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Info Service on Intellectual Property Issues (Mar26/01) London/Kochi, 12 March 2026 (Sangeeta Shashikant and Nithin Ramakrishnan): A new draft negotiating text dated 9th March for the Pathogen Access and Benefit Sharing (PABS) Annex to the Pandemic Agreement is strikingly aligned with the positions of the G6 countries — the European Union and other developed countries. The draft was prepared and circulated by the Bureau of the Intergovernmental Working Group (IGWG) at the World Health Organization. The draft, which promotes greater legal uncertainty, is weak in benefit-sharing, and effectively normalises biopiracy, should be of serious concern to developing countries. The text barely contains the key elements needed to be consistent with the objectives of the Convention on Biological Diversity (CBD) and its Nagoya Protocol on Access and Benefit-sharing. Instead, it risks establishing the PABS system as a precedent that could undermine multilateral access and benefit-sharing frameworks globally. Ironically, the proposed PABS system — which was meant to be the core mechanism of the Pandemic Agreement to ensure predictable and meaningful benefit-sharing — has been weaponised to create a mechanism of systematic exploitation of developing countries. The draft imposes mandatory obligations on countries to share pathogen samples and genetic sequence information yet pays little attention to the repeated demands by developing countries for accountability, safeguards, and equitable benefit-sharing. In an email to IGWG Member States, the Bureau explained that it will reach out widely in the coming days to informally discuss its proposals for the draft PABS Annex with IGWG members, with the aim of moving the negotiations toward agreement at the 6th meeting of the IGWG. The Bureau also noted that the draft text has been circulated informally in a “clean text” format. This means there are no annotations indicating what has been modified or deleted compared with the previous version (IGWG5 negotiating text as at 10.50 CET on 14 February 2026). Under the guise of facilitating progress, textual proposals from developing countries — many of which were repeatedly inserted into earlier drafts — have simply been removed, as if they had never been proposed. At the same time, the approach consistently advocated by the EU and other G6 countries has largely been preserved. Evidently, the Bureau has chosen to flip the negotiations against the interests of developing countries. By circulating a clean text without markings, it becomes far more difficult for delegations to identify what has been removed or retained. The Bureau and the WHO Secretariat appear to be relying on this opacity to minimise resistance and accelerate conclusion of the negotiations. Meanwhile, the EU, Norway and other developed countries can remain comfortable, appear to oppose, although much of what is in the Bureau’s draft is probably what they can live with, leaving developing countries to fight an uphill battle to restore balance to the negotiations. In effect, the Bureau’s proposals have been developed as if the extensive textual suggestions made by developing countries during the entire IGWG5 meeting never existed. The Bureau’s text has 3 parts. Part I is on “scope, objectives and use of terms”; Part II is on “Implementation of the PABs System. This is divided in 3 sections: “A. Operation of the PABS System”; “B. Access to PABS Materials and Sequence Information” and “C. PABS System benefit-sharing”. Part III is “Governance and review of the PABS System”. In Part II section A, the Bureau’s text says that the participants of the PABS system includes WHO Coordinated Laboratory Network (WCLN), WHO recognised sequence databases (WRSD); entities utilizing PABS Material and Sequence Information (PMSI) for commercial purposes and entities using PMSI for non-commercial purposes. Importantly, the text fails to define the boundary between non-commercial and commercial use, a gap that could generate significant legal uncertainty in the implementation of the PABS system. Section B elaborates on the obligation of a Party to share PMSI (sub-section B1); terms and conditions applicable to laboratories within WCLN (B2) and terms and conditions applicable to WRSD (B3). Section C outlines the benefit sharing obligations of participating manufacturers, entities using PMSI for commercial and non-commercial use. Benefit Sharing Developed countries have resisted any attempt to pre-determine and reflect in the text with specificity, benefits to be shared under the PABS system. Instead, they prefer benefits to be mentioned in a general, broad manner, with a menu of options and to leave the issue entirely up to bilateral negotiations between WHO and the users. It is thus no surprise that the Bureau has deviated from the mandate in Article 12.7 and 12.8 of the Pandemic Agreement (PA) which clearly states that the “PABS Instrument shall also include benefit sharing provisions”, “including options”. Yet as with previous Bureau drafts, the benefit sharing section is consistently limited to mere repetition of Articles 12.7 and 12.8 of the PA. On the other hand, following the PA mandate, in relation to Article 12.7 on benefit sharing during a public health emergency of international concern (PHEIC), developing countries have during IGWG5 and even before proposed text seeking pre-determined defined benefits. However none of their proposals are retained. For instance, developing countries have proposed text as follows: “[Reserve for] WHO at least 20% of real-time production of safe, quality and effective vaccines, therapeutics and diagnostics for the pathogen causing PHEIC (or of the stocks in the inventory, in case of no real-time production) and make available to WHO, on its request, at least 8% [10%] of real-time production free of charge and the remaining 12% [10%] at not-for-profit prices.]” “In the event of a public health emergency of international concern, in accordance with Article 12.7, Participating Manufacturers shall provide the following benefits: (i) agrees to provide promptly and on a priority basis to WHO, on its request, adequate supplies of vaccines, therapeutics and diagnostics for the pathogen causing public health emergencies of international concern, at affordable prices, based on needs assessed by the IHR emergency committee. (ii) granting of non-exclusive licenses for vaccines, therapeutics, and diagnostics for the pathogen causing the public health emergency of international concern;…” The specific proposals above are not reproduced in the Bureau’s text, which instead opts to reproduce Article 12.7 in a manner that shapes the benefit into options that a Participating Manufacturer can consider providing as it deems fit. The Bureau’s text states in Section C1 reads: “(b) In the event of a public health emergency of international concern, in accordance with Article 12.7, Participating Manufacturers shall implement benefit-sharing provisions, including options regarding access to safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the public health emergency of international concern, such as agreeing to provide, where available, promptly and on a priority basis to WHO on its request, such products at affordable prices, based on needs assessed by WHO. ” Developing countries have repeatedly emphasized that Articles 12.7 and 12.8 of the PA should not be interpreted as merely requiring the presentation of benefit-sharing options. Rather, these provisions envisage the inclusion of concrete benefit-sharing measures within the PABS framework. Even WHO’s Legal Office has clarified that benefit sharing under Articles 12.7 and 12.8 is not limited to options alone. Nevertheless, the Bureau’s draft text fails to reflect this interpretation and pays no meaningful attention to these clarifications. Similarly in operationalizing benefit-sharing required by Article 12.8 of the PA, the Bureau’s text again just mostly reproduces Article 12.8 of the PA. The following text proposals of developing countries were also discarded by the Bureau: “[2bis. In case the entity mentioned in para 2 is a developer of vaccines, therapeutics and diagnostics for pathogens with pandemic potential, it shall, in addition to benefits provided under Paragraph 2, grant to WHO non-exclusive, royalty-free, worldwide licenses, taking into account licenses that can be sublicensed to manufacturers in developing countries on standard terms and conditions, ensuring equitable geographic distribution and in accordance with sound public health principles, for the development, production and supply of vaccines, therapeutics, or diagnostics relevant to a public health emergency of international concern or a pandemic emergency, and during the inter-pandemic period in developing countries. These licenses shall continue to apply in the event that a pandemic emergency is declared.]” “Where a Party adopts measures affecting the export of pandemic-related health products, such measures shall not apply to quantities committed to or allocated through the PABS System, which shall be granted priority clearance and shipment.” With respect to sharing of monetary benefits, the Bureau’s draft text requires participating manufacturers (Section C1) and entities utilizing PMSI for commercial use (Section C2) to: “provide monetary benefits, including annual monetary contributions based on objective, transparent and measurable criteria, and taking into account their use of PABS Materials and Sequence Information as well as their nature and capacity;…” The proposed text lacks clarity as to who will establish the criteria and when this will be. Suggestion from developing countries that annual monetary contributions should be based on percentage of revenue generated, has been sidelined. Terms & Conditions vs Contracts A straightforward practical proposal from developing countries was that PABS Material and PMSI can only be transferred to entities that have accepted an enforceable contract with WHO, which would elaborate on the terms and conditions of using PMSI including fair and equitable benefit sharing. In December 2025, more than 80 developing countries (Africa Group, Group for Equity, Sudan, Egypt, Libya, Somalia) presented 3 standard contracts to the IGWG that would apply to the recipient, be it a laboratory within the WHO-Coordinated Laboratory Network (WCLN), or a third party seeking access to PMSI. Standard contracts are the core mechanism in any functional ABS regime linking access and benefit sharing. Standard contracts are the foundation on which 15 years of WHO’s Pandemic Influenza Preparedness (PIP) Framework has operated, for sharing influenza viruses of pandemic potential and benefit sharing on an equal footing. Internationally as well as domestically such contracts govern access and benefit sharing of biological materials and related data. The EU Regulation No. 511/2014 implementing the Nagoya Protocol itself recognizes “contractual arrangements” as necessary to set out specific conditions for utilization of the shared resources including fair and equitable benefit sharing. Universities, bio-banks around the world use such a model. And at IGWG5 (as in previous IGWG sessions) the importance of contracts was emphasized by the majority of WHO’s membership. Accordingly, developing countries added to the negotiation text, references to “contracts” and “legally binding terms and conditions in a contract with WHO” for recipients of PMSI including laboratories within WCLN, sequence databases, entities using for commercial and non-commercial use. G6 led by the EU was against the use of contracts when sharing PMSI for almost all recipients except for participating manufacturers, who they say may enter into a WHO PABS Contract with WHO. Accommodating the G6’s needs, in the draft text the Bureau has deleted all references to contracts placed by developing countries with respect to WCLN laboratories, WRSD, and individuals and entities using PMSI for non-commercial purpose. For this category of participants, the Bureau’s text says they would have “agreed to terms and conditions” that apply to their category. But these terms and conditions are not legally binding. The Annex is not legally binding on these categories of participants, as a Treaty can only bind Parties. In the Bureau text, contract is only mentioned in relation to the participant that are “entities utilizing PMSI for commercial purposes that have entered into legally binding WHO PABS Contracts”. There is however no indication that these contracts will be with WHO and that the terms will be standardised. There is a clear distinction in the Bureau’s text, between WHO PABS Contracts applied to a participant that are “entities utilizing PMSI for commercial purposes” and “agreed” “terms and conditions” applied to other participants (WCLN, WRSD and entities using for non-commercial purposes). Obviously, the intent is to distinguish between those two categories – one with contracts and the other without. The Bureau may argue that the WHO Director-General has been given the right to suspend or revoke the WHO recognition/designation in the part on Governance. However, that would only apply to the WCLN laboratories and sequence databases and not to the entities using PMSI for non-commercial purposes, for whom as highlighted above, the Bureau’s text mentions “agreed” “terms and conditions”. In the absence of a contractual framework, such terms and conditions lack legal enforceability. The draft text is silent on what happens to PMSI already shared if WHO recognition or designation is revoked. For example, it does not address whether such PMSI must be repatriated or destroyed, nor does it clarify the consequences if a recognised laboratory or database refuses to comply. These gaps underscore the importance of ensuring that all relationships are anchored in enforceable contracts. WHO-Coordinated Laboratory Network (WCLN) WCLN remains undefined in the Bureau’s text, a “black box” despite many discussions in formal and informal settings during IGWG meetings and inter-sessionally. In January 2026, prior to the resumed session of IGWG4, the Secretariat circulated “Guiding Elements for the Development of Terms of Reference for the WHO Coordinated Laboratory Network to facilitate PABS system”. In the midst of IGWG5, the Secretariat circulated a concept note which contained a list of at least 15 existing networks established between 1952 and 2024 relevant for pathogens with epidemic and pandemic potential as well as a list of laboratories involved in WHO’s R&D Blueprint on priority pathogens. And yet in the latest Bureau text, it remains an opaque concept. Previous versions of the Bureau’s text made mention of Terms of Reference of the WCLN labs. The report of IGWG5 also “requested the Secretariat to provide further technical information and to prepare draft terms of reference for the WHO-Coordinated Laboratory Network”, however there is no mention of ToR for WCLN laboratories in the text. During the IGWG5 discussion, the WHO Secretariat proposed that WCLN be structured as a “Network of networks”, a move that appears designed to preserve the existing architecture of numerous laboratory networks and affiliated institutions. Information circulated by WHO provided little clarity on the specific participants within these networks, while indicating that several of them involve very large memberships. A cursory review shows that these networks have wide-ranging participation, including various types of non-state actors such as business associations. For example, the Global Outbreak Alert and Response Network involves more than 300 technical partner institutions within this arrangement, including those engaged in commercial activities such as patenting. For instance, the Chan Zuckerberg Biohub, while presenting itself as a non-profit, engages in patenting its discoveries and technologies, often in collaboration with partner universities, with the aim to bring them to market. Hence while it is a not-for-profit entity, it engages in commercial use. The International Pathogen Surveillance Network membership consists of representatives from governmental organizations, intergovernmental organizations, non-governmental organizations, academic institutions, private sector business associations and philanthropic foundations. Its website further states that it engages with 366 active partner organizations which include 268 formal member organizations. In this context, agreeing to WCLN without defining it is risky. It will be left to the WHO Secretariat to define and given the vastness of existing networks, entities using the PABS system for commercial and non-commercial use may be considered as WCLN labs and consequently bypass all benefit sharing obligations in Section C of the Bureau’s text. In the absence of an agreed definition of WCLN, the line between WCLN labs, entities for commercial and non-commercial use will be blurred, and benefit-sharing easily evaded. WHO Recognized Sequence Databases (WRSD) The Bureau’s text on WRSD totally ignores the proposals from the developing countries from IGWG5 or even prior to the IGWG5 from the Bureau’s text itself. Even notes which record the status of negotiation have been removed. Developing countries had proposed that sequence databases be recognized by WHO only if they implement user registration, identity verification, and data access agreements for access to PABS sequence information, alongside the establishment and management of a WHO PABS database. While the concept of WRSD initially saw some convergence among Parties, consensus was not reached on the criteria and process for recognition, as the EU, Norway and other developed country allies consistently resisted these proposals without providing satisfactory justifications. During IGWG5, a note was attached to the chapeau of paragraph 3 of Section II.B, which addressed the terms and conditions applicable to WRSDs. It stated: “Note: without prejudice to further discussion of a possible WHO PABS database and the process for recognition of WHO-recognized sequence databases.” This note has now been removed from the latest Bureau’s draft text, thereby misrepresenting the actual state of negotiations. The current draft no longer mentions the possibility of a WHO database or the process for recognizing databases. Developing countries have consistently stressed the need for a contractual relationship between WRSDs and WHO, yet this requirement is absent from the Bureau’s text. A textual proposal from IGWG5 states: “WHO recognized sequence databases shall sign a binding agreement with WHO committing to: (i) implement and enforce all requirements; (ii) respect sovereignty of provider countries, including compliance with any access conditions specified; (iii) maintain transparent records of all data access, with such records available to provider countries upon request; (iv) immediately suspend access for violators; and (v) report annually to the PABS Coordinating Body.” Another proposal sought to mandate WRSD: “to require users of PABS Sequence Information to commit through a Data Access Agreement, prior to access, to: (i) appropriately acknowledge use in presentations and publications; (ii) acknowledge contributions of collaborators, including laboratories/countries providing PMSI; (iii) fulfill all benefit-sharing obligations; and (iv) not claim intellectual property rights over PABS Material and Sequence Information, including derivatives and modifications thereof.” Unfortunately, these proposals have not been reflected in the Bureau’s text. Countries such as Malaysia, Pakistan and South Africa have also called for the inclusion of the phrase “legally binding” before “terms and conditions” that WRSDs must agree to. This request has not been incorporated into the Bureau’s draft. The Bureau’s draft text as at 9th March simply reads : “The terms and conditions applicable to WHO recognized sequence databases for sharing of PABS Sequence Information shall require those databases to, inter alia:… (g). notify users of the requirements in Section A.6, and that utilization of PABS Sequence Information entails commitment to enter into a WHO PABS Contract or agree to terms and conditions as described in Section C.1, C.2, and C.3, as applicable; (i) notify users that failure to comply with the applicable terms and conditions and/or WHO PABS Contract may result in denial, suspension or termination of access to PABS Sequence Information, where applicable.” The Bureau’s suggestion is aligned with the G6 countries. It means that WRSDs do not have to implement systems that require user registration, verification and conclusion of PABS agreed data access agreement. So the Bureau is proposing (just like the G6 countries want) that Parties undertake an obligation to share PABS Sequence Information, while those who access such information will only be notified of PABS requirements but having no contractual obligation to comply with the terms of use of the PABS system and to provide benefit-sharing. Moreover, it is a bit of trickery by the Bureau to suggest that there is possibility of denial, suspension or termination. If the identity of the user is unknown, how will a sequence database deny, suspend or terminate access. Further, if there is no contractual obligation imposed on the user, how can the obligations be enforced by the database, and what happens to the sequences the user has accessed. A user can also hop onto another database that provides anonymous access. The Bureau text also creates confusion. The section on terms to be agreed by WRSD includes paragraph 3(f): “… enable the reporting of and preserve information on data provenance, including the country of origin and laboratory which generated the PABS Sequence Information”. The text as drafted suggests that the country of origin of the sequence information is the one that generates the data and not necessarily the one that shared the pathogen material. Such text is especially disadvantageous to less well-resourced developing countries or smaller nations that depend on better equipped laboratories in more advanced countries to generate the sequence information. On sequence information, the Bureau’s text also overlooks a critical issue: once PABS Materials are shared by a provider country with a WCLN laboratory—and subsequently transferred onward—what rules govern the sequence information generated from those materials by WCLN laboratories or other downstream entities? While a provider country may choose to upload the sequences it generates to a WRSD that implements user registration and data access agreement (DAA), subsequent recipients of PABS Materials who generate sequence information may choose to deposit those sequences in databases that do not require user registration or a DAA. This would effectively undermine the rights and safeguards sought by the provider country, as sequence information derived from the original materials could circulate freely outside the PABS framework. Such a concern would not arise if WRSD were limited to those that implement mandatory user registration and PABS agreed DAA, thereby ensuring that all users accessing or sharing PABS sequence information remain identifiable and subject to the same obligations of the PABS system. Limited Restrictions on Onward Transfer of PABS Materials & Sequence Information The proposed Bureau text is also riddled with major loopholes. One particular worrying loophole is due to inadequate provisions governing the onward transfer of PMSI. Section B1(a) states that the provider country shall share PABS Materials with “one or more WCLN laboratories of the Party’s choice” and upload PABS Sequence Information, “as soon as available, on a priority basis, to one or more WHO-recognised sequence databases of the Party’s choice.” It further provides in Section B1(b) that the provider country “agree to onward transfer and use of PABS Materials and Sequence Information, in line with the applicable terms and conditions”. Once a WCLN laboratory receives PABS Materials, the Bureau’s text allows it to transfer those materials outside the WCLN, subject to the requirements in Section A6. However, Section A6 offers no meaningful safeguards. Sub-section (c) merely requires recipients to “comply with applicable provisions regarding onward transfer of PABS Material”. The draft text fails to clarify what these “applicable provisions” are, leaving the scope of onward transfer essentially undefined. This creates a serious loophole in the PABS system. For example, an academic institution or biobank outside the WCLN could obtain PABS Materials from a WCLN laboratory and subsequently transfer them to other entities—whether for commercial or non-commercial purposes—without such other entities undertaking commitments under the PABS system. WHO would also not have any knowledge of transfers outside of the academic institution or biobank. On onward transfer of PABS materials, the Bureau’s text departs even from the WHO PIP Framework which in every standard material transfer agreement (SMTA) of PIP biological material clarifies that transfers of materials within and outside the Global Influenza Surveillance and Response system can only happen if the prospective recipients have concluded the relevant SMTA. Similar gaps exist with respect to PABS Sequence Information. There are no meaningful limits on onward transfer. Section B3 states that once sequence information is hosted in a WRSD, onward sharing will be governed by the hosting database’s own policies. With the exception of GISAID, which requires that onward transfer to third parties occur on the same terms as its DAA, most sequence databases—primarily based in developed countries—do not impose comparable restrictions and as discussed above also do not have user registration and DAA. As a result, any user may access sequences and further disseminate sequence information without any obligation to comply with the PABS system or provide fair and equitable benefit-sharing. These gaps in the proposed PABS framework, combined with the absence of mandatory user registration and data access agreements for WRSDs, would create a system in which PABS Materials and Sequence Information can circulate widely without traceability, accountability, or enforceable benefit-sharing commitments. Further, the idea of a PABS tracking mechanism, put forward by the developing countries has been dropped from Bureau’s text. Instead, it proposes “notify WHO of onward transfers of PAB Materials, both within and outside the WCLN”. Notification is not equivalent to a transparent, publicly accessible PABS tracking mechanism. WHO’s PIP Framework does have an influenza virus tracking mechanism which shows the flow of PIP biological materials from the provider countries, and onwards. Intellectual Property: Expansive Scope for Private Appropriation On the issue of intellectual property (IP), the Bureau’s text largely reflects what the EU and G6 countries appear willing to accept. Section A6(f) states that participants shall “not claim any intellectual property rights over the PABS Materials and Sequence Information, or their genetic parts or components, in the form received from the PABS system.” However, this provision is extremely limited in scope. While the PABS system requires provider countries to set aside their sovereign rights and national access and benefit-sharing (ABS) rules in order to facilitate the rapid sharing of PMSI, the Bureau’s text leaves ample room for private entities or individuals to appropriate these shared resources through the IP system. In practice, the proposed language allows recipients to claim IP over derivatives, modified versions, components, or outcomes arising from the use of PMSI, thereby enabling the creation of private monopolies over products/processes ultimately derived from shared public resources. This approach is particularly troubling given the widespread controversy surrounding IP protections during the COVID-19 pandemic, when many developing countries called for a waiver of certain obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in order to facilitate broader rapid access to vaccines, therapeutics, and diagnostics. In light of these experiences, the Bureau’s text should have explored more public-interest-oriented approaches to the treatment of IP, rather than preserving broad space for the assertion of exclusive rights over innovations derived from shared pathogen materials and sequence information. Notably proposals from developing countries to “agree not to claim intellectual property rights on PABS Materials and Sequence Information of parts thereof in any form, including any modified form or for any use” have been disregarded by the Bureau. The Bureau’s text also does not address the treatment of IP with respect to entities using PMSI for commercial purposes vis-à-vis other categories of participants, such as WCLN laboratories designated to support less-equipped laboratories, and participants engaged in non-commercial use. In practice, non-commercial use does not typically involve the pursuit of IP such as patents. And it is common for Material Transfer Agreements in developed countries to state that any claim of IP shall be treated as a commercial use and subject to terms and conditions applicable to such use. However, the Bureau’s draft provides no safeguards to prevent the subsequent appropriation of PMSI or related outputs through IP claims, even where the access occurred under the premise of non-commercial use. Overall – Bureau’s Draft Text Fails the Equity Test To realize the objective of equity, the PABS system was intended to be built, among other things, on the principles of transparency, accountability, legal certainty, and an “equal footing” between access and benefit-sharing. However, as the analysis above demonstrates, the Bureau’s draft text falls short on all these counts. With its numerous flaws, loopholes, and omissions, the proposed framework risks creating a system that facilitates free riding. In its current form, the text leaves significant gaps in areas such as enforceable obligations, traceability of users, regulation of onward transfers, and safeguards against the appropriation of shared pathogen materials and sequence information through intellectual property claims. Instead of ensuring fair and equitable benefit sharing, the draft risks enabling the exploitation and misappropriation—amounting to biopiracy—of shared resources within the very system meant to govern them. If adopted in its present form, the PABS system could institutionalize asymmetries between those who provide pathogen materials/sequences and those who ultimately derive commercial and technological benefits from them. Unless these structural deficiencies are addressed, the proposed PABS system risks entrenching existing inequities rather than correcting them, ultimately undermining both the credibility of the Pandemic Agreement and the global cooperation needed to respond to future pandemics.
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