Global Health Law: International Law and Public Health Policy

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Abstract

The field of global health law and the contribution of international organizations to its development are described. The growth and elaboration of the field of global health law in the last two decades is one of the most notable developments in global health policy. In this new era of global health governance, international law has an important, albeit limited, role to play in promoting and coordinating international cooperation and national action to protect and promote global health. Particular attention is paid to the global impact of binding international agreements and other international legal instruments developed under the auspices of the World Health Organization and the World Trade Organization.

Keywords: Framework Convention on Tobacco Control, Global Code of Practice on the International Recruitment of Health Personnel, Global health governance, Global health law, Globalization, HIV/AIDS, Human rights, International administrative law, International health law, International Health Regulations, International organizations, International relations, International trade law, Public–private partnerships, Public health law, Public health policy, Trade-related aspects of intellectual property agreement, Treaty, United Nations, World Health Organization, World Trade Organization

Introduction

The growth and elaboration of the field of global health law over the last two decades has been a notable development in global health policy. Traditionally, public health was viewed as a realm of almost exclusive national jurisdiction, and multilateral cooperation in this realm was restricted to discrete areas. Public health law today remains predominantly domestic and national, but the field of global health law is extant and growing. Through the codification of binding global health law standards that regulate interstate behavior and national conduct as well as the creation of other global norms that influence state actions, global health law has expanding significance in national public health law and policy.

The domain of global health law now encompasses increasingly diverse concerns, including aspects of biomedical science and human reproduction/cloning; organ transplantation and xenotransplantation; infectious and noncommunicable diseases; the control of the safety of health services; food and pharmaceuticals in international trade; access to medicines; and the control of addictive and harmful substances such as tobacco and narcotics. Global health law is also increasingly linked to other traditional areas of international legal concern. Environmental law and the control of toxic pollutants, arms control and the banning of weapons of mass destruction, human rights law, nuclear safety and radiation protection, international drug control, customs law, and occupational health and safety are increasingly recognized as inextricably connected to public health. Table 1 hereto provides a variety of examples of the wide domain of international law related to public health, including international agreements that have positive as well as negative implications for public health.

Table 1

Examples of international legal instruments and public health

This article provides an overview of the field of global health law. It examines the historical origins of the field and the factors contributing to its contemporary evolution. In addition, the article briefly reviews the nature and the significance of international law and the contribution of international organizations to the codification of global health law. Finally, the role of two international organizations, the World Health Organization (WHO) and the World Trade Organization (WTO), in the contemporary development of international law is considered in connection with examples of lawmaking with important public health and public health policy implications.

The Evolution of Global Health Law

Although public health is one of the earliest fields of international cooperation and one of the first domains in which an intergovernmental organization was created, the scope of international legal cooperation in public health was, until recently, highly limited.

Disease has been the unwelcome traveling companion of international commerce throughout history and international public health cooperation from the beginning was as concerned with facilitating trade as with protecting public health. The functions of the early international health organizations of the nineteenth and twentieth centuries centered on combating infectious and communicable diseases and preventing their spread across international boundaries (Pannenborg, 1979). For example, the Conseil superieur de santé (Superior Council of Health) of Constantinople, composed of delegates of the Ottoman Empire and the chief maritime states, was established in 1838 to supervise sanitary regulation of the Turkish ports to prevent the spread of cholera. As a further example, the international legal activities of the first permanent international health organization, L'Office International d'Hygiene Publique, were restricted to the administration of international sanitary conventions, including the international exchange of epidemiological information. International communicable disease control remained the predominant area of international legal cooperation throughout the mid-nineteenth century and most of the twentieth century.

With a focus limited to international communicable disease control, public health law remained a relatively neglected field of international legal concern throughout most of the twentieth century. In particular, the WHO, established in 1948 as the specialized agency of the United Nations in the field of health, stood out as unique among such UN agencies in that the Organization traditionally neglected the use of international legislative strategies to promote its global public policies (Taylor, 1992). WHO Member States also paid little attention to the potential contribution of international law in advancing global health during most of the last century. Although public health remained a narrow realm of multilateral cooperation for over 150 years, the long-standing historical connection between international law and communicable disease control pointed to the larger role that international law could serve in future international health diplomacy.

Global health law has been defined as a “field that encompasses the legal norms, processes, and institutions needed to create the conditions for people throughout the world to attain the highest possible level of physical and mental health” (Gostin and Taylor, 2008). In the last couple of decades, the field of global health law has expanded significantly. The breadth and depth of contemporary international health law can be traced to a number of recent and interconnected developments, including (1) the impact of globalization on public health diplomacy; (2) the growth of global concern with economic and social rights, including the right to health; and (3) expanding appreciation of the nexus between global health law and other realms of international legal concern.

Globalization and the Expanding Domain of International Health Law

It is widely recognized that contemporary globalization is contributing to the expansion of the field of global health law. Although increasing global integration is not an entirely new phenomenon, contemporary globalization has had an unprecedented impact on global public health and is creating new and increasingly difficult governance needs and health policy-making challenges. Globalization has contributed to the rapid decline in the practical capacity of sovereign states to address public health challenges through unilateral national action alone and expanded the need for health governance structures that transcend traditional and increasingly inadequate national approaches.

Treaty law, often referred to as conventional international law, has received new prominence as a mechanism or a tool that can be used by states to facilitate multilateral cooperation in this era of globalization, as states increasingly recognize the need for international cooperation to attain national public health objectives for which domestic law and other policy responses are increasingly inadequate (Taylor, 2004). For example, rapid worldwide dissemination of recent advances in scientific knowledge and technology has encouraged international cooperation in a wide range of treaties, including those concerning the safety of chemicals, pesticides, and food, and the disposal of hazardous wastes.

Globalization has increased the need for new, formalized frameworks for international cooperation, including international law, to address emerging global health threats. For example, the dynamics of globalization have created fertile global breeding conditions for the cross-border spread of emerging threats to health, such as weapons of mass destruction, including bioterrorism; emerging and reemerging infectious diseases; and the vectors of noncommunicable diseases including tobacco, alcohol, and obesity.

In addition, globalization has expanded global interest in codifying new international commitments to protect the health status of populations in low-income and emerging market states that have not benefited from globalization – the so-called losers of globalization. For example, the need to promote more equitable innovation and universal access in health-care products, including medicines, pharmaceuticals, diagnostics, and medical devices, is generating ongoing debate about the efficacy of codifying a new international instrument on medical research and design.

Because of the momentum of globalization, states must increasingly turn to international cooperation in order to protect and promote domestic health. Consequently, we are likely to see wider use of international legal instruments in this century to control the risks and threats to health associated with globalization and, perhaps, to take advantage of the opportunities to improve world health that have been afforded by global change. For example, the WHO International Health Regulations (IHRs), the sole international legal instrument designed to provide a framework for multilateral efforts to combat infectious diseases, were revised in 2005 to address the increasing threat posed by the transnationalization of infectious diseases and to incorporate newly developed mechanisms for international coordination and response. As a further example, in 2010 WHO Member States adopted the first international legal instrument to address the challenges increasingly raised by health worker migration in the WHO Global Code of Practice on the International Recruitment of Health Personnel. In addition, in 2011, the Member States of WHO adopted the Pandemic Influenza Preparedness (PIP) Framework to facilitate the sharing of influenza viruses and increase access to vaccines and antiviral medications in low- and middle-income countries.

Health and Human Rights

The evolution of global health law in the last two decades is very much tied to the protection and promotion of human rights related to physical and mental integrity. Although global health law is largely utilized as a mechanism to protect and expand state interests in an era of global interdependence, it is also conceived of and employed as a framework or tool for protecting the rights of individuals and, perhaps, creating a more just and equitable world (Meier, 2011).

The preamble to the WHO Constitution, the first international expression of the right to health, declares that “[t]he enjoyment of the right of the highest attainable standard of health is one of the fundamental rights of every human being without distinction or race, religion, political belief, economic or social condition.” The principal international legal basis for the right to health is found in the core instruments of international human rights law promulgated under the auspices of the United Nations: the International Bill of Rights, which consists of the Universal Declaration of Human Rights (1948), the International Covenant on Economic, Social and Cultural Rights (1966) (ICESCR), and the International Covenant on Civil and Political Rights (1966).

Read in conjunction with Article 2, Article 12 of the ICESCR, the most significant binding legal expression of the right to health, provides, among other things, that each state ‘undertakes to take steps,’ to the maximum extent of its available resources and with a view toward progressive achievement, toward “the highest attainable standards of physical and mental health of all individuals, without discrimination.” Beyond this broad formulation, however, Article 12 is replete with ambiguity. The Covenant neither defines ‘health’ nor the particular obligations of states necessary to realize the right to health.

No subsequent binding international legal instrument has provided an authoritative interpretation of the Covenant. In 2000 the Committee on Economic, Social and Cultural Rights to the ICESCR adopted General Comment 14, a detailed explanatory commentary on the right to health under Article 12 of the Covenant. Among other things, the broadly formulated General Comment 14 sets forth that the right to health is not simply a right to be healthy, but rather a robust human right extending not only to access to health-care services but also to the underlying determinants of health, including an access to safe water and adequate sanitation, occupational health and environmental conditions, and access to health-related education and information. Although highly influential, the legal significance of General Comment 14 remains controversial. The General Comment is not binding international law. In addition, some observers, including the United States, have directly questioned the legal authority of the Committee on Economic, Social and Cultural Rights, a committee established by a decision of ECOSOC and not pursuant to the Covenant, to issue authoritative interpretations of the ICESCR.

An important concern with the formulation of the right to health is whether it is an individual or a collective standard reflecting the health-related interests of communities. As a human right, the conventional interpretation of the right to health pertains to individual and not collective claims. However, in public health practice, the right to health is often used to refer to public or community health. There can also be tension between the idea of the collective right to health and the exercise of other human rights, including liberty, physical integrity, and privacy.

Despite the long historical linkage, the strong connection between health and human rights has only recently received significant attention. A number of emerging global concerns, including HIV/AIDS and women's health issues, including rape and other forms of violence against women, brought the intrinsic connection between health and human rights to the forefront of international policy concern beginning in the late 1980s and early 1990s. Of particular importance was a pioneering human rights approach to the global HIV/AIDS pandemic adopted by WHO in the late 1980s. It is widely recognized that this novel emphasis on the linkage between public health and human rights law had a groundbreaking impact in that it compelled governments to be publicly accountable on an international stage for their actions against persons living with HIV/AIDS. (Ultimately, this innovative global political approach to public health issues publicly highlighted for the very first time the underlying legal responsibility of governments to protect and promote the health of their populations and has served as a forerunner for increasingly widespread links between human rights and other public health issues (Mann and Tarantola, 1998).)

The domain of health and human rights has expanded significantly under the auspices of agencies and organs of the United Nations and other international organizations. Specific international legal instruments addressing the rights of particular populations, such as persons with HIV/AIDS, women, children, migrant workers, and refugees, have been adopted. For example, on 13 December 2006 the United Nations General Assembly adopted the Convention on the Rights of Persons with Disabilities.

Other contemporary developments are contributing to the further elaboration of international legal instruments in the realm of health and human rights, including, in particular, globalization. For example, widespread recognition of growing inequalities in health status and differential access to medical advances in rich and poor states has expanded interest in the relationship between social and economic rights and health. Of particular concern is the impact of international intellectual property protection under the WTO Trade-Related Aspects of Intellectual Property (TRIPS) Agreement, discussed in the section titled ‘The World Trade Organization, International Law and Global Health,’ in restricting access to essential medicines, particularly HIV/AIDS antiretrovirals, in low-income countries. The unprecedented human catastrophe posed by HIV/AIDS led the international community to adopt a number of nonbinding resolutions at the United Nations General Assembly, the former United Nations Commission on Human Rights and the WHO specifying the relationship between HIV/AIDS, human rights, and access to medicines. In June 2006, the United Nations General Assembly adopted a Political Declaration on AIDS (UN Res. 60/262) reaffirming that access to medicines in the context of pandemics, including HIV/AIDS, is one of the fundamental elements to achieving full realization for everyone of the international right to health. In May 2013 the UN Special Rapporteur on the right to health issued a report analyzing existing international challenges toward realizing access to medicines within a right to health framework and called upon the international community to shift from the ‘dominant market-oriented paradigm’ to promote access to medicine (A/HRC/23/42). Following the release of the report in June 2013, the UN Human Rights Council adopted a resolution on access to medicines (A/HRC/RES/23/14) broadly recognizing that access to medicines is one of the fundamental elements in achieving progressively the full realization of the right to everyone to the enjoyment of the highest attainable standard of physical and mental health.

Globalization is also furthering the elaboration of international instruments in this realm because increasing global integration is compounding the impact of other contemporary global developments associated with health status and human rights. An interesting recent development in this realm is the negotiation and adoption of the 2010 WHO Global Code of Practice on the International Recruitment of Health Personnel discussed in the section ‘The World Health Organization.’

As a further example, the links between scientific progress, global diffusion of new technologies and human rights is also receiving increased attention in the elaboration of international legal instruments. For instance, the implications of advances in biotechnology for the protection of human rights and human dignity have been a topic of interest by international and regional organizations, including consideration of bans on novel technologies. In 1997 the United Nations Educational, Scientific and Cultural Organization (UNESCO) adopted a nonbinding instrument, the Universal Declaration on the Human Genome and Human Rights, and in 2003 it adopted the International Declaration on Genetic Data. In addition, in the wake of failed treaty negotiations, in 2005 the United Nations General Assembly adopted a declaration urging Member States to prohibit reproductive cloning as incompatible with human rights. At the regional level, the Council of Europe adopted a Convention on the Protection of Human Rights and Human Dignity with regard to the Application of Biology and Medicine: the Convention on Human Rights and Biomedicine in 1997. Four protocols to the Convention – separate agreements – on human cloning, biomedical research, transplantation of organs and tissues, and genetic testing for health purposes have also been adopted by the Council of Europe between 1998 and 2008. Biomedical research is emerging as important topic in global and regional nonbinding and binding international legal instruments. For example, the European Union adopted a directive on clinical practice in the conduct of clinical trials on medicinal products for human use in 2001 and investigational medicinal products in 2005.

The biotechnology revolution is putting continuing pressure on the international community to develop international law, including human rights law, to effectively govern this realm, and we are likely to see further developments in the future. Notably, the elaboration of international law on biotechnology is exemplary of how the international community develops regulatory responses. Rather than codifying a comprehensive instrument in this realm, existing international agreements on biotechnology have been adopted in a piecemeal and, at times, incoherent fashion and today consist of different instruments, including guidelines, code of conduct, resolutions, and treaties adopted under the auspices different international organizations.

Linkage and the Scope of Global Health Law

The expanding domain of global health law can be understood, in part, as a product of enhanced appreciation of the interconnectedness of contemporary global concerns and, concomitantly, the linkage of health to other legal issues. International legal scholars traditionally compartmentalized and treated substantive subject matters such as human rights, environmental protection, arms control, and public health as discrete self-contained areas with limited connections. Rapid global integration propelled by contemporary globalization has contributed to the recognition of the nexus among different realms of international law.

As a consequence of issue linkage, international law and global health is increasingly understood to be a central component of other international legal regimes, including labor law, human rights, arms control, and international trade. The recent connection between health and human rights in contemporary international law and practice discussed in the preceding section is an important example of the linkage of two traditionally distinct realms of international law.

The evolution of the concept of human security provides another interesting example of this development. The traditional understanding of human security has come under increasing pressure in recent years, with growing support for a comprehensive approach to human security that addresses the wide-ranging factors that impact upon the vulnerability of people. In 2003, the UN Commission on Human Security released a report proposing a new security framework and recognizing the linkage between health and human security (United Nations Commission on Human Security, 2003).

WHO's 2005 IHRs described further herein have been at the center of discussion of the linkage between global health and security. The IHRs are designed to facilitate countries and the WHO working together to identify contain and control health risks. For example, at the time of the drafting of the revised IHRs expanding global concern with weapons of mass destruction and terrorism underscored the strong interconnection between public health and security and legal commitments established under the Regulations are clearly designed to apply to releases of biological, chemical, and radiological events, accidental and deliberate. Recent disease outbreaks, epidemics, natural disasters, and other health emergencies have reinforced the linkage between global health and security. For example, the recent Ebola outbreak discussed further herein has revitalized discussions of global health security, including a range of proposals for reframing the global health governance to strengthen the global health security regime (Kickbush, 2016).

The linkage between health, security, and other traditionally defined legal realms is also exemplified in the contemporary global threat of counterfeit medicines. Expanding international community concern with the global challenge of international trafficking in counterfeit medicines, including substandard, defective or adulterated medicines has underscored the interconnections among global health law, international customs law, international criminal law, and international trade law and led to expanding support for the adoption of an international legal instrument in this realm (Attaran, 2012).

The nexus between global health law and other traditionally distinct realms of international law is further exemplified by the rapidly evolving field of biotechnology described in the preceding section. Biotechnology closely interlinks many quarters of the law including, global health, human rights, intellectual property, trade regulation, and environmental law. For example, advances in biotechnology have prompted debate and development of the field of international environmental law with the main area of environmental concern being the potential effect of intentional or unintentional releases of genetically modified organisms (GMOs) for health and the environment. International instruments of relevance in this field include the Convention on Biological Diversity and its 2010 Cartagena Biosafety Protocol, the International Plant Protection Convention, and the WHO/FAO Codex Alimentarius. International trade law, particularly the General Agreement on Tariffs and Trade, the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), and the Technical Barriers to Trade Agreement (TBT Agreement), functions to discipline or restrict the authority of member states of the WTO to take food, safety, health, environmental and food security considerations into account in making regulatory decisions on the import and use of GMOs. Among regional instruments, the European Union regulatory framework in this realm is one of the most extensive, covering issues including import, cultivation, monitoring, and labeling of GMOs and GMO-derived material. The main piece of European legislation regarding GMO food is EU Directive 2001/18/EC, which was amended in 2008 by Directive 2008/27/EC and again in 2015 by Directive (EU) 2015/412. These directives govern ‘the deliberate release of GMOs in the environment’ and consequently cover both cultivation and imports of GMO crops. In addition, EU regulations set forth detailed rules regarding the authorization, labeling, and placing on the market of GMOs meant for food and feed.

An Introduction to Public International Law

The Nature and Sources of International Law

Understanding the implications of recent developments in global health law, including those for domestic public health policy, requires some appreciation of the nature of international law and the international political system. Since the end of the Thirty Years War in 1648, the global political system has principally involved the interactions of sovereign states. Consequently, the elaboration of international law has focused on the establishment of consensual rules concerning the status of states and their fundamental rights and obligations as well as commitments. International law, therefore, is primarily focused on the interactions of sovereign states and can broadly be defined as the rules that govern the conduct and relations of states.

International law is traditionally understood as consisting of two core realms: public international law and private international law. While public international law is primarily concerned with the relations of states, private international law focuses on the law of private transactions of individuals and corporations. The traditional distinction between public and private international law persists even though it is not fully accurate. For example, much of private international law concerns the transactions of public entities. In addition, while states are the primary subjects of public international law, they are not the only subjects. International organizations and, through the development of international human rights law, individuals, are also considered subjects of public international law.

In international law, the sources of legal rules are very different than in most domestic legal systems because the global political system of sovereign states differs fundamentally from domestic political systems. While there are important differences in the sources of law among countries, domestic law generally comes from national constitutions, municipal statutes, parliamentary or executive regulations, and decisions of municipal courts. In contrast to domestic political systems, there is generally no supranational authority within the global system to develop and enforce law against sovereign states. In the absence of a supranational authority, states establish the rules of international law. Article 38(1) of the Statute of the International Court of Justice is generally regarded as an authoritative list of the sources of international law ( Table 2 ).

Table 2

Statute of the International Court of Justice