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Info Service on Biodiversity and Traditional Knowledge (Jul26/01) WHO: Developing countries insist PABS must uphold Article 12 and ABS principles Geneva, 8 July (Nithin Ramakrishnan and Rajnia Rodrigues) – During the opening plenary of the seventh session of the Intergovernmental Working Group (IGWG 7) negotiating the Pathogen Access and Benefit Sharing (PABS) Annex to the World Health Organization (WHO) Pandemic Agreement, many developing countries underscored the importance of adhering to the fundamentals of access and benefit sharing, as well as parameters set out in Article 12 of the Pandemic Agreement. While expressing their commitment to intensifying efforts to reach consensus, developing countries consistently reiterated that a key red line is the inseparable link between access and benefit sharing, whereby access to pathogen materials and sequence information is subject to fair and equitable benefit-sharing obligations. They stressed that this interlinkage cannot be severed if the PABS system is to provide the legal certainty necessary to achieve fairness, equity and the objectives of Article 12. IGWG 7 began on 6 July at WHO headquarters in Geneva. The IGWG was set up by the World Health Assembly (WHA) in May 2025, following the adoption of the Pandemic Agreement. IGWG 7 is the first formal session after its mandate to negotiate the PABS Annex to the Pandemic Agreement was extended by the 79th WHA. Prior to IGWG 7, Member States had participated in several informal meetings spanning two weeks beginning 22 June, as precursor to the formal meetings. At the start of the session, the co-facilitators of the informal meetings presented several slides on some of the areas of convergence and key outstanding issues. The co-facilitators noted broad agreement that the overall objective of the PABS system remains rapid access to pathogen materials and sequence information and fair and equitable benefit sharing on an equal footing. Delegations also converged on the need for legally binding terms and conditions and terms of reference for both the WHO-Coordinated Laboratory Network (WCLN) and WHO-recognized sequence databases. However, further consideration is needed in defining the roles of different categories of laboratories, the accountability of databases, the criteria for recognition, and users’ obligations. The co-facilitators’ slides also revealed convergence on access issues that the onward transfer of pathogen materials should be accompanied by a contractual arrangement that should be concluded prior to shipping outside of the WCLN. However, differences remain over whether such a document should itself contain benefit-sharing commitments or only obligations relating to access and use, whether it should include a commitment to sign a PABS contract with WHO, and whether WHO should be a party to the arrangement. Regarding pathogen sequence information, the co-facilitators said there was openness to requiring users to accept a Data Access Agreement and click-wrap agreements, with recognition that they could be legally binding, to access pathogen sequence data. However, agreement had not been reached on the minimum content of such agreements, including whether they should contain benefit-sharing obligations, nor on whether WHO should be a party to them. User registration, fundamental to the identification of the individuals and entities accessing sequence information, and essential for an accountable PABS system, remains an outstanding issue, despite such registration being required by the majority of scientific databases in developed countries. There was no agreement that unique persistent identifiers (UPIs) are sufficient to replace user registration. There was however clarity that the originating laboratory (country) should assign them and they should be maintained downstream. Delegations broadly agreed that WHO-recognized sequence databases should be bound to WHO through a legally binding instrument containing mandatory terms and conditions and terms of reference. However, further negotiations are needed on requirements to be a WHO-recognized sequence database, the obligations applicable to databases, as well as on enforceability and the consequences of non-compliance. On benefit sharing, there was convergence around users making monetary contributions, although the formula for such contributions has not been agreed to, with some preferring revenue-linked contributions. Delegations also supported a mandatory minimum allocation of vaccines, therapeutics and diagnostics during public health emergencies of international concern (PHEICs), supplemented by an additional negotiable volume. However, significant differences remain regarding which PHEICs should trigger such obligations and how they should relate to the scope of the PABS system. Namibia requested corrections to parts of the summary, noting that some descriptions did not accurately reflect the discussions. It asked that the summary table not be circulated for further use until the corrections had been made, and placed on record that its proposed edits would be submitted to the Secretariat in writing. While the European Union and other developed countries also expressed a willingness to work towards solutions, Germany requested that the Secretariat provide an honest assessment of the resources available to support the continued work of the IGWG. Guyana, on behalf of Barbados, Dominica, Guyana, Jamaica and the Organization of Eastern Caribbean States, acknowledged the progress made in these negotiations, commending the strong unity demonstrated by developing countries in advancing proposals that promote fairness, equity and solidarity while helping to prevent a repeat of inequities witnessed during the COVID-19 pandemic. It said that the IGWG should consider the extended mandate as an opportunity to achieve a “balanced, effective, and broadly supported” outcome. It pointed out that the matter involves complexities and that the PABS Annex negotiations have been underway for less than a year. “By comparison, other multilateral health-related instruments have required considerably longer time frames to reach consensus.” Guyana stressed that the PABS Annex must reflect the following foundations: “Equal footing: the sharing of PABS materials and sequence information must be matched by the fair and equitable sharing of benefits arising from their use. This principle must be supported by comprehensive, transparent, and enforceable arrangements applicable to all providers and users.” “Binding standardized contracts: standardized PABS contracts must form the legal foundation of the system, creating clear and binding obligations across the PABS stream, and ensuring that the system delivers meaningful benefits for all.” Indonesia, on behalf of the Group for Equity (GfE), said, “What we decide here will shape how the world responds to the next pandemic, and that is not a responsibility any of us should take lightly.” It added that “[f]or our Group, there can be no credible landing zone that departs from Article 12: access and benefit sharing on an equal footing, delivered through a system that is safe, accountable, and transparent, and all elements of the PABS system shall come into operation simultaneously”. It further said that the PABS system “requires real certainty, at the point of access, about how benefit-sharing obligations will be operationalized and enforced”, adding that “benefit sharing cannot be something that materializes only when users happen to feel generous after the fact”. It stressed that “all users accessing PABS materials and sequence information must undertake certain obligations through legally binding contracts to share benefits arising from the sharing and/or use of such resources. We cannot accept, under any configuration, an approach that delinks access from benefit sharing”. “A system presented as an instrument of equity cannot rest primarily on aspirational language or unequal expectations,” Indonesia said, further stating that “accountability and transparency matter just as much. Obligations that cannot be enforced are not obligations at all, and enforcement is not possible if users are permitted to remain anonymous. This goes to the heart of biosafety and biosecurity, and to whether anyone can have confidence in this system at all”. Indonesia also said that “several foundational elements, including legally binding contracts, T&C [terms and conditions] and ToRs [terms of reference] for the WCLN and the PABS Sequence Database, had been suggested by some countries to be deferred until after the adoption of the Annex”, but that “Decision WHA79(7) obligates us all to also develop legally binding contracts as an outcome of this process along with the PABS Annex”. Indonesia clarified that “PABS was never meant to be ‘only’ about equitable access to medical countermeasures. It should help developing countries build local production, strengthen technological capacity, and strengthen their overall capacity when the next crisis arrives”. On behalf of the GfE, Indonesia said, “We understand the pressure building to conclude this Annex. Our Group shares the urge to finish. But finishing should not come at the cost of a weaker design, non- binding commitments, or lowered ambition.” It added, “Multilateralism is not measured by whether we produce an outcome. It is measured by whether that outcome changes the status quo for everyone, particularly those it is meant to protect.” In conclusion, Indonesia said, “History will not remember how quickly we finished. It will remember whether we got it right.” Pakistan, on behalf of the Group of WHO East Mediterranean Region (EMRO), highlighted four priorities: “First, standardized legally binding contracts for pathogen materials and pathogen sequence information must be finalized. These are the legal foundation without which the PABS system cannot be effectively implemented.” “Second, meaningful technology transfer and licensing must become operational realities, particularly during public health emergencies of international concern and during peacetime, rather than remaining aspirational commitments.” “Third, commercial beneficiaries of the PABS system must contribute mandatory, predictable and proportionate monetary benefit sharing. Cost recovery cannot substitute genuine benefit sharing.” “Fourth, traceability and accountability must remain integral features of the system. Anonymous pathways for access to pathogen sequence information would undermine transparency, trust and equitable benefit sharing.” Pakistan reminded the IGWG Member States that for the EMRO region, equity cannot remain as an abstract principle; it is a necessity for the region and must become a reality. The region faces nearly half of the global humanitarian burden even though it accounts for less than 10% of the world’s population. Pakistan pointed to Palestine and said that the occupying power has caused severe shortages of medicines and medical supplies, and institutions like WHO need to consolidate their access to supplies such that they can help affected areas and vulnerable populations. Pakistan said the EMRO region “cannot support any outcome that delinks access from benefit sharing or compromises the principle of equal footing. Equity is the foundation of Article 12, and it must remain the foundation of the PABS Annex”. Algeria, speaking on behalf of the 47 member states of the WHO African region, plus Egypt, Somalia, Libya and Sudan, expressed its commitment to achieving an equitable, balanced and operational outcome and emphasized six key priorities: benefit-sharing obligations must arise at the point of access; monetary contributions should “go beyond simple access fees”; WHO-recognized sequence databases must require mandatory registration and legally binding data access agreements; licensing must be mandatory and non-exclusive; standard contracts should be developed as appendices to the PABS Annex; and the PABS system must remain consistent with the Convention on Biological Diversity (CBD) and its Nagoya Protocol. Algeria also called upon IGWG Members to engage with drafts submitted by the Africa Group on a “universal PABS model” and also with the draft contractual instruments submitted by the Africa Group along with the GfE. Aligning with the Africa Group, Namibia stated the three pillars of its national position on PABS: “First, if Namibia is to share its biological materials and genetic sequence data, it must be met with mandatory, legally binding, and enforceable benefits, real access to vaccines, therapeutics, diagnostics, and the means to develop them. Goodwill is not a legal guarantee.” “Second, the pandemic agreement and its annex must not override our national laws. Namibia’s sovereign rights over its biological resources and the traditional knowledge of our communities must be protected in the text, not assumed but stated.” “Third, the rules of the laboratory network and the recognized databases must be agreed before the agreement enters into force. African laboratories must be partners in global science, not collection points for samples that enrich research conducted elsewhere.” Burkina Faso said the extension of the IGWG mandate was a positive sign, reflecting the collective will of Members to prioritize the credibility of the PABS Annex rather than seeking a hasty compromise. It added that the extended time is an opportunity to have a really operational text in line with the letter and spirit of Article 12. Burkina Faso also affirmed that access to PABS material and sequence information must remain inextricably linked to legally binding benefit-sharing provisions, and explained that standardized contractual provisions applicable to all users are the key to guaranteeing legal certainty and making sure that commitments are effective. Other participating delegations also called upon IGWG Members to consider the extended mandate as an opportunity. The EU said, “The Pandemic Agreement contains important provisions that may significantly enhance our collective capacity to confront pandemic emergencies. The PABS system has an important role to play in this context to better equip WHO to respond to emergencies and to support more equitable access to vaccines, therapeutics and diagnostics. To make this happen, we need to ensure that the system is truly conducive to enhancing the innovation in R&D that is vital for such medical countermeasures and can lead to broad participation by the private sector.” While the EU reaffirmed its commitment to equitable access, its emphasis on promoting innovation and broad private sector participation suggests that its negotiating position is being shaped primarily by the priorities of the pharmaceutical industry, rather than by the accountability and equity measures sought by developing countries. Discussions to amend negotiating modalities lead nowhere In order to expedite the process, several delegations sought to modify the modalities of the IGWG negotiations, but did not succeed in amending the modalities documents. There were proposals for adopting the PABS Annex text by vote, colour-coding of the text to reflect convergence and consensus, as well as for participation of all stakeholders in the drafting group sessions. These proposals were led by Colombia and Brazil. Colombia championed the idea of voting and some developing countries also extended support to Colombia’s proposal. However, there was a lack of broader support. Brazil suggested yellow-coloured marking for initial convergence on the text if the majority of the delegations agree to it (currently text is marked in yellow only after getting the initial agreement from everyone), and then marking the text in green to indicate final consensus. However, this proposal also did not receive full support. The EU expressed doubts about these proposals. Switzerland meanwhile wanted to change the modalities to bring textual inputs from the informal meetings to the formal drafting group. When the EU opposed the idea of voting and marking initial convergence based on majority agreement, Brazil asked whether the EU wanted to exercise veto power in WHO too. This did not, however, change the EU’s position. It continued to oppose not only voting but also the opening of drafting group sessions to stakeholders.
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