Global Health Law: International Law and Public Health Policy

Allyn L Taylor, University of Washington School of Law, Seattle, WA, USA

Ó 2017 Elsevier Inc. All rights reserved.

Introduction public health cooperation from the beginning was as con-

cerned with facilitating trade as with protecting public health.
The growth and elaboration of the field of global health law The functions of the early international health organizations
over the last two decades has been a notable development in of the nineteenth and twentieth centuries centered on
global health policy. Traditionally, public health was viewed combating infectious and communicable diseases and prevent-
as a realm of almost exclusive national jurisdiction, and multi- ing their spread across international boundaries (Pannenborg,
lateral cooperation in this realm was restricted to discrete areas. 1979). For example, the Conseil superieur de santé (Superior
Public health law today remains predominantly domestic and Council of Health) of Constantinople, composed of delegates
national, but the field of global health law is extant and of the Ottoman Empire and the chief maritime states, was
growing. Through the codification of binding global health established in 1838 to supervise sanitary regulation of the
law standards that regulate interstate behavior and national Turkish ports to prevent the spread of cholera. As a further
conduct as well as the creation of other global norms that influ- example, the international legal activities of the first permanent
ence state actions, global health law has expanding significance international health organization, L’Office International
in national public health law and policy. d’Hygiene Publique, were restricted to the administration of
The domain of global health law now encompasses international sanitary conventions, including the international
increasingly diverse concerns, including aspects of biomedical exchange of epidemiological information. International
science and human reproduction/cloning; organ transplanta- communicable disease control remained the predominant
tion and xenotransplantation; infectious and noncommunica- area of international legal cooperation throughout the mid-
ble diseases; the control of the safety of health services; food nineteenth century and most of the twentieth century.
and pharmaceuticals in international trade; access to medi- With a focus limited to international communicable disease
cines; and the control of addictive and harmful substances control, public health law remained a relatively neglected field
such as tobacco and narcotics. Global health law is also increas- of international legal concern throughout most of the twentieth
ingly linked to other traditional areas of international legal century. In particular, the WHO, established in 1948 as the
concern. Environmental law and the control of toxic pollutants, specialized agency of the United Nations in the field of health,
arms control and the banning of weapons of mass destruction, stood out as unique among such UN agencies in that the Orga-
human rights law, nuclear safety and radiation protection, nization traditionally neglected the use of international legisla-
international drug control, customs law, and occupational tive strategies to promote its global public policies (Taylor,
health and safety are increasingly recognized as inextricably 1992). WHO Member States also paid little attention to the
connected to public health. Table 1 hereto provides a variety potential contribution of international law in advancing global
of examples of the wide domain of international law related health during most of the last century. Although public health
to public health, including international agreements that remained a narrow realm of multilateral cooperation for over
have positive as well as negative implications for public health. 150 years, the long-standing historical connection between
This article provides an overview of the field of global health international law and communicable disease control pointed
law. It examines the historical origins of the field and the to the larger role that international law could serve in future
factors contributing to its contemporary evolution. In addition, international health diplomacy.
the article briefly reviews the nature and the significance of Global health law has been defined as a “field that encom-
international law and the contribution of international organi- passes the legal norms, processes, and institutions needed to
zations to the codification of global health law. Finally, the role create the conditions for people throughout the world to attain
of two international organizations, the World Health Organiza- the highest possible level of physical and mental health”
tion (WHO) and the World Trade Organization (WTO), in the (Gostin and Taylor, 2008). In the last couple of decades, the
contemporary development of international law is considered field of global health law has expanded significantly. The
in connection with examples of lawmaking with important breadth and depth of contemporary international health law
public health and public health policy implications. can be traced to a number of recent and interconnected devel-
opments, including (1) the impact of globalization on public
health diplomacy; (2) the growth of global concern with
The Evolution of Global Health Law economic and social rights, including the right to health; and
(3) expanding appreciation of the nexus between global health
Although public health is one of the earliest fields of interna- law and other realms of international legal concern.
tional cooperation and one of the first domains in which an
intergovernmental organization was created, the scope of inter-
Globalization and the Expanding Domain of International
national legal cooperation in public health was, until recently,
Health Law
highly limited.
Disease has been the unwelcome traveling companion of It is widely recognized that contemporary globalization is
international commerce throughout history and international contributing to the expansion of the field of global health

268 International Encyclopedia of Public Health, 2nd edition, Volume 3 http://dx.doi.org/10.1016/B978-0-12-803678-5.00238-1

 Global Health Law: International Law and Public Health Policy 269

Table 1 Examples of international legal instruments and public health

Category of public
health concern Date International agreement

Disability 2006 Convention on the Rights of Persons with Disabilities

Communicable disease control 2005 International Health Regulations (revised)
Global tobacco control 2011 Pandemic Influenza Preparedness Framework
2003 WHO Framework Convention on Tobacco Control
2012 Protocol to Eliminate Illicit Trade in Tobacco Products
Human rights 1966 International Covenant on Economic, Social and Cultural Rights
1966 International Covenant on Civil and Political Rights
1979 Convention on the Elimination of All Forms of Discrimination Against Women
1980 Convention on Certain Conventional Weapons
1984 Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or
Punishment
1989 Convention on the Rights of the Child
Arms control 1968 Treaty on the Non-Proliferation of Nuclear Weapons
1972 Biological Weapons Convention
1993 Chemical Weapons Convention
1982 UN Convention on the Law of the Sea
1996 Comprehensive Test Ban Treaty
Environmental health 1985 Vienna Convention for the Protection of the Ozone Layer
1987 Montreal Protocol to the 1985 Vienna Convention for the Protection of the Ozone
Layer
1992 UN Convention on Climate Change
1994 Convention to Combat Desertification
1992 Convention on the Transboundary Effect of Industrial Accidents
1997 Kyoto Protocol to 1992 UN Convention on Climate Change
1998 Convention on Prior Informed Consent for Certain Hazardous Chemicals and
Pesticides in International Trade
Health worker migration 2001 Stockholm Convention on Persistent Organic Pollutants
2013 Minamata Convention on Mercury
International narcotic drug control 2010 WHO Global Code of Practice on the International Recruitment of Health Personnel
1961 Single Convention on Narcotic Drugs
1971 Convention on Psychotropic Substances
1988 UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances
Occupational health and safety 1921 White Lead (Painting) Convention
1932 Protection Against Accidents (Dockers) Convention
1960 Radiation Protection Convention
1974 Occupational Cancer Convention
1981 Occupational Safety and Health Convention
International trade law 2006 Convention Concerning the Promotional Framework for Occupational Safety and
1994 Health
General Agreement on Tariffs and Trade (GATT 1994)
1994 General Agreement on Trade in Services (GATS)
1994 Agreement on the Application of Sanitary and Phytosanitary Measures
1994 Agreement on Trade-Related Aspects of Intellectual Property Rights
1994 Agreement on Technical Barriers to Trade

law. Although increasing global integration is not an entirely cooperation in this era of globalization, as states increasingly
new phenomenon, contemporary globalization has had an recognize the need for international cooperation to attain
unprecedented impact on global public health and is creating national public health objectives for which domestic law
new and increasingly difficult governance needs and health and other policy responses are increasingly inadequate
policy-making challenges. Globalization has contributed to (Taylor, 2004). For example, rapid worldwide dissemination
the rapid decline in the practical capacity of sovereign states of recent advances in scientific knowledge and technology
to address public health challenges through unilateral national has encouraged international cooperation in a wide range
action alone and expanded the need for health governance of treaties, including those concerning the safety of chemi-
structures that transcend traditional and increasingly inade- cals, pesticides, and food, and the disposal of hazardous
quate national approaches. wastes.
Treaty law, often referred to as conventional international Globalization has increased the need for new, formalized
law, has received new prominence as a mechanism or a tool frameworks for international cooperation, including interna-
that can be used by states to facilitate multilateral tional law, to address emerging global health threats. For
270 Global Health Law: International Law and Public Health Policy

example, the dynamics of globalization have created fertile of the Universal Declaration of Human Rights (1948), the
global breeding conditions for the cross-border spread of International Covenant on Economic, Social and Cultural
emerging threats to health, such as weapons of mass destruc- Rights (1966) (ICESCR), and the International Covenant on
tion, including bioterrorism; emerging and reemerging infec- Civil and Political Rights (1966).
tious diseases; and the vectors of noncommunicable diseases Read in conjunction with Article 2, Article 12 of the ICESCR,
including tobacco, alcohol, and obesity. the most significant binding legal expression of the right to
In addition, globalization has expanded global interest in health, provides, among other things, that each state ‘under-
codifying new international commitments to protect the health takes to take steps,’ to the maximum extent of its available
status of populations in low-income and emerging market resources and with a view toward progressive achievement,
states that have not benefited from globalization – the toward “the highest attainable standards of physical and
so-called losers of globalization. For example, the need to mental health of all individuals, without discrimination.”
promote more equitable innovation and universal access in Beyond this broad formulation, however, Article 12 is replete
health-care products, including medicines, pharmaceuticals, with ambiguity. The Covenant neither defines ‘health’ nor the
diagnostics, and medical devices, is generating ongoing debate particular obligations of states necessary to realize the right to
about the efficacy of codifying a new international instrument health.
on medical research and design. No subsequent binding international legal instrument has
Because of the momentum of globalization, states must provided an authoritative interpretation of the Covenant. In
increasingly turn to international cooperation in order to 2000 the Committee on Economic, Social and Cultural Rights
protect and promote domestic health. Consequently, we are to the ICESCR adopted General Comment 14, a detailed
likely to see wider use of international legal instruments in explanatory commentary on the right to health under Article
this century to control the risks and threats to health associated 12 of the Covenant. Among other things, the broadly formu-
with globalization and, perhaps, to take advantage of the lated General Comment 14 sets forth that the right to health
opportunities to improve world health that have been afforded is not simply a right to be healthy, but rather a robust human
by global change. For example, the WHO International Health right extending not only to access to health-care services but
Regulations (IHRs), the sole international legal instrument also to the underlying determinants of health, including an
designed to provide a framework for multilateral efforts to access to safe water and adequate sanitation, occupational
combat infectious diseases, were revised in 2005 to address health and environmental conditions, and access to health-
the increasing threat posed by the transnationalization of infec- related education and information. Although highly influen-
tious diseases and to incorporate newly developed mechanisms tial, the legal significance of General Comment 14 remains
for international coordination and response. As a further controversial. The General Comment is not binding
example, in 2010 WHO Member States adopted the first inter- international law. In addition, some observers, including the
national legal instrument to address the challenges increasingly United States, have directly questioned the legal authority of
raised by health worker migration in the WHO Global Code of the Committee on Economic, Social and Cultural Rights,
Practice on the International Recruitment of Health Personnel. a committee established by a decision of ECOSOC and not pur-
In addition, in 2011, the Member States of WHO adopted the suant to the Covenant, to issue authoritative interpretations of
Pandemic Influenza Preparedness (PIP) Framework to facilitate the ICESCR.
the sharing of influenza viruses and increase access to vaccines An important concern with the formulation of the right to
and antiviral medications in low- and middle-income health is whether it is an individual or a collective standard
countries. 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.
Health and Human Rights
However, in public health practice, the right to health is often
The evolution of global health law in the last two decades is used to refer to public or community health. There can also be
very much tied to the protection and promotion of human tension between the idea of the collective right to health and
rights related to physical and mental integrity. Although the exercise of other human rights, including liberty, physical
global health law is largely utilized as a mechanism to integrity, and privacy.
protect and expand state interests in an era of global Despite the long historical linkage, the strong connection
interdependence, it is also conceived of and employed as between health and human rights has only recently received
a framework or tool for protecting the rights of individuals significant attention. A number of emerging global concerns,
and, perhaps, creating a more just and equitable including HIV/AIDS and women’s health issues, including
world (Meier, 2011). rape and other forms of violence against women, brought the
The preamble to the WHO Constitution, the first interna- intrinsic connection between health and human rights to the
tional expression of the right to health, declares that “[t]he forefront of international policy concern beginning in the late
enjoyment of the right of the highest attainable standard of 1980s and early 1990s. Of particular importance was a pioneer-
health is one of the fundamental rights of every human being ing human rights approach to the global HIV/AIDS pandemic
without distinction or race, religion, political belief, economic adopted by WHO in the late 1980s. It is widely recognized
or social condition.” The principal international legal basis for that this novel emphasis on the linkage between public health
the right to health is found in the core instruments of interna- and human rights law had a groundbreaking impact in that it
tional human rights law promulgated under the auspices of the compelled governments to be publicly accountable on an inter-
United Nations: the International Bill of Rights, which consists national stage for their actions against persons living
 Global Health Law: International Law and Public Health Policy 271

with HIV/AIDS. (Ultimately, this innovative global political As a further example, the links between scientific progress,
approach to public health issues publicly highlighted for the global diffusion of new technologies and human rights is
very first time the underlying legal responsibility of govern- also receiving increased attention in the elaboration of interna-
ments to protect and promote the health of their populations tional legal instruments. For instance, the implications of
and has served as a forerunner for increasingly widespread links advances in biotechnology for the protection of human rights
between human rights and other public health issues (Mann and human dignity have been a topic of interest by interna-
and Tarantola, 1998).) tional and regional organizations, including consideration of
The domain of health and human rights has expanded bans on novel technologies. In 1997 the United Nations Educa-
significantly under the auspices of agencies and organs of the tional, Scientific and Cultural Organization (UNESCO) adop-
United Nations and other international organizations. Specific ted a nonbinding instrument, the Universal Declaration on
international legal instruments addressing the rights of partic- the Human Genome and Human Rights, and in 2003 it adop-
ular populations, such as persons with HIV/AIDS, women, chil- ted the International Declaration on Genetic Data. In addition,
dren, migrant workers, and refugees, have been adopted. For in the wake of failed treaty negotiations, in 2005 the United
example, on 13 December 2006 the United Nations General Nations General Assembly adopted a declaration urging
Assembly adopted the Convention on the Rights of Persons Member States to prohibit reproductive cloning as incompat-
with Disabilities. ible with human rights. At the regional level, the Council of
Other contemporary developments are contributing to the Europe adopted a Convention on the Protection of Human
further elaboration of international legal instruments in the Rights and Human Dignity with regard to the Application of
realm of health and human rights, including, in particular, Biology and Medicine: the Convention on Human Rights and
globalization. For example, widespread recognition of growing Biomedicine in 1997. Four protocols to the Convention – sepa-
inequalities in health status and differential access to medical rate agreements – on human cloning, biomedical research,
advances in rich and poor states has expanded interest in the transplantation of organs and tissues, and genetic testing for
relationship between social and economic rights and health. health purposes have also been adopted by the Council of
Of particular concern is the impact of international intellectual Europe between 1998 and 2008. Biomedical research is
property protection under the WTO Trade-Related Aspects of emerging as important topic in global and regional nonbinding
Intellectual Property (TRIPS) Agreement, discussed in the and binding international legal instruments. For example, the
section titled ‘The World Trade Organization, International European Union adopted a directive on clinical practice in
Law and Global Health,’ in restricting access to essential medi- the conduct of clinical trials on medicinal products for human
cines, particularly HIV/AIDS antiretrovirals, in low-income use in 2001 and investigational medicinal products in 2005.
countries. The unprecedented human catastrophe posed by The biotechnology revolution is putting continuing pres-
HIV/AIDS led the international community to adopt a number sure on the international community to develop international
of nonbinding resolutions at the United Nations General law, including human rights law, to effectively govern this
Assembly, the former United Nations Commission on Human realm, and we are likely to see further developments in the
Rights and the WHO specifying the relationship between HIV/ future. Notably, the elaboration of international law on
AIDS, human rights, and access to medicines. In June 2006, the biotechnology is exemplary of how the international commu-
United Nations General Assembly adopted a Political Declara- nity develops regulatory responses. Rather than codifying
tion on AIDS (UN Res. 60/262) reaffirming that access to medi- a comprehensive instrument in this realm, existing interna-
cines in the context of pandemics, including HIV/AIDS, is one tional agreements on biotechnology have been adopted in
of the fundamental elements to achieving full realization for a piecemeal and, at times, incoherent fashion and today consist
everyone of the international right to health. In May 2013 of different instruments, including guidelines, code of conduct,
the UN Special Rapporteur on the right to health issued a report resolutions, and treaties adopted under the auspices different
analyzing existing international challenges toward realizing international organizations.
access to medicines within a right to health framework and
called upon the international community to shift from the
Linkage and the Scope of Global Health Law
‘dominant market-oriented paradigm’ to promote access to
medicine (A/HRC/23/42). Following the release of the report The expanding domain of global health law can be understood,
in June 2013, the UN Human Rights Council adopted a resolu- in part, as a product of enhanced appreciation of the intercon-
tion on access to medicines (A/HRC/RES/23/14) broadly nectedness of contemporary global concerns and, concomi-
recognizing that access to medicines is one of the fundamental tantly, the linkage of health to other legal issues.
elements in achieving progressively the full realization of the International legal scholars traditionally compartmentalized
right to everyone to the enjoyment of the highest attainable and treated substantive subject matters such as human rights,
standard of physical and mental health. environmental protection, arms control, and public health as
Globalization is also furthering the elaboration of interna- discrete self-contained areas with limited connections.
tional instruments in this realm because increasing global inte- Rapid global integration propelled by contemporary globaliza-
gration is compounding the impact of other contemporary tion has contributed to the recognition of the nexus
global developments associated with health status and human among different realms of international law.
rights. An interesting recent development in this realm is the As a consequence of issue linkage, international law and
negotiation and adoption of the 2010 WHO Global Code of global health is increasingly understood to be a central compo-
Practice on the International Recruitment of Health Personnel nent of other international legal regimes, including labor law,
discussed in the section ‘The World Health Organization.’ human rights, arms control, and international trade. The recent
272 Global Health Law: International Law and Public Health Policy

connection between health and human rights in contemporary functions to discipline or restrict the authority of member states
international law and practice discussed in the preceding of the WTO to take food, safety, health, environmental and
section is an important example of the linkage of two tradition- food security considerations into account in making regulatory
ally distinct realms of international law. decisions on the import and use of GMOs. Among regional
The evolution of the concept of human security provides instruments, the European Union regulatory framework in
another interesting example of this development. The tradi- this realm is one of the most extensive, covering issues
tional understanding of human security has come under including import, cultivation, monitoring, and labeling of
increasing pressure in recent years, with growing support for GMOs and GMO-derived material. The main piece of
a comprehensive approach to human security that addresses European legislation regarding GMO food is EU Directive
the wide-ranging factors that impact upon the vulnerability 2001/18/EC, which was amended in 2008 by Directive 2008/
of people. In 2003, the UN Commission on Human Security 27/EC and again in 2015 by Directive (EU) 2015/412. These
released a report proposing a new security framework and directives govern ‘the deliberate release of GMOs in the
recognizing the linkage between health and human security environment’ and consequently cover both cultivation and
(United Nations Commission on Human Security, 2003). imports of GMO crops. In addition, EU regulations set forth
WHO’s 2005 IHRs described further herein have been at the detailed rules regarding the authorization, labeling, and
center of discussion of the linkage between global health and placing on the market of GMOs meant for food and feed.
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 An Introduction to Public International Law
IHRs expanding global concern with weapons of mass destruc-
The Nature and Sources of International Law
tion and terrorism underscored the strong interconnection
between public health and security and legal commitments Understanding the implications of recent developments in
established under the Regulations are clearly designed to apply global health law, including those for domestic public health
to releases of biological, chemical, and radiological events, acci- policy, requires some appreciation of the nature of interna-
dental and deliberate. Recent disease outbreaks, epidemics, tional law and the international political system. Since the
natural disasters, and other health emergencies have reinforced end of the Thirty Years War in 1648, the global political system
the linkage between global health and security. For example, has principally involved the interactions of sovereign states.
the recent Ebola outbreak discussed further herein has revital- Consequently, the elaboration of international law has focused
ized discussions of global health security, including a range on the establishment of consensual rules concerning the status
of proposals for reframing the global health governance to of states and their fundamental rights and obligations as well as
strengthen the global health security regime (Kickbush, 2016). commitments. International law, therefore, is primarily
The linkage between health, security, and other traditionally focused on the interactions of sovereign states and can broadly
defined legal realms is also exemplified in the contemporary be defined as the rules that govern the conduct and relations of
global threat of counterfeit medicines. Expanding international states.
community concern with the global challenge of international International law is traditionally understood as consisting
trafficking in counterfeit medicines, including substandard, of two core realms: public international law and private inter-
defective or adulterated medicines has underscored the inter- national law. While public international law is primarily con-
connections among global health law, international customs cerned with the relations of states, private international law
law, international criminal law, and international trade law focuses on the law of private transactions of individuals and
and led to expanding support for the adoption of an interna- corporations. The traditional distinction between public and
tional legal instrument in this realm (Attaran, 2012). private international law persists even though it is not fully
The nexus between global health law and other traditionally accurate. For example, much of private international law
distinct realms of international law is further exemplified by concerns the transactions of public entities. In addition, while
the rapidly evolving field of biotechnology described in the states are the primary subjects of public international law,
preceding section. Biotechnology closely interlinks many quar- they are not the only subjects. International organizations
ters of the law including, global health, human rights, intellec- and, through the development of international human rights
tual property, trade regulation, and environmental law. For law, individuals, are also considered subjects of public interna-
example, advances in biotechnology have prompted debate tional law.
and development of the field of international environmental In international law, the sources of legal rules are very
law with the main area of environmental concern being the different than in most domestic legal systems because the
potential effect of intentional or unintentional releases of global political system of sovereign states differs fundamentally
genetically modified organisms (GMOs) for health and the from domestic political systems. While there are important
environment. International instruments of relevance in this differences in the sources of law among countries, domestic
field include the Convention on Biological Diversity and its law generally comes from national constitutions, municipal
2010 Cartagena Biosafety Protocol, the International Plant statutes, parliamentary or executive regulations, and decisions
Protection Convention, and the WHO/FAO Codex Alimentar- of municipal courts. In contrast to domestic political systems,
ius. International trade law, particularly the General Agreement there is generally no supranational authority within the global
on Tariffs and Trade, the Agreement on the Application of Sani- system to develop and enforce law against sovereign states. In
tary and Phytosanitary Measures (SPS Agreement), and the the absence of a supranational authority, states establish the
Technical Barriers to Trade Agreement (TBT Agreement), rules of international law. Article 38(1) of the Statute of the
 Global Health Law: International Law and Public Health Policy 273

International Court of Justice is generally regarded as an customary international law and binding for all states,
authoritative list of the sources of international law (Table 2). including those that have not formally ratified it. Like treaty
Although there is a wide and complex array of binding inter- law, customary international law is said to emanate from the
national legal sources, most international law today, including consent of states. States party to a treaty explicitly consent to
global health law, can be found in treaties. The word treaty is be bound by codified rules, whereas with customary interna-
a generic term that encompasses all written instruments tional law states implicitly agree to be bound to particular rules
concluded between states by which states establish obligations through consistent state practice.
by and among themselves. Treaties function essentially as In addition to binding international law, states produce
contracts between states whereby states make binding written a wide variety of nonbinding international legal instruments
rules to govern their own conduct and the conduct of their indi- that can have an important impact on state behavior. Such
vidual and corporate nationals. When states become parties to instruments include resolutions, declarations, codes of
treaties, they explicitly agree to limit their sovereign freedom of conduct, guidelines, or standards. However named, general
action in some respect to achieve mutually agreed-upon goals. declaratory resolutions are, for the most part, intended to be
Generally, treaties are only binding upon states that give their nonbinding instruments expressing the common interest of
express written consent. many states in specific areas of international cooperation.
Treaties are also subject to a significant corpus of interna- Significantly, these nonbinding international legal instru-
tional law: the 1969 Vienna Convention on the Law of Treaties ments are not comparable to voluntary instruments adopted
(the Vienna Convention). The Vienna Convention, the so- at the national level or by industry. To begin with, nothing
called law of treaties, provides general rules of treaty imple- in such nonbinding intergovernmental resolutions prohibits
mentation and interpretation. The Vienna Convention states from incorporating the terms of the instruments into
confirms the generic use of the term treaty by defining a treaty national law. Although generally nonbinding, such instru-
as ”an international agreement concluded between States in ments are not without legal or political significance. Like
written form and governed by international law, whether treaties, these nonbinding instruments can be mechanisms
embodied in a single instrument or in two or more related for advancing international consensus on rules and for
instruments and whatever its particular designation.” The terms promoting consistent state action. There are prominent exam-
treaty, convention, protocol, and pact are largely used inter- ples of nonbinding instruments in public health with impor-
changeably in international legal parlance. Article 19 of the tant policy impacts developed under the auspices of different
Vienna Convention sets forth the basic legal principle concern- international organization. For example, the WTO Doha
ing the observance of treaties, pacta sunt servanda: “Every treaty Declaration on Trade and Public Health, discussed below, is
in force is binding upon the parties to it and must be performed widely considered to have advanced global understanding
in good faith.” and, perhaps, action on trade and health matters, particularly
A second important source of international law is in relation to access to essential medicines, even though the
customary international law. Analogous to domestic legal legal significance of the declaratory instrument is unclear.
concepts such as usage of the trade and course of dealing, the Another well-known example of a nonbinding international
idea behind customary international law is that widespread code with a significant public health impact is the 1981
international practice undertaken out of a sense of legal duty WHO Code of Marketing Breastmilk Substitutes that was
creates reasonable expectations of future observance and designed to protect and promote breastfeeding through the
constitutes implicit consent to the creation of legal rules. The provision of adequate information on appropriate infant
determination of whether or not a particular practice consti- feeding and the regulation of the marketing of breastmilk
tutes customary international law is a complex analysis that substitutes, bottles, and teats. Additional Health Assembly
is more like an art than a science. But, generally, the determina- resolutions adopted over the years since the adoption of the
tion requires near-uniform-state practice undertaken because of Breastmilk Code have further defined and strengthened the
a sense of legal obligation. With some important exceptions, instrument and, according to UNICEF, as of 2016 over 84
once a rule is recognized as part of customary international countries have adopted legislation implementing all or part
law, it is generally considered binding upon all states. For of the Code. Another example of a nonbinding legal regime
example, the Vienna Convention is accepted as declaratory of that has had an impact on state practice is the legal framework
established by 2001 United Nations General Assembly Special
Session (UNGASS) Declaration of Commitment on HIV/AIDS
Table 2 Statute of the International Court of Justice and the monitoring mechanism mandated under its auspices
and under two other subsequent UN General Assembly
The Court, whose function it is to decide in accordance with international law
such disputes as are submitted to it, shall apply: resolutions.
At times, nonbinding intergovernmental resolutions have
a. international conventions, whether general or particular, establishing been highly persuasive, and the conduct of states has tended
rules expressly recognized by the contesting states; to follow the principles embodied in these resolutions. The
b. international custom, as evidence of a general practice accepted as effectiveness of some nonbinding intergovernmental resolu-
law; tions in promoting international cooperation has led some
c. the general principles of law recognized by civilized nations;
commentators to refer to them as soft-law, although the term
d. subject to the provisions of Article 59, judicial decisions and the
is highly controversial. Such instruments are often carefully
teachings of the most highly qualified publicists of the various nations,
as subsidiary means for the determination of rules of law. negotiated and, at times, drafted with the intention to influence
state practice. Nonbinding legal instruments, at times, have
274 Global Health Law: International Law and Public Health Policy

also paved the way for the evolution of treaty law by generating law. The scope of international law was only expanded in the
an ongoing diplomatic forum. twentieth century to include individuals and international
Not all resolutions lead to the development of formalized organizations. However, the nature of global health and the
treaty obligations or are a significant factor in state practice. major actors in health policy are changing in such a way that
However, intergovernmental resolutions, particularly resolu- challenges this restricted approach to international legal coop-
tions of the UN General Assembly that are supported by influ- eration. To begin with, in an era of globalization, the exclusive
ential states often, have a political significance that can focus on territorial statehood is irrelevant to global health
stimulate national behavior and lead to the eventual develop- policy. Nonstates ranging from Taiwan to Palestine are
ment of binding international law. excluded from a range of international agreements because of
lack of statehood. In addition, the major actors in global health
policy today, including foundations, most notably the Bill and
The Limitations of Global Health Lawmaking in International
Melinda Gates Foundation, and a wide range of significant
Health Policy
public–private partnerships, such as the Global Alliance for
It is important to recognize that international law is an inher- Vaccines and Immunizations and the Global Fund for AIDS,
ently imperfect mechanism for international cooperation. The Tuberculosis and Malaria, or civil society organizations, such
innate weakness of international law stems in large part from as Medicines sans Frontiers, are also excluded from the interna-
the core principle of state sovereignty. The law that is made tional lawmaking process. A major challenge for this century is
and the law that is implemented depend upon the will of states. to establish mechanisms to promote more effective coopera-
In the treaty-making process, states are explicitly agreeing to tion between states and the other major health actors under
make rules to govern and, thereby, limit their own conduct international law. Recognition of the limitations of treaty
and that of their nationals through the development and making is contributing to growing interest in nonbinding legal
implementation of legislation and other policies, depending mechanisms for global governance in health and other realms
upon the terms of the treaty, which are consistent with their of international concern.
international commitments. The concept of sovereignty looms Despite the conspicuous limitations of the formal inter-
large in the international system, and states are generally loath national lawmaking process and the inherent challenges of
to sacrifice their freedom of action through the development of using treaties to promote collective action, treaties can be
binding international obligations. A related weakness stem- useful for raising global awareness and stimulating interna-
ming from the principle of sovereignty is the general lack of tional commitment and national action. As an increasing
formal enforcement mechanisms in most contemporary number of health threats are global in scope or have the
economic and social agreements. In contrast to the dispute potential to become so, international legal agreements,
resolution mechanism established under the WTO, described including treaties, are likely to become of increasing impor-
below in the section on the ‘World Trade Organization,’ in tance and an essential component of global health gover-
most social and economic treaties and other instruments states nance. Consequently, international legal agreements, both
do not include machinery to compel parties to comply with binding and nonbinding, are likely to become an increas-
their international legal commitments. ingly important factor underpinning and guiding national
The fact that many treaties tend to be well respected in prac- policy and action on health.
tice largely reflects the fact that they are generally seen as mutu-
ally beneficial for states’ parties. In addition, there is increasing
awareness that the failure of states at times to implement inter- The International Lawmaking Process and the Role
national commitments may reflect more a lack of capacity than of International Organizations
political will. Many states, particularly developing countries,
face acute problems of limitations of resources and capacity The process of international lawmaking, such as the identifica-
in implementing contemporary treaties. Recent advances in tion of international legal rules, is very different than it is in
the international legislative process have expanded mecha- most domestic legal systems. The unique character of the inter-
nisms to address these problems of domestic capacity through national lawmaking process, such as the international legal
international technical and financial assistance programs incor- rules themselves, can be understood as a consequence of the
porated in the texts of relevant conventions. core principle of state sovereignty. In the international political
International law and the international legislative process system, there generally exists no supranational authority to
suffer from other important difficulties. Notably, the interna- make binding international rules.
tional legislative process itself is characterized by numerous International health law is largely treaty-based, and most
challenges and limitations – including challenges to timely international treaty making today is typically conducted under
national commitment by states through timely treaty ratifica- the auspices of international organizations. The vast majority
tion and implementation – although considerable advances of international legislative projects tend to be undertaken at
have been made in the last few decades. public international organizations because such institutions
An emerging challenge in international health lawmaking is function as formal mechanisms for multilateral negotiation
the limited scope of entities that are subjects of international and cooperation for their member states. International organi-
law and thereby entitled to participate in international agree- zations can anchor and facilitate treaty-making efforts because
ments and hold rights and duties thereunder. As described their organizational structures and administrative arrange-
above in the ‘Nature and Sources of International Law’ section, ments enable them to serve as stable and ongoing negotiating
states have traditionally been the sole subjects of international forums.
 Global Health Law: International Law and Public Health Policy 275

In recent years, there has been considerable development “broadening the policy spaces within which relevant decisions
in the field of international organization with a significant are made.” International relation scholars have sought to
increase in the number of international organizations active distinguish this broader strategy of forum shopping by defining
in the domain of health. Within the United Nations system, it as ‘regime shifting’ (Helfer, 2004).
for example, organizations with significant involvement in An important example of potential ‘regime shifting’ in
the health sector include WHO, UNICEF, FAO, UNEP, global health revolves around intellectual property and access
UNDP, UNFPA, and The World Bank. Overall, an increasing to medicines, a topic of fierce political and legal battles in the
number of international organizations have served as plat- international community. The WTO TRIPS, discussed in the
forms for the codification of international health law, while section entitled ‘The World Trade Organization,’ ushered in
others have had a significant influence on the development a new era of powerful international intellectual property law
of international law in this field. that has had a critical impact on access to medicines, particu-
It is important to recognize that not all international orga- larly in low-income countries. TRIPS is also at the core of
nizations have lawmaking authority or the legal mandate to a wave of international legal instruments and processes
serve as a platform for international health negotiations. seeking to redefine the law of international intellectual prop-
The World Bank, for example, is an organization that is highly erty. Dissatisfaction with TRIPS and shifting power bases at
influential in the field of health but has no actual legal the WTO has led those who support stronger and weaker intel-
authority to serve as a framework for treaty negotiations. In lectual property protections in search of alternative and more
the international legal system, lawmaking authority is always favorable venues to promulgate treaties and other legal instru-
expressed and never implied. The existence and scope of ments. For example, some countries, along with nongovern-
lawmaking authority can generally be identified by carefully mental organizations, have undertaken efforts since 2005 to
examining an organization’s constituent instrument, typically initiate the development of a proposed treaty on medical
its constitution. research and development under the auspices of the WHO.
Today there is considerable jurisdictional overlap in the While public health efforts to shift debate and codification
field of international health lawmaking. Unlike most domestic to WHO have thus far stalled, other global health actors
systems where lawmaking efforts are largely coordinated into have undertaken steps to establish more robust intellectual
an integrated legal system, in the international legal system property than provided by TRIPS in a number of forums.
lawmaking efforts among different international organizations Most well-known are the so-called ‘TRIPS-plus’ bilateral and
are notoriously uncoordinated. In the absence of an umbrella multilateral agreements that establish intellectual property
organization to manage lawmaking efforts, the proliferation rights and obligations that are more stringent than required
of international organizations with overlapping legal authority under TRIPS. A significant recent example of a TRIPS-plus
and ambitions is creating the risk of institutional overload and agreement is the Trans-Pacific Partnership Agreement among
inconsistent standard setting (Taylor, 2004). 12 Pacific Rim countries that was adopted in October 2015
For example, during the early stages of the WHO Frame- and, at the time of this writing, has not yet entered into
work Convention on Tobacco Control (FCTC) negotiation force. Less well-known than TRIPS-plus agreements are
process, other international organizations initiated novel a range of global standard-setting initiatives that act below
efforts to negotiate binding instruments on global tobacco the level of formal international law through global
control. In 1998, for example, the Pan American Health Orga- networks of international regulators. Although not formally
nization, a regional office of WHO with separate constitu- international law, such standard-setting initiatives, can at
tional status, initiated efforts to develop a regional treaty on times have a powerful impact in harmonizing state practice.
tobacco control under the auspices of the Organization of In the field of intellectual property, the most important are
American States. As a further example, in 2000 the Secretary best practice standards for custom authorities established by
General of the World Customs Organization (WCO), an inter- the WCO. The WCO also cooperates with Interpol and the
national organization outside of the United Nations frame- Universal Postal Union to strengthen the enforcement of
work, advanced efforts to develop a WCO treaty on global intellectual property law.
tobacco control. While both of these overlapping treaty-
making efforts ultimately failed, problems of jurisdictional
The Process of International Lawmaking
overlap and inconsistent standard setting are occurring in
other realms. International law allows considerable flexibility in the process
Forum shopping is also a widely used policy tool in interna- by which multilateral agreements are developed. The primary
tional standard setting generally and of increasing importance source of international law governing the creation of treaties,
in the domain of global health. A host of factors that may influ- the Vienna Convention, provides a limited number of ground
ence the outcome of negotiations may shape the choice of rules for the conclusion of treaties, concerning the capacity of
negotiating forum, including differences in composition, juris- states to enter into agreements, adoption, and authentication
diction, decision-making procedures, working methods, and of a treaty by a valid representative, and expressions of consent
other characteristics of international organizations. Rising insti- to be bound by a treaty. Beyond these few basic requirements,
tutional density is contributing to expanded use of forum shop- the Vienna Convention does not mandate any particular
ping in global health and other realms of international legal methods of negotiation or ratification.
concern. In some cases forum shopping is aimed at gaining In the absence of binding international rules, international
a single favorable agreement. In other contexts, however, forum organizations have adopted a wide variety of strategies to
shopping is part of an iterative long-term strategy aimed at initiate, negotiate, and conclude international agreements.
276 Global Health Law: International Law and Public Health Policy

Despite the differences in legal processes, the treaty-making authority to develop conventions by serving as a platform for
process generally consists of four stages: initiation, negotiation, the negotiation of the 2003 WHO FCTC. Initiated in the early
adoption, and entry into force (Szasz, 1997). Negotiations are 1990s by Taylor and Roemer, the WHO FCTC was envisioned
the most difficult and generally the longest substage of the as a mechanism to promote national public health interven-
treaty process. In practice, all recent public health negotiations tions and multilateral cooperation on aspects of tobacco
have been open to participation by all states or all states’ control that transcend national boundaries. Formally negoti-
members of the international organization sponsoring the ated between 1999 and 2003 in six negotiation rounds open
negotiations. to all WHO Member States, the text of the treaty was adopted
by the World Health Assembly in May 2003 and entered into
force in February 2005. The final text of the Convention cuts
Examples of International Organizations across a wide range of tobacco control topics, including adver-
and International Lawmaking tising, production, smuggling and counterfeit cigarettes,
warning labels, clean indoor air policies, and health education
The World Health Organization
(Roemer et al., 2005). In 2012 the State Parties to the FCTC
The WHO, the largest international health agency and one of adopted the first protocol to the treaty – the Protocol to Elim-
the largest specialized agencies of the United Nations system, inate Illicit Trade in Tobacco Products.
has wide-ranging responsibilities to address global public As of October 2015, 180 countries have ratified the FCTC
health concerns based upon responsibilities assigned by its making it one of the most widely subscribed to treaties in the
constitution and by its affiliation with the United Nations. history of the United Nations. One of the important lessons
The structure of the relationship between WHO and the from WHO’s first treaty negotiation is the significance of the
United Nations, a separate international organization, is international lawmaking process itself in promoting national
grounded in the United Nations Charter and, in particular, action and international cooperation during negotiations
those sections that describe the objectives of the United before the treaty is adopted and after it has formally entered
Nations. Article 55 of the Charter describes the goals that the into force. I have described this phenomenon elsewhere as
United Nations has pledged to promote among its members, the ‘power of the process.’ It is widely recognized that WHO’s
including solutions to international economic, social, health, efforts to achieve global public support for an international
and related problems. As the United Nations specialized agency regulatory framework for tobacco control, stimulated national
with the constitutional directive to act as ‘directing and coordi- policy change in a number of countries and thus made an
nating authority’ on international health work, WHO has the important, albeit limited, contribution to curtailing the
cardinal responsibility to fulfill the aims of the Charter with epidemic well before global consensus on binding tobacco
respect to health. control norms was secured. The FCTC negotiations were also
WHO’s broad authority to serve as a platform for interna- the raison d’être for the establishment of the first global alliance
tional health lawmaking is expressly established by the terms of tobacco control activists, the Framework Convention Alli-
of its Constitution. Article 19 of the WHO Constitution specifies ance – a coalition of over 300 nongovernmental organizations
that the World Health Assembly, WHO’s legislative body worldwide – and thus further influenced the strengthening and
composed of all of its Member States, “shall have the authority deepening of tobacco control legislation in many states around
to adopt conventions or agreements with respect to any matter the world. Despite the significance of the treaty in mobilizing
within the competence of the Organization.” Article 1 of the national and international action, the record of implementa-
Constitution defines the objective of WHO as “shall be the tion has been mixed. The treaty has some key weaknesses
attainment by all peoples of the highest possible level of health.” that limit its effectiveness. As a consequence of the lack of
The broad scope of WHO’s mandate under Article 1 vests the consensus during the formal negotiation process, broadly
Organization with the legal authority to serve as a platform for drafted with significant wiggle room for interpretation. In addi-
conventions and agreements that potentially address all aspects tion, the instrument does not include a robust monitoring
of national and global public health, as long as advancing mechanism to supervise and encourage national action.
human health is the primary objective of such instruments. Finally, the tobacco industry and state interests that support
Although vested with broad legal authority to protect global it have pushed back against strong tobacco control measures
health and serve as a platform for global health lawmaking, the in national and international fora, including disputes brought
WHO has undergone severe financial and political challenges to the WTO and pursuant to investment treaties against Aus-
and has been in the process of instituting a reform agenda since tralia and Uruguay for their use of plain packaging of tobacco
2011. The splintering of WHO’s political and financial capacity products. At the time of this writing, these disputes have not
is contributing to the process of forum shopping in global been settled. As discussed further below, the conflict between
health governance. Elsewhere I have argued that expanded international trade and public health is increasingly an impor-
use of WHO’s extensive normative authority could help solidify tant theme in the realm of global health law.
an integral position for the Organization in the increasingly
crowded and complex global health institutional landscape International Health Regulations
of global health (Taylor, 2004). In another recent lawmaking initiative, on 23 May 2005 the
World Health Assembly adopted the new IHRs. As described
Framework Convention on Tobacco Control above in the ‘Evolution of International Public Health Law’
Despite WHO’s wide authority in the field of international section, virulent infectious diseases have a long history in civi-
health lawmaking, it has only recently used its constitutional lization, and international disease control was one of the
 Global Health Law: International Law and Public Health Policy 277

earliest areas of international cooperation. WHO, upon its Table 3 Article 21 of the Constitution of the World Health
founding, inherited the responsibility for the management of Organization
the international legal regime for the control of the interna-
The Health Assembly shall have the authority to adopt regulations concerning:
tional spread of diseases. The IHRs, first adopted by the Health
Assembly in 1951 and last modified in 1981, were designed to a. sanitary and quarantine requirements and other procedures designed
provide an effective framework for addressing the international to prevent the international spread of disease;
spread of disease while ensuring minimum interference with b. nomenclatures with respect to diseases, causes of death, and public
world traffic. However, the IHRs were ineffective in ensuring health practices;
national action and global cooperation to stop the spread of c. standards with respect to diagnostic procedures for international use;
disease. The IHRs only applied to a highly narrow subset of d. standards with respect to the safety, purity, and potency of biological,
pharmaceutical, and similar products moving in international
infectious diseases and were routinely ignored by states. The
commerce;
magnitude of the global impact of catastrophic appearances
e. advertising and labeling of biological, pharmaceutical, and similar
of new infectious diseases and the virulent reemergence of products moving in international commerce.
old contagions during the 1980s and 1990s underscored the
irrelevancy of the old IHRs in global health initiatives and initi-
ated global interest in securing more effective international
cooperation to control infectious diseases. to detect, assess, report, and to respond to public health risks
Although the IHR revision process had been underway since and emergencies of national and international concern.
1995, the negotiations were galvanized by the well-publicized However, progress toward implementing the core capacity
global threats of severe acute respiratory syndrome (SARS) in provisions of the instrument has been slow at the country level,
late 2002 and 2003 and outbreaks of both human (H3N2) and the Health Assembly has extended the deadlines for imple-
and avian (H5N1) influenza less than a year later. The SARS mentation. Significantly, the IHRs do not include any financial
epidemic spread rapidly from its origins in Southern China mechanism to assist states that lack capacity to implement the
until it had reached more than 25 countries within a matter broad public health system and reporting obligations of the
of months. The magnified public attention to these recent instrument.
epidemics jolted global awareness of the global vulnerability The emergency provisions of the new IHRs have been
spurred by the rapid spread of disease in this era of globaliza- invoked four times since the entry into force of the agreement,
tion as well as the necessity of international cooperation in each time raising criticisms both of the instrument and WHO.
halting the spread of deadly agents. As such, the SARS epidemic Recently, the Organization, Member States, and the Regula-
provided a mobilizing vision for coordinated health action. tions themselves faced considerable criticism in the context of
Consequently, the IHR revision process provides an important the outbreak of Ebola in 2013 in West Africa and, ultimately,
lesson in the significant role played by a galvanizing event, and the United Nations led the global response to this epidemic.
associated global public and media attention, in bringing states The Ebola outbreak, such as the HIN1 2009 outbreak, evidence
to the table in contemporary international law negotiations. that the global community is not prepared to respond to global
The new IHRs are also an important example of the linkage health emergencies. In the wake of the flawed response to
of traditionally distinct subject matters for the protection of Ebola, commentators have called for major reforms to prevent
global public health. The new Regulations bring together under future disasters and repair the global system for outbreak
one treaty intertwined concerns of public health, security, inter- prevention and response (Moon, 2015). WHO solicited an
national trade, and human rights. The complex regulations independent assessment of its efforts during the Ebola crisis
include 66 articles divided into 10 parts as well as 9 annexes. and agreed to major reforms at the 2015 World Health
The new IHRs expand the scope of disease coverage, incorpo- Assembly, including an overhaul of the IHR. Most recently, in
rate human rights principles, and institute demanding obliga- February 2016 the WHO Director-General declared a public
tions for state surveillance and response. health emergency of international concern in the context of
The IHRs were adopted pursuant to Article 21 of WHO’s the outbreak of the Zika virus in order to institute a coordinated
Constitution, a fairly unique lawmaking device in the interna- international response.
tional system. Article 22 of the WHO Constitution provides
that regulations adopted under Article 21 are adopted pursuant Global Code of Practice on the International Recruitment of
to a contracting-out procedure designed to simplify and expe- Health Personnel
dite the lawmaking process. Regulations come into force auto- The loss of highly skilled personnel, colloquially referred to as
matically for all WHO Member States, except for those states ‘brain drain,’ has been a central concern of low-income coun-
that notify WHO’s Director-General, the Organization’s execu- tries for the last half century. In the context of health personnel,
tive head, of any rejection or reservations. The drafters of the the global workforce shortage and the inequitable distribution
WHO Constitution severely circumscribed the scope of this of workers among and within nations has expanded in the
simplified lawmaking process, however, by limiting the scope last few decades and has now reached crisis proportions. The
of the regulatory authority under Article 21 to traditional WHO Global Code, adopted by consensus by the World Health
public health concerns (Table 3). In the case of the new Assembly in 2010, marks the first time that the world commu-
IHRs, WHO Member States who do not opt out of the IHR pur- nity has considered and sought to respect critical and, at times,
suant to WHO’s Constitution are legally required to update conflicting issues in this realm, including human rights issues.
policy and law to comport with the provisions of the new Such policy concerns incorporated in the Code include
instrument. The IHR core capacities required of countries are honoring the right to health of all persons, the right of
278 Global Health Law: International Law and Public Health Policy

low-income countries to strengthen their health systems and the The Uruguay round brought about a complete overhaul of the
right of health workers to migrate to countries that wish to international trading system by the conclusion of a number of
admit and employ them (Taylor and Dhillon, 2011). The new international agreements addressing trade issues and by
WHO Global Code of Practice on the International Recruitment the establishment of the new WTO.
of Health Personnel also reflects the increasing significance of Certain organizational features of the WTO make it
nonbinding instruments in contemporary global health gover- uniquely powerful in contemporary international relations
nance. It is only the second instrument of its kind adopted by and international law. First, as a condition of membership in
the World Health Assembly since the 1981 WHO Code of the new Organization, member states were required to agree
Marketing Breastmilk Substitutes described in the section enti- and bind themselves to 24 different agreements, contained in
tled ‘The Nature and Sources of International Law.’ In 2015 Annexes 1–3 of the Marrakesh Agreement. Second, the WTO
WHO held its first formal review of the nature and significance established a powerful dispute resolution procedure with
of the Global Code, finding that while the Code was highly rele- a structured process, a prompt timetable, and the capacity to
vant for global health, it was not yet widely significant in global enforce rulings that is very rare in the international legal
practice due, in part, to a lack of national and international system. Pursuant to the WTO Dispute Settlement Under-
resources devoted to its implementation. standing, a WTO Dispute Settlement Body is authorized to
formally adjudicate trade disputes between members and can
PIP Framework authorize the winning party to apply trade sanctions if the
An interesting example of a recent nonbinding international losing party does not modify the violating law or policy. This
legal instrument in communicable disease control is the mandatory and enforceable dispute resolution process stands
PIP Framework adopted as a resolution by the World Health in sharp contrast to the limited implementation mechanisms
Assembly in 2011. The PIP Framework was designed to address established by most treaties.
the controversy that erupted in 2007 when Indonesia reused to Notably, the WTO does not have a direct legal mandate in
share samples of influenza A (H5N1) with WHO collaborating international health. Article III of the Marrakesh Agreement
centers. Indonesian officials claimed sovereignty over a virus that established the WTO specifies that the Organization shall
that was identified within its jurisdiction in part because of “provide a forum for negotiations among its Members concern-
concerns that the country’s population would not receive ing their multilateral trade relations ..” The WTO’s impact on
a fair share of the benefits of any vaccine developed. Notably, health law and policy is collateral to its role in establishing
the IHRs do not address the thorny issue of access to vaccines a legal framework for international trade relations. Since the
and other medications in the context of influenza pandemics. principal aim of the WTO is the reduction of barriers to trade
The PIP Framework attempts to resolve the controversy. Article and not the protection of public health, the pervasive and
2 of the Framework sets forth the objective to improve growing influence of WTO agreements on national and interna-
pandemic preparedness and response systems with a benefit tional health policy has been a subject of increasing concern.
sharing system for influenza viruses that have human A number of the WTO trade liberalization agreements have
pandemic potential, and access to vaccines and other benefits a significant impact on health policy. For example, the WTO’s
including antiviral medications. Viewed as an international General Agreement on Trade in Services (GATS) has resulted
legal instrument, the PIP Framework has several interesting in the liberalization of international trade in health services
features. In particular, although adopted as a resolution of and has exacerbated concerns about equity and quality in the
the World Health Assembly, the framework is a hybrid instru- health sector in developing countries. The GATS may be
ment that includes contractual instruments, designated as Stan- applied to the international trade in health services, including
dard Material Transfer Agreements, and other mechanisms health insurance and health-care provision. As a further
designed to legally bind members of WHO’s Global Influenza example, the Agreement on Agriculture has had an important
Sharing Network and pharmaceutical companies involved in impact on food security through its downward pressure on
the production of vaccines. nontariff barriers to trade, opening up developing country
markets to food imports from industrialized states. Similarly,
the General Agreement on Tariffs and Trade (1994) has
The World Trade Organization
expanded international trade in harmful commodities, such
This article would be remiss if it did not discuss the significant as tobacco, by mandating that states lower tariff and nontariff
role of the WTO in international health law and policy. The barriers to trade. The TRIPS Agreement, SPS Agreement, and
connection between international trade and health is an impor- TBT Agreement are discussed further below.
tant example of the contemporary linkage of two traditionally
distinct realms of international legal concern discussed above. Trade-Related Aspects of Intellectual Property Agreement
The growth of international trade means that the link between The impact of the WTO’s TRIPS in impeding drug development
WTO treaties is becoming increasingly manifest in a wide range capacity and access to medicines in developing countries has
of areas, including access to medicines, health services, received the most public attention during the last decade. As
food security, nutrition, infectious disease control, and discussed above in the ‘Health and Human Rights’ section,
biotechnology. the concern about TRIPS has arisen particularly in the context
The WTO, formed at the conclusion of the Uruguay round of global access to HIV/AIDS antiretrovirals in poor nations.
of the General Agreement on Tariffs and Trade (1994), is the It is estimated that the vast majority of the world’s population
primary international institution governing international trade of 36 million people living with HIV live in low- and middle-
with over 90% of world trade conducted according to its rules. income countries, particularly in sub-Saharan Africa. Despite
 Global Health Law: International Law and Public Health Policy 279

important accomplishments over the last decade, according to new products through the TRIPS framework continues to
UNAIDS as of 2013, only one in three persons with HIV/AIDS dominate international public health law discourse. Despite
in sub-Saharan Africa who was eligible for treatment under the Doha Declaration and a subsequent, related WTO decision
WHO guidelines had access to prevention, care, or treatment for countries that lack domestic generic capacity, few countries
with life-saving antiretrovirals. have instituted TRIPS flexibilities to expand access to essential
The 1994 TRIPS Agreement brought intellectual property medicines and many have come under pressure from industri-
rights under one common set of international rules for the first alized countries to provide broader intellectual property
time and established minimum levels of protection that all protection than that required by TRIPS, particularly through
members of the WTO must accord to the intellectual property the use of bilateral agreements. In addition, the transition
of fellow members. According to the WTO, TRIPS attempts to period for most developing countries to become TRIPS-
balance long-term social objectives of providing incentives compliant has recently come to an end in 2005, meaning
for future inventions with short-term access to such inventions. that all new medicines are patentable in export-capable
TRIPS is the most comprehensive agreement ever reached on countries. The deadline for TRIPS-compliance has been
intellectual property. Notably, TRIPS is one of the mandatory extended several times for the poorest members, and in
agreements that all WTO members, including developing coun- November 2015 the TRIPS Council agreed to an extension
tries, were required to ratify. Developing countries were given until 2033 for the least developed country members of the
transition periods to bring their national intellectual property WTO allowing such members to maintain flexibility in their
legislation in compliance with TRIPS. By 2005, all member approach to pharmaceutical patents.
states of the WTO, except for the poorest, were required to be The battle over universal access to antiretroviral therapy is
TRIPS compliant. symptomatic of the overall challenge of securing access to
The most significant aspect of TRIPS, for public health essential medicines for developing nations. One-third of the
purposes, is that it strengthened international protection of world’s population lacks access to basic medicines. The intro-
pharmaceutical patents. Prior to TRIPS, most developing coun- duction of patent protection for drugs has made efforts to
tries did not recognize patents on pharmaceuticals in order to promote universal access more difficult by raising prices and
promote widespread and cost-effective access to medicines reducing access. Moreover, it is estimated that, between 2000
through generic competition and to strengthen the develop- and 2011, only 4% of new drugs or vaccines developed were
ment of the local pharmaceutical industry. TRIPS requires designed for neglected diseases. An increasingly significant
patent protection of pharmaceuticals for 20 years. The patent related legal challenge is the issue of patent protection for
monopolies established by TRIPS are a significant concern to repurposed medicines. Whether called repurposing, reusing,
many countries because such monopolies tend to increase reprofiling, or rescuing, the process of reusing previously
the price of medicines and restrict generic competition. patented medicines is expanding as an avenue for providing
The TRIPS Agreement contains a wide range of safeguards cost-effective and timely access to drugs in low- and middle-
that can be used to protect public health at the national level, income countries. Granting another patent on a known
including the possibility of overriding patents through compul- product for a newly discovered use or form adds an additional
sory licensing or parallel imports. These and other TRIPS flexi- layer of exclusive rights on the same chemical entity, although
bilities as well as the legal authority of developing countries to only for the new use. Opponents of patentability, such as MSF,
use them to protect public health were battled out in the WTO. have argued that granting such a new patent is a classic example
A large part of the concern was settled in November 2001 in the of ‘ever-greening’ that considerably extends the period of patent
Declaration on the TRIPS Agreement and Public Health, the so- protection for a known substance. Notably, TRIPS is silent on
called Doha Declaration, discussed above, in which WTO the issue of providing patents on new uses for old medicines.
members reaffirmed the right of states to use TRIPS flexibilities Debate on the issue of patentability of repurposed drugs is
to protect public health and, in particular, promote universal being taken up in other national and international venues,
access to essential medications. Although it is beyond the scope and there is no commonly accepted international legal practice.
of this article to provide a detailed analysis of TRIPS, it should However, the Trans-Pacific Partnership Agreement, which was
be noted that the Doha Declaration did not solve all of the adopted in 2015 by 12 states and has been designed as a plat-
problems associated with intellectual property protection and form agreement for other states to join, explicitly requires
public health. As described in the section ‘The International patentability for new uses, new forms, and new methods of
Lawmaking Process and the Role of International Organiza- use subject to some exceptions.
tions,’ dissatisfaction with TRIPS has encouraged both those Finding the right balance between health, trade, and intel-
who favor stronger and those who favor weaker intellectual lectual property policies to sustain innovation and ensure
property protection to search for alternative venues to forge widespread access to life-saving technologies is one of the
agreement. Most significantly, are the ‘TRIPS-plus’ bilateral primary public policy challenges of our time. The failure of
and multilateral agreements that establish intellectual the international community to secure an effective mechanism
property rights and obligations that are more stringent than under TRIPS to ensure the production and export of essential
required under TRIPS, including the recently adopted 2015 medicines to meet the health needs of developing states as
Trans-Pacific Partnership Agreement that has not entered into well as growing recognition of the link between access to medi-
force at the time of this writing. cines and human rights has led to proposals for a radical shift
The conflict between the imperatives of ensuring access in the way in which pharmaceutical research and development
to essential medications, particularly in the poorest is undertaken, including proposals for a new research and
countries and providing incentives to industry to develop development treaty described above.
280 Global Health Law: International Law and Public Health Policy

The WTO SPS and TBT Agreements Conclusion

The need to find an appropriate balance between free trade rules
and the rights of states to implement measures to protect public This article has provided a broad overview of the rapidly
health is a continuing challenge of the WTO regime. WTO law expanding field of global health law. This is an era of signifi-
includes an array of constraints on domestic measures that go cant change in health policy. Over the last decade and a half,
beyond its basic principle of nondiscrimination. In particular, public health has emerged as an issue central to virtually all
the WTO codified the SPS Agreement and the TBT Agreement to areas of multilateralism, ranging from arms control to security
address the emerging debate over the use of standards, including to human rights to trade. At the same time, the global dimen-
public health standards, in international trade. These agreements sions of public health are transforming traditional approaches
are designed to balance the competing demands for domestic to public health. Globalization has limited the capacity of
regulatory autonomy and the global harmonization of product governments to protect health within their sovereign borders
standards as well as prevent imposition of protectionist policies. through unilateral action alone and national and interna-
Some critics contend that the harmonization provisions of these tional health are increasingly recognized as intertwined and
global agreements interfere with the sovereign authority of states inseparable. In addition, the idea that governments have
to implement domestic public health standards and stop nations human rights responsibilities to protect and promote public
from taking preventive measures against health risks in the health and can and should be held accountable domestically
absence of scientific certainty. Others favor the harmonization and internationally for their actions is gaining widespread
provisions arguing that higher and more costly safety standards acceptance. In this new era of global health governance, inter-
in high-income states can be protectionist measures that act as national law has an important role to play in promoting and
barrier to access to the markets of high-income states. This issue coordinating international cooperation and national action.
has been hotly contested, particularly in the realms of environ- Through the establishment of international health commit-
mental health and of product standards for food safety. ments, states legally bind themselves to establish, implement
The SPS Agreement defines SPS measures basically as all and, at times, coordinate national health laws and national
measures instituted by states to (1) protect animal or plant health policy.
life or health in its territory from the spread of pests or disease; The effective design and management of international
(2) protect human or animal life or health in its territory from health law will be one of the major challenges for global
the risk arising from the presence of an additive, contaminant, health governance in this century. Recent developments in
or disease-causing organism in a food, beverage, or foodstuff; international health law and diplomacy have led to increasing
(3) protect human life or health in its territory from the risk calls for international lawmaking in an expanding number of
arising from a disease-causing organisms carried by an animal areas related to public health. It is important to recognize that
or plant; and (4) prevent or limit other damage in its territory international law is not an appropriate policy instrument for
from the spread of a pest. The SPS Agreement prohibits states all global health problems. Given the substantial limitations
from imposing measures that “arbitrarily or unjustifiably of international law and the international legislative process,
discriminate between Member where identical conditions careful consideration should be given to the selection of
prevail” and authorizes WTO members to impose SPS measures global health concerns and the construction of legal regimes
to protect public health that may impact international if such in future international health lawmaking enterprises. Policy-
measures are based upon internationally established guidelines makers must give high priority to identifying if and how legal
and risk assessment procedures and scientific justification. strategies can contribute to the agenda in international health
When existing scientific evidence is insufficient to determine cooperation, including, most importantly, the major chal-
risk, states are authorized under the agreement to adopt SPS lenges that plague many developing nations. At the same
measures on the basis of available information as an interim time, increased attention should be paid to the impact, both
measure, but must objectively ground their assessment of risk positive and negative, of existing international law on popu-
within a reasonable period of time. lation health. It is hoped that increased attention to the
The WTO divided the issue of technical standards or barriers impact of international law, most notably international trade
between the SPS and the TBT agreement, and the scope of these law, will open up critical avenues for advancing human
two treaties are mutually exclusive with the TBT Agreement health.
applicable to all regulations not covered by the SPS Agreement.
Like the SPS Agreement, the TBT Agreement is designed to See also: Foundations in Public Health Law; Health and Human
balance the policy goals of national autonomy in technical Rights: Overview; Legal Issues in Public Health.
regulations and free trade by obligating states to ensure their
technical regulations, including product standards, do not
unreasonably restrict international trade. Public health and
environmental health national standards have been the subject References
of dispute in a number of recent TBT cases, including cases
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tobacco plain packaging standards under the WTO dispute Public Health Ethics 1 (1), 53–63.
resolution mechanism primarily based on allegation that the Helfer, L.R., 2004. Regime shifting: the TRIPS Agreement and the new dynamic of
plain packaging regulation violates TBT obligations. international intellectual property lawmaking. Yale J. Int. Law 29 (1), 1–82.
 Global Health Law: International Law and Public Health Policy 281

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Meier, B.M., 2011. Global health takes a normative turn: the expanding purview
of international health law and global health policy to meet public health chal-
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mantown, MD. Kelly, T., 2007. The Impact of the WTO: The Environment, Public Health and Sover-
Roemer, R., Taylor, A., LaRivere, J., 2005. The origins of the framework convention on eignty. Edward Elgar.
tobacco control. Am. J. Public Health 95, 936–938. Mcgrady, B., 2011. Trade and Public Health: The WTO, Tobacco, Alcohol and Diet.
Szasz, P., 1997. General law-making processes. In: Schachter, O., Joyner, C. (Eds.), Cambridge University Press.
The United Nations and International Law. American Society of International Law, Taylor, A., Tobias, A., Hougendobler, D., Buse, K., 2014. Non-binding legal instru-
Washington, DC, pp. 27–55. ments in governance for global health: lessons from the global AIDS reporting
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500–508. tion, Geneva, Switzerland.