Global Health Law

& Policy
Ensuring Justice for a Healthier World
Edited by
L AW R E N C E O. G O ST I N
and
B E N JA M I N M A S O N M E I E R
 For those we lost in the COVID-​19 pandemic

May their memories inspire the next generation to build a healthier world . . .
 Contents

Foreword: The Law as a Fundamental Determinant of Global Health  xi

Dr. Tedros Adhanom Ghebreyesus
Preface: A Field Born of Trying Times  xv
List of Contributors  xix

Introduction: Foundations of Global Health Law & Policy  1

Lawrence O. Gostin and Benjamin Mason Meier

I . F R A M EWO R K S & I N S T I T U T IO N S O F G L O BA L
H E A LT H : SH I F T I N G AC T O R S & N O R M S I N A
G L O BA L I Z I N G WO R L D

1. Global Health: Global Determinants, Global Governance, and

Global Law  15
Lawrence O. Gostin and Alexandra Finch
2. Global Health Law: Legal Frameworks to Advance Global Health  39
Sharifah Sekalala and Roojin Habibi
3. Global Health Landscape: The Proliferating Actors Influencing
Global Health Governance  65
Benjamin Mason Meier and Matiangai Sirleaf
4. Global Health Norms: Human Rights, Equity, and Social Justice in
Global Health  91
Judith Bueno de Mesquita and Lisa Forman
5. Global Health Diplomacy: The Process of Developing Global
Health Law and Policy  119
Gian Luca Burci and Björn Kümmel

I I . G L O BA L H E A LT H G OV E R NA N C E F O R D I SE A SE
P R EV E N T IO N & H E A LT H P R OM O T IO N

6. Infectious Disease: Preventing, Detecting, and Responding to

Pandemic Threats under International Law  147
Pedro A. Villarreal and Lauren Tonti
viii Contents

7. Non-​Communicable Disease: Regulating Commercial

Determinants Underlying Health  175
Roger Magnusson and Lawrence O. Gostin
8. Mental Health: From Institutions to Community Inclusion  205
Priscila Rodríguez and Eric Rosenthal
9. Environmental Health: Regulating Clean Air and Water as
Underlying Determinants of Health  231
Marlies Hesselman and Benjamin Mason Meier

I I I . E C O N OM IC I N S T I T U T IO N S , C O R P O R AT E
R E G U L AT IO N & G L O BA L H E A LT H F U N D I N G

10. Sustainable Development: The 2030 Agenda and Its

Implications for Global Health Law  259
Stéphanie Dagron and Jennifer Hasselgård-​Rowe
11. Economic Development Policy: Poverty Alleviation for
Public Health Advancement  285
Diane A. Desierto and Erica Patterson
12. International Trade Governance: Free Trade and Intellectual
Property Threaten Public Health  311
Lisa Forman, Katrina Perehudoff, and Chuan-​Feng Wu
13. Commercial Determinants of Health: Corporate Social
Responsibility as Smokescreen or Global Health Policy?  339
Roojin Habibi and Thana C. de Campos-​Rudinsky
14. Global Health Funding Agencies: Developing
New Institutions to Finance Health Needs  365
Sam Halabi and Lawrence O. Gostin

I V. I N T E R NAT IO NA L L E G A L E F F O RT S T O
A D D R E S S R I SI N G H E A LT H T H R E AT S
15. Antimicrobial Resistance: Collective Action to Support
Shared Global Resources  395
Isaac Weldon and Steven J. Hoffman
16. Pathogen Sharing: Balancing Access to Pathogen
Samples with Equitable Access to Medicines  423
Mark Eccleston-​Turner and Michelle Rourke
 Contents ix

17. Sexual and Reproductive Health and Rights: Advancing Human

Rights to Protect Bodily Autonomy and Sexuality  447
Aziza Ahmed and Terry McGovern
18. Health in Conflict: International Humanitarian Law as Global
Health Policy  473
Jocelyn Getgen Kestenbaum and Benjamin Mason Meier
19. Climate Change: A Cataclysmic Health Threat Requiring
Global Action  501
Alexandra Phelan and Kim van Daalen
20. Universal Health Coverage: Whole of Government Approaches
to Determinants of Health  525
Lawrence O. Gostin and Benjamin Mason Meier

Afterword: Foundational Information for a New Generation  551

Steven Solomon
Index 555
 Foreword: The Law as a Fundamental
Determinant of Global Health
Dr. Tedros Adhanom Ghebreyesus

In 1948, as nations sought to build a new world order in the aftermath of

World War II, they adopted a foundational instrument of global health law: the
Constitution of the World Health Organization. In its unprecedented pream-
bular declaration, the Constitution affirmed that “the enjoyment of the highest
attainable standard of health is one of the fundamental rights of every human
being without distinction of race, religion, political belief, economic or social
condition.” In the decades since, global health law and policy have become cru-
cial to addressing major health threats in a rapidly globalizing world, including
infectious diseases, non-​communicable diseases, injuries, and mental health.
Having long championed the importance of law in global health, I congratu-
late Professors Lawrence Gostin and Benjamin Meier for this groundbreaking
book on Global Health Law & Policy, bringing together leading scholars in the
Global Health Law Consortium to provide an academic foundation for the next
generation of global health leaders.
Global health law, based on the best available evidence, can promote healthy
behaviors, regulate hazardous activities, and assure the safety and effectiveness of
vaccines, pharmaceuticals, and other medical products. These legal instruments
can also shape the underlying social, behavioral, and economic determinants of
health. Appropriate law reforms can structure affordable, accessible, and equi-
table health systems that promote universal health coverage (UHC), providing
access to high-​quality, affordable health services while ensuring financial protec-
tion against potentially impoverishing out-​of-​pocket expenses.
During my time as Minister of Health in Ethiopia, we made significant changes
to laws that increased access to health services and underlying determinants of
health for millions of people. These domestic reforms gave me a deep under-
standing of the importance of global health governance in supporting national
health policy—​and have informed my work in the World Health Organization
(WHO) to advance global health law and policy with WHO’s Member States in
the World Health Assembly.
Global health law and policy have always been central to WHO’s mis-
sion and mandate. The WHO Constitution provides the organization with
xii Foreword

expansive authority to negotiate and codify international treaties, regulations,

and recommendations, which WHO has used to develop international
instruments to encourage, and at times to bind, states to take action to reduce
threats common to all.
WHO’s first legal instrument was the International Health Regulations (IHR),
which provide the legal foundation for international efforts to prevent, detect,
and respond to potential public health emergencies of international concern.
Under the IHR, WHO has maintained its principal role in coordinating inter-
national cooperation in infectious disease control. Last revised in 2005, the IHR
have established a global surveillance and reporting system for infectious dis-
ease control and set national minimum standards to prepare for, and respond to,
infectious disease outbreaks—​balancing health with international travel, trade,
and human rights.
Beyond the IHR, WHO Member States have long been reluctant to use
WHO’s legal authority to adopt conventions or agreements. The most notable
exception is the adoption in 2003 of the Framework Convention on Tobacco
Control (FCTC), with WHO Member States developing a coordinated response
to tobacco under international law. The FCTC sets out specific legal obligations
in reducing the supply of and demand for tobacco, providing a crucial model for
employing global health law to respond to new health threats.
The COVID-​19 pandemic has revealed limitations in the global health ar-
chitecture. Despite an imperative to come together in facing a common threat,
including under the IHR, compliance with a range of global health obligations
remains a challenge. International assistance and genuine collaboration to build
resilient public health capacities and ensure equity continue to be lacking. The
pandemic has served as a stark reminder of the importance of global law for
global solidarity.
The international community must learn crucial lessons from the COVID-​
19 response to reform and rebuild key global norms and institutions. In pro-
viding a new legal foundation for global health governance, the World Health
Assembly has initiated a process for global health law reforms—​through both
amendments of the IHR and a new, legally binding WHO convention or agree-
ment on pandemic preparedness and response. The outcome of these interna-
tional negotiations will have significant implications for the future of global
health.
Global health challenges have changed drastically since WHO’s founding,
from rapid travel and mass migrations to zoonotic spillovers and climate change.
Yet, if globalization has presented challenges to disease prevention and health
promotion, global law and good governance offer the promise of bridging na-
tional boundaries to advance global norms and alleviate health inequities.
Safeguarding public health requires cooperation and shared responsibilities
 Foreword xiii

among state and non-​state actors, which can only be fostered through global
health law.
Still, there remain formidable challenges facing global health law. Financial
constraints and unsustainable debt threaten gains in health, with funding
cuts affecting domestic health systems, international organizations, and key
populations. Skepticism toward science and loss of public trust are undermining
crucial public health interventions such as vaccinations. Restrictions on civil
society and political freedoms are subverting social participation and universal
rights. Global threats such as environmental degradation, antimicrobial resist-
ance, and armed conflict are exacerbating divisions within and across nations.
In preparing the next generation to respond to these challenges, Global Health
Law & Policy draws from the history of the field to examine how the law can
be an effective tool to advance global health. Looking beyond the health sector,
this foundational text explains how we must meet new health challenges through
governance across a range of sectors. Such a comprehensive view of global gov-
ernance for health will be necessary to prepare today’s students for tomorrow’s
challenges.
I am confident this text will serve as an essential foundation for these
students—​our future leaders—​to make the right to health a reality and advance
global health with justice.
Dr. Tedros Adhanom Ghebreyesus
Director-​General, World Health Organization
 Preface: A Field Born of Trying Times

Global health faces an existential crisis. The COVID-​19 pandemic has shaken the
foundations of public health and revealed the importance of global governance.
Where no country acting alone can respond effectively to the health threats of
a globalizing world, global governance has become necessary to coordinate the
global health response. Yet, amid unprecedented global health challenges, na-
tional governments have rejected public health science, violated human rights,
and undermined global solidarity. It will be crucial to reform global health gov-
ernance to prepare for future global health threats, but the world remains di-
vided in confronting common threats through global action. These uncertain
times for global health call for the advancement of global health law.
Global health law encompasses the law and policy frameworks that apply
to the new public health threats, non-​state actors, and regulatory instruments
that structure global health. These legal frameworks, placing public health
obligations on the global community of state and non-​state actors, facilitate
social justice in global health through global institutions. Looking beyond the
scope of international legal instruments between national governments, global
health law extends to an encompassing set of global health determinants through
the obligations of state and non-​state actors, structuring new forms of global
governance responsive to the major health threats of a globalizing world and
establishing the normative frameworks necessary to realize global health with
justice.
The modern foundations of global health arose from the ashes of crisis. The
United Nations (UN) was formed out of the ruins of World War II, bringing
nations together to address collective threats through international action.
Giving rise to a new system of international governance, the UN Charter called
for the establishment of an international health organization, the World Health
Organization (WHO), which has evolved alongside other UN institutions
to shape global health law and policy over the past 75 years. The COVID-​19
pandemic has challenged this international system, threatening the global
solidarity necessary to establish global governance for health. The world now
approaches a pivotal crossroads in the global governance response, with cru-
cial global health law reforms being undertaken simultaneously amid this on-
going crisis.
xvi Preface

Following from these sweeping reforms, there is a need to prepare a new

generation to ensure justice for a healthier world, raising an imperative for a
foundational text to support students and scholars to address the global health
challenges of the future through global health law and policy.
Global health law offers the promise of bridging national boundaries to alle-
viate global inequities. Arising out of international health law—​which narrowly
focuses on obligations among states—​the academic field of global health law
seeks to address a new landscape for global health in a rapidly globalizing world,
including the rise of new actors in the global health landscape and new threats
beyond the reach of the state. Global health law and policy thus encompass the
changing global landscape, norms, and governance necessary to respond to the
health challenges of the 21st century. The rapidly expanding literature in the field
has fostered a generation of thought leaders in global health law, and the collabo-
rative efforts of these scholars come together in this volume.
Recognizing limitations in legal authority for global health, twenty fac-
ulty came together in April 2019 to form the Global Health Law Consortium,
bringing together their collective expertise to advance the academic field of
global health law; provide authoritative interpretations of legal instruments in
global health; and facilitate collaborative global health law research projects.
The work of the Consortium would become crucial as the world sought to come
together in an unprecedented pandemic response. Through these challenging
years, policymakers have looked to the Consortium’s academic research to struc-
ture the response to COVID-​19—​and to consider future legal standards in global
health governance. We now look to the future of our field. To support the next
generation of the field, scholars in the Consortium saw the need to develop this
foundational text.
Given the expansive growth of the field, it was necessary to bring together
a wide range of the field’s leading scholars to develop its seminal text, working
across the Global Health Law Consortium and complemented by a larger set of
global health scholars throughout the world. The authors who contributed to
this edited volume represent the academic leaders in their respective sub-​fields,
with this volume drawing on their combined expertise to provide a holistic
survey of the field. As scholarship on global health law and policy has expanded,
over the past decade and especially through the COVID-​19 response, these
contributors provide a comprehensive introduction to global health law—​
working together to advance law and policy to realize the highest attainable
standard of health.
Global Health Law & Policy seeks to define the academic field of global health
law, explore its major doctrinal boundaries, establish its relationship with global
health governance, and look into some of its enduring controversies. This volume
is organized in four main sections, devoted to:
 Preface xvii

I. Explaining the conceptual frameworks and governance institutions that

define the field—​introducing the reader to: the evolving nature of global
health and global governance, the encompassing scope of global health
law, the expanding actors in the global health landscape, the norms that
structure global health efforts, and the diplomatic processes by which
global health law and policy are developed.
II. Applying global health governance to disease prevention and health
promotion—​providing an understanding of the divergent law and policy
approaches taken in global health governance to respond to threats from:
the spread of infectious disease, the commercial products that underlie
non-​communicable disease, the human rights violations undermining
mental health policy, and the environmental health challenges that have
structured a “One Health” approach.
III. Examining economic institutions that influence global health—​exploring
poverty as a fundamental underlying determinant of health and looking
to development as a means to improve public health through: the adop-
tion of the Sustainable Development Goals, the evolution of economic
development policy, the responses to international trade law, the ad-
vancement of corporate social responsibility, and the establishment of
global health funding agencies.
IV. Analyzing international legal efforts to address the rising health threats of
a rapidly globalizing world—​recognizing efforts in global governance to:
frame collective action to address antimicrobial resistance, ensure path-
ogen sharing in exchange for access to medicines, safeguard sexual and
reproductive health and rights, implement international humanitarian
law in conflicts and emergencies, mitigate and adapt to the health threats
of climate change, and promote universal health coverage.

These sections are intended to be read sequentially, with each chapter building
from the one before it while adding new understanding of the field. This volume
is thus intended to be read as a single text, rather than a series of independent
chapters, providing a complete foundational education across the field of global
health law. As an educational text, the contributing authors have followed a con-
sistent structure for their respective chapters to ensure coherence across the
volume. With each chapter reviewing the historical evolution, current state,
and the forward-​looking areas of a distinct sub-​field, every chapter includes
three case studies—​to complement the theoretical analysis of the chapters by
highlighting the practical application of global health law. This volume can thus
provide a basis for teaching, and to facilitate this pedagogical use, each chapter
is followed by questions for consideration, prompting areas for further study
or classroom discussion. Upon completion of this theoretical and practical
xviii Preface

examination of global health law and policy, it is our hope that readers will have
acquired a thorough understanding of the social, economic, cultural, legal, and
political processes by which global health law and policy frame efforts to realize
global health objectives.
We remain immensely thankful for those who supported the development of
this foundational text for the field. As editors, we greatly appreciate the ground-
breaking contributors to this volume, who recognized the need for a founda-
tional text and employed their interdisciplinary expertise to explain the areas of
the field they know best. Developing this volume has required not only the sub-
stantive expertise of scholars in the field but also the administrative assistance
of students at our respective universities. We remain inspired by the dedicated
efforts of Mercy Adekola, Chris Burch, Taylor Corpening, Ryan Doerzbacher,
Eric Friedman, Quintin Gay, Hanna Huffstetler, Erin Jones, Ashley Lim, Kerstan
Nealy, Neha Saggi, Sonam Shah, Rishabh Sud, and Sarah Wetter, whose work
was crucial to developing our own research, reviewing the contributing chapters,
and compiling the complete volume. It is our hope that these early experiences
in the field will provide a foundation for their promising careers. Finally, we are
grateful to Oxford University Press, who have now worked with us on three sepa-
rate volumes to frame three distinct fields at the intersection of international law
and global health. Our publishers have long seen the value of this interdiscipli-
nary scholarship, and we continue to appreciate their faith in our vision for new
fields of study to advance health in a globalizing world.
Drawing from the steadfast efforts of our contributing authors throughout the
world, research assistants at Georgetown University and the University of North
Carolina at Chapel Hill, and editors at Oxford University Press, Global Health
Law & Policy reflects the dramatic development of the field—​highlighting the
successes of legal advancements, the challenges of the 21st century, and the re-
silience of global governance. We look to this book in providing a foundation
for students of global health law and policy. Global Health Law & Policy will be
widely used in policy contexts, health advocacy, and classroom teaching across
schools of law, public health, global studies, and public policy, laying an academic
foundation for the future of the field. In supporting the continuing struggle to
uphold law in global health in these trying times, we hope that this academic text
for the field will prove essential for this next generation—​who hold the power to
build a healthier world.
 List of Contributors

Aziza Ahmed is the R. Gordon Butler Scholar in International Law at the Boston
University School of Law and the Co-​Director of the BU Law Program in Reproductive
Justice. Her scholarship examines the intersection of law, politics, and science in the fields
of constitutional law, criminal law, health law, and family law.

Judith Bueno de Mesquita is the Co-​Deputy Director of the Human Rights Centre and
a Senior Lecturer in International Human Rights Law at Essex Law School and Human
Rights Centre at the University of Essex, United Kingdom. Her research and teaching
focus on global health, development, and human rights.

Gian Luca Burci is an Adjunct Professor of International Law at the Geneva Graduate
Institute of International and Development Studies and an Academic Advisor of the
Global Health Centre of the Institute. As the former Legal Counsel of the World Health
Organization, his research focuses on global health law and governance as well as the law
and practice of international organizations.

Stéphanie Dagron is a professor of international law at the medical and the law faculties
of the University of Geneva. She additionally practices international law in her work as
a member of the WHO Research Ethics Committee and of the Swiss National Advisory
Commission on Biomedical Ethics.

Thana C. de Campos-​Rudinsky is an Associate Professor at Pontifical Catholic University

of Chile and a research associate at the Von Huguel Institute, University of Cambridge. She
is the author of Global Health Crisis: Ethical Responsibilities (Cambridge 2017) and directs
the research program on Dignity and Equity in Women’s Health at the UNESCO Chair in
Bioethics and Human Rights.

Diane A. Desierto is a tenured Professor of Law and Global Affairs at both the Notre
Dame Law School and the Keough School of Global Affairs, University of Notre Dame.
She serves as the Notre Dame Law School’s Faculty Director for the LLM in International
Human Rights Law and the Founding Director of its Global Human Rights Clinic.

Mark Eccleston-​Turner is a Senior Lecturer in Global Health Law at King’s College

London, and an Academic Fellow at the Honourable Society of the Middle Temple. His
research addresses the field of international law and infectious diseases. He is a Fellow of
the Royal Society of the Arts in recognition of his work on access to vaccines.

Alexandra Finch is an Associate at the O’Neill Institute for National and Global Health
Law and an Adjunct Professor of Law at Georgetown University Law Center. She has
xx List of Contributors

degrees from the University of Sydney and previously worked as a solicitor advising on
the regulation of therapeutic goods in Australia. Her research and teaching focuses on
global health law and policy.

Lisa Forman is an Associate Professor and Canada Research Chair in Human Rights
and Global Health Equity at the Dalla Lana School of Public Health at the University of
Toronto. Her work focuses on the right to health in international law and its contributions
to advancing health equity, including in relation to access to medicines, universal health
coverage, and pandemic responses.

Jocelyn Getgen Kestenbaum is a Professor of Law at the Benjamin N. Cardozo School of

Law, where she directs the Benjamin B. Ferencz Human Rights and Atrocity Prevention
Clinic and the Cardozo Law Institute in Holocaust and Human Rights. Her scholarship,
teaching, and practice focuses on international law and atrocity prevention.

Lawrence O. Gostin is a University Professor (Georgetown University’s highest academic

rank), Founding O’Neill Chair in Global Health Law, and Director of the O’Neill Institute
for National and Global Health Law. In supporting global health law, he is the Director of
the World Health Organization Collaborating Center on Public Health Law & Human
Rights and serves on expert WHO advisory committees.

Roojin Habibi is an Assistant Professor at the Faculty of Law, University of Ottawa, and a
Research Fellow of the Global Strategy Lab in Canada. Her research and teaching focus on
health law (including global health law), international law, and human rights. In 2022, she
was appointed to WHO’s Review Committee on amendments to the International Health
Regulations (2005).

Sam Halabi is the Co-​Director of the Center for Transformational Health Law at the
O’Neill Institute for National and Global Health Law and a Professor at the Georgetown
University School of Health. His most recent volume, Borders, Boundaries, and Pandemics,
is forthcoming from Routledge.

Jennifer Hasselgård-​Rowe is a lecturer and researcher at the Institute of Global Health

at the Faculty of Medicine of the University of Geneva and a Policy Analyst at the Global
Commission on Drug Policy. Her research focuses on human rights law, drug policy, and
global health.

Marlies Hesselman is an Assistant Professor in Public International Law at the Faculty of

Law, University of Groningen and the current Chair of the Groningen Center for Health
Law. Her teaching and publications intersect at the areas of environmental health and in-
ternational human rights law, international environmental law, international climate law,
access to energy, and just transition.

Steven J. Hoffman is the Director of the Global Strategy Lab, Dahdaleh Distinguished
Chair in Global Governance & Legal Epidemiology, and Professor of Global Health, Law,
and Political Science, York University. His research leverages various methodological
 List of Contributors xxi

approaches to craft global strategies that better address transnational health threats and
social inequalities.

Björn Kümmel is the Deputy Head of Unit for Global Health in the German Federal
Ministry of Health. He covers the World Health Organization (WHO) with a spe-
cific focus on strengthening WHO’s role in global health governance. He has served as
the German representative to the Executive Board of WHO; Chair of the Programme,
Budget and Administration Committee of WHO; and Vice-​Chair of the WHO Executive
Board—​and led the work on WHO financing as Chair of the WHO Working Group on
Sustainable Financing.

Roger Magnusson is a Professor of Health Law & Governance at Sydney Law School,
The University of Sydney. He was Co-​Chair of the Working Group on Implementation,
Monitoring and Accountability for WHO’s Commission on Ending Childhood Obesity
and was principal author of the WHO report Advancing the Right to Health: The Vital Role
of Law (2017).

Terry McGovern is a Professor and Senior Associate Dean for Academic and Student
Affairs at the City University of New York Graduate School of Public Health and Health
Policy. Previously, she served as Chair of the Heilbrunn Department of Population and
Family Health at the Columbia University Mailman School of Public Health. Her re-
search focuses on health and human rights, sexual and reproductive health and rights,
and gender and environmental justice.

Benjamin Mason Meier is a Professor of Global Health Policy at the University of North
Carolina at Chapel Hill, a Senior Scholar at Georgetown University’s O’Neill Institute for
National and Global Health Law, and the Chair of the Global Health Law Consortium.
His interdisciplinary research—​at the intersection global health, international law, and
public policy—​examines rights-​based approaches to health.

Erica M. Patterson is a 2024 Georgetown University Law Center National and Global
Health Law LLM candidate and a Georgetown University Law Center Global Health Law
Scholar. She recently graduated from Notre Dame Law School with a Juris Doctorate in
May 2023.

Katrina Perehudoff is a health scientist and legal scholar with over a decade of experience
in pharmaceutical policy, intellectual property, human rights, and drug regulation. She is
an assistant professor and Co-​Director of the University of Amsterdam’s Law Centre for
Health and Life. Her research focuses on global and European aspects of pharmaceutical
law and access to medicines policy.

Alexandra Phelan is an Associate Professor at the Bloomberg School of Public Health at

Johns Hopkins University and a Senior Scholar at the Johns Hopkins Center for Health
Security. Her work focuses on international health law at the intersection of infectious
diseases and global impact events, advising numerous international organizations in
responses to infectious diseases and potential pandemic threats.
xxii List of Contributors

Priscila Rodríguez is the Associate Director for Disability Rights International (DRI),
where she has led DRI’s investigations, published reports, and filed cases at the regional
and international level to advance the rights of persons with disabilities. She previously
served as a mental health specialist for the United Nations High Commissioner for
Human Rights.

Eric Rosenthal is the founder and Executive Director of Disability Rights International.
Since 1993, he has conducted human rights investigations and trained disability rights
activists in more than forty countries, participated in drafting the UN Convention
on the Rights of Persons with Disabilities, and held the Father Robert Drinan Chair in
International Human Rights Law at Georgetown University Law Center.

Michelle Rourke is a Griffith University Postdoctoral Research Fellow at the Law Futures
Centre in Brisbane, Australia. She researches international Access and Benefit Sharing
laws with a focus on pathogens, genetic sequence data, and synthetic biology.

Sharifah Sekalala is a Professor of Global Health Law at the University of Warwick.

Addressing global health crises and the impact of law in curbing inequalities, her research
is focused primarily on Sub Saharan Africa. She is currently the Principal Investigator on
a Wellcome-​Trust-​funded project on digital health apps in Sub-​Saharan Africa.

Matiangai Sirleaf is the Nathan Patz Professor of Law at the University of Maryland
School of Law and a professor in the Department of Epidemiology and Public Health
at the University of Maryland School of Medicine. She serves as executive editor
at Just Security and is a member of the board of editors for the American Journal of
International Law.

Steven Solomon is the Principal Legal Officer at the World Health Organization in Geneva,
Switzerland, where he leads the Legal Office’s team on International, Constitutional and
Global Health Law matters. His work focuses on governance, and international and global
health law matters, with a particular emphasis recently on matters related to international
and institutional aspects of the COVID-​19 response.

Lauren Tonti is a researcher and doctoral candidate at the Max Planck Institute for Social
Law & Social Policy. Having earned degrees in both law and public health, her research
focuses on a variety of topics in the fields of public health law, legal epidemiology, global
health law, and the social determinants of health.

Pedro A. Villarreal is a researcher at both the German Institute for International

and Security Affairs and the Max Planck Institute for Comparative Public Law and
International Law in Germany. He has a PhD in Law from the National Autonomous
University of Mexico.

Isaac Weldon is a PhD Candidate in the Department of Politics and a Dahdaleh Research
Fellow at the Global Strategy Lab, York University, Toronto, Canada. His research explores
novel ideas, innovative strategies, and transformative approaches for addressing global
and planetary health challenges.
 List of Contributors xxiii

Chuan-​Feng Wu is an associate research professor at Institutum Iurisprudentiae, Academia

Sinica and the director of the Information Law Center. He also serves as a joint appoint-
ment assistant professor at the College of Public Health, National Taiwan University. His
specialty fields of study include public health law and ethics, healthcare distributive jus-
tice, international human rights law, and information law.
 Introduction
Foundations of Global Health Law & Policy
Lawrence O. Gostin and Benjamin Mason Meier

Globalization has unleashed new health threats, connecting societies in

shared vulnerability to common challenges, including infectious disease, non-​
communicable disease, environmental pollution, injuries, and inequitable pov-
erty. The COVID-​19 pandemic has made clear the cataclysmic health threats
of a rapidly globalizing world and the limitations of domestic law and policy in
addressing economic, social, and political determinants of health. No country
acting on its own can stem major health hazards that go well beyond national
borders. Where national laws cannot reach threats beyond national borders,
global law is necessary to promote health and justice. If globalization has
presented global challenges to disease prevention and health promotion, global
health law offers the promise of bridging national boundaries to promote public
health and reduce health inequities.
Global health law seeks to establish strong and innovative governance to re-
spond to the major health challenges of the 21st century. Law and policy have be-
come crucial to the advancement of global health. Global health law encompasses
the study and practice of international law—​both “hard” law treaties that bind
states and “soft” law instruments that shape norms, processes, and institutions to
realize the highest attainable standard of physical and mental health throughout
the world. As an academic field of study, global health law has become a basis to
describe new legal and policy frameworks that apply to the new set of public health
threats, non-​state actors, and regulatory instruments that structure global health.
Ensuring justice in global health, the field of global health law is infused with
norms of equity, social justice, and human rights, striving for collective action and
mutual solidarity throughout the world, with particular concern for the world’s
most disadvantaged people. This burgeoning field requires a foundational text.
This chapter introduces the central importance of global health law to ad-
vance global health with justice, providing a foundation for this book by laying
out the role of law and policy in global health. Framing the need for law in global
health, Part I examines public health at the global level, raising an imperative
for global health law. Part II defines global health law as encompassing binding
2 Global Health Law & Policy

international law, “soft” law, and global health policy. These law and policy efforts
have evolved rapidly in the 21st century, with Part III examining how contem-
porary challenges in a globalizing world have given rise to the academic field of
global health law. Part IV describes the academic basis for the field and outlines
the structure of this foundational text, delineating the chapters that describe the
institutions of global health law, the role of global health governance, the in-
fluence of global economic governance, and the challenges amid rising health
threats. This introduction concludes that despite the dramatic development of
the field of global health law, the world faces new challenges that threaten to di-
vide the world when solidarity is needed most, with ongoing reforms that will
shape global health for generations to come.

I. Law as a Foundation of Global Health

Globalization has tightened connections between nations and peoples, giving

rise to shared health threats across the world. These common challenges call
for collective action from the global community (Frenk and Moon 2013). In
responding to these threats, the modern public health order embraces a more
holistic approach to health, now considering socioeconomic conditions, social
justice, and preventative measures for health promotion. This framing requires
an examination of “the way society organizes itself, produces and distributes
wealth, and interacts with the natural environment”—​implicating “collective
responsibility for unhealthy behavior” (Gostin, Burris, and Lazzarini 1999, 64).
Such an expansive focus on the public health threats of a globalizing world allows
for consideration of an encompassing set of global health challenges, including
ecosystem threats, food availability, democratic governance, and realization of
human rights. Shifting away from “international health,” a colonial practice that
historically focused on controlling infectious disease across national borders,
global health looks across health threats to focus on achieving equity in health
worldwide (Koplan et al. 2009).
The field of global health has come to encompass the study, research, and prac-
tice of public health across the globe. Elevating the central importance of public
health, global health examines global determinants of health, recognizing the
interconnections between global contexts and local conditions. In the practice
of global health, however, a debate has endured on the importance and relative
priority of vertical and horizontal interventions:

• Vertical health interventions often look to narrow, disease specific, and

specialized approaches to individual health threats (Frenk and Gómez-​
Dantes 2017).
 Introduction 3

• Horizontal approaches look across health threats to implement health

system interventions that address a wide range of determinants of health
(Kickbusch and Buckett 2010).

Vertical health approaches have long faced critiques in public health for seeking
to address health threats in isolation, neglecting to address the underlying
determinants that lead to the spread of disease and the impediments to well-​
being across populations (Frenk, Gómez-​Dantés, and Moon 2014). Looking to
horizontal approaches to address public health, global health has come to span a
broad approach to determinants of health across sectors—​from education, em-
ployment, and income to behaviors related to infectious and non-​communicable
diseases. As an interdisciplinary field, global health now examines the systemic
determinants that underlie global health (Lomazzi, Jenkins, and Borisch 2016).
To address these determinants of public health at a global level, global health
brings together actors to improve underlying determinants of health throughout
the world, looking to global governance in structuring these global determinants
(Fried et al. 2010). In seeking to achieve this global health governance, state and
non-​state actors have joined together in a collective effort under global law.
The promotion of global health necessitates global governance beyond the
reach of national governments, requiring international organizations, na-
tional governments, and non-​governmental actors to come together under law
to respond to globalized health threats. Global health thus looks beyond the
individual state to encompass a diverse array of non-​state actors—​including
organizations, foundations, and corporations—​ in understanding and de-
veloping collaborative solutions to today’s public health challenges. To bring
together the work of these state and non-​state actors, global health actors en-
gage in varying functions, all with the goal of improving health across borders
and throughout the world. Global health looks to address interconnected
determinants of health through global collaboration, with local, national, and
international actors partnering and integrating their actions to form a global
governance structure that seeks to mitigate global threats that undermine
public health.
Where global health has come to frame efforts to advance public health across
actors, law has become crucial to address the global health governance challenges
that have arisen in a rapidly globalizing world. Law directly and indirectly
impacts health determinants and outcomes across local, national, and global
contexts (Gostin et al. 2019). Structuring health outcomes through law, legal
instruments shape underlying determinants of health. These “legal determinants
of health” thus influence societal interactions that structure, perpetuate, and me-
diate underlying determinants of health, establishing standards and norms that
guide conduct (e.g., tobacco taxes), resolve disputes (e.g., via courts of law), and
4 Global Health Law & Policy

govern institutions (e.g., public and private health systems) (Gostin and Wiley
2016). While laws are developed and operationalized across different levels of
governance (locally, nationally, globally), each have “downstream” influence on
the lives of individuals and shape the conditions for people to live healthy lives
(Gostin, Cohen, and Phelan forthcoming). If well designed, law can be a powerful
tool for advancing justice in health—​from protecting standards for health pro-
motion, to strengthening health systems, to holding institutions accountable for
health harms (Magnusson 2017). Operating at the global level to address global
determinants of public health through global action, global health law presents
a legal framework to structure new efforts by the global community to advance
global health.

II. Defining Global Health Law

Global health law encompasses the legal and policy frameworks—​both binding
and non-​binding—​that structure public health in a globalizing world. With
globalization giving rise to global health threats, global health law has become
necessary to address these common threats and shared burdens across nations
and sectors. Connecting societies in shared vulnerability, these globalizing forces
have exposed the limitations of domestic law in addressing global determinants
of health. Laws at the national level are not sufficient to address these global
threats because such domestic laws cannot reach beyond national borders, and
therefore, global health law is necessary to bridge the gap between global norms
and national laws to promote global health (Gostin and Meier 2019). Arising out
of international law, which focuses on multilateral cooperation among states, the
focus of global health has necessitated action beyond national governments. In
bringing together state and non-​state actors, global health law seeks to respond
to major health challenges in a rapidly globalizing world while improving the
health and well-​being of the world’s people through the establishment of global
governance for health.
Global governance has become crucial in developing legal norms and
implementing those norms through global institutions. Global health
law recognizes that all nations face interconnected public health threats,
requiring collective global action to realize global health equity (Gostin 2014).
Operationalized through common norms, global health law is guided by values
of social justice, mutual solidarity, and human rights (Meier and Gostin 2018).
Governance institutions can set norms for global action, form partnerships
with key stakeholders, and develop consensus on shared goals for global health
(Toebes 2018) under global health law. In uniting states under binding legal
obligations and bringing together state and non-​state actors under “soft law”
 Introduction 5

commitments, global health law could not exist without global health govern-
ance (Gostin, Cohen, and Phelan forthcoming).
Through an extensive body of governance institutions, actors have come to-
gether to respond to global challenges, working to create coordinated responses
to rising threats. International organizations serve as the primary governance
institutions for the creation of this legal framework across states—​including
both binding and non-​binding agreements—​which, in turn, shapes national
responses as states implement international legal obligations. Through the de-
velopment of international law, these global governance institutions can develop
global health law to frame the legal obligations of states, with international or-
ganizations providing a basis for member states to negotiate international legal
agreements, facilitate international accountability, and shape global health
norms (Meier et al. 2020). Yet numerous international organizations and legal
regimes now impact health through state and non-​state actors, and global health
governance requires global health law to encompass multiple sectors and mul-
tiple actors—​to coordinate actions between these actors and sectors to enhance
global health (Gostin and Sridhar 2014). With globalization exacerbating the
risks of disease and increasing the need for global cooperation, global health gov-
ernance grows increasingly crucial in developing international law and global
policy to unite state and non-​state actors against global threats.
Global health law can thus shape this expanding law and policy landscape for
global health, coordinating the global community through institutions of global
governance. Law has become a central aspect of governance, with global health
governance often taking the form of laws through constitutions, regulations, and
bylaws (Gostin 2014). Global health law presents a legal framework to structure
coordinated efforts by the global community to advance global health (Toebes
2018). Providing an international legal foundation for global health govern-
ance, global health law supports global institutions to negotiate a shared vision
of global health, coordinate with organizations across sectors, and align na-
tional laws to advance public health in a globalizing world (Gostin and Meier
2019). Global health law thereby sets the global goals necessary to structure
global health governance. Facilitating accountability for these shared global
health goals, global health law can provide an institutional basis for developing
benchmarks, monitoring progress, and enhancing compliance for achieving
global health with justice (Gostin 2014).

III. An Evolving Field

The expansion of health law scholarship to encompass global health law has laid
out a law and policy framework to structure efforts by the global community
6 Global Health Law & Policy

to advance global health. The need for law in global health has been in motion
for centuries, as populations came to recognize the importance of cooperation
across nations to protect public health. A variety of sanitary conventions in the
mid-​to-​late 19th century began to shape the field (Gross 2021). Arising out of
efforts to control infectious threats along international trade routes, these legal
efforts soon moved beyond infectious diseases to include aspects of environ-
mental health, non-​communicable threats of alcohol and tobacco, and occupa-
tional health across the globe (Fidler 2001). Some of the first international health
organizations, developed in the years leading up to World War II, laid a path for
international governance to establish international law to protect public health.
Following World War II, the birth of the United Nations (UN) and World
Health Organization (WHO) would provide a permanent foundation for
global health governance. These governing institutions, which remain the core
of law and policy in the international community, have solidified the focus
on law to advance global health (Meier et al. 2020). Amid rising tensions in
a globalizing world—​through the Cold War, pandemic threats, and inequi-
table development—​global health law would rise in importance (Bélanger
1989). Beyond WHO, global institutions formed rapidly to address global
determinants of health, establishing a complex landscape that serves to frame
health policies, programs, and practices in the global sphere (Moon et al. 2010).
In facing new health challenges, global health law now encompasses binding
and non-​binding instruments of health law, human rights law, environmental
law, trade law, and other law and policy instruments developed across sectors.
The interconnections between these areas of global health law have been re-
vealed amid the challenges of the COVID-​19 response (Gostin 2021). As the
importance of law and policy in global health became more evident, the field of
global health law emerged.
The field of global health law has expanded rapidly in the 21st century.
Arising out of international health law—​which focuses narrowly on interna-
tional legal relationships among states—​global health law has a vast scope, in-
cluding cooperative partnerships among state and non-​state actors and soft
law approaches to global health policy. Looking beyond the regulation of states
through international treaty law, global health law can apply new global policies
to facilitate cooperation across state and non-​state actors, frame institutions of
global governance, and realize global health with justice. Where once interna-
tional health law was the only option for states to address issues of international
health, contemporary soft law policy instruments (including non-​binding in-
ternational resolutions, global strategies, and codes of practice) have proven far
easier to negotiate and adopt—​without the need for formal ratification by states
(Sekalala 2017). While lacking the formal legal enforceability of international
law, these global health policies nevertheless codify consensus across the global
 Introduction 7

community, providing a foundation under global health law to set priorities, mo-
bilize constituencies, create incentives, coordinate actors, and facilitate account-
ability in global health. Through hard and soft law norm-​setting, global health
law seeks to create new policy institutions to alter behaviors, sustain funding,
and coordinate partnerships (Gostin 2014). Without the practical need to de-
velop international law, global health law and policy seeks to bind all the actors
that influence public health in a globalizing world. Shifting from international
health law (with treaties applicable to states) to global health law (with law and
policy applied to both state and non-​state actors), a proliferation of international,
national, non-​governmental, and corporate actors has organized to address a
multisectoral array of determinants of health (Szlezák et al. 2010). Global health
law thus encompasses the changing global landscape and governance necessary
to respond to the health challenges of the 21st century.
As an academic discipline, global health law describes the legal and policy
frameworks that apply to the expanding set of public health threats, non-​state
actors, and regulatory instruments that structure global health. Evolving be-
yond the traditional confines of formal sources and subjects of international law,
global health law seeks to describe legal institutions that speak to:

• Rising health threats—​including communicable and non-​communicable

diseases, injuries, mental health, dangerous products, and other globalized
health threats;
• Proliferating health actors—​including transnational corporations, private
philanthropists, civil society, and other non-​state actors; and
• Expanding health regulations—​including “soft law” instruments, strategy
documents, and other norms of global health policy (Gostin 2014).

As the limitations of international law led to the establishment of global health

law, stakeholders have engaged a diverse array of actors through the rise of new
policy institutions—​institutions developed through their normative foundations
in justice (Ruger 2018). These law and policy frameworks, placing public health
obligations on the global community of state and non-​state actors, facili-
tate justice in global health through global institutions that are governed well,
embracing values of transparency, monitoring, multisectoral engagement, and
accountability (Gostin, Cohen, and Phelan forthcoming).

IV. Structure of the Volume

Where law and policy are complementary approaches to global health law,
this foundational text looks to global standards by which to frame government
8 Global Health Law & Policy

responsibilities and establish global governance. This volume is organized in

four main sections: (1) explaining the conceptual frameworks and governance
institutions that define the field, (2) applying global health governance to disease
prevention and health promotion, (3) examining economic institutions that in-
fluence global health, and (4) analyzing international legal efforts to address the
rising health threats of a rapidly globalizing world. These sections are intended
to be read sequentially, with each chapter building from the one before it while
adding new information to the reader’s understanding of the field. To comple-
ment the theoretical foundations of the text, each chapter includes brief case
studies to highlight the practical application of law and policy in global health.
Section I introduces the reader to the conceptual frameworks and insti-
tutional foundations necessary to understand the role of law and policy in
protecting and promoting public health in a globalizing world. The first chapter
provides an understanding of the evolving meaning of global health, examining
the modern birth of global governance under the UN and establishment of in-
ternational legal authorities under WHO. Given the limitations of international
health law in a globalizing world, Chapter 2 introduces the legal foundations for
the book by defining global health law, conceptualizing the hard and soft law
authorities necessary to bind together the state and non-​state actors that make up
the expanding global health landscape. This landscape is the focus of Chapter 3,
which explores the proliferating actors and partnerships in the global health ar-
chitecture, analyzing the role of global health law as a foundation of global health
governance. Binding these actors together, Chapter 4 considers the normative
frameworks that structure global health efforts, considering equity and social
justice in global health and human rights under international law. Chapter 5
concludes Section I by looking to the diplomatic process by which global health
law and policy are developed, considering the politics of negotiating global
health law through global health governance.
This conceptual framework for global health law and policy in Section
I establishes a foundation for a closer examination of some of the most pressing
legal issues in global health in Sections II through IV.
Shifting to the application of global health law and policy in global health
governance, Section II provides the reader with an understanding of the di-
vergent approaches taken in global health governance to respond to leading
global health threats. Chapter 6 chronicles how global health law has evolved
to combat the spread of infectious diseases, tracing the evolution of the WHO
International Health Regulations, examining contemporary responses from
HIV/​AIDS to COVID-​19, and considering the importance of ongoing law
reforms to face future threats to global health security. This infectious disease re-
sponse is distinct from policy approaches to addressing non-​communicable dis-
ease, with the global trade of unhealthy products leading to a series of hard and
 Introduction 9

soft law approaches to the regulation of commercial determinants of health, and

Chapter 7 examines policies to shape smoking, eating, and drinking behaviors
throughout the world. Recognizing the underlying conditions that contribute to
physical, mental, and social well-​being, Chapter 8 explores changing approaches
to mental health under global health policy, analyzing how global health govern-
ance has shifted from institutionalization to medicalization to community-​based
rehabilitation. In focusing on the environmental threats of an industrializing
world, Chapter 9 investigates policy frameworks to support environmental
health through the regulation of environmental pollutants and the establishment
of a “One Health” approach to global health governance.
Section III considers the influence of economic governance on the public’s
health, examining the role of global health law in shaping economic develop-
ment, international trade, corporate regulation, and health funding for the re-
alization of a healthier world. Where economic development underlies public
health, the Sustainable Development Goals provide a foundation for all global
efforts to ensure sustainable development, with Chapter 10 delineating the wide
range of health-​related goals and targets. This focus on economic development
is extended through international economic governance under the International
Monetary Fund and World Bank, and Chapter 11 analyzes the evolving influence
of these development institutions in alleviating poverty to promote global health.
Expanding to international trade governance, Chapter 12 looks to efforts to liber-
alize international trade through the World Trade Organization, considering the
harmful consequences of trade agreements and examining rising efforts to chal-
lenge intellectual property protections to ensure access to essential medicines.
This focus on essential medicines requires transnational corporations, and
Chapter 13 looks to the rising influence of transnational corporations on com-
mercial determinants of health, analyzing models for regulating harmful corpo-
rate actions and considering whether corporate social responsibility doctrines
can support corporate engagement in global health governance. In bringing
these economic actors together to support global health, Section III ends by fo-
cusing on international assistance and cooperation in health, with Chapter 14
examining the establishment of new global health funding agencies, bringing
state and non-​state actors together to pool resources to meet basic needs and dis-
tribute essential medicines.
Globalization has fundamentally altered public health, raising an imperative
for international law to address rising health threats, and Section IV analyzes
these issues at the leading edge of global governance. Recognizing the importance
of anti-​microbials to the treatment of infectious disease, Chapter 15 confronts
the rising challenge of anti-​microbial resistance and the need for collective ac-
tion through international law to prevent and respond to resistant strains. This
focus on the infectious disease response is extended in Chapter 16, considering
10 Global Health Law & Policy

the rise of international agreements to ensure pathogen sharing as a basis for

both responding promptly to disease threats and ensuring access to medicines
and vaccines. Chapter 17 looks to the evolution of international law to safeguard
sexual and reproductive health and rights, exploring how human rights advo-
cacy has reframed health policy and transformed health institutions. Framing
international humanitarian law as global health policy, Chapter 18 examines in-
ternational efforts to protect public health and human rights in the context of
armed conflict and humanitarian emergencies, looking to health protections
for refugees and ethical responsibilities of health professionals in avoiding harm
and upholding human rights. Climate change is affecting the health of the en-
tire planet, and given the cataclysmic threat to planetary health, Chapter 19
considers climate change mitigation and adaptation under the UN Framework
Convention on Climate Change. Bringing together efforts across sectors to ad-
vance public health through global health law, Chapter 20 concludes Section IV
by examining evolving policies to promote Universal Health Coverage, seeking a
multisectoral approach to addressing health in all policies.

Conclusion

Global health law is rapidly expanding, creating new governance institutions to

alter behaviors, sustain funding, and coordinate partnerships for justice in global
health. This foundational text reflects on the dramatic development of the field of
global health law, highlighting the advancements of law and policy in promoting
health equity, the challenges exposed by the COVID-​19 pandemic, and the need
for new legal and governance frameworks in responding to the threats of the 21st
century.
Out of the ashes of World War II, institutions of global health have brought
the world together in unprecedented cooperation through global health law,
giving rise to the successes and opportunities detailed throughout this text. This
expansion of international law to encompass global health law has laid out a
legal framework to structure efforts by the global community to advance global
health. However, the current age of rising nationalism amid emerging threats
has cast doubt on many of these successes and raised obstacles to future prog-
ress. In violent contrast with the shared goals of a globalizing world, populist
nationalism seeks to retrench nations inward, with rising nationalist movements
directly challenging norms of human rights, violating tenets of international law,
and spurring isolationism in global affairs. These challenges to global health law
have coincided with sweeping new global health threats, as nationalist retrench-
ment has led to a rejection of global health law as a basis for global health sol-
idarity. Such compounding crises offer a unique opportunity to reform global
 Introduction 11

health law to effectively coordinate pandemic preparedness and strengthen legal

authorities to advance global health.
Global health law remains necessary—​now more than ever before. As infec-
tious disease threats expand, the global climate changes, and humans, animals,
and environments are increasingly interconnected, bold law and governance
have become vital to a world that is safer and fairer. Global governance provides
hope for the future, with these governance institutions facilitating the durability
of global health law through the unprecedented challenges ahead. In preparing
for future threats, a wide range of crucial global health law reforms are being
undertaken simultaneously in the coming years, with the chapters of this book
grappling with these ongoing reforms. These reforms of global health law,
while each responding to distinct concerns, must be considered as interrelated
instruments across an interconnected legal landscape, with the reforms
undertaken in the coming years shaping the next generation of the field.

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