Access to biodiversity for food production: Reconciling open access digital sequence information with access and benefit sharing

Societal Impact StatementDigitized molecular data are vital to numerous aspects of scientific research and genetic resource use. The Convention on Biological Diversity currently refers to this as “Digital Sequence Information” (DSI), a term not widely adopted by science and lacking a clear definition. There are concerns over the access to genetic resources and absence of benefit sharing by provider countries. Open access to DSI might exacerbate this, which is leading to increasing policy interventions and restricted access to genetic resources and DSI. We analyze current international debate and proposed solutions and provide case studies of DSI use producing tangible benefits for the provider countries and scientific research, demonstrating the importance of open access DSI to achieving conservation goals.SummarySubstantial advances in DNA sequencing over the last decades hold great potential to enhance food security and sustainable use of global biodiversity, benefiting the world's poorest people. Digital Sequence Information (DSI) plays a crucial role in catalyzing research applications that can contribute to international societal and biodiversity conservation targets. However, benefit sharing relating to DSI is difficult to identify and hindered by the lack of clear international governance and legislation, which in turn has led to a reluctance to make DSI publicly and freely available. Critically, no precise definition exists under the Convention on Biological Diversity (CBD), the Nagoya Protocol (NP), or the International Treaty for Plant Genetic Resources for Food and Agriculture (ITPGRFA). The key difference between DSI and biological resources, for which access and use are highly regulated under those frameworks, is that information is nonphysical. Information can be replicated and used without movement of, or access to, physical specimens. Thus, regulating the use of DSI is extremely challenging and remains controversial. Here, we review the regulation of DSI and the possible future steps by the international community, in the context of the benefit‐sharing obligations of the CBD, NP, and ITPGRFA. We highlight how multilateral agreements work in practice and are a solution to this impasse. We provide case studies demonstrating how the Royal Botanic Gardens, Kew, and its collaborators address the uncertainty surrounding the use of DSI, illustrating tangible and equitable benefits that have arisen from such use. We conclude that open access to DSI is needed for scientific research and international policy.

Digital sequence information on genetic resources plays an increasingly vital role in research on improving crop yields and reducing impacts of disease. However, there are still problems such as the imperfect rights' protection system, which hinders the protection and sustainable use of genetic resources and constrains the realization of the fair and equitable benefit-sharing objectives established by the Convention on Biological Diversity. To address these issues, we first define the connotation and legal nature of digital sequence information on genetic resources. Then, we elaborate how digital sequence information on genetic resources aligns with the modern intellectual property systems. For digital sequence information on genetic resources to be protected by intellectual property rights, we analyze the substantive conditions of novelty and practicality as well as the procedural conditions of registration. Building on this analysis, we identify the limitations of existing intellectual property frameworks in accommodating digital sequence information on genetic resources, and propose a normative structure of sui generis right of digital sequence information on genetic resources. The subjects of sui generis right are divided into two levels, i.e. static right attributed to the state, and dynamic right exercised by the farmer collective of specific communities and the uploaders of digital sequence information, exercising respectively in accordance with different functions. The contents of sui generis right include the informed consent right, the source indication right and benefit-sharing right based on licensing. Furthermore, we propose to establish the limitations on sui generis right, such as restriction on scope of application, compulsory licensing and protection periods. This framework established here is of great significance for achieving the balance of rights and interests, promoting innovation in plant breeding and protecting genetic diversity.

Contestations about the way in which digital sequence information is used and regulated have created stumbling blocks across multiple international policy processes. Such schisms have profound implications for the way in which we manage and conceptualize agrobiodiversity and its benefits. This paper explores the relationship between farmers’ rights, as recognized in the International Treaty on Plant Genetic Resources for Food and Agriculture, and the dematerialization of genetic resources. Using concepts of “stewardship” and “ownership” we emphasize the need to move away from viewing agrobiodiversity as a commodity that can be owned, toward a strengthened, proactive and expansive stewardship approach that recognizes plant genetic resources for food and agriculture as a public good which should be governed as such. Through this lens we analyze the relationship between digital sequence information and different elements of farmers’ rights to compare and contrast implications for the governance of digital sequence information. Two possible parallel pathways are presented, the first envisaging an enhanced multilateral system that includes digital sequence information and which promotes and enhances the realization of farmers’ rights; and the second a more radical approach that folds together concepts of stewardship, farmers’ rights, and open source science. Farmers’ rights, we suggest, may well be the linchpin for finding fair and equitable solutions for digital sequence information beyond the bilateral and transactional approach that has come to characterize access and benefit sharing under the Convention on Biological Diversity. Existing policy uncertainties could be seized as an unexpected but serendipitous opportunity to chart an alternative and visionary pathway for the rights of farmers and other custodians of plant genetic resources.

With the advent of synthetic biology, scientists are increasingly relying on digital sequence information, instead of physical genetic resources. This article examines the potential impact of this shift on the access and benefit-sharing (ABS) regime of the Convention on Biological Diversity (CBD) and the Nagoya Protocol. These treaties require benefit-sharing with the owners of genetic resources. However, whether “genetic resources” include digital sequence information is unsettled. The CBD conceives genetic resources as genetic material containing functional units of heredity. “Material” implies tangibility, and for some scholars, “functional units of heredity,” undefined in both treaties, mean full-coding sequences. This article argues that digital sequence information obtained from physical genetic resources, full-coding or not, should be treated as genetic resources. Literal construction of the CBD risks eroding its usefulness and the ABS regime. This is because through bioinformatics, sequence information can easily be obtained from genetic resources for utilization, without physically moving them or concluding ABS agreement with owners. The CBD must evolve with scientific progress also because sequence functionality depends on the state of knowledge. These arguments are vindicated by domestic ABS laws equating genetic information with genetic resources; Nagoya Protocol provisions deeming research exploiting the genetic composition of genetic resources as utilization of genetic resources; and CBD provisions requiring the sharing of benefits from the utilization of genetic resources. Moreover, treaty interpretation and case law demand that generic, scientific terms, such as “genetic resources” and “functional units of heredity” be interpreted in an evolutionary manner to capture scientific developments.

Societal Impact StatementThe international conservation of biological diversity is addressed under the Convention on Biological Diversity (CBD) and goals for the next decade will be discussed at the next Conference of the Parties. One issue under negotiation in the CBD is Digital Sequence Information (DSI), which has created tension between parties calling for preserving open access to DSI who also note its importance in addressing biodiversity and the UN Sustainable Development Goals and those parties calling for fair and equitable benefit sharing from DSI. This article introduces scientists to the current debate and political process on DSI within the CBD.SummaryMost biologists take open access to sequence data for granted. This open system, while a hallmark of innovation and collaboration for the scientific community, is being called into question as some parties to the Convention on Biological Diversity (CBD) assert that this access undermines their sovereign rights over their genetic resources and corresponding benefit sharing. The governance of sequence data and potentially other types of biological data, known in international policy circles as “Digital Sequence Information” (DSI), a placeholder term invented by negotiators, could be dramatically altered and ultimately change the way scientific research and publishing on sequence data is conducted. Many sequence‐using scientists are unfamiliar with the international political processes around DSI even though it could lead to irreversible decisions that might have significant impacts on research. This paper bridges that gap by providing an overview of the ongoing political process with a focus on the most recent studies on DSI commissioned by the Secretariat of the Convention on Biological Diversity (SCBD) and what these studies forecast about the political debate. With this information in hand, the scientific community can hopefully better engage with the political process and proactively promote evidence‐based decisions or even solutions that can bridge the demand for benefit sharing with the scientific need for open access to DSI.

The discussion on digital sequence information (DSI) on genetic resources under the Convention on Biological Diversity (CBD) started from 13th Conference of the Party (COP) held in Mexico 2016. The controversial negotiations on DSI continues, and the CBD Parties agreed on the 14th COP with decision 14/20 to seek further view and submissions on DSI. The issues at the CBD-COP are, according to Kobayashi (2018), the following: terminology or definition of DSI; the potential coverage of DSI under the CBD to ensure benefit sharing; relationship between use of DSI and mutually agreed terms; influence on the objectives of CBD; traceability and; relationship between utilization of DSI and public databases. terminology or definition of DSI; the potential coverage of DSI under the CBD to ensure benefit sharing; relationship between use of DSI and mutually agreed terms; influence on the objectives of CBD; traceability and; relationship between utilization of DSI and public databases. Among these issues, the first is pointed out by Australia as an issue leading to the amendment of the CBD. Also, the third is the issue regarding the rights and obligations of natural and legal persons. Halewood et al. (2018) proposed different views as a policy option, which are renegotiation of the legally binding instrument and adoption of a decision on mutually agreed terms in the current framework. Sollberger (2018) also pointed out that the most obvious solution could be to govern the use of sequence information via permission from national authority and contract between provider and user at the time of access to the original genetic resource. On the other hand, the evolution of the international environment agreement is to embody the Convention and the Protocol through decisions or resolutions adopted by COP, in addition to the amendment of the Convention and the adoption of the Protocol. Tamura (1999) reviewed the role of COP under the international environment agreement as follows: adjusts interests among the Parties; implements the obligations under the agreement; and enables a consensus building framework for the development and implementation of the agreement. However, the decisions adopted by the COP are not legally binding, despite the lack of articles on this matter in the agreement, there are cases, for instance, that the decision of COP is to proceed with rule making and begin to be implemented in each Party (Recio 2018). Thus, this paper examines whether the issue on DSI in the CBD contributes to the evolution of the Convention or not through the discussion from COP13 to COP14, including the submission of the views from Party and stakeholders, an Ad Hoc Technical Expert Group (AHTEG) on DSI on genetic resources and decision-making. As a tentative conclusion, the discussion on DSI could contribute to the evolution of the Convention. In confirming decision IV/20 of CBD-COP, COP decided to continue discussions on definition and scope, furthermore it is noted that mutually agreed terms can cover the benefits arising from the use of DSI on accessed genetic resources. This decision does not go beyond the current framework, but there is a possibility to create opportunities for the evolution or growth of the Convention, such as the development of standard contract models. The logic of this decision is the same as the derivatives of genetic resources identified during the negotiation of the Nagoya Protocol.

There is disagreement whether international agreements over genetic resources (GR) under the Convention on Biological Diversity, including the Nagoya Protocol, cover Digital Sequence Information (DSI). DSI is data on the composition of GR, which may be downloaded from databases and used by entities who have no contractual relationship with the country of origin of the original GR from which the data were derived, and with no applicable legal requirement to agree on benefit-sharing with that country. Proposals for inclusion of DSI under the CBD are intended as changing this situation and increasing benefit-sharing. However, inclusion of DSI under the CBD is contested, and there is a legal basis for both inclusion and exclusion, so any eventual decision must be based on policy agreement by parties. To date there has been little explicit basis for a definition of DSI; here a distinction between ‘inclusive’ and ‘exclusive’ definitions is discussed, the latter using the scope of the CBD to support the concept to include only Nucleotide Sequence Data. Irrespective of inclusion under the CBD countries are including DSI in national ABS legislation, through inclusion in PIC and MAT on newly accessed GR, stating sovereign rights over DSI already generated, and through article 5 (1) of the Nagoya Protocol. These approaches are discussed, and the need for further consideration of the practical implications of article 5 (1). Ultimately a strong focus of future discussions should be benefit-sharing and the ethical position of users.KeywordsABSNagoya ProtocolCBDDSIDigital Sequence Information

Societal Impact StatementReading and writing DNA is now possible with an unprecedented speed and ease. To catch up with digitization of genetic resources, scientists need to join with all relevant stakeholders and design new global governance mechanisms for digital sequence information. We propose the establishment of a Multi‐stakeholder Committee on the Governance of Digital Sequence Information (DSI). This multi‐disciplinary body will be dedicated to mitigate governance issues associated with the digitization of genetic resources. Solving the DSI conundrum is sorely needed given the forthcoming multilateral meetings of the Access and Benefit Sharing (ABS) framework (the next CBD COP is scheduled in 2021) that are central to tackle the global loss of biodiversity, global warming, pandemic risk and food insecurity.SummaryContemporary research is increasingly data‐centric and the rise of genomics revolutionized our approach and use of genetic resources. However, genomics developed relatively independently from the international instruments on the conservation of biological diversity, in particular the Access and Benefit Sharing (ABS) framework. The legal and political status of Digital Sequence Information (DSI) derived from genetic resources emerged recently as a contentious point in the various ABS instruments dealing with genetic resources. In view of the multiple parallel and uncoordinated debates that occurred in various forums dealing with plants, animals, terrestrial, microbial, marine and agricultural biodiversity, we propose here to take a step back in the discussion. We argue that DSI should be considered as an overarching issue to be addressed through a coordinated and inclusive Multi‐stakeholder Committee that would assess its position and role within the existing ABS regime complex. This Multi‐stakeholder Committee on the Governance of Digital Sequence Information, that may run under the auspices of the United Nations, will be dedicated to mitigate global governance issues associated with the digitization of genetic resources. In this paper, we sketch this body as a transversal and inclusive tool to facilitate long‐term coherence in all ABS policy forums.

Societal Impact StatementAs the world is facing a climate crisis and a growing population, feeding this population is a big challenge. Genebanks, conserving and providing access to genetic resources, and plant breeders, using genetic resources from genebanks to create new varieties, play important roles in meeting this challenge. Before making decisions potentially restricting access to digital sequence information (DSI) on genetic resources, it is therefore important to consider the impact of the decisions on the activities of these actors. In this paper, an analysis is made of DSI definitions and access and benefit‐sharing scenarios in the context of their consequences for genebank management.SummaryIt is currently discussed whether the use of digital sequence information (DSI) on genetic resources would need to be subject to access and benefit‐sharing obligations, like the use of genetic resources. In this paper, we analyse the consequences of genebank management of DSI definitions currently considered, and of scenarios proposed for dealing with the access and benefit‐sharing aspects of DSI.The analysis is based on publicly accessible literature and experiences of and discussions with genebank managers, researchers and experts on genetic resources policies. The key findings are as follows: the definition of DSI is still disputed and definitions currently considered vary from only the base sequence of genomic DNA to all information associated with genetic resources; four groups of scenarios proposed for arranging the access and benefit‐sharing aspects of DSI can be distinguished, with these scenarios differing in their benefit‐sharing modalities, technical feasibility, the complexity they generate and thus the ease of access to information and genetic resources; from a genebank perspective, the scenario generating the lowest complexity and the easiest access to DSI would be preferable. It is concluded that the multilateral and the free access scenarios seem most beneficial for genebanks, as these scenarios limit the complexity for users and allow easy access and use. We are aware of the political difficulties to arrive at these solutions, but hope this paper will contribute to guiding the discussions in a direction that will be beneficial for genebanks, for users of genebank materials and information, and ultimately for addressing the challenges to present and future food security.

At the UN Biodiversity Conference (COP16) in Cali, Colombia in October 2024 new decisions were reached on how benefits can and should be shared from digital sequence information (DSI). The COP16 DSI Decision 16/2 operationalizes a new benefit-sharing mechanism under the Convention on Biological Diversity (CBD) and creates new financial obligations for commercial users of DSI through a sector-based multilateral mechanism called the Cali Fund. The decision also ensures that non-commercial users of DSI can continue to publish in and use sequences in open access databases although DSI databases have new requirements imposed on them. This benefit-sharing approach differs from the bilateral approached under the CBD's Nagoya Protocol. The talk will explain what the DSI decision means for “real-world” scientists, database managers, and users of sequence data. And, in parallel, show what science policy work entails and what is happening on the ground during UN negotiations.

In 2016, negotiations of the Convention on Biological Diversity on access and benefit-sharing policies were shaken up by the emergence of digital sequence information (DSI) as policy issue. Open access to DSI on genetic resources in genetic databases is standard practice in data-driven biological research, but such access was argued to bypass access and benefit-sharing policies of the Convention. As Parties and observers had to take a position on governing DSI, this research investigated the influence of discourses on the negotiations through argumentative discourse analysis. Actors in international environmental negotiations mobilize ‘background’ discourses – both consciously and unconsciously – to define and ‘foreground’ issues, which in turn shape negotiation and decision-making processes. The analysis shows that existing discourses on access and benefit-sharing and biodiversity structured actors’ statements aimed at defining DSI, thus applying and redefining access and benefit-sharing principles in the context of DSI. Actors with similar and slightly varying interests formed discourse-coalitions on the basis of shared storylines. Developing countries formed a separate discourse-coalition to push for DSI regulation wherein ideas about sustainable development and environmental justice were integrated, and to a lesser extent about biopiracy (the notion that open access to DSI enables the misappropriation of genetic resources and associated traditional knowledge). In response, developed countries adopted narratives put forward by industry and research, advocating that open access to DSI is essential for science, biodiversity conservation and sustainable development. A third coalition, consisting of Indigenous peoples and local communities and civil society, also mobilized environmental justice and biopiracy discourses, but more prominently a unique holistic discourse on nature. Finally, holistic and biopiracy discourses were marginalized in official negotiation documents, while scientific and sustainable development discourses were adopted in official negotiation documents. The research provides a novel understanding of the DSI-negotiations as discursive politics, and highlights how different positionalities in discourses structure and are structured by statements in this political arena.

Genetic databases drive research by enabling open access. Recently, parties to the Convention on Biological Diversity agreed on new rules for sharing benefits from the use of digital sequence information (DSI) which upholds open access, and also imposed new requirements for data depositors, database managers, and users.

This paper presents results of the research of students at the Faculty of humanities and social sciences in Zagreb, Croatia about their attitudes and perceptions of digital scientific information landscape. The results of the research show that use of digital scientific information resources including use of open access information resources has become a constant activity among students in their daily academic activities. The students who participated in the research demonstrated their familiarity with the key characteristics of digital information resources which suggests their increased competence for selection and use of digital scientific information resources in their education. The increase in use of scientific digital content on mobile devices has also become a steady trend which calls for adapting digital content used in student's education. Unfortunately, students are still mostly self-taught about use of digital scientific information resources which should be changed.

Digital sequence information as a marine genetic resource under the proposed UNCLOS legally binding instrument

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