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This introductory column examines the development of the field, detailing the evolving scope and content of global health law. Beginning in the early history of international health law, national governments have long sought to address infectious disease threats through international regulations. This focus on international health law structured global governance for health in the aftermath of World War II, with the establishment of the World Health Organization (WHO) bringing states together to respond to common public health threats. Yet, WHO’s early efforts to stem the international 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 leading global health threats that will be explored in future columns, demonstrating the power of this emerging field in conceptualizing the legal response to global health.
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 eectiveness 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 eorts 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 oers 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
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
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 eorts 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
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
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
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
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 dier greatly
across countries, undercutting eorts
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 eorts
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 eective 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
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
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
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 eorts 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
immunization law to achieve wide-
spread vaccination and disease
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
planetary health and laws to miti-
gate and adapt to climate change,
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.
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.
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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... Across the life course, this contributes to an increased risk of overweight and obesity, cognitive impairments, reduced quality of life and non-communicable diseases (NCDs) [7,8]. The prevalence of childhood overweight and obesity globally is already at unacceptable levels with 38.2 million children under 5 years of age with overweight or obesity as at 2019 and over 340 million children and adolescents aged [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] with overweight or obese as at 2016 [8][9][10]. Such predatory marketing techniques, and the consequential effects, not only impact on children's physical and mental health, but they are also considered a breach of a child's right to health under the United Nations Convention on the Rights of the Child (UNCRC) [11,12]. ...
... It emerges from the more traditional field of international health law, which originally focused on the relationships between governments, in particular as they related to the international spread of specific infectious diseases. With the rise of globalisation and our interconnected world, global health law became the predominant terminology, encompassing a wide range of new actors including multilateral organizations like the UN, and a corresponding range of instruments relevant to this growing field [14][15][16]. ...
... There is a range of global health law instruments UN actors can utilise to call on Member States to act in relation to unhealthy food marketing [13,14,17]. Scholars define this suite of documents as encompassing a scale ranging from non-binding voluntary formal norms (no obligation to uphold the norms) backed by an authoritative body such as the International Code of Marketing of Breastmilk Substitutes to binding formal norms negotiated by authoritative stakeholders (i.e. ...
Full-text available
Introduction United Nations (UN) agencies are influential global health actors that can introduce legal instruments to call on Member States to act on pressing issues. This paper examines the deployment and strength of global health law instruments used by UN actors to call on Member States to restrict the exposure of children to unhealthy food and beverage marketing. Methods Global health law instruments were identified from a review of four UN agencies that have a mandate over children’s exposure to marketing of unhealthy food and beverage products namely: the World Health Organization (WHO); the Food and Agriculture Organization (FAO); the United Nations General Assembly (UNGA) and the UN Office of the High Commissioner for Human Rights (OHCHR). Data on marketing restrictions were extracted and coded and descriptive qualitative content analysis was used to assess the strength of the instruments. Results A wide range of instruments have been used by the four agencies: seven by the WHO; two by the FAO; three by the UNGA; and eight by the UN human rights infrastructure. The UN human rights instruments used strong, consistent language and called for government regulations to be enacted in a directive manner. In contrast, the language calling for action by the WHO, FAO and UNGA was weaker, inconsistent, did not get stronger over time and varied according to the type of instrument used. Conclusion This study suggests that a child rights-based approach to restricting unhealthy food and beverage marketing to children would be supported by strong human rights legal instruments and would allow for more directive recommendations to Member States than is currently provided by WHO, FAO and UNGA. Strengthening the directives in the instruments to clarify Member States’ obligations using both WHO and child rights mandates would increase the utility of global health law and UN actors’ influence.
... Informal services provide additional demand for services to maintain the minimum demand prerequisites for public services to be provided. This case provides empirical evidence from the opinion of Gostin & Meier (2019) which states that the existence of professional ethics can justify informal services provided with resources from the formal system. It is important to separate informal services from a legal perspective which allows informal services to be seen as illegal. ...
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The Sustainable Deveopment Goals prioritize universal essential public services as the second most important development goal after human basic needs in a global perspective. Indonesia implements a public service provision standard with a territorial approach and a set of minimum population requirement that lead to urban bias, resulting in border areas failing to meet the requirements for the provision of public services. Daerah Istimewa Yogyakarta Province is one of Indonesia's provinces with more than 70% of its border areas being rural, and more than 40% of border villages having limited essential public services. Because of the territorial delivery system for essential public services, formal cross-border services require a significant amount of resources. Using quantitative approach by indexing essential public services availability, this paper examines changes of essential public services coverage when cross-border services are provided informally. The case of Pustu Panggang informal crossborder service delivery provides lessons on how informal collaboration works. Although it involves misdeeds and omissions, the application of informal collaboration in cross-border services increases essential public service coverage by 57 percent in Daerah Istimewa Yogyakarta Province's rural border areas. As a result, informal collaboration should be viewed as a low-cost coping strategy in Indonesia's efforts to provide universal public service coverage.
... To maintain stability and restore the national economy, the government issued several policies to continue to support MSMEs during the pandemic. The policy is regulated in Government Regulation (PP) No. 23 of 2020 concerning the Implementation of the National Economic Recovery Program (PEN) which is a mandate from Perppu No. 23 Borne by the Government (DTP). The background of the tax incentives for the Final PPh DTP is an effort to expand the scope of tax incentives due to the impact of Covid-19 which also reaches MSME actors. ...
This study critically examines the role of legal safeguards in enhancing healthcare service quality. Utilizing normative legal research methods, the study employs legislative and conceptual approaches to explore the dual nature of legal protection: preventive and repressive, in the context of healthcare professionals adhering to established Standard Operating Procedures (SOPs). The findings suggest that healthcare practitioners' negligence level and the resultant harm to patients or the public determines the legal implications. Such implications range from allegations of SOP and ethical code violations, to civil litigation for damages, and even criminal charges if medical actions endanger lives, potentially causing patient mortality. Therefore, the study highlights the necessity for legal accountability for healthcare practitioners, emphasizing that their service delivery must align with the set SOPs. These findings have profound implications for policy-making, emphasizing the need for robust legal protection for both healthcare practitioners and service recipients, thereby ensuring improved healthcare service quality.Highlights: Dual nature of legal protection in healthcare. Negligence level dictates legal consequences. Emphasis on healthcare practitioners' legal accountability. Keywords: Legal Protection, Healthcare Services, Medical Negligence, Standard Operating Procedures, Legal Consequences
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The World Health Organisation (WHO) was inaugurated in 1948 to bring the world together to ensure the highest attainable standard of health for all. Establishing health governance under the United Nations (UN), WHO was seen as the preeminent leader in public health, promoting a healthier world following the destruction of World War II and ensuring global solidarity to prevent disease and promote health. Its constitutional function would be ‘to act as the directing and coordinating authority on international health work’. Yet today, as the world commemorates WHO’s 75th anniversary, it faces a historic global health crisis, with governments presenting challenges to its institutional legitimacy and authority amid the ongoing COVID-19 pandemic. WHO governance in the coming years will define the future of the Organisation and, crucially, the health and well-being of billions of people across the globe. At this pivotal moment, WHO must learn critical lessons from its past and make fundamental reforms to become the Organisation it was meant to be. We propose reforms in WHO financing, governance, norms, human rights and equity that will lay a foundation for the next generation of global governance for health.
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The paper outlines the contemporary legal framework of global health focusing on the legal duty of States to cooperate in the surveillance, prevention, and control of epidemic and pandemic disease. The paper details, in particular, the content and nature of States’ duty to cooperate under the International Health Regulations – the primary international legal instrument governing the global response to such events. It also examines the role of the World Health Organization and other UN bodies in fostering cooperation between States in the fight against epidemics and pandemics.
As Member States of the World Health Organization (WHO) meet in an International Negotiating Body (INB) to negotiate a legally binding agreement on pandemic prevention, preparedness, and response for submission to the 77th World Health Assembly in May 2024, this column reflects on creative but pragmatic and complementary means that could be employed in the short timeframe allotted for this important global health law negotiation.
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The role of the state has been underplayed in scholarship on global health. Taking a historical view, this paper argues that state institutions, practices and ideologies have in fact been crucial to the realisation of contemporary global health governance and to its predecessor regimes. Drawing on state theory, work on governmentality, and Third World approaches to international law, it traces the origins of the ‘health state’ in late colonial developmentalism, which held out the prospect of conditional independence for the subjects of European empires. Progress in health was also a key goal for nationalist governments in the Global South, one which they sought to realise autonomously as part of a New International Economic Order. The defeat of that challenge to the dominance of the Global North in the 1980s led to the rise of ‘global governance’ in health. Far from rendering the state redundant, the latter was realised through the co-option and disciplining of institutions at national level. To that extent, the current order has an unmistakably imperial character, one which undercuts its declared cosmopolitan aspirations, as evidenced in the approach to vaccine distribution and travel bans during the Covid-19 pandemic.
One of the legal rights that must be protected is intellectual property rights. This study analyzes intellectual property legal protection aspects based on a royalty system. This research is the normative legal research to produce legal arguments, usually called legal prescriptions. This study uses primary legal materials, which include: the 1945 Constitution of the Republic of Indonesia, the Patent Law, the Copyright Law, the Government Regulation on Song and/or Music Royalties, also the Plant Variety Royalties Act. Secondary legal materials include the results of studies and research on aspects of royalties in intellectual property rights. Non-legal material includes various non-legal studies of the royalty system in intellectual property. The approach in this research is a conceptual approach and a statutory approach. The results of the study confirm that the implication of the implementation of the royalty system in intellectual property rights requires the state to realize three fundamental legal values related to royalty policies, such as guarantees of legal certainty over the rules regarding royalties, guarantees of benefit from the distribution of royalties, as well as guarantees of fair distribution of royalties based on the principle of proportionality. In addition, legal protection with a royalty system in intellectual property rights needs to be carried out externally and internally.
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INTRODUCTION. Over the past decades under the influence of demographic processes, economic shocks, morbidity increase and other systemic problems a whole spectrum of threats to health has gradually formed at the international level, characterized by severe socio-economic consequences for each country regardless of the welfare level. Today, the challenges of ensuring universal coverage of services, access to safe, quality medicines, control of health care costs, effective response to health emergencies, antibiotic resistance are not limited by the WHO regulations, but are included in the agenda of the UN, ILO, FAO and other intergovernmental organizations. The need to form a unified approach to regulate activities of numerous participants in international healthcare regulation has served as an incentive for the gradual development of international legal regulation of the field of health protection, becoming the subject of study by leading legal scholars, as well as international organizations. The presented article provides a comprehensive analysis of the main historical stages in the development of international cooperation in the field of health protection, which served as the basis for the formation of international health law in the field of health protection as a new branch of international law. Special attention in the article is paid to the assessment of the role of globalization processes in changing the nature of threats to human and public health and their impact on the formation of global health governance concept. Based on the systemic problems that emerged during the COVID-19 pandemic, the author formulated the main directions for improving the international legal regulation of the health sector. MATERIALS AND METHODS. During article preparation the following document were studied: acts of a universal and regional nature, resolutions of international organizations, legal positions of UN specialized agencies, as well as professional scientific associations. The theoretical basis of the research are the scientific works of national and foreign scientists in the field of international law and international relations in the field of health protection. The article was prepared using the general scientific method of cognition, including the formal logical and situational method and private law methods, such as comparative, historical and formal legal methods. RESEARCH RESULTS. Within the framework of the study, a conclusion was formulated about the formation of "international health law" as a new branch of international law, uniting international legal norms and principles governing the relations of subjects of international law, as well as other participants in international relations in the field of human health. In the work, the author presents the main sources of "international health law" and formulates the subject of regulation of this branch of law. DISCUSSION AND CONCLUSIONS. Describing the features of international cooperation in the field of health protection, expressed in an increase in the number of involved international organizations and other participants which are not subjects of international law, the author substantiates the formation of the concept of global health management and analyzes the main scientific publications in this area. Having studied the nature of health threats that have formed over the past decade under the influence of globalization processes, as well as the systematic problems of international cooperation demonstrated by the coronavirus pandemic, the authors emphasize the need to implement the repeatedly proposed initiative to develop a universal act that forms the basis of international legal regulation of health protection.
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Objective To evaluate the impact of the WHO Framework Convention on Tobacco Control (FCTC) on global cigarette consumption. Design Two quasi-experimental impact evaluations, using interrupted time series analysis (ITS) and in-sample forecast event modelling. Setting and population 71 countries for which verified national estimates of cigarette consumption from 1970 to 2015 were available, representing over 95% of the world’s cigarette consumption and 85% of the world’s population. Main outcome measures The FCTC is an international treaty adopted in 2003 that aims to reduce harmful tobacco consumption and is legally binding on the 181 countries that have ratified it. Main outcomes were annual national estimates of cigarette consumption per adult from 71 countries since 1970, allowing global, regional, and country comparisons of consumption levels and trends before and after 2003, with counterfactual control groups modelled using pre-intervention linear time trends (for ITS) and in-sample forecasts (for event modelling). Results No significant change was found in the rate at which global cigarette consumption had been decreasing after the FCTC’s adoption in 2003, using either ITS or event modelling. Results were robust after realigning data to the year FCTC negotiations commenced (1999), or to the year when the FCTC first became legally binding in each country. By contrast to global consumption, high income and European countries showed a decrease in annual consumption by over 1000 cigarettes per adult after 2003, whereas low and middle income and Asian countries showed an increased annual consumption by over 500 cigarettes per adult when compared with a counterfactual event model. Conclusions This study finds no evidence to indicate that global progress in reducing cigarette consumption has been accelerated by the FCTC treaty mechanism. This null finding, combined with regional differences, should caution against complacency in the global tobacco control community, motivate greater implementation of proven tobacco control policies, encourage assertive responses to tobacco industry activities, and inform the design of more effective health treaties.
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The Universal Declaration of Human Rights, adopted on Dec 10, 1948, established a modern human rights foundation that has become a cornerstone of global health, central to public health policies, programmes, and practices. To commemorate the 70th anniversary of this seminal declaration, we trace the evolution of human rights in global health, linking the past, present, and future of health as a human right. This future remains uncertain. As contemporary challenges imperil continuing advancements, threatening both human rights protections and global health governance, the future will depend, as it has in the past, on sustained political engagement to realise human rights in global health.