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TWN
Info Service on Health Issues (Nov25/02) PABS talks begin, “equal footing” & legal certainty to deliver equity stressed Geneva, 10 November 2025 (TWN*) – Text-based negotiations on the Pathogen Access and Benefit-Sharing (PABS) System began at the third meeting of the Intergovernmental Working Group (IGWG3), with calls for the text to reflect the “equal footing” principle and legal certainty in the provisions governing access and benefit sharing, consistent with Article 12 of the Pandemic Agreement. The IGWG met at the WHO headquarters in Geneva on 3 to 7 November 2025. In advance of IGWG3, the Bureau circulated “Draft PABS Annex text” (A/IGWG/3/3), in accordance with the mandate to initiate text-based negotiations. At the opening of IGWG3, WHO Director General, Dr Tedros Adhanom Ghebreyesus, commended the Bureau for its “genuine attempt to find as much middle ground as possible” in developing the draft text of the PABS Annex. He also urged Member States to find consensus as much as possible by the end of 2025 and not defer key aspects to next year. “I have a simple request for you: please get this done for our world, for all people in all countries. Finalizing the pandemic agreements annex is our collective promise to protect humanity. Because the next pandemic is not a question of if, but when. And we must be ready," said the Director General. In their opening statements, developing countries criticized the Bureau’s draft PABS Annex as inadequate, incomplete, and inconsistent with the Pandemic Agreement, noting that many of their earlier inputs were not fully reflected in the Bureau’s text. These countries were united in defending the “equal footing” principle between access and benefit sharing as the cornerstone of the PABS system. They stressed the need for a PABS Annex that is operational, legally binding on the recipients of PABS materials and sequence information, and capable of delivering equity, traceability, and legal certainty. Many countries emphasized that the system should not have gaps (that allow recipients to avoid their obligations under the PABs system), rejected voluntary or deferred approaches, insisting that all key elements must be finalized within the current negotiating process. [TWN has previously reported on some of the key concerns concerning the Bureau’s text which will affect the effectiveness of the PABS system.] On the opening day, the Bureau hesitated to engage in line-by-line, text-based negotiations. Indonesia, on behalf of the Group for Equity (GfE) representing 37 countries, called for line-by-line, on-screen text negotiations, a proposal strongly supported by the Africa Group and several developing countries. In contrast, Norway, speaking on behalf of Australia, Canada, Norway, Switzerland and the United Kingdom, expressed openness to “different modalities and smaller groups”. However, following repeated calls from developing country delegations, the meeting soon shifted to detailed text-based discussions, during which delegations proposed numerous additions and deletions. Indonesia on behalf of the GfE said that “the PABS Annex must detail the full operational aspects of the PABS System and provide legal certainty regarding the rights and obligations of the providers of PABS materials and sequence information, as well as various users of PABS System”. Indonesia added that “to deliver equity, the current draft requires substantial strengthening” and the inclusion of substantive inputs from GfE. GfE
made it clear that they do not “support deferring key elements of
the Annex to the COP (Conference of Parties to the Pandemic Agreement)”
and that it was “critical to pave the way for full, timely, and effective
operationalization of the PABS System, upon the Agreement’s entry
into force”. “It
is also important that we do not backtrack from what we have agreed
in Article 12, including on a clear linkage between access and benefit
sharing, an equal footing relation between the two, provisions that
provide modalities, legal certainty, operational dimensions, and benefit
sharing outside the scope of Article 12.6, as well as the administration
of PABS System,” the Group emphasised. GfE called for “constructive engagement” “to operationalize Articles 12.7 and 12.8 (of the Pandemic Agreement), covering also mandatory and meaningful benefit sharing by different types of users”, emphasizing the “importance of benefit sharing that fosters geographically diversified local production, including through non-exclusive licenses to manufacturers in developing countries”. [Article 12.6 of Pandemic Agreement provides for access to vaccines, therapeutics and diagnostics (VTDs) as a benefit during pandemic emergencies. Article 12.7 however provides for the same during a public health emergency of international concern (PHEIC). Article 12.8 deals with other benefit sharing obligations including for access to VTDs to prevent PHEIC and manufacturing licensing for developing countries.] The Group said that a “standardized PABS contract will not only set out benefit sharing commitments, but also terms of access, use, and other general obligations. Access would be granted only upon the acceptance of these terms and conditions. Many of us have put forward key elements to be included, including terms and conditions on onward sharing, prohibition against claiming intellectual property rights over PABS Materials and Sequence Information, and compliance with COP decisions”. GfE also stressed that the “PABS System has to be safe, accountable, and transparent”, as well as “ensure respect for countries' sovereign right over their genetic resources, prevent free-riding, and foster trust in the System”. “Traceability
shall be an integral component of the System, and this cannot be limited
to PABS Materials”, GfE stated, highlighting the importance of unique
persistent identifiers that link the PABS sequence information to
the PABS material and to its originating laboratory, user registration
and identification, to build an accountable PABS System . Tunisia, on behalf of the Eastern Mediterranean Region (EMRO), echoed that the PABS can be “implemented immediately upon the entry into force of the Agreement", but highlighted the need for “strengthening clarity, coherence, and trust in the system by ensuring that the provisions of Article 12 are translated into practical modalities”. EMRO stressed that the IGWG should avoid “reopening of settled political issues, particularly the principle of equal footing between access and benefit-sharing, which remains a cornerstone of consensus under article 12”. It added that “the Annex should include practical measures – such as unique identifiers, user registration, and tracking of transfers – to ensure responsible use of materials and data, protect national ownership and maintain confidence among all parties” across the inter-pandemic period, during a PHEIC and a pandemic. Zimbabwe, on behalf of the Africa Group representing 47 Members, said “equity cannot remain aspirational language, it must be operational, enforceable and guaranteed to avoid the inequities of COVID-19” adding that “All flow of material and sequence information must go exclusively through the PABS System, any loopholes may undermine trust and deny developing countries fair access to life-saving tools”. Zimbabwe further said that “voluntary commitments and discretionary language are not sufficient” and “A PABS System that lacks enforceability becomes a charitable model and charity is not equity.” South Africa aligned itself with the statements by the Africa Group and the Group for Equity, adding its voice to the protest of not seeing their inputs reflected. “Member States requested the Bureau to use the submissions and outcomes of IGWG2 discussions and Informal session to develop a draft negotiation document, in preparation of the IGWG3. However, the draft which was received on 24 October 2025 in our respectful view, falls short of our expectations in terms of giving us clear foundations to the PABS System we are building”. South Africa stressed “The draft needs to be upfront with registration of all Users of the system, clarifying how sharing will be done, give specifics on obligation from Users including manufacturers during the three phases i.e. peace time, when [a PHEIC] is declared and during pandemic; important aspect will be for the IGWG3 to agree on a structure as the current draft is unbalanced, with partners given access to materials without obligations, legally binding contracts or traceability mechanism”. The Central African Republic (CAR) referred to the confusion and lack of clarity of the draft text. It stressed that it was important to specify the sequence of procedures that is envisaged. CAR questioned what precise procedure would have to be followed when you want to get information and resources from PABS, pointing to provisions in the Bureau’s text referring to notification of legally binding benefit sharing obligations and WHO PABS contracts. Understanding what happens and when is very important in order to reduce administrative complexity and burdens, CAR added. It strongly called for the need for legal guarantees for access to VTDs not only in periods of pandemic, but also when there are emerging pandemic threats. Ethiopia, aligning with the GfE and Africa Group statements, stated: “It is crucial to ensure accountability of the system for both access and benefit sharing requirements: clear and upfront expectations and enforcement modalities will allow for greater success, less ambiguity and future dispute. We suggest that early standardization will be desirable instead of leaving the details for future consideration by the Conference of the Parties. It is also important that the text provides guarantees that the system delivers not only during Pandemic Emergencies but also during PHEIC and inter-pandemic times. This is absolutely critical to build a trusted ecosystem that further incentivizes rapid and timely sharing of PABS materials and sequence information”. Brazil rejected the imbalance between obligations regarding access and benefit-sharing, saying “This imbalance must be corrected … One cannot exist without the other”. It called for clarity in operationalizing benefit-sharing not only during pandemics, but in between pandemics and also during PHEICs through the form of “detailed provisions on monetary contributions, capacity building, technology empowerment, licensing, and local and regional production". Responding to statements by developed countries that the PABS System should not disturb the current system, Brazil said: “We're not here to preserve the status quo. The system that some want to keep unchanged is the very system that during the last pandemics allowed a few countries to stockpile and waste hundreds of millions of vaccines, while numerous countries were still begging for access. It is the strengthening of global capacity, not its concentration or the safeguarding of charity that will truly help prevent the next pandemic”. Namibia evoked the stark inequalities of the past and the present stating "Namibia represents a people who survived colonialism, fought apartheid, and now refuse medical apartheid, disguised as global health governance”. It said that while it “approaches these negotiations with flexibility, but not on principles. We cannot afford another system built on promises that fail in practice” adding that “binding automatic and enforceable benefit-sharing obligations are the cornerstone of the pathogen access and benefit-sharing system. Every user, every access, every time, this must be the principle that anchors trust and global solidarity. Predictable access requires predictable benefits”. Malaysia also criticized the backtracking in the Bureau's text: “As it currently stands, the Bureau’s text does not yet meet the criteria of a PABS system that is safe, transparent, and accountable to Member States”. “Negotiations should build upon proven practices rather than reopen or weaken principles that have already demonstrated their effectiveness. Lessons from the PIP Framework, a model previously negotiated and accepted, offer valuable insights that should guide improvements – not regressions that risk delaying consensus", Malaysia said, also citing a tracking mechanism, unique persistent identifiers, and user registration to establish a “robust and accountable PABS System". [The PIP Framework is the WHO Pandemic Influenza Preparedness Framework was adopted in 2011 and has a functioning access and benefit sharing regime.] Malaysia further called for clarity on the “terms of use” with regards to sharing materials with the WHO-Coordinated Laboratory Network (WCLN) and outside WCLN and for sequence information, to define “how recipients may use such materials or data, and under what conditions further transfer may occur. This clarity is essential to maintain accountability throughout the system. Such accountability is already standard in data-sharing agreements". India aligned itself with the Group of Equity statement and emphasized calls for transparency across the process. “All stages—from pathogen data submission and sequence sharing to product development and benefit distribution—should be subject to adequate provisions for ensuring accountability for all parties involved, through a robust traceability mechanism,” India said. It further added that accountability must be applied across actors, providers of biological materials, developers and manufacturers: “(they) should have a legally binding duty to ensure fair access and benefit distribution. Such obligations should be clearly codified through standardized contracts within the PABS Annex itself and linked to access to pathogen data as a condition of participation”. India also said that the PABS System “will only be credible and effective if it operates as a mutual contract of responsibility—one where the providers of materials and the beneficiaries of innovation are held to the same high standards of fairness, openness, and accountability”. Nepal echoed the calls of the Group for Equity for balance between access and benefit-sharing, stating “With obligatory provisions on access part, and voluntary elements on benefit part, what we have is an unbalanced text. Operational aspects of many benefits are missing and lack legal certainty”. It also argued against deferring key aspects, stating “While the current draft has said that all elements of the PABS system shall come into operation simultaneously, a natural question arises regarding the way the zero draft has parked discussions on certain elements such as model terms and conditions to the first session of the COP”. Iran aligning with Group for Equity and EMRO said, “… beyond material benefits, [it] is fundamentally about promoting international public health and upholding our shared commitment to the highest attainable standard of health, and by fulfilling the right to health and the right to development”. Bangladesh called for the establishment of a WHO Database to ensure traceability in PABS. It said “We underscore the importance of traceability systems for PABS materials and sequence information to enhance transparency and trust among Member States. Any global system for data sharing must ensure transparency, data protection, and mutual accountability. A WHO PABS database can address the transparency, accountability issues while boosting the trust and confidence of the wider WHO Member States”. In contrast, the European Union, representing 27 Member States, took the side of the industry and emphasized that the system must remain attractive to private stakeholders, arguing that an effective PABS should “encourage, as opposed to compel or coerce, manufacturers to participate by voluntarily signing benefit-sharing contracts.” The EU also said that the PABS Annex must “incentivize participation of manufacturers of VTDs and contribute to better equipping the WHO and other international partners to prevent, prepare for, and swiftly and equitably respond to future pandemic emergencies, and a system that will foster researchers' and manufacturers' ability to rapidly develop vital countermeasures in the event of an international health emergency”. Norway, on behalf of Australia, Canada, Norway, Switzerland and the UK, noted that extensive traceability requirements “will influence the priorities and decisions of researchers, institutions, and companies”. Several delegations raised the issue of open science and data sharing. The Africa Group noted that “principles of open science must be upheld but never at the cost of fairness and sovereign rights.” Similarly, Iran reaffirmed that “the sovereign right of States over their biological resources must remain the backbone of the entire PABS system.” Across interventions, developing countries reiterated the principle of equity as central and that it should not remain aspirational. As Malaysia concluded, “The world is watching to see whether we will succeed in establishing a PABS system that upholds the principle of equity, or whether we will permit it to perpetuate inequities that marginalize those who contribute essential knowledge and materials yet remain excluded from access to the resulting products”.+ *By Rajnia de Vito, Sangeeta Shashikant and Nithin Ramakrishnan
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