WHO Constitution as a Mandate for Global Health Lawmaking

Under the 1946 WHO Constitution, states declared the “highest attainable standard of health” to be a fundamental human right, providing WHO with authority to develop international law on any public health matter through the adoption of:

• • Conventions (article 19) — treaties and agreements that set standards to promote public health,

• • Regulations (article 21) — legally-binding standards that designate specific actions that must be taken by member states, and

• • Recommendations (article 23) — non-binding guidelines that provide member states with standards to promote public health.Reference Gostin and Meier ¹

Although WHO was created as a normative agency, with a constitutional mandate to develop global health law, the organization has long been reluctant to exercise its legal authority under article 19 to develop conventions, looking instead to article 21 in advancing the International Health Regulations (IHR).Reference Meier ²

International Law to Prevent, Detect, and Respond to Pandemics

The IHR stand as the leading legal agreement to respond to the globalized threat of infectious diseases. Originating out of the international sanitary agreements that predated WHO, the World Health Assembly has revised the IHR several times to respond to changing health threats.Reference Gostin ³ The current IHR, revised comprehensively in 2005 following the SARS-1 epidemic, has broad participation from WHO member states, with 196 states parties adopting the regulations to guide efforts to prevent, detect, and respond to a disease outbreak. In balancing measures to facilitate global health security while maintaining international travel, trade, and human rights, the IHR empower WHO and member states in detecting and responding to public health emergencies of international concern.Reference Fidler and Gostin ⁴

Beyond the IHR’s binding standards, states have negotiated non-binding “soft law” frameworks to advance health security. The Pandemic Influenza Preparedness (PIP) Framework, while limited to pandemic influenza strains, brings together WHO, member states, and non-state actors (e.g., pharmaceutical companies and academic laboratories) to help coordinate international sharing of novel influenza pathogens, facilitating equitable distribution of the benefits of influenza research in developing vaccines and therapeutics.Reference Rourke, Eccleston-Turner, Phelan and Gostin ⁵ Outside WHO, states and international organizations have come together to establish the Global Health Security Agenda (GHSA) to enhance country capacities to prevent, detect, and respond to infectious diseases, emphasizing global health security as a national priority and targeting multisectoral gaps in national policy.Reference Katz ⁶

IHR Limitations

The international response to the COVID-19 pandemic has exposed severe limitations in IHR obligations (and state compliance) to shape an effective coordinated response to global public health emergencies. Despite major IHR reforms in 2005, the national and global response to COVID-19 has seen:

failures to notify WHO promptly of novel outbreaks. The IHR require states parties to report to WHO “timely, accurate and sufficiently detailed public health information.” China appeared to violate this norm by failing to promptly report a novel coronavirus circulating in Wuhan. WHO discovered the outbreak from “unofficial” sources, and even then, China downplayed the extent of community transmission. Since that time, China has not fully cooperated with WHO in impartially investigating the origins of SARS-CoV-2. The inability of WHO to assess events independently created delays in detection of, and response to, a novel coronavirus outbreak.

Delays in declaring a Public Health Emergency of International Concern (PHEIC).This inadequate reporting — compounded by a split in expert opinion, misapplication of the legal definition of a PHEIC, and WHO’s diplomatic hesitation — prevented a timely WHO PHEIC declaration, by which point a pandemic was already well underway. While the WHO Director General did declare a PHEIC on January 30, 2020, there were confused signals five weeks later when the Director-General declared a “pandemic,” as WHO has no formal legal power to declare pandemics under the IHR.

Non-compliance with WHO recommendations in the outbreak res–ponse. It is important to effectively manage an outbreak response at the global level as it spreads internationally. Yet, WHO was unable to influence state measures to contain the pandemic through evidence-based interventions. WHO’s public health guidance and temporary recommendations were repeatedly ignored by member states, with WHO lacking compliance mechanisms to monitor, investigate, and remediate harmful state actions.

State health measures disproportionate to public health risks. States rapidly imposed sweeping restrictions on international traffic, economic activity, and individual rights, with many state actions taken without adequate public health justification. Virtually every state would turn to complete, or substantial, bans on entry of international travelers, and while some countries imposed travel restrictions early as a valid public health measure, others acted arbitrarily or with discriminatory intent. With rising human rights violations and democratic backsliding, some heads of state used the crisis as a basis for expanding their powers through autocratic policies and practices.

Lack of global solidarity and equitable allocation of medical resources.Neglecting IHR obligations of international collaboration and assistance, states largely reverted to isolationist policies, geopolitical competition, and global neglect, which served to undermine a coordinated response, threaten WHO support, and lead to vaccine inequities. Even today, as many high-income nations have achieved high vaccination coverage and are returning to some normalcy, most low- and middle-income states face an extreme scarcity of vaccine doses, medical treatments, oxygen supplies, and personal protective equipment.Reference Gostin, Habibi and Meier ⁷

COVID-19 has highlighted the lack of clarity of state obligations, the failure of political will to follow public health guidance, and the absence of meaningful accountability for IHR violations, weakening WHO governance in the pandemic.

WHO Weaknesses

Global health law further shapes WHO’s legal and normative authority to lead the international response to novel outbreaks; however, WHO’s leadership has been tested by the pandemic as never before. Although global health law depends on strong governance, WHO has been unable to rally global solidarity throughout the pandemic where it lacks the legal authority and financial resources to effectively coordinate the public health response.Reference Taylor ⁸ Without the ability to independently verify state reports, inspect conditions on the ground, or hold states to account, WHO has at times floundered, drawing on “soft” power and moral pleas to guide the global health response.Reference Sekalala and Masud ⁹ These weaknesses in WHO governance call into question the continuing effectiveness of global health law and raise an imperative to develop a bold new pandemic treaty, strengthening WHO through political support, ample funding, and legal powers.

Early Proposals

Early proposals for a pandemic treaty arose out of academic analysis. Recognizing gaps in the scope of the IHR — especially relating to the production of and access to necessary equipment, medicines, and vaccines — scholars began to argue that a new treaty could strengthen WHO authority and generate financial resources for a pandemic response.Reference Nikogosian and Kickbusch ¹⁰ Given that the IHR focus on outbreak detection rather than disease prevention, scholars pushed for a pandemic treaty to have a “deep prevention” core mandate, including a vital “one health” perspective (especially around zoonotic disease) and a focus on upstream determinants of disease outbreaks.Reference Vinuales, Moon, Le Moli and Burci ¹¹ Beyond these substantive provisions, scholars and advocates recognized that key cross-cutting legal principles must serve as a foundation of the treaty, advancing principles of equity, human rights, and accountability.Reference Davis ¹² These early contributions would influence formal evaluations of the pandemic response and recommendations for fundamental reforms.

IPPPR Reports

WHO’s Director-General appointed the Independent Panel on Pandemic Preparedness and Response (IPPPR) to examine why COVID-19 became a global health crisis and to ensure that future infectious diseases outbreaks do not lead to another catastrophic pandemic. In preparing its report, the IPPPR commissioned a background paper on international law, with this paper concluding that “a Framework Convention — Protocol approach” to a pandemic treaty could facilitate governance reforms “in coherence with the broader international legal system, including under, or separate to, the auspices of the World Health Organization and with, or without, reforms to existing global health law, such as the International Health Regulations (2005).”Reference Phelan and Pillai ¹³ Drawing from WHO’s past experience in developing an article 19 convention through the Framework Convention on Tobacco Control (FCTC), the final IPPPR report recommended that states:

The IPPPR also recommended a broader global pandemic architecture, including a Global Health Threats Council endorsed by the United Nations General Assembly. Supported by the G20 High Level Independent Panel on Financing the Global Commons for Pandemic Preparedness and Response, this Council could ensure high level political leadership and attention to pandemic prevention, preparedness, and response, with the authority, financing, and accountability mechanisms to overcome gaps in national and global capacities. ¹⁵

World Health Assembly Debates

Delegates during the May 2021 World Health Assembly debated the development of a pandemic treaty to strengthen national, regional, and global capacities and guide a coordinated international response to future pandemic threats. Leading up to the World Health Assembly, twenty-five heads of government and international agencies (including WHO Director-General Tedros Adhanom Ghebreyesus) joined in an extraordinary call to develop a new treaty for pandemic preparedness and response, signaling high-level political support to protect the world from future health crises. ¹⁶ Director-General Tedros remained steadfast in his support for this pandemic treaty, arguing that such a treaty could promote increased sharing, trust, and accountability, thereby establishing the basis upon which to build other global health security mechanisms.Reference Ghebreyesus ¹⁷

World Health Assembly debates centered around the nature of international law that should be employed — whether a framework convention, regulations, or recommendations — and whether this legal development should be pioneered under the auspices of WHO.Reference Ravelo ¹⁸ Instead of convening an intergovernmental working group to begin negotiations on the text of a pandemic treaty, the Assembly resolved to hold a “special session” in November to focus on this singular issue. Some states had argued that further discussions about developing a treaty should be delayed until the pandemic is further contained, but others called for a special session to develop the treaty immediately, suggesting that states start negotiations quickly to be prepare for this special session of the World Health Assembly.

Policymaking Processes

Wide ranging diplomatic efforts are taking place through WHO, the United Nations, and other international forums that will shape the processes for developing a pandemic treaty. In determining the agenda of the Special Session, the WHO Executive Board will be meeting to decide the intergovernmental processes to draft and negotiate an international instrument. These initial debates will examine the exact legal nature of the proposed instrument and how this new legal authority will relate to the IHR.Reference Patnaik ²⁰ Leading up to the special session in November, a WHO Working Group on Strengthening WHO Preparedness and Response to Health Emergencies will be meeting to assess the possibility of a WHO convention or other global agreement. This Working Group will submit a report to the World Health Assembly, examining the benefits of a WHO treaty and supporting states as they discuss and negotiate this international instrument. The O’Neill Institute for National and Global Health Law at Georgetown University (a WHO Collaborating Center) is partnering with the Foundation of the National Institutes of Health to support WHO and member states in the pandemic treaty process.

Substantive Authorities

In identifying specific strategies for preventing, detecting, and responding to future pandemics, this prospective global health convention provides a unique opportunity to articulate key state obligations, with strong compliance and accountability mechanisms for:

One Health. Prioritizing prevention through land management, deforestation, and the effective regulation of wild animal markets and intense human-animal interchange — under a comprehensive “one health” approach across sectors — the new treaty could reduce the likelihood of naturally-occurring zoonotic spillovers and other novel threats.Reference Duff ²¹

Biosecurity and Biosafety. The treaty should address biosecurity and biosafety to ensure that laboratory conditions do not lead to disease outbreaks, creating mechanisms to reduce the possibility of an inadvertent or intentional release of dangerous pathogens through the regulation of gain-of-function research and laboratory safety protocols.

International Monitoring. In promoting outbreak prevention, detection, and response, strengthened global institutions must overcome obstacles of national sovereignty in order to monitor disease threats. International institutions like WHO must have authority to verify state reports, publish crucial outbreak data without state confirmation, investigate novel pathogens independently, and institute remedial actions.Reference Gostin, Wetter and Friedman ²²

Research and Data Transparency. Global governance must seek to advance biomedical research to develop therapeutic countermeasures (e.g., diagnostics, vaccines, and treatments). Coordinating research requires sharing of pathogen and genomic sequencing data, with norms of full transparency and scientific cooperation.

This new pandemic treaty must seek not only to construct strong national authorities that reflect good public health practice, but moreover must establish a system of good governance to advance the right to health and human rights principles of equity, transparency, and accountability in the pandemic response:

Good Governance. It is crucial that the new treaty stresses an evidence-based public health response while proscribing and sanctioning iniquitous government actions, including “authoritarian power grabs,” continuing monopolies in medical innovations, failure to resource health systems, heightened levels of pandemic-related hate crimes and violence, and an institutional neglect of low-income and marginalized communities.Reference Fukuda-Parr, Buss and Yamin ²³

Right to Health. Following from the WHO Constitution and core international human rights treaties, the pandemic treaty must be grounded in the human right to health, framing efforts to maintain core public health capacities; to ensure the availability, accessibility, and quality of health services; to provide access to basic needs during lockdowns; and to align global health law with human rights law in framing derogations of human rights to protect public health.Reference de Mesquita, Kapilashrami and Meier ²⁴

Human Rights Principles. Looking more broadly to human rights as a foundation of the pandemic treaty would provide a cross-cutting lens through which to assess rights-based public health practices, including equity and non-discrimination in the pandemic response, participation that engages affected communities, transparency in government decision-making, and accountability for health outcomes.Reference Knight ²⁵

In carrying out the aspirations laid out in developing and implementing a pandemic treaty, it will be essential to strengthen global health governance through WHO and other global actors. While Dr. Tedros has become the world’s moral conscience in the pandemic response, WHO has lacked the power, funding, and political backing to become the bold leader necessary to respond to this crisis. This unprecedented public health crisis offers a unique opportunity to reform WHO authorities and establish a broader pandemic prevention and response architecture to coordinate pandemic preparedness on a global scale, partner with other international organizations in a pandemic response, and ensure international assistance and cooperation through global health governance:

WHO Authority. In leading the response to pandemic threats, WHO must have a strengthened mandate for building national health system capacities, coordinating international collaboration, and influencing state behavior, with states conferring power to WHO to lead international action against pandemic-level threats and establishing mechanisms to facilitate accountability from non-compliant states.Reference Gostin ²⁶

Institutional Partnerships. It will be crucial for WHO to work with other institutions of global health governance (governments, the private sector, civil society, and other international organizations) to support the global response, ensuring fair intellectual property systems, equitable virus sample (and genomic sequence) sharing, and coordinated research and development systems; and sustaining partnerships developed in the current pandemic to share intellectual property, technology, and data for countering diseases.Reference Gostin, Karim and Meier ²⁷

International Assistance and Cooperation. As a foundation for responding to pandemic threats, it is imperative that the pandemic treaty recognize the ways in which global inequalities in access to vaccines, medicines, and diagnostics have prolonged the pandemic, providing WHO and the wider global pandemic governance architecture with the authority to work across states to facilitate the equitable distribution of medical resources and establish an International Pandemic Financing Facility to support rapid financing in a pandemic response.Reference Kavanagh, Gostin and Sunder ²⁸ This pandemic has revealed deep health inequities that must be rectified, including through new institutions to speed scientific discoveries and make them available globally.