6

Legal, Ethical, and Policy Considerations

Carla Saenz, Pan American Health Organization, opened the session by discussing the importance of having defined duties that are clearly assigned to actors in the disease prevention space. The aim of the session, she said, was to identify practical means of discharging these duties through policy and legal instruments.

POLICY CONSIDERATIONS FOR ONE HEALTH

Alex Phelan, Johns Hopkins University, noted that international law and policy regimes reflect the siloing of subject matter expertise that speakers in previous workshop sessions addressed. While One Health and interdisciplinary approaches to pandemic prevention and preparedness have focused on how to achieve cross-communication and cross-collaboration, she said, the international legal regime has struggled to defragment its siloed approach. Phelan noted that the process of negotiating the Pandemic Treaty reflects the challenges of implementing One Health in global governance.

Over the past 2 years in response to the COVID-19 pandemic, a few law reforms have emerged apart from the Pandemic Treaty that aimed to facilitate better One Health approaches and upstream prevention, Phelan noted. However, these reforms need to be further developed to remove international barriers and find solutions to more integrated approaches. One example is that the International Health Regulations (IHR), which govern the prevention of public health emergencies of international concern, now address core capacities to support disease prevention (WHO, 2024b). She said that details on how to operationalize prevention in core capacities for public health emergencies are not included in the current IHR text, though she expects that this guidance will be developed. Another significant change to the IHR following recent amendments relates to information sharing, she said (WHO, 2024b). The IHR typically is interpreted as once a human case or disease event is detected, it can be reported as a potential public health emergency of international concern. The recent amendments to the IHR have clarified that WHO is able to share information with other international organizations, such as World Organisation for Animal Health (WOAH) and Food and Agriculture Organization. While this is a step toward a more integrated information sharing system, this is a unidirectional and downstream system of notification that may not facilitate sharing of an animal health event, she concluded.

WOAH has a different international legal regime than WHO and does not rely as much on treaties. One challenge for WOAH is determining how to incentivize reporting, Phelan added. There are different rationales for reporting animal health events that might have human health implications, whether for scientific sharing and information gathering or to inform public health preparedness. Regardless of rationale, it is important to consider what the economic implications are for a country when reporting, particularly if the event affects an animal or environmental sector that contributes to a large industry for that country. International governance entities are discussing incentives and disincentives to reporting, and there is potential for change and international law movements, she said.

Another factor affecting IHR negotiations is the tension in priorities and economic and political power differentials between countries and groups of countries. Global inequity is a fundamental factor driving these discussions, she said. Phelan noted that it is a profound expansion of an expected legal mandate for a treaty under WHO’s auspices to include prevention so expressly in the IHR, she said. Though more specificity is needed in legal mandates regarding One Health, Phelan noted that this is a significant step in advancing an intersectoral approach to preparedness. She noted that language in treaties is inherently higher level and is not expected to address operational or programmatic details. The focus of the treaty is to appropriately capture the relevant duties, obligations, rights, and equities of the countries that will become parties to this treaty if it is successful, she noted. Phelan concluded that it is a profound shift that WHO is openly embracing prevention and One Health within a human health mandate space.

ENABLING ADVANCED WARNING TO PREVENT SPILLOVER

Jennifer B. Nuzzo, Brown University, discussed operational challenges and the groundwork underpinning policy implementation. She said that while progress has been made on gathering data to inform actions to prevent patient zero, there are still challenges with early detection and early warning. Environmental data sources and human behavioral information have been investigated to understand what causes spillover. As researchers increasingly recognize environmental drivers of human infections and outbreaks, particularly the role of climate and weather, work is ongoing to determine whether better tracking of those data can facilitate advanced warning of initial cases, Nuzzo said. The goal of advanced warning, she added, is not limited to detecting the first human cases but also includes preventing them from occurring.

Ideally, disease surveillance would be rooted in systems that can integrate environmental data streams, like climate and weather, with human health data to inform actions, said Nuzzo. Much work must be done to strengthen public health surveillance, she said. Global environmental datasets are limited by uneven surveillance capacities among countries in terms of quality and style. It is challenging to anticipate the potential progression of a public health event without knowing what is happening in other parts of the world, she added.

Nuzzo discussed diagnostic testing as an area of needed improvement in order to support advanced warning systems. Access to tests, both for clinical and research use, was a primary challenge during the COVID-19 pandemic (Alvarez et al., 2023). This is also one of the biggest challenges in the ongoing highly pathogenic avian influenza (H5N1) outbreak, Nuzzo

said, as limited testing hinders the ability to prevent additional cases. She also mentioned the recent example of a public health crisis of unknown origin in the Democratic Republic of Congo. While diagnostic tests are available, delays in performing testing have hindered a more prompt and effective response (Schnirring, 2024). Therefore, Nuzzo said, there is a need for more distributed testing to get answers faster and to prevent patient zero from spreading to patient 50.

It is important for global approaches for distributed medical countermeasures and access to benefits to be linked to testing, Nuzzo continued, because this is used to determine whether countermeasures are necessary and to gauge whether they will be effective. Performing the tests is important, but it is also essential to know what to do with the resulting information. This is one of the greater challenges with new technologies and surveillance systems, she said. Nuzzo said that wastewater surveillance is an underused tool for advanced warning. The challenge with realizing the full benefits of these systems is the absence of triggers to know whether the data observed are concerning enough to warrant action, what appropriate actions are, and at what point they should be initiated, she said. If it is unclear how disease surveillance systems will inform action, the systems are at risk of failing because of a lack of sustained support.

Much of the infrastructure built during the COVID-19 pandemic is imperiled because of potential budgetary lapses or a lack of understanding as to how it could be relevant outside of a pandemic, said Nuzzo. In many places, diagnostic testing is ongoing for COVID-19 but not for H5N1. She added that there is a need to define standard operating procedures to improve the sustainability and outcomes of these data systems.

Nuzzo then noted that incentives and disincentives are important to consider at the global level and local level, which is evident in the ongoing H5N1 outbreak. For example, more H5N1 disease surveillance is needed, but there are economic, social, and other disincentives to testing and reporting cases of disease. Unless these disincentives are overcome, the full potential of advanced warning systems will not be reached, she cautioned. If people are not willing to get tested because of the risk of losing income, the availability of tests will not have any benefit, she said. If farmers do not want disease surveillance on their farms because of real or perceived risks that their products will not be sold or that the farm operations might be shut down, the disease surveillance system will not be effective. If countries are penalized for reporting new diseases, they will not be as willing to do so. If communities feel stigmatized by having a disease surveillance program in place, this will erode willingness to participate. Similarly, if disease surveillance systems are misused to identify individual participants that contributed to environmental data, this may be an additional disincentive.

Nuzzo concluded that when discussing the larger problem of preventing patient zero, it is important to address not only tools and technologies but also the policies that enable their best use. If the social challenges associated with advanced technologies are not solved, then there will be little benefit from surveillance systems. These are pressing challenges that have a direct effect on the ability to detect and respond to disease outbreaks, she said.

Fifa Rahman, Matahari Global Solutions, discussed the political bargaining process for the Pandemic Treaty in 2024.¹ Rahman explained that she advised African negotiators from a technical and political standpoint on their approach and drafted scripts and rebuttals for use in the negotiations. She said that while technical and political issues were important topics of the Pandemic Treaty, ultimately the bargain centered on two issues: One Health and disease prevention, and pathogen access and benefits sharing (Ndembi et al., 2024).

Regarding One Health and disease prevention, various discussions during the negotiations involved laboratory biological risk management, including coordinated multisectoral disease surveillance, as well as zoonotic spillover prevention. Some issues, such as community-level disease surveillance, were widely accepted by African negotiators. However, there were concerns around four key areas. The first was on the mandate to negotiate on One Health topics, which was mostly a practical and bureaucratic issue. Most African countries were represented by only one negotiator from the Ministry of Health, and other ministries essential to One Health work were not involved, explained Rahman. Therefore, many of the negotiators stated that they could not negotiate on One Health as they did not have that mandate. The Global North negotiators said the negotiators from each nation would have to negotiate on One Health topics, as they did not represent only their ministry but their entire country. Because of a tight deadline, there was no time to go back to the home country to coordinate between the different ministries, Rahman said.

The second issue was financing (Ndembi et al., 2024). Rahman noted that when a treaty is in place, every state that signed it is subject to accountability and compliance procedures, which often occurs via a peer-review mechanism. Rahman said that many African countries were concerned how they would be critiqued if they could not meet all prevention measure requirements listed in the treaty. Many countries wondered what financing would be provided, because they do not have the fiscal resources to implement all the proposed measures. When it became clear that no additional

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¹ The 2024 Pandemic Treaty negotiations failed to reach consensus. Consensus on a draft of the Pandemic Treaty was later reached on April 16, 2025. See https://www.who.int/news/item/16-04-2025-who-member-states-conclude-negotiations-and-make-significant-progress-on-draft-pandemic-agreement (accessed April 20, 2025).

financial support would be provided, African negotiators asked to reduce the number of obligations and introduce flexible transition periods to facilitate implementation. These were complex discussions, Rahman said, and middle ground was difficult to find.

Another issue, Rahman said, centered on pathogen material access and benefit sharing. Countries wanted the Pandemic Treaty to specify that when pathogen sequences are uploaded to a global data system, the time and location of the upload can be identified along with the identity of the person or institution who provided the data. These steps require some identifier or digital tag in the system, she explained. In terms of benefit sharing, Rahman said, the treaty text suggested that 10% of pandemic product production be donated to the WHO free of charge and 10% be provided at affordable prices. During negotiations on these issues, Rahman said, there was a problem that arguments against certain measures were grounded in misinformation, which created bad faith and compromised the Pandemic Treaty conclusion, she said.

Overall, Rahman concluded, there is a need to consider domestic and regional contexts in formalizing pandemic responses. She also noted the need to address misinformation in negotiation arguments.

DISCUSSION

Factors That Lead to Change

Saenz asked the panelists what should be done to facilitate change and effectively communicate change. Phelan replied that normative as well as technical arguments need to be made to advance change. She said that many negotiations have failed to address the issue of equity. There is a false dichotomy between science and equity, she said, and it is important to communicate the link between the two. For instance, strengthening health systems was a key topic discussed during the Pandemic Treaty negotiations. Instead of considering health systems strengthening strictly as a matter of achieving technical milestones, said Phelan, it would be beneficial for negotiators to reframe their perspectives and consider equity and health promotion as primary driving goals. When looking at recent data on spillover detection, distance to health care facilities is one factor that most accurately predicts rapid spillover detection. Therefore, she said, by reframing values, health experts can also identify more efficient, effective, equitable interventions that affect change.

Nuzzo agreed that there are numerous challenges on the large scale, which is why she tends to focus on operational requirements. Some of the actions to prevent disease spillover are taken on a local level while others are global in scope. When pursuing new data approaches, she said, there is a need

to ensure that data are integrated in the day-to-day work of disease surveillance and to determine how to harmonize approaches with disease surveillance in other sectors. Often economics is the primary factor driving the effort in conducting disease surveillance and responding to emerging threats. It is important to understand the barriers and enablers at all levels and then determine the policies that support or overcome those barriers, she added; such an approach requires making the case to different sectors that have different values. Rahman added that it is important to speak about values in creative ways, which means framing the message differently for different audiences.

Saenz said that when communicating practical incentives, it is key to accurately articulate the risks so that the argument being made is persuasive yet truthful. Nuzzo agreed that this is important and noted that communicating risks in a way that still encourages a desired behavior is challenging. Five years after the onset of the COVID-19 pandemic, she said, people around the globe are weary and hesitant about certain protective measures. She asserted that in addition to risks, benefits should also be made clear. Mitigation measures offer broader benefits than disease prevention for a single person, such as cost savings and improved general health care, which are more visible to governments and policy makers. Phelan added that it is important to address benefits and risks for researchers. Some benefits have not been systematically quantified, but such benefits may include career benefits, citations, and economic benefits from patents. If it is possible to quantify how disproportionately Global North researchers have benefited from open access systems and resourcing, then it becomes more evident to negotiators why these factors are high priority among researchers in the Global South and how equitable benefit sharing is tied to the issue of risks and benefits.

Difficulties in Treaty Negotiations

Klugman asked Rahman about her thoughts on the likelihood of a financing mechanism being agreed upon in future pandemic treaty negotiations that would provide funding from high-income countries to lower- and middle-income countries. Rahman responded that the financing mechanisms in the treaty were quite complex and protracted. Initially, Africa requested a fund to be established within the Pandemic Treaty. However, many donor countries felt that there was already a pandemic fund at the World Bank, and another one would not be needed, she explained. The jurisdictional challenge with this argument, she explained, is that a pandemic treaty would be a World Health Organization treaty, not a World Bank instrument, which would make it difficult to link the obligations in the treaty to the World Bank to procure funding. Phelan added that there is a Pandemic Influenza Preparedness Framework in which industries make

a contribution that is based on accessing pathogen or outbreak samples for the development of products, such as diagnostics and vaccines. That financial contribution system currently supports 50 percent of the operating costs of the Global Influenza Surveillance and Response System, she said, and a similar model has also been discussed for the treaty.

Another issue with the treaty negotiations, Rahman said, is that there is a need for more African global health lawyers, global health communication experts, and social scientists, who are best positioned to frame and communicate the need for financing to various audiences. Agogo said that, additionally, many African countries do not have up-to-date public health laws, and there is a need to actively strengthen public health management systems.

Geopolitical Challenges

The panelists discussed the fact that treaty negotiations are taking place during a time where many countries in the Global North are pulling away from international cooperation. Phelan said that there has been a broader conversation on the importance of informal community networks engaging in this cooperation. These networks are closer to the ground where change is needed and can also be a means of advancing cooperation when barriers exist at government levels. Nuzzo said that it is important to have conversations and compelling arguments on what functionality might be lost if country partners withdraw from international cooperatives.

Munster noted that global health practitioners need to do a better job of demonstrating how all countries benefit when there is increased access to data and tools for disease prevention. He noted the importance of addressing pandemic preparedness and global health holistically within a country’s context. For example, for many African countries, pathogen surveillance for SARS-CoV-2 would be most useful if it were integrated into disease surveillance systems for endemic diseases of greater concern, such as malaria.

A participant said that many African researchers are hurt by how disease surveillance and benefits access were carried out during COVID19. There are lingering ethical concerns regarding data ownership and fatigue surrounding discussions of vaccines and disease surveillance. African researchers have seen their data being published without being credited. Additionally, there are issues like a high-level Africa Centers for Disease Control and Prevention worker not being able to obtain a visa to travel to a global health meeting. These factors all present barriers to collaboration.

Rahman said that it was challenging to conduct the treaty negotiations during a time when many feel distrust and anger owing to the lack of equity experienced during the COVID-19 pandemic. It is important to reframe issues of disease surveillance and benefit sharing differently for different

audiences, she said, clarifying that disease surveillance capacity strengthening yields benefits for health issues beyond pandemic preparedness. This should also be communicated to lay audiences, she said.

One Health

Rahman said that having coordinated structures on One Health at national levels is critical. Some countries have coordinated structures around One Health, but they often do not function as cohesively as they should. Phelan added that with the inclusion of pandemic prevention language in the IHR, there are opportunities for experts in the One Health space to develop more specific guidance and frameworks for implementation.

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