International Journal of Technology Assessment In Health Care, 8:4 (1992), 623-634. Copyright © 1992 Cambridge University Press. Printed in the U.S.A.
HEALTH TECHNOLOGIES FOR THE DEVELOPING WORLD Addressing the Unmet Needs Michael J. Free Program for Appropriate Technology in Health
Abstract This paper provides a critical overview of several strategies and mechanisms that have been employed by the Program for Appropriate Technology in Health over the past decade to address the unmet needs for health technologies in the developing world. Partnerships between public and private-sector organizations are emphasized in order to share risks, encourage efficiency, and ensure the availability of priority products for health care in resource-poor settings. Incentives for the involvement of the commercial sector, the means to protect the interest of the public sector, and the role of bridging organizations are discussed in the light of the shifting goals of the public sector.
GROWING AWARENESS OF THE NEED FOR PUBLIC-SECTOR INVOLVEMENT IN HEALTH TECHNOLOGIES
In the late 1970s and early 1980s, leaders in health care redoubled their efforts to improve health in the developing world. Following the declaration of "Health for All by the Year 2000," there began a period of review, debate, and planning to achieve this goal. The top priorities identified were: immunization and oral rehydration, nutrition, birth spacing, control of acute respiratory infections and vector-borne diseases, and the provision of clean water and adequate sanitation (3;8). The setting of these priorities emerged from a variety of considerations. First, the rates of infant and childhood death were unacceptably high in developing countries, varying from 2 to 20 times the rates in developed countries. Second, the priorities represented those interventions that might contribute most significantly to reducing mortality and morbidity among children. Third, it was argued that technologies to carry out these interventions had been developed. Although vaccines, oral-rehydration solutions (ORS), foods and food supplements, antibiotics, vector-control agents, water pumps, and latrines existed, these interventions were not sufficiently available. Over the next few years, the experience of implementing primary health care programs in developing countries supported the initial enthusiasm. Where programs were applied with strong political commitment and adequate funding, impressive reductions in infant mortality followed. It became increasingly clear, however, that "something was wrong." Infant mortality remained high even in countries with the best programs. Health experts realized that the early optimism that "technological solutions 623
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existed" was naive. In practically every primary health care program, problems had arisen with the application of technologies. These included the following: • Vaccines exposed to heat lost their potency (5;7). • Cold chains designed to protect vaccines required expensive equipment, fuel, and maintenance (5;7). • Syringes that were not properly sterilized resulted in the transmission of disease (5;7). • Mothers did not like the taste of ORS and demanded modified solutions (6;7). • ORS did not "cure" diarrhea, stimulating a search for a modified solution that reduces stool output and helps maintain nutritional status (6;7). • Vector-control agents resulted in the dominance of resistant strains and were considered to be dangerous to the environment, resulting in the abandonment of their use and the initiation of research of new products (2). • Contraceptives had side effects and were not effective or acceptable in other ways (1). • Water pumps broke down and could not be repaired easily in the field (4). • Latrines became sites of disease because they could not easily be maintained (4).
What appeared to be one of the "givens" of health — availability of safe, effective, acceptable, appropriate technology—was now seen as largely ephemeral. What was needed was the development of new technologies or the adaptation of existing products to meet the unique conditions of developing countries. A variety of approaches to each health problem were seen to be necessary to overcome the diverse cultural, political, economic, educational, and infrastructural problems of different regions and countries. The international health community has responded aggressively to many of these problems. Programs of research on new formulations of ORS are now well under way. There are major international efforts to develop new and improved contraceptives, notably by the Population Council, a pioneer in the noncommercial development of technologies for family planning in response to needs. The United States Agency for International Development (USAID) has funded the Water and Sanitation for Health project to work in water and sanitation. The World Health Organization (WHO) has established the Tropical Diseases Research program with a product-development unit. The WHO/Expanded Program on Immunization (EPI) has had a major impact on the quality and availability of cold-chain and other vaccine-related technologies. The WHO/Special Program in Human Reproduction (HRP) has taken a major role in the development of new contraceptives. USAID sponsored the Diagnostic Technologies for Community Health (DiaTech) program, an international program to develop new diagnostic tools for use in conjunction with immunization and other disease-control programs. USAID also sponsored Project SUPPORT (Supply, Production, and Promotion of Oral Rehydration Salts in Developing Countries), the Technologies for Child Health program (HealthTech), and a variety of vaccine development programs. It is of interest to note that each of these programs has been set up with funding from the public sector or charitable foundations. Industry did not step forward to invest the required funds. This reluctance is understandable in light of the perception that sales of health products to the public sector in developing countries are of marginal profitability. On the other hand, when economic realities have been addressed and a mutual (public/private) benefit is ensured, industry has been a willing collaborator in these programs. 624
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Furthermore, there has been a tendency to view primary health care needs as a low-technology imperative; to a certain extent, this approach helps to emphasize the decentralized and self-sufficient characteristics of primary health care. However, the impressive array of modern materials, electronic capabilities, pharmaceutical-packaging technologies, and mass-manufacturing processes offers abundant possibilities for new tools that meet the demanding criteria and fiscal constraints of community health care. PUBLIC/PRIVATE PARTNERSHIPS IN THE DEVELOPMENT OF PRIORITY TECHNOLOGIES FOR HEALTH
Products designed and developed expressly for the purpose of meeting a public health need range from simple products that are suitable for production by home or cottage industries to highly sophisticated technologies that require state-of-the-art industrial processes and materials. All of these "social" technologies differ in one important respect from the technologies that are developed for commerce: their development is driven by a perceived health need rather than a measured market demand. Because need does not equate with the ability to pay for the product, the economic viability of social technologies is always in question. Thus, the developer and sponsor of social technologies must pay a good deal of attention to creating a true demand for the product and gaining commercial-sector interest in the project to ensure long-term availability, quality, and low cost. It is not necessary for the public sector to carry the entire burden of risk for social technologies or to ensure that the resulting products will be available exclusively or even primarily through public-sector programs. Rather, products are brought to a stage where they can be transferred to parties whose primary business is manufacturing and/or marketing so that the products can become economically viable and therefore remain available. The strategy by which this goal is accomplished differs for each technology. However, in every case, a means must be devised whereby public-sector interests are protected and not usurped by private-market interests. In other words, a balance between incentives for the commercial sector's involvement on the one hand and the public sector's need for adapted, low-cost health products on the other must be found for each technology. A number of general strategies are described in the following paragraphs. AN OVERVIEW OF MECHANISMS BY WHICH THE PUBLIC SECTOR CAN ADDRESS HEALTH TECHNOLOGY NEEDS
The elements of a process by which technologies are developed to meet health care needs are shown in Figure 1. Principal activities are: Identification of Need
The development and promotion of clear criteria for each priority health need is a crucial first step in directing health technologies toward societal priorities for costeffective health care. If public health professionals are informed of these priorities and individuals or communities have the ability to pay for health care, the demand side of the market for health products may bring about the necessary redirection without further public-sector intervention. In resource-poor settings (generally the case in de^ veloping countries), further steps are required. The public sector must become involved in stimulating and directing design and development. Technological designs should be based on both expert opinion and the perceived needs of the potential users. Attention to users' needs during the design phase ensures that a technology will be appropriate, effective, and culturally relevant. Therefore, special INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 8:4, 1992
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Free IDENTIFY NEED IDENTIFY TECHNOLOGY Conceive
Clarify
Patents
Adapt Mode Prototype Refine Trade-olfs
COLLABORATE
Criteria
Test Laboratory Field Clinical
Development Manners
Confirm
International Agencies
Target groups
National Agencies
Cost/Benefit
Bilateral Agencies
Priority
^^^^^^^^H
SPECIFICATIONS
PVOs
^ ^ ^ ^ ^ ^ ^ ^ ^ H
Affordable Appropriate
DE
CONSENSUS
MANUFACTURE
PROMOTE
License
Private markels
Protect public sector rights
Procurement agencies
Regulatory approvals
Governments
Tooling OA/GMP Validate Scale up
INTRODUCE
Purchase orders
Model programs Training Locally adapted IEC Packaging National Programs Social marketing Commercial Retail Sales Commercial Markets
APPLICATION Post "Market' Surveillance Evaluation
Figure 1. Directing technologies toward priority health care needs.
effort must be made throughout the design process to incorporate users' feedback into the technology's development. Two important strategies are required to conduct local needs assessments. First, assessment efforts must be coordinated with national health authorities and key nongovernmental organizations. Second, users must participate in the identification of needs, the design of technological features, and the assessment of prototype models. Although this approach may extend the technology's initial design stage, the up-front investment increases the program's efficiency by ensuring that culturally appropriate features of the design are more accurately defined. Early identification of controllable and uncontrollable variables reduces the ultimate number of prototype iterations and the time required for the product's assessment, adaptation, and, eventually, national or regional introduction. Furthermore, the time and cost of identifying and securing manufacturers' collaboration also can be reduced.
Collaboration to Develop a Consensus of Need and a Strategy for Development
Public efforts to generate or direct the development of health technologies cannot be successful if they are isolated from other programs in health development. A high degree of interaction and cooperation with other programs and agencies is required at both international and national levels and between sponsoring countries and partner countries in the developing world. 626
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It is vital for publicly directed technologies, at any stage of their development, to have: (a) wide consensus concerning the need for the product; (b) sufficient understanding within the public or international health community of the development process; (c) general appreciation of the channels through which products can be successfully distributed and sustained; and (d) mutual trust and understanding among the interested public-sector agencies regarding the role of the private commercial sector, the necessary incentives for the private sector's involvement, and the strategies by which the public sector's interests are protected. Identification of a Technology to Meet the Need
The core technologies from which appropriate health products can be derived are available from many sources: the private commercial sector, universities, national laboratories, and other for-profit or nonprofit research and development organizations. Any of these organizations can be willing partners in the development of priority health technologies. Fundamental to the success of this activity is the freedom of the innovating partner to explore, invent, adapt, and assess technologies while guided by clear criteria of need within the constraints of realistic budget and time limits without external micromanagement. However, trade-offs between agreed-upon criteria and the desired cost or features of a product generally are required. Therefore, development must be tightly coupled with laboratory, field, and clinical assessment capabilities in order to guide this trade-off process and ultimately to validate the final design. Identification of Manufacturing Partners
The efficient engines of production are in the commercial sector. Mutually beneficial public/private partnerships with the commercial-manufacturing sector are the most effective means to ensure that publicly directed or developed technologies with high and uniform quality at the lowest cost become available and sustainable. To forge effective partnerships with the commercial sector, it is necessary for the public sector to understand commercial imperatives. On the other hand, strategies for protecting the public sector and meeting the objectives of priority health care needs must be clear and well defined. The issues boil down to: Profitability Versus Affordability. To resolve this issue, both parties must understand the actual costs. Emphasis must be placed on efficiency of production. Economies of scale must be exploited. Dual pricing in favor of resource-poor customers must be encouraged. Monopolistic behavior must be avoided. Risk Sharing. The public sector can reduce fixed costs by underwriting research, development, and assessment activities; by assisting with the product's introduction (marketing); by public endorsement; and by providing conditional purchase orders. Publicly funded technologies should carry a greatly reduced or no-royalty burden for sales to resource-poor customers. In exchange for the market opportunity, the commercial partner should carry the burden of product engineering, tool-up, validation, and scale-up. Opportunity Assessment. Commercial entities must consider the relative return on their investment in a project against other opportunities that are available to them. To make the best case for the opportunity that is presented, it is essential that the public-sector partner approach the negotiations with a clear understanding of the need for the technology, a quantitative assessment of its users and buyers, a clear specification for the product, and a flexibility and willingness to collaborate in a variety of ways. The Value of Intangible Benefits. Corporate philosophy and image may be important factors in the decision to collaborate on a project. Factors such as beneficial INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 8:4, 1992
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public relations, opening of potential new markets, achievement of internal economies of scale, or identification of offshore partners all can be of value to a commercial firm and should be considered in the mutual-benefit equation. Promotion
At the center of all successful strategies for directing technologies toward a priority need is creation of demand. Need alone, no matter how great, is not enough to outweigh the risks and mobilize the capital necessary to bring sustainable technologies into being. Some party or entity must be demonstrably willing and able to buy the product in sufficient numbers to ensure the return on investment. Public-sector involvement through funding can strategically reduce (or at least diffuse) the investment that is required to meet a targeted priority need and, therefore, bring down the cost to the eventual buyer. However, a market still must be developed. That market can be any combination of private users, health care providers and institutions, governments, international- or bilateral-assistance agencies, or private-assistance organizations. Public-sector promotion for acknowledged priority needs for health technology can usefully begin at the stage of the definition of the need. The public sector must then continue to be a partner in the promotion of these products until they are fully integrated and accepted into the health care system. Introduction
A well-designed, cost-effective, health care tool will not be effective unless its providers and users understand its application and limitations and are trained to use it effectively. Locally designed and tested training and informational materials that are suited to the level of education and literacy of the target groups are essential in the developing world to ensure that the technology will be understood in its cultural context. Propagation of techniques for effective application may require demonstration or model programs, tiered training, multimedia materials, and, in some cases, country-by-country introductory field trials. INCENTIVES FOR COMMERCIAL INVOLVEMENT IN SOCIAL TECHNOLOGIES
The most important factor determining the strategy that is to be used to gain commercialsector interest is whether a commercial market exists for the products. Some social technologies for the developing world have no significant private-market potential. For example, technologies such as a risk-assessment weighing device for newborns or a simple birthing kit are designed for use by nonliterate traditional birth attendants and have no obvious utility other than in primary health care settings of the developing world. Except in microeconomic arrangements involving women's groups or cottage industries, little or no commercial interest exists for these devices at a price that can be borne by health programs or assistance agencies. For this type of technology, there are no opportunities for gaining economies of scale or for recovering the cost of development and scale-up with profits from commercial-sector sales. If these products are to be available, the public health sector must bear most or all of the cost of these technologies by underwriting the development costs, purchasing the capital goods (in many cases), and paying a price that covers the remaining cost as well as margins. This type of technology usually involves simple materials and processes; therefore, the risks are bearable, and small- or medium-scale manufacturing can be carried out locally within the countries that need the product. Generally, it is useful to provide some business and marketing assistance to these manufacturing units as well as quality assurance 628
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auditing to the point where production and sale of the product to responsible agencies are well established. The risk of the project's failure is always high. When a social technology has an identifiable, commercial-market potential, the strategies can be quite different, depending upon the extent to which those private markets are marginal or exist only in the developing world rather than in the developed world. Some technologies cannot be scaled up, manufactured, or distributed without the collaboration or participation of a commercial manufacturer. It often is necessary to specify the nature and size of private markets in order to gain the commercial sector's interest. Other incentive-raising strategies include: demonstration of the public sector's commitment through grant funds for engineering or the issuance of purchase orders; reduction of the project's risks by providing loans at favorable terms; or the purchase of capital equipment using public-sector funds. For example, low-cost diagnostic tests for malaria or diarrheal diseases are not needed in the developed world but are purchased by both the public and private sectors in the developing world. On the other hand, some technologies that are developed for use in the developing world have an equal, if not greater, potential market in the developed world. Manufacturers, in this case, are much more willing to invest their own capital in a project to benefit the developing world in exchange for rights to sell the product at a profit to private markets. (Examples of such collaborations follow in the case study.) It is always necessary to preserve, as much as possible, the proprietary nature of the technology through the pursuit of patents, licenses, and confidentiality agreements to encourage the commercial party to view the technology as protected and therefore of value. By the same token, it often is necessary to offer exclusive rights to selected private markets based on specific geographic regions or market segments. Provided that the private markets are an economic reality or that public agencies are willing to make up-front commitments, a manufacturing collaborator usually can be identified. The next step is to implement other strategies to protect the public sector's interests in its negotiations with the collaborator.
PROTECTING THE PUBLIC SECTOR'S INTERESTS
It must always be assumed that the commercial collaborator is not motivated by the public health objectives for which the technology was developed. Rather, this collaborator is interested in recovering, as quickly as possible, any costs incurred from involvement in the project. In addition, the collaborator demands a profit to justify the risks of its investment. Consequently, protecting the public sector's interest (i.e., universal availability of the product, lowest possible cost, and responsiveness to local needs) becomes the full responsibility of those parties whose goals and objectives are aligned with the public sector's interest (e.g., a bridging agency or the public-sector purchaser). The broad strategies that must be adopted include maintaining sufficient control of the product as it moves into the commercial sector. Under the first strategy - maintaining control — it is necessary at the outset to protect the technology with patents, licenses, copyrights, design registrations, or even trademarks, so that title is clear and negotiations are not hampered by questions of ownership. Licensing strategies seek to avoid monopolies and maintain, as much as possible, the nonexclusivity of public-sector sales in order to promote price competition. If possible, price ceilings for public-sector sales are maintained. The emphasis, however, is on rewarding efficiency, as a reduction in costs can have a much greater impact than can profit margins on the price of the product. When a product is intended for use in the developing world, manufacturers who are already in the developing world are INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 8:4, 1992
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Free used whenever possible to encourage local development, reduce the length of the supply pipeline, and take advantage of lower costs. Dual pricing also is encouraged so that commercial markets can assume the burden of cost recovery and a return on the investment. Commercial manufacturers are encouraged to view public-sector sales not as a direct source of profit but rather as a means to achieve an internal economy of scale, thereby reducing production costs and increasing the margins on commercial sales. A combination of these strategies must be applied in a highly coordinated and flexible way that accounts for the commercial imperative of economic viability. THE ROLE OF BRIDGING ORGANIZATIONS IN PUBLIC/PRIVATE PARTNERSHIPS
The author of this paper has been associated, for the 13 years of its existence, with the Program for Appropriate Technology in Health (PATH).' PATH has experience in the development of effective partnerships between the public and private commercial sectors for the purpose of developing, manufacturing, and introducing priority technologies for health in the developing world. PATH'S activities over the past 12 years have extended to every aspect of technological advancement, including: user-based needs assessments; product development; intellectual property management; laboratory and field assessment; licensing for manufacture and distribution; introduction of new products; promotion; training; transfer of technology for local production; and development of quality test standards, specifications, regulatory procedures, and evaluation. Interactions with the private sector have been with companies in targeted developing-world countries and with commercial firms, nongovernmental organizations, and agencies in the developed world. One of the most important lessons that PATH has learned is the need for effective interaction and collaboration among funding agencies, nongovernmental organizations, commercial firms, host governments, and international health agencies. Without a good working relationship based on trust and mutual respect among these parties, development projects can be seriously impeded or even totally blocked. In the past, one major impediment to these interactions has been a lack of understanding by both the public and private sectors of each other's potential role. Organizations such as PATH serve as bridge builders or facilitators in harnessing the skills and efficiencies of the commercial sector to improve developing world/public-sector health programs. In order to build understanding, PATH has maintained a continuing dialogue with public agencies that enable or facilitate the development and dissemination of new technologies to the developing world. In key governmental and international agencies, a much higher level of understanding and sophistication about the process of product development and advancement and the imperatives for establishing and maintaining commercial-sector interest currently prevails. Another obstacle has been the antipathy or, in some cases, hostility of the commercial sector toward the public sector, especially with respect to the requirements of developing countries. Generally, the commercial sector considers procurement by the public sector to be marginal and capricious and, therefore, risky. In many cases, commercial companies have no knowledge of the conditions of use or other factors that can challenge the effectiveness or quality of their products. PATH has dealt with these obstacles by providing information on the health needs of the developing world, actively seeking technological opportunities to address these needs, and developing risksharing approaches to the development and advancement of products and markets.
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These bridge-building activities have helped a substantial number of commercial companies become willing to enter into collaborative projects and to take significant risks for the advancement of technologies that are designed specifically for health programs in the developing world. A CASE STUDY-TECHNOLOGIES FOR SAFE INJECTION
The strategies suggested here are derived from PATH'S experience with more than 100 diverse technologies, over 13 years, ranging from low-birth-weight scales and diagnostic kits to heat-exposure indicators for vaccines and monitors for use in disinfection by boiling water. Several technologies that are designed to improve the safety of the injection of vaccines and other medications provide concrete examples of some of the points outlined above. The need for better indemnity against the transmission of infection as a result of the injection of vaccines or other medications in developing countries became evident in the mid-1980s. This awareness was driven, in part, by the fear that AIDS and hepatitis B might be spread by the use of contaminated needles and, in any case, might cause people to avoid vaccination out of fear of contracting these diseases. PATH and others began to review this set of needs and the technological opportunities that were available to address them. Surveys were carried out by PATH and WHO to determine the availability of autodestruct syringes and to review their applicability to the developing world. WHO encouraged inventors and entrepreneurs to accept the challenge. Several of the devices that were developed at PATH were identified as the most promising designs. This finding led to a concern on the part of WHO about conflict of interest. PATH'S pursuit of patents and negotiations with potential licensees of its own inventions also caused concern among the agencies that funded it, as these are typically commercial activities that are not normally carried out by public-sector grantees or nonprofit agencies. These concerns were not resolved totally until licenses with private firms, royalty-free to the public sector and containing a variety of protection clauses for the public sector were executed and could be disclosed in full. One of PATH'S designs is a standard syringe with a feature added to it to make it nonreusable. Development at PATH was primarily supported by USAID under the Technologies for Child Health (HealthTech) program. Once the license was awarded, the multinational industrial partner carried all of the risks and the burden of the costs of scale-up, manufacturing, and delivery of the device. Now PATH'S role is limited to the development of printed and multimedia materials for training and disseminating information. Also, because of WHO'S concerns, an independent validation of PATH's technologies has been required and has provided an excellent opportunity for collaboration between USAID contractors. A highly effective and well-planned clinical field trial of this technology was carried out in a developing country by the USAID-funded REACH program run by John Snow, Inc. The trial was monitored closely by WHO and provided a basis for a WHO recommendation to UNICEF to distribute the technology. In 1990-91, orders to the multinational licensee were placed by the supply division of UNICEF. UNICEF will distribute this and two other designs of nonreusable syringes beginning in 1992. PATH plans postdistribution evaluation of the technology to determine its true impact on health in the developing world. Another technology that is supported by USAID is a prefilled, single-use injection device. This was judged by PATH to require an entirely different strategy for its development for several reasons: (a) it was less likely to replace existing syringes but INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 8:4, 1992
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would serve to extend immunization and other therapeutic practices that require injections outside the formal health system to village health workers; (b) it was both a package for medications and an instrument for injection and thus required the collaboration of multiple manufacturers of vaccines and other injectibles; and (c) the introduction of this technology would take a longer time and initially would result in relatively small orders. It was therefore necessary to demonstrate a potentially large market in the private sector in order to achieve the economies of scale that are required to make the device affordable in developing countries. Parallel with the development of this device, it was deemed necessary to raise the public sector's consciousness about the potential for the extension of vaccinations outside of the formal health system and outside of the existing cold chain. This expansion seemed immediately applicable to the more stable vaccines such as tetanus toxoid and hepatitis B, which, coincidentally, are required by pregnant mothers and children at birth. Most pregnancies and births in the developing world occur outside of the formal health system. PATH identified a primary licensee to scale-up and produce the plastic injection system, work with identified pharmaceutical manufacturers to carry out stability trials with different medications, and develop and transfer the device's filling and sealing capabilities. In exchange for potential private commercial sales of the device, the primary licensee acquired the burden of the production engineering and scale-up costs, as well as some costs of the field and safety evaluations. Collaborative partnerships with WHO, the Swedish National Bacteriological Laboratory, the Commonwealth Serum Laboratory in Australia, and a number of pharmaceutical manufacturers were developed to examine the potential of the device for use with a variety of vaccines and other injectibles. Among the industrial collaborators were U.S., French, Swedish, Korean, Indonesian, Australian, Indian, and Mexican firms. As both public and private institutions have become more familiar with the role of PATH and its goals and strategies, the process of forging partnerships has become easier. As new milestones in the development of these technologies are achieved, details are shared with the key agencies in WHO and with USAID and other bilateral overseas assistance agencies, as well as with signed public-sector partners and potential partners with interests in field evaluation or deployment in developing countries. Some setbacks or disappointments have occurred because of the difficulties of predicting the cost and, therefore, the cost-benefit of technologies in the early stages of development before the true scale-up, manufacturing, and final material costs can be calculated fully. Other concerns, such as the degree of protection against willful attempts to reuse the device, the impact on the cold chain, the cost of having to include a needle inside the refrigerators, the impact of the technology on vaccine wastage, and a litany of other legitimate questions result in continuing and cost-engendering tasks that have to be closely coordinated and efficiently resolved. These seemingly endless sequelae tax the patience of courageous public-sector funding agencies and try their resolve in seeing the technologies through to their introduction, often over a more than 5-year development period. UNICEF is a critical agency for primary introduction and distribution of new developing technologies in world health; many of PATH'S technologies have been developed or advanced with the assistance of USAID under the HealthTech program. A joint Technology Introduction Panel was inaugurated by UNICEF in 1988 so that UNICEF, USAID, and relevant WHO agencies could jointly examine the potential of some emerging technologies and define roles and strategies for their introduction. This type of interagency review has been immensely beneficial in avoiding duplication 632
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of effort and ensuring the efficient deployment of public funds toward improved health technologies. It remains to be seen how the scene with injection technologies plays out—whether the benefits will be as predicted. Taking a diverse, multitechnology approach to the final goal has been key. The needs of developing countries are diverse; one technology is unlikely to be suitable for all regions or countries. By addressing clusters of related needs and developing linked technologies, the public sector's investment in this area likely will reap a better-than-average return in public benefits for the developing world. The benefits are tangible and lasting and will stimulate a level of awareness and related or alternative actions that likely will have an even more far-reaching impact on health in the developing world. SUMMARY
Priority health technologies are often those that meet a perceived health need rather than a quantifiable market demand. These technologies make inherently risky business projects, because the ultimate users cannot afford to buy them directly and must rely on third parties such as social agencies, donors, government agencies, assistance organizations, and public programs. In developing countries, most priority health care needs are in this category. There is a role for the public sector in directing technologies toward priority health care needs. The public sector can achieve this by defining the markets, thereby creating demand, and by sharing the risks, thereby encouraging the private commercial sector to become involved. In both sectors during the 1980s, there occurred an increase in the awareness of the need and mechanisms for public/private sector collaboration. Building upon this trend in the present decade likely will bring about an unprecedented level of such collaboration as the efficiencies, win/win opportunities, and synergistic power of such partnerships become more generally recognized. For health care in particular, public/private collaboration likely will blossom in developed as well as developing countries as a consequence of the fundamental inadequacies of health care as a marketplace. NOTE 1
The Program for Appropriate Technology in Health (PATH) is a nonprofit, nongovernmental, international organization with headquarters in Seattle, Washington and offices in Washington, DC; Jakarta, Indonesia; Nairobi, Kenya; and Bangkok, Thailand. PATH's mission is to improve health, especially the health of women and children in developing countries. PATH's mission is accomplished by focusing on the effectiveness, availability, safety, and appropriateness of technologies for health and family planning. PATH's programs work to bridge the gap between technologies and potential users through a wide spectrum of activities including research and development, field assessment, communication, and technology transfer. Technologies that contribute to the health of women and children receive special attention. Program areas include reproductive health, such as safe birth and the introduction of contraceptive technologies; child health, including growth monitoring, oral rehydration therapy, and nutrition; immunization; diagnostic technologies; and information, education, and communication. In the mid-1970s, the founders of PATH and its sister organization, Program for the Introduction and Adaptation of Contraceptive Technology (PIACT), took account of the inadequacies of many health care products that found their way into developing world health care programs. They recognized that many other technologies existed that could be adapted to these special needs. They noted that many potentially useful technologies developed in the public sector were not moving out from investigators' laboratories and clinics and into scale-up, manufacturing, and distribution. They perceived some missing links: operations research to assist developing INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 8:4, 1992
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Free countries in identifying and defining technological needs; facilitating agencies to identify and channel technologies toward priority health needs; a bridge to join the public and private commercial sector in an effective partnership to meet those needs; and executing agencies to introduce, transfer, and adapt technologies to local settings. With the objective of providing those links, PATH has managed more than 500 health and family planning projects in 30 developing countries during its 13-year history. Support has been received from a wide variety of funding sources, including international health and family planning agencies, national governments, private foundations, and corporations. PATH, which is registered as a 501(c)(3) tax-exempt organization, has been designated as a WHO Collaborating Center in three areas: Hepatitis B Vaccination, Research in Human Reproduction, and AIDS. As a collaborating center, PATH provides technical expertise to WHO in each of these areas. PATH policies and broad program strategies are formulated by its board of directors. Its members come from 7 developing countries and represent a variety of disciplines. REFERENCES
1. Cates, W, Guest, E, Hatcher, R., et al. Contraceptive Technology 1990-1992, 15th Revised Ed. New York: Irvington Publishers, Inc., 1990. 2. Curtis, C. F. (ed.). Appropriate technology in vector control. Boca Raton, FL: CRC Press, Inc., 1990. 3. Mandl, P.-E. (ed.). Assignment children, a child survival and development revolution. Geneva: UNICEF Publications, 1983. 4. Morgan, P. Rural water supplies and sanitation. London: Macmillan Education Ltd. & Ministry of Health, Zimbabwe, 1990. 5. The Rockefeller Foundation. Conference report, protecting the world's children: Vaccines and immunization within primary health care. New York: The Rockefeller Foundation, June 1984. 6. Williams, G. A simple solution. Geneva and New York: UNICEF, June 1987. 7. Wilson, R. G., Ofosu-Amaah, S., & Belsey, M. A. (eds.). Primary health care technologies at the family and community levels. London: Thompson & Thompkins Publishers; Geneva: Aga Khan Foundation; New York: UNICEF, 1986. 8. World Health Organization. Formulating strategies for health for all by the year 2000. Geneva: World Health Organization, 1979.
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HEALTH TECHNOLOGIES FOR THE DEVELOPING WORLD Addressing the Unmet Needs Michael J. Free Program for Appropriate Technology in Health
Abstract This paper provides a critical overview of several strategies and mechanisms that have been employed by the Program for Appropriate Technology in Health over the past decade to address the unmet needs for health technologies in the developing world. Partnerships between public and private-sector organizations are emphasized in order to share risks, encourage efficiency, and ensure the availability of priority products for health care in resource-poor settings. Incentives for the involvement of the commercial sector, the means to protect the interest of the public sector, and the role of bridging organizations are discussed in the light of the shifting goals of the public sector.
GROWING AWARENESS OF THE NEED FOR PUBLIC-SECTOR INVOLVEMENT IN HEALTH TECHNOLOGIES
In the late 1970s and early 1980s, leaders in health care redoubled their efforts to improve health in the developing world. Following the declaration of "Health for All by the Year 2000," there began a period of review, debate, and planning to achieve this goal. The top priorities identified were: immunization and oral rehydration, nutrition, birth spacing, control of acute respiratory infections and vector-borne diseases, and the provision of clean water and adequate sanitation (3;8). The setting of these priorities emerged from a variety of considerations. First, the rates of infant and childhood death were unacceptably high in developing countries, varying from 2 to 20 times the rates in developed countries. Second, the priorities represented those interventions that might contribute most significantly to reducing mortality and morbidity among children. Third, it was argued that technologies to carry out these interventions had been developed. Although vaccines, oral-rehydration solutions (ORS), foods and food supplements, antibiotics, vector-control agents, water pumps, and latrines existed, these interventions were not sufficiently available. Over the next few years, the experience of implementing primary health care programs in developing countries supported the initial enthusiasm. Where programs were applied with strong political commitment and adequate funding, impressive reductions in infant mortality followed. It became increasingly clear, however, that "something was wrong." Infant mortality remained high even in countries with the best programs. Health experts realized that the early optimism that "technological solutions 623
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existed" was naive. In practically every primary health care program, problems had arisen with the application of technologies. These included the following: • Vaccines exposed to heat lost their potency (5;7). • Cold chains designed to protect vaccines required expensive equipment, fuel, and maintenance (5;7). • Syringes that were not properly sterilized resulted in the transmission of disease (5;7). • Mothers did not like the taste of ORS and demanded modified solutions (6;7). • ORS did not "cure" diarrhea, stimulating a search for a modified solution that reduces stool output and helps maintain nutritional status (6;7). • Vector-control agents resulted in the dominance of resistant strains and were considered to be dangerous to the environment, resulting in the abandonment of their use and the initiation of research of new products (2). • Contraceptives had side effects and were not effective or acceptable in other ways (1). • Water pumps broke down and could not be repaired easily in the field (4). • Latrines became sites of disease because they could not easily be maintained (4).
What appeared to be one of the "givens" of health — availability of safe, effective, acceptable, appropriate technology—was now seen as largely ephemeral. What was needed was the development of new technologies or the adaptation of existing products to meet the unique conditions of developing countries. A variety of approaches to each health problem were seen to be necessary to overcome the diverse cultural, political, economic, educational, and infrastructural problems of different regions and countries. The international health community has responded aggressively to many of these problems. Programs of research on new formulations of ORS are now well under way. There are major international efforts to develop new and improved contraceptives, notably by the Population Council, a pioneer in the noncommercial development of technologies for family planning in response to needs. The United States Agency for International Development (USAID) has funded the Water and Sanitation for Health project to work in water and sanitation. The World Health Organization (WHO) has established the Tropical Diseases Research program with a product-development unit. The WHO/Expanded Program on Immunization (EPI) has had a major impact on the quality and availability of cold-chain and other vaccine-related technologies. The WHO/Special Program in Human Reproduction (HRP) has taken a major role in the development of new contraceptives. USAID sponsored the Diagnostic Technologies for Community Health (DiaTech) program, an international program to develop new diagnostic tools for use in conjunction with immunization and other disease-control programs. USAID also sponsored Project SUPPORT (Supply, Production, and Promotion of Oral Rehydration Salts in Developing Countries), the Technologies for Child Health program (HealthTech), and a variety of vaccine development programs. It is of interest to note that each of these programs has been set up with funding from the public sector or charitable foundations. Industry did not step forward to invest the required funds. This reluctance is understandable in light of the perception that sales of health products to the public sector in developing countries are of marginal profitability. On the other hand, when economic realities have been addressed and a mutual (public/private) benefit is ensured, industry has been a willing collaborator in these programs. 624
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Furthermore, there has been a tendency to view primary health care needs as a low-technology imperative; to a certain extent, this approach helps to emphasize the decentralized and self-sufficient characteristics of primary health care. However, the impressive array of modern materials, electronic capabilities, pharmaceutical-packaging technologies, and mass-manufacturing processes offers abundant possibilities for new tools that meet the demanding criteria and fiscal constraints of community health care. PUBLIC/PRIVATE PARTNERSHIPS IN THE DEVELOPMENT OF PRIORITY TECHNOLOGIES FOR HEALTH
Products designed and developed expressly for the purpose of meeting a public health need range from simple products that are suitable for production by home or cottage industries to highly sophisticated technologies that require state-of-the-art industrial processes and materials. All of these "social" technologies differ in one important respect from the technologies that are developed for commerce: their development is driven by a perceived health need rather than a measured market demand. Because need does not equate with the ability to pay for the product, the economic viability of social technologies is always in question. Thus, the developer and sponsor of social technologies must pay a good deal of attention to creating a true demand for the product and gaining commercial-sector interest in the project to ensure long-term availability, quality, and low cost. It is not necessary for the public sector to carry the entire burden of risk for social technologies or to ensure that the resulting products will be available exclusively or even primarily through public-sector programs. Rather, products are brought to a stage where they can be transferred to parties whose primary business is manufacturing and/or marketing so that the products can become economically viable and therefore remain available. The strategy by which this goal is accomplished differs for each technology. However, in every case, a means must be devised whereby public-sector interests are protected and not usurped by private-market interests. In other words, a balance between incentives for the commercial sector's involvement on the one hand and the public sector's need for adapted, low-cost health products on the other must be found for each technology. A number of general strategies are described in the following paragraphs. AN OVERVIEW OF MECHANISMS BY WHICH THE PUBLIC SECTOR CAN ADDRESS HEALTH TECHNOLOGY NEEDS
The elements of a process by which technologies are developed to meet health care needs are shown in Figure 1. Principal activities are: Identification of Need
The development and promotion of clear criteria for each priority health need is a crucial first step in directing health technologies toward societal priorities for costeffective health care. If public health professionals are informed of these priorities and individuals or communities have the ability to pay for health care, the demand side of the market for health products may bring about the necessary redirection without further public-sector intervention. In resource-poor settings (generally the case in de^ veloping countries), further steps are required. The public sector must become involved in stimulating and directing design and development. Technological designs should be based on both expert opinion and the perceived needs of the potential users. Attention to users' needs during the design phase ensures that a technology will be appropriate, effective, and culturally relevant. Therefore, special INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 8:4, 1992
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Free IDENTIFY NEED IDENTIFY TECHNOLOGY Conceive
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Adapt Mode Prototype Refine Trade-olfs
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Test Laboratory Field Clinical
Development Manners
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International Agencies
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National Agencies
Cost/Benefit
Bilateral Agencies
Priority
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Affordable Appropriate
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INTRODUCE
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Model programs Training Locally adapted IEC Packaging National Programs Social marketing Commercial Retail Sales Commercial Markets
APPLICATION Post "Market' Surveillance Evaluation
Figure 1. Directing technologies toward priority health care needs.
effort must be made throughout the design process to incorporate users' feedback into the technology's development. Two important strategies are required to conduct local needs assessments. First, assessment efforts must be coordinated with national health authorities and key nongovernmental organizations. Second, users must participate in the identification of needs, the design of technological features, and the assessment of prototype models. Although this approach may extend the technology's initial design stage, the up-front investment increases the program's efficiency by ensuring that culturally appropriate features of the design are more accurately defined. Early identification of controllable and uncontrollable variables reduces the ultimate number of prototype iterations and the time required for the product's assessment, adaptation, and, eventually, national or regional introduction. Furthermore, the time and cost of identifying and securing manufacturers' collaboration also can be reduced.
Collaboration to Develop a Consensus of Need and a Strategy for Development
Public efforts to generate or direct the development of health technologies cannot be successful if they are isolated from other programs in health development. A high degree of interaction and cooperation with other programs and agencies is required at both international and national levels and between sponsoring countries and partner countries in the developing world. 626
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It is vital for publicly directed technologies, at any stage of their development, to have: (a) wide consensus concerning the need for the product; (b) sufficient understanding within the public or international health community of the development process; (c) general appreciation of the channels through which products can be successfully distributed and sustained; and (d) mutual trust and understanding among the interested public-sector agencies regarding the role of the private commercial sector, the necessary incentives for the private sector's involvement, and the strategies by which the public sector's interests are protected. Identification of a Technology to Meet the Need
The core technologies from which appropriate health products can be derived are available from many sources: the private commercial sector, universities, national laboratories, and other for-profit or nonprofit research and development organizations. Any of these organizations can be willing partners in the development of priority health technologies. Fundamental to the success of this activity is the freedom of the innovating partner to explore, invent, adapt, and assess technologies while guided by clear criteria of need within the constraints of realistic budget and time limits without external micromanagement. However, trade-offs between agreed-upon criteria and the desired cost or features of a product generally are required. Therefore, development must be tightly coupled with laboratory, field, and clinical assessment capabilities in order to guide this trade-off process and ultimately to validate the final design. Identification of Manufacturing Partners
The efficient engines of production are in the commercial sector. Mutually beneficial public/private partnerships with the commercial-manufacturing sector are the most effective means to ensure that publicly directed or developed technologies with high and uniform quality at the lowest cost become available and sustainable. To forge effective partnerships with the commercial sector, it is necessary for the public sector to understand commercial imperatives. On the other hand, strategies for protecting the public sector and meeting the objectives of priority health care needs must be clear and well defined. The issues boil down to: Profitability Versus Affordability. To resolve this issue, both parties must understand the actual costs. Emphasis must be placed on efficiency of production. Economies of scale must be exploited. Dual pricing in favor of resource-poor customers must be encouraged. Monopolistic behavior must be avoided. Risk Sharing. The public sector can reduce fixed costs by underwriting research, development, and assessment activities; by assisting with the product's introduction (marketing); by public endorsement; and by providing conditional purchase orders. Publicly funded technologies should carry a greatly reduced or no-royalty burden for sales to resource-poor customers. In exchange for the market opportunity, the commercial partner should carry the burden of product engineering, tool-up, validation, and scale-up. Opportunity Assessment. Commercial entities must consider the relative return on their investment in a project against other opportunities that are available to them. To make the best case for the opportunity that is presented, it is essential that the public-sector partner approach the negotiations with a clear understanding of the need for the technology, a quantitative assessment of its users and buyers, a clear specification for the product, and a flexibility and willingness to collaborate in a variety of ways. The Value of Intangible Benefits. Corporate philosophy and image may be important factors in the decision to collaborate on a project. Factors such as beneficial INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 8:4, 1992
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public relations, opening of potential new markets, achievement of internal economies of scale, or identification of offshore partners all can be of value to a commercial firm and should be considered in the mutual-benefit equation. Promotion
At the center of all successful strategies for directing technologies toward a priority need is creation of demand. Need alone, no matter how great, is not enough to outweigh the risks and mobilize the capital necessary to bring sustainable technologies into being. Some party or entity must be demonstrably willing and able to buy the product in sufficient numbers to ensure the return on investment. Public-sector involvement through funding can strategically reduce (or at least diffuse) the investment that is required to meet a targeted priority need and, therefore, bring down the cost to the eventual buyer. However, a market still must be developed. That market can be any combination of private users, health care providers and institutions, governments, international- or bilateral-assistance agencies, or private-assistance organizations. Public-sector promotion for acknowledged priority needs for health technology can usefully begin at the stage of the definition of the need. The public sector must then continue to be a partner in the promotion of these products until they are fully integrated and accepted into the health care system. Introduction
A well-designed, cost-effective, health care tool will not be effective unless its providers and users understand its application and limitations and are trained to use it effectively. Locally designed and tested training and informational materials that are suited to the level of education and literacy of the target groups are essential in the developing world to ensure that the technology will be understood in its cultural context. Propagation of techniques for effective application may require demonstration or model programs, tiered training, multimedia materials, and, in some cases, country-by-country introductory field trials. INCENTIVES FOR COMMERCIAL INVOLVEMENT IN SOCIAL TECHNOLOGIES
The most important factor determining the strategy that is to be used to gain commercialsector interest is whether a commercial market exists for the products. Some social technologies for the developing world have no significant private-market potential. For example, technologies such as a risk-assessment weighing device for newborns or a simple birthing kit are designed for use by nonliterate traditional birth attendants and have no obvious utility other than in primary health care settings of the developing world. Except in microeconomic arrangements involving women's groups or cottage industries, little or no commercial interest exists for these devices at a price that can be borne by health programs or assistance agencies. For this type of technology, there are no opportunities for gaining economies of scale or for recovering the cost of development and scale-up with profits from commercial-sector sales. If these products are to be available, the public health sector must bear most or all of the cost of these technologies by underwriting the development costs, purchasing the capital goods (in many cases), and paying a price that covers the remaining cost as well as margins. This type of technology usually involves simple materials and processes; therefore, the risks are bearable, and small- or medium-scale manufacturing can be carried out locally within the countries that need the product. Generally, it is useful to provide some business and marketing assistance to these manufacturing units as well as quality assurance 628
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auditing to the point where production and sale of the product to responsible agencies are well established. The risk of the project's failure is always high. When a social technology has an identifiable, commercial-market potential, the strategies can be quite different, depending upon the extent to which those private markets are marginal or exist only in the developing world rather than in the developed world. Some technologies cannot be scaled up, manufactured, or distributed without the collaboration or participation of a commercial manufacturer. It often is necessary to specify the nature and size of private markets in order to gain the commercial sector's interest. Other incentive-raising strategies include: demonstration of the public sector's commitment through grant funds for engineering or the issuance of purchase orders; reduction of the project's risks by providing loans at favorable terms; or the purchase of capital equipment using public-sector funds. For example, low-cost diagnostic tests for malaria or diarrheal diseases are not needed in the developed world but are purchased by both the public and private sectors in the developing world. On the other hand, some technologies that are developed for use in the developing world have an equal, if not greater, potential market in the developed world. Manufacturers, in this case, are much more willing to invest their own capital in a project to benefit the developing world in exchange for rights to sell the product at a profit to private markets. (Examples of such collaborations follow in the case study.) It is always necessary to preserve, as much as possible, the proprietary nature of the technology through the pursuit of patents, licenses, and confidentiality agreements to encourage the commercial party to view the technology as protected and therefore of value. By the same token, it often is necessary to offer exclusive rights to selected private markets based on specific geographic regions or market segments. Provided that the private markets are an economic reality or that public agencies are willing to make up-front commitments, a manufacturing collaborator usually can be identified. The next step is to implement other strategies to protect the public sector's interests in its negotiations with the collaborator.
PROTECTING THE PUBLIC SECTOR'S INTERESTS
It must always be assumed that the commercial collaborator is not motivated by the public health objectives for which the technology was developed. Rather, this collaborator is interested in recovering, as quickly as possible, any costs incurred from involvement in the project. In addition, the collaborator demands a profit to justify the risks of its investment. Consequently, protecting the public sector's interest (i.e., universal availability of the product, lowest possible cost, and responsiveness to local needs) becomes the full responsibility of those parties whose goals and objectives are aligned with the public sector's interest (e.g., a bridging agency or the public-sector purchaser). The broad strategies that must be adopted include maintaining sufficient control of the product as it moves into the commercial sector. Under the first strategy - maintaining control — it is necessary at the outset to protect the technology with patents, licenses, copyrights, design registrations, or even trademarks, so that title is clear and negotiations are not hampered by questions of ownership. Licensing strategies seek to avoid monopolies and maintain, as much as possible, the nonexclusivity of public-sector sales in order to promote price competition. If possible, price ceilings for public-sector sales are maintained. The emphasis, however, is on rewarding efficiency, as a reduction in costs can have a much greater impact than can profit margins on the price of the product. When a product is intended for use in the developing world, manufacturers who are already in the developing world are INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 8:4, 1992
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Free used whenever possible to encourage local development, reduce the length of the supply pipeline, and take advantage of lower costs. Dual pricing also is encouraged so that commercial markets can assume the burden of cost recovery and a return on the investment. Commercial manufacturers are encouraged to view public-sector sales not as a direct source of profit but rather as a means to achieve an internal economy of scale, thereby reducing production costs and increasing the margins on commercial sales. A combination of these strategies must be applied in a highly coordinated and flexible way that accounts for the commercial imperative of economic viability. THE ROLE OF BRIDGING ORGANIZATIONS IN PUBLIC/PRIVATE PARTNERSHIPS
The author of this paper has been associated, for the 13 years of its existence, with the Program for Appropriate Technology in Health (PATH).' PATH has experience in the development of effective partnerships between the public and private commercial sectors for the purpose of developing, manufacturing, and introducing priority technologies for health in the developing world. PATH'S activities over the past 12 years have extended to every aspect of technological advancement, including: user-based needs assessments; product development; intellectual property management; laboratory and field assessment; licensing for manufacture and distribution; introduction of new products; promotion; training; transfer of technology for local production; and development of quality test standards, specifications, regulatory procedures, and evaluation. Interactions with the private sector have been with companies in targeted developing-world countries and with commercial firms, nongovernmental organizations, and agencies in the developed world. One of the most important lessons that PATH has learned is the need for effective interaction and collaboration among funding agencies, nongovernmental organizations, commercial firms, host governments, and international health agencies. Without a good working relationship based on trust and mutual respect among these parties, development projects can be seriously impeded or even totally blocked. In the past, one major impediment to these interactions has been a lack of understanding by both the public and private sectors of each other's potential role. Organizations such as PATH serve as bridge builders or facilitators in harnessing the skills and efficiencies of the commercial sector to improve developing world/public-sector health programs. In order to build understanding, PATH has maintained a continuing dialogue with public agencies that enable or facilitate the development and dissemination of new technologies to the developing world. In key governmental and international agencies, a much higher level of understanding and sophistication about the process of product development and advancement and the imperatives for establishing and maintaining commercial-sector interest currently prevails. Another obstacle has been the antipathy or, in some cases, hostility of the commercial sector toward the public sector, especially with respect to the requirements of developing countries. Generally, the commercial sector considers procurement by the public sector to be marginal and capricious and, therefore, risky. In many cases, commercial companies have no knowledge of the conditions of use or other factors that can challenge the effectiveness or quality of their products. PATH has dealt with these obstacles by providing information on the health needs of the developing world, actively seeking technological opportunities to address these needs, and developing risksharing approaches to the development and advancement of products and markets.
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These bridge-building activities have helped a substantial number of commercial companies become willing to enter into collaborative projects and to take significant risks for the advancement of technologies that are designed specifically for health programs in the developing world. A CASE STUDY-TECHNOLOGIES FOR SAFE INJECTION
The strategies suggested here are derived from PATH'S experience with more than 100 diverse technologies, over 13 years, ranging from low-birth-weight scales and diagnostic kits to heat-exposure indicators for vaccines and monitors for use in disinfection by boiling water. Several technologies that are designed to improve the safety of the injection of vaccines and other medications provide concrete examples of some of the points outlined above. The need for better indemnity against the transmission of infection as a result of the injection of vaccines or other medications in developing countries became evident in the mid-1980s. This awareness was driven, in part, by the fear that AIDS and hepatitis B might be spread by the use of contaminated needles and, in any case, might cause people to avoid vaccination out of fear of contracting these diseases. PATH and others began to review this set of needs and the technological opportunities that were available to address them. Surveys were carried out by PATH and WHO to determine the availability of autodestruct syringes and to review their applicability to the developing world. WHO encouraged inventors and entrepreneurs to accept the challenge. Several of the devices that were developed at PATH were identified as the most promising designs. This finding led to a concern on the part of WHO about conflict of interest. PATH'S pursuit of patents and negotiations with potential licensees of its own inventions also caused concern among the agencies that funded it, as these are typically commercial activities that are not normally carried out by public-sector grantees or nonprofit agencies. These concerns were not resolved totally until licenses with private firms, royalty-free to the public sector and containing a variety of protection clauses for the public sector were executed and could be disclosed in full. One of PATH'S designs is a standard syringe with a feature added to it to make it nonreusable. Development at PATH was primarily supported by USAID under the Technologies for Child Health (HealthTech) program. Once the license was awarded, the multinational industrial partner carried all of the risks and the burden of the costs of scale-up, manufacturing, and delivery of the device. Now PATH'S role is limited to the development of printed and multimedia materials for training and disseminating information. Also, because of WHO'S concerns, an independent validation of PATH's technologies has been required and has provided an excellent opportunity for collaboration between USAID contractors. A highly effective and well-planned clinical field trial of this technology was carried out in a developing country by the USAID-funded REACH program run by John Snow, Inc. The trial was monitored closely by WHO and provided a basis for a WHO recommendation to UNICEF to distribute the technology. In 1990-91, orders to the multinational licensee were placed by the supply division of UNICEF. UNICEF will distribute this and two other designs of nonreusable syringes beginning in 1992. PATH plans postdistribution evaluation of the technology to determine its true impact on health in the developing world. Another technology that is supported by USAID is a prefilled, single-use injection device. This was judged by PATH to require an entirely different strategy for its development for several reasons: (a) it was less likely to replace existing syringes but INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 8:4, 1992
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would serve to extend immunization and other therapeutic practices that require injections outside the formal health system to village health workers; (b) it was both a package for medications and an instrument for injection and thus required the collaboration of multiple manufacturers of vaccines and other injectibles; and (c) the introduction of this technology would take a longer time and initially would result in relatively small orders. It was therefore necessary to demonstrate a potentially large market in the private sector in order to achieve the economies of scale that are required to make the device affordable in developing countries. Parallel with the development of this device, it was deemed necessary to raise the public sector's consciousness about the potential for the extension of vaccinations outside of the formal health system and outside of the existing cold chain. This expansion seemed immediately applicable to the more stable vaccines such as tetanus toxoid and hepatitis B, which, coincidentally, are required by pregnant mothers and children at birth. Most pregnancies and births in the developing world occur outside of the formal health system. PATH identified a primary licensee to scale-up and produce the plastic injection system, work with identified pharmaceutical manufacturers to carry out stability trials with different medications, and develop and transfer the device's filling and sealing capabilities. In exchange for potential private commercial sales of the device, the primary licensee acquired the burden of the production engineering and scale-up costs, as well as some costs of the field and safety evaluations. Collaborative partnerships with WHO, the Swedish National Bacteriological Laboratory, the Commonwealth Serum Laboratory in Australia, and a number of pharmaceutical manufacturers were developed to examine the potential of the device for use with a variety of vaccines and other injectibles. Among the industrial collaborators were U.S., French, Swedish, Korean, Indonesian, Australian, Indian, and Mexican firms. As both public and private institutions have become more familiar with the role of PATH and its goals and strategies, the process of forging partnerships has become easier. As new milestones in the development of these technologies are achieved, details are shared with the key agencies in WHO and with USAID and other bilateral overseas assistance agencies, as well as with signed public-sector partners and potential partners with interests in field evaluation or deployment in developing countries. Some setbacks or disappointments have occurred because of the difficulties of predicting the cost and, therefore, the cost-benefit of technologies in the early stages of development before the true scale-up, manufacturing, and final material costs can be calculated fully. Other concerns, such as the degree of protection against willful attempts to reuse the device, the impact on the cold chain, the cost of having to include a needle inside the refrigerators, the impact of the technology on vaccine wastage, and a litany of other legitimate questions result in continuing and cost-engendering tasks that have to be closely coordinated and efficiently resolved. These seemingly endless sequelae tax the patience of courageous public-sector funding agencies and try their resolve in seeing the technologies through to their introduction, often over a more than 5-year development period. UNICEF is a critical agency for primary introduction and distribution of new developing technologies in world health; many of PATH'S technologies have been developed or advanced with the assistance of USAID under the HealthTech program. A joint Technology Introduction Panel was inaugurated by UNICEF in 1988 so that UNICEF, USAID, and relevant WHO agencies could jointly examine the potential of some emerging technologies and define roles and strategies for their introduction. This type of interagency review has been immensely beneficial in avoiding duplication 632
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of effort and ensuring the efficient deployment of public funds toward improved health technologies. It remains to be seen how the scene with injection technologies plays out—whether the benefits will be as predicted. Taking a diverse, multitechnology approach to the final goal has been key. The needs of developing countries are diverse; one technology is unlikely to be suitable for all regions or countries. By addressing clusters of related needs and developing linked technologies, the public sector's investment in this area likely will reap a better-than-average return in public benefits for the developing world. The benefits are tangible and lasting and will stimulate a level of awareness and related or alternative actions that likely will have an even more far-reaching impact on health in the developing world. SUMMARY
Priority health technologies are often those that meet a perceived health need rather than a quantifiable market demand. These technologies make inherently risky business projects, because the ultimate users cannot afford to buy them directly and must rely on third parties such as social agencies, donors, government agencies, assistance organizations, and public programs. In developing countries, most priority health care needs are in this category. There is a role for the public sector in directing technologies toward priority health care needs. The public sector can achieve this by defining the markets, thereby creating demand, and by sharing the risks, thereby encouraging the private commercial sector to become involved. In both sectors during the 1980s, there occurred an increase in the awareness of the need and mechanisms for public/private sector collaboration. Building upon this trend in the present decade likely will bring about an unprecedented level of such collaboration as the efficiencies, win/win opportunities, and synergistic power of such partnerships become more generally recognized. For health care in particular, public/private collaboration likely will blossom in developed as well as developing countries as a consequence of the fundamental inadequacies of health care as a marketplace. NOTE 1
The Program for Appropriate Technology in Health (PATH) is a nonprofit, nongovernmental, international organization with headquarters in Seattle, Washington and offices in Washington, DC; Jakarta, Indonesia; Nairobi, Kenya; and Bangkok, Thailand. PATH's mission is to improve health, especially the health of women and children in developing countries. PATH's mission is accomplished by focusing on the effectiveness, availability, safety, and appropriateness of technologies for health and family planning. PATH's programs work to bridge the gap between technologies and potential users through a wide spectrum of activities including research and development, field assessment, communication, and technology transfer. Technologies that contribute to the health of women and children receive special attention. Program areas include reproductive health, such as safe birth and the introduction of contraceptive technologies; child health, including growth monitoring, oral rehydration therapy, and nutrition; immunization; diagnostic technologies; and information, education, and communication. In the mid-1970s, the founders of PATH and its sister organization, Program for the Introduction and Adaptation of Contraceptive Technology (PIACT), took account of the inadequacies of many health care products that found their way into developing world health care programs. They recognized that many other technologies existed that could be adapted to these special needs. They noted that many potentially useful technologies developed in the public sector were not moving out from investigators' laboratories and clinics and into scale-up, manufacturing, and distribution. They perceived some missing links: operations research to assist developing INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 8:4, 1992
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Free countries in identifying and defining technological needs; facilitating agencies to identify and channel technologies toward priority health needs; a bridge to join the public and private commercial sector in an effective partnership to meet those needs; and executing agencies to introduce, transfer, and adapt technologies to local settings. With the objective of providing those links, PATH has managed more than 500 health and family planning projects in 30 developing countries during its 13-year history. Support has been received from a wide variety of funding sources, including international health and family planning agencies, national governments, private foundations, and corporations. PATH, which is registered as a 501(c)(3) tax-exempt organization, has been designated as a WHO Collaborating Center in three areas: Hepatitis B Vaccination, Research in Human Reproduction, and AIDS. As a collaborating center, PATH provides technical expertise to WHO in each of these areas. PATH policies and broad program strategies are formulated by its board of directors. Its members come from 7 developing countries and represent a variety of disciplines. REFERENCES
1. Cates, W, Guest, E, Hatcher, R., et al. Contraceptive Technology 1990-1992, 15th Revised Ed. New York: Irvington Publishers, Inc., 1990. 2. Curtis, C. F. (ed.). Appropriate technology in vector control. Boca Raton, FL: CRC Press, Inc., 1990. 3. Mandl, P.-E. (ed.). Assignment children, a child survival and development revolution. Geneva: UNICEF Publications, 1983. 4. Morgan, P. Rural water supplies and sanitation. London: Macmillan Education Ltd. & Ministry of Health, Zimbabwe, 1990. 5. The Rockefeller Foundation. Conference report, protecting the world's children: Vaccines and immunization within primary health care. New York: The Rockefeller Foundation, June 1984. 6. Williams, G. A simple solution. Geneva and New York: UNICEF, June 1987. 7. Wilson, R. G., Ofosu-Amaah, S., & Belsey, M. A. (eds.). Primary health care technologies at the family and community levels. London: Thompson & Thompkins Publishers; Geneva: Aga Khan Foundation; New York: UNICEF, 1986. 8. World Health Organization. Formulating strategies for health for all by the year 2000. Geneva: World Health Organization, 1979.
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