Navigating the Global Landscape of Access and Benefit-Sharing (ABS) on Digital Sequence Information (DSI) Regulation: Dealing with Scope Confusion through Mutual Supportiveness

Since 1992, the United Nations (UN) Convention on Biological Diversity (CBD) has regulated access to material genetic resources and the sharing of benefits associated with their use in research and development (R&D) through a policy mechanism known as Access and Benefit-Sharing (ABS). Parties to the CBD (and other international ABS agreements) have spent the last three decades implementing domestic ABS measures. There have since been significant scientific advances, such that genetic resources can now be easily synthesized in the laboratory using ‘Digital Sequence Information’ (DSI). Increasingly many users of genetic resources no longer require access to material genetic resources to conduct R&D, as it may be sufficient to access and use DSI for some applications.Various UN fora (the CBD, via the creation of a DSI Multilateral Mechanism (MLM) for ABS on DSI, and its associated Cali Fund, the Food and Agriculture Organization of the UN, the World Health Organization, and the United Nations Convention on the Law of the Sea (UNCLOS)) have either established or are negotiating provisions for ABS on DSI. This paper examines the scope of the key international ABS instruments to consider how ABS on DSI is likely to be regulated by various international bodies in the coming years. Our analysis indicates that the scope of each international ABS instrument is not delineated using the same characteristics or legal concepts. Scope is sometimes based on the jurisdiction in which the organisms originate or are collected (e.g., CBD), sometimes on one or more properties of a genetic resource (e.g., its ability to cause certain disease states in humans), and on the intended application of the R&D being conducted (e.g., for food and agriculture). There may be different rules depending on the intent of the user (e.g., commercial or non-commercial R&D) and there are exceptions to scope based on types of genetic resources (e.g. human genetic resources under CBD and Nagoya Protocol) or certain activities (e.g., fishing-related activities under the UNCLOS Biodiversity Beyond National Jurisdiction (BBNJ) Agreement). Despite the broad scope of the CBD’s MLM, it is already apparent that the global complement of DSI being carved up along the same (or similar) lines as material genetic resources and managed across different international instruments. These DSI regulatory categories are likely to be based on various characteristics or legal concepts (e.g., jurisdiction, organism, intended use, etc.) that do not reflect distinctions found in nature or scientific practice, and will likely result in a fragmented, confusing and potentially ineffective DSI ‘regime complex’. Even if jurisdiction is clear, the genetic resources and associated DSI in question may fall within the scope of several different instruments depending on the intended application of the R&D process utilizing those resources. It is therefore difficult to determine (in legal terms) where each instrument begins and ends, whether they overlap and how they interact with each other. This could push users of DSI to find alternative access arrangements, resulting in a loss of both monetary and non-monetary benefits for the multilateral system, and the objective of fair and equitable benefit-sharing for the use of DSI going unrealized. This will not necessarily be based on a lack of willingness by users to contribute benefits but rather linked to how rational actors operate under conditions of regulatory uncertainty and complexity. It is unlikely that the various UN bodies with an existing stake in ABS will harmonize all DSI regulations. Therefore, we argue that proactive efforts are needed to both support the goals of each ABS instrument (for both material genetic resources and DSI) and to ensure efficiency, streamlined processes, as well as create outcomes that are practical, effective, and generate more benefits than costs for each DSI instrument. We therefore emphasize mutual supportiveness across instruments, and in doing so present six potential options to facilitate mutual supportiveness across the burgeoning DSI regime complex. We present a further option - option zero - which is, in our opinion, the ideal but least likely scenario where all DSI instruments are harmonized across the global complement of DSI (meaning that benefit sharing rules remain the same no matter what DSI is used in R&D). Thus, mutual supportiveness is framed as a process with significant political and law-making dimensions. Without further efforts to coordinate, the goals of each instrument may go unrealized.