TWN Info Service on Health Issues (Dec24/02)
12 December 2024
Third World Network

WHO Pandemic Agreement: INB Bureau pushes developing countries to agree

Geneva, 12 Dec (Nithin Ramakrishnan and Sangeeta Shashikant) – On the final day of the resumed 12th session of the Intergovernmental Negotiating Body (INB), the INB Bureau manoeuvred the process to pressure WHO Member States – particularly developing countries – into dropping their objections to the financing provisions of the Pandemic Agreement.

This last-minute push aimed to secure the “greening” of additional text as the session drew to a close. Negotiation text that is highlighted in green indicates initial agreement.

The resumed session, held from 2 to 6 December 2024, resulted in an initial agreement on Article 20 (Sustainable Financing) and Article 9 (Research and Development).

On Friday, 6 December, the INB Bureau unexpectedly altered the programme of work to prioritize Article 20, catching many delegations off guard, as this was not part of the agreed-upon agenda.

According to diplomatic sources, this move aimed to pre-empt African nations, which had signalled the previous day that they intended to revert to their original proposal for a new fund to support the agreement’s implementation.

The Bureau reportedly engaged in intensive lobbying, including at the ambassadorial level, to dissuade African nations from insisting on the dedicated fund. Bureau officials argued that failure to reach consensus on Article 20 by 6 December could lead to the incoming Trump administration – set to take office in January 2025 – blocking consensus on provisions related to financing.

Achieving broader consensus among WHO Members has proven to be an uphill battle. The INB Bureau and WHO Secretariat have been at the forefront of pushing for the conclusion of negotiations, but progress has been painfully slow since the original May 2024 deadline was missed.

Developing countries are increasingly alarmed that the Pandemic Agreement lacks meaningful provisions that will shift the status quo towards an equitable response during health emergencies. They advocate for tangible commitments like technology transfer, diversifying production and timely equitable access to medical products.

In contrast, developed countries have shown little interest in adopting concrete measures that meaningfully operationalize equity. Instead, their focus remains on reflecting obligations for multisectoral surveillance, data sharing, and the exchange of biological materials.

The divide between the Global North and South is starkly apparent. According to diplomatic sources, the Bureau and the Secretariat are worried about the future of the negotiations, with the impending inauguration of the Trump administration in January 2025.

Against this backdrop, a desperate INB Bureau and Secretariat have increased pressure on developing countries to make concessions and align with the G7’s demands, further deepening tensions in an already fraught negotiation process (see INB Bureau Pressures Global South to align with G7’s One Health and Prevention Agenda).

No new financial mechanism established or funding commitments

Since the beginning of the INB negotiations, G7 countries have been against establishing a fund or a new financial mechanism as well as taking on any financing commitments for the implementation of the Pandemic Agreement.

Instead, the G7 has favoured the agreement’s implementation to be dependent on ad hoc financing by agencies outside the WHO.

The idea of a “coordinating financial mechanism” (CFM), emerged as a WHO Secretariat-INB Bureau compromise, whereby WHO is expected to coordinate with external agencies to mobilize financial resources for pandemic prevention, preparedness and response.

During the 77^th World Health Assembly in May 2024, the CFM idea was captured and adopted by a parallel process i.e. the Working Group on Amendments to the International Health Regulations (WGIHR), as a last-minute replacement of developing countries’ proposals calling for a new Financial Mechanism. Accordingly, the IHR was amended with the addition of Article 44bis reflecting a coordinating financial mechanism.  The text for Article 44bis was taken from the draft text of Article 20 of the Pandemic Agreement which was then under negotiation in INB.

[Essentially CFM refers to an entity for coordinating with external financing agencies such as the World Bank or the Global Fund, mobilizing financial resources for health emergency preparedness and response under the IHR 2005, including for pandemic prevention, preparedness and response.]

Post the World Health Assembly, the Africa Group led by Nigeria, South Africa and supported by a number of developing countries sought to reignite the call for a new financial mechanism in the INB process, however with little success.

The G7 countries reiterated their objection towards such a mechanism within WHO, arguing that WHO cannot manage the large-scale financial resources required for the implementation of the Pandemic Agreement.

Their preference for the text to refer to the CFM established under Article 44bis of the IHR 2005 eventually led to North-South wrangling over the management of CFM.

The battle over the management of the Coordinating Financial Mechanism

The Africa Group, Russia and several other developing countries insisted on the creation of a CFM separate from the IHR, arguing that otherwise Parties to that other instrument, who are not Parties to the Pandemic Agreement, would continue to regulate the finances for the Pandemic Agreement. They proposed:

“A coordinating financial mechanism (the mechanism) is hereby established… The secretariat will ensure synchronization and collaboration between the mechanism and the coordinating financial mechanism contained in the Article 44bis of the IHR 2005 as amended to avoid duplication”.

This was not agreeable to most developed countries. They were of the view that the CFM established under the IHR 2005 could also operate as a CFM for the Pandemic Agreement.

Several developing countries were also open to the same CFM being applicable to both instruments as they believed that in any case the actual control over finance remained with the external agencies and the CFM activities would be anyway under the authority and guidance of the Conference of Parties (COP) to the Agreement.

The Bureau then emerged with a text proposal for the consideration of Parties:

“A Coordinating Financial Mechanism (the Mechanism) is hereby established to promote sustainable financing for the implementation of this Agreement to support strengthening and expanding capacities for pandemic prevention, preparedness and response, and contribute to the [prompt] [availability of] surge financing response necessary for day zero, particularly in developing country Parties, and the Coordinating Financial Mechanism established under the amended International Health Regulations (2005) shall be utilized as the Mechanism to serve the implementation of this Agreement.”

Some developing countries contested the proposal, questioning how the INB could be so sure that the Mechanism established under the amended IHR 2005 would work for the Pandemic Agreement. They also queried whether the proposed language prevents Parties to the Agreement from creating new financial mechanisms or relying on entities other than the IHR mechanism through COP decisions.

Malaysia therefore proposed the addition of “unless otherwise determined by the Conference of Parties” after “to serve the implementation of this Agreement”. This was supported by India, Pakistan, South Africa, Zambia, Colombia, and Bangladesh.

Developing countries also said “shall” should not be used in the second part of the sentence, as it refers to a mechanism already established under the mandate of another instrument.

Nevertheless, G7 was not agreeable, presumably because of the possibility that the Pandemic Agreement Parties would use COP to create additional CFMs, bypassing the suggestion in Article 20.

During an informal, Canada and the U.S. even told delegations they should not be misguided by the wording of the current paragraph 3. The phrase “hereby established” is used only symbolically, and the actual work will only be done by the mechanism established under the IHR 2005.

To this, South Africa replied that their delegation was not willing to waste time to discuss a symbolic establishment of a financial mechanism, ridden with legal language which creates only incoherence.

The INB Vice-Chair tried to suggest language indicating that the mechanism established under IHR 2005 may serve as a coordinating financial mechanism for the Pandemic Agreement following a COP decision. However, according to the U.S. and E.U., this does not change the situation much.

The U.S. then proposed to add the phrase “pursuant to Article 29”, after the Malaysian text “unless otherwise determined by the COP” such that the process of moving away from the IHR coordinating financial mechanism would require an amendment of the Pandemic Agreement under Article 29.

However, Malaysia responded by arguing that when the COP is mandated with certain decision-making power within the Agreement, there is no need for amendments. Moreover, according to the proposed language of the Bureau, Parties to the pandemic agreement are relying on external bodies for financing, including the coordinating financial mechanism from IHR 2005. In such a case, according to Malaysia, there is a need for the COP to act swiftly when such entities are not serving the needs of the Pandemic Agreement.

Meanwhile, Singapore came up with language which suggested “in a manner determined by COP”, instead of the proposed language “unless otherwise determined by the COP”.

The final text of paragraph 3 as agreed thus reads:

“A Coordinating Financial Mechanism (the Mechanism) is hereby established to promote sustainable financing for the implementation of this Agreement to support strengthening and expanding capacities for pandemic prevention, preparedness and response, and contribute to the prompt availability of surge financing response necessary for day zero, particularly in developing country Parties, and the Coordinating Financial Mechanism established under the amended International Health Regulations (2005) shall be utilized as the Mechanism to serve the implementation of this Agreement, in a manner determined by the Conference of Parties”.

Some developing country delegates were of the view that the accepted language provides some policy space to the COP to moderate its relationship with the CFM established under IHR 2005 while also being able to establish supporting or supplementary facilities to mobilize financial resources.

Some others remained concerned that the text would do very little in terms of financing of the Pandemic Agreement. Instead, it is likely to be another contentious issue that WHO Members will have to deal with during the first meeting of the implementation committee of the IHR 2005, which is mandated to develop the modalities for the mechanism’s work.

Trade off with Paragraph 4

The text of Paragraph 4 of Article 20 in the draft negotiating text was mostly agreed except for the phrase “new or existing funds”. As the resumed INB 12 began, the text of paragraph 4 was: “The Conference of the Parties shall take appropriate measures to give effect to this Article, including the possibility of exploring, additional financial resources to support the implementation of this Agreement [through [all sources of funding, existing and/or non-traditional funding sources.] new or existing funds]”.

The bracketed text was added in the previous INB 12 session in November 2024.

Interestingly, not much discussion took place on this text. The G7’s opposition to reference to new funds in paragraph 4 was withdrawn as a part of a trade-off, for referring to the IHR CFM in paragraph 3. According to a delegate “this was the compromise deal for financing”.

Certain delegations proposed the phrase “through all sources of funding, existing and new, including innovative and those beyond official development assistance”.

This proposal was accepted without much debate. The final agreed text is as follows:

“The Conference of the Parties shall take appropriate measures to give effect to this Article, including the possibility of exploring additional financial resources to support the implementation of this Agreement, through all sources of funding, existing and new, including innovative and those beyond official development assistance”.

Article 9: Developing countries secure language on post-trial access to health products

Paragraph 3 of Article 9 is the other critical provision that was agreed to last week.

The final agreed text states:

“Each Party shall, in accordance with their national or domestic circumstances and law, and taking into account relevant national and international ethical guidelines and guidance, promote, during public health emergencies of international concern and pandemic emergencies, the conduct of well-designed and well-implemented clinical trials in their jurisdiction, including by: (i) promoting representative trial populations; (ii) promoting, as appropriate, sharing of pandemic-related vaccines, therapeutics and diagnostics for use as comparator products^FN in the conduct of clinical trials of pandemic-related vaccines, therapeutics and diagnostics; (iii)  promoting  access to safe and effective products that result from these trials for such trial populations and for populations at risk in their communities.

FN: For the purposes of this paragraph, “comparator product” means an investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial”.

This language was accepted as a compromise package with the U.S. which agreed to incorporate a provision to promote access, as appropriate, to comparator products for clinical trials.

Promoting access to comparator products was previously not acceptable to the U.S. It had inserted “as appropriate” after “Each Party shall”, in the chapeau, as well as “voluntary” in clause (ii) between the words “as appropriate” and “sharing”.

The previous text (which was mostly agreed to except for what was in brackets) was as follows:

“Each Party shall, [as appropriate,] in accordance with their national or domestic circumstances and law, and taking into account relevant national and international ethical guidelines and guidance, promote, during PHEICs and pandemic emergencies, the conduct of well-designed and well-implemented clinical trials in their jurisdiction, including by: (i) promoting representative trial populations; (ii) promoting, as appropriate, [voluntary] sharing of pandemic-related vaccines, therapeutics and diagnostics for use as comparator products FN in the conduct of clinical trials of pandemic-related vaccines, therapeutics and diagnostics; (iii) [enabling] [promoting] access to safe and effective products that result from these trials for such trial populations[, including their communities].

Prior to the resumed INB 12, the U.S. reached out to several developing countries to strike a deal on the text, according to several sources. In one deal reached, the U.S. agreed to withdraw the caveats they had placed – “as appropriate” from the chapeau and “voluntary” from clause (ii) – in exchange for diluting post-trial access to communities at large in which clinical trials were conducted. They wanted to delete “enabling” and use “promoting” in clause (iii), as well as use the verb “encouraging” before “access to communities where clinical trials were conducted”.

The text of the U.S. and Canada for the deal reads:

“Each Party shall, in accordance with their national or domestic circumstances and law, and taking into account relevant national and international ethical guidelines and guidance, promote, during public health emergencies of international concern and pandemic emergencies, the conduct of well-designed and well-implemented clinical trials in their jurisdiction, including by:…(iii) promoting access to safe and effective products that result from these trials for trial participants and encouraging access for populations at risk in their communities”.

Norway and Mexico co-facilitated many of these discussions, and proposed the compromise text to the Bureau, as a package.

However, during the INB meeting some developing countries raised doubts over the use of “encouraging” for post-trial access. Malaysia argued that it was a very low standard if one compared this with policy space States have for requiring investigators to commit to post-trial access. According to Malaysia, its relevant authorities, including the ethical committee, are free to make prospective investigators wishing to conduct trials, commit to certain conditions that ensure post-trial access to successful products for trial participants and their extended communities.

Bangladesh questioned the different standards applied to participants of clinical trials and to the population at risk in those communities.

Many developing countries were of a similar view and not willing to accept the deletion of “enabling” and the resultant “dilution” of the obligation on post-trial access to trial participants and their communities. Many developing country delegates viewed the U.S. moves on paragraph 3 as “horse-trading”.

“The U.S. was playing a game with us by tying comparator product access and post-trial access to successful health products,” according to a developing country delegate.

The U.S. justified its proposal on the basis that the Helsinki Declaration is the only declaration that addresses access to trial participants, sources say.  To which Malaysia responded that the International Ethical Guidelines for Health-related Research Involving Humans, published by WHO and the Council for International Organizations of Medical Science (CIOMS), expands the concept of post-trial access to include other benefits targeting not only participants of clinical trials but also the communities where trials are hosted, particularly when the research is carried out in resource-limited settings. These are referred to as CIOMS guidelines.

(The Declaration of Helsinki is a statement of ethical principles for medical research involving human participants, including research using identifiable human material or data. It was adopted by the World Medical Association in 1964. The CIOMS guidelines are revised from time to time to respond to emerging ethical issues with the last revision in 2002. They were first issued in 1982.)

Malaysia also raised concerns over non-compliance with ethical standards by calling out non-registration of end-products in countries where trials were conducted as well as unaffordable pricing. It added that Article 9.3. should clarify that governments are obliged to guarantee access to communities, when they approve clinical trials and, in that context, it is too weak to be using “encouraging”.

Finally, the U.S. agreed to use “promoting access” for both trial participants and populations at risk in their communities, which allowed the adoption of a fully agreed Article 9.3.

According to some non-state actors observing the negotiations, even though the language lacks legal certainty, the paragraph is somewhat historic, since for the first time a legally binding instrument addresses the issue of post-trial access. At the same time, they lamented that the U.S. position hindered a more ambitious outcome. Some other non-state actors expressed their disappointment with the overall language on clinical trials and equitable access to health products.+