Ensuring fair access to essential medicines Mira ...

Sharing the benefits of medical innovation: Ensuring fair access to essential medicines Mira JOHRI1, 2; Stephen P. MARKS3,4; James J. ORBINSKI5,6; Thomas W. POGGE7,8; Daniel WIKLER4. 1

Département d’administration de la santé, Faculté de Médicine, Université de Montréal

2

Groupe de recherche interdisciplinaire en santé, Faculté de Médicine, Université de

Montréal 3

François-Xavier Bagnoud Center for Health and Human Rights, Harvard University

4

Department of Population and International Health, Harvard School of Public Health

5

Munk Centre for International Studies, University of Toronto

6

Centre for International Health , St. Michael’s Hospital, University of Toronto

7

Department of Political Science, Columbia University

8

Centre for Applied Philosophy and Public Ethics, Australian National University

Word Count (abstract): 425 Word Count (text): 12,284 Tables: 1 Figures: 0 MeSH Key Words: Drugs, Essential; Social Justice; International Cooperation; Developing Countries; Health Priorities, Cost Effectiveness, Patents Running Head: Ensuring fair access to medicines

Please address correspondence to: Mira Johri, Ph.D., MPH Département d’administration de la santé, Faculté de Médicine, Université de Montréal, CP 6128, succ. Centre-Ville, Montréal, QC Canada H3C 3J7. Telephone (514) 343-7318; Fax: (514) 343-2448 E-mail: [email protected]

Abstract Context: Improved access to essential medicines has the power to transform global health, bringing dramatic relief of pain and suffering to the afflicted. It also has the potential to improve the path of global development, because ill health greatly aggravates the poverty and economic stagnation of many societies and their members. These facts are not contested. Yet, the current global framework of political and economic institutions governing medical research, production and distribution of essential medicines continues to fail the world’s poor. Aims: To offer a normative analysis of responsibilities for ensuring just access to the benefits of medical innovation, and to identify policy options congruent with these responsibilities. The argument is developed with specific reference to essential medicines. As there is a plurality of reasonable value positions, our strategy is to develop an overlapping consensus. Methods: Section 2 provides an analytical backdrop, by introducing the main features of the current global medical innovation system. It examines the potential for essential medicines and other health technologies to reduce the global health gap. It then asks why this potential has not been realised. While access to medicines depends on many factors, we examine in detail the current system for medical innovation enshrined in the World Trade Organisation (WTO)’s Trade-Related Intellectual Property Rights Agreement(TRIPS). This system results in a profound misalignment between medical research and health needs. The section concludes by briefly examining this situation from a consequentialist perspective. Section 3 focusses on Rawls’ work on international justice. It examines the argument that, under non-ideal conditions, we have a duty of assistance to so-called “burdened societies.” We argue that improved access to essential medicines may be one of the most effective forms of intervention available to fulfil this duty of assistance. Section 4 develops an argument based on Thomas Pogge’s work on global justice. Pogge asks whether the current global institutional order—including institutions governing medical innovation—may in some instances cause harm to the global poor, by engendering foreseeable and avoidable poverty, suffering, morbidity and mortality. We argue that current institutional arrangements governing access to medicines frequently harm the global poor. Section 5 briefly outlines several policy avenues congruent with the responsibilities identified. These policy avenues include the establishment of prize funds to stimulate targeted research and development, public sector initiatives, and an alternative trade framework for medical research and development. Conclusions: We conclude that the urgent need for reform in the area of essential medicines is supported by an overlapping consensus, and that the realization of human rights must be a central focus of institutional design.

§1. INTRODUCTION

Improved access to essential medicines has the power to transform global health, bringing dramatic relief of pain and suffering to the afflicted (World Health Organisation 2000). It also has the potential to improve the path of global development, because ill health greatly aggravates the poverty and economic stagnation of many societies and their members(World Health Organisation 2001). The victims of preventable and treatable diseases are drawn overwhelmingly from the global poor, and more than 10 million per year are children under 5 years(Black, Morris, and Bryce 2003; Organizacion Mundial de la Salud 2005).1

These facts are not contested. Yet, the current global framework of political and economic institutions governing research, production and distribution of essential medicines continues to fail the world’s poor. This situation, in which market forces rather than public health priorities govern access to essential medications, is now acknowledged as a serious market failure(Commission on Intellectual Property Rights 2006; Drugs for Neglected Diseases Working Group 2001). Perhaps more profoundly, it is also a political and moral one.(Orbinski 2001)

The issue of neglected diseases has brought attention to that of neglected persons(Commission on Intellectual Property Rights 2006)(p.9)—to those individuals whose most basic aspirations remain unfilled despite increasing global prosperity. There is a growing international consensus on the right to health as constituting one of the core human rights(Hunt 2005; Hunt 2004a; Hunt 2003b; Hunt 2005), and on the role that essential medicines have to play in its realisation.(Hunt 2003a; Montréal Statement on the Human Right to Essential Medicines2005) However, there is far less consensus on responsibilities for implementing change. While it is commonly acknowledged that governments have obligations to ensure access to essential medicines at the national level, the current debate turns on the 1 In a recent survey commissioned for the Millennium Summit of the United Nations, good health ranked consistently as the number one desire of persons around the globe.(Millennium Poll2000) In 2002 alone, 33% of deaths (18.4 million) and 40% of the burden of disease (613 million disability-adjusted life years (DALYs) lost) were caused by starvation and easily preventable and/or treatable conditions.(World Health Organisation 2003) Virtually all of these deaths occurred in developing countries.

more controversial questions of whether we have responsibilities for ensuring access to essential medicines at the international level, and the reasons for and extent of these obligations. In order to build the political and financial commitment necessary for institutional reform, it is essential to offer a normative analysis of these issues in a style both compelling and inclusive.

In Political Liberalism Rawls describes a form of political conversation suitable for a society whose salient characteristic is social and ideological pluralism. In his view, the task of public reason consists in building an overlapping consensus on an issue – one that can be endorsed from a plurality of more comprehensive moral viewpoints.(Rawls 1993) We believe that this style of argument is suitable for an international community characterised by a plurality of reasonable outlooks.2

This paper presents an argument in this spirit. It offers an analysis of responsibilities for ensuring just access to the benefits of medical innovation from three theoretical perspectives: consequentialist, Rawlsian and that of Thomas Pogge. We will show that, while the nature and strength of the justifications differ, each position provides pressing reasons for taking action on this issue. Although not exhaustive, this survey suggests that from a variety of important perspectives, it is possible—indeed essential—to build a consensus on responsibilities for change.3 We end by sketching policy directions coherent with these argued responsibilities.

2 We recognise that this is a textual liberty. Rawls views the possibility of coming to an overlapping consensus as based on a commonality of institutions and values “viewed as latent in the public political culture of a democratic society”(Rawls 1993) (p. xvi) that he does not presume exists at the international level. 3

Our choice of perspectives reflects our sense of their importance, and of course, constraints of time and knowledge. We expect that similar conclusions could be reached from a variety of other perspectives. The exclusive focus on approaches drawn from Western philosophy may perhaps be forgivable as our argument is in the first instance addressed to the citizens and governments of highincome countries.

§2. ESSENTIAL MEDICINES AND GLOBAL HEALTH

This section provides an analytical backdrop for the normative discussions that follow. It is structured in two parts. The first examines the potential for essential medicines and other health technologies to reduce the global health gap, and asks why this potential has not been realised. Our presentation emphasises the current system for medical innovation enshrined in the World Trade Organisation (WTO)’s Trade-Related Intellectual Property Rights Agreement (TRIPS), which we argue results in a profound misalignment between medical research and health needs. The second assesses the evidence presented from a consequentialist perspective, and describes the contribution we feel that normative analysis can make to establish an international consensus on the just relationship between intellectual property rights, innovation and global public health.

2.1 A Primer on the Essential Medicines Debate

1. The potential of essential drugs to remedy the health gap is enormous – As part of its mandate to study the links between health and the economic development of societies, the WHO’s Commission on Macroeconomics and Health (CMH), sought to identify effective strategies for improving the health of the global poor.(World Health Organisation 2001) Many of the most effective strategies identified—such as a campaign for measles vaccination among children in Malawi or directly observed short course tuberculosis treatment in Peru—were based on ensuring that pharmaceutical advances reach the poor and underserved.(Jha, Bangoura, and Ranson 1998; Jha et al. 2002; Jha, Stirling, and Slutsky 2004)

WHO’s programme for Medicines and the Idea of Essential Drugs (EDM) works to close the tremendous gap between the life-saving potential of essential drugs and the reality that for millions of people—particularly the poor and disadvantaged—medicines are unavailable, unaffordable, unsafe or improperly used. WHO publishes a yearly Model List of Essential Drugs, selected with regard to public health relevance, safety, efficacy and cost-effectiveness. The list contains safe, effective treatments for the infectious and chronic diseases that affect

the vast majority of the world's population.(World Health Organisation 2004) It supports national governments in building evidence-based drug formularies.

2. However, access is currently poor. In 2003, over one-third of the world's population still lacked access to the drugs on the WHO Model List. In the poorest parts of Africa and Asia the figure rises to over 50%.(World Health Organisation 2004)

3. There is a fatal imbalance between treatment needs and pharmaceutical production. Table 1 introduces a categorisation developed by the Drugs for Neglected Diseases Working Group(Drugs for Neglected Diseases Working Group 2001), which helps to clarify the alignment between drugs currently produced by the pharmaceutical industry, health needs addressed, and population groups to which they belong.

Table 1. The types of disease Need Addressed

Characteristic Conditions

Category “A” – Global Diseases4

E.g. cancer, cardiovascular diseases, mental illness and neurological disorders, which constitute the major focus of the R&D based pharmaceutical industry. These diseases affect individuals in developed and developing countries.

Category “B”Neglected Diseases

E.g. malaria and tuberculosis (TB), for which the R&D-based pharmaceutical industry has only marginal interest. These illnesses primarily affect people in developing countries, although there is some overlap (e.g. anti-malarials for travellers, TB treatment).

Category “C” – Most Neglected Diseases

E.g. sleeping sickness, Chagas disease and leishmaniasis, which exclusively affect people in developing countries.

Category “Z” – Not purely medical

E.g. products addressing cellulite, baldness, wrinkles, dieting, stress and jet-lag, which represent a highly profitable market segment in wealthy countries.

4

The Commission on Macroeconomics and Health refers to Category “A” “B” and “C” diseases as “Type 1,” “Type II” and “Type III,” respectively.(World Health Organisation 2001) This terminology has been followed in the recent report of the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH).(Commission on Intellectual Property Rights 2006)

As Table 1 illustrates, the current medical innovation system results in two related problems with respect to access to essential medicines: 1. Access to currently existing pharmaceuticals. Current market-driven incentives for drug research and production ensure that treatments for the health conditions affecting the global rich (Categories A and to a limited extent B) are developed and produced. However, access to these drugs is sharply restricted. Most people in developing countries who require treatment for these conditions cannot afford these medications, and are thus not served by the pharmaceutical market.(Drugs for Neglected Diseases Working Group 2001) 2. Development of drugs to meet global health needs, and in particular, for currently neglected diseases (Category C). Because most patients affected with these conditions are too poor to pay for any kind of treatment, they have for the most part fallen outside the scope of the drug industry’s research and development efforts, and thus outside the pharmaceutical market.(Drugs for Neglected Diseases Working Group 2001)

4. Access to existing drugs (Categories A and B) is determined by many factors – A recent joint report of the World Health Organisation (WHO) and the secretariat of the World Trade Organisation (WTO) stresses that access to essential medicines and vaccines depends on many factors. They identify four critical elements: affordable prices, rational selection and use of medications, sustainable health system financing, and reliable drug supply systems.(WTO Agreements and Public Health: A joint report of the World Health Organisation (WHO) and the secretariat of the World Trade Organisation (WTO)2002)

5. But price counts. The economic impact of pharmaceuticals on country health budgets is substantial—especially in the developing world. Spending on pharmaceuticals represents less than one-fifth of total public and private health spending in most developed countries, 15 to 30% of health spending in transitional economies and 25 to 66% in developing countries.(World Health Organisation 2000) In most low income countries pharmaceuticals are the largest public expenditure on health after personnel costs and the largest household health expenditure.(World Health

Organisation 2000) Moreover, the costs of serious family illness, including drugs, are a major cause of household impoverishment. Fifty to 90% of drugs in developing and transitional economies are paid for out-of-pocket, with the heaviest burden borne by the poor.(World Health Organisation 2000)

6. The price of drugs reflects market forces and international agreements governing trade. A critical feature of the current incentive system for pharmaceutical research and sales is the patent protection granted to industry for new discoveries. The pharmaceutical industry markets products that originate through investment in research and development (R&D) –a process that is risky, expensive and requires considerable expertise. In order to survive, companies must recoup R&D expenses and make profits; however, drug production itself is relatively inexpensive. In an unregulated market, companies could therefore cheaply copy and sell drugs discovered by firms that have invested in R&D. This ability to free ride on the fruits of the R&D investing company’s research is a classic instance of a market failure. If left uncorrected, it would lead to a severe undersupply of medical innovations. The classic solution, enshrined in the World Trade Organisation (WTO)’s Trade-Related Intellectual Property Rights (TRIPS) Agreement, is to grant companies monopoly power, thereby enabling them to price products far above the marginal cost of production. Many developing countries view this solution as contrary to their interests, and global public support for the developing country stance is growing.5

A heated debate is underway concerning whether and how the patent system should be reformed. As most of the drugs on the WHO’s essential medications list are off-patent, and patent protection is weak in many developing countries, some have argued that patent protection plays little role in access problems, and that the critical elements are background

5

In 1997 South Africa passed a law permitting it to import generic medications, even for drugs patented in South Africa. When South Africa attempted to import generic antiretrovirals for treatment of citizens with HIV, a coalition of 31 pharmaceutical companies representing the international pharmaceutical industry attacked this law in the South African courts. Public outrage over the perceived struggle between profits for the global rich and life or death for the global poor rendered the suit a public relations debacle, leading the industry to withdraw its complaint in April 2001.(Barnard D. 2002; MSF 2004b; MSF 2004a)

factors such as poor health systems infrastructure or the poverty of many countries severely affected with a high disease burden.(Attaran and Gillespie-White 2001a) The WTO notes that medication prices can be reduced by a variety of measures compatible with existing market and trade rules, such as price negotiation for high volume purchasing or reducing import duties.(WTO Agreements and Public Health: A joint report of the World Health Organisation (WHO) and the secretariat of the World Trade Organisation (WTO)2002) However, a growing public consensus supports the notion that there is a moral imperative for reform of the pharmaceutical market and the regulatory system by which it is governed.(Apartheid Medicale2004; Commission on Intellectual Property Rights 2006)

One important indication of this support came via adoption of the 2001 Doha Declaration on the TRIPS agreement in public health. The Doha Declaration, widely seen as a victory for the developing nations, confirmed the right of developing nations to take measures to protect public health including use of mechanisms such as the issuing of compulsory licenses and parallel importation.(WTO 2004) However, few developing countries have tried to avail themselves of these mechanisms, due in part to fears over political and economic sanctions.(Ford et al. 2004; Wilson et al. 1999; MSF 2004e) Important sources of generic medicines dried up in 2005, as the most important sources, India and Brazil, are now required to respect TRIPS patent laws(MSF 2005a; MSF 2005b). Regional and bilateral trade agreements that stipulate levels of intellectual property protection higher than those found in TRIPS have further eroded the position of the developing countries.(MSF 2004d; MSF 2004c)

7. Investment in drug research follows market incentives. The pharmaceutical industry is reluctant to invest in the development of drugs to treat the major diseases of the poor, because return on investment cannot be guaranteed. The result is a critical shortage of effective drugs for tropical and infectious diseases that mainly affect the poor (Categories B and C).(Pecoul et al. 1999; Drugs for Neglected Diseases Working Group 2001) Currently, only 10% of global health research is devoted to conditions that account for 90% of the global diseases burden. This is known as the 10/90 gap.(Global forum for health Research 2000)

Tropical diseases serve as a paradigm example of this problem. Of the 1393 total new drugs approved between 1975 and 1999, only 1% (13 drugs) was for a tropical disease. Of these, 5 emerged from veterinary research.(Drugs for Neglected Diseases Working Group 2001; Trouiller et al. 2001) To compound the problem, lack of purchasing power among those needed often means that such drugs are withdrawn from the market.(Pecoul et al. 1999) This situation has lead to a call for a reorientation of priorities in drug development and health policy.(Trouiller et al. 2001; Drugs for Neglected Diseases Working Group 2001)

8. Redressing this imbalance is a key part of an effective strategy to promote global health equity… Infectious diseases cause the suffering of hundreds of millions of people. These individuals are often invisible. In a landmark World Bank report released in 1999, Gwatkin and Guillot demonstrated that the disease burden among the global poor reflects patterns substantially different from those of the global majority. Based on disaggregation of 1990 data, the authors estimate that communicable diseases cause 59 percent of deaths and 64 percent of DALY loss among the 20 percent of the global population living with the lowest per capita incomes, as compared with 34 percent of deaths and 44 percent of DALY loss among the entire global population.

Our success in redressing this situation depends on our choice of global priorities. Gwatkin and Guillot show that a focus on communicable diseases would improve the life expectancy of the global poor and reduce the projected health outcomes gap, while a continued focus on non-communicable conditions will augment the health gap. The report argues in favour of global strategies that prioritize communicable diseases and other poverty associated conditions.(Gwatkin and Michel Guillot 1999) Rendering medications accessible and orienting R&D towards tropical and infectious diseases is part of such a pro-poor disease focus.

9. And to change the path of global development.

Ill health aggravates poverty and the economic stagnation of societies. The WHO’s Commission on Macroeconomics and Health found that avoidable disease reduces the lifetime incomes of individuals, the annual incomes of society, and prospects for economic growth. Disease control may be one of the most effective instruments in the fight against global poverty, and a key component in maintaining political security.(World Health Organisation 2001; Jha, Stirling, and Slutsky 2004) Among the 10 recommendations for immediate action made by the CMH report, increasing access to medicines figures in two instances(World Health Organisation 2001)(recommendations 9 &10, p.17).

2.2 Health and Justice

These facts are by now widely accepted. However, widespread action has not followed. Why? Although apathy and protection of vested political and economic interests are important factors, we believe that a critical reason for this concerns a lack of agreement on who bears moral responsibility for ensuring change. As §2.1 suggests, analyses by economists and other applied specialists interested in public health are articulated principally in “consequentialist” terms. Consequentialism can be defined as an approach to ethics that holds that an action is morally right if the consequences of that action are more favorable than unfavorable. In choosing amongst options, an important criterion is to seek to maximise beneficial consequences.6 Gwatkin and Guillot, for example, base their analysis on projected health impact: pro-poor policies are advantageous in terms of offering a superior reduction in the burden of disease measured in DALYs.(Gwatkin and Michel Guillot 1999) The Commission on Macroeconomics and Health takes a broader perspective in the consequences it evaluates: the strategies it recommends are defended in terms of impact on 6

Although cost-effectiveness analysis using quality-adjusted life years (QALYs) (DALYs) is often motivated as a constrained maximization (minimization) problem in which each person counts for one, and thus resembles utilitarianism in its broad features(Weinstein and Stason 1977), we have deliberately avoided use of the term “utilitarian.” There are at least two important points of divergence. First, while a welfarist reading of QALYs views them as a preference-based measure of utility this reading is controversial(Brouwer and Koopmanschap 2000), and DALYs make no such claim.(Murray and Acharya 1997) Second, analyses tend to focus their interests on the health sphere, rather than to an assessment of overall consequences.

disease burden, and in terms of economic consequences at the individual, country and global levels (World Health Organisation 2001).

Conclusions about the morally appropriate policies to be adopted that can be drawn from this evidence differ sharply. If, as is commonly done, one considers policy impact only on those living within given state borders7, the current system of medical innovation may be perceived to work reasonably well for countries with higher levels of health and wealth, and extremely poorly for those with low levels of both. If, by contrast, one considers policy impact with reference to the entire global population8, actions to improve the health of the global poor such as increasing access to medicines and medical research are urgently required.

While theories of justice have traditionally been articulated on the assumption that the individuals affected share membership in a society or social group, the global system for medical innovation has benefits and burdens that cross frontiers. The point at issue between these two consequentialist readings reflects a central issue of ethics in an era of unprecedented global prosperity, inequality and interconnectedness: the normative significance of national borders (Beitz 1999; O'Neill 2000; Pogge 2002b; Singer 1997; Singer 1993; Rawls 1999b). We believe that to establish an international consensus on the just relationship between intellectual property rights, innovation and global public health, it is essential to address this question. We next consider two very different accounts of the nature of our moral responsibilities for poverty and ill health in other nations.

7

Robert Goodin’s eloquent defence of utilitarianism as a philosophy suitable for public policy formation, for example, is articulated exclusively at the societal level. See (Goodin 1995)

8

Peter Singer’s work has been pathbreaking in articulating a global utilitarian perspective. See (Singer 1997; Singer 1993)

§3. RAWLS: BURDENED SOCIETIES AND ACCESS TO ESSENTIAL MEDICINES

This section investigates the nature and scope of our responsibilities for ensuring access to essential medicines at the international level from a Rawlsian perspective. Specifically, it will focus on the account of international responsibilities given by Rawls in The Law of Peoples (henceforth, “LOP”).(Rawls 1999b) First published in 1999, LOP sets out a political conception of justice that applies to the principles and norms of international law and practice. It represents the culmination of Rawls’ reflections on how reasonable citizens and peoples might live together in a just world.

As we shall see, Rawls’ analysis of international responsibilities focuses on obligations to contribute to the development of societies that are politically “well-ordered.” It might seem that provision of access to medicines is an objective of a different sort altogether, and that its realisation plays no role in Rawls’ account. We shall argue that this is not so. In our view, enhancing access to medicines has a potentially important—albeit limited—function in achieving the goals Rawls sets out in LOP. In order to make this argument, we first outline several features of Rawls’ position.

3.1 Justice as Fairness

3.11 Overview In A Theory of Justice (henceforth, “TOJ”)(Rawls 1999a), Rawls presents a conception of justice which he refers to as “justice as fairness.” 9 Justice as fairness describes an ideal for the design of basic institutions for a constitutional democracy “conceived for the time being as a closed system isolated from other societies” (TOJ, p.6). The theory is introduced via a contrast with utilitarianism on the one hand, and intuitionism on the other. In its simplest form, utilitarianism defines right actions as those that maximise beneficial consequences, where this maximum is assessed via a procedure of impartial aggregation of consequences across 9

This presentation is indebted to Kymlicka’s formulation in Will Kymlicka, Contemporary Political Philosophy: An Introduction, 2nd edition. Oxford: Oxford University Press, 2002, pp 53-75.

persons. Due to this combination of features, the policies its recommends may be compatible with courses of action involving highly unequal distributions of benefits and burdens among persons and, in the extreme case, with suppression of individual rights altogether. Rawls argues that the utilitarian position is unsatisfactory in that it fails to provide an account of the moral priority of basic rights and liberties of citizens as free and equal persons, and thus to approximate our considered judgements of justice. In his view, utilitarianism fails to respect “the moral distinctness of persons” (TOJ, p.19-24). However, utilitarianism’s principal rival, intuitionism, suffers from a lack of precision and clarity which compromises its ability to provide explicit reasons for our sense of the priority of these basic rights and liberties (TOJ, p.30-36). Justice as fairness innovates by drawing upon the tradition of social contract theory to provide just such a justification.

In Rawls’ view, the justice of a social scheme depends not only on the guarantees it offers of rights and liberties, but also on how economic opportunities and social conditions impact on the life chances of the members of different sectors of society. A TOJ thus aims to formulate a conception of justice for what Rawls terms the “basic structure of society;” that is, the major institutions such as the political constitution and the principal economic and social arrangements that influence the life prospects of individuals via the social positions into which they are born, and which cannot—in Rawls’ view—be justified by an appeal to merit or desert. It does so by making use of a novel style of social contract argument. In its ideal form, Rawls views society as a fair system of cooperation over time among citizens viewed as free and equal persons (TOJ, p.6). The principles of social justice “provide a way of assigning rights and duties in the basic institutions of society and…define the appropriate distribution of the benefits and burdens of social cooperation” (TOJ, p.4). Justice as fairness aims to identify the principles of social cooperation that would emerge from an ideal form of social contract. Specifically, it describes those principles to which “free and rational persons concerned to further their own interests” would accept in hypothetical bargaining situation structured so as to guarantee equality among parties. Equality is guaranteed via imposition of a “veil of ignorance,” which offers an interpretation of the notion of moral impartiality. The veil of ignorance guarantees that the parties to the agreement are ignorant of all specific knowledge

regarding what will be their personal position in society, including their possession of natural assets such as intelligence, economic assets or social status, their specific conception of the good, and so forth. This device ensures that no one is able to design principles in her own favour (TOJ, p.118-123).

Via this choice situation, Rawls seeks to ensure the fair distribution of “social primary goods” among the individual members of a society. Social primary goods are things directly distributed by social institutions—such as basic liberties and freedoms, income and wealth, and the social bases of self-respect – that Rawls views as of use “whatever a person’s rational plan of life” (TOJ, p.54.). Alternatively, Rawls describes social primary goods as those things that persons need “in their status as free and equal citizens and as normal and fully cooperating members of society over a complete life.”(TOJ, p. xiii) By contrast, so-called “natural primary goods” such as “health and vigor, intelligence and imagination” are influenced by social institutions, but do not fall directly under their control. Natural primary goods are thus not in themselves appropriate objects of distributive justice on this account.

Rawls argues that the persons in the original position so described would choose the following two principles, of which the first is lexically prior: (1) Each person is to have an equal right to the most extensive total system of equal basic liberties compatible with a similar system of liberty for all. (2) Social and economic inequalities are to be arranged so that they are both a. To the greatest benefit of the least advantaged, consistent with the just savings principle10, and b. Attached to offices and positions open to all under conditions of fair equality of opportunity. (TOJ, p.266). Rawls’ first principle of justice is designed to guarantee the priority of equal and comprehensive rights and liberties for all citizens, and hence to respond to what he sees as the weaknesses of the utilitarian and intuitionist positions. Since Rawls views the distribution of natural primary goods and social starting points as morally arbitrary, the second principle of justice is designed to ensure that that the rewards derived from an individual’s good fortune in the natural and social lotteries are harnessed for the general good of society. It does so by specifying that social and economic inequalities be permitted only to the extent that they are 10

Principle 2a is also known as the “difference principle”

of greatest benefit to the least advantaged, where this is assessed in terms of the allocation of shares of social primary goods.

3.12Health and essential medicines: the domestic case

Neither health nor health care is included among Rawls’ list of social primary goods. Neither is therefore thought by Rawls to be regulated by the difference principle. Although some critics have argued that health status is directly relevant to assessing who is worst off,11 inclusion of health itself as one of the primary goods to be regulated by the difference principle has the potential to suggest illogical courses of action, such as investing all social resources to make an incurably ill person marginally better off.(Arrow 1973) A different understanding of the place of health in Rawls’ theory is found in the evolving work of Norman Daniels. In his 1985 work Just Health Care,(Daniels 1985) Daniels argues that, rather than viewing health itself as governed by the difference principle, we should see health care as an essential contributor to satisfying Rawls’ principle of equality of opportunity. Rawls describes fair equality of opportunity in the following terms. “[T]hose with similar abilities and skills should have similar life chances. More specifically, assuming that there is a distribution of natural assets, those who are at the same level of talent and ability, and have the same willingness to use them, should have the same prospect of success regardless of their initial place in the social system….The expectations of those with the same abilities and aspirations should not be affected by their social class.” (TOJ P.63) Daniels argues that a well-functioning public health care package is essential to making good on this guarantee. More recently, based on emerging evidence from the field of social epidemiology, Daniels and colleagues Bruce Kennedy and Ichiro Kawachi have argued that health status is largely determined by choices about what are known as the “social determinants of health.”12 This would suggest that health is in effect a social primary good

11

Will Kymlicka argues that natural primary goods such as health are in fact relevant in assessing who is worse off, as this may affect individuals’ abilities to make use of a bundle of social primary goods. Kymlicka (2002):70-71. See also Amartya Sen’s critique of resourcism in Sen A. Inequality Reexamined. Cambridge, Mass.: Harvard University Press, 1992.

12

The recently formed WHO Commission on the Social Determinants of Health describes the issue as follows: “The social conditions in which people live and work determine their health. The causes of illness are often related to social, economic and

rather than a natural one as Rawls had originally hypothesised, and thus a legitimate object of justice.(Daniels, Kennedy, and Kawachi 1999)

In sum, there seem to be strong reasons consistent with Rawls’s approach for a just society to provide basic health care to its citizens. This is confirmed in LOP, where Rawls claims that basic health care—of which essential medicines are generally thought to be a component(World Health Organisation 2000; Hunt 2004b)—should be one of the five guarantees of any constitutional liberal democracy (LOP, p.50). However, the key questions motivating this paper concern the nature and reach of our responsibilities for ensuring access to medicines at the international level. To construct a Rawlsian-style response we must first examine the main features of the theory of international relations presented in the Law of Peoples.

3.2 The Law of Peoples

3.21 Overview In LOP, Rawls extends the idea of the social contract from the domestic case analysed in TOJ to derive the content of what he terms the “Law of Peoples” – a “political conception of right and justice” that applies to the “principles and norms” of international relations and international law (LOP, p.3). The motivating idea underlying LOP is the belief that the greatest evils of human history –including war, persecution, starvation and poverty—are the consequence of political injustice, and the removal of such injustice the key to their resolution (LOP, p.7). LOP presents what Rawls sees as a realizable ideal, an international community that follows the beliefs and principles of the Law of Peoples in its mutual relations, and is thus able to live together over time in peace, harmony and mutual respect. The task of LOP is to describe this model community, to give content to and justify its system of laws, and to offer

political circumstances which produce inequalities within countries and between countries. These may include living in urban slums with no access to basic facilities such as clean water and sanitation; child malnutrition; lack of access to education; unemployment; exclusion from mainstream society on the basis of gender, race, refugee status and religion.” WHO Commission on the Social Determinants of Health, http://www.who.int/social_determinants/en/ Accessed 2006-04-07.

guidance for its realization (LOP, p.3). Accordingly, the first two parts are dedicated to specifying and defending Rawls’ ideal, while the third and final part addresses questions related to its attainment that arise from the “highly non-ideal conditions of our world” with its “great injustices and widespread social evils” (LOP, p.89).

In contrast to the approach in TOJ, the principal subjects of LOP are not individuals, but collectives of individuals that Rawls refers to as “peoples.” Peoples differ from states in several ways, one of the most important being that Rawls views states as inherently expansionist and hungry for power, prestige and wealth. By contrast, what Rawls terms “wellordered” peoples are fully prepared to grant equal respect and recognition to other peoples, and can thus be governed by the principal of reciprocity which serves as the foundation of the Law of Peoples13 (LOP, p.28-29). The set of “well-ordered” peoples comprises two types of societies: “reasonable liberal peoples” governed by constitutional democracies, or “decent peoples,” which refers to the set of non-liberal societies whose institutions meet specific conditions of right and justice, including respect for central human rights and participation in decision making (LOP, p.4).

The investigation of ideal theory in LOP proceeds via an imaginary social contract parallel in spirit to that offered in TOJ, in which the representatives of well-ordered peoples come together in an original position to make an agreement with other well-ordered peoples.14 The device of a veil of ignorance is once again used to preserve the symmetry, freedom and equality of the parties to the bargaining situation, thereby ensuring that the choice situation respects the criterion of reciprocity. Rawls argues that under a veil of ignorance which masks

13

In describing the domestic case, Rawls refers to the criterion of reciprocity as follows: “This criterion requires that, when terms are proposed as the most reasonable terms of fair cooperation, those proposing them must think it at least reasonable for others to accept them, as free and equal citizens, not as dominated or manipulated or under pressure caused by an inferior political or social position.” (LOP, p.14, cf. PL pp. 48-54) LOP aims to specify terms of fair cooperation satisfying the criterion of reciprocity in international relations; that is, freedom and equality between peoples (LOP, p.121).

14

Rawls acknowledges that the two exercises differ in many respects (LOP, p.40)..

specific knowledge of features such as country size, wealth and history, the representatives of well-ordered15 peoples would select 8 dictates to form the content of the law of peoples.16

Rawls believes it to be a fundamental trait of well-ordered peoples that they wish to live in a world where all peoples accept and follow the ideal of the law of peoples, and the aim of the Law of Peoples is to bring about this situation over time. His investigation of non-ideal theory asks how this goal might be pursued, with specific reference to duties and norms of conduct governing the relationship of well-ordered peoples to two types of non well-ordered societies: “outlaw states” that refuse to comply with the Law of Peoples, and finally—the focus of our interest—“burdened societies” which suffer from unfavourable conditions that compromise their ability to achieve a well-ordered regime17.

3.22 Duties to burdened societies

Consistent with the underlying vision of LOP, Rawls’ definition of burdened societies is made in political terms: burdened societies are those whose political arrangements do not satisfy the criteria necessary to be considered well-ordered. Moreover, Rawls situates the locus of responsibility for the current failures of burdened societies in the political culture and traditions of these societies themselves. While neither expansive nor aggressive, burdened societies in his view suffer from internal deficits that prevent them from achieving liberal or decent political

15

The argument is initially made first for representatives of liberal societies, and choice of laws is reconfirmed for representatives of decent societies (LOP, p.69). 16

The 8 laws are as follows: “1.Peoples are free and independent, and their freedom and independence are to be respected by other peoples; 2.Peoples are to observe treaties and undertakings; 3. Peoples are equal and are parties to the agreements that bind them; 4.Peoples are to observe a duty of non-intervention; 5.Peoples have the right of self-defense, but no right to instigate war for reasons other than self-defense; 6.Peoples are to honor human rights; 7.Peoples are to observe certain specified restrictions in the conduct of war; 8.Peoples have a duty to assist other peoples living under unfavorable conditions that prevent their having a just or decent political and social regime” (LOP, p.37).

17

Among types of societies, Rawls also specifies a fifth category of “benevolent absolutisms.” These are societies which honour most human rights but do not involve citizen participation in political decision-making, and are therefore not well-ordered. The category is little discussed, and not of direct relevance to this paper.

arrangements.18 As he explains, burdened societies “lack the political and cultural traditions, the human capital and know-how, and, often, the material and technological resources needed to be well-ordered” (LOP, p.106).

Burdened societies are not necessarily poor on Rawls’ account, nor are well-ordered societies necessarily wealthy. However, differences in levels of wealth between nations are not themselves a concern of justice. “The levels of wealth and welfare among societies may vary, and presumably do so; but adjusting those levels is not the object of the duty of assistance” (LOP, p.106). In taking this stance, Rawls does not mean entirely to neglect the salience of economic questions. He writes:

I believe that the causes of the wealth of a people and the forms it takes lie in their political culture and in the religious, philosophical, and moral traditions that support the basic structure of their political and social institutions, as well as in the industriousness and cooperative talents of its members, all supported by their political virtues (LOP, p.108). Rather, Rawls believes that the root causes of poverty and wealth lie at the level of the political arrangements, and that resolution of economic difficulties will follow upon improvements at the political level.19

Although he places the locus of responsibility for current failures within burdened societies themselves, Rawls believes that well-ordered peoples have a duty to assist burdened societies (LOP, p.106). He offers us three points of guidance on the nature and scope of these duties. First, while recognising that poverty and a lack of material resources may impact on a country’s ability to develop and maintain well-ordered political institutions, the aim of the duty of assistance is not to compensate for material lacks, to equalize levels of wealth across societies, or to permit continuous economic growth. Rather, the duty of assistance aims “to realize and preserve just (or decent) institutions, and not simply to increase, much less to 18

This feature of Rawls’ approach has come to be known as “explanatory nationalism.” It is conceptually separable from the focus on political virtues central to LOP, in that domestic political arrangements may themselves be influenced by external forces. See for example Thomas Pogge’s discussion of the resource and borrowing privileges in Thomas Pogge, World Poverty and Human Rights, (Cambridge: Polity Press) 2002: 146-167, and the following section.

19

This is an empirical thesis, which Rawls does not substantiate.

maximize indefinitely, the average level of wealth, or the wealth of any society or any particular class in society” (LOP, p.106). Second, in choosing mechanisms for assistance, well-ordered nations should bear in mind that the goal of the duty of assistance is to effect a change in the political culture and institutions of the burdened society. This is a complex matter. Rawls argues that economic transfers may not be the most appropriate mechanism for realising this goal. He explains: “…merely dispensing funds will not suffice to rectify basic political and social injustices (though money is often essential)” (LOP, p.107). Among recommended courses of action, Rawls stresses the importance of politicise and interventions that emphasise human rights, and in particular those that further the rights and fundamental interests of women (LOP, p.110). Third, the objective of assistance is to enable burdened societies to achieve the political arrangements that will enable them to become members of the “Society of well-ordered Peoples.” When this is achieved, further assistance is not required. This is so even if the society remains relatively poor (LOP, p.111).

In sum, Rawls argues that well-ordered societies have an important duty to assist burdened societies in acquiring the political arrangements necessary to become themselves wellordered. This duty is formalised in the eighth and final Law of Peoples, which states: “Peoples have a duty to assist other peoples living under unfavorable conditions that prevent their having a just or decent political and social regime” (LOP, p.37).Choice of policies is to be made in terms of their effectiveness in contributing to this goal.

3.3 International responsibilities for ensuring access to medicines

Recognising that we have a duty to aid burdened societies, this section examines whether it is consonant with (or perhaps, required by) a Rawlsian approach that we extend these duties to the medical arena, and in particular, to provision of essential medicines. It considers three arguments for the claim that improving access to essential medicines is a lever that would be favoured by Rawls’ duty of assistance.

Argument 1: The argument from human rights

The first argument is based on Rawls’ defence of human rights. The human right to health is codified in the Universal Declaration of Human Rights (1948), article 25; the International Covenant on Economic, Social and Cultural Rights, Article 12 (1966); the International Covenant on the Elimination of All Forms of Racial Discrimination, Article 5(e)(iv)(1965); the Convention on the Elimination of All Forms of Discrimination against Women, Article 11.1 (f) and Article 12 (1979); the Convention on the Rights of the Child (CRC), Article 24 (1989) and the General Comment 14 (2000), among others.(Health and Human Rights: Basic International Documents2004) The right to essential medicines is gaining increasing recognition as a sub-right of the right to health.(Montréal Statement on the Human Right to Essential Medicines2005; Hunt 2004b; Hunt 2003b)

It might be thought that the duty of assistance would strongly support policy interventions favouring the human right to health, including the sub-right to essential medicines, for at least three reasons: (1) the sixth Law of Peoples states: “Peoples are to honor human rights” (LOP, p.37); (2) in discussing the choice of appropriate policies for realizing the duty of assistance, Rawls emphasises the importance of policies that favour human rights over economic transfers; and (3) Rawls stresses the importance of policy interventions favouring women’s basic rights and interests. As women and girl children figure disproportionately among the global poor, suffer disproportionately from the burden of disease including complications of unsafe abortion and childbirth, figure increasingly among the victims of HIV/AIDS and disproportionately among new HIV/AIDS cases, and are documented in numerous settings to lack access to treatment across the spectrum of illnesses for reasons of gender discrimination in highly constrained economic circumstances, a policy supporting access to medicines can be assured to have a strong pro-female effect(World Health Organisation 2005; Dunkle et al. 2004b; Dunkle et al. 2004a; UNAIDS 2006; Glynn et al. 2001).

This argument does not go through, as it is based on equivocation in use of the term human rights. Rawls resists an expansive definition that might include all rights codified in international treaties in favour of a minimum that he sees as a more plausible basis for

international consensus. The human rights privileged by Rawls in LOP in fact reflect a sub-set of human rights that he views not only as widely supported in the political culture of liberal democratic societies, but also as capable of garnering similar support in decent nondemocratic societies. These human rights “express a special class of urgent rights” that is political in nature, including “freedom from slavery and serfdom, liberty (but not equal liberty) of conscience, and security of ethnic groups from mass murder and genocide” (LOP, p.7879). By definition, societies whose political institutions and legal order respect this special class of human rights are well-ordered, and cannot legitimately be subject to the use of sanctions or military force. These urgent human rights thus establish a minimum framework for commonality among peoples that Rawls views as non-ethnocentric (LOP, p.80, cf.p.121).

Argument 2: Redress for the unjustified distributive effects of cooperative organisations

According to Rawls, the states parties to the original position in LOP would not only agree to the eight basic principles or laws, they would also formulate guidelines for the establishment of cooperative organisations. Rawls hypothesises that three such organisations would be founded: one to ensure fair trade among peoples, another to institute a cooperative banking system, and a third to play a diplomatic and coordinating role similar to that of the United Nations (LOP, p.42). With respect to fair trade, Rawls argues that the parties to the original position negotiating behind the veil of ignorance would agree to fair standards of trade to keep the market fair and competitive as being to everyone’s mutual advantage in the long term, regardless of whether its economy is large or small. However, he emphasises that these standards must ensure the fairness of market transactions, and ensure that unjustified inequalities among people do not develop over time. Their role is thus analogous to that of the background structure in the domestic case presented in TOJ (LOP, p.43). In the event that these cooperative arrangements should lead to unjustified distributive effects between peoples, Rawls claims that “…these would have to be corrected, and taken into account by the duty of assistance….” (LOP, p.43, italics added).

The pharmaceutical industry and its advocates claim the current arrangements governing medical research and development contained in the WTO TRIPS agreement represent the optimal balance between stimulating innovation and promoting access. Even if this dilemma were true as posed, the impact of these policies is non-symmetrical and the distributive benefits accrue largely to the high-income nations where the pharmaceutical industry is concentrated. The United States alone is home to 7 of the top 10 pharmaceutical companies, ranked in terms of revenues.20 Under these circumstances, we have strong Rawlsian reasons to compensate via a duty of assistance those who have suffered the unintended distributive consequences of this situation. Interventions designed to increase access to medicines in developing nations would figure as logical avenues for redress.

Rawls adds a supplementary condition to his description of fair trade: “A further assumption here is that the larger nations within the wealthier economies will not attempt to monopolize the market, or to conspire to form a cartel, or to act as an oligopoly” (LOP, p.43). To the extent that this condition of fairness is violated the ideal of reciprocity among peoples is also violated and the legitimacy of our trade arrangements called into question. The history of the access to medicines debate provides more than ample illustration of these forms of behaviour on the part of the governments of the wealthy nations and the pharmaceutical companies(N.Ford & al. 2004; Treatment Action Campaign 2004; MSF 2004d; Replogle 2004).

Argument 3: Access to medicines as a transition strategy favouring the establishment of politically well-ordered nations

The final argument we consider takes up the question of whether a policy of improving access to medicines can be seen as an effective transition strategy enabling burdened societies to become politically well-ordered, and thus as a policy that should be favoured by Rawls’ duty

20

These are (2003 sales revenues in brackets, in billions): Pfizer ($49.151); Johnson & Johnson ($43.6); Merck & Co. ($30.301); Eli Lilly & Co. ($13.07); Abbot ($20.316); Bristol-Myers Squibb ($21.347); Aventis SA ($22.686). http://www.medtrack.net/research/Istats.asp

of assistance. We will argue that this is so. Our argument proceeds in two parts. The first claims that countries with a high burden of disease and severe shortfalls in terms of access to medicines fail to meet Rawls’ criteria for well-ordered societies, while the second argues that enhancing access to essential medicines would aid in the transition to becoming politically well-ordered.

As we saw in §2 of this paper, the principal correlates of a high burden of disease and lack of access to medicines are economic. Moreover, poor- and middle-income countries have adopted a variety of governance structures, ranging from democracies to dictatorships. What, then, has disease to do with being well-ordered? Answering this question will require a more detailed exploration of the characteristics of well-ordered societies.

Recall that well-ordered societies are either liberal, or decent. Rawls describes societies that fulfil a liberal conception of justice as satisfying three characteristic principles. The first guarantees “basic rights and liberties” of the sort familiar to constitutional democracies; the second assigns a “special priority” to these rights, liberties and opportunities, so as to delimit the claims of the general good and perfectionism values; and the third assures for all citizens “the requisite primary goods to enable them to make intelligent and effective use of their freedoms” (LOP, p.14). Justice as fairness, Rawls’s preferred approach in the domestic case, is one interpretation of these principles. However, different interpretations are possible and legitimate, so long as certain constraints are respected. The family of liberal approaches that satisfies these criteria must be consistent with a notion of the social contract that endorses the freedom and equality of all citizens, and of society as a fair system of cooperation over time (LOP, p.14).

In his examination of why democratic nations are peaceful, Rawls describes briefly the five features of the basic structure of society that he sees as essential to a reasonably just constitutional democracy that can endure over time. He argues that, to the extent that these features are met, peace is made more secure internally among citizens and externally among

states. His description lists the following five institutions, without which “excessive and unreasonable inequalities tend to develop” (LOP,p.49).

1.

2.

3. 4. 5.

A certain fair equality of opportunity, especially in education and training. (Otherwise, all parts of society cannot take part in the debates of public reason or contribute to social and economic policies). A decent distribution of income and wealth meeting the third condition of liberalism: all citizens must be assured the all-purpose means necessary for them to take intelligent and effective advantage of their basic freedoms. (In the absence of this condition, those with wealth and income tend to control political power in their own favour). Society as employer of last resort through general or local government, or other social and economic policies. Basic health care assured for all citizens. Public financing of elections and ways of assuring the ability of public information on matters of policy. (LOP, p.50 italics our addition).

Decent societies, while well-ordered, are subject to less stringent conditions. Rawls view decent societies as jointly satisfying the following two criteria: (1) lack of aggressive aims and means; and (2) a system of law guaranteeing human rights (LOP, p.65). While these human rights are primarily political, Rawls also emphasises the importance of basic economic entitlements. He explains that the right to life includes a claim “to the means of subsistence and security:”

[Henry Shue and RJ Vincent] interpret subsistence as including minimum economic security, and both hold subsistence rights as basic. I agree, since the sensible and rational exercise of all liberties, of whatever kind, as well as the intelligent use of property, always implies having general all-purpose means (LOP, p.65). In sum, decent societies must manifest a respect for human rights, including economic subsistence. This is necessary so that the legal and social system can be viewed by those in power as fulfilling an ideal of justice that furthers the common good of its people (LOP, p.66).

With these clarifications in mind, let us return to the question at hand. Is a high burden of disease a barrier to being politically well ordered in Rawls’ sense? •

On Rawls’ account, all liberal societies have a domestic responsibility to ensure provision of basic health care, of which access to medicines forms a part. While the level of provision may be acknowledged to vary, there are clearly many examples of low- and middle-income societies that guarantee political rights, liberties and freedoms, but that have not yet succeeded in providing basic health care or access to essential medicines to all citizens (e.g. South Africa, India, Guatemala.

•

Due to the social patterning of health, in which poor health is universally correlated with lower social position(Why are some people healthy and others not?1994; Wilkinson 1996; Marmot 1986), and the mutually reinforcing relationship between health and poverty(Wagstaff 2001; Gwatkin 2000), health problems are disproportionately concentrated in disadvantaged population sub-groups, and failures to provide access reflect and exacerbate social and economic differences between the members of these groups.

•

One consequence of this situation is that the principle of equality of opportunity in Rawls’ own preferred sense is in a real way violated. In TOJ, Rawls argues that equality of opportunity exists when those with similar abilities, skills and initiative have similar life chances, regardless of starting point in terms of social class ((TOJ P.63) and section 3.12 above). However, everywhere where the burden of disease is high, very substantial mortality differentials exist between the members of different social groups, with the result that the chance to survive to the adult phase of life when freedom, liberties and opportunities can be realised differs substantially across social classes and other group demarcations, including gender(World Health Organisation 2003). Morbidity differentials aggravate this situation by compounding inequalities in the ability to flourish.

•

Rawls’s description in LOP of the principle of equality of opportunity necessary to satisfy the conditions of a liberal society is less stringent than that presented in TOJ. However, he does stress the importance of some form of equality of opportunity, especially in education and training. Not only childhood mortality but also school performance is widely known to be affected by preventable and treatable conditions such as malaria, pneumonia, diarrhea and nemotodes and parasites, to take several highly prevalent examples.

•

Moreover, LOP recognises the importance of fulfilment of basic economic entitlements such as subsistence rights, without which one would have “not liberalism at all but libertarianism” (LOP P.49). A high burden of disease contributes to the entrenchment of poverty and threatens subsistence rights. Empirical evidence shows that the impact of this burden is always distributed among groups disfavoured in other

ways, such as income, wealth, power and prestige(Gwatkin and Michel Guillot 1999; Marmot 1986; Commission on Social Determinants of Health 2005). •

A lack of access to medicines aggravates this situation. As shown in §2 above, catastrophic illness is a serious source of household impoverishment in developing countries, and expenditures on medicines constitute the biggest out-of-pocket costs(World Health Organisation 2000).

In conclusion, we would argue that there are many societies in Europe, the Americas, Asia and Africa that are vibrantly democratic and on the way to being well-ordered, and for whom a lack of the social determinants of health and health care including essential medicines is an ongoing barrier to the achievement of this political goal. We would argue that societies facing this constellation of problems fail not only to conform to the formal characteristics of liberal democracies that Rawls sets out, but also to satisfy spirit of the criterion of reciprocity: such societies do not embody principles of social organisation that it is reasonable to accept as free and equal persons behind the veil of ignorance. These problems also compromise the ability of societies to conform to the criteria that Rawls lays out for decent societies, particularly by threatening subsistence rights.

We believe that where the burden of disease is still high, guaranteeing effective access to medicines would speed the process of transition to well-ordered societies, by making it possible for individuals to enjoy real exercise of their rights, liberties and opportunities and to avoid destitution. Plausibly, the resulting reductions in maternal and child mortality would empower women and free them from the task of exclusive childbearing, as Rawls recommends.

As the work of the CMH and others has shown, reducing the burden of disease in low- and middle-income countries would give these countries a chance to grow economically, an essential condition if a basic standard of living is to be provided to all, without external aid. Policies favouring access to medicines and other health sector interventions may hence be

more effective than monetary transfers in stimulating sustainable economic growth and alleviating poverty(World Health Organisation 2001).

Such a policy would also address threats to international peace which the international community has prudential reasons to alleviate. In some cases, such as that of HIV/AIDS, epidemic spread may be associated with food insecurity, drought and famine(Kmietowicz 2002), and serve as a precursor to war. The reality of this threat was recognised by the 2001 UN Special Session on HIV/AIDS, which marked the first time that the General Assembly met on a disease issue. This meeting resulted in the Declaration of Commitment on HIV/AIDS in which the international community for the first time supported provision of antiretroviral treatment (which also enhances prevention efforts) in developing nations as one strategy to combat the epidemic, as well as a matter of social justice.(United Nations Special Session on HIV-AIDS 2001)

Well-ordered peoples have an obligation to aid burdened peoples in joining the Society of Peoples. For the reasons given above, we believe that there are good empirical grounds for seeing a policy of improving access to medicines as an effective transition strategy that should be favoured by Rawls’ duty of assistance to burdened societies. Commitment to this policy is to be seen as a duty of charity, and is highly circumscribed. It would be valued instrumentally in terms of its contribution to the goal of fostering a society of well-ordered peoples, and may not apply to individuals living in outlaw states, or benevolent absolutisms. Moreover, our commitment would cease just as soon as it ceases to so contribute. Nonetheless, we maintain that enhancing access to medicines has a potentially important function in achieving the goals Rawls sets out in LOP. Importantly, this is so even if responsibility for current failures to guarantee access to medicines or to ensure a favourable distribution of the social and economic determinants of health is considered (as Rawls’ account suggests) to lie at the national level.

The obligation to assist in the area of access to medicines is strengthened by reflection on the current role of international cooperative organisations such as the WTO in structuring access,

as noted in argument 2 above. This insight is pursued and deepened in the work of Thomas Pogge, which offers a different explanatory and moral perspective on global poverty and access to medicines.

§4. POGGE: HUMAN RIGHTS AND ESSENTIAL MEDICINES

For Rawls, duties of justice in the international arena are reflected in the duty of assistance— a limited transitional principle that aims to enable burdened societies to acquire the requisite political institutions to become full members of the society of peoples. We argued in §3 that improving access to medicines is a strategy fully consistent with this duty of assistance, and provided reasons for its adoption valid from a rawlsian standpoint.

A stronger reading of our responsibilities for ensuring global justice has been developed by Thomas Pogge. This section sketches the main features of Pogge’s account, and considers its implications for the issues of health equity and access to medicines. Based on our causal relationship to current deficits, Pogge’s work demonstrates that we have an urgent duty of justice to take action on the issue of access to essential medicines. This duty is based in human rights, and extends to all individuals universally.

4.1 Pogge on Global Justice

In his 2002 volume of collected papers World Poverty and Human Rights: Cosmopolitan Responsibilities and Reforms and elsewhere, Pogge develops a position on global justice that challenges Rawls’s account on several levels.(Pogge 2002b) Asking why severe poverty and global inequality persist, Pogge argues that a key reason is that we—citizens of wealthy liberal democracies—do not find its eradication compelling. In so doing, he challenges the thesis of explanatory nationalism—the notion that the persistence of world poverty and inequality is sufficiently explained by appeal to local factors—upheld by Rawls. Rawls maintains that the key element in how a country fares overall is its political culture, rather than factors such as poor luck in its share of natural resources or external factors related to interactions between states (LOP, pp.105-120). In contrast, Pogge notes that in the international realm, citizens of the rich and powerful nations often stand as imposers of a planetary scheme of social cooperation. Inspired by the final clause of the 1948 Universal

Declaration of Human Rights which states: “Everyone is entitled to a social and international order in which the rights and freedoms set forth in this Declaration can be fully realized”(United Nations 1948), he argues that the pre-eminent requirement on any such coercive institutional scheme is that it be designed, insofar as reasonably possible, to guarantee human rights. Pogge interprets this to mean that such a scheme should afford each human being “secure access” to “minimally adequate shares” of basic freedoms of participation, of food, drink, clothing, shelter, education and health care. This criterion of universal justice is intended to provide a widely acceptable basis for grounding moral judgments about the global order and about other social institutions with substantial international causal effects. Based on a novel conception of human rights, Pogge’s framework provides a structured way to raise and answer the question of whether the current global institutional order—for which the governments of the rich nations (and hence their citizens) bear prime responsibility—may in some instances cause harm to the global poor, by engendering foreseeable and avoidable poverty, morbidity and mortality.(Pogge 2002b)

Pogge argues that Rawls’s approach (and that of the dominant alternative, consequentialism) tends to focus on what he terms “recipient-oriented” conceptions of justice. Such conceptions assess the justice of social institutions in terms of how they affect their participants, for example as concerns the distribution of valued goods, opportunities or outcomes. In contrast, Pogge argues in favour of a “relational” conception of justice, which distinguishes various ways in which an institutional scheme may causally affect the quality of life of its participants. The relational approach is more general than the recipient-oriented approach, as it enables us not only to address considerations of how social institutions affect people, but also to integrate concerns over how such institutions they treat people through the rules they impose.(Pogge 2002b; Pogge 2002a; Pogge 2005b)

Pogge’s explanatory perspective has important implications for our understanding of the nature and scope of our obligations as citizens of wealthy nations towards the global poor. Consonant with the popular view, Rawls’s duty of assistance assumes that we stand principally in the role of potential helpers to the citizens of burdened societies. On Rawls’s

account, we have strong and extensive duties of charity to come to the assistance of the global poor. These duties are grounded in the neediness of the poor.(Rawls 1999b) After this condition is met, inequalities between nations in areas such as wealth or income are not a concern of justice. (LOP, pp.115-120). However, it is commonly accepted that while (positive) duties of charity are somewhat discretionary, we are under a strict obligation not to harm others. What Pogge challenges is the thesis that we are not harming the poor, and that our global institutions are not serious contributors to the life-threatening poverty they suffer.(Pogge 2005b) This claim depends partly on empirical facts.21 If true, it would imply that we have a perfect duty (a duty of justice) to the poor that are actively harmed by our institutions. We would thus be under a moral obligation to reform our institutions to cease causing harm, and/ or to provide schemes to compensate for harms caused.(Pogge 2005b)

4.2 Global Institutions Governing Medical Innovation: A Case of Institutional Failure?

The WTO argues that the critical issue in granting of patent protection for pharmaceutical products is to establish a balance between two complementary public health goals, that of providing incentives for future inventions of new drugs, and that of ensuring affordable access to existing drugs.(WTO Agreements and Public Health: A joint report of the World Health Organisation (WHO) and the secretariat of the World Trade Organisation (WTO)2002) However, as documented in §2, access to the benefits of medical innovation has not yet been secured for a large proportion of the global population. Drawing upon Pogge’s recent writings, this section traces an analysis of this situation as an instance of a global institutional failure.(Pogge 2002a; Pogge 2005a)

Pogge challenges us to reflect the responsibility that citizens of the affluent countries might bear for the persistence of severe poverty and inequality in low and middle-income

21

It also depends on our choice of baseline for determining harm. We return to this point in §4.2.

nations, and in particular, on the relationship between their persistence and recent decisions concerning our path of globalization.22(Pogge 2005b) (p.55).

My focus is … on the present situation, on the radical inequality between the bottom half of humankind, suffering severe poverty, and those in the top seventh, whose per capita share of the global product is 180 times greater than theirs (at market exchange rates).”(Pogge 2005b) (P.55) Asking why the new global order is so harsh on the poor, Pogge raises two issues: first, that the governments of the rich nations “enjoy a crushing advantage in terms of bargaining power and expertise;” and second, that international negotiations are based on an adversarial system in which country level representatives seek to advance the best interests of the people in their own country. Systematic consideration of the needs of the global poor is not a part of the mandate of any of the powerful parties to the negotiation. The cumulative results of competition on a non-level playing field are, in Pogge’s view, predictable: a grossly unfair global order in which benefits flow predominantly to the affluent (Pogge 2005b) p.11).

We believe that the features of this analysis are borne out in the history of the debates over the design and interpretation of the TRIPS agreement, and in efforts to strengthen intellectual property rights beyond the standards required in TRIPS via mechanisms such as trade agreements. In analysing why the developing countries acceded to the TRIPS agreement, perhaps the most persuasive analysis suggests that developing countries gave way on TRIPS with foreseeable detriment on public health in order to gain concessions in other areas of economic importance to them, such as the lowering of agricultural subsidies in high-income nations. Economic considerations are necessarily vital in countries in which poverty is profound and widespread, and essential to fulfilling their citizens’ subsistence rights.

23

Evidence of adversarial behaviour abounds, and there

22

Some critics have understood Pogge as arguing for current responsibilities vis-à-vis developing countries with reference to events long past, such as the European colonization. As a clarification, Pogge states that what happened roughly pre-1980 is not a focus of his analysis. (Pogge 2005c; Pogge 2005b) p.55.

23

Pogge rebuts the claim that accession to the WTO and therefore TRIPS is voluntary, for the following four reasons: “1.Appeal to consent can defeat the charge of rights violation only if the rights in question are alienable and, more specifically,

is little doubt that the benefits of the current medical innovation system flow towards rich countries.

The case of access to medications thus provides a particularly good example of an issue in which local and global factors interact, and in which a global institutional scheme has substantial effects on the accessibility of medicines at the national level. This is not, of course, to say that global factors are the only ones that count.24 Pogge’s rebuttal of explanatory nationalism does not commit him to its opposite - explanatory globalism. Rather, he views both local and global factors are playing a key role in explaining the phenomenon in question.25 It thus poses no problem for his account to recognise, as per §2, that access to medicines is determined by a variety of factors, including several, such as country priorities and health systems planning and administration, that fall under the purview of national governments.(Hargreaves 2002) Pogge also emphasizes that currently existing local factors

can be waived by consent. Yet, on the usual understanding of human rights, they cannot be so waived….” “2. Appeal to consent blocks the complaint of those now lacking secure access to the objects of (some of) their human rights only insofar as they have themselves consented to the regime that perpetuates their deprivation. But most of those who are endangered by diseases or are severely impoverished live in countries that are not meaningfully democratic.” “3. Consent to a very burdensome global regime can have justificatory force only if it was not impelled by the threat of even greater burdens…. An appeal to consent thus blocks a complaint by the poor against the present global economic order only if, at the time of consenting, they had an alternative option that would have given them secure access to the objects of their human rights.” “4. An appeal to consent cannot justify the severe impoverishment of children who are greatly overrepresented among those suffering sever poverty and account for about two-thirds of all deaths from poverty-related causes (thirty-four thousand daily).” (Pogge 2005a) p.198-199. 24

To the best of our knowledge, no one has ever seriously advanced the claim that global factors are the only relevant factors in determining access to medicines. Notwithstanding, Amir Attaran and Lee Gillespie-White both advanced and refuted a variant of this notion—the claim that patents are solely to blame for a lack of access to existing AIDS treatments in Africa. Perhaps unsurprisingly, the authors found that other factors also play a role (Attaran and Gillespie-White 2001b; Attaran 2004).

25

In fact, Pogge emphasises that as explanatory variables, local and global factors often over determine the explanandum. It may often be sufficient to point either to local causes or to global causes to explain the persistence of severe poverty, for example. However, this recognition cannot diminish the share of moral responsibility attributable to either set of factors (Pogge 2002b; Pogge 2005b)(e.g. pp.118-145). Moreover, in the case of access to medicines, national factors are clearly in themselves insufficient to explain the failure of research into the diseases of the poor.

may often have current or past non-local causes.(Pogge 2005b)) For example, in Africa during the 1980s, national and global factors seem to interact to shape the relationship between economic stagnation and recession, World Bank structural adjustment policies and health system financing, as well as the financing of other health determinants such as public education, (van der and Barham 1998; Ogbu and Gallagher 1992; Jowett 1999; Sahn and Bernier 1995) all of which play a role in the ability of African health systems to provide access to medicines today.(Benatar 2004)

Pogge’s emphasis on global factors is motivated by the weight that this causal link gives to the analysis of moral responsibilities. Pogge argues that the strength of our moral reasons to prevent or mitigate particular medical conditions depends in part on how we are related to the medical conditions they suffer. He believes that we have especially stringent responsibilities to remedy health problems to which we contribute as imposers of the rules, regardless of whether those affected are compatriots, or foreigners (Pogge 2002b; Pogge 2002a; Pogge 2005b). By contributing to the failures of the current global medical innovation system, the citizens of wealthy nations via their democratically elected governments are, therefore, contributing to a severe harm.(Pogge 2005a; Pogge 2005b)

According to Pogge, this argument is based exclusively on a conception of negative duties – duties not to harm – and is therefore equally applicable to fellow citizens and foreigners. However, harm and benefit are comparative notions, and it is thus crucial to establish the correct baseline for determining harm. Taking an historical or “state of nature” perspective one might argue that, in the absence of something like the current global innovation system, the global poor would have been no worse off: their suffering and lack of access to treatment would be precisely the same, or perhaps worse, given that they do now benefit from existing medicines through various schemes such as pharmaceutical company charitable donations and the like.26 Moreover, concerning the failure to stimulate medical research and

26

This historical reading is contentious. The state of the world pre-TRIPS could very plausibly be argued to be superior in terms of human rights fulfillment with respect to access to essential medicines, as it did not foreclose the options of the developing

development to better address global health needs, proponents of this perspective might view it as incoherent to argue that this situation represents a harm to the poor, in any ordinary sense of the term. While agents are usually held morally responsible for their (deliberate) actions, it seems philosophically problematic to hold them responsible for their omissions. Among other things, this would seem to imply responsibility for an infinite number of events. It might be therefore be argued that failure to develop drugs for conditions affecting the global poor is a regrettable oversight, but not a harm in the sense needed to support a claim of justice.

This argument is unpersuasive. Pogge claims that the attribution of harm implicitly involves a “subjunctive” (as opposed to an historical) comparison, and that the correct subjunctive comparison would be the possibility of an alternative institutional order in which fewer human rights deficits would be produced (Pogge 2002a; Pogge 2005b; Pogge 2002b).

[O]n my account, the global poor are being harmed by us insofar as they are worse off than anyone would be if the design of the global order were just. Now, standards of social justice are controversial to some extent. To make my argument widely acceptable, I invoke a minimal standard that merely requires that any institutional order imposed on human beigns must be designed so that human rights are fulfilled under it insofar as this is reasonably possible…. “…an institutional order cannot be just if it fails to meet the minimal human rights standard.” (Pogge 2005c; Pogge 2005b) (p.56). In sum, according to Pogge, we are harming the global poor if and insofar as we impose on them an unjust set of global institutional arrangements. The criterion for assessing the justice or injustice of institutional arrangements is its ability to guarantee individuals “secure access” to “minimally adequate shares” of the objects of their human rights – basic freedoms of participation, food, drink, clothing, shelter, education and “health care.” An institutional order is unjust, then, insofar as it foreseeably perpetuates large-scale human rights deficits that would be reasonably avoidable through feasible institutional modifications.27

countries to produce generic medications. This situation is compounded by trade agreements including TRIPS-plus conditionalities. See (Pogge 2005a). 27

For Pogge, affluent persons are morally responsible for a given human rights deficit only if four further conditions are met: “1.The affluent persons must cooperate in imposing an institutional order on those whose human rights are unfulfilled. 2. This institutional order must be designed so that it foreseeably gives rise to substantial human rights deficits. 3. These human rights deficits must be reasonably avoidable in the sense that an alternative design of the relevant institutional order would not

Granting for the moment that the global medical innovation system meets these conditions of foreseeability and avoidability, does it make sense to say reform of this system is necessary as a matter of human rights? The concern here is whether this demand coheres with a reasonable notion of what it would mean to guarantee secure access to minimally adequate shares of health care in the form of essential medicines, or whether Pogge’s proposal open the door to a “human right” to sophisticated treatments that go well beyond “minimum shares”?28 This parallels worries raised over use of anti-retroviral treatment for HIV/AIDS in developing countries, for example, which saw antiretroviral treatment as a relatively sophisticated intervention that went beyond what was necessary, sensible or cost-effective in terms of a basic health care package.(Marseille, Hofmann, and Kahn 2002; Ainsworth and Teokul 2000)

We have two responses to this objection. First, in considering this charge, it is important to consider the impact of the overall innovation system rather than to focus on specific treatments. Current research and development priorities are so clearly skewed towards the health conditions of the global rich that, wherever the minimum lies, the concern that it might have been exceeded is not particularly worrisome at the moment.

Second, there may be very important reasons to exceed provision of minimum shares to health care, as a form of redress for the compound effects of human rights failures in this and

produce comparable human rights deficits or other ills of comparable magnitude. 4. And the availability of such an alternative design must also be foreseeable.”(Pogge 2005b) p.60. With respect to the issue of access to medicines, §2 and §4 address points 1 and 2, and §5 addresses points 3 and 4. 28

This critique parallels a concern raised by Alan Patten elsewhere that Pogge’s approach may unduly stretch the notions of harm (and, inter alia, moral responsibility and human rights). Patten is concerned that Pogge’s argument functions by virtue of reference to the non-optimality of social arrangements, with the consequence that any feasible reform that would relieve suffering becomes morally necessary (and failure to undertake such a reform an instance of harm). Pogge replies that his standard of social justice refers only to human rights deficits, and therefore retains its minimalist character. See(Patten 2005) p.26-27 and (Pogge 2005b) p. 60. The objection we consider in effect pursues Patten’s critique by questioning whether Pogge’s interpretation of human rights is consistently minimalist.

other areas. In contrast to an explanatory nationalist framework, which would presuppose that we stand in a purely external relation to the high burden of disease elsewhere, the study of health inequalities reveals the complex interconnections between local and global factors that profoundly affect people’s health, (Farmer 2003; Farmer 1999; Dying for Growth: Global Inequality and the Health of the Poor2000; Challenging inequities in health: from ethics to action2001), of which poverty is certainly the most important.(Wagstaff 2002; Gwatkin 2000) As we have seen, ill health is both highly correlated with poverty, and a key factor in its reproduction at the individual and national levels(Jha, Stirling, and Slutsky 2004; World Health Organisation 2001; World Health Organisation 2003; Claeson et al. 1996; International Bank for Reconstruction and Development/ The World Bank 1993; Gwatkin and Michel Guillot 1999). If Pogge is right about the causal role of global factors in the production of severe poverty, then these factors are also deeply implicated in generating the global burden of disease.(Pogge 2002a)29 We may thus see reason to prioritise strategies to address the health of the global poor via access to health technologies such as medications at a level that far surpasses “minimum shares.”

Pogge argues that the current institutional structures governing access to medications foreseeably and avoidably produce massive morbidity and mortality, and that this impact is both highly correlated with severe poverty and a key factor in its reproduction. We have an urgent duty of justice to change this situation. It is a necessary condition of Pogge’s argument being true that there be alternatives that would realise human rights better than our current institutions. To this issue we now turn.

29

Global (or non-national) factors affect the burden of disease in complex ways. The prevalence (burden) of disease is the product of disease incidence and disease duration, while duration is itself a function both of prognosis and the natural history of the specific disease. Disease incidence and prognosis have complex causes, some of which are related to global factors such as urbanisation (thought to be the source of the cross-over over endemic SIV into pandemic HIV)(Wolfe et al. 2004), industrialisation (the source of many disease exposures(Sauve et al. 2002)), environmental changes(Ghebreyesus et al. 1999) and other transformations related to economic globalisation. (Prognosis, depends inter alia on availability of treatment, which we argue in this paper is partly determined by global factors). Health interventions can be seen as a form of compensation to those who bear the brunt of such changes.(Pogge 2002a)

§5. POLICY AVENUES

There are a number of new and existing schemes to foster medical innovation for the diseases affecting the global poor. This section briefly describes two promising new directions.

5.1 Reward systems

Programs to encourage development of new products can be classified in two broad categories: push programs, which subsidize research inputs; and pull programs, which reward developers for producing the desired product. Rewards systems are “pull” proposals that aim to buy out or replace product patents by payments from public funds related to the incremental therapeutic value of the product. The aim is to better align priorities for innovation with those for public health. Some proposals are comprehensive(Medical Innovation Prize Act of 2005 - Bill H.R.4172005), while others focus specifically on meeting the needs of developed countries(Hollis 2006; Outterson 2006; Pogge 2005a; Kremer 1 A.D.).

These proposals pursue a variety of strategies designed to foster marginal-cost pricing for drugs, and to eliminate the price distortions produced by patents. While a number of technical issues need to be resolved, this is a very active area of research(Baker 2004).

5.2 Medical Research & Development Treaty (MRDT)

The basic aim of the medical research and development treaty is to create a new global framework for supporting medical research and development that is based upon equitable sharing of the costs of research and development, incentives to invest in useful research and development in the areas of need and public interest, and which recognises the human rights and the goal of all sharing in the benefits of scientific advancement.

Underpinned by a global commitment of governments to spending a certain proportion of national income on medical research and development, the treaty seeks to promote a sustainable system of medical innovation. Minimum levels of support depend upon national income, with high income countries contributing more in both absolute and relative terms. Two proposals are described (each expressed as a share of country GDP, where the country tariffs are based on grouping countries either by World Bank country income level classifications or by country groupings based on per capita income ranges) and it is proposed that minimum levels of support be reviewed periodically.

The treaty provides a mechanism whereby areas for priority research can be established at the international level, and financial incentives put in place for their realization. Parties are free to decide themselves on specific investments, finance mechanisms and management approaches.(Medical Research & Development Treaty2006)

The recent CIPIH report viewed this proposal as requiring further elaboration, so as to make it clear how it might work in practice. The Report recognised the need for an international mechanism to increase global coordination and funding for medical innovation, and recommended that the sponsors of the MRDT undertake further work so that government and policymakers may make an informed decision regarding various dimensions of feasibility.(Commission on Intellectual Property Rights 2006)

As the MRDT leaves open choice of financing mechanisms, these proposals are mutually compatible and would bring us closer to a world in which the human right to health and the human right to essential medicines is more fully realised.30

30

There are also promising non-economic policy avenues, such as the health and human rights impact assessment proposed by Paul Hunt. Because most of the pressure exerted on developing countries to accept TRIPS-plus standards regarding intellectual property comes via trade agreements, requiring that all policy decisions or agreements likely to have a significant effect on health should be preceded by a transparent, independent and mutually binding health impact assessment may be useful(Hunt 2004b; Montréal Statement on the Human Right to Essential Medicines2005).

§6. CONCLUSIONS: ENSURING FAIR ACCESS TO ESSENTIAL MEDICINES

The World Health Organization has called for a mobilization of global resources to address health inequities, based not only on rigorous science, but also on a clear ethical vision.(World Health Organisation 2003) This paper took up the challenge to delineate responsibilities to ensure just access to the benefits of medical innovation at the global level. Pluralism is a fact of our world, and action on pressing issues will hence involve building a consensus. We argued that a consensus for action on this issue can be defined and supported via considerations drawn from consequentialist philosophy, and from the works of John Rawls and Thomas Pogge. Moreover, we anticipate that it could be supported from a variety of other reasonable stances. The nature and strength of these obligations differ according to one’s theoretical framework, to be sure. However, this overlapping consensus is important, not least because international action lags far behind even the most modest interpretation of what is required. There are politically and economically feasible alternatives to the current system for medical innovation. Their pursuit is an urgent responsibility for the international community.

We are of course not neutral between the philosophical frameworks presented in this paper. In particular, we see Rawls’ explanatory nationalism as a poor basis for understanding the reasons for current failures of access. The medical innovation system is global in reach and consequences, and those with political and economic power—the governments of the wealthy nations and the pharmaceutical companies—have pushed for the arrangements that best serve their interests (and, for many readers of this paper, that means our interests). Insofar as access failures stem from defects in political culture, they stem from defects in the political culture of the powerful.

With Pogge, we believe that respect for the human rights of all persons must become central to the design and analysis of institutions and policies with global reach. What is particularly disturbing about the current situation with respect to essential medicines is the profound lack of concern for the global poor that it reflects(Pogge 2002b)(pp.27-51). In his analysis of the

complex impact of globalisation on health, Angus Deaton emphasises the central role played by medical technologies and medical innovations in realising its positive potential.(Deaton 2004; Deaton 2005) Ensuring just access to the benefits of medical innovation is essential to defining a path of globalisation that gives central place to human dignity.

ACKNOWLEDGEMENTS

This work was supported by the Canadian Institutes of Health Research (CIHR), Grant # 128557. MJ is a recipient of a Canadian Institutes of Health Research (CIHR) New Investigator Award. Please add in any funding sources. There are no conflicts of interest in completion of this research.

The idea for this paper emerged from a workshop on Human Rights and Access to Essential Medicines held in Montréal, Canada from September 30th to October 2nd, 2005. We gratefully acknowledge the contributions of workshop participants, and sponsors: The Centre for Applied Philosophy and Public Ethics (CAPPE), Australia; Health Canada; the Canadian Institutes of Health Research (CIHR); the International Development Research Centre (IDRC), Canada, Département d’administration de la santé, Université de Montréal; Harvard School of Public Health; Centre de recherche en éthique de l’Université de Montréal (CRÉUM), the University of Central Lancashire, and the Pan American Health Organization (PAHO). We also thank Marion Gerbier for her dedication, and for outstanding research assistance.

The Montréal Statement on the Human Right to Essential Medicines is open for consultation and signature at www.accessmeds.org.

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