Introduction
Global health law encompasses the expansive law and policy frameworks that structure global health. Drawing from Larry Gostin’s 2014 treatise on Global Health Law, the field captures both “hard” law treaties and “soft” law policies that shape norms to realize the highest attainable standard of health throughout the world. While early international health instruments took the form of binding treaties, global health policymakers have increasingly looked to soft law instruments to address health needs in a rapidly globalizing world. As the field has grown in the decade since the publication of Global Health Law, it is crucial to understand the broad conceptualization and operationalization of hard and soft law to address global health challenges across nations, actors, and sectors.
This article analyzes the complementarity of hard and soft law in the field of global health law. It begins by examining the challenges of developing hard law in global health, leading to a focus on soft law standards in global health governance. Despite groundbreaking hard law advancements at the start of the 21st century, policymakers have continued to expand the landscape of soft law policy instruments to promote global health. The COVID-19 response revealed the limitations of this soft law approach in addressing global health threats, with states now seeking hard law reforms to strengthen global health governance. This article concludes that hard and soft law — together — are necessary to prevent disease and promote health, raising a research imperative to analyze how these normative frameworks interact in global health.
From Hard Law to Soft Law
As Gostin recognized in Global Health Law, legal instruments in global health have expanded beyond hard law treaties that bind states under international health law to include soft law instruments that bring together state and non-state actors under global health policy.Reference Gostin1 Even as states established the World Health Organization (WHO) with authority to develop both hard and soft law, soft law instruments have come to hold a predominant role in WHO governance.Reference Gostin and Sridhar2 Where hard law standards have proven challenging to promulgate, soft law has offered a flexible path to develop policies across global health challenges.Reference Toebes, Burci and Toebes 3
International Law on a Continuum of Normativity
The traditional positivist approach to international law, narrowly focused on binding agreements among states, belies the complex and dynamic nature of rule-making in global governance and the plethora of non-state actors that engage in the policymaking process.Reference Pauwelyn, Pauwelyn, Wessel and Wouters 4 Given the limited influence of binding international law,Reference Hoffman 5 scholars have looked to soft law norms beyond formal legal sources.Reference Shaffer and Pollack 6 These norms encompass a variety of quasi-legal policy instruments whose binding force is weaker than international law — including resolutions, declarations, guidelines, and recommendations.Reference Chinkin 7
Accounting for the diverse means through which norms are developed, socialized, enforced, and implemented among state and non-state actors, many contemporary legal scholars have abandoned the binary distinction between hard and soft law, conceptualizing the normativity of international law as existing across a continuum — from binding to non-binding.Reference Guzman 8 Implicit in such a continuum is the diversity of actors engaged in the creation and enforcement of norms, shaping the evolving global legal order for health.Reference Abbott 9
While traditional international lawmaking in public health addressed only states parties, non-state actors have come to play a crucial role in formulating and applying global health commitments, thereby changing the scope of policymaking. These non-state actors have varied interests and increasingly use persuasion to encourage the development and implementation of soft law.Reference Sekalala 10 Additionally, non-state actors use soft law to clarify the normative content of hard law and fill gaps in legal obligations, looking beyond the hard law foundations of global health governance.Reference Habibi 11
Hard Law Foundations in Global Health Governance
In advancing legal frameworks in global health governance, the World Health Organization (WHO) emerged in the aftermath of World War II, with states seeking to establish a singular organization to coordinate international responses to rising health threats.Reference Doull and Simmons 12 The WHO Constitution provides expansive legal authorities to develop both hard and soft law instruments — through international treaties, regulations, and non-binding recommendations and other standards to support WHO’s mandate as the directing and coordinating authority on international health. These normative functions would enable WHO to set global standards on health and align national health policies to confront the mounting health challenges of a post-war world.Reference Meier and Finch 13
Article 19 of the WHO Constitution provides WHO’s treatymaking power, empowering the World Health Assembly (WHA) — WHO’s plenary governing body — to adopt binding conventions and agreements on any matter within WHO’s competence. 14 Offering additional hard law authority, Article 21 empowers the WHA to adopt regulations on select technical matters, including the international spread of disease, with such regulations binding on all WHO Member States unless they explicitly “opt out.” 15 Notwithstanding these binding legal authorities, WHO ordinarily exercises its normative function either by adopting non-binding recommendations under Article 23 or by issuing other soft law instruments, including resolutions, global strategies, action plans, and guidelines. While not strictly binding, these soft law instruments remain influential, reflecting the collective will of WHO Member States and offering policy advantages for advancing global health. 16
Advantages of Soft Law in Global Health
These soft law policy instruments have provided flexibility in global health negotiations — without the need for binding ratification by states. 17 Despite lacking the legal enforceability of international law, global health policies nevertheless establish consensus across the global community, offering a normative foundation to set priorities, mobilize constituencies, create incentives, coordinate actors, and facilitate accountability in global health. Global health policymakers have looked to these soft law instruments to:
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• Facilitate Cooperation Among State and Non-State Actors — Given the state-centric nature of hard law, such international legal agreements have been: focused on infectious diseases (that threaten state security interests), dependent on mutual agreement (among sovereign states), and reliant on international consensus (resulting in weak norms).Reference Hoffman, Røttingen and Frenk 18 Where global health is now increasingly shaped by non-state actors, soft law can facilitate cooperation across the expanding global health landscape.
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• Respond Rapidly to Evolving Threats — Binding legal instruments are ill-suited to rapidly evolving threats, especially threats characterized by scientific uncertainty and divisive politics, as hard law is slow to negotiate, with states only codifying the obligations they are prepared to uphold. In dynamic health contexts, soft law can develop progressively, responding rapidly by avoiding the contentious diplomacy necessary for legal codification of international health law.
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• Realize Global Health with Justice — Even as global governance has sought to mainstream human rights in global health, states have often been unwilling to codify health-related human rights under international health law.Reference Magnusson 19 Given this disconnect between international health law and human rights law,Reference Ruger 20 soft law can help to ensure norms for justice across institutions, providing a foundation for human rights in global health governance.Reference Meier and Gostin 21
In expanding the field from international health law to global health law — encompassing laws and policies applicable to state and non-state actors — a range of international, national, and nongovernmental actors have come together to advance global health law and policy.Reference Gostin 22
Evolution of Soft Law to Advance Global Health
Global health is now predominantly governed through soft law. 23 Through an expansive approach to law and policy — within WHO policy and across global governance — this evolution of global health law has supported global institutions to negotiate a collective vision of global health.Reference Gostin and Meier 24
Rising WHO Preference for Soft Law
The development of hard law through international agreements among states dominated international governance for health until World War II.Reference Fidler 25 Following the war, the establishment of WHO brought states together to respond to shared public health threats under expansive law and policy authorities.Reference Gostin, Finch, Gostin and Meier 26 Building from a long history of international sanitary conventions, WHO Member States rapidly exercised WHO’s hard law authorities to adopt the International Sanitary Regulations — soon renamed the International Health Regulations (IHR) — which have operated as the principal normative foundation for controlling the international spread of disease.Reference Fidler 27 Yet, while the WHO Constitution provided robust authority to develop binding international legal standards, WHO often avoided this authority in favor of soft law policies.
With WHO Member States initially paralyzed by Cold War divisions, the WHA was unable to advance public health under international law,Reference Gutteridge 28 as WHO instead sought in the 1950s and 1960s to advance global governance through technical guidance. However, with the end of colonization and rise of independent states in the Global South, the WHO Secretariat found new political support in the 1970s for soft law policies, 29 as WHO brought together state and non-state actors to advance primary health care policy under the 1978 Declaration of Alma-Ata. 30 Thereafter facing the unprecedented challenge of HIV/AIDS, WHO avoided international law, advancing human rights commitments through WHA resolutions. 31 This focus on non-binding commitments would persist into the 1990s, as the United Nations (UN) brought the world together to address poverty and health through the soft law agenda of the Millennium Development Goals (MDGs).
Rediscovering Hard Law at the Turn of the Century
Although WHO long neglected international law, it maintained its role as a platform for international legal cooperation in infectious disease control. Facing the threat of SARS at the turn of the century, WHO looked to revise the IHR, recognizing the inapplicability of antiquated legal authorities to emerging public health threats.Reference Gostin and Katz 32 Adopted under Article 21 of the WHO Constitution, IHR (2005) provide a range of legally binding commitments, including state obligations to: build “core capacities” for preventing, detecting, and responding to public health threats; notify WHO of events which may constitute a “Public Health Emergency of International Concern;” and avoid public health responses that unnecessarily interfere with international travel or trade. While remaining largely “technical” in nature, IHR (2005) provided a path to address public health risks through hard law obligations, with space for WHO to develop soft law recommendations to support pandemic prevention preparedness and response.Reference Whelan 33
Beyond this sweeping revision of the IHR, the WHA also responded to the growing burden of non-communicable diseases (NCDs) by adopting its first treaty under Article 19 — the 2003 Framework Convention on Tobacco Control (FCTC). This treaty built on a body of WHA resolutions on tobacco-related disease, but a binding treaty was seen as necessary due in part to the increasingly transborder aspects of tobacco control, including the regulation of advertising, promotion, and illicit trade that required multilateral cooperation.Reference Magnusson, Gostin, Gostin and Meier 34 These hard law obligations would be supported through the soft law developments by the FCTC Conference of the Parties, including interpretive guidelines and other decisions. Binding international health law remained a necessary means of governance, but such select legal developments were seen as impractical in addressing the rising health threats of a rapidly globalizing world.Reference Magnusson 35
Returning to Soft Law in Addressing Non-Communicable Determinants and Communicable Disease Threats
Despite treatymaking successes, global health governance continued to pursue soft law on a wide range of issues, as reflected in efforts to address the growing NCD burden and advance global health security. In regulating commercial determinants of NCDs, soft law was seen as politically expedient in the face of fierce industry opposition to international law.Reference Habibi, de Campos-Rudinsky, Gostin and Meier 36 WHO Member States adopted non-binding standards through the 2004 Global Strategy on Diet, Physical Activity, and Health, the 2010 Global Strategy on the Harmful Use of Alcohol, and the 2013 Global Action Plan for the Prevention and Control of NCDs. 37 Applying soft law to communicable diseases, the WHA adopted the 2011 Pandemic Influenza Preparedness (PIP) Framework, establishing a policy system of access and benefit sharing for strains of influenza with pandemic potential, as states looked outside WHO in 2014 in establishing the Global Health Security Agenda to support nations in preventing, detecting, and responding to infectious disease threats.Reference Ayala 38
This preference for soft law to advance global health policy was mirrored across the UN, guided initially by the MDGs and sustained through the 2015 adoption of the Sustainable Development Goals (SDGs).Reference Res 39 The UN General Assembly has convened multiple “High-Level Meetings” of heads of state and government to address a range of global health issues, including HIV/AIDS, NCDs, tuberculosis, antimicrobial resistance, universal health coverage, and pandemic prevention, preparedness and response — leading to the adoption of a series of Political Declarations.Reference Meier, Finch and Schwalbe 40 While non-binding, these resolutions of the General Assembly hold global influence, as they represent commitment at the highest levels of government and can build consensus across nations, incorporate best practices in public health, and catalyze action among civil society and other non-state actors.Reference Buse, Mialon and Jones 41 Through such soft law, these norms can set the course for global action, facilitate partnerships with diverse stakeholders, and foster common goals in facing shared threats.Reference Gostin 42
Seeking Hard Law Amid Pandemic Threats
The COVID-19 pandemic would challenge both hard and soft law approaches to global health. The IHR proved inadequate in guiding the global pandemic response, with states violating international legal obligations to notify WHO rapidly of novel outbreaks, take account of WHO recommendations on trade and travel restrictions, and cooperate under WHO governance.Reference Gostin, Habibi and Meier 43 As WHO turned to soft law authorities to guide the response, these too failed to realize global solidarity. States came to see global health law reforms as essential to strengthen WHO governance, with the WHA pursuing necessary reforms to prepare for future threats.Reference Solomon 44
Relying on Soft Law in the COVID-19 Response
Given the limitations of IHR (2005), WHO worked primarily through soft law instruments, looking to the WHO Constitution rather than the IHR for its legal authority to lead key aspects of the pandemic response.Reference Burci and Eccleston-Turner 45 In the initial days of the pandemic, the WHA recognized “immunization against COVID-19 as a global public good” and called on Member States to develop national COVID-19 preparedness and response plans. 46 The following year, the WHA pushed explicitly for vaccine equity, calling for the enhancement of production capacities across nations. 47 Yet, despite these repeated WHA resolutions, global solidarity faltered as vaccines were developed, with the COVAX facility proving unable to build on soft law pronouncements and voluntary commitments to realize vaccine equity. 48 As WHO sought to overcome these governance limitations in the COVID-19 response, independent review bodies recommended sweeping global health law reforms to prepare for future threats. 49
Negotiating Hard Law Reforms
States moved quickly to propose hard law reforms to strengthen WHO leadership. Rather than a single legal instrument, WHO Member States resolved to work simultaneously to negotiate amendments to the IHR alongside a new “convention, agreement, or other international instrument” that has come to be known as the “Pandemic Agreement.”Reference Gostin, Meier and Stocking 50 In response to IHR limitations, Member States negotiated targeted amendments to the IHR — drawing on principles of equity and solidarity, codifying obligations to facilitate the equitable distribution of pandemic health products, and establishing a new financing mechanism and implementation committee to support IHR implementation. 51 The adoption of these IHR amendments was an essential step toward strengthening the global health architecture,Reference Phelan 52 binding all WHO Member States that do not explicitly opt out; however, with equity now central to the amendments, the IHR’s focus may have transitioned from being strictly “technical” to now addressing inherently political issues.Reference Habibi, Eccleston-Turner and Burci 53 Moreover, substantive areas of the amendments rely on voluntary language and neglect central issues that now depend on the Pandemic Agreement. 54
WHO Member States looked to adopt these twin reforms at the same time at the WHA in May 2024, but divisions between states prevented consensus on both hard law instruments. The WHA successfully adopted the targeted IHR amendmentsReference Bloomfield and Assiri 55 while resolving to complete negotiations on the Pandemic Agreement within one year. 56 This new Pandemic Agreement will be needed to build research and development capacities and diversify production for pandemic response products, facilitate access to financial resources for future pandemics, codify governance for spillover prevention under a One Health approach, uphold human rights during pandemics, and establish mechanisms for the equitable distribution of health products, including a new system of pathogen access and benefit sharing.Reference Gostin and Finch 57
Yet even as states recognize the importance of these complementary binding legal instruments for responding to pandemics, additional policy tools will be essential to strengthen the global governance architecture. These hard law reforms must be considered as interconnected instruments across an expansive global health law landscape of hard and soft law norms. The COVID-19 response has highlighted the interaction between soft and hard law across legal regimes.Reference Sekalala, Habibi, Gostin and Meier 58 To strengthen pandemic governance, it will be necessary to complement hard law reforms through the adoption of soft law, rapidly developing implementation guidelines, tools, and action plans with targets and benchmarks. These soft law instruments, aligned with hard law reforms, provide a basis to ensure accountability, promote compliance, and accelerate implementation.Reference Sekalala and Masud 59
Conclusion
Global health law as a field of study and practice has grown to encompass both binding international health law and non-binding global health policies that operate along a continuum from hard to soft. To advance the field, hard and soft law must not be seen as distinct approaches but complementary norms – each with their own advantages and disadvantages. Rather than developing these normative instruments in isolation, effective global health governance necessitates leveraging both binding and nonbinding instruments in tandem. With advocates calling for new treaties to address rising health challenges — from environmental health treaties to a proposed Framework Convention on Alcohol Control — additional research will be necessary to understand where soft law is sufficient and where hard law is necessary. Global health law research must further study how these norms can support each other to ensure global health with justice.
