Following the 77th World Health Assembly (WHA)’s endorsement of a delay of up to one year for finalizing a pandemic agreement, the Intergovernmental Negotiating Body (INB) is set to resume talks on 16-17 July 2024. 

INB member states will face contentious procedural issues and thorny debates over the resolution of substantive matters including a system for Pathogen Access and Benefit Sharing (PABS), One Health; and a formula assuring more equitable access to pandemic health products, where wide gaps remain.

Debate around these outstanding issues is a focus of this latest issue of the Governing Pandemics Snapshot. The issue, produced by the Global Health Centre at the Geneva Graduate Institute, also unpacks the WHA-approved amendments to the International Health Regulations and their meaning.  

Contentious procedural issues

The INB is set to resume its work with a two-day session on 16-17 July 2024. At the 10th INB session, members face two potentially contentious procedural issues and resume discussions on how to tackle key unresolved substantive matters. 

The May WHA decision to continue the pandemic talks for up to one more year, also allows for the INB to decide on rotation of the INB’s leadership. Known as ‘the Bureau’, this consists of six regional country representatives including two co-chairs from The Netherlands and South Africa. 

Over the past few months, there was widespread grumbling amongst INB members regarding the Bureau’s management of the process involving both technical issues as well as perceptions of missed opportunities for bridging gaps in diverse country positions. At the same time, delegates also have acknowledged the difficult challenges the Bureau faces in forging consensus on hotly debated issues such as PABS.

While there are unconfirmed reports that the Dutch co-chair, Roland Driece, may be stepping down, the Africa Group is supporting its co-chair, Precious Matsoso, to continue in her position. Meanwhile, the status of the other Bureau members remains unclear. Maintaining the same members would ensure continuity, institutional knowledge, and established working relationships. 

Conversely, a change in the leadership structure could introduce fresh ideas and new approaches, and a more gender-balanced leadership team, given that the current structure is predominantly male (5 out of 6 members).

The composition of the Bureau is closely linked to the second matter of interest for member states: methods of work. How the Bureau has run the INB has frequently been mentioned as another source of frustration for member states. The wording of the WHA decision suggests that member states wish to retain the possibility of revising both the leadership structure as well as the organization of the INB’s work going forward. 

Closely linked to this is the question of how the group will handle the work completed during the first phase of negotiations? Will the ‘convergence’ already achieved on 143 paragraphs out of 177 be preserved? Or will they reopen the entire text for further negotiations?

PABS remains the key unresolved issue

One of the most challenging, unresolved issues is certainly the establishment of a PABS system, currently included in Article 12 of the draft agreement. Given its technical complexity and the deep disagreement signified by the almost complete lack of convergence text in the INB outcome report, it is likely to continue being the make-or-break article of the talks.  

Negotiators have so far reached agreement only on the fact that such a system should exist, and should enable the rapid and timely sharing of pathogen materials and sequence information with pandemic potential alongside the “fair and equitable” sharing of benefits that derive from them. 

But the precise architecture for pathogen sharing remains unresolved and will be central to the next phase of negotiations. Disagreements persist over the modalities, terms and conditions for sharing relevant materials – with pharma and high-income countries pressing for modalities that ensure the preservation of free access, while low- and middle-income countries aim for a closer linkage between sharing of pathogens and access to benefits. 

Related to this, the use of standardized, legally binding contracts, user registration requirements, intellectual property rights, remain open. And finally, there is the question of whether any sharing mechanism set out in the Pandemic Agreement would effectively supersede similar provisions of other international instruments, notably the Nagoya Protocol of the Convention on Biological Diversity – a key demand of pharma and high-income countries.

In relation to the sharing of benefits, another key disagreement regards the actual percentage, or proportion, of vaccine and medicines set-asides to be offered for free or at concessionary prices in the event of public health emergencies of international concern and pandemics.

Some factions, notably LMICs are pushing for higher, fixed percentages, while higher income countries say that the proportions need to remain flexible and responsive to the context and geo-location of any pandemic emergency.

PABS as a separate technical instrument? 

Given the obvious complexities, it also remains unclear whether the final details of the PABS system will be delineated in the framework of the Pandemic Agreement, or if they might possibly be moved into a separate protocol or other legal instrument. 

Pre-WHA, proposals on the INB table included the possibility of having the WHA launch an open-ended intergovernmental process to negotiate the details of the PABS system in a separate instrument. Notably, this option is not included in the most recent version of the draft INB text, as it was “frozen” before the Assembly. But the idea was being informally circulated by the INB co-chairs as part of a draft WHA resolution in the last INB negotiations (INB 9) just prior to the Assembly.

Given the substantial amount of technical and operational complexity required to create an effective PABS system, it is very possible that INB negotiators may ultimately reconsider this approach.

It is noteworthy that several countries have emphasized the necessity of broadening the discussion to include experts from beyond governmental spheres in the PABS debate, full of technical nuance. Engaging expert participation will be crucial for developing a robust and effective PABS system that will significantly impact scientists, universities, researchers, and industries.

One Health 

Negotiators have also extensively debated the inclusion of the One Health approach in the agreement, which acknowledges the interconnection between the health of people, animals, and ecosystems. Developed countries mainly support a strong One Health article in the pandemic text. But a number of developing countries, backed by CSOs, have raised concerns about the regulatory burden, costs, and potential barriers to agricultural trade that such provisions could imply.

While the draft agreement suggests an initial convergence on a One Health approach, the current text is very general and there remains divergence on developing an additional instrument after the adoption of the agreement to further define its modalities, terms, conditions, and operational dimensions. 

Developing country negotiators are aware of the importance attached to this approach by developed nations and may leverage it tactically in future negotiations.  

At the same time, a number of other prominent CSOs have protested this becoming a geopolitical football. Those One Health advocates point to the fact that high income countries, as well as LMICs, need to adopt stronger measures to prevent the spread of pathogens such as H5N1. And at the same time, LMICs that are on the front lines of pathogen spillover from the wild can reap huge benefits from greater integration of One Health approaches into pandemic prevention. 

Access to health products 

Intense discussions are also to be expected on substantive issues related to access to health products, as highlighted by our colleague Suerie Moon, in a separate article in this edition of the Governing Pandemics Snapshot. 

Considering these deep divides as outlined above, and a fading political momentum, experts have warned that one additional year of work still might not be enough to bring these discussions to a close.  

Strong leadership, political commitment, and good-faith international cooperation, such as that which facilitated the successful amendment of the International Health Regulations, will be essential to bring the Pandemic Agreement to a final agreement in time for the May 2025 WHA. 

Dragging deadlines

Concerns about meeting the latest deadline for WHA 2025 are all the more pertinent in light of the fact that the past six months of negotiations have seen member states repeatedly add to, and prolong, working sessions well beyond their original time frames. 

As of January 2023, negotiations had already been underway for almost two years, when the INB faced a crunch to complete the agreement by May 2024. That, as per its original WHA mandate received in December 2021, at the height of the COVID pandemic. 

Since the beginning of the year, four sessions of the Intergovernmental Negotiating Body (INB) have taken place. 

The eighth meeting of the INB, held from February 19 to March 1, 2024, advanced discussions through the work of the drafting group and thematic subgroups, focusing on a proposal tabled by the Bureau in October 2023. However, this marathon, two-week negotiation session did not achieve a significant breakthrough.

In early March, following member states’ request, the Bureau circulated a Revised Draft of the negotiating text of the WHO Pandemic Agreement. The INB9, which convened from 18-28 March 2024, considered that draft. 

Member states proposed numerous amendments and textual edits, resulting, at the end of the session, in a 110-page document with no clear strategy for bridging differing views. The gaps were all the more glaring in light of the Bureau’s stated intention of convening INB9 as the final meeting before WHA77. But delegates were so far divided on key topics at the close, that a new INB session was scheduled to continue negotiations.

‘Consensus-ready’ text did not bridge gaps 

A new Proposal for the WHO Pandemic Agreement was released on April 22 ahead of the ‘resumed’ INB9 (29 April to 10 May). This draft text, according to the Bureau, featured a streamlined, ‘consensus-ready’ text. 

It included ample use of qualifiers such as ‘voluntary’ and ‘as appropriate’. It also deferred the resolution of more contentious issues like PABS and One Health to two additional, separate instruments to be negotiated at a later stage.

The “consensus-ready text,” unfortunately, did not bridge divided opinions, as member states remained deadlocked in opposing blocs – including the “Equity Bloc” of primarily LMICs; a bloc of European Union, North American and other high income nations, as well as the African Group and other geopolitical alliances.  

Unwilling to concede turf, member states agreed to continue working in yet another resumed INB9 session from May 20-24, concluding only on the Friday just before the Monday start of WHA77. 

The net result was nearly a month of non-stop negotiations for member states under the auspices of the INB, as well as the separately constituted Working Group on International Health Regulations. 

By 24 May at 6pm it became clear that no agreement on the pandemic agreement would be reached, with convergence achieved for only 13 out of 34 articles – and the ball was punted to the WHA. 

More successful IHR Working Group 

By that same Friday, the IHR Working Group managed to arrive at a more successful conclusion, and the few outstanding issues remaining were resolved during WHA, leading to final approval of the amended IHR, on June 1, 2024. Unlike the Pandemic Agreement, the amendments don’t require member state ratification – although nations may opt-out from the amendments if they wish. 

Buoyed by the successful completion of the negotiations on the IHR, the hope is that the coming months will also put the INB over the goal post in time for the 78th WHA in 2025, at the latest, or if ready earlier, at a special session of the WHA in 2024.

Daniela Morich is Manager and Adviser of the Governing Pandemics Initiative at the Global Health Centre, and a lawyer with previous professional experience in multilateral negotiations.

Ava Greenup is Project Associate of the Governing Pandemics Initiative at the Global Health Centre.

This is an article from the fourth issue of the Governing Pandemics Snapshot, which also carries an analysis of the recently adopted International Health Regulations by Geneva Graduate Institute Professor Gian Luca Burci, as well as a discussion on access to health products within the IHR and the Pandemic Agreement, by Global Health Centre Director and Geneva Graduate Institute Professor of Practice Suerie Moon.

Image Credits: Wildlife Conservation Society .