The past two decades have
brought revolutionary changes in global health, driven by popular concern over
the acquired immunodeficiency syndrome (AIDS), new strains of influenza, and
maternal mortality.1 International development assistance for health — a crucial
aspect of health cooperation — increased by a factor of five, from $5.6 billion
in 1990 to $28.1 billion in 2012, with the private and voluntary sectors taking
on an ever-increasing share of the total.2 Given the rapid globalization that is
a defining feature of today's world, the need for a robust system of global
health law has never been greater.
Global health law is not an organized legal system, with a unified
treaty-monitoring body, such as the World Trade Organization. However, there is
a network of treaties and so-called “soft” law instruments that powerfully
affect global health, many of which have arisen under the auspices of the World
Health Organization (WHO). Global health law has been defined as the legal
norms, processes, and institutions that are designed primarily to attain the
highest possible standard of physical and mental health for the world's
population.3
Global health law can affect multiple spheres, ranging from national security,
economic prosperity, and sustainable development to human rights and social
justice. Each global health problem is shaped by the language of rights, duties,
and rules for engagement used in the law (see Glossary).
Understanding the Law and Global Health
Safeguarding the population's health traditionally occurs at the national level,
with a web of laws and regulations governing health services, injury and disease
prevention, and health promotion.4 However, in a globalized world in which
pathogens and lifestyle risks span borders, the need for collective action has
intensified interest in international legal solutions.5
The law relating to global health rests primarily within the domain of public
international law, which can be broadly characterized as the rules that govern
the conduct and relations of countries, including their rights and obligations.
Countries remain the major subjects of international law, but international
organizations and (through human rights law) individuals are also considered to
be subjects of international law.
There is a complex array of international norms, including those that are
binding, or “hard” (e.g., treaties), and those that are nonbinding, or “soft”
(e.g., codes of practice). Hard and soft legal instruments have many
similarities and often take similar forms, since both forms of instruments are
negotiated and adopted by countries, are administered by international
organizations, and have similar compliance mechanisms, such as setting targets,
monitoring progress, and reporting to governmental agencies. Soft instruments
can influence domestic law and policy and are often viewed as part of the corpus
of international law (Figure 1Figure 1Timeline of Major Milestones in Global
Health Law.; and the interactive timeline, available at NEJM.org).6
In recent years, the international community has moved toward a new language of
global governance.7 Neither global health law nor governance is well defined,
but the central feature of global health law is the negotiation, adoption, and
monitoring of normative rules among countries. Both law and broader governance
require institutions to do much of the work, including creating norms,
mobilizing resources, guiding multiple stakeholders to work collaboratively, and
ensuring accountability for results. The WHO is the most important institution
for negotiating international health agreements.8
WHO as a Normative Agency
The WHO has constitutional authority to negotiate and monitor normative
instruments — both treaties and soft instruments, such as recommendations. The
constitution of the WHO enunciates the universal value of the right to health —
a widely adopted international legal entitlement.9,10
The WHO uses a variety of policy tools to set soft norms, with varying levels of
institutional support. A World Health Assembly resolution expresses the will of
194 member countries. The agency has constitutional authority to adopt formal
recommendations; the two most prominent are the International Code of Marketing
of Breast-Milk Substitutes (adopted in 1981)11 and the Global Code of Practice
on the International Recruitment of Health Personnel (adopted in 2010).12 The
Assembly has also adopted influential global strategies and action plans.
The treaty-making powers of the WHO are extraordinary, with separate processes
for negotiating agreements, or conventions, and regulations. Member countries
must accept or reject a convention within 18 months after its adoption by the
Assembly.10 This is a powerful mechanism requiring countries to consider the
treaty in accordance with national constitutional processes. The WHO, however,
lacks the authority to enforce compliance and thus relies on governmental
implementation through domestic law and policy.
The WHO can negotiate regulations on a range of health topics, including
sanitation and quarantine, nomenclatures of diseases, and standards for the
safety, purity, and potency of pharmaceuticals. Regulations enter into force
after adoption by the Assembly, except for members that notify the
director-general within a specified time.10 Consequently, countries must
proactively opt out or they are automatically bound. The first WHO regulations —
on nomenclature for diseases — date back to the late 19th century as the
International List of Causes of Death; these regulations are now implemented
through the International Classification of Diseases.13 The second WHO
regulations date back to 1892, when European countries adopted the International
Sanitary Convention, a predecessor to the International Sanitary Regulations
(now called the International Health Regulations).3
The constitution of the WHO creates ongoing governmental obligations to report
annually on actions taken on recommendations, conventions, and regulations.10
Despite the normative powers of the WHO, modern international health law is
remarkably thin, with only two major treaties adopted since the creation of the
agency.
Framework Convention on Tobacco Control
The WHO did not negotiate a convention until the Framework Convention on Tobacco
Control (FCTC), which was adopted in 2003.14 The FCTC, which remains the only
convention adopted by the World Health Assembly, was ratified by 177 countries
that are home to 88% of the world's population, although the convention was not
ratified by 2 countries, the United States and Indonesia, which have the third
and fourth largest populations, respectively, worldwide.15 In 2012, the
Secretariat of the FCTC estimated that nearly 80% of the 159 countries that
submitted reports had strengthened national tobacco-control laws after
ratification.16 However, overall progress masks unequal performance — for
example, China showed “an alarming lack of progress,” whereas India's
implementation was “slow.”16
The FCTC created binding norms to reduce the demand for, and supply of, tobacco
products and to share information and resources. Efforts to reduce demand
include taxing and pricing guided by health objectives, the provision of 100%
smoke-free environments, disclosures of contents and emissions of tobacco
products, large warning labels on packaging of tobacco products, comprehensive
marketing bans, and tobacco cessation and treatment programs. Reducing the
supply of tobacco focuses on illicit trade (e.g., smuggling and counterfeiting),
which was estimated to account for 11.6% of global cigarette consumption in
2009, resulting in lost tax revenues of $30 to $50 billion per year.17
Despite the success of the FCTC in mobilizing governmental action and
civil-society engagement, the treaty has major weaknesses. First, it contains
ambiguous language, affording countries broad discretion in implementation.
Second, it does not provide resources to give low- and middle-income countries
sufficient capacity to implement and enforce policies outlined in the
convention. In addition, the tobacco industry has fought back against the FCTC,
bringing cases under the World Trade Organization and investment treaties
against Australia and Uruguay for their use of plain packaging of tobacco
products and adoption of tobacco-control legislation — a classic conflict
between health and commerce regimes.18,19
International Health Regulations
The World Health Assembly adopted a substantially revised version of the
International Health Regulations in 2005 in the aftermath of the severe acute
respiratory syndrome (SARS) outbreak, establishing a framework for global health
security.20 The aim of the regulations is to enhance the monitoring and
reporting of international health threats and to improve the coordination of the
response while avoiding unnecessary interference with traffic and trade.21 The
regulations govern surveillance and containment of disease within countries, at
borders, and in international travel.22
The regulations encompass a broad spectrum of health hazards of international
concern, regardless of their origin or source — biologic, chemical, or
radionuclear. Using a decision instrument as a guide, governments must monitor
health hazards and notify the WHO within 24 hours after events that may
constitute a public health emergency of international concern. The
director-general has the exclusive power to declare an emergency and has done so
only once — during the 2009 influenza A (H1N1) pandemic. The regulations permit
the WHO to take into account unofficial sources, such as nongovernmental
organizations, scientists, and social networks in print and electronic media.
Countries also agreed to develop core capacities — including legislation,
national focal points, and pandemic planning — to implement the regulations.
Pandemic Influenza Preparedness (PIP) Framework
Although not a treaty, the WHO PIP Framework is an innovative hybrid — a soft
law instrument that nonetheless can create binding obligations. Adopted in May
2011, the PIP Framework resolved the nearly 5-year controversy that erupted when
Indonesia refused to share samples of influenza A (H5N1) virus with WHO
collaborating centers. Claiming sovereignty over a virus that was identified in
their territory, Indonesian officials expressed concern that their country would
not receive a fair share of the benefits of scientific discoveries.23,24
The PIP Framework facilitates sharing of influenza viruses that have human
pandemic potential and increases access to vaccines and antiviral medications in
developing countries. The agreement incorporates “standard material transfer
agreements” between the WHO and biotechnology companies or universities. When
such agreements are signed, they create contractual duties to provide certain
benefits in exchange for access to biologic materials. Recipients of such
materials make monetary and in-kind commitments, including commitments to donate
vaccines to WHO stockpiles, offer products at affordable prices, and make
intellectual-property rights available. Sharing the benefits of scientific
progress is a vital aspect of global security and justice. However, the
intellectual-property controversy associated with the novel coronavirus that
causes the Middle East respiratory syndrome (MERS) reminds the international
community that the PIP Framework applies only to pandemic influenza, with no
WHO-negotiated agreement covering other emerging diseases.25
International Human Rights Law
The constitution of the WHO proclaims, “The enjoyment of the highest attainable
standard of health is one of the fundamental rights of every human being.”10
Reflecting the same sentiment, the International Covenant on Economic, Social,
and Cultural Rights, which complements the International Covenant on Civil and
Political Rights and which 161 countries have accepted as binding international
law, guarantees “the right of everyone to the enjoyment of the highest
attainable standard of physical and mental health.” It also spells out
governmental obligations to reduce infant mortality, promote the development of
healthy children, improve environmental and industrial hygiene, prevent and
treat diseases, and ensure the provision of medical services.26 In a
demonstration of the universal value of such provisions, all countries except
South Sudan have joined at least one treaty recognizing the right to health.27
The right to health requires that governments meet “minimum core obligations,”
including the provision of health facilities, goods, and services, without
discrimination and distributed equitably; nutritious and safe food; shelter,
housing, sanitation, and safe and potable water; and essential medicines. Health
goods, services, and facilities must be available in sufficient quantity, with
public accessibility, ethnic and cultural acceptability, and good quality, as
outlined in General Comment 14 of the U.N. Committee on Economic, Social, and
Cultural Rights.28
Whether human rights law influences governmental practices is disputed.29
However, health rights are incorporated into statutes and constitutions in many
countries and have formed the basis for landmark judicial rulings.3 The
real-world effect of human rights law depends on an active civil society, which
can highlight governmental violations, lobby parliaments, and litigate health
rights.30 The most successful national litigation has involved access to
essential medicines. For example, in 2002, the Constitutional Court in South
Africa struck down government limits on access to nevirapine for pregnant women
with human immunodeficiency virus (HIV) infection. As a result of this ruling,
the government had to begin to realize the rights of mothers and infants to HIV
prevention.31
Judicial decisions are increasing access to underlying determinants of health,
such as food, water, and housing. In 2001, the Indian Supreme Court held that
nutrition programs were legal entitlements and required that cooked meals be
provided for primary school children. In later orders, the court set timetables
for action on subsidized grain, maternal and child health, and food for the
homeless and rural poor.3 Table 1Table 1Human Rights Court Cases Showing the
Influence of International Law on Domestic Health Policy. shows country-level
court cases that illustrate the effect of human rights law on health policy.
Challenges in Global Health Law
Despite the potential of soft and hard instruments to set norms and mobilize
multiple actors, global health laws have major limitations (Table 2Table
2Limitations of Global Health Law.). First, governments are loath to constrain
themselves and, therefore, often reject international law or agree only to weak
norms. Second, high-income countries are reluctant to finance capacity building
in lower-income countries or to provide funding to the WHO without specific
earmarks. And third, compliance mechanisms for such laws are often weak or
nonexistent.
Because international law primarily addresses the rights and duties of
countries, it cannot easily govern nonstate actors, which range from individuals
and civil-society groups to foundations and private enterprises. Although newer
global health institutions (e.g., UNAIDS, Global Fund, and GAVI Alliance)
include civil-society representatives on their governing boards, the WHO has
resisted nonstate participation in its governing structures.32
The harmonization of governmental interests, moreover, can be difficult because
of the disparate perspectives.33 Although high-income countries often favor
trade liberalization, low- and middle-income countries seek greater access to
drugs and the fruits of technological progress. In 2001, World Trade
Organization members adopted the Doha Declaration on TRIPS (the Agreement on
Trade-Related Aspects of Intellectual Property Rights) and Public Health, which
allowed countries to issue a compulsory license during a public health
emergency, granting to itself or a third party the right to produce or import a
patented drug without authorization from the patent holder.34 So-called “TRIPS
flexibilities” were designed to ensure that intellectual property should not
prevent countries from providing affordable access to essential medications in a
public health emergency.
Increasingly, the reconciliation of these interests occurs at the national
level. For example, in 2013, the Supreme Court of India held that Novartis did
not have a valid patent in India on the lucrative cancer drug Gleevec.35 The
court ruled that Indian law grants patents only to new compounds and that
modified drugs must improve treatment for patients. The decision could embolden
other emerging economies to reject similar intellectual-property claims. At the
same time, developed countries are seeking stricter intellectual-property
protection in trade agreements, such as the Trans-Pacific Partnership, which
seeks to promote trade and investment among the partner countries.36
Trust in international organizations to act impartially and demonstrate
leadership is crucial to the future of global health law. As new health security
challenges arise, the integrity and efficient functioning of the WHO becomes
ever more important. The WHO, however, is struggling with a small group of
donors that contribute approximately 80% of its total budget.37 The term for
this type of financing is “multi-bi” aid — donors' earmarking of noncore funding
for specific sectors, diseases, or regions through multilateral agencies.38
Since the leadership of the WHO is unable to control most of its budget, these
aid arrangements endanger the perceived independence and normative influence of
the WHO.
Financing is intricately related to the challenge of building capacity to
fulfill duties created by global health law. The 2011 review committee on the
functioning of the International Health Regulations stressed that many countries
lacked capacity and were not on a path to fulfill their obligations.39 The same
failure to mobilize resources has plagued WHO normative development in such
areas as achieving ambitious goals set forth in action plans on noncommunicable
diseases and mental health.40-42
Strategy for Global Health Laws
Given the undoubted need for global cooperation, international norms are
accepted as important global health tools. The more difficult question is
whether to pursue hard or soft routes to address health challenges. This debate
plays out in international forums ranging from alcohol control and biomedical
research to broader reforms such as the Framework Convention on Global
Health.30,43-45 However, there are strengths and weaknesses to both approaches.
Soft agreements are easier to negotiate, with countries more likely to accede to
far-reaching norms if there is no formal obligation to comply. Countries can
assent to a soft norm without the national constitutional processes entailed in
ratifying a treaty. In addition, soft norms can be negotiated more quickly with
the use of fewer resources. Resolutions of the WHO Health Assembly represent a
major expression of political will and can lead to progressive deepening of
norms — enacted into domestic law, referenced by treaty bodies, or incorporated
into international law. The WHO, moreover, is building accountability mechanisms
into soft agreements, with targets, monitoring, and timelines for compliance.
However, national governments can largely ignore soft instruments, and as a
result, civil society often urges treaty development.30 No hard norms have been
enacted, for example, relating to food, alcohol, physical activity, injuries,
pain medication, or mental health. If the WHO acts principally through voluntary
agreements, while other sectors develop hard law, this weakens and sidelines the
agency. Civil society often points to the obligatory nature of international
trade law and its binding dispute-settlement mechanism, which often trumps WHO
norms.46
Even with all the funding and celebrity power that has entered the global health
space, key health indicators lag, whereas the health gap between rich and poor
has barely abated.47,48 A renewed attention to lawmaking efforts by the WHO and
the human right to health are crucial elements of progress. It is only through
law that individuals and populations can claim entitlements to health services
and that corresponding governmental obligations can be established and enforced.
It is through law that norms can be set, fragmented activities coordinated, and
good governance ensured, including stewardship, transparency, participation, and
accountability. Global health law, despite its limitations, remains vital to
achieving global health with justice.