TWN Info Service on Intellectual Property Issues (Oct25/03)
29 October 2025
Third World Network

EU’s flawed PABS proposal is inconsistent with the Pandemic Agreement & masquerades corporate charity as benefit-sharing

Geneva, 27 October 2025 (Nithin Ramakrishnan and Sangeeta Shashikant): The European Union (EU)’s proposal for a pathogen access and benefit-sharing (PABS) system undermines the very principles it claims to uphold. Disguised as a system of benefit-sharing, it effectively turns equity into corporate charity while diluting the role of the World Health Organization (WHO) and its Member States in the administration and oversight of the PABS system.

The EU’s deliberate approach, which favours unfettered access to PABS materials and sequence information, is fundamentally at odds with Article 12 of the WHO Pandemic Agreement (PA), as well as the Convention on Biological Diversity (CBD) and the Nagoya Protocol (NP), and risks upending the PABS negotiations and undermining trust and equity in pandemic preparedness and response.

The EU’s 10-page PABS proposal, dated 17 October 2025, was published on the website of the Intergovernmental Working Group (IGWG) which is tasked with negotiating and drafting the PABS Annex to the PA.

The proposal follows the submission of an initial 3-page document dated 25 July 2025. The latest detailed proposal comes significantly later than the more detailed proposals of developing countries, submitted mostly in August 2025. 

Establishment of a transparent and accountable PABS system through an Annex to the PA was agreed under its Article 12. The 78th World Health Assembly in May 2025 tentatively adopted the PA and set up the IGWG to complete negotiations of the Annex. 

The 3rd IGWG meeting will be held in Geneva on 3–7 November for the first round of text-based negotiations on the Annex.  

Under Article 12 of the PA, the PABS Annex is conceived as a global system that balances “the sovereign right of States over their biological resources and the importance of collective action to mitigate public health risks”. Article 12 underscores the importance of promoting “the rapid and timely sharing of ‘materials and sequence information on pathogens with pandemic potential’ (hereinafter ‘PABS Materials and Sequence Information’) and, on an equal footing, 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”.

Article 12.4 acknowledges that the PABS instrument “shall be consistent with, and not run counter to, the objectives of the Convention on Biological Diversity and the Nagoya Protocol” on Access and Benefit Sharing, having regard to Article 4.4 of the NP.

[Article 4.4 of the NP states: “…Where a specialized international access and benefit-sharing instrument applies that is consistent with, and does not run counter to the objectives of the Convention and this Protocol, this Protocol does not apply for the Party or Parties to the specialized instrument in respect of the specific genetic resource covered by and for the purpose of the specialized instrument.”]

Accordingly, throughout the Article 12 PA text, access and benefit-sharing are treated equally and interlinked, although on several occasions during the negotiations of Article 12, the EU had attempted, albeit unsuccessfully, to separate access from benefit-sharing.  

The latest proposal of the EU suggests it is back to its old tactics of trying to delink access and benefit-sharing. Its proposal guarantees only access to materials and sequences, abandoning the “equal footing” principle and the agreed balance, which provides legal certainty to both access to PABS materials and sequence information as well as fair and equitable benefit-sharing such as access to needed pharmaceutical products and monetary benefit-sharing.

It fundamentally redefines access and benefit-sharing (ABS) in ways that contradict the CBD and NP, reducing benefit-sharing to a voluntary act of corporate charity by some pharmaceutical manufacturers. Further, by omitting essential tools such as Standard Material Transfer Agreements (SMTAs) and Data Access Agreements (DAAs), the proposal intentionally avoids mechanisms that are needed to ensure fairness, predictability and equitable sharing of benefits in the PABS system.

Interestingly, Politico reported that the EU is internally divided over the proposal, with at least six EU members expressing dissatisfaction during recent Geneva meetings, especially feeling that the proposal was too pro–Big Pharma. One country even circulated a note distancing itself from the proposal, Politico reported. 

It would seem that the EU’s much-publicized commitment to pandemic prevention, repeatedly emphasized during the negotiations on the PA, stops at the doors of Big Pharma.

The EU proposal

The EU PABS proposal contains 42 paragraphs/sections, divided into 5 parts: (i) Use of Terms, (ii) Benefit-Sharing, (iii) Access, (iv) Governance, and (v) General and Final Provisions.

The first part sets out 12 definitions, including for key terms such as “pathogens with pandemic potential”, “PABS materials”, “PABS sequence information”, “participating manufacturers”, “PABS System Partners”, “Laboratory Network”, and “vaccines, therapeutics and diagnostics (VTDs)”.

The second part, on benefit-sharing, proposes that Parties to the PA shall encourage, individually and jointly, manufacturers of VTDs to willingly conclude legally binding benefit-sharing contracts with WHO as early as possible for the entry into force of the PABS system and thereafter continue with additional contracts. These manufacturers are referred to as participating manufacturers. This section also lists various optional benefits that may be obtained from the participating manufacturers. While it reflects the benefit of access to VTDs during a pandemic emergency, it does so in a way that undermines the agreement in Article 12.6(a) of the PA (see below). 

The third part deals with “access”, making it obligatory for Parties to share pathogens and sequences within 48 hours of the acquisition and assessment of the pandemic potential of such pathogens and sequences. The materials are to be transferred on “a priority but not exclusive basis”. It is not clear whose materials and sequences will be shared on a non-exclusive basis. This part also makes no mention of the acceptance of legally binding terms and conditions by recipients of the PABS materials and sequence information.

Article 12.5(b) of the PA is clear that the PABS instrument shall contain provisions regarding “modalities, terms and conditions on access and benefit sharing that provide legal certainty”. And yet both the access part and the benefit-sharing part of the EU proposal fall short of this standard.  

The fourth part elaborates on PABS governance and the establishment of a PABS Advisory Group. Its sections, however, depart from the understanding agreed in Article 12 that WHO will administer and coordinate the PABS system but may collaborate with other organizations and stakeholders as per its constitution and applicable principles, norms and standards such as the Framework of Engagement with Non-State Actors (FENSA). 

Contrary to Article 12, the EU’s text proposal suggests a multistakeholder approach to the administration of the PABS system, whereby decisions are taken by consensus, raising concerns of conflicts of interest, undue influence and violation of WHO’s norms and standards applicable when it engages with other actors. 

The EU’s text states: “The PABS System shall be administered by the WHO with the collaboration of the PABS System Partners, where appropriate. For this purpose, the WHO shall agree with the PABS System Partners on the terms of their collaboration in the administration of the PABS System. They shall collaborate in a consensual manner and contribute their respective expertise for the effective functioning of the System. The Conference of the Parties may recommend additional organisations to be included among the PABS System Partners.”

“PABS System Partners” is defined by the EU as “international and regional organisations which are competent to support and collaborate in the implementation of the Annex and the operation of the PABS System, including but not limited to GAVI, UNICEF and WOAH, as well as relevant stakeholders, including civil society and the private sector, as appropriate, with whom the WHO will collaborate in the operation of the PABS System”.

The final part of the EU proposal, on general and final provisions, seeks to shield participating manufacturers from unfounded fears that national ABS laws or other international regimes might claim benefits from PABS-covered materials or products. It also seeks to gain specialized international instrument (SII) status for the PABS system under Article 4.4 of the NP, even though the EU’s proposals are so blatantly inconsistent with the spirit and elements of the CBD and NP.

Taken as a whole, the EU proposal will create a PABS system with many gaps and loopholes, rendering the accountability and benefit-sharing aspect of the system dysfunctional, while establishing a legal obligation on Parties to share PABS materials and sequences within 48 hours.

Lacking accountability – access without SMTAs and DAAs

There are several critical omissions in the EU proposal, in particular the absence of SMTAs and DAAs to govern the exchange and use of PABS materials and sequence information and promote predictability on the terms of use and fair and equitable benefit-sharing.

These gaps are striking as such legally binding contracts (SMTAs and DAAs) are common tools utilized globally when sharing PABS materials and sequences. These tools provide legal certainty to both the provider and the recipient on the terms and conditions with respect to the use of the materials and sequences as well as fair and equitable benefit-sharing.

Further, Part III, Sections 20 to 30 of the EU proposal mention a “Laboratory Network” and “recognised databases” to which Parties must transfer pathogen samples and sequence data within 48 hours of acquisition of the pathogen and assessment of its pandemic potential. In addition, it obligates this network to transfer PABS materials and/or sequence information expeditiously and without discrimination to any entity that may request such resources.

As per Section 27, the laboratories and databases are only “requested” to inform recipients “of the expectations of benefit-sharing under the PABS System, as well as of the expectation that such entities acknowledge the providers of such material or information, where known, in relevant communication and publications and contribute as appropriate to public dissemination and transparency of research results”. But, there is no requirement for subsequent recipients to contractually agree to anything.

The EU’s proposal has major gaps in it. Any manufacturer can access the materials and sequences without having to make any commitment whatsoever. It may (if it wishes to), on the encouragement of a Party, enter into a contract with WHO. But why would any manufacturer do so, when it can easily free-ride on the system? Similarly, any researcher/academic institution/public or private laboratory/any other entity can access any materials and sequences without any commitment. Under the EU proposal, the recipients are free to use the materials and sequences for any purposes (even beyond the purpose of the PA), can transfer the materials and sequences further to any entity (this time without even informing about the benefit-sharing expectations), and may even make intellectual property claims over the shared resources. 

The proposal marks a complete departure from the tested Pandemic Influenza Preparedness (PIP) Framework, where all recipients operate under strict contracts whereby the terms of use such as intellectual property, onward transfer and specific use are detailed, and there is clarity on benefit-sharing obligations. The PIP Framework contains two SMTAs, one governing the sharing of materials between the provider country and the WHO network of laboratories dealing with influenza viruses with pandemic potential (IVPP) (known as the GISRS network), and the other the sharing of materials outside the GISRS network. And no onward transfer is possible except to recipients that are also bound by the terms of the SMTAs.

Most IVPP sequences are deposited in the GISAID database, which is accessible only to users who accept its data access agreement. Moreover, any sequences obtained cannot be shared outside the platform. Ironically, GISAID is supported by Germany and other European scientific institutions.

The Laboratory Network under the EU’s PABS proposal is defined as “laboratories or biorepositories participating in a network coordinated by the WHO in consultation with the PABS System Partners”. No governance structure is proposed, and there is a lack of clarity on the specific tasks of these laboratories and repositories, other than to just transfer the materials and sequences to other entities without any binding commitments. It also seems that other international organizations and relevant stakeholders have more of a say than the Conference of the Parties to the PA (COP) over which laboratory gets to be part of the network. In fact, the direct oversight of the COP over the network is not addressed.

Under the EU proposal, sequences are to be transferred not only to the Laboratory Network but also to one or more “recognised database”, defined as “a database which is publicly accessible, capable of receiving and transferring sequence data in a timely and secure manner and so recognised by a Party and/or the WHO”. Some databases (e.g., the INSDC) lack proper transparency and accountability mechanisms, allowing anonymous access and not ensuring compliance with ABS requirements . The EU proposal also does not anticipate any binding agreement between WHO and the recognised databases to make them accountable to the requirements of the PABS system and the COP.

[INSDC stands for the International Nucleotide Sequence Database Collaboration. It is made up of three major sequence databases: GenBank, maintained by the US National Center for Biotechnology Information; the European Nucleotide Archive, managed by the European Bioinformatics Institute in the UK; and the DNA Data Bank of Japan, hosted by the National Institute of Genetics in Japan.]

In summary, the EU’s proposal lacks essential accountability mechanisms for the sharing and use of PABS materials and sequence information. The omission of SMTAs and DAAs removes the very tools that ensure legal certainty, transparency, accountability and equitable benefit-sharing consistent with Article 12 of the PA.

The EU’s proposed system allows unrestricted access to materials and data – without binding commitments, oversight, or enforceable benefit-sharing obligations – creating opportunities for free-riding and potential misuse. In stark contrast to the PIP Framework’s proven contractual safeguards, the EU model dismantles established governance structures and replaces them with a loosely defined laboratory and database network devoid of clear accountability or COP oversight.

Reducing benefit-sharing to corporate charity

Part II of the EU proposal reframes benefit-sharing as voluntary, optional, corporate-driven charity, rather than a mandated obligation, which participating manufacturers “may undertake” at their “discretion”, despite enjoying facilitated access to pathogens and sequence information.

Firstly, it does not make access to PABS resources conditional upon undertaking benefit-sharing commitments and other terms of use. Once a few manufacturers agree independently to share VTDs for pandemic emergencies, the PABS system would then enter into force, granting unconditional access to all other users, even to those manufacturers who haven't undertaken any benefit-sharing obligations.

The very placement of Part II on benefit-sharing, independently ahead of the part discussing “access”, comes with the intent to delink access and benefit-sharing – a vision which the EU and their corporate lobbies cherish. The vision stands in stark contrast to the CBD and the NP, which treat access and benefit-sharing as interlinked legal obligations.

Under Section 2 of Part II, Parties to the PA (States) are obligated to encourage manufacturers to “willingly conclude” benefit-sharing contracts. The contracts are specifically referred to as “benefit sharing contracts” in an apparently deliberate bid to exclude terms of use or access conditions for PABS materials and sequence information. Unlike the standard contracts under the PIP Framework, these would be individually negotiated agreements between WHO and manufacturers, lacking uniformity or enforceable benchmarks.

Only manufacturers of VTDs are expected to participate in benefit-sharing. Section 6 explicitly exempts not-for-profit entities from benefit-sharing. This exception is broad enough to include university research centres or public laboratories that may also develop VTDs. Part II is further silent on commercial entities such as biotechnology and bioinformatic companies that would exploit PABS materials and information for research, innovation or product commercialization, both within and beyond the health sector. On the other hand, all these entities are guaranteed access to PABS materials and sequence information under Section 26. This guarantee is without corresponding benefit-sharing responsibilities.

Sections 7 to 15 of the EU proposal, which talk about benefit-sharing in terms of VTDs, are largely framed as discretionary and flexible, making even the delivery of VTDs committed under Article 12.6(a) of the PA, for declared pandemic emergencies, operationally weak and unpredictable.

[Article 12.6 states: “...in the event of a pandemic emergency, as determined in accordance with Article 12 of the International Health Regulations (2005): (a) each participating manufacturer shall make available to the World Health Organization, pursuant to legally binding contracts signed with the World Health Organization, rapid access targeting 20% of their real time production of safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the pandemic emergency, provided that a minimum threshold of 10% of their real time production is made available to the World Health Organization as a donation, and the remaining percentage, with flexibility based on the nature and capacity of each participating manufacturer, is reserved at affordable prices to the World Health Organization”.]

Sections 7 to 10 of the EU proposal add further conditions and uncertainty to the operationalization of this benefit-sharing. For example, Section 7 states that “Manufacturers may choose to fulfill this provision through partnership with other manufacturers, which may include voluntary licenses”, but what are the implications for the commitment undertaken in Article 12.6(a)? Section 9 states that “Donated products shall be made available ex-factory upon request of the WHO as early as possible in accordance with the provisions set out in the contract” (emphasis added), which suggests a departure from the “real time” production mentioned in Article 12.6(a).

In Section 10, the EU defines “affordable price” mentioned in Article 12.6(a) as including “consideration of equity tiered pricing”. Tiered pricing is nothing more than a standard commercial strategy used by pharmaceutical companies to charge different prices to different countries. Tiered pricing (equity-based or otherwise) does not guarantee affordable prices for a country in need.

All other benefit-sharing requirements, such as licensing for diversification of manufacturing of VTDs, access to VTDs during public health emergencies of international concern (PHEICs), or to prevent outbreaks becoming PHEICs etc., are merely “options” which manufacturers may consider. The consistent use of discretionary language (“may consider”, “may choose”, “as mutually agreed”) converts benefit-sharing requirements under the PABS system into corporate charity arrangements. Even monetary contributions (Section 12) are “on mutually agreed terms” and not mandatory. No methodology is proposed for the determination of monetary benefit-sharing.

Reducing the role of WHO in administering PABS and sharing benefits

Although the EU proposal claims that the PABS system will operate under the oversight of the COP (Section 31), with WHO tasked to “administer” it (Section 32) and an Advisory Group created by the WHO Director-General (Section 34), these assurances are undermined by provisions that embed the so-called “PABS System Partners”, including the private sector, directly into the governance and benefit-sharing structure of the PABS system. The result is a dilution of the public health authority of WHO as well as the COP. This is inconsistent with Article 12 of the PA, as explained above.

It must be noted that even for reporting to the COP regarding the PABS operations, WHO has to consult the PABS System Partners, thereby compromising the integrity and independence of these reports and, by extension, the COP’s oversight function.

Undermining the CBD and NP framework and compromising national ABS laws

Even though what the EU is proposing is a dysfunctional PABS system, it continues to seek a carve-out from national and international ABS laws for products covered under the contracts and any related PABS materials and sequences, with its text in Sections 37, 40 and 42.

Section 37 explicitly requires Parties to align their domestic and regional ABS provisions with the PABS system so that national laws “shall not apply” to any manufacturer participating in the system in respect to any VTD that is covered by a contract concluded by such a manufacturer and WHO or any related PABS material and PABS sequence information. Similarly, Section 40 excludes application of other international ABS provisions. Section 42 then designates the PABS system as a “specialised access and benefit-sharing instrument” (SII) within the meaning of Article 4.4 of the NP – which would automatically exclude the application of the NP to PABS materials and sequence information.

As mentioned above, Article 4.4 of the NP provides that where an SII applies that is consistent with and does not run counter to the objectives of the CBD and NP, the NP does not apply for the Party or Parties to the SII in respect of the specific genetic resource covered by and for the purpose of the specialized instrument. However, what an SII is and the criteria for forming an SII are still being negotiated by the Parties to the NP, and WHO cannot presently make a decision on this issue.

The EU proposal (with the aim to carve out national ABS laws) departs from the agreed international norms of the CBD and the NP, which recognize sovereign rights over genetic resources (Article 15 of the CBD and Article 6 of the NP), and facilitating “appropriate” access to such resources, taking into account those rights (Articles 1 of the CBD and of the NP), and based on the terms and conditions determined in the national legislations (Article 15 of the CBD and Article 6 of the NP). The EU proposal effectively reverses this established legal framework under the CBD and NP that safeguards States’ sovereign control over their biological resources.

In addition, the EU proposal does not contain any corresponding mechanisms for accountability, transparency or traceability to ensure that users of PABS resources are bound by legally binding terms and conditions that include commitments to share benefits fairly and equitably. Nor does it include safeguards to prevent the misappropriation of PABS materials or sequence information, opening the door to both traditional and digital forms of biopiracy.

Although Section 30 refers to an electronic system for registering materials transferred within the Laboratory Network, it limits reporting to “aggregate volumes” and omits public disclosure, whereby no information about the users of the system nor about benefit-sharing by the users will be made available. Sequence information is excluded altogether from traceability. Further, whatever  traceability there is does not apply to recipients of materials and sequences from laboratories and databases sharing onwards to other entities.

Thus, the EU’s proposed PABS system would fail to meet the criteria under Article 4.4 of the NP and therefore cannot be recognized as an SII. To qualify as an SII, an instrument must advance the objectives of the CBD and NP, i.e., appropriate access, taking into account all rights, and fair and equitable benefit-sharing. The EU’s proposal satisfies none of these. Moreover, the EU’s model would permit easy diversion of shared materials and data beyond PABS objectives, including, potentially, for non-peaceful or commercial ends outside PA priorities. Thus, the operational scope of the EU’s model is vague and open-ended, whereas an SII must be narrowly defined for specific genetic resources and explicit purposes (as per Article 4.4 of the NP).