Executive Summary
Health risks in the 21st century are beyond the control of any government in any country.
In an era of globalisation, promoting public health and equity requires cooperation
and coordination both within and among states. Law can be a powerful tool for advancing
global health, yet it remains substantially underutilised and poorly understood. Working
in partnership, public health lawyers and health professionals can become champions
for evidence-based laws to ensure the public's health and safety.
This Lancet Commission articulates the crucial role of law in achieving global health
with justice, through legal instruments, legal capacities, and institutional reforms,
as well as a firm commitment to the rule of law. The Commission's aim is to enhance
the global health community's understanding of law, regulation, and the rule of law
as effective tools to advance population health and equity.
The term law throughout is used to mean legal instruments such as statutes, treaties,
and regulations that express public policy, as well as the public institutions (eg,
courts, legislatures, and agencies) responsible for creating, implementing, and interpreting
the law. By establishing the rules and frameworks that shape social and economic interactions,
laws exert a powerful force on all the social determinants of health. Well designed
laws can help build strong health systems, ensure safe and nutritious foods, evaluate
and approve safe and effective drugs and vaccines, create healthier and safer workplaces,
and improve the built and natural environments. However, laws that are poorly designed,
implemented, or enforced can harm marginalised populations and entrench stigma and
discrimination.
This Commission brings together global leaders in the fields of health, law, and governance.
We make the case for better, more strategic linkages between health and law, and the
professionals who work in both fields. We begin by providing a short explanation of
legal terms and concepts, and the actors and institutions that govern health. Our
report is structured around four legal determinants of health, each of which powerfully
affects health outcomes. We use the term legal determinants of health because it demonstrates
the power of law to address the underlying social and economic causes of injury and
disease. These four legal determinants show how law can substantially influence health
and equity. We do not endeavour a systematic review of law in global health, but rather
to advocate for, and demonstrate, the crucial value of law in advancing global health
with justice. Finally, drawing on identified areas for reform, as well as principles
of good governance and the right to health, we offer seven concrete recommendations
for action.
Legal determinant 1 states that law can translate vision into action on sustainable
development. The UN Sustainable Development Goals (SDGs) present a bold and unifying
vision for global health and development. Law offers the mechanisms, frameworks, and
accountability measures to achieve this vision. In particular, law can be used to
lay the foundations for Universal Health Coverage (UHC), which is a crucial element
of sustainable development. We show how the power of law can be used to achieve health
with justice through a case study of how law can build and implement UHC. We make
two recommendations for action.
Recommendation 1 suggests that the UN, WHO, and international partners should set
standards to support the implementation of, and objectively evaluate compliance with
SDG 3·8 (UHC), as well as the upcoming UN political declaration on UHC in 2019.
Key messages
1
Law affects global health in multiple ways, by structuring, perpetuating, and mediating
the social determinants of health.
2
Although law has been central to major public health achievements in the past, its
capacity to advance global health with justice remains substantially underutilised,
particularly among professionals in the fields of health and science.
3
The right to health, a legally binding norm, provides a foundation for advancing global
health with justice and should underpin health-related legal reforms.
4
Every human being has a right to affordable, high quality health services. By embedding
equity and accountability in all health systems, the law and the rule of law can achieve
health coverage that is truly universal—delivering the Sustainable Development Goals'
promise to leave no one behind.
5
Although the ability to enforce compliance with international legal obligations is
generally limited, and largely dependent on power dynamics and political will, creative
mechanisms can foster compliance and help establish impetus for action.
6
Law can address the pressing health concerns of the 21st century, across diverse areas.
From tobacco control, non-communicable diseases, and road safety, to health emergencies,
law can implement fair, evidence-based interventions to save lives. The global health
community should champion evidence-based legal interventions and build the research
case for legal action.
7
Laws that stigmatise or discriminate against marginalised populations are especially
harmful and exacerbate health disparities. The global health community must oppose
laws that undermine the right to health and to equity.
8
To realise the full potential of law to advance global health with justice, the global
health community should build legal capacity and establish a sustained dialogue with
legislators, regulators, judges, civil society, and researchers.
Recommendation 2 advises that governments should strengthen or create a legal framework,
such as a constitutional or statutory right to health, to ensure rights-based UHC
on the basis of principles of equity and non-discrimination, including affordability,
financial protection, transparency, accountability, participation, privacy, and sustainable
financing.
Legal determinant 2 states that law can strengthen the governance of national and
global health institutions. Law can be used to structure and clarify the complex web
of institutions, norms, and processes that govern global health. We identify three
key governance challenges that undermine coordinated action for health, as well as
ways in which law can ensure good governance for health. First, where the mandates
of global health actors overlap, conflict, or leave gaps, law can harmonise mandates
and provide mechanisms to promote cooperation. Second, innovative legal and governance
strategies can foster state compliance and strengthen existing international rules.
Third, law can increase transparency, openness, inclusiveness, and accountability.
We make two recommendations for action.
Recommendation 3 suggests that the UN, WHO, and international partners should use
their respective powers and influence to safeguard the public's health and safety
through the creation or adoption of good governance standards, embracing the highest
principles of equity, inclusive participation, transparency, and accountability.
Recommendation 4 advises that governments should develop legal frameworks that establish
principles of good governance throughout national health systems and policy making,
form a country-appropriate mechanism to advise on legal interventions with high health
impact, and adopt legislation requiring health impact assessments for policies, programmes,
and projects that might seriously affect health.
Legal determinant 3 states that law can implement fair, evidence-based health interventions.
Evidence-based laws, effectively implemented and fairly enforced, can create the conditions
for good health. We provide a framework for evaluating health laws and identifying
those laws that advance health with justice. We offer concrete examples of such laws,
across three domains of health: infectious diseases, non-communicable diseases, and
injuries. In each domain, we discuss the ways in which international and domestic
laws interrelate and inform one another. We also show how laws that are not informed
by evidence and human rights could instead undermine health and justice, entrenching
inequality and discrimination. We make one recommendation for action.
Recommendation 5 suggests that WHO should increase its legal capacity to enable it
to spearhead development of a global evidence-base for public health laws and to support
the enactment and implementation of national and global health laws that are effective
and sustainable.
Legal determinant 4 emphasises the importance of building legal capacities for health.
Strong legal capacities are a key determinant of progress towards global health and
sustainable development. Yet, too often, countries lack either the basic legal infrastructure
or the capacity to build it. We make the case for productive, mutually reinforcing
linkages between law and health, and identify three aspects of legal capacity-building
for health: improving legal environments, growing the evidence-base with high quality
effectiveness research, and training key actors in law-making and law-implementing
skills. We make two recommendations for action.
Recommendation 6 suggests that governments should build national capacities to enact
and effectively implement public health laws.
Recommendation 7 suggests that WHO and The Lancet should partner with legal and health
experts to create an independent standing commission on global health and the law
that would advance the health-related SDGs by proposing evidence-based legal interventions
for addressing major global health challenges, reforms of the global health architecture
and international law, and strategies to build and strengthen global and national
health law capacities.
In making these recommendations, we acknowledge that law reform is a complex and drawn-out
process, presenting both technical and political challenges. Achieving global health
with justice will require international and interdisciplinary cooperation, as well
as leadership at all levels. However, as we underline in this report, law reform holds
enormous promise. With the ability to effect real change at the population level,
we argue, law should be considered among the key tools of the global health community.
By providing insight on the legal determinants of health, our aim is to empower the
global health community to strengthen its legal capacity, and to use law more strategically
in the pursuit of health and equity. Globalisation has heightened risks to our health,
but it also presents unprecedented opportunities to confront global health threats
collaboratively, drawing on expertise and lessons learned within and among nation
states. No government acting alone can achieve health with justice. Instead, we need
laws and policies at every level—local, national, and global—to achieve a world that
is healthier and safer.
Introduction
Health with justice
Health in the 21st century is being shaped by rapid globalisation. The unprecedented
movement of people, money, technology, and ideas around the world is changing the
profile of health and disease. Although previous decades have seen substantial reductions
in major global risk factors such as unsafe sanitation, and malnutrition, new threats
have emerged.
1
Global health hazards nowadays share four important features: (i) health hazards are
not bound by borders, ranging from infectious diseases, to non-communicable diseases,
and injuries; (ii) they have common underlying causes, such as dangerous pathogens,
unhealthy behaviours, or unsafe environments; (iii) they are exacerbated by inequities
linked to the socio-economic determinants of health; and (iv) they require a coordinated,
multi-sectoral global response.2, 3, 4 A crucial element of that response will be
the strategic use of law at all levels—local, national, and international—resting
on stronger cooperation between the legal and health professions. Just as the interdependence
of states and people heightens health risks, it also presents unprecedented opportunities
to confront global health threats collaboratively, drawing on expertise and lessons
learned within and among nation states.
The mission of the Lancet-O'Neill Institute of Georgetown University Commission on
Global Health and Law (the Commission) is to articulate a compelling vision of the
role of law in global health. In this report, we explain key legal concepts, offering
important ways in which law can be wielded to advance health and equity—not for an
audience of legal scholars, but for the global health community. Although many global
health professionals will be familiar with legal measures as an emergency response
to health crises, this is only one facet of law.
5
Less well understood is the role of law in governing global health institutions, in
resolving disputes, and in health promotion and protection. Even less visible are
those uses of law that, while not necessarily designed to affect health, have a profound
impact upon it. Understanding these forces, and how to harness them, will be vital
to improving population health in the 21st century.
Law and global health
We define global health as: study, research, and practice with the objective of preventing
injuries and diseases and promoting the public's health, while achieving equity in
health for all people worldwide—both within and among states.
6
In adopting this definition, our report builds on the 2014 Lancet-University of Oslo
Commission on Global Governance for Health (Lancet-Oslo Commission), which concluded
that “we must no longer regard health only as a technical, biomedical issue, but acknowledge
the need for global cross-sectoral action and justice in our efforts to address health
inequality.”
4
Global health is infused by the value of social justice, aiming to address gaping
health disparities within and among countries.
7
It strives to realise the universal right to health, grounded in international human
rights.
8
Law is a key determinant of health. By law, we mean the statutes, regulations, and
rules that express public policy. We also include the public institutions such as
legislatures, agencies, and courts in our definition, which are responsible for creating,
implementing, and interpreting the law.
9
Law exerts a powerful influence on health by structuring, perpetuating, and mediating
the risk factors and underlying conditions known as the social determinants of health:
10
education, food, housing, income, employment, sanitation, and health care. The impact
of law is felt not only in individual decisions (eg, of courts and tribunals) but
also in statutes and regulations that operate at the population level (eg, agricultural
subsidies, Universal Health Coverage [UHC], or mandatory seatbelt usage). As such,
law can be a powerful tool for securing and advancing health and equity. It can be
used to set and defend the norms and standards of good health, to establish and strengthen
resilient health systems, and to hold actors and institutions accountable.
However, law can also be a formidable barrier to achieving global health and equity.
Throughout history, misguided, out-dated, arbitrary, or discriminatory laws have caused
great harm. Punitive laws, for example, can discourage marginalised individuals from
accessing care, restrict reproductive rights, and enable discrimination in employment
or insurance. Whether driven by animus or unsupported by scientific evidence, bad
laws can undermine individual and population health, while entrenching inequalities.
They can exclude, stigmatise, and inappropriately punish individuals. Furthermore,
they can constrict the space for dissent and debate, for an independent press, and
for social action. In such cases, law reform is crucial—but often difficult. The process
of overturning old national legislation or adopting revised or new treaties often
involves bitter and drawn-out struggles. New or better health laws can threaten the
interests of powerful actors, including states, businesses, and lobbyists, who will
vigorously oppose reform. Even if law reform is possible, once in force, new laws
face challenges of monitoring and enforcement, in arenas often characterised by fragmentation
and contestation.
Approach and aims
The Commission views law and health as mutually reinforcing, and urges the legal and
health communities to work cooperatively toward a common goal of “global health with
justice”.
8
Working together, law reform should afford people “a fair and just opportunity to
be as healthy as possible”.
11
Law reform should also seek to eliminate the “systematic and potentially remediable
differences in one or more aspects of health across socially, demographically, or
geographically defined populations or population subgroups,”
12
as well as inequalities or differences in health that are “avoidable, unfair or [which
stem] from some form of injustice”.
13
This vision is expressed in the United Nations Sustainable Development Goals (SDGs),
which view health as a key component of a comprehensive, universal development agenda.
The SDGs envision “justice for all”, resting on “transparent, effective, and accountable
institutions”.
14
The multiple actors, institutions, and sectors in global health offer great promise
to achieve health with justice, but also face steep challenges. Governments and international
institutions do not harness the full power of law to improve health and save lives—whether
by dismantling barriers or by enacting affirmative reforms to safeguard population
health. Therefore, ensuring that the global health community clearly understands the
role of the law, and how best to use it, is imperative. This report makes the case
for the power of law to improve health, by informing the global health community about
the effects of law on health (through what we describe as the legal determinants of
health); exploring real-world case studies, opportunities and challenges; linking
the health and legal communities, while building shared capacity (ie, infrastructure
and resources); and empowering communities, countries, and global health institutions
to use law to advance global health with justice.
9
The Commission assembled a multidisciplinary team of experts from diverse backgrounds,
including law, health, policy, economics, and governance. While reflecting this richness
of expertise, our Report sits within the disciplinary tradition of public health law
scholarship,
15
and the emerging field of global health law scholarship.
7
Public health law is “the study of the legal powers and duties of the state to ensure
the conditions for people to be healthy … and the limitations on the power of the
state to constrain the…legally protected interests of individuals for the common good.”
15
Global health law, as a related field of study, uses a similar analytical orientation,
but focuses on the relationship between international law and health.
Law is the primary topic of analysis in our report. Public health law predominantly
uses legal doctrinal methods, informed by analytical frameworks from epidemiology
and population health. Public health law is beginning to incorporate empirical methods,
designed to evaluate the effects of law on public health,
16
and has a strong normative dimension: the view presented in this Commission is that
not only is law a powerful tool for achieving global health with justice, but also
that law should be used for this purpose. The universal right to health is a core
standard against which legal interventions should be assessed.
As the Lancet-Oslo Commission powerfully emphasises, issues far removed from the traditional
public health context—for example, market forces, income inequality, and global governance
structures—have a substantial effect on health. Law stands to influence almost every
one of these, meaning that the subject of global health and the law is potentially
vast. Therefore, the Commission has had to be selective, and, for this reason, is
necessarily limited in scope. Our concept of legal determinants is not the only way
to frame the topic. Rather, it reflects the Commission's views of what constitute
the major dimensions of law in global health, in the present era. The Commission has
identified areas of law that most directly affect population health, and which lie
within the remit of public health authorities. We do not purport to offer a systematic
review, but rather to enunciate core legal concepts, building the case for the value
of law in global health.
The legal determinants of health
Our Report begins with a short explanation of relevant legal terms and concepts: discussing
where and how law works locally, nationally, and internationally, and why the rule
of law is essential for health, development, and justice. We also describe the main
actors in global health. This provides a foundation for our four key legal determinants
of health: the areas identified in which stronger, more strategic linkages between
health and law could substantially strengthen the overall global health agenda.
The first legal determinant is that law can translate vision into action regarding
sustainable development. Law can help to achieve the SDGs' unifying vision for global
health and development. We illustrate the potential of law in advancing the SDGs through
a case study on UHC. The second legal determinant is that law can strengthen the governance
of national and global health institutions. The field of global health is complex,
comprising a web of institutions, norms, and processes at the global, national, and
subnational levels. Weak governance undermines leadership and coordinated action for
health. Law can strengthen health governance, including transparency, benchmarks,
and monitoring, with ongoing evaluation, civil society engagement, and accountability.
The third legal determinant is that law can implement fair, evidence-based health
interventions. Evidence-based public health laws—effectively implemented and enforced—can
create the conditions for healthy populations. We offer key examples of effective
laws across three health domains: infectious diseases, non-communicable diseases,
and injuries. We also show how law can undermine health and justice. The final legal
determinant is that law can be used to build legal capacities and reinforce all the
legal determinants of health. All the aforementioned determinants require stronger,
mutually reinforcing linkages between law and health. Effective health laws are guided
by science and translate the best available evidence on health improvement. Legal
capacity building includes stronger legal institutions (legislatures, agencies, and
courts), expanding the evidence-base with research evaluating the effectiveness of
laws, and training key actors in law -making and law-implementing skills.
In section 6, we offer seven recommendations, drawing on the major concepts identified
throughout the report. The recommendations encompass these four legal determinants
of health, covering rights-based UHC, good governance standards, fair and evidence-based
interventions, and building legal capacity.
Section 1: the legal system for global health
The concept of law has long been debated among legal scholars, as have modes of interpretation.
For the purposes of this report, the Commission proposes a “Primer on Law” intended
to be understandable to a public health audience. In this section, we define law and
explain how it is created, implemented, and enforced at the domestic and international
levels; describe the essential idea of the “rule of law”; articulate the obligations
of the state to ensure the conditions for health; and explain how law functions as
a tool to shape health outcomes. Finally, we identify the key actors and institutions
in global health.
What is law? How is it created, implemented, and enforced?
Although not always perceptible, law is all around us. The most common definition
of law is a body of norms (or rules of conduct) of binding force and effect, specified
and enforced by a recognised authority. Law is used to create rights and duties, which
should be applied fairly and consistently throughout society. Once implemented, people
experience the effects of law every day, as it shapes their lives through the enforcement
of legal standards and accompanying policies. This understanding of law is best illustrated
at the domestic level, where the recognised authority is the sovereign state—the supreme
authority within that territory. Because nation states have sovereign authority, they
can enact and enforce laws. However, no sovereign authority exists at the international
level, and the law requires states to agree to the terms of the legal instrument.
Even when governments do assent to international agreements, these can be hard to
enforce. Nevertheless, international legal norms remain essential for advancing health
rights.
Domestic and international law are interrelated and bi-directional in their impact
on health and justice. Innovations in domestic law and policy can offer a model for
other cities, countries, or regions to follow, or have a global effect; high-impact
litigation in one jurisdiction can empower advocates in other jurisdictions to undertake
similar action. International law, in turn, influences domestic law and policy by
creating widely accepted standards. Domestic legal norms diffuse to other jurisdictions
and up to international institutions, while international norms diffuse down to influence
local and national laws, regulations, and policies.
Domestic law
Law is used to establish norms, rules, and systems. In the health context, these rules
should seek to reduce or prevent risks of injury and disease equitably across populations.
17
In addition to imposing obligations on individuals and businesses in a society, law
also confers rights; for example, in many countries, every inhabitant has the right
to health care and public health services, and to equal justice under the law. The
state holds the primary obligation to fulfil these entitlements. Domestic law encompasses
the following sectors, each derived from different sources. Constitutions are the
highest law of the land. Statutes, regulations, and case law must conform to constitutional
norms and principles. Statutes (also called legislation, acts, laws) enacted by legislatures
such as Parliament or the Congress express public policy. Regulations, also termed
delegated legislation, from executive or administrative agencies safeguard the public's
health and safety (legislative bodies typically empower agencies to act). Case law,
from courts and other tribunals, interprets and applies the constitution, statutes,
and regulations to specific cases and sets judicial precedent. Beyond individual cases,
the effect of case law differs from country to country, depending on its constitutional
and legal traditions.
Constitutional law is widely regarded as the supreme law of the land. For the other
three sources of law, different jurisdictions might accord them different importance
or priority. We use the term “law” to encompass all four sources—each of which can
substantially affect health—as well as their interactions.
International law
International law does not take the same form as domestic law. The simplest definition
of international law is a set of norms or rules generally regarded and accepted as
binding, in relations between states and other groups such as international organisations.
International law primarily governs the conduct of states but can also substantially
affect private parties such as corporations (eg, in relation to trade law) and individuals
(eg, in relation to human rights law). Article 38 of the Statute of the International
Court of Justice offers the most authoritative statement of the sources of international
law, listing three primary sources: treaties, customary international law, and general
principles.
18
(panel 1
).
Panel 1
Sources of international law: treaties, custom, and general principles
Treaties are international agreements (which might also be referred to as conventions
or covenants), concluded between states in written form, and governed by international
law. However, States must give their consent to be bound—and even if they do so, they
might express reservations to exclude or to modify their legal obligations. A country
that has ratified or acceded to a particular treaty, and is therefore legally bound
by its provisions, is described as a state party. Certain international institutions
have law-making power. WHO has adopted two major treaties under its Constitution:
the Framework Convention on Tobacco Control (adopted under Article 19) and the International
Health Regulations treaty (adopted under Article 21).
18
Customary international law refers to legal norms that have emerged from general and
consistent state practice. Customary law is binding on all states, except those that
persistently object.
General principles of law refer to an amorphous body of law that emphasises broad
principles recognised in national legal systems such as common law, civil law, or
Islamic law (Sharia). Given the proliferation of treaty law, modern tribunals rely
less on general principles and consider them to be a secondary source of law.
Unlike in domestic law, there is no distinct international sovereign authority, and
no global government steers international relations and transnational cooperation.
Instead, various international institutions such as the UN, WHO, and the World Trade
Organization (WTO) have law-making powers or act as forums to facilitate negotiation
of treaties by member states. Additionally, states themselves might negotiate bilateral
or multilateral treaties or other transnational agreements.
Trade is an example within which various forms of international law are evident. The
WTO oversees several multilateral treaties, to which its member states adhere. States
are also free to negotiate their own trade agreements (FTAs), such as regional compacts
(eg, the United States–Mexico–Canada Agreement) or bilateral agreements, which might
create additional norms to those found in WTO treaties. Even though these agreements
are usually outside the sphere of the WTO, they must be consistent with WTO rules.
In the absence of a sovereign authority and a clear hierarchy of norms and rules,
international law faces multiple governance challenges, including ensuring efficient
implementation and compliance (see section 3). For example, international human rights
are a central goal of many global health organisations and an important commitment
for countries. However, states' compliance with human rights has been highly variable,
often undermined by powerful political and economic interests.
Across sectors, contemporary governance is characterised by the increasing use of
non-binding instruments adopted with a normative intent. These instruments aim to
guide, urge, or discourage particular behaviours. Soft legal instruments, covering
a broad range of topics, are known by various terms,
19
and we have chosen to use the term soft rules throughout this report.
The broad category of soft rules includes “any written international instrument, other
than a treaty, containing non-binding principles, norms, standards, or other statements
of expected behaviour.”
20
Codes of practice, global strategies, declarations and resolutions can all be described
as soft rules, as can recommendations, guidelines, and frameworks. UN and WHO resolutions,
although agreed through a formal legal process, usually do not create binding legal
obligations for member states. However, although not legally binding, these instruments
can have practical effects comparable to those of binding law, and are especially
important to benchmarking, monitoring, and transparency.
Soft rules have several advantages over formal law. They are usually less costly (in
both economic and political terms) and quicker to negotiate; they can be less rigid,
and therefore easier to amend; and they can reflect more ambitious targets. Governments
are often more willing to sign up to goals that are framed as targets or declarations
rather than obligations.
21
Furthermore, processes to develop soft rules can include a more diverse coalition
of actors beyond nation states, including voices from civil society that are traditionally
marginalised in treaty negotiations.
22
The relationship between soft rules and hard law is fluid. Soft rules can form a basis
for the development of formal international law, or international governments could
adopt non-binding standards into their legal instruments. For example, WTO's Agreement
on Sanitary and Phytosanitary Measures incorporates the non-binding guidelines of
the Codex Alimentarius Commission—a collection of internationally recognised standards,
codes of practice, and guidelines that apply throughout the food supply chain.
23
The United Nations Political Declaration on the Prevention and Control of Noncommunicable
Diseases (September 2011) offers another example of soft rules. Negotiated through
the General Assembly, the Declaration contains member states' commitments to prevent
and control non-communicable diseases.
Perhaps most importantly, soft rules can be adopted into domestic law through a nationally
sanctioned process (eg, through legislative or judicial decrees). Many soft rules
aim for national-level implementation, including the Joint United Nations Programme
on HIV and AIDS (UNAIDS) guidance on the prevention and treatment of HIV, and WHO's
guidelines on salt and sugar consumption. Countries have discretion to select which
soft rules to adopt domestically. Figure 1
shows the relationship between international and domestic law, including the translation
of soft rules into domestic law.
Figure 1
Relationship between domestic and international law
The rule of law
To earn and maintain the trust of the public, law makers—including legislatures, administrative
agencies, courts, and international bodies—must create, enforce, and interpret the
law impartially. These actions are the fundamental precept of the rule of law. Under
the rule of law, no individual, business, institution, or government official is above
the law: governments and public officials must be held legally accountable to act
in the public interest (panel 2
).
Panel 2
The rule of law
We adopt the definition used by the UN in its 2004 report, The Rule of Law and Transitional
Justice in Conflict and Post-Conflict Societies:
“A principle of governance in which all persons, institutions and entities, public
and private, including the State itself, are accountable to laws that are publicly
promulgated, equally enforced and independently adjudicated, and which are consistent
with international human rights norms and standards. It requires, as well, measures
to ensure adherence to the principles of supremacy of law, equality before the law,
accountability to the law, fairness in the application of the law, separation of powers,
participation in decision making, legal certainty, avoidance of arbitrariness and
procedural and legal transparency.”
24
SDG 16 links the rule of law to development, as a crucial foundation for the creation
and maintenance of “just, inclusive and peaceful societies”.
25
In the absence of the rule of law, neither health nor development can be fully realised.
State obligations to support the right to health
Governments in virtually every legal system have both the authority and the duty to
safeguard the health of the population.
15
This authority derives from domestic and international norms. Nation states derive
their authority through the concept of sovereignty: sovereign governments have sole
authority to make laws and regulations regarding the public's health. This principle
recognises that certain risks—such as infectious diseases, natural disasters, industrial
hazards, contaminated food and water—as well as the measures needed to prevent or
reduce those risks, are outside the control of individuals or groups. No individual
acting alone can assure the conditions for health and safety; only the State has the
power necessary to intervene at the population level, through coordinated action.
Many international instruments, including WHO's constitution and treaties, contain
state obligations to safeguard health-related rights. Article 12 of the International
Covenant on Economic, Social and Cultural Rights (ICESCR) from 1966 contains the foundational
expression of the right to health.
26
General Comment no. 14 of the Committee on Economic, Social and Cultural Rights (a
body comprising 18 independent experts that monitor state implementation of the ICESCR
by states parties) interprets and elaborates on Article 12.
27
General Comments offer guidance to states, clarifying treaty obligations and how they
should be implemented.
28
According to the ICESCR and General Comment no 14, the right to health is a “fundamental
human right indispensable for the exercise of other human rights”, and “every human
is entitled to the enjoyment of the highest attainable standard of health conducive
to living a life in dignity”.
29
States have an obligation to ensure available, accessible, affordable, and acceptable
health facilities.
The state's primary obligation is to protect the health and safety of its inhabitants,
not only citizens and lawful residents, but also asylum seekers, refugees, and undocumented
immigrants. Traditionally, states do not have duties toward individuals in other jurisdictions.
However, humanitarian law, human rights law, and WHO treaties can imply or even explicitly
prescribe transnational obligations. For example, states have a duty not to make,
store, or deploy banned weapons (such as chemical weapons), and not to violate fundamental
human rights. The International Health Regulations (IHR) contains non-binding language
encouraging state parties to help build health system capacities in lower-income states.
Soft rules, such as the Pandemic Influenza Preparedness (PIP) Framework, require parties
to share novel flu virus specimens and provide reciprocal benefits to other states.
When states act to ensure the public's health and safety, they can impose restrictions
on private interests.
30
Public health interventions can constrain personal autonomy, privacy, or liberty,
and can limit businesses' economic freedom. Finding a balance between protecting liberties
and securing population health is an enduring theme in public health law and ethics.
31
Failing to strike an appropriate balance might result in disproportionate personal
burdens, especially on marginalised populations. However, often, no conflict exists
between individual and collective interests. For example, protecting the rights of
individuals living with HIV or AIDS empowers them to access treatment, which both
improves their health and reduces the likelihood of transmission. The role of the
law, then, is to safeguard the health and safety of individuals and communities, while
not restricting personal freedoms more than strictly necessary to fulfil health objectives.
The Siracusa Principles on the Limitation and Derogation Provisions in the International
Covenant on Civil and Political Rights (ICCPR) 1985 guide states in striking the delicate
balance between protecting liberties and securing population health.
32
The Siracusa Principles were developed in response to concerns about governments illegally
or unjustifiably declaring martial law or a state of emergency to deny fundamental
rights and freedoms. The Principles were established to determine when such departures
from the ICCPR might be permissible. Restrictions might be justifiable when they are
in accordance with the law; based on a legitimate objective; strictly necessary in
a democratic society; the least restrictive and intrusive means available; and not
arbitrary, unreasonable, or discriminatory.
33
Under international law, the Siracusa Principles are persuasive but non-binding, meaning
that states should strongly consider but are not legally required to follow them.
Functions of law
Law has numerous functions, many of which directly or indirectly affect health. By
“functions of law”, we mean how the law shapes societal interactions.
34
The Commission chose to focus on three crucial functions. Law can be used to establish
standards and norms that guide conduct, resolve disputes, and govern public and private
institutions. Throughout this report, we draw on these three functions, explaining
their relationship to global health.
Establishing norms and standards in domestic and international law
In domestic law, the first duty of sovereign states is to protect the health, safety,
and welfare of the population. Governments fulfil this duty principally by developing
and enforcing rules and standards that structure the physical and social environment,
guiding behaviour of individuals and the conduct of organisations. National constitutions
typically empower governments to safeguard the public's health and might also allocate
responsibilities between states or provinces and the federal government, and between
legislatures, agencies, and courts.
In the health context, states set norms and standards using the following powers.
15
The power to tax and spend creates economic incentives (eg, agricultural subsidies)
or disincentives (eg, tobacco taxes) for individual and corporate conduct that affects
health. The power to alter the information environment and inform the public about
the health effects of products (labelling, warnings, health education) or restrict
deceptive marketing such as cigarette advertising. The power to alter the socioeconomic
environment can create more equitable societies with fairer access to public goods
(redistributive taxation, safety nets, and social welfare policies). The power to
alter the physical and built environment can improve the quality of water and sanitation
in communities, or can create liveable spaces and communities that are conducive to
physical activity, including parks, playgrounds, or bike paths. Governments use direct
regulation of people, professionals, and businesses to set and enforce rules for numerous
purposes —some of these include mandating childhood vaccinations or seatbelts, establishing
systems for credentialing and licensing health professionals, or determining standards
for motor vehicles or pharmaceuticals.
Indirect regulation through the tort system such as product liability and tobacco
litigation creates disincentives for businesses that make and sell unsafe or hazardous
consumer products. Finally, legal or regulatory reform provides substantive rights
in relation to health and to justice (eg, informed consent, confidentiality, privacy,
non-discrimination); or deregulation, in cases where existing laws or regulations
impede public health (such as law banning distribution of sterile injection equipment)
or stigmatise marginalised communities (such as criminal penalties for engaging in
same-sex behaviour).
States could also use inward-facing regulation to improve the machinery of government.
35
States should ensure the good governance rule of law, consisting of inclusive participation,
honest stewardship of public resources, and accountability, in addition to strong
regulatory capacities. For example, in 2011, the South African Constitutional Court
held that the nation's constitution contained an implied governmental obligation to
establish an effective anticorruption unit.
36
Inward-facing regulation can also improve the delivery of health goods and services
by ensuring a strong, well-funded health system. Inward-facing regulation is related
to the third function of law (governing institutions).
International law also sets norms and standards that have a direct or indirect effect
on health and safety, and with which states should, or must, comply. International
health-related norms include protecting the child's best interests and capacities,
37
prevention and control of non-communicable diseases, and access to essential medicines.
38
Standards that directly affect health include those for sanitary, which relate to
animals; phytosanitary, which relate to plants; environmental pollution levels, and
classification of diseases.
23
WHO oversees three major international legal instruments,
39
to which we refer throughout this report. The first is The Framework Convention on
Tobacco Control (FCTC), an international treaty and thus legally binding; the IHR,
another legally binding treaty; and The PIP Framework, which is not a formal treaty.
Many international rules were not created for a health purpose but have a profound
impact on health. International trade rules (including intellectual property agreements),
have far-reaching consequences for health. The relevant international regimes, their
rules, and their intersection with health are described in the appendix.
Countries often have broad discretion as to how, and to what extent, they conform
to international norms and standards. Full conformance often requires states to translate
international norms and standards into national legislation. For example, WHO's FCTC
(2003) requires states parties to adopt and implement effective national measures
to ensure that tobacco product packaging and labelling do not promote tobacco products
by false, misleading, or deceptive means.
40
States must act within their own legal systems to comply with international law. However,
states retain sovereignty in deciding whether to ratify the treaty and in how they
incorporate its requirements into their domestic law.
Domestic law can also provide greater precision than that which is expressed in expansive
legal instruments. International health-related rights—such as the rights to health,
privacy, and non-discrimination—are enshrined in many regional and domestic legal
frameworks, including national constitutions.41, 42 To fully realise the right to
health, governments must implement measures through domestic law and regulation (panel
3
). Broad international guidance requires detailed national policy making.
Panel 3
Case study of legal responses to infectious disease (hepatitis C)
Despite enormous gains in the treatment of disease, the increasingly globalised nature
of the world nowadays has made the spread of infectious diseases across borders a
persistent, global public health challenge. In seeking to contain the spread of infectious
disease, countries leverage a broad array of tools at their disposal. One important
tool is the law, which poses unique challenges and opportunities in its role to help
contain infectious disease. The global response to hepatitis C exemplifies some of
these challenges and opportunities.
Worldwide, approximately 70 million people live with chronic hepatitis C virus infection.
43
In the last decade, the development of direct-acting antivirals has provided an effective
cure in the form of oral, well tolerated treatment regimens for people with chronic
hepatitis C virus infection; cure rates of over 95% have been achieved with direct-acting
antiviral regimens.
44
Despite the existence of an effective cure, the number of people treated for hepatitis
C still remains a relatively small fraction of those infected or diagnosed.45, 46
Patent-related barriers that keep prices high substantially contribute to this problem.
46
Direct-acting antivirals have a wide range of patents, covering the chemical molecules,
manufacturing processes, methods of treatment, and formulations.
47
Patents covering various aspects of direct-acting antivirals prevent the entry of
competitors, allowing originator companies to select the price for the market.
48
Although these patents cover a broad range of features, the reality of country-specific
patent regimes means that a patent granted in one country might not be granted by,
or even filed in another country. In countries where patents are not filed or granted,
local production or importation of generics is possible, and the competition from
these generics, in turn, drops the price and increases access to the drug. An example
of this was observed in Georgia and Morocco;
49
in both countries, primary patents for the direct-acting antiviral sofosbuvir were
not filed. As a result, generic companies could produce that drug, enter the market,
and decrease the price of the drug.
In countries where patents are issued, another set of options have been utilised by
groups and countries to mitigate patent-related barriers. For example, some non-governmental
organisations have been attempting to systematically test or undermine patents issued
in certain countries to facilitate competition and access.
46
Many national patent regimes provide the opportunity for third party filings, which
serve as a way to register concerns about whether the compound has sufficiently met
the requirements of patentability. Non-governmental organisation attempts to undermine
patents have led to the rejection of key patent applications for direct-acting antivirals
in Brazil, China, Egypt, and Ukraine.46, 50, 51, 52, 53, 54, 55, 56, 57, 58
Where patents exist and have been unsuccessfully challenged, another option available
to groups and countries is voluntary licence agreements. These agreements formalise
originator companies' permission to manufacture and sell generic versions of their
drug regimens in specific countries or regions. As a result, countries included in
originator companies' voluntary licensing agreements are able to access generic direct-acting
antivirals from licencees at lower prices.
53
For example, one manufacturer licenced its products to eleven generic manufacturers
in India, facilitating the sale of generics in more than 100 countries.
53
Countries not included in voluntary licence agreements can still increase competition
and access by way of other strategies. The Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS),
54
an international legal agreement between all the member nations of the World Trade
Organization, acts to constrain actions for countries with respect to patents. However,
countries do have the right under TRIPS to grant government use or compulsory licences
in certain circumstances.54, 55 In September, 2017, Malaysia became the first country
to issue a compulsory licence for a direct-acting antiviral.46, 52 After issuing the
licence, Malaysia was then included in the voluntary licence agreement of some manufacturers.
56
The net effect of this global patchwork of patent laws and policies is, on the one
hand, a steep price cut in low-income and middle-income countries, and, on the other
hand, a slowly declining price trend in upper middle-income and high-income countries.
46
The former is promising because more than 60% of people with hepatitis C nowadays
live in a country that could access generic direct-acting antivirals.
46
However, not all countries that can access more affordable generic treatments do,
and, still more troubling, although some competition has altered prices in upper middle-income
and high-income countries, high prices of direct-acting antivirals continues to impede
access to an effective cure.
46
Resolving disputes at national and international levels
The second crucial function of law is as a tool to resolve disputes between individuals,
organisations, and governments. This role of the law can occur in diverse venues,
including traditional courts of law, and via alternative dispute resolution mechanisms,
such as mediation or arbitration. Although dispute resolution typically involves specific
parties, the outcomes can reach well beyond these parties. In the following sections,
we examine how two important forms of dispute resolution—strategic national litigation
and international dispute resolution—have been used in the health context, and how
their outcomes have been leveraged as broad public policy tools.
Strategic national litigation is the first important form of dispute resolution. Despite
landmark public health litigation—on issues ranging from mental health and tobacco
control, to access to medicines—the legal and public health communities continue to
debate the strategic value of litigation in pursuit of public policy goals or other
systemic change. Litigation is time-consuming, expensive, and technical, with unpredictable
outcomes. Any individual or corporation can bring a court case, potentially furthering
private interests inconsistent with the public's health. Corporations can use the
courts to overturn or diminish the effect of health and safety laws, or to defend
marketing unsafe or unhealthy products.
Moreover, public policy requires balancing competing interests, and courts are generally
not well suited to such determinations. In right-to-health litigation, courts are
charged with deciding which individuals are eligible to receive a specific health
service or product. However, judges have limited facts and perspective: they must
adjudicate according to the parties and evidence in front of them, rather than considering
issues at the population level. Are judges better placed to decide on the allocation
of scarce health resources than elected officials? When is it appropriate for a court
to decide that an individual litigant is entitled to access pharmaceuticals not listed
on the government's or WHO's essential medicines registries?
While acknowledging these weaknesses, and others, we believe that well targeted strategic
litigation—eg, proceedings that seek systematic change and remedies that extend far
beyond the individual litigants—can be effective in advancing public health, complementing
other approaches.
Tobacco litigation is perhaps the most familiar example of successful strategic litigation
to drive public policy.
57
In the USA, advocates and state attorney generals brought class action litigation
against tobacco companies after pursuing numerous other legal and policy avenues.
Tobacco control litigation, still in process, has produced two well known outcomes.
The first was the 1998 Master Settlement Agreement, which forced tobacco companies
to curtail marketing and to make annual payments, in perpetuity, to US states, and
the second was the “Tobacco Papers”, a vast cache of internal industry documents uncovered
in 1994 that revealed duplicitous industry actions such as concealing the harms of
tobacco use and the addictiveness of nicotine, and marketing directed toward children
and adolescents.
58
Tobacco litigation has had enduring effects on public health. The litigation exposed
the unethical behaviour of industry executives, informed the public of the devastating
dangers of tobacco smoke, and secured industry funds for health promotion. The Tobacco
Papers are housed in a public repository, informing subsequent tobacco control measures
throughout the world.
59
The FCTC emphasises the value of domestic litigation, asking parties of states to
share information and strategies.
Strategic litigation can also precisely interpret broad or abstract principles, such
as the right to health, leading to improved health care. Litigation on access to anti-retroviral
drugs is one area in which notable success has been achieved. In Minister of Health
versus Treatment Action Campaign (2002), the Constitutional Court of South Africa
held that government limits on the public sector provision of nevirapine were unreasonable
and unconstitutional. Nevirapine halves perinatal HIV transmission rates. The Court
found that limiting access was a breach of the right to health care, which was not
consistent with a positive state obligation to progressively realise the rights of
mothers and infants to essential health services.
60
Similarly, the Venezuelan Supreme Court (1999) required the State to provide HIV treatment
and to develop social awareness campaigns.
61
In 2000, the Argentine Supreme Court found that the “right to health falls within
the right to life…the first natural right of the individual”, and directed the government
to provide HIV treatment.
62
These cases, along with other right to health litigation, have contributed greatly
to social movements.
63
Controversies in public health litigation have also been reported. Modelled on the
cases described above, individuals have increasingly launched health rights litigation
around the world on issues including reproductive rights, mental health, and smoking
in public places.
64
Notably, this litigation often occurs in the context of democratic failure: litigants
turn to the courts because corruption, autocratic practices, and the dominance of
powerful interests provide little opportunity for changing policies through the political
system.
65
Although gaining traction,
66
the justiciability of the right to health (ie, the question whether or not a court
can adjudicate a claim brought on the basis of the right to health) remains a contested
issue in many jurisdictions.
64
The long-term effects of litigation on equity and justice are not yet clear,
64
and are dependent on context. For example, one study of litigation in a southern Brazilian
state concluded that “judicialization largely serves the disadvantaged who turn to
the courts to secure a wide range of medicines.”
67
However, in other cases, courts have granted individuals access to expensive medications,
some of which have little demonstrated value. When courts override careful policy
assessments by the legislature, they might divert resources for health that could
otherwise have been used for more cost-effective interventions. Consequently, scholars
have noted: “Courts in adjudicating health human rights need to frame the right in
the context of the larger equity and solidarity goals of a public health care system…one
danger with a rights-based approach is that it can reinforce the individual demands
for high-priced treatments, thus exacerbating the difficulties governments have in
running fair and efficient health care systems.”
68
This danger was realised in Colombia, where individuals bringing legal actions known
as tutelas overwhelmed the public health system in the 1990s and 2000s, requiring
a judicial ruling on the limits and definition of the right to health (panel 4
).
Panel 4
Litigation as a tool to define the right to health
In 1991, Colombia enacted a new Constitution followed by a series of reforms intended
to extend health insurance to all citizens. The 1991 Constitution enshrined economic
and social rights, establishing a Constitutional Court as a specialised tribunal to
oversee the new constitutional jurisdiction. This gave individuals the right, when
economic and civil rights were not being met, to take the government to court through
a writ called a tutela.
69
Tutelas give citizens an avenue to ensure that the government actively provides for
their constitutional rights, including rights to health care.
However, health-related tutelas rapidly overwhelmed the tribunal. According to a report
by the Human Rights Ombudsman's Office, between 1999 and 2008 there were 674 612 actions
for protection of constitutional rights in relation to health issues.70, 71 Additionally,
rather than creating a more equitable dispute resolution system for all Colombians,
tutelas were often exploited by members of the wealthier class.
72
The Colombian Constitutional Court subsequently issued a sweeping decision to improve
the equity and oversight of the health system and stem the tide of litigation.
73
The decision provided necessary definition and limits to the right to health for Colombia.
Moreover, the Colombian Court had to carefully assess the practical and financial
burden its decision would have on the government. As scholars have noted, “if health-related
rights are treated as unconditional and not limited by resource capacity, this can
put an unsustainable burden on public insurers and undermine the ability to [act]
as wise stewards of public resources through negotiating prices or resisting patent
extensions and so forth”.
68
However, individuals in many of these cases were simply seeking the treatments and
other services to which they were already legally entitled.
74
As scholars from multiple disciplines have recognised, there is no inherent conflict
between right to health adjudication and efficient and equitable priority setting.
75
Furthermore, litigation can be time-intensive, costly, and unpredictable, dampening
its potential benefits. In the US tobacco litigation, industry defendants imposed
enormous delays and high costs over the course of decades and multiple waves of litigation
before health advocates eventually gained traction in the courts.
76
Many industries, including the food, beverage, alcohol, and tobacco industries often
use litigation to diminish innovative public health laws. In 2012, tobacco companies
successfully halted US Food and Drug Administration (FDA) regulations to mandate graphic
warnings. The US Supreme Court found that the FDA rule violated the companies' constitutional
commercial speech rights. Industries' use of the commercial speech doctrine has also
undermined public health regulations designed to prevent obesity and other non-communicable
disease risk factors.
At the international level, multiple dispute resolution systems exist, with varying
degrees of effectiveness. The WTO's is among the most robust, with three main stages:
first, consultations between the parties; second, adjudication by panels, followed
by the Appellate Body; and finally, implementation of the ruling, including countermeasures
if the losing party fails to comply. The World Bank's International Centre for Settlement
of Investment Disputes (ICSID) offers another venue for transnational litigation.
The ICSID is charged with interpreting bilateral or multilateral investment treaties
designed to protect industry investments in governments that are parties to those
treaties.
The WTO and ICSID, as tribunals, must reach judgment on the individual cases before
them and not on their possible implications for public policy. In some cases, they
have protected industry interests over the public's health. Tobacco companies have
used both ICSID and WTO processes to challenge tobacco control laws in Uruguay (marketing
restrictions) and Australia (plain packaging). The ICSID arbitration panel ruled decisively
in Uruguay's favour in July, 2016, requiring Philip Morris to pay the costs of the
defendant and the court.
In contrast to certain well established dispute settlement systems, WHO's treaty dispute
mechanisms are weak. Under Article 27·1 of the FCTC, the parties must try to settle
their disputes “through diplomatic channels”, using negotiation or mediation. If the
parties cannot settle their dispute in this way, the FCTC envisages ad-hoc arbitration
with the exclusive jurisdiction of an arbitration panel. However, only three countries
have formally agreed to be bound by this arbitration, and the mechanism has never
been used.
The IHR (2005), the WHO treaty aimed at global health security, include a dispute
settlement process between state parties (Article 56), which is voluntary. State parties
should first seek to resolve the dispute through negotiation or mediation, after which
the matter might be referred to the Director-General. However, this voluntary dispute
settlement system has never been used.
WHO's PIP Framework uses a combination of non-binding norms and legally binding contracts
to achieve its aims. The PIP Framework was devised to forge a compromise among higher
and lower-income countries on virus sharing and equity. The associated contracts,
known as Standard Material Transfer Agreements (SMTAs), are used to bind non-state
actors who would not usually be subjects of international law, such as pharmaceutical
companies or academic institutions.
39
The SMTAs include a binding arbitration clause: “if a dispute cannot be resolved through
negotiations or other non-binding means of the parties' choice, disputes shall be
subject to binding arbitration on conditions that are mutually agreed by the parties.”77,
78, 79
Other dispute resolution models beyond international legal instruments include public–private
partnerships (PPPs), such as the Global Fund to Fight AIDS, Tuberculosis and Malaria;
and Gavi, the Vaccine Alliance, as well as institutions such as the World Bank. These
resolution models have rules and regulations related to how grant and loan resources
can be used, and how they must be accounted for.
Furthermore, regional and international human rights treaties often have quasi-judicial
dispute settlement systems for states that accept to be bound by them, which are available
once domestic avenues have been exhausted —for example, the Committee on the Elimination
of Discrimination Against Women (CEDAW), a treaty body tasked with monitoring state
party compliance with the international Convention on the Elimination of All Forms
of Discrimination against Women.
80
Unlike a court, a treaty body does not pass judgments, but monitors compliance and
issues recommendations. In 2011, CEDAW heard the matter of Alyne da Silva Pimental
Teixeira versus Brazil, which concerned human rights violations in the context of
maternal mortality. CEDAW recommended reparations for the individual harmed, also
recommending that Brazil reduce maternal mortality risks and discrimination against
pregnant women. Brazil complied with both aspects of the decision.
81
Governing public and private institutions
Finally, law can be used to establish, structure, and oversee public and private institutions.
This function overlaps with the first two functions (establishing norms and resolving
disputes) primarily with respect to scope and process. Law governs the operations
of government institutions that are involved in setting standards (eg, parliaments,
administrative agencies, and courts), as well as corporations and non-governmental
organisations. We briefly explain how law works to establish, structure, and oversee
the key players and organisations in global health.
Laws can establish institutions and define the reach of their activities by setting
out institutional mandates. A mandate refers to the explicit, implied, and customary
powers and responsibilities of an organisation.
82
A state's constitution defines the government's obligations to safeguard the public's
health and to protect personal freedoms and rights. Constitutions often establish
branches of government, allocating power among them (and setting limits on those powers),
and delineating responsibilities. Statutes establish a country's key agencies, such
as the Ministry of Health, defining its mandate and powers, while allocating funds
for its operations. Treaties establish and govern international institutions, such
as WHO. The WHO constitution is a legally binding treaty that defines the organisation's
mission, scope of its organisational activities, and the responsibilities of its organs
(assembly, executive board, regional and country offices, and secretariat). A corporation's
mandate—that is, the purpose for which the corporation has been established—is set
out in its charter or founding documents, such as a Memorandum of Association. Corporations
are formed under provincial or federal laws that specify their fiduciary duties, duties
to report and pay tax, and other responsibilities. Statutes and regulations can define
the activities, structure, and limitations of a not-for-profit organisation with a
global health mission. Non-governmental organisations must abide by the legal parameters
set for their operation. The proliferation of institutions working in global health
has added a new level of complexity, which includes the overlapping mandates of public,
private, and non-governmental organisations, and public–private partnerships. We elaborate
on these issues in section 3.
Law also governs processes and institutions by providing systems of checks and balances.
The classic example is the checks and balances between the legislative, executive,
and the judicial branches of government, which help prevent one branch from dominating.
Under this principle of government, “separate branches are empowered to prevent actions
by other branches and are induced to share power.”
83
The law specifies the powers of each branch and the ways in which each branch can
limit the powers of the others. The actions of legislatures and agencies are often
subject to judicial review, but the legislature can override decisions of judges (other
than with constitutional rulings). Checks and balances are crucial to the rule of
law (panel 5
).
84
Panel 5
Checks and balances and the rule of law
The rule of law is central to achieving health with justice, and systems of checks
and balances are central to the rule of law. Although checks and balances are often
codified, this is not always the case. The World Justice Project notes: “governmental
checks take many forms; they do not operate solely in systems marked by a formal separation
of powers, nor are they necessarily codified in law. What is essential, however, is
that authority is distributed, whether by formal rules or by convention, in a manner
that ensures that no single organ of government has the practical ability to exercise
unchecked power”.
84
However, their robustness depends on institutional design, as well as the legal system
and political culture within the jurisdiction.
Although governmental checks and balances provide the classic example, a similar framework
can operate within and between public and private institutions, and between institutions
making decisions at different levels—eg, national governments can modify the effect
of decisions made at the international level. WTO members are required to implement
the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
through national legislation recognising and enforcing pharmaceutical patents.
54
However, in many jurisdictions, these intellectual property protections have limited
individuals' access to medicines. In response, governments have devised mechanisms
to balance intellectual property protection with greater access to medicines.
85
Therefore, national legislation on medicines procurement or patentability criteria,
as well as TRIPS flexibilities, have sought to expand social goals, while recognising
private rights.
86
Yet further scope remains for countries to use the flexibilities that TRIPS provides
to enable greater access to medicines.
87
Non-state actors can also provide a check on unreasonable exercise of government power.
Civil society organisations are instrumental in demanding transparency and accountability
from governing institutions. Non-state actors have a powerful voice in pushing governments
and international institutions to use their legal tools in a manner that promotes
justice and human rights, such as by protecting marginalised or disadvantaged populations.
For example, advocacy on HIV has spurred government action around the world, ranging
from research funding through to expanded treatment access.
88
Whether at the grassroots level or internationally, participation by non-state actors
and civil society organisations in governing processes increases the legitimacy, transparency,
justice, and democracy of such processes.
Key players in global health
National public health agencies and intergovernmental institutions dominated the global
health landscape for decades. Although these actors remain central, the landscape
is changing rapidly: new institutions are proliferating, and traditional structures
of power and control are evolving (see section 3). Many of these key players do not
have the power to make law, but all are subjects of law. They are parties to contracts,
disputes, or rules of various kinds, and they can use their influence to either encourage
or impede legal reforms.
Nation states
Nation states remain the major force in the global governance system. The nation state
is “the fundamental building block of the global polity … [and] the primary authority
for the negotiation of global rules.”
4
Compared with other actors, nation states have the broadest range of powers, with
the sovereign power to directly govern and regulate health. While health ministries
continue to oversee most public health policy making, laws made by multiple different
agencies—across sectors such as agriculture, commerce, transport, and the environment—can
profoundly affect health outcomes.
Moreover, nation states make up the membership of intergovernmental organisations,
with a seat at the decision-making table. The major intergovernmental institutions
include UN agencies and programmes, regional organisations, and economic policy forums
such as the G7 and G20. Nation states also have a high degree of influence through
their overseas development aid programmes, and through bilateral or multilateral cooperation.
International organisations
The UN is the primary international organisation. The UN system is charged with ensuring
international cooperation, including promotion of health and human rights. UN organs
and agencies have historically engaged in global health work. The WHO, formed in 1948,
was the first specialised UN agency, and, under its constitution, has the primary
mandate for governing global public health. For many decades, WHO remained the preeminent,
if not the sole, institution in the global health space. The WHO has robust legal
powers to govern global health and to encourage action among countries, including
powers to make international treaties in the form of conventions and health regulations.
However, many other UN bodies operate in the arena of global health, including the
Food and Agriculture Organization (FAO, which has treaty-making powers)
89
the UNDP, UNICEF, the UN Population Fund (UNFPA), and UNAIDS,
90
all of which can influence both national and global health law.
Other multilateral organisations exert a substantial indirect influence on the legal
and economic dimensions of global health. Of importance are the WTO and the Bretton
Woods institutions. The WTO's mission is to “open trade for the benefit of all”.
91
WTO members must commit to certain legal obligations in fulfilling this mission, such
as enacting strong protection for intellectual property. This may create access barriers
for health services or impede public health policy by increasing the cost of essential
medicines.
92
Established in 1944 with an initial mission of post-World War II reconstruction, the
Bretton Woods institutions are the World Bank and the International Monetary Fund
(IMF). They shape the global health landscape through their financial and economic
support for global health and development. The World Bank provides financial and technical
assistance to developing countries to foster income growth and end extreme poverty.
93
Since the 1970s, its loans and grants have supported a range of development priorities,
including health. During 2000–16, the World Bank invested US$35 billion in health,
nutrition, and population.
94
In the aftermath of the Ebola epidemic in west Africa, the Bank has focused on global
health security.
The IMF is an intergovernmental institution comprising 189 member countries, with
a mission “to ensure the stability of the international monetary system”.
95
Their work includes lending and capacity development, and when providing support (or
bail-outs) to countries in financial difficulties, the IMF's assistance might be accompanied
with conditions such as deregulation or reduced health spending.4, 96
Non-state actors
Just as public health at the national level is no longer the sole purview of health
ministries, WHO has now been joined by an “explosion of actors in the global health
arena”.
97
Non-state actors—notably philanthropies, hybrid PPPs, and civil society organisations—have
become crucial to the development, influence, and funding of global health initiatives.
Through financial resources as well as social mobilisation and advocacy, these organisations
wield considerable influence and can use that influence to drive legal change. Corporations,
including in the tobacco, alcohol, food, and beverages sectors, can have negative
effects on health. The private sector also works to improve health outcomes, providing
funds but also expertise and personnel in response to specific needs such as health
emergencies. For example, during the 2013–14 Ebola outbreak, companies provided logistics,
communications, and transportation, as well as operating treatment units.98, 99
Private philanthropic organisations are non-state actors that have become major funders
of global health. The Bill & Melinda Gates Foundation is the single largest donor
of discretionary funds to WHO.
100
This Foundation has a strong focus on technical solutions to global health challenges,
investing in vaccines (eg, HIV, polio, and malaria) as well as family planning, nutrition,
and maternal and child health.
101
The Rockefeller Foundation is an older, more established philanthropic foundation
with a long history in public and global health, which champions UHC. Other examples
of philanthropic foundations include the Clinton Foundation working on HIV and AIDS,
Bloomberg Philanthropies working on tobacco control and liveable cities, Mundo Sano
working on neglected tropical diseases, the Children's Investment Fund Foundation
working on child health and poverty, and the Fundación Carlos Slim, working for health,
justice, and community development.7, 102, 103, 104 Other prominent philanthropies
include The Arab Gulf Programme for Development, working on poverty alleviation, human
development, and human rights; the Aga Khan Foundation, addressing human development
and strengthening civil society organisations; and the Sasakawa Memorial Health Foundation,
working on leprosy, and rights of people with disabilities.
A defining feature of the global health governance landscape is the rise of PPPs:
hybrid structures made up of non-state actors (eg, businesses, philanthropies, and
civil society organisations) working jointly with governments and health agencies.
These partnerships have both economic and legal dimensions. PPPs respond to the desire
of funders to exercise greater control over the use of their resources, and to bypass
bureaucratic and governance barriers in the UN system. Institutions established as
PPPs often have a specific mandate, with control and influence shared by the public
and private partners. They exist on a continuum, in which some are more public in
nature (eg, largely financed funding agencies that include private actors on their
boards), whereas others are closer to private institutions—eg, entities working closely
with the private sector to accelerate research and development (figure 2
).
105
Figure 2
The public–private partnership continuum
Adapted from National Academy of Sciences, Engineering, and Medicine,
105
by permission of The National Academies Press.
The largest PPPs operating in global health include the Global Fund to Fight AIDS,
Tuberculosis and Malaria; and Gavi, the Vaccine Alliance. Unitaid is a PPP that invests
in innovations to prevent, diagnose, and treat HIV, tuberculosis, and malaria. The
Coalition for Epidemic Preparedness Innovations is among the newer PPPs, working to
galvanise the development of new vaccines against diseases with pandemic potential.
In 2016, the US National Academy of Sciences found that PPPs could deliver “improved
responsiveness and accountability to society and…better outcomes in shorter timeframes.”
105
Civil society organisations—primarily non-governmental organisations—have long been
influential in global health as advocates for research and treatment, and for human
rights. Among the most well known non-governmental organisations are Médecins Sans
Frontières, CARE International, the International Red Cross and Red Crescent, Oxfam
International, Save the Children, Rotary, and Caritas. Many of these civil society
organisations work primarily in the humanitarian and development sectors, and as first
responders to health emergencies (eg, in natural disasters, epidemics, and war zones).
Other civil society organisations, such as the Center for Reproductive Rights, focus
their efforts (including leveraging the law) on advancing international health and
human rights. There are also civil society organisations at the country level undertaking
grassroots social mobilisation and advocacy, such as the Treatment Action Campaign
(HIV) and Section 27 (the right to health) in South Africa, and the Center for Health,
Human Rights and Development in Uganda. Patient rights groups have also been powerful
advocates for government policy, legal change, and funding, including in relation
to HIV, tuberculosis, and Alzheimer's disease, as have professional and scientific
associations and networks such as the American Heart Association and the International
Council of Nurses. Although these rights groups are often left out of formal global
diplomacy, civil society organisations can be an influential voice for human rights
and the right to health, especially domestically, as well as in multi-partner alliances
such as the Framework Convention Alliance on Tobacco Control.
106
Section 1 provided an introduction to the legal system for global health, including
explanations of three key functions of law and the key players. We now turn to the
substantive ways in which law can affect health and justice, which we characterise
as the legal determinants of health.
Section 2: legal determinant 1
The first legal determinant can be used to translate vision into action on sustainable
development. This determinant relates to the power of law to channel the SDGs' unifying
vision for global health into concrete action. We first briefly describe the SDGs'
agenda for global health. Because UHC is so crucial to the future of global health,
we present a case study showing how law can advance the SDGs' bold vision of health
and justice. We examine the legal foundations of UHC, as well as legal mechanisms
for its implementation.
The SDGs and global health
Adopting the 2030 Agenda for Sustainable Development in September, 2015, the UN General
Assembly articulated a transformational vision: “We envisage a world free of poverty,
hunger, disease and want, where all life can thrive. We envisage a world free of fear
and violence. A world with universal literacy. A world with equitable and universal
access to quality education at all levels, to health care and social protection, where
physical, mental and social well-being are assured. A world where we reaffirm our
commitments regarding the human right to safe drinking water and sanitation and where
there is improved hygiene; and where food is sufficient, safe, affordable and nutritious.”
14
Member states promised to rigorously implement this agenda, which comprises 17 goals
(the SDGs) and 169 targets, by 2030. They replace the Millennium Development Goals
(MDGs), while building on their success, expanding their scope, and highlighting unfinished
business. Committing to “leave no one behind”, the SDGs articulate an equity agenda,
developed through a crosscutting multisectoral strategy involving a consultative,
grass-roots process.
107
Health in the SDGs
Although the MDGs included several health-specific goals,
108
the SDGs have a single unifying health goal. Goal 3, supported by 13 targets, aims
to “ensure healthy lives and promote well-being for all at all ages”.
109
Referencing the millions of preventable deaths, including deaths of children and childbearing
women, goal 3 states: “these deaths can be avoided through prevention and treatment,
education, immunization campaigns, and sexual and reproductive healthcare. The Sustainable
Development Goals make a bold commitment to end the epidemics of AIDS, tuberculosis,
malaria and other communicable diseases by 2030. The aim is to achieve UHC, and provide
access to safe and affordable medicines and vaccines for all. Supporting research
and development for vaccines is an essential part of this process as well”.
109
Several other SDGs directly relate to the conditions needed for healthy people and
healthy communities. For example, goal 2: “end hunger, achieve food security and improved
nutrition and promote sustainable agriculture;”
110
goal 5: “achieve gender equality and empower all women and girls”;
111
and goal 6: “ensure access to water and sanitation for all”.
112
Virtually all other goals include targets that relate directly or indirectly to health,
such as: targets 4·2 (access to early childhood development and care); 7·1 (affordable
modern energy services); 11·6 (adverse environmental impact of cities, with special
emphasis on air pollution); 13·1 (climate related hazards and natural disasters, and
related mortality); 16·1 (reducing violence-related deaths); 16·9 (legal identity
for all, including birth registration); and 17·19 (measuring statistical capacity-building,
including the registration of births and deaths).
14
Justice in the SDGs
At the core of the SDGs' vision is equal and universal access to health care and justice,
with an emphasis on their interrelationship. For example, goal 3 aims to “ensure healthy
lives and promote well-being for all at all ages”,
109
and includes targets such as achieving UHC (target 3·8).
109
Goal 3 also relies on the concept of justice in its targets. Target 3·b focuses on
building support for “research and development of vaccines and medicines for the communicable
and non-communicable diseases that primarily affect developing countries”.
109
This goal relies in part on concepts of justice embodied in transnational legal agreements,
such as the Doha Declaration and the Agreement on Trade Related Aspects of Intellectual
Property Rights.
113
Furthermore, goal 16 aims to “promote just, peaceful and inclusive societies”, and
calls for “access to justice for all, and building effective, accountable institutions
at all levels”.
113
A goal 16 target promotes “the rule of law at the national and international levels”,
ensuring “equal access to justice for all”.
114
This formalises a longstanding understanding that the pursuit of justice is an essential
ingredient of sustainable development.
115
The role of law in realising the SDGs
With health linkages throughout the SDGs, the potential to advance health through
realising the SDGs is vast. However, the ability of law to achieve this remains largely
untapped and requires an enhanced understanding and recognition of how best to use
law in different SDG areas. For example, climate change—which threatens the health
SDGs and many others—is directly addressed in SDG 13, and is an area where the use
of law is robust (eg, UN Framework Convention on Climate Change, the Paris Agreement,
carbon taxes, and renewable energy incentives). However, the use of law specifically
to address the interaction between health and climate change is less well developed
and is an important agenda item for the future.
The SDGs and their targets give greater specificity to the broad principles expressed
in the right to health. Going well beyond health-care services, they encompass the
multiple conditions needed for health and safety throughout the lifespan. In turn,
law can help give these goals tangible effect, moving the question from “what is sustainable
development?” to “how can sustainable development be achieved?”
116
Governments use all three functions of law to establish the frameworks of authority
needed to move from principles to actions. In relation to the SDGs, laws are essential
to enshrine the right to health in national policy and to oversee the quality of health
professionals and hospitals through licensing and accreditation (eg, establishing
norms and standards); to adjudicate disputes between individuals, health providers,
and the State (eg, resolving disputes); and to establish new institutions with a specific
or broad health mandate (eg, governing institutions).
Regarding a broad, aspirational statement like SDG 3 (“ensure healthy lives and promote
well-being for all at all ages”), law can provide detail and accountability. What
does the concept of healthy lives mean? Who is obligated to ensure the conditions
for health and safety? Through what mechanisms will they do so? To what standards
will they be held? How will they be held accountable for good performance? UHC offers
a good illustration of the way in which law can translate vision into action on sustainable
development. In the next section, we use UHC as a case study to identify the ways
in which law functions both to lay the foundations for, and to implement, health for
all.
Case study: law as a tool to achieve UHC
UHC as a crucial component of sustainable development
Nationally and globally, there exist profound differences in health outcomes, the
socioeconomic determinants of health, and the availability and affordability of quality
health services. The WHO and the World Bank both estimate that at least half of the
world's population cannot obtain essential health services.
117
The most glaring inequities in health outcomes often correlate directly with unequal
access to health services: service coverage is often poorest where needs are greatest.
118
These inequities occur both between countries (healthy life expectancy is 44·4 years
in Sierra Leone, compared with 74·9 in Japan)
119
and within countries (ethnicity, geography, and socio-economic status can greatly
reduce the accessibility and quality of health care).
120
For example, in Australia, life expectancy for Aboriginal and Torres Strait Islander
men born from 2010 to 2012, was 10·6 years lower than that of non-Indigenous men.
The discrepancy for women was nearly as wide at 9·5 years.
121
The WHO views UHC as among its highest priorities.8, 117, 122, 123, 124, 125 In 2005,
the 58th World Health Assembly (WHA) adopted a resolution for sustainable health financing,
universal coverage, and social health insurance, calling on countries to plan for
the transition to UHC.
126
Since then, UHC has become a global priority and a central element of WHO's efforts
to strengthen health systems and improve the quality and distribution of health and
health services.127, 128, 129 With the UN General Assembly adopting the SDGs in September,
2015, UHC became a global target, which will be reinforced by the UN high-level meeting
on UHC in 2019.
130
SDG 3·8 views UHC as “financial risk protection, access to quality essential health
care services and access to safe, effective, quality and affordable essential medicines
and vaccines for all”.
113
SDG 3·8, if fully implemented, would help realise the universal right to health.
Definition and basic principles
UHC does not have a uniform definition and its variable meanings have created uncertainty.
The World Bank offers a broad, conceptual framing: “UHC is about people having access
to the health care they need without suffering financial hardship.”
131
WHO gives a more detailed definition, noting: “UHC means that all people can use the
promotive, preventive, curative, rehabilitative and palliative health services they
need, of sufficient quality to be effective, while also ensuring that the use of these
services does not expose the user to financial hardship.”
132
WHO emphasises equity in access to health services (everyone who needs services should
get them, not only those who can pay for them); the quality of health services; and
protection against financial risk—ensuring that the cost of using services does not
put people at risk of financial harm, so that people's ability to pay is not linked
to their ability to access health services.
UHC has been defined as a practical expression of the right to health,
133
drawing together all the health-related SDGs. However, it focuses primarily on access
to and provision of health care, whereas the right to health is considerably broader,
embracing multiple conditions for healthy and safe lives, such as potable water, nutritious
and safe food, adequate housing, and clean air.
Health systems range from national health systems with single or multiple payers,
to government subsidised access, to public or private insurance; therefore, no single
path exists to UHC.
134
However, countries embracing UHC tend to consider health a basic human right, often
enshrined in their national constitutions or laws. Since 2010, over 100 countries
have sought technical guidance from WHO and the World Bank to move towards UHC.
135
Countries representing half of the world's population (Brazil, China, India, Russian
Federation, and South Africa) are engaged in health system reforms to extend service
coverage and increase financial protection.
135
Although UHC often faces political resistance because of cost, the World Bank regards
it as high value for money.
134
UHC brings direct benefits such as improved population health and more productive
societies.
136
Health coverage also contributes indirectly to development, as healthy children learn
better,137, 138 and healthy populations facilitate economic growth.139, 140 Furthermore,
studies show that for every dollar spent on key health services, the direct and indirect
benefits would exceed costs by a factor of between 9 and 20, further showing the benefits
that arise from investing in health.
3
Legal foundations of UHC
The duty to provide UHC derives from two sources of law: national and international.
Regardless of a government's motivation for pursuing UHC, the legal foundations remain
the same in that a state has the sovereign duty and authority to safeguard the public's
health and safety.
15
The State's duty and power to implement UHC derives from its constitution or legislation.
For example, Thailand's constitution, promises that “health is considered as an entitlement
of Thai citizens and equal access to basic health services should be guaranteed.”141,
142 Brazil's Constitution likewise recognises health as a social right.86, 143 In
other jurisdictions, national public health legislation provides the mandate for UHC.
A legal right to health services is important but not sufficient. Governments must
abide by the rule of law to develop, implement, and adjudicate a UHC framework. If
the rule of law is weak, it will be difficult to engage other legal mechanisms to
achieve not only UHC, but also more basic tasks of governance. If public officials
or health professionals are corrupt, it will be difficult to garner the resources
and ensure the equity and functionality of UHC.
International law creates robust obligations to safeguard the right to health, strengthening
states' domestic duty. The ICESCR (Article 2·1) requires states parties to: “take
steps, individually and through international assistance and co-operation, especially
economic and technical, to the maximum of its available resources, with a view to
achieving progressively the full realization of the rights recognized in the present
Covenant by all appropriate means, including particularly the adoption of legislative
measures”.26, 144
Specifically, under Article 12, states parties “recognize the right of everyone to
the enjoyment of the highest attainable standard of physical and mental health”, and
undertake to take steps on concrete health goals, including the “prevention, treatment
and control of epidemic, endemic, occupational and other diseases”.26, 144
As described above, the UN Committee on Economic, Social and Cultural Rights offered
an authoritative interpretation of “the right to the highest attainable standard of
health” in General Comment 14.
29
Beyond the ICESCR, many treaties safeguard health rights, including non-discrimination
in access—for example, the UN Convention on the Rights of the Child, the Convention
on the Elimination of all Forms of Discrimination Against Women, and the Convention
on the Rights of Persons with Disabilities. Even though states may be parties to different
treaties, the overwhelming majority of countries are party to at least one treaty
that embodies the right to health, making it a virtually universal standard.
Human rights treaties place the primary responsibility for ensuring the right to health
on governments. Yet, governments are also obligated to provide international assistance
to protect and promote the right to health, for example under article 2(1) of the
ICESCR. The concept of shared responsibilities for health has a “solid textual foundation”.
42
The Office of the UN High Commissioner for Human Rights (OHCHR) guidelines on maternal
morbidity and mortality and human rights, the UNAIDS and OHCHR guidelines on HIV and
AIDS and human rights, and the Maastricht Principles on Extraterritorial Obligations
of States in the Area of Economic, Social and Cultural Rights all confirm the international
obligation to provide assistance on UHC. Furthermore, the UN Special Rapporteurs on
the Right to Health have been clear on the obligations of states in so-called hard
law and soft rules.
145
Because states hold the primary responsibility to create and maintain UHC, many argue
that gaping inequalities between countries are beyond legal remedy. We reject this
proposition. The international community holds a responsibility to reduce health disparities,
and international health assistance will remain an important funding source. Low-income
and middle-income countries do need to devote a higher percentage of their gross domestic
product (GDP) into health systems, but still might be unable to afford the estimated
US$86 per capita (2012) required for UHC, and $112 per capita (2014) to achieve the
health SDG.146, 147 The first Special Rapporteur on the Right to Health, Paul Hunt,
observed that “if there is no legal obligation underpinning the human rights responsibility
of international assistance and cooperation, inescapably all international assistance
and cooperation is based fundamentally upon charity. While such a position might have
been tenable 100 years ago, it is unacceptable in the twenty-first century.”
148
Although there is a strong ethos of charitable discretion in international health
assistance, sustainable funding requires a mutual sense of responsibility between
those providing and those receiving assistance.
149
Otherwise, the international system creates a situation in which governments can blame
each other for not doing enough.
150
Moreover, in low-income countries, or those with unstable governments, weak health
systems can exacerbate vulnerabilities leading to extremism and violence.
Development assistance for UHC is essential to global security—both health security
and human security. In this regard, countries have existing commitments: under the
UN Charter (to cooperate in achieving the universal observance of human rights) and
the ICESCR (to provide international assistance and cooperation). Therefore, establishing
an international legal or regulatory framework to clarify the obligations of international
health assistance would be appropriate. Under such a framework, countries could, for
example, agree to devote a percentage of their GDP towards national UHC, while higher-income
countries agree to fill financing gaps through international development assistance
for health.
The role of law in achieving UHC
Law provides both the mandate for UHC and the tools to achieve it. However, although
the mandate is universal (based on the right to health) the means of realising UHC
differ from country to country, depending on the legislative and regulatory mechanisms
available, as well as policy choices. These mechanisms and choices will affect each
of the crucial measures of UHC: access, equity, quality, cost, and choice. All these
measures are important, but they also entail subtle or overt political choices or
trade-offs. For example, universal access to high quality services, equitably distributed,
has substantial economic costs. If governments place a high value on individual choice
in the private market, this will affect measures such as access, equity, quality,
and cost.
151
States, of course, are not entirely restricted in the ability to make trade-offs:
their actions are constrained, at the very least, by their human rights obligations—especially
the right to health.
In its report about health systems financing, WHO noted, “all countries must make
choices and trade-offs, particularly in the way that pooled funds are used”.
152
The trade-offs inherent in realising UHC are often depicted as a cube (figure 3
), in which the X-axis depicts the population (who is covered?), the Y-axis depicts
the cost (the proportion of direct costs that are covered from pooled funds, that
is, prepaid funds from different sources that are accumulated and used to cover everyone
who is part of the pool, such as the entire population), and the Z-axis depicts the
services covered. Moving closer to universal coverage means expanding the cube: extending
coverage to more people, including the marginalised and vulnerable; offering more
services to meet essential health needs; and paying a greater part of the cost, thereby
protecting citizens from impoverishment.
152
Figure 3
Universal Health Coverage cube
Adapted from WHO,
152
by permission of World Health Organization.
Increasing coverage also requires good governance, and an understanding of both the
documented and practical gaps in UHC: the possible “bottlenecks and weaknesses that
prevent health systems from serving the entire population and from providing the full
suite of priority services at a cost that is affordable and sustainable.”
86
Crucially, UHC must be understood as effective, affordable access to quality health
services (UHC in practice)—and not merely covering everyone with some form of insurance,
regardless of whether they can in fact access quality health services (UHC on paper).
Effective access, particularly for those with the least means, will not only depend
on how health systems are designed (eg, strengthening primary health services), but
also on how health insurance systems are designed. Legal strategies relating to each
axis of the cube (figure 3), in addition to good governance, are further discussed.
The X-axis, or, the population axis, describes who is covered. The term “universal”
in UHC relates to a state's duty to provide health services to all people under its
jurisdiction. Without adequate legal frameworks to support it, so-called universality
might be no more than an aspiration, doing little to change “policies under which
many governments either deliberately or passively refuse to grant access to health
services to some people living within their national borders”.
153
Governments often exclude a wide swath of vulnerable people from high quality services,
including asylum seekers, refugees, undocumented immigrants, expatriate workers, indigenous
peoples, nomadic people, or groups that are historically marginalised because of sexual
orientation, gender identity, sex characteristics, disability, political beliefs,
or religious affiliation.153, 154 These populations are often already vulnerable,
and least able to afford out-of-pocket health care expenditures; they are precisely
the groups a UHC system should aim to cover. For example, in Rwanda, households are
means-tested on their assets and revenue and stratified accordingly. The government
then pays premiums for the 25% of the population who have been classified as the most
vulnerable.
155
The law should inclusively define the meaning of the term universal in a country's
UHC scheme, as well as providing redress in cases of discrimination or service denial.
This can be achieved by enshrining the right to health in a country's constitution
or legislation;
152
establishing a patient charter of rights that defines the right of access to the scheme,
along with a dispute resolution system to deal with complaints by those who are denied
health services to which they are entitled;
86
empowering a health-care ombudsman or health-care commission with powers to investigate
breaches of the State's duty to provide health services; decentralising or devolving
health systems management, so that people can access services (including dispute resolution)
at the local level, without having to travel; regulating the way in which health insurance
schemes (public and private) deal with membership and coverage, such as banning insurers
from discriminating against individuals with pre-existing conditions and requiring
coverage of essential services such as vaccines, primary care, nutrition services,
and child and maternal health; and ensuring statutory protection for the security,
privacy, and confidentiality of health information.
86
The Y-axis, or, the cost axis, describes financing in UHC. Governments express genuine
concerns about financing UHC.
152
Full funding entails developing health systems that can deliver all required health
services that are of good quality and readily accessible to the whole population.
Sustainable financing can involve one of two strategies. Governments can allocate
more of their overall budget to health—for example, at least 5% of GDP.156, 157 Alternatively
or in addition, they can find new ways to raise revenue, whether by improving general
tax administration and collection, increasing existing taxes, or introducing new taxes.
152
States can raise revenue for UHC in a variety of ways. In countries with a longer
history of UHC, funds are traditionally raised through compulsory pre-payment schemes,
such as taxation, compulsory insurance contributions, or a combination of both.
86
Conversely, low-income and lower-middle-income countries that have moved towards UHC
are using novel mixes of funding mechanisms for their national health insurance models.
158
These include general taxes, earmarked taxes (eg, raised from taxing unhealthy products
such as tobacco, alcohol, sugary beverages, or from airline taxes—a key source of
financing for Unitaid), payroll deductions, household premium contributions, and in
some cases, foreign assistance (eg, about half of the financing for South Africa's
UHC programme comes from the US President's Emergency Plan for AIDS Relief).134, 158,
159 However, countries, should not overly rely on international health assistance
because it can be inconsistent and unreliable, impeding the government's ability to
plan for and finance its health system over the long term. Additionally, donors often
give preference to their own special areas of health need, which might not match what
the host population needs.
Moreover, countries should generally avoid voluntary schemes (those in which people
are not required to purchase insurance) as these schemes are not effective ways to
achieve UHC. Increasing—or, particularly in the case of sugary beverages or other
categories of unhealthy foods, initiating—taxes on unhealthy products is a particularly
promising route, which creates a direct, positive health effect while also raising
revenue (panel 6
).
Panel 6
Policy options that involve the use of law and regulation, from WHO's menu of policy
options on non-communicable diseases160
Tobacco use
•
Increase excise taxes and prices on tobacco products
•
Implement plain or standardised packaging and large graphic health warnings on all
tobacco packages
•
Enact and enforce comprehensive bans on tobacco advertising, promotion, and sponsorship,
including cross-border advertising and using modern means of communication
•
Eliminate exposure to second-hand tobacco smoke in all indoor workplaces, public places,
public transport, and in all outdoor mass-gathering areas
•
Provide cost-covered, effective, and population-wide support (including brief advice,
national toll-free quit line services, and treatment for addiction) for tobacco cessation
to all those who want to quit smoking
•
Implement measures to minimise illicit trade in tobacco products
Harmful use of alcohol
•
Increase excise taxes on alcoholic beverages
•
Enact and enforce bans or comprehensive restrictions on exposure to alcohol advertising
(across multiple types of media)
•
Enact and enforce restrictions on the physical availability of retailed alcohol (via
reduced density of retail outlets and reduced hours of sale)
•
Enact and enforce drink-driving laws and blood alcohol concentration limits via sobriety
checkpoints
•
Establish minimum prices for alcohol if applicable
•
Enact and enforce an appropriate minimum age for purchase or consumption of alcoholic
beverages
•
Restrict or ban promotions of alcoholic beverages in connection with sponsorships
and activities targeting young people
Unhealthy diet
•
Reduce salt intake through the implementation of front-of-pack labelling
•
Eliminate industrial trans fats through the development of legislation to ban their
use in the food chain
•
Reduce sugar consumption through effective taxation on sugar-sweetened beverages
•
Implement subsidies to increase the intake of fruits and vegetables
•
Replace trans fats and saturated fats with unsaturated fats through reformulation,
labelling, fiscal policies, or agricultural policies
•
Limit portion and package size to reduce energy intake and the risk of becoming overweight
or obese
•
Implement nutrition labelling to reduce total energy intake (kcal), sugars, sodium,
and fats
Physical inactivity
•
Ensure that macro-level urban design incorporates the core elements of residential
density, such as connected street networks that include sidewalks, easy access to
a diversity of destinations, and access to public transport
•
Provide convenient and safe access to quality public open space and adequate infrastructure
to support walking and cycling
Each of these mechanisms can raise legal issues. For instance, donor funding is often
underpinned by international agreements with donor countries or organisations—eg,
World Bank or Global Fund payments come with clear contractual conditions. Moreover,
UHC programmes that combine public and private funding for health raise governance
challenges, underlining the need for appropriate and robust oversight and regulation
of coverage plans. For example, the Insurance Regulatory Authority in Kenya regulates
insurers, including licensure, quality assurance, and consumer protection and education.
161
Earmarking (also known as hypothecation) can be a useful way to raise revenue and
target behavioural health risks, as in the case of tobacco taxes that are earmarked
for health spending. However, existing laws may prohibit the use of earmarking, and
the practice is seen as contentious because it constrains fiscal policy making.
Furthermore, at each stage of the financing process (from revenue raising, to pooling,
to the purchasing of services by providers and governments) regulation plays an important
role in ensuring funds are allocated fairly and transparently.
86
Regulatory agencies are often empowered to require full disclosure of finances, and
can oversee the efficiency and honesty of funding flows.
The Z-axis, termed the services axis, determines which services are covered in UHC.
Health financing also concerns “the efficiency, equity, and effectiveness of the ways
in which resources are raised, pooled, allocated, and used to achieve desired health
systems outcomes”.
134
As WHO has warned, “pooled funds will never be able to cover 100% of the population
for 100% of the costs and 100% of needed services. Countries will still have to make
hard choices about how best to use these funds”.
152
This statement is in relation to the third axis of the UHC cube which describes the
services that are covered. When deciding what is covered and what is not, the central
challenge is to achieve the right balance between preventive, health promotion, and
treatment services, in a way that is equitable and does not entrench inequities within
populations.
162
Prioritisation and selection of health services are driven by national disease burden
and priorities, which in turn should be determined by evidence of cost-effectiveness,
affordability, and health impact. A country's essential medicines list, for example,
ought to be based on population needs, evidence of effectiveness, and cost.
Law and regulation are integral to making difficult choices, because they establish
processes and institutions to guide transparent decision making. States use legal
processes to express national health priorities, and legal frameworks define and delineate
that which is possible for a state to achieve. In determining what is and is not covered,
states use a variety of legal mechanisms and institutions, including the following
four examples. First, independent statutory authorities are tasked with reviewing
clinical and epidemiological evidence and providing advice to governments about the
effectiveness and cost-effectiveness of treatments and technologies—for example, the
UK's National Institute for Health and Care Excellence. Second, administrative agencies
are tasked with determining which medications are placed on formularies, and the amount
or extent of any government subsidy. Third, legislation can specify which services,
or categories of services should be provided under a UHC scheme. Finally, courts and
tribunals can make de-facto decisions on service prioritisation. In South Africa,
the Constitutional Court required access to antiretroviral medication for pregnant
women,
60
while in Brazil the judiciary has ruled on numerous claims of denial of access to
medicines. Conversely, Colombia's Constitution Court required priorities to be decided
through a participatory, evidence-based process (panel 4). Litigation can raise its
own problems, including the concern that it could favour wealthy litigants and thus
entrench health inequalities.
163
Finally, good governance is an important role of the law in achieving UHC. An effective
UHC programme requires a process of monitoring, evaluation, and accountability, including
independent review, dispute resolution, and a compensatory process in the event of
adverse outcomes, as well as other administrative, political, legal, and social remedies.
164
Again, law plays a vital role. Because health sector corruption drains scarce resources,
eliminating corruption is an essential component of good governance.
The World Bank and WHO have developed a UHC monitoring framework that focuses on three
key components: quality, essential health services, and financial protection.
165
In December, 2017, these two agencies launched the global monitoring report on tracking
UHC.
117
The report uses a set of indicators to monitor service coverage and financial protection.
It indicated that about 800 million people around the world spend more than 10% of
their household budget on health care, and almost 100 million people are pushed into
extreme poverty each year because of out-of-pocket health expenses.
Monitoring and evaluation provide crucial information on health system performance,
which assists countries in making further progress towards UHC.
118
Data could assist governments in selecting services, making wise investments, and
evaluating progress, particularly for marginalised populations or those with special
disease burdens. UHC requires a legal framework that adequately protects patient privacy
while retaining information integrity and security.
Law can also promote good governance in UHC adoption and implementation, including
transparency and inclusive participation. Although public participation in law making
varies from country to country, transparency and participation are widely agreed cornerstones
of effective governance.
166
For example, civil society participation in health policy can improve decision making
and secure grassroots support for UHC. Robust public accountability and participation
are more likely to result in reasonable and legitimate decisions, and fair, effective
implementation. Such mechanisms are essential when deciding on the overall strategy,
the specific pathways, and the appropriateness of central trade-offs, for UHC.
118
Finally, a functional UHC programme requires a framework for dispute resolution, with
explicit rules to guide those seeking relief. Different mechanisms for review and
dispute resolution exist, including litigation and alternative dispute resolution.
Considering the many public and private claims that arise under UHC, a country could
establish a separate adjudication process for individual claims, similar to the Colombian
tutela example (panel 5). Other models include a childhood vaccine compensation system
to cover rare adverse events caused by immunisation, as is present in the USA.
Law gives tangible form to the SDGs' goal of good health and wellbeing
Law provides mechanisms through which the vision and aspirations of the SDGs can be
realised. Through this UHC case study, we have discussed multiple entry points by
which law can influence UHC, from its legal foundations, to the establishment of fair
and effective monitoring systems. The vital role of law and regulation is often overlooked;
this case study makes visible the ways in which bad, or non-existent, laws might undermine
UHC. Conversely, it shows where well-designed and well-implemented laws can support
its achievement, and in so doing, give tangible form to the SDG promise of good health
and wellbeing for all.
Recommendations 1 and 2 relate to national and international regulatory frameworks
to strengthen national health systems, consistent with the SDG target of UHC. Recommendation
1 calls on the UN and WHO, along with international partners, to support the achievement
of SDG 3·8 by setting standards on implementation and compliance. Recommendation 2
gives greater detail at the national level: we urge governments to strengthen or create
a legal framework to ensure rights-based UHC, and we set out key functions of such
a framework.
Section 3: legal determinant 2
Governance challenges and the role of law
The second legal determinant states that law can be used to strengthen the governance
of national and global health institutions. The field of global health is complex,
comprising a web of institutions, norms, and processes at the global, national, and
subnational levels, in which activities might overlap, come into conflict, or leave
gaps. Institutional fragmentation undermines the effective functioning of the global
health system. Our second legal determinant of health relates to institutions and
governance.
Although governing is what states do, governance is a more diffuse concept, encompassing
a broad range of actors, processes, and forces.
167
Law is central to governance, but governance goes beyond law. We follow the Lancet-Oslo
Commission's definition of global governance: “The complex of formal and informal
institutions, mechanisms, relationships, and processes between and among states, markets,
citizens, and organisations, both intergovernmental and non-governmental, through
which collective interests on the global plane are articulated, rights and obligations
are established, and differences are mediated.”
168
The Lancet-Oslo Commission gave sustained attention to systemic weaknesses in global
governance for health, emphasising that norms, policies, and practices arising from
transnational interaction serve as political determinants of health that cause and
perpetuate health inequities.
4
The Commission noted that global governance for health requires a global economic
and political system that is rooted in commitments to global solidarity and shared
responsibility.
4
Here, we build on those findings by specifying areas where law can be used as a tool
to strengthen governance for health. We identify three key governance challenges and
propose ways in which law can strengthen and improve global governance for health.
Achieving good governance remains a work in progress. Failures of governance, including
the WHO's response to the west Africa Ebola epidemic, or national scandals relating
to food poisoning, or tainted milk or medicines, highlight institutional and systemic
weaknesses. Yet, institutions can also be remarkably effective, for instance in preventing
or quickly containing outbreaks, in empowering marginalised and disadvantaged populations,
or in catalysing funding for neglected health priorities. The law offers tools, some
of which are still evolving, which can build upon these successes and help strengthen
the institutional landscape.
Challenge 1: fragmented and overlapping mandates of actors and institutions
The mandates of national and global health actors frequently overlap, which can impede
the effective use of law to set norms and standards, and to resolve disputes.
At the national level, multiple ministries can have profound and sometimes conflicting
effects on health, resulting in policy incoherence. A country's agriculture and health
ministries, for example, often both have a mandate to regulate the safety and quality
of the food supply. Ministerial mandates might overlap (eg, with regard to responsibility
for food safety at various points in the supply chain) or might conflict. For example,
agricultural policies could be inconsistent with health and nutrition policies: the
Ministry of Health's (public health) aim of reducing sugar consumption could conflict
with the Ministry of Agriculture's (economic) aim of increasing sugar production.
169
A further example might be evident within countries, for example China, which supports
a state tobacco industry in which economic growth and health might be in conflict.
Similar overlaps occur at the international level, in which non-health actors can
have a profound effect on global health outcomes. However, the mandates, rules and
decision-making processes of these entities rarely take population health into account.
International organisations that deal with trade, investment, intellectual property,
security, and the environment are among the non-health regimes that can have major
impacts on human health (appendix).
Given the broad definition and remit of global health, multiple institutions can claim
a mandate on particular issues. States, international organisations, and private funders,
each deriving their mandate from a different legal source, could be involved jointly
or separately in the same project or problem. For example, in relation to reproductive
health, and maternal and child health, the activities of WHO, UNFPA, UNICEF, agencies
like the United States Agency for International Development, and non-governmental
organisations might overlap, conflict, or be hampered by poor coordination. Similarly,
multiple institutions operate in the HIV and AIDS space, including WHO, UNAIDS, the
Global Fund, and Unitaid (a WHO hosted partnership). Accomplishing results on complex
problems requires organisations to act in a well coordinated manner—for example, WHO,
FAO, and the World Organisation for Animal Health must work in conjunction to prevent
the spread of antimicrobial resistant organisms.
In theory, the potential for overlap, gaps, inadequate coordination and fragmentation
could be minimised by recourse to a sovereign decision-making authority or an authoritative
dispute resolution body. The International Court of Justice (ICJ) is the UN's judicial
organ, with the power to determine whether certain activities are within the mandate
of UN organs and specialised agencies. The ICJ decided in 1996 that WHO did not have
a mandate to deal with the legality of nuclear weapons.
170
However, global health governance involves multiple institutions beyond UN organs
and agencies. The ICJ has no jurisdiction over these institutions and cannot determine
whether activities fall within their mandate. Even within the sphere of the UN, the
ICJ's role as an arbiter is quite limited in practice.
Fragmentation also exists in the international legal system governing global health.
International law lacks a normative or institutional hierarchy,
171
meaning that multiple venues could have jurisdiction over similar issues. This fragmentation
affects the way in which law functions to set standards and resolve disputes. For
example, the WTO, WHO, and the UN Human Rights Council (UNHRC) each have a mandate
to set norms that affect access to pharmaceutical drugs. However, their mandates require
the institutions to examine problems arising in trade, public health, and human rights
through different legal lenses. This approach leads to conflicting outcomes: the WTO
will continue to prioritise international trade and intellectual property, while WHO
and the UNHRC will prioritise affordable access to medicines and the right to health.
With limited avenues and no global sovereign entity, global health continues to rely
on the traditional tools of international diplomacy to resolve conflicting decisions
across international organisations—with mixed results.
In dispute resolution, parties may seek to use the fragmentation of international
law to their advantage. States and other actors engage in so-called forum shopping
(choosing the venue based on the outcome sought), leading to inconsistent standards.171,
172, 173 Tobacco giant Philip Morris reorganised its corporate structure in order
to use the most favourable investment treaty to challenge Australia's plain packaging
legislation (a 2015 arbitration panel found this to be an abuse of process).
174
Meanwhile, the tobacco industry apparently funded a few WTO member states in order
to access the WTO dispute resolution system and challenge Australia's plain packaging
law.
Addressing the challenge of fragmented institutional mandates
Law can be an effective tool to harmonise mandates, clarify functions, and promote
multiagency cooperation. Law can be used to designate the responsible agency to resolve
a particular issue, or to create new entities to coordinate activities across multiple
agencies. General legal principles can inform and direct all institutions to abide
by and promote the rule of law, with particular attention to social justice. SDG 16
on the rule of law includes target 16·3: “promote the rule of law at the national
and international levels and ensure equal access to justice for all.”
114
UNAIDS offers a prime example of an institution that spans multiple UN agencies operating
to prevent and treat HIV and AIDS. Established by the UN Economic and Social Council
in 1994, UNAIDS is a Joint Program bringing together 11 UN agencies with different
mandates, to promote interagency dialogue and cooperation, while mobilising resources
and political will.
175
UNAIDS has a more modern governance system than other UN bodies, with civil society
members represented on its governing board in a non-voting capacity.
176
Because of the strong normative effect of non-binding instruments, soft rules can
also fill gaps and clarify mandates. WHO's PIP Framework (adopted in 2011) governs
the ways in which countries are expected to share virus samples to facilitate research,
while enhancing equitable sharing of the fruits of that research.
39
As of 2018, WHO is working with states parties of the Nagoya Protocol to the Convention
on Biological Diversity (2010) to resolve a mission conflict between the PIP Framework
and the Nagoya Protocol. The former is designed to foster global sharing of virus
samples, while the latter purports to grant states sovereign ownership of viruses,
and naturally, the right not to share. Finding synergies between these two international
instruments to enable WHO to develop a legal resolution that fosters the global common
good requires good faith negotiations between international institutions representing
different interests and governance systems.
Since establishing a supreme dispute-resolution body is a remote, and perhaps undesirable
possibility, several actors can work together to reduce fragmentation. WHO and WTO
have had ongoing discussions about resolving conflicts in areas such as access to
medicines and tobacco control. WHO's IHR formally recognise the importance of international
trade. In turn, the WTO has recognised FCTC guidelines as legitimate standards in
WTO dispute resolution decisions.
177
The WTO's Agreement on the Application of Sanitary and Phytosanitary Measures explicitly
recognises the sanitary and phytosanitary standards of the Codex Alimentarius Commission
as the relevant food safety standard-setting entity.
178
Under this commission, WHO and FAO work together. In these examples, and others, international
regimes are beginning to recognise and act to harmonise decision-making processes,
and, in so doing, improve the public's health.
Challenge 2: weak monitoring, compliance, and enforcement
International law can be an important tool for global health because of its power
to create norms that are binding on states parties. However, even though treaties
are binding legal instruments, their implementation can be suboptimal because of weak
enforcement and inadequate compliance. Typically, international law is built on a
foundation of inter-state cooperation and shared responsibility. The norms of international
law guide behaviour, but often, treaty oversight bodies have few means by which to
compel, or even incentivise, compliance. In extreme circumstances, UN organs can authorise
economic sanctions, but these tend to be limited to the arenas of global security,
eg, counterterrorism, cybersecurity, and non-proliferation of nuclear weapons.
179
The WTO can also authorise sanctions through its dispute resolution process.
180
The inability to enforce and ensure compliance with international law has stymied
the international community's ability to fully use human rights law to prevent or
ameliorate gross inequalities.
In global health, the options to incentivise or coerce behaviour in the face of non-compliance
are even more limited.
181
The FCTC and IHR—the two major international legal instruments under the direct authority
of WHO—have been plagued by incomplete state compliance.
39
This poor compliance has resulted, in part, from external and political forces, and
partly from limited technical, legal, and financial capacity.
The IHR seeks to prevent the spread of public health threats from any source (including
biological or even radio-nuclear), but primarily aims to prevent the spread of infectious
diseases. The IHR covers areas such as state surveillance requirements and obligations
to notify WHO regarding potential public health threats of international concern and
establishes WHO procedures for when the organisation has been notified. Furthermore,
states parties are required to have, or develop, eight minimum core public health
capacities to prevent, detect, and respond to specified health hazards: legislation
and policy, coordination, surveillance, response, preparedness, risk communication,
human resources, and laboratory.
182
Each of these core capacities requires substantial resources and investment from national
governments. These activities are largely unsupported by WHO or through other forms
of international assistance.
183
Although the IHR encourage international assistance to build capacity in lower-income
states, higher-income states—with notable exceptions, such as the US-led Global Health
Security Agenda (GHSA)—have largely ignored the treaty's norms of international financial
and technical cooperation.
Weak monitoring, assessment, and follow-up capacity can also present a challenge to
the effectiveness of international instruments like the IHR. Before 2016, countries
were required to self-assess their IHR compliance and competencies. In 2016, WHO worked
with the GHSA to introduce a new process and tool, the Joint External Evaluation (JEE).184,
185 Under the JEE, independent experts work alongside national officials to ensure
transparent reporting. However, JEE is voluntary and some countries remain reluctant
to adopt it, in some cases because of concerns about national sovereignty. Furthermore,
regarding the points at which JEE does identify gaps in IHR competencies, no comprehensive
global mechanism exists to assist low-income countries to finance required reforms.
As observed during the Ebola crisis, this absence of a global mechanism presents a
potential threat to global security.39, 99
Additionally, states could withhold cooperation for political or economic reasons.
For example, the IHR require rapid state identification and reporting of novel infections
to WHO. However, if states parties do report novel infections they could face travel
and trade restrictions or loss of tourism and prestige. Consequently, states might
be reluctant to comply in a timely manner with the IHR's reporting obligations. States
parties in west Africa were late in reporting Ebola in 2014. When an epidemic did
engulf these countries, governments widely ignored WHO recommendations not to impose
travel and trade restrictions. Airlines also unilaterally suspended flights to the
region.
186
Addressing the challenge of weak treaty compliance
There are creative ways to foster state compliance, even if it is extraordinarily
difficult to assure that compliance. Treaty oversight bodies need to work with states
and other stakeholders to find innovative ways to promote treaty implementation. This
is also true for soft rules, which are often amenable to similar compliance-enhancing
incentives and methods. The following are examples of tools that could facilitate
compliance, and many already exist in most compliance-enhancing international instruments.
Setting targets and monitoring progress are important tools. Oversight bodies should
set clear targets and benchmarks based on norms set in the treaty or soft rule. Having
set clear, transparent targets, in collaboration with stakeholders, the oversight
body should monitor progress through objective and transparent mechanisms and make
its findings publicly available. For instance, WHO's Global Action Plan for the Prevention
and Control of Noncommunicable Diseases 2013–20 is supported by a monitoring framework,
which includes voluntary targets and indicators. Countries' progress in taking actions
to achieve the targets is now also being regularly monitored through the WHO Progress
Monitor.187, 188
Another tool is state reporting. Both hard law and soft rules could require or encourage
states to self-report their progress. Fully transparent reporting is vital, and the
oversight authority (such as WHO's Director-General) publicly holds states accountable
for abiding, or failing to abide by the relevant norms. For example, the public should
know if states fail to rapidly report novel infections as required under the IHR.
Greater transparency encourages states to abide by global norms.
Working under a mandate from the UNHRC, UN Special Rapporteurs are independent experts
who examine, monitor, advise, and publicly report on human rights from a thematic
or country-specific perspective.
189
As of 2018, 43 thematic and 13 country mandates are present. The Special Rapporteur
on the Right to Health is Dainius Pūras. Other health-related thematic mandates, for
which Special Rapporteurs exist, include access to safe drinking water and sanitation,
extreme poverty and human rights, and the right to food.
Treaty monitoring bodies can also receive so-called shadow reports, which supplement
the reports provided by states. Shadow reports can come from non-governmental organisations,
UN organisations, and academic institutions, and can be presented to all the human
rights treaty monitoring bodies, including CEDAW and the Committee on Economic, Social
and Cultural Rights, as well as the UNHRC. Because states might not report fairly,
completely, or truthfully, shadow reporting provides a mechanism for civil society
organisations to provide their own public reports on states' compliance with their
treaty obligations.
External evaluations can also be used as tools that could facilitate compliance. As
mentioned previously, many states do not have the capacity or political incentives
to properly assess their own compliance with global health norms. The majority of
states have either not reported or under-reported their compliance with IHR core health
system capacities. In the wake of Ebola, several global commissions criticised WHO
for failing to ensure more independent assessments.
186
The JEE was developed in response to these criticisms, but, as mentioned above, faces
challenges for implementation.
Lower-income states often require financial and technical assistance to comply with
treaty obligations. This assistance both incentivises and aids governments in fulfilling
their responsibilities. The Global Health Security Agenda (a partnership between nations,
international organisations and non-governmental organisations) provides financial
and technical assistance in exchange for full cooperation with independent health
system preparedness evaluations, which in turn strengthens compliance with the IHR.
190
A further tool that can be used to assist compliance is transparency and public disclosure.
State performance can often be hidden, or partially hidden from public scrutiny. Indeed,
there is a subtle norm within certain international organisations not to publicly
name or criticise member states. Yet, good governance requires openness and public
accountability. Civil society and oversight bodies can push for compliance with international
health norms by emphasising state actions.
As mentioned in section 1, WHO treaties have weak dispute resolution systems. These
treaties could be amended to model more rigorous dispute resolution. Alternatively,
WHO should work with states to emphasise the importance of routinely submitting to
such resolution mechanisms for the common (public) global good.
The final tool that can be used to assist compliance is private law dispute resolution.
As previously described, under the WHO's PIP Framework, parties can be subject to
private contracts that are binding, to strengthen compliance with the non-binding
PIP Framework. Understandably, many observers will continue to lament the absence
of strong enforcement mechanisms in international law. Unfortunately, most international
legal obligations are hard to enforce, for example, in relation to human rights, climate
change, or arms control. However, the above examples describe ways in which the innovative
use of legal and governance tools can enhance compliance with international rules,
ultimately strengthening the governance of global health.
Challenge 3: new legal entities, old governance regimes
In the aftermath of World War II, WHO stood unrivalled in the global health space.
As of 2019, the same space is occupied by more than 200 international agencies and
initiatives.
191
New institutions bring a host of benefits—more funding, an enhanced voice for civil
society, and innovative ideas—but also new challenges in leadership, oversight, and
accountability. In many cases, old regimes have not fully adapted to the emergence
of these new players, raising concerns relating to finding the appropriate level and
means of participation by new institutions in governance processes such as those of
WHO, and improving the internal governance arrangements of both old and new institutions.
Traditional actors in global health (states and intergovernmental organisations) are
governed by established domestic and international legal frameworks. Frameworks originally
established many decades ago can fail to take account of new actors and values. Member
states, for example, have almost exclusive governance powers under the WHO constitution.
By contrast, valuable voices, such as those in civil society, are often not fully
heard. Although non-state actors can informally contribute to the Organization's work
and attend governing body meetings, they are not permitted to engage in actual decision-making
processes.
192
This raises questions of equity, transparency, and accountability. At the same time,
although civil society organisations often bring considerable practical and technical
expertise, assessing their legitimacy or their sources of finance can be difficult.
As reported by the Lancet-Oslo Commission, global health is characterised by imbalances
in political power, leading to inequities in health.
4
Powerful, entrenched actors might influence international institutions to advance
their private interests, rather than the health of the public. For example, civil
society has criticised WTO for diminishing access to essential medicines in favour
of private commercial interests in intellectual property (eg, patent protection for
pharmaceuticals).
193
WHO itself suffers from so-called capture by its powerful member states and non-state
actors, who fund almost 80% of its annual operating budget.
194
The Gates Foundation has considerable influence on WHO's agenda. At the same time,
WHO has been struggling to find an appropriate way to engage with the private sector.
Health and human rights advocates have expressed concern about an overly close relationship
between WHO and vested corporate interests.
Although WHO and other post-World War II intergovernmental agencies often have clear
governance arrangements, oversight of new players and new legal entities (eg, civil
society organisations, foundations, and PPPs) presents a greater challenge. Large
PPPs often have limited transparency and accountability because of participation of
private actors.
195
At the national level, private entities such as corporations and charitable foundations
are subject to government oversight, especially to protect private shareholders and
the general public.
196
However, no single state can fully control the activities of large, transnational
corporations that operate in multiple countries and regions. States' oversight of
major non-profits such as the Gates Foundation is also inadequate.
This limited transparency can pose governance concerns: some PPPs have been criticised
as vehicles for market penetration (increasing a product's market share through strategies
such as bundling, advertising, lower prices, or volume discounts), or as a means for
private actors to wield influence over international law-making and policy-making
processes.
197
In the fast-changing arena of global health, the potential efficiency of newer actors
should not be traded against “good governance, transparency, participation and engagement;
clear accountability for success and failure; coordination and coherence; and a new
eye on priority setting to achieve ambitious global goals while balancing equity and
efficiency”.
105
Good governance should both facilitate efficiency, while still ensuring effective
oversight and accountability.
Addressing the challenge of new and old governance regimes
To some extent, governance regimes are evolving in response to these new players.
In 2016, WHO member states negotiated a Framework for Engagement with Non-State Actors,
192
which includes non-governmental organisations, private sector entities, philanthropic
foundations, and academic institutions. The Framework guides and strengthens the ways
in which WHO interacts and works with these entities, seeking to ensure “transparency,
openness, inclusiveness, accountability, integrity and mutual respect”, while “protecting
its work from potential risks such as conflict of interest, reputational risks, and
undue influence”.
192
The Framework could assist WHO to strike a better balance between active engagement
with outside actors, and maintaining the integrity of its own governance arrangements.
Yet, many in civil society continue to campaign for more participatory decision making.
Overcoming the problem of limited participation in WHO governance will require innovative
thinking. The WHO's Executive Board has granted a small number of non-governmental
organisations, international business associations, and philanthropic foundations
an official relations status on the basis that they “have a sustained and systematic
engagement in the interest of the Organization…and contribute significantly to the
advancement of public health”.
192
This criteria has excluded smaller non-governmental organisations working in the health
space, separating them from WHO. The Organization should find a way to better harness
the creativity and energy of civil society organisations.
Innovative governance arrangements in newer entities could help improve inclusiveness
and transparency. For example, The Global Fund has implemented innovative governance
for greater civil society participation, described as follows.
7
The first implementation was non-governmental organisation representation—including
from developed and developing countries, as well as from communities living with the
Fund's targeted diseases—on its Board, alongside representatives of the private sector,
national governments, and philanthropies. Additionally, local, multi-sector, multi-stakeholder
committees, known as Country Coordinating Mechanisms (CCMs) were introduced to oversee
grant implementation at the local level. CCMs must include members of communities
living with the Fund's target diseases and must document the involvement of marginalised
or vulnerable populations in their work. The Global Fund has also adopted standards
to manage conflicts of interest with CCMs.
198
Dual-track financing, whereby the CCMs nominate both a governmental and non-governmental
principal recipient for financing was introduced;
198
and finally, community systems strengthening through activities such as partnerships,
capacity building, service delivery, as well as planning, monitoring, and evaluation.
The Global Polio Eradication Initiative is another example of a PPP that has adopted
innovative governance arrangements to foster greater transparency. The Initiative—a
partnership between WHO, Rotary International, the US Centers for Disease Control
and Prevention, UNICEF, and the Gates Foundation—is overseen by an Independent Monitoring
Board of global experts. The Board evaluates the Initiative's work against key milestones.
If milestones are deemed to be at risk, off track, or missed, the Board reports to
the partners, and makes its reports public.
199
Independent and civil society voices are crucial for holding global health actors
accountable. Arrangements such as these provide legal and governance mechanisms for
those voices to be heard, leading to more robust processes, and ultimately, outcomes
that achieve health with justice.
Legal reforms could greatly enhance the governance of global health
Law can shape the governance of global health in various ways. Law defines the mandates,
powers, and structures of, and the interactions between, key players in global health.
However, the potential to deliver health with justice is weakened by multiple governance
challenges: fragmentation and overlap, poor compliance and enforcement, and disjunctions
between actors with great influence over global health and the regimes intended to
govern them. In this section, we have built on the work of the Lancet-Oslo Commission,
specifically identifying ways in which law could strengthen good governance for global
health. We have identified measures to harmonise institutional mandates, mechanisms
for review of decisions, forums for ensuring international policy coherence on health,
and innovative compliance-enhancing arrangements. In each of these ways, law can address
vital governance challenges in global health. Specifically, recommendation 3 proposes
that the UN set good governance standards for UN specialised agencies and programmes,
including WHO. This proposal is supported at the national level by recommendation
4, which states that governments should develop legal frameworks establishing principles
of good governance throughout national health systems and policy making.
Section 4: legal determinant 3
Law can be used to implement fair, evidence-based health interventions, and can be
a powerful tool for global health.
3
Statutes and regulations can be used to implement interventions that lower the exposure
to risk factors across entire populations. As a result, law has been integral to many
of the great public health successes of the past century, including motor vehicle
safety, tobacco control, infectious diseases control, a safer food supply, workplace
safety, and childhood vaccinations.
200
Many public health interventions require enactment and enforcement of laws and regulations,
such as taxes on tobacco, alcohol, or sugar-sweetened beverages; marketing or sponsorship
bans; and minimum age of purchase requirements. In other cases, laws facilitate effective
health interventions, such as immunisation requirements for school entry or creation
of safe injection sites for drug users.
However, law is only a tool. When used without sufficient evidence, or without regard
for justice and human rights, statutes and regulations may be ineffective—or worse,
could undermine health. Law could also perpetuate injustice, such as by establishing
a multi-tier UHC health insurance system that provides real benefit to some people
(eg, civil servants, formal sector employers) but only limited benefits to others
(eg, informal sector workers). Our third legal determinant of health is the effective,
fair, and evidence-based enactment and implementation of legal interventions.
In this section, we first offer a framework for evaluating health laws, and propose
four characteristics of effective laws that advance health with justice. We then provide
key examples of effective laws, across three risk factor domains: infectious diseases,
non-communicable diseases, and injuries. In each domain, we describe ways in which
international and domestic laws interrelate and inform one another. Sharing of experiences
and research regarding the effectiveness of public health laws among jurisdictions,
and with international organisations, will be crucial to the global dissemination
of just, evidence-based legal interventions. Finally, we explain how laws that are
not informed by evidence and human rights principles could undermine health, while
entrenching inequality and discrimination.
Evaluating health laws: does this intervention advance health with justice?
The Commission concluded that across the spectrum of global health hazards, legal
interventions will be most effective when they are based on sound science, and guided
by the values of justice, transparency, and inclusion. The most just and effective
public health laws share the following four core characteristics: they are evidence
based, equity promoting, multisectoral, and supported by good governance (figure 4
). Laws that share all these characteristics will best advance health with justice.
Figure 4
Core characteristics of legal interventions that advance health with justice
Health laws must be evidence-based
Sound scientific evidence is the most important characteristic of effective public
health laws.
201
Laws should be informed by scientific evidence, rigorously answering the question:
do they improve the health and safety of the population, while not posing undue burdens
on individual rights? Although we emphasise the important role of innovation and well
considered novel approaches in public health law and regulation, this should always
be implemented in conjunction with well designed evidence gathering and rapid evaluation.
In section 5, we suggest ways to expand and strengthen the evidence base for, and
the legal capacity to, implement legal interventions.
Policy makers sometimes—perhaps often—must act on incomplete evidence or scientific
uncertainty. A classic example of the need to act without complete information is
when a major health hazard or emerging health risk demands an urgent response, and
perhaps an innovative approach. For example, the Democratic Republic of Congo deployed
investigational new vaccines and therapies in response to Ebola in 2018–19, even though
regulatory agencies had not yet found the vaccine and drugs to be safe and effective.
The absence of full information to thwart legal innovations should not be allowed.
If policy makers always had to wait for an exhaustive research study, many substantial
threats to the public's health would persist. Evidence might come from analogy to
other areas of law, such as the effectiveness of taxes on reducing sugary beverages,
based on effectiveness of taxes in reducing tobacco use. Similarly, evidence of effectiveness
for portion controls on sugary beverages might come from studies showing increased
portion size, and its relationship to overweight or obesity. In such cases, policy
makers need to make informed choices for law reform, in the absence of complete evidence.
While using the best available (albeit incomplete) evidence at the time, evaluating
the law's effect to ensure continuous quality improvement in health legislation is
imperative. Even then, though, law makers might need to accept some uncertainty, such
as where there is clear evidence that a suite of legal measures is effective at addressing
a complex health threat (eg, obesity, or gun violence), but it is difficult to determine
the specific contribution of any single intervention. For example, in tobacco control,
a comprehensive approach using a host of demand and supply reduction measures has,
in combination, substantially reduced smoking rates over time.
Health laws must promote equity
Poor and disadvantaged communities often have a disproportionate burden of morbidity
and premature mortality, as well as the social and economic consequences of disease
and injury. These populations include people with mental or physical disabilities;
racial, ethnic, or sexual minorities; and women and children. Poor health outcomes,
in turn, further entrench disadvantage. Poor and marginalised populations—whether
living in low-income and middle-income countries, or in wealthier countries—often
live, work, recreate, travel, and go to school in unsafe or unhealthy environments.
They also benefit less from prevention services and have less access to high-quality
treatment and rehabilitation services.
202
Interventions that target inequalities are thus fundamentally linked to those that
address ill health.
203
Achieving health with justice requires non-discrimination; equitable distribution
of benefits and resources within and across communities, within countries, and globally;
and protecting underserved communities. At a national level, law makers should pay
particular attention to the needs of the poorest, the most vulnerable, and those who
are marginalised. At the global level, it is important to translate international
norms to the national and local levels to reduce health disparities among and within
states. If the world is to achieve the SDG's pledge of “leaving no one behind”, public
health laws must target areas of deep inequity.
Health laws must engage sectors beyond health
Laws far beyond the health sector influence the conditions for achieving population
health and reducing inequalities. The criminal justice system, taxes and transfers,
urban planning and development, trade, agriculture, housing, and the environment are
incidental to, but deeply affect population health.
10
If not conceived with due consideration for health objectives, laws in these sectors
could have powerful adverse effects on health. For example, agricultural subsidies
for corn, sugar, or meat can exacerbate major health and environmental threats.
Conversely, multiple sectors have the potential to improve population health and justice.
Urban planning, education, social services and other portfolios can have major health-enhancing
features. Yet, public health researchers and officials often neglect agencies outside
of health ministries. Achieving health with justice requires an all-of-government
approach, supported by the head of government.
Health Impact Assessments (HIAs) measure the health effects of proposed initiatives
in diverse sectors (criminal justice, education, housing, nutrition, education, and
revenue) using quantitative, qualitative, and participatory techniques, with particular
regard for health equity. HIAs adopt an all-of-government or health-in-all-policies
(healthy policies) approach to governance. HIAs dynamically improve health and wellbeing
across sectors. Several countries and sub-national jurisdictions, such as Thailand,
Slovakia, and several US states, have laws requiring HIAs for policies substantially
affecting public health or for policies or programmes in certain sectors. Other laws
empower public health authorities, or even the public, to request an HIA,
204
as evidence shows that HIAs can have a substantial positive effect on public policy.205,
206
In 2008, the WHO Commission on the Social Determinants of Health recognised the importance
of reform in multiple sectors. Despite this, international institutions (including
WHO itself) and governments have not devoted the attention and resources needed to
address the social determinants of health. We argue that law can be highly effective
in defining and operationalising government action. By creating and implementing social
norms and redistributing resources, law can create the conditions for the public's
health. Examples of the power of law to affect the social determinants of health include
social welfare and income support programmes; market regulations that enhance income
and agency for workers (minimum wages, paid sick leave or family leave); protection
of union and labour rights; redistribution policies, such as pre-tax limits on compensation
levels, progressive taxation, and negative income taxes; nutrition policies, such
as subsidising healthy foods and restricting unhealthy foods in school lunches; consumer
protection; and occupational health and safety regulations.
Health laws must be supported by good governance
Finally, health with justice can only be delivered against a backdrop of good governance,
sound regulatory principles, and the rule of law. These include transparency and openness;
civil society or community engagement and inclusive participation; monitoring and
evaluation systems; honesty, non-corruption, and stewardship; and accountability at
all levels, from legislating, through implementation, to enforcement. We have addressed
these concepts in detail elsewhere in this report, in sections 3 and 5.
Effective legal interventions
Despite past successes, law remains underutilised as a tool for population health.
207
In this section, we discuss legal and regulatory interventions across three broad
health domains: infectious diseases, non-communicable diseases, and injuries. These
interventions have been effective because they share the characteristics previously
discussed. For each, we provide key illustrations, complementing the other examples
and case studies found throughout this report. A comprehensive list of domains and
interventions from around the world can be found in the report from WHO, International
Development Law Organization, O'Neill Institute, Sydney University: Advancing the
right to health—the vital role of law.
86
In keeping with our global health lens, we also focus on the ways in which national
and global health law intertwine, showing the potentially far-reaching effects of
law. Legal interventions that successfully advance health with justice at the local
and national levels have been adopted (and adapted) in other jurisdictions, as well
as translated into international norms. At the same time, international norms have
been codified in national and local laws. This interaction shows the multidimensional
nature of creating and diffusing highly effective health laws from the global level
to the local and national levels, and vice versa (figure 1).
Infectious diseases
During the 20th century, improvements in sanitation and hygiene, vector abatement,
and surveillance ushered in substantial advances in infectious disease control.
208
Previously devastating infections are now treatable, even as the global health community
wrestles with the frightening prospect of antimicrobial resistance. The advent of
vaccination laws vastly reduced deadly childhood diseases such as measles, mumps,
and rubella. Smallpox was a major killer before mass immunisation led to its eradication.
Before the Salk vaccine, people feared the paralysing effects of polio. WHO, along
with international partners, is now aiming to eliminate polio around the world.
Throughout modern history, law has played a major role in reducing infectious diseases
through national public health laws and regulatory frameworks, international legal
agreements, and governance reforms. As of 2019, the international community faces
new challenges and must undertake health system and animal husbandry reforms, while
also incentivising development of new medicines to combat antimicrobial resistance.
National legal frameworks in the form of laws and regulations give public health agencies
wide-ranging powers to control infectious diseases. These regulations include powers
to identify individuals (testing) or populations (screening) who can potentially transmit
infections; require health providers and others to notify public health agencies of
cases of infectious disease; trace contacts of infected individuals or notify partners;
vaccinate exposed persons, their contacts, and broader populations; directly observe
individuals to ensure they take the full course of their medications such as directly
observed therapy for tuberculosis; and separate people who are infected (isolation)
or have been exposed (quarantine) from healthy populations. Law can also require rigorous
community and hospital infection control, such as disinfection, hand hygiene, and
personal protective equipment. It can limit animal–human interchange to prevent pathogens
jumping from animals to humans (table
). When public health officials exercise compulsory powers, they should provide due
process or natural justice, such as a fair hearing. Procedural safeguards are often
necessary to prevent health officials from acting in an arbitrary or discriminatory
manner.
Table
National public health laws to control infectious diseases
Purpose of intervention
Actions necessary for success of intervention
Legal interventions related to testing, screening, reporting, contact tracing, and
partner notification can improve surveillance data, while protecting confidentiality
and privacy
Improving essential data through early warning, identify individuals at risk, reduce
transmission, monitor incidence, facilitate response
Improve public health infrastructure: labs, workforce, data systems
Legal interventions related to occupational health and safety, so-called wet markets,
animal quarantines, and culls can decrease animal–human interchange
Protecting animal health, and preventing so- called species jumps to humans
Improve hygiene and infection control in animal farming, and meat and poultry markets
Legal interventions related to hand-washing, disinfection, respiratory hygiene, potable
water, and sanitation can improve community hygiene
Reducing transmission in families and the community
Public education grounded in risk communication science, clean water and sanitation
systems
Legal interventions related to disinfection, hand hygiene, personal protective equipment,
and health-care worker vaccinations can help control hospital infections
Reducing transmission among patients, health workers, and families and communities
Training and monitoring in infection control, greater acceptance of vaccination by
health professionals
Legal interventions related to the closing of public places, cancelling public events,
and restricting mass transit can help decrease social mixing in the event of an outbreak
Slowing the spread of infection in public settings
Target closures to high-risk settings based on evidence
Legal interventions related to screening (entry and exit), reporting, health alerts,
passenger data, travel advisories, hygiene (inspection, disinfection, and pest extermination)
can help improve border controls
Preventing cross-border spread of infectious diseases
Adequate resources for surveillance, treatment, and response in affected areas and
national borders
The law can prevent spread of infectious diseases through isolation and quarantine,
and ensuring respect for human rights. Laws should ensure that in the event of an
outbreak, any isolation or quarantine strategies, including so-called shelter in place
policies, are safe and humane, evidence-based, and no more restrictive than necessary
to protect public health
Separating the infected or exposed from the healthy
Safe and humane settings, assure necessities of life, logistics, modern laws with
due process
Legal interventions related to vaccines and antivirals can help improve medical countermeasures
Implementing prophylaxis, and reducing infectiousness
Stable, viable supplies: incentives, public–private partnerships, tort reform, compensation
Legal interventions related to antibiotic use in humans and animals, and falsified
or substandard medications can help in preventing drug-resistant infections
Reducing spread of drug-resistant infections in animals and humans and developing
new antimicrobial medications
Appropriate medical prescribing, reduced use of antimicrobials in farmed animals,
curbing the trade in falsified and substandard medications, incentivising research
and development of new antimicrobials
In addition to the IHR and PIP Framework, which relate to human pandemic illness,
countries should prepare for, and evaluate preparedness for, zoonotic diseases (animal
diseases that can be transmitted to humans). Even diseases that infect only animals
can damage economies by curtailing meat exports, or driving up domestic food prices.
As of April, 2017, only six countries worldwide had undergone two external evaluations
of their ability to withstand a global pandemic. One evaluation is for human diseases
(the JEE, in cooperation with WHO) and the other relates to animal diseases (in cooperation
with the World Organization for Animal Health).209, 210
Law can also be used to help limit the spread of organisms that are resistant to antimicrobial
medications. For example, regulation can operate to better ensure appropriate prescribing
of antimicrobials. Law can also be used to ban the prophylactic use of antibiotics
in animal populations or to promote growth, thus reducing the reservoir of drug resistant
organisms in farmed animals. Similarly, regulations can require surveillance of drug
resistant infections in both human and animal populations.
Law plays a particularly important role in limiting the manufacture of, and trade
in, falsified and substandard medicines. When patients take antimicrobials that have
sub-optimal doses of active pharmaceutical ingredients, they can develop drug resistant
infections. Countries should update legislation to provide clarity on what qualifies
as falsified and substandard medicines according to the definitions that the WHA approved
in 2017,
211
strengthen criminal penalties to deter manufacture and sale of these products, ensure
adequate registration and quality surveillance systems, and sufficiently resource
public health regulatory and customs agencies for increased surveillance and enforcement.
Legislation could require that pharmacists are trained in detecting falsified and
substandard medicines. The WHA should adopt a code of practice on falsified and substandard
medicines that sets standards on surveillance and international reporting and provides
guidelines for and coordinates regulation and law enforcement.
212
Because infectious diseases do not respect national borders, global health law and
governance are just as important as national legislation. WHO has adopted two major
legal instruments to safeguard global health security, but both face major problems,
as does WHO governance itself.
The 2014–15 Ebola virus epidemic in west Africa revealed “deep inadequacies in the
national and international institutions responsible for protecting the public from
the far-reaching human, social, economic, and political consequences of infectious
disease outbreaks.”
99
A review of four global commissions in the wake of the epidemic drew together recommendations
and suggested reforms for future global health pandemic preparedness.
186
Many proposed reforms involved law and regulation, including surveillance, disease
notification, infection control, and strengthening national health systems. Good governance
for health was another major aspect of the required reforms, both at the national
and global levels—for example, transparency, monitoring, risk communication, community
engagement, and accountability.
Crucial to this last function is strengthening and scaling up WHO's IHR and PIP Framework,
and building capacity at WHO itself.
39
Implementation of the IHR during the Ebola epidemic was deeply flawed: WHO delayed
its declaration of a Public Health Emergency of International Concern (PHEIC) for
over 4 months after the first international spread.
213
Declaration of a PHEIC under the IHR carries normative weight under international
law, and allows WHO to alert and engage the international community.
214
At the same time, only 30% of states parties had reported meeting the IHR requirements
to develop core health system capacities,
215
and states widely ignored WHO travel recommendations. During the Ebola epidemic, the
PIP Framework was not even applicable, as its narrow scope is limited to pandemic
influenza strains.
The post-Ebola commission reports urged research and development of vaccines and anti-microbial
medications to be better funded and expedited. Yet, regulatory frameworks such as
intellectual property, so-called ownership of viruses, inconsistent regulatory approval
pathways, legal liability for pharmaceutical companies, and divergent clinical trial
standards can hinder rapid development of medical technologies to respond to public
health emergencies. These regulatory frameworks need to be reformed, or made more
flexible, to support the development, procurement, approval, and deployment of effective
therapeutic countermeasures. Legal obstacles to the effective deployment of countermeasures
should be addressed and resolved in advance of future pandemics.
The law can also offer a protective function, helping to ensure that patients and
human participants in research are treated with dignity and respect, while safeguarding
them against unethical research and unsafe products. Liability reform can incentivise
manufacturers to more rapidly develop and deploy products. Additionally, the formation
of multi-disciplinary partnerships that include patients, health care providers, experts,
industry partners, ethicists, lawyers, and others would promote a clearer understanding
of regulatory rules and ethical practices, as well as better sharing of research information.
Despite considerable progress, the burden of infectious diseases remains unacceptably
high, particularly in low-income and middle-income countries, and among poor and rural
populations.
3
Each year, millions of people die from diseases such as HIV and AIDS, tuberculosis,
malaria, hepatitis, influenza, and neglected tropical diseases (although WHO is making
substantial progress in controlling negative tropical diseases).
119
The unprecedented movement of people and goods around the globe is amplifying the
spread of infectious diseases, as is climate change.216, 217 In settings where health
systems are weak, populations are all the more vulnerable to emerging or re-emerging
infectious diseases. Since 2000, the world has experienced major outbreaks of novel
infections such as Severe Acute Respiratory Syndrome, Middle East Respiratory Syndrome,
new strains of pandemic Influenza (H1N1), Ebola, and ongoing Zika virus transmission.
186
Outbreaks of cholera, plague, and yellow fever have caused considerable illness and
death.
Infectious disease laws are crucially important, but must respect human rights, promote
equity, and reflect international norms such as the Siracusa Principles.
Non-communicable diseases
WHO estimates that non-communicable diseases cause 40 million deaths annually, amounting
to 70% of all deaths globally.
218
People die too young from these diseases, with negative consequences on productivity
and socioeconomic development. In 2015, 16·9 million deaths were estimated to occur
before age 70 years and 9·2 million before age 60 years. Moreover, the huge toll of
death and disability from non-communicable diseases does not affect all populations
equally; 31 million (or three quarters of the total) of global non-communicable disease
deaths occur in low-income and middle-income countries. The main non-communicable
diseases—cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes
mellitus—share four main behavioural risk factors: tobacco use, physical inactivity,
the harmful use of alcohol, and unhealthy diets.
160
Evidence shows that social and economic circumstances can significantly increase the
risk of non-communicable diseases.
219
An increasingly strong evidence base exists regarding how population-level interventions
can be used to prevent and control non-communicable diseases. WHO's Global Action
Plan for the prevention and control of non-communicable diseases 2013–20, including
the updated appendix 3, represents the most important normative instrument on non-communicable
diseases at the global level.
160
Many of its policy recommendations, some of which are so-called best buys for public
health (highly cost-effective, evidence-based interventions), include the use of law
and regulation (panel 6). Building on the strong evidence of success in Denmark, New
York City and other settings, WHO now recommends that countries use legislation to
eliminate industrial trans fats in the food supply.
Tobacco control is important in containing the spread of non-communicable diseases.
WHO's non-communicable diseases Global Action Plan incorporates the FCTC's provisions
in its recommended actions. Updated appendix 3 calls on states parties to “strengthen
the effective implementation of the WHO FCTC and its protocols”, including by establishing
“national mechanisms for coordination of the WHO FCTC implementation as part of national
strategy with specific mandate, responsibilities and resources”.
160
The action plan also invites member states that are not parties to the FCTC to “consider
implementing the measures set out in the WHO FCTC and its protocols, as the foundational
instrument in global tobacco control”.
160
The FCTC provides a prime example of the inter-relationship between international
and domestic law, providing a precedent for future global health governance. The WHA
in 1995 urged member states that had already successfully implemented all or most
of a comprehensive strategy for tobacco control to provide assistance to WHO.
220
This aid would allow WHO to provide advice and support to other member states seeking
to improve their tobacco control strategies. The following year, the WHA voted to
begin work on developing a framework convention. A decade later, the FCTC entered
into force.
221
The FCTC has had a substantial effect on global tobacco control, with its norms widely
implemented at national and local levels. Particularly in high-income countries, a
so-called suite of national and local laws and regulations has resulted in large declines
in tobacco use. A combination of legal interventions all operate to reduce smoking
in youth and adults, including lowering the legal age for buying tobacco products,
marketing bans or restrictions, bans on smoking in public places, high taxation, and
graphic packet warnings. For example, 111 of 181 FCTC states parties require pictorial
warnings on cigarette packages, as recommended under Article 11.
222
Governments are now implementing major so-called endgame strategies, such as gradually
increasing the legal smoking age, and vast reductions in the nicotine levels in cigarettes,
which addict virtually all smokers.
223
However, the FCTC faces substantial compliance challenges, particularly in low-income
and middle-income countries. For instance, Article 14 encourages countries to put
in place tobacco cessation infrastructure but does not provide the resources to allow
low-income and middle-income countries to do so. As of 2013, only a minority of countries
had in place the infrastructure necessary to offer cessation support to tobacco users.
224
Furthermore, compliance and enforcement challenges are only made more difficult in
the presence of aggressive opposition from vested commercial interests.
225
Ongoing monitoring, and strategies to strengthen the capacity of states to comply
with their FCTC obligations, are two important ways to bolster the effect of this
instrument.
Dietary salt reduction provides another good illustration of countries incorporating
WHO guidance on non-communicable disease prevention, fitting global norms into their
social, political, and regulatory contexts. High salt intake is estimated to be associated
with nearly half of the disease burden ascribed to hypertension, a major contributor
to global morbidity and mortality.226, 227, 228 The physiological requirement for
salt is less than 1 gram per day,
229
and WHO recommends less than 5 grams per day for adults.
230
Yet, in 2010, the global mean salt intake was twice this level, or 10 grams per person
per day.
231
WHO's Global Action Plan has set a target of a 30% reduction of population-level salt
intake by 2025.
232
Population salt reduction is among WHO's so-called best-buys to reduce chronic disease—an
intervention that could lead to substantial health benefits as well as cost savings.233,
234 In the USA, it has been estimated that a regulatory intervention designed to achieve
a reduction in salt intake of 3 grams per day would save 194 000 to 392 000 quality-adjusted
life-years and US$10–24 billion in health-care costs annually, and would be more cost-effective
than using medications to lower blood pressure in all people with hypertension.
235
From a population perspective, the most effective and equitable means of reducing
salt consumption is to reduce the salt content of manufactured foods.236, 237 In many
countries, processed foods substantially contribute to salt intake,
238
regardless of any action individuals might take to reduce the salt they add to food.
Countries are adopting population-level salt reduction strategies to achieve WHO's
30% reduction target by 2025. Many of these focus on reductions at the manufacturing
level (reformulation), complemented by public information campaigns and nutrition
labelling. The strategies also use diverse regulatory forms. In 2006, the UK became
the first country to set salt targets for food composition. Using a voluntary approach,
but with strong government leadership and oversight, UK manufacturers agreed to progressive
reduction targets for around 80 categories of processed foods. Their reformulation
efforts were supported by consumer education and improved food labelling. The approach
was highly successful, resulting in a 15% decrease in salt intake across the population.
239
South Africa was the first country to set legislatively mandated salt reduction requirements
across a wide range of processed foods. In March 2013, the South African Minister
of Health issued the Regulations Relating to the Reduction of Sodium in Certain Foodstuffs
and Related Matters.
240
The requirements took effect on June 30, 2016, with more stringent maximum levels
coming into force on June 30, 2019.
240
Argentina has used a combination of voluntary and mandatory salt reduction techniques.
Initially, the Ministry of Health and large food companies signed a voluntary agreement
in 2011 to gradually and progressively reduce sodium in processed foods.
241
Voluntary targets were set according to the category of food, with reductions ranging
between 5–18% over a 2-year period, and a government campaign supporting and encouraging
behaviour change. In 2013, to build on the success achieved through the voluntary
scheme, Argentina enacted a national law regulating the sodium content of processed
foods. As of 2019, 83 countries have salt reduction strategies in place or planned,
including 35 countries with voluntary targets and nine with mandatory, legislated
targets. Almost all countries use a multifaceted regulatory approach, with 70 counties
implementing, or planning to implement more than one type of strategy, and 33 countries
incorporating legislative initiatives such as taxes, maximum limits, or warning labels.
242
Programmes are now being implemented in countries across all WHO regions and across
countries with a broad range of income levels.
242
An example of these changes is described in the case study of the regulation of sugar-sweetened
beverages (panel 7
).
Panel 7
Regulation of sugar-sweetened beverages
Sugar-sweetened beverages (SSBs), generally defined as liquids with added sugars (soft
drinks, sports beverages, energy drinks, sweetened waters) are a known contributor
to a variety of non-communicable diseases such as obesity, type 2 diabetes, heart
disease, kidney disease, non-alcoholic liver disease, tooth decay and cavities, and
gout.
243
In response to the non-communicable disease epidemic, countries have begun to regulate
SSBs, primarily through excise taxes, which add a per ounce fee to the SSB sales price,
although traditional sales taxes have sometimes been employed.244, 245 The trend toward
taxation has increased substantially over the past decade, and particularly during
the past 5 years. As of 2019, more than a dozen countries, including France, the UK,
Norway, Portugal, Chile, Saudi Arabia, South Africa, Thailand, and Mexico, along with
numerous localities, have adopted sugar taxes of varying scope and size.
246
Two of the most studied tax cases were in Mexico and Berkeley, California. Mexico
was among the first countries to implement a substantial tax on SSBs, in 2014, levying
a 10% excise tax on all SSBs except milk. Researchers found an immediate reduction
in SSB consumption during the following years, with sales of SSBs falling by 5·3%
in 2014 and 9·7% in 2015, while sales of untaxed beverages increased in 2014 and fell
by only 1% in 2015.
247
In Berkeley, which adopted a 1 cent per ounce tax on SSBs, researchers found that
SSB sales decreased by 9·6% while untaxed beverage sales increased by 3·5%, driven
primarily by a 15·6% increase in sales of bottled water.
248
Importantly, the tax did not seem to meaningfully affect overall consumer shopping
habits, as average grocery bills did not increase, and Berkeley store revenue did
not decrease compared with control cities. Multiple studies (in addition to those
in Mexico and Berkeley) found that SSB taxes lead to moderate reductions in consumption,
which could support positive downstream health outcomes.
249
WHO supports adoption of SSB taxes as a strategy to help combat non-communicable diseases,
particularly obesity and diabetes, citing evidence that an SSB tax that increases
consumer prices by 20% can lead to an approximate 20% reduction in consumption.
249
Crucially, researchers have cautioned that SSB taxes must be relatively high to reduce
consumption; at lower levels retailers could elect to absorb the cost of the tax in
order to retain customer business, particularly if customers are readily able to purchase
comparable goods from a nearby retailer in a location without such a tax.
250
Supporters of SSB taxes often argue that improved population health resulting from
SSB taxes will eventually reduce health-care costs. WHO cites estimates that, over
10 years, a tax on sugary drinks of 1 cent per ounce in the USA would result in more
than US$17 billion in health-care cost savings.
249
Supporters argue that the revenue generated by SSB taxes can offset health-care expenses.
For example, WHO cites estimates that an SSB tax of ¥1 (US$0·16) per litre in China
would generate an estimated ¥73·6 billion (US$11·8 billion) in revenue.
249
As policy makers have become more interested in taxation and other regulation of SSBs,
so too has the beverage industry, adopting creative techniques to forestall new regulation.
For example, in response to local efforts to implement SSB taxes within California
(the largest state in the USA, with over 39 million residents), the beverage industry
engaged in an aggressive and ultimately successful strategy to preempt local taxation
authority. In California, the generally liberal state government would normally be
unlikely to adopt a state wide ban on new soda taxes. However, in 2018, the beverage
industry deployed a two-pronged effort to curb local SSB taxing authority, first,
by financing a ballot initiative in support of a sweeping preemptive tax law251, 252
that would have been devastating to localities, and later, by agreeing to withdraw
the proposed initiative if a more narrow food and beverage tax ban bill passed, a
move that was characterised by some legislators as “blackmail” and “being held hostage”.
253
The industry's forceful techniques were effective. In June, 2018, the California legislature
passed a bill preempting any new local food or beverage taxes for 12 years,
254
joining Michigan and Arizona in adopting state wide bans on new soda taxes. Several
other states in the USA have considered such bills, and the industry appears likely
to continue to lobby in support of their passage in the USA and globally.
The California example is emblematic of the challenges facing policy makers and health
advocates. Although research shows that SSB taxes are an effective legal tool to help
combat the non-communicable disease epidemic, the industry has mobilised to defeat
any important new regulation. With industry willing to spend heavily in support of
its objectives, public health advocates must be prepared for a more difficult path
toward adoption of future SSB taxes.
Physical inactivity is the fourth leading risk factor for global mortality and was
associated with an estimated 55·3 million deaths globally in 2008.255, 256 A European
prospective investigation of over 334 000 men and women found that twice as many deaths
could be attributed to lack of physical activity, compared with the number of deaths
attributable to obesity. Even a modest increase in physical activity could have significant
health benefits: a brisk 20 minute walk each day could be enough to reduce an individual's
risk of early death.
257
WHO recommendations go further, recommending that adults undertake 150 minutes of
moderate-intensity physical activity, or 75 minutes of vigorous-intensity physical
activity, throughout the week.
258
Building on these findings and recommendations, an emerging body of evidence on legal
and regulatory interventions is aimed at increasing physical activity.
Features of the built environment, including the so-called walkability of a city,
are strongly associated with the prevalence of obesity. A gender equity dimension
is also present, as women tend to be further disadvantaged in their opportunities
for physical activity where cities are not walkable.
259
This is another area in which laws and regulations that affect population health might
lie well outside the usual reach of health ministries, thus requiring intersectoral
cooperation. In a 2009 review of the evidence, WHO found that modifying the built
environment, policies that reduce barriers to physical activity (such as walking,
biking, and recreation), transport policies, and increased space for recreational
activity were all effective interventions.
260
Examples of effective laws and regulations to increase physical activity include urban
planning, land use management and zoning, transport policy (including taxes on car
use, availability and accessibility of public transport, and bicycle and walking paths),
and road and traffic control.
261
Local governments can play an important role because land use and zoning frequently
fall under their remit. Local governments can implement building, zoning, and development
regulations that encourage more physically active lifestyles: streets that are welcoming
and safe for pedestrians and cyclists, facilities for public recreation (parks and
playgrounds), and traffic calming measures.
15
The common theme among legal and regulatory interventions to prevent non-communicable
diseases is that they promote small changes, across entire populations, for a mass
impact. By simply changing a default option (eg, reducing salt in processed food,
forbidding smoking in certain areas, or making public transport easier than car use),
law has the power to facilitate profound changes in behaviour. Good laws can make
healthier and safer behaviours the easier or normal choice. In conjunction with health
promotion and awareness campaigns, countries can use law to support and encourage
communities to resolve the problems arising from the shared risk factors of non-communicable
diseases.
Injuries
WHO estimates that more than 5 million people (equivalent to 9% of global mortality)
die each year as a result of injuries, and many more endure temporary or permanent
disability, along with great social and economic hardship.
262
Leading causes of injuries include road traffic crashes, drowning, poisoning, falls,
burns, and violence.
262
Again, the burden falls disproportionately on the poor, and more than 90% of injury-related
deaths occur in low-income and middle-income countries. Unsafe workplaces or dwellings
expose people to high levels of injury risk: prominent incidents include the 2012
Tazreen Fashion factory fire on the outskirts of Dhaka, Bangladesh, and the 2017 Grenfell
Tower fire in London, UK. In both episodes, fire safety laws were substandard, poorly
enforced, or both. In lower-income countries, countless women sustain debilitating
injuries or death from unsafe cooking stoves. Around the world, injuries from the
mining and extractive industries disproportionately affect men, and young men bear
a disproportionate burden of motor vehicle injuries. Yet, a strong evidence base exists
for legal interventions in injury prevention, with road safety being the most prominent
example.
The UN General Assembly declared 2011–20 as the Decade of Action for Global Road Safety,
263
and road safety is integrated into SDGs 3 and 11. Each year, 1·24 million people die
as a result of road traffic injuries, and a further 20 million to 50 million sustain
non-fatal injuries.
263
Road traffic injuries are the leading cause of death among people aged 15–29 years.264,
265 Evidence shows that legislating on five key behavioural risk factors—speeding,
drink driving, helmet use, seat belt use, and child restraint use—could significantly
reduce this toll.
266
The regulation of environmental and design factors, such as safer vehicles and roads,
has also proved highly effective in preventing road crashes. Such interventions include
energy-absorbing crumple zones on cars, passive restraints, visible roads with clear
lane markings, traffic separation (eg, oncoming vehicles or bicyclists), and traffic
calming (eg, roundabouts and speed bumps). However, few countries have systematically
implemented laws that target behavioural risk factors and design features, or laws
that implement best practices. In particular, low-income and middle-income countries
often have substandard laws, and poor compliance and enforcement.
267
Global health institutions can establish norms that promote the uptake of such laws.
Efforts to define technical standards for safety and to conduct policy surveillance
of national road safety laws can be effective in helping to spread better laws. For
example, seatbelts are a proven way to reduce road traffic injuries and have been
mandatory in northern Europe and the USA since the 1970s.268, 269 In 2004, the WHA
adopted resolution WHA57.10, recommending that member states implement mandatory seatbelt
laws. The following year, the UN General Assembly adopted its own resolution, A/60/5,
similarly calling for mandatory seatbelt legislation. Since then, there has been a
significant increase in the number of states that have legislated for national mandatory
seatbelt use.
270
Botswana, Cuba, and Kyrgyzstan had a notable drop in road fatalities after mandating
seatbelt use for all vehicle occupants.
Wearing helmets can substantially reduce road traffic injuries, and laws mandating
helmets for motorcycle drivers and passengers are making an impact around the world.
The UK and many US states have had such laws in place since the late 1960s and early
1970s; however, many states in the USA have since repealed their helmet laws, which
has significantly increased head injuries. Helmet laws have been proven to be highly
effective, reducing the risk of head injuries by 69% and the risk of death by 37%.
271
In 1997, Taiwan introduced legislation making it compulsory to wear a motorcycle helmet.
The government supported this legislation with, on one hand, a public information
campaign, and on the other, strict fines for both riders and passengers.
272
The results have been powerful: between 1991 and 2008, motorcycle-related deaths almost
halved (from 7322 to 3646), despite an increase in both motorcycle use and crashes
during the same period. In 2007, Vietnam introduced a similar law,
273
supported by large fines for non-compliance. The Ministry of Health in Vietnam and
WHO reported that road traffic head injuries and deaths had decreased by 16% and 18%,
respectively, 3 years after the law was introduced.
274
When laws do not advance health with justice
When used effectively, law can be the foundation for sustainable, transformational
social change. However, when used inappropriately, law can cause grievous harm—sanctioning
discrimination and inequality, imposing barriers to access, creating intentional obfuscation,
and increasing complexity. As we have reiterated throughout this report, law is only
a tool, and its effectiveness depends on how this tool is used. Emphasising the risks
that arise when laws do not have the characteristics set out above is important.
The criminal justice system has had a particularly tenuous relationship with public
health. Criminal laws can provide a powerful incentive for behaviour change that improves
public health, as in the case of road safety. However, too often, the criminal law
is used in ways that cause harm to health and to dignity. The history of laws relating
to mental health, substance abuse, sexual and reproductive health, sexually transmitted
infections, and poverty are often particularly harmful.
Even with an ostensible public health objective, laws can institutionalise inequality,
discriminate against already vulnerable populations, and remove opportunities for
stigmatised populations to access testing and treatment. We see this most often where
criminal laws are enacted to promote a moral norm, rather than to punish a harmful
act. For example, numerous international commissions have called for the de-criminalisation
of HIV exposure or transmission.
275
The overly broad criminalisation of HIV non-disclosure, exposure, or transmission
are not only contrary to established public health evidence, but have also been shown
to negatively affect health outcomes.275, 276 In many countries it is a crime for
a person with HIV infection to have sex without disclosing his or her HIV status.
In these settings, such laws are inequitably enforced, fail to meet any tangible public
health objective —ie, reduce rates of HIV transmission
277
—and additionally, embed stigma and punish people for engaging in common behaviours
such as sexual activity. The result is that individuals are driven underground, preventing
them from accessing treatment, and potentially placing the broader community at risk.
275
Similarly, criminal laws have also posed barriers to the treatment and rehabilitation
of people who use drugs (panel 8
).
Panel 8
Effects of the criminalisation of drug use on health and justice worldwide
Control of the cultivation, trafficking, and use of illicit drugs is an issue of global
concern. The international legal drug control system is comprised of three treaties:
the Single Convention on Narcotic Drugs of 1961, the Convention on Psychotropic Substances
of 1971, and the UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances of 1988. Countries have a two-pronged obligation: to ensure adequate availability
of drugs for medical and scientific purposes, while also preventing illicit production,
trafficking, and use of such drugs.
278
Although the drug conventions require governments to take steps to reduce supply and
demand for controlled drugs, these efforts must be balanced with countries' human
rights obligations,
279
including their citizens' rights to health, dignity, and freedom from arbitrary detention.
The UN Office on Drugs and Crime has stated that the UN drug conventions do not require
penalisation of drug use or drug possession for personal use,280, 281 and the system
is grounded in a health framework explicitly stating that the “health and welfare
of mankind” is its overarching concern.
282
Despite this, countries across the globe use criminal law measures to try and address
the reduction of demand prong of their obligations—including 33 countries that maintain
the death penalty for drug-related offences.
283
In many countries, sentences for minor drug dealing are longer than sentences for
serious acts of violence such as murder, rape, or armed robbery,
284
and people imprisoned on drug-related charges make up a substantial proportion of
prison populations worldwide.
282
In many countries, punitive drug control efforts have resulted in serious human rights
abuse, including torture and ill treatment by police, mass incarceration, extrajudicial
killings, arbitrary detention, and denial of essential medicines and basic health
services.
282
The criminalisation of drug use has facilitated the spread of blood-borne viruses,
particularly HIV, among drug users. Some of the most severe drug-related harms are
associated with injecting drug use. Outside of sub-Saharan Africa, up to 30% of all
new HIV infections occur among people who inject drugs with unsafe injecting practices.
285
In fact, HIV prevalence in countries that rely on punitive approaches is substantially
higher (37–42% vs less than 5%) than countries that use public health approaches to
drug use.
275
Furthermore, criminalisation has also been used to limit access to treatment options.
Drug control efforts often have a disproportionate effect on vulnerable groups and
marginalised communities, including indigenous populations, the poor, and racial or
ethnic minorities.
286
In some countries, including the USA, treatment for hepatitis C has been restricted
on the basis of a person's active injecting status. Criminalisation has also resulted
in reduced access to disease prevention interventions, and proliferation of high-risk
drug use behaviours in the absence of accessible harm reduction technologies.
Criminalisation can lead to people avoiding health (and potentially other needed)
services for fear of arrest, and because of concerns about discrimination. Consequently,
their health and wellbeing are harmed.
Another pertinent example involves people with mental disabilities incarcerated in
the criminal justice system, rather than treated in a therapeutic environment. Studies
of the US prison system show that “about 20 per cent of inmates have a serious mental
illness, 30 to 60 per cent have substance abuse problems and, when including broad-based
mental illnesses, the percentages increase significantly.”
287
Most inmates placed in seclusion have a mental health disorder. Beyond lack of any
therapeutic intent, incarcerating people with a mental health disorder results in
further marginalisation and discrimination of an already vulnerable group (panel 9
).
Panel 9
Law as a tool to support improvement of mental health disorders
WHO defines mental health as “a state of well-being in which every individual realises
his or her own potential, can cope with the normal stresses of life, can work productively
and fruitfully, and is able to make a contribution to her or his community”.
288
The WHO and Institute for Health Metrics and Evaluation category of mental health
and substance use disorders encompasses several conditions including depression, anxiety,
bipolar disorder, eating disorders, schizophrenia, intellectual developmental disability,
and alcohol and drug use disorders.
Globally, the burden of mental health disease is substantial. Approximately 15–20%
of the world's population have one or more mental or substance use disorders;
289
in 2016, approximately 1·1 billion individuals had a mental or substance use disorder.
Some argue that the true burden of mental health and substance use disorder is even
higher because of factors such as difficulties in accurate measurement and reporting,
along with challenges in categorisation of overlapping conditions.
290
Mental health is neglected in most countries, particularly in relation to physical
health conditions. Individuals with mental health disorders face pervasive stigma
and discrimination, resulting in considerable disparities between the services available
for physical and mental health, with decreased availability, accessibility, and quality
of mental health services.
290
Although countries vary widely in access to mental health services, even the best
performing systems have yet to meet the need, leaving a wide treatment gap between
the need for treatment and actual service delivery. Estimates range from 76% to 85%
of people with mental disorders not receiving treatment in low-income and middle-income
countries, compared with 50% of comparable individuals in high-income countries.
291
WHO has identified the development of mental health policies and laws that promote
human rights as crucial to the protection of people with mental health disorders,
observing that such policies and laws are inadequate in most countries.
292
WHO's Mental Health Action Plan 2013–20 set a target that 50% of countries should
have developed or updated their mental health laws in line with international and
regional human rights instruments by 2020.
293
Although successful mental health policy involves myriad components, a foundational
issue is access to affordable, quality mental health services, which requires laws
supporting such access along with adequate funding for services. Historically, countries
devoted their scarce mental health resources almost exclusively to high-cost inpatient
services for relatively few acute cases, which has contributed to the treatment gap.
As evidence has shown the effectiveness of community-based outpatient treatment and
integration of mental and physical health services, countries are slowly transitioning
their laws and policies accordingly.
A notable example is the UK's Improving Access to Psychological Therapies (IAPT) programme.
Initiated in 2008, the IAPT programme provides evidence-based outpatient services
to people with anxiety or depressive diagnoses. The programme has several unique features,
including mandatory use of standardised evidence-based protocols with intensive clinical
supervision and, crucially, providing the services free of charge at the point of
care.
294
The UK invested £400 million in the programme from 2011 to 2015, and data indicate
that about 950 000 people per year access IAPT for an initial assessment, of whom
more than 537 000 receive therapy.
295
This increase in access has helped narrow the treatment gap by improving treatment
rates for adults with anxiety or depression from 24% in 2007 to 37% in 2014.294, 296
Another example of a law designed to improve mental health is India's Mental Healthcare
Act of 2017, a broad bill that seeks explicitly to comply with the UN Convention on
the Rights of Persons with Disabilities. India has traditionally underfunded its mental
health services, spending only 0·06% of its total health expenditures on outpatient
mental health care,
297
and has a severe shortage of mental health providers, even when compared with other
low-income and middle-income countries.298, 299 Among the new law's provisions is
a requirement that insurers cover mental and physical health services in parity, which
supporters hope will help combat the stigma surrounding treatment and lead to improved
mental health outcomes.
The ongoing stigma surrounding mental health conditions and continued shortfalls in
funding mean that change will come slowly, but the actions of countries such as the
UK and India show that targeted laws can help speed progress toward improved mental
health outcomes, particularly when coupled with adequate resources.
The criminal justice system can be especially unfair to women, particularly with regards
to sex work and reproductive health. Laws criminalising sex work are globally ubiquitous.
Sex workers are a highly marginalised group, and the illegality of their work often
results in scant protection against abuse, violence, and financial extortion.
300
The criminalisation of sex work virtually eliminates the negotiating power of people
engaged in sex work. Criminalisation makes it harder for sex workers to negotiate
safe sex with their clients, and it increases the risk of violence, because sex workers
are deterred from reporting violence to police. Some jurisdictions, such as New Zealand,
have legalised sex work, but both legalisation and decriminalisation are controversial
and politically difficult.
In many jurisdictions, reproductive choice and health, including access to safe contraception
and abortion, are threatened. Despite WHO guidance, many countries have criminalised
abortion and restricted family planning, and in some countries, women are imprisoned
for involuntary miscarriage.
301
A 2016 study found that “abortion rates are not substantially different across groups
of countries classified according to the grounds under which abortion is legally allowed.”
302
However, the study did find “the level of unmet need for contraception is higher in
countries with the most restrictive abortion laws than in countries with the most
liberal laws, and this contributes to the incidence of abortion in countries with
restrictive laws.”
302
Laws that restrict or penalise reproductive health programmes and family planning
not only cause stigma, but can also undermine public health messages. Several Latin
American countries restrict reproductive rights. These restrictions caused major concern
during the Zika epidemic, given fears about neurological disorders and neonatal malformations.
303
Countries in the Americas have observed an increase in babies born with microcephaly,
with a clear association between microcephaly and exposure of the mother to Zika virus
during pregnancy.
304
In 2016, WHO recommended that women in countries where Zika virus infection is a threat
should delay pregnancy for several months to several years.
305
However, at the same time, several affected countries have strict barriers to accessing
abortion, including laws that criminalise abortion for any purpose.
306
Women are consequently placed in an untenable position and can face a violation of
their human rights. Such laws endanger the health of women, especially those who seek
unsafe abortions because of the lack of access to legal abortion services.
Laws in other realms can also adversely affect the public's health. Many countries
ban or restrict access to health services for non-nationals—particularly, but not
only, undocumented immigrants. The law can also undermine the health of migrants in
other ways. For example, immigration laws often require deportation of non-citizens
infected with tuberculosis, which drives the population underground (panel 10
).
Panel 10
The effect of international law on the health of refugees—the case of tuberculosis
Nowadays, the world is facing the highest levels of displacement on record.
307
With an unprecedented 68·5 million people around the world forced from their homes—of
whom, nearly 25·4 million are refugees and 10 million are stateless people—the origins
and consequences of the displacement crisis remain some of the most formidable challenges
of our modern time.
307
Attempting to address the myriad challenges that face refugees and asylum seekers
across the world, the international community, by way of international law and treaties,
has sought to foster norms on how countries treat refugees. The core instruments of
international refugee law—the 1951 Convention relating to the Status of Refugees,
and the 1967 Protocol
308
—provide protection for refugees by prohibiting refoulment of refugees, or forcible
returning of refugees to places where they fear for their lives or freedom.
309
Although the law has taken important steps to protect the wellbeing of refugees, profound
gaps persist and negatively affect the rights and experiences of refugees, particularly
with respect to health. Yet even more troublingly, laws and policies themselves can
hinder health outcomes and contravene well established public health principles. This
twin dynamic of unmet need and avoidable harm is exemplified in national laws and
policies surrounding refugees and tuberculosis.
310
From the start of the journey, through to arrival at the country of asylum, refugees
and others who are subject to forced migration are susceptible to contracting tuberculosis.
This vulnerability begins with refugees' experiences in their home country, where
health-care infrastructure might be lacking or have broken down because of war. For
example, before the 2011 crisis began, Syria had a relatively low burden of tuberculosis.
311
Although data regarding tuberculosis in Syria remains elusive, reports show a rapid
rise of the disease in the country, which is still believed to only be a fraction
of the actual burden.311, 312
After refugees leave their home country, the journey exacerbates their susceptibility
to tuberculosis. Economic, social, and legal barriers increase the likelihood that
tuberculosis will spread along the way and block access to care for those who contract
it. These barriers, in turn, can lead to increases in the prevalence of tuberculosis
in countries of asylum. Lebanon has been a country of asylum for Syrian refugees from
the start of the conflict in 2011.
313
In the first year of receiving Syrian refugees, Lebanon saw a 27% increase in tuberculosis
cases.
311
Reflecting this dynamic, countries enact national laws and policies regarding migrants
and tuberculosis. For instance, some countries will not provide essential medical
services to migrants with tuberculosis, some have legal requirements that individuals
with tuberculosis undergo treatment as a condition of attaining legal status, and
many detain and deport individuals who have or develop tuberculosis, frequently without
providing necessary treatment.
310
In the USA, active tuberculosis is still one of the communicable diseases that trigger
inadmissibility under the Immigration and Nationality Act, though a waiver may be
possible.
314
These national restrictions based on tuberculosis claim public health as a justification,
but directly contravene established public health principles and violate international
law.
The WHO emphasises that screening of migrants, including refugees, for active or latent
tuberculosis “should always be done with the intention to provide appropriate medical
care, and never to exclude or preclude entry”.
315
Because tuberculosis is preventable, treatable, and curable, public health principles
guide the international community towards identifying and treating every individual
with active tuberculosis, regardless of location, immigration status, or socioeconomic
status.
310
This approach builds on the experience of countries' HIV and AIDS responses and the
International Health Regulations, which call for any measure to prevent the spread
of an infectious disease to use the least restrictive means possible.
316
With respect to international law, countries have a right to exercise their sovereignty
in imposing immigration restrictions.
317
However, international law requires that states only undertake measures that are consistent
with human rights and other international obligations. These obligations include non-discrimination
on the basis of other status, which includes health status. If states do indeed opt
to limit rights, states must show that the limitations are necessary to achieve a
legitimate aim, that the means achieve the stated aim, and that they are the least
restrictive means.
318
People who fear deportation are unlikely to seek testing and treatment, placing infected
individuals and the wider public at risk. Moreover, by interrupting continuity of
care, deportation can jeopardise tuberculosis treatment for those who have already
started it, which risks resistance developing to first-line tuberculosis medications.
310
Healthy people in healthy communities
A substantial body of evidence and learned experience shows that legal interventions
can advance global health with justice. Around the world, law has been used to reduce
health risks, examples of which include vector control and immunisation for infectious
diseases, tobacco control, food reformulation, healthy built environments for non-communicable
diseases, vehicle and road design, and increased road safety measures.
But the lessons of evidence and practice also run in the opposite direction. Too often,
governments have used law for improper purposes, or with little consideration for
the values of health with justice. In such cases, law can raise risks and create stigma.
Inappropriate use of the criminal law has been deeply harmful in multiple spheres.
For these reasons, policy makers should monitor and evaluate the effects of law on
health and on justice. Legal determinant 3 encapsulates the need for ongoing evaluation
of public health laws, ensuring that laws and their implementation are evidence-based,
fair, intersectoral, and transparent. Laws that promote human rights, particularly
the right to health, can be transformative; however, those that violate human rights
can be deeply harmful.
Despite the firm foundation of the right to health in international law, the persistence
of unconscionable health inequities and the lack of accountability to health commitments
have led to calls for a new treaty on the right to health. The Framework Convention
on Global Health (FCGH), an idea first suggested a decade ago, is a major proposal
for a treaty based on the right to health.
319
The FCGH has since been supported by a growing number of civil society organisations,
as well as national and global health leaders,320, 321 with this movement now crystallised
through the FCGH Alliance. The FCGH would reinforce norms of equity, justice, and
human rights; create mechanisms for inclusive participation, cross-sector cooperation,
and accountability; and delineate national and global responsibilities for sustainable
financing.
322
Rather than a piecemeal approach to discrete global health challenges, the FCGH would
function as an overarching, rights-based framework under which all the vital components
of the right to health could be realised, with additional protocols where needed to
fill gaps. The FCGH would respond to the SDGs call for governments and international
institutions to “leave no one behind.”
When research tells us that an intervention works, and when governments operate on
the basis of sound scientific evidence and the rule of law, it becomes possible to
create the conditions in which people can achieve health with dignity and human rights.
Healthy populations and healthy communities start with the enactment and implementation
of effective and just public health laws. Recommendation 4 urges governments to form
country-appropriate mechanisms to advise on legal interventions that will impact the
public's health and safety. These might take the form of national health law commissions,
task forces, or other structures, with the aim of developing a systematic plan to
identify and propose effective legislation. As part of this process, we also recommend
that governments adopt legislation requiring HIAs for policies, programmes, and projects
that might seriously affect health.
At the international level, recommendation 4 proposes that WHO use its constitutional
law-making powers to adopt further international legal instruments to safeguard the
public's health and safety. This approach would build on the successes of existing
instruments, while also addressing deficiencies, and aim to understand and improve
underserved areas such as mental health.
Section 5: legal determinant 4
Our final legal determinant of health underpins all the others: building and strengthening
legal capacities for health. Robust legal architecture and resources for enacting,
implementing, and monitoring public health legislation can bring to fruition all the
legal determinants of health. Law and health should be mutually reinforcing, but the
two fields often do not work synergistically, whether in research, practice, or philosophical
orientation. In this section we make the case for, and set out the key features of,
the legal capacities required to achieve health with justice.
Why build capacity?
Strong legal capacity for health will be a key determinant of progress towards global
health and sustainable development. Yet, too often, countries lack the basic legal
infrastructure or the capacity to build it. The WHO report, Advancing the right to
health: the vital role of law,
86
put forward several reasons why legal capacity building is essential.
First, the report states that over time, laws have become outdated, fragmented, ambiguous,
or incoherent. Therefore, health officials might lack the mandate and legal powers
to implement new, evidence-based interventions. Outdated laws and existing interventions
might stigmatise or penalise vulnerable individuals and communities, driving epidemics
underground. Secondly, new and emerging health hazards might require new legislative
frameworks. Public health laws are often introduced reactively, and then stay on the
books for decades. In the face of emerging threats—whether novel pandemics, or new
paradigms such as non-communicable diseases—these laws might not be fit for purpose.
Conversely, an ambitious goal like achieving UHC calls for forward planning and proactive
regulation. The WHO capacity building report also stated that governments might lack
the legislative and regulatory tools to discharge their public health and human rights
responsibilities effectively. Public health officials need a wide-ranging set of powers
to carry out their responsibilities to safeguard the population. At the same time,
the law must protect the civil and political rights of individuals, as well as their
social, economic, and cultural rights, including non-discrimination and equal protection
under the law. Protecting such rights is particularly relevant to achieving the SDGs,
in which health, development, and human rights are closely intertwined.
In settings where regulatory and governance capacity is lacking, laws intended to
protect the public's health might be poorly drafted or ineffectively implemented.
In the absence of a sound legal infrastructure, the law might even undermine health
goals.
How do we define legal capacity?
The term capacity building (or capacity development) originally comes from the lexicon
of sustainable development.
323
Capacity can include “infrastructure, institutions, human knowledge and skills, and
collective attributes such as social relationships, leadership and management.”
324
The UN Economic and Social Council defines capacity development as “the process by
which individuals, organizations, institutions and societies develop abilities to
perform functions, solve problems and set and achieve objectives.”
325
Just as public health requires governments to invest in health systems, it also requires
investment in regulatory capacity and effective legal environments.
86
Legal capacity for health refers to three interlinked dimensions: effective legal
environments (which include the infrastructure for drafting, implementing, and enforcing
laws that promote health with justice, as well as fairly resolving grievances that
arise); a strong and growing evidence base, built on the rigorous monitoring and evaluation
of existing laws; and an empowered, transdisciplinary health law workforce. The latter
includes connected networks of well trained professionals—legal and non-legal—who
share information and strategies, and who provide technical legal assistance.
16
Building capacity means attending to each of these dimensions (figure 5
).
Figure 5
The overlapping dimensions of legal capacity building for health
An effective legal environment: a process, not an endpoint
Enacting a good health law is only the first step towards building an effective legal
environment. Laws that are defined as on the books must be supported by effective
processes for their drafting (including public participation), implementation, enforcement,
monitoring, evaluation, and ultimately their revision or repeal where necessary (figure
6
). Ongoing evaluation and continuous quality improvement lead to legislation and regulations
that demonstrably improve the public's health and safety.
Figure 6
Features of an effective legal environment
Drafting and enacting public health law
The most visible aspect of an effective legal environment for health is so-called
law on the books—the group of enacted laws and regulations that makes up public health
law. Traditionally, the focus of public health law was on the management of unsanitary
environmental conditions (eg, drains, water, food, and housing), and the control of
infectious diseases.
17
Nowadays we recognise that public health law encompasses a far wider range of topics.
Specific public health laws include “laws that are intended as health interventions,
laws that define the powers, duties and boundaries of health agencies and systems,
and laws that have an impact on health but were not enacted primarily with population
health in mind”.
5
Examples for each of these categories are provided (panel 11
).
Panel 11
Public health laws
Laws intended as health interventions
•
Standards: food safety; consumer protection; air quality; drinking water; drugs, cosmetics
and medical devices; pesticides; occupational health and safety; road safety; hygiene
and sanitation; vector control
•
Regulation and licensing of tradespersons and professionals: health workers; social
workers; hair and nail stylists; tattoo artists
•
Regulation and inspection of premises: hospitals and nursing homes; bars and restaurants;
food markets; docks; swimming pools; tattooing and tanning establishments
•
Pest and animal control: vector abatement (eg, mosquitoes, fleas, and rodents); dangerous
or exotic animals
•
Infectious disease response: vaccinations; testing and screening; isolation and quarantine;
contact tracing and partner notification; directly observed therapy
•
Tobacco control: age limits, smoking bans in public places; taxation; advertising
and marketing bans and restrictions; packet labelling (or warnings) and plain packaging;
bans on cigarette flavouring; nicotine reduction
•
Alcohol control: age limits; restrictions on marketing and advertising, package warning
labels; prohibiting driving while intoxicated
•
Mental health laws: guardianship and civil commitment; mandatory or community treatment;
rights protections
•
Promoting healthy diets: nutrition labelling on food products and restaurant menus;
regulation of junk food advertising aimed at children; regulating food ingredients
(eg, limits on trans fatty acids, added sugars or sodium); portion size limits; taxes
on unhealthy foods (eg, sugar-sweetened beverages)
Laws that define the powers, duties, and boundaries of health agencies and systems
•
Laws establishing and governing public health agencies, including mission, powers,
limits
•
Laws establishing and governing health-care agencies, including quality assurance,
eligibility for services, essential medicines list, reimbursement for services
•
Laws protecting patients' and service users' rights and privileges
•
Privacy laws governing data held by health agencies and health-care providers, including
data protection and confidentiality
Laws that have an effect on health, but were not enacted primarily with population
health in mind
•
Planning and zoning laws: walking and biking paths; parks, playgrounds, and recreation;
pedestrian zones and congestion taxes; limiting fast food outlets and encouraging
supermarkets
•
Firearms regulation: weapons bans (eg, automatic discharge firearms); smart firearms
(eg, discharge only with owner's fingerprints); safe gun storage; firearms training;
background checks prior to purchasing
•
Social, welfare, and housing services and programmes: child protection and benefits;
community centres (for the elderly or vulnerable) and support groups (for drug or
alcohol dependency); pensions and disability benefits; income supports; nutrition
programmes; public and subsidised housing
•
General taxation: progressive tax structures; negative income taxes; deductions for
health care, child care, and public transportation expenses; eliminating tax havens
or loopholes; fair and efficient tax collection
From pandemic responses to the prevention of non-communicable diseases, law on the
books is a crucial determinant of what is achievable: empowering and obligating agencies
to safeguard the public's health, but also protecting individual rights by placing
limits on government and private action.
Governments first need capacity to write and enact laws and regulations. Such drafting
should ensure that laws are comprehensible and systematic; adhere to principles of
good governance and sound regulation, such as being developed through transparent
processes with public participation; are evidence-based; are transparent and clearly
communicated to the public, setting out health officials' powers and responsibilities,
as well as their limits; are consistent with, and supportive of human rights; and
promote equity. Many of these features are addressed in sections of this report.
Effective legal environments, like effective health environments, require transparency
and accountability. Effective legal environments give affected populations and civil
society organisations meaningful opportunities to participate in the decision-making
process. Translating the goals and processes of health laws from the immediate context
of policy makers and legal or health practitioners, to the wider public and the organisations
that represent their interests, is crucial. This idea goes far beyond education or
health promotion: rather, it means that affected communities should be genuine partners
in, rather than targets of, health policy.
The global response to HIV and AIDS provides the most powerful illustration of community
mobilisation. In the face of stigma, discrimination, and neglect, advocates raised
social and political awareness, which ultimately generated the political will to take
action. They demanded high quality research into the prevention and treatment of HIV
infection. When interventions were developed, they advocated for the right to affordable
access throughout the world. The response to HIV and AIDS is, of course, an ongoing
struggle, and is only one major health hazard among the many that urgently require
social mobilisation.
In areas where civil society voices are not yet sufficiently empowered—for instance,
for non-communicable diseases,
326
injuries, or mental health—governments should actively seek public involvement in
policy making, using public announcements, open forums, and public comment sessions.
Consumers and health advocates should be invited to attend important meetings as partners
alongside public officials, health professionals, and scientists. These governance
mechanisms can incentivise public participation and help “dispel potential concerns
of suspicion or mystification that might surround the development of public health
laws”.
327
Public participation and open forums also enable civil society to understand the purpose
of health law and engage more effectively in the policy process. In turn, this can
support adherence to the norms and standards established by health laws. For example,
in Denmark, public health groups worked with the government, industry bodies, and
civil society organisations, to raise public awareness of the cardiovascular risks
of consuming artificial trans fats.328, 329 This type of public engagement meant that
when regulation limiting these harmful fats was introduced in 2003, it already had
a high level of public confidence and support, and strong industry compliance—ultimately
leading to a successful public health legal intervention.
Public participation can also mean opening the door to powerful vested interests.
New York City's regulation limiting the portion size of sugary drinks (known popularly
as the soda ban) received a great deal of community opposition. However, research
subsequently showed that much of this opposition was led by organisations supported
by the sweetened beverage industry.
330
The American Beverage Association (with Coca-Cola and PepsiCo as members) spent millions
of dollars swaying public opinion against the soda ban, and ultimately succeeded in
having the courts strike down the measure. Elsewhere, the food industry has spent
lavishly to influence legislative processes on issues ranging from menu labelling
to taxes on sweetened beverages.
331
Furthermore, as sales of unhealthy foods in higher-income countries have begun to
lag, food companies are expanding their markets in developing countries by targeting
community networks. An exposé in The New York Times,
332
describes the use of direct marketing by multinational Nestlé to sell sugary foods
to poor people in Brazil, under the guise of nutrition and community empowerment.
These grassroots efforts take place while food and beverage conglomerates enjoy an
enormous amount of political and economic power in Brazil.
Policy makers must be alert to the risk that genuine community voices are likely to
be weaker, less organised, and less well-funded than commercial players with substantial
interests to defend. As such, governments should empower civil society organisations
to meaningfully participate in the development of health laws. Health advocates also
need to anticipate industry opposition and build broad-based community coalitions
for health.
333
Implementation: inspections, monitoring, and enforcement
Effective legal environments are supported by systems of monitoring, inspections,
and tools for enhancing compliance with public health laws and regulations. A range
of different professions—including public health, food and drug, and environmental
health officers; medical and nursing practitioners; scientists; and even police in
certain contexts
17
—will have responsibility for monitoring and enforcing public health laws. These professionals
exercise statutory powers as health officials, officers, or inspectors. For the purposes
of enforcement, these powers usually include a range of responsibilities, described
as follows: inspect and search premises or goods—eg, to ensure safe workplace environments,
purity of food and drugs, or sanitary conditions of farms or restaurants;
327
issue orders to cease and desist unsafe conditions or activities, such as pest or
animal abatement; issue formal notices of failure to comply; levy and collect fines;
confiscate unsound goods; shut down unsafe businesses or premises; sanction professionals
for poor quality or safety lapses, including the loss of a licence, permit, or accreditation
needed to legally operate; publicly disclose instances in which there has been a failure
to adhere to public health standards, such as by issuing prominent notices on restaurants
of their sanitation and hygiene rating; and finally, engage in dispute resolution,
when there is a legitimate disagreement between regulators and the regulated party.
327
Where disputes arise, the court system or other means of redress must be empowered
to impartially adjudicate disputes, ensuring fair application of the regulations,
and allowing regulated professionals or industries to contest decisions.
Research and evaluation
Ongoing monitoring and evaluation of the effects of laws and regulations are crucial
steps in the process of ensuring effective legal environments for health, but are
often overlooked. Because law has the power to affect diverse populations in different
ways, it is crucial that policy makers rely on evidence, whenever possible, to distinguish
between laws that work, laws that do not work, and laws that cause harm. Yet, nowhere
else in the realm of public health are interventions used to treat so many people
with so little evaluation of the effects.
201
A few exception areas, including alcohol and tobacco control, have showed the importance
of evaluation in developing and spreading highly effective legal solutions. In the
following section, we focus on a second dimension of legal capacity for health: a
strong evidence base.
A strong evidence base, informed by the values of justice and equity
Health laws and regulations should be informed by a robust body of evidence regarding
their effectiveness in reducing risks of injury and disease. In this section, we make
the case for strengthening the evidence base in relation to the design and use of
health law research. At the same time, we acknowledge the important role of values
in health policy innovation. As we have noted throughout this report, public health
is not simply the application of technical solutions to health problems. Rather, it
is unabashedly infused with the values of social justice and grounded in the language
and practice of human rights. Although we recognise that the law-making process is
embedded in politics, we urge policy makers to critically evaluate existing evidence,
support ongoing health law research, and prioritise the right to health and other
human rights.
Health laws must be based on robust evidence
Since the turn of the 21st century, public health law as a field of scholarship has
undergone a renaissance: its philosophical orientations, conceptual frameworks, and
core debates have been well articulated.
15
Building on this, researchers and policy makers are now recognising the growing need
for empirical research. Empirical research can relate to any of the stages in figure
6—from the design of laws, to their monitoring and enforcement—and aims to answer
the questions: which laws or practices are associated with better health outcomes?
Which laws or practices are associated with worse health outcomes? Which laws impose
undue burdens, particularly on disadvantaged populations? How can these laws or practices
be improved, for population health and the protection of human rights?
Law is rarely amenable to what scientists regard as the so-called gold standard of
evaluation, which is the randomised clinical trial. Nevertheless, the impact of law
can be studied scientifically, the study of which leading scholars describe as legal
epidemiology.
334
Legal epidemiology aims to study law as a variable that can affect health outcomes.
For example, it might rigorously examine whether a law is correlated with a particular
health outcome, or compare outcomes in jurisdictions that have implemented similar
or different laws—noting that contextual factors will mean that success in one jurisdiction
will not necessarily predict success in a neighbouring jurisdiction. Comparison of
health effects before and after implementation of a law is also a useful research
tool. Health law research can also survey those who implement laws, and those affected
by them, to ascertain their effects on the ground.
Empirical health law research employs scientific, quantitative methods to assess the
effect of laws and to improve their design. Such empirical research methods include
evaluating the policy-making process, so-called mapping particular categories of laws
or regulations, examining how laws are implemented and enforced in practice, intervention
studies, and close analysis of the legal mechanisms of particular interventions.
334
Beyond strengthening the evidence base, this type of research can have far-reaching
social and political effects. Research findings can strengthen political and public
support for the enactment of particular health laws (by giving an evidence-based rationale
for their implementation) and, at a deeper level, can also help strengthen the philosophical
and practical linkages between law, health, development, and related disciplines.
A persistent reason for public opposition to health laws lies in the claim that they
are paternalistic: an intrusion by the so-called nanny state onto individuals' freedom
to choose what to eat or how to behave. Opponents argue that certain public health
laws force individuals to act in ways they would not otherwise choose—such as compelling
them to wear a motorcycle helmet or raising the price of sugary drinks. Health advocates
can use normative reasoning to address claims of paternalism—arguing, for example,
that these laws increase wellbeing and reduce health-care costs. However, objective
evidence of positive behaviour changes that improve health can be a more powerful
counter to such so-called nanny state arguments.
Well designed studies often require access to large datasets, medium-to-long-term
funding and perhaps most importantly, a workforce of interdisciplinary researchers.
335
Universities, which have played an important role in the expansion of global health
as a discipline,
6
can help to build such a workforce by offering health training to legal graduates,
and legal training to health professionals. As a global health community, we need
to set, and drive forward, a clear and ambitious research agenda. We need to build
consensus on the key questions that require answers and the laws in most urgent need
of evaluation, and to prioritise resources accordingly.
336
Given that society invests substantial political and economic capital in enacting
and enforcing public health laws, devoting resources to enable high-quality research
into their effects would be worth the investment.
But evidence is not the only consideration
Even as we advocate for high-quality empirical research on the relationship between
law and health, we recognise that evidence is only one important aspect of a well
regulated society. Policy makers often must act on the basis of incomplete scientific
information, taking social values into account. In some cases, the call for full objective
evidence before enacting any public health intervention can stifle innovation. If
a new law represents a sharp turn from accepted practice, the case for reform will
often require building an evidence base over time.
In settings where law makers have good grounds for believing that legislation will
have positive effects, and have a plan for ongoing evaluation, they should have the
leeway to introduce novel ideas. For example, following the first case of HIV transmission
via drug-injecting equipment in 1985, Australia quickly introduced a Needle and Syringe
Programme (NSP). The NSP provided sterile drug injection equipment and facilities
for the safe disposal of used equipment. The programme also became a first point of
contact between injecting drug users and health services, providing education, information,
and onward referrals to drug treatment, medical care, and legal and social services.
337
Evaluations of NSPs in Australia found them to be “the single most important and cost-effective
strategy in reducing drug-related harms among [persons who inject drugs]”,
338
and the programme has been endorsed by WHO, UNAIDS, and the UN Office on Drugs and
Crime. Yet initially, experts and policy makers faced intense opposition. The evidence
was not watertight, but policy makers had to act decisively to stem a potential epidemic.
In doing so, they were guided by human rights principles and the need to protect a
susceptible community. Once adopted, programmes such as NSPs can and should be subject
to rigorous empirical examination. As of 2019, we have robust evidence that NSPs help
prevent the transmission of blood-borne diseases and save lives. As observed with
so many public health successes, the lack of complete evidence did not act as a barrier
to innovation. Therefore, governments should establish infrastructure to enable early,
rapid, and systematic evaluation of innovative policy ideas.
339
An empowered, transdisciplinary health law workforce
Finally, effective legal environments are only possible with a knowledgeable and capable
health law workforce. As the linkages between global health and the law become stronger,
the need for an empowered, transdisciplinary health law workforce will become more
pronounced. Recognition of the potential for legislative and regulatory interventions
to improve population health is growing; however, this is not matched by the availability
of skilled professionals who can implement and evaluate such interventions.
340
Although difficult to quantify numerically, in our assessment, the deficit is marked.
We identify three aspects central to building the necessary workforce capacity: building
disciplinary bridges, building knowledge and skills, and building networks.
Building disciplinary bridges
Researchers and practitioners in law and in health have traditionally worked in quite
distinct ways. In the medical profession, as in the wider public, understanding or
recognition of the power of law to drive behavioural and social change is lacking.
Health professionals might even have a negative view of the legal profession, perceiving
lawyers as adversaries bringing malpractice litigation.
340
For their part, lawyers can be protective of their turf and unwilling to acknowledge
the limits of their subject-matter expertise. This silo mentality leads to missed
opportunities for teaching, research, practice, and problem-solving. Colleges and
universities are uniquely positioned to address this problem, but these institutions
alone are insufficient to foster the necessary health law ecosystem. Building the
empirical evidence base for effective health laws first requires building disciplinary
bridges: mutual understanding, collaboration, common terminologies, and an appreciation
of how different skill sets can be applied to public health problems. It also requires
genuine interdisciplinary (or even transdisciplinary)
16
research, drawing on the expertise of legal scholars, epidemiologists, clinical scientists,
policy analysts, behaviour change experts, and anthropologists, amongst others, working
together.
Building knowledge and skills
The interdisciplinary or transdisciplinary nature of health law presents unique challenges
for teaching and training. Nevertheless, equipping law graduates with health knowledge
and epidemiological skills, and health graduates with an understanding of the role
of law and governance in creating healthy environments, is crucial for building capacity.
Both health graduates and law graduates should be introduced to the basics of international
human rights law. Education in public health, law, and policy should include the range
of skills needed in a transdisciplinary public health law practice, including policy
development, basic principles of law and legal procedure, advocacy, ethics, implementation
and enforcement, and legal epidemiology.16, 201 Schools of medicine, nursing, public
health, and law can teach a broad curriculum encompassing a variety of transdisciplinary
skills. These schools can also collaborate to offer joint degrees, such as a Juris
Doctor with Master of Public Health or Juris Doctor with Doctor of Medicine.
Academic institutions have the opportunity to successfully deliver training and teach
skills to help resolve specific health challenges—for instance for non-communicable
diseases, access to medicines, and injuries. Solutions to all of these complex health
problems require a variety of scientific and legal skills. Progress in these areas
can be achieved only if health advocates have access to the training and resources
needed for deep understanding not only of the health hazard, but also of the legal
rules and mechanisms that govern the particular field. Understanding the field of
non-communicable diseases and the law requires a strong understanding of multiple
other areas, including consumer law, marketing law, food law, tax law, and environment
and planning law.
341
Similarly, the law surrounding access to medicines requires understanding the linkages
between trade law, intellectual property law, and health.
340
Health advocates push for affordable access to medical technologies, but to be truly
effective they need the acumen to understand the legal rules governing the pricing
and regulation of vaccines and medicines.
342
Health diplomacy is another crucial legal capacity. Whether at the national, regional,
or global level, legal and health professionals must develop the skills and gain the
experience needed to bridge often bitter ideological and political divisions to forge
effective norms and standards. Health diplomacy requires the ability to genuinely
listen to the concerns of stakeholders, while identifying common ground and finding
fair and innovative ways to coax the parties toward consensus. WHO explains that global
health diplomacy “brings together the disciplines of public health, international
affairs, management, law, and economics, and focuses on negotiations that shape and
manage the global policy environment for health”.
343
Effective health diplomacy can operate at the national level (eg, negotiations over
new legislation or regulations, especially where health considerations need to be
integrated in non-health legislation) and at the transnational level (eg, negotiations
over new health treaties, global action plans, or codes of practice). The complex
negotiations over the FCTC, the IHR, or the PIP Framework all provide good examples
of the need for skilful health diplomacy. Academic institutions can partner with governments
and international organisations to fill these gaps in knowledge and skills. For instance,
academic institutions could help train the workforce charged with implementing health
laws and international agreements.
Building networks
Trained health law professionals must also have the opportunity to share knowledge,
strategies, and expertise. This approach is of particular relevance in relation to
new and emerging areas of law, and in resource-constrained environments. Many low-income
and middle-income countries do not have a cadre of trained health law professionals,
and health lawyers are also scarce in many high-income countries. In such cases, networks
of experienced health lawyers could collaborate with local health professionals, lawyers,
and policy makers to strengthen local capacities.
Training in health law could strengthen the contribution of a variety of professions
or groups to advancing health with justice. These include officials of international
organisations such as WHO, the WTO, and the World Bank; officials in regional organisations
such as WHO regional offices, regional alliances such as the Association of Southeast
Asian Nations, the Organization of American States, or the European Union; policy
makers and public officials in health or justice ministries who have responsibility
for developing, implementing, or enforcing health laws and regulations; officials
in other ministries, whose work could have an impact on public health (eg, agriculture,
trade, urban planning, foreign affairs);
86
front-line government workers who might be involved in enforcing health laws (eg,
customs or taxation officials);
344
personnel responsible for funding decisions, programmes, and policy making within
health-related entities, such as non-governmental organisations, philanthropies and
PPPs; lawyers who work closely with health agencies or programmes;
336
and lawyers tasked with defending new health laws from legal challenges.
Network-building and collaboration have been especially important in cases where health
advocates face powerful, organised resistance from vested interests. The FCTC explicitly
calls for legal capacity building and knowledge sharing in litigating tobacco control
cases, such as defending strong tobacco control laws or suing tobacco companies for
deception or unfair marketing. These calls have been realised through the efforts
of professional groups (eg, the so-called lawyer's circle for tobacco control, which
connects legal expertise in high-income countries with that in low-income and middle-income
countries), civil society (eg, the Framework Convention Alliance, made up of 500 member
groups worldwide), and philanthropies (eg, the Bloomberg International Legal Consortium,
which provides resources for legal capacities in tobacco control). Earlier we mentioned
food industry opposition to new laws facilitating healthier population diets. Ensuring
that the food industry does not undermine efforts to protect public health could be
another area in which cross-jurisdictional networking would be particularly valuable.
As multinational organisations expand their markets, a trained cadre of well-connected
health lawyers can help guide health legislation, regulations, and litigation to ensure
the public's health and safety.
Public interest law organisations can act as centres of excellence, sharing their
knowledge and expertise gained from grassroots experience. In South Africa, Section
27 combines legal action with research and advocacy in its pursuit of human rights
and social justice. Building on past success in mobilising legal and community action
around HIV and AIDS, as of 2019, Section 27 focuses on access to health care, the
right to food, and good governance. In India, the Lawyers' Collective works at the
intersection of health, human rights, and the law; fighting for access to medicines;
and the rights of women, the lesbian, gay, bisexual, transgender and intersex community,
and those living with HIV and AIDS.
In the USA, the Network for Public Health Law lawyers connects public health practitioners;
local, tribal, state and federal officials; policy makers; public health advocates
and organisations; and provides training and technical assistance.
345
Its areas of legal expertise include overdose prevention, health data sharing, injury
prevention, maternal and child health, and environmental health. In the USA, medical–legal
partnerships bring together health, public health, and legal expertise for the benefit
of patients, but also bring about systemic changes and improve population health.
346
Medical–legal partnerships guide patients through the complex terrain of the health-care
system, enabling them to claim their rights and gain access to the services they need.
Strong capacity for an effective legal environment
Throughout this report, we have identified multiple ways in which the law can be a
powerful instrument for the public's health and justice, focusing on effective, coordinated,
and strategic uses of law. Building legal capacity is the common denominator. Governments,
international organisations, funders, non-governmental organisations, academic organisations,
and other health institutions can take concrete, practical action to support states
as they build legal capacity. Such measures fall under three interlinked dimensions:
effective legal environments, which should be supported by a strong evidence base,
and an empowered, transdisciplinary health law workforce.
Although all of our recommendations relate to capacity-building, we have made four
targeted recommendations to a variety of institutional actors. In recommendation 5,
we call on WHO to partner with governments, foundations, and civil society, to expand
the evidence-base for public health laws (including research and information sharing),
and support strategies to enact and implement national and global health laws that
are effective and sustainable. Recommendation 6 is for governments to build national
capacities to enact and effectively implement public health laws. This relates to
leadership, planning, funding, and professional training. Finally, in recommendation
7, the Commission offers to partner with The Lancet to create a standing commission
on global health and the law, building on the momentum of this Commission.
Section 6: recommendations
In the following seven recommendations (summarised in panel 12
), we propose a public health law action agenda consisting of legal instruments, legal
capacities, and institutional reforms as tools for achieving global health with justice.
Our programme of action is based on principles of human rights and good governance,
founded on the right to health. Overarching the specific aims in each recommendation,
we intend these recommendations to help foster conversations among policy makers and
health workers, researchers, public health authorities, civil society, and others
who work in global health.
Panel 12
Commission recommendations for the legal determinants of health
Legal determinant 1: using law to translate vision into action on sustainable development
Recommendation 1: the UN, WHO, and international partners should set standards to
support the implementation of, and objectively evaluate compliance with SDG 3.8 Universal
Health Coverage (UHC), as well as the upcoming UN political declaration on UHC in
2019
Who must take actionable steps: the UN, WHO, and international partners Recommendation
2: governments should strengthen or create a legal framework, such as a constitutional
or statutory right to health, to ensure rights-based UHC on the basis of principles
of equity and non-discrimination, including affordability, financial protection, transparency,
accountability, participation, privacy, and sustainable financing Who must take actionable
steps: national governments
Legal determinant 2: using law to strengthen the governance of national and global
health institutions
Recommendation 3: the UN, WHO, and international partners should use their respective
powers and influence to safeguard the public's health and safety through the creation
or adoption of good governance standards, embracing the highest principles of equity,
inclusive participation, transparency, and accountability Who must take actionable
steps: UN, WHO, and international partners Recommendation 4: governments should develop
legal frameworks that establish principles of good governance throughout national
health systems and policy making, form a country-appropriate mechanism to advise on
legal interventions with high health impact, and adopt legislation requiring health
impact assessments for policies, programmes, and projects that might seriously affect
health Who must take actionable steps: national governments
Legal determinant 3: using law to implement fair, evidence-based health interventions
Recommendation 5: WHO should increase its legal capacity to enable it to spearhead
development of a global evidence base for public health laws and to support the enactment
and implementation of national and global health laws that are effective and sustainable
Who must take actionable steps: WHO, national governments, foundations, and civil
society
Legal determinant 4: building legal capacity for health
Recommendation 6: governments should build national capacities to enact and effectively
implement public health laws Who must take actionable steps: national governments
Recommendation 7: WHO and The Lancet should partner with legal and health experts
to create an independent standing commission on global health and the law that would
advance the health-related SDGs by proposing evidence-based legal interventions for
addressing major global health challenges, reforms of the global health architecture
and international law, and strategies to build and strengthen global and national
health law capacities
Who must take actionable steps: The Lancet and WHO
Legal determinant 1
Recommendation 1 states that the UN, WHO, and international partners should set standards
to support the implementation of, and objectively evaluate compliance with, SDG 3·8
(UHC), as well as the upcoming UN political declaration on UHC in 2019.
WHO should develop a joint external evaluation (modelled on the IHR's JEE) of country
compliance with SDG 3·8 and the UHC political declaration. Under the JEE, national
and peer country stakeholders and external experts would evaluate UHC laws, regulations,
and programmes against rights-based benchmarks, make such evaluations publicly available,
and issue recommendations.
WHO or the UN should establish an international legal framework to ensure that high-income
countries and other development partners provide the funding and expertise necessary
for all countries to implement UHC, in line with their right to health obligations.
157
Recommendation 2 states that governments should strengthen or create a legal framework,
such as a constitutional or statutory right to health, to ensure rights-based UHC
on the basis of principles of equity and non-discrimination, including affordability,
financial protection, transparency, accountability, participation, privacy, and sustainable
financing.
Governments should promote sustainable financing and financial protection by allocating
an adequate share of GDP to implement UHC. They should ensure quality through accreditation
systems for public and private sector health facilities, pharmacies, and professionals;
inspection of health facilities; and drug and medical device approvals based on safety
and efficacy. They should also prevent health sector corruption and misappropriation
of resources by establishing strong public financial management systems and anticorruption
mechanisms, and avoiding conflicts of interest.
Legal determinant 2
Recommendation 3 advises that the UN, WHO, and international partners should use their
respective powers and influence to safeguard the public's health and safety through
the creation or adoption of good governance standards, embracing the highest principles
of equity, inclusive participation, transparency, and accountability.
The UN General Assembly should adopt a set of good governance standards, reflecting
best practices in governing complex public institutions for UN specialised agencies
such as WHO, civil society organisations, and others. These standards should ensure
the operations of the institutions are consistent with the highest principles of equity
and transparency. WHO should additionally establish an independent unit tasked with
ensuring effective implementation of such governance standards.
As a normative agency with law-making powers, WHO should use these powers to adopt
international legal instruments to safeguard the public's health and safety, prioritising
health threats in low-income and middle-income countries and developing compliance
mechanisms. They should explore a global treaty focused on the right to health, equity,
and accountability, such as the proposed FCGH.
Recommendation 4 suggests that governments should develop legal frameworks that establish
principles of good governance throughout national health systems and policy making,
form a country-appropriate mechanism to advise on legal interventions with high health
impact, and adopt legislation requiring health impact assessments for policies, programmes,
and projects that might seriously affect health.
Governments should develop national laws and regulations that safeguard inclusive
participation in health-related decision making, from community to national levels,
which require transparency. They should also establish mechanisms that ensure accountability,
guarantee equitable distribution of health services, and require multi-sector action
on health equity.
Governments should form a national health law commission, task force, or other structure
to develop a systematic plan to identify and propose legislation with high impact
on the public's health and safety. The commission or other mechanism should base its
recommendations on the best available evidence, focus on equity, propose repealing
or reforming existing laws that undermine the right to health, and address the broader
socioeconomic determinants of health.
Governments should develop HIAs through inclusive participation, with compliance,
and reinforced by independent oversight. These should analyse the anticipated impacts
of health and non-health sector policies on health before implementation, should be
regularly monitored, and where possible, should be enhanced with real-time assessments.
HIAs should actively promote the public's health and guide decision makers' choices
about available options to prevent injury and diseases.
Legal determinant 3
Recommendation 5 suggests that WHO should increase its legal capacity to enable it
to spearhead development of a global evidence-base for public health laws and to support
the enactment and implementation of national and global health laws that are effective
and sustainable.
The WHA should provide WHO with the resources and political backing to develop WHO's
capacity to support member states in developing public health laws on the basis of
evidence, equity, and human rights.
The WHO should increase its legal capacities to include a robust global network of
well-trained experts, linking existing repositories and databases of national health
legislation, and developing platforms and information systems. These changes would
enable health lawyers, medical professionals, policy makers, and advocates to share
information and strategies on laws and litigation, as well as increasing legal skill
sets within the WHO Secretariat at headquarters, and at regional and country levels.
Legal determinant 4
Recommendation 6 states that governments should build national capacities to enact
and effectively implement public health laws.
Ministries of health and justice should lead an inter-ministerial, multi-stakeholder
process, which includes civil society, to develop a strategic plan to build health
law capacities, working to strengthen or create institutions to lead and coordinate
health law research and development, identifying priority areas for public health
laws.
Governments and foundations should support research to build a high-quality empirical
foundation for evidence-based, rights-based, equity-based laws that provide health
coverage and safeguard the public's health and safety, expanding research on existing
public health laws and developing open access databases to share public health law
research.
Recommendation 7 suggests that WHO and The Lancet should partner with legal and health
experts to create an independent standing commission on global health and the law
that would advance the health-related SDGs by proposing evidence-based legal interventions
for addressing major global health challenges, reforms of global health architecture
and international law, and strategies to build and strengthen global and national
health law capacities.
As an example, this standing commission could recommend a comprehensive and legal
reform agenda for global health security that would examine issues such as potential
improvements to the IHRs, incentives for bringing countries into full compliance with
IHR obligations and the JEE process, better coordination of laws relating to animal
and human health, greater harmonisation of regulatory standards to accelerate development
of vaccines and other countermeasures, and improvements to benefit-sharing frameworks.
This potential legal reform agenda could feed into the work of the newly established
Global Preparedness Monitoring Board, which will monitor progress, identify gaps,
and advocate for efforts needed for global preparedness for outbreaks and other health
emergencies, and help ensure it fully considers legal issues and possibilities.