A circular bio-economy approach to regulating genetic resource research: rethinking access and benefit sharing

Abstract

Access and benefit sharing (ABS) regulates the collection and use of genetic resources, associated traditional knowledge and in some cases digital sequence information for research and development (R&D) purposes and the equitable sharing of monetary and non-monetary benefits from their use. Global examples of benefit sharing have fallen short of expectations under this framework and there is little empirical data about the effects of regulation on bio-innovation. This article argues that the limited ABS tools of authorization and contracts are not effectively delivering benefit sharing aspirations because of the disconnect between linear assumptions underlying genetic resource R&D. Through a critical legal analysis of ABS, circular economy principles and legal mechanisms, it rethinks ABS governance to propose a new circular bio-economy system for more efficient benefit sharing. It proposes a pathway for transforming the linear ‘single use’ regulatory model toward a generative value chain model, supported by a range of legal tools that facilitate long-term benefit sharing for the planet and its people.

I. INTRODUCTION

The last decade has ushered in a new era for transformative outcomes-oriented approaches to tackle the triple planetary threats of biodiversity loss, climate change, and pollution/resource depletion. Proffered solutions include ‘Nature Positive’, ‘Net Zero’, and ‘Circular Economy’ to address these respective threats. Nature Positive is an outcome-oriented movement for mainstreaming action toward the Kunming Montreal Global Biodiversity Framework (GBF) goal to ‘halt and reverse biodiversity loss to put nature on a path to recovery for the benefit of people and planet by conserving and sustainably using biodiversity and by ensuring the fair and equitable sharing of benefits from the use of genetic resources’.¹ It focuses on net (positive) biodiversity outcomes (regeneration), rather than simply protection against loss, requiring transformation of relationships between societies, economies, and institutional arrangements.² The concept of net-zero emerged from physical climate science to transform these relationships through specific reduction trajectory to avoid the most severe consequences of global warming.³ Transitioning toward a circular economy contributes to net positive and decarbonization by transforming consumption, production, and ecologically sustainable development.⁴ Achieving these transformations is dependent on accelerating research and development (R&D),⁵ which draws from a wide range of physical and social sciences and other knowledge systems collectively called bio-R&D in this article. Bio-R&D outcomes are critically dependent on access to physical biological and genetic resources, their associated data, information, and knowledge, as well as the infrastructure and know-how to use them (bio-innovation).⁶ This, in turn, is dependent on effective governance and regulatory settings to support bio-R&D and deliver long term benefits, including access and benefit sharing (ABS) regulation. Yet there are increasing calls to re-think ABS regulation, because there is little evidence that existing regulatory models are delivering the expected benefits and conservation outcomes.⁷

International ABS law is a matrix of six agreements (Table 1) that set out obligations for state parties (or members) about the regulation of biological or genetic resources and associated traditional knowledge for the purpose of bio-R&D innovation. Their scope is carved out by jurisdictional area (geographical origin of the regulated subject matter) and sector (the intended use of the subject matter). They vary in their objectives, but each aim for the fair and equitable sharing of benefits from the use of genetic resources. They vary significantly in the extent to which (and the processes by which) they regulate: (i) the physical genetic material; (ii) the genetic sequence information it contains, called digital sequence information (DSI); and (iii) traditional knowledge associated with genetic resources. This jurisdictional and sectorial approach to ABS requires evidence of provenance of the regulated objects to determine which regime applies to an R&D activity.

Table 1.

Objectives, scope, and legal tools under the six International ABS regimes.

International ABS regime	Objectives	Scope	Access tools	Benefit sharing tools
1992 Convention on Biological Diversity (CBD)	(1) Conservation; (2) sustainable use; (3) fair and equitable benefit sharing (art 1)	Non-human biological resources* and associated traditional knowledge from areas within national jurisdiction	Prior Informed Consent (PIC) (authorization) of the Provider country (Party)	Mutually Agreed Terms (MAT)
2010 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (Nagoya Protocol)	(1) Fair and equitable benefit sharing that contributes to conservation and sustainable use (art 1)	Non-human biological resources and associated traditional knowledge from areas within national jurisdiction	‘PIC’ (authorization) of the Provider country (Party) ‘PIC’ or ‘approval and involvement’ of Indigenous peoples and local communities	MAT (contracts eg benefit sharing agreements, material transfer agreements, data transfer agreements)
2001 International Treaty on Plant Genetic Resources for Food and Agriculture (Plant Treaty)	(1) Conservation; (2) sustainable use; (3) fair and equitable benefit sharing for; (4) sustainable agriculture and food security (art 1)	Plant genetic resources for food and agriculture	Facilitated access to the multilateral system samples	Multilateral mechanism and information sharing platforms; contract (Standard Material Transfer Agreement—SMTA); benefit sharing fund.
2011 World Health Organization's Pandemic Influenza Preparedness (PIP) Framework	(1) Improve PIP and response; (2) protect against pandemic influenza; (3) fair, transparent, equitable, efficient and effective system for the sharing of influenza viruses with pandemic potential and access to vaccines and sharing other benefits (art 2).	H5N1 Influenza virus and other influenza viruses with pandemic potential (but not seasonal influenza viruses)	Facilitated access to the multilateral system samples	Contract (SMTA), information systems.
2022 CBD Digital Sequence Information (DSI) on Genetic Resources Multilateral Mechanism on Benefit Sharing (DSI MLM) under the 2022 Kunming-Montreal Global Biodiversity Framework.	(1) Support generation, access and use of DSI; (2) fair and equitable benefit sharing; (3) achieving CBD objectives and sustainable development (preamble)	DSI of genetic resources within publicly accessible databases, subject to some exceptions	Open access	Benefit sharing fund; other non-monetary benefits
2023 Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas Beyond National Jurisdiction (BBNJ Agreement)	(1) Fair and equitable benefit sharing; (2) capacity building; (3) generation of knowledge, scientific understanding and technological innovation; (4) transfer of marine technology (art 9)	Marine genetic resources (MGR) of areas beyond national jurisdiction (ABNJ) and associated DSI and traditional knowledge	Notification to the clearing house mechanism for pre-collection, post-collection and utilization activities; PIC and MAT for traditional knowledge associated with MGR in ABNJ	Notification mechanism (information sharing); non-monetary benefit sharing; benefit sharing fund includingdirect Party payments; requirements to deposit resources and DSI in publicly available repositories and databases; future monetary benefit sharing modalities to be determined.

^*Note that the scope of all of the agreements are more nuanced than can be captured in this summary table.

These six regimes can be conceptualized on a spectrum of transactional, collaborative, and open access models of ABS. The multilateral systems under the International Treaty on Plant Genetic Resources for Food and Agriculture (Plant Treaty),⁸  Pandemic Influenza Preparedness (PIP) Framework⁹ and Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas Beyond National Jurisdiction¹⁰ (BBNJ Agreement) employ collaborative techniques for sharing information and benefits at the scale of the broader R&D communities that operate within sectors using plant, virus, and marine genetic resources from areas beyond national jurisdiction, respectively (Table 1). Under these models, researchers engage with the collective system so that financial and other benefits flow back to the multilateral mechanism and its designated purposes.¹¹

The bilateral systems under the Convention on Biological Diversity¹² (CBD) and Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity¹³ (Nagoya Protocol) take a transactional approach to ABS. These require states Parties to implement measures that support a transboundary system of prior informed consent (PIC) and mutually agreed terms (MAT) between a ‘provider’ and a ‘user’ for each transaction with the regulated subject matter. While an authorized activity may approve a range of uses within the one ABS transaction, the term ‘single use’ is used in this article to conceptualize the CBD’s case-by-case authorization approach within the parameters of a defined project. Here, regulation is targeted at the individual researcher level, employing administrative law (authorizations including permits), and contractual law techniques to direct benefits from the use of the regulated subject matter back to national law system. The CBD’s GBF DSI multilateral mechanism is an evolving multilateral system attempting to shift away from the single use model toward more collaborative and open access models for the use of DSI within scope.¹⁴

States Parties that implement their CBD and/or Nagoya Protocol obligations have mostly unique and sometimes multiple systems under their national laws. The broad interpretation of international obligations to suit national circumstances have produced wide variations in the subject matter scope (physical samples, associated information, and associated traditional knowledge), the geographical scope (in situ, ex situ, private, public lands, waters, or repositories), the temporal scope (new utilization of previously collected samples), the regulated activities (access, utilization, export, fields of R&D) and uses (commercial, non-commercial), and procedures for authorization, benefit sharing, monitoring, and compliance.¹⁵ The result is a complex global web of ABS law and policy.

There is little empirical evidence that ABS frameworks have met expected monetary and non-monetary benefit sharing from the use of samples,¹⁶ DSI,¹⁷ and traditional knowledge.¹⁸ Complexity, ambiguity and extreme heterogeneity of national ABS legislation is prohibitive for small to medium-sized enterprises to engage in bio-innovation.¹⁹ Some researchers have argued that the time and resources spent on compliance issues with complex regimes are disproportionate to the benefits that could be generated and shared through ABS contracts.²⁰

The aim of this article is to re-imagine the ABS concept by bringing its guiding principles, regulatory focus, and legal tools into a technologically, socially, and economically different world than the one envisaged over 30 years ago when the CBD’s transactional solution was conceived. This article argues that at the core of the inefficiency of ABS regimes are a series of linear misassumptions about bio-R&D that shape regulation under the single use model toward unintended adverse outcomes for R&D, which undermines the realization of conservation, sustainable use, and equity objectives. The article reconceptualizes ABS through a circular economy lens because: (i) circular bio-economy systems are designed to accommodate non-linear R&D, value chains and resource flows, with lessons for ABS regulation for more effective benefit sharing; and (ii) bio-R&D increasingly plays a key role in the transition toward a circular economy, requiring transformation in benefit sharing systems.

After an examination of the conceptual shifts underlying the circular economy concept (section II) and examples of the non-linear nature of bio-R&D (section III), the article critically analyzes the linear assumptions underlying the CBD/Nagoya Protocol regulatory model (section IV). Section V proposes an alternative to the single use model approach of regulating objects: a value chain model that regulates the relationships beyond a regulated transaction for long-term benefit sharing, institutional and community-based capacity building and large-scale collaboration to accelerate bio-R&D nationally and worldwide. This approach does not affect rights of PIC of Indigenous People and local communities (IPLCs) and suggests a conceptualization of a legal framework that is more open to legal pluralism to protect rights of self-determination and data sovereignty. Inspired by circular economy strategies, section VI proposes a more diverse toolkit than existing permit and contractual approaches under the single use model, aimed at regulating the relationships between stakeholders to accelerate more strategic and long-term benefit sharing outcomes. The article concludes that the value chain model could offer a prototype to generate discussion for a range of other models and further empirical investigation into practical options for re-thinking ABS to achieve its objectives.

II. CONCEPTUAL SHIFTS TOWARD CIRCULAR BIO-ECONOMY GOVERNANCE AND REGULATION

The circular economy concept is often associated with addressing the twin threats of resource depletion and environmental degradation arising from unsustainable production and consumption practices. Addressing these threats are priorities under Sustainable Development Goals,²¹ and GBF.²² There is no universal definition of a ‘circular economy’, but there is general agreement that it requires a fundamental systems or paradigm shift from the existing dominant social/economic model, rather than incremental change.²³ The concept has been widely critiqued, including its potential for increasing greenwashing, production, consumption, and its failure to effectively integrate social equity considerations.²⁴ However, the concept is helpful for fundamentally re-thinking how systems level changes to social structures and networks (including regulations, markets, industries, institutions, and communities) can transform social and economic development with net positive benefits for nature on which society depends.²⁵

A circular economy can be conceptualized as an antonym of a linear economy. A linear economy promotes a one-way system of production and consumption where resource inputs are converted to products, consumed, and become waste.²⁶ This linear model leads to environmental deterioration by removing natural capital from nature, resulting in pollution, economic loss, and social upheaval.²⁷ Instead, a circular economy is regenerative by design, where waste is reconceptualized as a resource. Think tanks²⁸ and governments²⁹ often conceptualize three principles underlying a circular economy:

1. eliminating waste: this requires designing production within a circular system (including economic and legal infrastructure) so that after initial use, materials and products are returned to the economy for further use;

2. circulating products and materials at their highest value in the system for as long as possible: this may be achieved through strategies in the ‘R’ hierarchy:

• a) refusing new material use or reducing the amount of waste generated;

• b) reusing, redesigning, or repairing materials/products to fulfill the same purpose for which they were originally made;

• c) refurbishing, remanufacturing, or repurposing them to fulfill a new purpose;

• d) recycling by processing waste into new products or materials that can be used for new products; and as a last resort;

• e) recovering energy by converting waste that cannot be recycled into sustainable sources of energy;³⁰

• 3. regenerating nature: as with the outcome-oriented goal of Nature Positive, the focus of circularity is on (positive) biodiversity outcomes (regeneration), rather than simply protecting against loss, for net conservation gains and long-term benefits.

Implementing these principles in practice requires transformation of how societies manage their interfaces with natural resources, including through markets, economies institutions, and social constructions.

Whereas policies that support the development of bio-based economies gained traction from 2006,³¹ the more specific concept of a circular bio-based economy or ‘circular bio-economy’ has only recently emerged.³² There is no universal definition of a ‘bio-economy’, but early neo-liberal articulations of the idea focused on the sustainable use of natural resources to provide goods and services for growing populations and economies.³³ The bio-economy is commonly framed as a political and economic endeavor to support new forms of capitalism, focused on commodification and privatization of nature.³⁴ However, circular economy principles and bio-economy goals have merged into a circular bio-economy concept, recognizing biomass as a precious and finite resource, which should be primarily used when upgraded to its full potential and optimized value of conversion of all types of biomass.³⁵ For example, higher value feed and food ingredients can be first recovered from biomass before residual fibers make biofuels.³⁶ Bio-R&D, is key for unlocking the potential and value of these biological resources to achieve circular economic, environmental, and social objectives.³⁷

Governance is part of a broad range of factors that pose barriers and opportunities for transitioning to a circular bio-economy.³⁸ Addressing governance barriers requires an integrated policy and legislative framework aligned with circular bio-economy goals, with clear, measurable and enforceable objectives for policies.³⁹ Intervention may range from explicitly labeled circular economy laws, to laws embodying circular principles, to the network of public and private laws in a society that support systems change necessary for the transition.⁴⁰ In other words, regulation (law and policy) has a central role to play in the transition far beyond waste and pollution laws. Arguably, modern (western) legal regimes have been designed around social constructs that support the ‘take-make-dispose’ model of progress and development, but there are gaps in scholarship about how a broader range of laws can support systems change.⁴¹ At the time of writing, there is no scholarship about the role of ABS in supporting a circular economy transition, even though the transition relies on accelerated bio-R&D.

III. NON-LINEAR NATURE OF BIOLOGICAL R&D ACTIVITIES AND COMMUNITIES

‘The whole is more than the sum of its parts’ (Aristotle).

There is not a homogenous R&D sector that can be easily targeted as ‘the’ regulated entity under national ABS law, but rather a complex network of communities. Wide diffusion of the bio-economy concept across multiple scientific fields results in different roles for R&D based on multiple values, drivers, and foci such as biotechnology (eg synthetic biology), bio-resources (eg biological raw materials in sectors such as agriculture, aquaculture, forestry and bioenergy), and bio-ecology (eg circular and integrated processes and systems for conservation and sustainability) and so on.⁴² Researchers who work in the bio-economy system are distributed across many different fields of science including natural and engineering sciences and social and behavioral sciences, which intersect with other disciplines like law and economics.⁴³ The boundaries of collective phenomena like technoscientific fields ‘are ambiguous, flexible, contested and redefined in action’.⁴⁴ For example, definitions of synthetic biology are fluid but usually merge the techniques of engineering with biology.⁴⁵ Section IV argues that this fluidity of R&D communities, fields and actors poses challenges for simplistic assumptions about the subject of regulation under single use ABS models.

Bio-innovation is an iterative, collective process, dependent on multiple inputs and outputs over different time scales. Past centuries demonstrated leaps in understanding from key discoveries like Mendelian genetics, Germ Theory, and deoxyribonucleic acid (DNA).⁴⁶ In recent decades, there has been an explosion of fields within the biological sciences including genomics, proteomics, bioinformatics, molecular genetics, systems biology, next-generation sequencing, and metabolomics.⁴⁷ Reduction in the cost of DNA sequencing and synthesis combined with technical breakthroughs means that researchers are no longer dependent on physical samples for lab-based research but could use genetic data or sequences (DSI).⁴⁸ DSI is commonly used with, or in the place of, the physical biological materials for many biological fields⁴⁹ and it is now widespread practice for academic and commercial researchers to use DSI from publicly accessible databases like GenBank.⁵⁰

The US National Intelligence Council has predicted that over the next 20 years a more multidisciplinary, digital, and data-intensive approach to sciences will propel new leaps in understanding and ability to manipulate living matter.⁵¹ For example, generative biology already combines artificial intelligence (AI), advanced life sciences technologies (like platforms for recombinant protein production), and dry and wet-lab automation ‘to revolutionize the process of designing novel biomolecules with prescribed properties’.⁵² The impact of generative biology will depend on the availability of data (including hundreds of millions of genetic sequences) to train the models, and effective data management.⁵³ Biological innovation is generative, radical, and incremental,⁵⁴ which section IV argues does not fit within ABS linear assumptions about the innovation process.

The collaborative nature of bio-innovation demonstrates fluid, non-linear relationships between the regulated subjects (R&D communities). Historically biotechnology research has been concentrated in a limited number of countries because it depends on clusters of innovation harnessing academic and technological communities.⁵⁵ Early advocates for synthetic biology recognized the expected revolution was beyond the capacity of talented individuals but required an entire scientific community sharing foundation resources like ideas, practices, technologies, and infrastructure (commons-based peer production).⁵⁶ Democratizing science through greater access to research tools and publicly available open sequences and data has ushered a new era of do-it-yourself biotechnology.⁵⁷ Crowd sourcing and community laboratory spaces reduce dependence on institutions for funding and other resources, indicating a shift in how and by whom science is done, although the vast majority of bio-R&D is performed within institutions (eg universities, government entities) and industry.⁵⁸ Section IV argues that researchers participate in the simultaneous production and consumption of the value of the resource,⁵⁹ which does not neatly fit the ABS legal distinction between providers, users, intermediaries and subsequent third-party users of the genetic value for R&D.

In summary, ‘almost every aspect of biology is non-linear.’⁶⁰ R&D often involves experimentation with multiple organisms in multiple forms originally collected from different locations, jurisdictions, or timescales,⁶¹ which are passed through multiple commercial value chains.⁶² The rise of fully autonomous technologies, environmental DNA techniques, open-source sequences and AI have modified many R&D practices with often simultaneous (not linear) collection, use and output activities for both tangible and intangible regulated objects.⁶³

IV. LINEAR ASSUMPTIONS UNDERLYING SINGLE USE ABS MODELS

‘Law is the essential foundation of stability and order both within societies and in international relations’ (J. William Fulbright)

The transactional approach underlying the CBD/Nagoya Protocol is decades old, posing challenges for responding to rapid changes in bio-R&D.⁶⁴ This section argues that the assumptions underlying this model help to explain its simplistic linear regulatory framework that does not easily accommodate non-linear R&D realities. These linear assumptions are pervasive in the single use model’s approach to the regulated objects (IV.A), regulated entities (IV.B) and regulated activities (IV.C) and its approach to effective tools for regulating behavior (IV.D). This section offers a rationale for why the lens of circularity could be relevant for understanding the limitations under existing regulatory approaches and to shed light on new regulatory solutions proposed in sections V and VI.

IV.A. Assumptions About the Nature and Value of the Regulated Objects

The CBD/Nagoya Protocol regulate genetic material as objects of regulation, but the linear (mis)assumptions about the object’s form, function and value under the single use regulatory model has unintended outcomes for the regimes' efficiency. Under the CBD/Nagoya Protocol model, a genetic resource means ‘genetic material of actual or potential value’ and genetic material means ‘any material of plant, animal, microbial or other origin containing functional units of heredity’.⁶⁵ While this has been interpreted broadly at the international level to mean material from any biological source or form (where units of heredity are operating or having a function),⁶⁶ there is wide variation under national laws about whether this extends to derivatives and information associated with the genetic resource such as DSI.⁶⁷ Given that the potential value of genetic resources is drawn from genetic information, Ruiz Muller (2015) and others have argued that the objects of access should be identified as ‘natural information’.⁶⁸ However, this section offers a rationale for transitioning away from regulating objects and toward regulating relationships, which may avoid the need for debate about the nature and form of genetic resources within legal definitions of scope.

The single use model was designed with the assumption that an identified biological resource would be collected and utilized for its genetic properties to create something of value, such as a blockbuster drug.⁶⁹ This assumes that genetic material is a blueprint, where distinct parts of the genome specify instructions for distinct developmental processes.⁷⁰ Regulatory regimes driven by these metaphors imply a linear and deterministic relationship between genotype and phenotype⁷¹ and have been criticized as oversimplifying biological processes.⁷² Lawson 2022 argues that founding a regulatory scheme on the ‘misleading picture of bottom-up information flowing from DNA sequences may perpetuate perverse outcomes and (further) undermine the purpose and integrity of ABS schemes.’⁷³ This is because information in DNA sequences is predominantly about mRNAs and proteins and only accounts for a part (often very minor) of the caused phenotype. The problem is that bundling all the value into an ABS contract does not accommodate the value of information about the form and function of the DNA sequence causing the phenotype and its performance in an ecosystem.⁷⁴

A conceptual variation is the ‘recipe’ metaphor with the genome being a set of ingredients (materials) and a set of instructions for how to bring them together.⁷⁵ The cooking conditions (eg chemistry and physics influences) lead to variability in the outcome (but within a phenotypic range).⁷⁶ However, this metaphor has also been criticized as overly linear and failing to account for epigenetic influences.⁷⁷

In contrast, systems biology and machine learning have prompted conceptualizations of genes as ‘continuous, noisy, and dynamic elements in a connectionist network.’⁷⁸ A ‘generative’ metaphor captures the ‘indirect, distributed and nonlinear relationship between information in the genome and the form of the organism’ where the ‘the latent variables⁷⁹ embodied by the genome collectively constrain biochemical interactions such that certain cellular and developmental processes tend to occur in certain ways.’⁸⁰ Reconceptualizing genetic resources within the regulatory framework as 'generative by design' might inspire regulatory tools that support multiple outcomes from their use beyond the targeted authorized use.

In keeping with a linear deterministic understanding of regulated objects, the CBD fora has decided to split ABS regulation into separate regimes for the physical materials and DSI, resulting in regulatory loopholes for the contextual information and technical know-how from the regulated objects. Challenges for benefit sharing from the use of sequence information separate to the samples have long been known⁸¹ but it wasn’t until 2022 that the CoP agreed that regulating DSI requires a distinctive solution.⁸² Countries agreed on a non-binding multilateral mechanism for DSI on genetic resources that aims to be efficient, feasible, practical and ‘consistent with open access to data’.⁸³ The regulated object of DSI is undefined but is not likely to include contextual and functional information.⁸⁴ A sequence of DNA nucleotides bears information but ‘is not just a linear text that can be directly translated with fixed, universal rules into another linear text: it is not a cipher at all, in fact. It is, rather, part of a dynamic control system with combinatorial, contextual dynamics that allows cells to regulate their own biochemistry under many different conditions.’⁸⁵ This indicates the value for ABS includes genetic information and structure. Whereas sequence analysis focuses on the order of nucleotides or amino acids (information), genetic structure analysis focuses on the high dimensional (n-space) structure of genes and proteins to understand molecular function and interactions.⁸⁶ Unlocking their value depends on the technical know-how and contextual (including environmental) information which seems to be outside the scope of the regulated object of DSI.

The DSI monetary benefit-sharing fund (Cali fund) applies to publicly available DSI if it is not subject to MAT at the time of access and not subject to rules under other international ABS instruments.⁸⁷ Other international ABS fora are closely watching developments for lessons that may be applicable to their own regimes.⁸⁸ However, the practical reality is that many biodiversity rich countries already enclose genetic information under their single use ABS measures but with little detail about how measures are managed and enforced in practice.⁸⁹ This means that a sequence derived from a genetic resource that is subject to multiple ABS regimes, may be subject to multiple obligations, posing challenges for R&D and efficient benefit sharing. Whereas the multilateral system applies to DSI databases, researchers increasingly rely on genetic structure databases,⁹⁰ which may be outside scope if regulators persist with the blueprint metaphor to conceptualize the regulated object. The confusion for determining which objects are regulated is likely to continue with this linear thinking, undermining certainty for bio-R&D.

There has been increasing scholarship by authors from Indigenous communities about the lack of understanding of Indigenous knowledge systems by those who design international agendas for ABS.⁹¹ ‘Traditional knowledge’ or ‘Indigenous knowledge’ are contested terms and mean different things for different communities and different world views.⁹² Unlike scientific knowledge that is broken down into disciplines or pedagogies, they are complete knowledge systems.⁹³ For example, ‘Mātauranga spans Māori knowledge, culture, values, and worldview..(it) is dynamic, not static.’⁹⁴ These knowledge systems are inextricably linked with people, place and nature, encompassing ways of being and relating to environments.⁹⁵ This connectivity poses challenges for linear frameworks that conceptualize samples, DSI and traditional knowledge as discrete regulated objects.

Whereas a linear single use model splits regulated objects into discrete components, creating blockages in data and knowledge sharing, ‘generative’ assumptions about regulated objects might promote reuse and regeneration of data. Modern science depends on data sharing for large scale analyses and reproducibility.⁹⁶ Data sharing is a scientific norm with nearly half of researchers using data generated by other scientists, yet up to 80% of the data is lost within 20 years.⁹⁷ Central to the circular economy concept are strategies to maintain circulation of the inherent value of a resource, including the contextual information and technical know-how to unlock multiple values for as long as possible through the value chain.⁹⁸ This idea is embedded in the FAIR principles, which have become international best practice⁹⁹ aimed at reducing data waste and support data re-use. FAIR ensures that data is findable, accessible, interoperable, and reusable by others.¹⁰⁰ The DSI multilateral mechanism and Cali fund not only requires consistency FAIR principles but also the CARE principles of collective benefits, authority to control, responsibility and ethics.¹⁰¹ The BBNJ Agreement is the first treaty to explicitly require FAIR data, and its ABS measures connect the physical sample, DSI and the contextual/functional data obtained through its notification mechanism within the one information/benefit sharing framework.¹⁰² This approach marks a turning point toward more circular principles for international ABS data governance and holistically managing relationships between samples, DSI and contextual information/know-how.

IV.B. Assumptions About the Regulated Entities

Original ideas behind the transactional (single use) approach to ABS under the CBD/Nagoya Protocol model included addressing a market failure for biodiversity conservation,¹⁰³ and to address inequities from the unfair exploitation of low-income biodiversity-rich countries.¹⁰⁴ By creating a market and value for genetic resources, ABS regulation was expected to ensure that users of genetic resources compensate the providers for the costs of conserving the biological resources in their countries.¹⁰⁵ By ensuring benefit sharing with the provider country of a relevant resource, ABS regulation was also expected to tackle biopiracy by promoting a more equitable distribution of resources and income between high and low income countries.¹⁰⁶

Thirty years on, there is little empirical evidence that ABS has had the expected positive impact on reversing biodiversity loss and reducing biopiracy.¹⁰⁷ There are many reasons for this¹⁰⁸ but one reason is a simplistic assumption about linear biological resource flows from the Global South (biodiverse rich, technologically poor countries) to the Global North (technologically rich countries).¹⁰⁹ There are many examples of unfair exploitation of the Global South;¹¹⁰ however, studies demonstrate the biological resource flows and risks of biopiracy are more complex than this assumption of linear movement between South and North.¹¹¹ For example, the flow of aquatic genetic resources for use in global aquaculture is predominantly South to South and North to South.¹¹² The flow of DSI for use in a wide range of biological research is complex and multi-directional but is primarily from North to South.¹¹³ Basing regulation on simplistic linear assumptions about material flows may arguably lead to greater inequities if complex rules restrict resource and information sharing between countries in the Global South.

The CBD/Nagoya Protocol model is premised on ascertaining the provenance of regulated subject matter to identify which regime applies and the benefit recipient. It regulates transactions between a user and a ‘provider’ country (which may be the country of origin or a country that ‘acquired’ the resource in accordance with the CBD¹¹⁴), rather than directly with the original country of origin.¹¹⁵ The extent to which national laws regulate their domesticated and non-native species as the provider country or country of origin varies widely between countries.¹¹⁶ The ‘provider’ with rights to receive benefits is normally a government, but can include Indigenous communities and private land owners and the provider may redistribute benefits eg toward nature or R&D.¹¹⁷ The CBD and Nagoya Protocol do not adequately provide frameworks for managing intermediaries (such as gene banks) that are neither providers nor users but hold a genetic resource in trust, posing complications for the legal status of samples.¹¹⁸ In contrast, the Plant Treaty cooperative model of ABS accommodates and promotes ‘in trust’ legal relationships with resources as the core of its benefit sharing strategy.¹¹⁹ Legal tools for supporting ‘trust’ relationships remove the artificial legal distinction between providers, users and intermediaries for broader sample sharing outside a specific project or use.

The use of permits and contracts to tether benefits (for the provider) to the regulated objects that are accessed (by the user) has resulted in complex procedures for regulating the movements and uses of the regulated objects. ABS obligations (including the terms of benefits to be shared) depend on intent of the proposed research, which is difficult to monitor and enforce.¹²⁰ Many ABS laws have different rules for proposed non-commercial and commercial uses, with more onerous benefit sharing obligations for the latter. These are often accompanied by time consuming change of intent procedures, often requiring provider permission for new uses. The permit and contractual legal relationships are between the provider and user, so there are usually complex procedures regulating third party access (eg subsequent users), often requiring the provider’s permission for sample transfers. To ensure benefits return to the provider, laws usually have reporting, checkpoints and other tools for tracking and tracing regulated objects through assumed linear R&D pipelines. International fora have recently recognized that tracking and tracing DSI is neither feasible nor practical, prompting a global rethink about how to manage benefit sharing from DSI.¹²¹ However, all international and national ABS regimes will continue to be tethered by provenance as long as they focus on regulating objects.

In contrast to ABS linear assumptions of material movements and provider/user relationships, circular economy concepts include assumptions about the interconnectedness of economies, biological cycles and relationships within R&D and other communities.¹²² Roles of regulation supporting circularity include measures to: (i) avoid rules that directly or indirectly promote waste from a one-way flow of resources out of an economy; and (ii) promote incentives to keep the resources and their informational value circulating in the economy in various forms for as long as possible before returning to the biological system. This means an equitable share of the burden of benefit sharing throughout the value chain at the institutional, R&D communities and commercial end-user levels. Rethinking the linear assumptions about the flow of biological resource materials within and between R&D communities and end-use sectors could lead to frameworks and rules that promote greater efficiency. Section VI outlines regulatory tools that focus on the value chain, which can accommodate interconnected relationships between R&D communities and the broader social, environmental and economic communities.

IV.C. Assumptions About the Nature of Regulated Activities—The Bio-R&D Processes

The single use model assumes a simplistic ideal of innovation, envisaging a biological resource from a specific location for a particular use. It assumes a linear legal transfer of an object between provider and recipient (user), where a genetic resource is collected (take), used in R&D to create an outcome (make) and then produces an output. As long as the recipient has fulfilled their permit and contractual obligations for the defined use (eg for that project), the legal obligations are discharged, which is the end of the line for the resources (dispose). In other words, the single use model assumes a take-make-dispose model of R&D (Fig. 1).

Figure 1.

Assumptions underlying the linear single use ABS model and the proposed generative value chain ABS model.

It also assumes researchers will know what properties they are looking for (and benefits they can share) prior to negotiating benefit sharing terms required before collecting genetic resources from the wild or ex situ collections under many laws. It is difficult, sometimes impossible, to estimate the commercial value of a potential innovation at that point in time,¹²³ creating inefficiencies and power imbalances in the negotiating process.¹²⁴ Under this linear model, the opportunity for monetary benefits from the results of research are wasted other than for rare projects reaching commercialization of a product decades after collection.¹²⁵ Non-monetary benefits might be distributed during the research project (such as capacity building or research collaboration). However, the single use model artificially imposes benefit sharing within the confines of the permitted use (at the project level), rather than at the higher value chain level where the required institutional arrangements to support benefits (eg collaboration) are likely to sustain more long-term benefits and collaborations beyond the life of the individual project. Recognizing that benefit sharing at the project level does not preclude institutional benefit sharing and institutional relationships do not always result in benefits, moving from the single use model can open up tools that support benefit sharing relationships throughout value chains—from projects, to institutions and beyond.

The Cali monetary benefit sharing fund under the DSI multilateral mechanism appears to elevate regulation to the sectoral level, rather than the individual researcher/project level. Expectations to contribute monetary benefits are borne by private entity ‘users’ of DSI in sectors that directly or indirectly benefit from its use in their commercial activities.¹²⁶ Details about how the fee will be calculated and how it will be imposed are not determined at the time of writing, but payment by individual users is not envisaged.

However, the scope of regulation is still, arguably, tethered to DSI as a regulated object. A typical use (eg BLAST¹²⁷) would compare thousands or millions of sequences in a public database for patterns in a sequence in a single search, and these sequences may have different providers or countries with multiple areas of origin that fall within scope of different ABS regimes.¹²⁸ A low percentage of DSI have origin labels, making it challenging or impossible for a researcher to know the origin so that they can determine which ABS rules may apply to their activities on a case-by-case basis.¹²⁹ It is usually impossible to determine the precise contribution of individual DSI in a finished product,¹³⁰ which is why the Cali Fund appears to target entities/sectors that benefit from DSI, rather than individual users. But scope depends on a determination about whether a specific sequence in a BLAST of millions of sequences in the database was subject to MAT at the time of access,¹³¹ which demonstrates lingering linear assumptions about science and seems impractical.¹³²

Better alignment of the Bio-R&D iterative and generative processes with ABS assumptions can open new strategies for regulation. For example, the circular design-build-test-learn (DBTL) model (Fig. 1) is an iterative framework widely used in science, and a central principle of engineering biology and synthetic biology.¹³³ It provides a structured approach to innovation by continuously improving biological systems or products through successive cycles of designing, building, testing and learning for further designing, building, testing and learning.¹³⁴ Recent technological innovations in the ‘design’ of biological systems have prompted a surge in the number of samples characterized in the ‘test’ stage of the DBTL cycle,¹³⁵ prompting the use of generative AI and vast amounts of data (including DSI) as part of the research process.¹³⁶ Regardless of automation, bio-R&D is usually the result of iterative research methods throughout value chains that builds on the body of knowledge, rather than the simplistic linear assumptions of take-make-dispose underlying the single use ABS model.

The circular economy concept is more likely to accommodate the collaborative and iterative feedback loops of bio-R&D. Inherent in circular economy strategies is the idea that there are multiple users using multiple resources through multiple value chains at different points in time.¹³⁷ Circular principles aim to design out waste (in the sense of inefficiency) by embedding information and benefit sharing objectives in consumption and production activities, rather than sharing benefits at the end of a process through a linear model of consumption.¹³⁸ Section V.C demonstrates what a value chain model might look like in practice for ABS.

IV.D. Assumptions About Legal Tools to Regulate Behavior

Implementing ABS international regimes under national law has offered a limited range of legal tools for achieving benefit sharing. Table 1 outlines the legal tools explicitly embedded in the different ABS regimes and their institutional arrangements, which for the Nagoya Protocol model, has been limited in practice to authorization/registration mechanisms and benefit sharing mechanisms of contracts and/or benefit sharing funds. State practice demonstrates that while each national ABS law has variations in detailed procedures, most have implemented these limited tools.¹³⁹ This procedure-based approach to benefit sharing has resulted in a lack of diversity of legal tools for generating benefit sharing outcomes. However, the constructively ambiguous language under the CBD and Nagoya Protocol means that countries can be creative in their implementation of procedures so long as they meet the treaty’s substantive obligations.

The ABS focus on regulating objects raises complex questions of ownership and control. Property is not a ‘thing’ but a description of a legal relationship with a ‘thing’ and property rights are recognized in law as a degree of power permissibly exercised over something.¹⁴⁰ In many western legal systems, property constitutes a ‘bundle of rights’, where ownership may be separate from possession, for example between an owner as lessor and a tenant as lessee.¹⁴¹ Possession is a complex legal concept and can include resources in the custody of another (ie under their control) or control over the access and use of information and knowledge, etc. There is often a misunderstanding that under ABS users ‘own’ the biological resources in the legal sense, but depending on the national regime in question, they may simply have possession of the resource to conduct R&D in a manner that accords with the authorization, without affecting other interests. For example, a landowner might enter into an agreement to receive benefits from the use of a biological resource collected from land within their control. This might be subject to agreement of other ‘providers’ under the legislation, for example governments and IPLCs. Customary law systems have a variety of other concepts and approaches that govern these relationships.¹⁴²

However, embedding contracts into the regulatory framework to manage relationships creates an expectation of ownership or at least control over resources to the exclusion of others and results in complex arrangements for passing on ‘rights’ to downstream users. Contracts might be in the form of benefit sharing agreements or material transfer agreements between users and intermediaries or subsequent users. The nature of control over resources may change from use to use. For example, a repository may hold a voucher sample¹⁴³ ‘in trust’ for current and future generations but may also have rights to research and develop other products from the same genetic material but a different sample.¹⁴⁴ Whereas the Plant Treaty uses an ‘in trust’ model over time scales, the Nagoya Protocol is more oriented toward a regulatory model for the specific transaction in question, creating complicated legal arrangements for subsequent users (reuse) and power imbalances for those negotiating benefits.

Power imbalances for contractual negotiations arise for a range of reasons including cultural, social and financial reasons and language/world view barriers.¹⁴⁵ For example, Tualima and Bowrey (2020) argue, ‘the authority assumed in legal discourse through western-style negotiations over contractual terms that determine access and distribution of benefits has the potential to obliterate custom and strip knowledge of meaning and significance.’¹⁴⁶ They suggest ‘improvements in this area requires the commercial and research participants to commit long term to working collaboratively with knowledge holders, including learning Samoan language and custom, which is not necessarily what they value.’¹⁴⁷

There is anecdotal evidence that ABS regulation has disrupted informal sharing practices of biological samples and information within R&D communities, which has been at the core of innovation throughout history.¹⁴⁸ In contrast to the ABS procedural approach to sharing information and benefits as a result of the authorized use of a regulated object (an optional form of benefit sharing), the starting point of circular economy approaches is sharing information, resources and benefits through strategies like collaboration and co-production. This does not mean open access, which can result in inequities from the free exploitation of IPLC's resources and traditional knowledge for example.¹⁴⁹ Rather, it recognizes that essential infrastructure of shared resources such as ‘physical and social platforms, technological routines and processes, and institutional norms’, must usually be available prior to an activity to maximize scientific outcomes and benefits, rather than being generated during or after the activity on an ad hoc basis.¹⁵⁰

What this means for ABS is a conceptual shift from regulating the objects (genetic resources and DSI) for defined authorized uses and toward recognizing and supporting the relationships and incentives within the broader existing sharing economy of R&D. The mainstream sharing economy (that continues to exist alongside the financial economy) denotes a ‘collaborative consumption’ through sharing, exchanging or renting resources instead of the transfer of ownership in the commercial economy.¹⁵¹ Sharing activities fall into at least four broad categories: (i) increased utilization of durable assets; (ii) recirculation of goods; (iii) exchange of services; and (iv) sharing of productive assets.¹⁵² Orienting ABS regulatory frameworks toward the monetary prize at the end of an R&D project arguably prioritizes financially-oriented motivations above socially-oriented motivations,¹⁵³ distorts the inherent value of the resource, and undermines a sharing economy.¹⁵⁴ There needs to be more empirical research about the motivations in R&D communities for sharing the benefits from their research. However, in the meantime, section VI highlights some regulatory tools beyond those employed by the single use model that could drive behavior toward more effective benefit sharing.

IV.E. Summary

Viewing the assumptions underlying the ABS single use model about the regulated objects, entities, activities through the lens of circularity highlights a fundamental misunderstanding of bio-R&D. Scientific practices demonstrate that the value of genetic resources to R&D is not solely the physical material or the information in the DNA sequence, but in their dynamic interplay with the contextual (like environmental data¹⁵⁵) and functional information and the technical know-how for unlocking properties and value (information about sequences).¹⁵⁶ Whereas ABS assumes a linear relationship between the regulated object and the R&D outcome, sections III and IV provided examples of how R&D depends on a dynamic interplay between the researcher, the regulated object and context/know-how. Table 2 summarizes these and other assumptions underlying ‘ABS thinking’ and ‘circular thinking’ as a starting point for re-thinking exactly what, why, who, when and how we are trying to regulate in this age of rapid scientific and technological development.

Table 2.

Assumptions underlying ABS and circular thinking matched to the ‘what, why, who, when and how’ of governance.

Assumptions about…	ABS single use thinking	Circular thinking
…the nature of the regulated object (IV.A) [what?]	Linear relationship between the genome (blueprint) and output—focus of regulation is on the object	Non-linear dynamic elements in a connectionist network (generative)—focus of regulation is on the relationships
…the value of the regulated object (IV.A) [why?]	Genetic value for the proposed output in the regulated ABS transaction	Samples, sequences, contextual information and know-how that unlocks multiple values for as long as possible through the value chain
…the regulated entity (IV.B) [who?]	Linear relationship between provider, user and output, where most of the benefit sharing burden falls on the individual researcher at time of access (collection)	Interconnected relationships between providers, intermediaries, users and third parties, with equitable responsibility of benefit sharing throughout the value chain at the institutional, R&D and commercial end-user levels
…the nature of regulated activities (IV.C) [when?]	Linear R&D phases of collection, utilization and output at the end of project (ie linear take-make-dispose assumptions)	Generative, collaborative and iterative feedback loops of R&D (eg circular design-build-test-learn assumptions)
…the nature of legal tools for effective regulation (IV.D) [how?]	Procedure-based tools (authorization and contracts) to trace regulated objects	Outcomes-based tools for managing relationships of people throughout the value chain

V. A CIRCULAR BIO-ECONOMY VISION FOR ABS

‘Everything in the world has changed except our thinking’ (Albert Einstein)¹⁵⁷

Rapid technological changes and transformative agendas for biodiversity and economies mean that the time is right for a fundamental rethink of benefit sharing governance. This section demonstrates how reconceptualizing CBD objectives through the lens of circular economy principles can reframe some of the linear assumptions about the ‘why, what, who, when and how’ of governance (Table 2).¹⁵⁸ The proposed prototype generative value chain governance model is intended as a starting point for discussing new pathways, through co-design and co-production by stakeholders, to institutionalize sustained benefit sharing while accelerating bio-R&D in a fair and equitable manner with resource and knowledge providers.

V.A. Why Is There Regulatory Intervention?

Effective regulation requires clear goals, actions and indicators for achieving those goals. The ABS concept, which began with environmental objectives under the CBD, is being stretched in different directions under ABS fora, including food security and health security objectives (Table 1). Objectives influence interpretation of treaty obligations and a Party’s approach to implementing their obligations under national law.¹⁵⁹ While treaty objectives cannot easily be changed, there may be scope for Parties to interpret and balance these ABS objectives through a broader range of legal tools.

There is increasing literature suggesting the CBD/Nagoya Protocol ABS model is not achieving its objectives.¹⁶⁰ The following CBD objectives,¹⁶¹ and suggested alternative legal tools to support their achievement (section VI), can be reinterpreted through the circular economy principles of: (i) eliminating waste by design; (ii) circular resources at their highest value; and (iii) regeneration:¹⁶²

1. fair and equitable benefit sharing: instead of the existing short-term focus of intra-generational equity,¹⁶³ legal tools could support intra and inter-generational equity and deter obsolescence to eliminate the concept of waste (eg tools in sections VI.A-D). ‘Waste’ in the ABS context can refer to unused or discarded materials that have lost their primary value under the single use model;

2. sustainable use of the components of biodiversity: instead of narrowly focusing on consumption (exploitation) of resources enclosed in an ABS transaction, legal tools could support multiple cycles of consumption and production that circulate resources at their highest value through collaboration and institutional capacity building (eg tools in sections VI.A and C); and

3. conservation of biodiversity: instead of procedural-oriented benefit sharing linked to exploitation, legal tools could incentivize regeneration outcomes supporting the intrinsic value of nature, building natural capital and supporting fundamental research tackling planetary threats (eg tools in sections VI.B and C).

Countries that are not a Party to the Nagoya Protocol have a greater opportunity to adopt a more transformative approach to ABS, but arguably there is still flexibility under the Nagoya Protocol for approaches that move away from single use regulatory models of authorizations and contracts on a case-by-case basis.

V.B. What and Who Is Being Regulated?

A linear ABS model conflates the regulated object with the legal fiction of property so that legal tools (authorization and contracts) attempt to control the movement of the ‘things’, instead of the connections (relationships) between the ‘things’.¹⁶⁴ A mistaken assumption that the ‘things’ are stable (a blueprint) and capable of ownership, arguably force regulators to continually patch up benefit sharing loopholes caused by a flawed starting point for ABS—that genetic material, DSI and traditional knowledge are discreet objects capable of being owned and regulated.¹⁶⁵

Whereas the single use model regulates objects as subject matter, a value chain model outlined below aims to regulate the relationships—the connections between people, between people within nature, and between people and the changing nature of the regulated subject matter beyond a specific R&D project. Employing more diverse tools for regulating relationships such as those in section VI below, can orient a legal system toward ‘commons-expansion’.¹⁶⁶ Large-scale co-production and collaboration could significantly accelerate bio-R&D worldwide,¹⁶⁷ but this requires long term benefit sharing, institutional change and community-based capacity building including:

• supporting conservation systems at local levels—including land trusts, Indigenous-managed protected areas and local employment in conservation management beyond short term political cycles;

• infrastructure investment—shared laboratory equipment, computing and data storage facilities;

• data management and analysis—shared platforms and protocols for collecting, storing, analyzing and interpreting genetic and other data;

• human investment—building social capital between institutions and communities;

• funding—sustainable and reliable sources of funding across and beyond project cycles;

• co-production and ongoing engagement—fostering participation and partnerships at the researcher, institution and community levels, and across disciplines and timescales; and

• governance—designing regulation (policy and law) that support long term relationships with biodiversity.¹⁶⁸

Targeting regulation at an aggregate institution or community level (rather than the individual project level under the single use model) can facilitate long-term commitments to working collaboratively with resource providers, traditional knowledge holders and IPLCs.¹⁶⁹ This could promote genuine long-term benefits and ongoing relationships with community instead of ad-hoc encounters of knowledge extraction for the lifetime of a project.

V.C. When Are Obligations Triggered?

This article proposes a starting point, or prototype, for rethinking ABS frameworks that drive behavior, which is more aligned to bio-R&D loops. Section IV.C proposes a conceptual shift from R&D being regulated under the current single use ‘take (collection)—make (utilization)—dispose (end of project)’ model that wastes benefit sharing opportunities, to a regulatory approach that is iterative by design.¹⁷⁰ What this requires are frameworks and legal tools that encourage extending the use of genetic materials, information products and data beyond the lifespan of a single project to keep them in circulation for as long as possible, such as through a generative value chain model where collaboration, innovation and sharing genetic resources and other long term relationships and benefits are supported within and beyond the bio-R&D loop (Fig. 1).

This model acknowledges the multiple starting points and pathways for unlocking the R&D value of a genetic resource beyond the simple linear assumption that a targeted resource will be collected from the wild or a repository (eg it may be found in a fridge from a previous lab project with unknown origin). It recognizes that experimentation and unexpected results may lead to a different path for developing technology and this path has unplanned commercial potential. The model delinks access from benefit sharing so that instead of a temporal trigger where piecemeal benefits are determined prior to each ‘access’ event, there is an ongoing commitment at the institutional and industry level to share benefits with designated ‘resource providers’, society and nature in a collaborate–innovate–share–collaborate feedback loop model of achieving benefit sharing (outer ring of the generative value chain model in Fig. 1). A challenge for Indigenous communities would be how to protect their rights to PIC and benefit sharing at different points along the bio-R&D loops. Rethinking when obligations are triggered is not intended to undermine existing rights of IPLCs but rather to guard against loopholes or challenges for engagement under the single use model. Ensuring IPLCs co-design ABS measures with other regulators and stakeholders, including measures that span legal systems (section VI.D), may offer more workable solutions for when obligations are triggered along value chains.

V.D. How Is Benefit Sharing Achieved?

Regulating relationships at the institutional and industry level across value chains requires a broader range of tools than access authorizations and benefit sharing contracts under the single use model. However, the generative value chain model is designed to co-exist with permission and PIC safeguards for conservation, equity and fairness. Most countries have authorization requirements outside their ABS laws for the collection of species and biological resources from the wild for R&D purposes. The purpose and conditions of these authorizations (eg permits) vary but often they often relate to research, import and export.¹⁷¹ This authorization mechanism has been appropriated by the ABS concept as a means of policing benefit sharing at the input stage. An alternative is a stand-alone benefit sharing mechanism with obligations at the institutional and industry level at the R&D and output stages and where appropriate, the input stage.

Similarly, free, prior, and informed consent (FPIC) from IPLCs for the use of traditional knowledge associated with genetic resources continues to be an important safeguard for equity and safeguard against misappropriation. This FPIC model is entrenched under a range of international fora including ABS, intellectual property, human rights and labor fora.¹⁷² The value chain model provides space for a conceptual shift from realizing benefit sharing on a case-by-case basis at the project scale and elevate these benefits to longer term co-production and benefits with IPLCs and traditional knowledge holders at the institutional scale. Any regulatory or governance shift would need to be led by IPLCs or the traditional owners, who may instill measures to safeguard against an artificial separation of governance for traditional knowledge and the biological resources with which the knowledge is associated.¹⁷³ Tualima and Bowrey 2020 highlight the benefits for moving away from a one-way flow of legal concepts under the ABS agenda,

Indigenous People are forced to fit their knowledge within western framing of legal concepts or make sense of concepts that are not consistent with how knowledge exists in the communities…Indigenous People are left to work with ill-suited concepts and find meaning which, at times, has meant marginalising the significance of their own knowledge and creating further gaps in the protection and preservation of knowledge.¹⁷⁴

Legal concepts are not static and those setting a reconceptualized agenda would draw from diverse world views and knowledge systems.

The agenda setting for a stand-alone benefit sharing mechanism would need to clarify who receives the benefits from bio-R&D. ABS laws already specify who is entitled to benefits as ‘resource providers’, which can include governments, IPLCs and private landholders, depending on the law in question, but is often silent about how benefits flow back to nature and society in general.¹⁷⁵ Few, if any, ABS laws explicitly require benefits to flow to R&D communities to generate further bio-innovation and future benefits. At the core of the collaborate–innovate–share–collaborate feedback loop model of the value chain model (Fig. 1) is the need for infrastructure and institutional arrangements that support co-design, co-production and alternative models of ownership from the outcomes of research. These could include circular business models such as circular supply chains, product life extension, sharing platforms and product as a service models.¹⁷⁶

Applying the ‘R’ hierarchy to biological resource governance could guide policy toward a system that supports more visible information and benefit sharing outcomes that are already present in the scientific (informal) sharing economy.¹⁷⁷ For example, this may draw on circular economy strategies of:

1. ‘reducing waste’ by promoting (at the institution level) ideas of co-production, collaboration and practices that reduce duplication of effort and discarding of resources or information at the end of individual projects;

2. ‘reusing resources’ with policy settings to encourage the sharing of samples, DSI and know-how available for multiple projects;

3. ‘repurposing resources’ through public information about the location of samples and DSI so that subsequent users can access them for new purposes; and

4. ‘recycling resources’ through publications, patents and publicly available commercial outputs to build on the body of knowledge.

R&D communities and the private sector may already engage in these strategies but section VI provides examples of a diverse regulatory toolkit that targets relationships along value chains in a way that explicitly supports unlocking multiple values of biological resources, knowledge and know-how for as long as possible.

Feedback loops are fundamental to circular economy systems, which like R&D, are iterative by design.¹⁷⁸ In 2024 the CoP to the CBD highlighted the importance of mainstreaming indicators of effectiveness of benefit sharing across the ABS forums.¹⁷⁹ At the time of writing, none of the ABS instruments require their Parties or members to monitor and report on the effectiveness of national arrangements for fair and equitable benefit sharing. There are initiatives to develop practical non-binding indicators under the GBF¹⁸⁰ but arguably these are constrained by the GBF focus on quantitative measures of benefit sharing rather than qualitative,¹⁸¹ which might determine whether the benefits had lasting effects for communities. This arguably undermines measuring whether benefits reach through to the right communities at different time scales to design out waste in benefit sharing. Significantly, it also overlooks that the regulatory agenda and its measure of success are set by mainstream western world views, which may compound inequities for communities with other world views.

V.E. Summary

In summary, reconceptualizing ABS through a circular bio-economy lens re-focuses the ‘why, what, who, when and how’ of governance:

• why regulate—to achieve ABS objectives and long-term benefit sharing and co-production of bio-R&D for intra and inter-generational equity;

• who is regulated—institutions and industries that benefit from the use of biological resources, traditional knowledge, bio-R&D data and technical know-how;

• what is regulated—relationships between actors in value chains, rather than the objects themselves;

• when are obligations triggered—an ongoing commitment at the institutional and industry level to share benefits throughout R&D loops and value chains (rather than triggered on a case-by-case basis at the project level); and

• how benefit sharing is regulated—though a diverse regulatory toolkit that targets relationships along value chains with benefits directed to resource and knowledge providers, nature and current and future generations.

Table 3 compares the linear single use ABS model and a circular value chain ABS model in terms of regulatory focus and approaches.

Table 3.

Key differences between a single use ABS model based on linear thinking and a value chain ABS model based on circular thinking.

	Single use ABS model	Value chain ABS model
Nature of the model	Transactional (case-by-case at the project level)	Cooperative
Regulatory assumptions about bio-R&D	Linear	Non-linear
Regulatory approach	Static and risk averse	Iterative and adaptive
Value of the genetic resource	Genetic materials and sequence information	Dynamic interplay between the genetic materials, information in the sequences (eg DNA, proteins), information about the materials (the contextual/functional information) and the technical know-how for unlocking their properties/value (people’s relationship to the materials, information and traditional knowledge)
Equity focus	Intra-generational equity	Inter- and intra-generational equity
Sustainable use focus	Exploitation (one-way flow)	Circulation at their highest value in communities and economies
Conservation focus	Single use	Regenerative
Regulatory starting point (trigger)	Objects (samples, information and knowledge)	Relationships between the regulated entities that benefit from bio-R&D
Regulated entity and onus for benefit sharing	Individual researchers (eg project level)	Entities throughout the value chain at the institutional, R&D communities and commercial end-user levels
Research activities in scope	Determined on a case-by-case basis within a proposed project	R&D that benefits from genetic materials and information in or about the sequences
Benefit system	Procedure-oriented	Outcomes-oriented
Benefit outcomes	Short-term (within the lifetime of the authorized activity)	Long term (beyond the lifetime of the authorized activity)
Regulatory tools	Authorizations, contracts and monetary funds	A diverse regulatory toolkit of private law, market based, command-and-control, technology and customary law measures (section VI)

VI. EXPANDING THE REGULATORY (POLICY AND LAW) TOOLKIT FOR BENEFIT SHARING

A conceptual shift toward circular principles can unlock a broader range of legal and policy tools for regulating human relationships with each other and nature over different time scales. Ballardini et al. (2021) argue that to date, the regulatory focus for transitions to circular economies is on legal techniques common in the domain of public law (governing relationships between government and private parties/sectors), rather than private law (relationships between private parties).¹⁸² Outlined in this section are a range of public and private law regulatory tools commonly used to promote circular economy objectives, that could be considered or modified to suit circular ABS regulatory frameworks (Table 4).

Table 4.

Expanding the regulatory toolkit for practical and long-term benefits.

Measures	Current ABS regulatory tools	Adapting circular economy regulatory tools to R&D governance
Private law measures	1. Contracts	VI.A(i). Co-regulatory agreements and covenants VI.A(ii). Open and commons-based peer production VI.A(iii). The Sharing Economy, including products-as-a service, leasing, renting or pooling products and subscription models VI.A(iv). ‘In trust’ models
Market-based measures	1. Certification (limited)	VI.B(i). Tradeable credit schemes VI.B(ii). Take-back (end of life) schemes, including deposit schemes VI.B(iii). Corporate disclosure and natural capital accounting VI.B(iv). Certification, rating and labeling schemes
Command- and-control measures	1. Authorization 2. Benefit sharing funds (limited)	VI.C(i). Financial models—incentives and funds VI.C(ii). Life cycle models—extended producer responsibility models and right to repair
Legal pluralism measures	1. PIC 2. Bio-cultural protocols (ad hoc)	VI.D. Models from a range of legal and knowledge systems

This section does not suggest that every tool be employed for national implementation of ABS. The biggest factor in inefficient ABS regulation is the over-engineering of domestic arrangements leading to complexity and blockages for the flow of samples and information across artificial legal boundaries like borders and regulated sectors. Instead, this section is designed to briefly illustrate that beyond authorizations and contracts there are a vast array of measures that could influence behavior for sharing benefits from biological resources beyond a single research project. Any of these approaches could be adapted to support implementation of ABS policy guided by circular objectives and principles. A more diverse toolkit may assist with eliminating waste (inefficiencies) in resource use, keeping materials at their highest value in the economy/research communities and regenerating nature. Importantly, expanding the toolkit can promote an outcomes-oriented approach, rather than the existing process-oriented approach to ABS for more efficient delivery of benefits.

VI.A. Private Law Measures

i. Contractual relationships—co-regulatory agreements and covenants

Contracts are the primary means of effecting benefit sharing under the single use model. Whereas section IV.D outlines how solely relying on contractual negotiations at the project level may deter innovation, agreements at the institutional level (across a range of projects) might encourage long term financial and other benefits for categories of resource or knowledge providers and bio-R&D capacity building. Covenants are a tool for meta-regulation, where a government overseas self-regulatory arrangements (regulating the regulators).¹⁸³ Whereas self-regulation can lack incentives for compliance, meta regulation aims to promote incentives for regulatory buy-in through promoting good will, best practice and cooperation between the regulated entities.¹⁸⁴ One example is the Australian Packaging Covenant under the National Environment Protection (Used Packaging Materials) Measure 2011 (Cth). It sets up a not-for-profit entity responsible for managing and administering a Covenant between Australian governments and businesses.¹⁸⁵ The Covenant outlines the shared responsibility for managing the environmental impacts of consumer packaging and its signatories are subject to agreed Covenant obligations.¹⁸⁶ So long as signatories comply with their obligations, they are not subject to the more onerous legislative requirements, which is an incentive for compliance with the Covenant.

In the ABS context, the Covenant model might be a useful legal tool for regulating relationships of key players in value chains. A Covenant might include universities, large research institutions, IPLC representative bodies, repositories and funders that can shape the scheme. Regulating large institutions and industry through a Covenant model could support more impactful benefit sharing at aggregate and local levels, with longevity of benefit sharing outcomes beyond the short funding cycle of individual research projects. There are examples of national ABS regimes allowing for umbrella benefit sharing agreements at the institutional level, such as in Queensland Australia.¹⁸⁷ However, the Covenant model regulates at a broader level and could offer reputation and economic incentives for a value chain benefit sharing system (the carrot) that sits alongside existing ABS regulation, which would apply (the stick) if signatories fail to comply with their Covenant obligations.

ii. Access relationships—control, openness, and commons-based peer production

Open innovation plays an important role in transitioning to a circular economy. Open innovation encourages businesses to use internal and external ideas to accelerate innovation while making their ideas, knowledge and technologies available to the external market for others to build on.¹⁸⁸ It is premised on collaboration and co-production (eg partnerships and joint ventures) and exchange of knowledge and capacity building to accelerate pathways for innovation and commercialization.¹⁸⁹ Studies demonstrate that external collaboration is fundamental for a transition to a circular economy.¹⁹⁰ Decentralized commons-based peer production or open collaboration in biosciences depends on infrastructural resources.¹⁹¹

In contrast, open science is a set of principles and practices aiming to make scientific research accessible to all for the benefit of the R&D communities and society generally.¹⁹² It has become international best practice and funders and publishers often require the sharing of data in open access repositories as a prerequisite for funding or publishing.¹⁹³ Open access licenses are a common legal tool to promote open science and innovation.¹⁹⁴ While a publication may be freely available, the producer usually pays the license cost, which is often beyond the reach of researchers in low-income countries whose research and perspectives are often silenced under this open access model oriented toward consumption, rather than production and dissemination.¹⁹⁵ Open access to DSI in databases does not necessarily mean free access, nor that the data accessed is free of intellectual property restrictions.¹⁹⁶

Any movement toward open access models needs input by IPLCs to avoid undermining equity objectives with respect to their traditional knowledge, Indigenous data governance and customary law.¹⁹⁷ Concerns about secondary use of data incorporating unauthorized use of traditional knowledge and lost opportunities for benefit sharing prompted the introduction of CARE principles for indigenous data governance: collective benefit (for inclusive R&D and equitable outcomes); authority to control (recognizing rights and interests), responsibility (for Indigenous worldviews and languages) and ethics (for future use and justice).¹⁹⁸ These principles are designed to address fundamental inconsistencies between the open data and open science movements and cultural approaches of collective ownership and control of data.¹⁹⁹

iii. The sharing economy—product-as-a-service and subscription models

Sharing resources, information and knowledge is the mainstay of the scientific method and is central to achieving both ABS and circular economy objectives.²⁰⁰ Single use transaction-based ABS models distort the existing sharing economy of R&D communities and informal exchange of samples and information, once the cornerstone of global R&D communities, is disincentivized by institutionalizing private financial gain and patenting of organisms.²⁰¹ ABS tools could be re-examined to facilitate informal exchanges and collaborations within research communities.²⁰² Commercial and sharing economies, including those in the bio-economy, can co-exist or complement each other.²⁰³ Expanding ABS regulatory tools toward outcomes-oriented sharing objectives, such as product-as-a service model may be a means of bridging commercial and sharing economies.

The ‘product as a service’ model retains ownership of products with the provider instead of transferring ownership to a customer or third party. Under ABS, the regulated entity (R&D communities and end use sectors) could have legal relationships as service sectors (producers) as well as users of resources and products (consumers). Product-oriented business models have incentives to maximize the number of products sold through increased market share and profit (with resulting waste from duplication of effort or single use resources).²⁰⁴ On the other hand, service-oriented business models make money through services offered with incentives to prolong the service life of products.²⁰⁵ This ensures the resources are being used intensively with re-use of parts for as long as possible after the product’s life.²⁰⁶

This strategy is a shift in mindset from selling products to selling access to services and outcomes. For example, a provider might grant access to original biological resources or know-how for biological product development through a subscription. This can include use-oriented services, where ownership remains with the provider and shared with multiple users such as product leasing (by a single user), product renting or sharing (sequential use by different users) or product pooling (simultaneous use of the product by various users like carpooling).²⁰⁷ Alternatively, it could include result-oriented services, where the provider and recipient agree in principle on a result with no pre-determined product involved. For example, there may be a pay-per-service (subscription) for private contextual data per DSI comparison (per BLAST), which would be similar to paying for an ink subscription per photocopy.²⁰⁸

Subscription models are not new to ABS. The PIP Framework employs a subscription fee model for ABS where manufacturers of vaccines, diagnostics and pharmaceuticals using the WHO Global Influenza Surveillance and Response System make an annual payment (‘Partnership Contribution’) to fund capacity building, pandemic response activities and the PIP Secretariat.²⁰⁹ This subscription approach is being considered under other ABS regimes²¹⁰ and could be extended to the CBD/Nagoya Protocol framework. What may help is a conceptual shift from the property and ‘ownership’ model toward a sharing economy model.²¹¹

iv. Stewardship—biobanks and ‘in trust’ models

Genetic resource or germplasm banking (biobanking) conserves or preserves genetic samples to maintain genetic diversity for future uses. Genetic materials may be stored in in situ²¹² or ex situ²¹³ conditions. In situ conservation is the preferred method because it maintains populations in the habitat or culture systems that give them their special characteristics and facilitate continued evolution.²¹⁴ There is a range of conservation strategies including:

• in situ in vivo (free living, wild populations);

• on farm in situ (captive populations on agriculture or aquaculture farms);

• ex situ in vitro (eg collections of seeds, cryopreserved sperm, embryos and other tissues); and

• ex situ in vivo (live research populations eg in aquaria).²¹⁵

Ex situ collections include herbaria, museums, zoos, botanic gardens, cell banks, germplasm and culture collections.²¹⁶ Some may be publicly or privately funded (or both) with a range of regulatory and contractual obligations about how the biological resources can be stored, used and transferred to third parties. Many of these repositories have established networks such as sectors for plant genetic resource (eg CGIAR Collections under the Plant Treaty) with mutually supportive protocols, procedures and data management practices, whereas other sectors have less established connections such as those using/conserving aquaculture genetic resources and microorganisms.²¹⁷

National ABS law differs significantly about whether and how they regulate private and public ex situ collections, adding confusion and division for these crucial networks. Informal exchanges of samples have driven collaborations but at the project level there may still be waste. For example, despite the crucial importance of conserving micro-organisms, only a small fraction of the astronomical numbers of microorganisms (that have been isolated from natural populations) have been preserved with most lost or left unattended after a project is terminated or the research focus changes.²¹⁸ The transactional ABS model perpetuates this waste with its focus on single use using authorities and contracts for defined projects and timeframes, which undermines collaborations and networks for long term in situ and ex situ conservation.

Under the single use ABS model, sharing samples is an optional form of benefit sharing, unlike circular economy with sharing at its core. Under cooperative models like the Plant Treaty and the BBNJ Agreement, conservation and exchange of germplasm are central to the functioning of the multilateral system.²¹⁹ Whereas the Plant Treaty uses an ‘in trust’ model for some of its collections,²²⁰ the BBNJ Agreement requires deposits of samples and DSI that are subject to utilization in publicly accessible repositories and aims to make information about the location of the samples publicly available for further use by others.²²¹ Curation of biological resources is expensive, which raises questions about who pays for storage and conservation.²²² To reduce a disproportionate burden on public repositories for curation and to reduce the risk of destruction, a value chain model (targeting regulation at the institutional or industry level) might include a digital information tool linking research institutions and collections, like the PIP Frameworks Influenza Virus Traceability Mechanism and the BBNJ Agreement’s BBNJ Standardized Batch Identifier, instead of requirements for physical re-location of samples to public repositories for sharing.²²³

VI.B. Market-Based Measures

i. Tradeable credit schemes

Recent years have seen a proliferation of token or tradeable credit schemes, which enable stakeholders to trade rights or entitlements to ‘use’ nature. In the fields of natural resource management and environmental law, they are a common tool for regulating user behavior with respect to fisheries,²²⁴ water,²²⁵ forests,²²⁶ climate change,²²⁷ and biodiversity.²²⁸ Some of these are offset schemes, which can be targeted at different scales (eg species-based, habitat-based or jurisdictional-based) with different strategies. For example, rehabilitation/restoration (direct) offsets provide direct environmental benefits for impacted species (providing full environmental compensation for environmental impacts) whereas the more common averted loss (indirect) offsets manage actions that benefit different species or ecosystems to those impacted (not leading to the recovery of impacted nature).²²⁹ The principle of regeneration under circular economy and Nature Positive concepts favor the former, with its outcome goals of regeneration instead of ‘no net loss’.

Regulators could think about how ABS might fit within existing tradeable credit schemes or a dedicated bio-innovation scheme. A key goal of circular strategies would be to avoid duplication of time and resources, which might favor the former. This strategy might be paired with other strategies like certification or financial models outlined below.

ii. Take-back, end-of-life—schemes

Take-back, end-of-life and recycling schemes are widely used as environmental programs and could be a regulatory option for value chain ABS models.²³⁰ These strategies use circular thinking because they promote embedding the benefits into the design of the production and consumption relationships. For example, under container deposit schemes such as those in several Australian states, the price of the deposit is included in the price of a ‘good’ like a drink, which is reimbursed when the container is returned.²³¹ A similar approach under ABS could require a deposit to be paid to a government provider by a research institution for access to categories of biological species by their researchers under a range of projects and collaborations. This deposit could be reimbursed when the results of research or forms of benefit sharing are ‘returned’ to government/community or the public domain for further use (eg location of publications, patents or commercialized products). These incentives may promote a circular approach to benefit sharing between providers, intermediaries, users and subsequent users under a value chain model, rather than a one-way flow of benefits for the life of a project under the single use model.

iii. Corporate Disclosures and Natural Capital Accounting

From a circular economy perspective, governments have recognized that adaptive reuse and refurbishment can be supported by financial incentives, including environmental, social and governance (ESG) frameworks that include retrofitting activities.²³² The private sector has indicated support for ABS objectives as part of its commitment to fair and ethical business practices and sustainability.²³³ Benefit sharing from the use of biological resources could similarly be embedded in these frameworks. ESG is an evolution of corporate social responsibility and refers to a set of criteria that can be used by stakeholders to assess a company’s overall impact on society.²³⁴

Financial disclosures and natural capital accounting are important tools for operationalizing ESG. Natural Capital Accounting is a framework for integrating economic and environmental data in decision-making.²³⁵ There is guidance for this approach at the international and national levels. For example, in 2023 the Taskforce on Nature-related Financial Disclosures endorsed by G7 and G20 Ministers released recommendations and guidance for organizations with a risk management and disclosure framework to act on nature-related risks, impacts, dependencies and opportunities.²³⁶ Disclosure and accounting initiatives could embed ABS objectives, principles and legal tools to ensure that fair and equitable benefit sharing becomes core business of regulated institutions and industries under the value chain model.

iv. Certification, rating, and labeling schemes

Research indicates that certification or product labeling schemes have a role in a transition to a circular economy.²³⁷ Rating and labeling schemes can build the foundation for reform focused on modifying consumption and production behavior and achieving circularity outcomes.²³⁸ There have also been initiatives for ABS certification schemes demonstrating ethical behavior such as through benefit sharing when sourcing natural ingredients.²³⁹ Certification can place pressure on supply chain actors to source biological resources in ways that promote biodiversity,²⁴⁰ and likewise could promote circularity behavior in bio-R&D. It is beyond the scope of this paper to review the effectiveness of certification, rating and labeling schemes, but they could play a role in standardizing transparency throughout value chains and be combined with other strategies in section VI to elevate governance to the institutional, joint-venture and industry levels.

VI.C. Command-and-Control Measures

i. Financial models—taxes, levies, incentives, and funds

Whereas market-based approaches may be relevant policy instruments for supporting growth phases of industries that support a circular bio-economy approach, economic policy incentives have an important role in stimulating investment at concept and development phases.²⁴¹ Public procurement,²⁴² subsidies, tax incentives,²⁴³ and tariffs²⁴⁴ play a role in stimulating bio-based innovation.²⁴⁵ The current focus on inputs (access and consumption) under ABS regimes instead of outputs (production and dissemination) has arguably contributed to the linear model of regulation. Economic policy incentives could be useful tools to encourage R&D communities to engage in responsible sourcing of genetic resources and traditional knowledge as well as responsible re-use throughout value chains.

The role of taxes and levies as a monetary form of benefit sharing have been debated in ABS forums and literature, particularly as an option for monetary benefit sharing from DSI.²⁴⁶ This might be an option for charging entities and industries that directly and indirectly benefit from the use of biological resources and traditional knowledge under the value chain model, rather than piecemeal taxes (eg one off payments) at the individual researcher level under the single use model as an optional form of benefit sharing. A challenge will be stakeholder buy-in for the criteria for entities and industries that ‘directly or indirectly benefit'.

Benefit sharing funds are becoming a common tool of ABS. The Plant Treaty, PIP Framework, BBNJ Agreement and DSI multilateral mechanisms each have international benefit sharing funds (Table 1), although there are ongoing questions about how to fairly and equitably distribute the money. There are also a growing number of national benefit sharing funds.²⁴⁷ In recent years, a handful of circular economy funds have been launched, usually as part of larger sustainability funds.²⁴⁸ Lessons for ABS from the sustainable fund sector is that ethical or socially responsible funds generally outperform conventional funds.²⁴⁹ Transparency to demonstrate fairness and equity in distributions from ABS funds is key to drawing contributions from stakeholders, which requires clear criteria and a common understanding for what fairness and equity means in practice (eg efficiency, intergenerational equity, etc.). To close the feedback loop, goals, actions and indicators of effectiveness could be aligned to transformative bio-R&D governance.²⁵⁰

ii. Life cycle model—extended producer responsibility and right to repair

Extended producer responsibility (EPR) schemes are designed to incentivize circular product design to keep products in the system for as long as possible and could be a useful tool in the value chain ABS model. Under EPR, a producer’s (or supplier’s) responsibility (legal, physical, financial) for a product is extended to the post-consumer stage of the product’s life cycle.²⁵¹ This reverses the underlying rights and duties in the product chain, holding both producers and consumers responsible for the cost of waste management instead of society (taxpayers), creating incentive to minimize those costs at the product design phase (with environmental benefits).²⁵²

From an ABS perspective, taking an EPR approach could help policy makers to re-think the targeted regulated entity. R&D communities at the start of the value chain are largely the target of the single use model, imposing greater cost and time burden on non-commercial R&D than for downstream commercial users (product producers).²⁵³ Under an EPR approach, end-users of biological resources eg commercial entities like big pharma would be a regulated entity responsible for embedding benefit sharing and other EPR measures in their product model throughout the value chain. Combining this with a Covenant model²⁵⁴ could target governance at the aggregate industry or institutional level for greater buy-in and reward from the scheme.

EPR measures can encompass eco-design requirements for repairability and take back schemes and information requirements for repair and reuse.²⁵⁵ There is no universal definition of a right to repair but it essentially tackles the problem of planned obsolescence (forcing consumers to buy new products) by giving consumers the information and know-how (or access to spare parts) to repair the product for longevity and re-use.²⁵⁶ From a biological resource R&D perspective, this could mean a requirement to share not just DSI as a form of benefit sharing but the know-how for their use (eg contextual information that connects samples and DSI) through longer term research collaborations and co-production.

VI.D. Legal Pluralism Measures

The single use model has been shaped to fit dominant western legal systems and worldviews. Non-western knowledge systems and legal systems, including eastern²⁵⁷ and Indigenous systems²⁵⁸ may offer legal concepts and tools that better manage relationships rather than objects. ABS discourse is largely limited to knowledge and legal systems of IPLCs, who are identified as potential biological resource and knowledge providers under the CBD and Nagoya Protocol, but there are important lessons for more effective benefit sharing tools and approaches from all integrated knowledge, legal and social systems.

There is a large body of scholarship about how to bring Indigenous customary law systems and western legal regimes together for a better integration of diverse world views into governance.²⁵⁹ ‘There is no universal definition of “custom” and “customary law”…Rather the meaning is guided by practice and lived experience…and difficult to convey to outsiders….’²⁶⁰ Biocultural rights offer one means of bridging the legal systems, which are the ‘collective rights of communities to carry out traditional stewardship roles vis-à-vis Nature, as conceived of by Indigenous ontologies.’²⁶¹ Biocultural protocols ‘provide a process for Indigenous Peoples to determine whether to allow access to their knowledge and lands for research and biodiversity conservation purposes.’²⁶² Some commentators argue that their customary measures are forced to operate within the western legal construct of ABS as an ongoing form of colonialism that undermines self-determination.²⁶³ Legal pluralism can offer a framework and space for the co-existence of multiple worldviews and expansion of legal toolkits to manage relationships with nature and culture.²⁶⁴ Understanding world views requires ‘actually living and breathing in the country and villages sharing knowledge for an extended time’.²⁶⁵ A framework that supports ideas of circularity, regulates relationships and long-term co-production and benefit sharing beyond the life of a single project, could provide space for legal pluralism in bio-R&D governance.

VII. CONCLUSION—REGULATORY TRANSFORMATION OR TINKERING AROUND THE EDGES?

‘First Peoples’ Law says that nothing is created or destroyed because of the infinite and regenerative connections between systems. Therefore time is non-linear and regenerates creation in endless cycles. Second Peoples’ law says that systems must be isolated and exist in a vacuum of individual creation, beginning in complexity but simplifying and breaking down until they meet their end. Therefore, time is linear, because all things must have a beginning, middle and end.’ (Tyson Yunkaporta)²⁶⁶

Thirty years on from the adoption of the CBD, a vacuum remains for a more equitable sharing of resources, tackling biopiracy and compensating providers for the costs of conservation which originally inspired the ABS concept. The transactional (single use) ABS model was an innovative regulatory experiment that combined public (eg permits) and private (eg contracts) law, but its undoing is arguably the simplistic underlying linear assumptions about the nature and value of genetic resources/knowledge, ownership/control, R&D/commercialization practices and relationships. The intention of this article was not to perpetuate unhelpful dichotomies by framing linear as ‘bad’ and circular/non-linear as ‘good’ because effective governance depends on a range of worldviews and pathways. Instead, the intention was to shed light on regulatory assumptions that may unnecessarily limit decision-making frameworks and legal tools for facilitating benefit sharing outcomes.

‘Rethinking ABS’ exists on a spectrum from tinkering with policies or procedures, to transformative change in governance and regulation. Transformative change results in profound shifts in values, underlying principles and institutions through the emergence of new behavioral norms and new social structures.²⁶⁷ Structural changes would include changes to regulations, markets, institutions and communities, including R&D communities, that create new decision-making contexts for individuals to transform the system as a whole.²⁶⁸ The CBD/Nagoya Protocol single use model is arguably a product of last-century economic thinking before radical transformations in digital and biological technologies. It does not align with policy transformations that tend toward circularity and regeneration under Nature Positive, Net Zero and Circular Economy movements for example. Re-interpreting the three ABS objectives and principles under the CBD/Nagoya Protocol model toward circular principles can offer a lens for regulatory reform that is better aligned with the non-linear nature of bio-R&D and global initiatives for tackling the triple planetary threats.

Adopting a simplistic linear ‘collection (take)–utilization (make)–output (dispose)’ approach to the regulated activity has generated limited tools (authorization and contractual measures). These are used as blunt instruments for benefit sharing that disproportionately burdens researchers engaging in fundamental research, rather than other actors along the value chain. The result is a complex web of international and national regulation blocking the flow of information and long-term benefits for resource and knowledge custodians, communities and nature. Conceptualizing a non-linear understanding of R&D processes like the feedback bio-R&D loop of design-build-test-learn could reframe the temporal scale of benefit sharing throughout value chains.

The value chain model presented here is only intended as a starting point to provoke self-reflection of world views and assumptions about the objects regulated under national laws. It aims to inspire empirical investigation by stakeholders into options for transforming ABS governance. It is not intended to undermine the rights of IPLCs to determine the rules around the use of their knowledge systems, which is intricately connected with nature at all levels. This model is designed to press pause and carve out space in the rapidly changing world of ABS regulation so that the people and communities most affected by bio-piracy, inequity and marginalization from the use of genetic samples, information and traditional knowledge can re-set the regulatory agenda from the perspective of their world views and understandings about the connections between people and nature.

A fundamental flaw in the transactional single use model of ABS is arguably its focus on regulating objects, not relationships. Regulating objects is inefficient when the value of a biological resource is the complex relationships between people, nature and the information and know-how for unlocking genetic possibilities. The lens of circularity reframes regulation away from objects and toward accommodating complex relationships between R&D communities, end-use sectors and the original custodians of the organisms and associated traditional knowledge. This opens a range of new tools that regulate these relationships: covenants, open innovation, sharing economy including products as a service models (eg leasing, renting or pooling products), bio-banking, ‘in trust’ models, tradeable credit schemes, take-back (end of life) schemes, corporate disclosures and nature capital accounting, economic policy incentives (procurement, tax and subsidies), benefit sharing funds, extended producer responsiblity, right to repair, co-production, certification, rating and labeling schemes and pluralist legal measures.

Choosing from a more diverse toolkit to achieve ABS objectives may assist policy makers to implement more dynamic and adaptive regulation that better aligns with dynamic bio-R&D and technologies. As Campos (2012) says, ‘synthetic biology today remains a diverse collection of endeavors, technologies and actors. To reify and ossify such a complex social constellation would be to miss the phenomenon of interest entirely.’²⁶⁹ Circularity thinking promotes an outcomes-oriented approach, rather than the existing process-oriented approach to ABS for more efficient delivery of long-term benefits for the planet, including its people. Tackling the triple planetary threats of biodiversity loss, climate change and resource depletion/degradation urgently requires transformative systems-thinking. More effective ABS governance and regulatory frameworks are only part of the puzzle, but they play a crucial role in supporting the R&D on which a transition to Nature Positive, Net Zero and Circular Economy depend.