In December 2021, the World Health Assembly agreed to establish an intergovernmental negotiating body (INB) to develop a WHO instrument to strengthen pandemic prevention, preparedness and response. Currently under development, the ‘pandemic treaty’ aims to protect and promote the well-being of all people and help to keep future generations safer from the impacts of pandemics. This Epidemic Ethics webinar sought to explore the ways in which such a treaty should ensure that the ethical values and judgements that ought to inform decisions about how pandemic priorities should be addressed at multinational, national, institutional and individual levels are identified and appropriately addressed.
Prof. Ross Upshur, Head, Division of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, Canada
Alexandra Phelan, Assistant Professor, Center for Global Health Science and Security, Georgetown University, Washington, DC
Calvin Ho, Associate Professor, Department of Law and Centre for Medical Ethics and Law, The University of Hong Kong, Hong Kong SAR, China
Dr.Mohga Kamal-Yanni MPhil. MBE, Senior health policy advisor to UNAIDS and The People’s Vaccine Alliance, Global Health and Access to Medicines Consultant, Key Advisor to NGO reps at UNITAID board
Dr Alexandra Phelan remarked that the pandemic treaty has two overarching goals: Preventing and responding to pandemics. Pandemic prevention aims to reduce the risk of spillovers and outbreaks. Pandemic response aims to mitigate the destructive impact pandemics cause. This impact is wide-ranging, but is particularly evident in exhausted healthcare systems, which increase the sociological drivers of spillovers, and make societies more vulnerable to future pandemics. This is what is referred to as a pandemic cycle. In order to create a safe operating space for global health, societies must reduce spillover risk, pandemic risk, and impact risk, while simultaneously promoting healthcare system recovery and resilience. Dr Phelan drew upon her own theoretical work in this area, arguing reducing the spillover risk depends on global health solutions, local health solutions, and zoonotic risk assessment. Reducing pandemic risk depends on surveillance assessments, biomedical research and development (R&D), and health system strengthening. Reducing pandemic impacts depends on equitable access to global goods, emergency legal preparedness, and using the least restrictive measures. Finally, recovery and resilience depend on adaptive governance, accountability and transparency, and a reduction in broader inequities and injustice. Implementing and integrating these elements is complex and multifactorial. High income countries tend to focus on spillover risks and thereby seek to develop global and local health solutions alongside zoonotic risk assessments. However, this assumes that all spillover events can be stopped, and is over-reliant on technology. When we balance healthcare systems in an economically efficient manner instead of just focusing on high-cost risk assessment, and when we strengthen healthcare systems around the world, we create a series of global health benefits. Dr Phelan cited the ethical imbalance in healthcare policy as the impetus for her model on strengthening global health systems in the first place. She also argued equitable access to global goods should be a core priority of the pandemic treaty. In regard to distributive justice, there must be limitations on export controls and the use of advance purchase agreements. Advance distribution mechanisms must be embedded into the treaty. To reduce inequities and injustice, binding non-discrimination obligations should be utilized. To promote adaptive governance, there should be equitable representation. The pandemic treaty is also an opportunity to look at reparative justice. This means financing and facilitating independent research, development and manufacturing capacity in LMICs, thereby recognizing self-determination and promoting equitable access to global goods. To reduce injustice and inequity, countries must recognise their common but differentiated responsibilities across member states. For adaptive governance, high income countries have a disproportionate voice in international governance organizations; while it is true global health forums are more democratic, (as evidenced in the WHO’s 194 member states) there’s still an opportunity to use global health as a forum for law-making, and to put LMIC perspectives front and center.
Dr Calvin Ho used his presentation to discuss how well WHO member states, communities and individuals are prepared to draw on digital technology in order respond to the public health challenges of an outbreak. He noted that there is a dearth of international law related to global health with the key instrument being the International Health Regulations (IHR). While this sets up important norms and mechanisms by which countries can respond to public health emergencies through collective action, it is a relatively old document. The IHR in fact has its roots in the 19th century International Sanitary Conferences. This led to the 1951 WHO International Sanitary Regulations, which later became the IHR in 1969. Since then, the regulations have undergone several iterations, but the changes have been relatively minor; with the most recent revisions being implemented in 2005. Dr Ho noted the 2005 document adopts a broad, all-hazards approach as well as multi-sourced risk assessment and events-based surveillance. There’s also quite a lot of emphasis on member states developing core capacities to prepare and respond to health emergencies. These relate to global health goals, but not the values that underpin them. Dr Ho argued that to address this, there should be a framework to guide action, the precedent being The Framework Convention on Tobacco Control. This came about through WHO exercising article 19 under its constitution and speaks to its power to make treaties and regulations. Dr Ho noted that we must recognize and accept that WHO has no enforcement power and therefore needs buy-in from member states, communities and individuals; and this is also true in regard to digital capabilities. The adoption of the Digital Health Resolution by WHO member states, which outlined a requirement for a digital global health strategy, speaks of a need to embed health and wellbeing in all digital policies, while remaining inclusive, sustainable, and resilient. In terms of pandemic preparedness, there is a paucity of information on digital capability. The digital health index only reflects a small number of states who have done a digital health assessment. These tend to naturally be higher-resourced member states, who are necessitated to deploy such things. However, even here digital exclusion remains a problem. What we find in high-income countries (HICs) will be an exacerbation of what is manifesting in health systems worldwide. Dr Ho reiterated this is why a framework is needed. When thinking about digital technologies, it’s worth remembering this can include a broad range of actors including the private sector, non-governmental organizations (NGOs), charities, or even commercial organizations. How, then, do we involve them? How do we think about governance in this space? This is quite different from the Westphalian assumptions embedded in the IHR as we find it today. Dr Ho argued that there are no particular mechanisms which can animate values. For example, the ‘health for all approach’ of the World Health Organization posits values of democracy, equity, solidarity, inclusion and human rights. These are not self-enabling, so mechanisms are needed and we need to track them for the betterment of individuals, and to ensure they live a life that is worthwhile.
Dr Mohga Kamal-Yanni argued establishing ethical values in the treaty, as human rights or obligations, resides predominantly with governments who act as duty-bearers tasked with ensuring their implementation. This is critical for the treaty’s success. For example, if there is technology-transfer, then there’s a commitment on the part of governments to ensure that not just themselves, but research institutes, implement it. However, the WHO has limited ability to ensure implementation, and so commitments without a mechanisms of implementation cannot be actualized. She noted the geopolitical division between HICs who want sharing of the viral materials and data, while those in low- and middle-income countries (LMICs) want and need access to products that result from sharing this data. Recalling the long debate on benefit-sharing in regard to influenza, she argued Indonesia stood strong against HIC interests, and was therefore able to negotiate an affordable price on vaccines because they shared viral data. This resulted in the Pandemic Influenza Preparedness Framework, where both parties share data and products are sold at an affordable price. Dr Kamal-Yanni cited this is a good example of implementing ethical values that enable innovation and access at the same time. In regard to fair allocation of medical products between countries, it’s important to remember that there is always a shortage of supply at the start of a pandemic. Governments had left three important questions in the hands of pharmaceutical companies: How to produce, where to sell, and the price. Naturally, pharmaceutical companies sell in high markets to get a high price. This is matched with rich countries wanting to vaccinate citizens. The desire to vaccinate populations combined with vaccine hoarding meant for most of 2021 Africa had limited supply, and the supply of available vaccines was the result of bilateral deals between countries, mainly China. COVAX came late, and was too reliant on Astra-Zeneca. In April 2020, WHO developed a fair allocation framework which identified those most at risk, with health workers as number one, then older people, and so on; however this particular system of prioritization was used by countries in the context of their own national populations, ensuring vaccine hoarding continued. Dr Kamal-Yanni argued the treaty is a good opportunity to insert certain commitments that can be made in relation to the reality of the supply shortages. One answer is technology-transfer, but this is not happening. High-income countries, particularly the UK and the United States, went forward with advanced purchasing with no conditionality. As a result, everything went to the North. This conditionality of technology and fair allocation should be included in the pandemic treaty. Another question is how to support fair allocation within countries. In the context of high-risk groups, who is prioritized first? For example, if a hospital has a limited vaccine supply, are you going to vaccinate the manager of the hospital sitting in the office or the cleaner who is cleaning patients’ rooms? Dr Kamal-Yanni said this dilemma is affecting other groups such as migrants, prisoners, and ethnic minorities as well. She argued this is a national responsibility that has to be managed by governments effectively. Returning to the access issue, R&D investment is critical. What’s happening now is that the interest and focus is ‘let’s develop a vaccine in 100 days’ but the question is who will do this, and, by extension, who will control it? This is not a debate about how to ensure there is research and manufacturing capacity in developing countries; it’s not about investment alone. Instead, governments should prioritize medical research and therefore lead by example. South Africa and Rwanda are leading in this. High-income countries can, however, fund collaborative research, and put conditionality on technology-transfer. In preventing pandemics we’re dealing with outbreaks. However, if we see this treaty as simply dealing with an outbreak, it might result in measures that don’t actually deal with the outbreak in a sustainable way. Citing MPOX, Dr Kamal-Yanni said it’s been in Africa since 1970; however, it’s only now we’re worried about vaccines. Like with COVID-19, rich countries are hoarding vaccines to treat it. Meanwhile, in Africa, countries subsist once more with the historical legacy of no R&D and no investment in research or technology transfer. A question for the pandemic treaty must be: ‘how can we invest in dealing with outbreaks, and in a way which benefits people in affected settings?’ Finally, R&D and resilient healthcare systems are national responsibilities; they require national leadership. What the international community can do is help with technology transfer, prevent international law placing barriers on governments doing the right thing, and ensure transparency and accountability for all stakeholders.
How can ethical considerations be recognised in the treaty?
Dr Phelan argued that ethicists need to be submitting contributions to the INB. However, another way is through the crafting of language in order to elevate the ethical dimensions of a given topic and ensure it reaches a wider audience. This also allows governments to understand ethical considerations more clearly. Dr Ho followed up on this, indicating we need to think carefully about what constitutes broad participation and why this matters. Ethics is still a foreign notion to lay people, and therefore, they too need to understand why these ethical considerations, and the treaty itself, matter. Formalistic requirements are easy enough to identify; however, making this a people-centered document is more difficult. Dr Kamal-Yanni emphasized the need to talk with governments. Unless member states lead and push for ethical considerations to feature in the treaty, they most likely will not. Regional consultations are starting in August, and so this is a good opportunity for civil society to engage with them.
What are the mechanisms to ensure ethical considerations are included in policy, and how do we evaluate whether they are fulfilled or not?
Dr Ho argued we should draw upon principles and mechanisms that guide research governance. While not perfect, they enact and animate ethical values, and ensure wider community participation. There are less clear mechanisms for managing digital health data, and so this is something that should be developed in accordance with best practice. Dr Kamal-Yanni argued the important aspect of the various mechanisms is an independent review process, and data-collection that is diversified and collected from various sources to ensure it accurately reflects the views on the implementation process. However, funding will be an issue. Dr Phelan commented there are three angles or approaches to ensure mechanisms exist to embed ethics into treaties of this nature. The first one is directly limiting, restricting or prohibiting certain behaviour or conduct, or the facilitation of such behaviour. The second way is through human rights. What is the state’s obligation to its citizens in regard to accessibility, acceptability and healthcare? Using a human rights framework is also a way to regulate conduct; however, a human rights approach doesn’t necessarily reflect a public health approach. Thirdly, the catch-all term ‘equity’ is an opportunity for public health and global health ethicists to truly define this. This is not just about distributive justice between countries, but reparative justice; while not palatable for high-income countries, there are ways to embed this reparative justice in the treaty to ensure it is recognizable and acceptable to states.
Is the IHR 2005 still fit for purpose or is this treaty needed? If a pandemic treaty is needed, are there any implicit or explicit harms the pandemic treaty may cause, to the extent other critically important health issues may be overlooked?
Dr Kamal-Yanni argued COVID-19 evidenced gaps in the IHR, which is why a pandemic treaty is warranted. Views have changed; concepts such as equity are now at the forefront, and therefore the pandemic treaty should be complementary to the IHR. However, Dr Kamal-Yanni said other health issues are already being neglected, but this is not necessarily because of the pandemic treaty but due to political decision-making. Dr Ho argued we need to think carefully about equity: If we are using a treaty, how should we introduce an institution that invites this kind of reflection? Within the IHR, there were provisions for data-collection and evaluation; however, there wasn’t a framework for ethical evaluation, nor mechanisms to draw in different voices. This is why a pandemic treaty is needed. Dr Phelan argued the IHR has a deep colonial history, and the early notification and alert system was all about protecting Europe from the ‘Other.’ This remains part of the IHR, and a core part of how it operates. Any new instrument cannot be representative only of a global health security approach that protects high-income countries. There also needs to be a provision for regular forums for consultation to ensure the treaty remains relevant, and governments are engaged to obligations.
How much local and national capacity will be preserved to respond to pandemic threats? How do we square animal health and wellbeing with human health and wellbeing in any pandemic treaty?
Dr Phelan commented that right now there isn’t an incentive, channel or process to share what is happening in animal health at a local level when there are small scale outbreaks. The academic process commences, but public health bodies aren’t necessarily notified. A pandemic treaty or reformed IHR can assist with this by codifying new mechanisms and obligations. Dr Ho highlighted that in regard to animal health, we haven’t got a clear international law framework, except perhaps the Paris Convention which includes some earth science matters. Therefore, fragmentation and data-sharing are both key challenges. And when combined with different interests, this confounds matters further. Collating all this information is formidable, and this is even when leaving aside the various capabilities of governments and state entities. Collective action and the means of forging multilateral action are needed. Dr Kamal-Yanni argued there are huge opportunities to link the local and national with animal and human health. Local communities see animals as assets and they have a vested interest in protecting them. Therefore, working with these communities is how you get notifications. We speak about surveillance as a technocratic function, but it is the community health workers on the ground, who have built trust, who will be providing updates. Trust is created by the provision of services that are needed. Health workers can then be the channel through which information is shared. This is the basis of all surveillance. The local and the national must be joined up.
How would we know whether a treaty is successful or not?
Dr Kamal-Yanni argued the treaty will be successful if developing countries are considered in its development. The same is true of academics and civil society. Dr Ho argued that in regard to the Framework Convention of Tobacco Control, the targets are clear. Therefore, a pandemic treaty needs great clarity, particularly in regard to objectives, and specificity of language. Dr Phelan commented that a lot of the challenges have already been dealt with in the realm of international law; international climate law can inform the development of the pandemic treaty, including norm-building, principles, and structuring of frameworks conventions. If we are looking at different system levels, two approaches are needed. The first is minimum obligations, which everyone is held too, and that are important for pandemic preparedness, response and recovery. The second is the common but differentiated obligations. High-income countries in particular have a role in technology-transfer and capacity-building. Taking these two approaches creates a normative framework of delivery that is ethical.