“Inadequate” and “unbalanced” were some of the complaints levelled against the first draft of a Pathogen Access and Benefit-Sharing (PABS) system when World Health Organization (WHO) member states met for text-based negotiations in Geneva on Monday.

Once agreed, the PABS system will be an annex to the Pandemic Agreement, but several member states at the Intergovernmental Working Group (IGWG) described the first draft as simply a “cut and paste” of text already in the agreement.

However, even before text-based negotiations began, members confronted a contentious process issue. Despite an agreement at the last IGWG meeting in September that “relevant stakeholders” would be included as observers in the negotiations as a “pilot”, it emerged that some member states had privately objected to this. 

This prompted IGWG co-chairs to call for more consultation “for a day or two” before opening the doors. 

“Not everybody is comfortable to proceed with the pilot at IGWG 3, but I do want to reassure those with concerns that we will actively talk with you as members, talk with relevant stakeholders, to find a way forward,” said an apologetic IGWG co-chair Matthew Harpur, adding that some member states were particularly uncomfortable with the drafting process being opened to stakeholders.

However, Brazil, supported by Colombia, objected to the process U-turn and called on member states with objections – reputed to be Russia and its allies – to stand up and discuss these openly.

First draft is ‘just a first draft’

WHO Director General Dr Tedros Adhanom Ghebreyesus described the draft as “a genuine attempt by the Bureau [the IGWG administration] to find as much middle ground as possible based on the input of member states and relevant stakeholders”. 

“But of course, a first draft is just a first draft, and we all know that further discussions will be needed to bring views and positions closer together,” he added, noting that only three further IGWG meetings remain until the April 2026 deadline.

“Bringing it to completion will require you all to engage in open and frank discussion and to find compromise and flexibility,” added Tedros.

There was consensus that the seven-page draft was inadequate as it does not set out in enough detail how information about pathogens with pandemic potential can be shared, and how countries sharing this information can access any vaccines, therapeutics and diagnostics (VTD) that arise from them sharing this with pharmaceutical companies.

Tunisia, speaking for the Eastern Mediterranean Region (EMRO), said that if the PABS system is to be “reliable and functional, all participants need clarity on how it will operate in practice”. 

EMRO wants the PABS annex to “establish standard material transfer agreements, as in the Pandemic Influenza Preparedness (PIP) Framework” along with terms and conditions that define the rules and responsibilities of providers, laboratories, databases and manufacturers. 

It also wants the annex to explicitly include the transfer of technology to enable different regions to produce their own VTDs.

Lack of operational detail

Indonesia, representing the Group of Equity, also criticised the lack of operational detail about how the PABS system would work, and the “lack of legal certainty regarding rights and obligations” of both providers of pathogen information and users of the PABS system.

Advocating for immediate line-by-line negotiations, Indonesia called for benefit sharing that “fosters geographically diversified local production, including through non-exclusive licences to manufacturers in developing countries”. 

Zimbabwe, speaking for the WHO Africa region plus Egypt, Somalia, Sudan and Libya, described the draft as “inadequate”, asserting that “a PABS system that lacks enforceability becomes a charitable model, and charity is not equity.

“Equity cannot remain aspirational language. It must be operational, enforceable and guaranteed to avoid repeating the catastrophic inequities witnessed during the COVID-19 pandemic,” added Zimbabwe.

South Africa fleshed this criticism out, calling the draft “unbalanced” for enabling access to pathogen information without legally binding benefit-sharing terms.

While the European Union (EU) said it did not have a detailed response to the text, it warned against onerous benefit-sharing terms.

“An implementable PABS system can only encourage, as opposed to compel or coerce, stakeholders, in particular, manufacturers of vaccines, therapeutics and diagnostics, to participate by voluntarily signing legally binding PABS benefit-sharing contracts,” said the EU.

Norway, speaking for Australia, Canada, Japan, Switzerland and the UK, said that the annex needs “precision and flexibility”.

“Market failure is the norm, not the exception, for emerging infectious diseases”, with research and markets “driven almost exclusively by public funding”.

“This has serious implications for what we can expect to deliver through the PABS system,” Norway warned.

It called for engagement with experts and the need to test concepts, including through simulation, “to ensure that we can build a feasible and implementable PABs system”. 

Stakeholder reflections

The Pandemic Action Network (PAN), speaking for several other stakeholders, said that the annex “must fully operationalise Article 12 of the Pandemic Agreement, and it must create legal certainty for benefit sharing”. 

The heart of the Pandemic Agreement includes the agreement that, during a “pandemic emergency”, each manufacturer participating in the PABS system will target to make 20% of their real-time production of safe, quality and effective VTDs available to the WHO, with at least 10% of this as a donation.

“More details are needed to advance the 20% real-time production goal, including on non-exclusive licences and technology and knowledge transfer, as well as on timelines, traceability and accountability,” said PAN.

The South Centre stressed that the PABS system needs to align with international rules and proposed that it include “standard contracts” with manufacturers.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said that the annex needs to define measures “to strengthen, facilitate and accelerate research and innovation, as well as the fair and equitable sharing and distribution of benefits and avoid reopening already agreed principles”. 

However, the IFPMA said that the current draft “introduces overly broad definitions that could capture pathogens with no real pandemic potential and mandatory financial contributions that will disincentivise participation”. 

The IFPMA also warned that the draft fails to ensure that national Access and Benefit-Sharing (ABS) laws “will not apply to PABS,  leading to potential stacking of obligations and legal uncertainty”.

ABS regulations are country regulations that set out the terms for obtaining genetic resources and sharing the benefits derived from them, based on the Nagoya Protocol and the Convention on Biological Diversity (CBD).

The IFPMA also said that the draft harms “critical innovation by making broad restrictions on intellectual property”.

“These provisions not only fall short of offering practical solutions to improve equitable access, but they also actively threaten the mechanisms that enable the industry to rapidly develop and scale up delivery of effective products during the last pandemic,” the IFPMA concluded.

Most stakeholders appealed for full access to the talks, as previously agreed. Knowledge Ecology International stated that an open and transparent negotiation process, as is the practice at the World Intellectual Property Organization (WIPO),  would help to diminish misinformation about the Pandemic Agreement.