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Info Service on Intellectual Property Issues (Mar26/03) WHO: Developing countries reject Bureau’s text as negotiation basis Geneva, 24 March (Lauren Paremoer and Rajnia de Vito) – Developing countries rejected the Bureau’s draft negotiating text (Bureau’s Text) as a basis for negotiation during the sixth meeting of the Intergovernmental Working Group (IGWG) on the WHO Pandemic Agreement. The negotiations are on the Pathogen Access and Benefit Sharing System (PABS) under Article 12 of the Agreement. IGWG6 is taking place at the WHO Headquarters in Geneva from 23 to 28 March in a hybrid mode. When IGWG Co-Chair Ambassador Tovar da Silva Nunes moved for the adoption of the agenda and programme of work, South Africa proposed that the agenda be amended to specify that negotiations during IGWG 6 would use the onscreen text of 14 February i.e. the last day of the 5th meeting of the IGWG (9-14 February) as the basis for negotiation. This intervention was supported by a number of African States including Namibia, Nigeria, Angola, Uganda, and the Central African Republic. The Bureau ignored the textual suggestions from developing countries proposed during IGWG5 and produced a new text on 9th March. The proposed Bureau’s text was favoring the position of the European Union. Namibia noted that the Bureau’s text of 9 March was not a clear reflection of the positions the parties shared during IGWG5 and that elements of the Bureau’s text were in contravention of a number of Namibian laws. Though Co-Chair Tovar proposed that the meeting agenda proceed on the understanding that all text produced to date be used as the basis for negotiations, Namibia insisted that clarity on the negotiating text was important. Further, South Africa pointed out that clarity was important in order to get mandates from capitals on how countries should position themselves during the negotiations. Namibia echoed this point by indicating that the IGWG5 text would be a more appropriate basis for discussion, given directives African delegations received in a meeting of ambassadors of the Africa region earlier in the morning of 23 March. The Central African Republic argued that IGWG6 would proceed more efficiently if the 14 February text was used, as the Bureau’s text of 9 March required that all previous proposals be resubmitted once again, which would add to the time pressure. To move forward, Namibia proposed an amendment to the provisional agenda to reflect that the IGWG5 text would be designated as the negotiating text for this meeting, and that the Bureau’s text of 9 March be designated as a reference document. In the amendment text the textual insertions listed the “IGWG5 on-screen text” as point 2(a) of the agenda, and “The Bureau’s proposal of 9 March” as agenda point 2(b), without explicitly denoting one text as the basis for negotiations and the other as a reference document. Even after the adoption, the negotiation was suspended during the afternoon session for a while when the Africa Group objected to Bureau’s attempt of projecting both texts side by side on the screen. Finally, a compromise was reached to include the Bureau’s text below the onscreen text of 14 February. The onscreen text on 23rd March states as follows: “Yellow highlighting: text for which initial convergence was reached at IGWG 4 and IGWG resumed; Blue highlighting: Bureau’s original proposal for IGWG 3; No highlighting: Bureau’s proposal sections of text for IGWG 4 resumed” This effectively made the 14 February text the basis for the negotiation. Developing countries demand change in status quo IGWG6 started with the opening remarks of WHO Director General (DG) Dr. Tedros Adhanom Ghebreyesus. He recalled the article co-authored by him and 27 heads of state exactly five years ago that initiated the negotiations for the Pandemic Agreement, noting that "we're so close, but not there yet." He urged delegates to move quickly toward conclusion: "We must get this done. The next pandemic will not wait. The conflict in the Middle East and crisis elsewhere in our world are reminders that health emergencies can erupt suddenly and affect multiple countries, increasing the risk of disease outbreaks." Dr Tedros added that this week is probably the only chance to secure an outcome on PABS. “I have heard some of you say that Article 12 and the PABS Annex are the heart of the WHO agreement. Now is your opportunity to bring a bit to that heart and bring it to life," he urged. After the adoption of the agenda delegations took the floor to make opening statements. Burkina Faso, speaking on behalf of the Africa Group and Egypt, Sudan, Libya and Somalia expressed concerns that the Bureau’s text did not fully reflect a number of important elements that are necessary to ensure balance, legal certainty and equity in the PABS system. These include requiring mandatory registration for all users of PABS materials and digital sequencing information, clearer and more foreseeable access to products during public health emergencies of international concern (PHEIC), and mechanisms to safeguard against certain users of the PABS system only being asked to meet benefit-sharing provisions at a later stage. The Group statement also called for greater clarity on definitions such as real time production and affordable pricing. It closed with a call that the Annex should protect the sovereign rights of States over their biological resources while ensuring that access and benefit sharing are placed on an equal footing. Indonesia on behalf of the Group for Equity also called for a safe, accountable and transparent PABS system that requires user registration to enable monitoring of pathogen and sequencing information that are used, including for purposes of ensuring biosafety and biosecurity, and for legal clarity regarding contracts and the architecture of the WHO Coordinated Laboratory Network (WCLN) and WHO recognised databases. The Group of Equity also rejected rushing toward a conclusion: "Multilateralism is not simply about reaching an outcome. It is about producing an outcome that significantly changes the status quo. At times, multilateral outcomes may appear to show progress on paper, but underlying inequities remain insufficiently addressed. We are asking for a higher standard”. The Group further stressed that disagreements should be resolved in favor of provisions that advance equity: "There may not be a single model that is ideal for everyone, but there are certainly choices before us that move us closer to equity and help us ensure that the next pandemic does not repeat the failures of the last". China supported the statement by the Group for Equity statement, stating that it fully shared the concerns with the Bureau’s text expressed by the Group and the Africa Group. It called for legally binding obligations for state parties to be finalized at this session and not to be deferred to future COPs (Conference of the Parties to the Pandemic Agreement), as this would be the only way to provide legal certainty for countries to proceed with ratification of the Agreement. Bangladesh on behalf of the South East Asia Region (SEARO) indicated that the Bureau’s text falls short of what genuine equity requires, as allowing anonymity and onward sharing makes monitoring compliance and having assurances on biosecurity and biosafety impossible. Like other parties, the statement called for legal certainty regarding contracts, and for the institutional roles of the WCLN and databases to be clearly defined so that state parties know what they are agreeing to. Tunisia also noted that respect for the sovereign rights of states over biological resources and sequencing information was one of the key principles informing its negotiating position, and that the credibility of the PABS mechanism would rest on benefit sharing being legally binding. It also called for ensuring contributions from all entities accessing PABS materials, capacity building that would allow states to build industrial capacity and full traceability of all PABS sequencing information. South Africa aligned itself with the positions of the Africa Group and the Group for Equity, and voiced particular concern over the Bureau's text and the removal of Global South proposals. "We are particularly concerned that critical proposals from countries of the global South, including standardized legally binding contracts, have been diluted into aspirational language or deferred to future meetings of the COP. Equity cannot be subject to availability or deferred to a later date", South Africa said. It also called for technology transfer and the enablement of regional manufacturing to be time-bound and enforceable. Pakistan noted that the Bureau’s text was imbalanced and gave greater clarity and precision regarding obligations around pathogen access while benefit sharing mechanisms remained vaguely articulated and couched in ‘best endeavour’ language. This includes allowing users of PABS materials and sequencing information to effectively remain anonymous, and lacking legal certainty and clarity regarding the terms and conditions governing databases and lab networks, and absence of legally binding benefit sharing contracts. Pakistan objected to these issues being deferred to future meetings as this would create legal uncertainty. It noted it could not subscribe to the notion that the annex (on PABS) should be concluded simply to bolster trust in multilateralism. It noted that equity could not be confined to downstream distribution alone, and that it should be reflected in concrete and enforceable benefit sharing measures including non-exclusive licensing, technology transfer and support for local and regional manufacturing capacities as this would help create structural corrections capable of breaking the dependency of developing countries on Global North suppliers of vaccines, therapeutics and diagnostics (VTDs). The Central African Republic (CAR) and Lesotho both emphasised the challenges landlocked countries with limited productive capacities had in accessing VTDs during the COVID-19 pandemic. CAR objected to their proposal on access to VTDs during health emergencies not being reflected in the Bureau’s text without the inclusion of valid alternatives being proposed, and reiterated the importance of predictable guarantees of VTDs. Nigeria noted that the IGWG5 text reflected genuine disagreements about who bears the costs of the pandemic and who benefits, and emphasised that binding commitments to VTDs should be secured, that modified pathogens should be brought within the ambit of PABS materials, that manufacturing capabilities in the Global South should be strengthened and the experience of COVID-19, where developing countries shared pathogens but received only inequity in return, should not be repeated. Namibia called for percentages in relation to VTD allocations to be retained, clarity on the handling of intellectual property claims over derivatives and modifications of pathogens, the inclusion of standard contracts in the PABS Annex, making technology transfer mandatory during emergencies and to specify the formulae according to which monetary contributions will be determined. Namibia rejected rushing negotiations stating that "An annex that is worse than no annex is not an achievement, it is a defeat. It is a defeat dressed as success, and it sets a precedent for every future negotiation.". It added that the mandate for negotiating the Annex should be extended to the 80th meeting of the World Health Assembly in May 2027 to ensure that negotiations do not result in an unbalanced text. Colombia called for binding operational provisions to ensure fair monetary and non-monetary benefit sharing with a view to strengthening pandemic prevention, preparedness and response (PPR) capabilities in developing countries, including in periods between pandemic emergencies. It also called for clearly defined and differentiated responsibilities for all commercial and non-commercial users of the PABS system. Nepal expressed concern that benefit-sharing obligations remain insufficiently unpacked, while State Parties face stringent obligations on pathogen access and sequence information as well as with the lack of adequate traceability and safeguards in relation to WHO Recognised Sequence Database. “The benefit-sharing framework under Articles 12.7 and 12.8 of the Pandemic Agreement has not been adequately translated into the PABS text”, it added, stressing that user registration and meaningful regulation of onward transfers are essential. Malaysia noted the importance of ensuring that WCLNs should be guided by clear terms of reference, and that legally binding elements upholding access and benefit sharing (ABS) should be included in the PABS system while preserving domestic ABS laws and strengthening domestic systems to support and uphold the PABS system. India aligned with the Group of Equity and SEARO group stressed the need to ensure the equitable access to pathogens and digital sequence information while guaranteeing fair and predictable benefit sharing. Further, India highlighted the need for strict traceability rules, user registration and safeguards for biosafety and biosecurity. Jamaica stressed that access should be contingent on user registration and contractual obligations. The European Union (EU) and its 27 Member States took a markedly different position, pushing back against the equal footing principle between access and benefit sharing enshrined in Article 12 of the Pandemic Agreement. The EU framed the annex's purpose as creating "a system for rapidly sharing pandemic pathogen samples and genetic data, while significantly improving equitable access to vaccines, treatments and diagnostics for parties. The EU called for concluding negotiations: "We have a responsibility to conclude these negotiations and unlock the far reaching potential of the Pandemic Agreement [...] we call on all delegations to muster the necessary result to overcome our remaining differences in the time we have left for this process." It also stressed that "there is a public health imperative that must drive us all in the final stages of this process," underscoring the need for an open, collaborative and multilateral approach to pandemic prevention, preparedness and response. Japan noted that it was committed to two key points: operationalizing Article 12 by developing a detailed and workable system without creating new obligations beyond what is stated in Article 12, and that the PABS system should be developed in a manner that is mindful of the capabilities of WHO and the incentives manufacturers would require to contribute to the PABS system. (Lauren Paramoer is Associate Professor of Political Studies at University of Cape, South Africa.)
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