aim of innovation – to raise “humanitarian standards”, change public health policies or improve the living conditions of local communities, for example – but these various objectives and the type of resistance they may encounter are often interconnected.

Hence, questioning the links between independence and innovation in humanitarian action is to reflect upon the many unexpected ways in which our own evolution has changed the social and political environment in which we now work, for better or for worse. J

Social and political processes As this lengthy account of MSF’s experience with nutrition in Niger has attempted to show, there is no simple equation between independence and innovation. Interdependence is more often than not the modus operandi of humanitarian NGOs in the field. It is not their invocation of a “core principle”, but their readiness to oppose, when necessary, the culture of consensus, allied to the weight and credibility their voice has acquired through years of effective relief action, that enables them (albeit not always) to avoid being tied to the agendas of others. Historically the humanitarian sector has developed through a series of innovations, usually referred to as professionalization. This process began in the 1980s, when NGOs were faced with the daunting task of meeting the needs of populations living in refugee camps. The purpose of professionalization was to develop the means of delivering effective assistance to large groups of people, but it also increased humanitarian agencies’ autonomy of decision and action. In the Cold War context, however, aid provided by primarily Western NGOs was hardly perceived as independent.

Medical kits, new logistics tools and water engineering are the most obvious innovations of this period. But professionalization subsequently incorporated other forms of innovation, including some borrowed from the commercial and other sectors like new means of communication, standardized recruitment techniques and accounting

Xavier Crombé is currently a research director at the Fondation MSF and teaches humanitarian affairs at the Institut d’Etudes Politiques in Paris has been working for the humanitarian organization Médecins Sans Frontières (Doctors Without Borders/MSF) since 2000 and has completed several field missions, including in China (Tibet), Afghanistan and Darfur. He joined the Fondation MSF, a research unit in the Paris office of Médecins Sans Frontières in 2004. He has recently co-edited with Jean-Hervé Jezequel a book on the 2005 food crisis in Niger: Niger 2005, Une Catastrophe Si Naturelle, Paris, MSF/Karthala, 2007.

References 1

106

The following section is derived from various contributions in Xavier Crombe & Jean-Herve Jezequel (eds.) Niger 2005, une catastrophe si naturelle. Paris Karthala/MSF, 2007 (English version forthcoming 2008).

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For a useful synthesis, see Jean-Pierre Olivier de Sardan, Anthropology and development, understanding contemporary social change. Zed Books, London, 2005.

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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 (CCT) Programme, called Progresa (subsequently Oportunidades), in Mexico, was paradoxically rooted in the willingness to cut social spending. As the Mexican economy was seriously hit by the Peso crisis, the Ministry of Finance decided to replace the traditional in-kind transfers to the poor by an innovative experiment that would target fewer, more needy households, and offer them cash on the condition that they comply with a set of requirements, intended to break the vicious circle of poverty1. Initially implemented on a relatively smallscale, Progresa was found to be an effective mechanism particularly for improving uptake of preventive interventions for children by 2001, and subsequently scaled-up at the national level in Mexico. Its principles were soon replicated in other Latin American countries, and more than 10 years later, dozens of other CCT schemes have now flourished from Honduras to Ecuador or Nepal, with one of the most recent implemented in the city of New York.

Conditional cash transfers have been categorized as a particular form of performance-based payments2, which make cash payments to households contingent on a set of behavioural requirements, such as attending regular health check-ups or sending oneâ&#x20AC;&#x2122;s children to school. The ultimate objective of CCT is twofold. In addition to a short-term poverty reduction created by the increase in income, CCTs are designed to act as powerful incentives for households to adopt a behaviour that will positively impact on their wellbeing, and break the cycle of poverty in the long run.

This particular feature is based on the recognition that there might be a series of demand-side barriers restraining individuals from using preventive and basic curative health services. The first demand-side obstacle consists of the financial cost individuals must bear when they decide to use health services. This cost can be the direct cost of using health services (when they are not completely free), the indirect cost (in particular the cost of transport can create major obstacles), and the opportunity cost (for example the loss of revenue incurred by the use of health services instead of spending that time on income-generating activities).

T

Finally, these programmes are also justified by the need to address more entrenched demand-side obstacles, such as cultural barriers or the failure to perceive the benefits of preventive health interventions.

Characteristics of experiences to date Following the success and promotion of the original Mexican programme, many Latin American countries have implemented similar conditional Cash Transfer Programmes (see Table 1).

CCT programmes have been less common in other parts of the world, although recent experiences with health components have been launched in Turkey3, Nepal4, India5, Kenya6 and at a small scale in Malawi7. It is worth noting that the majority of CCT interventions have occurred in middle-income countries.

This is likely to be due to their relatively high cost, and the fact that they often rely on complex information and management systems8.

Inspired by the original example of Progresa, many countries have introduced CCT programmes where the compliance with health conditionalities is only one dimension of a broader intervention (see Table 1). This is justified by the overall objective of those interventions which is to provide support to families dwelling in extreme poverty, in order to develop the potential of the household members in the long run.

A more limited number of programmes have had much narrower objectives, typically focusing on improving particular preventive health behaviour. Examples include the use of CCT to incentivize the participation in testing for HIV status7 and provide incentives for mothers to deliver in health facilities in Nepal4 and India5.

Most programmes implemented in Latin American countries have targeted the poorest groups of the population. As poor people usually face the greatest barriers to access, CCT mechanisms thereby act as transfer mechanisms that redistribute resources to reduce health inequities. Other CCT programmes, in particular in lower-income settings, have not targeted specific groups, either because the information systems did not allow them to, or to maximize the effects when initial overall uptake rates were very low in the population4, 5.

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Country, programme name and reference Target population

Transfer size

Conditionalities For pregnant and lactating women: attending educational workshops, regular check-ups and vaccinations up-to-date. For children under 7: maintaining vaccinations up-to-date and growth monitoring

Brazil – Bolsa Alimentação22

Up to maximum of US$ 18.25. US$ 6.25 per Poorest households from selected municipalities (chosen person beneficiary in the household (pregnant according to infant malnutrition women or children under 7) prevalence)

Colombia – Familias en Acción 13, 33

Poorest households from selected municipalities (also chosen on poverty criteria)

Ecuador – Bono de Desarollo Humano34

Children under 16 and house- US$ 15 per month per household; senior and For children aged 6–16 year old: attending school regularly (more 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 growth and development checkups and immunizations per month second quintile of income

El Salvador – Red Solidaria35

Children under 15 and expectant women from families living in extreme poverty within priority municipalities

Honduras – Programa de Asignación Familiar 11

Children and women from poor US$ 17 on average (US$ 4 per family, US$ 5 per Attending primary school and regular health visits households, living in designated child). Approximately 10% of household consumption beneficiary municipalities (chosen on socioeconomic criteria)

India – Janani Suraksha Yojana5

Pregnant women belonging to Rs 700 in rural areas and Rs 600 in urban areas poorest households, aged older than 19 years, and for up to 2 live births (extended after the third live birth if the mother chooses to undergo sterilization immediately after the delivery)

Jamaica – Programme for Advancement Through Health and Education15

Children under 17 years old, pregnant and lactating women, elderly over 65 years, destitute adults under 65 years

Kenya6

Poor households having Orphan Ksh 1000 (US$ 13.86) for households with up and Vulnerable Children (OVC) to 2 OVC, Ksh 2000 (US$ 22.72) with 3–4 OVCs, and Ksh 3000 (US$ 42.58) with 5 or more OVCs aged 0–17 years old as permanent members

Malawi7

Collecting HIV test result Individuals doing an HIV test, in US$ 1.04 on average – vouchers of values between US$ 0–3 per individual were randomly rural areas assigned

Mexico – Progresa Eligible households (selected on poverty criteria) among selected (renamed Oportunidades) 10, 16, communities (selected on 18-21, 36 poverty criteria)

Nepal – Safe Delivery Incentive Programme4

Pregnant women with no more than 2 living children or an obstetric complication

Parallel intervention(s) Children received nutrition supplements

US$ 50 on average US$ 20 per family; US$ 6 For children under 7: attending health and nutrition check-ups. For per primary school child; US$ 12 per secondary children aged 8–18 year old: attending school. For mothers: school child. Approximately 30% of household attending health education workshops consumption

For women: participating to training courses, and complying with US$ 15 if eligible for health component only, US$ 20 if eligible for both health and education basic protocol concerning preventative health. For children aged 6–14 years old: attending school components, US$ 10 if eligible for education component only (between 15% and 18% of the minimum rural salary, bimonthly)

US$ 9 per month per child eligible for education component, US$ 9 per month per household member eligible for the health component

Attending at least 3 antenatal and post-birth check-ups and delivering in a public health facility (programme benefits are supposed to be extended to women delivering in private facilities too)

Institutional strengthening activities (strengthening the beneficiary selection system (SelBen) for social programmes) Strengthening of the education system (improving facilities and teaching material availability), and a US$ 19 million programme of contracting out NGOs to ensure the provision of basic health and nutrition services -

In low-performing States (with low institutional delivery rates), an incentive is paid to the accredited health worker for each delivery (Rs 600 in rural areas and Rs 200 in urban areas)

For children aged 6–17 years old: attending school. For other beneficiaries: complying with required health visits per year (number depends on beneficiary age and status)

For children aged 6–17 years old: attending school. For children under 5: regular health centre visits for immunizations. For children 0–1 year and for growth monitoring and vitamin A supplement for children 1–5 years

US$ 20 on average; US$ 13 per family; US$ 8–17 per primary school child; US$ 25–32 per secondary school child; US$ 12–22 grant once a year for school supplies – approximately 25% of household consumption

For children: attending primary and secondary school attendance; and complying with regular health visits and immunization schedule. For pregnant women: complying with regular health visits and attending health education workshops

Children received nutrition supplements – allocation was not random and children in “control” areas could also have received them

1500 NRs in mountain areas, 1000 NRs in hill areas, 500 NRs in the lowlands (30–50% of the mean transport cost to the health facility)

Giving birth in a public health facility

Trained health workers receive an incentive of NRs 300 for each delivery, and facilities are reimbursed NRs 1000 per delivery to recover the cost (as deliveries are free of charge for women). The programme trained and contracted private providers to deliver the health services required.

Nicaragua – Red de 42 municipalities chosen to Protección Social12 participate in the pilot phase: 50% randomly selected for intervention

For mothers of children under 5: attending educational workshops US$ 25 on average US$ 18 per family; US$ 9 per family with school-age child; US$ 20 once a and bringing children to preventive health programmes For children aged 7–13 years old: attending school year for supplies. Approximately 20% of household consumption

Children aged 0–14 (including Paraguay – Red street children), and pregnant de Protección y Promoción Social37 women in extreme poverty

Health and education transfer of US$ 5 per child aged 0–14 years old (up to 4 children per household) plus an additional US$ 10 per household.

For children aged 25–60 months: attending educational centres (early stimulation). For children aged 5–14 years: attending basic schooling. For children aged 0–24 months: visits to health centre for growth/development monitoring. For children aged 25–60 months: visits for growth monitoring.

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

US$ 33

For children under 5: preventative health care visits for children 0–5 years. For pregnant and lactating women: complying with pre- and postnatal care visits, attending nutrition training sessions. For children aged 6–14 years old: attending school. For all: obtaining birth certificates or ID cards (for individuals older than 18 years)

Peru – Juntos38

Children and pregnant or lactating women from poorest households in rural communities

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 13 for boys, US$ 16 for girls; secondary US$ 20 visits to health clinics. For pregnant women: regular attendance to prenatal and postnatal checkpregnant women Management ups and giving birth at hospitals for boys, US$ 28 for girls.

Project3 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

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Finally, it should be underlined that many of the early CCT programmes have been carefully designed and implemented in a fashion that has allowed a robust evaluation of their impact9.

This is an innovative trait for such large-scale social interventions, which seems to have originated from the initial commitment to rigorous design of the evaluation of Progresa.

Even when randomized evaluations have not been possible for political or logistical reasons, close monitoring and meticulous data collection have usually allowed independent researchers to carry out good impact evaluations9. In this respect CCT programmes have set an example to be emulated by other policy-makers and demonstrated that it is politically and administratively feasible to randomize access to potentially beneficial interventions when their benefits have not yet been shown.

Overall CCTs display several innovative features. Their requirements intend to go beyond the traditional wealth effect of simple cash transfers, by incentivizing households to adopt beneficial behaviours while at the same time addressing demand-side obstacles to accessing health services.

Evidence of effectiveness A series of positive effects of CCT programmes on health-related outcomes have been demonstrated.

CCTs have been found to improve significantly the uptake of preventive services. A small scale project in Malawi7 found that monetary incentives increased the percentage of individuals collecting HIV test results, and that the effect was increasing with the amount of the cash transfer. In Mexico, families benefiting from Progresa visited health facilities twice as much as non-beneficiary families10. In Honduras, the PRAF programme significantly increased health service utilization for pre-school children11, the uptake of routine child check-ups and growth monitoring visits, and the use of antenatal care, even if no effect was found on the uptake of post-delivery check-ups.

In Nicaragua, the Red de Protección Social scheme improved the proportion of disadvantaged infants (0–3 years old) taken to health centres in the past six months, both one and two years after it had started12. Finally, in Colombia, CCTs were found to increase the uptake of preventive health care visits for children aged less than 4 years old13, 14. The PATH programme in Jamaica was recently found to be effective at increasing the use of preventive health care for children in recipient families15.

Lastly, the Safe Delivery Incentive Programme in Nepal was found to be effective in increasing use of skilled attendance at delivery and reducing the probability of a woman delivering at home4.

Conditional cash transfer programmes have also sometimes proved to be an effective intervention to increase immunization rates among children. Positive effects were found in Mexico on measles and TB vaccination rates16, in Honduras on the coverage of the first dose DTP/pentavalent vaccine and in Colombia on the probability that children aged 24 months old had complied with the DPT vaccination schedule. The absence of long-term effects of Progresa on immunization rates suggest that CCTs are less effective in further improving rates where these have reached a high level9. The lack of impact of these programmes on vaccination coverage among particular age

groups should also noted, although the reasons behind these differences in findings are unclear, except in one case where contamination in control groups might have hidden a positive effect12. Some of the apparent differences in different age groups may also be spurious and related to multiple subgroup analyses.

Finally, some of these mechanisms have been linked to improved health outcomes. The Colombian programme Familias en Acción, improved the nutritional status of newborns and infants13, although not that of children older than 24 months old. Progresa was found to have improved the nutritional status and growth of children17-20 and was associated with lower prevalence of obesity and hypertension amongst adults21. The proportion of under-weight and stunted children had been reduced amongst the beneficiaries of the Nicaraguan CCT programme12. However, the Brazilian programme Bolsa Alimentação programme was found to have a negative impact on weight-for-age for children under 7 years old, which seems to have been caused by a misunderstanding of eligibility criteria for the programme by participating mothers22.

The potential positive effects of CCTs on anaemia are more subject to debate, as the positive effects found for the Mexican programme17, 19 might have been biased9, 20, while the Nicaraguan intervention was probably not12. Finally, two programmes demonstrated some positive effects on children’s health as reported by their mothers13, 17.

In addition to their direct benefits on health outcomes, CCTs have proved effective at increasing investments in what economists call “human capital”, thereby potentially improving long-term opportunities and living standards of beneficiaries.

First, several CCT programmes have increased enrolment rates of children from beneficiary households at school8, which is widely recognized as critical for the improvement of children’s future opportunities. A study of the Mexican programme also showed positive effects on cognitive development for children18.

Second, CCT programmes have demonstrated a positive effect on household food consumption. Two studies, one on the Colombian experience23 and the other on the Mexican programme24, have shown that receiving cash transfers was associated with an increase in quantity and quality of food consumed, which would undoubtedly be beneficial for the health of beneficiaries. Third, some findings suggest that CCT can provide opportunities to poor households to break the vicious circle of poverty. For example, investments in incomegenerating activities have been associated with CCTs in Colombia23 and Mexico25.

Overall, despite some methodological concerns9 there is a broad and reasonably robust body of evidence suggesting that CCTs are powerful instruments to improve directly or indirectly the health of beneficiaries, or increase the uptake of preventive health measures.

Limitations Despite these successes, a series of issues should be kept in mind to apprehend the replicability of CCT programmes to other settings, in particular in low-income countries, or to consider their extension to new areas.

To start with, most CCT programmes have been imple-

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mented in middle-income countries where they have benefited from the existence of adequate basic infrastructure (banks, roads and health facility network) and information systems that have contributed to the success of their targeting strategies.

Some programmes have in fact been complemented by supply-side interventions (see Table 1) to ensure the provision of good quality health or education services. The lack of reliable infrastructure in lower-income settings might mitigate the success of CCTs. Preliminary findings in Nepal suggest that failure to provide good quality care and referral transportation means might compromise the success of the programme4.

Besides, the actual implementation of CCT programmes requires substantial human and technical capacity, which might be more difficult to find in low-income settings. Recent reports from the Nepali and Jamaican schemes4, 15 show that lack of communication around the scheme, failure to provide clear guidelines to health workers, and financial mismanagement resulting in payment delays can jeopardize its success.

Moreover, there are a number of unresolved questions concerning the costs of such programmes. First, as for many social safety net mechanisms where the proportion of administrative costs can constitute an important part of the programme budget26, the cost efficiency of CCTs can be challenged. Indeed, Caldes and Maluccio27 show that two key components in most CCT programmes, targeting and conditionality, are important driving factors for costs. For the Colombian CCT programme, administrative costs represented half of the value of actual benefits delivered to beneficiaries27.

Second, given that the entire eligible population satisfying the conditionality receives monetary transfers, regardless of whether or not they were meeting the conditionality before the 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 expansion of CCT programmes to countries where means testing is too costly or not effective15, 29, makes this issue even more critical. Indeed, not targeting the poorest groups will increase the marginal costs of the programmes since utilization of health services are usually higher among the better-off. This raises the issue of the benefit incidence of such non-targeted incentive schemes where a disproportionate share of the budget might be spent on wealthier groups. The Nepali CCT scheme provides a direct illustration of this concern, as existing inequalities in use of delivery care services resulted in a greater proportion of beneficiaries amongst the richer groups4. Thirdly, the cost-effectiveness of CCT should also be measured against that of other traditional approaches to improve the uptake of 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 introducing conditional cash transfer mechanisms.

Finally, the expansion of CCT interventions might raise ethical issues. On the one hand, existing programmes have shown that perverse or unanticipated effects could occur, when individuals might seek to become or stay eligible to benefits22, 30. On the other hand, due consideration should be given to the ethical implications of a policy tool that can be powerful enough to change the behaviour of poor or vulnerable

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groups. In particular, the ethics of some programmes using monetary incentives to encourage irreversible contraceptive methods5, 31 should be questioned. Similarly, one can wonder whether it is ethical to use monetary donations as an incentive for individuals not to contract sexually transmitted infections, and stop providing them when they are found to be sick32.

Conclusion The introduction of conditional cash transfers represents a new and potentially valuable financing tool at the disposal of policymakers to tackle health issues. These programmes have been found particularly successful at decreasing demand-side barriers to access for poorest populations, and incentivize them to increase the use of health services. It is also hoped that their effects might carry over beyond their existence, by initiating behavioural changes among beneficiaries, although to date there is a lack of evidence on that aspect.

Despite a series of limitations that should be kept in mind regarding their implementation in low-resource settings, the early experiences in Latin America are generally promising and further investigation should be made into the desirability and feasibility of such schemes in lower-income countries. In that regard, the lessons learnt from a recent intervention in Nepal will be very useful to inform further experiences.

Yet, as for any innovative scheme, there is still scope for improvement to understand how they should be designed to avoid unexpected adverse effects or to maximize their impact in low-income settings. Public debate on the ethical aspects of such schemes should also be encouraged, particularly where they are designed to incentivize procedures that may be irreversible or may have unintended adverse consequences.

Key messages

Conditional cash transfers have proved to be effective demand-side incentives to increase the uptake of health services and even sometimes improved health outcomes.

When effective targeting mechanisms have been available, CCT programmes have increased access of poorest populations to health services.

The presence of adequate infrastructures, political commitment and technical capacity have often contributed to the successful implementation of CCT interventions.

Further investigation should be made into the feasibility and cost-effectiveness of Conditional Cash Transfers in low-income settings.

Mylene Lagarde is an economist by training and joined the Health Economics and Financing Programme of the London School of Hygiene & Tropical Medicine as a Research Fellow in Health Economics in 2005. She is involved in projects on health financing mechanisms, and health workersâ&#x20AC;&#x2122; career choices and motivation in low- and middle-income countries. She had previously worked as a Health Economist in the Ministry of Health in Cameroon, and was in charge of the analysis of a KABP survey on HIV/AIDS in France.

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Andy Haines became Director of the London School of Hygiene & Tropical Medicine in 2001. He was previously Professor of Primary Health Care and Director of the Department of Primary Care & Population Sciences, at Royal Free and University College Medical School, and worked part-time as a general practitioner. His research interests are health services research and epidemiology. He has undertaken major intervention trials in primary care settings and studied the impacts of climatic factors on health. He sits on many national and international committees. He was knighted in the 2005 New Years Honours list for services to medicine.

Natasha Palmer is a Lecturer in Health Economics & Policy with 15 years of experience in policy and research in the health sector in low- and middle-income countries. Her research interests include health system financing, scaling up HIV treatment and care services, contracting services to nongovernmental organizations, human resources and motivation. She is involved in teaching and research degree training at the London School of Hygiene & Tropical Medicine, and has collaborative research linkages with institutions in a variety of developing countries. She received her doctorate from the University of London.

References 1.

Grimes C. Do the right things. Financial Times, 24 May 2008, London.

Oxman AD and Fretheim A. An overview of research on the effects of resultsbased financing. Report Nr 16-2008, 2008, Nasjonalt kunnskapssenter for helsetjenesten, Oslo.

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World Bank, Turkey – conditional cash transfer, in Profile prepared for the Third International Conference on Conditional Cash Transfers (Istanbul, Turkey, 26–30 June 2006). World Bank: Washington, DC, 2006.

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Powell-Jackson T et al. Evaluation of the Safe Delivery Incentive Programme: final report of the evaluation. Support to Safe Motherhood Programme, Nepal. Kathmandu, 2008.

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Ministry of Health and Family Welfare, Janani Suraksha Yojana: Guidelines for implementation. Government of India: New Delhi, 2005.

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World Bank, Kenya – cash transfer programme for orphan and vulnerable children, in Profile prepared for the Third International Conference on Conditional Cash Transfers (Istanbul, Turkey, 26–30 June 2006). World Bank: Washington, DC, 2006.

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Thornton R. The demand for and impact of learning HIV status: evidence from a field experiment. Harvard University, 2006.

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Rawlings LB and Rubio GM. Evaluating the impact of conditional cash transfer programs: lessons from Latin America. World Bank Research Observer, 2005 (20): p.29-55.

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Lagarde M, Haines A and Palmer N. Conditional cash transfers for improving uptake of health interventions in low- and middle-income countries – a systematic review. Journal of the American Medical Association, 2007, 298(16): p.1900-1910.

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Gertler P. Final report: the impact of PROGESA on health. International Food Policy Research Institute, 2000.

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Morris SS, Flores R, Olinto P and Medina JM. Monetary incentives in primary health care and effects on use and coverage of preventive health care interventions in rural Honduras: cluster randomised trial. Lancet, 2004, 364(9450): p.2030-37.

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Maluccio J and Flores R. Impact evaluation of a conditional cash transfer program: the Nicaraguan Red de Protección Social. In: Food Consumption and Nutrition Division discussion paper No 184. International Food Policy Research Institute: Washington, DC, 2004.

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Attanasio O et al. The short-term impact of a conditional cash subsidy on child health and nutrition in Colombia. The Institute of Fiscal Studies: London, 2005, p.15pp.

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Attanasio O et al. Baseline report on the evaluation of Familias en Accion.

The Institute of Fiscal Studies: London, 2004, p.168pp.

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Levy D and Ohls J. Evaluation of Jamaica’s PATH program: final report.

Mathematica Policy Research: Washington, DC, 2007.

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Barham T. The impact of the Mexican conditional cash transfer on immunization rates. Department of Agriculture and Resource Economics, UC Berkeley, 2005.

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Gertler P. Do conditional cash transfers improve child health? Evidence from PROGRESA’s control randomized experiment. American Economic Review, 2004, 94(2): p.336-341.

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Fernald LC, Gertle PJ and Neufeld LM. Role of cash in conditional cash transfer programmes for child health, growth, and development: an analysis of Mexico’s Oportunidades. Lancet, 2008, 371(9615): p.828-37.

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Rivera JA et al. Impact of the Mexican program for education, health, and nutrition (Progresa) on rates of growth and anaemia in infants and young children: a randomized effectiveness study. Journal of the American Medical 2.

Association, 2004, 291(21): p.2563-2570.

Behrman JR and Hoddinott J. Programme evaluation with unobserved heterogeneity and selective implementation: the Mexican PROGRESA impact on child nutrition. Oxford Bulletin of Economics and Statistics, 2005, 67(4): p.547-569.

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Fernald LC, Hou X and Gertler P. Oportunidades program participation and body mass index, blood pressure, and self-reported health in Mexican adults.

Preventing Chronic Disease, 2008, 5(3): p.2-12.

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Morris SS et al. Conditional cash transfers are associated with a small reduction in the rate of weight gain of preschool children in Northeast Brazil.

Journal of Nutrition, 2004, 134(9): p.2336-2341.

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Attanasio O and Mesnard A. The impact of a conditional cash transfer programme on consumption in Colombia. The Institute of Fiscal Studies: London, 2005.

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Hoddinott J and Skoufias E. The impact of PROGRESA on food consumption.

Economic Development and Cultural Change, 2004, 53: p.37-61.

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Gertler P, Martinez S and Rubio-Codina M. Investing cash transfers to raise long-term living standards. In: World Bank Policy Research Paper 3994. The World Bank: Washington, DC, 2006.

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Grosh M. Administering targeted social programs in Latin America: from platitude to practice. The World Bank: Washington, DC, 1994.

27.

Caldes N and Maluccio J. The cost of conditional cash transfers. In: Economic and Sector Study Series RE2-04-014. Inter-American Development Bank: Washington, DC, 2004.

28. de Janvry A et al. Can conditional cash transfers serve as safety nets in keeping children at school and from working when exposed to shocks?

Journal of Development Economics, 2006, 79(2): p.349-373.

29.

Jalan J and Murgai R. An effective “targeting shortcut”? An assessment of the 2002 below-poverty line census method. Centre for Studies in Social Sciences, Calcutta and the World Bank, India, 2006.

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Stecklov G et al. Demographic externalities from poverty programs in developing countries: experimental evidence from Latin America.

Department of Economics, American University, Washington DC, 2006.

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Weeden D et al. Community-based incentives: increasing contraceptive prevalence and economic opportunity. Asia-Pacific Population Journal, 1986, 1(3): p.31-46.

32.

Jack A. World Bank backs anti-AIDS experiment. Financial Times, 25 April 2008: London.

33.

Attanasio O et al. How effective are conditional cash transfers? Evidence from Colombia. Institute for Fiscal Studies Briefing Notes, 2005.

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World Bank, Ecuador – Bono de Desarrollo Humano (BDH), in Profile prepared for the Third International Conference on Conditional Cash Transfers, Istanbul, Turkey, 26–30 June 2006. World Bank: Washington, DC, 2006.

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Support for the solidarity network program loan proposal. Inter-American Development Bank: Washington, DC, 2005.

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Gertler P and Fernald L. The medium term impact of Oportunidades on child development in rural areas, 2004.

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World Bank, Paraguay – Red de Protección y Promoción Social, in Profile prepared for the Third International Conference on Conditional Cash Transfers, Istanbul, Turkey, 26–30 June 2006. World Bank: Washington, DC, 2006.

38.

World Bank, Peru – Programa Nacional de Apoyo Directo a los más Pobres “Juntos” in Profile prepared for the Third International Conference on Conditional Cash Transfers, Istanbul, Turkey, 26–30 June 2006. World Bank: Washington, DC, 2006.

20.

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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

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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 Group on Public Health, Innovation and Intellectual Property and Marleen 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 establish an inter-governmental working group (IGWG) that could draft a multilateral strategy on public health, innovation and intellectual property rights. We will reflect on the outcome of the IGWG process and present some ideas on how best to put the strategy into practice.

T

Background Today 4.8 billion people live in developing countries and 2.7 billion of them live on less than US$ 2 a day. Half of all diseases in these countries are communicable. Governments, the pharmaceutical industry, foundations, nongovernmental organizations (NGOs) and others recognize that poverty is a major factor in preventing access to medicines in the developing world and are working to encourage the development of new or adapted medicines and to improve access to them2.

The urgency of a new multilateral strategy: developing countries are missing out on innovation and access In the 20th century medicines were developed according to an established pattern: pharmaceutical companies would develop a vaccine or medicine though trial and error, investing enormous amounts of time and resources in the process. Once a vaccine or medicine had been developed, it was patented, creating a monopoly position for the developer, who could then recover high research-and-development costs by setting a high monopoly price. Provided they were applied appropriately, patents were assumed to encourage innovation2.

The search for the “blockbuster” – a top-selling, often onesize-fits-all medicine – has always been the basis for the big pharmaceutical companies’ R&D strategies4. The innovation cycle in developed countries has to a large extent been relatively sustainable over the years5.

What was this strategy’s effect on health care in developing countries? Where innovation was concerned, the traditional approach to developing medicines failed. There was no significant market demand due to a lack of (collective) purchasing power and inadequate health systems in developing countries. Pharmaceutical companies were not inclined to develop new medicines for diseases in resourcepoor countries without a clear market demand that promised

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a reasonable return on investment. In general, both the public and private sectors lacked the resources to invest in research.

As a result, the products of innovation that developing countries had to rely on were designed principally to meet the health-care needs of developed countries with well-organized health-care systems6. In most developing countries, patent protection did not bring greater innovation as the market was too small, and scientific and technological capabilities were inadequate7. Furthermore, the monopoly costs associated with patents impacted the affordability of patented healthcare products8. As a consequence, developing countries still face problems related to access – medicines are often very expensive, difficult to obtain and ineffective within the healthcare systems that are in place – and to innovation: for some diseases, no treatment, vaccine or cure exist.

Over the years this traditional system to develop medicines has started to crack. Public health-care funding (including medicines) in developed countries has become an increasingly difficult issue because costs have risen due to demographic changes. What is more, climate change and globalization have altered the traditional map of diseases.

Those diseases that historically occurred only in developing countries are now taking root in developed countries and vice versa: the prevalence of noncommunicable diseases such as cancer and cardiovascular disease has rapidly increased in developing countries. Drug-resistant bacteria and pandemic influenza are major threats to global public health, in both the developed and developing worlds. Until now, it has been difficult, if not impossible, for pharmaceutical companies to respond adequately to this complex situation. And the patent system has had difficulties of its own: low standards of patentability and shortcomings in patent clearance have led to patents of poor quality or dubious validity9.

A new, more complex system of innovation has now emerged: active campaigns by NGOs have increased public awareness of the lack of accessible and affordable medicines in developing countries and the issue is now receiving more attention. Pharmaceutical companies have started to invest more in research on diseases that affect developing countries, setting up specific programmes to this end. Large private funds have donated resources aimed at finding cures for diseases like malaria, HIV/AIDS and tuberculosis. Some companies have introduced tier-pricing systems for

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differentiating medicine prices in developing countries.

Public-private partnerships have been set up to counter the market’s failure to develop sufficient products for diseases that affect the poor. And in researching and developing medicines, there is now more consideration for local circumstances and resource-poor environments. In the TRIPS9 Agreement, all World Trade Organization (WTO) members have adopted a framework of minimum standards for intellectual property rights protection, though Least Developed Countries have been allowed to delay implementing them until 2016 at the latest11. The 2003 Doha Declaration on the TRIPS Agreement and public health was very important in balancing commercial interests against public health interests where intellectual property rights are concerned. The 2003 Declaration facilitated access to affordable medicines for developing countries by allowing flexibility on intellectual property rights. Progress was under way, but more needed to be done.

The outcome of the IGWG process A more structured effort was needed to better understand the barriers to innovation in, and access to, medicines, and how the situation might be improved. For this reason, a WHO Commission on Intellectual Property, Innovation and Public Health was asked to draft a report with recommendations on the relationship between public health, innovation and intellectual property rights. When the report was completed, Resolution WHA 5925 established an intergovernmental working group to draw up a global strategy and plan of action in order to “provide a medium-term framework based on the recommendations of the Commission and to secure, inter alia, an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionally affect developing countries and to propose clear objectives for research and development, and estimating funding needs in this area”12.

After complex negotiations lasting two years, the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Rights, prepared by the Intergovernmental Working Group of Experts on Public Health, Innovation and Intellectual Property (IGWG), was approved at the 61st World Health Assembly in May 2008 (see WHA 6122).

The result is a broader palette of policy options, for example in terms of securing funding, stimulating new types of R&D and R&D cooperation, and implementing the TRIPS flexibilities where they relate to public health. These have been described in the strategy and fleshed out in the (partly unfinished) plan of action (PoA). Policy choices have been made more explicit and the various stakeholders identified.

The following results are especially noteworthy and will be useful for the Global Forum’s 2008 meeting in Bamako in November.

Content a) The role of intellectual property rights where they relate to public health has been put into perspective Intellectual property rights should be applied according

Key elements of the IGWG Global Strategy and Plan of Action13

1. Prioritizing R&D needs 2. Promoting R&D 3. Building and improving capacity 4. Transfer of technologies 5. Application and management of intellectual property (IP) contribute to innovation and promote public health 6. Improving delivery and access 7. Promoting sustainable financing mechanisms 8. Establishing monitoring and reporting mechanisms to the multilateral agreements on TRIPS. There is now a more common understanding of the need to be careful when adopting public health-related legislation that goes beyond the TRIPS Agreement.

The means for increasing developing countries’ access to medicines, as provided for in the TRIPS Agreement, have been made more explicit. In addition, the WHO member states have reaffirmed that developing countries can use the TRIPs flexibilities to the full.

New mechanisms for fostering research and development on neglected diseases have been identified, which allow intellectual property rights to be applied in a flexible, non-traditional way. b) Inclusion of Type I diseases The strategy will promote R&D focusing on Type II and Type III diseases and the specific R&D needs of developing countries in relation to Type I diseases14. The strategy does not therefore place limitations on which diseases warrant most focus. The inclusion of Type I diseases in the strategy acknowledges their rapidly growing significance in developing countries. This is a positive outcome. Developing countries can prioritize Type I diseases in their health research strategies if they consider them to be a threat to public health. c) An expert working group on financing and R&D coordination The strategy gives developing countries an opportunity to raise the profile of alternative R&D mechanisms and, in the longer term, mobilize financial and technical support for programmes, whether existing or new15. An expert WHO working group is to be established to examine current financing and coordination of research and development, as well as to propose new and innovative sources of funding.

Process a) The inter-sectoral aspect of the negotiations This was one of the most interesting features of the IGWG process. Because such a broad range of topics were discussed, many of the member states’ delegations were larger than usual. In the Netherlands’ case, representatives of the Ministry of Health, Welfare and Sport, the Ministry of Foreign Affairs and the Ministry of Economic Affairs formed part of the official delegation. Although we were like-minded in many areas, it took some time to achieve consensus, even at national, interministerial level. The three ministries concerned held broad national consultations with industry representatives and NGOs. This helped us to focus and reach

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a common position.

The same was true for the multilateral organizations involved in the process. The IGWG evolved in the interfaces between the mandates of the WHO, WTO and WIPO and others16. While implementing the strategy will require a greater level of coordination between these organizations, we are cautiously optimistic that this collaboration will bear fruit, given the generally positive atmosphere during the IGWG negotiations17.

The initial culture clash between health and trade/IP professionals during the negotiations eventually led to a positive outcome: there is now greater understanding and awareness on both sides of how public health relates to intellectual property rights and trade issues. Health professionals in particular can benefit further by re-examining national intellectual property rights policies and engaging actively in international trade negotiations.

These, of course, were not the only stakeholders.

Companies, NGOs and PPPs all tried to influence the proceedings and the outcome. Some were better organized than others, but it was fascinating to be a part of a multistakeholder environment in which global interests were at stake. b) The interplay of forces During the negotiations we had the sense that IGWG was one of the first processes within WHO in which lower- and middle-income countries strongly voiced their opinions. The traditional North-South divide made way for a more multidimensional dynamic. The European Union partners, including the European Commission, were notable for the mediating role they played in the negotiations. c) The duration of the process Reaching agreement on this complex issue is quite an achievement. But to have done so in such a short time is remarkable. During the negotiations the differences between countries’ positions were clear and it sometimes felt as though a consensus would never be reached18. Everyone involved felt the urgency to act, however, and agreement was reached by all parties in a relatively short period. d) The complexity of the strategy The strategy identifies a complex set of actions that link public health with innovation and intellectual property rights. It also names stakeholders, and sets out the required timetable and a rudimentary budget. The principal merit of the strategy and plan of action lies in its breadth of policy choices rather than its prioritization of required actions. The budget still needs to be fleshed out – no small task! e) The role and mandate of WHO Much of the debate (especially during the final hours of discussion on the PoA) was devoted to the role of WHO. Where should WHO take the lead, where should it be just one of the actors, and where should it not be involved? We feel that ultimately, despite some unresolved points in the PoA, the “spirit of Geneva”19 prevailed and WHO’s role was confirmed. Director-General Margaret Chan’s personal commitment, charisma and ability to build bridges with the WTO and the World Intellectual Property Organization (WIPO) certainly contributed to this result20, but it is nonetheless a

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result that needs consolidating. Member states themselves have an important role to play in coordinating their WHO, WTO and WIPO policies at national level.

Putting the IGWG Strategy and Plan of Action into practice: some ideas We left Geneva exhausted but in high spirits, with a completed strategy, and ready to embark on an urgent priority: implementing the strategy in our respective countries.

So where do we go from here?

Firstly, a broad range of innovations is required. Research efforts may focus on diverse forms of creative thinking and result in equally diverse discoveries: not only new drugs, new vaccines, new diagnostics, but also new strategies for utilizing them and new social or economic policies that can reinforce their use or create a supportive environment for their application.

The IGWG process revealed the interfaces between public health, innovation and intellectual property. The actions that have been identified are all interconnected. It is important that policy-makers are aware of the links between the three areas and take a coherent approach to the issue. If the goal is to increase access to, and innovation in, medicine, it would be unwise for policy-makers to focus on only one element.

Isolated policy interventions will create more, rather than fewer, problems.

The complexity of this policy area may require a networked approach in which innovators attempt to create a forum, a central network in which all the actors agree that the network is worth building and defending21. Learning capacity is crucial: policy-makers, researchers and industry which operate in the international system should learn from one another’s initiatives, ideas and achievements. The process as started in IGWG is arguably a good example of such a network. It is a hybrid structure, technical as well as social in nature, in which the interests of the stakeholders, while different, converge.

By leading the overall process, the World Health Organization played a crucial role in the IGWG. Hopefully, WHO will be equally significant in promoting the implementation of the strategy. WHO should encourage governments to act on what they have promised, stimulate the business community and NGOs to work more closely together and encourage the UN institutions and the WTO to play an active role in the network. Another important task for WHO is to promote the exchange of information and thus increase learning capacity throughout the network, and monitor the performance and the progress being made with implementation.

What next? a) Public health and innovation: setting a decentralized agenda on innovation It is possible that decentralizing the agenda on innovation in both developing and developed countries might offer a solution to the innovation problem. The current agenda sometimes seems too prescriptive, cumbersome and centralized to effectively tackle the problems of the poor. Too often there is a tendency to define diseases in fixed terms,

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Examples of networks that may fall under the umbrella of the overall IGWG strategy

An interesting new European initiative, which could promote innovation and the implementation of the decentralized innovation agenda in developing countries, is the European Solutions Enterprise on Neglected Diseases (euSEND). This public-private partnership’s innovative approach could result in a sustainable model to alleviate the burden of most, if not all, neglected tropical diseases – in terms not only of new drugs and/or treatments, but also of new technologies and practical methods for local delivery and support22.

The “Yaoundé Agenda” is another example. One of the outcomes of the OECD23 High Level Forum on Medicines for Neglected and Emerging Infectious Diseases: Policy Coherence to Enhance their Availability which took place in Noordwijk in the Netherlands in June 2007, was an offer, by the Minister of Public Health of Cameroon, to host a meeting to develop a complementary agenda. The Noordwijk Agenda reflected mostly on the coherent policies, incentives and partnerships needed in OECD countries to foster innovation and scale up research on neglected and emerging infectious diseases that disproportionately affect developing countries. It was felt that a complementary Yaoundé Agenda was needed to specifically address African needs and incentives in terms of health innovation and drug development, production and regulation. The meeting is expected to take place after the Bamako Global Forum. The Dutch Government is taking an active interest in this meeting and will provide financial assistance.

funded research;

supporting the creation of voluntary open databases and compound libraries;

encouraging the use of appropriate licensing, including but not limited to open licensing; and

considering, where appropriate, the use of the “research exception” on patents for innovation purposes24.

In each of these innovation mechanisms, intellectual property rights are applied in a flexible, non-traditional way.

Policy-makers involved in public-private partnerships are encouraged to take a stance on IP that maximizes public availability of the results of innovation. This may mean that a public entity is obliged to become co-owner of the intervention to ensure public access. And when clinical trials are paid for with public funds, data exclusivity should ideally be reduced to a minimum25. c) Including alternative models in policy options and generating firm commitments The results of the IGWG open the door to exploring alternative financing mechanisms. While this outcome has yet to be confirmed by an expert working group “to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding”26, now is the time to act. Industry, PPPs and NGOs should seek out neutral ground and deliver common proposals to carry this forwards. Initial thoughts and ideas have been mooted from several sides27 and have already sparked the first concrete activities in this area28.

Conclusion The goal of the IGWG process was to increase poor people’s access to medicines by optimizing the interfaces between Key messages

without taking into account local or other variations or indeed the problem of resistance. The search tends to be for the cure rather than a cure. Incremental innovation could be crucial to developing countries seeking to adjust Westernized products to the local situation. The ability to respond to local circumstances and needs requires flexibility. Equally important, the innovation agenda should be set in the public domain, with the widest possible range of stakeholders involved by means of networks and platform technologies.

This is one way to achieve creative outputs that are relevant to the health needs of developing countries. b) Innovation and intellectual property rights: improving access to research data and knowledge Decentralizing the agenda and boosting innovation rely heavily on the accessibility of research data and knowledge.

Without access to information that is already available, innovation will be severely hampered. The IGWG strategy identifies a number of alternative innovation mechanisms that could ensure that research results are made publicly accessible: promoting the creation and development of accessible public health libraries; promoting public access to the results of government-

The goal of the IGWG process was to increase poor people’s access to medicines by optimising the interfaces between public health, innovation and intellectual property rights.

To achieve that ambition: we needed a broader palette of policy options: on securing funding, for example, promoting new kinds of R&D and R&D cooperation, implementing TRIPS in a public health oriented, non-traditional, manner, and acknowledging the significance of Type I diseases for developing countries.

Implementing the strategy is both important and urgent. Maintaining the strategy’s coherence and synergy will be vital.

The strategy should be implemented flexibly, using hybrid (decentralised) networks and innovation agendas. At the same time, WHO should maintain close oversight of implementation, measure progress and promote greater cooperation between stakeholders and the various networks.

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public health, innovation and intellectual property rights. To achieve that ambition, we needed a broader palette of policy options: on securing funding, for example, promoting new kinds of R&D and R&D cooperation, and implementing TRIPS in a public health oriented manner. A further result of the negotiations was the acknowledgement of the significance of Type I diseases for developing countries. And the IGWG process established that intellectual property rights should be applied in a flexible, non-traditional manner if we want to improve new innovation mechanisms and increase access to research data and knowledge.

Until now, many features of this broader palette are still only ideas on paper. Implementing the strategy is both important and urgent. Maintaining the strategy’s coherence and synergy will be vital.

The strategy should be implemented flexibly, using hybrid (decentralized) networks and innovation agendas. At the

same time, WHO should maintain close oversight of implementation, measure progress and promote greater cooperation between stakeholders and the various networks.

Bart Wijnberg is an adviser at the Pharmaceutical Affairs and Medical Technology Department of the Ministry of Health, Welfare and Sport of the Kingdom of the Netherlands. He was Vice-Chair, on behalf of the Euro region, of the WHO Inter-Governmental Working Group on Public Health, Innovation and Intellectual Property (IGWG).

Marleen Monster is a senior policy adviser at the Directorate General for International Cooperation’s Coherence Unit at the Ministry of Foreign Affairs of the Kingdom of the Netherlands.

References 1.

The authors would like to thank Ms Gerda Vrielink, at the Netherlands’ Permanent Mission to the UN in Geneva, Ms Marja Esveld and Mr Theo van de Sande of the Dutch Ministry of Foreign Affairs (Development Cooperation) and Mr Frank van der Zwan of the Dutch Ministry of Economic Affairs for their valuable comments on an earlier draft of this paper.

2. http://www.who.int/mediacentre/events/2008/wha61/issues_paper1/en/ 3.

Report of the Commission on Intellectual Property Rights, Innovation and Public Health, hereafter cited as CIPIH report, (2006): Public Health, Innovation and Intellectual Property Rights, p.32 4. www.wikipedia.org 5.

CIPIH report, p.193.

6.

CIPIH report, p.193.

7.

CIPIH report, p.35.

8.

CIPIH report, p.32.

9.

CIPIH report, p.34.

10.

Trade-related aspects of Intellectual Property Rights.

11.

CIPIH report, p.34.

12.

Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Rights (http://www.who.int/gb/ebwha/pdf_files/A61/ A61_R21-en.pdf).

13.

Ibid.

14.

“For the purpose of this strategy, the definitions of Type I, II and III diseases, are as referred to by the Commission on Macroeconomics and Health and as further elaborated in the CIPIH report: Type I diseases are incident in both rich and poor countries, with large numbers of vulnerable populations in each. Type II diseases are incident in both rich and poor countries, but with a substantial proportion of the cases in poor countries.

Type III diseases are those that are overwhelmingly or exclusively incident in developing countries. The prevalence of diseases and thereby their categorization in the typology can evolve over time” – Global Strategy and

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Plan of Action on Public Health, Innovation and Intellectual Property Rights (http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf) p.7).

15.

Fink C. Intellectual property and public health: an overview of the debate with a focus on US policy. Center for Global Development, 2008, p.26.

16.

Notably the OECD. 17.

Notwithstanding the failure of recent WTO negotiations.

18.

We had the feeling that we were negotiating a treaty text, which, of course, was not the objective. Attempts to open negotiations on the content of existing IP rules further extended the process.

19.

A term used frequently during the negotiating process to try and achieve a cooperative sprit. William Safire’s Political Dictionary, 2008, traces the use of this term to 1955 when President Eisenhower first used it.

20.

The constant, positive presence of WTO and WIPO representatives during the IGWG and the World Health Assembly also contributed to the end result.

21.

See Latour B. Reassembling the social: an introduction to actor-networktheory. Oxford, Oxford University Press, 2005.

22. www.tipharma.com 23.

Organisation for Economic Cooperation and Development.

24.

For further details see IGWG strategy, under 2.4 (http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf).

25.

Differences may exist between PPPs which could make tailor-made solutions necessary.

26.

WHA 61.21, paragraph 4(7).

27.

One such proposal was made by Paul Herrling from Novartis. Others have been put forward by James Love of Knowledge Ecology International.

28.

UNITAID decision of 2–3 July 2008 to create a “patent pool” (http://www.unitaid.eu/en/Eighth-Board-Meeting-Geneva-2-3-July2008.html).

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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 transformed the way medicine is practised and has brought substantial benefits in the prevention, diagnosis and treatment of diseases. But the innovation system has failed to deliver new medicines, vaccines and diagnostics to address infectious diseases that primarily affect the developing world.

Our understanding of the ecosystem for innovation, from basic research through to delivery to the patient, needs to be brought up to date and new ways of networking research and development (R&D) need to be found to: make the process of innovation more efficient so that more products are developed more quickly and at lower costs; change the incentives faced by innovators, so as to encourage more firms and researchers to become involved in R&D; improve the commercial viability of small market products; and, create more capacity, especially in disease endemic countries.

O

Why the OECD? OECD countries (see Box 1) have many reasons to be involved in this issue. Besides ethical and humanitarian imperatives, there are strong economic reasons driving involvement. New and emerging infectious diseases can spread rapidly and affect health, the economy and security in all countries, including those of the OECD. Meantime, if the productivity decline across mainstream health innovation (especially for new medicines) is to be turned around substantial efficiency gain will be necessary. Greater competition, shorter product life-cycles and shorter time to market, coupled with growing costs and risks put the traditional approach to innovation under rising pressure and with it the block-buster model of drug development we have seen in recent decades. In fact, many of the policies and practices being put in place or considered to enhance the availability of drugs, vaccines and diagnostics for neglected infectious diseases may also be relevant to markets for health innovation in advanced industrialized countries. Thus the innovation system itself needs a thorough health check and some much overdue medicines.

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Box 1: The OECD

The Organisation for Economic Co-operation and Development (OECD) was born after the Second World War in order to coordinate and implement the “Marshall Plan” for the reconstruction of Europe. The OECD today has 30 member countries in North America, Europe and Asia-Pacific as well as 100 observer/partner countries.

The OECD focuses on economic, social and technological issues and contributes to economic growth and globalization. The OCED is a forum for discussion among governments and provides governments with peer reviews, guidelines, best practices and policy recommendations as well as data, statistics and indicators.

The Noordwijk Medicines Agenda (NMA) This is the context for the OECD, in collaboration with the government of the Netherlands organizing a High Level Forum on Availability of Medicines for Neglected and Emerging Infectious Diseases (HLF) which took place 20–21 June 2007 in Noordwijk-aan-Zee, Netherlands. The HLF was attended by high level officials from OECD and developing countries, industry, research and funding organizations, academia, philanthropic foundations, and international and nongovernmental organizations who came together with a common goal of building a coherent open agenda for action to stimulate innovation and radically accelerate the availability of new medicines, vaccines and diagnostics for neglected infectious diseases.

The Noordwijk Medicines Agenda (NMA) represents a broad consensus reached at the HLF among the participants about the problems, goals, and work ahead in order to improve the availability of medicines for neglected infectious diseases. It sets out a number of specific actions to bring about change in the way we innovate in this area, calling for improved efficiency and coherence and strengthened collaborative efforts among innovators and other stakeholders, in particular the WHO (see Box 2).

Many of the actions contained in the NMA can only be achieved by partnerships between many players across many

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Box 2: The Noordwijk Medicines Agenda

Box 3: The importance of the OECD

Recognizing that it is important to scale up and expand new for-profit and non-profit models of innovation for tackling neglected infectious diseases in the developing world, the Noordwijk Medicines Agenda calls for several changes to the present health-innovation system (for full details, see www.oecd.org/sti/biotechnology/nma).

The added value that the OECD brings to the issue of improving the availability of medicines for neglected and emerging infectious diseases is its: • Capacity for sound economic analysis and evidencebased policy advice on the different policy options for action, including the scale up of R&D networks and the incentives necessary for bringing new products to market; • Understanding of the innovation system and groundbreaking work on new research models that could improve the efficiency of the discovery, development and delivery of new medicines by removing disincentives to sharing data and material and opening up innovation; • Ability to broker whole of government buy-in and build coherent policies, by virtue of the OECD organizational structure which includes cross ministry representation (i.e. Health, Development and Aid, Finance, Innovation, Economic Development and Industry).

Innovation system efficiency 1. Prioritise research and development needs and align research to a common purpose.

2. Facilitate the development and operation of a sustainable architecture for sharing and exchange of knowledge, data and research tools.

3. Explore collaborative mechanisms for IP management.

4. Promote the transfer of technology, knowledge and technical skills to strengthen innovation systems in developing countries.

5. Support developing country led efforts to provide their own health, local production and research systems.

Changing incentives to build capacity 6. Create incentives for R&D through alternative policy mechanisms to reward innovation.

7. Explore for-profit and not-for-profit models to promote and stimulate development of drugs, vaccines and diagnostics.

What can the OECD bring to this issue?

8. Pursue the viability of a global virtual collaborative drug development network that scales up existing initiatives and is more open.

9. Identify infrastructure needs to underpin a global virtual collaborative network.

sectors. The OECD can bring some very unique skills and abilities to these partnerships. In particular we can provide a strong foundation for evidence-based policy-making through processes that involve actors from across government, industry, and other parts of civil society (including public research organizations, NGOs and philanthropies).

Advancing the NMA at the OECD At present, we have a wide range of work going forward across the Organisation that directly or indirectly addresses the issues raised in the NMA. The indirectly relevant work is too broad ranging to present here, but a major themes of OECD work is especially pertinent – namely our work on improving the efficiency of the system of health innovation, mainly brigaded under a major new OECD-wide project known as the Innovation Strategy.

The NMA puts forward several actions which focus on developing new models for innovation. Our newly launched OECD Innovation Strategy focuses on improving economic performance and social welfare. Its aim is to assist policy-

makers in harnessing innovation to achieve sustainable growth and development in a way that takes account of the growing complexities – and some of the exciting experimentation – in the practice of innovation. In a sense, it provides the key actors with a laboratory to test out the workings and impacts of some of these new directions in innovation. The focus is broad, well beyond health innovation, but the scope and ambition of the work overlaps substantially with that of the NMA. Some of the key elements from the perspective of the NMA are: Knowledge markets The concept of knowledge markets is one that supposes that 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 knowledge as well as new kinds of markets through which knowledge can be valued and exchanged. Knowledge markets attempt to address the inefficiencies in knowledge management especially in the underuse and undersharing of the large amounts of data and information created throughout the life science innovation cycle.

The concept of knowledge markets thus encompasses a number of different mechanisms or marketplaces where buyers and sellers trade a variety of knowledge intensive goods and services. Mechanisms such as intellectual property exchanges, patent pools, consortia, matching or brokering services, as well as knowledge “warehouses” are all examples of new ways of deriving value from knowledge assets. In the life sciences, examples of tradable assets could be scientific data such as outcomes of clinical trials and toxicology data.

Achieving greater access and exploitation of existing knowledge, by facilitating the trading and sharing thereof, would increase the efficiency of the health innovation cycle and potentially deliver a number of positive health and economic outcomes.

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There are real challenges of course in identifying which knowledge assets it makes economic sense to trade as well as in articulating and developing the kinds of market platforms that would need to be created to support this.

The first step is to understand what kind of knowledge is 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 One of the actions in the NMA is to explore “collaborative mechanisms” for IP management. These are mechanisms that rights holders voluntarily enter into (often, though not exclusively, explicitly for-profit) to ease access to patented inventions that allow more open innovation and collaborative research as well as more rapid and less costly (mainly through diminished transaction costs) access to knowledge. Some examples of collaborative mechanisms include clearinghouses, IP exchanges/auctions, patent pools, cross-licensing schemes, and intellectual property sharing agreements. Our focus on these collaborative mechanisms so far has been to try to document what practices are beginning to emerge, determine their impact and consider what normative action – if any – may be necessary to enable maximal positive impacts on innovation.

New models for pharma-business innovation As I mentioned above, the current block-buster model for developing new medicines is creaking at the seams. Many new models have been articulated in recent years, some have been tried and fewer have been successful – at least in some cases.

Meantime, the advent of genomics as well as evidence-based medicines and targeted therapy has demonstrated that efficiencies in terms of the health benefits to patients from new innovations are possible – but only in smaller, more discrete markets. In many ways, this shift shares a number of similarities with the challenges facing drug discovery and delivery for infectious diseases. The key question is how innovation in drug development can continue to remain an attractive proposition for mobile capital when markets may be smaller, competition higher, and public expenditure on health care under continual pressure.

Our focus here is on how policies around the use of pharmacogenetics and genomics, as well as biomarkers more generally, can be developed that improve innovation efficiency and that support the servicing of smaller markets. Some of the questions therefore are around what is required in terms of changes in the regulatory systems and clinical trials, and what is required in terms of drug evaluation systems.

There needs to be more work done in this area as to how can we identify which of the proposed new models can continue to attract capital in the long term, that can meet the identified health need and that will not unnecessarily distort markets in so doing.

Evaluating the policy mix The HLF also recognized the need to look at what the best mix of mechanisms (push and pull) might be to encourage companies and researchers to work on neglected infectious

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Some examples of collaborative mechanisms include clearinghouses, IP exchanges/auctions, patent pools, cross-licensing schemes and intellectual property sharing agreements

diseases. We in the OECD do substantial work on how policies (subsidies, tax breaks, orphan drug act, patents) influence firm or country innovation. For infectious diseases, and other small, uncertain markets for drugs, other policies of course have been mooted and sometimes used, such as patent extensions, AMCs, prizes, global funds etc. But we do not have the kind of analytical work for these new mechanisms that we have for more “traditional” interventions. Work therefore needs to be done to look at these specific policies in terms of identifying their strengths and limitations, evaluating their effectiveness and understanding what mix of mechanisms is necessary to address different types of disease or situations.

Innovative finance mechanisms Finally, it has been recognized that reliance on philanthropic and public funding is not sustainable for R&D into neglected infectious diseases as these sources could be endangered by a shift in priorities. To that end, new and innovative funding mechanisms have been put forward to help generate more sustainable and longer-term resources. A Global Forum, Lessons for Development Finance from Innovative Financing in Health, was held on 7 October 2008, organized by the Development Cluster of the OECD. The Forum considered donor and recipient governments’ views on the issues and opportunities created by recent innovative financing mechanisms. In particular, the Forum looked at lessons learned from the International Finance Facility for Immunization Company (IFFIm), the costs and benefits of new approaches, how to leverage private sector investment and future developments in the innovative financing mechanisms as well as the opportunities, and adaptability of these mechanisms across sectors.

On the face of it, pulling all these strands together into a coherent picture could be one of the greatest challenges we could face from the policy perspective. But this is where our innovation strategy approach is really different. We advocated new ways of working in the NMA. We pushed for collaboration and new ways of working. We decided that if we were asking others to work this way then we in the OECD had to show that this could be done. So that is precisely what we are doing – bringing together government actors from science, industry, competition, education, development, investment, employment and many other ministries to work together on changing the face of innovation.

This is the challenge for the OECD – and it remains the challenge laid at the feet of us all by the NMA. The effort needed to make such collaboration work is high; but the rewards are potentially much higher.

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Key messages

The way we look at innovation needs to change – from a linear model to an iterative, complex interactive cycle. In this new model there is a need for new tools, new actors and a collaborative, multidisciplinary, horizontal approach.

There is a need for new models of innovation that are more open and global. In order to support this more open model, we need new infrastructures to support them including governance models, regulatory frameworks, guidelines and tools.

No one can do this alone, more partnerships, networks and policy coherence are needed to drive a health innovation strategy that is more efficient and reactive to global public health needs.

Bénédicte Callan is Principal Administrator in the Biotechnology Division of the OECD where she leads work on health-related biotechnology, with a primary focus on technology, innovation and intellectual property rights policies. She was previously Fellow for Political Economy at the Council on Foreign Relations in New York. Dr Callan has a PhD in political science

from the University of California, Berkeley and a BA in biology from Yale University.

Susanne Huttner is Director of the OECD Science, Technology and Industry Directorate. Previously she was Associate ViceProvost for Research for the University of California System, Executive Director of the Industry-University Cooperative Research Programme, and Director of the Biotechnology Programme. She holds a PhD in neuroscience.

Iain Gillespie has been Head of OECD’s Biotechnology Division since 2001. Previously he worked in academia and in the biotechnology industry before joining government service in 1991, holding policy posts in four different UK government departments. He holds a BSc and PhD (microbiology), an MA (international relations and European politics) and an MBA. Barbara Slater is a consultant focused primarily on strategic health policy (population health, infectious diseases, biotechnology and innovation). She has wide experience at the provincial and national level in Canada as well as internationally.

Ms Slater is adjunct professor in the Faculty of Medicine, Department of Health Policy, Management and Evaluation at the University of Toronto, Canada.

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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.

Nowhere is this clearer than in international health, where a new generation of donor, philanthropic and public-private initiatives is emerging and attracting increasing funding. These hold out promises of new drugs, vaccines and infrastructure applications, with some claiming major technological breakthroughs that could solve longstanding health problems and tackle emerging disease outbreaks in the developing world. This “race to universal fixes” for health and development problems is valuable. It is an important counter to innovation approaches aimed simply at a race to the top in the global economy, assuming that health and poverty-related problems will be solved by trickle down. Yet as this article argues, it risks missing the finishing line if a complementary – and slower – race is not pursued. This “slow race” emphasizes pathways to tackling ill-health and disease which are specific to diverse and dynamic local contexts; creates hybrids between local and external knowledge and perspectives for appropriate solutions; recognizes that technological fixes are not enough and that social, cultural and institutional dimensions are key, requiring a systems approach to health and innovation, and embraces uncertainty and unpredictable change through adaptation and learning.

In this view, innovation for health and development is part of a bottom-up, participatory process in which citizens in resource-poor settings must take centre stage.

In the race to the universal fix, much current investment is justified by the prospect of “big hit” technologies with the potential for global scope and applicability, and the capacity to deliver these on a large scale. This is exemplified by the 14 “grand challenges” for research in global health identified by the Bill and Melinda Gates Foundation, which range from new and improved (e.g. needle-free, non-refrigerated) vaccines, to genetic and chemical technologies to control disease vectors, and enriched crops to improve nutrition.

Another, and growing, strand of investment focuses on responses to outbreaks and pandemic threats. Here, as in the approaches of the World Health Organization and others, the focus is on universalized, generic emergency-oriented control

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of outbreaks at source, aimed at eradication – as for example in responses to human pandemic and avian influenza, and to haemorrhagic fevers such as Ebola. The emphasis is on a plethora of technological and infrastructural initiatives focused on early warning, risk assessment, surveillance, rapid response teams, treatment and vaccination. In both cases, the nature of the health problem is assumed to be broadly similar across vast areas, so that technological and associated institutional solutions are unproblematically transferred, and can be applied “at scale”.

Alongside the obvious merits of these approaches, however, lie many telling examples of failure. These include potentially good health technologies left sitting on laboratory benches because they failed to fit local circumstances. They include examples of disease eradication programmes thwarted by unexpected microbial resistance to the drugs involved, or by public resistance to programmes perceived as inappropriate – as in the cases of the global polio eradication initiative in Nigeria in 2003–042, or tetanus toxoid campaigns in Uganda and Cameroon. In Gabon in 1995–96, for example, American and French Ebola control measures were perceived as so inappropriate and offensive by villagers that they aroused deep suspicion, and international responses to a further outbreak there in 2001 met with fierce local armed resistance3. Avoiding such problems requires complementary approaches to understanding and policy, with four key elements contributing to the necessary slow race.

First is to recognize the diversity of interlocking dynamics that shape health problems, and must inform responses to them. Challenges to human health have always involved intimate relationships between social, political and economic processes, ecosystems and potential pathogens. The acceleration of population growth, mobility and urbanization, human-animal interactions, change in industrial, livelihood and food production systems, and technological and environmental processes has in many instances brought new challenges4, such as the emergence of new infectious diseases and zoonoses5. Yet these dynamics play out in specific ways in diverse local settings, varying across regions, localities and sometimes even within communities, producing multiple patterns and multiple needs. Thus a one-size-fits-all solution is often inappropriate. And given that problems of

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disease and ill-health are not just the result of technical matters, a focus on technology as a separate domain carries many dangers, leaving important social and political causes unaddressed. A more context-specific and integrated approach to linking technologies, health and development is therefore needed.

Second, different people and groups in society tend to understand and experience these dynamics in very different ways. The scientific perspectives of biomedical doctors or epidemiologists offer only some among multiple “framings” of health problems and possible solutions. Other framings emerge from, for instance, local cultural understandings, knowledge and experiential expertise. Such cultural framings can be crucial to understanding both why technologies work and are acceptable in particular settings – and why they are sometimes rejected. For example childhood vaccines are high on global policy agendas. In The Gambia, mothers go to great lengths to build and protect their own and their children’s strength, which they see as dependent on proper quantity and flow of blood and body fluids. They value immunizations in these terms, as introducing a powerful substance that, going into the blood, either builds its strength or builds in the blood defences against disease: “The injection strengthens the health of the child. It gives the child good body”. Within this logic, many feel that vaccinations are effective against illness in general. 29% of urban and 48% of rural mothers could name no biomedically “correct” vaccinable diseases, yet were actively seeking immunization – reflected in national coverage rates of 90% in 2003. Such ideas about strength, fluid and substance do not conform to biomedical notions of an immune system, disease-specific vaccines and strong distinctions between prevention and cure. Yet they ground strong appreciation of immunization in areas across The Gambia, Guinea, Sierra Leone and beyond.

Yet the same framing can also underlie anxiety: in a social context in which mothers often miss clinic sessions due to workloads and problems at home, they often worry greatly that a backlog of such vaccinations will have “stacked up” and that nurses will give their child several at once. This can be seen as too much substance for the blood and body to cope with6. Thus understanding why people accept (and why they sometimes reject) technologies such as vaccines requires engaging with local cultural framings that may differ strongly from those of mainstream scientists and policy-makers.

Local knowledge and cultural logics can similarly inform and be integrated into epidemic response strategies, helping to make these more context-specific, locally appropriate and acceptable. In Uganda, for example, local cultural categories around Ebola outbreaks were linked to elaborate social protocols to control the disease, and from 2001 these were successfully integrated into responses by the World Health Organization3. Attention to local cultural logics also offers ways to understand local resistance to top-down external interventions and adapt accordingly. Thus, understanding local categories and fears would assist with several current challenges in dealing with haemorrhagic fevers: encouraging more cases to be identified early and brought to hospital, and addressing prevalent anxieties that treatments themselves

“kill”. Overall, there is a need for responses to be attuned to local knowledge and circumstances. Context matters, and technologies and practices suited to one place might be rejected in another.

Third, the slow race implies a different approach to thinking about innovation. Rather than assume – as in the “universal fix” view – that technologies can be developed “upstream”, often in international centres, and then transferred in a linear way to the resource-poor settings that need them, a more participatory and systemic approach is required. This can helpfully draw lessons into the health sector from participatory technology development approaches – as pioneered in agriculture and natural resource management, for instance – that put local users at the centre of the innovation process, working in collaboration with scientists both to design new technologies and to adapt existing ones to local circumstances. These approaches recognize the value of local knowledge, moving away from the image of people as passive recipients of externallyderived health technology, to involve them as active, creative partners in technology development processes.

Yet such participatory interactions raise many questions about who controls the innovation process, and whose perspectives drive it. Too often, participation has meant simply co-option of local people into pre-set technological agendas. The huge imbalances in the power, reach and resources of people living in resource-poor settings and research agencies has contributed to this. Even where true collaborative arrangements have been established, these have often been isolated and dependent on the interest of key individuals and on temporary project funds, rather than being fully institutionalized in national and international innovation systems.

Rather than isolated project examples, an innovation systems approach emphasises the networked interaction of multiple actors, both public and private, local and national, in processes which initiate, import, modify and diffuse technologies7. It emphasizes the links between these actors that enable them to operate as an effective system, involving issues of funding, marketing and the encompassing policy and legal framework. This involves not just building the “hardware” of research and development (R&D) infrastructure and capacity, but fundamentally, considering the “software” of social and political relations among the many actors that are now involved, and the question of who controls science and technology agendas in whose interests.

The development of the International AIDS Vaccine Initiative (IAVI) illustrates many aspects of this approach8. The initiative aims to further HIV vaccine research worldwide, including the search for candidate molecules, the funding of clinical trials, work on delivery issues and wider policy and advocacy efforts, working towards an effective and cheap vaccine for resource-poor settings. Vaccine development partnerships have been created between developing country organizations and northern research agencies, both public and private. The initiative spreads its funding across a diversity of players, and focuses on vaccine development and delivery issues rather than upstream research. It currently

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operates in 22 countries, and is increasingly decentralized in its operation, responding to early accusations of top-down, central control. The existence of regional offices and growing links with nongovernmental organizations (NGOs) and civil society means the initiative is broad based and attuned to social and political issues. Nevertheless despite its scale it still remains a small player in the overall HIV/AIDS technology innovation and delivery network, dwarfed by larger funds spent on more conventional upstream research.

Furthermore, innovation should focus not just on the technology, but also on the social, cultural and institutional relationships that make it work. There are numerous examples where technologies already exist that could have major impacts on health and poverty problems, yet they remain out of reach. To make existing technologies – sometimes everyday, old technologies – accessible to people living in poverty often means linking the technical with the social. For example in parts of South Asia, a revolution in “community-led total sanitation” has occurred as community organization, empowerment and learning has facilitated the widespread building of extremely low-tech, low-cost latrines – in contexts where adoption of existing sanitation technologies in the past had been very low9. To enable people to make use of technologies that may be available, but are poorly understood often requires culturally-appropriate communication strategies, improving people’s knowledgeability, capacity and power to make technology choices.

In other cases, institutional innovations – for instance in the ways that health services are financed, delivered and relationships between people and providers negotiated – can be crucial in enabling people to access technologies and their benefits, as part of building health systems that work for the poor. For example many health systems in Nigeria have become increasingly pluralistic and poor people are faced with a confusing myriad of health providers and drug sellers.

Old barriers between private and public, modern and traditional, and formal and informal health providers are breaking down. In this context innovative learning and regulatory arrangements are being developed to increase the knowledge of medicine vendors and local people about appropriate drug treatment for malaria, and to address the problems of access to and use of low quality anti-malarial drugs by the poor (http://www.futurehealthsystems.org/ country/nigeria.htm).

Fourth, the complex interaction of multiple dynamics involved with health issues today – biological, demographic, ecological, economic, social, political, cultural – operating at different scales and at different speeds – results in deep uncertainties – and often ignorance – about likely outcomes and their consequences4. Despite this, the design of technological research and development, of health systems and of approaches to epidemics frequently proceed as if the world were stable, and as if uncertainties and possibilities of surprise could be reduced to risks which can be assessed and managed. In today’s world, in which deep uncertainty and surprise are inevitable, this is, more than ever, a flawed approach. It may be time to move towards more adaptive, learning-process approaches in building pathways to health

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and development. This will require new institutional and administrative arrangements which can embrace surprise, deal with uncertainty and accept ignorance, along with appropriate bureaucratic and other procedures. There are as yet few examples in the health sector, but this is a frontier area for future development.

Running the slow race to make health technologies work for the poor therefore requires an embracing of dynamics and diversity; of multiple forms of knowledge and framing; of an innovation and health systems approach, and of adaptation and learning to cope with uncertainty. This in turn carries major implications for the organization of research, funding and policy.

An overarching challenge is to foster more, and more effective, interdisciplinary, user-oriented and participatory research of various kinds. This involves creating research and innovation partnerships between scientists and potential users, especially poor people themselves, remembering and recapturing longstanding experiences in participatory technology development that have been overshadowed of late by today’s new global technology-transfer hype. It involves linking natural science and biomedical disciplines with the social science that can illuminate how technologies might engage with society. It involves linking different sectors – and the social and technical debates within each – so as to generate, for instance, lesson-learning from the agricultural and natural resource management fields across to health, and vice versa. This carries implications for research funding, much of which – whether from development donor agencies, foundations or research councils, is still strongly divided by natural science – social science boundaries, or split into sectoral silos. The last few years have seen the take-off of some exciting and important funding initiatives which do promise support for the kind of interdisciplinary and international partnership work which is needed, but these remain drops in the ocean of the levels of funding devoted to disciplinary, technical research. The challenge is to mainstream the social into the technical and vice versa, through genuinely trans-disciplinary openness in funding regimes focused on (health) problems and issues, not disciplines.

At the same time, new policy approaches and institutions are needed which bring together poor people, health providers, scientists, administrators and health policy-makers in new ways that promote dialogue: about long-term futures and technology options; about health problems; about technology adaptation to local contexts; and about risks and uncertainties and ways to understand and adapt to these.

Such institutions would need to enable both more openended dialogues which take their lead from peoples’ felt health and well-being needs and debate the technological options that might help address these, and more focused dialogues around particular problem areas (e.g. how to address child deaths from diarrhoea, or an emerging zoonosis) or particular new technologies, their potentials, benefits and risks (e.g. a new vaccine). While some such institutions might operate at local scales, they would need to articulate with national, regional and global equivalents, in a

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networked interaction.

This slow race may be less glamorous than the technology breakthroughs that capture global headlines. It is not a substitute for these, but it is a vital complement in the ongoing, painstaking task of linking science and innovation to the complex, diverse needs of people in resource-poor settings, and in helping to ensure that, in a dynamic and uncertain world, investments in science and technology for health are firmly enmeshed with inclusive debate about the social and political values they serve. J

ESRC STEPS (Social, Technological and Environmental Pathways to Sustainability) Centre, a global hub linking environmental sustainability and technology with poverty reduction and social justice. Her research focuses on science-society, health and environmental issues, especially in West Africa.

Ian Scoones is an agricultural ecologist and Professorial Fellow of the Institute of Development Studies, Sussex. He co-directs the ESRC STEPS Centre. His research links natural and social sciences, focusing on relationships between science and technology, local knowledge and livelihoods and the politics of agricultural, environment, epidemic disease and development policy processes.

Melissa Leach is a social anthropologist and Professorial Fellow of the Institute of Development Studies, Sussex, where she leads 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 for the poor. London: Demos, 2006.

2.

Yahya M. Polio vaccines â&#x20AC;&#x201C; no thank you! Barriers to polio eradication in Northern Nigeria. African Affairs, 2007, 106(423):185.

3.

Hewlett B, Hewlett BL. Ebola, culture and politics: the anthropology of an emerging disease. Thomson-Wadsworth, 2007.

4.

Bloom G et al. Health in a dynamic world. STEPS Working Paper 5.

Brighton: STEPS Centre, 2007.

5.

Jones Kate E et al. Global trends in emerging infectious diseases. Nature, 2007, 451, 990-993.

6.

Leach M, Fairhead J. Vaccine anxieties: global science, child health and

society. London: Earthscan Publications, 2007.

Hall A et al. Why research partnerships really matter: innovation theory, institutional arrangements and implications for developing new technology for the poor. World Development, 2001, 29(5):783-797.

8.

Chataway J, Smith J. The International AIDS Vaccine Initiative (IAVI): is it getting new science and technology to the worldâ&#x20AC;&#x2122;s neglected majority?

World Development, 2006, 34(1):16-30.

9.

Kar K. Subsidy or self-respect: participatory total community sanitation in Bangladesh. IDS Working Paper 184, Brighton: Institute of Development Studies, 2003.

7.

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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

as a potential tool to address the inequalities in health care nformation and communication technologies (ICTs) are between the low- and middle-income countries (LMICs) and increasingly being recognized as essential health high-income countries. We focus here on two current technology, giving individuals at all levels of the health examples of leapfrogging which are already being workforce and other stakeholders access to information that successfully implemented in many developing countries: helps them protect and improve health and save lives. Radio ePublishing and mobile phones. Other leapfrog technologies and television are ever-present in many parts of the world, and potential benefits and risks of their use for health in and their uses in health care, health education, and health 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., among IT support workers and system managers in services through telemedicine despite distance and LMICs) time barriers.

Attitudes and Acceptability, perceived needs based on a needs analysis, Debate continues as to the roles and relative perception attitudes towards technology, concepts of development and importance of ICTs in socioeconomic development1 aid, and focus on the problems to be solved (i.e. being peopledriven and problem-oriented not kit-driven) including health development. Many people believe that ICTs are a necessary component of every facet of Cultural and Language, cultural views towards technology, sharing of community issues resources within the community, appropriateness of a specific development, ranging from infrastructure projects and 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 and treatments, other intellectual property issues implementing ICTs and health technologies in developing countries (see Table 1) and many argue Technical issues Access to electricity grid and alternative power supplies, power schedules and reliability, UPS back-ups, ongoing maintenance that clear precedence must be given to clean water, of computers. Inappropriate access devices and inappropriate sanitation and jobs. There have been many efforts to Internet technologies including low bandwidth. Insufficient language and cultural adaptation of content and the digital divide use older ICTs for health and development in developing countries. Radio and television networks Environmental Effects of weather, temperature, humidity and dust on equipment. issues Security and accessibility of equipment. Isolation, transport can be powerful tools for widespread health education. issues There have been many efforts to donate legacy systems Sustainability Ongoing upgrades of technology, ongoing costs, and older computers to developing countries, issues cost-effectiveness although some argue that this is more a means of Practical issues of Corruption, borders and customs in equipment transport, dumping eWaste than a philanthropic effort. MIT 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 barriers, time zones and communication issues of working in computer using the older Apple II hardware and remote geographical areas software in parallel with the One Laptop per Child Health care In health, insufficient means to implement health care and take (OLPC) initiative. 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 chain facilities for vaccines countries should be able to benefit from the most current technologies and bypass older legacy systems Table 1: Potential barriers to implementing leapfrog technologies in as a more efficient means of achieving technology developing countries transfer. This paper looks at leapfrogging technologies

I

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Technology

Examples of potential applications in developing countries

Examples of potential risks and implementation problems in developing countries

Telemedicine technologies

eRadiology, ePathology, teleSurgery, Store and Forward Telemedicine can enable access to necessary expertise and help in overcoming the â&#x20AC;&#x153;brain drainâ&#x20AC;? of medical personnel in developing countries

Differing cultural understandings of illness; medico-legal implications; bandwidth issues

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 and social networking

Advances such as Web 2.0 and wiki will mean that health professionals and Poor quality controls for information; 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 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 virtual patient simulation

The creation of these new resources is both exciting and precarious as Lack of acceptance; technology transfer 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 interactions

High development costs

Alternative network technology

3G, 4G mobile phone networks and digital satellite radio offer the potential for access in remote areas

High establishment costs

Eco-technologies

Environmental sustainability, sanitation, clean water, bioremediation

High development costs

Solar technology

Power for computers, phones. A lesser known health sector application for solar technology is the application of solar ovens to dispose of hazardous medical waste

Reliability

Genomics and recombinant technologies

Sequencing pathogen genomes to assist in development of antimicrobials; Intellectual property and patent issues 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

Cost and limited bandwidth access limit utility

Table 2: Examples of leapfrog technologies

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developing/LMIC countries are outlined in Table 2.

Case studies have recently been published outlining eHealth activities and results in Peru, South Africa, Turkey, Vietnam and Rwanda2. The South African case study3 confirmed that the needs of developing countries differ from those of the developed world in some areas. Issues of 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 implementation of eHealth policy remains a concern.

The training of the workforce needed for successful eHealth implementation is globally a common focus. Apart from residential degree courses, online training opportunities are now also offered, such as Drexel University’s Certificate in Healthcare Informatics4 and Certificate in Medical Billing and Coding5. An important part of eHealth, albeit sometimes viewed as on the periphery, is consumer health sites. Such sites should preferably be accredited by the Health On the Net Foundation (HON), whose mission is to guide Internet users to reliable understandable accessible and trustworthy sources of medical and health information6. However, the apparent success of consumer health sites can result in – or unveil – another problem for health-care consumers and providers. A recent survey in the USA commissioned by Envision Solutions found that more than 85 million adults in the USA – almost 40% – have doubted their health-care providers’ opinions when the information did not match what they found online7.

A good example of technology leapfrogging is mobile phones, which have enabled low- and middle-income countries to overcome the barriers of poor or insufficient telecom infrastructure and leapfrog into 21st century mobile technology. ICT leapfrogging also applies to digital technologies whereby many low- and middle-income countries have been able to leapfrog to the digital age without going through the analogue era technologies. This possibility to leapfrog extends to eLearning and eHealth as well.

Currently, most of the popular eLearning and eHealth programs and applications require sophisticated hardware and software, and in many cases access to high-speed Internet. As a result, countries that need eLearning and eHealth services the most are also the ones least able to access and use them. With the introduction of mobile technologies and devices, it is possible to provide eLearning and eCapacity building programmes to public health providers, even in remote and isolated areas. By 2010, the total number of mobile phone users is expected to grow to 3.3 billion globally, or approximately half the world’s population. Although the more affordable mobile phones in developing countries may not yet have sophisticated features found in Smart Phones, mobile phones are becoming ubiquitous in Asia, Africa and Latin America. This is expected to result in an increase in mobile-enabled health systems and services throughout the world. The recent development of “mobile web” is already turning web browsing into an “any time, any place” phenomenon. The mobile web will essentially function as “personal computers”. If at least one

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The UN hopes that if the very poor in Africa have mobile phones they will be able to use them effectively in medical emergencies and also to access appropriate and useful health information

doctor and one nurse in every hospital in developing countries, especially those in rural and peripheral areas, were to have access to (and effectively use) a mobile “smart” phone with web capability, it could have a major impact on provision of health care.

The UN Millennium Villages Program has initiated a plan in which some of the world’s poorest people in several African countries will be connected to cellular networks and be able to use mobile phones. This is expected to have a significant impact on health care and education. They will not have access to mobile web browsing yet, but that could be available to them within a few years. The UN hopes that if the very poor in Africa have mobile phones they will be able to use them effectively in medical emergencies and also to access appropriate and useful health information. A rural hospital would be able to make a call to the nearest specialty hospital or specialist and thus help save lives during emergencies.

Mobile web browsing, at the very least, could provide instant access to the most relevant and up-to-date health information to health practitioners, especially if the most relevant and appropriate information were available in easily accessible forms, and it would offer a private and personal form of learning experience. The mobile web can be a “knowledge repository” for both providers and consumers of health care. Other mobile devices such as patient monitoring devices, PDAs and wireless radios can all be used in public health education, training and capacity enhancement. For example, they can be used in real-time monitoring of patient vital signs and in accessing important and useful health information.

One of the main constraints that prevents developing countries from being fully part of the emerging global ICT infrastructure is the lack of resources, both financial and human, to acquire and apply the technologies. The latter is true, especially in public health. Even if the government or donor agencies are prepared to invest in the required infrastructure, at present there are not enough skilled people within the health sector, especially in the rural areas, who are able or willing to use most ICTs effectively. Mobile phones and some other hand-held wireless devices, however, do not seem to pose too much of a challenge to the users.

Medical record-keeping is an area which begs for leapfrogging. In the tsunami-hit hospitals in Sri Lanka and other countries, for example, paper-based health records and patient records were washed away or destroyed. Having one’s medical records available on a mobile phone would also help doctors, nurses and pharmacists make the right decisions,

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developments in public health research. In many parts of the developing world, unlimited Internet access is now available on a monthly rate basis. Health personnel with such access can easily have individualized professional development by just going through these online Initiative/organization Comment 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 openDevelopment 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 available through HINARI and even some evidenceFirst Voice International Uses WorldSpace Digital Satellite Radio for broadcast of health 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 health professionals in many developing countries. for Developing Nations Health Organization (WHO), allowing free or very low priced (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 making a real impact, rather than merely by Interactive Health Nonprofit organizations dedicated to using online 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 system of publish or perish merit system measured by marginalized in society. Works in Africa and Asia-Pacific 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 collaboration in ways not yet envisioned. An open (INASP) 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 real paradigm shifts and important innovative Union Information Society (WSIS). http://www.itu.int 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. technology diffusion in developing countries and www.idrc.ca/acacia 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; impacts. “Technological advances do not need to be promoting health equity for women, among the world’s most vulnerable – and influential – populations and vaccine extraordinarily complex or reliant on the most programmes. www.path.org sophisticated technology to have important development impacts”. This holds true for health ICTs. Rockefeller Foundation Sponsors think tank meetings on E-health aimed at improving 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 information is used and processed. More and more (AMIA), International Medical Informatics Association (IMIA), 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 phones than their desk top or laptop computers, Group Foundation Technology Partnership, University of 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.

based on a patient’s health history.

Electronic public health journals offer a very inexpensive form of eLearning. They keep readers up-to-date on new

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Table 3 shows some examples of international efforts toimplement Leapfrog technologies in developing countries for health care.

Conclusion In public health practice, ICTs enable the identification of disease and risk factor trends, analysis of social and demographic data, and increase access to publications and databases. As free and open source software continues to evolve, the uses of ICTs for health will expand exponentially. ICTs can be used by medical professionals and community health workers to improve not only health services but also entire health-care systems, while beneficiaries can use ICTs to access health information and make well-informed decisions regarding their own health. However, not all members of the health workforce or the public have equal access to ICTs. The digital divide – the gap between those with effective access to ICTs and those without it – contributes directly to the persistent health inequality both between and within countries. In health, lacking or limited access to ICTs impedes the provision of health care and the effectiveness of public health work.

Efforts to bridge the gap in access to ICTs have varied dramatically in their effectiveness and their usefulness.

Beyond the creation of systems for cell phone and Internet use, we need to ensure that access to ICTs for health will link individuals to the health information and modes of communication that are most useful to them, and that the most necessary, valid and useful information is available in the most acceptable and useable forms.

Thomas Kuhn in The Structure of Scientific Revolutions in 1962 put forward that true scientific knowledge does not advance as a linear increase in understanding based on logical models. He proposed that true advances occur naturally as a series of revolutions, replacing the old paradigms and resulting in a “paradigm shift”: a new way of thinking about a problem. Thus, to advance development, the use of leapfrog technologies must extend this process to include ecologically, financially and socially sustainable means of tackling poverty and heath inequalities. Examples of such paradigm shifts include very recently the effect of the Internet on information retrieval, and earlier the discovery of penicillin and vaccines for combating infectious diseases.

ICTs are already having an impact in health in developing countries through the rapidly growing use of mobiles and through Open Access initiatives for ePublishing10. There is a unique opportunity for developing countries to harness eHealth technologies in a way that will ensure a paradigm shift in how we “deliver” or “support” development and how health is progressed in these regions. It offers the potential of greater transparency, improved governance and access to essential tools and expertise, irrespective of geography or of financial or resource implications. J Harry McConnell is a neuropsychiatrist specializing in disability with more than 20 years’ experience in both the clinical and public health aspects of health and disability. He has published five textbooks and worked as a Clinical Editor at BMJ Clinical Evidence.

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He has a keen interest in Open Access and innovative use of IT to make scientific publishing more available in developing countries.

Professor McConnell has worked extensively with the WHO, World Bank and other international agencies on the implementation of eHealth programmes in developing countries. He trained in the USA, Canada, New Zealand and the UK. Professor McConnell also has a keen interest in evidence-based policies for disability services and in health and disability in developing countries. He is a Consultant Psychiatrist and Professor of Neuropsychiatry at Griffith University School of Medicine.

Prita Chathoth PhD has more than 20 years of international experience in eLearning, eHealth and ICTs for development. She worked at the World Bank in Washington, DC, from 1993 to 2007.

During this time, for more than seven years, she served as senior operations officer in the Global Development Learning Network (GDLN). As Task Manager of the GDLN Global Dialogues Program, Dr Chathoth worked extensively with all regions of the world.

From July 2005 to December 2006, Dr Chathoth was on assignment at the WHO Office in Sri Lanka as eCapacity Building Coordinator and Project Manager of the Sri Lanka eHealth Project.

Prior to joining the World Bank, she worked at INTELSAT, in Washington, DC, as a training specialist. In 2007, Dr Chathoth worked as a consultant at the Pan American Health Organization (PAHO). She has researched, written and produced more than 15 broadcast quality documentaries. Dr. Chathoth currently works as an independent eLearning/eHealth Consultant.

Ashley Pardy is the co-director of the Interactive Health Network (IHN) and project manager of the Academy for Sustainable Health Equity and Development (AHEAD). Both are nongovernmental organizations dedicated to improving health and disability services in developing countries through the use of information communication technologies. Now a full-time PhD student at Griffith University in Australia, Ashley started her university education at Queens University in Canada, where she completed her BA and then continued on to Australia to do her masters in International Relations. She is currently focusing her dissertation on mental health research in Ethiopia and is actively involved in development projects in the Asia pacific region. Ashley has worked as a volunteer in Asia, Africa and South America.

Camille Boostrom is a PhD candidate in public health at Griffith University, Australia. Her research analyses the sector-wide approach in Mozambique’s health sector and its impacts on the country’s HIV/AIDS prevention efforts, specifically on the negotiation and dissemination of HIV/AIDS communications. Camille is also a Research Associate with the Georgetown University Medical Center.

Eugene Boostrom MD, DrPH is a public health specialist with more than 30 years’ experience in the development of health systems and health personnel. He has worked in Africa, Latin America and the Caribbean, the Middle East and South Asia with bilateral and multilateral agencies, universities, foundations and the private sector. He retired from the World Bank as Senior Public Health Specialist in 2002 and now lives in Okinawa, Japan, where he is a Visiting Researcher at Meio University Research Institute. He also teaches public health, epidemiology, health project and human

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resources planning and management, and sustainable development related topics for the Japan International Cooperation Agency (JICA), Japan’s National Institute of Public Health, and Hokkaido University Medical School.

Koos Louw is an eHealth consultant living in Cape Town, South Africa. He served for many years in the top management of the South African Medical Research Council as Executive Director: Informatics and Knowledge Management. He is an acclaimed role player in the area of health informatics and knowledge management, nationally and internationally, and has a track record of various successful large multi-institutional eHealth projects. He holds a PhD from Stellenbosch University, South Africa. This university appointed him in the honorary position of Visiting Professor: Information Science (Knowledge Management) and as an Associate of its Centre for Knowledge Dynamics and Decision Making.

Luis Gabriel Cuervo is a Medical Doctor with an MSc in Clinical Epidemiology & Biostatistics from the Universidad Javeriana, and qualified as a Specialist in Family Medicine at the Universidad del Valle, Colombia. He brings first hand experience as producer and user of evidence for health care in the clinical, academic, and research fields working in various communities in rural and urban environments in Colombia. He has developed a career around

knowledge management including summarizing evidence and developing strategies to systematically inform policy and practice with research evidence. From his position as Clinical Editor at BMJ Clinical Evidence he emphasized evidence-based programmes and access to developing countries and worked closely with the World Health Organization and International NGOs including the Cochrane Collaboration and INCLEN. More recently he has coordinated the response of the Pan American Health Organization (PAHO/WHO) to the 2004 Mexico Declaration on Health Research.

Sumiko Ogawa, MS in Medical Sciences, MPH, PhD, is Associate Professor at Meio University, Okinawa, Japan, where she teaches Public Health. Her successful work with WHO and JICA in developing Primary Health Care and Village Drug Revolving Funds and improving water supplies in the Lao PDR’s remote Khammouane Province from 1992 to 1996 led the Government of Laos to award her its Labor Medal, and the Japan Chamber of Commerce named her Japan’s Outstanding Young Person of 1997. With support from Japan’s Ministry of Education and JICA, she documented the postWorld War Two recovery and development of health systems and human resources for health in war-ravaged Okinawa. She is President of Okinawa’s Association of Former Overseas JICA Experts and a member of the board of Japan’s Association for Overseas Volunteer Studies. She continues her work with the Lao PDR MOH and also teaches and consults for JICA.

References 1

Dzenowagis J. Bridging the digital divide in health: the role of free and open source software. World Health Organization Expert Meeting on Free & Open Source Software UNCTAD, Geneva, 2004. Available at: http://r0.unctad.org/ecommerce/event_docs/fossem/dzenowagis.pdf 2 Refer: www.ehealth-connection.org/content/country-case-studies 3 Refer: www.ehealthconnection.org/files/resources/County%20Case%20Study%20for%20eHeal th%20South%20Africa.pdf 4 Refer: www.drexel.com/online-degrees/information-sciences-degrees/certhci/index.aspx 5 Refer: www.drexel.com/online-degrees/nursing-degrees/medical-billingcoding/index.aspx 6 Refer: www.hon.ch/ 7 Monegain B (ed). Online info has patients doubting doctors, survey founds.

In: Healthcare IT News, 30 July 2008 http://www.healthcareitnews.com/story.cms?id=9654 8 McConell H. Pardy Medical Publishing in Snyder et al. Medicine and the media (in press), 2008.

9 http://econ.worldbank.org/WBSITE/EXTERNAL/EXTDEC/ EXTDECPROSPECTS/GEPEXT/EXTGEP2008/0,,menuPK:4503385~page PK:64167702~piPK:64167676~theSitePK:4503324,00.html 10 McConell H. Pardy Medical Publishing in Snyder et al. Medicine and the media (in press), 2008.

Furthur reading Berger M. Nanotechnology patents and the future of the pharma industry.

Nanowerk LLC, 2007. http://www.nanowerk.com/spotlight/spotid=2912.php Bernhardt JM. Health education and the digital divide: building bridges and filling chasms. Health Education Research, 2000, 15(5):527-531.

Brodie A et al. Health information, the internet, and the digital

divide. Health Affairs, 2000, 19(6):255.

Dzenowagis J. Bridging the digital divide in health: the role of free and open source software. World Health Organization Expert Meeting on Free & Open Source Software UNCTAD, Geneva, 2004. Available at: http://r0.unctad.org/ecommerce/event_docs/fossem/dzenowagis.pdf Improving health, connecting people: the role of ICTs in the health sector of developing countries. A Framework Paper, InfoDev, 2008. http://www.infodev.org/en/Project.38.html McConell H. Pardy Medical Publishing in Snyder et al. Medicine and the media (in press), 2008.

McConnell H, Shields T and Drury P. Leadership in Global Health Technology Update. World Hospitals and Health Services, 2006.

McConnell H and Marchibroda J. Leadership in Global Health Technology (LIGHT): an international dialogue towards cooperation in medical education, clinical, and research initiatives in healthcare. World Hospitals and Health Services, March, 2004.

Salamanca-Buentello F et al. Nanotechnology and the developing world.

PLoS Medicine, 2005, 2(5): e97 doi:10.1371/journal.pmed.0020097.

Singh JP. Leapfrogging development? The political economy of telecommunications restructuring. SUNY Press, NY, 1999.

Steinmueller E. ICTs and the possibilities for leapfrogging by developing countries. International Labour Review, 2001, 140(2):193-210.

Tan-Torres Edejer T. Disseminating health information in developing countries: the role of the internet. British Medical Journal, 2000, 321(7264):797-800.

Warschauer M. Reconceptualizing the digital divide. First Monday, 2002, 7(7). Available at: http://firstmonday.org/issues/issue7_7/warschauer/index.html Global Economic Prospects 2008: Technology Diffusion in the Developing World. World Bank, 2008.

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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 getting a new childhood vaccine introduced into a developing country is more than simply a matter of obtaining good results from clinical trials, getting it licensed and introduced into immunization programmes in industrialized countries, and expecting developing countries to follow suit. A large number of obstacles stand in the way.

First, country policy-makers, as well as donors, may consider the new vaccine unaffordable, especially compared to the pennies-per-dose basic childhood vaccines, such as DPT and oral polio. Second, a number of countries, especially large Asian countries, such as China, Vietnam, India and Indonesia, have a policy of self-reliance in vaccine production, requiring them to produce or at least fill/finish and package locally any vaccine used by the national immunization programme. The new vaccine may be patentprotected, too complex or too expensive to produce locally.

One way to deal with both of these issues is to develop technologies for vaccine manufacture and testing that can be transferred to qualified vaccine producers in developing countries so that they can manufacture high quality vaccines at affordable prices.

Another common obstacle to introducing a new or underutilized vaccine into developing countries is that local policy-makers may not be convinced of the need for the vaccine in their country. This may be because the disease is part of a syndrome or group of diseases and not recognized as a distinct disease (e.g., diarrhoea caused by rotavirus virus other enteric pathogens); the disease is not well diagnosed, due in part to a lack of specific, accurate or low-cost diagnostic tests, and thus is under-reported (e.g., typhoid fever); or the disease mainly affects poor, marginalized or rural populations and is therefore not on the radar screen in urban areas where policy-makers and the media are concentrated (e.g., cholera, Japanese encephalitis).

Estimates of the burden of the specific disease are therefore required, which may include conducting prospective disease surveillance studies. The vaccine’s effectiveness in local populations may also be questioned, especially when the trials for licensure have been conducted solely in industrialized countries or only in certain parts of the world1.

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Because populations can differ in their immune response to a particular vaccine, national policy-makers are increasingly demanding local or at least regional data on a vaccine’s efficacy or field effectiveness.

Finally, country policy-makers may be uncertain of their population’s demand for or acceptance of the new vaccine.

This is perhaps less of an issue for vaccines introduced into the infant immunization schedule, such as the new rotavirus and pneumococcal conjugate vaccines, since children are simply given the additional vaccine during their regular immunization sessions. However, it can be an important issue for vaccines provided outside of the infant schedule, such as the new human papillomavirus (HPV) vaccine (given to pre-adolescent girls), and vaccines against cholera and typhoid fever – which are not licensed for use in children under the age of one or two years. These vaccines require special efforts to administer – such as school- or communitybased vaccination campaigns – thus increasing the potential for resistance or disinterest on the part of health authorities and the community. Conducting sociobehavioural studies and private demand surveys concerning the particular disease and vaccine in target populations can help predict demand for the vaccine, as well as preempt possible negative reactions or lack of interest (e.g., by using commonly-held beliefs or attitudes to inform social mobilization activities and messages), and inform the design of effective vaccination strategies.

A number of product development partnerships (PDPs) have been established in recent years – primarily with funding from the Bill & Melinda Gates Foundation – to undertake the complex, multi-faceted and coordinated set of activities that are required to address the above issues in order to accelerate the development and introduction of specific vaccines into developing countries. Examples are the Malaria Vaccine Initiative, the International AIDS Vaccine Initiative (IAVI), the Rotavirus Vaccine Project, the Aeras Global TB Vaccine Foundation and the PneumoADIP. While most PDPs use a model that combines in-house activities and expertise with those that are out-sourced to diverse partner organizations, the approach of the International Vaccine Institute, an independent international organization founded in 1997 and based in Seoul, Korea, has been to build

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development of Shigella vaccines, since natural immunity against Research for Vaccine Vaccine discovery shigellosis is believed to be vaccine development: and design: species- and serotype-specific. An introduction: effective vaccine would likely have to contain antigens from a • Genotyping • Collection of • Laboratory process large number of species and (pathogen detection) epidemiological, development serotypes and would need to be • Novel antigens economic and • Assays developmodified each year, based on • Novel adjuvants socio-behavioral ment (immuno circulating serotypes, making the • New routes of data monitoring) development of such a vaccine administration • Studies of vaccine • Technology (e.g., sublingual) scientifically challenging and the feasibility, accepttransfer for large• Reformulation and ance and field ultimate production logistically scale production improvement of effectiveness complex and expensive. These • Clinical trials 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.

This research led to the discovery of proteins common to all in-house capacity in all three major areas along the “vaccine species and serotypes that can potentially serve as antigens continuum” – namely vaccine discovery and design; vaccine for a cross-protective Shigella vaccine. Such a vaccine is development and field testing; and vaccine introduction. currently in development at the IVI’s laboratories and initial These in-house capabilities “from bench to community” (see tests in animals have been positive.

Figure 1) have been built through the Institute’s Laboratory In the remainder of this paper, we describe how the IVI’s Sciences and Translational Research divisions and its in-house capabilities have been put to work to accelerate the Product Development and Technology Transfer unit. use of new-generation cholera vaccines in cholera-endemic Having in-house capacities in all or most of the areas countries. These activities are depicted in Figure 2. required for getting a vaccine introduced into developing countries has a number of advantages. Conducting most of Research to the activities and research inVaccine vaccine house can quicken the pace of development: introduction: progress, as well as save costs by reducing the need to hire Reformulation Ref formullati tion and d iimprovement mprovementt iin n IV IVI’ IVI’s I’s • Prospective disease surveillance subcontractors with additional laboratories of a low-cost oral killed studies in several sites whole-cell (WC) cholera vaccine produced administrative fees and overhead • Cost-of-illness and vaccine demand in Vietnam surveys costs. It also enhances flexibility, • Socio-behavioral surveys by more easily and rapidly • Demonstration of mass vaccination Testing of the safety and Immunogenicity allowing the researchers to switch using Dukoral in Mozambique and of the improved oral killed WC vaccine for gears and move into the direction assessment of its protective impact licensure in Vietnam and India that the data take them without Phase III trial of involving multiple layers of Technology transfer improved WC Analysis of herd effects and overall of improved WC bureaucracy.

For example, vaccine in Kolkata impact of oral killed WC-based vaccines vaccine to highfor licensure and prospective surveillance of quality developing WHO preshigellosis (bacterial dysentery) country producers qualification Site-specific impact and costconducted 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 Analysis, synthesis and dissemination Field Fi ld ttesting ti off a li live oral, l single-dose i l d species and serotypes of Shigella of global and country-specific data to Peru-15 vaccine in Bangladesh and India inform decisions about use of cholera from country to country and even vaccines from year to year within the same country was greater than Figure 2: The IVI’s Cholera Vaccine Programme to accelerate the use of low-cost oral cholera commonly believed.

These vaccines for endemic populations findings greatly complicate the

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The IVI’s programme to accelerate the use of new-generation oral cholera vaccines in endemic populations At the time the IVI began its Cholera Vaccine Program in 2000, there were two internationally licensed new-generation oral cholera vaccines. One was Dukoral™, produced by Swedish Bacteriology Laboratories (SBL), and consisting of killed whole cells Vibrio cholerae O1 strains with a purified recombinant B-subunit of cholera toxin (rBS-WC). The vaccine, which requires the administration of two doses given one to six weeks apart, was found in field trials in Bangladesh to confer around 50% protection after three years2. It is licensed for persons two years and older, costs several dollars per dose, and thus its use has been largely limited to travellers from industrialized countries traveling to choleraendemic areas. The second was a live, attenuated vaccine (CVD 103HgR or Orochol™), manufactured by Berna Biotech of Switzerland. This vaccine had been licensed for travellers in several industrialized countries, but was not found to be protective in cholera-endemic populations and is no longer being produced3.

Despite recommendations from the World Health Organization (WHO) for the use of new-generation cholera vaccines in 1999, no country has yet introduced cholera vaccines into its immunization programme, with the exception of Vietnam. As a result of technology transfer from Sweden, Vietnam manufactures an oral killed whole-cell (WC) vaccine, which does not contain the purified B-subunit of the cholera toxin and is consequently less expensive to produce (<$0.50/dose). The vaccine was found in field trials in Vietnam to provide 66% efficacy during a cholera outbreak 8–10 months after vaccination in a trial in Hue, Vietnam4.

After reports of cholera epidemics caused by the O139 strain occurring in South Asia, this strain was added to make a bivalent (O1/O139) vaccine. Long-term effectiveness studies showed that the bivalent vaccine conferred similar protection as Dukoral™ (~50% protection 3–5 years after vaccination)5.

The vaccine is used in Vietnam by the national immunization programme in high-risk areas of the Mekong Delta, central coastal areas and some provinces in Northern Vietnam, especially during floods.

This vaccine could not be used outside of Vietnam, however, because the country’s national regulatory authority (NRA) does not meet WHO requirements. The vaccine also did not conform to the WHO guidelines for the production of killed oral cholera vaccines – specifically, in the way the antigen content was determined and in the presence of low but detectable levels of cholera toxin6.

Therefore, at the inception of the IVI’s Cholera Vaccine Program there was the need for a low-cost, safe and effective cholera vaccine for use in endemic countries and the only available new-generation vaccines were either ineffective in endemic populations, too expensive for public sector use in developing countries, or did not meet international standards.

There was also a need to demonstrate to the global health community and to skeptical policy-makers in choleraendemic countries the need for, feasibility and effectiveness of vaccination to prevent cholera using new-generation vaccines.

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The first challenge that the programme undertook was to develop a source of low-cost cholera vaccine that met WHO requirements for safety and quality for use in public health programmes throughout the cholera-endemic world. The Product Development and Technology Transfer unit of the IVI worked with the local Vietnamese producer, VaBiotech, to improve the Vietnamese WC vaccine so that it complied with WHO guidelines. This involved reformulating the vaccine by replacing a high toxin-producing strain with a low toxinproducing strain, changing the antigen content of other strains, and developing new lot release assays that both provide greater consistency in the formulation of the product and that better detect the removal of cholera toxin. These efforts resulted in a vaccine that meets quality standards, is safe and yet remains affordable in cholera-endemic settings.

The next challenge was to achieve licensure of this improved cholera vaccine in Vietnam, as well as in other potential countries of manufacture. The IVI’s Translational Research Division conducted Phase II clinical trials, with the National Institute of Hygiene and Epidemiology (NIHE), among adults in Sonla, Vietnam and found a greater increase in serum vibriocidal antibodies and higher rates of seroconversion than those seen after receipt of the original Vietnamese vaccine7. The improved WC vaccine is in the process of being licensed in Vietnam, based on these results.

Internationalizing the use of this vaccine required that it be produced by vaccine manufacturers in countries with NRAs approved by WHO. Following a due diligence process, the IVI chose Shantha Biotechnics of Hyderabad, India, as the first company to receive the production technology for the new WC vaccine. Before the vaccine could be licensed and produced in India, a series of clinical trials was also required in that country. First, the Translational Research Division, in collaboration with the National Institute for Cholera and Enteric Diseases (NICED), conducted Phase II trials first among adults and then children in Kolkata, India. More than half of adults and 80% of children developed four-fold or greater increases in serum vibriocidal antibodies to V. cholerae O1, indicating a strong immune response in this cholera-endemic population. Next, bulk vaccine from VaBiotech in Vietnam was shipped to Shantha, where it was filled and finished for use in a Phase III randomized, placebocontrolled trial involving more than 67 000 children and adults. This trial, conducted jointly by NICED and the IVI, began in 2006 and will continue with disease surveillance for three years following vaccination to estimate the new vaccine’s efficacy.

At the same time, the IVI’s Product Development and Technology Transfer unit completed the development of quality control assays and showed that the new process worked at laboratory scale. The production technology for this vaccine will be transferred to Shantha, which will enable the company to produce the vaccine from scratch under strict good manufacturing practice (GMP) conditions. Licensure in India and the subsequent production of the vaccine by Shantha can begin after the Phase III clinical trial in Kolkata is completed, if the results are shown to be favourable. The ultimate goal is for this vaccine to be pre-qualified by WHO to

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enable its use by UN agencies and by the GAVI Alliance, if and when the alliance decides to support the introduction of cholera vaccines into GAVI-eligible countries where cholera still poses a public health threat.

Seeing the need for additional oral cholera vaccines, especially ones that require only a single dose and could therefore be used to control currently-occurring outbreaks, the Cholera Vaccine Program has also worked on the clinical development of a promising live attenuated oral vaccine (Peru-15), developed at Harvard University and licensed to Avant Immunotherapeutics in the United States. The vaccine also has the promise of being effective in infants. The IVI’s Translational Research Division collaborated with the ICDDR,B in Bangladesh to evaluate the safety and immunogencity of Peru-15 in adults, toddlers and infants8,9.

The trial results were positive and have led to plans for further Phase II and Phase III trials of the vaccine in Bangladesh and India. As with the oral killed WC vaccine, the aim is to have the vaccine produced by a qualified vaccine manufacturer in a cholera-endemic country – following technology transfer from Avant – and for its prequalification by WHO, so that it can be an important, affordable tool for the control of both epidemic and endemic cholera throughout the cholera-endemic world.

In parallel with these efforts in the laboratory and in the field to develop and test low-cost new-generation cholera vaccines for global use, the Cholera Vaccine Program 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 choleraendemic countries. This programme of translational research began with prospective laboratory-confirmed cholera surveillance studies in two field sites in Asia (slum areas in North Jakarta, Indonesia and Kolkata, India) and one in Africa (Beira, Mozambique)10. Nested into these studies were studies of the cost-of-illness from cholera, conducted in collaboration with the University of North Carolina (UNC) School of Public Health, which tracked the treatment and other costs of cases identified by the disease surveillance studies. Sociobehavioural surveys to determine the beliefs, knowledge, attitudes and practices of these cholera-plagued communities regarding the disease and preventive measures were also conducted at these field sites, as were household surveys to estimate private demand for new-generation cholera vaccines, both in these impoverished communities and in nearby middle-class neighborhoods11,12.

To provide additional information on the population demand, feasibility and effectiveness of mass cholera vaccination, the Translational Research Division conducted a demonstration of the DukoralTM vaccine in Beira, 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 study conducted during a subsequent cholera outbreak provided further data on the vaccine’s effectiveness – found to be 78–84% over at least five months – in a population with a high prevalence of HIV infection14.

As one step in determining the overall potential impact of

cholera vaccination, the Translational Research Division, in collaboration with the University of Washington, performed analyses of the herd effects of killed WC-based oral cholera vaccines (both DukoralTM and the WC vaccine without the Bsubunit), using surveillance data from the original clinical trials of these vaccines in Bangladesh conducted in the mid1980s15. The herd effects of these vaccines were found to be substantial; stochastic (probability) modelling estimated that vaccinating only 50% of the population in a cholera-endemic area would result in an estimated 93% overall reduction of disease incidence in the entire population16. These herd effects, along with country-specific incidence rates, cost-ofillness and private demand results from the cholera field studies were incorporated into a model, developed by UNC and the IVI, to estimate the impact and cost-effectiveness of different programme options for cholera vaccination in four cholera-endemic settings (Matlab, Bangladesh; Kolkata, India; North Jakarta, Indonesia and Beira, Mozambique).

Using these and further analyses of the global impact and cost-effectiveness of cholera vaccination, the IVI will work with policy-makers at the country and international levels to inform decisions about whether to invest in cholera vaccine introduction in endemic countries. Already, the IVI’s research has had an impact on global vaccine policy, as the Board of the GAVI Alliance recently prioritized cholera vaccines for future support.

Key messages

The development and introduction of a new vaccine in developing countries requires a complex and coordinated set of activities encompassing vaccine discovery and design, vaccine development and testing, and research to inform decisions regarding vaccine introduction.

The IVI’s in-house capabilities in all three areas creates synergies between its laboratory, translational research and product development sections and enhances flexibility to resolve problems and change direction in response to research findings.

Using its in-house capabilities, the IVI’s Cholera Vaccine Program has developed a new low-cost oral cholera vaccine, coordinated the technology transfer and clinical testing of this vaccine for production by a high-quality developing country producer, coordinated field trials of an oral live attenuated vaccine candidate, and generated multi-faceted data to inform decisions to introduce cholera vaccines in affected countries.

Denise DeRoeck serves as the Coordinator for Social Science Research and Institutional Development at the International Vaccine Institute, based in Seoul, Korea. She has a Masters in Public Health degree and more than 10 years of experience in the areas of immunization financing, policy analysis and data synthesis regarding the introduction of new vaccines in developing

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countries, as well as 20 years of experience overall in the field of global public health.

development and technology transfer, with a focus on vaccines against cholera and typhoid fever.

Anna Lena Lopez, MD, is a paediatric infectious diseases specialist by training. She is presently a senior scientist and epidemiologist at the IVI where she heads the Cholera Vaccine Program.

John D Clemens, MD, Director-General of the International Vaccine Institute, is an international expert on the evaluation of vaccines in developing countries. He served as Chief of the Epidemiology Branch of the National Institute of Child Health and Human Development, US National Institutes of Health (NIH) and as Director of the first WHO Collaborating Centre for Vaccine Evaluation in Developing Countries. His research has focused on innovative methodological approaches to evaluating vaccines in developing country populations. He has conducted clinical studies of vaccines against cholera, enterotoxigenic Escherichia coli, typhoid fever, pneumococcus, tuberculosis, Haemophilus influenzae type b, measles and Japanese encephalitis.

Rodney Carbis worked at CSL in Australia, where he was responsible for developing and implementing changes in the manufacturing process of influenza vaccines as well as developing high yielding influenza seed lots. He then joined Sartorius (Australia) and assisted pharmaceutical companies in developing downstream processes and optimizing filtration systems. He joined the IVI in 2003, where he leads a team involved in vaccine process

References 1.

This has been the case of new oral rotavirus vaccines, which, because they had only been tested in the Americas and Europe, have not yet been recommended by WHO for use in Africa or Asia.

2.

Clemens JD et al. Field trial of oral cholera vaccines in Bangladesh: results from three-year follow-up. Lancet, 1990, 335:270-273.

3.

Cite Jakarta study paper.

4.

Trach DD et al. Field trial of a locally produced, killed, oral cholera vaccine in Vietnam. Lancet, 1997, 349:231-235.

5.

Thiem VC et al. Long-term effectiveness against cholera of oral killed whole-cell vaccine produced in Vietnam. Vaccine, 2006, 24:4297-4303.

6.

WHO Expert Committee on Biological Standardization: fifty-second report.

Geneva, Switzerland, 2006.

7.

Anh DD et al. Safety and immunogenicity of a reformulated Vietnamese bivalent killed, whole-cell, oral cholera vaccine in adults. Vaccine, 2007, 25:1149-1155.

8.

Qadri F et al. Peru-15 Study Group. Randomized, controlled study of the safety and immunogenicity of peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh. Journal of Infectious Diseases, August 2005, 192(4):573-9.

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9.

Qadri F et al. The PXV Study Group. Peru-15, a live attenuated oral cholera vaccine, is safe and immunogenic in Bangladeshi toddlers and infants. Vaccine, 2007, 25(2):231-8.

10.

Deen JL et al. The high burden of cholera in children: comparison of incidence from endemic areas in Asia and Africa, PLoS Neglected Tropical Diseases, 2008, 2(2):e173.

11.

Lucas ME et al. Private demand for cholera vaccines in Beira, Mozambique. Vaccine, 2007, 25(14):2599-609.

12.

Kim D et al. Private demand for cholera vaccines in Hue, Vietnam. Value in Health, Janâ&#x20AC;&#x201C;Feb 2008, 11(1):119-128.

13.

Cavailler P et al. Feasibility of a mass vaccination campaign using a twodose oral cholera vaccine in an urban cholera-endemic setting in Mozambique. Vaccine, May 2006, 24(22):4890-5.

14.

Lucas ME et al. Effectiveness of mass oral cholera vaccination in Beira, Mozambique. New England Journal of Medicine, 2005, 352(8):757-67.

15.

Ali M et al. Herd immunity conferred by killed oral cholera vaccines in Bangladesh: a reanalysis. Lancet, 2005, 366: 44-49.

16.

Longini IM et al. Controlling endemic cholera with oral vaccines. PLoS Medicine, 2007; 4(11): e336.

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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, McLaughlinRotman 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

The application of science and technology is fundamental, and indeed indispensable, to the social and economic transformation of our countries… We in Africa must either begin to build up our scientific and technological training capabilities or remain an impoverished appendage to the global economy...

There is no reason to believe that Africa cannot achieve what others have achieved in these fields.

HE PAUL KAGAME, PRESIDENT OF RWANDA

to Z Textile Mills, a company in Arusha, Tanzania, in a joint venture with the Japanese company Sumitomo, is the largest manufacturer of long-lasting insecticide impregnated bednets in Africa. Pellets containing insecticide are shipped from Japan to Arusha, where they are melted, turned into long strings, which are rolled onto spools, and then formed into nets, cut, packaged and shipped using company owned trucks to points of distribution in many African countries particularly in East and Central Africa. A to Z currently manufactures about 12 million bednets a year, which are WHO-certified and reasonably priced. Moreover, A to Z has created more than 5000 jobs for Tanzanians, supporting at least 20 000 people. As an example of manufacturing a science-based health product for one of Africa’s most burdensome diseases, A to Z is a huge success.

Now imagine a company like A to Z that relied not on imported technology but on domestic African health research.

Over the same time period that A to Z was manufacturing malaria bednets, distinguished East African researchers like Wen Kilama of the National Institute for Medical Research in Tanzania and Onesmo Ole Moi Yoi of ICIPE in Kenya were studying and publishing on the malaria parasite and mosquito vector. Imagine if this domestic East African research was the source of the technology for innovations in long lasting insecticide-treated bednets! Unfortunately, the linkages between African researchers and research institutions, and companies – even those that are domestically based – historically has been weak.

A

In this article, we propose that African innovation – and in particular African life sciences innovation – could and should become a prime driver for health and economic development on the continent. We consider a model to catalyse life sciences innovation and commercialization in Africa through “convergence innovation”, which overcomes the problem of missing links between science, business and capital, and provides a specific focus on product development. Our main focus is life sciences innovation for health but with an understanding that applications in agriculture and energy could also benefit from convergence innovation. In a previous essay Accelerating health product innovation in sub-Saharan Africa we set out our initial ideas1. Here we review the concept of convergence innovation, elaborate on our realworld experiences in three African countries, and set out opportunities and proposals for the future. While our initial focus has been on Ghana, Rwanda and Tanzania, our vision is a continent where many countries are capturing the health and economic benefits of their own domestic health research.

Vital role of science, technology and innovation in African development The Global Forum for Health Research has long advocated the importance of domestic health research, sufficient resources and capacity strengthening in the developing world, highlighting in its most recent report the continuing underresourcing of research applied to the needs of developing countries2. Similarly, a UN task force has emphasized the importance of science, technology and innovation for reaching the UN Millennium Development Goals (MDGs)3.

In 2007 African Union Heads of State strongly urged member states to promote research, development and innovation by allocating at least 1% of Gross Domestic Product (GDP) of national economies to this area by 20104, with the aim of improving local technological and human capacity to address local problems. The involvement of the private sector as critical enabler of innovation, economic development and social welfare has also become better understood and emphasized5.

Life sciences – with applications as diverse as health,

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Box 1: Stagnant technologies

Schistosomiasis dipstick test Professor Kwabena Bosompem of the Noguchi Memorial Institute for Medical Research, Ghana, has developed a dipstick assay for schistosomiasis disease, an endemic problem in Ghana caused by parasites which are present in infected water. Although it has a low mortality rate, schistosomiasis often is a chronic illness that can damage internal organs and, in children, impair growth and cognitive development. Schistosomiasis is the second-most socioeconomically devastating disease after malaria (Danso-Appiah et al, 2008). Despite having developed a prototype test for the disease several years ago, the commercial potential of the test has not been exploited due to a lack of technology transfer capacity or support for product development, field trials or market assessment.

Artemisia annua Artemisia annua grows in the highlands in Arusha, Tanzania, with 2–10 times higher yield than anywhere else in the world (transcripts from participant interviews, Tanzania). At the National Institute for Medical Research, scientists developed an innovative process to enhance the production of Artemisia, which is not being locally applied. Once grown, however, all Tanzanian Artemisia is farmed, dried and exported to Kenya, where extraction occurs, before being shipped to Switzerland where it is further processed for use in the antimalarial Coartem ® produced by Novartis. Little commercial value is captured locally, and though there are efforts to commercialize Artemisia locally using innovative processes these remain uncoordinated across the private sector, government and universities.

Agricultural research This included a fertilizer formulated at the Institute of Research into Science and Technology in Rwanda by a scientist who refused to disclose its formula. Due to lack of awareness of the innovation process and support structures to protect inventions, the potential value of this discovery was untapped. In another example, seed varieties developed at Rwanda’s Institute of Agriculture and Scientific Research are being marketed in Malawi – no royalties are flowing back to the Institute, hence no local value has been captured. agriculture and environment – have found special attention from national governments and policy-making bodies such as the African Union6 and United Nations. Countries are being encouraged by pan-African and multilateral bodies to see life sciences as a route through which innovative, entrepreneurial activity can be channelled to produce local solutions to local problems, in time helping to diversify economies, capitalize on local talent and reduce dependency on outside sources for needed technologies.

Realizing this goal will require not only increased investment in R&D, but also in the tools, skills and

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infrastructure to commercialize R&D, turning it into products and services for local benefit and, ultimately, regional and global export. Included under this umbrella are a vibrant private sector, flexible financing mechanisms for small businesses, support structures for small business development and expertise in management, technology transfer, intellectual property and regulation7. Most importantly, as we shall argue below, the disparate elements of science, business and capital need to be brought together and collectively energized.

Other developing countries, now known as “emerging economies” – with India and China as leading examples – are beginning to commercialize innovative health products8 ,9, 10.

Will African countries also begin to turn their domestic health research into products and services that address their local health problems?

MRC research in Ghana, Tanzania and Rwanda The McLaughlin-Rotman Centre for Global Health (MRC), based at the University Health Network and University of Toronto, Canada, has built expertise in the use of life sciences in the developing world, with an emphasis on health technologies. In 2002, we published our study on the Top Ten Biotechnologies for improving health in developing countries within the next 5 to 10 years11 conducted in partnership with scientists from around the world. In 2004, we published a series of seven case studies which explored the national health biotechnology innovation systems in the developing world, primarily in emerging economies, and set out policy recommendations12. Current activities include a project on biotechnology firms in a number of emerging economies, including India, China, Brazil and South Africa, which seeks to raise the profile of indigenous innovation and understand the challenges and opportunities facing these firms.8, 9, 13 MRC is also involved in technology-specific projects, such as the role of human genomic variation projects and regenerative medicine technologies in improving public health in developing countries14, 15.

Since early 2007, we have been working with three African governments to explore ways to strengthen their life sciences innovation, and accelerate the commercialization of sciencebased health products based on domestic African health research. So far more than 100 stakeholders from academia, private sector, government and civil society have been interviewed face-to-face in Ghana, Tanzania and Rwanda, with the aim of gaining understanding of the obstacles to innovation and product development and commercialization and exploring potential solutions. Several hundred stakeholders have been engaged through workshops where we reported back results and discussed health product commercialization in these countries. In each country, we have sought to identify the areas of local strength which offer the greatest promise of commercialization and ways in which this process could be catalysed through “convergence innovation”.

The first country we began working in was Ghana, where we were hosted by the Ministry of Health and Honourable

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Old approach

= Science x Capital x Business x = Linear

Results • slower process • increased risk

Business

New approach

=

= Science

Capital

Synergistic

Results • Demand based, outward focused innovation • Increased speed • Improved scope • Scalability • Multi dimensional innovation

Figure 1: Old and new approaches to innovation

Minister Courage Quashigah. Through our interviews, we found many of the key elements of innovation to be in place – a strong regulatory body for food and drug products; pockets of innovative research; a relatively strong pharmaceutical sector accounting for the production of 30% of Ghana’s health products (including La Gray Pharmaceuticals, a facility focusing on the production of Active Pharmaceutical Ingredients); the existence of financing mechanisms for science-based businesses (for example the Government’s Venture Capital Trust Fund); and an entrepreneurial mindset among Ghanaians, reflected in the number of business schools and the growing success of the IT industry. Particular knowledge areas that were considered to be of most promise were traditional medicine and tools for diagnosis of local diseases. Some elements of innovation policy and practice, such as technology transfer

and intellectual property protection, were found to require attention, however the key limitation in the product development pathway was the lack of inter-sectoral linkages.

Connections between researchers and the private sector, between government and end users, and between all other entities in the innovation system, need to be built.

In Tanzania, we conducted a case study at the invitation of the Minister of Communications, Science and Technology.

Here, we found a strong research and tertiary education base both in the private and public sector, with a number of universities running biotechnology programmes. Again, the regulatory system is strong and there is government commitment to building innovative economic sectors and diversifying Tanzania’s economy. As in Ghana, traditional medicine and diagnostics were the leading contenders for commercialization, given the right support, but the

Physical Centre • Entrepreneurs • Private sector • Capital providers • Government/NGOs

• Research groups • Manufacturing • Distribution centres • Professional services

Virtual platform life science stakeholders

Internal/external life science stakeholders • Research institutes • Entrepreneurs • Capital providers/investors • Private sector • Technology transfer groups • Policy makers/government • NGOs • Other Incubators/research parks • International organizations

Figure 2: Life science convergence platform

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entrepreneurial mindset was not evident among the research community. A number of institutes for traditional medicine are producing products for local consumption; however, these could be significantly improved with the application of business rigour. There were some very interesting efforts to create clusters and SME clubs, but these were relatively small-scale in any particular focus area. Again, there was enormous scope for increasing linkages between researchers and entrepreneurs.

In Rwanda, our host was the Minister in the President’s Office in Charge of Science, Technology, Scientific Research, and Information Communication Technologies. The Rwandan case presents a different though exciting model since, compared to the other two countries, the life sciences research base is less well developed and, sadly, there is a smaller base of highly trained science professionals. The government is actively seeking to build capacity with a view to transforming its current agriculture-based economy to a knowledge-based economy by year 2020, and to use science, technology and ICT as a key enabler of this transformation. An important building block, in the shape of the Science and Technology master plan, is already in place16.

As yet there is no framework to harness health and biotechnology inventions but the government is keen to develop one – for example, the Pharmacy Task Force in the Ministry of Health is working with Tanzania to establish a food and drugs regulatory agency; a patent office is being formed in the Ministry of Commerce and a recent patent law has been passed. There are no major links between scientists in Rwanda and Rwandan scientists abroad and little awareness of scientific investment opportunities by Rwandan entrepreneurs.

One phenomenon that we came across in all three countries was “stagnant technologies”: technologies at early stages of development, in need of product development support and expertise, but lacking the means (both resources and experience) to realize their true value (see Box 1).

The main finding from our research in all three countries was a need for improved linkages among different elements in the innovation system – science, business, and capital – to enhance knowledge flow and to stimulate the “innovation culture” necessary to underpin future growth of a knowledgebased economy. Currently, limited contact between sectors and a lack of awareness of the tools to stimulate innovative performance is resulting in the failure to harness the creativity of African scientists, as illustrated by stagnant technologies and an overall lack of examples of locally-driven innovative activity coming from these three countries. In short, Africa is more successful at health research than at commercializing that research into health products aimed at local and regional health problems.

Convergence innovation and convergence platforms Having seen that little African health research is translated into health products, what can be done about this? What approach to innovation can help catalyze new approaches that are more socially and economically productive?

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The traditional view of innovation has seen it as a linear process, starting with investment in fundamental science, then seeking capital to further develop applications, leading to the formation of a business or uptake of the technology by the private sector and then to distribution (see Figure 1). This is a slow process, often not directed by market and consumer need, and as such subject to increased risk and uncertainty.

“Convergence innovation” embodies a new approach to innovation, and involves the bringing together of science, business and capital – three key elements of innovation – to create a dynamic environment where scientific knowledge, the demands of the marketplace and the realities of funders exist together. This model aims to increase speed of product development and relevance of products to the population, and reduce risk to investors.

Support structures are needed to create this type of environment including both virtual and physical platforms for stimulating innovation, encouraging cross-sectoral learning and nurturing technologies. Examples of such structures include science parks, technopoles and clusters, each of which differ slightly in approach but for our purposes will be treated as variations on the theme of convergence innovation.

Our model is of a “convergence platform” that offers services necessary to grow nascent scientific and entrepreneurial capacity into an organized and fully realized cluster. Acting as the focal point for science, business and capital stakeholders, the platform will provide a forum to effectively integrate diverse expertise and interests and facilitate partnerships.

Additionally, a convergence platform will be involved in public advocacy, provide training and offer entrepreneurial support and awareness, providing a balanced approach to bridging business and science. We define a convergence platform as a physical or virtual place that: attracts a breadth of talent and resources from science, business, and capital communities across the innovation value-chain to a single point; offers entrepreneurial support and services to facilitate business planning, business development and partnership formation; provides opportunities for knowledge exchange and shared learning opportunities – entrepreneurial training, special programmes and events, mentorship and peer-topeer learning; provides a focal point for the attraction of risk capital; is adaptable to local circumstances and markets – one size does not fit all; facilitates connections to related platforms and other institutions locally and internationally.

A concrete example of a convergence platform is the MaRS Centre in Toronto, created with the explicit goal of realizing benefits from the wealth of life sciences research in the Toronto region. By mingling talent across the functional innovation system – from basic scientists to venture capitalists – MaRS provides research and business incubation facilities, co-located with professional services firms and investors, technology transfer offices and venture capital groups. MaRS has connected science, technology and

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entrepreneurs with business skills, networks and capital to stimulate innovation and accelerate the creation and growth of successful Canadian enterprises by building a community in which innovators, entrepreneurs, scientists, professionals and investors can meet to establish linkages and exchange knowledge17.

Key elements of the proposed convergence platforms in Africa Ghana, Tanzania and Rwanda are three African countries seeking to capture the value of local life sciences research.

MRC has been working with these countries, and with SHI Consulting, a strategy consulting firm based in Canada which serves the innovative life sciences sector, to develop business plans for convergence platforms which will enable accelerated health product commercialization and improve innovation capacity. Though each platform has subtly different features, in essence they all consist of three main elements which, together, create a dynamic environment for product commercialization: Physical centre: this is a physical building which colocates tenant space for research, companies of all sizes, business advisors, investors, office space and professional services. The aim of the physical centre is both to provide physical infrastructure (Internet access, laboratory services, conferencing facilities, scientific equipment) and to house activities for networking, entrepreneurial services and training which would lead to increased local product development. Activities that would occur in the centre include hands-on advisory services in commercialization and business development, entrepreneurial programming and networking sessions. The location of the physical centre must be well-chosen, ideally within a major city as the “hub” of research, government organizations and private sector activity. It must also be located in a neutral space with accessibility to a critical mass of stakeholders.

Virtual network: the virtual network links together higher education, public and private research institutions, government and other stakeholders, through, for example, events, email listings and site visits. It also manages the preincubation and development of promising technologies to support the technology transfer process. Examples of activities include a “technology audit” to identify promising technologies in each country ripe for commercialization, and an annual Venture Forum which will draw out innovative ideas from the research community for further business support and development. The virtual network helps to ensure a national effort – and serves the crucial function of scoping promising technologies, which could later represent “deal flow”, as widely as possible. The virtual network also enhances various functions of the physical centre by supporting formation of linkages, deal flow between partners, inter-sector and cross-institutional communication and collaboration, and entrepreneurship/commercialization training.

Product development programme: the product development programme (PDP) acts as a specialized “technology development accelerator programme” to develop

pre-commercial technologies identified locally to the point of market readiness. Technologies or ideas selected for the PDP are co-developed with the platform’s expert team and given initial seed funding to take them past the proof-of-concept stage and make them attractive to risk capital investors – thus taking technologies across the so-called “valley of death”. The PDP will therefore play a key role in facilitating partnerships with local and global risk capital investors and receptors capable of taking the technology to a viable commercial stage. Initially, the PDP will develop pilot projects, focused on areas with potential to realize short-term gains to generate revenue. Anchored by rigorous scientific and business criteria that select only the most promising precommercial technologies for further development, the PDP will build a reputation as a consolidator of investor-grade life sciences assets.

Over time, each convergence platform will be networked into its counterparts in other countries, leveraging experience, skills and lessons learned across the continent.

Some of these platforms are in the same African region (e.g.

Tanzania and Rwanda), in which case the platforms could work together to become hubs for regional innovative activity and attract promising projects from the entire region. Other regional and international incubators and science park networks and associations such as the Africa Incubator Network (AIN), as well as convergence platforms outside Africa, will also be potential partners for collaboration.

Financing convergence platforms and resulting companies The convergence platforms (consisting of physical, virtual and product development elements) are structured as not-forprofit entities with an independent board of directors. The platforms have the opportunity to become sustainable in the mid-term through fees for services or rent. Reaching sustainability, however, requires an infusion of start-up capital in the millions of dollars, for which several potential funding sources exist. Generally, according to our financial models, the platforms should break even within five years, although they will continue to pay off debt resulting from the initial capital investment for a longer period of time.

Initial funding for the platforms could come from a range of public sources, structured as loans or grants. African governments themselves could be direct funders of convergence platforms, seeing them as promising mechanisms to address a number of economic, health and wider societal goals and to leverage the benefit of R&D investments already being made.

The public sector window of the African Development Bank (AfDB), with its mandate to promote economic and social development through loans, equity investments and technical assistance, is another potential sponsor. Indeed, a recent ADB High Level Panel Report, Investing in Africa’s future – the AfDB in the 21st century outlines a new role and strategic plan for the AfDB. It highlights the need to foster innovation in Africa and recommends that “the Bank support the development of national and regional centres of excellence in the health sciences and in energy and

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environmental technologies. There are significant potential benefits from linkages between life science and the private sectorâ&#x20AC;?18. Like the traditional infrastructure investment of a bridge joining two sides of a river, a convergence platform is an infrastructure investment for joining science and capital for social and economic benefits to the host country and its people.

The World Bank, with its interest in capacity-building in the crucial areas of science, technology and innovation, is another potential sponsor for the virtual component of these platforms, as are a wide variety of donor agencies for whom science, technology and innovation play a central role in future economic development.

By contrast to the platforms themselves, financing for the technologies which have reached the point of proof of principle or market readiness should come from private investments in the form of equity or debt. In terms of private capital providers for technologies and spin-out companies, there are a number of entities with potential interest in making investments in Africa, including the private sector window of the ADB and the International Finance Corporation (IFC), the private sector arm of the World Bank. In December 2007, the IFC, with support from the Bill & Melinda Gates Foundation, released a report entitled The Business of Health in Africa, on opportunities for private-sector approaches to health in sub-Saharan Africa. The report covers health services provision, medical and nursing education, risk pooling arrangements, distribution and retail of health products, and also life sciences manufacturing and innovation19. In a promising development, the accompanying announcement states that there are plans to mobilize up to US$ 1 billion in investment and advisory services support over the 2008â&#x20AC;&#x201C;2012 time frame, including an equity investment vehicle starting with US$ 100 million (growing to up to US$ 300â&#x20AC;&#x201C;350 million over this time frame).

Venture capital firms both within and outside Africa are another potential source of risk funding. Two examples are South-African Bioventures, the only wholly life sciencesfocused VC firm in sub-Saharan Africa, which has made a number of successful investments in that country, particularly in the medical device area; and Bridgeworks, a Kenya-based VC, which also has a special focus on health technologies and over the last few years has gained extensive experience in the requisite measures to identify, develop, support and finance small science-based ventures in Africa. These investments would also be appealing for social investors, who will tolerate lower returns in exchange for social benefits.

Lessons learned and next steps Having begun to operationalize convergence innovation on the ground through working with local governments and other stakeholders, including writing business plans and sourcing potential funders, a number of lessons have been learned which will improve the likelihood of success.

First, flexibility is key. One size does not fit all across Africa and each platform is being developed with sensitivity to local circumstances, goals and capacities. In Ghana, for example, emphasis is being placed on a virtual model that links

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together stakeholders through events, activities and other virtual means; a central secretariat will coordinate this approach but, at this stage, no physical centre is being proposed. In contrast, the Tanzanian stakeholders are pursuing an integrated physical and virtual model to better leverage local capacities and existing institutions. In Rwanda, again there is likely to be a physical and virtual component, with emphasis on both scientific and entrepreneurial capacity building, and a focus on both health and agriculture.

Second, local champions to spearhead these platforms are vital. Throughout our work in Africa, we have encountered a good deal of local enthusiasm for the convergence innovation concept from those eager to capitalize on the opportunity and catalyze a different approach to health and economic development. Involvement of local partners is the only way to ensure that these platforms are realistic in scope, responsive to local needs and financially sustainable. This is occurring in Ghana, where a Task Force on Life Science Commercialization and Convergence was established by the Honourable Minister of Health and mandated to advise him on next steps. Led by an eminent academic Professor Francis Nkrumah, the task force meets on a monthly basis and is in the process of further developing a business plan for the platform, appointing a secretariat and sourcing funding for the first one or two years of operations. In Tanzania the business plan for its convergence platform has been presented to the Minister and the next step is to appoint a local steering committee to develop and deliver the plan. In Rwanda, the business plan has been presented to the Minister and local champions are being identified.

Third, the role of the local private sector is critical.

Ultimately, it is the private sector which has the skills and expertise to commercialize technologies. Prominently included in the local champions mentioned above must be leading entrepreneurs.

The potential benefits, and metrics of success, of a convergence platform include: increased product commercialization in Africa; increased formation of life science enterprises and growth of support industries and therefore increased high value employment; enhanced life science-based entrepreneurial culture; increased formation of sustainable public-private partnerships, linkages and knowledge flow among science, business and capital stakeholders in Africa; increased inward investment and risk capital; increased exports, initially regionally but ultimately globally, of health products; and lastly, and most importantly, improved health, social and economic outcomes for Africa.

Of course, there are also risks. Convergence platforms are complex endeavours highly dependent on the mobilization of sufficient critical mass. Commercialization of innovation is a high-stakes game that fails much of the time. Innovation requires a long-term commitment. To be successful, governments must also simultaneously address gaps across the functional innovation system.

How can this model of convergence innovation, facilitated through convergence platforms, be extended to other countries in Africa and suitably networked so as to gain maximum leverage within and across regions? The first step

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is to engage the wider audience of African Health Ministers, both to raise the profile of what has been done so far and to consider how this model of innovation might help them to achieve their public health goals by enabling the growth of indigenous health innovation. Ministers of Science and Technology and of Finance should be interested in these initiatives for what convergence innovation can mean for their countries’ social and economic development. A few examples of successfully commercialized products based on African health research will go a long way to building the confidence of African and international investors. If one were a private investor, one would have no idea how to scope promising technologies against health, agricultural, environmental or energy problems in Africa. The convergence platform provides one-stop shopping for investors, greatly decreasing the complexity and cost of identifying promising technologies.

Given the ingenuity, creativity and entrepreneurialism in Africa, it is inevitable that the continent will move towards a more diversified economy through increased knowledgebased activities. What is not at all inevitable is that this process will be as quick and efficient as possible. Failures of both individual technologies and models will pave the path to ultimate success, and mechanisms to leverage learning will be highly desirable. By focusing explicitly on commercialization of domestic African health research, and learning how best to translate this research into commercial products and services, convergence platforms pave a path for African countries towards accelerating social and economic development. As noted by President Kagame, the alternative paths are much less desirable. J Acknowledgments Helpful comments and suggestions were received from Hassan Masum. This study was funded by Genome Canada through the Ontario Genomics Institute and the Canadian Institutes of Health Research through a Michael Smith award to Dr Singer. The McLaughlin-Rotman Centre for Global Health, Program on Life Sciences, Ethics and Policy is also supported by the Bill & Melinda Gates Foundation and other partners listed at www.mrcglobal.org. ASD and PAS are supported by the McLaughlin Centre for Molecular Medicine.

Peter A Singer is Interim Director of the McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, and Professor of Medicine at the University of Toronto.

He is also a fellow of the Royal Society of Canada and the Canadian Academy of Health Sciences, and a member of the Scientific Advisory Board of the Bill & Melinda Gates Foundation Grand Challenges in Global Health initiative. In 2007 he received the Michael Smith Prize, as Canada’s “Health Researcher of the Year” in Population Health and Health Services, from the Canadian Institutes of Health Research.

Abdallah S Daar is a senior scientist at the McLaughlin-Rotman Centre for Global Health, University Health Network and University of Toronto, and Professor of Public Health Sciences

and of Surgery at the University of Toronto. He is a fellow of the Royal Society of Canada, the Canadian Academy of Health Sciences, and of the Academy of Sciences for the Developing World (TWAS). He won the UNESCO Avicenna Prize for Ethics and Science in 2005.

Sara Al-Bader is studying for her Masters/PhD at the Institute of Medical Sciences, University of Toronto. After a BSc in Physics and an MSc in the History and Philosophy of Science from the University of London, Sara worked as a science communicator in several science museums in the UK and US. She then worked in the UK government’s Department of Trade and Industry, promoting the involvement of women in science at all levels. In 2001 Sara joined the policy section at the UK’s Academy of Science, the Royal Society. Her role there was to coordinate and supply scientific advice to policy-makers nationally and internationally, in a range of areas. Sara is part of the commercialization team, researching the state of life sciences commercialization in South Africa and Ghana.

Ronak Shah is a research project coordinator at the McLaughlin-Rotman Centre for Global Health. He joined the group in May 2007 after finishing his Masters in Bioscience enterprise at the University of Cambridge, UK. He did his undergraduate degree in Microbiology from the University of Guelph in Ontario, Canada. His interests lie in product development and translation of life science research to products in low-resource settings.

Ken Simiyu is studying for his PhD at the Institute of Medical Sciences, University of Toronto. He received a Bachelor’s degree in Veterinary Medicine and Masters degrees in Veterinary Public Health and Business Administration from the University of Nairobi, Kenya and completed a Masters in Public Health degree at George Washington University, Washington DC. In Nairobi, He provided marketing research and business development expertise to the Kenyan government, the Kenyan Trypanosomiasis Research Institute and international pharmaceutical companies based in Nairobi. In Washington, he worked with the International Organization for Migration (IOM) as a health policy consultant. His current area of focus is health research commercialization in Africa.

Ryan E Wiley is Managing Director of SHI Consulting. He has successfully worked with industry, governments, academic institutions and nonprofit organizations throughout the Americas and in Asia. In addition to his work with SHI Consulting, He is an adjunct professor in McMaster University’s Faculty of Health Sciences, past Chair of New Leaders of Sunnybrook Foundation, Director of Women’s College Hospital Foundation and founding Co-chair of Newchapter at Women’s College Hospital Foundation.

He holds a PhD in immunology from McMaster University and has published extensively in the areas of asthma/allergy, immunology, pharmacology and gene therapy.

Pamela Kanellis is an analyst with SHI Consulting. She has expertise in the areas of economic development and business planning, working with clients from industry and academia. Most recently, she performed an inventory assessment for the region of

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Waterloo and the province of Prince Edward Island in Canada, providing a foundation for strategy development. Prior to joining SHI Consulting, she earned a PhD in Medical Genetics from the University of Toronto, where she focused her studies in the area of oncology. She also brings her knowledge of high-throughput functional genomics, DNA repair and bacterial genetics. Her work has been published in several top-tier peer reviewed journals.

Menaka Pulandiran graduated from the University of Toronto with a Human Biology Major and with double Minors in Zoology and Classical Civilization. In the past she has worked with an international health organization known as Child Family Health International on their Infectious Diseases programme in Mumbai,

India. She was also involved with the Centre for International Health where she researched cost-effective, community-based health promotion strategies to address the concerning issue of China’s rapidly ageing population. She is a summer student at the McLaughlin-Rotman Centre for Global Health.

Marilyn Heymann is entering her fourth year at the University of Toronto to complete a major in Political Science and Health Studies. She has spent two years working with the University of Toronto’s Center for International Health working on an African AIDS Initiative and also travelled to Cambodia with the Center for International Health. She is a summer student at the McLaughlinRotman Centre for Global Health.

References 1

Masum H et al. Accelerating health product innovation in sub-Saharan Africa. MIT Innovations, 2007, 2:129-149.

2 Burke EM, Francisco A and Matlin S. Monitoring financial flows for health research: behind the global numbers, 2008.

3 Juma C and Yee-Cheong L. Innovation: applying knowledge in development. UK & US: Earthscan, 2005.

4 Assembly of the African Union. Eighth Ordinary Session 29–30 January 2007. Addis Ababa, Ethiopia. Decisions and Declarations.

5 Unleashing entrepreneurship: making business work for the poor. United Nations Development Programme, 2004.

6 Freedom to innovate: biotechnology in Africa’s development. Report of the High-Level African Panel on Modern Biotechnology. Addis Ababa, Ethiopia: African Union and Pretoria, South Africa: New Partnership for Africa’s Development, 2007.

7 Gardner et al. Health Affairs, 2007, 26:1052-1061.

8 Frew et al. India’s health biotech sector at a crossroads. Nature Biotechnology, 2007, 25: 403-417.

9 Frew et al. Chinese health biotech and the billion-patient market. Nature Biotechnology, 2008, 26: 37-53.

10 Frew SE, Kettler HE and Singer PA. The Indian and Chinese health

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biotechnology industries: potential champions of global health? Health Affairs, 2008, 27:1029-1041.

11 Daar AS et al. Top ten biotechnologies for improving health in developing countries. Nature Genetics, 2002, 32:229-232.

12 Thorsteinsdottir et al. Introduction: promoting global health through biotechnology. Nature Biotechnology, 2004, 22:DC3-DC7.

13 Rezie et al. Brazilian health biotech – fostering crosstalk between public and private sectors. Nature Biotechnology, 2008, 26:627-644.

14 Seguin et al. Genomic medicine and developing countries creating a room of their own. Nature Reviews, 2008, 9:487-93.

15 Greenwood L et al. Regenerative medicine: new opportunities for developing countries. International Journal of Biotechnology.

16 Government of Rwanda. National science, technology, scientific research and innovation policy. Conference draft. Kigali, Rwanda, 2005.

17 Cooksey D. A review of UK health research funding. UK Treasury Report, 2006, 97–98, London.

18 African Development Bank. Investing in Africa’s guture – the ADP in the 21st century. High Level Panel Report, 2007.

19 International Finance Corporation. The business of health in Africa: partnering with the private sector to improve people’s lives, 2007.

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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

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Making drugs accessible to poor populations: a funding model Article by Paul L Herrling, Head of Corporate Research, Novartis International, Switzerland

20051, several of which are in early clinical testing. A more recent survey is shown in Figure 1.

Despite the high attrition rate it is to expected that several of these projects will approach full development towards registration with costs of several hundred million US dollars per project. A study by Dalberg, commissioned by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and Novartis2 estimates that US$ 6–10 billion will be needed for that purpose in the next 10 years.

ccording to a recent publication by Mary Moran et al1, public-private partnerships (PPPs) or product development partnerships (PDPs) involving nongovernmental organizations (NGOs), academia and the pharmaceutical/biotech industry have generated a growing early pipeline of new drug therapies for neglected diseases such as malaria, tuberculosis, Dengue and parasitic diseases such as Leishmaniasis, human African trypanosomiasis and Chagas disease. This activity resulted in about 63 projects in

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*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)

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Fund for R&D in neglected diseases Board: strategy, diseases, tools F unders: current & new i.e. BMG F , W T etc. plus governments from Developed countries and D eveloping world ffunds unds P ortfolio management T eam: medical, scientific, technical professionals (fund only to next go/no go decision) projects p roje c ts and l i licenses li t exclusive to neglected disease g

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Figure 2: A funding model for R&D for neglected diseases

In comparison, in the same study the estimated cost of building this early pipeline was around US$ 0.5 billion, allocated by a variety of private and public donors to PDPs. There is no indication that the current donors could generate sufficient funds for full development of the neglected diseases pipeline. There is a danger that a very unfortunate situation will arise where innovative compounds for neglected diseases in the pipeline that show a promising proof of concept in early human studies will stall in further development for lack of funding.

The model proposed (see Figure 2) describes a possible way to address this situation that attempts to take into account the needs of all stakeholders. It has been discussed with several pharmaceutical companies and representatives of NGOs such as MÊdecins Sans Frontières, Oxfam and the World Health Organization, who have all indicated that they had no have fundamental objections and encouraged us to further develop it. The model is complementary to others such as Advanced Marketing Commitments and Prizes and the differences will be discussed.

A model to fund R&D for neglected diseases (Fund for R&D in Neglected Diseases, FRIND). The model (Figure 3) is designed to apply only to disease areas with large medical need but where no commercial returns can be expected and where normal market mechanisms therefore do not apply and where pharmaceutical and biotech companies can only invest very limited R&D funds. Examples are the 10 diseases on the TDR list3.

Funding and governance. The fund can be financed by the current donors to PDPs but in view of the magnitude envisaged governments of both developed and developing

nations will have to contribute. Representatives of the donors would constitute the Board of the fund in which the disease scope, product scope (e.g. medicines/vaccines only, or to include diagnostic methods etc.) and the strategy would be defined. The Board would not be involved directly in the portfolio management within the strategy. The mission of the fund must include the obligation to make available the therapies it funds to poor patients in the developing world for free or at an affordable price, or at least at no profit (if a profit can be made, then the normal market mechanisms will be applicable). FRIND would only finance the R&D component and would need partners/other donors for manufacturing and distribution.

Potential applicants. Any entity, academic, biotech/ pharmaceutical company or PDP with a therapeutic/ diagnostic project fulfilling a medical need for a neglected disease within the scope of FRIND can apply to the fund.

Portfolio management team/scientific advisory board.

The members of the portfolio management team should have the same profile and skills found in large pharmaceutical companiesâ&#x20AC;&#x2122; portfolio decision teams, i.e. scientific-, medical, technical-R&D, regulatory-, economics- experts familiar both with the therapeutic area and the environment in which the new drugs should be applied (field experts).

Prioritization and allocation principles. The portfolio decisions should be made exclusively on scientific, medical, technical and economic criteria excluding political factors as much as possible. To reduce potential waste of resources it is essential to apply a fund allocation rule where having estimated the totality of funds required for the entire development of the product, the portfolio team would then only allocate the funds

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Portfolios are fragmented across players – even in key diseases 1 00% 90% 80% 70%

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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 results would be evaluated and a new decision to continue funding to the next stage or stop would be made.

Overcoming the fragmentation of the neglected disease portfolio. An analysis of the current neglected disease portfolio2 indicates that even within single diseases there are several actors working in parallel and with limited communication between them (Figure 3).

It is expected that the fund under discussion would become the major source of funds for R&D for neglected diseases and one consequence would be that the portfolio management team would eventually see most projects within a disease area which would allow them to compare them, invest in the best ones or combine them.

Intellectual property protection. Intellectual property protection is essential for fostering investments in research for new medicines worldwide and should not be an impediment to access to medicines in the developing world4. In the context of FRIND, intellectual property could be handled as follows: The inventors of the new product to be funded by FRIND (academic institutions, biotech companies, PDPs or pharmaceutical companies) would usually patent their inventions and retain ownership. If any of the entities above apply to FRIND for funding of their project in R or D they in

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return would allocate an exclusive licence to the fund for the particular neglected disease within the mission of FRIND. The inventors would retain the rights for all other applications.

This is important because nature does not distinguish between diseases of the rich and poor. For instance, a compound developed for Dengue fever, a neglected disease of increasing impact, might very well show useful activity in hepatitis C, an indication with commercial blockbuster potential, because both the Dengue virus and the hepatitis C virus (HCV) are genetically close because both belong to the genus Flaviridae. The inventor might very well want to develop the commercial application (HCV) using their own funds to later sell it with profit where a commercial market exists. If, however, the entity marketing such a therapy uses data that has been elaborated in a FRIND funded activity, royalties and/or milestones should be due to the fund to reimburse their expenses for the data generation.

Discussion There are several alternative models in discussion to stimulate R&D in neglected diseases, e.g. Advance Market Commitments (AMC) 5 or Prize mechanisms as proposed by James Love6. The current FRIND proposal overcomes a major drawback of the two models discussed above. Any entity that wants to access either AMC or Prize money needs to invest at

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risk in the full development of its product for neglected disease and as about 7 out of 10 projects in clinical phase one fail before registration all that investment would be lost.

This is a major disincentive not only for pharmaceutical companies but is outright unaffordable for many PDPs, academic institutions or small biotech firms. In addition since many advances in the treatment of disease are incremental, the concept of a â&#x20AC;&#x153;prizeâ&#x20AC;? for the first successful product is inappropriate and might be a disincentive to parallel activities. In contrast the current FRIND model would fund the individual R&D phases upfront and would bear the risk. An additional benefit is that through FRIND a portfolio management approach across different players might be established that allows more optimal allocation of (scarce) donor resources to the most promsing R&D projects.

The model proposed here and AMCs or Prizes are not mutually exclusive but rather complementary to increase the probability of the creation of urgently needed new therapies for neglected diseases. The brief description of the model in this paper is intended to stimulate discussion and to evaluate its acceptance from the main stakeholders and potential donors. It has already received constructive contributions

from NGOs such as MSF, representatives from WHO, Oxfam and other pharmaceutical companies and is currently being presented to national governments. If sufficient support for this concept can be generated a more detailed model will be elaborated in a second phase. J Acknowledgements The author would like to thank Stephanie Meredith, Tido von Schoen-Angerer and Lee Wells for constructive discussions.

Paul L Herrling is Head of Corporate Research at Novartis. He is also Chairman of the Board of the Novartis Institute for Tropical Diseases (NITD) in Singapore, a long-term endeavour to advance medical research in tropical infectious diseases. In addition, he oversees the Friedrich Miescher Institute (FMI) in Basel, Switzerland, the Genomics Institute of the Novartis Research Foundation (GNF) in California, USA and the Novartis Vaccines Institute for Global Health (NVGH) in Siena, Italy.

He is also a Professor of Drug Discovery Science at the University of Basel, Switzerland. In addition to scientific editing activities, he also served on several boards.

References and abbreviations 1.

Moran M. A breakthrough in R&D for neglected diseases: New ways to get the drugs we need. PLoS Medicine 2005, 2:828-831.

2.

Feasibility study for a fund for R&D for neglected diseases. Dalberg Global Development Advisors. Commissioned by IFPMA and Novartis International AG, 2008.

3. http://www.who.int/tdr/diseases/default.htm Abbreviations AMC: advanced market commitments Bill & Melinda Gates Foundation BMGF: D0: drug discovery phase 0, target finding D1: drug discovery phase 1, high throughput assay formatting D2: drug discovery phase 2, high throughput screening, hit finding D3: drug discovery phase 3, lead optimization, medicinal chemistry for small molecules D4: drug discovery phase 4, late preclinical phase DNDi: Drugs for Neglected Diseases Initiative FRIND: Funding Model for R&D in Neglected Diseases GATB: Global Alliance for Tb Drug Development, Tb Alliance GSK: GlaxoSmithKline

4.

Herrling P. Patent sense. Nature, 2007, 449:174-175 (2007). http://www.vaccineamc.org/mechanism.html 6.

Love J. The big idea: prizes to stimulate R&D for new medicines.

Knowledge Ecology International, Tim Hubbard, Wellcome Trust Sanger Institute. Revised March 2007.

5.

HAT: HCV: IFPMA: IOWH: MMV: NGO: R&D: TB: TDR: VL: WT:

human African trypanosomiasis hepatitis virus C International Federation of Pharmaceutical Manufacturers & Associations Institute for One World Health Medicines for Malaria Venture nongovernmental organization research and development tuberculosis WHO special programme for research and training in tropical diseases Visceral Leishmaniasis Wellcome Trust

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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 improve health in high-income countries, its application has been more challenging in developing nations. Low-income settings usually do not offer large financial incentives to drive commercial investment in technology development. In addition, local research, development and manufacturing capacity are often limited in poorer countries.

Program for Appropriate Technology in Health (PATH) is an international, nonprofit organization that creates sustainable, culturally relevant solutions that enable communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, we help advance affordable and culturally appropriate health technologies. PATH’s experience over the past 30 years suggests that one of the best ways to ensure that effective health technologies are developed and made available in developing countries is through public-private partnerships (PPPs). PATH helps to bridge the gap between public health needs and commercial interests. It negotiates solutions that are mutually beneficial for the public and private sectors by guiding technology development towards the priority health needs of poor populations. Acting as an intermediary between industry and the public sector, PATH has successfully advanced and facilitated the commercial introduction of more than 50 new technologies for improving public health in developing countries1.

Globally, most new health technologies come from the research and development efforts of private industry.

Commercial enterprises not only have the expertise and resources to carry a product forwards through the complex and expensive testing and regulatory approval process, but also have strong market-driven incentives to do so.

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PATH helps to bridge the gap between public health needs and commercial interests. It negotiates solutions that are mutually beneficial for the public and private sectors by guiding technology development towards the priority health needs of poor populations

Unfortunately, the drive to pursue projects with the highest potential profit means that private companies usually do not consider developing products tailored to the needs of poor countries because markets in those countries are often unstable and perceived risks diminish projected return on investment.

The public sector, by contrast, often lacks the capability and experience to design, develop, produce and distribute novel technologies on its own. Thus, the challenge for the public sector is to harness the innovation capability of the private sector to produce global public goods. This can be accomplished by shifting market forces enough to attract private sector involvement in developing appropriate, costeffective health care technologies – and then making those technologies broadly available in low-income settings.

To accomplish this task, the public sector must co-invest in necessary and suitable technologies. By underwriting some of the costs of research and development, sharing risk, and supporting the infrastructure to test products in poor countries with high rates of endemic disease, it is possible to leverage commercial interest and investment in technological solutions for otherwise neglected diseases. PPPs are primarily supported by funds from private foundations and governments and, while offering private companies the potential for a reasonable commercial return on their investment in product development, they insist on commitments to supply, pricing and intellectual property rights that help ensure the affordability and accessibility of these innovations.

In addition to these up-front investments to “push” the development of needed technologies, public sector organizations also can help to ensure larger and more 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 products through the strengthening of health delivery systems in poor countries. Growing demand for effective health products, combined with efficient and regular delivery, sends a strong market signal to product innovators.

Currently, a variety of innovative financing mechanisms – such as advanced market commitments – are being piloted

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as pull mechanisms to further incentivize commercial research and development investment in health technologies for poor countries.

Much of PATH’s experience with PPPs has involved work to improve immunization in developing countries, especially in Africa. We have been especially active in forging partnerships to develop new vaccines against malaria and meningitis. This paper summarizes our work related to the Meningitis Vaccine Project as an example of how PPPs can be used effectively to address health issues in low-income settings2.

Case study: reducing the burden of meningitis in Africa

three meningococcal C conjugate vaccines were developed for use in the United Kingdom to control an increased incidence of meningococcal C cases. It is worth noting that the epidemic disease burden in Africa was more than 1000 times higher that that noted in the United Kingdom.

By the 1990s the components to develop a group A meningococcal conjugate vaccine already existed.

Technology was available for conjugating, or chemically linking, the meningitis A polysaccharide to a protein carrier, which makes the vaccine highly immunogenic and effective in young children, provides long-lasting protection, and decreases carriage and transmission rates. Two meningitis A/C conjugate vaccines were tested in clinical trials in Africa, but these projects were dropped by their commercial sponsors. The challenge was to develop a programme that would motivate a vaccine producer to take a risk on a market unable to pay high prices for this vaccine.

In 2000, the World Health Organization (WHO) commissioned an independent assessment of existing intellectual property on conjugation technology and of the costs for product development and production for a group A or group A/C meningococcal conjugate vaccine intended for Africa. The assessment showed that development of an affordable vaccine was feasible. Soon after, the Bill & Melinda Gates Foundation awarded PATH a ten-year grant to establish the Meningitis Vaccine Project (MVP), a partnership between PATH and WHO, to develop, test, license and introduce meningococcal A vaccines for Africa.

One of the first actions of MVP was to convene a consultation with health officials from the African meningitis belt. These early consultations with African leaders and health officials quickly revealed what they wanted in a vaccine. Hassane Adamou, the secretary general for Niger’s Ministry of Health, said: “Please don’t give us a vaccine we can’t afford. That is worse than no vaccine”2. African leaders felt that a vaccine that was priced at US$ 0.50 per dose or

Meningococcal meningitis is a serious and potentially lethal bacterial infection in the membranes that surround the brain and spinal cord. Despite prompt treatment with antibiotics, often difficult in remote areas of Africa, about 10% of affected individuals die, and up to 25% of survivors are left with permanent disabilities, such as deafness or mental retardation3. Sub-Saharan Africa is particularly prone to relatively small annual epidemics of meningococcal meningitis, which expand to catastrophic proportions every 10 to 12 years. Most of these epidemics are caused by a single meningococcal strain, group A. The group A epidemic in 1996–1997 caused more than 280 000 cases and 25 000 deaths4. These meningitis epidemics have plagued Africa for 100 years.

To deal with these recurrent epidemics, countries in Africa’s “meningitis belt”, have relied on a “reactive” strategy that focuses on first detecting outbreaks and then mounting reactive immunization campaigns using meningococcal polysaccharide vaccine. The polysaccharide vaccine is affordable, but it doesn’t work very well. Although it may prevent those carrying the bacterium from getting sick, it does not stop them from passing it on to others. Immunity lasts only a few years, and the vaccine has minimal 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 LLC been interested in committing the resources to develop such a vaccine when the returns have Figure 1: Public-private partnership developed for the Meningitis Vaccine Project, an effort led been at best poorly defined. collaboratively by PATH and the World Health Organization By contrast, during the 1990s,

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less would be affordable and sustainable. MVP began its development work with that goal in mind. Over the course of the project, MVP has been informed by a Project Advisory Group entirely composed of African health leaders, as well as an Expert Advisory Group of leading vaccine and meningococcal research scientists.

The Meningitis Vaccine Project provides an illustrative example through its facilitation of the development of an affordable group A conjugate vaccine for use in Africa’s meningitis belt, including countries such as Mali, Senegal, 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 polysaccharide (one of the two main components of the vaccine); the Serum Institute of India Limited (SIIL) in Pune, India, which agreed to supply tetanus toxoid (the second main component of the vaccine) and to scale-up the manufacturing processes for the final vaccine; and the Center for Biologics Evaluation and Research at the US Food and Drug Administration (FDA) in Bethesda, Maryland, which agreed to transfer a conjugation technology (see Figure 1).

This consortium formed a new model for vaccine development: a key raw material came from one source, the technology from another and the final scale-up for production from another. Moreover, it included a North-to-South transfer of technology and capacity.

PATH first negotiated a nonexclusive licence for the conjugation technology from the US National Institutes of Health Office of Technology Transfer (on behalf of the FDA), which PATH then sublicensed to SIIL. To protect the charitable mission of the project, PATH and SIIL agreed that if SIIL were to cease developing or producing the vaccine, SIIL would transfer to PATH the manufacturing know-how developed during their collaboration to enable another manufacturer to make the vaccine. In addition, the PATH-SIIL agreement set out an explicit initial pricing of US$ 0.40 per dose for sales to the public sector in Africa, with SIIL having the freedom to sell the vaccine in the private sector at higher prices. PATH’s agreement with SIIL also includes explicit procedures and remedies should SIIL not meet public sector demand or charge the public sector more for the vaccine than the maximum agreed-upon price.

The pivotal phase II trial of the Meningitis A conjugate vaccine, which included 600 healthy toddlers aged 12–23 months in Mali and The Gambia, showed that the conjugate vaccine produced antibody titers almost 20-fold higher than the current polysaccharide vaccine5. Phase II and II/III clinical trials of MVP’s Meningitis A vaccine candidate are currently under way in Mali, The Gambia, Senegal and India. Barring any delays, the vaccine will be introduced at public health scale in Burkina Faso in late 2009, with other countries to follow.

Key factors driving partnership development It is important to recognize that unique circumstances inform the design of each partnership between the public and private sector. Different degrees of scientific uncertainty, technical risks and relative co-investment to meet capital requirements determine what conditions can be negotiated regarding supply, pricing and intellectual property rights. What key

factors enabled successful creation of this PPP for developing a new meningitis vaccine for Africa?

First, the scientific base required to make a conjugate Meningitis A vaccine was reasonably well known. The independent assessment commissioned by WHO in 2000 established that it was feasible to develop an affordable Meningitis A conjugate vaccine, indicating that the risks of innovation were manageable.

Second, the geographic market and likely financing for the product was clear because the vaccine was targeted for subSaharan Africa’s meningitis belt. Through the Project Advisory Group, African public health officials in the affected nations indicated that sustained use of this vaccine was possible.

Controlling meningitis epidemics in the belt was a major public health priority, and if the vaccine was priced at less than $US 0.50 per dose, leaders indicated that they could likely purchase the vaccine within the donor consortia that are the basis for much of the existing vaccine purchasing in these countries.

Third, the intellectual property ownership was relatively straightforward and the cost of the ingredients and conjugation method were known with reasonable certainty, and were inexpensive. SIIL already manufactured the tetanus toxoid protein carrier. SynCo had a well established polysaccharide manufacturing process. The FDA owned the critical intellectual property, which was quickly transferred to SIIL via PATH. Both SynCo and the FDA agreed to participate in technology transfer activities supported by MVP. Fourth, the manageable technical risks, priority of meningitis control in the African region, and secure and straightforward intellectual property landscape justified an approach where the project could underwrite most of the capital costs for product development and, consequently, exert significant leverage in determining the supply and public-sector pricing arrangements.

This set of circumstances led MVP to explore a specific yet strategic approach to PPP development. The manageable technology risk made the meningococcal A vaccine an ideal product for technology transfer to a developing country manufacturer. In addition, the need to keep costs low fit well with the strengths of a developing country manufacturer such as SIIL. Greater uncertainty – whether around the science, the markets or the intellectual property – would pose greater risk for all involved and make it more difficult for the public sector to underwrite such a large proportion of the research and development costs and, thereby, to achieve such firm commitments to specific supply and pricing arrangements.

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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 essential technical expertise and innovation, and public partners can reduce risk through developing unique partnerships, clarifying the market and strengthening delivery systems. For example, WHO played a key role in enhancing surveillance activities, facilitating links with African ministries of health and providing a sound introductory platform for the Meningitis A conjugate vaccine.

A public sector nonprofit organization, such as PATH, can help to successfully bridge gaps between public health needs and commercial interests through public-private partnership.

Developing effective public-private partnerships requires attention to many factors such as the state of the science, the identified market for the product, and the complexity of intellectual property issues.

Effective partnerships must solicit and follow guidance from developing country leaders on a variety of issues such as product presentation, cost, communication and introduction strategies.

Acknowledgments The authors wish to thank PATH staff member John Ballenot for his contributions to this article. The Meningitis Vaccine Project has received funding from the Bill & Melinda Gates Foundation.

Christopher J Elias MD MPH is President and CEO of PATH, an international nonprofit organization dedicated to improving the health of people around the world by advancing technologies, strengthening systems and encouraging health behaviours. PATH works in more than 70 countries in the areas of health technologies, maternal and child health, reproductive health, vaccines and immunization, and emerging and epidemic diseases. Dr Elias was honoured as the Schwab Foundation’s Social Entrepreneur of the Year for the United States in 2005. He received his MD from Creighton University and his MPH from the University of Washington.

Yvette Gerrans MBA, MS, RN is the Strategy and Policy Analyst at PATH, where her work focuses on special initiatives 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 consulting with Deloitte & Touche and she has lived and worked abroad, primarily in East Africa and South-East Asia. She has an MS in public policy and management from Carnegie Mellon University and an MBA from the University of Pittsburgh, as well as a BS in nursing from Duquesne University.

While the MVP partnership model could and should be applied to other new vaccine products where the underlying science and manufacturing costs are well established, it will be less applicable for novel products where the science, product formulation, and manufacturing process development are still to be discovered. Successful PPPs must be designed strategically to match the circumstances of the particular products they are pursuing.

F Marc LaForce MD is the Director of the Meningitis Vaccine Project, which is a partnership between PATH and the World Health Organization aimed at developing, testing, licensing and introducing conjugate meningococcal vaccines in sub-Saharan Africa. During a long and distinguished career in disease prevention, vaccinology and international health, he has also held positions with the US Centers for Disease Control and Prevention, the University of Colorado School of Medicine and the University of Rochester School of Medicine and Dentistry. Dr LaForce earned his MD from the Seton Hall College of Medicine and Dentistry.

Summary Over the past 30 years, PATH’s work has demonstrated the value of public-private partnerships for developing technologies to address health issues in poor populations.

The Meningitis Vaccine Project provides an illustrative example through its facilitation of the development of an affordable group A conjugate vaccine for use in Africa’s meningitis belt, including countries such as Mali, Senegal,

References 1.

Brooke S, Harner-Jay CM, Lasher H, Jacoby E. How public-private partnerships handle intellectual property: the PATH experience. In: Krattiger A, Mahoney RT, Nelson L et al, eds. Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. Oxford, UK: MIHR and Davis, USA: PIPRA, 2007, 1755–1763. Available online at www.ipHandbook.org.

2.

Roberts L. An ill wind, bringing meningitis. Science. 2008, 320:1710–1715.

3.

Oostenbrink R, Maas M, Moons KG, Moll HA. Sequelae after bacterial meningitis in childhood. Scandinavian Journal of Infectious Diseases, 2002, 34:379-82.

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4.

World Health Organization. Enhanced surveillance of epidemic meningococcal meningitis in Africa: a three-year experience. The Weekly Epidemiological Record, 2007, 82:34-40.

5.

Sow S, Okoko B, Preziosi MP et al. A Phase II, observer-blind, randomized study to evaluate the safety and immunogenicity of a new meningococcal group, a conjugate vaccine, in healthy African toddlers residing in the meningitis belt. Presented at: Royal Society of Tropical Medicine and Hygiene Centenary Conference, 14 September 2007, London, UK.

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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 population, are afflicted with neglected tropical diseases1. Between 1984 and 1994 in southern Sudan, 100 000 of a population of 280 000 died from visceral leishmaniasis (VL) during famine and civil war2. Why, then, are such diseases “neglected”? To most people in developed countries, VL, onchocerciasis, schistosomiasis and other illnesses on the World Health Organization’s list of neglected tropical diseases (NTDs)3 are unknown or remote.

Even in developing countries where they are endemic, they often receive little attention from governments.

Sufferers become trapped in a vicious cycle of poverty and disease. Disability and disfigurement caused by NTDs lead to stigma and social isolation, with devastating impact on economic productivity and quality of life. Health care in most developing nations is not free at the point of use and the cost of treatment, when available, pushes patients deeper into debt and destitution.

Mortality rates of many individual NTDs are lower than for some “less neglected” tropical diseases such as malaria, and while the combined burden of disease for NTDs is substantial, the populations affected are usually the poorest, living in remote rural areas, urban slums or conflict zones1.

These factors have long conspired to maintain a low profile of NTDs on national and international agendas, according to WHO Director General Margaret Chan4. Even in the UN’s Millennium Development Goals, which aim to tackle by 2015 some of the most pressing issues relating to global poverty, NTDs are given little direct attention5. Goal 6 is to “Combat HIV/AIDS, malaria and other diseases”.

How can interest in NTDs be raised? What can be done to bridge the inequality in research and development (R&D) funding between diseases affecting rich and poor?

Mahoney and Morel have discussed the evolution of a “global health innovation system”. They identified three types of “health failure” that justify attention to such a system: science failures, market failures and public health failures.

They noted that, to address globally the science and market failures that have resulted in the absence of safe and effective drugs or vaccines against a range of infectious diseases, we need more basic and applied research, which requires not

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only increased funding but also enhanced strategies for developing new products that will be accessible to the poor in developing countries6.

Multinational pharmaceutical companies are often best placed in terms of compound libraries, financial resources and facilities to carry out R&D into NTDs. Indeed several, including GlaxoSmithKline and Novartis, have dedicated NTD research divisions7. However, the traditional patent-based model of financial reward is not conducive to targeting the cash-strapped and unstable markets of developing countries8.

Returns are derived from exclusive intellectual property rights to a drug for a fixed period, after which cheaper “generics” may be produced. To recover the cost of bringing a drug to market and generate profit, companies must charge a relatively high price for the branded product. A 1999 report in the Journal of the American Medical Association found that since 1975, only 13 of 1233 new drugs reaching the market worldwide had been developed for NTDs9.

Now fresh hope for NTD research is emerging from innovative models designed to encourage pharmaceutical companies to target markets that would otherwise be economically unattractive.

Prizes Large cash prizes, offered by governments, charities or WHO, could be used to stimulate research into NTDs. In January 2008, experts in drug development, public health, economics and intellectual property gathered at an international workshop in Maastricht, Netherlands to discuss this possibility10. Such a scheme could potentially bypass patents, or their use to control the manufacturing and sale of new therapies. Prizes could prove particularly beneficial in the area of vaccines, which are disfavoured by the current patenting system as they are used by patients on a one-off or short-term basis. In the USA, this idea has already been proposed in a bill introduced by Senator Bernie Sanders. The Medical Innovation Prize Fund Act of 2007 aims to “decouple the reward for product research development from the price of the product”, reducing treatment costs. An award would be made for every new FDA-registered therapy, depending on its health impact. Government funding would begin at US$ 80 billion per year (tied to GDP), with 4%

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allocated specifically to NTDs11. Precedents for medical prizes include a US$ 1 million award announced by the charity Prize4Life in 2006 for a biomarker to track the progression of amyotrophic lateral sclerosis12. Some concerns about the details of prize schemes remain to be addressed, including the difficulty in gauging in advance an appropriate amount for the reward.

Advance Market Commitments Advance Market Commitments (AMCs) are an alternative specifically targeted towards vaccine development. They guarantee a market to support this long, costly and otherwise risky process, which is normally driven by high predicted return when the product is marketed. 25% of global child deaths result from diseases preventable by vaccination13. The prophylactic nature of vaccine interventions could produce a dramatic health impact, but their introduction to developing countries is often hindered by a lack of infrastructure and guaranteed finance and by uncertain demand among affected populations (problems of penetrance and patient compliance).

The premise of an AMC is that, during the agreement’s specified lifetime, donor governments commit to support a developing country market at a pre-agreed price, sufficient to provide the incentive driving R&D. The recipient country also contributes a determined, affordable proportion and continues to purchase the vaccine at this price after the AMC expires14. Following a consultation by the UK Department for International Development, in February 2007 the UK Treasury announced a commitment of US$ 485 million at the launch of a pilot AMC for vaccines against pneumococcal disease, with further contributions from Italy, Russia, Canada, Norway and the Gates Foundation15. Details of AMCs must still be optimized, in particular how to set pricing levels several years in advance of a product launch and how to ensure that research activity and funding are not distracted from second generation products16. However, then-UK Chancellor Gordon Brown welcomed the initiative for high volume, low cost drug production, which he said will “ensure that the many will not be denied the medical advances available to the few”.

Fast Track Option The Fast Track Option (FTO) is a third scheme designed to promote NTD research. This is a mechanism to raise funds, without public sponsorship, through the auction of a voucher to a pharmaceutical company. Proceeds from the sale are dedicated to R&D for NTDs17. The voucher entitles the bearer to nominate a commercial drug for expedited review by the US Food and Drug Administration (FDA). FTO vouchers can be sold on to another company, or used by the purchaser to

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reduce the timescale of FDA assessment from an average of 18 to perhaps 6 months. Economists estimate that this time saving could be worth more than US$ 300 million for a “blockbuster’ treatment”18, compared with an average cost of US$ 400 million for development of a new chemical entity.

“Thus, a voucher could enable a company to recoup a significant portion of the cost of developing a new drug”, states a report by the International AIDS Vaccine Initiative19.

Enhanced dialogue between a company and the FDA throughout development also increases the early attrition rate for drugs that will never reach the market, allowing resources to be diverted to those most likely to succeed.

FTO vouchers for NTDs were approved by the US congress in September 2007, based on a precedent for success from the Orphan Drug Act of 1983. There is potential to extend the scheme to Europe, now that a legal framework exists within the European Medicines Agency17. Provisions are made to ensure that time savings are made only in the efficiency of the review process for the commercial drug, and no shortcuts are taken in safety or efficacy trials. The scheme is not limited to vaccines, and addresses some of the problems associated with prizes and AMCs, particularly those relating to prediction of markets and health benefits.

However, as the IAVI review points out19, the FTO does not guarantee that the R&D funding will ultimately generate an adequate supply of an affordable new treatment to developing countries.

Conclusion Prizes, AMCs and FTOs represent innovative responses to the current reality that the market fails poor people suffering from economically unattractive diseases. However, it is still too early to assess their effectiveness. To have a real impact on NTDs, these schemes must be implemented together with synergistic efforts by governments and international organizations to create supporting health infrastructures and adequate surveillance and reporting in developing countries.

Pharmaceutical companies can then develop and distribute affordable new NTD therapies to affected populations.

Eradicating NTDs would benefit developing country economies and societies in ways far beyond the implied scope of the “other diseases” mentioned in the Millennium Development Goals. Perhaps in the foreseeable future we will be able to drop the epithet “neglected”. J Arianne Matlin holds a PhD in Biochemistry/Molecular Biology from the University of Cambridge, UK. She has carried out postdoctoral research in Cambridge and at Brandeis University, USA, into the control of eukaryotic gene expression. She currently works in science publishing.

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References 1.

Savioli, L. WHO/CDS/NTD/2006.2. WHO Neglected Tropical Diseaes brochure http://www.who.int/neglected_diseases/ director/en/index.html 2.

Seaman, J., Mercer, A.J. and Sondorp, E. (1996) The epidemic of visceral leishmaniasis in western Upper Nile, southern Sudan: course and impact from 1984 to 1994. Int. J. Epidemiol., 25, 862-871.

3.

WHO Global Plan to combat Neglected Tropical Diseases, 2008-2015.

4. http://www.who.int/dg/speeches/2007/190407_ntds/en/index.html 5.

Boutayeb, A. (2007) Developing countries and neglected diseases: challenges and perspectives. Int. J. Equity Health, 6: 20.

6.

Mahoney, R.T. and Morel, C.M. (2006) A global health innovation system (GHIS). Innovation Strategy Today, 2, 1-12.

7.

Moran, M., Ropars, A.-L., Guzman, J., Diaz, J. And Garrison, C. (2005) The new landscape of neglected disease drug development.

Pharmaceutical R&D Policy Project.

8. http://www.yale.edu/macmillan/igh/index.html 9.

Pecoul, B., Chirac, P., Trouiller, P. and Pinel, J. (1999) Access to essential drugs in poor countries: a lost battle? JAMA, 281, 361-367.

10.

Travis, J. (2008) Prizes eyed to spur medical inovation. Science, 319,

713. http://www.keionline.org/index.php?option=com_content&task= view&id=150 12. http://www.prize4life.com/page/about_us 13.

Affolder, R., Rizzo, I., Burgess, C., Bchir, A. and Lob-Levyt, J. (2007) A prescription for drug delivery. Nature, 449, 170-172.

14.

Hollis, A. (2007) Prize, Advance Market Commitments and pharmaceuticals for developing countries. New ICTSD series on new opportunities through innovation fostering R&D and promoting access to medicines.

15. http://www.hm-treasury.gov.uk/newsroom_and_speeches/ press/2007/press_18_07.cfm 16. http://www.dfid.gov.uk/Pubs/files/amc-consultation-report.pdf 17. http://www.who.int/intellectualproperty/submissions/Mary.Moran2.pdf 18.

DiMasi, J., Hansen, R. and Grabowski, J. (2003) The price of innovation: new estimated of drug development costs. J. Health Econ., 22, 151-185.

19. https://www.iavi.org/file.cfm?fid=47963 11.

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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 United States involving entrepreneurs, academic institutions, venture capital investors and corporate partners have created successful start-up businesses that deliver science-based functional food products to the US market in a speedy, capital-efficient manner. These companies and their products provide preventive wellness solutions to personal and public health concerns including weight management and obesity, cardiovascular health, immune system and digestive health, and sleep and stress discomforts. Each of these areas has a large and wellestablished US market for costly prescription drugs to treat related ailments and chronic diseases; these food-based solutions are intended to offer an alternative approach to keeping people healthy.

Concurrently, advances in progressive entrepreneurial and investment models in developing countries such as India, Pakistan and Africa are receiving increased attention and capital. A broad range of nongovernmental stakeholders including foundations, private investors, entrepreneurial intermediaries and multinational corporations are beginning to pursue product-driven, market-based solutions to pressing health issues related to nutrition, hygiene and disease prevention.

Both efforts flourish when diverse stakeholders with complementary capabilities and resources collaborate to form a common vision and embrace an open innovation ecosystem model for venture formation and implementation. The multinational corporation is a key actor and stakeholder common to both endeavours, and as such is in a unique position to provide initiative, capital and business resources necessary to catalyze and accelerate global health innovation.

A

Brand new brands: case study of a collaborative innovation model In April 2004 my partners and I organized a venture-capital backed incubator called Brand New Brands (BNB) to create next generation functional food products and launch them as new platform companies in the United States healthy foods market. Our team developed a rapid and cost-effective innovation process that linked academic-based scientific research about novel food ingredients (with accompanying

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clinical research and patents) to unmet health needs of an ageing baby boomer population.

We began by researching six major health issues affecting large populations that could be addressed through nutrition: heart health, weight management, cognitive development, bone health, sleep and stress and immune system health.

Simultaneously, we identified and inventoried the latest science-based ingredient technologies at leading academic institutions. Our creative team then generated 75 new product concepts that delivered the most scientifically credible active ingredients in convenient and attractive food forms. These preliminary product ideas, illustrated only as a name, product description and a drawing of a package were tested on early-adopter “healthy-food” consumers for their conceptual appeal using an Internet-based market research tool. The market for the products was defined as “The Worried-Well” – educated consumers with discretionary financial resources who cared about, and believed in preventive health practices.

We then sourced samples of the appropriate food ingredients and began discussions with university tech transfer and licensing offices about proprietary use. The 12 most promising concepts (as determined by the research) were developed into prototype products on the bench at Mattson and Associates, a leading culinary design firm. The chefs and food technologists at Mattson were able to assess which novel ingredients could be practically incorporated into product forms that were great tasting, convenient and affordable while delivering efficacious amounts of the active ingredients (as determined by existing clinical studies). The group of 12 prototypes was culled to seven that had a strong chance of becoming high-growth business platforms. During the ensuing months, entrepreneurial teams of experienced business leaders, food developers and marketing experts were recruited to evolve the prototypes into commercial products and brand-driven businesses and launch them in the market.

The expectation of the entrepreneurs and investors was that these new ventures could grow quickly (four years or less from launch) and cost-efficiently (spending a fraction of what large companies do) in the market, attract loyal customers and achieve a substantive sales velocity that would be indicative of future scale and potential to become leading

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Brand New Brands’ products and companies were developed ntermedia for a fast growing US market re ispecifically Social ventu ry 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

Venture investors

Entrepreneurial leadership

Academic research centres

Corporate investors

Figure 1: Venture ecosystem for a US based business incubator designed to launch new functional food brands

brands – US$ 50 million or greater in sales. At that point, the BNB businesses could be sold to larger food companies looking for opportunities to extend and expand their business into high-growth healthy food segments.

Brand New Brands was financed by a consortium of lifescience and consumer-focused venture capital funds and the venture capital group of a multinational corporation. With US$ 6 million in capital and in less than 24 months, the BNB incubator launched four new businesses, complete with their own dedicated entrepreneurial teams and product lines.1 The incubator was able to attract the capital of these investors because of the potential to achieve sizeable financial returns as established by a pattern of high-value acquisitions by large food companies of emerging healthy food brands during the prior decade2.

The collaboration of the cohort exemplified the potential for diverse partners to contribute effectively to a creative innovation effort. Experienced food entrepreneurs with links to leading academic researchers, backed by venture capital investors (several of whom had strong relationships with research institutions and ingredient manufacturers) were able to generate significant competitive advantage in terms of product innovation and speed to market over traditional large food companies. The BNB incubator was enhanced by the active participation of Unilever, one of the world’s leading food and personal care companies, which not only contributed capital through its venture capital group, but also made several executives readily available to BNB’s entrepreneurial leadership on an ongoing basis. These scientific and business resources provided insights and assistance about ingredient technologies, competition, markets and supply chain considerations. Additionally, Unilever dedicated a senior business executive with expertise in brand management, business development and M&A to assist the companies as a board observer after they were spun-out from the incubator. (It is worth noting that Unilever invested its capital on the same terms as the venture capital investors without any preferential rights to acquire or control

the BNB businesses. The intellectual capital of Unilever’s executives was offered as part of their “value-add” and was a natural extension of the company’s recent commitment to an “open innovation”3 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 into the company’s core efforts.

Brand New Brands’ products and companies were developed specifically for a fast growing US market 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. However, the principles of using rapid innovation processes with a consortium of partners who share a common vision about value creation could be implemented to address global health issues in developing markets.

The venturing ecosystem Brand New Brands was a carefully designed enterprise where all of the stakeholders – entrepreneurs, investors, corporate and academic collaborators – had aligned interests and incentives and shared a commitment to a core purpose.

These guiding principles were memorialized in a “constitution” by the stakeholders4. An incubator model was chosen, despite a history of mixed success, because of its appropriateness for rapid screening of manifold opportunities and the need for swift product commercialization. The US was identified as the focal market for many reasons: the experiences of the leadership team, growth dynamics of the consumer market, existence of an established distribution system, the availability of venture capital financing and the precedence of successful financial exits.

BNB’s incubator model had several unique structural attributes. It was not owned or controlled by any one party, and as such it functioned independently under motivated entrepreneurial leadership. This is distinct from corporate and academic incubators that often have flat institutional compensation structures and cultures that are burdened by the bureaucratic nature of large organizations. All of the entrepreneurs involved in BNB received meaningful equity incentives and were motivated by success in the marketplace. As such BNB was able to develop a distinct culture as a rapid-learning organization where entrepreneurs cooperated and competed in a resource- and timeconstrained environment.

It was also agreed that all of the new products should be

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At Unilever, the company manages a diversified portfolio of investments in a global cadre of leading venture capital and private equity funds

able to be made by contract manufactured by established food co-packers. This would also enable speed to market and avoid costly investment in facilities and equipment. Another innovative design feature was that BNB had a formal â&#x20AC;&#x153;enddateâ&#x20AC;? and fixed budget when it would cease inventing and incubating ideas. This forced the teams to make decisions within a constrained timeframe and push their ideas to market. This structure reinforced a sharp focus on product innovation and market success. Open-ended incubators attract talented product development resources but can lack an orientation to take the innovations to market.

Expanding the collaborative cohort to create a global venturing ecosystem Subsequent to the launch of four new functional food companies, the BNB team had been approached by several multinational companies seeking to explore ways to stimulate innovation and entrepreneurial models that address unmet needs in developing country populations, particularly in the areas of nutrition, hydration and hygiene. This has inspired us to think about how we could leverage our venture ecosystem model to spur innovation in developing markets.

By expanding the stakeholder base in the cohort to include entrepreneurs, intermediaries and investors working in developing markets, the team at BNB, with its global academic partners, could simultaneously evaluate ingredient

and food delivery technologies that had market potential in other parts of the world. This would be a simple and costeffective way to leverage the scouting level efforts that were undertaken as part of the basic incubator model but would require local market expertise and additional scientific and medical expertise.

Similarly, we could look to identify opportunities to transfer technologies and fully developed products through licences to existing entrepreneurial teams or companies on the ground in developing countries. With the appropriate financing and distribution partners, these teams could launch new businesses intent on rapid distribution of appropriate products into underserved markets. This venture ecosystem might benefit from participation by foundations or other funders intent on financing or underwriting costs that would make products immediately affordable and accessible to the poor, while also providing necessary educational and technical support for market development.

Leadership roles for the multinational corporation and social venture intermediary While the overall effort is best orchestrated by experienced entrepreneurial leadership, a key partner in a global health innovation ecosystem is likely to be a multinational corporation that has relevant product and domain experience, local market and distribution expertise, a proclivity for strategic venturing and growth strategy that embraces open innovation. In the past several years a number of Fortune 50 companies have announced strategic commitments to developing markets and are beginning to consider ways of replicating or adapting venturing models and best practices developed through US and Europe

Global venture investors

Venture investor

re intermedia Social ventu ry US entrepreneurial leadership

Academic partner

Social venture intermedia

Local entrepreneurial leadership

Corporate partner

Foundation

Figure 2: Expanded venture ecosystem linking US incubator to local developing country effort for global health innovation

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experiences. A committed multinational corporation can provide myriad resources while helping to mitigate risks for all members of the cohort.

The first valuable resource is risk capital that may be committed as part of a larger portfolio of strategic venturing activities. At Unilever, the company manages a diversified portfolio of investments in a global cadre of leading venture capital and private equity funds. The scope and activities of these funds match Unilever’s strategic interests and geographic focus. With the appropriate co-investors, limited partners and fund managers, a corporate investor might join an investment fund focused on starting and growing businesses in relevant developing markets. One related example is Acumen Fundi, a non-profit global investment vehicle that converts philanthropic contributions into investment capital to deploy in market-based innovations to solve the problems of poverty.

The multinational corporation can also contribute valuable market research and insight, and executive talent that can inform strategy. In some cases, the corporate partner may be in a position to structure distribution relationships or jointventure partnership that could accelerate access or success of a new venture in market. (There are some positive precedents for this approach between large corporations and entrepreneurial start-ups in the US food sector.)

A successful global venturing ecosystem may also need a social intermediary partner to bridge the innovation ecosystem from the developed world to the developing world. International intermediaries that support entrepreneurship in developing countries such as Endeavor and Volans Ventures2 might be ideal partners to steward the creation of a linked and parallel venturing ecosystem. These groups are set up to help for-profit and socially focuesed entrepreneurs scale innovations to enhance overall impact.

By taking a comprehensive design approach to an issue like

micro-nutrition, hygiene or disease prevention, a social venture intermediary might be in the best position to identify and align the interests of appropriate entrepreneurial, financial and corporate stakeholders for a successful global venturing ecosystem.

Key messages

A venturing ecosystem can flourish when a diverse stakeholder cohort shares a common vision and commits to an open innovation model for new business creation. This approach seems well suited for transferring health product innovations related to nutrition, hygiene and clean water from the US to developing markets.

Best practices developed and proven in the US could be linked and leveraged through partnerships with multinational corporations and social venture intermediaries to extend a venturing ecosystem from developed countries into developing markets.

A successful multistakeholder open innovation effort requires entrepreneurial leadership, creativity, and a shared design ethic intent on aligning the interests, incentives and outcomes for all stakeholders in the venturing ecosystem.

William Rosenzweig is Managing Director of Physic Ventures, a venture capital firm based in San Francisco that invests in keeping people healthy. He was a founder and CEO of Brand New Brands, CEO and Minister of Progress for The Republic of Tea and co-author of the best-selling book The republic of tea: how an idea becomes a business. Since 1999 he has been a faculty member at the Haas School of Business at UC Berkeley, 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 companies and their products. See www.lightfullfoods.com; www.corozonasfoods.com; www.attunefoods.com; and www.dreamerz.com 2.

Phil Howard, assistant professor at Michigan State University in the department of Community, Agriculture, Recreation and Resource Studies, has written extensively about the rapidly evolving industry structure of the organic foods sector. He has produced a series of intriguing diagrams that illustrate a web of relationships connecting entrepreneurial enterprises with multinational corporations. His papers and illustrations are available at http://www.msu.edu/%7Ehowardp/. See Figure 3.

3.

“Open innovation” describes a new paradigm for the management of industrial innovation in the 21st century, in which firms work with external partners to both commercialize their internal innovations and to obtain a source of external innovations that can be commercialized. The term was coined by Henry Chesbrough, based on his research on the innovation practices of large multinational companies. www.openinnovation.net 4.

Brand New Brands: core purpose and values statement Core purpose We aspire to improve and enhance the lives of adults and children by introducing the next generation of foods designed specifically to promote health and support the prevention of disease.

Approach Brand New Brands uses a portfolio-based incubator model to develop and market the highest potential new functional food business opportunities for the US marketplace. Core to our approach is the commitment to create food and beverage products that are efficacious (by medical standards) honest and transparent in their claims, and satisfying to eat or drink. By vetting and assessing the potential of scores of new product concepts, we take the most promising opportunities and fuse them with talented, passionate and proven entrepreneurial teams who turn ideas into thriving new ventures.

We focus our efforts and resources by innovating “category-creating” brand platforms that are capable of crossing over from niche markets to the mainstream in three to five years. We only pursue opportunities where we can claim distinct competitive advantages over large food companies through IP, brand creation or non-traditional distribution. Our strategy is to take the most promising new nutritional technologies and deliver them to the marketplace through great-tasting products with engaging “lifestyle” brands that educate and attract loyal customers and progressive retail partners. We take opportunities to market that are likely to scale quickly due to the convergence of scientific advances, consumer readiness and media attention.

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References continued ocial venture intermedia

We define success by 1) thrilling our customers while serving their health needs and, 2) creating and capturing value by rapidly growing high performance businesses that offer long-term potential to strategic buyers.

S ry benefits. Brands exude creativity and charisma. We guarantee the safety and integrity of everything we do and are forthright and accurate in our claims.

Core values Impact and Innovation – our products delight our customers and fulfill the unmet health needs of large and expanding populations.

Entrepreneurial leadership – we are highly resourceful and strive for leverage, scale and speed to market. We pursue ambitious visions creatively, with rigorous execution.

High performance teams – we foster a communicative, coordinated and collaborative “green light” culture that values initiative, personal responsibility and mutual respect.

5.

Acumen Fund is a non-profit global venture fund that uses entrepreneurial approaches to solve the problems of global poverty. We seek to prove that small amounts of philanthropic capital, combined with large doses of business acumen, can build thriving enterprises that serve vast numbers of the poor. Our investments focus on delivering affordable, critical goods and services – like health, water, housing and energy – through innovative, market-oriented approaches. www.acumenfund.org www.endeavor.org and www.volans.org are global venture development intermediaries which provide capital and technical assistance to help forprofit and socially oriented entrepreneurs leverage their impact.

Ownership – we initiate and act with the passion, commitment and accountability of owners. We strive to create value for all of our stakeholders by creating valuable, profitable new businesses.

6.

Product excellence – Brand New Brands develops breakthrough products of the highest quality, taste, convenience and efficacy. Product platforms are backed by scientific rigour, intellectual property and tangible health

Organic Industry Structure : Acquisitions by the Top 30 Food Processors in North America

Green & Black's

Seeds of Change

2002, 5% Equity May 2005, 100% Equity

M&M Mars

Cadbury Schweppes

ConAgra

Alexia Foods

#1 0

Frutti di Bosco

Millina's Finest

#1

October 2001

September 2003

White Wave/Silk

Earth's Best

May 2002 $189 M

Alta Dena

Mountain Sun

ShariAnn's

MaraNatha

SunSpire

Westbrae

#7

Bearitos Horizon April 1999

June 2007 From Dean

Dean

May 1999

July 1998 13% Equity January 2004 100% Equity $216 M

Heinz June 2003

March 2008

TofuTown

Westsoy

Little Bear

October 1997 $23.5 M March 2008

SunSpire

December 1998

DeBole's April 1998 $80 M

Hain Celestial #85

April 1999 $80 M

March 2000 $390 M

December 2002

Celestial Seasonings

Coca-Cola #1 5

Pepsi #3

October 2006

Dagoba Phil Howard, Assistant Professor Dept. of Community , Agriculture, Recreation and Resource Studies Michigan State University

February 2008 40% Equity $43M

Honest Tea

Figure 3: Organic industry structure

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October 2001 $181 M

Odwalla

November 2006

Naked Juice

Cascadian Farm March 1998

Muir Glen

Breadshop

Rich Products Corp.

January 2007

May 2002

Garden of Eatin' Arrowhead Mills

Cargill #18

August 2003

Hershey Foods #23

Spectrum Organics

August 2005 $33 M

September 1999 $100 M 19.5% Equity; December 2005 0% Equity

December 1999

French Meadow

Nile Spice

#27

MaraNatha

The Organic Cow of Vermont

Larabar

September 1999 From Heinz

Walnut Acres

Kraf t Back to Nature

#6

June 2008

June 2001

February 2000

General Mills

July 2007

#9

#1 6

Boca Foods

Jul y 2008

Lightlife July 2000

1997

Health Valley Casbah

Imagine/Rice Dream/Soy Dream

Bear Naked

Food Processors#

Kellogg #1 2

November 2007 $122 M

Wholesome & Hearty Kashi

June 2000

November 1999 $307 M

Morningstar Farms/Natural Touch

Organic Brand Acquistions Strategic Alliances # Numbers refer to rank in North American food sales according to Food Processing, August, 2007

Social venture intermediary

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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 has more than it possibly needs, it is painful to envision that most of the world does not have nearly enough to survive. It is widely accepted that proper nutrition is the backbone for overall health. However, obtaining food for survival far outweighs obtaining optimal nutrition in countries where the economic reality is harsh. In fact, in an unstable financial atmosphere, making sound and affordable nutritional decisions is a luxury many cannot afford.

Therefore, it is no surprise that under- and over-nutrition, along with diet-related chronic disease, account for more than half of the worldwide disease burden1. Under-nutrition is defined as a diet that does not provide adequate calories and/or micronutrients for growth and maintenance, whereas over-nutrition is defined by a diet that includes too many calories. More than one third of child deaths worldwide are attributed to under-nutrition2. In poorer nations, undernutrition affects one out of four preschool-aged children, and, among pregnant women, leads to one out of six infants born with low birth weight. Micronutrient deficiencies affect 2 billion people worldwide and contribute to infections, birth defects and impaired physical and mental development.

Stunting, a key indicator of chronic malnutrition, affects about 178 million children globally3.

Increases in chronic diseases, such as cardiovascular disease, certain cancers and diabetes, are directly linked to the increasing prevalence of obesity caused by poor diet and a sedentary lifestyle1. Two out of three overweight and obese people now live in emerging and transitional markets. The outwardly visible signs of obesity are often misleading and can cause individuals to search for a “quick fix” to the most visible symptoms of over-nutrition. Beneath the surface of this epidemic are malnourished overweight and obese populations who suffer from substantial micronutrient deficiencies.

The world nutrition crisis has reached a level of such magnitude that to not explicitly focus on it would be unconscionable. With a challenge so significant, how can the private sector, and specifically the food industry, share its business resources and expertise? Can the industry’s insight into consumer behaviour in developed countries unlock new approaches to escalating problems for consumers in emerging

I

economies? How will the private and public sectors build mutual trust, so that programmes can be created to provide measurable results for those most in need?

Building trust and creating partnerships between the public and private sectors Creating trust and building relationships is at the heart of good business. Industry, government, non-government organizations, and academia each provide unique expertise. Working together to harness knowledge from all angles can provide the highest possible rate of success. Distrust regarding both intentions and capabilities present roadblocks that must be addressed.

Partnerships built on a foundation of trust, shared values and common aspirations seem to be the most productive way to reach realistic, measurable goals. In fact, as Rosabeth Kanter Moss of the Harvard Business Review4 notes, “When giants transform themselves from impersonal machines into human communities, they gain the ability to transform the world around them in very positive ways… Values turn out to be the key ingredient in the most vibrant and successful multinational (corporations). I refer … to the serious nurturing of values in hearts and minds.”

At PepsiCo*, for instance, our company’s value system emphasizes that we should seek to combine financial performance with the explicit purpose of addressing complex social problems… performance with purpose5. In fact, we have developed a comprehensive agenda of sustainability with respect to nurturing internal talent, protecting natural environmental resources, and nourishing individuals with healthful products through human nutrition.

Partnerships that have the greatest chance of succeeding will be those that are formed with a strong understanding of the practical challenges to be overcome in the communities they hope to help. Business practices, cultural nuances and the presence or absence of distribution systems and infrastructure * Given the prominence of the Pepsi brand in our corporate name, we recognize the perception that soft drinks are at the heart of our business.

However, soft drinks account for only 15% of our revenue. We are constantly working to reformulate and develop new healthier offerings for our consumers. The evolution of our portfolio into nutritionally sound products demonstrates commitment to our values.

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affect the daily reality of bringing products and solutions to individuals. Even with excellent global policy, translation into the language of local needs is necessary. Through dialogue regarding capabilities and shared values, public-private partnerships have the potential to effectively deal with these issues.

The compelling role of the private sector There is a compelling role for the private sector, and specifically the food industry, to continue to play in addressing the global nutrition crisis. PepsiCo has a comprehensive approach to engaging individuals and organizations from a variety of disciplines, with success even in these early stages. The greatest asset that PepsiCo brings to bear in these relationships and efforts is our drive to perform with purpose.

PepsiCo’s goal is to put nutritionally sound products within the reach of every consumer. We do this through a uniquely acquired understanding of, and adaptation to, consumer needs. We have experience in building the infrastructure to deliver products and solutions where they are needed, as well as in maximizing benefits related to cost, scale, distribution and agriculture.

The public sector brings particular strength in identifying global and national priorities based on broad health needs, abilities and the mandate to development norms and standards to guide how products should be developed and marketed. Together, the public and private sectors must collaborate to co-author the “playbook” or strategic action plan.

Governments recently recognized this when they endorsed the Global Strategy on Diet and Physical Activity at the May 2008 World Health Assembly. Only if both parties write the action plan will the unique capabilities of each be maximized.

Our commitment The world’s leading food and beverage companies believe it is our responsibility to provide affordable, accessible and nutritionally sound food and beverages to our consumers in developing countries. Evidence of this commitment was recently contained in an unprecedented approach taken by leading food companies. On 13 May 2008, the CEOs from seven multinational food and non-alcoholic beverage companies (Kellogg Company, Kraft Foods Inc, Mars Incorporated, Nestlé SA, PepsiCo Inc, The Coca-Cola Company and Unilever) signed a Global Commitment to Action in support of implementing the World Health Organization’s Strategy on Diet, Physical Activity and Health. Set forth originally in 2004, the WHO Strategy acknowledges that an effort to help people improve their health and nutrition requires actions by all stakeholders, including the private sector.

Through this coalition, five key global commitments will be carried out over the next five years.

Innovate product composition and availability to provide healthier product options that address both excess and deficient consumption of specific nutrients and calories.

Clearly, micronutrient deficiencies are a pressing need in developing nations and could be addressed in part through functional foods.

Provide clear nutrition information to consumers, including

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consumers in regions where nutrition information is not required.

Globalize individual company and regional measures to ensure responsible marketing and advertising of foods and non-alcoholic beverages to children, bringing increasing proportions of the industry into the fold.

Target individual company communications and forge public-private partnerships to cultivate awareness and adoption of healthier lifestyles worldwide.

Commit our time, expertise and resources to support public-private partnerships to accomplish the objectives of the WHO Strategy.

This global, coordinated, private sector commitment comes at the halfway mark of the United Nations Millennium Development Goals’ (MDGs’) target of 2015. While extensive global effort has been targeted to MDG 1 (eradicating extreme poverty and hunger), the specific roles of private and public sector partnerships in supporting this has been missing.

In those countries where progress on the MDG 1 goals is waning, therefore, PepsiCo is developing a more orchestrated approach to its core business capabilities in consumer fundamentals, health policy, nutrition, product and food production research and development, distribution systems and marketing.

One specific effort is to develop affordable and nutritious products for mothers and families at the base of the economic pyramid in India, Nigeria and South Africa. The level of iron and zinc deficiencies and stunting in these populations is staggering; health professionals agree that such deficiencies lead to a multitude of lifelong physical and intellectual problems that undermine national competitiveness. PepsiCo is partnering with both governments and leading academic researchers in these three countries, as well as with key NGOs, such as the Global Alliance for Improved Nutrition. Consistent with our sustainability agenda, we are giving a great deal of attention to crafting sustainable business models to offer affordable, nutritious foods and beverages to consumers in these areas.

The PepsiCo Foundation has a proven track record of supporting successful community interventions on a local level. For example, in collaboration with the Centers for Disease Control and Prevention and The Friedman School of Nutrition Science and Policy at Tufts University, PepsiCo Foundation co-funded Shape Up Somerville, a three-year, groundbreaking intervention designed to help prevent obesity in high-risk, elementary school children using environmental changes in the community, in schools and at home that affect behaviour6. Citywide policy changes were made that directly affected the behaviours of children and their families. Tufts is currently working to scale-up the initial success of Shape Up Somerville. Internationally, the PepsiCo Foundation has started to fund four major community-based interventions in Mexico, India, China and the UK. Initial baseline results are expected within six months, but already the investment has led to enhanced local capacity-building research and advocacy skills required to tackle chronic diseases.

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Nutrition science: the missing elements required for sustained progress

who have too much to those who have too little.

This type of approach to breaking down the larger problem into deliberately simple concepts not only would address the over-nutrition crisis in developed countries, but also offer direct and measurable results to those in an under-nutrition crisis.

As this concept moves from idea to reality, we have the opportunity to bring together the current network of social entrepreneurs who are dedicated to solving problems at the local level.

PepsiCo itself and many other food companies are stepping up their investments in research so that future food products will increasingly address epidemiologically determined nutrition needs. These needs range from macro- and micronutrients so desperately needed if we are to reduce the levels of acute and chronic under-nutrition. We bring more than technical knowledge about the nutrient needs and possible solutions – we also bring a deep understanding of how to ensure that we meet consumers’ sensory needs and desires in a fun way. A problem we face – and one that bests the public sector as well – is that nutritional science in many developing countries remains trapped in a 20th century paradigm of what is possible. We need to learn from other sectors about how best to stimulate innovation. Further, we need to work together to invest in building the much-needed capacity in nutrition science that is critical/essential for the public and private sectors in emerging markets.

The recent review of governance in nutrition, part of the landmark Lancet series on nutrition, highlighted how most research in nutrition globally focused on overweight and obesity; and even the work on under-nutrition and micronutrients was dominated by researchers from a handful of developed countries. The Global Forum is to be commended for having played a key role in facilitating the development of pharmaceutical research capacity development in many developing countries. Now is the time to do the same for nutrition science. PepsiCo and leading food companies are ready to join forces in such efforts.

Key messages

It is paramount to the success of impacting the global nutrition crisis that we create a platform of trust between the public and private sectors through acknowledgment of our common values and shared goals, especially those that transcend cultural, regional or socioeconomic differences.

It is the responsibility of the private sector to develop innovative strategies that utilize and share business know-how with partners in the government, academic, research and non-governmental arenas.

The same comprehensive performance with purpose approach that is employed to reach corporate goals must be applied to the urgent purpose of alleviating the global nutrition crisis.

It is our in-depth knowledge of the individual consumer that puts us in a unique position to solve problems in practical ways. As a food industry leader, we can reach individuals in communities, bringing the promise of global nutrition policy into the daily lives of those who need it most.

Invest together in nutrition science.

The future: redistributing caloric wealth The global nutrition crisis magnifies the chasm between the “haves” and the “have-nots”. Economic disparity is closely associated with nutritional disparities. To close these gaps, the 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 private sectors must discard traditional thinking and invent programmes that transfer business know-how to and from emerging and developed countries.

We believe turning caloric wealth into social currency through a unique collaboration with micro-lending institutions could be just such an innovative programme. Although currently in the embryonic stage, it is our hope to fine-tune an innovative transfer of resources – a “social will” – from those

Dondeena Bradley PhD is Vice President of Nutrition at PepsiCo and therefore responsible for delivering global nutrition science strategies and education platforms for its principal businesses. She was previously Director of Strategic Marketing at McNeil Nutritionals, accountable for development of new technology platforms and strategic planning of new health platforms. Dr Bradley received a Doctorate of Philosophy in Food Science from The Ohio State University and a Master of Science in Food and Nutrition from Purdue University.

References 1.

2.

3.

4.

World Health Organization. Nutrition for Health and Development Programme. Internet: http://www.who.int/nutrition/en/index.html.

Accessed on 1 August 2008.

Horton, R. Maternal and child undernutrition: an urgent opportunity. The Lancet, 2008, 371:9608, 179-85.

Lawn, JE, Cousens, S & Zupan, J. 4 million neonatal deaths: When?

Where? Why? The Lancet, 2005, 365:9462, 891-900.

Moss, RK. Transforming giants: what kind of company makes it its business to make the world a better place? Harvard Business

5.

6.

7.

Review, 2008.

PepsiCo 2007 Annual Report: Performance With Purpose. Internet: http://media.corporate-ir.net/media_files/irol/78/78265/2007_AR.pdf.

Accessed on 1 August 2008.

Economos, CD et al. A community intervention reduces BMI z-score in children: Shape Up Somerville first year results. Obesity, 15, 2007, 1325-36.

Yamada, T. In search of new ideas for global health. New England Journal of Medicine, 2008, 358, 1324-5.

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Innovating against hunger and undernutrition Article by Josette Sheeran, Executive Director, United Nations World Food Programme

The United Nations World Food Programme reaches more than 90 million people a year with a life-saving food intervention. The vital question we are now asking is whether that intervention is the smartest, most powerful and targeted nutritional intervention possible? That will be the leading edge of our work for the years to come

he numbers of hungry and undernourished in the world today are staggering – one in seven people or 854 million go to bed hungry each night1. And just in the past year alone, the global food crisis has thrown another 100–130 million into the ranks of the urgently hungry, threatening to unravel progress on the Millenium Development Goal of halving the proportion of hungry in the world2, 3). Despite overwhelming advances in medicine, science and technology in the past few decades, every day 25 000 people die from hunger and related causes, 14 000 of them children4. Beyond health indicators, the direct cost of child and maternal under-nutrition in developing countries is an estimated US$ 30 billion per year5. The implications for the future prosperity of developing economies are serious and the need for action is crucial considering one in four children are under weight and 40–60% of children in developing countries suffer from iron-deficiency anaemia, which impairs mental development6.

The United Nations World Food Programme (WFP) – the world’s largest humanitarian organization with the mandate to combat global hunger – is transforming food aid to create a new paradigm for affordable and accessible nutrition for the world’s poor. We call this a shift from being a food aid agency to a food assistance agency. In this, WFP is examining how innovative programmes for providing food and foodassistance can be used to break the cycle of hunger at its root and so be a part of a long-term solution. For example, today half of WFP’s budget is cash, and 80% of this cash is used to purchase food from small low-income farmers in 69 developing nations7. This is a win-win solution which helps to reduce malnutrition and poverty by promoting the livelihoods of local farmers through assured incomes and, consequently, the economic development of local communities.

T

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In Senegal, where iodine-deficiency disorders including goitre are a health concern due to lack of iodized salt, WFP purchases salt for its assistance programmes from 7000 village salt producers and works with the partnering nongovernmental organization (NGO), the Micronutrient Initiative, to provide them with the equipment and technical 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 while providing a sustainable and local health solution.

Today, WFP is launching a set of pilot projects in 18 developing nations (in Africa, Asia and Latin America) to examine how it can better use its large purchasing power in developing countries to support the sustainable development of food security which can ultimately improve the livelihoods, health and well-being of these populations. The programme, which is supported by the Bill and Melinda Gates Foundation and the Howard G Buffett Foundation, is called Purchase for Progress (P4P). It builds on WFP’s decades-long operational experience, its extensive deep-field presence and its strong food procurement background.

WFP has been procuring food locally for decades and spent over US$ 1.2 billion buying food in Africa alone from 2001 to 20077. In 2007, 80% of WFP’s food purchases were made in developing countries, totalling US$ 612 million – 56% of the total quantity purchased was procured in least developed and low-income countries, while 24% was procured in middle-income developing countries. In 2008, food purchases in the developing world are expected to reach nearly US$ 1 billion7. By using innovations in WFP’s local food procurement strategy that will strengthen sustainable local agricultural markets and enhance production, P4P will provide more cash to smallholder and low-income farmers in developing countries, thereby boosting rural livelihoods and ultimately reducing the level of poverty in local populations.

A key element of the programme is outcomes monitoring, measuring the impact on agricultural production, livelihoods, food security, food consumption and coping strategies will be assessed. Integral to P4P is support by partners including national governments, UN agencies, the World Bank, as well as NGOs and research-based institutions. National governments develop the overall strategy for the agricultural

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sector while leading the investment drive to improve agricultural production, marketing and rural infrastructure, while the cash for food procurement comes from donor countries contributing towards WFP’s global operations.

WFP has entered a new paradigm in tackling malnutrition by increasing its efforts and attention on the right types of food it provides to beneficiaries, particularly children. The Lancet series on under-nutrition found that a key to reducing undernutrition is to focus effective interventions on vulnerable groups including children less than 24 months of age9. While fortified blended foods such as Corn Soya Blend (CSB) have long been used in food assistance programmes, their composition has largely remained unchanged for 30 years despite increased knowledge on how to best meet the nutritional needs of young children.

Ready-to-use foods are energy- and nutrient-dense foods that come in the form of spreads or pastes, do not require water, and are designed to meet the specific nutritional needs of children. Ready-to-use therapeutic foods (RUTF) such as Plumpy Nut®, have revolutionized the treatment of severe acute malnutrition among children greater than six months of age by enabling a new type of programming – Community Therapeutic Care (CTC)10. Due to the antibacterial properties of RUTFs, which are based on peanuts or other groundnuts rather than water, children can be more quickly discharged from clinics to complete their nutritional recovery at home, fed by their parents rather than clinic staff. By increasing the number of children who can be treated, reducing exposure to disease and reducing drop-out rates, the CTC approach is far more effective than conventional centre-based care with therapeutic milk11.

While approximately 3.5% of children less than five years of age in developing country populations suffer from severe acute malnutrition, moderate acute malnutrition and chronic malnutrition typically affect about 10–30% of under-fives9.

Both conditions, though less severe than acute malnutrition, significantly increase children’s risk of death9. The conventional approach to treating these conditions is to provide fortified blended foods through supplementary or maternal and child health nutrition programmes. However, concerns about the nutritional adequacy of fortified blended foods for young children (6–24 months) and children with malnutrition have led many in the nutrition community to call for improved food commodities to prevent and treat malnutrition12, 13.

Ready-to-use supplementary foods (RUSFs), used in 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.

Though only one of several potential options to address malnutrition, RUSFs represent a promising nutrition opportunity that could improve the nutritional status, wellbeing and future productivity of children in developing countries. With further research, RUSFs may also have a role in the nutritional rehabilitation of adults, particularly among HIV/AIDS and tuberculosis-affected beneficiaries.

One of the greatest challenges to wide-scale adoption of RUSFs by WFP and other agencies is the increased cost

compared with fortified blended foods. Drawing upon decades of experience helping countries and local industry to produce low-cost micronutrient-fortified blended foods, WFP is moving forwards to innovatively develop locally adapted and produced RUSF at the country level. This is another winwin solution which minimizes purchase costs and also fosters the development and growth of local industry. For example, the WFP Country Office in India, in partnership with local industry and with guidance from food technologists, has developed a micronutrient-fortified spread based on chickpeas which was designed according to currently available knowledge on the nutritional composition of foods required for the prevention and treatment of moderate malnutrition. The product is affordable, acceptable to the population and produced using inputs from Indian agricultural producers. It will ultimately be used within the context of India’s Integrated Child Development Services Programme and, with further development, in WFP’s food assistance response to the Myanmar Cyclone. Encouraged by this success and with the objective of providing affordable, accessible and nutritionally beneficial food, WFP is exploring similar efforts in Ethiopia, Egypt and Liberia.

The future sustainability and success of RUSF in largescale operations requires concurrent research by the scientific and research community – not only on the efficacy of RUSF – but implementation and delivery science research that will provide nutrition programme designers and fieldoperations staff with readily-usable information on the most appropriate delivery modalities, age-groups to target, as well as nutrition education that is needed at the household and community level.

The world has a moral, ethical and economic imperative to develop and support innovations that will end child undernutrition. Organizations involved in the prevention and treatment of malnutrition such as the World Food Programme have an obligation to ensure that people are not only fed, but that they are fed with foods of the right nutritional composition to ensure that they can be healthy and thrive nutritionally. While effective tools now exist for the treatment of severe acute malnutrition where it arises, it is much less expensive to treat child malnutrition before it progresses to the stage where it is life-threatening. In fact, a study from Haiti released this year found that focusing efforts on preventing malnutrition among children of less than two years of age was more effective than treating cases of malnutrition among under-fives where they emerged14.

The world has a moral, ethical and economic imperative to develop and support innovations that will end child under-nutrition. Organizations involved in the prevention and treatment of malnutrition such as the World Food Programme have an obligation to ensure that people are not only fed, but that they are fed with foods of the right nutritional composition to ensure that they can be healthy and thrive nutritionally

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We know today that investing in child nutrition pays longterm dividends that greatly outweigh the short-term costs. A study in Guatemala undertaken over a span of nearly 40 years found that children who had received a nutritious food supplement when they were less than three years old earned more than 46% more as adults than their counterparts who had not received the same supplement15. Furthermore, micronutrient supplementation and fortification both ranked in the top three most cost-effective interventions in the 2008 Copenhagen Consensus16.

At the heart of the World Food Programme’s transformation from a food-aid to a food-assistance agency is the ability to innovatively re-think, develop and implement food and food assistance interventions that can ultimately break the root causes of hunger that afflict millions of poor. In partnership with scientific research, policy and field operations

communities, such global innovations can improve the future livelihoods of generations of children living at risk today. J Josette Sheeran became the eleventh Executive Director of the United Nations World Food Programme in April 2007. As leader of WFP, Ms Sheeran oversees the world’s largest humanitarian agency.

Ms Sheeran comes to the post after serving as Under Secretary for Economic, Energy and Agricultural Affairs at the United States Department of State. She has developed several important US initiatives and aided development of critical multilateral projects to aid reconstruction in Afghanistan, in Pakistan after the 2005 earthquake, and in Lebanon after the 2006 war. In 2006, she was appointed by Secretary-General Annan to the High-level UN Panel on System-wide Coherence in the areas of development, humanitarian assistance and the environment. Ms Sheeran has received numerous awards.

References 1.

Food and Agriculture Organization (FAO), United Nations. State of Food Insecurity in the World, 2006.

2.

World Food Programme (WFP), United Nations. Programme Design and Support Division, 2008a.

3.

World Bank, News and Broadcasts “Food Price Crisis Imperils 100 Million in Poor Countries, Zoellick Says”, 2008.

4.

Food and Agriculture Organization (FAO), United Nations. State of Food Insecurity in the World, 2002.

5.

Food and Agriculture Organization (FAO), United Nations. State of Food Insecurity in the World, 2004 (http://web.worldbank.org/WBSITE/EXTERNAL/NEWS/).

6.

UNICEF and Micronutrient Initiative (MI). Vitamin and Mineral Deficiencies: A global progress report. Micronutrient Initiative, 2004.

7.

World Food Programme (WFP), United Nations. Food Procurement Services, 2008b.

8.

Micronutrient Initiative (MI). 2006–2007 Annual Report, Canada, 2008.

9.

Black RE et al. Maternal and child undernutrition: global and regional

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exposures and health consequences. Lancet, 2008, 371.

Collins S. Changing the way we address severe malnutrition during famine. Lancet, 2001, 358.

11.

Collins S et al. Management of severe acute malnutrition in children.

Lancet, 10, 2006.

12.

Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food and Nutrition Bulletin, 25, 2004.

13.

Lutter CK, Dewey KG. Proposed nutrient composition for fortified complementary foods. Journal of Nutrition, 133, 2003.

14.

Ruel MT et al. Age-based preventive targeting of food assistance and behaviour change and communication for reduction of childhood undernutrition in Haiti: a cluster randomised trial. Lancet, 71, 2008.

15.

Hoddinott J et al. Effect of a nutrition intervention during early childhood on economic productivity in Guatemalan adults. Lancet, 371, 2008.

16.

Copenhagen Consensus, 2008. (http://www.copenhagenconsensus.com).

10.

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Riders for Health: an award-winning social enterprise ensuring health care delivery across Africa Article by Ngwarati Mashonga, Acting Operations Director, Riders for Health

“I’d stand by and watch children die of treatable diseases because there was no means of getting them to treatment or treatment to them”.1 SHERIFF SENGHORE, COMMUNITY HEALTH NURSE IN THE GAMBIA

heriff Senghore has worked as a Community Health Nurse (CHN) in The Gambia for more than 20 years. He is responsible for preventive and basic health care, ranging from advice about sanitation and hygiene to treatment for minor ailments. His first posting was in the remote Basse region where he served a catchment area of approximately 34 000 people. Initially he was lucky enough to be given an ambulance to get around, but the vehicle was in such poor condition that he had to push start it every morning. The ambulance eventually broke down completely, forcing Sheriff to resort to using a bicycle to visit his communities. As the roads in the region are so bad, he spent more time pushing and carrying the bike than riding it. Eventually he stopped using the bike altogether and simply walked.

One of the villages within Sheriff’s catchment area was 18 km from his home. He would start walking at 6.30am, carrying all his equipment. If he found any sick children in the villages, he had to track down a horse cart to refer them to hospital. Long, bumpy journeys under the hot sun seldom helped his patients but there were no other options. In a region where malaria causes 29% of under five mortality2, regular health care visits to educate and monitor are vital if the Millennium Development Goal (MDG) of reducing infant mortality is ever to be achieved.

Over the years, Sheriff was given a number of vehicles by various humanitarian agencies, all of which broke down within a short space of time because there was no maintenance infrastructure in place and no replacement parts were supplied. Time and again, Sheriff was left to walk to the communities in his care.

With these ongoing challenges faced by all medical staff tackling rural health issues, it is hardly surprising that The

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Gambian Department of State for Health has been losing on average 50 employees a year3.

Children are dying of treatable diseases because they can’t be reached This alarming trend is not specific to The Gambia. Across Africa, rural communities continue to suffer chronically from treatable diseases simply because they are isolated by distance, harsh terrains, lack of transport and poverty. And across the continent, health workers are giving up the battle and leaving in search of less frustrating employment.

The billions of dollars spent on developing new vaccines, donating mosquito nets, producing condoms or providing food supplies will have no effect unless these measures reach their destinations. In countries where more than half of the population resides in rural communities, health care delivery depends on reliable outreach systems. Health workers, like Sheriff in The Gambia, who travel out to communities and focus on basic preventive health care, are Africa’s best hope for reducing its huge mortality rates.

These health workers must travel vast distances to reach their patients, bringing with them as much as possible as they are unlikely to return to the community for another fortnight.

There is little or no public transportation, the best roads are little better than dirt tracks and, without the infrastructure for maintenance, the few vehicles available rapidly break down for want of replacement parts or basic servicing. A breakdown can mean that a health worker will miss seeing as many as 200 people in a day, with fatal consequences for those left unreached. Not one of the MDGs mentions transport, yet the achievement of each one is dependent on reliable access to rural communities.

Riders’ solution: the planned preventive maintenance system For Andrea and Barry Coleman, founders of Riders for Health (Riders), this situation was wholly unacceptable, and they set about finding a practical solution to the isolation of rural communities. Drawing on their knowledge and experience

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from the world of motorcycle racing, they founded Riders on one basic principle: to find a way to get 100 000 reliable kilometres out of a motorcycle, or any other motorized vehicle, no matter how harsh the conditions. Riders now works to ensure that health care delivery in the areas in which it works is never undermined by vehicles failing – no matter how harsh the conditions.

From the outset, Riders worked in support of healthfocused organizations, providing them with the transport infrastructure to deliver their own services on a predictable and cost-effective basis. Riders’ innovation was the design of an appropriate, sustainable infrastructure in which to manage vehicles used in the harshest of conditions in Africa.

The system, known as Transport Resource Management (TRM), focuses on preventive maintenance and involves the management of viable vehicles (assessed according to age, mileage and condition) owned by the partner agency. It has been tried, tested and costed, and has the potential to be replicated across Africa.

Central to the effectiveness of the TRM system are several key elements. The first is the practice known as outreach maintenance, or in other words, “taking the service to the customer”. In some countries, ministries of health and other humanitarian agencies sometimes attempt to bring vehicles into capital and provincial cities for servicing. Even when (rarely) this results in appropriate servicing, the cost (in money and in time) is unacceptably high. In contrast, Riders’ technicians meet health workers in the field to service the vehicles regularly. This removes the danger of vehicles missing services and breaking down as a result, and means that valuable resources are not wasted on travelling to central workshops.

The second element is high-quality training of the vehicle users. The quality of driving and riding is possibly the largest factor in the longevity and cost-effectiveness of any vehicle.

Riders’ training is highly successful at instilling a culture of pride and preventive maintenance in drivers and riders, who are trained to conduct daily checks on their vehicles to identify potential issues before they cause damage, extending the vehicle life and ensuring correct performance until the next service.

The third element and crucial benefit offered by TRM is that it is based on the true costs of running a vehicle in harsh conditions. Ministries of health and many indigenous nongovernmental organizations (NGOs) have no experience in vehicle management and yet vehicles are vital to meet their health goals. High costs, unreasonable “down time” and often the loss of relatively new vehicles through negligence are common consequences, with negative outcomes on the health of the people served and a demoralizing effect on agencies’ and governments’ health workers.

Rather than simply charging for fuel and parts on an adhoc basis, Riders’ unique cost-per-kilometre (CPK) calculation takes into account the costs of regular maintenance as well as management and logistics costs.

This enables vehicle management to be based on a precise understanding of how much money vehicles are using in terms of management, fuel and parts. The CPK also provides for a replacement fund, giving organizations the chance to

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Riders at a glance

Operates more than 1000 vehicles across sub-Saharan Africa, enabling health workers to reach more than 10 million people reliably and predictably.

Operates on a national scale in Zimbabwe, Lesotho and The Gambia in partnership with Ministries of Health and works with partner agencies (NGOs, UN agencies or community-based organizations) in Kenya and Nigeria.

Employs more than 200 staff in Africa.

Has the ability to calculate accurate cost-per-kilometre budgets for clients.

Provides sophisticated, tried and tested economic models to suit the needs of each client/partner.

build up the capital costs for replacing a vehicle at the end of its life. This enables ministries of health and other agencies to know the precise cost of each kilometre travelled by the health workers to which they have allocated vehicles.

Accurate budgets can then be produced bringing clarity for planning and accountability to the process of health care delivery.

Riders’ values and systems are specifically designed for developing country markets and enable them to provide notfor-profit, cost-effective services which meet a pressing need in the market, providing rates that allow clients and partners to relocate valued resources to others areas of need. TRM proves that communities need no longer be excluded from access to health care because of distance or harsh terrain and illustrates to ministries of health and other health agencies that they can save money and also streamline effectiveness by adopting this model.

Impact Riders employs 200 people across Africa, running more than 1500 vehicles and keeping health and community workers from a variety of organizations “on the road”. Riders run national programmes in Zimbabwe, Nigeria, Lesotho and The Gambia, and have smaller community-focused programmes in Kenya and Tanzania.

Improving health In 2002, the Gambian government handed over the running of its entire health fleet to Riders. Since the programme began, the number of health workers using motorcycles has increased by 110%. These health workers are now seeing five times more people and will see all of the people they serve within any given month. One such health worker is Manyo Gibba, who cares for more than 15 000 people in 14 villages. “Before I had the motorcycle I had to walk or hire a donkey,” she says. “Many of the communities would not see me for a month or more. Now I see them once a week.”

This effective mobilization has led to a rise in infant immunization rates from 62% to 73%, as well as a 261%

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increase in the diagnoses of diarrhoea, a 75% increase in the diagnoses of acute respiratory infection and a 55% increase in diagnoses of malaria for the period 2001–20024.

Many of these diseases are preventable through provision of education in health and hygiene. In Zimbabwe, Environmental Health Technicians (EHTs) play an important role in disease control, disseminating of health information, implementing sanitation programmes, protecting water sources, controlling disease outbreaks, and avoiding water, air and land pollution.

Michael Marime is an EHT in the Ministry of Health and Child Welfare in Zimbabwe. The coverage of the area he serves could not be done on foot or bicycle. He was trained for three weeks in riding and efficient operation of his Yamaha AG100 motorcycle and has since covered more than 90 000 km without a single breakdown.

“In 1999 there was a cholera epidemic in my area with 99 recorded cases”, recounts Michael. “The motorcycle enabled me to effect follow-up visits that saved lives, where death would have been inevitable. I have assisted in malaria control and flood disease prevention where, truly, motorcycles have saved lives”.

Gambian Department of State for Health5.

Furthermore, Riders’ work contributes to the empowerment of women by proving that women can learn to drive and maintain motorcycles and four-wheeled vehicles as well as men. In Zimbabwe, around 15% of health professionals trained to ride motorcycles by Riders have been women.

“We have a culture where men do some things and women do other things”, commented the Deputy Director of the Farm Community Trust of Zimbabwe. “Now here we have a programme for children. The men will not work with the children and the women can’t get to the children. The training puts women on bikes and gets them there”.6 Riders also encourages the hiring and training of female technicians. These new skills increase women’s earning capacities and raise their status in the community, as well as challenging notions of women’s roles in primarily patriarchal societies. Women across Africa are now not only the “natural caregivers” of the community; they are also the local mechanics.

“Some people they find it funny to see a female riding a motorcycle”, says Manyo Gibba. “Even my mother, she was complaining that I shouldn’t ride a motorcycle. I told her it, well, it’s part of my job. I have to do it”.

Empowerment and changing perceptions Not only is Riders helping to access remote communities, but the locally-managed systems also empower the health workers and technicians, thereby building local capacity. With a well-maintained motorcycle, health workers can see more people, more frequently and for longer periods. Health workers’ job satisfaction improves as faster travel means more time doing what they were trained to do and being able to go home to their own families every night. Additionally, without the strain of walking for miles each day, the health workers themselves are healthier too.

Increasing confidence and self-reliance, and changing attitudes, are important objectives for Riders, with its systems being adapted by local people to suit national conditions and to simultaneously bring about change in traditional practices.

The indigenous knowledge that comes with local staff and the ability to interact effectively with rural communities ensures that Riders’ programmes are sustainable. In exchange, Riders contributes to community development by instilling a culture of preventive maintenance, developing management and transparent accounting skills and promoting gender equality.

By working closely with Riders, local communities have found that, contrary to their previous experience, the life and performance of a vehicle can be extended through basic preventive maintenance. As other agencies had not trained local people in vehicle maintenance, the only option was to use the equipment until it broke and then discard it.

Following their collaboration with Riders, communities now understand that daily maintenance procedures will guarantee them a reliable transport service that never breaks down.

Instilling this culture of preventive maintenance is crucial to building sustainable infrastructure in Africa.

“We have had vehicles just stop working after one year.

One year and that’s it. Under TRM they keep working for three years or more”, observes the Director of Planning in the

“Whenever there is a problem we can get there quickly.”

Sheriff Senghore now manages a health centre at Albreda, a large village 20 km from the nearest hospital on the north bank of the river Gambia. Albreda health centre is responsible for the welfare of approximately 15 000 men, women and children.

The centre has an ambulance managed and maintained by Riders for Health which, despite being two years old, still looks brand new and has never yet had a breakdown. The ambulance is used for both outreach visits to neighbouring villages and the referral of emergency cases to Banjul Hospital.

It has been particularly useful in the recent national programme for malaria control, in which all the communities in the regions were visited and 2700 mosquito-nets distributed to pregnant women and mothers of under-fives.

“Riders taught us how to maintain it properly to ensure it will run for a long time without breaking down”, reported Sheriff. “We can now provide reliable services in roadworthy vehicles which means that whenever there is a problem we can get there quickly. This has helped to immensely reduce our mortality rate”.

Key messages

Managed transport is essential to the success of any health intervention or other development initiative in Africa.

Locally-managed infrastructure, based on the principles of preventive maintenance, is key to building the necessary capacity and creating sustainable models for effective development.

Well-managed transportation has a huge impact on the cost-effectiveness of health-focused organizations and the ability to reach their health goals.

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Ngwarati Mashonga, now Acting Operations Director of Riders for Health, joined Riders in his native Zimbabwe in 1996 after qualifying as a motorcycle mechanic. He became programme director in 2001, overseeing a team of 41 staff and the management of nearly 600 vehicles. He also completed a

Bachelor of Commerce degree (specializing in Transport Economics) by distance learning. In 2007, Mr Mashonga was appointed to the post of Field Programme Coordinator, to oversee the replication of Riders’ programmes into new countries.

References 1.

4.

2.

5.

Malaria and motorcycle maintenance. The Times, 5 January 2008, p.33.

Countdown to 2015. Maternal, newborn and child survival. 2008 Report.

The United Nations Children’s Fund (UNICEF), 2008.

3.

Figures taken from an interview with Sehou Omar Toure, Planning Director for the Department of State Health, 25 July 2008.

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OC&C. Due diligence report on Riders’ operations in Africa, 2005 p.3.

OC&C. Due diligence report on Riders’ operations in Africa, 2005, p.5.

6.

OC&C. Due diligence report on Riders’ operations in Africa, 2005, p.38.

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WHO/C BLACK

UNITAID: innovative financing to scale up access to medicines Article by Jorge Bermudez, Executive Secretary, UNITAID

urely, we all agree that we are confronting what could be called a “global state of emergency”. This complex situation is affected and worsened by the impact of inequity in global health.

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The global context: challenges and responses Currently there are nearly 6.5 billion people worldwide, of which 84% live in low- and middle-income countries.

However, these people consume less than 11% of global health expenditure and are responsible for more than 93% of the global burden of disease. If we consider the pharmaceutical market whose current value is estimated at nearly US$ 650 billion and forecasted to reach near US$ 900 billion by 2011, we note that 85% of this budget is consumed mainly in the USA, Europe and Japan. In other words, medicines are on the north; patients are on the south.

In addition to this, nearly 10 million children die every year worldwide. The fact remains that half of all these deaths are avoidable if access to vaccines and treatment were more widely available.

When considering human immnodeficiency virus/acquired immunodeficency syndrome (HIV/AIDS), there are currently more than 2 million deaths each year caused by the disease and an estimated 33.2 million people worldwide are living with HIV. The antiretroviral treatment coverage levels are on average as low as 31% of what is needed. Surely increase treatment coverage is imperative.

Let us now look at the burden of tuberculosis (TB). Most recent estimates according to WHO show that almost 2 million people died from TB in 2006, including 231 000 people with HIV. Globally there were 9.2 million new TB cases in 2006, which included 709 000 cases among people living with HIV. Latest global TB estimates show that the estimated number of multidrug resistant TB (MDR-TB) cases is 489 000 and the estimated number of deaths to be 130 000. For extensively drug resistant TB (XDR-TB), the

When considering HIV/AIDS, there are currently more than 2 million deaths each year caused by the disease and an estimated 33.2 million people worldwide are living with HIV

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estimated number of deaths is approximately 20 000. This is an expanding worldwide problem.

With regards to malaria, which is endemic in many regions of the world, particularly low- and middle-income countries, more than 500 million people are infected each year which converts into a range of between 1 and 1.5 million deaths in more than 100 countries. Resistance to commonly used medicines is posing new challenges. There is now a real need to introduce artemisine combination treatments (ACT) on a much larger scale. The cost of this medicine is several times more than what is traditionally available.

Of course, we can acknowledge that the world has secured a global response to this global challenge. The right to health is included in the Universal Declaration of Human Rights established in 1948. The Millennium Development Goals, which carry defined targets and goals, five of which are directly linked to health, represents a worldwide commitment by the United Nations Member States, setting the objectives to be reached by 2015. Other commitments and achievements could also be mentioned, but there remains an unaddressed gap when it comes to the resources currently being made available for global health.

Why UNITAID? The natural question one could ask might be: when combining all elements of a coordinated and comprehensive global response, is there really a need for an additional initiative? What was envisaged by UNITAID establishment in September 2006?

The answer to this is that there are unaddressed issues at stake, including adequate medicines for children, as well as second- and third-line treatments. In addition, UNITAID is a “plus” to existing initiatives, offering support to the worst affected and most vulnerable countries. It is a new innovative mechanism for financing treatment, originally instigated on 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 both demand and supply factors. UNITAID is building solid and strong partnerships with current initiatives that deal with access to medicines and it represents a multi-dimensional approach, addressing quality, regulation, intellectual property rights, pricing and in-country support for supply systems. It surely is influencing the current health agenda.

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UNITAID’s mission and overarching principles are very clear and they aim especially at scaling up access to treatment of HIV/AIDS, malaria and tuberculosis for the poorest people in low- and middle-income countries by lowering the prices of quality-ensured medicines and accelerating availability of new products. Overarching principles include predictability, sustainability, partnership and additionality, solidarity and aid effectiveness, adaptability, independence, transparency and accountability.

UNITAID added value is based on the facts that with a stable, predictable and innovative form of financing, associated with strong mobilization of its partners, it is possible to support long-term, sustainable programmes which will: Impact market dynamics and reduce current prices of available medicines, therefore allowing for more treatments with the same budget. This has been achieved with reductions of prices for ARVs (paediatric and second line by up to 60%).

Allow for availability of manufactured medicines that are better adapted to patient needs, such as fixed-dose combinations for paediatric ARVs. Contribute to address and ensure quality of products, by supporting WHO Prequalification Programme and speed up the pace in which priority medicines are assessed.

Deliver medicines and other commodities more rapidly in the countries in need, by decreasing initial delivery lead time, as has been achieved for ARVs, TB and malaria products in several countries.

In the two years since UNITAID’s launch it has become a central actor in the fight against pandemics and has established the necessary partnerships with major stakeholders. Its capacity of budgeting with a stable, predictable and innovative form of funding is mobilizing both members and partners, responding to crucial and strategic issues that were previously not being adequately addressed, in particular the focus on specific niches.

What is UNITAID? UNITAID is an innovative mechanism of financing and scaling-up access to medicines and diagnostics for HIV/AIDS, TB and malaria. It was launched in the context of the Global Action against Hunger and Poverty, in support to the achievement of the health-related Millennium Development Goals. For many years the international community has searched for adequate tools to ensure stable financing for development. Mainly based around the idea of a solidarity air ticket levy or tax, the main advantage of this is its ability to be implemented on a national scale, clearly without any negative impact on the countries.

The idea of a solidarity contribution on air tickets is simple, equitable and an economically adequate tool. It can be easily implemented and is based on a tax payment structure on departing flights in the country where the tickets are issued.

Let us take the example of France and how this levy works. The solidarity contribution on air tickets has been in force since July 2006. France has chosen a progressive mechanism based on the flight distances and the class choice of the traveller so that the contribution varies

accordingly. For domestic and intra-European flights, the contribution is 1 euro per passenger flying in economy class and 10 euros for business and first class flights. For the other international flights, the contribution rises to 4 euros in economy class and 40 euros in business and first class.

There are currently eight countries implementing this levy – France, Chile, Côte d’Ivoire, Democratic Republic of Congo, Republic of Korea, Madagascar, Mauritius, and Niger – which makes up 70% of UNITAID’s funds.

It is interesting to note the relevance of this type of contribution – as little as 1 euro can provide treatment for two children with malaria and 40 euros is enough to maintain the treatment of an HIV-positive child for one year.

The contribution raised by passengers on board a full airplane from Paris to New York will cover the treatment of 60 HIV-positive children or one case of MDR-TB for a whole year.

Initially proposed by five countries (Brazil, Chile, France, Norway and the United Kingdom), during the United Nations General Assembly in September 2006, UNITAID is currently supported by 27 countries, most of them are on their way to implementing the innovative financing mechanisms. Other countries, as well as the Bill and Melinda Gates Foundation, have pledged multi-year support to UNITAID, subject to annual reviews and assessment of key performance indicators. This unique solidarity has broken the barriers between North and South, as both contribute within their respective possibilities. As a concrete example, 19 African countries joined the pledge to support UNITAID in 2007 and Mauritius and Niger already have taken the lead and have made contributions in 2007.

UNITAID has implemented a very specific business model. The main decision-making body is the Executive Board, composed currently of 11 members including: the five founding countries, Brazil, Chile, France, Norway and the United Kingdom; the Republic of Korea representing the Asian countries; the African Union; NGO representatives; communities living with the diseases; the World Health Organization; and private foundations represented by the Bill and Melinda Gates Foundation. Within a hosting agreement, UNITAID (the Secretariat and Trust Fund) is hosted by the World Health Organization. Therefore, in addition to the hosting arrangements, UNITAID relies on the technical expertise of WHO. UNITAID funds are utilized for medicines and diagnostics and all our activities are implemented by means of partnership agreements, therefore countries are not directly financed by UNITAID. It is important for me to stress that all our projects are approved by the Executive Board and implemented in the field by partner organizations under close coordination and monitoring by UNITAID. Current actions funded by UNITAID include support to more than 80 countries worldwide in activities related to scaling-up access to medicines and diagnostics for HIV/AIDS, TB and malaria.

Main achievements to date In the two years since its inception, UNITAID has demonstrated major achievements related to approved niches and has contributed to making these solutions accessible to

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most low- and middle-income countries.

With regards to HIV/AIDS and in partnership with the Clinton HIV/AIDS Initiative, UNITAID is contributing to increase the number of children receiving HIV treatment. A baseline of 135 000 children in treatment was established for early 2008, the aim is to reach 235 000 by the end of this year and to continue this increase by 100 000 a year in 2009 and 2010. The cost of an HIV child treatment for a year has decreased from US$ 200 two years ago to just US$ 60 today. In addition to this dramatic price reduction, the drugs offered on the market have improved and new and better-adapted formulations are now available. With the same partnership, UNITAID is also addressing secondline ARVs for adults; this project has allowed 70 000 patients to benefit in 2007 and an additional 140 000 more will benefit in 2008 in 26 countries. The project has also achieved relevant market impact with a 30% decrease in prices.

In partnership with UNICEF and WHO, the acceleration of the global scale-up of national PMTCT (Prevention of mother-to-child transmission) programmes is being insured. An initial project targeted eight countries and aims to reduce the cost of diagnostics as well as test 1.2 million pregnant women and subsequently treat 340 000 of them. In addition, treatment of any infected infants will be insured by linking them to our ongoing programmes for paediatric ARVs. Increased access to primary prevention and family planning services will also be secured in these countries with the improved integration of these PMTCT services into prenatal care with a stronger link to health services.

A total of 51 countries are currently benefiting from UNITAID funding related to HIV/AIDS. Scaling-up Artemisinin-based combination therapies (ACT) is a part of UNITAID’s contribution to malaria control in endemic countries. In partnership with UNICEF and WHO, more than 1.4 million treatments were delivered in Burundi and Liberia as they faced the risk of disruption of treatments in 2007. With UNICEF and the Global Fund to Fight AIDS, TB and Malaria (GFATM), the support to the GFATM Round methodology has meant 55 million treatments in 20 countries have been delivered, impacting delivery time, prices of products and avoiding “stock-outs” of these products.

Current UNITAID TB programmes include support for 740 000 first-line treatments (in 19 countries) and the establishment of a strategic rotating stockpile to reduce lead times and overall treatment costs, in addition to achieving cost containment in the short term and opening the prospect for price reductions in the medium term. Other projects support paediatric TB covering over 750 175 children and ensure the development of new child-friendly formulations for infants under four years in at least 58 countries and supporting the purchase of 5757 treatments for MDR-TB in 17 countries with an objective to achieve price reductions of up to 20% for second-line anti-TB drugs by 2011. More recently UNITAID has financed MDR-TB diagnostics with the objective of securing access at the

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lowest possible price to diagnostic instruments, reagents and supplies through UNITAID support.

Strong support for the WHO Prequalification Programme ensures high-quality new products being introduced more rapidly on the international market. This support has enabled a streamlined process to be developed between receiving the manufacturer’s dossiers and the assessment or inspection of their manufacturing sites; doubling the number of training workshops for capacity building; organization of technical assistance missions to support improvements in the quality of products; and the development of guidelines and standards to facilitate global quality assurance activities.

Besides prequalifying 21 additional products in 2007, including five products for TB and three for malaria, the planning and implementation of a field sampling and testing programme has been developed within this framework of cooperation. WHO has been able to restart the prequalification of laboratories in low- and middle-income countries thanks to UNITAID support.

Forward challenges The priorities that drive UNITAID are ever present in the health agenda worldwide. For the reasons appointed, UNITAID has a clear mandate and an added value, which will bring a positive impact on market dynamics and access to medicines globally. Certainly the progress reports made by the World Health Assemblies over the next coming years will include the impact UNITAID has had with regards to better medicines for children and the impact on the drugs and diagnostics market. It is essential to deliver both hope and quality of life to vulnerable populations in need.

UNITAID’s Executive Board will be examining the current scope of action and niches in the near future, as the innovative way of funding and delivering results is being taken as a concrete example of results-driven initiatives. The recent calls for proposals and innovative concept notes have uncovered potential new initiatives and may broaden potential partnerships.

Additional innovative mechanisms for funding in conjunction with air ticket levy may also ensure sustainability and long-term predictability. An international solidarity citizenship programme could raise the levels of revenues, therefore justifying the approach of UNITAID as a laboratory for innovative financing, while scaling up access to medicines.

The principle of establishing a patent pool as a platform for negotiation and ensuring a win-win situation with patent holders and potential patent grantees may also represent a pioneering way to ensure market stability and expand access to high-quality and low-priced new products for low- and middle-income countries.

Building and maintaining solid partnerships is crucial in searching for additionality among the stakeholders which are responsible for ensuring a global response to this “global state of emergency” that the world is confronted with.

UNITAID is helping to tackle the imbalance and inequities that are hampering the achievement of better health conditions and quality of life for all those in need. It is a collective mission for all.

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Key messages

Although low- and middle-income countries face a global state of emergency in HIV/AIDS, TB and malaria, the international community has responded with the creation of UNITAID and several initiatives which are reducing the inequities and addressing the gaps to ensure access to medicines as a fundamental human right.

Innovative financing mechanisms are a way to ensure the scale-up of access to medicines and diagnostics as they are a sustainable and predictable way of enabling long-term commitments 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 betteradapted 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.

Jorge Bermudez, a Brazilian Medical Doctor with an MSc in Tropical Medicine and a PhD in Public Health has been UNITAID’s Executive Secretary since July 2007. Originally a Senior Researcher at the Brazilian National School of Public Health and responsible for the establishment of the Nucleus for Pharmaceutical Policies at that school, he was also Unit Chief for Essential Medicines, Vaccines and Health Technologies at the Pan American Health Organization (PAHO/WHO) in Washington DC (2004–2007) and Director of the Brazilian National School of Public Health, Rio de Janeiro (2001–2004). Other previous posts were held within the Brazilian health system. He is the author of several books, book chapters and papers dealing with access to medicines and medicines policies within public health.

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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 decades faced challenges in promoting consistency regarding the action of multiple dietary constituents on health risk indicators. Whether for carotenoids, sodium, dietary cholesterol or fatty acid composition, or most recently long chain fatty acid alcohols, nutritional and food scientists have often failed to achieve consensus in delivering a united message concerning the ability of these dietary ingredients to improve disease risk. Notwithstanding, consumers, as well as marketers of foods and food ingredients have been eager to use health claims, even when supported by such controversial data. The lack of consistency in positioning of health messages concerning efficacy of food-based bioactives has, however, resulted in a confidence gap on the part of consumers. Notwithstanding, over the past several years both our ability to design human feeding trials of superior quality, as well as to analytically assess the nature of the bioactive constituents, have advanced considerably. As a result of such advances, legislation originating largely in Japan began to surface in the 1980s. It started to systematize the question as to how much scientific information is required to substantiate a health claim for any given dietary agent which might modify a physiological process in a manner consistent with disease risk reduction. Through the advancements made in Japan, many countries globally have now developed precise and systematic approaches for evaluating scientific data making linkages between food ingredients and disease risk reduction. These approaches share common objectives of identifying and defining the threshold of published evidence required to substantiate authoritative statements to the public at large as label claims for a given marketed food product.

The process of developing a formal assessment of scientific data connecting functional ingredients with health attributes benefits multiple stakeholders within this field. First,

T

These approaches share common objectives of identifying and defining the threshold of published evidence required to substantiate authoritative statements to the public at large as label claims for a given marketed food product

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consumers profit from guidance on functional foods possessing the potential to ward off degenerative disease and extend longevity. Secondly, health care systems benefit from reduced operating costs due to a healthier population with reduced dependency on pharmaceutical agents. Thirdly, for regulatory bodies, health claims provide a means of protecting the public from misleading or unsubstantiated information on product labels. Furthermore, food companies realize an improved market share subsequent to increased acceptance and sales of products bearing health claims in the marketplace. Lastly, food producers and farmers enjoy higher commodity prices from these food constituents possessing added health value. In addition, research activity in the agriculture-food-health continuum remains vibrant to ensure continued livelihood of scientists and technologists which in turn stimulates the biotechnology sector.

A recent supplement has delved into the topic of how much evidence is required to substantiate a health claim1. This cross-jurisdictional review presented examples of current models for establishing health claim legislative policies. While not providing a comprehensive coverage of all territories globally, the range of examples included spans from Japan representing a jurisdiction in which health claim legislation is well advanced, along to the cases of countries such as Canada which has demonstrated a more conservative health claims development history over past decades. The second half of the aforementioned supplement seeks to deal with cases where specific functional ingredients are defined under the more general global pattern of health claim legislation.

Using category specific examples, this section looks at the complex scientific issues to be addressed for ascertaining health claims. Various bioactive categories are discussed from the standpoint of the level of substantiation of current evidence identified as being required to support a claim approved by various regulatory authorities.

Currently, various organizations are also in the midst of reviewing and revising existing health claims standards. In 2007, the European Regulation on nutrition and health claims was established, thus the European Union (EU) is 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

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South East Asian Nations developing regulations close to EU standards with EU support2. Similarly, Codex Alimentarius, a commission created by the Food and Agriculture Organization and World Health Organization to develop global food standards and guidelines, has been working to create a document on how health claims are substantiated.

The guidelines of just how much and what type of evidence is required to substantiate a health claim has been brought up recently, as some members of the scientific community feel that the draft document presented by Codex had too much emphasis on clinical trials3. It has been noted that although Codex is not a regulatory body, its decisions are used as an international benchmark; and even though Codex does not have the same force of law as do regulations stemming from a national legislation, it is used as a reference point for countries that are looking at revising or creating health claim legislation4.

Despite their purported health benefits, foods with health claims should always be considered within the context of healthy diet eating practices. Augmenting a conventional diet with functional foods should not be taken as correcting an otherwise inadequate intake. It is important that foods possessing health claims be efficacious in terms of their ability to improve physiological performance, overall wellbeing and disease risk reduction. However, these foods need to also possess a high safety profile at elevated levels of intake. Regarding safety issues, the general principle that foods must be safe, of course applies to foods with health claims. The messages contained in health claims can promote over-consumption of foods to which they may be affixed as consumers can often regard these positive messages as invitations to ingest higher than usual amounts of these foods. As such, reassurances must be provided within existing health claim frameworks that safety issues have been given thorough consideration. Global jurisdictions that appear to exercise greater caution in permitting health claims may do so to increase the assurance of public safety, particularly given the possibility of higher consumption patterns among a sub-set of consumers who may overrespond to health claim messages. As a rule, nutrition profiles must always be discussed in terms of “nutritional safety” implying that functional foods cannot counteract the general guiding principles for a balanced and complete diet.

The ultimate criterion of success for a given functional food in terms of benefiting the chief stakeholders identified above depends on the general consumers’ understanding of, as well as confidence in, health claim messages. The multiple groups holding a key interest in this area, including government regulators, industrial partners as well as the scientific community must unite to find reasonable compromises between issues of simplicity and understandability of claims for consumers versus the scientific rigor needed to ensure that food-related health claims corresponds to their scientific background. It is essential that health claim messages be kept straightforward and simple in order to sustain the confidence of consumers.

It is also important to identify that some of the current issues and vagaries surrounding the validity and benefits of

claims on foods are likely to be resolved within the nearer future due to the continuing development of superior technologies. Advances in emerging areas such as nutrigenomics and metabolomics are certain to enhance our understanding of interactions that exist between nutrition and genes, nutrient utilization and trafficking at the molecular level, as well as the influence of these entities on overall function will improve future understanding of relationships between diet and disease. Such advances are likely to improve the possibility of not only identifying precise nutritional needs of specific groups and individuals with shared genetic and metabolic characteristics, but provide additional means of meeting those needs in a novel manner by using foods with individual-specific nutrient content. This knowledge should lead to innovative approaches in arriving at solutions to diet-related diseases such as diabetes, cardiovascular disease and cancer. When the potential economic importance of this area is considered, together with current global sales in nutritional products approaching US$ 200 billion, it is understandable that a strong interest exists from both industry and governments to capitalize on these opportunities. By the same token, consumers should benefit from improved access to foods with health benefits as well as the enhanced availability of authoritative scientific statements in the form of health claims permitting them an informed choice. J Key messages

Health claims on foods can be beneficial to many stakeholders including consumers, health-care systems, regulatory bodies, the food industry, food producers and research scientists.

Currently, there is no universal consensus on how much and what type of evidence is required to substantiate a health claim. However, recently, organizations such as the European Union, Association of South East Asians and Codex Alimentarius are implementing and/or developing region-wide common regulations.

Peter J Jones, the Canada Research Chair in Functional Foods and Nutrition, joined the University of Manitoba in 2005 as Director of the Richardson Centre for Functional Foods and Nutraceuticals. Before 2005 he was professor at McGill University serving as Director of the School of Dietetics and Human Nutrition from 1994–1999.

Dr Jones serves as President of the Danone Institute for Nutrition in Canada and is also Chairman of the Functional Foods and Nutraceuticals Board of the Vancouver-based Forbes Meditech group. Dr Jones also has sat on the Food and Agriculture Organization of the United Nations, World Health Organization, and United Nations University (FAO/WHO/UNU) Expert Consultant Panel for Energy and Protein Requirements in Human Nutrition.

Dr Jones has published many articles and reviews in international journals, as well as chapters in leading nutrition textbooks. He received the Young Investigator Award for Excellence in Nutrition Research in 1997.

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workshops focused on functional foods and nutraceuticals. She currently works for Agriculture and Agri-Food Canada as a Special Project Assistant focusing on food health claims.

Stephanie Jew graduated as a Registered Dietitian in 2004 before working in the School of Dietetics and Human Nutrition at McGill University as a Research Assistant. During this period she was involved in co-authoring publications and organizing

References 1.

2.

3.

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Evidence for health claims on food: how much is enough. Journal of Nutrition (supplement), June 2008.

Sterling S. EU regulations attract global attention. (http://www.nutraingredients.com/Regulation/EU-regulations-attract-globalattention, accessed 4 September 2008).

Daniells S. IADSA keeps pressure on Codex over science for health

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4.

claims. (http://www.nutraingredients.com/Regulation/IADSA-keepspressure-on-Codex-over-science-for-health-claims, accessed 4 September 2008).

McNally A. Codex will look again at health claims science. (http://www.nutraingredients.com/Regulation/Codex-will-look-again-athealth-claims-science, accessed 4 September 2008).

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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 point in the world through hand-held devices. We can bake a potato in six minutes. Our cars tell us directions to our destination. We listen to hours of music stored in a gadget smaller than a human hand.

From smart phones to GPS devices, corporations are making countless innovations in an effort to make life easier.

At Eli Lilly and Company, we are employing innovation in an effort to make life possible.

In 1882, Dr Robert Koch announced his discovery of Mycobacterium tuberculosis, the bacteria causing tuberculosis (TB). Tuberculosis is an airborne bacterium that can spread to any organ of the body, most often the lungs. Symptoms may include severe and prolonged coughing, fever, weight loss, chest pain and night sweats. At the time of Dr Koch’s discovery, TB killed one in seven people in Europe and the United States of America.

Today, TB remains a vicious and deadly disease. Of the nine million people diagnosed with TB each year, nearly two million will die of the disease. By the end today, close to 5000 people will have lost their lives to TB. Yet, these are more than mere statistics – these are someone’s father, son, mother, daughter… people whose lives mean everything to their loved ones.

Equally worrisome is the fact that each year, multidrugresistant tuberculosis (MDR-TB) strikes nearly half a million people around the world. MDR-TB can develop from first-line TB, or be contracted by patients without their knowledge. It occurs when medicines used to treat TB are misused or mismanaged, resulting in a more virulent strain. MDR-TB, like TB, is airborne and contagious, but treatment is more complex and longer in duration. It is highly contagious, and the hardest hit are often the most vulnerable and least able to fight.

The good news, however, is that given adequate health care infrastructure and adherence to proper medication regimens, MDR-TB is treatable and curable. People infected with this disease now have the chance to go on to lead productive and fulfilling lives. Lilly has invested US$ 135 million in programmes to make this chance a reality for thousands of MDR-TB patients.

A global health innovator for more than 130 years, Eli Lilly and Company saw an opportunity to use its pharmaceutical

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manufacturing expertise to improve local availability of essential drugs in the developing world in the late 1990s. TB strains that are resistant to first-line drugs can be treated with a combination of various drugs, including two of Lilly’s older antibiotics. Their patents had expired, but the market for them was too small to attract generic manufacturers. While transferring local technology to partners, we began this initiative by supplying our medicines at concessionary prices to resource-constrained countries facing outbreaks.

We recognized, however, that the spread of MDR-TB cannot be halted by medicine alone. In 2003, we officially created the Lilly MDR-TB Partnership, a public-private initiative now mobilizing 18 partners on five continents. It is important to realize that Lilly has no commercial interest in TB as the company has transitioned out of the anti-infective market. The Lilly MDR-TB Partnership is strictly a humanitarian initiative and is Lilly’s signature corporate social responsibility programme.

Each Lilly partner is a global leader in its respective function.

Together, the partners comprise the five main components of the Partnership: transferring manufacturing technology to local pharmaceutical companies and continuing to supply medicines at concessionary prices; implementing MDR-TB health care treatment and training programmes and strengthening surveillance of drug resistance; promoting community support and patient advocacy; working with policymakers to raise awareness and prevent the spread of MDR-TB. And, recently, we started conducting research for new drug discovery.

From the start, one of our primary goals was to increase the supply of high-quality, affordable medicines to the people who need them most. To do so, Lilly devised a strategy for transferring technology and expertise so that these medicines could be manufactured in hard-hit countries where MDR-TB is most prevalent. We share the formula, trademarks and technologies for our two MDR-TB-fighting antibiotics with manufacturing partners in the four countries with the most MDR-TB cases – Aspen Pharmacare in South Africa, Shasun Chemicals and Drugs in India, Hisun Pharmaceutical in China, and SIA/Biocom International in Russia. In addition to transferring technology, Lilly provides financial assistance to purchase the equipment necessary to manufacture the medications. This approach not only enables access to

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medicines at lower prices for MDR-TB patients, but also supports local economies and the manufacturing of highquality medicines. Purdue University, in the United States, shares its Good Manufacturing Practices programme with these facilities and is also helping in raising overall standards 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 core of this Partnership is a deep-rooted conviction that having trained and motivated health-care professionals is indispensable in the effective delivery of life-saving treatments and prevention strategies, especially at the grassroots level.

For this reason, Lilly made training, treatment and surveillance a cornerstone of its multi-pronged corporate social responsibility effort. Having worked in Africa and for UNICEF, I know first-hand of the pivotal role that nurses, midwives and primary caregivers have in providing good health care. Lilly has been instrumental in ensuring that front-line health workers have the necessary knowledge and skills to provide the best possible treatment, care and support for people living with TB and MDR-TB. Lilly supports Harvard Medical School and Partners in Health, the International Council of Nurses, the International Hospital Federation, and the World Medical Association in the creation of global training courses for nurses, doctors and hospital administrators worldwide. The Partnership is educating health-care workers to recognize and treat MDR-TB, and also empowering them to transfer their knowledge by training others.

Our partners understand that meaningful changes must occur in the communities where MDR-TB patients live and work. Lilly and the International Federation of the Red Cross and Red Crescent Societies, TB Alert, TB Survival

Scientific innovation will always remain a key component to fighting disease and restoring health. MDR-TB can be treated with existing medicines, but the regimen is time intensive and requires isolation from family and friends

Project/Advocacy Partnership, and the World Economic Forum design and implement community support and patient advocacy programmes locally. Those infected with MDR-TB are encouraged to seek and complete treatment, and educational programmes are conducted in workplaces to reduce the stigma associated with TB. As feelings of depression and isolation are common among MDR-TB patients, the opportunity for patients and former patients to connect via one-to-one patient mentoring through the TB Survival Project website is invaluable. Our partners have established community outreach, psychological support and food aid programmes serving tens of thousands of patients and carers throughout the world.

In addition, Lilly works with RESULTS Education Fund, the Stop TB Partnership and the WHO to raise awareness and prevent the spread of this global pandemic. Developed country governments have played a crucial role in fighting the TB pandemic by creating such multilateral organizations as the Global Fund for HIV/AIDS, TB and Malaria, and UNAIDS. Through its bilateral efforts, including the US governmentâ&#x20AC;&#x2122;s PEPFAR programme, the Partnership advocates for increased resources and policy action to stop the spread of TB. We also encourage the media to help disseminate our message: Lilly and the Stop TB Partnership created an Award for Excellence in Journalism on TB to recognize outstanding reporting in print that increases public understanding of TB and MDR-TB.

Figure 1: The Lilly MDR-TB Partnership has active programmes in nearly 60 countries

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A final challenge for all regions in defeating MDR-TB is research. Scientific innovation will always remain a key component to fighting disease and restoring health. MDR-TB can be treated with existing medicines, but the regimen is time intensive and requires isolation from family and friends. In addition, other deadly strains of TB, known as extensively drug resistant tuberculosis (XDR-TB) have emerged, resulting in an 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 the United States. The goal of the initiative is to tightly integrate medicinal chemistry expertise from the pharmaceutical industry with academic expertise in chemistry, microbiology and TB, particularly basic biology genetics and molecular biology. People involved in the initiative will scour millions of molecules in medicinal libraries donated by Lilly and another manufacturer and work with other collaborators to identify and develop promising new drug candidates.

As leading international policy makers, attendees of the Global Ministerial Forum on Research for Health play a critical role in setting the global health agenda. This responsibility includes identifying and dedicating resources to the pandemics afflicting the world’s most vulnerable people.

We encourage you to support new thinking on programmes designed to curb the spread of MDR-TB. We also urge your countries to comply with WHO standards of treatment, because compliance with this effective regimen saves lives and slows the evolution of multidrug-resistant strains. The Partnership fully supports TB activities as an entry-point to strengthen health-care systems and place patients under the supervision of a health-care worker to ensure appropriate and complete treatment.

The Lilly MDR-TB Partnership is proof that public-private partnerships can work in confronting disease on a global scale.

Our Partnership works because each member does what it

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As leading international policy makers, attendees of the Global Ministerial Forum on Research for Health play a critical role in setting the global health agenda. This responsibility includes identifying and dedicating resources to the pandemics afflicting the world’s most vulnerable people

does best – from manufacturing life-saving pharmaceuticals, to training health-care workers, to advocating for supportive policies and resources. The lesson for private sector responses to disease and poverty is that the battle must be waged on many fronts.

Lilly is moving aggressively to realize the WHO goal of treating 1.7 million MDR-TB patients by 2015. We have a great deal of work ahead of us, and look forward to working with governments and private sector providers to develop sustainable strategies against TB for better health in countries with limited resources. With the help of our partners and your leadership, we will continue to fight MDR-TB in 2008 and beyond. J Patrizia Carlevaro, Head of the International Aid Unit and Team Leader of Lilly’s MDR-TB Partnership, has worked in global public health and international development for the past 20 years. Prior to joining Lilly, Patrizia was Head of the Essential Drugs Unit at UNICEF where she was responsible for global pharmaceutical policies and programmes. Patrizia lived and worked in West Africa, where in partnership with the United Nations Industrial Development Organization (UNIDO), she established a national generic-drug manufacturing plant in the Republic of Guinea. She serves on the advisory board of various health-care industry committees and is on the Board of Directors of the Florence Nightingale International Foundation.

ideas and discoveries from research, it may cross many sectors and disciplines involved in the development and applicaƟon of a novel product or process.

The Global Forum for Health Research focuses on promoƟng an environment that fosters innovaƟve soluƟons for the health of poor populaƟons. In doing so, it places parƟcular emphasis on health equity as the central goal, i.e. reducing health dispariƟes within and between populaƟons.

Global Forum Update on Research for Health Volume 5

InnovaƟon for health is a vital driver of development. Drawing new

The fiŌh volume of the Global Forum Update on Research for Health provides insights into the newest thinking on innovaƟon for global health. Some 30 leading insƟtuƟons and professionals from around the world reflect on how policy, social, technological and corporate innovaƟons can be fostered for global health.

Fostering innovaƟon for global health Global Forum Update on Research for Health Volume 5

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 Health Research.

Editors Monika Gehner, Susan Jupp and Stephen A Matlin, Global Forum for Health Research

Editorial Advisory Board Pan American Health OrganizaƟon

Andrés de Francisco

The Partnership for Maternal, Newborn and Child Health

Nirmal Kumar Ganguly

NaƟonal InsƟtute of Immunology, India

Stuart Gillespie

Plaƞorm on Agriculture and Health Research

Odile Leroy

European Malaria Vaccine IniƟaƟve

Judith Sutz

Universidad de la República, Uruguay

Alfred Watkins

World Bank

Derek Yach

PepsiCo, Inc.

ISBN: 978-2-940401-12-3 Cover - Final_layout.indd 1

Pro-Brook

Luis Gabriel Cuervo

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