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Context: The World Health Organization (WHO) adopted the Pandemic Influenza Preparedness Framework (PIP Framework) after being forced to grapp with the demands of developing countries for the fairer distribution of vaccines and antivirals created using influenza viruses isolated from within their territories. Though adopted as a nonbinding resolution, the PIP Framework has been praised for its novel legal approach to access and benefit-sharing (ABS), using Standard Material Transfer Agreements (SMTAs) to create binding terms and conditions on both providers and users of PIP biological materials. The PIP Frameworks SMTA1 regulates the movement of influenza viruses with human pandemic potential through the WHO's Global Influenza Surveillance and Response System (GISRS) as it operates to monitor the spread of seasonal influenza and detect the emergence of pandemic strains. Member States give consent to the WHO to transfer their materials to third parties under the terms of a negotiated SMTA2. The SMTA2 details benefits such as vaccines and antivirals to be made available to the WHO for distribution in the event of an influenza pandemic. Methods: I analyzed the PIP Framework, its SMTAs, and secondary sources to determine whether the PIP Framework will effectively function as an ABS instrument during an influenza pandemic. Findings: The SMTAs do not create any direct or binding agreements between Member States and third-party recipients of influenza viruses. In the lead-up to and during a pandemic, the SMTA1 secures access to influenza viruses for the WHO, and the SMTA2 secures access for commercial users of virus samples, but the SMTA2 may be ineffective in securing tangible benefits for the sovereign providers of those materials. Conclusions: As the international community starts to consider how to best regulate access to nonpandemic influenza pathogen samples, it is imperative that we first address the shortcomings of the only pathogen-specific international ABS instrument available, and we should do so before it is put to the ultimate test.

Societal Impact Statement The “Parts Agenda” is an approach to synthetic biology that fragments genetic resources into functional bioparts to help design and build biological devices and systems. Access and benefit‐sharing (ABS), and the issue of how to regulate digital sequence information (DSI) within the current ABS regime, poses a problem for synthetic biology because it assumes fragmented and ed bioparts can be traced to their country of origin for the purposes of benefit‐sharing, and that contributions to information and knowledge can be quantified and appropriately valued. Any DSI regulatory solutions should account for genetic resource fragmentation and other complexities of modern scientific practice. Summary The inclusion of digital sequence information (DSI, including genetic sequence data) in the existing access and benefit‐sharing (ABS) regime will alter the practice of synthetic biology. The potential impediments could be magnified for the “Parts Agenda”: the approach to synthetic biology that fragments genetic resources into their smallest functional units to create standardized, interchangeable “bioparts”, the building blocks for assembling synthetic biological devices. These biological devices are themselves interchangeable and can be used to engineer higher order synthetic biological systems. This article examines how the extension of ABS laws to include DSI could foreseeably apply to the creation and use of plant‐derived and other bioparts in engineered biological devices expressed in plant chassis. The article demonstrates that ABS issues will be similar for all approaches to synthetic biology, but that the Parts Agenda is uniquely exposed to the potential regulatory burden of bilateral ABS transactions between users and providers of genetic resources. The original vision for bioparts was one of openness and sharing, with access and use unencumbered by intellectual property. This article shows that open access to bioparts will not last long if DSI is enclosed within the current ABS regime, destabilizing the values of openness and sharing in synthetic biology that are ostensibly foundational to this still developing field. The “Parts Agenda” is an approach to synthetic biology that fragments genetic resources into functional bioparts to help design and build biological devices and systems. Access and benefit‐sharing (ABS), and the issue of how to regulate digital sequence information (DSI) within the current ABS regime, poses a problem for synthetic biology because it assumes fragmented and ed bioparts can be traced to their country of origin for the purposes of benefit‐sharing, and that contributions to information and knowledge can be quantified and appropriately valued. Any DSI regulatory solutions should account for genetic resource fragmentation and other complexities of modern scientific practice.

COVID-19 reveals gaps in international law that can inhibit timely sharing of information, samples, and sequences The coronavirus disease 2019 (COVID-19) pandemic has demonstrated the critical importance and persistent challenges of rapidly sharing public health and scientific information, biological samples, and genetic sequence data (GSD). Sharing these resources is crucial to characterizing the causative agent, understanding its spread, and developing diagnostics, antiviral treatments, and vaccines. But even though these resources are critical for the global health community, there is currently no legal obligation for countries to share physical pathogen samples or associated GSD. To date, researchers have often shared such resources in a spirit of scientific openness. Yet ongoing scientific cooperation has been insufficient ( 1 ) despite the scale of the pandemic threat. The lack of a clear legal obligation to share pathogens or associated GSD during a health emergency represents a blind spot in international law and governance, impeding pandemic response and scientific progress. We examine the sharing of public health information, biological samples, and GSD in the still early days of the COVID-19 pandemic, identify barriers to sharing under the current international legal system, and propose legal and policy reforms needed to enhance international scientific cooperation.

Several UN policy processes are embracing a calcified approach to conservation and equity in science Access and benefit sharing (ABS), a policy approach that links access to genetic resources and traditional knowledge to the sharing of monetary and nonmonetary benefits, first found expression in the 1992 United Nations (UN) Convention on Biological Diversity (CBD). Predicated on the sovereign rights of countries over their biodiversity and associated genetic resources and intended to harness the economic power of those resources to create incentives for and fund biodiversity conservation, the ABS transaction was conceived to foster equitable relations between those parties providing genetic resources and associated traditional knowledge and those wishing to make use of them for research and development. Yet although challenges faced within the CBD suggest that it is time to rethink ABS, several other international policy processes under the auspices of the UN have instead been embracing the ABS approach, and are doing so largely outside of mainstream scientific discourse and attention. The resulting policies could have a major impact on how genetic resources and associated information are collected, stored, shared, and used, and on how research partnerships are configured. We highlight implications for science of the recent expansion of ABS in global policy, in particular the potential incorporation of genetic sequence data.

Access and benefit sharing (ABS) is a transactional mechanism designed to allow countries to trade access to their sovereign genetic resources for monetary and non-monetary benefits, with the ultimate goal of channelling those benefits into sustainable development and environmental conservation. Arguments about how pathogens are not the sort of genetic resources the world ought to conserve eventually gave way to a recognition that pathogens are indeed sovereign genetic resources under the Convention on Biological Diversity and its Nagoya Protocol, and that the ABS transaction may be an effective way to deliver scarce vaccines to developing nations as benefits received in exchange for shared pathogen samples. This article argues that categorising vaccines as benefits given in exchange for access to pathogen samples creates opposing incentives for providers and users of virus samples and undermines the human right to health because it makes that right a commodity to be bought. The provision of pathogen samples to the global research commons and the fair and equitable distribution of medicines should be two parallel public goods to be pursued as goals in and of themselves. We conclude that the linking of these goals through the ABS transaction should be reassessed.

In the light of the urgency raised by the COVID-19 pandemic, global investment in wildlife virology is likely to increase, and new surveillance programmes will identify hundreds of novel viruses that might someday pose a threat to humans. To support the extensive task of laboratory characterization, scientists may increasingly rely on data-driven rubrics or machine learning models that learn from known zoonoses to identify which animal pathogens could someday pose a threat to global health. We synthesize the findings of an interdisciplinary workshop on zoonotic risk technologies to answer the following questions. What are the prerequisites, in terms of open data, equity and interdisciplinary collaboration, to the development and application of those tools? What effect could the technology have on global health? Who would control that technology, who would have access to it and who would benefit from it? Would it improve pandemic prevention? Could it create new challenges? This article is part of the theme issue 'Infectious disease macroecology: parasite diversity and dynamics across the globe'.

Societal Impact Statement Future research and development of biological materials for foods, feeds, fibres, materials and medicines will increasingly rely on information and knowledge using Artificial Intelligence (AI) applications for detecting patterns to make useful decisions. The access and use of this information and knowledge is increasingly being regulated under international laws according to an ideal that delivers money and other benefits from the uses of the information and knowledge. We conclude these issues will require specific attention to ensure the ideals of fair and equitable benefit sharing are sustainable and can deliver real benefits. Summary The global regulation of access and benefit sharing (ABS) biological materials is starting to impose complex rules for governing information and knowledge about those materials. Artificial Intelligence (AI) poses existential challenges for the research and development of those materials for foods, feeds, fibres, materials and medicines under these ABS schemes. We speculate these challenges are in three distinct scenarios: (1) data used to train the AI models; (2) data used to test (and verify) the AI models; and (3) data used in applying the models to reveal useful patterns. Building in ‘explainability’ to the AI algorithms may be a solution, at least in part, to delivering on fair and equitable ABS. We then posit two issues for ABS: (1) negotiating the ownership status to use the input data with each data owner for training, testing (and verifying) and using the models (although a further complication here is that most data is without an owner because it is already open and free as a public domain without intellectual property restrictions); and (2) following the data per se through the AI models (explainability). We conclude that how ABS will be addressed in developing and applying AI models will require careful consideration to avoid the apparent dulling effects of current ABS regulation and the potentially significant consequences this may have for biology‐based research and the commercialisation of biology‐based products and services. Future research and development of biological materials for foods, feeds, fibres, materials and medicines will increasingly rely on information and knowledge using Artificial Intelligence (AI) applications for detecting patterns to make useful decisions. The access and use of this information and knowledge is increasingly being regulated under international laws according to an ideal that delivers money and other benefits from the uses of the information and knowledge. We conclude these issues will require specific attention to ensure the ideals of fair and equitable benefit sharing are sustainable and can deliver real benefits.

Equity is a foundational concept for the new World Health Organization (WHO) Pandemic Treaty. WHO Member States are currently negotiating to turn this undefined concept into tangible outcomes by borrowing a policy mechanism from international environmental law: “access and benefit-sharing” (ABS).

During the COVID-19 pandemic the international community repeatedly called for the equitable distribution of vaccines and other medical countermeasures. However, there was a substantial gap between this rhetoric and State action. High-income countries secured significantly more doses than they required, leaving many low-income countries unable to vaccinate their populations. Current negotiations for the new Pandemic Treaty under the World Health Organization (WHO) attempt to narrow the gap between rhetoric and behaviour by building the concept of equity into the Treaty's substantive content. However, equity is difficult to define, much less to operationalize. Presently, WHO Member States appear to have chosen ‘access and benefit-sharing’ (ABS) as the predominant mechanism for operationalizing equity in the Treaty. This article examines ABS as a mechanism, its use in public health, and argues that ABS is fundamentally flawed, unable to achieve equity. It proposes other options for an equitable international response to future pandemic threats.