An International Agreement on Pandemic Prevention and Preparedness

On March 30, 2021, the heads of state of 26 nations, joined by the executive director of the World Health Organization (WHO) and the president of the European Council, called for an international treaty on pandemic prevention and preparedness—the highest level of political action to avert and respond to future health crises.¹ In an historic action, 194 countries passed a World Health Assembly (WHA) resolution to host a special session devoted solely to an international pandemic agreement, now scheduled for November 29, 2021.² The WHA special session will be preceded by the United Nations (UN) General Assembly and the G20 group of nations on September 14 and October 30, 2021, respectively. WHO Director-General Tedros Ghebreyesus referred to these 3 events as critical in shaping global health security.³ Georgetown University’s O’Neill Institute, partnering with the Foundation of the National Institutes of Health, is hosting international expert consultations to support the WHO and its member states in the development of an international agreement on pandemic prevention and preparedness.

The response to the unfolding COVID-19 pandemic has exposed severe limitations in both the International Health Regulations (IHR) and the WHO’s institutional capacities. The IHR, fundamentally revised in the aftermath of SARS-CoV-1, exposed gaps in global governance, including (1) the WHO’s inability to independently verify state reports, as highlighted by China’s failure to notify the WHO promptly of a widely circulating novel coronavirus in Wuhan; (2) weak WHO compliance mechanisms to enforce IHR obligations and its own recommendations; (3) the WHO’s lack of power to monitor, investigate, and remediate harmful actions; (4) insufficient transparency and international exchange of scientific data; and (5) lack of global cooperation, especially in the equitable allocation of vaccines and other medical resources.

Even the most basic investigations, such as to ascertain the origins of SARS-CoV-2, have thus far proved unsuccessful. Perhaps most important, two-thirds of countries do not have IHR core health systems capacities to detect and alert the global community about novel outbreaks, including communications, surveillance, and response.

While the WHO and the IHR have been the focus of global attention, the UN has extensive power and experience in negotiating large-scale treaties such as the Framework Convention on Climate Change and the Convention on the Rights of Persons With Disabilities. The Global Preparedness Monitoring Board, convened by the WHO and the World Bank, recommended a pandemic treaty under UN auspices. The UN has comparative advantages, including its multisectoral approach (climate, food, animal health), enhanced compliance capabilities, and the ability to raise pandemic preparedness to the highest levels of government. The UN also has wide experience in financing, supply chain management, and humanitarian response, all vital during a global health emergency.

The WHA envisaged a WHO instrument, as the leading UN specialized agency for health. The WHO has broad constitutional authority to adopt regulations under article 21, such as the IHR. The assembly could renegotiate those regulations, but the IHR has limited scope and weak compliance. The WHO can also adopt a convention or agreement under article 19, which it has done only once for the Framework Convention on Tobacco Control. A framework convention grants countries wide flexibility, enabling consensus on broad principles of global health security that can be strengthened over time with detailed protocols.

The United States has expressed interest in heightened transparency and accountability through a nonbinding agreement as opposed to a new treaty.⁴ Article 23 empowers the WHA to adopt nonbinding recommendations, which has created important global health norms, such as on the marketing of infant formula and the international recruitment of health care workers. The organization has also negotiated the Pandemic Influenza Preparedness (PIP) Framework to facilitate equitable sharing of pathogens for novel influenza viruses. Under the PIP Framework, pharmaceutical companies and laboratories committed to real-time production of vaccines, or other contributions, to benefit poorer countries.

The UN system, including the WHO, has broad authority to create powerful norms and compliance mechanisms to strengthen global health security, with choices ranging from revising the IHR and adopting a framework convention through to nonbinding recommendations or instruments.

The potential breadth of pandemic prevention and preparedness is wide-ranging and negotiations among 194 WHO member states will be challenging. Responding to vast gaps in the COVID-19 pandemic response should include the following.⁵

The IHR focuses on response to novel outbreaks after they occur. A new instrument could focus also on prevention of naturally occurring zoonoses, which may potentially contribute to an estimated 75% of new human diseases.⁶ Separating animal and human populations could prevent spillovers, such as through land management, reforestation, and the effective regulation of wild animal trade and markets. Researchers have already generated predictive models to identify where spillovers are likely.

While SARS-CoV-2 most likely occurred in nature, a laboratory leak at the Wuhan Institute of Virology is an alternative theory of the origin of the virus. Rigorous regulation and inspection of laboratory safety, as well as gain-of-function research, could help prevent unintentional or deliberate release of novel pathogens. The WHO has issued international guidance on biosafety that could be incorporated into a new agreement.⁷

Responding to weak IHR compliance and accountability mechanisms, a new international instrument should enhance WHO or UN authority and legitimacy to independently verify state reports, publish crucial outbreak data without state confirmation, investigate novel outbreaks, and institute remedial actions. Norms are only effective if they are implemented at the national and local levels in a fully transparent and cooperative manner.

Undoubtedly, the greatest success during the pandemic response was the rapid development of vaccines and therapeutics, including with innovative mRNA technologies. Yet, open access and sharing of real-time virus samples, genomic sequencing, and clinical trial and other research data and tools were often lacking. A new legal instrument could channel significant research funding, while promoting open access, full transparency, public/private partnerships, and scientific cooperation.

Underpinning rapid and effective response to novel pathogens requires robust health system capacities, including human resources, surveillance, laboratories, and risk communication. Capacities for testing, contact tracing, and vaccinating populations are crucial. Clinics, community health workers, and hospitals are needed to care for and treat patients during spikes in serious disease, as well as meeting everyday needs such as childhood vaccinations, maternal care, and caring for patients with noncommunicable diseases. An international agreement could address states’ failures to comply with article 44 of the IHR, which calls for international technical and financial assistance to strengthen national public health capacities.⁸

The COVID-19 pandemic revealed cavernous divides based on race and ethnicity, sex, disability, and socioeconomic status both in the disproportionate numbers of hospitalizations and deaths and in access to essential medical countermeasures. High-income countries dominated the global market in diagnostics, personal protective equipment, therapeutics, and especially vaccines. The WHO and partners designed the Access to COVID-19 Tools (ACT) Accelerator to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines. Yet, as of September 3, 2021, COVAX (the ACT Accelerator’s vaccine pillar) had shipped only 236 million COVID-19 vaccines to 139 countries, leaving most lower-income health workers and vulnerable populations unprotected.⁹ Any new international agreement must plan for adequate supplies of medical resources and equitable allocation among countries. This could include securing supply chains, intellectual property waivers, knowledge-sharing and technology transfers, along with ample donation of supplies.¹⁰

The compound health, economic, social, and humanitarian crises caused by the novel coronavirus, SARS-CoV-2, provides a compelling justification for a new international agreement on pandemic prevention and preparedness. It is possible to significantly reduce the likelihood of future novel outbreaks and to fortify the response through international cooperation, an empowered and well-funded WHO, and strong domestic health systems.

Corresponding Author: Lawrence O. Gostin, JD, O’Neill Institute for National and Global Health Law, Georgetown University Law Center, 600 New Jersey Avenue NW, Washington, DC 20001 (gostin@law.georgetown.edu).

Published Online: September 15, 2021. doi:10.1001/jama.2021.16104

Conflict of Interest Disclosures: The authors are leading the O’Neill Institute/Foundation for the National Institutes of Health (FNIH) project on an international instrument for pandemic prevention and preparedness. The foundation provided funding to the O’Neill Institute for the project. Dr Gostin is director of the World Health Organization’s Collaborating Center on National and Global Health Law.

Disclaimer: The views in this Viewpoint are those of the authors and do not necessarily reflect the views of FNIH.