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Info Service on Biodiversity and Traditional Knowledge (Jul26/02) Geneva, 17 July (Nithin Ramakrishnan and Sangeeta Shashikant) – Recent negotiations show a growing recognition that users of pathogen materials and/or sequence information (PMSI) from a proposed multilateral pathogen access and benefit sharing system must be identifiable and subject to contractual obligations to ensure compliance with terms of use of PMSI and benefit-sharing. This was the conclusion after the first week of the seventh meeting of the Intergovernmental Working Group (IGWG7) negotiating the Pathogen Access and Benefit-Sharing Annex to the WHO Pandemic Agreement that were held at the WHO Headquarters in Geneva from 6 to 17 July. Developing countries reaffirmed that an effective pathogen access and benefit sharing (PABS) system must include user registration and legally binding contractual arrangements to ensure safe, transparent and accountable operation, and to deliver fair and equitable benefit-sharing. While there was increasing convergence on the need for user identification and contractual arrangements to operationalise the PABS system, WHO Members explored over the first week how these elements can be operationalized. Discussions focused on the different types of contracts that may be required, when they should be concluded, who should be required to sign them, and the most appropriate mechanisms for identifying users. Extensive discussions took place on the WHO-Coordinated Laboratory Network (WCLN) and WHO-Recognized Sequence Databases (WRSD), and the suite of contracts to be developed alongside the PABS Annex. Several delegates engaged in the negotiations from developed and developing countries speaking to Third World Network, were of the view that progress was being made even though divergences remain, as there is now a better understanding of the different positions, creating a stronger basis for finding agreement. Push for Standardized Contracts in the Annex The Group for Equity and the Africa Group, representing more than 57 developing countries, called for discussion on the text of the standardized contracts to be used in the PABS system. They proposed the very same contracts should be developed by the IGWG alongside PABS Annex as per the mandate given by the 79th Session of World Health Assembly (WHA79). [In December 2025, the Group for Equity and the Africa Group, plus Egypt, Libya, Somalia and Sudan, representing more than 80 countries and around 75% of the world’s population, presented 3 standard contracts on the sharing of PMSI and urged the IGWG to begin negotiations on standardized PABS contracts. See Developing countries call for standard PABS contracts under Pandemic Agreement. The proposed standard contracts were:
Developed countries, especially the European Union, rebutted to the demand by saying that the text proposals are 6 months old and do not necessarily reflect the progress IGWG has made in the last few months. The EU also said that there is considerable overlap between the provisions in the PABS Annex and in the contracts and therefore they are not interested in duplicating the negotiations. Nevertheless, the Group for Equity and the Africa Group defended their demand saying there is no duplication of negotiations, as whatever is agreed in the PABS Annex can be reflected in the contracts and vice versa without much debate. They also invited all other WHO Members to engage with their text proposals and said, in that process, the texts can be updated wherever necessary. Developing countries have insisted that this discussion is necessary to have clarity on the text that will appear in the standardized contracts that WCLN laboratories and WRSD agree with WHO, as well as in the standardized contracts that will be signed by the recipients of PMSI. There were also divergent views regarding the nature of legal instruments that will be used in the different components of the PABS System. The current draft text of Annex employs inconsistent terminology when referring to the legal arrangements governing recipients of PABS materials and/or PABS sequence information. In some provisions it refers to “contracts”, in others to “agreements”, “terms and conditions”, “terms of reference”, and even “notices”. Several developing countries observed that it remains unclear which rights and obligations will ultimately be contained in which legal instrument and have repeatedly called for clearly specifying the type of instrument that will be applicable. “Countries like South Africa and Pakistan have called for harmonisation of these terms in order to ensure PABS remain effective. However, there are divergent views regarding when and how those instruments will be concluded, and upon whom the respective obligations will fall. Hence, it’s not easy”, a diplomatic source pointed out. According to sources, certain developed countries argue that the term “contracts” should only be used to refer to the agreement signed by commercial users and WHO, adding that developed countries do not want standardised contracts, but would prefer WHO to enter into bilateral negotiations with each commercial user. According to sources, too, the WHO Legal Counsel at one point had suggested that standardised contracts not only contain the standardized provisions but also can include model terms and conditions. However, developing countries disagreed, referring to the precedent in WHO i.e. the standardized material transfer agreement in the Pandemic Influenza Preparedness Framework. The EU has acknowledged that contractual arrangements would exist between WHO and WCLN laboratories in the context of discussions on whether laboratories located in countries that are not Parties to the Pandemic Agreement (non-Parties) can be recognized as WCLN Labs. According to diplomatic sources, the EU said that sharing with non-Party laboratories was not a concern as the sharing would be governed by WHO contracts. However, some Members are opposed to allowing laboratories located in non-Parties to be designated as WHO reference laboratories or to receive PABS materials and sequence information through the PABS System. Debate on User Registration and Data Access agreement: Databases invited to share views According to sources, the EU, Norway, Japan, Switzerland, among a few others, remain opposed to commonly used measures such as user registration and data access agreement, arguing that there are technical feasibility constraints. These countries insisted on having their databases brief developing countries, leading to a technical discussion between databases and WHO Members in the first week of IGWG7. Information shared during the technical sessions does not seem to have shifted any positions. “We heard nothing which makes these measures [user registration and data access agreement] technically impractical or difficult”, said a delegate involved in the discussions. The technical discussions were attended by the International Nucleotide Sequence Database Collaboration databases i.e. Genbank, European Nucleotide Archive and DNA Databank of Japan as well as GISAID and Pathoplexus databases. The discussions took place over several hours on 7 and 8 July. Following the discussions and presentations from databases, some delegations informed that they did not find the databases to be operating consistent with any of the access and benefit-sharing (ABS) regimes. Another developing country delegate sharing insights from the technical discussions said to TWN: “Scientists will protect their interests, and the databases are mostly managed by such professionals. They rightly should do so, but not at the expense of the people of their own country or elsewhere. That said, it is for us, the Member States, to step in and correct these practices, not by penalizing them, but by providing better facilities that serve both the interests of scientists and the interests of the public”. Several developing country delegations that participated in the technical discussions, said that the exchange confirmed that developing country proposals such as user registration and data access agreement were technically feasible, and not incompatible with interoperability. “It’s clear there is no technical difficulty, it’s only a matter of political will or policy choice”, a developing country delegate informed TWN on condition of anonymity. [Data is said to be interoperable when data from different sources can be readily re-used and processed across different applications, enabling different information systems or databases to work together with little or no manual adjustment of the data. Interoperability does not mean allowing copying or transferring data from one database or information system to another.] The positions put forward by INSDC databases only resonated with the developed countries, several of whom were hosting these databases, and whose researchers and industries would benefit immensely from data extraction, without any meaningful traceability of their commercial and industrial use of such data. The spokespersons from three databases of INSDC attempted to spread a “fear narrative” that databases were being asked to do policing and take up enforcement rules, sources say. It was then clarified by several developing countries that WHO Members would like the database to recognize and support the realization of the rights of providers of genetic resources, add additional features in their facilities such as user registration, and require users to agree to data access agreement with obligations to share benefits. They specifically do not want to facilitate biopiracy by enabling anonymous access to sequence information in the name of open science. Database Managers admit “UPI Mining” in patent and regulatory documents is difficult Ironically, while arguing that databases should not “police” users through user registration and Data Access Agreements, all the database representatives, except GISAID, proposed a far more intrusive approach: extensive artificial intelligence-assisted surveillance of downstream users through mining of patent applications, regulatory documents and publications to identify accession numbers and other unique persistent identifiers linked to PABS Sequence Information. Several developing country delegations were of the view that while they were seeking to create a transparent, fairer and trusted research space, using user registration and common data access rules for all users, databases were asking them to do surveillance, investigation and compliance check of the data users. The first approach is a straightforward one that facilitates fair and equitable benefit sharing through contractual obligations, while the latter does not even guarantee that users will conclude benefit sharing agreements, let alone actually share benefits. Several developing countries with expertise in intellectual property work, explained the practical difficulties in mining patent applications and regulatory documents. At the end of the discussions, the databases agreed that mining of patent applications or regulatory documents is not an easy process and there were several hurdles in relying on that approach. A couple of developing countries said that GISAID had expressed full support for their needs and demands during the meetings and put in “extra effort” to show how it can help WHO Members – “PABS Access Token”, while other databases only showed only what their databases currently do. Another database Pathoplexus expressed willingness to provide support to a PABS facility which WHO Members may want to create, with or without user registration and data access agreements, provided that such support fits with their values. However, a developed country delegation expressed doubts about its ability to scale-up to meet the requirements of the WHO’s PABS System and stressed the need for a hybrid PABS system, where anonymous access databases can co-exist with databases with user registration, said sources. Following, three rounds of technical discussion with the databases, it is evident that it is feasible for databases to provide user registration and standardized data access agreements and that modern bioinformatics already rely extensively on features and facilities like authenticated users, trusted research environments, application programming interface and federated data infrastructures. Secretariat asked to revise draft Terms of Reference for laboratories and databases Discussions also took place on the draft Terms of Reference (ToRs) prepared by the WCLN and WRSD, in the first week of IGWG. Several developing countries argued the draft ToRs largely duplicated the proposed “terms and conditions” already under negotiation, creating confusion over the distinction between the two, sources say. It was also explained that WHO Members had requested ToRs setting out the technical functions of laboratories and databases, while the terms of use for access and benefit-sharing obligations should instead be addressed through the negotiated terms and conditions. Delegations also noted that the draft PABS Annex still does not specify the legal instrument through which either the ToRs or the terms and conditions would become binding on laboratories and databases, according to diplomatic sources. Some expressed concern that, without clear contractual arrangements, the PABS system could replicate existing WHO laboratory networks that operate without comprehensive legally binding agreements, sources say. The WHO Secretariat subsequently circulated revised drafts for both the terms of reference and terms and conditions, applicable to WCLN and WRSD provisions. A delegate noted that the revised text still omitted key technical functions of national and reference laboratories, including the development and distribution of candidate vaccine strains, primers, reagents and other reference materials.
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