Creating a Framework for Progress
Globalization’s emerging transnational social organization and epidemiological structure have transformed national public health into an international issue and necessitated the development of global health policy and governance. This chapter summarizes the workshop presentations and discussions on how sovereign states and nations must adopt a global public health mind-set. Also emphasized was the need for a new organizational framework to exploit the opportunities and overcome the challenges created by globalization and build the capacity needed to respond effectively to emerging infectious disease threats.
The trend toward increased funding for international health, such as that made available through the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund) and President Bush’s recently proposed Millennium Challenge Account (MCA), suggests that global public health is finally receiving the political attention it deserves, largely by virtue of its implications for economic development and national security. Global public health is no longer perceived as a costly charity endeavor; rather, it is increasingly being viewed as a cost-effective way of doing business, with countries poised to take action on selected diseases when there is an economic benefit to doing so.
Nonetheless, this increased funding and focus do not necessarily mean enough is being done collectively to enhance the global capacity to respond to either intentionally or naturally introduced infectious disease threats. As one workshop participant noted, global infectious disease control demands new approaches, and despite the welcome recent influx of funding, a fully coordinated and effective response will require even more money. Others
admonished, however, that a lack of money should not be used as an excuse for not moving forward.
This chapter begins with a summary of the workshop discussion on the economic, national security, and other factors responsible for the changing perception of international health. This is followed by a summary of presentations and comments regarding some of the sources of and concerns about increased funding for international public health. The Global Fund and the MCA were discussed in some detail. The participants also briefly discussed the potential public health role of interim debt relief. Despite the promises of new funds and potential sources of even more funding, participants expressed many concerns, particularly with regard to how the funds would be used and whether they would be sustainable. Questions about the role of money also led to a brief discussion regarding the relative value of evidence-based public health and good governance.
With regard to the newer approaches required for global infectious disease control, several different but overlapping ideas were discussed. In addition to the need for consortia of financiers, such as the Global Fund, which are bigger and more flexible than individual agencies, most of the discussion focused on the need for public–private collaborations among states, interstate and regional organizations, nongovernmental organizations (NGOs), multinational corporations, and various other nonstate actors. Not only does the increasingly interconnected world provide opportunities for public–private collaborative responses on an international scale never before possible, but the intensifying cross-border traffic of microbes characteristic of globalization also demands that this opportunity be seized.
Greater interaction and fluidity between the developed and developing worlds, as exemplified by the bidirectional training programs discussed in Chapter 3, were also identified as a vital component of any effort to improve global public health. Throughout the workshop, participants discussed the most effective and sustainable ways to approach and manage collaborations with institutions, governments, and other partners in the developing world. Although some of these comments were included in the discussion of multinational research and training initiatives in Chapter 3, others are presented here.
Most of the public–private and other partnerships discussed during the workshop have been or are being designed to address the urgent and critical public health needs of the developing world and other countries with particular needs, such as Russia. Thus there was some discussion of the need to continue addressing U.S. domestic public health needs as well, especially the rise of antimicrobial resistance. Another important component of global public health identified by participants was the concept of public health as a global public good, especially with regard to product development and the dissemination of knowledge. The former was touched upon during the
discussion on access to and delivery of antiretroviral agents in sub-Saharan Africa, as summarized in Chapter 3.
As globalization creates new governance challenges with respect to infectious disease prevention and control, the role of international law in infectious disease control policy has been shifting in important but uncertain ways. The chapter includes a summary of presentations on the revised International Health Regulations (IHRs) and the changing role of international law.
The chapter ends with a summary of the discussion pertaining to the need to study and understand the emergence of infectious disease threats within the larger social and political context. Historically, study of the emergence of infectious diseases has been restricted to the realm of biology. The political ecology of disease provides a new conceptual framework for understanding the public health consequences of globalization, including, for example, investment decisions that lead to environmental alterations, changing vector ecologies, and increased risk of the emergence and spread of infectious diseases.
THE CHANGING PERCEPTION OF INTERNATIONAL HEALTH1
A significant change in the perception of international health has occurred over the past decade. If asked 10 years ago to think about where international health dollars were being spent, most people would probably have thought of charity or the work of Mother Theresa or Albert Schweitzer. Today, international health is no longer perceived as a costly charity endeavor. Rather, as noted above, it is increasingly being perceived as a cost-effective investment with national security implications. The political and economic instability of sub-Saharan African countries with high HIV infection rates, for example, threatens the potential for strong international trade partnerships and poses a serious national security risk to the United States.
Although the renewed interest in international public health can be attributed mainly to economic and national security concerns, numerous other factors are at play. One participant described this renewed interest as a convergence of economic, humanitarian, and other ideals and strategic interests, including the following:
Diplomacy—Public health is playing an increasingly important and constantly evolving role in international relations. Addressing the burden of
disease in other countries by developing training and research programs, as described in Chapter 3, builds bridges of friendship and trust between U.S. and international scientists and fosters a deeper understanding and mutual respect between the United States and its partner nations. This represents a form of diplomacy with tremendous economic potential.
Economic development—The global burden of infectious disease, which accounts for about 42 percent of the total global burden of disease, is not just about disease but also about money. The causal links among improved health status, an improved standard of living, and economic development are well established. The impact of HIV on economic growth in developing countries, for example, has been tremendous (see Figure 4-1). According to predictions by economist Jeffrey Sachs (WHO, 2000), if malaria had been eliminated 35 years ago, up to $100 billion would have been added to sub-Saharan Africa’s 2002 gross domestic product of $300 billion. Because large-scale epidemics generally increase expenditures, reduce revenues, and raise the cost of doing business, businesses do what they can to minimize those impacts and avert lost productivity. Thus, for purely economic reasons, the private sector has taken a renewed interest in international public health, as have many governments. Unfortunately, increases in morbidity and mortality do not, by themselves, always tell a compelling story until the data are translated into economic terms. Money—not inci-
dence and prevalence rates—is the language finance ministers and treasury secretaries understand.
Increased opportunities for international trade—By investing in the public health systems of developing countries, the United States can develop valuable trading partners, thereby fostering its own economic growth.
International political stability—Better health, improved economies, and stronger diplomatic relationships all foster stronger ties between the United States and its international partners and contribute to the latter’s political stability.
U.S. national security—Much of the renewed interest in global public health in the United States stems from concerns about national security. This was true even before the 2001 anthrax attacks. As one participant suggested, it is imperative for policy leaders and key decision makers to realize that global public health and infectious disease control are critical to preserving national and international economic and political security. In 1998, 200,000 people in Africa died in wars, and 2.2 million died from AIDS. In some countries, more than 30 percent of the military and 40 percent of teachers are infected with HIV. The national security implications of the growing global threat of infectious diseases were highlighted in a recent National Intelligence Council (NIC, 2000) publication, The Global Infectious Disease Threat and Its Implications for the United States.2 The report contained several predictions and warnings, and since its publication, some of its predictions have clearly begun coming true:
Infectious diseases are on the rise, and their potential costs are likely to be very high and far-reaching.
Growing international concerns about infectious disease are likely to lead to travel- and trade-related frictions among countries.
There is a growing risk of a bioterrorist attack against U.S. targets, both at home and abroad.
HIV/AIDS will cause major demographic disruptions, perhaps to the point of undermining political stability in the poorest, hardest-hit, and most vulnerable countries.
HIV infection rates among members of the armed forces are likely to be high enough that some militaries will be weakened and their ability to support U.S. peacekeeping missions limited.
The primary responsibility of the National Intelligence Council, a U.S. government strategic think tank, is the production of long-term strategic intelligence analysis for the President of the United States and other members of the President’s national security team. The report can be viewed online at http://www.cia/gov/cia/publications/nie/report/nie99-17d.html.
Opportunities made available by advances in technology—Some cause for optimism comes from the existence of proven or promising technologies that can potentially be used for the prevention and control of infectious diseases. Vaccines, radiation therapy, and insecticide-impregnated bed nets are just a few examples.
Confidence that comes from the recognition of past successes—Smallpox eradication demonstrated what global partnerships can achieve, given the necessary political will. The effort to control onchocerciasis in West Africa is another success story.
Humanitarian concerns—The world is increasingly recognizing the inequity of a situation in which a tiny fraction of the world’s population enjoys relatively robust health while the vast majority live from day to day with serious, avoidable morbidity and premature mortality.
Improved U.S. public health—Lessening the burden of communicable diseases globally reduces the risks of importing diseases such as polio and tuberculosis (TB) into the United States. In addition, research advances made abroad often guide improvements in health care in the United States. The use of oral rehydration therapy (ORT) to treat the effects of severe cholera in overseas settings is an excellent example of how research advances abroad can lead to health improvements at home (i.e., the use of ORT to treat dehydration secondary to diarrhea, regardless of the cause). ORT is a low-tech scientific discovery that did not attract the notice of national research interests in the United States.
The rule of law on a global level—One participant pointed out that most of the workshop discussion appeared to revolve around the notion of health as a humanitarian, economic, or national security goal. He called attention to the notion of health as an inalienable human right.
Thus for a number of reasons, infectious disease issues are being viewed as requiring a unified, global response despite differences in local interests. In March 2002, U.S. Senators William Frist and Jesse Helms announced plans to seek $500 million in additional funding for the fight against HIV/AIDS as part of the Bush Administration’s emergency supplemental funding request for the war against terrorism and homeland security. In the Untied States, the need for international health expenditures is the subject of broad political consensus.
Likewise, to the extent that internationally agreed-upon goals, such as the development goals of the MCA, signify international consensus on the need to strengthen efforts to combat infectious diseases, such efforts are central to the global agenda as well. Public health is prominent among the MCA development goals, and infectious diseases are key elements of those public health goals. For example, one of the goals is to reduce by two-thirds the mortality rate among children under age five between 1990 and 2015. Another is to reverse the spread of HIV/AIDS, malaria, and TB.
However, the political attention that emerging infectious diseases are finally garnering does not necessarily mean that enough is being done collectively. For example, a number of countries are off track with regard to achieving a two-thirds reduction in the child mortality rate by 2015. This is especially true of the sub-Saharan African region, and of countries within other regions (including Eastern Europe and Central Asia, the Middle East and North Africa, and Southeast Asia) to varying degrees. This is not a country-specific or even a regional but rather a global concern.
INCREASED FUNDING FOR GLOBAL INFECTIOUS DISEASE CONTROL: SOURCES AND CONCERNS3
Although the renewed political commitment to international public health has led to increased funding for global infectious disease control, many workshop participants expressed concern regarding the sustainability of the funds, the realization of promised federal funding, the way the funds will be used, and whether the funds are sufficient to support the effort. According to 2001 estimates from the World Health Organization (WHO) Commission on Macroeconomics and Health, the price tag for new country-level programs, research and development, and the provision of other global public goods is $27 billion per year until 2007 and $38 billion per year by 2015. Current commitments total less than $7 billion.
Recent increased funds for global infectious disease control are coming largely from the U.S. government, for example, through greater expenditures on international health by the National Institutes of Health (NIH) and the U.S. contribution to the Global Fund. These funding sources are described below, along with President Bush’s recently proposed MCA. In addition to their financial contributions to global infectious disease control, the Global Fund and the MCA exemplify the strong trend toward public– private partnerships within the context of global public health. Private-sector investments, such as funding from the Bill and Melissa Gates Foundation and Ted Turner’s gift to the United Nations Foundation, have also contributed to the effort and are fueling a much greater awareness of the importance of these issues.
In addition to U.S. public and private investments, international organizations, such as Médecins sans Frontières (Doctors without Borders) and the Global Fund, are contributing to the effort. In fact, Europe and Japan each devote more of their gross national product to international health than does the United States.
Although NIH funding for visiting overseas scientists has remained steady, direct foreign research awards have grown and are expected to continue to rise rapidly, and the foreign component of domestic NIH awards has risen about four-fold over the last six or seven years. Expenditures for NIH training grants are also beginning to increase slightly. In fiscal year 2002, overall NIH expenditures in the area of tropical infectious disease totaled $255,400,000. In late 2002, this figure was probably above the $300 million mark.
The Millennium Challenge Account4
On March 14, 2002, President Bush proposed the MCA—$5 billion of new and additional resources to complement the current bilateral assistance program of the U.S. Agency for International Development (USAID). The purpose of the MCA is to encourage greater responsibility and commitment by host governments to practice good governance, address social problems, and engage in a number of other efforts to improve their economy and standard of living. A number of criteria for eligibility and funding availability are being developed. The goal is to involve as many partners as possible, including the private sector.
The basic principle behind the MCA initiative is to shift from dispensing international assistance merely for geopolitical or political purposes toward directing resources to countries that have the greatest potential to make progress and the best policies in place, or to those whose policies the United States expects to change and improve over time. When the President announced the program, he enunciated three criteria for investment:
Governance issues—Does the country have good policies in place for democracy, transparency, openness, and political participation?
Investing in people—Does the country have, on its own, adequate policies for investing in education and health?
Issues of economic freedom—Does the country have good macro-economic and fiscal policies in place? What is its stance with regard to trade liberalization and privatization?
The program is in the process of developing a set of indicators for measuring a country’s progress in terms of these criteria and, perhaps over time, translating this progress into eligibility to receive funding. This is
Updated information on the MCA can be found at the website http://www.usaid.gov/mca/.
being done on an interagency basis, led by the U.S. Departments of State and Treasury and USAID. Program developers are seeking input on how to apply these three criteria and determine which countries are the most deserving of the additional assistance over and above what is provided by current international assistance programs, such as those of USAID and the U.S. Department of Health and Human Services (DHHS). The grants will be used as rewards for encouraging the development of good policies and making positive changes.
The decision to base the new grants on accomplishments rather than need was heavily influenced by work done at The World Bank showing that assistance has been effective in countries with better health policies and ineffective in countries with poor policies. A participant noted that the MCA represents an attempt to bring many of the issues discussed at the workshop into the arena of international development assistance in a way new to the U.S. government. In fact, the MCA and the Global Fund both serve as models for how the United States and perhaps other governments can revamp their models of foreign assistance in ways that better account for the role of public health in economic development.
At the same time, workshop participants raised some concerns about the proposed MCA. First, what impact will it really have on fighting infectious disease? The President has indicated that this is a general fund, not a health fund. By mentioning both health and education in his announcement, the President signaled that both sectors will receive substantial portions of the funds, but the amounts have not been determined. At this point, only an unspecified amount will be made available for HIV/AIDS and possibly other health concerns, such as TB and malaria. Moreover, while the scale of the MCA is quite significant compared with previous investments, and while the money to address these critical problems is potentially of enormous value, the details of implementation will ultimately prove the worth of the initiative.
It is important to note that, according to the President, the MCA will be independent of U.S. contributions to the Global Fund, and regardless of how the MCA is structured, the U.S. commitment to the Global Fund will continue. Whether the MCA is being created for humanitarian reasons or to serve U.S. interests, it reflects an increased appreciation for the importance of global health and the need for the United States to make real commitments to improving health in other parts of the world.
A second major concern regarding the MCA is the notion of performance-based funding. Globalization has led many to believe that capitalism works, that public health should learn from business, and that public health practitioners should operate in the same way as business-people. Although this may be true to a certain extent, some question whether public health practitioners should adopt the approaches of business through-
out the international public health arena. The idea of performance-based funding has its positive aspects, and rewarding results is good practice. However, performance-based funding must not divert attention from the need to help those populations that have been failed by their governments.
The Global Fund to Fight AIDS, Tuberculosis, and Malaria
The concept of an international fund to fight HIV/AIDS, TB, and malaria was first proposed at the July 2000 Group of Eight (G8) Summit. By 2001, many governments and international agencies began discussing a variety of ideas for a global fund, including commodity purchase funds, advance-purchase commitment funds, broad health-sector interventions, funds for HIV/AIDS, and funds for a number of other specific diseases. Nothing crystallized, however, until May 11, 2001, when President Bush, along with the Secretary General of the United Nations (UN), announced that the United States would be the first donor to a global fund for HIV/ AIDS, TB, and malaria.
The original contribution was $200 million. Since then the United States has increased its pledge to $500 million, including $200 million for fiscal year 2003. This commitment—about 25 percent of the $2 billion total pledged to date—represents by far the largest commitment by any government or institution to support the global fund concept.
Priorities of the Global Fund
When the President and the UN Secretary General announced the original commitment from the United States, the President outlined five principal priorities and emphases. As of this writing, the Global Fund has already achieved considerable progress toward meeting these five goals.
1. The Global Fund must be an independent, international public– private partnership, representing a new way of doing business and a new paradigm for foreign assistance. The United States and others had no interest in simply recreating the UN or even housing a new program within one of the UN agencies. Nor was the intent to divert attention from the important work done by the UN; rather, there was a frank recognition that there are limits to the work multilateral organizations as currently structured can do. In particular, there was a perceived need for a vehicle that would be attractive to both the nonprofit, nongovernmental private sector and the corporate private sector, as well as philanthropic organizations.
The Global Fund is incorporated as a nonprofit foundation under Swiss law. The governing board includes representatives of seven donor governments (the United States, Japan, the European Commission, Italy, France,
the United Kingdom, and Sweden, the last three of which represent constituencies of smaller donors); seven developing-country governments, one from each of the seven WHO regions (Nigeria, Uganda, Brazil, Ukraine, Thailand, Pakistan, and China), plus an extra seat for Africa; and four private-sector entities, including an NGO from the northern hemisphere (a medical missionary organization from Germany), an NGO from the southern hemisphere (a community-based organization from Uganda), the Bill and Melinda Gates Foundation (which has contributed $100 million to the effort), and McKinsey and Company, which represents a broad coalition of for-profit private-sector actors. The private-sector representatives have been involved in structuring the Fund’s secretariat, recruiting candidates for chief executive officer, and providing advice on the strategy and structure of the staff of the Fund. The board has four ex officio seats: The World Bank as trustee; WHO, which will be providing administrative support; the Joint United Nations Programme on HIV/AIDS (UNAIDS); and an additional NGO representing infected people and people affected by the three diseases.
The President intended the Global Fund to be a lean organization and a financial institution, not an implementing agency. It is a mechanism designed to move money to, not to operate, programs and partnerships. However, some internal functions will require personnel if the Fund is to achieve all of its goals.
Along with the notion of partnership, the intent was for the Global Fund to operate under a bottom-up approach. The Fund is not interested in dictating to countries how to spend their money or how to design their programs. Rather, countries are to inform the donors and international community of their priorities. During the current proposal process, the Fund is hearing about local needs and ways in which community organizations can work with their governments to develop and implement strategies.
2. The Global Fund should adopt an integrated approach. A critical priority is to achieve a balance among regions, the three diseases, the prevention and treatment of each disease, and the care and support of those afflicted. Judging from the many proposals that have been recommended for funding thus far, the Fund has achieved a good balance; nevertheless, there is more work to be done.
3. The Global Fund must adopt a performance mind-set and be financially and programmatically accountable. The Fund must ensure that the money is well targeted and well spent and that funded interventions have meaningful impacts on reducing morbidity and mortality. A key component of this goal is monitoring and evaluation of the Fund’s performance over time.
4. The Global Fund will evaluate proposals through an independent technical review process. The independent, impartial vetting of proposals by public health, scientific, and development experts is key to ensuring that
the Fund offers added value and is distinct from other organizations and institutions. In fact, the principle of technical review should set the Fund and its operations apart from most current efforts in the international arena.
The technical review panel currently comprises 17 experts from around the world, including the United States: six with expertise in HIV/AIDS, three with expertise in TB, three with expertise in malaria, and five with cross-cutting skills in the development and implementation of economic programs in other fields. The panel reviewed more than 330 proposals, nearly half from Africa, in mid-2002. After completing the review process, the panel referred a number of proposals to the board for its consideration.
5. The Global Fund should not be a lever for infringing on intellectual property rights. The Fund must respect such rights and the need for innovation in the next generation of therapies and must find a way to respect international law and agreements within the context of the Doha Declaration.
March 2002 Global Fund Board Meeting
The Global Fund board members met in March 2002. Health and Human Services Secretary Tommy Thompson served as U.S. representative on the board; health ministers and ministers from most other governments involved were also present. The top item on the agenda was determination of the proposals to be funded, and the first grants were announced after the board met. The board also chose a chief executive officer.
In addition, the board discussed procurement policies and a framework for monitoring and evaluation. It finalized an agreement for the first phase of the initiative with The World Bank as the fund’s trustee and the agreement with WHO as the provider of administrative support.
The Fund expressed its appreciation for the support, flexibility, and vision of Dr. Gro Harlem Brundtland, former Director-General of WHO, in creating a structure that allows the Fund to take advantage of the privileges of the UN system and save money by not recreating payroll systems, benefit systems, and pension programs; allowing the Fund’s staff some of the diplomatic immunities and privileges of UN personnel; and giving the director and board broad latitude in hiring, firing, contracting, and making rules and regulations for its own internal operations.
Challenges of the Global Fund
Despite its success thus far, the Global Fund faces several challenges:
Monitoring and evaluation—The Fund must demonstrate success, not only because of the inherent value of showing the worth of this ap-
proach, but also to increase funding over time. The U.S. Congress and other legislatures around the world will be reluctant to provide additional money unless the Fund can demonstrate that it has done something different and has had a measurable impact in a relatively short amount of time. Deciding what is going to be measured, how it is going to be measured, and, ultimately, who is going to do the measuring poses an enormous challenge. Many of the Fund’s donors recognize that money will have to be spent on monitoring and evaluation and that the Fund will need to acquire, either by contracting or by hiring staff, experts who know how to monitor grants on an ongoing basis and conduct evaluations ex post facto. Although the board is sympathetic to the idea that future funding of grants needs to be contingent on meeting performance targets, it is not clear what those targets are or how they should be measured.
Procurement—A large number of applicants and successful proposal recipients intend to use Fund resources to purchase drugs and commodities. As this was the intent of the Bush Administration and donors, it poses no problem. However, recipients of the funding should respect certain principles regarding transparency, openness, and fairness of bidding, and they should base their purchase decisions on quality and sustainability, not just price. The board members have explicitly stated that they will not mandate any single methodology for procurement or the use of any particular agency to conduct procurement activities, nor will it list specific drugs or commodities to be considered for procurement. Local partners will be given the flexibility to inform the board regarding what they need to purchase and how. The board requests, however, that the purchasing occur within a rational framework.
Proposal preparation, including potential assistance to countries and partnerships as they develop their proposals—The Fund learned some valuable lessons during the first round of proposal preparation, which occurred in a rather hasty manner. Most important, the Fund failed to provide enough clear information to partnerships and countries as they were preparing their applications, which contributed to the 50 percent rejection rate of proposals that did not meet the initial screening criteria for eligibility for future consideration. It was not clear who could submit proposals and how they should submit them, and there was a lack of involvement on the part of technical agencies, both bilateral and multilateral, in proposal preparation. DHHS, through the Centers for Disease Control and Prevention (CDC), provided technical assistance in the preparation of five or six proposals worldwide, although only one of these made it through the technical review process. Also, the number of proposals submitted far exceeded the Fund’s expectations, and it was not ready to handle the more than 300 proposals it received. In the future, longer lead times for proposal preparation should be allowed, and much clearer and more explicit instruc-
tions on proposal preparation should be provided. The board needs to decide whether resources for planning grants should be invested up front or whether seed money should be provided to help partnerships prepare their proposals in a better way.
Budgeting and investment strategy—The Fund had about $800 million in working capital for its first year. The amount available after that was uncertain. The board had to decide how to allocate resources among the recommended proposals and whether to make one year or multiyear commitments. If the entire $800 million were used during the first year and the availability of that same amount thereafter were uncertain, the Fund would be unable to plan for a second year of proposals. To honor its commitment to long-term funding, the Fund thus needs significantly more than $800 million.
Economic and geographic balance—With regard to economic balance, the Fund has explicitly stated that it would like to focus on the poorest countries with the severest problems. Clearly, however, there are countries, such as Botswana, that have slightly higher incomes but still have terrible disease burdens. Many places in the world, such as the countries of the former Soviet Union, also face the potential for an explosion of epidemics but would be ineligible for aid if the Fund adopted a strict income scale. With regard to geographic balance, it is likely that the vast majority of the Fund’s resources will be applied in Africa. However, the Fund does not want to neglect other parts of the world, such as the Caribbean, that also have significant problems deserving assistance, especially places where funding would be in the best interests of the United States.
Achieving balance and establishing quotas—The Fund has set no guidelines for quotas for the prevention and treatment of AIDS, TB, and malaria and care for patients with these afflictions. Rather, the proposals dictate the priorities. Thus far, this has been a rational and reasonable approach. As the Fund moves forward, however, political pressure will likely lead to the setting of such quotas.
Ceilings and floors for each proposal—The board has set neither lower nor upper limits on what a proposal can request. However, it has been recommended that the board consider setting such limits, as they would facilitate planning and budgeting over time.
Involvement of the private sector—From the perspective of the Fund’s administration, the one remaining task is to fully engage the private sector, including both for-profit and nonprofit organizations. It is generally believed that the Fund will not be sustainable over time without the commitment of nongovernmental entities, in terms of not just money, but also the design and implementation of proposals. There is still a great deal of skepticism and uncertainty within the private sector with regard to the Fund. In addition, the private sector was not fully engaged in the prepara-
tion of a number of proposals in the first round, and the partnerships created were not fully representative of nongovernmental and private-sector entities. The United States and its partners must work to ensure that the principle of partnership is fully applied. For this to occur, the for-profit sector must be comfortable with the Fund and recognize it as en entity with which it would like to do business.
Questions and Concerns About the Global Fund
As with the proposed MCA, workshop participants cited several concerns about the details and potential effectiveness of the Global Fund. One participant expressed discouragement that the Fund had already begun to review proposals and make some perhaps very significant awards in terms of funding without knowing what funding will be available in the future. Moreover, concern was voiced that appropriate criteria had not yet been put in place to evaluate success; that no ceilings had been set for proposals; and that no predetermined criteria had been established for distributing funds among AIDS, TB, and malaria. This issue is of particular concern with regard to the involvement of the private sector, which would likely be more supportive if these criteria were in place.
Thus the board did not make what are admittedly some difficult political decisions in January 2002, before announcing the first round of grant recipients. Although the United States has resisted pressure to award the funds quickly without addressing some of these important questions, others have been more willing to do so. Fortunately, however, in large part because of the excellent job done by the technical review panel, the proposals up for consideration, with one or two possible exceptions, are well conceived. The most costly proposals were eliminated during the review process because they were not well prepared and could not justify the amount of money being requested. Nonetheless, the future of the Fund is at risk if the board does not make the decisions discussed above.
Two of the board’s immediate goals are to set ceilings and floors for proposal amounts and to develop a process for evaluating the financial accountability and absorptive capacity, as well as the programmatic quality, of approved proposals before the money is distributed. The board addressed ceilings and floors for proposals at a meeting held after the workshop. With regard to a process for evaluating financial accountability and absorptive capacity, as well as programmatic quality, it is too late to develop such a process from the perspective of the grant-making agencies. Nevertheless, carrying out that process before the first round of checks are cut will at least ensure that the process is in place before the second and third rounds.
Another concern with regard to the Global Fund relates to what many
consider to be the inexcusably low 23 percent rate of implementation of directly observed treatment, short-course (DOTS). It was suggested that rectifying this situation should be one of the highest priorities in the awarding of funds, or even that some of the funds might be used to train scientists and physicians in how to influence political leaders, not just in the United States but also worldwide, with regard to the use of DOTS. In this connection, one participant noted that a number of the final first-round grants are for TB-related efforts, and one of the primary emphases of many of these efforts is the expansion of DOTS coverage.
One positive aspect of the Global Fund noted by a workshop participant was the emphasis on evidence-based public health. It was suggested that although there is considerable discussion of evidence-based medicine in the medical literature, there is far too little dialogue on the subject among the public health community. The long-term implications of certain practices often do not receive as much consideration as they should. That evidence-based public health is an important component of the Fund’s priorities as part of the technical review and long-term evaluation processes is thus commendable (but see the summary below of the discussion of the value of evidence-based public health versus the need for good governance).
Other Possible Funding Sources for Global Infectious Disease Control
In addition to the above-described sources of new or increased funding for international public health, there are a variety of other potential funding sources, including international credit finance; domestic, nonpublic sources; and public budgets within countries, including debt relief. Of these, only interim debt relief was discussed in any detail during the workshop.
In contrast with traditional public finance, whereby government decides where expenditures should be made, interim debt relief funds go directly to the public treasury. It was suggested that the stream of income from debt relief received by a country over a period of several years can significantly increase the country’s public budget and, if used appropriately, can also significantly benefit its public health. Indeed, a participant noted that at a recent UN General Assembly meeting, member states agreed that a portion of debt relief monies must be used to address health issues. While developing their plans for spending their debt relief monies, recipient nations must designate how they will spend the funds in the health sector. The general goal is to use the funds to build public health infrastructure, and to ensure that there is a health component to the debt reduction plan as well. On the basis of preliminary data from The World Bank, some of the approximately 32 countries recently eligible for interim debt relief are planning to increase their health expenditures by about 25 percent per year, depending on how much money they receive.
Already in Madagascar and Cameroon, for example, significant sums of money from debt relief have been channeled into health, particularly for new HIV/AIDS resources. The same thing has happened elsewhere, for example, in Chad, Burkina Faso, and Malawi. In total over the past several years, an additional $36 million annually has been allocated for health in some nine or 10 countries, depending on how the scope of the health sector is defined.
At the same time, several factors will determine whether this source of funding is actually going to make a difference. First, success will require that the recipient nation have a strong central political commitment to health, with a champion other than the prime minister or minister of finance, who is more likely to use debt relief funds for roads or agriculture. Second, the recipient nation should be very specific about where the funds will be directed. In Cameroon, for example, recent interim debt relief funds were targeted specifically at interventions for high-risk transmitters of HIV, including the military. Finally, the recipient state should be able to anticipate the difficulties associated with spending money rapidly. In Cameroon, for example, although the amount of money was not large in absolute terms, it was much larger than what the country had been accustomed to. Considerable effort was required to use the money effectively.
Answers Other Than Money
Despite the clear call for more funds and greater flexibility in how those funds are used, many workshop participants agreed that money is not a cure-all. They warned that funding must not become an overriding issue in the discussion of what steps need to be taken next with regard to the prevention and control of emerging and reemerging infectious diseases on a global scale.
As one participant argued, funding global infectious disease control is not just a matter of doing more; it is also a matter of doing better and channeling external assistance where it will make a significant difference. Care must be taken to spend the money well and to consider the capacities of countries and agencies to absorb it. In the past, aid that has been well targeted has been well spent. When funds have been channeled to places where the disease burden is high and where there are reasonably good policies in place or prospects for changing bad ones, the money has generally been used to good purpose. This contrasts with situations in which the money has been spent purely for narrow political or geopolitical reasons. Nor should the world be diverted by this large sum of money from funding other ongoing programs that are already making a difference.
Other workshop participants agreed that simply putting money into problems is not necessarily going to solve them. First, problems need to be
identified and delineated; this often requires strengthening basic research capacity. The money then needs to be targeted accordingly. For example, it is not necessarily enough to know that pathogens are being distributed around the world in the wheel wells of airplanes. Growing evidence suggests that only certain types of pathogens, such as the Spanish strain of Streptococcus pneumoniae, are in fact spreading globally. This raises the question of what makes the Spanish strain of this bacterium so globally adept. As another example, salmonellosis in general is not necessarily the problem in the United States, but a specific strain that is resistant to five drugs (although there was some disagreement on this point).
One participant acknowledged that insufficient funding can kill a project but noted that most successful international collaborations with developing countries have not been contingent on access to additional money. The amount of money needed to conduct the task at hand is usually not enormous and should not be seen as an obstacle to moving forward. Others disagreed on this point, however.
Another participant suggested that, because globalization is not necessarily something new, but rather changing in its degree and pace, the fundamental problems of public health have not changed. The biggest issue is still a lack of resources—not just those required to research new products, but also the tens of billions of dollars needed to get existing products into use and to strengthen health system management in the poorest countries. The funding needed to address these underlying problems should not be underestimated, and care must be taken not to let aspects of globalization that exacerbate public health problems detract from meeting this need.
Some participants expressed concern that too great an emphasis on evidence-based public health, as is the case with the Global Fund, could deflect attention from underlying problems that play a more fundamental, etiological role in the growing global threat of emerging and reemerging infectious diseases. For example, the implementation of DOTS is not necessarily a matter simply of applying evidence-based public health. Perhaps more important, good governance is a prerequisite for employing any kind of public health, evidence based or not, in the fight against emerging and reemerging infectious diseases, as the current public health situation in Russia illustrates.
With regards to DOTS, one of the greatest problems faced by Russia is the sheer political complexity of implementing such a program on a large scale in a country that has its own, very different established practices and institutions. The implementation of DOTS on a countrywide scale is not an exercise or technical challenge per se; it has more to do with transactions and bargaining. For many reasons, including the fact that the country had its own way of doing things in the Soviet era, Russia has as yet not officially adopted DOTS as either a treatment or a diagnostic approach. To move from the
point where Russia is today—with respect to not only DOTS but also other outdated or unscientific means of diagnosis and treatment—to the point where leading Russian scientists are collaborating with their partners in other parts of the world and adopting internationally recognized practices will require a dialogue with local institutions and interest groups that were trained under and are comfortable with the old system. Recent discussions in Moscow offer hope that progress is being made in this direction.
Although Russia is making progress, good governance is proving a much more difficult task in other parts of the world. It was noted that in the Middle East, for example, only one government truly exercises democracy; other governments, which often distort the Islamic religion for political purposes, are not accepted by their populations. One participant pointed out that to establish public health systems in the Middle East that are functional and efficacious in the long term, it will be necessary to encourage the other countries in the region to accept democracy.
Good governance must precede any large-scale effort to improve the public health system. The Republic of South Africa, for example, needs good governance to influence NGOs involved in the distribution of HIV/ AIDS drugs to the neediest populations. As another example, public health is virtually nonexistent in the Democratic Republic of Congo, where, not surprisingly, so many reemerging infectious diseases originate. But how should good governance be established? It is essential that American or European public health strategies not be imposed in other parts of the world without modifications appropriate to local conditions. (The issue of governance was also discussed within the context of the changing role of international law in the global public health arena, as summarized at the end of this chapter.)
THE ROLE OF PUBLIC–PRIVATE PARTNERSHIPS5
One of the recurring themes of the workshop was the vital role of public–private partnerships in building the global capacity to prevent and control emerging and reemerging infectious disease threats, whether intentionally or naturally introduced. It was noted that the Global Fund, as described earlier in this chapter, reflects this new spirit of partnership in a unique way. Not since the founding of the United Nations Children’s Fund (UNICEF) 50 years ago has the world seen the creation of an entity with so
much potential in the international health arena. A number of other, similarly promising partnerships have also recently been formed, including the Global Alliance for Vaccines, Stop TB, UNAIDS, and the International AIDS Vaccine Initiative. In addition, CDC’s Framework for Progress strategy, discussed in detail below, places a heavy emphasis on partnership. WHO also has a number of new partnerships with private industry, in addition to its many traditional partnerships with laboratories, ministries of health, and universities. For example, the WHO program Roll Back Malaria involves working with oil companies (e.g., ExxonMobil and Eni) to extend medical assistance to surrounding communities in the countries in which they operate; with mining companies (e.g., Placer Dome and World Alliance for Global Health, BHP Billiton) to spray insecticides to stop the spread of malaria among employees and their families; and with tourist hotels (Zimbabwe Sun and Kenya Hotel Association) to spray insecticides and apply other measures to reduce the incidence of malaria in communities.
Public–private partnerships are a conduit for providing critical treatments for disease in countries where so many people still lack access to such treatments. The arrangements are most useful in situations in which complementary skills are needed to solve otherwise intractable problems. As one participant described them, public–private partnerships tackle problems that are otherwise not being addressed, are globally important, are historically intractable, disproportionately affect the poor, perpetuate poverty, and require the skills of both the public and private sectors.
Moreover, today’s public–private initiatives serve as potentially valuable social experiments. It is hoped that by examining their progress over the next 10–20 years, the most effective way for such partnerships to operate can be determined.
The key way to obtain the best return on the dollar is the establishment of public–private partnerships that are long-lasting, that is, that endure longer than a funding cycle of one, two, or even five years. Such partnerships can build capacity over the long term. A participant noted that the partnerships developed by the U.S. armed forces worldwide are a model for success: they have very long funding cycles, they build capacity over the long term, and they include collaborators in developing countries as equals. Another participant suggested that the U.S. government’s long-term narcotics-fighting and customs partnerships in the Caribbean can be instructive. The U.S. Customs Service has formed such partnerships to stem the tide of illegal drugs coming from the Caribbean into the United States. U.S. personnel travel to the Caribbean countries to train their personnel and influence local systems. The Pan American Health Organization–administered Caribbean Epidemiology Center is trying to apply this same approach in its management of HIV/AIDS.
Although public–private partnerships are an important trend, they are
not a panacea. In fact, like money, they often detract from dealing with the root causes of public health problems and from holding accountable those who should be addressing those problems. Public–private collaborations cannot substitute for governments, both rich and poor, that properly fulfill their responsibilities to build and maintain the necessary public health infrastructure and ensure that their citizens receive proper health care services.
A participant noted that the use of these partnerships in a global effort to improve public health capacity requires adoption of a bottom-up, grass-roots approach whereby all agencies, organizations, and persons involved maintain a global mind-set and focus on how they can work together to better address the many issues they must confront. On the other hand, with no effective “global government” or feasible means of top-down implementation, the question arises of how to orchestrate a bottom-up approach that encourages entrepreneurial action on the part of thousands of different agencies. One of the largest obstacles to a global response is its management.
Types of Public–Private Partnerships
A participant suggested that, to avoid making broad, inaccurate generalizations about how public–private partnerships form and why they work, it would be helpful to define “public,” “private,” and “public interest” and clarify whether public goods can come from private products. The Initiative for Public–Private Partnerships and Health, which has recently been studying these issues, has defined three basic components of the public and private sectors on the basis of who owns the assets under discussion: the public sector, civil society, or for-profit organizations (see Figure 4-2). If the organization is based on state-owned assets, it is part of the public sector, which includes both governmental agencies and intergovernmental agencies such as WHO. If the organization is based on assets that are not state owned, it is either a civil-society or for-profit organization. Some of the former tend to define themselves by what they are not, that is, NGOs. Others are academic institutions, which receive money from the public sector but are still essentially private unless they are state universities, philanthropies, or other nonprofit organizations. For-profit organizations include pharmaceutical companies, biotechnology companies, and other commercial, non–health-sector companies.
These organizations can collaborate and interact in numerous ways, resulting in many different modes of operation. In developing countries, for example, NGOs have traditionally collaborated with governmental organizations in the delivery of health care services. Also, both health-related and non–health-related industry organizations conduct activities in the interest of health or other social concerns, whether related to their core business or not. For example, GlaxoSmithKline, in response to concern about teenage
suicide in Eastern Europe, started supporting hotlines so teenagers could talk about their problems; ExxonMobil funds the Medicines for Malaria Venture, a public–private partnership dedicated to the development of new antimalaria drugs; a South African power company, Eskom Enterprises, supports AIDS prevention efforts; and Apple Computer has, through various programs, donated both hardware and software to educational institutions.
Where the secretariats of these collaborations are located is an important issue, since a partnership tends to operate according to the rules of the secretariat’s organization or host institution. Thus many partnerships, such as the Global Alliance for Vaccines and Immunization and Roll Back Malaria, are more strictly public-sector programs with private-sector participants. When the pharmaceutical industry is represented by only one member of a board of 18 people, for example, the collaboration is not essentially a joint venture.
Public–private interactions among organizations range from more traditional relationships that involve grant giving and receiving and the procurement of goods and services to some newer modes of interaction, including privatization of the delivery of health services, with the public sector
setting and monitoring the rules and quality of service. This new type of interaction is occurring more frequently in both developed and developing countries, contrary to the popular notion that governments are the primary providers of health care services in the latter. In India, for example, 80 percent of the population receives health care services from private providers.
Joint Venture Partnerships
Another type of nontraditional public–private interaction that is becoming increasingly common is the achievement-oriented joint venture partnership. Its attributes include:
A shared objective agreed upon by all participants, even though their motivations and values may differ.
Shared risk taking, which has become inherent in new ways of doing business and can lead to innovation.
Shared decision making, without which there is not a true partnership.
Contributions from each participant.
Benefits to each partner, although these may differ.
About 70 international partnerships with these attributes are involved in health research, health care, and health care delivery. These include partnerships that generate basic knowledge in the area of health (e.g., genomics) and are funded by private industry but involve government agencies and private universities; product development partnerships; collaborations that involve the delivery of donated, discounted, or subsidized products; partnerships that strengthen health services, especially in areas where AIDS is endemic and where health services must be strengthened to ensure the proper use of the products that are delivered; education partnerships; product quality or regulation improvement partnerships; and various broadly coordinated, multifaceted efforts.
Approximately 40 of these 70 partnerships are involved in the development and delivery of donated products (including drugs, vaccines, diagnostics, contraceptives, vector control agents, and devices and equipment) in the poorest countries, which generally lack the financial and public health infrastructural resources for product delivery. Examples include the Concept Foundation (contraceptives), the International Trachoma Initiative, the Botswana Comprehensive HIV/AIDS Partnership, and the Mectizan Donation Program (river blindness). A significant proportion of deaths from infectious diseases that occur in the poorest parts of the world are preventable by cheap, satisfactory, off-patent medications that exist but are inaccessible to people disadvantaged by poverty and a weak public health infrastructure. In fact, the approximately 300 WHO-listed “essential” drugs
never make it to 50 percent or more of the world’s population (see Figure 4-3). A smaller fraction of these deaths are caused by a lack of access to new products, such as AIDS medications and treatments for drug-resistant malaria and TB, which are considered too costly to introduce into low- and middle-income developing countries, where prospects for a return on such an investment are poor. A price concession is usually necessary for new products to be introduced at the earliest possible opportunity.
These collaborations generally address any and all aspects of product development and delivery, from the initial research phase to product introduction. Thus, collaborators from different partnerships often face similar challenges with regard to conducting clinical trials, managing intellectual property, devising a plan for product introduction, conducting market assessments, and a variety of other tasks. These partnerships are also continually evolving; some partnerships currently involved in delivering donated drugs originated as research collaborations. One of the goals of the Initiative for Public–Private Partnerships for Health is to foster the exchange of knowledge and information among these many partnerships, which usually are legally independent or work separately. For example, collaborations that are only now addressing basic research questions can learn from other partnerships that have previously worked on similar issues.
Partnerships Involving Nongovernmental Organizations
Because the globalization of infectious diseases requires a highly coordinated and yet highly diversified response on the part of many public- and private-sector partners, it was suggested that the U.S. public health community and government tap the expertise of NGO leaders. NGO humanitarian responders have become increasingly important over the past decade in serving as the focal point for the implementation of foreign aid. They can also serve as a good source for ideas, collaborators, and colleagues. They form an international community that includes many young Americans who are funded by U.S. government grants; they have a good understanding of the issues in infectious disease and globalization; they are improving prevention and surveillance capacities and are sensitive to issues of human rights and international law; they have a good sense of public health priorities and population-level needs; and they have developed laudable processes for standards setting, accountability, outcome evaluation, and strengthening of institutions.
It was suggested that the U.S. public health community should consider the potential role of twinning, an arrangement that involves matching sister
cities or organizations or institutions from different cities so they can share expertise, transfer technologies, enhance their surveillance capabilities, and generally assume responsibility for each other. The practice has become very popular in Europe and appears to provide a realistic solution to ensuring that local needs are met while being tied to a greater international network of needs. In Germany, for example, prisons are twinning in an effort to fight the rise of TB among the prison population. Also in Europe, countries themselves are twinning. Germany is twinning its public health sector, including its insurance system, with that of Poland; many similar efforts are being undertaken as a way to prepare countries in Eastern Europe to join the European Community. Twinning, however, is still a relatively undeveloped idea in the United States.
Involving Multinational Corporations in Global Public Health
Given the obvious role of multinational corporations in public–private partnerships, workshop participants discussed at length how to engage the interest of these companies more fully in global infectious disease control. The question was raised of what incentives exist for multinationals to maintain healthy workforces and otherwise contribute to dealing with global public health crises. As one of the strongest sectors of global society, multinational corporations could potentially make a tremendous contribution to efforts to improve global health. This is especially true in countries that lack the necessary infrastructure, for example, those where DOTS does not exist. Workshop participants cited several challenges that must be overcome if multinational corporations are to be recruited for this purpose:
The fluctuating nature of business makes it difficult to maintain alliances with the private sector over time. Even though in 1996, when the Asia-Pacific Alliance was established in an effort to include multinationals in the fight against AIDS, corporations were generally receptive to being involved in promoting AIDS prevention, that receptiveness did not necessarily last. The reality is that business cycles up and down, leadership changes, and priorities within the corporate culture do not always include the company’s continuing that type of underwriting.
Cultural divides make it difficult to institutionalize public health practices in transnational corporations that are operating in multiple cultures. For example, there is a strong reluctance to impose in other countries workplace policies that would be considered appropriate in the United States, especially with regard to HIV-related programs.
Issues of intellectual property rights can slow progress. The tension between intellectual property rights and access to drugs illustrates a fundamental difference between the interests of multinational corporations and
those of the global public health system. In particular, pharmaceutical companies want to protect their highly lucrative markets, for example, against cheap antiretroviral agents available from other parts of the world.
The notion that it is not the responsibility of private companies to provide public goods can also slow progress. Companies that are increasingly being asked to participate in public–private partnerships or to fund public health efforts typically respond by arguing that public health is a public good and should be the responsibility of the governments of the developing countries where the problems exist. Many argue that it is both unfair and unsustainable to ask for a public good from private enterprises.
Some believe that small businesses should play a role. Although the responsibility of transnational corporations may be more apparent, about 80 percent of employed people worldwide work for small to medium-sized businesses, many of which are involved in international trade. In many countries, moreover, the informal trade sector is actually much larger than the formal trade sector, and some would argue that these other, smaller enterprises also have a responsibility.
The communication gap between the public health system and the private sector can make it difficult for the two to work together. If inappropriate trade restrictions were to be imposed on a country because of an outbreak of an infectious disease, for example, public health officials could assist the private sector by providing information on why a product posed no threat of transmitting the disease.
There is a need for a new economic model that would provide incentives for multinational corporations to participate, especially given the competing priorities unrelated to infectious disease within both individual companies and the larger market. It is unclear what such a model should or could entail.
Creative strategies are thus needed to address misaligned incentives, encourage the commercial sector to participate in global public health efforts, and build bridges between the NGO and corporate sectors. Some participants commented that devising such strategies will be extremely difficult. Others noted, however, that several groups, such as the World Economic Forum and the International Chamber of Commerce, are encouraging business programs to combat infectious diseases, including HIV/AIDS, TB, and malaria, and some strategies that are already known may be worth examining or revisiting.
For example, it might be possible to learn from examining the histories of companies that have long provided health care for their employees, as was done during the era of plantation medicine. Likewise, several ongoing case studies are examining the role of the private sector in global public health. For example, if the cease-fire and agreements in Angola continue to
hold, the United States and other governments will continue to put considerable pressure on the major oil companies to play a more positive role in the country’s reconstruction and to move from the cities into long-neglected rural areas. As another example, Anglo American, a global leader in mining and natural resources, recently decided not to comply with the recommendation of an in-house feasibility study to provide free antiretroviral therapy to its HIV-positive employees in South Africa. The HIV incidence rate among the company’s workforce is estimated to be 20 percent, but there were concerns about sustainability and how free antiretroviral therapy would fit into the overall position of the country on the treatment of HIV/ AIDS. This kind of enlightened self-interest on a company’s part can create a dual system whereby company employees have substantially greater access to health care than the general population. The company intends to engage in discussions with other major companies in South Africa, as well as the South African government, before moving forward.
A participant suggested that the diverse market interests of different companies could be exploited to provide opportunities for improving global public health in some basic ways. For example, Procter & Gamble, a large transnational manufacturer of consumer products, produces a number of items, such as soap, that are relevant to public health. The company could make soap available at low cost to a market of billions of people around the world who have very limited economic power. Other companies could do the same with safe drinking water. Although bottled water is a large industry in developed countries, it is too costly for most of the populations in need in developing countries. Other water treatment products may be more affordable, and the companies that make these products could participate in efforts to provide cheap, safe drinking water. In response to this suggestion, however, a participant noted that this kind of business philanthropy is quite different from the enlightened self-interest that motivates a company to seek to preserve a healthy workforce. It is important to recognize that companies, regardless of what business they are involved in, have motivations very different from those of health care agencies.
A participant suggested that interactions with multinationals be focused at the early stages of investment, when business decisions are first made. For example, if a company moving into an area could configure itself or the way it does business so as to lower the incidence of AIDS among its workers, this might be more effective than waiting until a treatment approach is the only choice. This point speaks to the general question of what the commercial sector can do so that bad health is not an adverse outcome of development. Preproject health assessments may provide at least a partial solution.
Preproject Health Assessments
When companies move into new areas, they usually conduct cost– benefit assessments, which typically include environmental assessments whose results are presented in environmental impact statements. Likewise, when considering loaning or guaranteeing money for certain infrastructure projects or the facilitation of foreign investment in other countries, The World Bank and U.S. government agencies, such as the Overseas Private Investment Corporation, are starting to use highly sophisticated and extensive environmental assessment rules to make their decisions. It was suggested that the public health community might benefit from examining this environmental model and evaluating the extent to which health issues could be addressed by this type of proactive approach.
A public health assessment would benefit not only the health of the workforce and potentially that of the general public, but also the company’s productivity and economic profit. If a particular decision were not cost-effective, it would be extremely difficult to convince a company to make that choice in the interest of either the health of the workforce or general public health. On the other hand, if an assessment predicted that a particular decision would cause an increased incidence of malaria in the workforce, which in turn would lead to decreased productivity, it would be in the company’s best interest not to make that choice.
One participant expressed concern that environmental impact statements often accomplish nothing other than generating paper and employing consultants who have a vested interest in affirming the decision already made by a company. The potentially negative long-term environmental impacts of a project often are not reflected in the statement. Disease impact statements would likely by plagued by the same problem. Nevertheless, even the developing world has expended a great deal of effort on environmental issues, and in so doing has captured the imaginations of many populations and effectively sent the message that they must preserve their environment. The public health community has never captured anyone’s imagination in quite the same way. Perhaps there is something to be learned from the environmental movement.
Industry as an Educational Resource
A few participants commented on the innovative roles that private industry could potentially play in global infectious disease control. When people seek help from the pharmaceutical industry, they usually ask for money or products, not intellectual or educational capacity. Industry can, however, provide the latter resources and in so doing, serve as a partner in
global health. For example, a multifaceted collaboration involving the public health community and the pharmaceutical and communications industries could provide a powerful opportunity to address the emergence of drug-resistant pathogens.
A major cause of multidrug resistance is a lack of adherence to recommendations for the proper use of medicines. The pharmaceutical industry and public health community have a mutual interest in addressing this problem, and the global communications industry could provide the means to do so. This kind of effort would be especially helpful in developing countries, where there are fewer educational resources in general and where the challenges to maintaining high rates of adherence to therapies, particularly DOTS and antiretroviral therapy, are great. Some efforts along these lines have recently been made in the United States, including the distribution of educational materials on antimicrobial resistance from CDC and the American Medical Association by pharmaceutical company sales representatives. As another example, the secretary of Health and Human Services recently announced a new program whereby pharmaceutical company sales representatives will be distributing educational materials on anthrax, smallpox, and other potential bioterrorism agents.
The Centers for Disease Control and Prevention’s Framework for Progress: An Emphasis on Partnerships
For public health workers, the global movement of people, animals, and goods and the concomitant movement of diseases across national borders has always been a fact of life, and CDC has long engaged in efforts to prevent and control infectious diseases beyond the borders of the United States. In recognition of the accelerating pace of globalization, CDC has prepared a document, Protecting the Nation’s Health in an Era of Globalization: CDC’s Global Infectious Disease Strategy, which is meant to serve as a framework for enhancing, consolidating, and focusing CDC’s efforts to prevent and control infectious diseases on a global scale. The document begins by stating, “it is not possible to adequately protect the health of our nation without addressing infectious disease problems that occur elsewhere in the world” (CDC, 2002, p. 6). The strategy places a strong emphasis on partnerships.
In preparing the document, the authors drew on many sources, including previous reports of the Institute of Medicine. In addition to extensive internal review of the document, comments from experts were solicited at a November 2000 meeting in Atlanta, Georgia. The strategy, released at the International Conference on Emerging Infectious Diseases, held in Atlanta in March 2002, identifies six priority areas, described below.
1. International outbreak assistance. In hospital wards, refugee camps, villages, and almost every other setting where outbreaks occur, CDC has built a reputation for providing expert technical assistance in identifying and controlling risk factors for disease transmission. Rather surprisingly, CDC’s international outbreak assistance has been provided largely ad hoc, with little long-term planning, dedicated funding, or ability to provide follow-up assistance after the acute emergency response.
Outbreaks offer unique opportunities to learn more about the dynamics of disease transmission; the effectiveness of prevention, control, and treatment strategies; and the risk factors for severe and fatal disease. Because of the public nature of disease outbreaks, they also offer opportunities to bring organizations together. Knowledge gained in one investigation can often be applied to other situations, including those within the United States.
Thus, one of the underlying principles of CDC’s global infectious disease strategy is that international outbreak assistance is an integral function of CDC, as opposed to an ad hoc activity. To take full advantage of the opportunities offered by international outbreak investigations, CDC must have targeted resources and an enhanced capacity for laboratory and epidemiological investigations, as well as the ability to offer support for follow-up activities, including surveillance and the development, implementation, and evaluation of long-term preventive measures.
2. Global approach to disease surveillance. Accurate information about emerging infectious diseases must travel at least as rapidly as the diseases themselves, which in this day of jet travel is quite rapid indeed. To remain one step ahead of multiple epidemic waves, public health authorities worldwide are increasingly relying on modern, rapid laboratory diagnostics; electronic connectivity; and communications networks.
Despite the many and real obstacles to global surveillance (see Chapter 3), some progress has been made. Many global surveillance networks exist, including both those that are disease specific, such as the WHO Global Polio Laboratory Network, and those that are regional. Notable progress has been achieved at the regional level; examples include the Amazon and southern cone networks in South America (see Chapter 3). Many of these regional networks are supported through CDC partnerships.
However, a global approach to disease surveillance will require that in the long run, regional and disease-specific networks expand, interact, and evolve into a global network of networks. WHO has assumed a leadership role in organizing this effort, of which CDC is a critical component.
3. Applied research on diseases of global importance. Several years ago, one could easily have argued that understanding the complex ecology of the West Nile virus was neither an appropriate nor a high priority for
CDC, as the virus did not affect U.S. citizens to any great degree. The introduction of West Nile virus into New York City and its subsequent spread throughout the eastern United States changed that perception and highlighted the value of conducting applied research not just on diseases that occur in the United States, but also on those that are globally important. Indeed, experience gained by CDC personnel while investigating an outbreak of West Nile virus in Romania in the mid- to late 1990s helped ensure that CDC virologists, entomologists, and epidemiologists would be familiar enough with the disease to recognize it early in the course of the New York City outbreak and provide informed advice for prevention strategies.
The breadth and depth of CDC’s laboratory and epidemiological capacities are critical resources. CDC’s global infectious disease strategy argues that it is in the best interest of the United States to maintain and strengthen that capacity through an active program of applied research on diseases of global importance.
4. Application of proven public health tools. To carry out its mission, CDC must engage in implementation research that translates science into meaningful differences in the rates of morbidity and mortality from infectious diseases on a global scale and in a timely manner. A good example of the kind of proven public health tool addressed by this priority area is the insecticide-impregnated bed net, which has been shown in many field trials to reduce rates of morbidity and mortality from malaria. Yet despite this knowledge, the bed nets are used by less than 10 percent of people at risk. There are many other underutilized but proven public health tools, such as auto-disable (one-use) syringes to prevent bloodborne transmission of hepatitis B and C viruses and HIV, point-of-use chlorination and safe water storage to prevent waterborne diseases, routine immunization with vaccines for hepatitis B and other diseases, and single-dose therapy to prevent perinatal HIV transmission.
Each of these tools is underutilized for slightly different reasons, although there are some common underlying problems that could be addressed by CDC and its partner institutions. These include a lack of awareness of the importance of these interventions among public health authorities, a lack of knowledge among the target populations, and economic and logistic barriers. In an effort to address these underlying problems, CDC and its public and private partner institutions have been bringing together experienced health communicators, economists, manufacturers, marketing experts, and other professionals with competencies not stressed by public health in the past. For example, through a partnership with Procter & Gamble, WHO, CARE, and USAID, CDC has made point-of-use chlorination of public drinking water available to about a million people in more than a dozen countries. This is a notable accomplishment; nonetheless, another estimated 1–1.5 billion people in the world still do not have
safe drinking water and bear the brunt of diarrheal diseases and other waterborne infections as a result.
5. Global initiatives for disease control. CDC has been participating for many years in global initiatives for disease control, often in collaboration with WHO and other partners. Smallpox, polio, and dracunculiasis, for example, have been eradicated or are well on their way to being eradicated worldwide through partnerships that have included CDC. Other infectious diseases slated for eradication include measles, trachoma, and filariasis. These eradication campaigns are supported by dedicated staff in both Atlanta and the host countries, where CDC personnel advise national authorities on control strategies.
CDC has also dedicated significant human, financial, and scientific resources to many widely recognized global public health efforts, such as Roll Back Malaria, Stop TB, and the Global AIDS Program. The latter is one of the largest international programs in which CDC has ever been involved.
6. Public health training and capacity building. Although CDC has been involved in international public health training and capacity building for many years, its involvement in terms of financial resources has not been as great in this area as in some others. Nonetheless, there have been some significant successes, such as Field Epidemiology Training Programs and International Emerging Infectious Diseases Laboratory Fellowships. At the same time, significant benefits would accrue from additional investments in public health education and training on the part of CDC.
As with other priority areas in CDC’s global infectious disease strategy, a heavy emphasis is placed on partnerships. CDC is actively working with The World Bank, USAID, the Rockefeller Foundation, the Lilly Foundation, and many others to develop training programs for epidemiologists and public health laboratory scientists. One of the new elements proposed in the CDC strategy is the creation of a series of International Emerging Infections Programs (IEIPs) that would serve as national and regional centers for surveillance, applied research, training, and education on diseases of national and global importance. The hope is that these new IEIPs will:
Become the building blocks of a sophisticated international network that will conduct laboratory, population-based surveillance for a broad range of globally important infectious diseases.
Be long-term, in-country partnerships and collaborations with ministry of health scientists that will be used to build an international and global capacity for disease control. Ministry of health and CDC scientists would train together while learning about the epidemiology and laboratory aspects of emerging infectious diseases.
Provide a broad platform for basic and applied research on infec-
tious diseases, including the development, application, implementation, and evaluation of public health tools.
Help support outbreak response efforts and, in so doing, strengthen the capacity to control emerging pathogens.
The first IEIP was launched in 2001 in Bangkok by the Thai Ministry of Health and Scott Dowell of CDC. The program works closely with the local Field Epidemiology Training Program and the local U.S. Department of Defense laboratory. At the time of the workshop, CDC hoped to choose the site for and launch the second IEIP later in 2002.
Response to the 2001 Anthrax Attacks: An Example of Effective Cooperation
Bioterrorism continues to shape and reshape both domestic and global public health agendas. Within hours of the first reports of bioterrorism-related anthrax in the United States, public health agencies around the world were faced with a myriad of questions from the highest levels of their governments, their clinicians and laboratory scientists, the media, and their citizens. Many of these agencies turned to CDC for information and advice. Over the period of a few short weeks, CDC received more than 160 calls and e-mails from officials and other individuals in about 70 countries requesting assistance or consultation on bioterrorism-related concerns. In many of these countries, the threat manifested itself as letters containing suspicious white powder that were delivered to various targets, including U.S. embassies, multinational corporate offices, local political groups, and ordinary citizens.
For example, the offices of a newspaper in Kurachi, Pakistan, were closed following the receipt of hate mail containing a suspicious white powder. A CDC colleague in a Karachi laboratory isolated gram-positive rods from the white powder and, suspecting that they were Bacillus anthracis, e-mailed a photograph of the bacteria to CDC in Atlanta. CDC microbiologists who were working with U.S. anthrax isolates were able to review the photo and provide direct consultation to individuals in Karachi. Later in the investigation, CDC arranged for the transfer of these isolates and highly suspect isolates from about a dozen other countries to the United States for testing by the U.S. Laboratory Response Network. Only three positive isolates were found—two in mail delivered to U.S. embassies in Peru and Vienna and the third in Chile.
Clearly, in this situation any government would be sensitive to information about anthrax-related bioterrorism or suspected bioterrorism in its own country. The willingness of so many ministries of health to collaborate closely with CDC and other U.S. institutions on these highly sensitive mat-
ters is a tribute to the trust and relationships that have developed in international public health over the years. More than 100 CDC employees assigned to countries worldwide received e-mail updates on the anthrax investigation and were able to serve as assistants or information sources for the local ministries of health, UN agencies, and U.S. embassies. The IEIP in Bangkok, Thailand, and the Southeast Asian regional office of WHO hosted a training course on anthrax during the investigation; there were more than 60 participants from 16 countries.
Partnering with the Developing World
Give a man a fish and you feed him for a day. Teach him how to fish and you feed him for a lifetime.
—Lao Tzu (Chinese Proverb)
Participants made several comments throughout the workshop regarding the manner in which the United States and other developed countries must interact with their partners in developing countries to ensure sustainable progress. Some of these comments were made within the context of opportunities for transnational research and training programs, such as the Gorgas Course (see Chapter 3); others were made within the context of the discussion on public–private partnerships summarized above.
First, past experience has shown that one of the critical prerequisites for a successful international health collaboration is for all involved to be treated as equal partners, especially when there are major disparities in resources. It is extremely important, whether the dialogue is about health or some other global issue, for developed countries to listen to their partners in developing countries and ask those involved to describe their problems and how interested developed countries can help resolve them.
The partnership between Instituto de Medicina Tropical “Alexander von Humboldt” in Lima, Peru, where the Gorgas Course is held, and the Belgian-run Institute of Tropical Medicine in Antwerp (described in Chapter 3) illustrate the value of this type of egalitarian approach. So, too, does the Southern Cone Initiative. Member countries were asked to list their top five problems, after which appropriate steps were taken, including the transfer of necessary technology and the implementation of training programs tailored to the needs and skill levels of the recipients. For example, Argentina listed hemolytic-uremic syndrome as one of its top public health problems; in response, steps were taken to provide the necessary resources, training, and technology transfer to help manage the problem.
Second, several participants expressed concern about the long-term sustainability of international collaborations. A foundation and methods need
to be in place to sustain long-term collaborations among international partners in a mutually beneficial manner. The Fogarty International Center within NIH has taken a substantial step in the right direction by transitioning some of its collaborations to commitments of 10 years or longer. This should serve as a model for other coordination and partnership efforts (see Chapter 3 for additional details). In addition, CDC has indicated that it will be developing programs incorporating more permanent field involvement.
Third, the sharing of information between developed and developing countries should have practical benefit. Generally, collaborating countries expect to be informed of known best practices for addressing the specific problems they face. The mismanagement of dengue hemorrhagic fever by clinicians, for example, can have devastating consequences. Simple training, an understanding of the pathogenesis of the disease, and knowledge of the appropriate clinical interventions can dramatically reduce the mortality rate.
Fourth, when the United States implements initiatives or sends trainees or clinicians to the developing world, it is important for the experience to provide value to the host developing country. A participant questioned whether value is provided when trainees who may have idealistic notions about working in a developing country but are not even experienced enough to deal with patients in clinics in U.S. cities are sent to help those in need. A better approach might be to learn from the experiences and successes of local communities in resource-limited environments in the United States and then apply what has been learned in other settings.
Fifth, there is a critical need for bidirectionality in any international collaboration: developed and developing countries can learn equally from each other. The health of the populations and the economies of both can benefit. For example, many Latin American countries, as well as other countries worldwide, are learning important lessons about how to manage antimicrobial resistance; it would behoove all countries to learn these lessons. The same applies to food safety. As another example, clinicians in developed countries are ill prepared to address the multitude of infectious diseases that emerge among refugees or migrants from other parts of the world. Programs such as the Gorgas Course provide important training opportunities for clinicians from developed countries to see and observe first-hand diseases endemic to the developing world.
Finally, as history has shown, it is critical for local communities to be involved. For example, Peru has a long history of terrorism, perpetrated most notably by the Shining Path guerrillas (also known as Sendero Luminoso and the Communist Party of Peru). In the 1980s, the Shining Path was initially believed to be a small group distributed among very isolated villages. By the beginning of the 1990s, however, the group had claimed 20,000 lives and cost Peru an estimated $20 million. When the government, the police, intelligence officials, and especially the community
at large realized the magnitude of the problem and made the decision to take control of the situation, the Shining Path leaders were captured within two months. One of the important lessons to be learned from Peru’s experience with the Shining Path terrorists is that surveillance does not always reveal the magnitude of a problem and how that problem is developing. More important, Peru’s experience illustrates the importance of different groups within a country working together and, in particular, of using the local community in combating a problem. This lesson has been learned repeatedly throughout history, from the U.S. experience in Vietnam to the costly experience with the 1991 South American cholera epidemic. With regard to the latter disease, in one Peruvian hospital today, for example, the rate of mortality from cholera is one per 2,000 cases, compared with one per 250 cases in the United States. This low mortality rate is due to a cooperative effort among scientists, academicians, politicians, public health workers, and the local community.
Infectious Disease Problems in the United States
Problems with emerging and reemerging infectious diseases are not confined to developing countries. As efforts to bridge the growing gap between the developed and developing worlds intensify, care must be taken not to lose sight of the serious infectious disease problems that exist in the United States and contribute to the global vulnerability to such diseases. There are many places in the United States where conditions are essentially the same as in developing countries. Several problems generally perceived to be problems of the developing world, such as improper adherence to medication regimens and limited access to health care, also occur in the United States. Indeed, some problems, such as multidrug resistance, are even worse in the United States and other developed nations than in the developing world.
Methicillin-resistant Staphylococcus aureus and ampicillin-resistant beta-lactamase-producing Haemophilus influenzae are two examples of drug-resistant microbes that are creating much greater public health problems in the United States than in most developing countries. Although the misuse of antibiotics is a major problem associated with the emergence of multidrug-resistant microbial strains, it was suggested that perhaps an even larger problem is person-to-person transmission of resistant strains, particularly in day-care centers, nursing homes, and hospitals. It was also noted that although antibiotic resistance occurs at a much lower rate in most developing countries than is currently the case in either the United States or Europe, there is good reason to expect that the world will soon have to deal with the problem on a much broader scale, including in developing countries. The issue of multidrug resistance was not discussed at
length during the workshop, however; participants suggested that it should perhaps be reserved for in-depth discussion at another workshop.
Another issue of concern in the United States is how the new requirements for clinical trials will affect the development and Food and Drug Administration (FDA) approval of effective drugs. It was pointed out that the requirements are restricted to certain criteria; thus, they are not likely to be as detrimental as originally anticipated. That said, however, the requirement for larger numbers of patients for separate indications, even for the same antibiotic, in a clinical trial will clearly add to the cost of developing new antibiotics and, given competing costs and market opportunities, may discourage antibiotic research and development. FDA’s Center for Drug Evaluation and Research is apparently addressing this issue and trying to distinguish requirements necessary to determine the appropriate use of antibiotics from those that would simply add expense to clinical trials.
THE NEED FOR A NEW, GLOBAL LEGAL FRAMEWORK6
The increasing global movement of people and products is forcing countries to confront heightened threats from the cross-border transmission of pathogenic microbes. Yet few if any domestic public health systems have adequate surveillance or other capabilities to manage these heightened threats independently. Public health capacity aside, unilateral efforts by individuals countries to manage public health threats that arise from cross-border microbial traffic can have only a limited impact when the source of the problem is beyond the jurisdiction and sovereignty of the affected country. Therefore, international law is a critical mechanism for facilitating an internationally cooperative public health response to the globalization of infectious disease.
Even before the current era of globalization and since the beginning of international cooperation on health-related matters in the mid-nineteenth century, international law has played an important role in facilitating intergovernmental cooperation in the control of infectious disease. The last several decades have, however, seen some significant shifts in this relationship between international law and infectious disease control. Never before has the role of international law been so important, or so uncertain. Although the IHRs have been revised to better accommodate the growing and urgent need for internationally coordinated response capabilities,7 it is
This section is based on the workshop presentations by Fidler (2002) and Klaucke (2002); see also Appendix B.
Note that at the time of the workshop and the writing of this report, the IHRs had not yet been revised. The revised IHRs were adopted by the World Health Assembly on May 23, 2005.
unclear how the revised regulations will actually improve the ability to prevent and control infectious diseases.
The International Health Regulations: An Effort That Needs Improving
In 1995, the World Health Assembly voted to review and revise the IHRs. Their stated purpose, however, would remain the same: to “ensure the maximum security against the international spread of disease with a minimum interference with world traffic.” The decision to revise the regulations was based on two major factors: (1) the public health need for more effective IHRs with respect to both emerging and reemerging infectious disease threats and vectors and the development of new technologies and approaches for controlling these diseases, and (2) environmental changes resulting from the globalization of markets, the increased transnational movement of goods and people, and the increased access to information.
Prior to being revised, IHRs specified that countries must notify WHO when cases of cholera, plague, and yellow fever arose and when areas were free of infection; required that ports, airports, and frontier posts be adequately equipped to apply the IHR measures; stated the maximum health measures applicable to international traffic, which a country could require for the protection of its territory against cholera, plague, and yellow fever; and required certain health documents, such as the Maritime Declaration of Health and Aircraft General Declaration. The IHRs were constrained in several ways: they were limited to three diseases; they depended on country notification to WHO; there was no mechanism for collaboration between individual countries and WHO; there was no incentive for countries to report; and they were limited in scope and lacked risk-specific measures for responding to urgent events.
The guiding principle of the revised IHRs is that the best way to prevent the international spread of disease is to detect public health threats early and to coordinate and implement an effective response when a problem is small and localized. Implementing this principle requires early detection of unusual disease events by an effective national disease surveillance system and an internationally coordinated response.
The revised IHRs have several important new features:
They focus more on responding to unexpected events and improving preparedness at both the national and global levels. In contrast, the old IHRs were designed to contain known risks.
They include procedures for real-time management in addition to the permanent procedures (e.g., environmental and epidemiological measures, such as insect and vector control) that were included in the old IHRs.
The information for real-time management is to be compiled from various IHR documents, such as regulations, annexes, and technical guides; the WHO-coordinated Global Outbreak Alert and Response Network (see the section on the use of the World Wide Web in international surveillance and response in Chapter 3); WHO-based epidemic intelligence; and IHR focal points in every country. A key component of the real-time event management aspect of the revised IHRs is confidential, or provisional, notification. Countries can enter into a dialogue with WHO regarding the best way to control a situation without the dialogue becoming general knowledge. Other real-time management features of the revised IHRs include WHO’s ability to accept information from unofficial sources, after which verification would be obtained from the country; WHO’s provision of network response support; and the availability of a template of recommendations and measures based on risk assessments for particular events.
Under the new IHRs, each country is required to maintain core surveillance capacities, as defined in the IHRs, including the ability to detect and report infectious diseases and to respond at both the local public health and national levels. Initially, this will be a target capacity for many countries, and WHO will need to work with these countries to develop their capacities. Each country will receive technical guidelines for the establishment of early-warning systems.
The criteria for reporting under the new IHRs include “public health emergencies of international concern.” WHO and the Swedish Institute of Infectious Diseases have been developing an algorithm for determining when a public health emergency may have an international effect and thus whether WHO should be notified. Following notification of WHO, consultation and collaboration between the country and WHO will be used to determine the appropriate response. The four main components of the algorithm are as follows: Is this event serious? Is it unexpected? Could it or has it spread internationally? Is there a risk of international sanctions?
Of course, even the revised IHRs will face numerous challenges:
Convincing countries that notification of urgent public events under the new IHRs is to their advantage.
Ensuring that international reactions to events are appropriate and that other countries do not impose inappropriate sanctions.
Developing the national political will to detect, investigate, and control problems instead of ignoring them and waiting for them to disappear (which has often been the case in the past for those diseases not required to be reported).
Developing the national capacity for surveillance and response.
International Law and Emerging Infectious Diseases
The public health challenges created by globalization can be categorized conceptually as either vertical or horizontal. Vertical challenges represent problems countries face within their own borders, such as weak surveillance capabilities. Horizontal challenges are the public health problems that arise from increased cross-border traffic of microbes resulting from the greater speed and volume of international trade and travel. Public health strategies against infectious diseases can be similarly categorized. A vertical strategy is an attempt to reduce the prevalence of an infectious disease inside a single country from within that country. In contrast, a horizontal strategy is an attempt to create cooperation among countries to minimize disease exportation and importation.
Usually, the onus of implementing both types of strategies falls on the individual country. After all, public health is a public good, which means it is the government’s responsibility; private-sector actors have neither the resources nor the incentives to do what is necessary to protect the public’s health. Thus, the individual country is a critical component of the governance response to emerging and reemerging infectious disease threats. It can operate within one of three overlapping governance frameworks:
A national governance response occurs within a country’s territory and under its own laws, and as such is a vertical strategy. For example, national quarantine practices in the first half of the nineteenth century took place without international cooperation; each country managed its own strategy with regard to infectious disease threats.
An international governance response is the classic intergovernmental cooperation that occurs, for example, in WHO or the World Trade Organization (WTO). International governance is aimed primarily at creating horizontal public health strategies regarding disease exportation and importation. The IHRs are an example of such a response.
A global governance response involves nonstate actors—including multinational corporations and NGOs—all of which play a significant and sometimes formal role in handling issues at the global level. At this level, the multinational corporations and NGOs are effectively built into the governmental response mechanisms. The primary strategic emphasis of global governance is vertical. The attempt is to reach down to the local level, and there is little interest in intergovernmental cooperation. The role of international law in global governance is not structural; rather, it is to provide norms that influence vertical public health strategies. The Global Fund is an example of global governance.
The first century of international health diplomacy, which began in the mid-1800s, witnessed the creation of three primary horizontal interna-
tional legal regimes relating to infectious diseases: the classical, organizational, and trade regimes. The classical regime dates back to the inception of the early International Sanitary Convention in 1851, which was replaced by the International Sanitary Regulations in 1951 and then renamed the IHRs in 1969. The IHRs’ stated purpose—“to ensure the maximum protection against the international spread of disease with minimum interference with world traffic”—captures the essence of the classical regime, which constitutes the central and most important use of international law in infectious disease governance at the international level, at least within the first 100 years of international health diplomacy.
The organizational regime represents the various state-created international health organizations (IHOs), beginning in 1902 with the Pan American Sanitary Bureau. This regime involves the use of international law to create permanent IHOs, such as today’s WHO, in an effort to facilitate intergovernmental cooperation on infectious diseases and other international public health problems. In contrast with the classical regime, the organizational regime’s legal responsibilities for infectious disease control have been shallow at best.
The best example of the trade regime, which represents efforts to liberalize trade among states, is the General Agreement on Tariffs and Trade (GATT), adopted in 1947. Although its explicit purpose is not infectious disease control, GATT includes rules that allow states to restrict trade to protect human, plant, and animal life and health. Thus, it figures in the use of international law in the international governance of infectious disease control.
Over the last five decades, there have been several important shifts in governance with important implications for infectious disease control. First, within the realm of horizontal international governance, there has been a shift in emphasis from the classical to the trade regime. This was evident in the number of times WTO was mentioned during the workshop and is referred to in this report—far more times than either the IHRs, which represent the classical regime, or WHO, which represents the organizational regime. The classical regime has been widely recognized as failing to achieve its objective of maximum protection against the international spread of disease with minimum interference with world traffic, for several reasons (see the preceding section on the IHRs). WTO came into existence in 1995, almost simultaneously with WHO’s recognition that the IHRs were inadequate to deal with the challenges posed by globalization.
Since its inception, WTO has become the central horizontal regime for international law on infectious diseases. Two WTO agreements in particular have garnered attention: the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS agreement) and the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) in connection with food safety.
This shift from the classical to the trade regime raises some questions with regard to WHO’s revision of the IHRs. Participants suggested that there was some indication that a revised set of IHRs might not even be necessary. For example, with regard to maximum protection against the spread of infectious disease, there has been a shift away from relying on the binding legal duty to provide notification of specific diseases to a reliance in WHO on new information technologies. This shift is epitomized by WHO’s Global Outbreak Alert and Response Network, which is being used to gather global epidemiological information outside the framework of the IHRs. It is unclear whether the IHRs are necessary for WHO to make progress on global epidemiological surveillance. As another example and with regard to minimum interference with traffic and trade, many irrational trade-restricting health measures are sometimes instituted when countries report real or supposed disease outbreaks (see Chapter 3). Despite WHO’s attempt to give the IHRs more teeth to deal with the issue, WHO is no longer the most important player, but WTO. Not only does this shift from the classical to the trade regime raise questions about the usefulness of the IHRs and the need to develop revised IHRs, but it also raises the question of whether we are witnessing the rejuvenation of the classical regime or its death.
A second change that has occurred over the past several decades with regard to the governance of infectious diseases is the evolution after World War II of vertical international regimes that influence global strategies on infectious disease much more dramatically than do the traditional horizontal approaches. Although these regimes—the soft-law regime, the environmental regime, and the human rights regime—are not international, their objectives are to deal with issues that concern individual countries and to improve conditions inside countries; their purpose is not necessarily to regulate intergovernmental cooperation.
For example, the soft-law regime, which includes WHO’s development of norms, principles, guidelines, and best practices on infectious disease control (e.g., the DOTS strategy for TB control), is not legally binding on WHO member states (hence the term “soft law”). Indeed, voluntary compliance is an important aspect of how WHO has historically worked. Adoption of these norms and practices generally has a beneficial impact inside the country for both the government and the public health system. Unfortunately, compliance with soft-law guidance from WHO is not very good, as the lack of compliance with DOTS illustrates.
The environmental regime, another development after World War II, is an attempt to improve environmental practices inside countries so that their populations can enjoy better environmental conditions. Thus, to many people’s surprise, it is also an international body of law concerned with the protection of human health. One of its weaknesses with respect to infectious disease, however, is that it focuses very little if at all on local air and
water pollution, two of the greatest environmental sources of morbidity and mortality from infectious disease.
The human rights regime, which imposes obligations on governments in connection with their treatment of persons living within their territories, also has the potential to have a significant effect on public health. Respect for human rights, including the right to health, has been part of strategies for dealing with a number of public health crises, including the HIV/AIDS pandemic, as well as treaties such as the UN Convention on the Rights of the Child. This regime is now quite powerful.
A third critical change in governance of infectious disease over the last 50 years is the development of global governance mechanisms that support the new trade and vertical public health strategies. Again, unlike international governance, which involves only states, global governance involves states, intergovernmental organizations, and nonstate actors, and the strategy is vertical, not horizontal. The involvement of NGOs and multinational corporations is a key component of these new mechanisms, whose strategic objective is to produce global public goods that states, especially developing countries, can use within their own territories to reduce the rates of morbidity and mortality from infectious disease. Currently, one of the most prominent features of these new global governance mechanisms is the development of public–private partnerships, such as the Global Fund. As another example, infectious disease surveillance, especially via the Global Outbreak and Alert Response Network (see Chapter 3), is often fueled by the participation of nongovernmental actors who acquire their information from nongovernmental sources, such as the press, the online website ProMED, and NGOs.
One of the most controversial developments in the infectious disease arena as regards global governance is the development of the new access regime, which arose from a clash between the trade and human rights regimes. The objective of the access regime is to improve access to essential drugs, vaccines, and medicines in developing countries; the regime is being driven largely by nonstate actors, as opposed to intergovernmental organizations or states, and is characterized by the heavy involvement of NGOs (e.g., the Global Fund and the Global Alliance for Vaccines and Immunization). The emergence of the access regime was marked by the dramatic adoption of the Declaration on the TRIPS Agreement and Public Health at the WTO Doha Ministerial Meeting in November 2001. The declaration clearly supports placing public health objectives, especially access to medicines, above the trade-related goal of increasing patent protection for pharmaceuticals. Experts view the declaration as a victory for the human right to health and for public health governance generally.
Another development involves arguments that infectious diseases represent national security threats, and as such should be a priority on foreign
policy agendas. In contrast to the movement toward vertical global governance characteristic of the access regime, these arguments seek to reconnect infectious disease control with national and international governance by reengaging the great powers in international public health. Should these arguments take hold, one might foresee reinvigorated national and international governance on infectious disease.
However, it would be prudent to be cautious about arguments that infectious diseases represent national security and foreign policy threats. Historically, the great powers have not hesitated to bend, break, or abandon international law when they believed national security was being threatened. Although the United States has focused energy and new funding on homeland security against bioterrorism, it has rejected multilateral efforts to strengthen international governance as it pertains to the threat of biological weapons. Many experts are concerned about what appears to be a rejuvenated U.S. unilateralism in an area in which public health plays a strategic role.
At the same time, the tepid and tardy responses to the HIV/AIDS catastrophe in sub-Saharan Africa hardly suggest that infectious disease problems in faraway countries have risen high on many national security and foreign policy agendas. The shift from binding commitments in international governance efforts to nonbinding, voluntary participation in global governance efforts may suit the narrow public health interests of the great powers at the expense of strengthening national and international governance of infectious disease.
Never before has the role of international law been so important in infectious disease control. At the same time, there is a great deal of uncertainty about where these new developments will lead and whether they will really have an impact on improving the ability to prevent and control infectious disease at the global level.
THE NEED FOR A SOCIAL SCIENTIFIC FRAMEWORK FOR UNDERSTANDING INFECTIOUS DISEASE EMERGENCE8
Attempts to understand the etiology of the emergence of infectious diseases cannot be restricted to a purely biological approach. Rarely, if ever, is the emergence of an infectious disease caused exclusively by biological factors. The word “syndemic” was recently introduced into the English language to refer to the convergence of factors that typically contribute to
This section is based on the workshop presentations by Mayer (2002) and Patz (2002); see also Appendix C.
the emergence of infectious diseases (Singer, 1994). This is perhaps no better illustrated than by the emergence of West Nile virus in New York City, an event that was the culmination of the convergence of a number of different human ecological factors.
Only by studying the complex interplay among the social, environmental, and biological factors that underlie the emergence of infectious disease can one hope to gain an understanding of disease distribution patterns and changes. In the original IOM (1992) report on microbial threats, Emerging Infections: Microbial Threats to Human Health in the United States, five of the six factors identified as contributing to the emergence of infectious disease are explicitly social in nature (i.e., human demographics and behavior, technology and industry, economic development and land use, international travel and commerce, and a breakdown in public health), and the sixth (microbial adaptation and change) is partly the result of social behavior and social change.9 The effects of dam construction, land clearance projects, and other environmental modifications on vector ecology illustrate the necessity of adopting a social approach to understanding the global emergence of infectious diseases. To understand the effects of globalization on vector ecology, one must study not only vector ecologies per se, but also the role of human activities and behaviors.
Despite the vital role of social factors in the etiology of infectious disease emergence and the fact that the literatures of many of the social sciences, such as demography and political geography, could inform our understanding of infectious disease emergence, the vast preponderance of research and policy on the emergence of infectious diseases has been explicitly biological in nature. Little social science has been incorporated into epidemiological, public health, or infectious disease research and policy.
One of the consequences of the failure to take a social scientific perspective in attempting to understand the emergence of infectious diseases has been a restrictive definition of globalization in public health—a definition that tends to focus only on surface phenomena, such as the movement of people and commodities. Even within the workshop, as summarized in Chapter 1, most of the descriptions of phenomena that characterize the globalization of infectious disease revolved around the movement and interaction of people and goods. There was comparatively little discussion on the movement of capital and the critical role of political and economic
decision-making power that transcends national borders. Yet understanding the relationships between changing vector ecologies, for example, and globalization necessitates an understanding of how political and economic decisions, particularly those that alter the landscape, change human– environment relations at the local, regional, and global levels. Failure to recognize the importance of the latter could compromise efforts to strengthen the global capacity to prevent and control emerging and reemerging infectious diseases.
How can a social scientific perspective be incorporated into the study of emerging and reemerging infectious diseases? Classic geographic disease ecology has been developing since about the time of World War II, when Jacques May, a French surgeon who practiced in French Indochina, became intrigued by the role of the interaction of local social, cultural, and environmental conditions in the development of patterns of contagion for a number of infectious diseases. He eventually gave up his surgical career to become the medical geographer at the American Geographical Society in New York City, where he produced numerous volumes and papers on disease ecology, including a monumental 30-volume collection of works demonstrating how disease ecology could be understood from a more integrated and less purely biological perspective (May, 1958). As significant as his work was, however, May did not consider the impact of other regions on local conditions. Thus, even though interregional patterns of commodity shipments, cultural contact, and cultural change are aspects of global interdependency that were apparent decades ago, May did not incorporate them in his descriptions and analyses. Nor did he consider the effects of power and politics on local disease conditions. That tradition has continued to today. Even when social factors are considered, disease ecologists tend to focus only on isolated regions and generally fail to consider regional hierarchies and interregional interactions and flows, such as the migration of people and the movement of capital.
The political ecology of disease may provide the best way yet to conceptualize the impact of these factors on local disease ecologies. Political ecology, which is based on a combination of political economy and cultural ecology, is “the attempt to understand the political sources, conditions, and ramifications of environmental change” (Bryant, 1992, p. 13). It can and has been used as a way to understand the unintended consequences of environmental decisions, particularly those, such as dam building, that alter human–environment relations and affect emerging infectious diseases (Mayer, 2000).
In addition to adopting a political ecology approach, another means suggested for improving the conceptual framework for understanding the emergence of infectious diseases is to strengthen the type of interdisciplinary research that addresses key knowledge gaps related to how factors of
emergence converge and interact. This will be a challenging task, as it will require long-term cross-disciplinary collaboration. As an example of the current failure of cross-disciplinary communication, not a single climatologist was included in a recent multiauthored paper on climate and malaria in the African Highlands published in the journal Nature, even though the work was essentially a climate study and made use of an extant climate database (Hay et al., 2002). Indeed, the climatologist whose climate database was used in the study prepared a rebuttal for publication in the journal pointing out how the database was used inappropriately and how the results are flawed. If a climatologist had been part of the original research team, this situation could have been avoided.
As the impacts of dam construction and land modification projects on emerging infectious diseases attest (see Chapter 1), the need to understand emergence within the larger social and political context is clearly not just an academic exercise. Human activity associated with the expansion of free-market capitalism threatens to destroy ecosystems and opens the door to the rapid emergence of new diseases. If left unchecked, the current economic model that allows such environmental devastation will likely lead to future public health crises. Moreover, recent research suggests that scarcities of vital environmental resources—especially cropland, freshwater, and forests—contribute to violence in many parts of the world, a phenomenon that feeds back into and amplifies the effect of the devastation. As the competition for scarce resources increases, environmental devastation worsens, the potential for economic prosperity decreases, and public health deteriorates.
Adeyi O. 2002 (April 17). Considerations for Shaping the Agenda. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
Bryant RL. 1992. Political ecology: An emerging research agenda in third world studies. Political Geography 11(1):12–36.
Cash R. 2002 (April 16). Impediments to Global Surveillance and Open Reporting of Infectious Diseases. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
CDC (Centers for Disease Control and Prevention). 2002. Protecting the Nation’s Health in an Era of Globalization: CDC’s Global Infectious Disease Strategy. Atlanta, GA. [Online]. Available: http://www.cdc.gov/globalidplan/global_id_plan.pdf [accessed September 12, 2005].
Cleghorn F. 2002 (April 16). Considering the Resources and the Capacity for the Response. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
Fidler D. 2002 (April 16). International Law, Infectious Disease, and Globalization. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
Gardner P. 2002 (April 17). New Directions in Capacity Building. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
Gordon D. 2002 (April 16). The Global Infectious Disease Threat. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
Hay SI, Cox J, Rogers DJ, Randolph SE, Stern DI, Shanks GD, Myers MF, Snow RW. 2002. Climate change and the resurgence of malaria in the East African Highlands. Nature 415(6874):905–909.
IOM (Institute of Medicine). 1992. Emerging Infections: Microbial Threats to Health in the United States. Washington, D.C.: National Academy Press.
IOM. 2003. Microbial Threats to Health: Emergence, Detection, and Response. Washington, D.C.: The National Academies Press.
Kimball AM. 2002 (April 16). Invited Discussion: Considering the Resources and Capacity for the Response. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
Klaucke D. 2002. Globalization and Health: A Framework for Analysis and Action. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
Kurth R. 2002 (April 17). The Global Application of Tools, Technology, and Knowledge to Counter the Consequences of Infectious Diseases: A Discussion of Priorities and Options. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
Leaning J. 2002 (April 16). Health, Human Rights, and Humanitarian Assistance: The Medical and Public Health Response to Crises and Disasters. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
LeDuc J. 2002 (April 17). The Global Application of Tools, Technology, and Knowledge to Counter the Consequences of Infectious Diseases: A Discussion of Priorities and Options. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
May JM. 1958. The Ecology of Human Disease. New York: M.D. Publications.
Mayer JD. 2000. Geography, ecology, and emerging infectious diseases. Social Science and Medicine 50(7-8):937–952.
Mayer JD. 2002 (April 16). The Global Movement of Populations, Products, and Pathogens. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
NIC (National Intelligence Council). 2000. National intelligence estimate: The global infectious disease threat and its implications for the United States. Environ Change Secur Proj Rep 2(6):33–65.
Patz J. 2002 (April 16). Invited Discussion: Considering the Resources and Capacity for the Response. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
Singer M. 1994. AIDS and the health crisis of the U.S. urban poor: The perspective of critical medical anthropology. Social Science and Medicine 39(7):931–948.
Steiger W. 2002 (April 17). The Global Fund: A Brave New World. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
WHO (World Health Organization). 2000 (April). Economic Costs of Malaria Are Many Times Higher Than Previously Estimated. Press Release WHO/28, 25. Joint report issued by the World Health Organization, Harvard University, and the London School of Hygiene and Tropical Medicine at the African Summit on Roll Back Malaria in Abuja, Nigeria. [Online]. Available: http://www.who.int/inf-pr-2000/en/pr2000-28.html [accessed September 12, 2005].
Widdus R. 2002 (April 17). Partnering for Success: The Role of Private-Public Sector Collaboration. Presentation at the Institute of Medicine Workshop on the Impact of Globalization on Infectious Disease Emergence and Control: Exploring the Consequences and Opportunities, Washington, D.C. Institute of Medicine Forum on Emerging Infections.
World Bank. 2000. Economic Analysis of HIV/AIDS. ADF 2000 Background Paper. AIDS Campaign Team for Africa. Washington, D.C.: The World Bank.