oxford handbook of bioethics

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people, the virus could recombine and render bird flu transmissible from human to human. Although the first cases of bird flu in humans were reported in Vietnam and subsequently in Thailand, avian influenza has been fatal in chickens in South Korea and Japan, as well as in the two countries where human disease has appeared.

This phenomenon of global spread of infectious diseases has given rise to multinational public health efforts, often led by WHO and with the cooperation of other governments and their agencies, such as the Centers for Disease Control and Prevention (CDC) in the United States. The experience with SARS is an interesting case study of the way a global health concern prompts a transnational response, raising public health, political, and ethical issues — as well as fears. The quarantine of infected individuals and those who had close contact with them is one example of a relatively rare response to an outbreak of disease in recent times.

SARS first appeared in Guangdong province, China, in November 2002, and quickly spread to other Asian countries and to Canada. The first worldwide outbreak killed 774 people by the end of 2003. By early 2004 new cases were detected in China. A highly infectious disease, SARS spread rapidly in densely populated areas despite the fact that China had a fairly elaborate system of public health law, designed to detect communicable diseases, prevent their spread, and enforce violation of the provisions of the laws. Those include the authority to quarantine and isolate people, close factories, schools, and shops, and even confiscate homes. Some new public health laws in China were put in place as a direct response to the SARS epidemic.

Meanwhile, because SARS had become a global threat, WHO was tracking the epidemic and became aware that China was underreporting SARS cases. WHO publicly rebuked China for failure to provide a full account of the number of cases — an unusual action for the international agency since WHO typically does not criticize its member states. The Chinese government itself also took an unusual political step when it permitted WHO to visit Taiwan to monitor the epidemic there, a move that it had earlier blocked. Coming less than a month after WHO’s criticism of its underreporting, this signaled China’s willingness to cooperate in what was now seen as a global health threat. According to one report, ‘international political and economic realities led the PRC to institute massive isolation and quarantine and other measures to contain the spread of SARS’ (Institute for Bioethics, Health Policy and Law 2003).

Whereas public health and governmental officials in China were slow to provide full and accurate reports of the disease, that information was forthcoming from other sources within China as a result of modern telecommunications and the Internet. Only after non-governmental sources provided information to WHO and the media did the official, governmental reports follow. In contrast, the government of Vietnam cooperated fully with WHO from the start. Taiwan also cooperated, although it is not a member nation of WHO.

The steps taken by the United States and other countries to determine whether travelers were infected when they arrived from countries where there was an

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outbreak of SARS were unusual, to say the least. Symptomatic passengers had their temperatures checked at airports, and passengers arriving by ship, maritime crews, and others crossing international borders faced the same procedures. Singapore, Taiwan, Hong Kong, and other areas where SARS cases were reported took similar measures. Although such surveillance measures are justifiable at the height of an epidemic, how long should they continue when there is no longer a perceived threat? One example cited is thermal sensors used to detect fever in international travelers entering a country. Thermal imaging and other screening measures were implemented without a thorough scientific knowledge of their effectiveness (Institute for Bioethics, Health Policy and Law 2003). Without such knowledge, there is a risk of false positives and false negatives, a risk that may be temporarily acceptable during the crisis. However, once the emergency situation abates, these and other intrusive measures should be suspended and evidence for their effectiveness carefully gathered.

The efforts made to contain the spread of SARS raise the perennial question of how to strike an ethical balance between protecting public health and preserving civil liberties. Isolation and quarantine in the SARS epidemic proved dramatically successful in containing the spread of the epidemic once the disease was recognized and these measures were put in place. Yet they are indisputably extreme measures in restricting individual liberty and intruding on privacy, arguably justified for the protection of public health. Still, critics could contend that the death rate from SARS was sufficiently low to question the use of extreme measures and the resulting worldwide fears that media reports caused. Was Taiwan justified in requiring that all airline passengers from SARS-infected areas wear masks? Was it justifiable to quarantine visitors from infected areas even if they had no disease symptoms, a measure imposed by India and Thailand?

Such questions could be answered fully only by using the gold standard in scientific methodology: controlled experiments in public health. To do that would raise practical, political, and ethical problems. The main practical problems are: Who would mount such experiments? And what would be the unit of analysis? The country? Different airplanes in Taiwanese airlines? Political problems would ensue if, for example, WHO were to conduct such experiments. Permission would have to be granted by the governments of any countries involved, and that would almost certainly give rise to objections by governments that would not consent to have their country randomized in a controlled experiment.

A likely ethical objection to randomized, controlled public health experiments would be the absence of individual informed consent, a standard requirement for research involving human beings. However, individual consent cannot be obtained for the type of experiments in which the unit to be randomized is a hospital or a community, yet those experiments are arguably necessary for answering certain types of questions. The most telling response to the concern about informed consent is that when public policies of all sorts are put in place, there is no informed

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consent by the public and, most often, no possibility of opting out. The only way of opting out of such policies (or experiments) would be choosing not to travel at all during health emergencies like SARS. All things considered, it would be preferable to seek to conduct such experiments if the practical and political barriers could be overcome.

In sum, the ethical issues that arise from infectious disease epidemics include the classic dilemma in public health: the trade-off between limiting the liberty of individuals suspected of having or carrying transmissible diseases and the public health need to halt or mitigate the spread of those diseases. With globalization, this tension — which formerly occurred within countries and primarily at the level of individuals — has been transformed into one that affects nations and calls for governments to establish policies and procedures, often those recommended by the World Health Organization.

The SARS outbreak resulted in limitations on travel of entire populations and the closing of borders of countries where disease outbreaks occurred. While some public health officials argued that these steps were desirable and necessary, others contended that the measures were unduly restrictive and alarmist. What is clear, however, is that the types of restrictive measures taken to contain the spread of SARS could never be justified in the case of HIV/AIDS. Although some people did promote such measures in the early stages of the AIDS pandemic, and Cuba actually did for a time impose mandatory isolation for people living with AIDS, that response was not only the most restrictive (and unwarranted) alternative, but also, as demonstrated in Cuba, ineffective in preventing the spread of HIV in the population.

GLOBAL DI SEASES AND IN EQUI TABLE

ACCESS TO TREAT MENT

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One of the more striking disparities in the global picture is the inequality in access to medical treatment among different populations in the world. The burden of disease is heaviest in developing countries, whereas access to treatments (not always cures) is greatest in the industrialized world. Many studies have demonstrated that health disparities between socioeconomic classes exists within countries — including wealthy ones — as well as in poorer countries. But the global disparity among rich and poor nations is an even greater inequity because the majority of the population in poor countries lacks access to medical treatment (as well as to clean water and adequate nutrition, in many cases). Until the early 1990s the response to this global inequity on the part of wealthier nations was, at best, some aid in the form of what is best described as charity. The traditional picture began to change with the establishment of international public – private partnerships between and among a

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variety of organizations. Private, nonprofit foundations, national governments, the WHO, newly created entities such as the Global Fund to Fight AIDS, Malaria, and Tuberculosis, and for-profit companies have formed various alliances aimed at making medical treatments affordable and accessible in countries where the majority of the population lacks access to such treatments.

Numerous factors besides lack of money hinder access to drugs in many developing countries, although poverty is the single most important reason why people in developing countries cannot obtain the drugs they need. These other factors include inefficiency and waste in health care delivery systems, inadequate systems for distribution of drugs within a country, lack of reliable scientific information and appropriate education and training of health care personnel, and local perceptions and beliefs about illness and medicine (Page 2002). The relatively poor health care infrastructure in many developing countries is a leading factor that inhibits access to drugs by large numbers of people. It would not be easy to remove these diverse barriers to adequate access to much-needed drugs, even if cheaper medications are made available and the Global Fund provides financing for drugs to treat AIDS, malaria, and tuberculosis.

These background conditions pose a question about the responsibility of industrialized countries to seek to redress the inequities in health status and access to treatment between the industrialized and developing world. The increasing number of public – private partnerships is evidence of a growing recognition that such a responsibility exists. Two of the latest efforts are described below.

The Global Fund

One of the initially most promising developments was the initiative taken by several United Nations agencies in establishing the Global Fund to Fight AIDS, Tuberculosis and Malaria. The call for the creation of a huge fund to combat diseases that kill or disable millions of people in poor countries came from both Gro Harlem Brundtland, the former Director-General of WHO, and Kofi Annan, the Secretary-General of the United Nations. Both leaders envisaged the need for commitments from government in rich and poor countries alike, as well as from private foundations, nongovernmental agencies, and the private sector to mount this effort. It would require funds not only for the purchase of drugs from manufacturers, but also to mount better educational and prevention programs, build new clinics or enhance existing ones, train health care workers, and strengthen the infrastructure in other ways.

Secretary-General Kofi Annan called for the establishment of a global fund on AIDS and health at the Organization of African Unity summit in Abuja in April 2001. In his ‘Call to Action’ Annan urged greater coordination among nations and a strong political and financial commitment to support efforts to combat AIDS

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(UNAIDS 2001). Soon thereafter, pledges to the fund began coming in, with the United States initially pledging $200,000,000 and the United Kingdom an equal amount. A United Nations General Assembly Special Session on HIV/AIDS took place in New York in June 2001, and the United Nations adopted a declaration of commitment that set out clear goals for a global battle against HIV/AIDS. As of April 2003 pledges to the Global Health Fund totaled more than $US3 billion. The majority of the pledges were from governments, including contributions from rather poor African countries (Uganda and Zimbabwe).

The Global Fund formally adopted the stance of encouraging poor countries to purchase generic drugs instead of the more costly brand-name drugs still under patent protections by the big pharmaceutical companies. This approach was designed to enable manufacturers of generics in countries like Brazil and India, which have that capability, to sell their products to other resource-poor countries. However, the WTO’s intellectual property agreement has been a major barrier to full access by poor countries to generic copies of medications that are still under patents held by the huge pharmaceutical companies (see discussion of the WTO in the next section).

Despite the promise inherent in the creation of the Global Fund, many have expressed extreme disappointment at the level of contributions, especially from the United States. In February 2002 the New York Times reported that donations to the fund had fallen far short of the amount initially sought by Secretary-General Kofi Annan — at least $7 billion a year — when the fund was established. Advocates for the fund blamed the White House, claiming that the $200 million pledge by the United States sets a poor example for other countries. However, much to the surprise of many people, in January 2003 President George W. Bush proposed his own Emergency Plan for AIDS Relief. Bush asked Congress to commit $15 billion over the subsequent five years, including nearly $10 billion in new money. The money was slated for the most afflicted nations of Africa and the Caribbean (Stolberg and Stevenson 2003). It was not clear at the time the announcement was made how much of those funds would go to the Global Fund.

One year later Bush’s AIDS initiative appeared to be faltering, as well as succumbing to ideological and self-serving interests. By February 2004 the US government was about to make a first round of grants — only $350 million of the proposed $15 billion. While this initiative could easily have committed a significant portion of its promised money to the Global Fund, the Bush administration declined to do so. Instead, the individual appointed to run the program (a former chief executive of the huge pharmaceutical company Eli Lilly) decided to give much of the money to American contractors rather than to African groups. In addition, decisions about how to set priorities for use of the funds are delegated to the American ambassador in each country in which the United States provides technical assistance. Moreover, the director of this initiative is a supporter of the form of AIDS education that focuses only on abstinence, ignoring instructions

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on using and negotiating the use of condoms. Thus, despite the enthusiasm and optimism with which the Global Fund to Fight AIDS, Tuberculosis, and Malaria was launched, it has been in financial trouble almost from its inception and will continue to suffer a significant shortfall without the financial contribution the United States could readily make.

The WHO/UNAIDS 3 × 5 Initiative

One of the latest efforts to provide access to treatment for people in developing countries is the World Health Organization’s 3 × 5 Initiative, a program WHO launched in December 2003 aimed at providing antiretroviral (ARV) treatment to 3 million people living with AIDS in developing countries by the year 2005 (WHO 2003). Only time will tell whether the hope and promise of this initiative by WHO and the Joint United Nations Programme on HIV/AIDS (UNAIDS) will be more successful than the Global Fund has been in seeking to fulfill its target. WHO and UNAIDS will not provide a major portion of the funding for this ambitious effort, but are taking a leadership role in partnerships that will include governments of WHO member nations along with industry and other organizations in the private sector.

Initiatives such as 3 × 5 bring with them new ethical challenges: as treatment programs are rolled out, how to select who goes first? Is there a clear and uncontroversial way of determining which groups in a population should be given first priority when all cannot be treated, at least initially? Is this challenge best met by coming up with a fair process for decision making rather than by seeking substantive criteria for equitable access to medical treatments? In its announcement and description of the 3 × 5 Initiative, WHO and UNAIDS included the following among the guiding principles:

•Ethical Standards. The Initiative will identify options for an ethical approach to meeting 3 by 5 targets.

•Equity. The Initiative will make special efforts to ensure access to antiretroviral therapy for people who risk exclusion because of economic, social, geographical or other barriers.

(WHO – UNAIDS 2003: 10)

Ideally, the 3 × 5 Initiative would provide ARV treatment free of charge through public health care institutions. This would ensure not only that the poor will not be excluded from the scaling up of ARV treatment, but also that priority will be given to the large numbers of people in developing countries for whom existing treatments have not been affordable and who would continue to be excluded if they had to pay out-of-pocket for ARV treatment. Moreover, on a practical level evidence from existing programs in which people in developing countries have had to pay for some or all of the cost of ARVs demonstrates an array of negative medical

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and social consequences, including interruption of therapy, deteriorating health status, poor adherence, and development of drug resistance (Attawell and Mundy 2003).

Although not everyone agrees that the poor should be given preference in scaling up ARV treatment, an argument in favor of giving preference to the poor is supported by a leading ethical principle: concern for the worst off, or the least advantaged — a principle known by the infelicitous term ‘prioritarianism’. It means, essentially, that it matters morally that we help those who are least well off. The prioritarian principle calls for giving preference to those who are worst off in some relevant respect. In the context of health care delivery, this is usually understood to refer to those who are worst off in terms of health status, but it could also apply to the poorest members of society; the lowest socioeconomic class; the most vulnerable (for example, children, especially orphans); groups that are marginalized or most discriminated against (in many societies, intravenous drug users, sex workers, and men who have sex with men). Although the principle sets up a presumption in favor of least advantaged and most vulnerable groups, it does not call for giving strict priority to those groups.

Several ethical principles in addition to the prioritarian principle are potentially relevant and can provide justifications for choosing one or another scheme for access to ARV treatment. The utilitarian principle, applied specifically to health policy, aims at maximizing health benefits for the society as a whole. The best policy would be one that embodies a mix of health care services that produces the greatest overall health effects. An egalitarian principle of equity in this context would call for distributing resources equally among persons, or distributing goods, such as health care services, or health, equally among different groups. This could mean either that everyone should receive the same amount of resources for health care; or that everyone should receive the same amount of health care services; or that as far as possible, health status among different groups should be minimized. This principle is the basis for schemes that emphasize health equity over health maximization; there is thus a conflict with the utilitarian approach. The goal is to reduce disparities in health status among different groups or strata in society: the poor, women, people living in rural areas, ethnic or racial minorities, and others.

The three principles described here are likely candidates for a justifiable scheme that might be used by policy makers to set priorities within countries. These principles point to criteria or concerns that must be considered; but the principles can conflict, and it then becomes necessary to balance competing concerns. There is no uniquely correct way of doing this balancing. Moreover, there is no consensus on how the different principles ought to be weighted, or on how the goal of maximizing health should be weighted against other social goods. Different people often have different weightings. For these reasons, leading commentators have urged that emphasis has to be placed on fair processes (Daniels and Sabin 2002). To the extent that decision makers in each country can agree on principled ways to set priorities

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for equitable access among the various individuals and groups eligible for ARV treatment, the aforementioned principles can be used to justify their decisions. Even given such agreement, the use of fair procedures remains necessary since equity demands adherence to both substantive and procedural aspects of ethics.

In publicizing the 3 × 5 initiative, WHO described the situation regarding HIV/AIDS in developing countries as a ‘public health emergency’. This raises the question of what follows from labeling a situation as an ‘emergency’. Does it call for a response different from that in which the health needs of large numbers of people are identified as ‘urgent’? In the WTO’s agreement known as TRIPS — Trade Related Aspects of International Property — the concept of a national health emergency is a key condition that opens the door to loosening the strict patent protections that have reigned under the influence of the global pharmaceutical industry.

The World Trade Organization and Barriers to Access

In addition to the failure of market forces to ensure access to drugs, another significant factor contributing to the establishment of public – private partnerships has been the restrictions imposed by intellectual property rights. The question is whether the goal of promoting health merits exemption from the rules that govern world trade in all other commercial products. The stated purpose of intellectual property rights — patents, in particular — is to encourage commercial investments in research and development. Industry spokespersons maintain that patent protections are necessary for promoting research, and the resulting products benefit everyone, poor nations included.

The international trade agreements that protect the financial interests of patent holders in world markets have come under increasing scrutiny in the health arena. Critics of globalization claim that the WTO’s protection of patents is responsible for the many ills that globalization produces, including poor health of vast numbers of people in developing countries (Singer 2002; Bloch and Jungman 2003). The TRIPS agreement, which became operative in January 1995, requires all member countries to respect the patents held by pharmaceutical and biotechnology companies and to pass laws respecting medical patents. Although the patent system serves the interests of manufacturers, the system is viewed by many to be in the public interest, as well as a benefit to the financial interest of industry. One description of the TRIPS agreement describes it as ‘an attempt at the multilateral level to achieve the difficult task of balancing the public health interest in providing incentives for research and development into new drugs with the public health interests of making existing drugs as accessible as possible’ (Watal 2001).

There is one provision in this agreement that enables countries to make an exception to the rule that requires respecting the patent rights of pharmaceutical companies. That provision permits countries to manufacture copies of patented

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drugs in case of a ‘national emergency’. The mechanism for this is to obtain a ‘compulsory license’ to make a generic copy of a drug, and the patent holder is paid a reasonable royalty under this arrangement. Somewhat less certain under this provision has been the ability of a country to import a generic copy of a patented drug. An obvious question is what constitutes a ‘national emergency’? Arguably, the AIDS epidemic in countries with a high prevalence rate would qualify. Does the same hold for countries with a high incidence and prevalence of malaria and tuberculosis?

Drug companies and their international umbrella organization, the International Federation of Pharmaceutical Manufacturers Associations, have long resisted efforts to invoke the provision that would allow countries to make or import generic copies of patented drugs under the compulsory licensing clause. Over a four-year period the United States came to soften its initial strong opposition to allowing South Africa (and by implication, other countries) to seek compulsory licensing for AIDS drugs.

Although many observers expected a reversal of the softened US stance with the arrival of the pro-business Bush administration, that did not happen with respect to South Africa. In fact, thirty-nine multinational drug companies that had brought a suit against South Africa began to negotiate to settle the lawsuit, especially after the European Union, WHO, and the National AIDS Council in France publicly supported South Africa’s position (Swarns 2001). In April 2001 the companies withdrew their suit, thus allowing South Africa to import cheaper anti-AIDS drugs and other medications.

This move did not end other ongoing battles, however. Since 1998 Brazil has been a major challenger to the international pharmaceutical industry by copying and manufacturing AIDS drugs. State-owned laboratories in that country have produced generic copies of several patented AIDS drugs. Another country in the forefront of this development is India, where private companies have been manufacturing generic drugs. The most prominent of these companies is Cipla.

In May 2001 the Bush administration threatened trade sanctions against Brazil. The head of the Brazilian HIV/AIDS program called the US position ‘unacceptable’ (Crossette 2001a). In a surprising reversal, in June 2001 the United States withdrew the complaint it had made against Brazil in the WTO, agreeing to settle its dispute out of court. This decision by the United States was announced on the first day of a three-day meeting at the United Nations General Assembly devoted to the global AIDS crisis. The agreement between Brazil and the United States proposed to establish a joint panel that would deal with patent cases (Crossette 2001b).

Advocates of compulsory licensing have argued that it is the best alternative among the various efforts designed to provide essential drugs to developing countries, especially for treating HIV/AIDS. The authors of one article argue that ‘making use of the . . . TRIPS provision or even breaking international trade agreements might be a given developing country’s most effective means of providing