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Info Service on Health Issues (Mar26/03) WHO: Developing countries should not be forced to accept unbalanced PABS system Geneva, 25 March (Lauren Paremoer*) – Civil society organisations (CSOs) expressed concerns over the attempt to force developing countries to accept an unbalanced Pathogen Access and Benefit Sharing (PABS) system during the opening session of the Sixth meeting of the Intergovernmental Working Group (IGWG), the negotiating body for the PABS system. The meeting is taking place at the WHO Headquarters in Geneva from 23 to 28 March in a hybrid mode. CSOs that closely follow the negotiations process have been calling on developing countries to resist a one-sided PABS system, which goes against the international norms and standards on access and benefit sharing of genetic resources. Nearly 19 non-state actors took the floor to express their views on various aspects of the PABS system on Monday, 23 March. CSOs emphasised the need for concrete benefit sharing commitments as well as effective mechanisms for the enforcement of benefit sharing obligations, transparency and accountability. Health Action International along with Salud por Derecho and Public Citizen in a joint statement expressed concern “that some of the issues yet to be properly addressed will have a critical impact on the ability of the international community to adequately respond to future pandemic outbreaks and other health emergencies”. They stated that transparency and accountability in health emergency responses should be non-negotiable. They further stated that: “While technology transfer is widely hailed as a pilar for an equitable response to pandemics, neither the INB (Intergovernmental Negotiating Body for the Pandemic Agreement) nor this process have recognised the urgency of delivering an operational framework that promotes cooperation over profit. In that sense, the proposed voluntary basis risks becoming an obstacle to engaging in effective sharing of knowledge and transfer of expertise”. The statement warned that “a vague text with no binding obligations, workable schemes or enforceable commitments should not be considered a success. We urge you to create a fair PABS system that can save lives in future health crises”. Medicines Mundi International (MMI) expressed concerns over the absence of following requirements for accessing pathogens in the negotiating text: Registration requirements to access database containing digital sequence information of pathogens of pandemic potential; legally binding contracts as a precondition for accessing pathogen samples or its digital sequence information (DSI); benefit-sharing mechanisms during public health emergencies of international concern (PHEIC); “applicable terms and conditions” governing onward sharing. It stated that such loopholes in the PABS System would “risks setting precedents that will hollow out ABS principles in this forum and elsewhere.” Medecins Sans Frontieres (MSF) expressed its concern “that current negotiations may not deliver a meaningful multilateral PABS system that guarantees fair access to pandemic vaccines, diagnostics and treatments for countries and populations most in need.” It urged negotiators “to endorse a PABS system with enforceable benefit-sharing obligations agreed before system access, including non-exclusive licensing, technology transfer, secured WHO‑coordinated stockpiling and health-needs-based allocation (including in humanitarian settings), and strong transparency requirements. IGWG6 should define the contractual arrangements. The world cannot afford another failure of global solidarity.” Public Services International (PSI) in its statement criticized the position of certain developed countries arguing for unrestricted access to pathogens and DSI and stating that regulations such as user registration, contractual obligations for benefit sharing as a precondition for access etc. would impede open access and open science. According to PSI: “This discussion is not about open science or open access. If the countries that are now pushing for unrestricted access to pathogens, genetic sequences and information were concerned with open access, then the (WTO) TRIPS Waiver would have been approved without delay during the pandemic. Open access means impeding the monopolization and privatization of technologies”. Further it stated that “… biodiverse countries should not be asked to sign an instrument that will institutionalize their sharing without mechanisms preventing the privatization of benefits derived from this …” PSI stated that provisions on PABS DSI databases must include user registration, data access agreements, attaching unique persistent identifiers to PABS materials, and transparent and legally binding onward-sharing provisions. Without such requirements “… the PABS system will put the needs of commercial manufacturers first, not patients or health workers. This undermines Article 7’s requirement to ensure "priority access to health technologies” for healthcare and essential workers. Even worse: it will institutionalize the cruel understanding that some lives are worth more than others”. Finally, it stated that “Delegations should not be pressured to adopt an unbalanced text that is only in the interests of developed countries and corporations”. Third World Network (TWN) stated that the Bureau’s text is one sided and obligates states to share pathogens and data without a corresponding obligation to agree on terms and conditions for benefit sharing. Further, it listed the following inconsistencies in the Bureau’s text with Article 12 of the Pandemic Agreement, which establishes the PABS system. “First, Article 12.1’s equal footing principle (between access and benefit sharing) is violated; Second, the text is inconsistent with Article 12.3, since the instrument does not address traceability or open access. Third, anonymous access and access with contracts run counter to the objectives of the Convention on Biological Diversity and its Nagoya Protocol under their respective Article 1, and hence Article 12.4 is also violated. Fourth, Article 12.5 is also violated as there is no legal certainty of access and benefit sharing, especially as WHO is expected to negotiate contracts bilaterally with pharmaceutical companies. Fifth, it risks the benefits of Article 12.6 because the bilateral contract negotiations between WHO and Pharma can be not concluded or may be concluded in a manner whereby delivery is effectively diluted. Sixth and seventh, Articles 12.7 and 12.8 are not satisfied because the PABS Annex does not incorporate benefit sharing provisions or options mentioned in these paragraphs”. TWN also stated that WHO’s existing coordinated laboratory networks and data-sharing practices are not consistent with international norms and best practice, and facilitates biopiracy and increases biosecurity risks. Indirectly referring to the WHO Director-General’s call for compromises in the PABS negotiations to show the success of multilateralism TWN said that “Multilateralism cannot be used to legitimize an unequal system and compel a compromise on developing countries,” calling out the model proposed in the Bureau’s text as not neutral and promotes extraction and bio-colonialism. TWN cautioned that WHO “would not end up adopting such a model”. Geneva Global Health Hub (G2H2) welcomed and supported the positions of the Africa Group and the Group for Equity. It urged countries, mainly high-income countries, to keep the following three facts while moving forward: “First, the historical basis of these negotiations flow from COVID-19, and as terrible as the COVID-19 experience was, we might have dodged a bullet. Every pandemic, every health emergency is a different animal. Not enabling equity now puts the whole world at risk. As Palestine pointed out, there are no borders to pathogens. Secondly is the fact that in our view it is not primarily the people in the countries standing against the Global South position that stand to benefit, it’s more of the corporations and the billionaire class. It’s the sort of people that include the 40 new pharma billionaires that emerged from the COVID-19 pandemic. And lastly, we realise consensus is of utmost importance but it must not be a sword of Damocles on equity. It must not be a sword of Damocles on the will of the majority.” In an indirect reply to the WHO Director General, G2H2 stated that the “debate is a struggle for a multilateralism which has decolonisation of global health at its heart.” Knowledge Ecology International (KEI) stated that the 9 March Bureau Text “provides a database model of providence rather than a system of tracking users. It does a good job of the traceability of the data but it stops short of requiring users’ data to be verified or even known. The approach in Article 69 of the European Health Data Space regulation for secondary use of health data is appropriate for digital sequencing information (DSI).” Medicines Law and Policy stressed “that multilateralism will only succeed if it delivers meaningfully and ensures equity in access to products and the technologies needed to produce them”. Oxfam hoped that by the end of the week IGWG6 “can give the world an agreement that can protect everyone when health crises strike and to transform the document from sanctioning inequality into legally binding commitments for benefit sharing on products, technology and monetary benefits.” It further said that “Pressuring countries to accept a text without legal obligations on benefit sharing just to stick to a deadline is unfair, unjust, and would not protect North or South. With serious changes in content and process you can turn this (PABS) annex into an agreement that protects public health”. South Centre stated that the Bureau text of 9 March does not provide a legally suitable basis for adoption of the Annex to the Pandemic Treaty. It further cited the following reasons: First, by deferring key elements of the PABS to future negotiations and consideration by the Conference of Parties of the Pandemic Agreement, the adoption of the proposed World Health Assembly (WHA) resolution would give the WHA authority to override the Pandemic Agreement’s binding provisions that are critical to ensure that the Agreement's objectives are achieved, notably regarding equity.”. Second, “The draft text does not meet two fundamental conditions and several provisions in Article 12. Notably, it does not ensure that access and benefit-sharing will operate on equal footing nor that all elements of the system will enter into force simultaneously. The draft text binds States unconditionally to share pathogens while no commercial user is obliged to enter into a WHO PABS binding contract.” In the current text: “There is no guarantee that even the ~ 20% allocation of vaccines, therapeutics and diagnostics for public health needs will ever be met; there is no guarantee of licenses being provided to manufacturers from developing countries, so that production can be diversified rapidly during health emergencies; monetary benefit sharing remains uncertain; there is no commitment by entities engaged in non-commercial use to make available their outputs in the public domain; when a non-commercial use becomes commercial, the only safeguard is self-reporting obligation.” Further, it stated that “WHO members should not be constrained by a merely procedural decision on the expected adoption of the Annex by the forthcoming WHA”. The second round of interaction with stakeholders will take place on 25 March from 9 am to 9.30 am. * Lauren Paramoer is Associate Professor of Political Studies at University of Cape Town, south Africa
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