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LGD 2004 (1) - Editorial


Contents

Editorial : Towards a Global Health Law

 John Harrington
Professor of Law,
School of Law,
University of Liverpool, UK

john.harrington@liverpool.ac.uk

Guest Editor Profile

John Harrington is Professor of Law at the University of Liverpool in the UK. He has previously lectured at the University of Warwick and the Free University of Berlin. Harrington is also an Associate Fellow at the Institute of Health, University of Warwick and was a Jean Monnet Fellow at the European University Institute in Florence from 2001 - 2002. He has also taught at the University of Cape Town, South Africa and at the University of Dar es Salaam in Tanzania. Harrington's research interests are British and global health law, African legal history, epistemology and law. He is currently completing a book on The Common Law and Medical Knowledge with Hart Publishing due out next year, and is concluding a Nuffield-funded research project on legal education and African decolonisation with Ambreena Manji of the School of Law, University of Warwick.


This Editorial was published on 4 June 2004, updated 10 June 2004.

Citation: Harrington, J, 'Editorial', 2004 (1) Law, Social Justice and Global Development.
<http://elj.warwick.ac.uk/global/issue/2004-1/editorial.html>. New citation as at 15/07/04: <http://www2.warwick.ac.uk/fac/soc/law/elj/lgd/2004_1/editorial/>.


1. Introduction

The process of globalization has been much discussed. In what does it consist? Is it destructive or ameliorative? Has it happened before? Is it really happening now? There is some broad agreement that globalization is manifested by increased flows of capital, goods, and people across borders. It is marked by the almost universal extension of the market, by a growth in humanitarian police powers, and by a steady, if uneven increase in transnational governance structures. All of these developments have profound implications for health. Accelerated disease flows, sale of health care facilities into foreign ownership, the global drug patent regime, internationalist concern with the health rights of women and the impoverished are all manifestations of globalization in this sphere. Each controversy establishes a transnational theatre for policy debate, law making and the acquisition of regulatory powers in health matters. New sources of normativity establish themselves in a struggle between international, regional and national institutions. New actors play an entrepreneurial role, defining and presenting global health crises and lobbying for their solution.

Health issues have provided the substance for several definitive episodes of contemporary globalization: SARS, access to AIDS therapies, the global market in human organs, third world drug trials, international tobacco control. Each has been well studied by analysts from relevant disciplines: public international law, international law, trade law, political theory and so on. Health lawyers have not generally been as responsive to these developments. Their horizons have commonly been defined by the relevant domestic system of private law, the rights provisions of state constitutions and the actually existing structure of national health care provision. The global now enters into each of these spheres: foreign victims of drug trials sue in United States’ courts; gender inequalities in medical care are exposed and criticised by the United Nations’ human rights bodies; health systems in the developing world are crucially dependent on donations from the industrialised states and their corporations.

A global health law is developing quite different from the thin body of international treaties and agreements which minimally regulated interstate health matters. It penetrates into national and regional law. The global is present in the local of health policy. Competent health lawyers are obliged to study and comprehend this reconfiguration of their normative world. The essays in this collection discuss many of the substantive themes outlined above. Each demonstrates the formal heterogeneity of global health law. No overarching set of normative principles is offered to bind together its different instantiations. Instead we are presented with a varied and illuminating testament to the contingency and mutability of the new field.

2. Global Health Governance and International Law

2.1. Sustaining the Revolution in Global Health Policy

The content and forms of global health law are decisively shaped by the specific health problems, such as AIDS or SARS, presently faced by different states and their peoples. The potential use of microbial agents in weapons of mass destruction and terror attacks has also become a matter of intense political concern. Domestic and international controversies over these weapons have often been framed in terms of health policy and health law. Health has moved from the periphery to the centre of global politics.

David Fidler’s contribution rests on the insight that these new microbial threats have provoked a revolution in global health policy. A fresh set of normative ideas have asserted themselves, supported by a decisive exercise of power within the world system. Fidler develops a sophisticated matrix allowing us to track precisely the co-ordinates of change in global health policy. The new dispensation succeeds two earlier phases, which he labels Westphalian (from 1851 to 1945) and post-Westphalian (from 1945 to 1989) respectively. Under the former phase, states collaborated in trying to defend themselves against exogenous health threats (like cholera) while minimising the resulting interference with interstate trade. The frontiers of this ‘horizontal’ regulation were set resolutely at the borders of the sovereign states. The International Sanitary Conventions (from 1892 onwards) were its chief legal embodiment. Under the latter phase, concern was focussed on threats to the health of individuals, particularly in developing countries. This ‘vertical’ or interventionist mode rested normatively on the right to health, as enshrined in the constitution of the World Health Organisation and in the International Convention on Social, Cultural and Economic Rights.

The current revolution in health policy has displaced the state-centred orientation of the Westphalian mode. Global health governance is now characterized by the activism of both non-governmental organisations and commercial concerns. These shape health policy often through direct dealings with the relevant international institutions (especially the World Health Organization, but also the World Trade Organisation and regional bodies like the European Union). The post-Westphalian emphasis on the right to health has also been superseded. As Fidler shows, promoting health is now viewed simply as a means to other, greater ends by many theorists and policymakers. These ends are determined by a mix of concerns articulated in the context of contemporary microbial threats. Neo-Westphalians would promote health in order to eliminate the potential for bioterrorism and ensure political stability in disease-affected regions. Neo-conservatives would promote health as a necessary pre-requisite to the local enjoyment of political and commercial rights.

Fidler emphasises that a congruence of these different normative perspectives is essential to the durability of the new dispensation. The united front of global health politics can be sustained only by an effective and concentrated exercise of power. Defence of the revolution falls to the United States, sole superpower, military hegemon and the ‘indispensable nation’ in this sphere as elsewhere. However, as Fidler carefully explains, the imposition of this universal burden on one history-bound nation poses a distinctive set of dilemmas. Would there be effective ‘vertical’ concern with specific infectious diseases shown to be irrelevant to the security interests of the United States? Will the normative components of the new health policy, be overborne by one nation’s forceful exercise of force in its name? Can the utopian expectations raised by commitments to global disease eradication be met, or will they be frustrated by fiscal and spending limits in the developed world? These dilemmas are posed by the role of power in mediating between universalist aspirations and the specific national setting in which they have first been realised. The hazards for both the nation and the revolution itself have been faced by very different revolutionaries in very different times. It remains to be seen whether they can be avoided here and now.

2.2. Revising the International Health Regulations

The matrix of global health governance developed by Fidler can help us to comprehend recent developments at the World Health Organisation (WHO). Since 1945 the Organisation has been the pre-eminent institutional representative of post-Westphalian global health policy. This phase reached its practical high point in the successful global campaign to eliminate small pox. The Alma Ata declaration of 1978, promising ‘health for all by the year 2000’, was its normative apotheosis. However the WHO also carried over some distinctively Westphalian functions from the pre-1945 era, mostly to do with containing epidemics. The exercise and development of these functions has gained renewed prominence within the current policy mix of neo-Westphalianism and modified post-Westphalianism.

Recently proposed revisions to the WHO’s International Health Regulations (IHR) are the focus of Yutaka Arai-Takahashi’s paper. The Regulations have their origins in the International Sanitary Conventions discussed above. They define the relative roles of nation states and the WHO in combating the global spread of infectious diseases. At their heart is a surveillance system which obliges nation states to notify the WHO within 24 hours of the outbreak of listed conditions. The IHR also mandate the supply of information on the source and extent of the outbreak, the number of cases and deaths and the prophylactic measures taken. As Arai-Takahashi points out this system has been heavily criticized on three main grounds. First, it ascribes a merely passive role to the WHO in the promotion of global public health. As a result, compliance with the IHR has been poor. Second, its conception of how disease spreads, and of the measures to be taken against this are premised on an outdated model of exclusive nation state sovereignty. Third, the actions required under the IHR are confined to a list of three infectious diseases: cholera, plague and yellow fever.

In January 2004, against the background of new and re-emerging disease threats, the WHO published a working paper containing a set of draft revisions to the IHR. The proposed reforms are animated by three guiding principles. First, all public health risks of urgent international concern should be reported under the IHR framework. Second, protective measures should have no unnecessary impact on international travel and trade. Third, detection and surveillance systems should be sufficiently flexible to respond to new and re-emerging disease threats. Arai-Takahashi examines the detailed reform proposals in the light of these principles, paying particular attention to their likely impact upon developing nations.

The draft revision would implement a new model of global health governance in overcoming the deficiencies of the old surveillance model. The focus of the IHR would be expanded, allowing the WHO to respond to all conditions falling within the broad category of ‘any public health emergency of international concern’. Furthermore, the WHO would be empowered to provide active support to states struggling with epidemics. Ad-hoc and standing guidelines can be issued for this purpose. Institutional reconfiguration at national and WHO level is envisaged in order to implement this more interventionist regime. Adjudicative mechanisms are to be established allowing states to prosecute disputes regarding the implications of the IHR. As such the WHO would converge on models already developed by the WTO and the European Union. A tendency to impinge on national sovereignty is also evident in the extension of notification rights from states to non-governmental bodies. NGOs will also be represented on the WHO’s monitoring committee and in the drafting of new public health guidelines.

The effect of actual or reported disease outbreaks on trade and tourism has been of acute concern to developing countries. As Arai-Takahashi reminds us foreign trade embargos arising out of an outbreak of plague in 1994 cost India dearly. Yet health is a global public good whose promotion benefits residents of rich and poor countries alike. Non-disclosure of outbreaks ultimately undermines the confidence of trading partners in affected countries. In recognition of this problem the draft revisions to the IHR include an optional procedure allowing states to make confidential notification of a disease outbreak for a limited period. This should restore some confidence in the surveillance system and improve compliance. The draft revisions to the IHR are now the subject of consultations with member states, NGOs and others. After further revisions it is expected that they will be put before the World Health Assembly in 2005.

2.3. International Human Rights and Women’s Health

Worldwide half a million women die from complications of pregnancy each year. The risk to women in developing countries can be as high as one in nine. Almost eight million stillbirths occur each year, many of them as a result of poorly managed pregnancies and births. The risks of pregnancy and childbirth are not the only threats to women’s health, however. Women are also specifically burdened by inequitable access to health care and nutrition, unsafe abortions, inadequate contraception, domestic violence and female genital mutilation. In her paper Dina Bogecho seeks to clarify the way in which these acute health needs register in terms of international human rights law.

Bogecho’s is no merely speculative exercise. Her essay can be read, not just as a forceful commentary on the scope of existing human rights law, but also as a guide to activists and NGOs in the field of women’s health. It is clear that a number of international human rights conventions apply to these problems. The International Covenant on Economic, Social and Cultural Rights, for example, includes recognition of the right to health, which is of direct relevance to the issues mentioned above. The Convention on the Elimination of All Forms of Discrimination Against Women (‘Women’s Convention’) contains numerous provisions on women’s health and reproductive rights. While noting the positive effect of these affirmations of women’s specific rights, Bogecho is sceptical of their utility as a means of holding states to account. The very existence of a ‘right to health’ is still contested in the realms of politics and philosophy. More practically several signatories to the Women’s Convention have entered reservations effectively sheltering their domestic family law in so far as it still discriminates against women in matters of health and otherwise.

Instead Bogecho focuses on the International Convention on Civil and Political Rights (ICCPR). While this convention does not refer specifically to a right to health, its catalogue of better established ‘liberal’ rights can, she argues, be brought to bear in the context of women’s health. The effectiveness of the ICCPR is supported by an optional protocol, allowing individuals and groups to bring a complaint against states in violation of Convention rights. Monitored by a Human Rights Committee (HRC) this protocol has been signed by 104 countries. By contrast the equivalent protocol to the Women’s Convention has only had 60 signatories to date.

Bogecho offers a detailed review of the work of the HRC in order to demonstrate that reproductive and other health issues can indeed be comprehended within the ICCPR. In particular she discusses Article 6 of the Convention which obliges states to respect the right to life. This provision was traditionally understood to concern the application of force by the state; for example, in the form of the death penalty or the use of lethal force by police or the military. More recently, however, the HRC has broadened its interpretation. Extremely high rates of maternal mortality have been condemned as a violation of Article 6, for example. States have been criticized for their inadequate legislative responses to domestic violence, marital rape and the problem of illegal abortions, all of which place women’s lives at risk.

However, the existing system suffers from a number of weaknesses. The HRC’s opinions take the form of Concluding Observations on the reports submitted by state parties to the Convention. Unfortunately the HRC has not been consistent in the substance or precision of its recommendations. Some states are urged to take ‘all necessary action’, while others are given more precise advice on legislative change. States with particularly poor records are exhorted to end the hostility to women’s health rights prevalent in their territories, but without sufficient direction on how to do so. Bogecho renders a service to all active in this field by making precise suggestions as to how the reporting system may be reformed. In particular she recommends greater standardisation in the reports submitted by states and the inclusion of a broader set of data (eg regarding maternal mortality). This would allow study of a state’s record over time, as well as facilitating comparison as between states.

3. Public Health - Policy, Law, Rights and Ethics

3.1. The G8 and the Global Fund for AIDS, Tuberculosis and Malaria

Non-state actors are increasingly involved in the creation and implementation of global health policy. NGOs are most prominent among these in the public consciousness. Yet a decisive role is also played by private corporations. Industry associations lobby for policies conducive to the profitability of their members. We shall see that this has been an important feature of the global intellectual property regime since 1994. But corporations are also engaged in funding and delivering health care to disadvantaged regions of the globe, whether as the operators of privatised medical services or as charitable donors.

Obijiofor Aginam directs our attention to the novel interaction between states and corporate interests in the Global Fund for HIV/ AIDS, Tuberculosis and Malaria. He concentrates on the role of the G8 group of the world’s most powerful states in supporting it. As an annual meeting of ‘the individuals who matter most in the world’, the G8 gives direction to international policy in the fields of economics and security. Given the intimate connection between health and both of these fields it is surprising that the G8 largely ignored public health issues until its meeting at Okinawa in 2000. There the states acknowledged for the first time the dramatic health crisis faced by the developing world. In Genoa the following year, they pledged USD 1.3 billion to the Global Fund.

The Fund is, as Aginam shows, a novel institutional arrangement for support health efforts in the global South. It is conceived as a public-private partnership, with corporations contributing financially in return for voting rights. Civil society bodies (eg NGOs) are also represented. The Fund is estimated to require USD 7 - 10 billion each year to fight HIV/ AIDS alone. Yet, notwithstanding the support of the G8 at Genoa, the wealthy nations of the world have been less than generous in their donations. With the exception of a number of Northern European states, all have fallen far short both of the amount required and the amount initially pledged. Nor has the corporate contribution been commensurate with the influence accorded to business in the administration of the Fund.

Aginam makes a forceful plea for this to be rectified. He notes that the interdependence characteristic of globalization is obviously manifest in the case of infectious diseases. He appeals not only to the moral sensibilities of the industrialised nations, but also to their self-interest. Given the ‘microbial superhighway’ connecting North and South, donations to the Fund would be money well spent. The G8, he argues, needs to revive its original commitment.

3.2. Access to Life-Saving Drugs under the TRIPS Agreement

The emergent system of global health governance has been sharply defined in the recent struggles over access to life-saving drugs. The contested interpretation and application of the WTO’s Trade Related Intellectual Property Rights agreement (TRIPS) was perhaps the first global health law issue to capture the attention of non-specialist audiences. TRIPS demonstrated the salience of trade law to welfare issues, such as health, not previously considered within the framework of international economic law. Duncan Matthews offers us a closely observed account of the attempted adaptation of TRIPS to the needs of developing countries beset by HIV/ AIDS, malaria and other epidemics. He asks whether the widely criticised pattern of negotiation which preceded the conclusion of TRIPS in 1994, was repeated in the run up to the WTO Decision on TRIPS and Public Health adopted in 2003.

The original TRIPS negotiations were undertaken to a great extent in accordance with the ‘Green Room’ formula, whereby the United States, the European Communities and Japan were widely understood to have overborne their weaker partners from the developing world. Lacking adequate expertise, the latter submitted to a global intellectual property regime which clearly favoured the large pharmaceutical companies concentrated in the global North. After 1994, however, NGOs such as Médecins sans Frontières, Oxfam and Health GAP exposed the manner in which TRIPS impeded developing countries in their response to the catastrophic spread of HIV/ AIDS. Although Article 31 of the agreement allowed compulsory licensing of drugs needed in a national emergency, this was effectively limited to those few countries which had the capacity to manufacture the pharmaceuticals themselves.

At the 4th Ministerial Conference in November 2001, WTO members issued the Doha Declaration acknowledging the pressing health needs of developing countries. They also committed themselves to find a solution to the problem of states unable to produce generic drugs to meet their own needs. As Matthews shows, subsequent negotiations were characterised by the hardline stance of the United States which insisted that the diseases for which generics could be imported be limited to an enumerated list. They also sought to limit the exception to so-called least developed states, the world’s poorest, excluding higher income developing countries. The European Communities took a more moderate stance, accepting an open list of conditions.

Ultimately the US position was not tenable in full, especially given renewed intense criticism from NGOs. The ensuing Decision of the WTO allows states to waive their obligations under the agreement after notification of the organisation’s TRIPS Council. A number of higher income developing countries have undertaken to do so only in a national emergency, while the developed countries have opted out of the system entirely. Matthews assesses the likely impact of the Decision. He notes that least developed countries are entitled to waive their obligations even where a disease does not constitute a national emergency. Nonetheless the path to this is not smooth. Companies wishing to export generic drugs to an affected state must pass through a dense thicket of notification and consultation requirements. The cost of generics will be further increased by an obligation to produce and package the drugs in such a way as to make them distinguishable from the patented versions sold in developed countries.

Some progress has been made. The role of NGOs in the process of negotiation has certainly increased. They are now able to form and invoke global public opinion in their contests with the drug companies and the wealthy states. Developing countries have not fared as well, however. Again they suffered from negotiation fatigue due to their relative lack of resources and expertise. They remain vulnerable to bilateral deals and trade-linked agreements imposing so-called TRIPS-plus obligations in excess of those demanded by the WTO’s multilateral system.

3.3. A Collective Right to Health ?

Written largely from the post-Westphalian perspective described above, Maria Stuttaford’s paper offers an interdisciplinary and comparative perspective on the form and scope of rights to health. Her inquiry proceeds from a factual recognition of trends in contemporary health policy in both developed and developing countries. Upon this description she then builds a persuasive case for developing collective legal rights to health care, while acknowledging the likely impediments to this strategy.

In the last decade public health models have returned to prominence in national and global strategies for promoting health. Long eclipsed by the traditional individualist focus of clinical medicine, public health has gained renewed credibility with the spread of infectious diseases and the intractability of developing country health problems. As an aggregative science public health is intrinsically oriented to the collective. Stuttaford shows that this orientation has objective and subjective dimensions. Objective in the sense that groups defined by shared risk are the usual focus of health interventions. These groups have traditionally been targeted from outside by experts seeking to contain genetic defects or suppress negative behaviours. Recognizing the cognitive and motivational limits of professional expertise, more modern opinion stresses the subjective moment of public health strategies. Groups themselves are mobilised to develop their own strategies for disease prevention and health improvement.

The changing political economy of health care over the last two decades has also influenced public health work. These changes too have had their objective and subjective moments. Objectively the global triumph of neo-liberalism has been manifested in the progressive dismantling of post-war welfare systems, including health care. The state has retreated, to be replaced by a mix of for-profit corporations, non-governmental organisations and individual insurance.

The subjective reflex of neo-liberalism is most evident in the reconceptualisation of health as a commodity available to those who can pay for it. This emphasis on autonomy has been bolstered by what Stuttaford calls a ‘responsibilisation’ of citizens in health matters. Drawn more directly from communitarian, than liberal sources, this policy posits an active role for citizens and communities in promoting their own health. These normative changes are obviously co-terminous with modern participatory public health strategies discussed above.

Against this background Stuttaford develops a framework for collective rights to health. She notes that the right to health is recognised in the founding documents of the WHO and the UN, in the South African Constitution, and (extra-legally) in the policies of the present British government. The specific form and content of right to health, she implies, is to be determined by current understandings of health and health policy. Thus, the renewed prominence of public health medicine, as well as the structural changes in health care delivery should be reflected in the scope and application of the right. In particular a collective right to health should be recognised. This adaptation of the right would register in both procedural and substantive terms. Thus groups affected by health policy or seeking to assert their right to health ought to be guaranteed rights of audience and representation in relevant proceedings. This would promote the active participation of affected groups in the development and implementation of health policy. It would also endow them with an additional weapon in their often unequal struggles with state and corporate power.

There are some problems for proponents of collective health rights which Stuttaford takes care to outline. The constitution of the relevant groups is often contested. For example, an ethnic or geographically defined group which enjoys the right to health will itself be subject to internal stratification and conflict. There is furthermore a representation problem. If consultation and implementation procedures, as well as litigation, are to be successful, the broader collectivity will have to speak with a coherent, if not a singular voice. Stuttaford develops a rich taxonomy of the ‘interest groups’ which take up this task of representation. These groups run the obvious risk of capture by the state or large corporations. This risk is accentuated by a tendency to vanguardism and bureaucratisation whereby activist groups mould and reshape the interests which they were called into being to represent.

3.4. Towards a Global Public Health Ethics

Modern medical ethics or bioethics have been the constant companion of health law since the 1960s. Professional deontology has formed the substratum of legal regulation, filling the lacunae in legislation and inculcating a habit of obedience to the law in health care workers. Critical reflection on medical ethics has allowed open and reasoned consideration of technological and political developments. The international applicability of this deontology has been realised both by the extension of western medical practice over the globe and by the commonly universalist form of ethical reflection. Medical ethics have developed organically from the privileged form of western-style medical practice. A practical focus on the individual clinical moment is reflected in a set of rights and duties which condition behaviour in that setting. This is not of course the setting of public health which, as noted above, has a primary focus on the collective. We can, therefore, expect any public health ethics to display significant differences from its more established clinical counterpart.

The distinctive form and functions of public health ethics are addressed in Robyn Martin’s paper. Moved to reflection by the recent SARS outbreak, she explores the possibility of developing a global code of ethics to inform the behaviour of public health workers and institutions and to condition the expectations of individual citizens. Public health is already saturated with moral imperatives. Specialists are motivated to preserve and improve the health of the population and thus to promote the general good. Behaviours are expressly approbated or anathemised (eg ‘unsafe sex’ or, in an earlier era, spitting). States of being, such as obesity are stigmatised as unhealthy and irresponsible.

Yet these strategies will be ineffective without a mobilization of the population as a whole, or relevant sub-groups. What has been described above as the subjective moment of public health requires a moral appeal to individuals and groups to participate in health improvement. As Martin points out this dialogic promotion of public health can only be facilitated by a clear and thorough articulation of the underlying ethical principles. It is both right and instrumentally desirable that the moral assumptions of public health practice be excavated and exposed to criticism and revision.

Public health ethics are of even greater importance in the international context. Responses to fast-spreading disease often take a legal form, but effective coordination requires more than this. Transparency and trust between the different states, as well as between states and their peoples are also necessary. In an era of globalization effective public health interventions depend upon shared understandings of the purposes and values of the discipline.

Elaborating a global code of public health ethics will be a difficult task. Martin offers some suggestions as to the methodologies which might be used. The traditional utilitarianism of public health must be tempered, though not ultimately confined, by a Kantian concern for individual rights. Means-end calculations should be subject to the proportionality principle familiar to constitutional and public lawyers. The case of SARS illustrates some possible applications of these principles. The rights and responsibilities of health care workers were engaged. Public health protection had to be balanced against general economic welfare. The relative allocations of resources to SARS and other less prominent health problems had to be considered with reference to criteria of justice. For Martin, however, the task of open and critical reflection is more important than any specific substantive principles. In Rawlsian fashion global public health ethics will emerge not from abstract speculation, but in a reciprocal dialogue between principle and practice.

4. Global Health and National Legal Systems

4.1. Obstacles to Redress for Victims of Foreign Drug Trials

Global health law doesn’t only emerge as a response to transnational health challenges. It is also produced by the often uneven and conflict-ridden spread of the health industry across borders. The area of health law most intimately connected with capitalist globalization is that which governs the production and distribution of health services, medical instruments and pharmaceuticals. A mix of international treaty obligations, regional commitments and national law defines the health care landscape in most countries. States increasingly commit themselves, voluntarily or involuntarily, to allow free capital mobility, to privatise health care systems and to permit foreign service providers to enter the domestic market. Thus, much global health law is in fact (national and international) economic law.

In their contribution, Jolyon Ford and George Tomossy investigate one important legal aspect of the globalization of the health care industry, ie. the ability of plaintiffs injured in developing country drug trials to sue for damages in the home jurisdictions of the responsible companies. Fearing bias and collusion, such plaintiffs are often reluctant to initiate litigation in their own jurisdictions. However, they face several significant obstacles in the courts of developed countries. For one thing there is a dearth of sufficiently specific international law norms governing the misconduct of clinical trials. Instruments such as the Declaration of Helsinki and the Nuremberg Code are of uncertain status in international human rights law and are unlikely at this point to ground successful claims.

As Ford and Tomossy show, there are also formidable procedural impediments to recovery. States are the main bearers of human rights obligations under international law. Claims against pharmaceutical multinationals are unlikely to receive a hearing in international fora. At national level, the United States has proved most hospitable as a result of its Alien Tort Claims Act. This permits US courts to hear claims against defendants subject to their jurisdiction taken by non-US nationals for torts committed ‘in violation of the law of nations’ anywhere in the world. Note, however, that the problem of finding an applicable norm governing the conduct of drug trials is posed again, to the plaintiffs’ disadvantage, in this context.

US courts have also been asked to apply domestic tort law in adjudicating claims against American defendants. It is claimed, for example, that failure to obtain the informed consent of a research subject should sound in battery or negligence against the organisers of the trial. Such claims are, however, subject to the private international law doctrine of forum non conveniens. Nigerian plaintiffs seeking recovery against the Pfizer Corporation, for injuries sustained during a trial of the drug Trovan, were recently defeated on just this ground in a New York District Court. Out of respect for their foreign counterparts, and a general sense of restraint, the court held that it would be more appropriate to hear the action in a Nigerian forum. As Ford and Tomossy show the US courts’ application of the forum non conveniens doctrine is significantly broader and therefore more ‘defendant-friendly’ than that of their English and Australian counterparts.

The deterritorialization of commercial drug production, and its rearticulation across borders is merely one example of the general shift in global production. Nation states operate nowadays as the territorial guardians of this new liberalized economic order. States are differentiated within that order by the criterion of competitiveness, which commonly equates to low labour costs. On this model research subjects can be seen as labourers for the pharmaceutical industry. Compensating them is a cost to be avoided at national level, at least in the poor countries by methods fair (eg legislative exclusion) or less fair (eg collusion between governments and industry). The progress of globalization is also manifested in the litigation strategies of affected trial subjects. The search for compensation is equally deterritorialised and rearticulated across jurisdictional and doctrinal borders. However, as Ford and Tomossy show, its success is less assured.

4.2. Organ Donation - Comparative Perspectives on Presumed Consent

The development of organ transplantation in the last two decades has posed intense dilemmas at national and global level. Unbalanced relations between the global North and the global South have shaped a flourishing transnational market in human organs. Demand for these organs comes largely, though not exclusively, from the wealthy nations. This demand is produced where the promise of medical salvation, held out by progress in transplantation, is disappointed by a shortage of transplantable organs. National legal regimes in the North, it is argued, impede supply by prohibiting commercial transactions in human body parts. Much has been written about the symbolic nature of such prohibitions: their place in a modern web of taboo which is more fit for anthropological, than philosophical explanation.

In her contribution Graciela Nowenstein illuminates the symbolic dimensions of the law on organ procurement more broadly. She addresses the variety of non-market legal regimes which seek to increase post-mortem (or ‘cadaveric’) organ donation. These are usually classed either as opting-in, or opting-out systems. Under the former, the potential donor must, before their death, have expressly consented to the removal of their organs for transplantation purposes. Under the latter, their consent is presumed unless they have expressly refused to allow removal. Debate and scholarship in European states has been rigidly structured by this polarity. A priori arguments have, however, lacked the empirical dimension crucial to a sphere of health care policy such as this. As Nowenstein reveals, it is hard to say that the precise legal regime governing consent to transplantation significantly determines the actual level of organ donation in a given country.

Nowenstein seeks to illuminate some of the reasons for this seeming irrelevance of positive law. Drawing on extensive interviews with key professionals working in the Paris region, she reveals important ambiguities in the day-to-day application of France’s opt-out system. Although transplant staff are permitted to exclude patients’ relatives from all discussion, they do not do so in practice. Instead the legally enshrined presumption of consent is used a starting point for discussions with relatives which will, it is hoped, lead them to agree to the donation. Surgeons, nurses and counsellors do not function as the mere transmission belt of legislative intentions. Rather they creatively appropriate the law, using it as a discursive resource in an open-ended process of negotiation with families. The normative force of this framework derives from the symbolic values of solidarity and progress shared by the medical profession and the French republic within which it functions.

Nowenstein’s paper constitutes a useful empirical check upon abstract discussion of principle, the more valuable since it rests on data from a number of European jurisdictions. It also directs us to consider ethical questions in their institutional and anthropological context. These contexts will vary as between different states and regions. They influence legal regimes and their implementation in the same way as the contested taboo against commodifying the human body.

4.3. International Norms and the Death Penalty in the United States

The death penalty is fast disappearing from the liberal democracies. The United States is one of the few nations on earth which retains capital punishment. Their isolation in this regard is not simply a factual matter. In so far as there is a consensus of international opinion against the death penalty this represents a normative standard against which American (and other states') practices are to be criticised. Jon Yorke tackles this broader question in his contribution. His chief focus is on the application of the death penalty to persons with learning disabilities (or 'mentally retarded' as they are known to lawyers and the psychiatric profession in the US). He offers valuable insights into the conjuncture of domestic punitive practice, international standards and medical knowledge which has shaped developments in this area of American law.

In particular he concentrates on the decision of the United States Supreme Court in the case of Atkins v Virginia (2002). Abandoning its previous practice the Court there held that execution of mentally retarded persons was a violation of the eighth amendment to the US constitution which prohibits the imposition of cruel and unusual punishment. When it had previously considered the issue in 1989 only two states had passed legislation outlawing the execution of people with learning disabilities. Since then the number had grown to eighteen. This increase led the Court to hold that a national consensus against imposing the death penalty in such cases had emerged. The majority also recognised that the penological aims of retribution and deterrence could never be met in the case of mentally retarded defendants. There was literally no sense to executing them.

Justice Stevens, writing for the majority, included an intriguing footnote in his opinion to the effect that 'evolving standards of decency in the international community' would now prohibit executions in these cases. Although relegated to a footnote this has important implications. For one it echoes comments in cases dealing with other aspects of the death penalty. It also transmutes the raw fact of a global trend away from executing people with learning disabilities in to the normative gold of a shared value of the 'international community'. This development is supported by changing national legal regimes worldwide. It also rests on the accrued practice of the United Nations. As Yorke shows the United Nations Declaration on the Rights of the Mentally Retarded Persons injuncts states to protect the due process rights of defendants with learning disabilities. The UN Commission on Human Rights and the UN Economic and Social Council have also recommended the elimination of the death penalty in these cases. Although the minority in Atkins disapproved any attempt to use the constitution to impose the values of other countries upon Americans, this looks to be one of the effects of the majority decision.

Yorke also considers the implications of Atkins for expert witnesses and defence counsel. He shows that a great deal has been left to the states as regards determining the procedural rights of the defendants with learning disability. In particular the right to have an expert competent in the field of learning disability has not been fully clarified. The unevenness of post-Atkins legislation is also noted. Different definitions of mental retardation may lead to defendants being liable to execution in one state, where they would not have been in another. This would, of course, engage the fourteenth amendment to the US constitution. Echoing a theme of Martyn's paper, Yorke notes that the defensibility and practicability of the capital punishment system after Atkins will depend greatly on the ethical formation of expert psychologists and psychiatrists and on their views and beliefs regarding the death penalty.

5. Acknowledgements

This special issue would not have been possible without the efforts of Celine Tan, Paul Trimmer and Shireen Irani, or the patient advice of Ambreena Manji and Abdul Paliwala. Thanks are also due to our referees for their critical engagement with the papers sent to them. I wish finally to express my gratitude to the contributors for sharing with us the fruits of their rich and diverse labours.

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