The PABS system under the pandemic agreement: Current status, controversies in negotiations, and future trends

Highlights

• •The article identifies three key deadlocks in PABS negotiations: scope, benefit-sharing, and governance.
• •The analysis examines the 20% VTDs commitment and unresolved allocation challenges.
• •The study highlights the need for clearer definitions and stronger oversight mechanisms.

Abstract

The World Health Organization (WHO) Pathogen Access and Benefit-Sharing (PABS) system, established under Article 12 of the WHO Pandemic Agreement, aims to promote timely sharing of pathogen materials and sequence information with pandemic potential while ensuring fair and equitable benefit-sharing. Proposed in response to inequities exposed during the coronavirus disease 2019 (COVID-19) pandemic and limitations in existing arrangements, the PABS annex remains under negotiation within the Intergovernmental Working Group. This article analyses the institutional background, core design, and key areas of contention in the PABS system. It highlights three challenges: Defining key terms and scope, designing benefit-sharing and allocation mechanisms, and establishing operational and governance arrangements. It also proposes recommendations to strengthen clarity, feasibility, and institutional coherence for pandemic preparedness and response.

On 20 May 2025, the World Health Assembly (WHA), through resolution WHA78.1, adopted the World Health Organization Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and Response (the Pandemic Agreement), following more than three years of negotiations [1]. The Agreement establishes a set of principles, priorities, and objectives for pandemic prevention, preparedness, and response, with the aim of ensuring equitable access to pandemic-related health products and strengthening collective capacity to prevent and respond to future pandemics in a more coordinated and effective manner.

However, consensus has not yet been reached on the content of the annex to Article 12 of the Pandemic Agreement, which is intended to establish a multilateral Pathogen Access and Benefit-Sharing (PABS) system. Negotiations on the PABS annex remain ongoing. The annex is being developed under the auspices of an Intergovernmental Working Group (IGWG), which is responsible for drafting and coordinating discussions on its detailed provisions. The operational rules and implementation modalities of the PABS system will continue to be negotiated through subsequent intergovernmental processes.

Drawing on relevant legal, policy, and negotiating materials, including draft annex texts, World Health Organization (WHO) progress documents, and proposals submitted by Member States [2], this study systematically examines the background, core architecture, and key challenges of the emerging PABS system. It further proposes analytical considerations and policy-oriented recommendations, with the aim of contributing to ongoing scholarly discussion and policy exploration surrounding the design and implementation of the PABS system.

1. Background and necessity of the PABS system

1.1. Addressing the global challenge of transboundary pandemics

Since the beginning of the 21^st century, the world has experienced a series of major infectious disease outbreaks, including severe acute respiratory syndrome (SARS), human infection with avian influenza A (H7N9), Middle East respiratory syndrome (MERS), Ebola virus disease, Zika virus disease, and mpox [3]. Pandemics transcend national borders, and all countries may be affected either directly or indirectly, as pathogens can spread rapidly across regions without regard to territorial boundaries [4]. Experience from global outbreak responses has demonstrated that the sharing of pathogen samples and genetic sequence data among laboratories, governments, and pharmaceutical companies plays a critical role in epidemiological surveillance and in the development of vaccines, therapeutics, and diagnostics [5].

In June 2024, the WHO released an updated scientific framework for pathogen prioritization, identifying priority pathogens [6], prototype pathogens, and so-called “Disease X”, referring to an as-yet-unknown pathogen with the potential to cause a future public health emergency of international concern (PHEIC) or pandemic [7]. Disease X is characterized by features such as high transmissibility, limited population immunity, the potential for cross-species transmission, and high pathogenicity, which together make its emergence and spread difficult to predict using existing pathogen-specific preparedness approaches [8].

Against this background, the rationale for establishing the PABS system lies in creating a multilateral mechanism that enables the rapid, timely, and standardized sharing of pathogen materials and sequence information. By requiring such materials and data to be submitted to a coordinated PABS sequence database and laboratory network, the system aims to support cross-border surveillance, early warning, and variant monitoring, thereby strengthening global capacity to detect and respond to emerging threats and reducing the risk of uncontrolled epidemic or pandemic spread.

1.2. Correcting inequities in access to VTDs during past pandemics

Previous pandemics exposed profound structural inequities in global access to vaccines, therapeutics, and diagnostics (VTDs). During the coronavirus disease 2019 (COVID-19) response, some countries, supported by strong fiscal capacity and control over supply chains, secured early and abundant access to VTDs [9]. In several cases, vaccine stockpiles far exceeded domestic needs, with some countries acquiring quantities equivalent to approximately 990% or 837% of their populations by March 2022 [10]. By contrast, many countries faced severe shortages during peak phases of the pandemic owing to limited financial resources, asymmetric political power, and fragile public health systems [11]. These countries were often unable to obtain sufficient VTDs through market-based mechanisms and were therefore compelled to rely on allocations coordinated by international organizations.

These disparities heightened the risk of sustained global transmission and underscored persistent inequities in access to essential health products during public health emergencies [12]. Health equity has consequently emerged as a central concern in global health governance [13]. Inequities in pathogen sharing and benefit allocation have previously triggered international controversy. In 2009, Indonesia invoked the Convention on Biological Diversity to challenge the imbalance between influenza virus sample sharing and access to vaccines under the WHO Global Influenza Surveillance Network [14]. On 25 June 2021, large-scale public demonstrations took place in South Africa under the theme “March to Save Lives”, calling on the international community to expand access to COVID-19 vaccines [15]. According to Our World in Data, as of 7 April 2022, full COVID-19 vaccination coverage reached 74.10% in high-income countries and 76.68% in upper-middle-income countries, compared with 50.51% in lower-middle-income countries and only 11.51% in low-income countries [16].

The Pandemic Agreement recognizes serious deficiencies in preparedness, prevention, and response capacities at national, regional, and global levels during public health emergencies of international concern, including pandemics. Against this backdrop, the PABS system is designed to draw lessons from inequities in access to vaccines during the COVID-19 response and to address structural shortcomings in the allocation of VTDs, aiming to promote more equitable, predictable, and timely access in future global health emergencies.

1.3. Remedying structural deficiencies in existing pathogen-sharing mechanisms

The evolution of global pathogen-sharing arrangements has consistently been guided by core principles of fairness, equity, timeliness, and equality [17], [18]. Nevertheless, existing mechanisms continue to suffer from systemic deficiencies, including institutional fragmentation, weakened obligations, and imbalances in benefit distribution. The 1992 Convention on Biological Diversity (CBD) [19] established three overarching objectives: The conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from the utilization of genetic resources. Over the past decades, international efforts have emphasized legal compliance in genetic resource frameworks more than measurable outcomes, focusing on legislative, administrative, and policy measures. As a result, the need for a global approach and measurable indicators to assess benefit-sharing outcomes has been increasingly recognized [20].

Against this backdrop, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization (the Nagoya Protocol) [21], adopted in 2010 as a supplementary agreement to the CBD, introduced concrete implementation mechanisms for the legal concept of access and benefit-sharing (ABS). In 2022, the fifteenth meeting of the Conference of the Parties to the CBD adopted the Kunming–Montreal Global Biodiversity Framework [22], which explicitly affirmed that benefits arising from the use of digital sequence information on genetic resources should be shared in a fair and equitable manner. In 2024, the sixteenth meeting of the Conference of the Parties further proposed the establishment of a multilateral benefit-sharing mechanism, including the Cali Fund, to ensure equitable benefit-sharing from the utilization of digital sequence information. Under these arrangements, States may voluntarily determine conditions for access to their genetic resources and require users to share both monetary and non-monetary benefits derived from their utilization [23].

In practice, traditional mechanisms have been characterized by limited legal enforceability, the absence of mandatory sharing obligations, and persistent inequities in the distribution of commercial benefits [24], thereby failing to ensure that benefits are effectively returned to provider countries. The PABS system builds on CBD/ABS equity principles and seeks greater legal certainty by conditioning access on legally binding agreements with participating manufacturers. However, PABS has yet to specify robust incentives and benefit-sharing modalities, which may weaken manufacturers’ participation. Its ability to deliver equitable benefit-sharing will therefore depend on detailed implementing rules and operational arrangements.

1.4. Addressing the limitations of the PIP framework

In 2011, the WHO adopted the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits (PIP Framework) through resolution WHA64.5 [25]. It aims to strengthen global preparedness for influenza pandemics and promote equitable access to vaccines and antivirals based on public health risk and need [26]. However, its scope is limited to specified human influenza viruses and does not cover genetic sequence information. Implementation relies on Standard Material Transfer Agreements (SMTAs), which set binding terms for both providers and recipients of PIP biological materials. Member States transfer influenza materials to laboratories in the WHO-Coordinated Global Influenza Surveillance and Response System (GISRS) under SMTA1, and onward transfers to third parties occur under SMTA2 [27].

Benefit-sharing under the PIP Framework is primarily implemented through voluntary contributions or the provision of vaccines and other medical countermeasures at affordable prices, as well as through support for GISRS capacity-building and technology transfer to developing countries [28]. While this framework has played an important role in improving influenza preparedness, its regulatory design entails several limitations in terms of scope, access modalities, and benefit-sharing arrangements. In particular, its applicability is confined to a narrow category of pathogens, and it does not cover sequence information or broader pathogen data essential for contemporary surveillance and research.

By contrast, the PABS system is intended to apply to materials and sequence information related to pathogens with pandemic potential, without being restricted to a single virus type. It further requires participating manufacturers to enter into legally binding agreements with the WHO and to provide a defined proportion of VTDs during a pandemic emergency, thereby introducing a stronger degree of enforceability and predictability [29]. Rather than serving as a replacement for the PIP Framework, the PABS system is designed to build upon its experience while addressing its structural limitations, expanding the scope of covered pathogens, and establishing a more comprehensive multilateral mechanism for benefit-sharing in the context of future pandemics.

2. Main components of the PABS system

2.1. Overall positioning and legal basis of the PABS system

The WHO Pandemic Agreement represents a central effort to reform global health security governance in the aftermath of the COVID-19 pandemic. Through this instrument, Member States seek to improve global health governance, address shortcomings revealed during the COVID-19 response at both national and WHO levels, and strengthen collective capabilities to prevent, prepare for, and respond to future pandemics [30]. The Agreement proposes the establishment of a series of new platforms and mechanisms, among which Article 12 defines the core principles, objectives, institutional structure, and operational direction of the PABS system, as well as the benefit-sharing arrangements applicable in the event of a pandemic emergency or other public health emergencies. Article 12.1 emphasizes that the PABS system must promote the rapid and timely sharing of “materials and sequence information on pathogens with pandemic potential” (“PABS Materials and Sequence Information”), and ensure the rapid, timely, fair, and equitable sharing of benefits arising from the sharing and/or utilization of PABS Materials and Sequence Information for public health purposes.

The specific institutional arrangements of the PABS system are to be operationalized through an annex to the Pandemic Agreement, namely the “PABS Instrument”. Articles 12.2 and 12.3 require that this instrument specify the definitions of PABS Materials and Sequence Information, modalities, legal nature, terms and conditions, and operational dimensions of the PABS system. Subsequent discussions will continue to address traceability measures and open access to data. All components of the PABS system are intended to enter into force simultaneously upon the entry into force of the Agreement. Articles 12.4 and 12.9 adopt safeguarding clauses to clarify the relationship between the PABS system and other international legal instruments. These provisions further require that the implementation of the PABS system be consistent with the objectives of the CBD and the Nagoya Protocol, while at the same time ensuring that such consistency does not impede the fair, transparent, accountable, and equitable implementation of the PABS system.

2.2. Benefit-sharing mechanisms under the PABS system

In international law, benefit-sharing is not a uniform concept; rather, its content and operation vary across different legal regimes and according to the legal status of the resources concerned [31]. Where biological resources fall within national jurisdiction, States exercise sovereign rights over such resources located within their territories. Articles 12.5 to 12.8 of the PABS system categorize benefits into two broad types: monetary and non-monetary. Monetary benefits are reflected in forms such as annual contributions and financial payments, while non-monetary benefits encompass VTDs, capacity-building and technical assistance, research and development collaboration, the granting of non-exclusive licenses to manufacturers in developing countries, and technology transfer. Article 12.6 establishes the core obligation concerning the sharing of health products. It stipulates that, in the event of a pandemic emergency determined pursuant to Article 12 of the International Health Regulations (2005), each participating manufacturer shall enter into a legally binding contract with the WHO and provide rapid access to 20% of their real-time production of safe, quality, and effective VTDs. Of this amount, 10% shall be provided to the WHO as donations, while the remaining 10% shall be reserved for the WHO at affordable prices, subject to flexible arrangements based on the nature and capacity of each participating manufacturer.

Additionally, Article 12.7 further requires that the PABS Instrument specify benefit-sharing arrangements applicable in situations involving a PHEIC, while Article 12.8 clarifies that additional benefit-sharing commitments shall be implemented through subsequent contractual arrangements. Using legally binding contracts, the PABS system seeks to mandatorily activate responsibility on the production side of the global health supply chain, thereby transforming benefit-sharing from a general principle into concrete resource commitments. At present, however, the PABS system mandates only the sharing of 20% of VTDs, and key issues concerning the implementation and allocation of these products remain unresolved. Member States may therefore assess the practical operation of product allocation during pandemic emergencies when deciding whether to participate in the PABS system [32]. Taken together, these provisions outline the basic institutional architecture of the PABS system, and lay the groundwork for the following analysis of key disagreements over scope, benefit-sharing, and governance (Fig. 1).

Fig. 1.

Key elements of the Pathogen Access and Benefit-Sharing (PABS) system under the World Health Organization (WHO) pandemic agreement. Abbreviations: ABS, access and benefit-sharing; PIP, Pandemic Influenza Preparedness; R&D, Research and Development; CBD, Convention on Biological Diversity; IHR, International Health Regulations.

3. Key divergences in the development of the PABS system and related recommendations

Current negotiations on the draft annex to the PABS system indicate that divergences among Parties are concentrated in three main areas: the definition and scope of key terms, the design of benefit-sharing and allocation mechanisms, and the operational and governance arrangements of the system. These issues have consistently formed the core points of contention, reflecting differing approaches to balancing scientific openness with fair and equitable sharing. Equity is not only a normative principle but also a prerequisite for credible and actionable pandemic science [33]. Without consensus on equitable distribution mechanisms, the PABS system is unlikely to gain broad trust among stakeholders.

3.1. Clarifying core terminology and the scope of application of the PABS system

Throughout the negotiations on the PABS system, the use of terminology has remained one of the most fundamental and central issues but also one of the most contested. Terminological ambiguity is widely regarded by Parties as a key institutional factor contributing to the current negotiation deadlock [34]. Many Member States have emphasized that the absence of clear and operational definitions for core concepts would directly affect the scope of application of the system, the boundaries of obligations, and the triggering conditions for benefit-sharing. Based on a review and synthesis of proposal texts submitted by States during the negotiations and publicly available information released by the WHO [35], [36], [37], [38], [39], the most contentious terms include “Pathogen with Pandemic Potential”, “PABS Materials and Sequence Information”, and “Participating Manufacturer”.

3.1.1. Defining “Pathogens with Pandemic Potential”

Significant divergences exist among States regarding the scope of the term “Pathogens with Pandemic Potential”, which has direct implications for the system’s scope of application, the design of obligations, and the basis for benefit-sharing. According to the first draft of the PABS Annex released by the WHO on 29 October 2025 [40], the proposed definition of this core concept is relatively narrow, focusing on pathogens characterized by high transmissibility, high virulence, high severity, and a significant risk of wide geographical spread. In the negotiations, some States have shown a preference for a narrower definition, to avoid an overly broad scope of application of the system. Other States have advocated for a broader and more precautionary definition. They argue that only an expanded scope can effectively prevent the circumvention of obligations through definitional loopholes. Going forward, the definition should be sufficiently adaptable to accommodate advances in updated biosafety risk assessments and emerging evidence from pandemic science.

3.1.2. Defining “PABS Materials and Sequence Information”

Defining the scope of “PABS Materials and Sequence Information” is particularly complex, as blurred data boundaries have generated divergent views among Member States regarding the distinction between derivative information, metadata, and sequence data. According to the WHO, the scope of “PABS Materials and Sequence Information” encompasses samples, specimens, isolates, derivatives, metadata, and associated clinical or epidemiological data. However, the heterogeneity of these data types makes it difficult for some countries to distinguish “derivative information” from “digital sequence information.” Similar definitional controversies have previously arisen in other international instruments, including the International Treaty on Plant Genetic Resources for Food and Agriculture adopted by the Food and Agriculture Organization of the United Nations in 2001 (the Plant Treaty), as well as the Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas beyond National Jurisdiction adopted in 2023 (the BBNJ Agreement) [41]. Accordingly, the PABS system could draw on approaches under the Plant Treaty and the BBNJ Agreement by explicitly classifying data categories and providing further clarification through interpretative annexes or technical guidance. This approach would help establish an operational and legally workable foundation for the implementation of the PABS system.

3.1.3. Defining “Participating Manufacturers”

With respect to the definition of “Participating Manufacturers”, Member States remain divided over both the scope of covered entities and the stringency of benefit-sharing obligations. These divergences reflect structural tensions related to sovereignty, capacity, and expectations regarding benefit distribution. Some Member States tend to oppose imposing binding legal obligations prematurely and argue that entities engaged solely in research and development should be excluded. Other Member States, by contrast, advocate a more stringent definition, maintaining that any entity seeking access to PABS materials or sequence information should be required to enter a legally binding PABS contract with the WHO prior to access, with mandatory and enforceable benefit-sharing obligations. These positions reflect differing national priorities in sovereignty, public health capacity, and benefit allocation. To reconcile these considerations, the definition should delineate covered entities, adopt a graduated framework of obligations, and link access to benefit-sharing commitments. This approach could preserve inclusiveness while maintaining operational feasibility and ensuring that obligations are enforceable and practicable, thereby balancing resource access with global public health interests.

3.2. Strengthening the institutional framework for benefit-sharing and distribution

Controversies surrounding benefit distribution under the PABS system are primarily concentrated on two dimensions: The lack of clarity regarding product measurement and allocation criteria, and the uncertainty surrounding the triggering mechanisms for benefit-sharing obligations of participating manufacturers. Questions of benefit distribution bear directly on future access guarantees for certain countries during pandemics, while also affecting market incentives and compliance costs for participating manufacturers, making them particularly difficult to reconcile during IGWG negotiations. Moreover, robust national legal frameworks will be essential to translate PABS benefit-sharing commitments into enforceable and equity-oriented actions [42].

3.2.1. Clarify the measurement criteria and allocation basis for the 20% of VTDs benefits

Article 12.6 of the Pandemic Agreement requires participating manufacturers to provide 20% of their real-time production of VTDs to the WHO, among which 10% of VTDs are mandatory donations, and the remaining 10% shall be handled flexibly based on the nature and capacity of participating manufacturers. Different temporal standards and interpretations exert a significant impact on the actual output of VTDs. The existing text does not clearly specify the calculation method of “real-time production”, including the measurement period, baseline scope, or whether domestic security demand should be deducted. Although the remaining 10% of VTDs are reserved for the WHO at an affordable price, the pricing criteria, cost structure, and decision-making entity remain undefined. The allocation of VTDs shall be based on public health risks and needs. However, the specific allocation criteria, priority order, and decision-making procedures still need to be refined, which are crucial to the actual operation and equitable access of the PABS system.

Some Member States argue that unclear measurement basis and criteria will affect the stability of industrial supply chains and worry that supply shortages may trigger export controls and domestic political pressures [27]. Other Member States hold that only quantified product transfer obligations can ensure equitable access to VTDs. They further note that many low-income countries lack domestic vaccine production capacity, and therefore mostly rely on purchases from high-income countries or assistance from international organizations [43]. Without clear allocation basis, market mechanisms will hardly guarantee sufficient access to VTDs for low-income countries. It is necessary to clarify the measurement criteria and product allocation basis for VTDs in the annexes to enhance the enforceability of the system while balancing the reasonable considerations for the operational stability of participating manufacturers.

3.2.2. Clarifying triggers and quantifiable standards for benefit-sharing obligations of participating manufacturers

Under the PABS system, manufacturers participate on a voluntary basis; however, once they enter into legally binding agreements, their benefit-sharing obligations become mandatory upon the occurrence of a pandemic emergency or a PHEIC. However, the triggering conditions remain unclear. The calculation methods and payment requirements are also not specified in sufficient detail. It is unclear whether obligations are activated only after a formal declaration of a PHEIC or a pandemic emergency, or whether they begin as early as the initial access to PABS materials and sequence information. It is also uncertain whether financial contributions should be linked to indicators such as company size, market share, or production capacity, thereby enabling differentiated responsibilities across participating manufacturers.

The participation of a sufficient number of manufacturers is one important element for the effective operation of the PABS system. If manufacturer participation remains limited, the system may be more difficult to implement in practice, and the sustainability of the benefit-sharing mechanism may also be undermined. This underscores the importance of considering appropriate incentives to encourage participation and compliance. The PIP Framework provides a useful reference in this regard, as it establishes a contribution-sharing mechanism based on sales-based tiers, offering clearer differentiation of responsibilities among companies [44]. The PABS system could draw on the quantitative arrangements of the PIP Framework to enhance the predictability of manufacturers’ obligations and reduce uncertainty in implementation. Future annexes to the Pandemic Agreement should therefore further clarify the triggering conditions for benefit-sharing obligations and specify detailed calculation rules, to strengthen manufacturers’ willingness to participate in the PABS system and enhance its overall operability and stability.

3.3. Clarifying the operational and governance model of the PABS system

The core controversies surrounding the operational governance of the PABS system center on two issues: first, the pathways for accessing PABS materials and sequence information, and the related data-flow arrangements, remain unclear; and second, responsibilities and accountabilities within the system’s operational architecture have yet to be clearly delineated. These uncertainties could impede the effective functioning of the PABS system, obscure the identification of responsible actors, and create breaks in the circulation of information and samples, thereby undermining its credibility.

3.3.1. Establishing a traceable and enforceable mechanism for PABS materials and sequence information

In the ongoing debates over access pathways and data circulation mechanisms for PABS materials and sequence information, the current draft proposed by the WHO reveals an insufficient alignment between the data and material transfer system, laboratory networks, and existing sequence databases. Countries differ greatly in laboratory capacity, risk assessment standards, and biosafety levels. In the absence of a common procedure, the cross-border transport of pathogens may entail heightened safety and compliance risks. It is therefore necessary to clarify laboratory mechanisms between States for sharing and transporting PABS materials and clinical specimens, including laboratory eligibility criteria, risk assessment requirements, biosafety standards, export control and domestic approval procedures involved in material shipment [45]. Although the PABS system proposes that PABS sequence information be managed through WHO-recognized sequence databases, it does not clearly define the relationship between these databases and existing platforms, nor does it specify rules regarding unique identifiers, access rights, limits on use, or responsibilities allocation [46]. It is essential to establish a coherent framework for data governance and traceability within the PABS system [47]. By setting clear access conditions, confidentiality obligations, and limits on use, and by introducing unified identifiers and tracking mechanisms, the system can ensure that the use of sequence information is effectively linked to subsequent benefit-sharing obligations.

3.3.2. Establishing a clear and enforceable operational framework for the PABS system

At present, uncertainties surrounding the governance authority, oversight mechanisms, and accountability pathways have caused many Member States to worry about whether the PABS system can be enforced in the future. In the WHO’s current draft, arrangements for the governance and review of the PABS system remain mostly general and abstract. How the system will interact with other international organizations and relevant stakeholders has yet to be clearly articulated, leading some countries to question whether the external involvement could dilute the WHO’s leadership role or give rise to unclear legal responsibility. The draft further proposes the establishment of a PABS Advisory Group to provide evidence-based reports and recommendations on system implementation. However, its mandate, composition, member selection procedures, conflict-of-interest management, and relationship with the WHO Secretariat have not been clearly defined. For non-compliance, although the draft mentions measures such as suspending access or revoking eligibility for manufacturers or database users who breach contractual obligations, it does not establish cross-border oversight or a clear enforcement pathway. These gaps raise concerns about the PABS system’s practical effectiveness and credibility. To address these challenges, it is necessary to clarify the governance structure, standardize oversight arrangements, and specify enforcement pathways to improve the binding force, feasibility, and operational enforceability of the PABS system.

4. Prospects for the global PABS framework

As global health governance undergoes structural reconstruction in the post-pandemic era, the PABS system, as a core mechanism established under Article 12 of the WHO Pandemic Agreement, is expected to evolve at the intersection of multilateral rule-making dynamics, technological developments, and international public health needs. Although significant divergences among States persist with respect to the scope of application, benefit-sharing modalities, and system governance, Member States have continued to seek common ground through the IGWG meetings, and ultimately to finalize the PABS Annex through multilateral negotiations, thereby enabling a timely and effective institutional response to future pandemics [48].

An emerging tension between multilateral mechanisms and bilateral arrangements may shape the practical implementation of the PABS system. Recent reporting suggests that the United States has pursued pathogen surveillance and sample sharing through bilateral cooperation memoranda with multiple African countries under the America First Global Health Strategy, with new health assistance conditioned on recipient countries’ commitments to share pathogen materials and data [49]. In this context, some developing countries may find themselves balancing the immediate resource support offered through bilateral cooperation against the rule-based commitments envisaged under WHO-led multilateral negotiations [50]. This landscape may therefore heighten the challenge of achieving a broad consensus on the design and implementation of the PABS system.

Equitable sharing of data, samples, and the benefits derived from them during pandemics requires a degree of trust and solidarity [51]. The long-term sustainability of the PABS system will depend on balancing respect for State sovereignty with the protection of global public health interests. National differences in public health capacity, political–economic structures, legal systems, and technological capability shape negotiating positions and priorities. Further development of the PABS system will therefore require region- and country-specific studies to better understand Member States’ needs and capacities and to align multilateral rules with national conditions, thereby strengthening long-term resilience [52].