Talks to finalise a global pandemic agreement have been extended, with the Intergovernmental Negotiating Body (INB) picking up discussions again from 16 July at which member states will face contentious procedural issues and thorny debates over the resolution of substantive matters.
In Health Policy Watch, the Global Health Centre at the Geneva Graduate Institute unpacks the World Health Association (WHA)-approved amendments to the International Health Regulations and their meaning.
Procedural issues
The May WHA decision to continue the pandemic talks for up to another year also allows the INB to decide on rotation of the INB’s leadership – known as The Bureau – comprising six regional country representatives including two co-chairs from The Netherlands and South Africa.
There has been discontent among INB members regarding the Bureau’s management of the process but delegates also have acknowledged the difficult challenges it faces in forging consensus on issues such as Pathogen Access and Benefit Sharing (PABS).
While there are unconfirmed reports that Dutch co-chair Roland Driece may be stepping down, the Africa Group is supporting its co-chair, Precious Matsoso, to continue in her position. The status of the other Bureau members remains unclear.
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 (five out of six members).
PABS the key unresolved issue
One of the most challenging, unresolved issues is the establishment of a PABS system, currently included in Article 12 of the draft agreement, and which may 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 deriving from them.
But the precise architecture for pathogen sharing remains unresolved and will be central to the next phase of negotiations. Pharma and high-income countries are 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 standardised, legally binding contracts, user registration requirements, intellectual property rights, remain open. And finally, there’s the question of whether any sharing mechanism 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.
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 the proportions must remain flexible and responsive to the context and geo-location of any pandemic emergency.
PABS as a separate technical instrument?
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 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 before the Assembly.
Given the substantial amount of technical and operational complexity required to create an effective PABS system, it is likely that INB negotiators may reconsider this approach.
Several countries have emphasised the need to broaden the discussion to include experts from beyond governmental spheres in the PABS debate, with engaging expert participation seen as crucial for developing a robust, effective system .
Negotiators have also debated the inclusion of the One Health approach in the agreement, acknowledging 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.
Developing country negotiators are aware of the importance attached to this approach by developed nations and may leverage it tactically in future negotiations.
Experts have warned that one additional year of work still might not be enough to finalise discussions.
Strong leadership, political commitment, and good-faith international cooperation will be essential to bring the Pandemic Agreement to a final agreement in time for the May 2025 WHA.
Dragging deadlines
As of January 2023, negotiations had already been under way for almost two years, when the INB faced a crunch to complete the agreement by May 2024.
Since the beginning of the year, four sessions of the Intergovernmental Negotiating Body (INB) have taken place.
The eighth meeting – from 19 February to 1 March 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 session did not achieve a significant breakthrough.
In early March, after member states’ request, the Bureau circulated a Revised Draft of the negotiating text of the WHO Pandemic Agreement, which was considered by the INB9 from 18-28 March.
Member states proposed numerous amendments and textual edits, resulting 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 22 April before the ‘resumed’ INB9 (29 April to 10 May). It included ample use of qualifiers such as ‘voluntary’ and ‘as appropriate’, and also deferred the resolution of more contentious issues like PABS and One Health to two additional, separate instruments to be negotiated later.
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 result was nearly a month of non-stop negotiations under the auspices of the INB, as well as the separately constituted Working Group on International Health Regulations.
By 24 May it became clear no agreement would be reached, with convergence achieved for only 13 out of 34 articles – and the ball was punted to the WHA.
On the same day, the IHR Working Group arrived at a more successful conclusion, and the few outstanding issues remaining were resolved during WHA, leading to final approval of the amended IHR on 1 June 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 IHR negotations, 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.
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Global pandemic treaty talks grind to a halt