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Info Service on Health Issues (May26/04) WHA79: PABS negotiations extended; legal certainty stressed by developing countries Geneva, 20 May (Rajnia Rodrigues and Nithin Ramakrishnan) – The 79th Session of World Health Assembly (WHA79) decided to extend the negotiations on the Pathogen Access and Benefit Sharing (PABS) Annex to the Pandemic Agreement for one more year. Developing countries stressed that access to pathogens and their sequence information and benefit-sharing must remain “interlinked”, enforceable and grounded through legally binding contractual arrangements signed at the time of the access. One of the main reasons that the PABS Annex is not concluded at the ongoing WHA79 (18 to 23 May) is the reluctance of developed countries to commit to a legally binding contract at the time of accessing PABS resources. The decision adopted by the WHA79 says that the negotiations will continue in the Open-Ended Intergovernmental Working Group (IGWG) with a view to adopt the PABS Annex either at the 80th session of WHA or in a special session of WHA that may be organized in 2026 for this purpose. Delegations emphasized that the Annex is essential for operationalizing Article 12 of the Pandemic Agreement and enabling the treaty to move toward signature and ratification. The statement by the European Union indicates an expectation that the IGWG’s work on PABS will continue until the next WHA in 2027, while the Africa Region signalled the need for working towards a possible conclusion by 2026. Brazil and Botswana called for the early conclusion of the PABS negotiations within 2026 itself, while many Member States cautioned against rushing the negotiations, particularly in a manner that could compromise the legal certainty of benefit sharing obligations. Legal certainty to the benefit sharing is only ensured if the recipients are under a legal obligation to share benefits fair and equitably. Such obligation is established through contractual arrangements in access and benefit sharing (ABS) regimes, particularly through standardized contracts in multilateral ABS regimes. These contracts ensure access and benefit sharing are interlinked and weakening this link would mean benefit sharing remains voluntary as it was during the COVID-19 pandemic. Developing Countries Stress on Legal Certainty Speaking on behalf of the WHO South-East Asia Region, Bhutan stated that “access and benefit sharing must remain interdependent and operationalized on equal footing across pandemic and inter-pandemic contexts.” The region also called for “robust traceability mechanisms” throughout the lifecycle of PABS materials and sequence information, including through “standardized legal instruments, unique identifiers, and transparent arrangements” across “the full cycle of PABS materials and sequence information”. Bangladesh stated that all elements of the PABS ecosystem, including the enforceable WHO PABS contract, the tracing mechanism, and the beneficiary modalities should come into operation at the same time. It stressed that pathogen sharing without the guaranteed benefits is not equity, but the status quo that was observed during the COVID-19 pandemic. It argued that user registration is a pre-condition to the traceability and expressed support for a WHO Database, adding that WHO recognized databases or WHO databases should be guided by the principle of accountability, transparency, and traceability. India said it is essential that the PABS framework be underpinned by standardized and legally binding contracts governing access to pathogens with pandemic potential and associated pathogen sequence information as well as the equitable sharing of benefits arising therefrom. India called for robust traceability mechanisms including through application of advanced digital technologies. For China, the PABS system represents a new set of rules, mechanisms, and networks that would be built based on the existing framework. However, China said that such new rules must be determined to change the status quo, which is inequitable, and should be operational, providing sufficient legal certainty. Indonesia argued that a credible landing zone for a compromise between developed and developing countries on PABS should deliver certainty at the point of access on how benefits sharing obligations will be operationalized and enforced. Nepal similarly stressed that “a credible and effective framework must ensure legal certainty, transparency, and accountability,” emphasizing “the importance of standardized contracts” and calling for “technology transfer, substantive scientific collaboration, the strengthening of national laboratories, and support to local manufacturing”. South Africa on behalf of the Africa Region was of the view that ensuring traceability, transparency, and clear contractual arrangements at the point of access can safeguard the interests of all countries while facilitating scientific collaboration. They called for national oversight of laboratories participating in the WHO-coordinated network, and measures that promote accountability and traceability in data access, such as user registration and data access agreements. Botswana underscored the importance of strengthening provisions of PABS, including on user registration, ensuring access to products during public health emergencies of international concern (PHEIC), and sustainable financing. They also called for meaningful representation of the institutions from developing countries, including laboratories, research centers and manufacturers, in the PABS system. The Central African Republic said that PABS cannot turn into a mechanism that promotes biopiracy. It argued that “traceability, contracts, and obligations to share benefits must be guaranteed from the moment that resources are accessed”. Nigeria insisted that “benefit sharing obligations must be legally binding and enforceable, not bracketed away into discretion”. Namibia cautioned the Member States that “If access obligations read ‘shall’, while benefit-sharing obligations read ‘options’ and ‘where available’, we will have written inequity into international law with our own hands”. Namibia emphasized the need for legally binding contracts as a “transversal issue that must define the participation architecture across the entire annex,” and said the same cannot be deferred to the Conference of Parties to the Pandemic Agreement. Morocco, on behalf of the Eastern Mediterranean Region (EMRO), similarly underscored that “the linkage between access and benefit sharing must remain central and indivisible”. It warned that “any approach that risks weakening this connection would undermine trust and fail to deliver a system that is equitable, predictable, and sustainable”. EMRO underpinned the need for standard contracts to operationalize a PABS System based on legal certainty, clarity and enforceability. They emphasized “the importance of maintaining the integrity of contracts as legally binding instruments and avoiding ambiguity through terms that may dilute their legal standing.” They also stressed that “a credible and effective PABS system must be grounded in legal certainty, clarity, and enforceability”. Iran similarly insisted that the future system “must be built on a foundation of trust, transparency, and legal clarity”. According to Iran, “legal clarity requires that obligations are binding and enforceable,” while transparency requires that countries can “trace what is shared with whom and for what purpose”. Tunisia stressed that “our health security is collective security. It is interdependent and based on solidarity,” adding that “rapid, equitable, and affordable access to vaccines, health products, diagnostics, and to medical technology… cannot be seen as an option. It is a collective responsibility and an imperative for global public health”. It also highlighted the need for technology transfer, resilient health systems, and governance “based on trust, transparency, and respect for national sovereignty”. Pakistan called for finalizing the standardized contracts for PAB materials and sequence information in the next round of PABS Annex negotiations. It said these contracts are the legal teeth, without which PABS would remain unenforceable, and called for categorical rejection of anonymous access to sequence information as this is a pathway to biopiracy. Qatar stressed that “any agreement that does not guarantee the sharing of benefits will come short with regard to achieving the aspired goal”. The United Arab Emirates also emphasized that legally binding measures “should be clearly determined” in a way that ensures “legal certainty and the full respect of state sovereignty, including the sovereign rights on pathogens and their sharing”. The Central African Republic stressed that the IGWG “does not have a mandate to renegotiate the principles already agreed under Article 12”. It stated that the PABS system “must maintain the balance between access and sharing of benefits” and warned that it “must not become a mechanism that legitimizes biopiracy in the name of global health”. The delegation added that countries providing pathogen materials and sequencing information “have the right to know who is accessing these resources for what ends and in which conditions”. It further stressed that “traceability, contracts, and obligations to share benefits must be guaranteed from the moment that resources are accessed”. Several developing countries also emphasized sovereignty over biological resources and the need for transparent governance and traceability systems. Burkina Faso said the COVID-19 pandemic exposed “the limits of a system based on voluntary commitments and on inequalities of access to medical countermeasures”. It reiterated the need for “robust traceability and transparency mechanisms” and protection of “state sovereignty over their biological resources”. Brazil while promoting to engage constructively to finish negotiations by 2026, stated “We cannot in any way relinquish the principles of equity and solidarity that inspired the negotiation of the Pandemic Agreement itself. Nor can we accept any distortion or backtracking from what has already been agreed as fundamental under Article 12, namely the equal footing between access and benefit sharing under terms and conditions that ensure legal certainty for both pillars of the system”. Paraguay stated that progress on the Pandemic Agreement as a whole “is linked to the level of definition and operationalization” of the PABS system and stressed that implementation mechanisms must create certainty that “access to genetic resources will be linked to benefit sharing”. It added that the system “must have a clear, verifiable, and practical application” and should not create “extra burdens for member states with fewer technical and financial capacities”. Uruguay stressed that “the inequality amongst countries in terms of access to health technologies cannot be repeated,” warning that “agreements with suppliers and the holding of knowledge are barriers to access”, It emphasized the need for “a PABS system that ensures biosecurity and traceability and the responsibility of all states,” while reaffirming commitment to “benefit sharing and pathogen access equally shared”. Developed Countries talk compromise The European Union stated that it remains committed to developing an equitable, effective, and implementable PABS system that will make a real difference on the ground. The EU stated that they worked hard in the past few weeks with a view to identifying a set of possible landing zones and that they hoped that talks could be finalized by the 79th Session of WHA itself. Norway stated that they remain committed to finding workable solutions that deliver more equitable access to vaccines, diagnostics, and therapeutics for pathogens with pandemic potential, while enabling a robust R&D landscape to deliver the innovations we need. Canada expressed disappointment that the PABS negotiations are not yet concluded, welcomed more time and expressed confidence in the trajectory of negotiations. They called for more conceptual clarity. France, while joining with the statement of the EU, noted that key subjects need deep in-depth discussions. It cautioned that while these discussions are necessary, they must not slow down the collective speed that was undertaken in recent years. France reiterated that only a coordinated multilateral response will allow us to protect populations sustainably. Six years after the COVID-19 pandemic, “we cannot accept facing a new crisis with the same vulnerabilities”. Spain said that it is necessary to intensify both formal and informal dialogue. It called for working towards the next negotiation round in July and finding points bringing the positions closer together so that it can lead to the conclusion of negotiations. Emphasising that the world needs a regulatory framework which is solid to prevent, prepare, and respond to health emergencies, Spain promised WHA79 that it can be counted on to build genuine solutions. Germany recognized the divergences preventing consensus but asked Member States to “bridge existing gaps and to find realistic landing zones… We need both pragmatism and mutual understanding of each other's interests and flexibilities”. Developing Countries Call Out Backtracking from Article 12 Developing countries however clearly called out that despite the progress in the negotiations over the last one year, there are attempts to back track from commitments already made under Article 12 of the Pandemic Agreement – sometimes even in the name of finding a landing zone or compromise. Pakistan stated “we are witnessing a sustained effort by some Member States to hollow out Article 12, which clearly establishes the principle of equal footing and envisages a multilateral, safe, accountable and transparent access and benefitsharing system. It said that “proposals for a so-called hybrid system - with parallel open and closed access pathways - are designed to preserve the commercial privileges of a handful of manufacturers while offering developing countries little more than goodwill gestures in return. We will not be asked to sign off on a multilateral success story that serves the interests of industry over the health security of billions. The PABS Annex must operationalize Article 12 fully and faithfully — not negotiate it away”. Indonesia said a credible landing zone is one that does not backtrack from Article 12 of the Pandemic Agreement, stressing the primacy of access and benefit sharing on equal footing and a system that is fully safe, accountable, and transparent. The Central African Republic cautioned that the Intergovernmental Working Group does not have a mandate to renegotiate the principles already agreed under Article 12. South Africa said it is patient with the process, but not patient with injustice. It said charity is not equity. “Good intentions do not vaccinate anyone. We need to set aside real time production of vaccines, therapeutics and diagnostics for swift use in developing countries for pandemic prevention, preparedness and response," said South Africa. Colombia attributed the failures of the former pandemic response to intellectual property and argued that the negotiations must be guided above policy differences and trade interests. It argued that a new and more inclusive method of work could be positive “in order to ensure that we have negotiations that are more transparent, inclusive, and aimed at results through open negotiation, not behind closed doors, a progressive step-by-step approach which will allow us to progress and consolidate convergences gradually”. The African Group reminded WHA79 that “true preparedness demands that benefit sharing is operational before a crisis escalates,” warning that “delaying contracts until products are produced and protected by intellectual property rights is procrastination”.
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