The COVID-19 pandemic has tested public health law throughout the world. This unprecedented threat — revealing limitations of laws to prevent, detect, and respond to pandemic challenges — has raised an imperative to reform public health laws across nations. Laws have long been recognized as central to public health, establishing governmental authorities through legislative frameworks, policy guidance, and accountability mechanisms to prepare for public health emergencies. In the COVID-19 response, laws enabled governments to declare an emergency, coordinate the response, and distribute essential countermeasures to prevent disease and promote health. Where the absence of effective public health laws can hamper health security, as seen clearly in the COVID-19 response, national governments have sought to advance legal preparedness for the health emergencies to come.
The Global Health Security Agenda (GHSA) advances this imperative for strengthening legal preparedness across nations. To support governments in preventing, detecting, and responding to health emergencies, the GHSA was first developed in 2014 to provide multilateral political and technical support to strengthen global health security. Recognizing a need for effective legal authorities amid the COVID-19 pandemic, the GHSA Steering Group in 2021 approved a new “Legal Preparedness” Action Package. This new technical working group promotes legal preparedness as a health security capacity and supports national governments in establishing legal capabilities to map, develop, refine, and utilize legal instruments across sectors in the context of public health emergencies. The GHSA Legal Preparedness Action Package has brought together experts across sectors and around the world to, among other actions, advance capacity building for legal preparedness and map existing laws for health security.
This column examines the legal authorities necessary to meet the objectives of the Legal Preparedness Action Package, framing national law reforms to prevent, detect, and respond to public health emergencies. The column opens by introducing the importance of national public health law to health emergency preparedness, linking global health law frameworks and national public health law reforms. To advance national law reforms, the column then describes the development of the GHSA Legal Preparedness Action Package, analyzing efforts to conceptualize “legal preparedness” to support countries in a more effective response during health emergencies. Based upon this conceptual framework, highlighting key aspects of national laws, the column looks ahead to build capacity for legal preparedness and identify specific gaps in national legislation that have hampered national responses to global health security challenges. This column concludes that global partnerships remain essential to reform national laws to prepare for future health emergencies.
Strengthening Global Health Security Through Public Health Law
Public health law is crucial to global health security, with legal preparedness necessary to prevent, detect, and respond to public health emergencies. However, limitations across national legal authorities highlight the need for effective national public health laws commensurate with contemporary health challenges. With national public health laws framed and coordinated by global health law standards, these standards have evolved under the GHSA to provide a global foundation for national reforms.
Public Health Law as a Determinant of Health
Laws frame the authorities, norms, and accountability measures necessary to realize public health.Reference Gostin1 Under legal frameworks, governments structure the physical and social environments that guide individual behaviors and institutional actions.Reference Gostin and Wiley2 Such laws establish governance over public health, which remains crucial to preventing, detecting, and responding to health emergencies. Yet the legal response to the COVID-19 pandemic revealed limitations in the effectiveness of public health laws,Reference Bennett, Freckelton and Wolf3 with governments lacking legal authorities to initiate public health measures (such as quarantine, isolation, masking policies, and border control measures), ensure the availability, accessibility, and quality of personal protective equipment (PPE), provide liability limitations for manufacturers and providers, and ensure the development and distribution of medical countermeasures, including vaccinations.Reference Ayala4 Realizing the promise of law in health emergencies will require efforts to strengthen legal preparedness.Reference Moulton5
Legal preparedness must be strengthened throughout the world to ensure global health security, but legal capacities and institutional authorities differ across nations. Many national governments have enacted laws to support public health, but legal limitations remain, resulting in divergent health systems across nations based on the legislative capacity of governments and the legal institutions that govern public health.Reference Meier, Ransom and Valladares6 Some nations have avoided public health law reforms altogether due to inadequate resources for public health, lack of political will, or inattention to rising threats.Reference Marks-Sultan7 These inadequacies in legal preparedness have limited effective national responses to past health emergencies, including SARS, Ebola, Zika, mpox, and COVID-19.Reference Meier8 Ineffective national laws undermined the COVID-19 pandemic response, with national laws that did not clarify government authorities, uphold human rights, support vulnerable populations, or prevent disease transmission.Reference Kyriakidis, Zahariadis and Papadopoulos9
The need for national law reforms has become apparent in the face of public health emergencies, where national reforms are needed to implement global standards.Reference Maliqi10 Many nations are currently undertaking legal reforms to address challenges exposed by COVID-19, seeking increasing transparency and accountability, establishing public health advisory boards, and strengthening coordination across sectors.Reference Hodge, Dunning and Piatt11 Governments must address these national gaps in legal authority, but shared vulnerabilities in an interconnected world reveal the limitations of individual national laws in addressing global health threats.Reference Aginam12 With global threats raising an imperative to strengthen national public health authorities throughout the world, these national legal limitations have elevated the need for global health law to frame coordinated national responses that can respond to rapidly emerging threats.Reference Gostin13
Global Health Law to Guide Law Reforms Across Nations
This imperative to coordinate national laws has led to an evolving global health law landscape to guide legal preparedness across nations. International law to structure public health preparedness has developed over the centuries to prevent the spread of disease across national borders.Reference Fidler14 From the early foundations of international health law in the nineteenth century, global health law arose in the twentieth century to develop global norms to bridge national boundaries and alleviate health inequities.Reference Gostin and Meier15 Through the codification of global health law under the World Health Organization (WHO), member states established legal frameworks to address the international spread of disease under the International Health Regulations (IHR). However, the COVID-19 pandemic made clear that the contemporary global health law landscape remains limited.Reference Gostin, Habibi and Meier16 This recognition of the pandemic limitations of global health law has triggered parallel international initiatives to, among others, reform global health law under WHO governance and launch the Legal Preparedness Action Package under the GHSA.
Global Health Law Under WHO Governance
Developed under WHO governance, the IHR remains the principal international legal instrument in public health emergencies, with IHR reforms seeking to support national health capacities to prevent, prepare for, and respond to the international spread of disease. Seeking to address IHR limitations revealed during the 2002 SARS outbreak, WHO member states revised the IHR in 2005 to improve national prevention and detection mechanisms and strengthen global governance in addressing public health emergencies of international concern.Reference Meier and Finch17 The IHR (2005) requires states to establish “core capacities” for emergency preparedness and response, aligning domestic health systems with IHR obligations.18 Yet states were slow to build up their public health capacities, with the “self-assessment” of states parties seen to be insufficient to facilitate accountability for IHR implementation.19 These limitations in state assessments pushed WHO member states to seek new monitoring mechanisms, with the WHO Secretariat drawing from an early GHSA country assessment toolkit to facilitate accountability for national reforms.Reference Bell20 The resulting WHO Joint External Evaluation (JEE), launched in 2016, has created a review process to assess national progress in meeting IHR core capacities.Reference World Health Organization21 With growing recognition of the importance of national laws amid the COVID-19 response, the WHO Secretariat worked with partner institutions and member states to update the JEE in 2022 to review “legal instruments.”22
Given continuing IHR weaknesses in the COVID-19 response, WHO Member States sought to strengthen national capacities and promote global health security by amending the IHR. Complemented by the development of a new “Pandemic Agreement,” the World Health Assembly established a working group to consider targeted IHR amendments, which were negotiated extensively by member states and adopted in 2024 by the World Health Assembly.Reference Phelan23 These amendments work alongside WHO authorities to prevent, detect, respond, and recover from the international spread of infectious disease and to escalate the international response to a pandemic emergency, establishing a new financing mechanism and a new committee to assist states in implementing the IHR.Reference Habibi, Eccleston-Turner and Burci24 For these global health law reforms to prepare nations for future emergencies, including pandemics, IHR states parties will need to align national laws with international obligations. Where national public health law reforms can build the core capacities necessary to meet global health law obligations, states have looked to the GHSA to advance legal preparedness.Reference Meier, Habibi and Gostin25
Global Health Security Agenda
Notwithstanding WHO efforts to support states in building public health capacities and meeting IHR responsibilities, there has remained a continuing need to strengthen national health systems. Global health actors responded to these weaknesses in national capacities in 2014 by establishing the GHSA, coming together to accelerate national progress in implementing specific “Action Packages,” the technical working groups delineated in Figure 1, for preventing, detecting, and responding to public health emergencies.
Original GHSA Action Packages (2014).
These GHSA Action Packages found increased support amid the 2014-2016 Ebola outbreak in West Africa. Although countries at the epicenter for the Ebola outbreak were bound by the IHR, they nevertheless lacked the health system capacities and public health laws needed to address the outbreak.Reference Harman26 The Ebola outbreak demonstrated the limitations of national and global institutions in public health emergencies, catalyzing needed momentum for the GHSA to become a national security priority.Reference Burkle27
Realizing these Action Packages would require public health law reforms. Where gaps in national laws have hindered government efforts to address infectious disease outbreaks, scholars emphasized the need to raise awareness of legal mechanisms to address public health emergencies.Reference Gostin28 The GHSA came to recognize laws as foundational to establishing national authorities in accordance with the IHR, yet examinations of national laws and policies found continuing legal gaps in meeting GHSA Action Packages.Reference Meier29 The COVID-19 pandemic brought new attention to the need to reform legal authorities. Amid these new pandemic legal challenges, a new Legal Preparedness Action Package came to be seen as necessary to guide rapid legal action in public health emergencies, reframing the intersection of law and health emergencies as a preparedness capacity.
Framing Legal Preparedness Under the GHSA
Legal preparedness acknowledges that law is pivotal in building and fortifying public health capacities across all stages of a public health emergency — through prevention, detection, response, and recovery. The GHSA established the Legal Preparedness Action Package in 2021 to support public health emergency preparedness efforts across nations: creating a shared knowledge base, expanding competencies in responding to public health emergencies, and developing resources to facilitate capacity building to strengthen public health law.30 This new Action Package has sought to define legal preparedness in the context of public health emergencies, laying out an agenda to strengthen government “capability to map, develop, refine, and utilize legal instruments across sectors that enable the implementation of capacities to prevent, detect, and respond to infectious disease threats.”31
Establishing a New Action Package
As COVID-19 overwhelmed national governments, the lack of global legal guidance during the early stages of the pandemic highlighted the importance of national legal preparedness as a basis for global health security. Many governments recognized that challenges in coordinating the COVID-19 response were related to the general lack of legislative authority to guide an emergency response.Reference Ayala32 To strengthen global governance to support national preparedness before the next health emergency, national governments and academic partners worked together to propose a new GHSA Action Package to advance legal preparedness. The GHSA was well-positioned to serve as a key platform to promote and advance public health emergency legal preparedness as a critical capacity across nations, supporting governments to build capacity at the country level to support global health security. The Legal Preparedness Action Package was established by national governments and technical experts, across sectors and throughout the world, to focus international dialogue around legal preparedness and facilitate coordinated efforts in support of the GHSA.33
Launched in September 2021, the Action Package has brought together technical legal experts throughout the world, addressing the specific challenges facing fractured public health emergency responses and the need to strengthen legal preparedness across nations. The Legal Preparedness Working Group has sought to meet the workstreams of the Action Package through the development of Sub-Working Groups, as described below and diagrammed in figure 2:
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• Regulatory — identifies and prioritizes the regulatory challenges and issues that present barriers to access and use of needed medical countermeasures, including vaccines and antivirals, during public health emergencies.
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• Liability — addresses liability risk management challenges related to deploying and accessing medical countermeasures during public health emergencies.
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• Legal Mapping — deepens understanding of the importance of legal instruments in supporting health emergency preparedness, providing practitioners and policy professionals with knowledge, data-driven inputs, and guidance tools needed to understand and review, develop, or revise the legal authorities essential to advance legal preparedness.
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• One Health — strengthens interdisciplinary and cross-sectoral approaches that address not only disease prevention but also biodiversity conservation, climate change, and sustainable development.
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• Capacity Building — supports efforts among national, regional, and global stakeholders to build capacity for legal preparedness for the prevention of and response to public health emergencies.
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• Outreach and Advocacy — amplifies the work that is being done by the Action Package members and the Sub-Working Groups.
Organizational Chart of the Legal Preparedness Action Package.
The Action Package has sought to strengthen capabilities for legal preparedness by hosting webinars with experts across sectors and disciplines, presenting at conferences on the importance of legal instruments in supporting public health emergency measures, and drafting policy briefs to foster understanding of the legal challenges faced by governments. In advancing understanding of the challenges ahead, the Action Package has detailed the scope and content of legal preparedness.
Detailing Legal Preparedness
The Legal Preparedness Action Package has defined legal preparedness and detailed five core elements of legal preparedness that are necessary to ensure an effective and coordinated response to public health emergencies.34
Legal Analysis
Legal analysis is a comprehensive process of legal mapping, legal assessment, and legal surveillance. At the foundation of this process, experts review a nation’s existing legal framework for prevention, preparedness, and response to public health emergencies. This exercise facilitates the development, refinement, implementation, and strengthening of legal tools before an emergency. From this foundation, legal assessments evaluate the national legal framework for public health emergencies, screening for gaps in the law (as seen in simulation exercises), guiding the improvement of legal tools, and tracking law reforms over time.Reference Kavanagh35
Legal Frameworks
Legal frameworks reflect the country-specific laws that provide for different aspects of the prevention, preparedness, and response to public health emergencies. This legal framework (at the national and subnational level) may include the national constitution, legislation, administrative orders, and regulations, establishing the legal foundation and infrastructure needed in an emergency.Reference Negri36 Such national legal frameworks should align with international legal frameworks, including under global health law, human rights law, and international trade law. Governments should regularly review their legal authorities and revise laws relevant to public health emergencies to address identified gaps.
Capacity
Capacity refers to the ability of officials to use the legal framework for public health emergency preparedness and response, including the establishment of clear roles and responsibilities, understanding of roles and responsibilities (as seen through regular training exercises), and ability to utilize the legal framework across a public health emergency.37 Developing capacity under the GHSA can support the development and maintenance of IHR core capacities for detection, assessment, reporting, and response, ensuring coordination in public health emergencies.
Coordination
Coordination concerns the ability to carry out the legal framework for public health prevention, preparedness, and response across sectors and government areas in all phases of the emergency. Such coordination necessitates complex interactions across governments, international agencies, civil society, and industry sectors, notably where the public health emergency arises from the human-animal-environmental interface and requires a holistic legal approach across One Health sectors.38
Implementation Tools
In realizing legal preparedness, implementation tools are necessary to guide the interpretation of the legal framework, support governments in utilizing the framework in an emergency response, and build capacity by training government officials and non-governmental actors. These implementation tools — including framework guides, legal mapping tools, standard operating procedures, simulation exercises and trainings, and awareness campaigns — provide a basis to ensure the capacities needed at each stage of a public health emergency.
To operationalize these components of legal preparedness for future health emergencies, it will be crucial to build legal capacity and map legal authorities across nations.
Advancing Legal Preparedness Through Capacity Building and Legal Mapping
With the Legal Preparedness Action Package renewed under the 2022 “New Seoul Declaration on the Global Health Security Agenda,” GHSA members expressed their strong commitment to actively engage in multi-sectoral preparedness in the next phase in GHSA activities.39 The Legal Preparedness Action Package will continue to advance efforts in this next phase (2024–2028) to:
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• build legal preparedness capacity at national, regional, and global levels;
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• address regulatory and liability challenges related to accessing medical countermeasures;
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• strengthen inter-sectoral governance and coordination across legal systems to support One Health responses; and
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• promote advocacy, raise awareness, and foster global cooperation to enhance legal preparedness for public health emergencies.
This renewal provides a foundation to build capacity for legal preparedness and map the legal landscape across nations, supporting governments in identifying limitations of legal authorities and addressing those limitations through law reforms.
Capacity Building
While law reforms are being undertaken at both global and national levels to address the governance challenges exposed by the COVID-19 pandemic, the ability of public health law reforms to enhance global health security will depend on the capacity of national stakeholders to effectively advance legal frameworks in their national and sub-national systems. A key component of legal preparedness is thus the capacity of national stakeholders to understand, develop, implement, map, review, assess, and reform national legal instruments, ensuring the rule of law in public health emergencies.40 Capacity building provides a basis to facilitate knowledge exchange on public health law and translate best practices across countries into legal training tools. Building legal capacity to address public health emergencies will be essential to strengthening legal preparedness.
Amid the COVID-19 response, the World Health Assembly recognized the importance of strengthening national capacities to promote an enhanced response to future health emergencies and urged WHO member states to increase efforts to build, strengthen, and maintain national capacities.41 Legal capacities are a critical component of an improved health emergency response. To sustain this capacity building endeavor, WHO member states have called for international cooperation in providing tailored support and capacity building tools to countries to bridge identified gaps in core capacities.42
Responding to pressing national needs for enhancing public health legal capacities, the GHSA Legal Preparedness Action Package has sought to advance capacity building for legal preparedness in the prevention of and response to public health emergencies. This capacity building effort has worked to develop training resources, including a legal preparedness training module; support capacity building initiatives at global, regional, and country level; and provide technical expertise through the establishment of a global network of experts on legal preparedness. The training modules are tailored for national, regional, and international stakeholders unfamiliar with legal preparedness and designed to address foundational concepts of public health law and the legal domains delineated by the Action Package. Such trainings are designed for different audiences and differing lengths, including a one-day training course to briefly familiarize health ministries with the concept of legal preparedness; a one-week training course to train mid-career professionals in the basics of legal preparedness and legal mapping; and a one-semester course for students, developing the next generation of leaders in legal preparedness. These capacity building initiatives seek to support countries in mapping their laws and identifying law reforms.
Legal Mapping
As legal preparedness differs dramatically across countries, legal mapping provides a crucial means to readily ascertain the legal preparedness landscape in a specific country. Legal mapping turns legal texts into data by creating a set of factors or questions that are used to capture, code, analyze, and compare features of legal instruments across countries.Reference Lafond43 Such legal mapping seeks both to understand the current legal landscape within an individual country, creating data about the legal content of specific legislation, and allow for comparisons across legal jurisdictions with varied health systems.44 Through legislative coding, the Action Package can compare national and regional legal preparedness and critically examine the law reform challenges facing a country.
The Legal Preparedness Action Package has piloted legal mapping in low-, middle-, and high-income countries. This legal mapping coded relevant legislation across eight legal domains:
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1. Coordination of IHR and Facilitation of Multisectoral Response
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2. Development of Public Health Emergency Operations Centers (PHEOCs) for Coordination of Preparedness Response Functions
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3. Sustainable Financing for Preparedness and Response to Public Health Emergencies
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4. Promoting Access to Medical Countermeasures
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5. Public Health Surveillance Systems
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6. Establishment and Regulation of National Laboratory Systems
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7. Biosecurity and Biosafety (Operation of Safe and Secure Laboratories)
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8. Zoonotic Disease Prevention and Control Under a One Health Approach
The legal domains were identified by the Action Package as priority areas for capturing existing legislative frameworks, using surveys and follow-up discussions among working group members to refine the identified attributes. In each domain, the coding began with broad questions (e.g. “Does the legal instrument enable development of a public health surveillance system?”) and would narrow to increasingly more specific questions (e.g. “If yes, are there exemptions to share personal health data for IHR reporting purposes?”). The legal mapping team sought to identify national legal instruments relevant to the legal domains in each pilot country, answering binary questions (yes or no) about the legal instruments in that country. Researchers met weekly to discuss their coding process, ensuring consistent coding protocols across countries.
With this legal collection presenting examples of national legislation that meet each legal domain, these national models provide a means to understand the role of public health laws as a determinant of global health security, with legal mapping providing a foundation to share best national practices. This legal mapping thus provides a basis for policy surveillance, tracing the ongoing development of national laws for legal preparedness. With policy surveillance permitting comparative empirical analysis, correlating public policy reforms with public health outcomes, these policy data can then analyze law reforms that contribute to legal preparedness, translating public health evidence into public health law reforms to meet future health emergencies.
Conclusion
Legal preparedness to advance global health security must be based upon national legislation that effectively authorizes governments to prevent, detect, and respond to public health emergencies. Where national public health laws have been incommensurate to contemporary public health threats, law reforms will be needed to strengthen legal preparedness across countries. The GHSA provides a path to advance legal preparedness throughout the world, looking to global partnerships to build national capacities and map legal landscapes to uphold global health security.
