TWN Info Service on Health Issues (Dec25/01)
3 December 2025
Third World Network

Developing countries call for standard PABS contracts under Pandemic Agreement

Geneva, 3 Dec (Sangeeta Shashikant and Rajnia de Vito) – The Africa Group and the Group for Equity plus Egypt, Libya, Somalia and Sudan, representing more than 80 countries and around 75% of the world’s population, have called on the Intergovernmental Working Group (IGWG) negotiating the Pathogen Access and Benefit Sharing (PABS) Annex to the Pandemic Agreement to begin negotiations on standardized PABS contracts, emphasizing that this “important work cannot be deferred to the Conference of the Parties”.

Following the statement on 1 December, the coalition presented three standard contracts for the consideration of the IGWG the following day:

• PABS Material and Sequence Information Agreement 1 – Standard Material Transfer Agreement Within the WHO Collaborating Laboratory Network (WCLN)
• PABS Material and Sequence Information Agreement 2 – Standard Material Transfer Agreement for the Sharing of PABS Materials and Sequence Information from WCLN Laboratories and Recipient Outside of WCLN
• Data Access Agreement – Applicable to Any Person/Entity Registered with the WHO PABS Sequence Database or the WHO-Recognized Sequence Database to Access PABS Sequence Information (SI Recipient)

The 4th session of the IGWG is taking place in Geneva from 1–5 December.

In a show of unity, Zimbabwe, speaking for the Global South coalition, said that the “PABS Annex must articulate the full operational details of the PABS System”. It added that finalizing standardized contracts now will give governments clarity as they consider ratification and will ensure the system is fully operational at entry into force.

On behalf of the coalition, Zimbabwe said that much of the necessary content already exists in the “access” and “benefit sharing” sections of the text under negotiation and can be reorganized into contracts, which must cover not only benefit-sharing obligations but also the rights and responsibilities of providers and users, including terms of access and use.

Zimbabwe clarified that while participation is voluntary, access to PABS Materials and Sequence Information would depend on acceptance of contractual terms – essential for respecting sovereign rights, preventing free-riding and building trust.

Zimbabwe also underlined the need to address biosafety and biosecurity risks, including those amplified by advances in AI-enabled DNA design, to ensure the Pandemic Agreement is future-proof against emerging threats.

[The statement of the Africa Group and the Group for Equity plus Egypt, Libya, Somalia and Sudan is reproduced below.]

IGWG-3, held between 3 and 7 November, had ended with a draft PABS Annex full of insertions and heavily bracketed text, revealing deep North-South divisions across the text, as reported earlier.

Many hope that the standard contracts presented by the coalition for the consideration of the IGWG will facilitate the IGWG negotiations, as the IGWG is mandated to complete its tasks by the time of the World Health Assembly in May 2026.

Zambia reiterated the calls from the Global South, arguing for setting the full operational details of the contracts under the PABS system. “Some provisions in the draft annex would be better suited under contracts. Moving relevant provisions to contracts, which would be discussed at some stage under the IGWG process, would help us to further streamline the text. […] Article 12.9 provides leeway for the IGWG to consider other elements that would enhance the operationalization of the PABS system. We therefore wish to emphasize that this process should operationalize Article 12 in its entirety. A skewed focus on a few clauses of Article 12 in the drafting and negotiation process would undermine legal certainty,” Zambia said.

Uganda, aligning itself with the coalition, said that its position is based on previous experiences with Ebola, Marburg and mpox, and that “predictable and equitable sharing of benefits is a matter of life or death”.

Uganda proposed that “definitions and user terms be finalized in parallel with the negotiation of substantive provisions rather than in isolation at the very beginning. Terminology must emerge from and be informed by the practical realities of the provisions themselves. This is essential for clarity, coherence and operational relevance”.

During the open session with relevant stakeholders at the end of the first day of IGWG-4, there was support for the developing-country positions.

A Third World Network (TWN) representative said that the present draft text lacks legal clarity and operational details required to make sure the PABS system promotes trust, equity and effective early response, reaffirming that access to materials and predictable benefit sharing are inseparable pillars of the PABS system.

TWN argued that Article 12.5(b) requires implementation through legally clear, enforceable modalities covering both countermeasures and monetary benefit sharing. It further called for stronger governance provisions, including greater specificity on the Conference of the Parties’ oversight role, full transparency in PABS operations, and WHO-led administration of the PABS system.

Regarding parallel legal frameworks regulating similar resources, Knowledge Ecology International (KEI) explained that, contrary to a narrative disseminated to IGWG members, the European Health Data Spaces Regulation is a comprehensive framework. KEI clarified that the EU rules, in force since March 2025, include regulations on a comprehensive array of aspects, like patient records, genomic data, pathogen data, blood samples, clinical trial information and more. It creates a structured system for researchers seeking secondary use of data, with obligations for authorization, appropriate use, record keeping and audits.

KEI suggested that this framework creates a highly regulated system of access for researchers who want to benefit from the system for what are referred to as secondary uses of health data. “The data space regulation sets out a system for registration of users of the data and obligations to ensure that the data is only used for authorized purposes and to keep records and be subject to audits. These provisions may provide a useful model for some elements of the PABS,” KEI said.

Global Vaccine Alliance (GAVI) said that the PABS Annex should clearly describe how pathogens with pandemic potential will be identified, classified and, when necessary, reclassified. The definition should be grounded in scientific evidence and the process for updating should be transparent and guided by an independent scientific body, it said, adding that such a process will help maintain consistency, predictability and trust among all the stakeholders.

GAVI also highlighted the need for the contracts to include robust benefit-sharing commitments in the event of a public health emergency of international concern (PHEIC), including, for example, a minimum percentage of real-time production of vaccines, therapeutics and diagnostics which targets the pathogen causing the PHEIC.

The South Centre cautioned against any imbalance between access obligations and those governing use and benefit sharing. It noted growing support for standardized contracts as a core implementation tool for Article 12 offering legal clarity to providers, researchers and manufacturers. Such contracts, it argued, should include clear specifications for benefit sharing and traceability, thereby enhancing transparency and trust throughout the system.

Médecins Sans Frontières (MSF) urged that access and benefit-sharing obligations in PABS be mandatory, binding and treated equally. It reminded members of their obligations to promote technology transfer and non-exclusive licensing as per the Pandemic Agreement. MSF also called for full transparency, including public disclosure of PABS recipients, concluded agreements, allocation decisions, and regulatory approval information for products developed using PABS resources.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), representing industry interests, contradicted the calls that echoed the Africa Group and the Group for Equity, arguing that current proposals introduce excessive bureaucracy, restrict access and create legal uncertainty, which could deter research and development. IFPMA called for flexibility in meeting the 20% real-time set-aside, and opposed traceability requirements as “onerous”.

[IFPMA had also been opposed to the operationalization of access and benefit sharing in relation to influenza viruses with pandemic potential (IVPP). It opposed use of standardized contracts applied to recipients of IVPP materials, making similar arguments. Yet the Pandemic Influenza Preparedness (PIP) Framework adopted in 2010 has since greatly benefitted IFPMA members and is generally considered an innovative way of promoting equity.]

The following is the statement of the Africa Group and the Group for Equity plus Egypt, Libya, Somalia and Sudan presented at IGWG-4:

• I am delivering this statement on behalf of the Africa Group and the Group for Equity, representing more than 80 countries and nearly 75% of the world’s population. 

• We reaffirm that the PABS System is the heart of the WHO Pandemic Agreement. It must deliver on the promise of equity. We underline the importance of timely conclusion of the PABS Annex, for submission to the next World Health Assembly. 

• To achieve this, we must continue text-based negotiations, with all Member States’ textual proposals clearly reflected on the screen. Our two Groups have engaged constructively and provided substantive inputs throughout IGWG-3, and we hope to “yellow” some texts in IGWG-4.

• We firmly believe that the PABS Annex must articulate the full operational details of the PABS System. In this regard, IGWG-4 must also begin the negotiations on the PABS contracts. This important work cannot be deferred to the Conference of the Parties. 

• Finalizing the standardized contracts in IGWG will give clarity on the obligations of PABS users. Such clarity is essential for our governments as they consider ratification of the Agreement, and also to enable full operationalization of the System upon the Agreement’s entry into force. 

• Most of the critical elements of the PABS contracts already exist in the “access” and “benefit sharing” sections. Some of them can be reorganized into the contracts and will fit better there. 

• We reject a notion that the PABS contracts would only set out details of benefit-sharing obligations. The contracts will also define the rights and responsibilities of providers of PABS Materials and Sequence Information, as well as users of the PABS System, including terms of access and terms of use. 

• Entering into PABS contracts will, of course, be voluntary. No one is compelled. But access to PABS Materials would be granted only upon acceptance of terms and conditions in the contracts. 

• This is key to ensuring respect to countries’ sovereign rights over their genetic resources, preventing free-riders, and building a trusted ecosystem, in which all actors understand and uphold their obligations. 

• Encouragingly, many stakeholders […] in the informal interactive dialogues last week have expressed readiness to participate in the PABS System. 

• Our two Groups also reaffirm that benefit sharing is not optional. It is mandatory. We cannot backtrack from what we have agreed in Article 12. 

• At the same time, Paragraph 12.9 of the Pandemic Agreement also enables us to consider additional elements necessary for the fair, transparent, accountable, and equitable functioning of the System. We urge other IGWG members to take part in detailing benefit-sharing obligations of participating manufacturers during a PHEIC and in peacetime, as well as benefit-sharing obligations of other users of the System. 

• We suggest beginning with the “Governance and Review” section of the Annex in IGWG-4, noting that it may provide a constructive entry point for our discussions. 

• We would also welcome continued informal discussions on key elements of the PABS System, but these should only complement, and not in any way replace, the drafting sessions. Both must be used to their fullest. 

We stress the importance of addressing biosafety and biosecurity, especially as new technologies create new risks. Advances in artificial intelligence are making it easier to design DNA sequences. [In] the wrong hands, these tools greatly increase the risk of engineered pathogens, whether through misuse or accidental release. Our Agreement must, therefore, be future-proof and prepared for these emerging threats