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TWN
Info Service on Biodiversity and Traditional Knowledge (Jul26/03) WHO: Working group considers conceptual design of PABS system Geneva, 22 July (Sangeeta Shashikant and Nithin Ramakrishnan) – The 7th session of the Intergovernmental Working Group (IGWG7) negotiating the Pathogen Access and Benefit Sharing (PABS) Annex to the World Health Organization (WHO)’s Pandemic Agreement concluded with WHO Members taking home competing designs of the PABS system for further consideration and examination. Discussion on the conceptual design of the PABS system occupied most of the second week of IGWG7, which met at WHO headquarters in Geneva from 6–17 July. The IGWG will next convene in September for two days of informal meetings (3–4 September) and for its 8th session (14–18 September). Generally among a large number of developing countries (Group for Equity and Africa Group, plus Egypt, Libya, Somalia and Sudan), there is agreement over the need for legally binding contracts with standard terms and conditions specifying the terms of use including benefit-sharing obligations for the sharing of pathogen materials (PABS materials) and their genetic data (sequence information). There is also convergence among these countries over the need for databases hosting shared sequence information to provide facilities for user registration and data access agreements, so that the user can be identified for the purpose of ensuring compliance with the PABS system. This group of over 80 developing countries representing 75% of the world’s population had, in December 2025, presented draft standardised contracts on the sharing of PABS materials and sequence information (PMSI) and urged the IGWG to begin negotiations on the same. IGWG7 did discuss standard contracts prepared by the WHO Secretariat. In the second week of IGWG7, the Africa Group went further, building on the shared elements with the Group for Equity. South Africa on behalf of the Africa Group presented a model called the “federated PABS system”, with the tagline “Balancing sovereign access and global public health”. Other developing countries seem interested in further understanding and exploring this approach, sources say. This presentation was preceded by a presentation from Spain titled “PABS hybrid model – An operational landing zone for an equitable PABS System”. The presentation, with the tagline “One WHO-coordinated architecture for sharing materials and sequence information”, reveals that European focus remains on access to pathogens and sequence information, and not benefit sharing. Spain’s conceptual design has come to be referred to as the European Union (EU) model. This model – promoted under various labels, including "hybrid", "blended" and "landing zone" model – was not well received by most developing countries participating in the negotiations, as they considered it fundamentally inconsistent with Article 12 of the Pandemic Agreement. The Group for Equity, aligned with the Africa Group, continued to oppose the model, maintaining that there can be no access to PABS materials or sequence information without corresponding acceptance of benefit-sharing obligations. (See TWN report “EU proposes burdensome “Blended model” – access to pathogen samples and sequence data without benefit sharing contracts”.) The WHO Secretariat, on its own accord, also advanced a model, claimed to be an amalgamation of all the models and proposals presented by the various groups. According to sources from both developed and developing countries, there was little interest in the Secretariat’s model, which highlights sharing of PABS materials and sequence information outside of the PABS system. During the concluding plenary session of IGWG7, some regional groupings explained their demands and aspirations for the PABS system and the work ahead. Malaysia on behalf of the Western Pacific region (WPRO) called for practical, inclusive and implementable outcomes. It said that the current session improved Members' understanding of concepts underlying the PABS design and the various models available before them, including the new proposals. It acknowledged divergences and called for further focus on conceptual understanding and then work on developing and negotiating the text. Sri Lanka on the behalf of the South-East Asia region (SEARO) acknowledged the greater clarity that IGWG7 brought in relation to convergences and divergences, reiterating that the outcomes must uphold the letter and spirit of Article 12, in particular the interlinkages between access and benefit sharing. It stressed that a credible and effective framework must provide legal certainty, traceability, transparency and accountability, and called for safe, transparent, accountable and traceable sharing of PABS materials and sequence information. Barbados on behalf of the Caribbean Community (CARICOM) reaffirmed its conviction that in accordance with the consensus in Article 12, access and benefit-sharing pillars must remain inseparable and be implemented on equal footing. It emphasised that neither pillar should be subordinated to the other, if the PABS instrument is to achieve its objectives of promoting equity, strengthening global health security and fostering trust between Members. CARICOM further said that its position is informed not only by principles but also by the experience of the COVID-19 pandemic where, after timely sharing of pathogens and sequences, the small island developing states found themselves at the end of the queue when health products like vaccines, therapeutics and diagnostics became available. CARICOM reminded the IGWG that they had been at the back of the queue not because there was no need on their part, but because their purchasing power was low. It categorically stated that voluntary measures would not help them. CARICOM highlighted the importance of establishing a WHO-coordinated system that strengthens transparency, accountability, traceability and scientific collaboration whilst respecting national sovereignty. Algeria, on behalf of the Africa Group, Egypt, Somalia and Sudan, said it is essential to resolve the remaining conceptual differences, while being firmly anchored in the principles and objectives of Article 12, before embarking on further drafting of the PABS Annex. It also said that further work is needed to clarify the treatment of derivatives, including synthetic products and compounds developed from pathogen sequence information shared through the PABS system, as well as to address issues relating to intellectual property. Pointing to its federated model, which protects the sovereign rights of Parties, the Africa Group demanded that provider countries of biological materials and pathogen sequence information must receive fair, equitable, predictable and tangible benefits, consistent with the objectives of Article 12. Implementation of the PABS system must also be accompanied by adequate financial, technical and capacity-building support for developing countries, particularly for the establishment of national laboratories and the sustainable operation of laboratories participating in the WHO Coordinated Laboratory Network (WCLN). The African federated PABS model: Addressing capacity gaps in developing countries The African federated PABS model aims to design a PABS system where sovereign rights over pathogen materials and sequence information are not compromised. The model seeks to ensure custody of materials and information is not surrendered, while access is provided for research and development. Under the federated system, the physical materials move from a national laboratory to a reference laboratory, along with a unique persistent identifier and standard material transfer agreement (SMTA), which is accepted before the shipment of materials. Any recipient of the materials should have signed this SMTA. The model proposes to store sequence information in the database of Parties’ choice, ideally in national databases. These databases are recognised as sovereign nodes and will be accessible through a WHO Core Hub which operates as a trusted research environment. Those who want to access data would need to register once with the Hub and take up one credential. While registering, the terms of using the PABS sequence information, including benefit-sharing obligations, are accepted. The Hub will not allow downloads of raw sequences if not permitted by the provider Member States. According to the Africa Group presentation, the federated system adopts a workbench approach towards research and analytics, whereby it provides a secure and standardised virtual environment allowing researchers to access, analyse and run complex models across the distributed sites (databases), eliminating the need for transferring or pooling raw data to an external server or machine. An African delegate involved in the negotiations, speaking on condition of anonymity, said that the current R&D ecosystem is biased against those without laboratory and digital capacities, compromising the sovereign rights of States as well as equity. This divide, said the delegate, has to be addressed, with capacities to host, handle and analyse pathogen material and sequence information established in all countries in the Global South. The European hybrid model: Green light for a pathway that does not guarantee benefits The hybrid model of the EU, in sharp contrast to the African model, provides several pathways for a Party to share PABS materials and sequence information with the PABS system, each differing in its approach to benefit sharing. It even includes a pathway in which pharmaceutical companies and other recipients of PABS resources do not have to undertake any commitment to share benefits. On access to PABS materials through the WCLN, the EU suggests three pathways by which Parties may share PABS materials: first, a green traffic light pathway where access to materials is provided after signing a material transfer agreement (MTA) (called a “shipping agreement”) but with no benefit-sharing conditions attached. Second, an orange traffic light pathway will provide access after an MTA is concluded with a commitment to sign a PABS contract. Third, under a red traffic light pathway, access to PABS materials will be provided only after the recipient signs a PABS contract which will contain provisions on access and benefit sharing. The EU's preferred option is presented as a green traffic light pathway to visually suggest easy access to pathogen materials. By highlighting other pathways as orange and even red, the EU intends to suggest that these pathways are burdensome, even though they are more in line with the requirements of Article 12 including equal footing and legal certainty. Under the EU’s preferred option, Parties may incentivise recipients to share benefits but there is no obligation for the recipients to conclude WHO PABS contracts and to share benefits. The orange pathway has its roots in EU Regulation 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union, wherein pathogens causing public health emergencies of international concern may be accessed expeditiously without access and benefit-sharing contracts, but with a commitment to conclude such contracts within a specified time period. However, in the PABS hybrid model, no such time limits are prescribed; neither does it address the consequence if the recipient does not follow through on its commitment to sign the WHO PABS contract. Interestingly, the EU's presentation indicates that it has moved away from its earlier, regressive and illogical suggestion that dangerous pathogen materials should be shared without contractual obligations, despite the fact that MTAs are the established norm for the transfer of biological materials. The presentation unequivocally states, "No WCLN transfer takes place in a legal vacuum. Every material transfer is governed by a legally binding MTA/shipping agreement." This confirms that legally binding contractual obligations (presumably with standardised terms and conditions) will apply to the transfer of PABS materials both within the WCLN laboratories and to recipients outside the WCLN. "However, this is not a compromise,” said a developing-country source. “Everyone recognises the need for a standard MTA which is a standard contract when sharing biological materials. The EU's earlier position was only aimed at complicating the negotiations. It was a farce, and everyone knew it.” With regard to sequence information, the EU’s model suggests that the sharing of such information should be with WHO-recognised sequence databases, which will include registration databases (sequence databases requiring user registration and acceptance of a data access agreement) and non-registration databases (sequence databases allowing anonymous access and a click-wrap agreement but without identifying the user). Here too, the EU model adopts a traffic-light approach: a green light pathway, where the user is not required to conclude a PABS contract with WHO and thereby does not need to agree benefit-sharing obligations; an orange light pathway, where the user will take on a commitment to sign a PABS contract; and a red light pathway, where the user has to sign a PABS contract prior to access. Developing countries oppose the inclusion of databases that do not require user registration because they permit anonymous access. This would place the burden on WHO to do surveillance and track thousands of users and chase them to comply with benefit-sharing obligations. Not only is this an almost impossible task but the approach will also allow users to dispute or easily evade their benefit-sharing obligations. And as mentioned above, the EU’s traffic-light approach is considered to be inconsistent with Article 12. The WHO Secretariat model: Contributing to divergence and confusion? The WHO Secretariat also presented a PABS model during IGWG7 but did not take ownership of the design. Instead, it claimed that the design was based on discussions among Members. Nevertheless, several WHO Members were of the view that the design created more confusion than convergence. A developing-country delegate told TWN, “There is nothing surprising in the Secretariat appeasing the Global North in [its] documents and presentations, but this time the Secretariat barely captured any of our proposals.” A delegate from a developed country confirmed with TWN, “The Secretariat model got us wrong, it does not represent our proposals correctly.” Under the Secretariat’s model, WCLN laboratories receiving materials from Parties can share the materials with various types of users within the PABS system, via a shipping agreement. The participants of the PABS system would have already signed the WHO PABS contract which is a benefit-sharing agreement, distinct from a shipping agreement. However, the WCLN laboratories are also allowed to share materials outside of the PABS system, once recipients agree to the shipping agreement. There is no commitment on benefit-sharing obligations; the same may/would be negotiated later. According to sources, the Secretariat’s framing of the PABS system as having an “inside” and an “outside” component is very confusing: since the discussion is about the operation of the PABS system, why does the design refer to shipping agreements and PABS contracts outside the system? With respect to PABS sequence information, the Secretariat’s design consists of recognising databases that employ user registration as well as those enabling anonymous downloads. And while all sequence databases will have a pop-up click-wrap agreement which will be accepted by the user, the agreement will not contain information about the use and neither will the user’s identity (name, affiliation, contact information) be known. The Secretariat’s assumption seems to be that if the users are already participants of the PABS system, the WHO PABS contract will have them covered for their benefit-sharing obligations. If the users are not already participants, then they may be tracked and WHO may/would negotiate a PABS contract with them post-access. However, there is no guarantee that benefit sharing will be realised. With this approach, even the Secretariat will struggle to identify the users of PABS sequence information. Several Members indicated that the WHO Secretariat lacked understanding about the concept of “open access”. There is clear evidence that user registration does not go against open access; for instance, Germany itself has argued many times in WHO that the GISAID database with user registration and data access agreements is an open-access database. The UNESCO Recommendation on Open Science 2021 also indicates that attaching terms and conditions or exercising vigilance over the use of data is not against openness. During informal meetings with database managers, the IGWG was reportedly told by Pathoplexus, a database claimed as open access, that user registration is not necessarily against its values of open access.
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