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TWN
Info Service on Health Issues (Apr26/07) WHO: EU proposes burdensome “Blended model” - access to pathogen samples and sequence data without benefit sharing contracts Geneva, 29th April 2026 ( Sangeeta Shashikant and Nithin Ramakrishnan): Members of the European Union informally circulated a document titled the “Blended model for the sharing of PABS Material and Sequence Information”, the much-discussed hybrid compromise, in the lead-up to the resumed session of the 6th meeting of Intergovernmental Working Group (IGWG6R) negotiating the Pathogen Access and Benefit-Sharing (PABS) Annex to Pandemic Agreement. Disregarding the mandate in Article 12 of the Pandemic Agreement (PA), the document was presented as a landing zone for the EU and Norway (and possibly other developed countries). It proposes a PABS system with two parallel pathways for sharing pathogen materials and sequence information: one subject to contractual obligations including benefit-sharing requirements, and another that permits access without such conditions. During Tuesday’s informal discussions, this “blended” approach came under sustained questioning and criticism from multiple delegations and was reportedly rejected by the Africa Group, according to diplomatic sources. However, the proposal may yet resurface, with or without modifications, during the formal sessions in the week. At its core, the blended model normalises a dual-track system in which ‘accountability’ becomes optional. While EU members framed it as a pragmatic convergence framework, in practice it risks creating a PABS system that is difficult to govern, administratively unworkable, and structurally tilted towards avoiding fair and equitable benefit sharing. Under the guise of flexibility and compromise, it would enable access without commensurate obligations, while conferring WHO recognition and legitimacy on practices that facilitate biopiracy. Interestingly, diplomatic sources suggest that the proposal originated from well-intentioned EU member states, reportedly including Spain and France, but will not be formally tabled by the EU itself. Instead, the EU and its members are said to be reaching out to other countries, to advance the proposal on their behalf. According to diplomatic sources, Mexico has indicated an interest to make the proposal formally. Well-intentioned or not, the substance of the proposal is revealing. It is difficult to characterise it as anything other than an attempt to legitimise, through the PA, what many developing countries have consistently resisted in other fora: biopiracy and the open-ended extraction of biological resources and data under conditions where benefit-sharing obligations are uncertain, diluted or easily avoided. The blended model The proposed blended approach would allow Parties to share pathogen materials and sequence information through multiple parallel routes, depending on their stated preferences. For physical pathogen materials, Parties would first share with a laboratory within the WHO Coordinated Laboratory Network (WCLN). The WCLN lab may then transfer materials onward within the network. While the WCLN labs would have to agree to terms and conditions to be a part of the network, there is no mention that these terms and conditions would be contractually enforceable. The WCLN Labs will also onward share PABS materials outside the network to manufacturers of vaccines, therapeutics, and diagnostics (VTDs), other commercial users and to non-commercial users. According to the proposal, the provider country can choose through three modalities of sharing when sharing with VTD manufacturers and other commercial entities:
Onward sharing with non-commercial users is following accepted terms and conditions, but there is no mention that such terms and conditions will be enforceable contractually. For sequence information, countries can choose to upload data into different categories of “WHO-recognized” databases, ranging from (i) so-called open-access repositories permitting anonymous access (ii) to databases with registration and data access agreements, (iii) databases with customized conditions, and (iv) other databases operating following the terms and conditions as per the PABS Annex. The proposal also states that “onward sharing and use of sequence information follows the policy of the database of choice”. It further states that the “Provider/originating country shall inform WHO on their preferences. WHO to keep a list of countries’ preferences and make available to all PABS Parties as well as WCLN laboratories, and make public.” Contravention of Article 12 The blended approach is fundamentally inconsistent with Article 12 of the Pandemic Agreement, which establishes the mandate and parameters for the design of the PABS system. Article 12 articulates four core principles that should underpin the system: (i) parity between access and benefit sharing (“equal footing”); (ii) legal certainty regarding modalities, terms and conditions on access and benefit sharing; (iii) accountable system; and (iv) enforceable benefit-sharing obligations. The blended approach effectively dismantles each of these pillars. While the proposal obligates the sharing of PABS materials and sequence information, it simultaneously creates pathways through which such access can occur without any corresponding obligation to conclude PABS contracts and to provide fair and equitable benefit sharing. This directly undermines the principle of equal footing. Article 12.6 of the PA requires that “each” participating manufacturer provide access to VTDs for pathogens with pandemic potential pursuant to legally binding contracts with WHO. Despite such agreement, the blended approach contemplates the sharing of PABS materials and sequence information with VTD manufacturers even in the absence of such contracts. This constitutes a clear departure from this requirement. Similarly, Articles 12.7 and 12.8 of the PA require that benefit-sharing obligations be set out in legally binding contracts with WHO. By allowing access without such contractual commitments, the proposal weakens both the enforceability and the predictability of benefit sharing and violates Article 12. The approach also undermines Article 12.5(b) of the PA, which calls for “legal certainty” regarding modalities, terms, and conditions governing access and benefit sharing. A system that permits access without obligations and enables anonymous use of sequence information cannot credibly claim to provide “legal certainty”. In sum, while Article 12 of the PA mandates the establishment of a multilateral, accountable PABS system grounded in clear and enforceable obligations, the blended approach introduces unregulated and unaccountable pathways that erode these foundational requirements. False Promise of “Sovereign Rights” The blended proposal is framed as preserving sovereign choice, suggesting that countries remain free to decide how to share pathogen samples and sequence information. In reality, this “choice” is deeply misleading on at least two fronts. First, the proposal entrenches an unequal exercise of sovereign rights between developed and developing countries. Developed countries seek to retain the option of sharing PABS materials with manufacturers and commercial users without conditions, while simultaneously aggressively pursuing the dilution of benefit-sharing and other obligations within the multilateral framework. In effect, they preserve flexibility for themselves while narrowing the policy space for others. Second, for many developing countries, particularly those reliant on external financing, research partnerships, and laboratory collaborations, this supposed choice is illusory. “In practice, they may face significant pressure from funders, partners or external actors to opt for the unconditional pathway, regardless of their national interests”, a developing country delegated told TWN. Several developing country scientists confirmed this experience. The overall result of the proposal is that it undermines the ability of countries to set and enforce access conditions at the national level. And at the same time, such conditions are diluted through multilateral negotiations and subsequently circumvented through funding arrangements and collaborative dependencies. Anonymous Access Rebranded as Open Science Even more troubling aspect of the proposal lies in its treatment of sequence information. By seeking WHO-recognition for databases that permit anonymous access, alongside those that require user registration and data access agreements, the proposal attempts to legitimise such models (i.e. databases permitting anonymous access) as acceptable forms of “open access”. This framing is fundamentally misleading. Anonymous access is not open science; it is unaccountable and non-transparent access. The 2021 UNESCO Recommendation on Open Science does not equate openness with the absence of conditions or user identification. On the contrary, it emphasises accountability, transparency, management of conflicts of interest, and the pursuit of collective benefit. The proposal appropriates the language of open access and open science while inverting its meaning. It effectively legitimises highly extractive data infrastructures, i.e. databases that delink access from benefit sharing through anonymous use and uploads that separate sequence data from both the underlying biological material and its country of origin. In doing so, it risks normalising both digital biopiracy and biopiracy more broadly. The proposal also raises serious biosecurity concerns, as it proposes to allow pathogens with pandemic potential and their sequence information, to circulate through channels where users may remain unidentified. Even the most robust safeguards are undermined if the identity of users are unknown. In a context of rapidly advancing AI-driven biological tools and expanding synthesis capabilities, anonymous access is not a viable or responsible option. User registration is the most basic layer of accountability, whether for enforcing benefit-sharing obligations or for upholding biosecurity safeguards. Removing this baseline requirement weakens the integrity of the entire system. Neglect of Obligations under the Convention on Biological Diversity (CBD) and Human Rights Conventions The blended approach rests on the premise that Parties are free to provide access to their genetic resources without attaching benefit-sharing conditions. However under the CBD, which has near universal membership, CBD Parties also have obligations to take measures to facilitate benefit sharing with countries that provide genetic resources. Article 19 of the CBD explicitly obliges Parties to take “all practicable measures” to promote and advance such benefit sharing, particularly with developing countries. When read with Article 4 of Nagoya Protocol, Parties are required to take all practicable measures to ensure the fair and equitable sharing of benefits with provider countries, especially in those within multilateral access and benefit-sharing (ABS) frameworks, aspiring to be recognized as Specialized International ABS Instruments. By contrast, the blended proposal fragments the PABS system and introduces legal uncertainty and administrative complexity that would help recipients of PABS resources to avoid sharing fair and equitable benefits. In doing so, it undermines both the spirit and the letter of the CBD and the Nagoya Protocol. This is particularly problematic given that many countries participate in pathogen and data sharing with the legitimate expectation of reciprocal benefits. The proposal frustrates these expectations and runs counter to Article 12(4) of the Pandemic Agreement, which requires that the PABS system operate in a manner supportive of, and not contrary to, the objectives of the CBD and the Nagoya Protocol. Beyond treaty obligations, the proposal raises serious human rights concerns. By effectively making access to life-saving health products contingent on the discretion of States, it sidelines fundamental rights, including the right to health and the right to benefit from scientific progress. A system that weakens benefit-sharing obligations and accountability in PABS risks deepening inequities in access to essential medicines, vaccines and diagnostics, particularly for developing countries. Increased Transaction Costs and Administrative Chaos Instead of establishing a single, clear accountable pathway for sharing of the pathogen materials and sequence information, the blended approach introduces a menu of access routes, some subject to benefit-sharing obligations, others effectively unconditional. Even on its own operational terms, the proposal is close to unworkable. WHO has 194 members. Even if only half of its Members became Parties to the Treaty, according to the blended approach, each country can adopt different preferences for onward sharing of PABS materials and separately for the onward sharing of PABS sequence information resulting in a patchwork of conditions applicable to laboratories, databases and downstream users. In practice, this would require WHO, WCLN laboratories, databases, and other recipients to track and apply a complex matrix of country-specific requirements across more than a hundred Parties and potentially numerous pathogens. This is not meaningful flexibility, it is going to be administratively burdensome, costly and chaotic. This is more so as Parties may also from time to time change their preferences. Further what penalties and liabilities will apply to a WCLN lab which inadvertently fails to follow the pathway chosen by a Party. Concerns about the adverse impact of the proposal are not limited to developing countries. Even developed countries, including Canada, have reportedly acknowledged in informal discussions at the IGWG that the blended approach risks significantly increasing administrative and transactional burdens. Ironically, the proposal is coming from the very same group of countries that have previously said they want to avoid standardized contracts to reduce transactional costs.
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