|
||
|
TWN
Info Service on Health Issues (Feb26/04) Geneva, 19 February (Nithin Ramakrishnan and Sangeeta Shashikant): The European Union (EU) and its allies, including Norway, the United Kingdom, Japan and Australia, demonstrated a troubling disregard for the commitments enshrined in Article 12 of the Pandemic Agreement, as well as for established international law, precedents and evidence during the Fifth Meeting of the Intergovernmental Working Group (IGWG5). IGWG5 is mandated to negotiate the Pathogen Access and Benefit Sharing (PABS) Annex to the World Health Organization (WHO) Pandemic Agreement (PA) adopted in May 2025. IGWG5 took place from 9 to14 February 2026 at the WHO Headquarters in Geneva. Throughout the negotiations, these developed countries, sometimes supported by the IGWG5 Bureau, pressed developing countries to “show flexibility” in accepting a PABS system that would require mandatory sharing of pathogens with pandemic potential and their genetic sequence data, without binding assurances that all recipients would be subject to clear, contractually enforceable terms and conditions, including fair and equitable benefit sharing. Such an approach not only undermines the equity objective underpinning the PA but also contradicts developed countries’ own obligations and practices at both international and domestic levels, where access to valuable biological resources is typically conditioned on legally enforceable commitments. In the closing session of IGWG5, developed countries attempted to shift responsibility for the lack of progress onto developing countries. Germany, speaking on behalf of the EU, called for pragmatism and flexibility. Yet it exposed its own rigidity by asserting that the IGWG should “leave out issues where there will not be consensus — not now, not tomorrow, and potentially not in a year’s time”. Switzerland urged delegations to draw inspiration from the INB negotiations, suggesting that outcomes need not leave any party fully satisfied. These remarks expose a stark disregard, particularly by European delegations, for the core equity objectives of the Agreement. Their interventions promote a regulatory “race to the bottom”, where in the name of expediency, equity safeguards are stripped away to secure consensus at any cost. Instead of strengthening global governance for pandemic preparedness, this approach entrenches structural inequities, normalising a system where pathogens and sequence data flow freely from developing countries, while intellectual property systems are used by recipients to appropriate any results derived from the use of the pathogens and their sequence data. The benefit sharing also remains optional, uncertain and unenforceable. It also sets a dangerous precedent for future global health negotiations. Namibia forcefully countered that countries which provide biological materials and genetic sequence data for the development of vaccines, therapeutics and diagnostics must not find themselves at the back of the queue when those very products become available. It underscored that a PABS system cannot be structured to impose binding obligations on some participants while leaving compliance optional for others. Such asymmetry would fundamentally undermine fairness and erode trust in the system. Namibia further warned that vague definitions and weak legal drafting would inevitably be exploited by powerful actors. It cautioned that the loopholes in definition and legal text will be exploited by the powerful entities, and the price will have to be paid by the vulnerable people. Pakistan squarely rejected the blame game attempted by the EU and Germany, and said: “We must respond clearly to the suggestion that some delegations are delaying progress or acting without pragmatism. That characterization is neither fair nor accurate. Our engagement has been consistent, constructive, and solutions oriented. Raising legitimate concerns about equity and balance is not obstruction — it is responsible negotiation.” “If progress has slowed, it is not because of a lack of pragmatism on our part. It is because flexibility has not been demonstrated on certain core issues that are fundamental to developing countries. Equity, predictable benefit-sharing, licensing, and technology transfer are not peripheral demands; they are the very foundation of a credible PABS system.” “Consensus cannot be built by asking some to lower their expectations while others preserve their red lines. True pragmatism requires movement from all sides. Inflexibility on key principles is what divides us — not the insistence that those principles be respected.” “We remain ready to engage, to compromise where possible, and to work intensively toward agreement. But let us be clear: agreement must be balanced, fair, and reflective of shared responsibilities. That is not delay — that is the path to a durable and legitimate outcome.” Brazil said that, “Progress is best ensured when we build on existing consensus rather than revisit settled issues. We cannot reopen provisions that have already been agreed in the pandemic agreement. Back tracking on established consensus undermines trust we can see in the negotiation process …” The IGWG5 concluded by adopting a report. With regards to the next steps, the report states the following: “… in view of the mandate of the IGWG to submit its outcome regarding the PABS Annex to the Seventy-ninth World Health Assembly, IGWG members agreed to continue informal discussions during the intersessional period, including discussions focusing on elements to ensure legal certainty, including the consideration of contracts, with a view to finding common understanding. The IGWG requested the Bureau, with the support of the Secretariat, to continue to facilitate informal focused discussions with all IGWG members and to present proposals for sections of texts for the draft PABS Annex, as soon as possible in advance of the sixth meeting of the IGWG, building upon the on-screen text and discussions at the fifth meeting of the IGWG. The IGWG also requested the Secretariat to provide further technical information and to prepare draft terms of reference for the WHO-Coordinated Laboratory Network and possible WHO PABS recognised databases and to propose viable approaches for possible recognition of such databases”. EU and other developed countries renege on agreed Article 12 of PA. One of the most concerning trends during the IGWG5 negotiations was developed countries’ constant backtracking on the agreed Article 12 of the PA. Article 12.5(b) of the Agreement is explicit that the PABS instrument must establish “modalities, terms and conditions on access and benefit sharing that provide legal certainty”. However, developed countries prefer selective implementation of that paragraph. They insist on legal certainty for uninterrupted access to pathogens with pandemic potential and associated genetic sequence data. Yet when it comes to legal certainty for provider countries, the same governments resist any kind of safeguards and seek to promote anonymous access to genetic data. They oppose requiring recipient entities to conclude contracts at the point of access and reject the imposition of legally binding obligations on recipients, including contractually enforceable commitments to provide fair and equitable benefit sharing. In effect, they seek guaranteed access for users, while denying guaranteed rights and protections for providers – a one-sided interpretation of “legal certainty” that departs from both the letter and spirit of Article 12.5(b). Notably, the IGWG Bureau has advanced text that reinforces this imbalance by proposing the establishment of a non-exhaustive list of pathogens for the purposes of the PABS system. Further, Article 12(3) of the PA requires that “the development of a safe, accountable and transparent PABS System shall address traceability measures and open access to data.” And yet developed countries have objected to any proposal from the developing countries that ensures access to data as well as traceability. Articles 12(7) and 12(8) of the PA requires the inclusion of benefit sharing provisions in the event of a “public health emergency of international concern” (PHEIC) and to prevent PHEICs. These provisions reflect a clear commitment by WHO Members to embed equity at the operational core of the PABS system. Yet developed countries are now resisting the inclusion of binding obligations on manufacturers of vaccines, therapeutics and diagnostics (VTDs). They contend that Articles 12(7) and 12(8) refer to providing “options” for benefit sharing and therefore preclude mandatory commitments. This interpretation is difficult to sustain. The relevant language in Articles 12(7) and (8) refers to “including options” – a formulation that does not reduce benefit sharing to voluntary measures. According to sources engaged in the negotiations, even the WHO Secretariat clarified that “including options” means “not only options.” In other words, the text permits and indeed anticipates the inclusion of binding benefit sharing obligations alongside other modalities. Despite this legal clarification from the WHO, the EU and other developed countries objected to the incorporation of any mandatory benefit sharing provisions with respect to access to VTDs to prevent PHEICs or during PHEICs. The Central African Republic (CAR) has repeatedly insisted on the need for the benefit-sharing provisions to contain specific set-asides of real-time production of VTDs, made available for distribution during PHEIC as well as to prevent PHEIC. It however expressed willingness to engage in negotiation and be flexible, and even sought alternative proposals from developed countries, to ensure access to VTDs for countries like the CAR. Yet developed countries did not provide any alternative suggestions but kept reiterating their opposition to the proposal from the CAR. [Article 12.7 of the PA reads: “The PABS Instrument shall also include benefit sharing provisions, in the event of a public health emergency of international concern as determined in accordance with Article 12 of the International Health Regulations (2005), including options regarding access to safe, quality and effective vaccines, therapeutics, and diagnostics for the pathogen causing the public health emergency of international concern, pursuant to legally binding contracts signed by participating manufacturers with the World Health Organization.” Article 12.8 of the PA reads: “The PABS Instrument shall also include additional benefit sharing provisions to be set out in legally binding contracts signed with the World Health Organization, including options for (a) Capacity-building and technical assistance; (b) research and development cooperation; (c) facilitating rapid access to available vaccines, therapeutics and diagnostics with a view to responding to public health risks and events in the context of Article 13.3 of the International Health Regulations (2005); (d) the granting of non-exclusive licences to manufacturers in developing countries, for the effective production and delivery of vaccines, therapeutics and diagnostics; and (e) other forms of transfer of technology as mutually agreed,16 including transfer of relevant knowledge, skills and technical expertise.”] A Pseudo Multilateral ABS System in the Making In December 2025, during IGWG3, 85 developing countries tabled a joint proposal calling for the use of “standard contracts” to be concluded between the WHO and recipients of shared pathogen materials and genetic sequence data at the point of access. A multilateral access and benefit (ABS) system built on pre-negotiated standard contracts directly addresses the oft-repeated criticism that bilateral ABS negotiations between provider countries and recipients are slow and cumbersome. By establishing clear, uniform and pre-agreed terms applicable to all users, such a system would enhance legal certainty, streamline access, and ensure that benefit sharing obligations are triggered automatically, without the delays inherent in case-by-case bargaining. But the EU and its allies are even opposed to pre-negotiated standard contracts. In direct contradiction with the international obligations under the Convention on Biological Diversity (CBD) and its Nagoya Protocol, they are proposing that developing countries share pathogens and genetic sequence data without requiring binding contracts at the point of access. Instead, they anticipate the WHO Director-General to negotiate bilateral agreements with pharmaceutical companies seeking voluntary benefit sharing commitments. The EU also seeks to defer any negotiations on contracts until companies begin manufacturing products. Sources indicated that the EU, Norway and the United Kingdom opposed proposals to require WHO to negotiate contracts with commercial entities beyond participating VTD manufacturers, while also resisting measures that would restrict access for entities unwilling to assume obligations. Crucially, the EU model contains no standard contracts with recipients of pathogens or genetic data — even though contracts at the point of access are the cornerstone of operationalising ABS regimes under the CBD and its Nagoya Protocol. In specialized multilateral systems, standard agreements provide legal certainty, predictability and speed. Essentially, the main objective of the EU and its allies is to disrupt the well-established international law on access and benefit sharing and undermine States’ sovereignty over their biological resources by shifting negotiating authority from national governments to the WHO Director-General. Thus, the EU will utilise WHO through the PABS System as a vehicle to promote biopiracy, including digital biopiracy, rather than a fair and equitable access and benefit sharing system that provides a win-win situation for developed and developing countries, in furtherance of global public health. Disregarding Evidence and Established Practice, the Bureau Aligns with Developed Countries Throughout IGWG5, the EU and its allies repeatedly restated their positions without grounding them in evidence or established precedent. By contrast, developing country proposals drew on well-established ABS practices multilaterally as well as domestically, especially in developed countries. The Pandemic Influenza Preparedness (PIP) Framework 2011 negotiated by WHO Members demonstrates that Standardized Material Transfer Agreements (SMTAs) can enhance trust, speed and predictability in pathogen sharing. It also shows how tracking systems strengthen accountability and improve actual delivery of benefits. The PIP Framework’s scope is however limited to influenza virus of pandemic potential. Beyond WHO, model material transfer agreements (MTAs) or ABS agreements from institutions such as the Swiss Academy of Sciences, the University of Oslo and the European Molecular Biology Laboratory (EMBL) confirm that concluding agreements when exchanging biological materials, including associated data and sequence information, is standard practice in the science world. Notably, the EMBL and the Oslo MTA explicitly include information related to materials within its scope. Nevertheless, the EU and its allies appeared to have influenced the Bureau and Secretariat to discount this evidence, arguing that the PIP Framework is limited to a single class of pathogens and that SMTAs would deter academic and public research institutions. They also opposed MTAs placing conditions on data (sequence information) generated from materials. The co-chairs of the Bureau, citing these arguments, discouraged incorporation of developing country text proposals into the negotiating draft with respect to MTAs and data governance, and instead urged developing countries to craft language acceptable to developed countries. Precedents from other multilateral systems tell a different story. The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) manages 64 food crops, encompassing multiple varieties and millions of accessions, under a single standard material transfer agreement. Over 117,000 such agreements have been concluded covering both commercial and non-commercial uses, and most of such agreements have been signed by public institutions rather than commercial actors. Scientific organisations have also written to WHO Member States urging that all recipients of pathogen samples and/or sequence information be clearly identified and bound by legally enforceable minimum biosafety and biosecurity obligations. They emphasised that verified user identities and transparency are now critical elements of effective bio-risk management. [A very recent article in the journal Science (Biological Data Governance in the age of Artificial Intelligence) also asks for user registration and data access agreements when providing access to sequence information of pathogens with pandemic potential] Despite this growing body of evidence, the EU and its allies have resisted all calls for user identification and data access agreements, maintaining support for anonymous access models. During IGWG5, representatives of GISAID, a pathogen sequence database initiative, reportedly pressed Germany to explain why it is shifting from “transparent” data access models toward “anonymous access” models in the name of openness. Germany has offered little justification beyond the contested view of some scientists who argue that user registration may hinder machine-to-machine interaction and interoperability. The same group has also argued that benefit sharing should be sought only downstream, i.e. once products or technologies are developed, when commercial actors have advantages in terms of negotiating leverage against WHO and its States parties. Norway: From CBD Champion to Facilitating Digital Biopiracy? Once a supporter of the CBD and its Nagoya Protocol, Norway is now promoting “anonymous access” to PABS sequence information under the banner of open science. In the PABS negotiations, Norway is pushing for WHO recognition of databases that permit such anonymous access. Anonymous access would allow recipients of pathogen sequence data to avoid identification and, in practice, evade obligations to respect provider countries’ rights and share fair and equitable benefits arising from the use of sequence information, a right well established under international law. Developing countries have proposed that WHO-recognised databases operate under contractual arrangements, provide non-discriminatory access to registered and verified users and require data access agreements. Norway is insisting that databases offering anonymous access must also qualify as WHO-recognised and at the same time, has also opposed the PABS Annex from requiring any contractual relationship between databases and the WHO. While asserting that countries should remain free to decide where to deposit their sequence data, Norway simultaneously seeks to preserve the right of its own laboratories to upload derived sequence information into any WHO-recognised database, including those that permit anonymous access. Yet if users of sequence information cannot be identified and cannot be shown to have contractually agreed to terms of use, accountability collapses. A system built on non-transparency and anonymity makes it virtually impossible to trace use or prevent misuse or abuse. It merely facilitates biopiracy through digital facilities. Europe and Developed Country Allies: A Coordinated Negotiating Strategy & Double Standards IGWG5 revealed an increasingly coordinated “good cop, bad cop” dynamic, according to several sources familiar with the negotiations. The EU and certain European states advanced proposals framed as pragmatic scientific compromises, while Japan adopted a more sceptical stance, questioning even those same “middle-ground” ideas, sources said. The effect was to shift the debate away from developing countries’ core demands and redefine the negotiating baseline. During a side event hosted by Germany and Colombia, speakers linked to a scientific network backed by certain European Countries, promoted the use of unique persistent identifiers (UPIs) to track PABS sequence information and downstream products through patent analysis. Germany, Switzerland and Norway presented this as an alternative to developing countries’ calls for user registration and binding data access agreements. Developing country negotiators, however, noted that identifiers alone do not create legal obligations, in the absence of user identification and enforceable agreements at the point of access. Japan, playing the “bad cop”, questioned even the need for unique identifiers, raising technical doubts about sequence fragmentation, with the aim to complicate IGWG discussions. Many negotiators observed that assigning identifiers to digital files is routine database practice, often automated and provided at no cost. The debate thus appeared less about technical feasibility and more about preventing any convergence arising on the issue of data governance under PABS. Meanwhile, the EU and its allies especially Switzerland resisted addressing intellectual property with respect to the pathogen materials and sequence information in the PABS Annex arguing that such matters belong to fora like the World Trade Organization or the World Intellectual Property Organization. While pressing developing countries to share pathogen samples and sequence information without conditions, the EU and Switzerland opposed provisions requiring their own entities to share modified pathogens and modified sequence data, even though such modifications are central to the development of vaccines, therapeutics and diagnostics. They claim these modifications are proprietary and cannot be subjected to sharing. At the same time, they resist language in the PABS Annex that would allow providers of the original materials to bar IP claims over the modifications and use of shared materials. This exposes a stark double standard on the part of the EU and other developed countries. When it comes to biological resources originating in developing countries and local communities, the expectation is that access should be swift, unconditional, and free of binding benefit-sharing obligations or enforceable terms of use. Yet when the resources in question are controlled by them or their entities—whether modified pathogens, proprietary technologies, or finished products such as medicines—the rules change. Access becomes subject to bilateral negotiations, strict contractual conditions, high prices, and unequal purchasing power, with developing countries often left waiting at the back of the queue. This unequal treatment reveals more than policy inconsistency—it signals a structural imbalance that echoes colonial patterns of extraction and control. Resources and knowledge from developing countries are treated as global commons when it serves powerful interests, but the benefits derived from them are enclosed, commodified, and tightly controlled. In the IGWG negotiations, this posture is not subtle. It is expressed clearly in developed countries’ proposals that dilute the rights of providers of biological resources and related data including their right to benefit-sharing while preserving stringent intellectual property. If the Pandemic Agreement is to stand for equity and justice, this imbalance must be confronted directly.
|
||
