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TWN Info Service on Health Issues
6 December 2024
Third World Network
www.twn.my
WHO: INB Bureau Pressures Global South to align with G7’s One Health and Prevention Agenda
Geneva, 6 Dec (TWN) – The Bureau of the Intergovernmental Negotiating Body (INB) tasked with negotiating the WHO Pandemic Agreement has aligned itself with the demands of developed countries, exerting significant pressure on developing countries to compromise, especially on the European Union’s demand for an Annex to the agreement to address a One Health approach to pandemic prevention.
The WHO Secretariat is also understood to be pressuring developing countries not to pursue their proposals in the run-up to negotiations on Article 12 on the Pathogen Access and Benefit Sharing (PABS) system.
Many developing countries consider the PABS system to be the core of the pandemic agreement for delivering some equity during health emergencies, in an instrument that is widely known to be lacking in meaningful deliverables.
In the ongoing resumed 12th session of the INB taking place in Geneva from 2 to 6 December a particular target of the Bureau’s aggressive lobbying has been the Africa Group, which has remained steadfast in its call for meaningful outcomes.
A diplomatic source participating in the negotiation informed Third World Network “that the Bureau’s only focus is on adopting some text as a Pandemic Agreement at the earliest and nothing else matters to them, not even meaningful equitable outcomes”.
INB Bureau tells Africa Group to give in to EU’s demand for an Annex
On Tuesday, 3 December, the Bureau disrupted the INB’s adopted programme of work to directly speak with the Africa Group. In a meeting that lasted about 2 hours, the Bureau expressed its unhappiness with the Africa Group’s textual proposals on Article 4 on pandemic prevention and surveillance, which was also supported by several other developing countries.
The EU has been relentless in its call for a legally binding Annex to the WHO Pandemic Agreement that will flesh out measures for pandemic prevention especially through a multisectoral surveillance lens (One Health approach) for implementing Article 4.
As a counterproposal, the Africa Group sought to mandate the agreement’s Conference of Parties to adopt guidelines and recommendations along with other non-binding measures to promote implementation of Article 4.
[Article 4 is titled “Pandemic prevention and surveillance”. Article 4.2 speaks of Parties’ implementation of measures including on (a) prevention of the emergence and re-emergence of infectious diseases; (b) coordinated multi-sectoral surveillance and risk assessment; (c) early detection and control measures including at community level; (d) water, sanitation and hygiene; (e) routine immunization; (f) infection prevention and control; (g) prevention of infectious disease transmission between animals and humans, including zoonotic disease spill-over; (h) vector-borne disease surveillance and prevention; (i) laboratory biological risk management; (j) prevention of antimicrobial resistance.]
The EU backed by its Group of 7 (G7) allies have indicated their desire for the proposed Annex to reflect concrete measures under each of the above headings with particular emphasis on obligations to implement One Health surveillance. However, the EU has persistently refused to provide any indication of possible measures they may be considering for inclusion in the proposed legally binding Annex.
Apparently, the EU and other G7 countries have claimed that they are not in a position to explain what the contents of the legally binding Annex would be, only that each of the sub-headings under Article 4.2 should have specific measures.
[“G7” comprises Canada, France, Germany, Italy, Japan, the United Kingdom and the United States. The EU is a non-enumerated member, i.e. it is not included in the number count of the grouping as it is a supranational entity, not a sovereign state. Thus references to G7 in this article includes the EU.]
Developing countries have serious concerns that the Pandemic Agreement which is supposed to deliver outcomes to address inequities experienced during health emergencies, is being used by the EU to impose surveillance and other obligations under the guise of pandemic prevention. These obligations, developing countries fear, will come with significant trade, economic, security and national security consequences including impinging on national sovereignty.
On numerous occasions developing countries including the Africa Group explained to the EU and its G7 friends that there was no clarity on the contents of the proposed legally binding Annex, stressing that they cannot be expected to hand a “blank cheque” for G7 countries to impose legal obligations, especially front-loaded on surveillance measures.
To move the matter forward, some developing countries even welcomed the EU and its allies placing substantive or specific measures into the text of Article 4 within the current INB process to realize the objective of pandemic prevention, rather than wait for agreement on an Annex.
However, this was not acceptable to the EU.
The Bureau then weighed in, claiming that opposition to the EU’s demand for an Annex is failing the negotiations, shifting the blame to developing countries, for not compromising, according to delegates participating in the negotiations.
The INB Bureau discontinued the INB proceedings to focus its attention directly on the Africa Group. In an informal meeting that lasted about 2 hours, the Bureau confronted the Africa Group on its position, presumably on the assumption that if the Africa Group changes its position, other developing countries can be forced to compromise.
However, the Africa Group stood firm and pushed back, diplomatic sources say. They expressed immense frustration with the Bureau, their tactics and the INB process generally, emphasizing that the Africa Group had already shown extensive flexibility thus far, while the G7 had barely moved on any of its positions across the text of the Pandemic Agreement. The Group requested the Bureau to instead press the G7 countries as to what compromises they will be making in the INB process.
Thus far the G7 positions have crippled most possibilities of equitable outcomes in the Pandemic Agreement. They have opposed or substantially diluted any legally binding commitments to provide financial support, technology transfer or even timely access to affordable vaccines, therapeutics and diagnostics to prevent and deal with health emergencies.
Back in the INB drafting group, several developing countries including India, Malaysia, Iran and Indonesia were irked with the Bureau’s connivance.
India raised a point of order and questioned the appropriateness of the Bureau’s approach. It said “closed door” negotiations with a particular regional group, which put other scheduled sessions on hold without notice and agreement of the INB, is a violation of the Programme of Work adopted by the INB in the Opening Session.
India asked the Bureau how such closed meetings can make the process fair, transparent and inclusive and how this approach is conducive to building confidence in the negotiation process. It then went on to ask the Bureau to report on the outcomes of the closed-door meeting with the Africa Group.
The Bureau’s response was muted, explaining that they wanted a frank discussion with the Africa Group, and did not prefer any regional group over the other. Some Bureau members apologized for not providing proper intimation of the said meeting but also argued that the adopted programme of work was not a strict document to be followed literally.
The Bureau then went on to continue negotiations on Articles that were not in the adopted programme of work which many negotiators were unprepared to address (as they had not been scheduled for discussion).
A delegate involved in the negotiations was of the view that “it is highly inappropriate on the part of the Bureau to blame one side for having not compromised, and even more to target a large negotiation bloc amongst the developing countries and speak to them for about two and a half hours in the middle of a negotiation and try to convince them to compromise, without anything concrete in return”. The same delegate added that it was “frustrating to see when the Bureau treats texts and words coming from developed countries as neutral and makes them appear readily on the screen, while the developing countries have to insist multiple times to see their text on the screen”.
According to various sources, the Bureau then called for a meeting with the Group of Equity compromising around 30 developing country Member States.
Secretariat Influencing positions on set-asides for PHEICs
It is no secret that the WHO Secretariat is rather desperate to conclude the Pandemic Agreement. For the WHO Director-General, the adoption of the agreement is a personal ambition, a matter of his legacy. Thus, unsurprisingly the Secretariat is also leveraging its influence, disposing of issues not agreeable to developed countries, even if these are important from an equity perspective.
Since the beginning of the Pandemic Agreement negotiations, the Africa Group has consistently called on manufacturers of vaccines, therapeutics and diagnostics to ensure minimum set-asides to be reserved for WHO during pandemic emergencies and public health emergencies of international concern (PHEIC) to enable WHO to roll out such products to countries in need.
While the INB text for such manufacturer set-asides reserved for WHO for the situation of pandemic emergencies is yellowed (i.e. preliminarily agreed) similar language for PHEIC was removed from the text by the Bureau when it streamlined the PABS text for the 11th INB session.
[See INB Bureau further streamlines text on PABS, presenting weak benefit-sharing commitments]
Many viewed the Bureau’s move as accommodating the position of developed countries that have opposed set-asides in situations of PHEICs.
On numerous occasions, the Africa Group has pointed out that the Bureau’s weak text on PHEIC is not acceptable. Instead, they stressed the need for specific manufacturer set-asides reserved for WHO during PHEIC and for the Director-General to be empowered to call for the release of these set-asides at the pre-PHEIC stage to supply affected countries or to replenish WHO stockpiles.
Several developing countries have on different occasions supported the Africa Group’s call to effectively address PHEIC. They have pointed out that PHEICs are a more regular occurrence, than a pandemic emergency and hence there has to be certainty of equitable access.
[Since 2005, there have been eight PHEIC declarations: the 2009–2010 H1N1 or swine flu pandemic, the ongoing 2014 polio declaration, the 2013–2016 outbreak of Ebola in Western Africa, the 2015–16 Zika virus epidemic, the 2018–2020 Kivu Ebola epidemic, the 2020–2023 declaration for the COVID-19 pandemic, and the 2022–2023 and 2024 Mpox outbreaks.]
According to various sources, this remained the Africa Group position, until the intervention by the WHO Secretariat.
On Tuesday (3 December) for the first time, paragraph 8 of the INB text was discussed.
Paragraph 8 as proposed by the Bureau reads: “When a PHEIC is determined, the PABS System shall also include specific benefit sharing provisions, including, as appropriate, taking into account IHR temporary recommendations, for access to safe, quality and effective vaccines, therapeutics, and diagnostics for the disease causing the PHEIC”.
The practical effect of the Bureau’s proposal is that it parks this important matter to be resolved in the future. Notably, there is no indication of an upfront commitment from manufacturers using the PABS system to allocate a specific percentage of vaccines, therapeutics and diagnostics (VTDs) for WHO, thereby allowing manufacturers to instead prioritize supply to wealthier nations that have entered into advance purchase agreements with the manufacturer.
In contrast, based on previous proposals, the Africa Group and other developing countries have suggested that manufacturers allocate about 15% (initially 20%) of their real-time production of each VTD for WHO. Of this allocation, at least 50% would be provided free of charge, with the remainder offered at “not-for-profit” prices.
Expectations that the Africa Group would push to reflect manufacturer set-asides for PHEIC were soon dashed as they seem to suggest that the matter can be dealt with in the future.
The Africa Group did however press for advance release of VTDs by the Director-General to prevent outbreaks progressing into PHEICs, adding that manufacturers shall comply with the Director-General’s request for advance release. However, without a set-aside commitment by manufacturers, it is not clear how manufacturers would be in a position to honour the request of the Director-General for advance release.
Diplomatic sources confirmed that this was due to the intervention of the WHO Secretariat which met with the Africa Group and some other developing countries, convincing them that WHO was already negotiating with companies and countries that held stockpiles of health products, to obtain them for PHEIC. They claimed small manufacturer set-asides as part of the PABS system reduce their capacity to negotiate for more with these companies and countries.
This view is inherently flawed.
Emergencies of COVID-19, Mpox as well as Ebola show that during PHEIC outbreaks WHO has consistently struggled to obtain immediate access to needed VTDs as the manufacturers tend to prioritize supplies to and stockpiles by rich countries. Access to VTDs during these emergencies has largely been ad hoc, dependent on the goodwill of rich countries. For example, in the case of Mpox, of the 5.3 million pledged doses, only 281,880 vaccines have arrived on the African continent as of early October 2024.
Further, requiring manufacturers using the PABS system to agree to specific set-asides as a matter of contractual commitment to be supplied during PHEIC does not preclude WHO from negotiating for more supplies or for an additional commitment to be added requiring a manufacturer to provide more VTDs should that be required.
According to various diplomatic sources, the Bureau also sought to soften the stance of the Africa Group, on the argument that most pathogens are from Asia.
Machinations of the Secretariat and odd suggestions of the Bureau highlight their desperation to conclude a Pandemic Agreement at any cost.
Developed countries continue to push for “voluntary” approach to benefit sharing in PABS negotiations
Developed countries, especially Norway, Australia, the United States, Japan, Switzerland and the EU, reiterated their opposition to the idea that users of the physical materials and sequence information shall have to agree to legally binding conditions. They also remained opposed to measures ensuring transparency and accountability about users of the PABS system.
Subjecting access to materials and sequences, to acceptance of enforceable contracts is the foundation of an effective access and benefit-sharing system and thus the PABS system. This approach is essential to set out clearly for the user the conditions for using the shared materials and sequence information and for obtaining fair and equitable benefit-sharing commitments. They are also tools of accountability and transparency, imperative to avoid free riders, misappropriation of shared resources and abuse of the PABS system.
Norway’s evolving role in international negotiations: pro-equity to not-so-pro-equitable access
Norway often plays the role of a bridge builder in international negotiations. It has been a keen supporter of ABS-related treaties such as the Convention on Biological Diversity and its Nagoya Protocol. The conclusion of the Pandemic Influenza Preparedness (PIP) Framework negotiations, a multilateral ABS instrument for the sharing of influenza virus of pandemic potential and fair and equitable benefit sharing, is also in a small part credited to Norway reinvigorating the negotiations as one of the chairs of the process.
However, in the current INB process, Norway has taken on a more adversarial role. It mostly pays lip service to ABS principles, elements and implementation. In particular, it is opposed to transparency and accountability measures applied to users of the PABS system as well as to databases involved in the sharing of PABS sequence information. This is despite the fact that such measures, in particular user registration, data access agreement and labelling, are being applied by GISAID a private database that hosts the majority of sequence information of pathogens with pandemic potential. In fact, such measures are the very reason for the popularity of the GISAID database, although concerns about unilateral decision-making and the absence of governance in GISAID remains.
Norway’s position is also based on double standards. It is a staunch proponent of pandemic prevention in the context of Article 4, even supporting the EU’s call for an Annex. Yet at the same time, Norway outrightly opposed Africa the Group’s proposal that allows the Director-General to call for advance release of VTDs, to prevent an outbreak from becoming a PHEIC.
A developing country negotiator commented candidly, “… they want us to continue sharing of pathogens and sequences without oversight and traceability. We won’t know if someone diverts the same for dual use, such as for developing bioweapons. And then we would get nothing in return, other than an opportunity to wait in the queue for health products”.
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