Rupture in Africa Group Muddies Waters, But Developing Countries are Fighting Back for Equity Considerations in Pathogen Access & Benefit Sharing
Newsletter Edition #90 [Treaty Talks]
Hi,
At this point, WHO member states are about 48 hours away from the stated deadline to conclude the negotiations for a new Pandemic Agreement. And yet there are miles to go before they sleep.
Today, we bring you a quick update on the evolving state of play in the Pandemic Agreement negotiations at WHO, particularly with respect to the make-or-break discussions around the Pathogen Access Benefit Sharing System that could unlock eventual success for the overall process - or failure.
After we published reports this week, one on informal processes, and another on One Health, we received some gentle push back on these editions. I just want to re-emphasize that we take this responsibility with utmost sincerity and caution. We have no other agenda, other than to bring to fore information and perspectives that we observe.
We are acutely mindful of the sensitivities of diplomatic spaces and inchoate processes in fast-moving negotiations. We do exercise judgement and apply a dispassionate, forensic examination of views and facts presented to us. However, we are also deeply aware of the unbalanced field of play that international diplomacy is. And it is our endeavor to reflect what we see.
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I. ANALYSIS: PANDEMIC AGREEMENT NEGOTIATIONS
Rupture in Africa Group Muddies Waters, But Developing Countries are Fighting Back for Equity Considerations in Pathogen Access & Benefit Sharing
The negotiations on the Pandemic Agreement took a decisive turn this week, when at least two African countries became a part of a wider cross-regional group lending their support for a proposal that also reportedly has the backing of the EU and the U.S., in the context of the critical provision on Pathogen Access and Benefit Sharing, according to multiple sources.
Some of these countries are now being referred as the Group of Friends, who presented their proposal at a drafting group session this week, at the Intergovernmental Negotiating Body meeting underway in Geneva.
Countries discussed a revised proposal from the INB Bureau that builds on the informal proposal brought by the new group and on earlier feedback from member states. The drafting group is considering Article 12 on PABS, where countries are negotiating text in a plenary format in late evening sessions. Sources told us that what is now on the table is only a couple of paragraphs that capture, principles, components and proposed modalities for such a mechanism.
In this story we discuss the prevailing political dynamics, and the substantives elements of the PABS discussion.
THE POLITICS OF PABS
We reported earlier this week, that some countries including developed and a few African states came together, in an alleged non-inclusive process to bridge closer positions on PABS.
Diplomatic sources, and others tracking these discussions told us that the lead negotiator for the Africa Group, Ethiopia made a statement on behalf of the Group of Friends while presenting the proposal on PABS.
“The lead negotiators from the Africa Group have been captured,” according to one source, alluding to alleged behind-the-scenes diplomatic manoeuvres by some countries. The second country to be part of the group is understood to be Botswana. (Queries sent earlier to four African countries who were part of these discussions went unanswered. We published EU’s response from the European Commission here.)
“It is perhaps unprecedented in international treaty making that some African countries have sided with the EU and the U.S.,” one developing country negotiator told us this week.
During the discussion on PABS, this week, developing countries reportedly referred to “Divide and Conquer” pointing to the alleged orchestrated split in the Africa Group.
As we noted earlier, Africa Group has been remarkably coordinated and united in bringing bold, path-breaking proposals to not only the Pandemic Agreement process, but also to the amendments to the International Health Regulations. After three years of consistently working on these far-reaching reform proposals, the regional bloc is now addressing factions within.
The fracture in the Africa Group comes at a critical time of these negotiations, with less than 48 hours left for the conclusion of these discussions – unless WHO member states buy more time. (This is not being ruled out by some countries.)
The fallout in the Africa Group is a setback to the wider group of developing countries who more or less agree with the PABS initiative spearheaded by the 54-member regional bloc. Countries are now dealing with trust issues, instead of deeper coordination at this penultimate stage of the negotiation, sources said.
And yet, on the floor, developing countries pushed back against language they did not agree. Instead of a coordinated group position, countries are now fending for themselves, sources say.
Developing countries including the large ones, are invested in the PABS mechanism and are keen on having a workable mechanism despite Africa Group dynamics.
There is realisation at the INB, that without PABS, the Pandemic Agreement could unravel. Many have pointed out that the real-time access to medical products during a health emergency is the only material benefit for countries, in the context of a wider weakened agreement, where most of the commitments have been watered down with several qualifiers.
Elements of the revised proposal
Some of the key contentious elements, among others, in the PABS discussion are the following:
· On the scope of what needs to be shared via the PABS system with developing countries pushing more specific information on pathogens in relation to pandemic potential, while developed countries prefer a wider approach to sharing.
· On whether the system needs to have “accountable” sharing
· On tracking users of the information including through registration and traceability – proposed by developing countries
· Intellectual property on PABS material and information - with developing countries pushing against IP rights on products developed based on the information.
· On exclusive licensing or technology transfer as an assured benefit
· On the percentage of real-time production, with developing countries pushing for “at least 20%” and not “up to” a certain percentage. (It cannot be 0.1%, as one diplomat pointed out)
· There is pushback on terming these contributions as “donations” and to understand them as obligations in return for access to pathogens.
· On mandatory monetary contributions – similar to ongoing commitments in the PIP Framework that sets a precedent for these negotiations.
· A promise of legal certainty by declaring the PABS system as a Specialised International Instrument, as demanded by developed countries.
· Implications on future governance of such a system and the underlying legal nature. (There are suggestions that PABS can be adopted under Article 21, once the Intergovernmental Working Group finalizes the modalities of such a mechanism, in order to make this workable and insulate it from the delays and uncertainties of the ratification of a Pandemic Agreement)
Revised PABS text from Bureau
We publish the latest text (as on May 8, 8:00 pm):
(Note that countries are negotiating this text and positions will have moved)
“1. Recalling the sovereign right of States over their biological resources and the importance of collective action to mitigate public health risks, and underscoring the importance of promoting the timely, safe, transparent, accountable and rapid sharing of materials and information on pathogens with pandemic potential (hereafter Materials and Information) for public health purposes, and, on an equal footing, the timely, fair and equitable sharing of benefits arising therefrom, taking into account relevant national, domestic, and international laws, the Parties hereby establish a multilateral system for access and benefit sharing for pathogens with pandemic potential, the ‘WHO Pathogen Access and Benefit-Sharing System’ (PABS System). The PABS System shall be coordinated and convened by WHO [working in cooperation with relevant stakeholders].
2. The provisions governing the PABS System, including scope, definition of pathogens with pandemic potential and relevant information, modalities, terms and conditions, and operational dimensions shall be developed and agreed in a legally binding instrument. All elements of the PABS System shall come into operation simultaneously in accordance with the terms of such instrument, which will come into force no earlier than the date at which this Agreement comes into force.
3. The PABS System shall have the following components, that shall be defined in the Instrument referred to in paragraph 2:
(a) access to Materials and Information, and on an equal footing, the sharing of benefits;
(b) modalities on access and benefit sharing that provide legal certainty to providers and users of the PABS System;
(c) implementation in a manner to strengthen, facilitate and accelerate research and innovation, as well as the fair and equitable distribution of benefits;
(d) implementation in a manner that is complementary to the Pandemic Influenza Preparedness Framework;
(e) implementation in accordance with applicable laws, regulations, and standards, including as related to safety, security and data protection;
(f) robust, inclusive, transparent, and evidence-based governance, review, accountability and oversight,;
(g) intellectual property rights of PABS Materials and Information;
(h) the intention of recognition of the PABS System as a specialized international access and benefit-sharing instrument, within the meaning of paragraph 4 of Article 4 of the Nagoya Protocol, including the process for such recognition, noting that only states Party to the Nagoya Protocol are bound thereby.
4. The PABS System, that shall be defined in the Instrument referred to in paragraph 2, shall comprise, and not be limited to, the following elements:
(a) The timely, predictable, systematic, access to Materials and Information including, but not limited to, through existing WHO coordinated laboratory networks, and recommended sequence databases;
(b) The fair, equitable and timely sharing of benefits, both monetary and non-monetary, including the following:
(i) in the event of a [PHEIC] and/or pandemic emergency, expected rapid access by the PABS System to [up to]/[at least] 20% of the production of each of safe, quality, efficacious and effective vaccines, therapeutics, and diagnostics against pathogens to be covered by the Instrument;
o No less than 10% of the production free of charge
o [Up to 10% of the production at a not-for-profit price]
Such products shall be made available for use on the basis of public health risk and need, and upon request, with particular attention to the needs of developing countries.
(ii) Annual monetary contributions shall be administered by the PABS System.
(c) the fair and equitable allocation and distribution of the vaccines, therapeutics, and / or diagnostics against pathogens with pandemic potential to be covered under the PABS System, shall take into account public health risks and needs;
(d) that entities that use PABS Materials and Information for non-commercial purposes are to, at a minimum, acknowledge the providers of Materials and Information in relevant presentations and / or publications.
5. The PABS System shall include additional benefit sharing provisions. It shall also include specific benefit sharing provisions in the event of a PHEIC, which may include access to relevant vaccines, therapeutics, diagnostics. The modalities, and a list of additional benefits, shall be defined in the Instrument referred to in paragraph 2.
6. Each Party that has manufacturing facilities in its jurisdiction that are involved in the production of vaccines, therapeutics, and / or diagnostics against pathogens to be covered by the Instrument shall take appropriate measures to facilitate the manufacture and export of such products [subject to national/domestic, and international law].”
The urgency
Senior diplomats from developing countries told us that establishing a workable PABS system is critical. “The H5N1 outbreak is at the door. We need a system that assures benefits. It is takes three more years for PABS to take effect, developing countries are losing out – as we continue to share pathogens for Ebola, Mpox among others, without anything in return.”
In addition, legal experts point out that the success of a PABS system will depend on large participation with a depth of information on pathogens. Reducing the PABS instrument to an annex in the Pandemic Agreement, will limit participation, experts caution.
The devil is as always in the details. Diplomats caution that defining PABS modalities in a future workstream will become a “hot potato”. It is crucial that countries agree on a basic set of principles that will inform future negotiations they say.
There is a deep sense of frustration, that developing countries are being forced to negotiate complex issues in a matter of hours. “The system is rigged against us and we are being forced to play,” one observer said.
The PABS proposal was submitted more than a year ago by the proponents. It was in December 2023, that the EU came back with a revised proposal. The Bureau worked on the provision through sustained informals in early 2024 taking it through from conceptual design to legal text.
Countries are also dealing with the toss up between a proposed new One Health instrument, favored by some developed countries, with the future PABS instrument.
Some point out that it is unfair to treat both these equally. “Developed countries have managed to define a great deal of detail in surveillance and One Health related provisions already. But PABS is still in an incipient stage and we therefore need a fleshed out instrument. We cannot compare and trade across these different types of instruments.” It is learned that some developed countries have said a PABS instrument will be conditional on an instrument for One Health in the context of these discussions.
Expect a nail-biting finish.
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