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Info Service on Biodiversity and Traditional Knowledge (Jan26/01) London/Kochi, 6 Jan (Sangeeta Shashikant and Nithin Ramakrishnan) – As the new year begins, there is considerable anticipation surrounding the content of the Bureau’s forthcoming draft text for the Pathogen Access and Benefit Sharing (PABS) Annex. In December, the Intergovernmental Working Group (IGWG) mandated by the World Health Assembly to negotiate the PABS Annex to the World Health Organization (WHO)’s Pandemic Agreement (PA) formally requested the Bureau “to present proposals for sections of texts for a draft PABS Annex, in advance of the resumed session of the fourth meeting of the IGWG, building upon the on-screen text and inputs provided by IGWG members”. [See “Europe continues to defy emerging consensus on PABS”, TWN’s report on the 4th session of the IGWG that met in Geneva from 1-5 December 2025.] The Bureau is expected to circulate its draft text in advance of the resumed 4th meeting of the IGWG set to formally convene on 20-23 January 2026. A central question now facing many Member States and observers is whether the Bureau’s draft will meaningfully reflect the joint proposals submitted by more than 80 developing countries containing standardised contracts applicable to all persons/entities seeking access to pathogen materials and sequence information through the PABS System. Inclusion of these proposals in the Bureau’s draft is essential for negotiations on standard contracts – widely recognised as critical to effective operationalisation of a PABS System. However, emerging information suggests that the Bureau may sideline these proposals, potentially deferring or avoiding negotiations on standard contracts altogether. Such an approach would effectively amount to acquiescence to the European Union’s unjustifiable objections to the Global South’s longstanding and legitimate calls for standardised contractual arrangements, and the EU’s preference for a “PIP-minus” approach (explained further below). During the 4th meeting of the IGWG in December, the Africa Group and the Group for Equity (GfE) plus Egypt, Libya, Somalia and Sudan, representing more than 80 countries and around 75% of the world’s population, called for the IGWG to focus its attention on negotiating standardised PABS contracts, emphasising that this “important work cannot be deferred to the Conference of the Parties”. Towards this end, the coalition presented three standard contracts for the consideration of the IGWG:
These proposed contracts build on similar standardised contract templates previously negotiated in the context of the Pandemic Influenza Preparedness Framework (PIP Framework) and applicable to the sharing of influenza viruses with pandemic potential (IVPP). According to a developing-country delegate, the proposed approach for PABS is PIP Framework–plus, as the coalition’s proposals also include a standard contract applicable to the sharing of pathogen sequence information, a component absent from the PIP Framework. This is not the first time that developing countries have called for the negotiation of standard contracts applicable to users of pathogen materials and sequence information. At the outset of negotiations in the Intergovernmental Negotiating Body (INB) on the Pandemic Agreement, the Africa Group had submitted (later supported by the GfE as well) concrete textual proposals on the architecture of the PABS System, including the use of standard contracts. As negotiations on the PA progressed, these proposals were repeatedly sidelined by the INB Bureau, ostensibly on the grounds of insufficient time to conclude negotiations on the detailed text put forward by the Africa Group and the GfE. At the time, it was understood that developing-country proposals, including those on standard contracts, would be taken up during negotiations on the Annex to the PA mandated to elaborate the modalities and operational dimensions of the PABS System. The question now is whether history will repeat itself: whether the IGWG Bureau will once again sideline/avoid/defer negotiations on standard contracts, core components for the effective functioning, legal certainty and equity of the PABS System. Importance of Standardised Contracts in PABS Contracts Are Central to Operationalising ABS The Convention on Biological Diversity (CBD) and its Nagoya Protocol are based on the recognition of the sovereign authority of States over their biological resources, and access to such resources is subject to the national legislation of the provider State and mutually agreed terms between the provider and the recipient of such resources. The mutually agreed terms will set out the terms of use of the shared resources, including fair and equitable benefit sharing. Notably, Article 6(3)(g) of the Nagoya Protocol explicitly states that mutually agreed terms between provider and recipient of genetic resources “shall be set out in writing and may include, inter alia: (i) A dispute settlement clause; (ii) Terms on benefit-sharing, including in relation to intellectual property rights; (iii) Terms on subsequent third-party use, if any; and (iv) Terms on changes of intent, where applicable”. The right to determine the conditions of access and to fair and equitable benefit sharing also extends to digital sequence information (DSI) of such biological resources. The recent Decision 16/2 of the Conference of the Parties to the CBD affirms the continued primacy of national legislation and contractual arrangements concluded at the time of access in governing the use of DSI. It reflects that States may regulate the generation and use of DSI through domestic law and mutually agreed terms established at the time of granting access to genetic materials. The decision further acknowledges that the use of DSI may also be addressed under other international instruments that apply their specialised regulatory or contractual approaches to access and benefit sharing (ABS). Enforceable contracts are thus integral to the functioning of any ABS regime. The European Commission’s guidance document on the scope of application and core obligations of Regulation (EU) No. 511/2014 of the European Parliament and of the Council on the compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union also recognises that these mutually agreed terms include not only specific conditions for the fair and equitable sharing of benefits arising from the utilisation of genetic resources but also “further conditions and terms for such utilisation as well as subsequent applications and commercialisation”. Recognising that sequence data can be well within such mutually agreed terms of access to genetic resources, the guidance document further asserts that “those who accessed the genetic resources and obtained sequence data from them should respect the conditions of the agreement entered into, and inform subsequent actors about any rights and obligations attached to the data obtained and related to any further uses of it”. Article 4(2) of the EU Regulation (EU) No. 511/2014 of the European Parliament and of the Council of 16 April 2014 on the compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union requires that “genetic resources and traditional knowledge associated with genetic resources shall only be transferred and utilised in accordance with mutually agreed terms if they are required by applicable legislation or regulatory requirements”. Standardised Contracts Are the Global Norm When Sharing Biological Materials and Sequence Information The use of standard contracts for the sharing of biological materials and related sequence information is well established as a global norm. When biological materials are shared, it is standard practice for the provider and the recipient to conclude a Material Transfer Agreement (MTA), typically based on a standardised template. Such agreements specify, inter alia, the parties to the agreement, the subject matter covered by the agreement, the respective obligations of the provider and the recipient, conditions for termination, and mechanisms for dispute resolution. With respect to recipient obligations, the MTAs inter alia clarify the permitted uses of the shared materials, conditions governing transfer to third parties, benefit-sharing commitments, the treatment of intellectual property etc. Standard MTAs may also address the handling and use of data and sequence information linked to the shared physical materials. The use of standardised MTAs is widespread at the national level, particularly in developed countries, and is routinely employed by government agencies, biobanks, research institutions and universities, e.g., the US NIH Uniform Biological Material Transfer Agreement (as early as 1995), the UK Biobank’s MTA, and the European Molecular Biology Laboratory material transfer agreement standardised for non-commercial users. Standard Material Transfer Agreements (SMTAs) are also integral to the operation of multilateral ABS mechanisms. Notable examples include the sharing of IVPP under the PIP Framework as mentioned above; the exchange of plant genetic resources under the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA); and the sharing of biological materials with epidemic or pandemic potential (BMEPP) within the context of WHO’s BioHub System. Each of these SMTAs clarifies the obligations of the recipients with respect to the shared resources. Even access to pathogen sequence information is routinely subject to standard terms and conditions that clearly set out the permitted and prohibited uses of the shared resources. A prominent example is GISAID’s standard Database Access Agreement (DAA), which must be accepted by any individual or entity seeking to register with GISAID and access its sequence databases. The DAA establishes binding conditions governing the use of sequence information, including permitted uses, restrictions on onward transfer to unauthorised users, as well as provisions on termination and dispute settlement. GISAID hosts the majority of sequence data relating to pathogens with pandemic potential, and its operations are supported by numerous entities and agencies from the Global North, including the German government and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which represents the interests of large pharmaceutical companies. However, GISAID is a private entity and is neither transparent nor accountable to WHO Member States. Another database, GBIF, also has separate agreements for data publishers and data users. Further, the European Genome-phenome Archive (EGA), a global network for permanent archiving and sharing of personally identifiable genetic, phenotypic and clinical data generated for the purposes of biomedical and healthcare research projects, requires completion of a Data Access Agreement as part of applications to its Data Access Committee for access. Notwithstanding its shortcomings, GISAID’s model, granting access only to registered users who have accepted standard, enforceable terms and conditions, as well as examples of other databases, demonstrate the practical feasibility of such an approach. In particular, such examples reinforce the joint proposal by developing countries for the establishment of a standard Data Access and Use Agreement under the PABS System. Legal Certainty and Enforceability Article 12.2 of the PA envisages that provisions governing the PABS System will include modalities, terms and conditions, as well as its operational dimensions. Article 12.5(b) stipulates that the PABS instrument must contain “modalities, terms and conditions on access and benefit sharing that provide legal certainty”. To meet these agreed requirements, the negotiation of standard contracts is a prerequisite. Standard contracts should constitute the foundational pillars of the PABS System, as they provide the operational mechanisms through which access and benefit sharing is implemented, as well as the legal clarity, predictability and enforceability required by the PA. In the absence of such contracts, any elements set out in the Annex, including benefit-sharing commitments, cannot be made binding on recipients of pathogen materials and sequence information shared under the PABS System. Citing objections raised by the EU and its allies, some have proposed a step-by-step approach, namely, setting out in the Annex certain elements of the terms and conditions that may apply to recipients of pathogen materials and sequence information, while deferring negotiations on the actual standard contract templates until after the ratification of the PA has begun. This approach raises serious legal uncertainties and practical shortcomings. Once the ratification process is underway, there would be little incentive for the EU to conclude negotiations on outstanding issues. On the contrary, the EU could prolong discussions, anticipating that developing countries will eventually be pressured to abandon their proposals. At the same time, the EU could deploy diplomatic and trade channels to encourage developing countries to ratify the PA in order to bring it into force – thereby activating provisions in Articles 4 and 5 on surveillance and “One Health” which are of particular interest to the EU. This approach would also risk constraining developing countries in subsequent negotiations on standard contracts. Time pressures and political dynamics could result in the Annex reflecting only limited elements of the terms and conditions, insufficient to support effective, enforceable standard contracts. Moreover, it would place developing-country governments in an untenable position: facing strong pressure to ratify the PA, an unbalanced, inequitable legal instrument, even as the core operational architecture that is expected to deliver equity remains unfinished. From a practical standpoint, this approach is also illogical. If there is sufficient consensus to articulate elements of the terms and conditions in the Annex, there is no credible justification for not reflecting those same elements directly in standard contracts. “PIP-Minus” Approach of the EU violates CBD and Nagoya Protocol The EU does not envisage that recipients of pathogen materials or sequence information under the PABS System will be subject to any legally binding terms and conditions. Even “participating manufacturers” would retain discretion over whether to enter into legally binding contracts with WHO. Under the EU’s proposal, State Parties would be obliged to share pathogen materials and sequence information within 48 hours of availability, yet recipients would assume no binding obligations with respect to the use of the shared materials and sequence information, including fair and equitable benefit sharing. Accordingly, it opposes starting negotiations on standard contracts. The EU argues that requiring a laboratory, researcher or manufacturer to conclude contracts (even if standardised) would hinder R&D. And yet, as explained above, concluding standard material transfer agreements and database access agreements is widespread practice within the EU, and such an approach is widely supported by its members and the pharmaceutical industry. The EU’s hypocritical position represents a clear regression from the PIP Framework – the only multilateral ABS mechanism in global health that has been operationalised to date. The PIP Framework, negotiated by WHO Member States including the EU, requires all recipients of IVPP – including WHO-designated laboratories, researchers, developers and manufacturers – to accept legally binding terms and conditions – SMTA 1 or SMTA 2. While the handling of sequence information remained an unresolved issue, the Framework nonetheless established binding contractual obligations as a non-negotiable foundation for access and benefit sharing. By contrast, the EU’s current proposals on the PABS System seek to avoid binding SMTAs, entrenching inequitable access, weakening scientific provenance and attribution, facilitating biopiracy, raising biosecurity concerns, and rendering benefit-sharing obligations effectively meaningless. The EU’s model will effectively create a PABS System where access to PABS materials and sequence information is not subject to any enforceable terms of use, very much susceptible to transfer of samples and data to any entity including pharmaceutical companies that are not committed to any benefit sharing – a clear violation of the requirements of the CBD (e.g., Article 15) which clearly stipulates that access where granted should be subject to prior informed consent and fair and equitable benefit sharing on mutually agreed terms, as well as various related provisions of the Nagoya Protocol. As one seasoned observer of WHO negotiations noted, this “PIP-minus” model is untenable for anyone except private, profit-driven interests. The apparent strategy is to advance a deliberately weakened model, compelling developing countries to expend political capital merely to restore PABS to the level of PIP, while marginalising legitimate calls for a more equitable “PIP-plus” framework – one that would also address the governance of sequence information. It would be deeply concerning if the Bureau and Secretariat were to reinforce this unjustifiable position. Yet these concerns are widely shared among developing countries as they await the Bureau’s draft text. Standard Contracts Enable Access – They Do Not Delay It The EU and its stakeholders often advance a narrative that material transfer and data access agreements impede the rapid sharing of pathogen materials and sequence information. What this narrative ignores is that ungoverned sharing, without contractual obligations on users, entrenches inequities and undermines trust. There is ample evidence that the absence of fair, enforceable terms over the use of the materials and sequence information creates mistrust and ultimately delays data and sample sharing. Providers reasonably fear misinterpretation, misuse, misappropriation, economic harm, security risks, and loss of recognition or collaboration opportunities. These concerns act as well-documented barriers to timely sharing in public health. In practice, standard contracts, particularly for pathogens with pandemic potential, are therefore not an obstacle to access; they would instead create trusted research partnerships or collaborations that would promote not only rapid and predictable access to pathogens and sequence information, but also the fair and equitable sharing of benefits such as vaccines, therapeutics and diagnostics effective against such pathogens.
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