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TWN
Info Service on Health Issues (Dec25/02) WHO: Europe continues to defy emerging consensus on PABS Geneva, 17 Dec (Nithin Ramakrishnan and Sangeeta Shashikant) – The European Union continued to defy emerging consensus on the operations of the Pathogen Access and Benefit Sharing (PABS) System during the 4th session of the Intergovernmental Working Group (IGWG4) that met in Geneva from 1-5 December. On the second day of IGWG4, 80 developing countries proposed standard contracts containing the terms of use, including fair and equitable benefit sharing, that would be required of users of pathogen materials and sequence information with pandemic potential (PABS Materials and Sequence Information – also known as PMSI). The EU however persisted with its indefensible position, seeking to gut internationally agreed access and benefit-sharing rights by replacing them with voluntary corporate goodwill, opposing any move in the IGWG to begin negotiating standard contracts that would be applicable to the users of PMSI. IGWG4 negotiating the PABS System as part of the World Health Organization (WHO)’s Pandemic Agreement was suspended on 5 December and will resume on 20 January 2026 for three days. The 5th session will take place on 9-13 February 2026. According to the IGWG4 interim report, “In view of the May 2026 deadline, the IGWG decided to hold a resumed session of IGWG4 to be held from 20-22 January 2026. The IGWG further requested the Bureau to present proposals for sections of texts for a draft PABS Annex, in advance of the resumed session of IGWG4, building upon the on-screen text and inputs provided by the Member States.” Further, the report says, “As next steps, the Bureau was requested to continue to facilitate informal focused discussions with all IGWG Members during the intersessional period, including to regional and cross-regional discussions, to support the IGWG to work towards the convergence.” The Secretariat is also requested to provide technical information on the International Health Regulations (2005) and the PABS System, WHO-coordinated laboratory network structure and terms of reference as well as approaches for possible WHO-recognized sequence databases. Throughout IGWG4, the EU continued to advance its version of a PABS System under which some pharmaceutical manufacturers may choose to sign contracts with WHO to provide a target of 20% of vaccines, therapeutics and diagnostics (VTDs) for pandemic emergencies, of which only 10% donations would be confirmed. Under this approach, manufacturers are not required to have signed such contracts prior to accessing PMSI, nor are all manufacturers that receive PMSI required to enter into benefit-sharing contracts. All other users of the PABS System, when accessing PMSI from the system, would face no obligations regarding the use or benefit sharing, including when profiting from it. This model is inconsistent with the foundational principles of the Convention on Biological Diversity (CBD) and the Nagoya Protocol, which require that access to PMSI be conditional on agreed terms of use, including fair and equitable benefit sharing. Under the EU’s proposal, WHO Members would be expected to rapidly provide pathogen samples, their sequence information, and associated clinical and epidemiological data without any terms or conditions governing their use, restricting intellectual property claims, or ensuring benefit sharing. Yet the EU also wants WHO to declare the PABS Annex as being consistent with the CBD and Nagoya Protocol and consequently obligate Parties to exempt PMSI and pharmaceutical products from their national and regional access and benefit-sharing (ABS) regimes or laws. The EU also questioned both the necessity and scope of a WHO-Coordinated Laboratory Network (WCLN) and WHO-recognised sequence databases that would be accountable to the Conference of the Parties to the Pandemic Agreement. It continued to oppose mechanisms that would require identifying users of sequence information or ensuring accountability for how such data is used and sharing of benefits arising from the use of the sequence information. In contrast, as previously reported, 80 developing countries called for standard contracts for the sharing and utilisation of pathogen samples and sequence information. These contracts would establish terms of use covering scope of use, handling of PMSI, restrictions on intellectual property claims and dual-use research concern (DURC), as well as elaborating on the user’s benefit-sharing commitments. The developing countries stressed that such contracts are the norm amongst the scientific community and commercial users when sharing biological materials or sequence information. Such contracts are applied to the sharing of influenza virus of pandemic potential in the context of the Pandemic Influenza Preparedness (PIP) Framework, while data access agreements are a standard feature of GISAID – a sequence database supported by Germany and other European States – that all users have to accept in advance of accessing any sequence information. Yet developed countries – led by the EU, particularly Germany – initially opposed any reference to the standard contracts proposed by the 80 developing countries in the IGWG4 interim report adopted on 5 December. Their overwhelming and unjustified resistance to acknowledging this simple factual development forced the IGWG to convene a separate huddle to finalize the report. According to sources, only after this small-group huddle did the EU reluctantly agree to make reference to the proposed contracts, and the German delegate reportedly even angrily referred to the standard contracts as the “damn thing”. The final interim report thus states: “In relation to agenda item 2 (Draft PABS Annex Text), the IGWG Members continued negotiations and discussions on the draft PABS Annex text, on the basis of the on-screen text from the third meeting of the IGWG. Initial convergence was found on certain parts of the text. The IGWG also discussed submissions from the IGWG members, including on the scope and use of terms, modalities of access and benefit sharing, governance of a PABS system, and a possible PABS Advisory Group, and the proposals for the draft contracts for the PABS System.” Bureau’s text proposals received mixed responses At IGWG4, the IGWG4 Bureau made several textual suggestions on key aspects of the PABS System, such as the definitions of “pathogens with pandemic potential” and “participating manufacturer”. There was also discussion on the core components of the PABS System like the WCLN, WHO PABS Sequence Database, WHO-recognized sequence databases, categories of users and their benefit-sharing obligations, as well as on the governance of the PABS System especially the establishment and functions of the PABS Advisory Group. However, the Bureau’s text proposals failed to generate consensus. Use of terms On the definition of “pathogens with pandemic potential”, the Bureau proposed several versions of text. In an initial version, a Bureau member proposed: ‘“Pathogens with pandemic potential’ means any pathogen that has been identified to infect a human, and to which humans have limited or no immunity, and that has the potential for sustained human-to-human transmission, and is highly virulent, and that causes a communicable disease that potentially: (i) has, or is at high risk of having, wide geographical spread to and within multiple States; and (ii) is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; and (iii) is causing, or is at high risk of causing, substantial social and/or economic disruption, including disruption to international traffic and trade; and (iv) requires rapid, equitable and enhanced coordinated international action, with whole-of-government and whole-of-society approaches.” On the penultimate day of IGWG4, the Bureau proposed definitions for “pathogens with pandemic potential” and “participating manufacturer”:
There was no agreement on the proposed definitions. A proposed definition of “pathogens with pandemic potential” with the list approach (first proposed by the EU) was unacceptable to several delegations, especially as it would hand the WHO Director-General (DG) full authority to expand the list at any time, which would immediately obligate Parties to share biological materials and sequence information through the PABS System. Several delegations were of the view that the Bureau’s text was unfair, as it deprived States of their right to decide what should be shared, sources said. The definition of “participating manufacturer” is a contentious issue between developed and developing countries. The former preferred a narrow definition focusing on those entities actually engaged in the manufacturing of vaccines, therapeutics and diagnostics. Developing countries counter-argued that the definition should include “developers” of VTDs, as they often hold the intellectual property rights and can at any time venture into manufacturing. It is noteworthy that the PIP Framework’s definition of manufacturers includes “developers”. Operation of the PABS System With respect to Section II.A of the draft text on the operation of the PABS System, the Bureau proposed the following text among other options:
A key concern that emerged on the suggested text revolved around the treatment of access and benefit sharing as distinct pillars, and the proposal that benefit sharing be triggered at a later stage. Thereafter the Bureau put forward another text proposal:
According to sources, developing countries highlighted the absence of mention of the standard contracts submitted by 80 developing countries that would apply to the laboratories within the WCLN, participating manufacturers and other participants accessing PMSI. They stressed that the standard contracts were essential as the PABS Annex cannot directly bind recipients of PMSI. Concerning paragraph 3(c), developing countries reiterated that it should be a prerequisite for all recipients of PMSI to agree to the standard contracts, i.e., standard material transfer agreement as well as data access agreement, before accessing PMSI. Several countries pointed to the unacceptable differential treatment of participating manufacturers and other participants, where the former are required to sign PABS contracts while the latter have the option to sign contracts “where appropriate”. Some countries queried why the PABS contracts with participating manufacturers were only about “commitments for benefit-sharing”, while others expressed discomfort with the mention of “notice of benefit-sharing commitments”, questioning its utility and adding that it suggests non-obligatory commitments to provide benefit sharing. Developed countries deployed various excuses against the use of contracts, claiming that they would stifle research collaboration and development especially at the university and/or not-for-profit academic levels. The Africa Group challenged such reasoning, arguing that completing contracts is part of a scientist’s everyday life, including for research collaborations, to obtain research funding, and to access laboratories and databases of various types. Relationship with other ABS instruments On paragraph 4, developing countries said the proposed text was not technically sound. For instance, what the PABS contracts deal with is the “use of the PABS Materials and Sequence Information for the purposes” covered under Article 12 of the Pandemic Agreement, and the benefits are covered only as incidental thereto. The Bureau’s text exempts the benefits from other national or regional ABS laws, even if other local genetic resources (beyond the pathogens within the PABS System) are used in the development of the benefits. This is not legally feasible, as the PABS Annex does not affect the application of national or regional ABS laws on genetic resources beyond PMSI, even if they are used in the development of the benefits covered by the PABS contracts. Developed countries were also not satisfied with the proposed text, as it did not carve out PABS resources completely from the application of national and/or regional ABS laws. In
this context, the EU’s position is particularly problematic and made
in bad faith: while it resists the application of legally binding
terms of use governing PABS resources, it simultaneously seeks a blanket
exemption from national ABS laws. This approach would effectively
undermine the legal authority of developing countries and hollow out
their national ABS frameworks, without offering any corresponding
accountability mechanisms and safeguards against biopiracy, including
digital biopiracy. Benefit sharing and user categories At IGWG4, the Bureau elicited feedback on a table with user categories and benefit-sharing options under each category,
According to various delegations, developing countries were deeply dissatisfied with the document. Their concerns included: (a) the false distinction between VTD manufacturers and VTD developers; (b) the presentation of options, in particular, treating key benefits such as the grant of non-exclusive licences as optional; (c) the absence of concrete commitments to provide set-asides during a public health emergency of international concern (PHEIC); (d) treating acknowledgement of contributions as benefit sharing when it is an ethical issue; (e) limiting monetary benefit sharing to product manufacturers, failing to recognize other commercial uses of PMSI beyond the production of VTDs; and (f) reference to “No specified timeframe”, making it unclear when the benefit would be delivered. The Group for Equity delegations questioned the proposed classification, and called for classification to be done on the basis of the use of the PMSI such as developing/manufacturing VTDs, other commercial uses, and strictly non-commercial use. An African country submitted a proposal containing seven categories of users, sources said. PABS Advisory Group On the question of the PABS Advisory Group, the options document proposes three choices to IGWG Members. The first is a PABS Advisory Group constituted by the WHO Director-General and reporting to the DG, which could be established upon the adoption of the PABS Annex, even before the entry into force of the Pandemic Agreement. The second option is a PABS Advisory Group which will be established by the Conference of the Parties (COP) after entry into force of the Pandemic Agreement and which will report to the COP. The third option is for the DG to establish the group before the entry into force of the Pandemic Agreement and then hand over the function to the COP once the Agreement enters into force. In this option, the group would report on technical/operational aspects to the DG and on normative/policy aspects to the COP. According to sources, there is a difference of opinion between IGWG Members regarding these options. Some Members want the PABS Advisory Group to be completely outside COP interference, while others want the COP to have a due say on the terms of reference of the group and oversight regarding recommendations from the group, in terms of both policy and implementation of the recommendations. Many developing countries including South Africa have asked for the options to be modified accordingly.+
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