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788 journal of law, medicine & ethics
The Journal of Law, Medicine & Ethics, 47 (2019): 788-793. © 2019 The Author(s)
DOI: 10.1177/1073110519897794
Introducing Global Health Law
Lawrence O. Gostin, J.D., LL.D. (Hon.), is University Professor at Georgetown
University and the Founding Linda D. & Timothy J. O’Neill Professor of Global
Health Law at Georgetown University Law Center and Director of the World Health
Organization Center on National and Global Health Law. Benjamin Mason Meier,
J.D., LL.M., Ph.D., is an Associate Professor of Global Health Policy at the Uni-
versity of North Carolina at Chapel Hill and a Scholar at the O’Neill Institute for
National and Global Health Law.
Global Health Law
Lawrence O. Gostin and
Benjamin Mason Meier
Global health law describes the legal
frameworks that structure global
health. Laws and regulations, when
based on the best available evidence,
can promote healthy behaviors, regu-
late hazardous activities, and ensure
socially responsible corporate mar-
keting and products. These regula-
tory frameworks operate in virtu-
ally every realm of health, including
infectious and noncommunicable
diseases, mental health, injuries, and
the safety and eectiveness of vac-
cines, pharmaceuticals, and medi-
cal products. Law can help structure
universally affordable, accessible,
and equitable health systems that
promote universal health coverage.
Beyond discrete attention to health
risks, the rule of law and good gover-
nance are crucial for ensuring health
and well-being.
Where global health has come to
frame eorts to advance public health
across countries, law has become cru-
cial to addressing the global health
threats that have arisen in a rapidly
globalizing world. Globalization has
unleashed the spread of disease, con-
nected societies in shared vulnerabil-
ity, and highlighted the limitations
of domestic law in ensuring global
determinants of health. In this inter-
connected world, no country acting
alone can stem health hazards that go
beyond national borders. Yet if glo-
balization has presented challenges
to disease prevention and health pro-
motion, global health law oers the
promise of bridging national bound-
aries to advance global norms and
alleviate health inequities.
Arising out of international health
law — which has long structured
multilateral cooperation to respond
to infectious disease threats — global
health law seeks to structure the con-
temporary governance architecture
for global health. In responding to
health harms throughout the world,
global health law has “evolve[d]
beyond its traditional confines of for-
mal sources and subjects of interna-
tional law” to advance global health
with justice.1 This focus on global
health has necessitated action beyond
the reach of national governments,
requiring both state and non-state
actors to come together to respond
to globalized health threats. Global
health law seeks to frame this new
governance to respond to the major
health challenges of the twenty-first
century.
The field of global health law has
thus become a basis to conceptualize
the legal institutions that apply to the
changing public health threats, non-
state actors, and regulatory norms
that structure global health. Beyond
the traditional purview of interna-
tional health law, global health law
describes evolving legal efforts to
address:
• New health threats — including
non-communicable disease,
injuries, mental health, dangerous
products, and other globalized
health threats,
• New health actors — including
transnational corporations, private
philanthropists, civil society, and
other non-state actors, and
• New health norms — including
“soft law” instruments, global strat-
About This Column
Lawrence O. Gostin and
Benjamin Mason Meier serve
as the section editors for Global
Health Law. Professor Gostin is
University Professor at Georgetown
University and the Founding Linda
D. & Timothy J. O’Neill Professor of
Global Health Law at Georgetown
University Law Center and Director
of the World Health Organization
Center on National and Global
Health Law. Professor Meier is an
Associate Professor of Global Health
Policy at the University of North
Carolina at Chapel Hill and a Scholar
at the O’Neill Institute for National
and Global Health Law. This column
will feature timely analyses and
perspectives on law, policy, and justice
in global health.
Gostin and Meier
symposium 1: the promise and challenges of microbiome-based therapies • winter 2019 789
The Journal of Law, Medicine & Ethics, 47 (2019): 788-793. © 2019 The Author(s)
egies and action plans, and other
normative standards of global
health policy.2
Global health law instruments can
codify public health obligations
across the global health landscape,
realizing health and justice — both-
within and among nations. These
legal frameworks can promote good
governance among national and
global institutions, embracing values
of transparency, setting targets, mon-
itoring progress, structuring multi-
sectoral engagement, and facilitating
accountability. As legal scholarship in
global health has expanded, it is nec-
essary to consider global health law
as a distinct part of health law.
This introductory column exam-
ines the development of the field,
detailing the evolving scope and
content of global health law. Begin-
ning in the early history of interna-
tional health law, national govern-
ments have long sought to address
infectious disease threats through
international regulations. This focus
on international health law struc-
tured global governance for health
in the aftermath of World War II,
with the establishment of the World
Health Organization (WHO) bring-
ing states together to respond to
common public health threats. Yet,
WHO’s early eorts to stem the inter-
national spread of infectious diseases
have proven too narrow to meet the
expanding legal challenges faced by a
globalizing world. This column ends
by framing the new field of global
health law and outlining the lead-
ing global health threats that will be
explored in future columns, dem-
onstrating the power of this emerg-
ing field in conceptualizing the legal
response to global health.
Origins in International Health
Law
Global health law is built upon the
foundations of international health
law. International regulation of pub-
lic health far predates modern health
law, with international agreements
long viewed by states as vital for col-
lective action to safeguard national
economic and security interests.3
Borne of a time when medicine was
unable to treat illness, the rapid
transmission of disease along trade
routes forced the major trading pow-
ers to acknowledge that infectious
diseases could no longer be construed
as solely within the sovereign author-
ity of independent states.4
This early “sanitary period,” marked
by its emphasis on the prevention
of epidemic disease, determined
the course of international public
health regulation through bilateral,
regional, and multilateral treaties.
The first International Sanitary Con-
ference, held in Paris in 1851, brought
together physicians and diplomats to
reach consensus among those states
having trading interests in the Medi-
terranean basin.5 These states held a
second conference in Paris in 1859,
with subsequent conferences held
in Constantinople (1866), Vienna
(1874), Washington, DC (1881),
Rome (1885), Venice (1892), Dres-
den (1893), Paris (1894), and again
in Venice (1897). While international
sanitary regulations were crafted at
various points in the long march of
International Sanitary Conferences,
none of these early regulations mus-
tered the widespread national ratifi-
cation required for adoption.6
This legislative inertia would not
be broken until widespread scientific
agreement was reached on disease
etiologies and government authori-
ties. By the time of the 1892 Ven-
ice Conference, states had reached
the necessary consensus on public
health practice to draft and ratify a
convention to prevent the spread of
infectious disease. At the eleventh
International Sanitary Conference in
Paris, delegates in 1903 drafted the
first International Sanitary Regula-
tions of widespread applicability.7
The International Sanitary Regu-
lations set the stage for the Interna-
tional Health Regulations (IHR) that
followed and laid the groundwork
following World War II for the devel-
opment of international health law
through WHO.
Foundations of Global
Governance for Health
The 1946 WHO Constitution would
be the first treaty to codify states’
expansive post-war mandate for
medical care and underlying determi-
nants of health, with WHO’s consti-
Arising out of international health law — which
has long structured multilateral cooperation to
respond to infectious disease threats — global
health law seeks to structure the contemporary
governance architecture for global health. In
responding to health harms throughout the
world, global health law has “evolve[d] beyond
its traditional confines of formal sources and
subjects of international law” to advance global
health with justice. This focus on global health has
necessitated action beyond the reach of national
governments, requiring both state and non-state
actors to come together to respond to globalized
health threats. Global health law seeks to frame
this new governance to respond to the major
health challenges of the twenty-first century.
790 journal of law, medicine & ethics
JLME COLUMN
The Journal of Law, Medicine & Ethics, 47 (2019): 788-793. © 2019 The Author(s)
tutional framework piercing the veil
of national sovereignty to respond
to public health threats throughout
the world. Complemented by a wide
range of other United Nations agen-
cies, which would support an expan-
sive array of health determinants
under their respective institutional
mandates, WHO would have consti-
tutional authority to adopt conven-
tions, regulations, and recommenda-
tions on any public health matter.8
With this international legal author-
ity to set regulatory norms for public
health, WHO assumed responsibility
for the IHR, creating a harmonized
surveillance and reporting system for
infectious disease control and setting
both binding state obligations and
permissible limitations on individ-
ual rights and commercial interests
for disease prevention.9 However,
beyond the IHR (last revised in 2005
to address past IHR weaknesses and
reflect modern health threats), WHO
has rarely exercised its lawmak-
ing powers, with states in the World
Health Assembly employing WHO’s
legal authority to develop only two
other treaties: the 1967 Nomen-
clature Regulations and the 2003
Framework Convention on Tobacco
Control.
There are limits to international
health law in creating universal legal
standards to ameliorate global health
inequities. Where once public health
was a central focus of international
negotiation, the international regu-
lation of public health has waned in
international relations, as states have
avoided limitations on their sovereign
authority.10 Because of the state-cen-
tric nature of international law, these
international health agreements have
been focused on infectious diseases
(that threaten security interests),
dependent on voluntary agreement
(exclusively by sovereign states),
and reliant on international consen-
sus (which results in unenforceable
norms).11 International health law is
seen as inherently incapable of facili-
tating collective action to address con-
temporary global health priorities.12
Although international health law
remains a necessary area of research
and practice, framingmultilateral
cooperation to respond to global
health security threats, such narrow
legal frameworks are incommensu-
rate with the rising health threats of a
rapidly globalizing world.13
International health law cannot
speak to contemporary changes in
statehood, international relations,
and global public goods for health.
With public international law bear-
ing most directly on states, which
exercise only limited influence on
the global forces that underlie pub-
lic health, the underlying conditions
for health are increasingly shaped
by non-state actors, including global
institutions, transnational corpora-
tions, individual philanthropists, and
civil society. As international health
Figure 1
International Sanitary Conference
Figure 2
World Health Assembly
Gostin and Meier
symposium 1: the promise and challenges of microbiome-based therapies • winter 2019 791
The Journal of Law, Medicine & Ethics, 47 (2019): 788-793. © 2019 The Author(s)
law has lost the capacity to influence
public health across the world, “global
health” has become the dominant ter-
minology to describe the interdepen-
dent needs of all peoples, rather than
those of particular countries, and the
global action necessary to meet these
needs across nations, actors, and sec-
tors.14 This focus on global health,
addressing global determinants of
public health, demands an expanded
scope and influence of health law to
meet the public health needs of an
interconnected world, redressing
health inequities within and across
countries through global health law.15
Applications to a Globalizing
World
Law is crucial to the advancement of
global health. Structuring health out-
comes through law, legal instruments
shape underlying determinants of
global health, and these “legal deter-
minants of health” provide a path to
safeguard public health in a global-
izing world.16 Yet legal capacities and
government authorities dier greatly
across countries, undercutting eorts
to assure global equity in health.17
There is a rising need for evidence-
based law reforms — in all countries
and through global governance.18
Global health law presents a legal
framework to structure new eorts
by the global community to advance
global health.19
Looking beyond the regulation of
states through international treaty
law, global health law can apply new
sources of soft law to facilitate coop-
eration across state and non-state
actors, frame new institutions of
global governance, and realize global
health with justice.
Global health law applies “soft” law
in global health policy. Where once
international health law was the only
option for states to address issues of
international health, contemporary
soft law instruments (including non-
binding international resolutions,
global strategies, and codes of prac-
tice) have proven far easier to negoti-
ate without the need for formal state
ratification.20 While lacking the legal
enforceability of international law,
soft law nevertheless codifies global
consensus to set priorities, mobilize
constituencies, create incentives,
coordinate actors, and facilitate
accountability. Without the practi-
cal need to develop international
law, global health law applies new
sources of soft law to bind the state
and non-state actors that influence
global health.
In an expanding global health
governance landscape, safeguarding
the public’s health requires coop-
eration among state and non-state
actors, and this coordination can be
fostered through global health law.
International health law continues
to govern the actions of national gov-
ernments, especially where binding
obligations on states are necessary
to prevent infectious disease through
state action;21 however, international
relations between states does not
encompass the entirety of contem-
porary global health diplomacy.22
Shifting from international health
law (applicable to states) to global
health law (applied to both state and
non-state actors), a multi-level pro-
liferation of international, national,
nongovernmental, and corporate
actors have organized to address
a multi-sectoral array of determi-
nants of health.23 Global health law
can frame this expanding landscape
for global health, coordinating the
global community of state and non-
state actors through institutions of
global governance.24
Global health law shapes the legal
foundation of global governance for
health. Global governance has become
crucial in developing legal norms and
implementing those norms through
global institutions.25 Operating under
global health law, well governed
institutions can be more eective in
setting standards, coordinating dis-
parate actors, forming partnerships
with key stakeholders, and developing
consensus on shared goals for global
health.26 These new instruments of
global health law endow global insti-
tutions with the tools to negotiate a
shared vision of good governance for
global health, coordinate with other
organizations across sectors, and align
national law with global health law to
advance public health throughout the
world.27 Facilitating accountability
for these global health goals, global
health law can provide an institutional
basis for developing benchmarks,
monitoring progress, and enhancing
compliance.28
The application of global health
law can thereby establish a norma-
tive framework for achieving global
health with justice. In creating an
Figure 3
WHO Director-General Tedros Adhanom Ghebreyesus
792 journal of law, medicine & ethics
JLME COLUMN
The Journal of Law, Medicine & Ethics, 47 (2019): 788-793. © 2019 The Author(s)
imperative for global health insti-
tutions to meet an expanding set
of global challenges to underlying
determinants of health, global health
law can codify normative frame-
works to realize the human rights
that underlie global health.29 As the
limitations of international law have
moved global health law beyond the
confines of international legal agree-
ments, stakeholders have engaged a
diverse array of state and non-state
actors through the rise of new policy
institutions — institutions developed
through their normative foundations
in justice.30 Global health law can
solidify these vital norms for justice
across institutions, providing a foun-
dation for human rights in global
health.31
Column on Global Health Law
The expansion of health law schol-
arship to encompass global health
law has laid out a legal framework to
structure eorts by the global com-
munity to advance public health.
Through hard and soft law norm-set-
ting, global health law seeks to create
new policy institutions to alter behav-
iors, sustain funding, and coordinate
partnerships.32 Global health law
extends beyond the scope of discrete
health-focused international legal
agreements between national gov-
ernments — addressing an encom-
passing set of global health determi-
nants through the obligations of state
and non-state actors, structuring new
forms of global governance reflective
of the major global health threats,
and framing the normative foun-
dations necessary to realize global
health with justice.
This column will seek to capture
these contemporary advances in
the theory, research, and practice of
global health law. Early columns will
focus on the role of law in:
• global health security and the
International Health Regulations,
• non-communicable diseases and
WHO framework conventions,
• universal health coverage under
the Sustainable Development
Goals,
• immunization law to achieve wide-
spread vaccination and disease
prevention,
• zoonotic disease and the need for
laws at the intersection of public
health, animal health, and environ-
mental health,
• international trade law in structur-
ing commercial determinants of
health,
• planetary health and laws to miti-
gate and adapt to climate change,
and
• human rights law as a foundation
of global health governance.
This quarterly examination of con-
temporary advances in global health
law will build the research founda-
tion for global health law reforms,
analyze evidence-based legal inter-
ventions that promote public health,
and explore the normative influence
of human rights in global health.
Through these columns, it will be
possible to develop an understand-
ing of legal “best practices in global
health,” extending policy surveillance
and legal epidemiology globally to
understand how law reforms can best
succeed in improving public health.
Conclusion
With the rise of the field of global health
law, this column seeks to expand the
reach of this interdisciplinary scholar-
ship as part of the larger field of health
law. Global health law has become
central to health law in a globalizing
world, and it is necessary to broaden
the links between domestic and global
health law in legal theory, empirical
research, and normative application.
Extending burgeoning global health
analysis in the Journal of Law, Medi-
cine & Ethics, this column will pro-
vide a home for scholars to apply legal
analysis to promote global health,
serving as a central resource for aca-
demics, practitioners, and advocates
in the years to come.
Note
The authors are grateful to Lindsay Wiley,
Montrece Ransom, Edward Hutchinson,
and Aaron Kesselheim for recognizing
the importance of global health law to the
advancement of health law and for provid-
ing thoughtful advice in developing this
inaugural column. The authors have no
conflicts to declare.
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