 |
||
|
TWN
Info Service on Health Issues WHO: WHO Member States proceed carefully with PABS negotiations Geneva, 4 October 2026, (Nithin Ramakrishnan) – WHO Member States are moving ahead, albeit slowly, to carefully build convergence on some of the nuanced issues relating to Pathogens Access and Benefit Sharing. The 8th meeting of the Intergovernmental Working Group (IGWG8) took place on 14 to 18 September 2026 in hybrid mode. The IGWG was established by WHO Member States in 78th World Health Assembly to develop key components of the WHO Pandemic Agreement, in particular the Annex relating to Pathogen Access and Benefit Sharing (PABS) System. The meeting continued negotiations on selected provisions of the draft Annex: Section II on Implementation of the PABS System, focusing on the issue of actions to be undertaken by the Parties to the Agreement upon detection of pathogens, nature of the participants such as laboratories and sequence databases; Section I on the use of the term “pathogens with pandemic potential”; and Section III on Governance on the constitution and reporting lines of the PABS Advisory Group. Although discussions did not result in consensus, convergence on the issues was evident, according to the delegations that Third World Network interacted with during the week. Both the developed and developing countries expressed that the atmosphere of the negotiations remained calm and pleasant, despite divergences on the issues and some isolated moments of tensions. The final report of IGWG8 confirmed the conduct of the informal meetings on 5 to 9 October, ahead of the IGWG9 meeting which will take place on 2 to 13 November. Paragraph 5 of the report reads: “The IGWG then discussed the proposed schedule of October informal meetings which are, as reflected in the timeline adopted by the IGWG at its seventh meeting, to be held from 5 to 9 October 2026, in advance of the ninth meeting of the IGWG scheduled for 2 to 13 November 2026, and agreed that the schedule would be circulated to all IGWG members in advance of the informal meetings. It was further agreed that the informal meetings would be organized by the Bureau and where appropriate led by Co-Facilitators, and would be structured to facilitate understanding leading to convergence, with the aim to develop draft textual proposals for the consideration of the ninth meeting of the IGWG. During the informal meetings, an additional session would be dedicated to a discussion with laboratories, with further details to be provided by the Secretariat. In advance of the informal meetings, the Secretariat was requested to provide discussion draft papers on the WHO Coordinated Laboratory Network and approaches for possible WHO PABS-recognized sequence databases, to be circulated no later than 25 September 2026.” According to a few country delegations each of the elements discussed during this week is foundational and it was agreed that there was no reason for Parties to rush, given the stakes involved. Definition of Pathogens with Pandemic Potential At the start of the IGWG8 negotiations Section I.B.(a) read as follows: “For the purposes of the WHO Pandemic Agreement: (a) “Pathogen with pandemic potential” means any pathogen that has the potential for sustained transmission in humans and the potential to cause a pandemic emergency as defined in Article 1(c) of the WHO Pandemic Agreement. [NOTE: Subject to further consultation – including on risk assessment, non-exhaustive list of pathogens, and exclusion of influenza viruses for the purpose of the PABS Annex] ”. During the week’s discussion this note has been removed, and Member States have come to an understanding that both approaches to the identification of pathogens with pandemic potential, i.e. a non-exclusive list-based approach and the risk assessment-based approach, are important. Accordingly, the negotiating text in Section I.B.(a) now reads: “For the purposes of the WHO Pandemic Agreement: (a) “Pathogen with pandemic potential” means any pathogen that has the potential for sustained transmission in humans and the potential to cause a pandemic emergency as defined in Article 1(c) of the WHO Pandemic Agreement, including / [comprised of]: i) pathogens in the list referred to in III.A.3.p; and ii) [pathogen which is previously unknown or undetected and] novel pathogens [or variants of a known pathogen[, including mutations,]] meeting [all] the criteria referred to in III.A.3.q”. It must be noted that both III.A.3.p and III.A.3.q are yet to be discussed. There is also a note to this text on Section I.B.(a) that says, “subject to further consultations”. According to those familiar with the negotiations, the text underlined and bolded above in Section I.B.(a) have been marked yellow to express some form of initial convergence between Member States that both the list and the risk assessment based approaches will be used to identify pathogens with pandemic potential. Some delegations indicated that there is a new practice, where the IGWG Bureau is marking yellow on the text which is in brackets too. This has created some confusion as to the status of the text. Usually, text inside brackets mean that there are opposing views regarding the words inside the bracket. But then marking them in yellow, conveys a view that there is convergence as well on these words. The main contentious issue in the above language was about the words “including” and “comprised of” in the chapeau, with most developed countries and a few developing countries asking for “including”. Many developing countries seek “comprised of”, such that the scope of the PABS System is definite and clear. There were also detailed informal discussions regarding how the list mentioned above should be developed and what should be the criteria that will be applied to determine the pandemic potential of unknown pathogens. A developing country delegate summarized the key message from this discussion: “The list should be science-based, non-exhaustive, and regularly updated, while the criteria should follow an algorithm that should provide for classifying pathogens. Both list and together should provide clarity to the scope of the PABS system, legal certainty and clarity on the benefit sharing obligations”. According to the delegate, there was also debate on what pathogens need to be covered in the list. Whether a pathogen causing epidemics or having potential to cause a public health emergency of international concern (PHEIC), but not of pandemic scale should be covered in the PABS. Some developed countries wanted access to those pathogens but then were not willing to commit to benefits such as access to health products during a PHEIC or an early outbreak. Many others, including both developed and developing countries, on the other hand started suggesting that the list be narrow at the very least for the first stages. Another developing country delegate told TWN if pathogen materials and sequences need to be shared because it can create a PHEIC or international spread of disease, then there should be benefit sharing not only during a pandemic emergency, but also during PHEICs and outbreak stages. “As long as they (developed countries) object to having access contracts and sharing benefits at early stages, we will not be able to take obligations to share pathogen materials and sequence information. In any case we will have to first do national risk assessments,” the delegate stated. When to Share Pathogens with Pandemic Potential and Sequence Information IGWG8 also discussed the exact process flow of sharing pathogen materials and sequence information, i.e. What happens when a country detects a pathogen? Will it have to share pathogens immediately? If yes, with whom? Or is it enough that the country informs WHO and then later shares them with participants of PABS, upon their request? There seems to be convergence on 4 elements. First, when a pathogen is detected, risk assessment and identification of pathogen will take place. Second, WHO will be notified. Third, materials and sequence information will be made available through authorized or designated entities. Fourth, universal persistent identifiers will be attached to both materials and sequence information. Nevertheless, there is no agreement as to whether Parties will undertake this as a matter of legal obligation. This will depend on the access conditions and benefits that the PABS system will finally offer to the Parties. Many countries in particular developed countries want the pathogen with pandemic potential to be notified to WHO as soon as it is identified and then share the materials and sequence information with other participants of the PABS system upon request. These countries propose that the time gap between identification of pathogens with pandemic potential, and notification is 24 hours. According to sources, the European Union wants to avoid a situation where a pathogen with pandemic potential is identified, but the country avoids notifying or sharing the same, because there is no active risk. Nevertheless, this is not acceptable to many countries, as sometimes such novel pathogens could be identified from remote reservoirs in their territories, while not posing risks of immediate human infection. They argue that there should be risk assessment and only upon such risk assessment, the pathogens may be notified. Therefore, the text currently reads as follows in Section II.B.1, with only the phrase “Each Party” marked in green: “1. Each Party [shall]/[may]:
Participant Laboratories and Databases One of the long-standing debates in the IGWG negotiations is the nature of laboratories and databases that work in the PABS. The major issues are whether they are authorized by national authorities or selected by WHO. Whether they will enter into agreement with WHO and accept terms and conditions with respect to the handling of materials and sequence information respectively. Also, whether and what benefits they will have to share with the WHO. Certain countries opposed the role of WHO in setting up the network of laboratories and databases. Some of them told TWN that the WHO currently maintains several networks, but hardly any of such networks are supporting ABS laws and regimes and this makes them feel WHO will not do a fair job in handling laboratories and databases. However, several developed and developing countries highlighted the role of WHO coordinated Laboratory Network and databases that share sequence information, showing a growing convergence that there should be some specific terms and conditions. Interestingly, what those terms and conditions will be are yet to be finalized. The discussion on the nature of these laboratories and databases is not only a definitional issue, but they also affect the operational aspects. Since there was no commitment from developed countries to make these laboratories and databases network accountable and transparent, there were several attempts by developing countries to put caveat language and/or add critical elements such as “legally binding agreements”, in many paragraphs referring to these entities. According to sources, Indonesia and Mexico suggested to Member States from both sides to refrain from inserting all elements they want into every other paragraph. They called for a step-by-step approach. They requested first to have a paragraph/provision to simply mention who the participants are. Second, they called for another paragraph which talks about how they are established and by whom and finally, a third provision to detail their purposes and terms of use with respect to pathogen materials and sequence information. The proposal was appealing to most in the negotiating room. Meanwhile, the Co-Chair of the IGWG Bureau also proposed to separate “terms of reference” from “terms and conditions” with respect to laboratories and databases. According to the Co-chair, the terms of reference (ToRs) are technical and scientific in nature and need regular updating, unlike other terms and conditions in the agreement between laboratories and WHO, and databases and WHO which could deal with issues of material transfer, information sharing, benefit sharing, dispute settlement etc. The Co-chair proposed ToRs will be a stand-alone document outside the Annex and the instruments (agreements/contracts) to be signed by the laboratories and database with WHO. Annexes and instruments will refer to ToRs, which would then create an obligation on the entities to abide by the ToRs as well. Indonesia proposed the following text to Paragraph 6 of Section II.A: “The Participants of the PABS system shall include: (a) Laboratories, constituting WCLN, subject to T&C established herein. (b) Sequence databases subject to T&C established herein”. This text proposal generated some initial convergence; however, several delegations then populated the text and the text has currently become lengthy and complex. PABS Advisory Group A PABS Advisory Group has been proposed as a technical expert group overseeing and supporting the implementation of the PABS system in Section III of the Annex, dealing with PABS governance. The major debate on the establishment and operations of the PABS Advisory Group was on the appointment of members of the expert group. Many countries want such a group to be constituted of experts appointed by the Conference of Parties (COP). Some others want the WHO Director-General to constitute the group by selecting experts from the WHO Roster. While developing countries came together with a view that it should be COP appointing the members of the group, the Africa Group proposed a method where regions nominate experts and COP appoints them. This was not acceptable to many regions such as the Western Pacific (WPR) and Pan-American (PAHO) regions. Meanwhile, developed countries tried to refer to the WHO Regulations for Expert Advisory Panels and Committees and indicated that the regulations might provide a flexible approach, where parties nominate experts and the WHO Director-General appoints them. They also insisted that the Advisory Group should first report to the Director-General, before the document is made available for COP. A developing country delegate said the developing countries are not willing to make the WHO Director-General the immediate reporting line for the PABS Advisory Group. “We are very clear the WHO Secretariat can have an administrative function of transmission, but the PABS Advisory Group has to be independent of any form of Secretariat influence and must report their recommendations and findings to the COP,” the delegate explained.
|
||
