The world’s first meningitis B vaccine was developed by Cuba

https://www.healthaffairs.org/doi/full/10.1377/hlthaff.26.4.1052

https://www.cgdev.org/sites/default/files/GAVI-Appendix-2014-10-16.pdf

Technological And Social Innovation: A Unifying New Paradigm For Global Health

This paper highlights the growing capacity for innovation in some developing countries. To maximize the potential of this phenomenon for global health, 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. A strong capacity for both technological and social innovation in 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.

I n colloquial use, the term ” innovation ” is often seen as synonymous with “invention.” To the global health community, “innovation” may carry baggage associated with patents and the high cost of medicines. However, the definition used by economists is far broader than invention and is highly relevant to considerations of access: It encompasses the entire process—from idea to implementation—for new products, services, processes, practices, and policies. 1

 

 

Improving access to essential products and services requires three forms of innovation: technological, to ensure availability of products that are more cost-effective than existing interventions; social, to ensure the distribution of essential goods and services; and adaptive, involving both providers and communities, to contextualize the adoption of goods and services to local settings. 2 Technological solutions in health include new drugs, devices, diagnostics, and vaccines. Social and adaptive solutions include new ways to organize human resources, information, and decision making in health systems. In all cases, innovation involves both the solution and its implementation.

Unfortunately, “technological utopians” and “systems utopians” seem to speak different languages; at worst, they compete fiercely for finite resources in the global health field. 3 Yet, in our view, technological and systemic solutions are two sides of the same valuable coin. New products always require social and adaptive innovations to ensure their introduction, distribution, uptake, and use. New ways to organize funders, producers, distributors, managers, providers, patients, and communities often spotlight needs and opportunities for further technological innovation. Ideally, each should enable the other, helping make health systems more effective and equitable

Economists and business leaders have long understood these different facets of innovation. 4 This inclusive view might help bridge a long-standing ideological divide in the global health community. Ultimately, the only sustainable goal must be to build capacity for local innovation so that developing countries can continuously improve the effectiveness and equity of their own health systems.

Health Technology Innovation

On their own, innovation systems respond best to the needs of those who can afford their outputs. Therefore, numerous initiatives have been created or proposed over the past decade to “reengineer” those systems to address the needs of poor people. 5 These interventions affect various components of innovation systems, from research to manufacturing to distribution, predominantly in industrialized countries. 6

Re-engineering innovation systems.

For example, product development partnerships (PDPs) were explicitly modeled after partnerships in the private sector. 7They have business plans and corporate management structures, conduct market analyses, and acquire and manage portfolios of candidate products to speed them through the development process. Several countries are testing industrial policies such as tax breaks, liability protection, and expedited regulatory approvals to stimulate product development. 8Finally, huge procurement funds have been created such as the GAVI Alliance (formerly known as the Global Alliance for Vaccines and Immunizations) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.

Advance market commitments (AMCs) have been proposed to create “pull” incentives for companies to develop new products for neglected diseases. Donors would offer binding contracts to guarantee future procurement. The merits of AMCs are still hotly debated. 9 In a widely respected paper, Mary Moran argues that AMCs would be less cost-effective than PDPs and might actually hinder PDPs’ efforts. 10 Yet at least two PDPs have welcomed AMCs in the belief that they would make it easier to attract new private partners. 11

It seems clear there is a need for implementation research—defined here to include research on policies and practices affecting distribution, adoption, and availability. 12 There is a need to document the impact of these policy and programmatic experiments and to gain a better understanding of their potentially synergistic or antagonistic impacts on global health.

Innovative developing countries.

Another positive development over the past decade has received far less attention: A handful of innovative developing countries (IDCs) have emerged as world leaders in the manufacture of essential drugs and vaccines. 13 These countries are all adjusting and refining their national innovation systems. However, this process often occurs through a discourse that is driven more by ministries of industry, trade, and science and technology than by ministries of health. 14 We believe that a critical window has opened to share lessons learned among countries (both North-South and South-South) in the development and adaptation of policies that promote both public health and economic development.

Obviously, major differences exist among developing countries. A recent analysis of the 1967–1987 worldwide declines in infant mortality identified “differing rates of technical progress (or diffusion) as the principal source [66 percent] of the (large) cross-country variation.” 15 Although just a few countries can be considered technological IDCs, all developing countries can aspire to develop, adopt, and adapt social innovations to implement new technologies.

Growing public and private investments.

Public spending on health research by developing countries now exceeds $2 billion per year. 16 Local ingenuity, as well as lower labor costs and overhead, amplifies the purchasing power of these investments (Goldman Sachs estimates that research and development [R&D] in India costs 12.5 percent of R&D in wealthy countries). 17 Unlike donor funding, this local public investment is, presumably, sustainable. Private R&D investments in IDCs by both local and global drug companies are also growing. 18

Increasing publications and patents.

Over the past decade, the number of highly cited academic papers from Brazil, China, India, and South Africa nearly doubled, while the number of U.S. biopharmaceutical patents increased tenfold. 19 When Carlos Morel and colleagues ranked countries by U.S. biopharmaceutical patents per gross domestic product (GDP) per capita, the top fifteen included not only Organization for Economic Cooperation and Development (OECD) countries, but also India (third), China (fourth), Brazil (eleventh), and South Africa (fourteenth). 20

Lost in translation.

A recent survey of biotechnology in IDCs highlighted several health product success stories arising from local public-private R&D partnerships. 21 However, it also found a lack of national and institutional policies and experience to manage such partnerships, which suggests that these successes were exceptions rather than the rule. Without such capacity, public investments may produce a multitude of academic jobs and publications but fail to translate new ideas into products. 22

Low-cost products.

Drug manufacturing in India costs 70 percent less than it does in wealthy countries. 23 Currently, 67 percent of India’s drug exports and 74 percent of Brazil’s go to other developing countries. 24 India is now the world’s leading manufacturer of diphtheria-pertussis-tetanus (DPT) vaccine; Brazil, of yellow fever vaccine; and China, of penicillin. 25 The world’s first meningitis B vaccine was developed by Cuba, which now exports it throughout Latin America (and recently licensed the product to GlaxoSmithKline). 26 India recently approved a low-cost Japanese encephalitis vaccine, developed and produced in China. 27 Brazil, Cuba, India, and Indonesia now meet 64 percent of the vaccine requirements (excluding oral polio vaccine) of the United Nations Children’s Fund (UNICEF). 28

“Re-engineering” national innovation policies in IDCs.

There are mixed views on the likelihood that manufacturers in technological IDCs will engage in R&D and manufacturing to address local needs without external incentives. 29 As a rough starting point, however, some of the “interventions” noted at the global level could be adapted locally. 30 All countries—even the wealthiest—could benefit from lessons learned as IDCs experiment with national innovation policies to promote economic growth and (ideally) the development of new products to address the needs of poor people.

Social And Adaptive Innovation: What Is Needed

Social innovations are needed within health systems to achieve the maximum uptake of essential new drugs, vaccines, and diagnostics; to assist public and private efforts to deliver essential services; and to promote healthy behavior at the community and individual levels. Recent calls by the World Health Organization (WHO) and the Global Forum for Health Research (GFHR) to support health policy and systems research and by others for “implementation research” are essentially pleas for social innovation to increase the effectiveness and equity of health systems. 31

New products often involve centralized production and widespread adoption; social innovations almost always require adaptation to local conditions. 32 As innovation economist Richard Nelson points out: “Just as with innovation at the frontier of knowledge, organizational innovation involves a lot of trial and error learning, hard work and thoughtful adjustments; while practices used elsewhere may serve as models, almost always there are going to be modifications needed to fit the new context.” 33

Worsening health indicators and slow progress toward Millennium Development Goals (MDGs) have spotlighted the need to strengthen health systems in developing countries. Numerous nontechnological initiatives have been proposed or implemented to address this challenge. 34 The What Works Working Group has collected examples of such initiatives. 35These include conditional cash transfers to encourage prenatal visits and vaccinations in Mexico; professionalization of midwives and systematic use of health information in Sri Lanka; involving grandmothers as volunteers to deliver low-cost vitamin A capsules in Nepal; and the “SAFE” strategy (surgery, antibiotics, face washing, and environmental change) to reduce trachoma prevalence in Moroccan children.

One problem stands out from these examples: Very few of them are home-grown. 36 This is not for lack of indigenous ingenuity. Richard Mahoney and Carlos Morel have argued that least-developed countries themselves can innovate by developing new approaches to train health workers, manage clinical trials, increase procurement and distribution efficiencies, fight counterfeit drugs, improve the governance of national regulatory authorities, improve priority setting, increase the effectiveness of locally adapted education campaigns, and ensure that communities and patients have a voice in demand-driven local health systems. 37 Unfortunately, as a Disease Control Priorities Project report notes, “evidence on which approaches work best is limited.” 38

Expert systems.

A shortage of health providers in the least-developed countries has evoked calls for more resources to support health workers and for efforts by industrialized countries to stem the “brain drain.” 39 To date, there has been little discussion of how increasingly common and inexpensive information and communication tools could allow countries to restructure who gets trained, how they get trained, who is needed, and where they are needed. To the extent that a new cadre of field workers can work effectively with a small number of professionals in specialist centers or can use expert systems software to aid in diagnoses and referrals, currently extrapolated human resource needs would change. 40

Business innovation.

C.K. Prahalad has analyzed “breakthrough innovations that dramatically alter cost, quality and delivery standards” for high-volume, low-margin production and service delivery in the developing world. 41 Examples include Aravind Eye Care, the world’s largest provider of cataract surgery, and Narayana Hrudayalaya, a leading provider of cardiac care—both profitable Indian businesses that provide low-cost products and services to the poor. The secret of success in such “bottom-of-the-pyramid” models is a commitment to excellence combined with a hyperspecialized division of low- and high-skilled labor that is unheard-of in costly hospitals of the industrialized world.

Microfranchising is another form of business innovation that combines the best of public goals with small-scale entrepreneurship. BroadReach, in South Africa, uses communication technology to deliver expert medical advice to clinics in remote settings. 42 CFW Shops in Kenya are supported by a central nonprofit organization that sets quality standards, uses pooled procurement of generic medicines to lower costs, and provides training and medium-scale loans to help local entrepreneurs establish small pharmacies in rural and periurban settings. 43

Optimism And Caution For Technological Utopians

The field of innovation economics considers the “healthy” functioning of the components of innovation systems, and the dynamic interlinkages among those components, to be essential for a robust system that produces positive outcomes for society. 44 We believe that it is possible to pursue innovation policies with win-win outcomes for both economic development and the generation of essential public goods. At the country level, this will require policy research to guide decisionmakers and careful attention to the linkages between innovation policies and health priorities.

Some caution is in order, however, when considering policy interventions. The truth is that we do not yet know which initiatives are most cost-effective, which are synergistic, and which may cross-react to produce unwanted side effects. Just as great gaps in our knowledge of health systems require “health policy and systems research,” enormous gaps in our knowledge of health product innovation systems require “health innovation policy and systems research.”

Some IDCs are beginning to play an active role in helping to address health challenges in the least-developed countries. For example, Brazil’s Ministry of Health now provides technical assistance in HIV/AIDS prevention and care to eleven African countries. 45 In 2003 Brazil signed an agreement to help Mozambique manufacture antiretroviral drugs. 46 And FIOCRUZ, a major publicly funded research and manufacturing center in Rio de Janeiro, is helping Angola and Mozambique establish new schools of public health. 47

During a recent meeting convened by South Africa’s Council for Scientific and Industrial Research in Tshwane, policymakers and research leaders from developing countries called “for the IDCs to act collectively and think globally” to harness science and technology for sustainable development. 48 Participants highlighted the need for “close networking of universities, research councils and industry” to facilitate “the creation of affordable…products and services for poor people.”

A New Paradigm: Agenda For Action

Recognizing the need for technological, social, and adaptive innovation, as well as the growing capacity of developing countries, represents a potentially unifying new paradigm for global health. Within this context, we believe that three areas require greater attention by both developing countries and donors.

Translation and stewardship.

In North America, where more than 40 percent of biotechnology patent applications are filed by universities and other publicly funded research institutions, effective university-industry partnerships are essential to translate “academic” ideas into tangible products. 49 We believe that they can also give greater traction to the more than $2 billion in public funds that developing countries invest each year in health research.

Since publicly owned intellectual property (IP) can be used as a kind of currency to achieve public goals, promoting good stewardship of IP in such partnerships can help ensure affordability and access, while also attracting and leveraging private-sector know-how to address the problems of the developing world. 50 Global PDPs have pioneered such creative approaches to IP management in their negotiations with the private sector.

Both the U.K. Commission on IP and the WHO Commission on IP, Innovation, and Public Health (CIPIH) have called for capacity building in this area. 51 Such work is also consistent with a large body of analysis from the field of innovation economics and represents a logical complement to the efforts of global PDPs. We are aware of only one international organization that is dedicated to such capacity building (the Centre for the Management of Intellectual Property in Health Research and Development, or MIHR). 52

Implementation research.

Total development assistance for health now exceeds $10 billion per year. 53 This includes large vertically oriented disease programs that are stretching the limits of human resources in developing countries’ health systems. Given these huge investments and the complexity of health systems, it is shocking that less than 1 percent of the total is invested in research to document and understand which programs work and which do not. 54 A dearth of data to guide policymakers has led to calls for major increases in implementation and health systems research.

We wish to highlight a complementary need for South-led implementation research on policies and practices affecting the availability, distribution, and adoption of health products and services (including conditions that enable local technological, social, and adaptive innovation to build more effective and equitable health systems). As the CIPIH report has noted, “South-South networks have often been neglected in the past but may become especially useful now that world-class expertise exists in some developing countries.” 55

Morel and colleagues have called for a South-South health innovation network to analyze and promote enabling policy environments to develop products and services and deliver them to poor people. 56 This would complement—not replace—Northern efforts to address health challenges in the South. Specifically, such a network would (1) foster active support by key opinion leaders in developing countries to create an effective policy environment in this area; (2) support research on national policies and organizational practices that affect the generation and implementation of new products and services to improve health systems’ effectiveness; and (3) engage in global debates on policies that have national relevance and help shape the global health policy architecture.

A network of this kind would be unique in the public health field but could build upon other relatively new South-South networks highlighted by Morel and colleagues and the CIPIH report (for example, the India-Brazil-South Africa Dialogue Forum and Developing Country Vaccine Manufacturers Network). It could also take lessons from the WHO Collaborating Centres and the Global Health Policy Research Network (among others).

The power of individuals.

These first two needs cannot be addressed without the third: individual leadership. To the extent that thought leaders in the global health community—North and South—begin to articulate a broader and more inclusive vision for health innovation, local policymakers in developing countries will be better equipped to craft national policies that promote both economic development and public health. Donors might also listen and adjust their strategies.

Concluding comments.

New international treaties, new trading partners, and the challenge of both emerging and chronic diseases call for new strategies to support health innovation in developing countries. An “innovation systems lens” highlights the need to create and implement both social and technological solutions. It may thus provide a much-needed framework to design the “architecture of global health” called for recently by health experts. 57 Local public-private R&D partnerships and South-led networks for policy and implementation research could help developing countries play a more prominent role in global health. There is a critical need to maximize outcomes from the substantial investments in health research that some countries are now making and to recognize, help, and encourage countries that make deliberate efforts to improve the effectiveness and equity of their health systems.

Charles Gardner ( CGardner@rockfound.org ) and Tara Acharya are associate directors of the Rockefeller Foundation in New York City. Derek Yach is director, Global Health Policy, at PepsiCo in Purchase, New York.

The authors thank Richard Isnor, Hannah Kettler, Richard Mahoney, Carlos Morel, Richard Nelson, and Amitav Rath for helpful comments and suggestions on earlier drafts. The views expressed in this paper are those of the authors in their individual capacities and do not necessarily reflect those of their respective organizations.

 

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