Amid rising disease threats, it is “critical” that the World Health Organization (WHO) presents a completed pandemic agreement to the United Nations (UN) High-Level Meeting (HLM) on Pandemic Prevention, Preparedness and Response in 2026, WHO Director General Dr Tedros Adhanom told member states at the start of negotiations on the final outstanding annex to the agreement on Monday.

“The next pandemic or major global health emergency is not a question of if, but when,” Tedros told the Inter-governmental Working Group (IGWG) meeting in Geneva to conclude talks on a Pathogen Access and Benefit-Sharing (PABS) system.

The PABS annex is due to be adopted by the World Health Assembly in May next year, and thereafter taken to the HLM, said Tedros.

According to Article 12 of the pandemic agreement, the IGWG needs to develop provisions to govern the PABS System, “including definitions of pathogens with pandemic potential and PABS materials and sequence information, modalities, legal nature, terms and conditions, and operational dimensions”.

The negotiation timetable is extremely tight, but the IGWG Bureau has drawn up a draft outline of what PABS needs to cover, suggested definitions and compiled a list of experts to guide the talks.

Some of these experts were suggested at an informal meeting of the IGWG last week. They include the Dr Farida Al-Hosani from the United Arab Emirates, who chairs the WHO’s Pandemic Influenza Preparedness (PIP) Framework Advisory Group; Australia’s Dr Jodie McVernon, director of Doherty Epidemiology and public health lead at the Doherty Institute; Italian pharmocologist Dr Marco Cavaleri, who heads the European Medicines Agency’s (EMA) office of biological health threats and vaccines strategy, and Thailand’s Professor Punnee Pitisuttithum, head of the Vaccine Trial Centre at Mahidol University in Bangkok.

Member states have acknowledged that the process needs expert guidance as the annex will need to harmonise with several international agreements covering intellectual property and trade, as well as the Nagoya Protocol, which determines how to share the benefits arising from the use of genetic resources fairly and equitably.

Standard contracts

Several stakeholders who addressed the open session of the IGWG called for the annex to include standard, legally binding contracts for manufacturers who want to use pathogens to develop vaccines, diagnostics and therapeutics.

Drugs for Neglected Diseases Initiative (DNDi) proposed “model contracts that embed equity”, and “non-exclusive licencing approaches” to enable technology and knowledge transfer and capacity strengthening.

The Third World Network advocated for legally binding contracts and clear governance mechanisms.

The Coalition for Epidemic Preparedness Innovations (CEPI) “embeds contractual obligations for access in our agreements with partners developing pandemic products”, but said that this “only addresses access in one part of the value chain”.

PABS benefit-sharing provisions should not discourage innovative developers and manufacturers, CEPI stressed. 

CEPI is developing a biospecimen sourcing initiative of samples from survivors of infectious disease outbreaks, “which will provide a practical example of how to enable timely, ethical access to clinical specimens for immunoassay development and vaccine development”. 

Avoid ‘excessive obligations’

The IFPMA’s Grega Kumer warned against “excessive or unclear obligations” and “a complex legal maze”, which would undermine the “fragile” pandemic innovation ecosystem.

“Free and unhindered access to pathogens and their associated sequence information is fundamental to global health security,” said Kumer.

“This openness, regardless of origin or intended use, must be preserved to maintain the agility of the research and innovation ecosystem.”

The IFPMA also wants PABS to be operational for pandemics only and not public health emergencies of international concern (PHEIC).

Gavi, the vaccine alliance, called for clear definitions of terms, particularly pathogens with pandemic potential, and called for a PABS system that can “deliver an end-to-end solution, from access to materials and sequence data to the fair allocation and delivery of vaccines, therapeutics and diagnostics”

The European Union’s (EU) Americo Zampetti stressed that the PABS system should “increase the availability and affordability of safe vaccines, therapeutics and diagnostics (VTDs)” during a pandemic emergency.  

It should also “enhance the ability of WHO and other key partners in the UN system and beyond to swiftly and effectively act to save lives by distributing relevant and safe VTDs to those most in need”.

However, he warned that the EU “will not support a system that negatively impacts the innovation ecosystem and disincentivises innovation”.

‘Not a business deal’

Addressing the open session, Bangladesh urged member countries to remember that they are “not negotiating a business deal, but an agreement to save lives”.

Malaysia, speaking for the Association of Southeast Asian Nations (ASEAN), said the association has made significant strides to safeguard members in pandemics, including through the ASEAN Centre for public health emergencies and emerging diseases, biological threat surveillance centre and Emergency Operation Centre network. 

However, the PABS system will provide a “more coherent and structured regional framework for pandemic preparedness and response”, enabling “a regional platform for technology transfer”, pool procurement of VDTs, and building regional research, laboratory, regulatory and manufacturing capacity “so that benefit sharing is translated into lasting resilience”. 

Tanzania, speaking for the Africa plus plus Egypt, Sudan and Tunisia (usually part of WHO Eastern Mediterranean Region), said the annex presents an opportunity to “operationalize equity in tangible ways”.

“The Africa region underlines the need for legal certainty and for the primacy of mutual trust, cooperation, accountability and transparency in the PABS system.”