TWN Info Service on Health Issues (Nov25/01)
3 November 2025
Third World Network

An Unequal and Incomplete PABS System: Legal Ambiguity and Key Omissions in Bureau’s Draft Text

Geneva, 26 October 2025 (Nithin Ramakrishnan and Sangeeta Shashikant) – The Bureau of the Intergovernmental Working Group (IGWG) tasked with negotiating the Pathogen Access and Benefit-Sharing (PABS) Annex to the World Health Organization (WHO)’s Pandemic Agreement (PA) has released a draft text for the Annex in advance of the third IGWG meeting (IGWG3).

 Unfortunately, the draft text presented by the Bureau (“Bureau’s text”) contains several critical omissions – notably, the absence of standardized contractual terms governing the sharing of PABS Materials and Sequence Information (PMSI), the lack of traceability measures, and the omission of transparency measures. A major loophole in the proposed system is the absence of any provision regulating the transfer of PMSI to third parties.

The Bureau’s text also falls short of the standards set out in Article 12 of the PA. It fails to reflect the agreed principle that access and benefit sharing must be on an “equal footing”, and does not uphold the foundational requirement in Article 12.5(b) that there be “legal certainty” in the “modalities, terms and conditions on access and benefit sharing”.

While the draft creates a legal obligation on national laboratories to share PMSI, the absence of standard contracts means there is no corresponding legal obligation on recipients or users of PMSI to comply with the stated terms and conditions. Moreover, with the exception of “Participating Manufacturers”, the text does not impose any benefit-sharing obligations on other recipients or users – undermining the reciprocity and equity that should be central to the PABS System.

Bureau’s text also adopts a somewhat delinked approach, whereby access to PMSI, is not subject to acceptance of terms and conditions including benefit sharing. thus tilting the text in favour of the European Union (EU) flawed position, which has consistently sought to have a PABS system that delinks access from benefit sharing.

This article examines the key gaps and risks in the current draft – and what’s at stake if they are not addressed.

The Bureau’s text contains three sections: (I) Scope and objectives, and use of terms; (II) Provisions for implementation of the PABS System; and (III) Governance and review of the PABS System.

The IGWG3 discussions are expected to mainly focus on Section II, with six dedicated sessions. Sections I and III will each be discussed in two sessions.

Section I has two subsections: (A) Scope and objectives; and (B) Use of terms. Subsection A contains the objectives and a “non-exhaustive list of parameters for the implementation to meet the objectives of the Annex” mainly drawn from Article 12 of the PA. A Bureau note says that “additional provisions in Section II may be needed to operationalise some of the listed parameters”, perhaps recognising that its text is incomplete.

Section II has three subsections: (A) Operation of the PABS System (3 paragraphs); (B) Access to PABS Materials and Sequence Information (4 paragraphs); and (C) PABS System benefit sharing (5 paragraphs). Section III contains two subsections, one on Governance (subsection A) and the other on Review of the PABS System (subsection B).

Overall, Section II of the Bureau’s text is proposing that national laboratories rapidly share PABS Materials with laboratories that are part of the WHO Coordinated Laboratory Network (WCLN), and PABS Sequence Information with a WHO-recognized sequence database or databases. The Bureau’s text then sets out a few terms and conditions that the WCLN laboratories and WHO-recognized sequence database or databases have to comply with.

Section II, subsection C, under the title “PABS System benefit sharing”, addresses, albeit inadequately,  benefits from Participating Manufacturers and “all participants”, without addressing other conditions regarding the use of PMSI. In fact, there is not even clarity as to where the Participating Manufacturers and “all participants” will get PABS Materials from. 

Subsection A contains a paragraph that states “All elements of the PABS System shall come into operation simultaneously”, and another which requires Parties to the PA to review and align their national and/or regional access and benefit-sharing measures in accordance with Article 12.5(d)(ii). While both reflect text from Article 12 of the PA, the latter is concerning.

Article 12.5(d)(ii) was adopted by WHO Member States with the tacit understanding that the PABS Annex would set out a fully developed and operationally ready PABS System. The Bureau’s text does not, however, provide any assurance that the system will be ready for implementation upon the entry into force of the PA, and yet Parties are unfairly required to carve out PMSI from their national and/or regional ABS systems.

Use of Terms and Scope

Section I, subsection B describes key terms – “pathogen with pandemic potential”, “PABS Materials and Sequence Information” and “Participating Manufacturer” – adding that other terms may be added by the IGWG. The proposed definitions have several shortcomings.

The Bureau’s text proposes that “pathogen with pandemic potential” be defined as: “a known pathogen that is determined to have caused a public health emergency of international concern, or a novel pathogen or a variant of known pathogen infecting humans, and to which humans have limited or no immunity, with the risk of high transmissibility, virulence, severity, wide geographical spread, and which may cause a public health emergency of international concern that may develop into a pandemic emergency” (emphases added).

 

Effectively, the proposed definition covers pathogens that cause a public health emergency of international concern (PHEIC) as well as those pathogens that may lead a PHEIC situation to become a pandemic emergency. However, so far the Bureau’s text only requires the sharing of vaccines, therapeutics and diagnostics (VTDs) during a pandemic emergency. Based on the “equal footing” principle of the PABS System, as the scope of the system extends to PHEICs, the benefit sharing should also deliver access to VTDs to deal with PHEICs.

Similarly, the definition of “Participating Manufacturer” is overly narrow, as it excludes product developers engaged in contract manufacturing or those that may scale up or expand production sometime in the future. The proposed definition diverges from a WHO precedent – the Pandemic Influenza Preparedness (PIP) Framework, another access and benefit-sharing system functioning under WHO, where the definition of manufacturers encompasses developers of VTDs. The European Union is also opposed to the inclusion of “developers” in the definition of “Participating Manufacturer”.

An inadequate definition means many potential VTD producers will not be required to undertake benefit-sharing commitments to provide access to VTDs and other benefits during a public health emergency, thereby compromising the effectiveness of the PABS System in delivering key benefits when they are most needed.

Separately, the definition of PABS Sequence Information does not cover the sequences of amino acids generated from protein molecules, which are currently gaining more prominence in pharmaceutical research and development. For example, in the case of therapeutic monoclonal antibodies and engineered protein biologics, the primary research object is an amino‑acid sequence rather than a nucleotide sequence.

Missing Standard Contracts & Legal Uncertainty

Globally as well as in multilateral forums such as WHO and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), the sharing of biological materials and related information is governed by Standard Material Transfer Agreements (SMTAs). These are standardized contracts that govern the relationship between the provider and the recipients, setting out the terms of use and fair and equitable benefit-sharing obligations. In fact, WHO has been administrating SMTAs in the context of the PIP Framework and the BioHub for many years, more than a decade in the case of the Framework. 

Standardized contracts have also been applied by GISAID to users seeking access to sequence information. GISAID, is a database that hosts sequence information, and which requires users to register themselves, and accept a data access agreement (DAA), prior to accessing the hosted sequences. It is supported by developed countries and industry alike. Standard contracts have been a demand of the developing countries – the Africa Group and the Group for Equity (GfE) representing a large number of developing countries – for many years.

And yet, rather shockingly, the Bureau’s text does not present any standardised contracts.

In fact, a WHO PABS Contract is only mentioned in connection with Participating Manufacturers. Section II, subsection A, paragraph 1(b) requires “manufacturers of vaccines, therapeutics and diagnostics seeking to access PABS Material and Sequence Information through the PABS System to sign a WHO PABS Contract with WHO, setting out their commitments for rapid, timely, fair and equitable benefit-sharing”. In subsection C, there is another reference to a Participating Manufacturer (a manufacturer of vaccines, therapeutics and diagnostics) concluding a PABS Contract with WHO.

However, no standard contract is presented; rather, the Bureau’s text envisages that the Conference of the Parties to the PA (COP) will agree on  “model terms and conditions” for the WHO PABS Contract with Participating Manufacturers. Paragraph 4 of subsection C states: “The Conference of the Parties shall, at its first session, agree on the model terms and conditions for the aforementioned WHO PABS Contracts and the notice, as well as the relevant modalities with respect to the annual monetary contributions.”

“Model terms and conditions” does not necessarily equate to standardized contracts. In the case of the former, there is a risk that the WHO Secretariat can be pressured to diverge from the model terms and conditions.

For participants that are not manufacturers, the Bureau’s text in subsection A speaks of making “possible legally binding commitments for rapid, timely, fair and equitable benefit sharing, based on their nature, capacity and use of PABS Materials and Sequence Information”. Again, there is no reference to any standardized contracts.

Both the concepts of WHO PABS Contract and “possible legally binding commitments” generate significant legal uncertainty. They are also used only in the context of benefit sharing (subsection C) but not with regard to the “terms of use” of the Materials and Sequence Information.

As discussed below, certain terms and conditions for using the Materials and Sequence Information are laid out in the Bureau’s text, but in the absence of any contracts, this worsens the legal uncertainty. 

The Bureau’s text also has several other uncertainties and seems to even head down the path of delinking access from benefit sharing, as the European Union has been attempting to do. Subsection C (on benefit sharing) says that “All participants in the PABS System shall receive notice of possible legally binding benefit-sharing commitments...”, followed by a list of possible benefits that can be provided.

There is no explanation as to whom “all participants” covers, when they become participants, and whether these participants are expected to sign PABS contracts. If so, will it be before accessing PMSI, and what will happen after the participants receive the notice and what exactly will the notice say? Embedded in that provision is also the possibility that some participants using the PABS resources may not sign any contract with WHO.

In fact, overall Bureau’s text suggests that access will be granted to anyone that desires it, and thereafter a notice will be issued presenting the possibility of providing legally binding benefit sharing. The suggested approach appears to delink access from benefit sharing, in contradiction with the Convention on Biological Diversity and the Nagoya Protocol.   

Paragraph 2 of subsection C adds to this ambiguity. It simply states: “To be recognized as a Participating Manufacturer, a manufacturer of vaccines, therapeutics and diagnostics must conclude a PABS Contract with WHO which shall cover all access to PABS Materials and Sequence Information for the duration of such Contract….” While it stipulates that the contract shall cover all access to PMSI during the duration of the contract, it does not mention that benefit-sharing obligations shall be applicable beyond the duration of the contract. It must be clear that termination of the contracts does not exonerate the recipients of PABS resources from sharing the benefits.

Unequal Bargain: Legal Obligation to Provide PABS Materials But Uncertainty on Terms of Use and Benefit Sharing 

According to subsection B, PMSI detected shall be shared in a rapid and timely manner. PABS Material shall be shared “through a laboratory or laboratories authorized under relevant national or domestic procedures”, with a laboratory that is part of the WCLN, while sequences shall be shared with “a WHO recognized sequence database or databases”.

Essentially, paragraph B.1 places a legal obligation on Parties to share PMSI through their national laboratories. However, most of the other aspects are not similarly subject to legal obligations.

For example, paragraph B.3 speaks of terms and conditions that laboratories in the WCLN have to comply with, such as the handling of materials in accordance with applicable biosecurity and biosafety standards, commitments not to claim intellectual property rights, ensuring proper acknowledgement of the originating laboratories and countries providing the PMSI, the scope of use of PMSI etc.

But unless the terms and conditions are articulated in a contract, they are not a legal obligation as laboratories are not Parties to the PA (only States are Parties to the PA).

Similarly, paragraph B.4 states that WHO-recognized sequence databases receiving PABS Sequence Information shall comply with certain terms and conditions, but in the absence of a contract with WHO, there is no legal obligation on them to do so.

Some may argue that under the Governance section of the Bureau’s text, the WHO Director-General has the right to take action. While on paper this may be the case, in practice, when violations happen, such laboratories and databases will argue that they did not undertake any legal obligation. The DG will find his hands tied.

Further, some of the listed terms and conditions are directed at the users seeking access to sequence information, again in the absence of a contract. There is thus no legal obligation on such users to comply with any terms and conditions. In fact, there is not even a legal obligation on users to provide benefit sharing.  

Subparagraph B.4(b) states that a WHO-recognized sequence database shall “inform users of its database of the WHO Pandemic Agreement and the PABS System, including notification of possible legally binding benefit-sharing commitments under Section C”. If PABS databases merely inform their users without collecting their user information and obligating acceptance of benefit-sharing commitments, via data access agreements, it is impossible to operationalize benefit sharing. Users will be able to access the sequence information anonymously and use it without ever complying with the requirements of the PABS System –  nothing short of facilitating digital biopiracy.

Similarly, subsection C, paragraph 1 states that “All participants in the PABS System shall receive notice of possible legally binding benefit-sharing commitments to be undertaken based on their nature, capacity and use of PABS Material and Sequence Information”, which indicates participants will be approached to provide benefit sharing but there is no real obligation to do so.

Evidently, the Bureau’s text presents an unequal bargain, inconsistent with the agreed foundational principles in Article 12 of the PA that access and benefit sharing should be on “equal footing” and that provisions governing the PABS System should feature “modalities, terms and conditions on access and benefit sharing that provide legal certainty” (Article 12.5(b)).

Glaring Loopholes: Unconditional Third-Party Transfers Undermining PABS System

A glaring omission in the Bureau’s text – one that, if left unaddressed, could fundamentally undermine the PABS System – is the absence of any condition governing third-party transfers of PABS Materials or Sequence Information.

While the Bureau’s text sets out certain obligations for WCLN laboratories receiving PABS Materials and for users accessing PABS Sequence Information from WHO-recognized databases, it fails to impose any restriction on onward transfers. As a result, users obtaining sequences from a WHO-recognized database could freely share them with third parties. Likewise, any WCLN laboratory, manufacturer or other entity accessing PABS Materials could transfer such materials without being bound by the requirements of the PABS System.

This gap is compounded by the ambiguity in paragraph 2 of subsection B, which provides that PABS Materials and Sequence Information “may be shared outside of the PABS System, provided that they are shared on a priority basis” with a WCLN laboratory and/or WHO-recognized sequence database. The provision fails to distinguish between (a) materials and sequences shared with the PABS System, and (b) those belonging to a country and subject to its sovereign rights to share outside the System. Without such a distinction, the paragraph effectively permits any recipient to transfer PABS Materials and Sequence Information outside the PABS System.

This omission is particularly surprising given the WHO Secretariat’s extensive experience in implementing the PIP Framework, which is clear that onward transfers are only to prospective recipients that have signed the required SMTAs.

Whether intentional or inadvertent, this lack of specificity creates a significant loophole, enabling recipients and users to free-ride on the PABS System and opening the door to potential biopiracy.

Missing Traceability and Transparency Mechanisms

One key demand of developing countries generally is for adequate traceability and transparency measures, and there have been extensive discussions on the same. The Group for Equity and many other developing countries have called for sequence databases hosting sequences to require user registration to identify users, without which benefit sharing cannot be operationalized.

There were also proposals for a tracking mechanism for the sharing of PABS Materials, so there is clarity on the providers and recipients of the PABS Materials, drawing inspiration from the PIP Framework which has the influenza virus tracking mechanism that provides information on materials shared with and outside the WHO Global Influenza Surveillance and Response System (GISRS).

The Group for Equity and several other proposals also stressed on transparency, calling on WHO to make publicly available information on PABS System operations including the list of recipients of PABS Sequence Information; the list of WCLN laboratories; monetary contributions received from each recipient and their utilization; and standard contracts concluded with each recipient. 

Despite extensive discussions among WHO Members on these aspects, and developing countries repeatedly presenting evidence that such mechanisms are possible, the Bureau’s text is mostly silent thereon. One small measure proposed is the assignment of unique persistent identifiers to the PABS Materials and Sequence Information, but insufficient to address traceability as the recipient/user of the PMSI remains unknown.  

Further, subsection C on benefit sharing requires only benefit-sharing commitments undertaken by a Participating Manufacturer to be made public. There is no proposal to do the same for other users.

Benefit-Sharing Commitments Remain as Options and De-linked from Access

Subsection C has two parts, one addressed to “all participants in the PABS System” and the other addressed to Participating Manufacturers.

The first part says “All participants in the PABS System shall receive notice of possible legally binding

benefit-sharing commitments to be undertaken based on their nature, capacity and use of PABS Material and Sequence Information” and this is followed by a list of options of benefits: (a) providing access to pandemic-related health products; (b) capacity-building and technical assistance; (c) research and development cooperation; (d) granting non-exclusive licences to manufacturers in developing countries for the manufacture of pandemic-related health products; (e) other forms of transfer of technology as mutually agreed; (f) engaging scientists from originating laboratories especially those from developing countries in scientific projects associated with research on PABS Material and Sequence Information and in preparation of manuscripts for presentation and publication; (g) appropriately acknowledging in their presentations and publications, the contributions of collaborators, including laboratories/countries providing PABS Material and Sequence Information; and (h) monetary contributions.

A key concern on this is that there is no firm requirement for all participants to provide benefit sharing. The text only says that participants will receive notice concerning benefit sharing. And from the list, monetary benefit sharing is optional rather than mandatory for users generating revenue. In fact, there are no mandatory benefits required of the participants, other than Participating Manufacturers.

The other part of subsection C states: “To be recognized as a Participating Manufacturer, a manufacturer of vaccines, therapeutics and diagnostics must conclude a PABS Contract with WHO which shall cover all access to PABS Materials and Sequence Information for the duration of such Contract, and shall contain the following obligations by the Participating Manufacturer:

(a) to use the PABS Materials and Sequence Information for public health purposes;

(b) in the event of a pandemic emergency, to make available to WHO rapid access to their real time production of safe, quality, and effective vaccines, therapeutics, and diagnostics for the pathogen causing the pandemic emergency, in accordance with Article 12.6(a), for distribution in accordance with Article 12.6(b); and

(c) provision to WHO of annual monetary contributions referred to in Article 12.5(a), with flexibility based on the Participating Manufacturer’s nature and capacity.”

Missing from the list of mandatory benefits to be provided by the Participating Manufacturer is the grant of non-exclusive licences to developing-country manufacturers as well as real-time allocation of VTDs to affected countries during a PHEIC. Both of these benefits have long been demands of developing countries, and are important for rapidly providing access to VTDs as well as for scaling up production and expanding supply options. However, these key aspects are listed only as options in paragraph 3.

Paragraph 3 states that a Participating Manufacturer would also have to provide additional benefits such as those referenced in Articles 12.7 and 12.8 of the PA, including options for:

(a) providing access to vaccines, therapeutics, and diagnostics for pathogens causing public health emergencies of international concern, in accordance with Article 12.7;

(b) capacity-building and technical assistance;  (c) research and development cooperation;

(d) facilitating rapid access to available vaccines, therapeutics and diagnostics with a view to responding to public health risks and events in the context of Article 13.3 of the International Health Regulations (2005); (e) granting non-exclusive licences to manufacturers in developing countries, for the effective production and delivery of vaccines, therapeutics and diagnostics; and  (f) other forms of transfer of technology as mutually agreed, including transfer of relevant knowledge, skills and technical expertise.

A developing-country delegate involved in the PABS negotiations, speaking to TWN, said: “In Article 12 we used the word options, meaning there will be various options mentioned in the PABS Annex operationalizing those benefits mentioned in Article 12.7 and 12.8. They are not optional benefits and their operational details including trigger points and delivery modes have to be agreed upon by Member States in the Annex.”

The Bureau’s approach appears to be to defer detailed aspects of the Annex to the COP following the entry into force of the PA, rather than resolving them within the IGWG process, a position inconsistent with Article 12 of the PA.

Equally problematic is the failure to define mandatory benefit-sharing obligations for other categories of participants, including users engaged in commercial use of PMSI. Many such entities are well positioned to contribute monetary and non-monetary benefits that would strengthen public health systems in developing countries. Ensuring these obligations are clearly defined from the outset is therefore essential for the integrity and equity of the PABS System.

Inadequate Provisions on Governance

Section III on governance is quite inadequate. While paragraph 1 states that the “Conference of the Parties shall oversee implementation of the PABS System”, most of the functions are delegated to the WHO Secretariat, with minimal roles prescribed for the COP. In fact, there are no provisions on reporting by the Secretariat to the COP on the implementation of the PABS System.

Section III also sets up a PABS Advisory Group to “provide evidence-based reporting and recommendations on implementation of the PABS System”. However, no guidance is provided on the setup of the Advisory Group, such as how many members it will have, how long they will serve, and the functions and working procedures of the Advisory Group.

Strikingly, inconsistent with Article 12.2 of the PA, the Bureau’s text says that the Secretariat will “collaborate with relevant international organizations and relevant stakeholders” to “administer and coordinate the PABS System”.

Article 12.2 limits collaboration with relevant international organizations and relevant stakeholders only to matters related to “coordination” and “operation”, as opposed to “administration”, of the PABS System, and that too, according to the PA, has to be in accordance with the Constitution of WHO and applicable principles, norms and standards of WHO.

IGWG3 will take place in Geneva from 3^rd to 7^th November, and is expected to begin text-based negotiations.