TWN Info Service on Health Issues (Oct25/02)
22 October 2025
Third World Network

WHO: Resource Persons Stress Need for Accountability in Pathogen Access & Benefit Sharing System (PABS)

Kochi, 22 October (Nithin Ramakrishnan) – Exchanges with resource persons convened by the WHO to inform the Intergovernmental Working Group (IGWG) negotiations on the Pathogen Access and Benefit-Sharing (PABS) System underscored the need for mechanisms to ensure transparency and accountability within the new framework.

The outcome of the negotiations will be an Annex to the WHO Pandemic Agreement adopted by the World Health Assembly in May 2025.

This includes the establishment of standardised, legally binding contracts requiring users to accept standard terms of use and comply with benefit-sharing obligations when accessing PABS materials and sequence information.

The exchanges with the resource persons were organised as a part of a week-long informal IGWG meeting on 6-10 October.

There were 5 sessions of 1 hour 50 minutes each, where delegations interacted with the resource persons working in areas of relevance to the PABS System. These sessions were open to all relevant stakeholders. They covered the following: 

·         Public health events and risk assessments;

·         PABS materials and laboratory networks;

·         PABS Sequence Information and Databases;

·         Development and Manufacturing of Vaccines, Therapeutics and Diagnostics (VTDs);

·         Other ABS instruments and mechanisms.

Across the different sessions, resource persons highlighted both responsible sharing of PABS resources and the effective implementation of fair and equitable benefit-sharing obligations. Each of these sessions was followed by closed discussions only among WHO Members.

Each session brought to the table a set of information, mostly known already; nevertheless, such information underscored the need for better governance of the PABS system.

Information shared by the resource persons consistently demonstrated that mechanisms advocated by developing countries such as WHO-coordinated governance, access based on user registration, and pre-agreed benefit-sharing obligations are not theoretical constructs but proven approaches already implemented in practice. Such information can also help dispel concerns expressed by some developed countries that these instruments might impede research or innovation.

Overall, the exchanges with resource persons made it clear that every component of the PABS System from the sharing of PABS materials and the use of sequence information must be governed effectively, with robust measures to ensure accountability and transparency, in order to close the loopholes that could otherwise emerge in the design and operation of the system.

PABS materials and laboratory networks

The WHO Secretariat presented on several laboratory networks it coordinated such as the Global Influenza Surveillance and Response System (GISRS), WHO Coronavirus Network (CoViNet), the Global Polio Laboratory Network (GPLN), Global Measles Rubella Laboratory Network 2025, the Arbovirus Diagnosis Laboratory Network of the Americas (RELDA), WHO Emerging and Dangerous Pathogens Laboratory Network (EDPLN), Global Alliance of Laboratories for High Threat Pathogens (GLAD-HP), and the BiSoHub System.

Nevertheless, it emerged during the discussion that, except in the case of influenza virus of pandemic potential (governed by the PIP Framework), polio and smallpox, there was little World Health Assembly oversight over the operation and governance of these networks.

(The PIP Framework is the WHO Pandemic Influenza Preparedness Framework implemented since 2011 that contains benefit sharing obligations.)

Some questions were raised about overlaps in the networks and possible fragmentation, reinforcing the benefits of streamlining their governance and operational aspects of these networks.

Another resource person for the session, Anne von Gottberg, from the National Institute for Communicable Diseases (NICD), South Africa, referred to the importance of “neutral” and “contractually bound” laboratories to avoid confusion about “who is to be trusted” for sharing specimens and to “reduce operational burden”.  She also stressed the need for the “political buy-in” of these contracts.

“So we have the specimens, and we were asked by multiple countries to send, and it was completely overwhelming for us as one laboratory to be able to send to all those countries ,..  there were politically big countries wanting the specimens or the vaccine manufacturers or people wanting to do serology ...” she said, adding that clarity in these aspects could be managed through better WHO coordination, especially when there are contractual relationships between laboratories and the WHO.

Prof.  Kanta Subbarao from the WHO Collaborating Centre for Influenza was very confident of the work within the scope of the PIP Framework, and said that there are laboratories that have appropriate biosafety and biosecurity. These are traceable, and they upload the sequence information from pathogens into GISAID (a database for influenza virus sequence data) after sequencing and confirming the sequence. “We work within the prior agreements that had been generated by PIP, and we... use SMTAs for transport (of biological materials),” Prof. Subbarao added.

[There is significant positive WHO experience in using Standard Material Transfer Agreements (SMTA) for the sharing of biological materials of influenza virus of pandemic potential in the context of the PIP Framework, when sharing among GISRS labs (SMTA1 is applicable) as well as outside of such labs (SMTA2 is applicable). The SMTAs set out the terms of use of PABS Materials as well as benefit sharing obligations.]

Comments of resource persons highlighted that in the absence of an agreed framework based on standardised legally binding contracts, underpinning WHO’s coordination of laboratory network, there is likely to be mistrust, duplication, fragmentation, compromising not only benefit sharing but also timely access to pathogen materials and sequence information.

Therefore the PABS System, via standard material transfer agreements, transparent and accountable governance systems, presents an opportunity to establish a structured network for the sharing of PABS materials and sequence information with designated laboratories under WHO coordination, which would help ensure greater predictability, transparency, and equity in the functioning of WHO-coordinated networks.

PABS Sequence Information and Databases

The discussion focused on the GISAID model for sharing sequences, which protects the rights of the submitter by requiring user registration and acceptance of the data access agreement, before allowing access to sequence information. This model (but applied to a WHO database that is multilaterally governed) is also the preferred approach of developing countries, for it provides an accountable system for sequence information sharing, which can support operationalisation of fair and equitable benefit sharing.

In contrast, databases like the INSDC do not require any identification of the user nor data access agreements, allowing anonymous access.

[INSDC stands for the International Nucleotide Sequence Database Collaboration. It is made up of three major sequence databases: GenBank – maintained by the U.S. National Center for Biotechnology Information; 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.]

The current system for sharing of sequences is also happening through databases outside of the governance of WHO Members. There is also no guarantee that researchers will be granted access without discrimination. These databases also do not implement systems that ensure compliance with internationally accepted principles on access and benefit sharing (ABS) and thus can be said to be contributing knowingly or unknowingly to bio-piracy.

Hence, the debate revolved primarily around introducing accountability in the sharing of sequence information, such as the value of user registration and data access agreements.

Kieny also commented that if the WHO can help coordinate or oversee “a constellation of databases” that operate under the same principles, that would “serve best” the purpose of the Pandemic Agreement.

Another resource person, Nada M. Melham from American University of Beirut told the IGWG that the sequence information of pathogens of potential epidemic and/or pandemic threat is mainly shared through research activities or outputs or through relational pathways between national health authorities and academic institutions using the available platforms that they work with, but stressed that such platforms lack transparency. She also expressed concerns that segregated data and metadata sharing compromise the link between sequence information and epidemiological or clinical data, leading to delays in guiding public health policies and shaping innovation in research.

Melham also asserted that user-friendly and “harmonized platforms” are extremely important for the management of interoperable and accessible systems. “The latter would effectively address bottlenecks such as data duplication, lack of structured storage formats, as well as variation in data collection practices, thus promoting coordination for sustainable sharing of sequence information.”

She suggested that to address the legality of sharing the information and global access, agreements with Member States and with public health authorities are important.

Josefina Campos (WHO Hub for Pandemic and Epidemic Intelligence) talked on how rules of data-sharing licenses and use of Digital Object Identifiers can promote accountability, calling for a mechanism to trace sequence data, to cite and to make sure that there is an accountable reference to the origin of that data. She also spoke about the possibility of the WHO developing licensing arrangements that can be applied across databases, which would then set the terms of use applicable to the users.

Oliver Morgan (WHO Health Emergencies Program), meanwhile, spoke about unique identifiers and the possibility of developing “PABS-ID”, another universal unique identifier. Responding to queries from developing countries, Morgan also agreed with the need for maintaining some identifiers persistently and the role of governance in this regard. “We do that regularly in other domains that are non-pathogen genome domains,” he stressed.

A stakeholder queried about interoperability between databases with user registration and data access agreement, and databases without such attributes and the impact on R&D.

The response from the resource person was that it is not a question of interoperability, but a question of the purpose why those two models exist.

Kieny replied, “The crux of the matter is that (data access) should not be anonymous. Because if it's anonymous downloading, anybody can download and do whatever they want with it ...”  She was also categorical that sharing data from a protected database (i.e. with user registration and data access agreement) to an unprotected database would “defeat the purpose” of the protected database.

She added that “many Member States and scientists want their right to be preserved. So is identification and registration putting any barrier on R&D? Not at all. Because most of the scientists, WHO scientists, but scientists in NIH all over the world and manufacturers, scientists in companies have their... account, if I may say, the personal account within GISAID. So the very first minute a sequence is available, everybody can access it, individuals who register can access it and start working on it. So there is no barrier to R&D, if the database is using registration.”

Melham responded saying that cross-talk between two systems is important; nevertheless, she also pointed out the need for the ability to trace data and users, not only cross-talk. Responding to the queries from the Chair about whether databases need to be standardised or data structures need to be standardised, she explained her preference to standardise data structures. She said that “availability of consistent data structure ... is better and would promote the cross-database integration, analysis, and interoperability”.

At a separate session of the informal IGWG, Gagandeep Kang, a resource person from Product Development for Vaccine Advisory Committee and Strategic Advisory Group of Experts (SAGE) for Vaccines and Immunizations Working Group on COVID-19 Vaccines, also talked about a platform named Terra, which allows for analysis, secure sharing, and global collaboration on biomedical data.

South Africa queried on the efficiency of the workbench solutions that Terra provides (data analysis without copying or moving data from its original source) and its suitability for sequence analysis.

Kang responded, saying, “In Terra, there are both commercial users as well as users for whom access has been enabled for free. And across many countries, there are researchers are using TERRA for being able to analyze their own sequences.” However, she cautioned that the original funding for the platform was from the United States and the funds need not be predictable and sustainable in future. 

A synthesis of the discussions on databases made it clear that requiring users of sequence information to identify themselves and agree to standard terms and conditions as well as having unique identifiers are all, desirable, doable and do not hinder R&D. The discussion also highlighted the critical need for a network of databases adhering to common standards including shared metadata fields, compatible data exchange mechanisms, and standardized formats, if the current challenges of interoperability are to be addressed meaningfully.

This underscores the importance of the Group of Equity’s proposal that databases should participate in the PABS system by entering into agreements with the WHO, thereby ensuring accountability and transparency under the authority and guidance of the Conference of the Parties to the Pandemic Agreement.

The establishment of a central WHO PABS database or repository – as described differently by several developing countries such as Malaysia and South Africa – would significantly enhance the effectiveness of such a network by serving as its central node or coordinating hub. Indeed, the Group of Equity also has rightly emphasised the necessity of such a WHO database.

Development and Manufacturing of Vaccines, Therapeutics and Diagnostics (VTDs)

Another crucial point of debate during the informal IGWG was the definition of participating manufacturers. The European Union (EU) and other developed countries have been keen to limit the definition only to entities presently engaged in manufacturing VTDs, excluding developers of VTDs, despite existing precedence in the context of the PIP Framework, which has a more comprehensive and inclusive definition of manufacturers.  

By limiting the definition, the EU and its allies are seeking to limit users of PABS materials and information that will be required to sign the SMTAs and data access agreements and provide fair and equitable benefit sharing. The EU and its allies are also opposed to any terms and conditions applying to other users of PABS materials and information.

The Chair invited the resource persons to comment on the technical implications of defining ‘participating manufacturer’.

Information from the resource persons confirmed the existence of early-stage researchers and developers (who would also hold intellectual property) accessing PABS material and sequence information. Most resource persons, with some exceptions, explained that while researchers or developers like to have rapid access to PABS materials and information, having pre-agreed benefit-sharing arrangements will provide for better and faster access. 

 Amadou Alpha Sall, from the Technical Advisory Group on COVID-19 Vaccine Composition said that “agreeing on benefit sharing provision for ethical sourcing of biospecimens can accelerate and facilitate research and innovation and help build this trusted partnership that we need in advance of the next pandemic”.

Explaining the concept of ethical sourcing, Sall said, “it's very, very important when we talk about preparedness. We do it with the community and we make sure, when we do that, their rights are protected. And that's why I was insisting on the sourcing, but the sourcing has to be ethical because what we have from the people – the sequence that's going to be derived in all the information – is going to somehow lead to a development that may lead to huge benefit. So it's important that everything is done correctly from the first part. That's what I mean really in ethical sourcing and with the consent of the people, with the framework that would save their rights and make sure actually the benefit somehow to its community”.

Sall also said that “the Member States of the WHO should really establish conditions on public research and development funding during non-pandemic periods to ensure that broadly applicable scientific innovations, such as immunogen design, remain globally accessible. They can rapidly be utilized in all regions of the world when an outbreak occurs. In this regard, it's also important to understand that to enable equitable access to countermeasures, perhaps benefit sharing must focus on building trust in R&D and manufacturing partnerships in advance. It means that in peacetime - that's when we can do that”.

Deusdedit Mubangizi explained that often contract manufacturing organizations (CMOs) were involved in manufacturing VTDs on behalf of the product developer and that these manufacturers “don't have the rights or benefits, they don't have the right to ownership of the product”.   

Mubangizi also made a further critical observation drawing on his experience being involved in the WHO pre-qualification of VDTs. He said, “You may have great manufacturing capacity in one, but when they are shut down by a pandemic, whether they are good or not, the workers cannot go to the industry, to the factory, or there's no transport for that, or even... I mean, the ports are closed and there's a shutdown. So we should see that geographically diversified manufacturing should be part of an instrument (PABS instrument) to make sure that we have capacity for manufacturing to respond to the pandemic”.

Sylvie Briand explained the relevance of WHO stockpiles in containing the spread of a pathogen. She said “interest of having a stockpile at global level is useful to have VTDs in hand to respond quickly to emergencies so that we can contain the outbreak” adding that “it's also very important when there is a limited production of VTDs. So by having a stockpile, we can have a predictable demand and negotiate with manufacturers the cost of those... so that it's more affordable”. She explained further that currently stockpiles are built or replenished through donations, and/or by purchase of countries which have the capacity to do so and that stockpiles are also nowadays usually maintained by the manufacturers. 

Gagandeep Kang stated that “if we can do really well-designed technology transfer and licensing arrangements, that is an incredible contribution to global health security and promotes equitable access and regional preparedness for any kind of pathogen threats. Acknowledging that multiple actors come before manufacturers, Kang was clear that “... thinking about what it takes for us to move forward as quickly as possible with vaccines, with therapeutics, with diagnostics – actually requires us to have had some experience of doing tech transfer and licensing before the emergency arises, because that is the most efficient way of doing it”.  

Various interventions, therefore, indicated that the proposed definition of participating manufacturer is too narrow, stressed the need for manufacturing licenses to be provided to developing country manufacturers to rapidly scale up production, and the real benefit is preparedness achieved through diversification of production and management of emergency stockpiles that can prevent outbreaks from becoming emergencies.

Other ABS instruments and mechanisms.

Resource persons also presented on various ABS instruments, including the PIP Framework, the Convention on Biological Diversity (CBD) and its Nagoya Protocol on ABS, the CBD Multilateral Mechanism for the Fair and Equitable Sharing of Benefits Arising from the Use of Digital Sequence Information (DSI), including the Cali Fund, the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), and the Agreement on Marine Biodiversity Beyond National Jurisdiction (BBNJ), which covers marine genetic resources of the high seas.

The resource person from the CBD, Kathryn Garforth, clearly articulated that “expeditious access to medical treatments” is a special consideration that Nagoya Protocol Parties should take into account when designing ABS systems for public health.

The discussions on the CBD’s Multilateral Mechanism and the Cali Fund made it clear that the use of DSI is subject to national legislation, and that mutually agreed terms established at the time of sharing genetic or biological materials can address DSI generated from those materials. It was also pointed out that the CBD’s Multilateral Mechanism will be operationalized in a complementary and mutually supportive manner with other international ABS instruments, and will not be implemented in a duplicative way.

As long as WHO maintains an ABS platform that covers DSI generated from the use of pathogens shared under that platform, the CBD Mechanism will not exercise jurisdiction over such information. Consequently, industry concerns about the stacking of obligations are effectively removed.

The BBNJ representative provides the current status of the Agreement and emphasised the need to operationalise its ABS mechanism in the coming days (BBNJ is expected to enter into force in January 2026).The discussion also extended to the use of batch identifiers, which, according to the resource person, is instrumental in achieving monitoring and transparency, as well as in implementing notifications at different stages of activities related to marine genetic resources and DSI. There are also ongoing discussions on how the standardised batch identifier developed under the BBNJ could be utilized within existing databases. It was also recalled during the meeting that, unlike the WHO and CBD frameworks, BBNJ addresses marine genetic resources in the high seas, where no country exercises sovereign rights.

Some developed country delegations expressed concern that non-commercial researchers might hesitate to use formal access agreements and the same would hinder research and innovation. However exchanges with resource persons dispelled lingering doubts about the role of formal access instruments – SMTAs and data access agreements – in scientific research. It became clear that these instruments are a normal part of any research process, and non-commercial users often sign such agreements.

The ITPGRFA representative reported that more than 110,000 SMTAs have been concluded, covering over seven million transfers of materials – mostly by public or non-commercial institutions. The users of the ITPGRFA system signing SMTAS are mainly non-commercial researchers. The PIP framework also continues to work efficiently, whereby any entity outside the GISRS laboratory network has to sign SMTA2 to receive the pathogen sample and this has not deterred R&D.+