Access to medicines and the rhetoric of responsibility.

Barry, Christian ; Raworth, Kate

The story of the decade, and perhaps the century, has finally made it to the front pages: millions of people who could be saved are dying from AIDS. The reason for their unnecessary, premature, and often agonizing deaths is now becoming clear: it is pure, unadulterated greed.

--Mark Weisbrot Co-Director of the Center for Economic and Policy Research (1)

Virtually all African countries have centralized government drug import and distribution centers, and most of them are broken or corrupted ... HIV in Africa is contracted and spread through a web of causations--economic, developmental, social--and when you start focusing on a single solution, like anti-retrovirals, you fail.

--Josef Decosas Director of the Southern Africa AIDS Training Program (2)

There is, as yet, no cure or vaccine for HIV/AIDS. The only life-prolonging treatment available is antiretroviral (ARV) therapy. The World Health Organization (WHO) estimates, however, that less than 5 percent of those who require treatment in developing countries currently enjoy access to these medicines. In Africa fewer than 50,000 people currently receive ARV therapy, which represents less than 2 percent of the people in need. (3) These facts have elicited strongly divergent reactions, and views about the appropriate response to this crisis have varied widely. Some have called for permitting developing countries to make independent policy on patent laws, hence enabling them to produce or purchase low-cost generic drugs without censure. Others have asked pharmaceutical companies to sell their medicines at the cost of production to low-income countries. Still others have demanded substantial contributions to a global fund that would purchase the necessary drugs from pharmaceutical companies at the market price.

While disagreements about policies and practices are sometimes purely empirical, with advocates of opposing positions differing only on the best means to achieve shared aims, the intensity of the debate concerning access to medicines, and the heated rhetoric with which it is often conducted, suggests that it may be rooted in deeper disagreements of value.

It is not obvious, however, what disagreements of value are at stake in this debate. Most participants agree that the current situation is morally unacceptable and that "something must he done" to remedy it. But advocates have seldom articulated their underlying justifications for why this situation is unacceptable, and they have thus provided little basis for determining whether or not their chosen policies would constitute progress.

In a recent article in the New York Review of Books, for instance, Helen Epstein and Lincoln Chen claim, "Patenting drugs that could, if they were cheaply available, extend the lives and postpone the suffering of thousands or even millions of poor people in developing countries raises serious ethical concerns." (4) The authors then leave readers to figure out for themselves what, more precisely, these serious concerns are and what practical significance they have. This is understandable in one sense, for who could deny that there is something bad about suffering on such a scale? The problem is that judgments about the "unacceptability" of the current situation must be translated into obligations before they can help guide action. And precisely because they are only indirectly action-guiding, these claims are often put forth in unclear and evasive ways. The "right to health" is sometimes invoked in this context--but without being backed up by rigorous analysis of who bears counterpart obligations for its realization. (5)

When the rhetoric in a debate surrounding an important practical dilemma is either heated or evasive (and often both), participants may accuse one another of bad faith or naivete about the facts of the case. They are also likely to invoke principles that support their side of the argument without thinking through their argument's broader implications or perhaps purposefully ignoring them. These tendencies make it more difficult to identify correctly the true nature of the disagreements--and hence the evidence and argumentation that could be relevant to resolving them.

By analyzing the statements of scholars, public officials, activist organizations, and private sector representatives, each of whom may endorse very different policy recommendations on access to HIV/AIDS drugs, we have identified and created a typology of the different sources of disagreement in the debate. We conclude that the central disagreements concerning access to medicines arise from competing understandings of how responsibilities for bringing remedy to hardships should be allocated to different agents and institutions. (6) A central lesson that emerges from our analysis is that thinking about "health equity" must engage more honestly with the difficult question of how responsibilities for bringing remedy to health crises should be allocated in complex social contexts. (7)

The key area of dispute, it seems, concerns the question of who bears (to use David Miller's phrase) "remedial responsibilities" with respect to the crisis in access to medicines. "To be remedially responsible for a bad situation" means, as Miller puts it, "to have a special obligation to put the bad situation right, in other words, to be picked out, either individually or along with others, as having a responsibility toward the deprived or suffering party that is not shared equally among all agents." (8) Although all the participants in this debate agree that someone is morally required to provide the resources to lessen significantly the suffering that this crisis has caused, they differ in their understanding of which particular agent or agents are under an obligation to improve the situation.

Three disagreements concerning remedial responsibilities seem to be at stake in the debate. The first concerns the character of remedial responsibilities: whether what is needed is a change in the behavior of individual or collective agents or, instead, a change in the framework of rules and institutions within which these agents act. The second is due to differences over the principles that should be used--and what weight each should be given--in allocating these responsibilities to various agents. The third concerns disagreements about how the appropriate principles should be applied.

DISAGREEMENT 1: THE CHARACTER OF REMEDIAL RESPONSIBILITIES

This disagreement concerns whether the identified remedial responsibilities are conceived as moral responsibilities or as responsibilities of justice. Moral remedial responsibilities--whether to refrain from harming, to care for those with whom one has special relationships, or to promote general well-being--are held directly to other agents. Remedial responsibilities of justice--such as those to institute and uphold just institutions, to ensure that they are complied with, or to bring remedy to hardships when they are lacking--are held only indirectly to other agents insofar as they are affected by social rules.

Moral Remedial Responsibilities

Appeals to moral remedial responsibilities do not attempt to address the structure of social institutions but instead call on agents to change their behavior within it. In the case of access to HIV/AIDS drugs, pharmaceutical companies are often called upon to change their practices in order to improve the distribution of benefits and burdens that the prevailing market structure engenders. Such appeals do not question the basis of these companies' entitlements, but rather the way they conduct themselves toward others within this framework of entitlements. Such appeals tend to treat corporations as comparable to individual moral agents, attributing to them responsibilities to promote a better distribution of population health and to prevent deaths where possible. They call, in effect, for the redistribution of assets on the basis of these principles. (9)

The pharmaceutical industry has emphasized its drug donation programs (for other disease areas) as the answer to any questions about their moral responsibilities:

 Through a number of philanthropic programs, the pharmaceutical
 industry has demonstrated its commitment to help relieve the pain
 and suffering of patients in need around the world.

 --Pharmaceutical Research and Manufacturers of America (PhRMA) (10)

Some have appealed to pharmaceutical companies on these grounds simply to extend their drug donation programs, or to lower prices for the needy to at least the marginal cost of production--from the $12,000 offered in December 2000 to the $350 (and below) now proven possible by the generics firms. Other ideas for fulfilling moral obligations are more elaborate, and propose challenges to the prevailing intellectual property regime, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. On this score, observers have asked pharmaceutical companies to issue voluntary licenses to generics producers, so that these firms might produce cheap, life-saving drugs without fear of penalty under the TRIPS regime:

 We urge all drug companies to issue nonexclusive voluntary licenses
 that allow generic antiretroviral drugs to be produced in and
 imported into any poor country.

 --Zackie Achmat, Treatment Access Campaign, South African (11)

They have also asked pharmaceutical companies to drop legal cases against governments that have sought to exploit clauses in the TRIPS agreement that enable governments to issue compulsory licenses to generics companies to make use of patented knowledge in extraordinary circumstances (such as in cases of extreme public-health risks or national emergencies) when the patent holder has refused to grant a voluntary license to use the patent. This appeal was successful last year in South Africa, where thirty-nine major drug manufacturers dropped their suit under international public pressure.

Pharmaceutical companies have been defended against claims that they are neglecting their moral remedial responsibilities in several ways. First, it has been argued that they are merely doing what all companies do, which is compete to attract shareholders and survive in the highly competitive global market. If the outcomes of that competition fly in the face of public interest, it is claimed, then it is the rules governing competition that need to be changed--and that is a matter of public policy, not one of reforming the behavior of individual firms and industries:

 We need rules which are fair and transparent and rules which do not
 hamper our ability to sell our medicines because a local industry
 has failed to stay modern.--Shannon Herzfeld, Senior Vice President
 for International Affairs, PhRMA (12)

Second, some have invoked a principle that Thomas Pogge calls the "sucker exemption." (13) Pharmaceutical firms behaving within the constraints of the market channel their resources to research on diseases affecting affluent populations, located mostly in developed countries, because if they fail to do so they will not survive for very long and will be replaced by firms that are eager to do so. Any particular corporation can reasonably question why it should constrain itself by moral values if it has little assurance that others will follow suit. Why should it, or indeed, the pharmaceutical industry as a whole be made the "sucker"--with others profiting from their imprudent moralizing? Similarly, governments may reasonably claim that endorsing policies that run contrary to the interests of the pharmaceutical and other industries dependent on intellectual property might cause these companies to relocate overseas, robbing them of much needed jobs and capital.

Third, it has been pointed out that pharmaceutical companies have participated in drug donations and have initiated price cuts--only to receive criticism rather than praise for their "good corporate citizenship." Finally, they have been defended on the grounds that moral remedial responsibilities in the absence of any special connection are, in fact, quite limited. (14) That they have been demonized and chastised is due, on this account, to the fact that their enormous wealth and high profit margins make them politically convenient targets:

 In the face of this, there is the duty to do all we possibly can.
 But there's also an imperative not to engage in rituals of easy
 blame, or to attempt something that cannot be realistically
 achieved, or to demonize those who are a critical part of the
 solution.

 --Andrew Sullivan, New Republic (15)

It is not only the pharmaceutical companies, however, that may have moral remedial responsibilities. The governments of developed nations have been asked to desist from threats to take developing country governments to the WTO dispute resolution mechanism when they make use of the option of compulsory licensing. (16) Likewise, many have backed Kofi Annan's call to the governments of wealthy nations to provide adequate funding for a Global AIDS Fund:

 Considering the degree of suffering that would be reduced (by larger
 contributions to the Global Fund), this seems an infinitesimal
 sacrifice for Americans.--Paul G. Harris and Patricia Siplon,
 Ethics & International Affairs (17)

These appeals have not been terribly persuasive, however, to many of those living in developed nations who have put forward principles and pragmatic reasons for rejecting such increases in aid. In a recent poll conducted by the Washington Post, only 40 percent of Americans felt that provision of more assistance would help remedy the situation. (18) And many have argued that assigning responsibilities to developed countries would only serve to bail out irresponsible national policies and to reward unhealthy individual behavior--thus constituting a significant moral hazard.

Remedial Responsibilities of Justice

Appeals to remedial responsibilities of justice, on the other hand, call for agents to remedy the crisis by restructuring social institutions, such as by changing the duration and scope of patent rights or other market rules. Agents are addressed insofar as they have played, currently play, or could potentially play a significant role in the shaping of rules and institutions that have, are, or will contribute to the inaccessibility of essential medicines in the developing world. When fair rules exist, agents may also bear remedial responsibilities of justice to ensure that they are sufficiently respected and enforced. These appeals ask, then, for a revision of the entitlement-producing processes that have strongly influenced the accessibility of medicines in the first place.

Remedial responsibilities of justice have become a main focus of the debate because of an increasing recognition that agents like the pharmaceutical companies are highly influential in the process of setting the rules and, hence, might bear obligations to reform them. This duality of roles--as both actors within the rules and framers of the rules--is particularly clear in the case of the TRIPS agreement. Pharmaceutical company executives often accompanied national delegations in the negotiations that created the agreement, and the influence of specific companies in this process has been well documented. (19) While each particular company or government may legitimately claim that unilateral efforts to create access to HIV/AIDS drugs will be self-defeating, taken together they cannot so easily claim to be powerless to reshape intellectual property and other rules.

Many civil-society organizations have asserted that appeals to corporate and state beneficence will be of limited value, and that only through reform of the intellectual property system will an acceptable and sustainable solution be achieved. In fact, some have pointedly rejected programs such as drug donations not only because of their purported lack of effectiveness, but also because they inaccurately characterize the nature of the responsibilities of the pharmaceutical companies and developed countries. They fear that gestures such as drug donations or interest-free loans for drug purchases may serve to preempt more fundamental institutional reform:

 In effect, corporations in the pharmaceutical sector are offering
 islands of philanthropy, while promoting a global patents system
 which would enhance their profitability, but could also consign
 millions to unnecessary suffering.--Oxfam (20)

Others appeal to moral responsibilities, invoking responsibilities of justice only if they prove ineffective:

 If industry cooperation is not enough, or not forthcoming on a
 general or reliable basis, the rules of international trade
 involving access to essential medicines should be applied in a
 manner that ensures the same results [of near-production cost drugs
 available in low-income countries].--Jeffrey Sachs et al. (21)

Both the pharmaceutical industry and developed country governments have replied that deeper institutional reforms are unnecessary. They stress instead the potential of good-faith efforts to achieve an acceptable outcome through collective and voluntary donations and price-cutting. They argue, in short, that the current system is just, and that they have already identified effective means of discharging their moral remedial responsibilities. The pharmaceutical companies have thus acknowledged their collective role in framing the rules but assert that their influence is a purely beneficial one:

 Whether we're stimulating strong intellectual property protection or
 boosting freer markets overseas or opposing legislation that would
 hurt the industry's research for cures--we're working to make good
 things happen and to defeat bad policies that would hurt patients by
 discouraging innovation.--PhRMA (22)

Appeals to responsibilities of justice could potentially ask for the reform of rules at many different levels. Those rules currently governing intellectual property rights (IPRs), for example, are couched within the assumptions of the broader framework of global market capitalism--which itself depends upon a broader framework of personal property rights and state sovereignty.

DISAGREEMENT 2: PRINCIPLES FOR ALLOCATING REMEDIAL RESPONSIBILITY

By what principles should responsibilities--whether of morality or of justice--to improve access to medicines be allocated to different agents? Three approaches feature repeatedly in the debate. The first appeals to agents' responsibilities based on their connectedness with those suffering. The second allocates responsibilities to agents on the basis of their contribution to the current crisis. The third claims that remedial responsibilities ought to be allocated according to the capacity of different agents to discharge them.

Connectedness

The claim is that remedial responsibilities should be allocated on the basis of connectedness, whether this is based in joint activities, voluntary commitments, shared institutions, membership in solidaristic communities, or shared histories. The idea is that those who are connected in these ways have especially strong independent reasons for bringing remedy to one another's hardships. (23) According to a very expansive view of connectedness, shared humanity is sufficient to ground the obligations, where possible, to remedy the hardships of others. In our world, no particular person is uniquely picked out to remedy hardships of this magnitude, because all are connected in this ethically significant way:

 In many occupied nations during World War II, the Nazis ordered Jews
 to wear a yellow star, as prelude to their destruction. But not in
 Denmark. According to legend, the Danish king, Christian X,
 threatened that, if Danish Jews were to wear the star, he would,
 too. The story is almost certainly a myth, but its meaning is
 not.... "If some Danes are under siege," the story means to say,
 "then all Danes are under siege. So, for now, we are all Jews." So
 now we all have AIDS.--Donald M. Berwick, President and CEO,
 Institute for Healthcare Improvements (24)

Some disagree, justifying their view by demonstrating the lack of a sufficient connection with those suffering from the crisis:

 One e-mail correspondent asked why he should care about AIDS in
 Africa. "What does this have to do with me?" he asked. "I deeply
 believe we are one world," I responded, "and all humankind are
 connected." He replied instantly with a further question, which
 haunts me still. "Where did you get that idea?" he asked.--Member of
 the U.S. Public (25)

Narrower variants of the connectedness principle are more commonly appealed to, assigning weighty special responsibilities to intimates, associates, and to those with whom one stands in relations of reciprocity because of participation in joint cooperative systems. The understanding of connectedness that is taken to be most relevant concerning access to medicines stresses the moral significance of membership within states. That is, remedial responsibilities are judged to fall directly on states. While we may bear some responsibility toward those who live in other states to "aid" them and to ease their burdens--primary responsibility for remedying hardships is seen to fall on their own governments. Supranational institutions, other states, and nonstate actors are correspondingly conceived as playing only a supporting role to states, enabling them to meet their own responsibilities to their residents.

Special responsibilities that are based on connectedness are also commonly invoked by citizens in developed countries to shield them and their governments from the claims of foreigners:

 When I mention this legislation [which would provide $938 million
 for AIDS prevention, education, and awareness programs, and $100
 million for pilot AIDS treatment programs] to Republican colleagues,
 they wonder why I'm doing it. They say we have domestic problems.

 --U.S. Rep. Henry Hyde (R-Ill.) (26)

Critics of this view have suggested that assigning remedial responsibility to states for the crisis fails to acknowledge adequately the limited capacities of some to fulfill them, even with substantial support from outsiders. They can reasonably argue, moreover, that since the rich tend to be more strongly connected to the rich, and the poor more strongly connected to the poor, this principle for allocating responsibilities will systematically tend to favor the rich. (27) Perhaps most important, they have asserted that the connections of greatest moral importance are formed when persons come to coexist under shared rules and institutions that affect the life prospects of each.

Contribution

This principle maintains that agents are to be held remedially responsible for situations when, and to the extent that, they have contributed to bringing those situations about. This principle finds support in what Samuel Scheffler has recently called the "commonsense" view that "individuals are thought to be more responsible for what they do than for what they merely fail to prevent." (28) While conduct and social rules can plausibly be regarded as in some sense contributing to deprivations in a variety of different ways, the most direct relationship of this kind is causal--those who cause harm are certainly viewed as contributing to it.

Some commentators invoke this principle to prove that contributory responsibility does not lie with themselves, or with the policies and practices of Western societies, by demonstrating that sufficient causes lie elsewhere. Causal responsibility is sometimes assigned to the individual, in other cases to the societies suffering from the crisis:

 AIDS in most parts of the world is associated with behavior ...
 something over which people have some control.--Member of the U.S.
 Public (29)

 In the middle of the global AIDS epidemic, it is easy--although
 misguided--to assume that the cost of drugs used to treat HIV and
 AIDS is the primary barrier to people in poor countries having
 greater access to such drugs. In reality, the crux of this problem
 is more fundamental. The main barrier to access is the lack of
 adequately resourced healthcare systems.--Richard Sykes, Chairman
 of GlaxoSmithKline (30)

Critics reply, in effect, that demonstrating that one's actions or policies are not the sole cause of the crisis does not establish that they have not been a substantial cause:

 Imagine that the poverty problem in Africa's poorest countries had
 already been somewhat alleviated via international aid. More patents
 would have been sought, drug prices would have increased, and aid
 money would purchase fewer drugs than would have been possible if it
 were not for intellectual property protection. If this retrospective
 analysis is correct, then it is misleading to claim that poverty
 rather than patents poses barriers to care.--Michael J. Selgelid and
 Udo Schuklenk, University of Witwatersand, South Africa (31)

Indeed, even in legal contexts it is often the case that establishing that agents are a significant cause of some deprivation is sufficient to hold them responsible for the whole deprivation. These critics claim that while pharmaceutical companies may not be directly responsible for creating all the relevant background conditions for the crisis, their insistence that patents be valid world wide is one of its important causes. These disputes seem to depend on a substantial disagreement about how causation should be understood in social contexts. Some hold that for actions or social rules to cause a deprivation they must be a necessary condition of it, while others require merely that they be a substantial factor in or contribute to the outcome, which they often express through locutions such as "blocking access," or "standing in the way" (32):

 At the very least, the developed world has stood in the way of the
 developing world's efforts to solve AIDS and other health-related
 problems in the most cost-effective ways possible.--Paul G. Harris
 and Patricia Siplon, Ethics & International Affairs (33)

Capacity to Act

According to this principle, capacity to bring remedy entails the responsibility to do so. The claim is that some agents have the capacity to alleviate the situation through technology and resources, and so they should. As David Miller puts it, its rationale is, "If we want bad situations put right, we should give responsibility to those who are best placed to do the remedying." (34) This principle is purely forward-looking--allocating responsibility to whoever can bring remedy most efficiently, irrespective of their connectedness to the sufferer, or their role in causing the deprivation.

Estimates of the capacities of different agents to bring remedy to a situation vary significantly depending upon whether they are understood individually or collectively. Some have defended themselves against charges of moral failures by stressing their individual incapacity to remedy the crisis:

 It's not entirely our responsibility. We can't be an NHS [National
 Health Service] for the whole of Africa.--The Association of British
 Pharmaceutical Industries (35)

Others have emphasized the collective capacities of different agents:

 We are talking about a problem that if addressed collectively by the
 world community could be solved. Where the pharmaceutical companies
 have responsibilities, they've got to accept them.--British
 Chancellor Gordon Brown (36)

The application of the capacity principle must also be sensitive to the distinction between capacities of agents to bring remedy within the prevailing institutional framework (that is, to take on moral responsibilities), and their capacities to bring remedy by altering the framework itself (that is, to take on responsibilities of justice). As noted above, the capacities of a single agent may be more limited with respect to one of these tasks than to the other.

PLAUSIBLE CONCEPTIONS of remedial responsibility will be likely to give some weight to each of the principles discussed in this essay, and perhaps to others as well. One might, for instance, grant some weight to principles that allocate remedial responsibilities for deprivations to those who are thought to be "morally responsible" for them, or to those who have benefited from the unjust rules or conduct that have caused them. These principles can thus he understood in diverse ways, granted different weights, and adopted in various combinations. (37)

DISAGREEMENT 3: THE APPLICATION OF THESE PRINCIPLES

Disagreement about the adequacy of conceptions of remedial responsibilities can only be resolved by recourse to moral theory, and it is not within the scope of this paper to defend any substantive view. But even in cases where there is rough agreement about the principles that should be used in assigning remedial responsibilities and the character of the responsibilities assigned, there may well be disagreement about the conduct, policy, or institutional change that can achieve the desired outcomes. On the surface, the debate is often focused on differences between economic theories that state various necessary and sufficient conditions for ensuring secure access to medicines. In addition to this familiar domain of disagreement, there are, however, deeper differences that are less explicitly debated. These include the time frame and the scope of concern for assessing the policy proposal, the use of contradictory or inadequate data, and the status of claims about unprecedented future scenarios.

Time Horizon and Scope of Concern

Some differences among policy recommendations arise out of the time horizon being considered or the specification of whose welfare is deemed important. Many commentators emphasize, for example, the urgency of rectifying the immediate situation (noting, for instance, the additional number of people who will have contracted AIDS by the time the reader has finished reading his or her article). Importance is also placed on the immediate actions that could be taken--the force of which is often derived by demonstrating the pharmaceutical companies' immediate capacity to act:

 Here is what the world needs: free anti-AIDS medicines ... Here is
 how it could happen: the board chairs and executives of the world's
 leading drug companies decide to do it, period.... They say,
 together, the same thing ... "We are taking one simple action that
 will save millions and millions of lives."--Donald M. Berwick,
 President and CEO, Institute for Healthcare Improvement (38)

In contrast, others concentrate on long-term effects, emphasizing that many of the apparently straightforward solutions to help those currently suffering will harm the prospects of future generations because of the disincentives that the recommended policy will create:

 Price controls and the wanton destruction of intellectual property
 will do little to improve public health. But they will reduce
 innovation. The lag in HIV research and treatment will condemn the
 African continent to deeper darkness and death.--Robert M. Goldberg,
 Wall Street Journal (39)

It may make a substantial difference in the recommended policies if the welfare of future persons is included within a principle's scope of concern:

 No nation would refuse to fight an invading army because some expert
 argued it would be cheaper to invest in defences against future
 invasions. It is not a matter of prioritizing lives now over lives
 tomorrow.--Peter Piot, UNAIDS Executive Director (40)

Data Discrepancies

Apparent disagreements over economic theory sometimes turn out to be disagreements about the facts of the case--and this is true in the debate over the cost of research and development of new drugs:

 Discovering and developing new medicines is expensive and
 increasingly time consuming.... Today the cost of new drug discovery
 and development is likely to be ... $500-600 million or more.--PhRMA
 (41)

 The industry's claim that it costs US$500m to bring a new drug to
 market is misleading, and the significant contribution of public
 funding is often glossed over.--Oxfam (42)

Lack of public access to industry data on the costs of research and development lies at the center of this disagreement, and the high costs of drug development are a key reason cited by the companies against allowing the use of compulsory licensing. Civil-society groups have attempted to piece together the costs of particular drugs, but such shadow estimates inevitably involve significant margins of error that prevent the case from being confirmed one way or the other.

Short of demanding greater transparency, one way to prevent such ignorance of costs from falsely eliminating viable solutions is a proposal that creates an incentive for companies to reveal their costs in cases where their profitability is truly threatened by compulsory licensing. Take the case of a patent holder wishing to challenge the issuance of a compulsory license in a developing country on the grounds that it would undermine its profitability. Under this proposal, the burden should fall on the patent holder to provide the data of the cost of research and development that would show this to be the case. (43) This type of mechanism could be used to make policy even when disagreements about the facts are unresolved, because it builds in incentives for companies to contest the use of compulsory licensing only in those cases in which it does potentially have negative consequences for long-term drug development.

Unprecedented Scenarios

Some disagreements over the effect of proposed policies stem from different opinions about the extent to which future outcomes can be deduced from the evidence to date. Some commentators make very broad deductions, claiming that the theory holds for all countries, regardless of their stage of development:

 Kenya's decision to bring its patent law into conformity with its
 international obligations affirms the role of intellectual property
 as an incentive to research and development of new medicines and
 vaccines and as a necessary precondition for investment in countries
 regardless of their stage of development.--PhRMA (44)

In opposition, others claim that such a deduction cannot be made because there is no equivalence between the current circumstances of developing countries and the past experience of developed ones:

 If at their stage of development the developed countries had had to
 adhere to the minimum standards set by TRIPS, it is most doubtful
 many of them would have attained the levels of technology and
 industrialization that they achieved.--Martin Khor, Third World
 Network (45)

In rebuttal to this, others imply that such predictions of harm have little weight, and that if a country has not tried and tested a policy, no plausible claims can be made about its expected negative consequences.

CONCLUSION

In closing, we would like to note three important methodological issues that are likely to confront the application of conceptions of remedial responsibility for problems concerning access to medicines.

First, in many cases there may be uncertainty about which agents are picked out by a conception of remedial responsibility. It may be unclear, for instance, whether a particular state, corporation, or domestic policy has contributed to a deprivation, or whether two peoples are connected in an ethically significant way. In contexts of this kind, it is not obvious how these agents should understand their responsibilities. In criminal legal contexts, high evidential thresholds are set for proof of contribution to harm, and the burden of proof is placed with the prosecution. But different standards and presumptions of the burden of proof may be reasonable for different purposes. In civil law, for instance, a preponderance of evidence that an agent has contributed to harming another can be grounds for attribution of remedial responsibility. In still other contexts the mere suspicion that one may have been involved in causing a severe deprivation could give one sufficient reason to act to remedy it. How agents conceive of their remedial responsibilities in the presence of uncertainty may significantly affect their understanding of what they owe others, and of the fairness of different policies, rules, and institutions that could potentially be adopted.

Second, assigning remedial responsibilities to real-world problems such as lack of access to medicines must also take into account the fact that those who should act often will be unlikely to do so. If, for instance, governments are deemed to have primary responsibility for securing their peoples' access to medicines, but are unwilling or unable to do so, this will raise important questions such as whether (and which) others should step in to help or whether the burdens of these unmet responsibilities should be left to the deprived. In such contexts, many implicitly rely on an account of what might be called "default responsibilities," which are held only when others fail to comply with responsibilities that apply to them. (46) No single principle for allocating remedial default responsibilities seems obvious, yet how we conceive of them may have great practical significance.

Finally, assertions of remedial responsibilities of justice concerning access to medicines have tended to focus almost exclusively on the necessity of reforming the rules of intellectual property--taking as given the wider institutional framework. More extensive challenges might claim, for example, that innovation can take place in a cooperative system (thereby challenging the necessity of intellectual property rights at all) or that public research and development could play a far greater role in the pharmaceutical sector (thereby proposing that the market needs to be supplemented).

This focus is most apparent when the case for the contributory responsibility of Western policies and practices is made. This case tends to rest almost exclusively either on the causal role of pharmaceutical patents or on the failure of developed countries to provide sufficient development "assistance" to the poor. Patent rules and international aid policies are isolated from broader causal processes, and the debate avoids discussion of the many ways that the West's current and past policies may have contributed both to the crisis itself and to the difficult conditions for institutions in developing countries trying to address the crisis. Foremost among historical injustices is the existence of a colonial system, which effectively locked in developing countries as suppliers of raw materials and suppressed the growth of their industries. More recent examples include International Monetary Fund and World Bank policy conditionalities that led to cuts in public health spending (leaving countries without the resources to deal with public health crises) and support for and loans to military dictators, which contributed to debt crises and high levels of corruption. On a still deeper level, one can reasonably question the fairness of different aspects of the international order: the fact that national boundaries determine ownership of, full control over, and exclusive entitlement to all benefits from land and natural resources, and that international agreements and institutions are shaped through a process of intergovernmental bargaining that strongly reflects the interests of more powerful countries. (47)

The contribution principle is narrowly interpreted for similar reasons. Imputing responsibility for economic outcomes is usually extremely difficult, given the multiplicity of actors and transactions involved. When deprivations are not clearly brought about by a single agent, or by a small number of specific agents, people often do not divide responsibility for them among many persons but rather stop making claims about responsibility altogether. One reason why the issue of lack of access to medicines has received great attention is that it represents an instance where deprivations seem imputable to an easily identifiable class of agents: Western pharmaceutical companies. There may also be strategic reasons for this narrowness. Some may fear that focusing on the contribution of historical or deeper structural factors to the current crisis will erode the clarity and appeal of their message. And others may worry that raising such contested issues as the relationship between past injustice and current conditions might be so difficult that it would only serve to divide advocates of the same policy. Moreover, many people engaged in the debate seem to believe that they can make strong cases for the policies they want without making reference to historical injustice or to the unfairness of other aspects of the international order.

It is unclear whether the limited challenges to the broader framework of global rules and institutions and their potential contributions to the current crisis, are due to a genuine conviction that they do not need to be challenged or, rather, due to a desire to retain credibility in a domain that is increasingly framed within the terms and arguments of neoliberal economics. This neglect of the broader framework of rules may simply be a result of what G. A. Cohen has called the "tendency to take as part of the structure of human existence in general any structure around which, merely as things are, much of our activity is organised." (48) The debate concerning rules governing intellectual property may be one example of a wider phenomenon: we all focus intensely on the tip of the institutional iceberg because only that is above water. If, however, participants on both sides of debates concerning global problems fail to consider the unfairness of deeper and older aspects of the international order--which mediate the effects of these new and highly visible institutional arrangements, such as the WTO and the TRIPS agreement--their allocations of remedial responsibility for global problems may well be dangerously distorted.

(1) Mark Weisbrot, "A Prescription for Scandal," Baltimore Sun, March 21, 2001, p. A17.

(2) Quoted in Thomas L. Friedman, "It Takes A Village" New York Times, April 21,2001, p. A25.

(3) Abigail Zuger, "Beyond Temporary Miracles," New York Times, July 16, 2002, p. F5.

(4) Helen Epstein and Lincoln Chen, "Can AIDS Be Stopped?" New York Review of Books, March 14, 2002, pp. 29-31.

(5) For a discussion of the limitations of the rights idiom with respect to health, see Onora O'Neill's contribution to this section, "Public Health or Clinical Ethics: Thinking beyond Borders," pp. 35-45.

(6) It is, of course, sometimes the case that public statements are made dishonestly, inconsistently, and in bad faith. Our analysis nevertheless takes these statements at face value. We have done so not only because this debate is already characterized by a lack of trust among participants, but also because identifying the broader commitments that are often implicit in public statements may help to identify their authors' dishonesty, inconsistency, and bad faith.

(7) Indeed, the debate is not rooted in disagreements that have been the focus of much recent writing on health equity, such as: the legitimate scope of moral concern (e.g., all persons, groups, compatriots, or community members); whether we should focus on access to healthcare resources, health outcomes, or opportunities for health; and distributive considerations (e.g., whether one ought to use sum-ranking, maximin, or some indicator of inequality as an interpersonal aggregation function for assessing the fairness the current situation).

(8) See David Miller, "Distributing Responsibilities," Journal of Political Philosophy 9, no. 4 (2001), pp. 453-71.

(9) See, e.g., Paul G. Harris and Patricia Siplon, "International Obligation and Human Health: Evolving Responses to HIV/AIDS" Ethics & International Affairs 15, no. 2 (2001), pp. 29-54.

(l0) Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Primer 2001: A Century of Progress (Washington, D.C.: Pharmaceutical Research and Manufacturers of America, 2001), p. 10; available at www.phrma.org/publications/01192PhRMAdProfPrimer.pdf.

(11) Zackie Achmat, "Commentary: Most South Africans Cannot Afford Anti-HIV Drugs," British Medical Journal 324, no. 7331 (2002), pp. 214-18.

(12) Quoted in Gumisai Mutume "Africa Shuns U.S. Move Allowing Access to Cheaper AIDS Drugs," Inter Press Service, July 26, 2000; available at www.aegis.com/news/ips/2000/IP000713.html.

(13) See Thomas W. Pogge, World Poverty and Human Rights (Cambridge: Polity Press, 2002), pp. 127-29.

(14) See, for example, Dan W. Brock, "Some Questions about the Moral Responsibilities of Drug Companies in Developing Countries," Developing World Bioethics 1, no. 1 (2001), pp. 33-37.

(15) Andrew Sullivan, "Profit of Doom?" New Republic, March 26, 2001; available at www.tnr.com/032601/trb03260l.html.

(16) More significant, perhaps, is the threat of being put on the Special 301 watch list of countries whose trade practices the United States dislikes and is considering placing under sanctions. Several authors have claimed that it is bilateral pressures outside the WTO that have been most constraining to the trade-related policies of developing countries See Carlos Correa, "The TRIPS Agreement: How Much Room to Maneuver?" Journal of Human Development 2, no. 1 (2001); and Michael E Ryan, Knowledge Diplomacy: Global Competition and the Polities of Intellectual Property (Washington, D.C.: Brookings Institution Press, 1998).

(17) Harris and Siplon, "International Obligation and Human Health," p. 43.

(18) Richard Morin and Claudia Deane, "Americans on AIDS in Africa: Help and Discipline Needed," Washington Post, July 6, 2002, p. A3.

(19) See Oxfam's report on GlaxoSmithKline, which documents meetings company executives attended as part of the TRIPS negotiation process, as well as personal and professional conflicts of interest of both government officials and corporate employees. Oxfam, "Dare to Lead: Public Health and Company Wealth" (Oxfam briefing paper, London, 2001); available at www.oxfam.org.uk/cutthecost/downloads/dare.pdf. See also Ryan, Knowledge Diplomacy.

(20) Oxfam, "Patent Injustice: How the World Trade Rules Threaten the Health of Poor People" (Oxfam briefing paper, London, 2001); available at www.oxfam.org.uk/cutthecost/downloads/patent.pdf.

(21) Commission on Macroeconomics and Health, Macroeconomics and Health: Investing in Health for Economic Development (Geneva: World Health Organization, 2001); also available at www3.who.int/whosis/cmh/cmh_report/report.cfm?path=cmh,cmh_report &language=English.

(22) Alan F. Holmer, "President's Message," in PhRMA 2001-2002 Annual Report (Washington, D.C.: Pharmaceutical Research and Manufacturers of America, 2002), p. 6; available at www.phrma.org/publications/publications/annual2001/phrma_annre port2001.pdf.

(23) Miller refers to this as the "community" principle. Miller, "Distributing Responsibilities," p. 462.

(24) Donald M. Berwick, "We All Have AIDS," Washing ton Post, June 26, 2001, p. A17.

(25) Quoted in Donald M. Berwick, "'We All Have AIDS': Case for Reducing the Cost of HIV Drugs to Zero," British Medical Journal 324, no. 7331 (2002), pp. 214-18.

(26) John Diamond, "Hyde: Boost AIDS Funds across Africa," Chicago Tribune, June 7, 2001, p. 18.

(27) For discussion of this claim, see Samuel Scheffler, Boundaries and Allegiances (New York: Oxford University Press, 2001), pp. 58, 85; and Pogge, World Poverty and Human Rights.

(28) Scheffler, Boundaries and Allegiances, p. 4

(29) Berwick, "'We All Have AIDS': Case for Reducing the Cost of HIV Drugs to Zero," p. 215.

(30) Richard Sykes, "Commentary: The Reality of Treating HIV and AIDS in Poor Countries," British Medical Journal 324, no. 7331 (2002), p. 216.

(31) Michael J. Selgelid and Udo Schuklenk, "Letter to the Editor: Do Patents Prevent Access to Drugs for HIV in Developing Countries?" Journal of the American Medical Association 287, no. 7 (2002), p. 842. See also, Consumer Project on Technology, "Comment on the Attaran/Gillespie-White and PhRMA Surveys of Patents on Antiretroviral Drugs in Africa," October 17, 2001. Available at www.cptech.org/ip/health/africa/dopatentsmatterinafrica.html.

(32) For discussion, see A. M. Honore, "Causation in the Law," in Stanford Online Encyclopedia of Philosophy (electronic edition, 2001), available at plato.stanford. edu/entries/causation-law; and Richard G. Wright "Once More into the Bramble Bush: Duty, Causal Contribution and the Extent of Legal Responsibility" Vanderbilt Law Review 54, no. 3 (2001), pp. 1071-132.

(33) Harris and Siplon, "International Obligation and Human Health," p. 34.

(34) Miller, "Distributing Responsibilities," pp. 460-61. As Miller points out, views of this kind may be sensitive both to the efficiency of different agents and institutions in bringing remedy and to the cost to these agents of doing so. See also Henry Shue, "Mediating Duties," Ethics 98, no. 4 (1988), pp. 687-704.

(35) Faisal Islam and Nick Mathiason, "Brown: Let Africa Have Cheap Drugs," Observer, online edition, April 15, 2001; available at www.observer.co.uk/business/story/0,6903,473190,00.html.

(36) Ibid.

(37) For discussion, see Miller, "Distributing Responsibilities"; and Christian Barry, "Global Justice: Aims, Arrangements, and Responsibilities," in Toni Erskine, ed., Can Institutions Have Duties? (Basingstoke: Palgrave, 2002).

(38) Berwick, "We All Have AIDS," p. A17.

(39) Robert M. Goldberg, "Fight AIDS with Reason, Not Rhetoric," Wall Street Journal, April 23, 2001, p. A22.

(40) Peter Hot, "Keeping the Promise" (speech given at the XIV International AIDS Conference, Barcelona, July 7, 2002); available at www.unaids.org/whatsnew/speeches/eng/2002/Piot070702Barcelona.html.

(41) PhRMA, Pharmaceutical Industry Primer 2001, p. 4.

(42) Oxfam, "Implausible Denial: Why the Drug Giants' Arguments on Patents Don't Stack Up" (Oxfam Policy Paper, London, 200l); available at www.oxfam.org.uk/policy/papers/trips/trips2.b.htm.

(43) James Love made this proposal in UNDP, Human Development Report 2001, p. 108.

(44) PhRMA, "PhRMA Statement on Kenya Industrial Property Bill for 2001" (mimeograph presented to Kate Raworth by Susan Kling Finston, Assistant Vice President for Intellectual Property and Middle East/Africa Affairs, PhRMA, June 2001).

(45) Martin Khor, Rethinking IPRs and the TRIPS Agreement (working paper no. 1, International Property Rights Series, Third World Network, Penang, Malaysia, 2001), p. 5.

(46) This phrase is adapted from "default duties," which was coined by Henry Shue in another context. For related discussions, see Liam Murphy, Moral Demands in Non-Ideal Theory (New York: Oxford University Press, 2000).

(47) For discussion, see Charles Beitz, Political Theory and International Relations, rev. ed. (Princeton: Princeton University Press, 1999); Hillel Steiner, An Essay on Rights (Oxford: Blackwell, 1994), esp. pp. 260-75; and Thomas W. Pogge, World Poverty and Human Rights.

(48) G. A. Cohen, "Capitalism, the Proletarian and Freedom," in Alan Ryan, ed., The Idea of Freedom (New York: Oxford University Press, 1982), p. 14.

For discussions of earlier versions of this article, we are grateful to participants in the workshops, "Public Health and International Justice," Carnegie Council, and "Assigning Duties to Institutions: Debating Hard Cases," British Academy Network on Ethics, Institutions, and International Relations. Special thanks are owed to Paige Arthur, Robert Bach, Carolyn Deere, Ludmila Palazzo, Thomas Pogge, Joel Rosenthal, and Anthony So for their helpful written comments, and to Morgan Stoffregen and Lydia Tomitova for their valuable research assistance. The views expressed in this paper are those of the authors alone, and not of the institutions with which they are affiliated.

Kate Raworth is Policy Advisor at Oxfam Great Britain. Previously, she was Economist and Co-Author for UNDP's Human Development Report, writing on issues of globalization, technology, human rights, and intellectual property rights and access to medicines. Prior to joining UNDP, she was Fellow of the Overseas Development Institute posted in the Ministry of Trade, Industries, and Marketing in Zanzibar, where she worked with local microenterprises.