The First Working Draft of the WHO’s ‘Pandemic Treaty’: attempting to cover normative gaps indicated by the COVID-19 pandemic?

Given its cross-border nature and the threat to global health, the COVID-19 crisis has shown the world the importance of strengthening global pandemic governance. In particular, the pandemic has prominently indicated significant flaws in the WHO’s International Health Regulations (IHR, 2005) as the current instrument governing pandemics. In addition to recognizing that revisions are urgently needed to the IHR (2005), a call to adopt a new international legal instrument that specifically governs pandemic prevention, preparedness, and response began at the end of 2020. Spearheaded by Charles Michel, President of the European Council, the pandemic treaty idea gathered support from a group of world leaders upon which the 74^th World Health Assembly (WHA) of May 2021 adopted a decision to consider the benefits of developing a new international treaty on pandemics at a special session starting on 29 November 2021. In this second-ever special session of its kind in the WHA’s history, an Intergovernmental Negotiating Body (INB) was established by WHO Member States to draft and negotiate a pandemic treaty, and a concrete timeline was also determined. In order to present a final version of the draft to the WHA by May 2024, the INB has started to work on the potential substantive elements to be included in the scope of the pandemic treaty as well as its legal nature, i.e., should it be a WHO convention, regulations, or a recommendation? The INB presented the first working draft of the WHO pandemic treaty in July 2022, marking substantial yet preliminary progress in the drafting process.

Against this backdrop, this post aims to provide a brief overview of the first working draft of the WHO pandemic treaty and to indicate the key issues which appeared during the negotiation process. It mainly argues that the drafters attempted to cover the vast majority of the normative gaps indicated by the COVID-19 outbreak, while striving to consider the simultaneous revision of the International Health Regulations which still retain their force as a legal instrument of  global pandemic governance.

The first working draft in a nutshell

The Preamble of the first working draft seems to address the key concerns previously circulating in academia well before and during the negotiation process, such as the need to demonstrate the adherence to the so-called ‘One Health approach’, to take into account the post-COVID legislation on the various national and supranational levels, or to consider the simultaneous revision of another key legal instrument on pandemic regulation, namely the IHR.

Developing the Preamble, Art. 4 ‘Principles’ defines ‘One Health’ as ‘multisectoral actions that recognize the importance of animal health, human health and environmental health working together to achieve better public health outcomes’. Since the internationally agreed-upon definition of ‘One Health’ was missing before, the long-awaited ‘formalization’ of this crucial concept of global health governance could be seen as one of the key achievements of the first working draft. Moreover, it is likely to be retained in the final version of the document.

Given that the text remains flexible, ‘living’, and descriptive in nature, the vast majority of the provisions have a declaratory character, therefore inviting further suggestions from the WHO’s Member States. At the same time, the WHO has already mapped the main normative directions and suggested the following structure: Part I ‘Introduction’ comprises two articles, devoted to the definitions and use of the key WHO pandemic treaty terms. The treaty’s objectives (Art. 3), principles (Art. 4), and scope (Art. 5) are accommodated in Part II ‘Objective(s), principles and scope’. Part III ‘General obligations’ outlines the potential text of general obligations, not articulating them in the separate articles – and therefore clearly opening the floor for the submissions from the WHO Member States.

Furthermore, Part IV ‘Specific provisions/areas/elements/obligations’ maps the areas considered crucial for the effective implementation of the pandemic treaty, in view of the issues previously indicated by the COVID-19 pandemic. The drafters highlighted 14 areas requiring this intervention – among those are equity, timely access and benefit sharing, strengthening and sustaining health systems’ resilience and capacities, One Health, financing etc. Part V ‘Institutional arrangements’ focuses on the institutional arrangements for implementing and applying the pandemic treaty, namely its governance mechanism, oversight mechanisms, assessment and review mechanism, and financial mechanisms. The last part elaborates on the final provisions, such as possible protocols and annexes, amendments, and reservations.

Art. 19 of the WHO Constitution as the legal basis for adopting the pandemic treaty

The long-awaited answer was provided to the question of the legal basis for the adoption of a WHO pandemic instrument, since the basis would define the scope and the nature of the said legal instrument. The WHO Constitution allows for three possible routes, namely adoption under Art. 19 (‘conventions or agreements’), Art. 21 (‘regulations’), or Art. 23 (‘recommendations’). Most INB members found Art. 19 of the WHO Constitution the most suitable provision, even though this track seems to be a more complex option from the technical point of view. Adopting an instrument in the form of the WHO Convention requires the (two-thirds) majority vote of the WHA. It also requires the subsequent ratification by the Member States for implementation on the national level.

However, the rationale behind this choice seems to be the more comprehensive scope of Art. 19 (‘any matter within the competence of the Organization’) in comparison with one of Art. 21 of the WHO Constitution. The latter provision allows to pass the WHO regulations only concerning the international (1) sanitary and quarantine requirements, (2) diseases nomenclatures, (3) standards of diagnostic procedures, (4) safety standards for the medicinal products, as well as (5) their advertising and labeling. Hence, the authors of the first working draft presumably demonstrate an intention to cover not only these five selected areas of pandemic control, but to attend to other essential aspects of pandemic governance.

Apart from this premise, another convincing reason for relying on Art. 19 of the WHO Constitution could be the willingness to enable the European Union to participate in the pandemic treaty under the so-called ‘REIO’ clause, which is perceived within the given context as the provision(-s) allowing the regional economic integration organizations instituted by sovereign States (REIO-s), to accede to the WHO conventions or agreements. A similar scenario was already realized with the WHO Framework Convention on Tobacco Control (2003), the first international public health treaty negotiated under WHO auspices. However, unlike in the Tobacco Control Convention, where the REIO clause is present throughout the whole text of the document, the only direct mention of the ‘regional economic integration organizations’ is now made in the ‘Background, methodology and approach’ section of the first working draft. The negotiations’ documents presumably reflect the sensitivity of the issue and underline that, in case of the changes in the current situation, the possibility of adopting a pandemic instrument under Art. 21 of the WHO Constitution remains open.

Responding to the revision of the International Health Regulations?

Predictably, the pandemic treaty drafters seem to take into account the parallel developments concerning the abovementioned IHR (2005) which are currently undergoing revision by the WHA as well. The correspondence between the WHO pandemic treaty and the International Health Regulations remains one of the key topics in the negotiations process, as both legal instruments aim to address (partly) overlapping issues detected by the COVID pandemic.

Indeed, the COVID-19 outbreak prominently indicated such important gaps in the IHR as the narrow scope of application (primarily focused on reporting), lack of effective control mechanism over enforcement, a persistent need to enhance the communication between multisectoral administrative stakeholders and operational stakeholders, as well as in strengthening communication between the National Focal Points and other stakeholders.

The WHO initiated the IHR (2005) revision process in January 2022 based on an amending proposal submitted by the United States. The proposal suggests such key novelties as the development of the centralized ‘early warning’ system, faster sharing of pathogen genetic sequence data, shortening deadlines for reporting and responding to emerging threats, allowing a WHO Regional Director to declare a public health emergency of regional concern and establishing a Compliance Committee to oversee and report on global International Health Regulations’ implementation. WHO Member States are now invited to submit their observations concerning the proposal, and to notify the Director-General of rejections or reservations pursuant to Arts. 61 and 62 of the International Health Regulations.

The first working draft of the pandemic treaty prominently attempts to cover similar issues – which poses a question about the need to coordinate the implementation of corresponding provisions of these two legal instruments in the future. At this point of time, the provisions of the first working draft of the pandemic treaty look more far-reaching, therefore going beyond the scope of IHR (and their proposed amendments) – which can be explained by the drafters’ intention to address all legal gaps indicated by the COVID-19 crisis in a full-fledged manner. In addition to attending to the significance of mounting effective preparedness, prevention, and response to disease outbreaks, as also emphasized by (the reform of) the IHR, the first working draft of the pandemic treaty has the potential to ‘break the pandemic cycle’ by incorporating pandemic recovery. Moreover, since COVID-19 has corroborated the drawbacks of the IHR in sharing vaccines and other medical countermeasures, the first working draft of the pandemic treaty aims to, notably, facilitate the acceleration of the national ‘emergency approval procedures and to ensure the availability of essential pandemic-response products in the countries’ (Part IV. 1 ‘Achieving equity’). This differs from the IHR amendments in question, which insist on increasing the WHO General Director’s executive emergency powers. Further, the drafters of the first working draft of the pandemic treaty call to establish a comprehensive system for access and benefit sharing, by building upon or adapting mechanisms and/or principles contained in existing or previous instruments – such as the Convention on Biodiversity and its Nagoya Protocol (Part IV. 6 ‘Health workforce’).

Conclusion

The Regional Committees are now requested to submit their observations and proposed amendments to the first working draft of the pandemic treaty (August to October 2022). The third meeting of the INB is scheduled for 5–7 December 2022, where these inputs will be consolidated, and the second version of the working draft will be adopted based on the progress achieved. One can expect more detailed elaboration on the REIO clause(-s) creating a legal framework for the EU’s participation in the WHO pandemic treaty, the general obligations of the States Parties (now Part III of the first working draft), the specific provisions/areas/elements/obligations (now Part IV), as well as on the institutional arrangements (now Part V). The critical concern remaining is ensuring consistency between the work of the INB and the Working Group on Amendments to the IHR, as both documents are deemed to be complementary to each other and will be applied by the WHO Member States simultaneously in the future.