oxford handbook of bioethics

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The net effect of paragraph 6 was that only a small group of developing countries would be able to manufacture affordable generic medications for their own populations. Argentina, China, India, Mexico, and South Korea are among the developing countries in which the level of development of their pharmaceutical industries is sufficiently high to have innovative capabilities. Countries at the next lower level (having pharmaceutical industries with reproductive capabilities — active ingredients and finished products) include Brazil, Cuba, Egypt, Indonesia, and Turkey. There is a long list of countries with no pharmaceutical industry, including many in Africa, with high rates of HIV/AIDS: Botswana, Burkina Faso, Burundi, Central African Republic, Congo, Rwanda, and Senegal (Correa 2002).

The end of 2002 marked the deadline for finding an expeditious solution to the problem posed by paragraph 6 of the TRIPS agreement. The year 2002 came and went without a solution. In late December of that year the United States led other industrialized nations in refusing to accept the draft accord because it covered more drugs and more diseases than the United States was willing to accept. As in the March 2002 meeting, the United States insisted on limiting the drugs for those needed to combat HIV/AIDS, tuberculosis, and malaria, ‘or other infectious epidemics of comparable gravity and scale’ (Becker 2002). The other countries joining the United States in its opposition were Canada, the European Union, Switzerland, and Japan. All were seeking to protect the patents of the pharmaceutical industry, while still making available medicines to treat HIV/AIDS, malaria, and tuberculosis.

These countries balked at broadening the scope of any exceptions to paragraph 6 of the TRIPS agreement to include diseases like cancer and asthma. The United States and its industrial allies argued that allowing countries like China, Brazil, and India to manufacture generic copies of patented drugs for export without the consent of the patent holders would ‘open the door to copying Viagra as well as ointments for baldness’ (Becker 2002). In addition, the United States continued to insist that only the poorest countries should be able to benefit, which rules out countries such as Peru and the Philippines. The United States and its industrial allies cared more about protecting the pharmaceutical companies from inroads into their profits from remedies for sexual dysfunction and baldness than they cared about the suffering of millions of inhabitants of developing countries who have diseases other than the big three: AIDS, malaria, and tuberculosis.

There is, however, a reasonably happy ending to this story of intransigence on the part of the pharmaceutical industry and the United States as industry’s major champion. In August 2003 the deadlock was broken when the United States signed an implementation agreement that enabled individual governments to determine which health problems could justify compulsory licenses that would allow for the export of medications. The decision effectively waives the obligations countries had under the provision of the TRIPS agreement (Article 31(f) ) that prohibits such exports. WTO member nations agreed that this waiver would remain in effect until the article is formally amended. An interesting feature of this 2003 agreement is the

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voluntary exclusion from the waiver of twenty-three developed countries, despite the eligibility of all WTO members to import under the decision (WTO News 2003).

In contrast to what appeared to be a concession by the United States in its stalwart protection of the patent rights of pharmaceutical companies, in other less noticeable actions the United States continued to wield power preventing poor countries from gaining access to generic drugs for their populations. One example is the US – Central American Free Trade Agreement (CAFTA), made public in February 2004. That agreement revealed that a level of intellectual property protection greater than that of the amended TRIPS agreement restricts access to medicines for countries in Central America.

According to a report by Medecins´ sans Frontieres` (MSF):

Provisions related to marketing authorization are particularly worrisome. For instance, if an existing AIDS drug is not registered in one of the five CAFTA countries because the manufacturer has no interest in the market, under CAFTA, registration of generics would be prevented for five years, even if the drug is not patented, and until the end of the patent term if it is. Unlike with patents, which authorities can redress through compulsory licensing, there is no recourse to provisions restricting marketing authorization. (MSF 2004)

MSF observed that weak or small countries that negotiate with the United States in small groups tend to agree to provisions that are less favorable to them than the international standards for trade and intellectual property rights such as those established by the WTO. Negotiators from these Central American countries caved in to pressures from the United States, providing further evidence that when it comes to medications badly needed in poor countries, the benefits of globalization accrue to industry, backed by the most powerful nations.

GLO BAL HE ALT H AND HU MA N RIG HTS

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Scholars in human rights and public health have identified several different provisions in human rights instruments as a basis for the claim that there exists a right to health care, as well as the right to health. Although some people have ridiculed the very idea that there can be a ‘right to health’, that criticism reflects a confusion between the right to health and the right to be healthy. Properly understood, the right to health is understood in terms of the obligations that governments have to protect the health of their populations and to establish policies that promote health and eliminate or decrease causes of disease. Since human rights pertain to all people, wherever they may live on this earth, the connection between human rights and health is global in scope.

The relevant human rights provisions begin with Article 25 of the Universal Declaration of Human Rights, which explicitly recognizes a claim to health:

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‘Everyone has the right to a standard of living adequate for the health and wellbeing of himself and his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.’ Article 27 of the UDHR identifies another pathway to a right to health: ‘Everyone has the right freely . . . to share in scientific advancement and its benefits.’ To share in the benefits of scientific advancement can be interpreted to mean that the fruits of biomedical research must be made available to everyone who needs information or products developed in such research.

Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) addresses ‘the right of everyone to the highest attainable standard of physical and mental health’, requiring states to take certain defined steps, including ‘the prevention, treatment and control of epidemic, endemic, occupational and other diseases’ and ‘the creation of conditions which would assure to all medical service and medical attention in the event of sickness’. The wording of Article 12 recalls the preamble of the 1946 constitution of WHO, a member of the United Nations family of organizations: ‘The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social conditions.’

How can these fundamental human rights claims regarding health care and health be realized in the poorest countries in the world today, given the prevalence of diseases that are difficult to prevent and costly to treat? Which actors should play a role in the progressive realization of these rights? Do the governments of industrialized nations have any human rights obligations to protect and promote the health of people in developing countries? As explained below, wealthier countries do have such obligations, whether or not they contributed in any way to the poor health of people in developing countries, and even if that poor health is a consequence of decisions and actions by the leaders of those countries.

One of the tasks of the United Nations committees authorized to monitor the implementation of human rights treaties is to make ongoing reviews of progress in light of changing circumstances. This process results in the periodic issuing of General Comments. One pertinent example is a comment issued by the Committee on Economic, Social and Cultural Rights when it revisited Article 12 of the International Covenant on Economic, Social and Cultural Rights: the right to the highest attainable standard of health. The Committee observed that much has changed in the world health situation since the ICESCR was adopted in 1966, noting that more determinants of health are now recognized, such as resource distribution and gender differences (Committee on Economic, Social and Cultural Rights 2000).

The Comment identifies accessibility as one of the essential elements required for fulfilling the right to health. This includes accessibility to health facilities, goods, and services with four overlapping dimensions: nondiscrimination (accessibility to

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everyone), physical accessibility, economic accessibility, and information accessibility. In addition to enumerating various detailed actions that states parties must undertake in order to respect, protect, and fulfill their obligations regarding this right, the Comment includes a section on international obligations. It refers states parties to a declaration that ‘proclaims that the existing gross inequality in the health status of the people, particularly between developed and developing countries . . . is politically, socially and economically unacceptable and is, therefore, of common concern to all countries’ (Committee on Economic, Social and Cultural Rights 2000: 11). Compliance with their international obligations requires countries with available resources to ‘facilitate access to essential health facilities, goods and services in other countries, wherever possible and provide the necessary aid when required’ (Committee on Economic, Social and Cultural Rights 2000: 11 – 12).

It is clear from this detailed commentary on the right to the highest attainable standard of health that wealthier countries (among those that have ratified the ICESCR) have international obligations to assist in providing access to health facilities, goods, and services to resource-poor countries. Although only states parties are accountable to fulfill this and other human rights obligations, the Comment also addresses nonstate actors. It states that all members of societies have responsibilities regarding the right to health, including intergovernmental and nongovernmental organizations, civil society, and the private business sector. The Comment specifically identifies the WTO, which is a member of the United Nations system, as one of the organizations that should cooperate effectively with states parties regarding the implementation of the right to health. Although the WTO ministerial conference at Doha did not go far enough, the agreement reached in August 2003 goes a long way toward allowing member states to make policies for importing or exporting drugs that fulfill their responsibility as stipulated in Article 12 of the ICESCR — the right of everyone to the highest attainable standard of physical and mental health.

Obviously, it is not sufficient to issue and reissue ethical and human rights guidelines. Monitoring activities are needed to ensure that implementation of provisions in these guidelines is taking place. To that end, a guideline that stipulates human rights obligations with regard to HIV/AIDS specifies a large array of actions that governments must take. These actions include setting benchmarks and targets for measuring progress; consulting with people living with HIV/AIDS, nongovernmental organizations, and international health organizations; enacting laws to ensure that an adequate supply of medicines is available in a timely manner; allocating funds for research, development, and promotion of therapies; and working with the private sector to achieve these goals; among many others.

A key recommendation for implementation of this human rights guideline for HIV/AIDS explicitly acknowledges the obligations of wealthier nations toward poorer countries in a globalized world. This recommendation says:

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States and the private sector should pay special attention to supporting research and development that address the health needs of developing countries. In recognition of the human right to share in scientific advancement and its benefits, States should adopt laws and policies, at the domestic and international levels, ensuring that the outcomes of research and development are of national and global benefit, with particular attention to the needs of people in developing countries and people who are poor or otherwise marginalized. (Office of the United Nations High Commissioner for Human Rights and the Joint United Nations Programme on HIV/AIDS 2002)

An array of conceptual, ethical, and policy questions regarding the interpretation of human rights provisions require further study and discussion. How can it be determined when the highest attainable standard of health has been reached? Against which measures is ‘highest attainable’ to be defined? How should priorities be set among the competing health-related needs in developing countries, and what role, if any, should donor nations and international organizations play in promoting some priorities over others in working with ministries of health in developing countries? Making drugs more affordable to the populations in developing countries is only a first step toward realization of the human right to health, but it is a giant step.

INTER NAT IONAL OBLIGAT IONS OF JUST ICE

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The facts of globalization raise the fundamental question of what, if anything, rich countries owe to poor countries in the realm of health. Is health essentially different from other public goods, such as education and police protection, for which it is the responsibility solely of national, state, or local governments to provide for their people? And if rich countries ought to provide major assistance in helping resource-poor countries meet the health needs of their populations, is it because there is a moral obligation to do so? Or is it because the interests of rich and powerful countries are threatened by the destabilization that occurs in countries where the crisis produced by AIDS and other devastating diseases affects not only the health infrastructure but also the entire governmental structure and its ability to provide education and social services? Do obligations of distributive justice cross international boundaries? Or should industrialized nations assist in providing health benefits to poor countries because it is in their own national self-interest to do so?

Depending on one’s political convictions and views about social justice, different answers to these questions will be forthcoming. People of varying political persuasions are likely to agree that a global response to infectious diseases like SARS and avian influenza is warranted, since failure to take timely and effective steps can have dire health consequences for populations in all countries, rich or poor, industrialized or least developed. This is a case in which national self-interest coincides with global health interests. A straightforward application of the utilitarian principle, aimed at health maximization, serves as a justification for assisting

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other nations in their efforts to contain transmissible diseases. Disagreements will inevitably arise, however, on the justification for specific decisions and actions where a tension occurs between health and civil liberties. Additional disagreements are also inevitable regarding the amount of resources that should be expended for this purpose. These disagreements are no different from ones that occur regarding domestic situations that are relevantly similar.

Principled disagreements are likely to arise over whether wealthy nations have a moral obligation to assist poor nations in providing access to health care and necessary medications for their populations. Adherents of the principle of justice that calls for providing assistance to the least advantaged or worst off will use that principle as a direct justification for providing financial, technical, or medical assistance to combat diseases in poor countries. Among those adherents, disagreements may arise with regard to the severity or scope of diseases that affect the populations in resource-poor countries. Does the principle justify providing assistance to treat all diseases equally? Should priority be given to the most devastating diseases, such as HIV/AIDS, malaria, and tuberculosis? What about diseases that affect smaller numbers of people but are nonetheless serious and endemic in tropical areas, such as parasitic infections that pose no threat to countries in the North? Here again, specific disagreements are inevitable in making choices and setting limits.

Those who reject the principle that calls for providing assistance to the least advantaged in the global arena might still endorse a more limited basis for help in circumstances where rampant or endemic disease leads to destabilization of a country and thus ultimately threatens countries in North America and Europe. This is the ‘enlightened self-interest’ rationale for helping poor countries with their health needs in an era of globalization. Whether it is fear of being overwhelmed by illegal and unhealthy immigrants, worries about providing a breeding ground for terrorists, some other perceived threat, or unalloyed beneficence, even the ‘America first’ administration of George W. Bush can justify providing billions of dollars for antiretroviral drugs to treat people living with AIDS in Africa.

Only under the most severe international pressure did the United States and other industrialized countries that support huge pharmaceutical companies give in to proposed reforms of the WTO’s TRIPS agreement. Permitting poor countries to import affordable generic drugs from other developing countries that manufacture them seems like such an obvious remedy in confronting the disease burden in developing countries, it is hard to conceive of a moral argument that could prohibit it. In fact, there is no moral argument. It is, rather, the age-old principle of ‘might makes right’: the power and influence of the pharmaceutical industry that have prevailed for so many years in this domain.

When it comes to the various United Nations human rights treaties, the United States has an abysmal record. The only major treaty that the United States has signed and ratified is the International Covenant on Civil and Political Rights. The United States has not ratified (but has signed) the International Covenant on Economic,

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Social and Cultural Rights, the Convention on the Elimination of All Forms of Discrimination Against Women, or the Convention on the Rights of the Child. Does this mean that the United States does not have any obligations imposed by those treaties? No, because human rights can be identified in international custom and treaties, as well as in the decisions of treaty bodies and organizations that contain human rights as a central aspect of their mandate. Treaty laws may become customary international law if widely enough observed. Moreover, when a country signs but does not ratify a treaty, it is still bound not to contravene the treaty’s terms.

Although bioethicists have devoted relatively little attention to the relationship between ethical principles and human rights provisions, the latter are a source of obligations recognized in a wide variety of global contexts. For those bioethicists who find merit in the use of ethical principles, the principles of both beneficence and distributive justice can readily serve to justify public health policies that have a global and not merely intranational reach. If the principle that calls for policies that maximize health and minimize the burden of disease applies domestically, why should it not also apply globally? If the principle that mandates an equitable distribution of health-related benefits and burdens applies within a country, why should it not also apply across national boundaries?

In today’s globalized world, public health is global health. Since public health is a public good, it requires contributions and commitments from all sectors — public, private, governmental, nongovernmental, and international. Although some may argue that it is justifiable for national interests to override the plight of those in faraway lands, it is hard to see how it is in the interest of any nation to ignore or dismiss the health needs of everyone in a globalized world.

REFERENCES

ATTAWELL, L., and MUNDY, J. (2003), Scaling up the Provision of Antiretroviral Therapy in Resource-Poor Countries: A Review of Experience and Lessons Learned (London: DFID Health Systems Resource Center for the UK Department for International Development in collaboration with WHO).

BECKER, E. (2002), ‘Trade Talks Fail to Agree on Drugs for Poor Nations’, New York Times, 21 Dec.; <http://select.nytimes.com/search/restricted/article?res=F40D15F634590C728ED DAB0994DA404482>.

BLOCH, M. G., and JUNGMAN, E. R. (2003), ‘Health Policy and the WTO’, Journal of Law, Medicine and Ethics, 31/4: 529 – 45.

BROCK, D. W. (2001), ‘Some Questions About the Moral Responsibilities of Drug Companies’, Developing World Bioethics, 1/1: 33 – 7.

COMMITTEE ON ECONOMIC, SOCIAL AND CULTURAL RIGHTS (2000), ‘Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights’, General Comment no. 14, E/C.12/2000/4, 11 Aug.

CORREA, C. M. (2002), ‘Implications of the Doha Declaration on the TRIPS Agreement and Public Health’, WHO, Essential Drugs and Medicines Policy, EDM Series, no. 12 (Geneva: World Health Organization), Annex 2, 1 n. 5.

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CROSSETTE, B. (2001a), ‘Brazil’s AIDS Chief Denounces Bush Position on Drug Patents’,

New York Times, 3 May, A5.

(2001b), ‘U.S. Drops Case Over AIDS Drugs in Brazil’, New York Times, 26 June. DANIELS, N., and SABIN, J. E. (2002), Setting Limits Fairly (New York: Oxford University

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FEACHEM, R. G. A. (2001), ‘Globalisation Is Good for Your Health, Mostly’, British Medical Journal, 323: 504 – 6, <http://bmj.bmjjournals.com/cgi/content/full/323/7311/504>.

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INSTITUTE FOR BIOETHICS, HEALTH POLICY AND LAW (2003), Quarantine and Isolation: Lessons Learned from SARS, <http://www.louisville.edu/medschool/ibhpl/publications /SARS%20REPORT.pdf>.

LABONTE, R. (2003), Dying for Trade: Why Globalisation Can Be Bad for Our Health (Toronto: CSJ Foundation for Research and Education).

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PAPPAS, G., HYDER, A. A., and AKHTER, M. (2003), ‘Globalisation: Toward a New Framework for Public Health’, Social Theory and Health, 1: 91 – 107.

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RICUPERO, R. (2001), ‘The Poverty of Globalisation, the Globalisation of Poverty’, Global Future (First Quarter), 3 – 5.

SCHUKLENK,¨ U., and ASHCROFT, R. E. (2002), ‘Affordable Access to Essential Medication in Developing Countries: Conflicts Between Ethical and Economic Imperatives’, Journal of Medicine and Philosophy, 27/2: 179 – 95.

SINGER, P. (2002), One World: The Ethics of Globalisation (New Haven: Yale University Press).

STIGLITZ, J. E. (2002), Globalisation and Its Discontents (New York: W. W. Norton).

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SWARNS, R. L. (2001), ‘Companies Begin Talks with South Africa on Drug Suit’, New York Times, 18 Apr., A3.

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c h a p t e r 3 0

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B I O E T H I C S A N D

B I O T E R R O R I S M

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J O NAT H A N D . M O R E N O

UNTIL the terrorist attacks of 11 September 2001, and the subsequent anthrax scare, modern bioethics paid little attention to issues concerning preparation for and response to bioterrorism (Moreno 2002). Yet a number of foundational bioethical problems are engaged or given a new twist by this topic, including the rights of human research subjects, resource allocation, the appropriate balance of human rights and public health, and special responsibilities of emergency health care workers. Bioterrorism also takes bioethics into novel territory, such as the social obligations of private industry and the uses of genetics both in developing terror weapons and in defending against them.

Although the term ‘bioterrorism’ has only recently come into widespread use, the tactical notion of using biological or chemical agents to spread terror among enemy forces reaches back to the First World War. The psychological impact of waging terror campaigns against civilians using various destructive means was first evident in the American Civil War, especially during Union General William T. Sherman’s infamous march through Georgia. In the Second World War both sides attempted to terrorize non-combatants, the Nazis by bombing the British mainland, and the Americans with firebombs in Germany and Japan and, of course, the first atomic weapons. Terror campaigns by radical political movements, rather than nation-states, took place in the 1960s in Europe and the United States, mainly in the form of attacks on financial institutions and the air transportation system. The novelty of twenty-first century bioterrorism lies in the prospect that it will combine political radicalism with techniques that were once largely the province of state military establishments.