December 5, 2022
The Intergovernmental Negotiating Body (INB), established by the World Health Assembly to draft and negotiate a pandemic agreement or other international instrument, is currently reviewing a Conceptual Zero Draft prepared by the INB Bureau. The Conceptual Zero Draft will form the basis of future member state negotiations on what is popularly termed a Pandemic Treaty, with the INB meeting December 5-7, 2022, to consider this conceptual draft, a “flexible, ‘living’ document.” The INB intends to have a “zero draft” ready for negotiations to begin in earnest in February 2023. World Health Organization (WHO) member states have agreed that the final treaty should be ready for the World Health Assembly to consider in May 2024.
The Pandemic Treaty is one of two ongoing transformations in global health governance in the wake of the COVID-19 pandemic. WHO is also revising the International Health Regulations (IHR), with the IHR Review Committee and Working Group on the IHR underway. This is a historic moment for creating a safer and fairer world. Future health crises are likely to arise more frequently and with greater severity, with considerable evidence that we are now living “in an age of pandemics.”
Legal Grounding for the Pandemic Treaty
With the world continuing to suffer the consequences of the deep failures of national and global responses to the COVID-19 pandemic, on December 1, 2021, at a rare special session, the World Health Assembly agreed to establish an INB to negotiate an agreement or other international instrument on preventing, preparing for, and responding to pandemics, with the aim of adopting the agreement at the May 2024 World Health Assembly. This past July, the INB determined that the new instrument will be legally binding. The INB determined that the pandemic instrument will be negotiated under WHO Constitution Article 19: the power “to adopt conventions or agreements with respect to any matter within the competence of the Organization.” Such conventions can be adopted by a two-thirds vote of the World Health Assembly. The pandemic treaty would be only the second convention adopted under the organization’s Article 19 authority, following the Framework Convention on Tobacco Control, adopted almost two decades ago (2003).
This O’Neill Institute briefing* reviews and analyzes the core elements of the Conceptual Zero Draft.
Objective, Principles and Scope
Overview of Conceptual Zero Draft Contents
The Conceptual Zero Draft sets out to save lives and protect livelihoods through strengthening the world’s capacities for preventing, preparing for, responding to, and health system recovery from pandemics. It expressly covers a range of equity and good governance principles, such as the right to health, benefit sharing, non-discrimination, solidarity, transparency, and accountability, while also reaffirming the principle of state sovereignty.
The Conceptual Zero Draft is bolder and more extensive than expected — responding to strong advocacy of civil society organizations and low- and middle-income countries (LMICs). While robust in many ways, the draft omits three key provisions. First is a financial mechanism to support LMICs that are often most vulnerable to health crises. Much like the financial protection fund in climate change proposals, LMICs have pushed for similar financial protection against economic loss in preparing for pandemics, as well as the economic repercussions during and after pandemics. The World Bank established the Financial Intermediary Fund for Pandemic Prevention, Preparedness and Response earlier this year, but its scope is too narrow and likely funding levels — so far it has raised $1.4 billion-plus — are far too low.
Second, the draft neglects mobilization of resources to support LMICs in implementing robust, non-discriminatory social protection programs, such as income, education, employment, and mental health.
Third, the draft largely neglects protection of human rights. There are no clear standards to safeguard against civil and political rights violations, widespread during COVID-19. The International Commission of Jurists and Global Health Law Consortium are developing guidelines on civil and political rights protections during health emergencies; the pandemic treaty should incorporate them where possible.
Also, the draft’s definition of sovereignty is at odds with human rights. The definition provides for states’ “sovereign right to determine and manage their approach to public health…pursuant to their own policies and legislation provided that activities within their jurisdiction or control do not cause damage to other States and their peoples.” Yet states’ approaches to public health are also constrained by human rights. Their approaches may not discriminate, for example. Their approaches must not be at odds with science, and they must not pursue public health in ways that violate civil and political rights, with strict confines on the extent to which states may limit some rights, as described in the Siracusa Principles on the Limitation and Derogation Provisions in the International Covenant on Civil and Political Rights, while other rights are inviolable.
Throughout the Conceptual Zero Draft, provisions are left open as to whether states “should” or “shall” adopt certain measures. “Shall” entails binding commitments — failing to act accordingly would violate the treaty — whereas failing to enact a “should” provision would not, though it would be a failure to act in the spirit of the treaty.
In certain circumstances, there may be sound reasons to use nonbinding language, for instance where it is necessary to secure agreement on including the provision at all, or where provisions incorporate different levels of action, with states required to take minimum measures but encouraged to go further. In general, though, the INB should use binding language wherever possible.
Chapter III: Achieving equity
i. Overview of Conceptual Zero Draft Contents
The chapter on equity is the most extensive, encompassing a wide range of measures to enable equitable distribution of pandemic response products. Beginning with measures for building a reliable global supply chain for pandemic response products, including strategic stockpiles, allocating raw materials based on public health need, and using international consolidation hubs, Article 6 lays the foundations for the development and equitable distribution of lifesaving tools in a health emergency. In so doing it responds to a central failing during the COVID-19 pandemic.
The chapter rightly focuses on capacity-building, calling on parties to strengthen global and regional manufacturing capacities for pandemic response products, particularly during inter-pandemic times and in developing regions, including through measures that have been the subject of extensive debate on the global stage, such as open scientific sharing, incentives for private sector technology transfer, and waivers on intellectual property protections (Art. 7). As a corollary to this, it calls on parties to strengthen regulatory authorities’ capacities to accelerate licensing and approval of pandemic response products and harmonize regulatory requirements worldwide. Article 8 focuses on capacity building for research and development (R&D) through resource sharing, incentives in private sector contracts and for joint venture initiatives, information sharing, and greater transparency over R&D funding.
Echoing the Pandemic Influenza Preparedness (PIP) Framework, Article 9 calls on parties to develop provisions for a system of equitable access to samples and genetic sequence data of pathogens of pandemic potential (conditioned on laboratory safety) and to the benefits of such sharing, namely pandemic response products, though does not itself establish such a system. The instrument for calls for national plans that prioritize populations in vulnerable situations, necessary for equitable distribution of these products.
This chapter is notable for its breadth. Its vision for national and regional capacity-building, including for manufacturing pandemic response products, is precisely the right model of equitable distribution of these technologies. Elements including technology transfer, open science, and transparency in pricing, and even the particularly contentious issue of intellectual property waivers, should help make this possible. Critically, the draft is cognizant of the fact that global health goods should be distributed equitably at all levels, and directs states to develop national action plans that prioritize access for health workers and people in vulnerable situations.
However, the draft contains no language that would limit bilateral deals with manufacturers, as it should. It could have stronger provisions on open scientific sharing and technology transfer, which cover only publicly-funded research and resulting pandemic products, but not pandemic products that result from privately-funded research. While the growth of publicly-funded research may limit this risk, the gap should be closed in the draft.
Article 9’s vision for a specialized system for equitable access and benefit-sharing is welcome, as it expands beyond the scope of the PIP Framework to encompass all pathogens with pandemic potential and genetic sequencing data (the PIP Framework only applies to pandemic influenza strains and biological samples). But the Conceptual Zero Draft simply calls on states to design and implement the system, with minimal parameters. This lack of specificity makes its potential effectiveness unknowable. COVAX, a system designed to ensure equitable access, suffered from a lack of financial and political support and was undermined structurally by permitting bilateral deals with vaccine manufacturers and an inability to control supply. The draft should at the very least establish a process to develop the system of access and benefit-sharing, as well as define core elements required for its success.
Chapter IV: Strengthening capacities
i. Overview of Conceptual Zero Draft Contents
Article 10 outlines measures to strengthen public health capacities and functions that include but extend far beyond those in the International Health Regulations (2005) (IHR), encompassing One Health surveillance systems, genomic sequencing, equitable and affordable access and, linking to universal health coverage, both the continued functioning of health services during emergencies and their recovery afterwards. It incorporates the need to strengthen laboratory and diagnostic capacities and networks at all levels and to build digital health capacities, and calls for financial, technical support, assistance, and cooperation to strengthen health systems.
Recognizing the significance of a skilled workforce, Article 11 calls for a range of measures to ensure their training and retention, including through better opportunities and working environments, particularly for women, who the instrument recognize still experience significant inequalities. It also calls for human and financial resource mobilization and a global emergency workforce deployable to countries affected by health emergencies.
Finally, pandemic preparedness capacities must be measured and tested to be effective. Mirroring components of WHO’s IHR Monitoring and Evaluation Framework but going further, the draft calls on parties to develop monitoring and evaluation plans to assess and test pandemic-related capacities, and to drill their national action plans through simulations, including after action reviews of any public health emergencies. It calls for the creation of a global peer review mechanism to assess preparedness capacities at the national, regional, and global level. And parties are called to implement recommendations generated from each of these review mechanisms (Art. 12).
The instrument’s chapter on public health capacity building has much to offer, extending far beyond the IHR’s scope to a more holistic suite of capacities. Tying in the One Health approach and universal health coverage to these capacities is especially welcome. Devoting an article to the health workforce, the treaty rightly places health workers at the core of public health capacities, and commitments around addressing stigma and discrimination, including with respect to barriers that women face, are particularly welcome. Nonetheless, while the draft instrument calls on states to provide better opportunities and working environments for health workers, it is difficult to see how the treaty will make a difference in these areas, as it is doing little more than direct states to do what they have agreed to do already through various international instruments but that face persisting barriers, including funding. The health workforce article could be strengthened, with more specific language and by tying commitments to the Global Health and Care Worker Compact, which the World Health Assembly adopted last May. The increased “meaningful representation, engagement, participation and empowerment of all health workers” the draft calls for could be directly linked to the governance and other mechanisms in the compact. And like the global compact, the treaty should also incorporate care workers and use the more inclusive terminology “health and care workers.”
Further, as experience with the IHR demonstrates, voluntary self-evaluation processes can produce unreliable results and are therefore not good measures of pandemic preparedness and response capacities. The treaty’s envisioned review mechanisms should be transformed into mechanisms that are mandatory and have a measure of independence. Such mechanisms’ remit could extend beyond assessing public health capacities to also evaluating, for instance, and harkening back to Chapter III, countries’ national action plans for prioritizing health workers and prioritizing people in vulnerable situations. The treaty could also require that civil society be included in all review mechanisms and national reporting processes.
Chapter V: Coordination, collaboration, and cooperation
i. Overview of Conceptual Zero Draft Contents
The chapter on cooperation extends in all relevant dimensions. Article 13 encompasses political commitment, coordination, and leadership to further the treaty’s objective, support for evidence-based policies, support for WHO as the directing authority on health including its rapid access to outbreak areas, and obligations to develop inclusive policies that recognize the needs of vulnerable persons and promote equitable participation. Solidarity is the stated aim, particularly regarding countries reporting public health emergencies in order to incentivize timely reporting of public health events – responding to concerns that countries may withhold information to avoid being hit with travel restrictions, as South Africa was following its timely reporting of the Omicron variant to WHO. Article 14 calls for parties to adopt whole-of-government and multistakeholder approaches to pandemics and to tackle the social, environment, and economic determinants of health that contribute to their emergence, spread, and impacts.
Article 15 reaches into communities, calling for inclusive decision-making processes, with community engagement including through two-way communication with civil society and communities, while Article 16 stipulates efforts to improve scientific and public health literacy, with measures to combat misinformation, strengthen public trust, and promote public health awareness. Multisectoral collaboration extends to integrated One Health surveillance systems, One Health action plans to limit antimicrobial resistance, and equitable access to medical technologies (Art. 17).
Obligations in respect of One Health approaches to antimicrobial resistance and pandemic prevention and preparedness, if operationalized and supported, could be transformational. The section on collaboration stands out for its emphasis on participation and inclusion, such as calling for inclusive decision-making at global and regional levels, disaggregated data, policies that recognize the needs of vulnerable populations, and engaging civil society and communities in pandemic-related actions. Likewise, the article on public health literacy recognizes that the public is a necessary partner in pandemic prevention, preparedness, and response. This article should emphasize the importance of governments working hand-in-hand with civil society, communities living in vulnerable situations, and local leadership in strengthening public health literacy, countering misinformation and disinformation, and strengthening public trust. More broadly, a lack of specific standards regarding civil society and community engagement risks severely limiting this critical feature’s potential to effect change.
i. Overview of Conceptual Zero Draft Contents
The instrument calls for parties to prioritize domestic financing for pandemic-related national actions, financing of international mechanisms for pandemic-related capacity-building, and financing for equitable access to global health goods (Art. 18).
Financing to support the instrument’s implementation is the primary responsibility of governments, but the instrument requires parties to financially support national activities directed towards its objects. It also requires them to promote the use of bilateral and multilateral channels for pandemic program financing, and for those represented in intergovernmental organizations to encourage them to provide specific financial assistance for developing country parties (Art. 22).
While access to adequate financing is central to enabling lower-income countries to develop public health capacities, the draft only calls for states to finance capacity-building through new or existing financing mechanisms. One of the central failings of the IHR has been that its requirement for states to collaborate, including with respect to mobilizing financing, lacks specificity. Without standards, benchmarks, formulas, or other such details, or actually establishing a new mechanism and determining its parameters and attendant state obligations, the requirement had little real force.
Institutional and Accountability Mechanisms in Chapter VII-VIII
i. Overview of Conceptual Zero Draft Contents
The Conference of the Parties (COP), established under Article 19, is to be the instrument’s “supreme policy setting organ,” responsible for reviewing and promoting implementation of the instrument and any related instruments that the COP may adopt. Beyond this body is an “Enlarged-COP” — a “polylateral diplomacy venue” for broader stakeholder inputs on COP decision-making, composed of party delegates, representatives of organizations of the UN system (e.g., WHO), and of other bodies supported by a two-thirds majority of the COP, including NGOs, international organizations, and private sector organizations. Together these bodies, forming the Governing Body, can determine procedures to promote compliance and address non-compliance, such as “accountability measures” by means including “periodic reports, reviews, remedies and actions” (Art. 20).
The draft does provide for dispute resolution with respect to “the interpretation or application of the” treaty, including binding arbitration should negotiations fail, to which parties can consent upon acceding to the treaty (Art. 33).
Lack of effective accountability and enforcement is the chief impediment to success of most international treaties, including those in the most critical realms, such as human rights and climate change. Apart from a global peer review mechanism regarding public health capacities and a reporting mechanism, accountability mechanisms are largely left for the treaty’s governing body to determine, with vague possibilities like “remedies and actions,” but also “advice or assistance.” Yet these are fundamental concerns that should be incorporated into the treaty itself to bolster its overall effectiveness. Weak mechanisms could undermine the treaty. While the draft provides for opt-in compulsory arbitration following failed negotiation of disputes, historically such mechanisms are rarely used.
The most forceful accountability mechanisms enforce limitations on state sovereignty — such as an independent mechanism empowered to investigate outbreaks or treaty violations — and impose significant sanctions, such as through the World Trade Organization’s Dispute Settlement Mechanism. Both approaches would be welcome here.
Further, the treaty should require civil society and people in vulnerable situations to be part of state parties’ delegations to the COP. The treaty does, encouragingly, include additional stakeholders in its Governing Body — its “Enlarged-COP” — but should specify that these stakeholders should include civil society and people in vulnerable situations. The requirement that two-thirds of the COP — that is, of states parties to the treaty — approve these stakeholders risks politics unduly interfering with approvals. A state that opposes certain civil society organizations from joining — perhaps representing disfavored populations or organizations that are particularly assertive — could gain enough allies on the COP to block such organizations, even as these may represent the voices that most need to be listened to.
Missing element: Rapid Outbreak Response
The instrument could more thoroughly address the need for rapid responses to public health emergencies and unusual or unexpected public health events that may become public health emergencies — key to containing outbreaks and preventing them from becoming epidemics or pandemics. The draft includes several provisions, such as that on solidarity with countries reporting public health events, and a provision lacking in specifics on mobilizing resources for affected countries to contain outbreaks.
But the draft treaty could do more. As addressed at the beginning of this briefing, it should establish a specific mechanism, which could have a broad mandate and processes that enable rapid disbursement of funds. Or at the least, the treaty could include specific funding obligations with respect to existing financing mechanisms, such as WHO’s Contingency Fund for Emergencies. The independent investigatory mechanism we recommend could ensure rapid and accurate information on public health events, as could well-financed surveillance capacities. The draft could address real-time technology transfer to ensure rapid global production and dissemination of countermeasures. And once outbreaks reach a certain level of concern — short of public health emergencies of international concern under the IHR — they could trigger the development, with WHO’s leadership, of global response plans to facilitate a coordinated, rapid global response.
A strong draft, but still a way to go
The Conceptual Zero Draft has huge potential. It stands out for its emphasis on equity at all levels and for its breadth. The INB should be commended for developing an expansive document which encapsulates so many of the concerns relevant to good pandemic governance, from resilient health systems and a strong health workforce to One Health and antimicrobial resistance, health literacy and even measures connected to the social determinants of health. Yet, while it is a strong start, the draft should go further if it is to become the pandemic treaty the world needs, above all with greater accountability — including binding and specific norms.
There is little doubt that while we, and many global health advocates, will push the INB to be even bolder, powerful high-income countries will push in the opposite direction. With all the suffering — health, social, educational, and economic — wrought by the COVID-19 pandemic, now is not the moment for modest or incremental reforms. History will judge whether the world truly changed course in the aftermath of the pandemic. Let’s hope the arc of health and justice sharply rises as WHO member states draft and negotiate a fundamentally revised IHR and a bold pandemic treaty.
* Lawrence Gostin is director of the World Health Organization Collaborating Center on National and Global Health Law and is a member of the WHO’s International Health Regulations Review Committee (IHRRC). The ideas in this O’Neill Briefing are the authors’ alone and do not represent those of WHO or the IHRRC.
In addition to this briefing, the O’Neill Institute is partnering with the Foundation for the National Institutes of Health (FNIH) to hold a series of international consultations in support of the World Health Organization and Intergovernmental Negotiating Body for a Pandemic Treaty. The next O’Neill/FNIH consultation will be on the subject of equity mechanisms with lessons learned from various international legal and institutional regimes. The consultation will be held at UNAIDS Headquarters, Geneva, in January 2023.