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

Abstract

Over the last 40 years or so, a complex web of international legal agreements was developed that regulate the access, transfer, and use of plant genetic resources. These include the Convention on Biological Diversity (CBD), the Nagoya Protocol, and the International Treaty on Plant Genetic Resources (Figure 1). In developing these legal regimes, policy makers struggled to balance a number of conflicting demands. These included ensuring that access providers share in the benefits that arise from the use of their genetic resources; that users who value-add to genetic resources can protect their innovations via intellectual property; and, at the same time, that scientists and breeders have ongoing access to genetic resources. While there are problems with the existing regimes, they have reached an uneasy compromise of sorts. In recent years, dramatic changes in the life sciences have threatened to undermine this complex and fragile balance (Unamba et al., 2015Unamba C.I.N. Nag A. Sharma R.K. Next generation sequencing technologies: the doorway to the unexplored genomics of non-model plants.Front. Plant Sci. 2015; 6https://doi.org/10.3389/fpls.2015.01074Crossref Scopus (5) Google Scholar). These changes have been facilitated by new genomic technologies such as gene editing and synthetic biology (McDaniel and Weiss, 2005McDaniel R. Weiss R. Advances in synthetic biology: on the path from prototypes to applications.Curr. Opin. Biotechnol. 2005; 16: 476-483https://doi.org/10.1016/j.copbio.2005.07.002Crossref PubMed Scopus (122) Google Scholar), by improved and cheaper sequencing technologies (Shaffer, 2007Shaffer C. Next-generation sequencing outpaces expectations.Nat. Biotechnol. 2007; 25: 149https://doi.org/10.1038/nbt0207-149Crossref Scopus (52) Google Scholar) that rapidly increased the availability of DNA sequence data, and advances in whole-genome sequencing (Figure 1). Genomics is now a major source of data, rivalling big data disciplines like astronomy in the pace of data acquisition, storage, and analysis (Stephens et al., 2015Stephens Z.D. Lee S.Y. Faghri F. Campbell R.H. Zhai C. Efron M.,J., Iyer R. Schatz M.,C., Sinha S., Robinson G.E. Big data: astronomical or genomical?.PLoS Biol. 2015; 13https://doi.org/10.1371/journal.pbio.1002195Crossref Scopus (684) Google Scholar). Open access international data repositories, such as GenBank, the DNA Databank of Japan, and European Molecular Biological Laboratory, that house a huge amount of DNA sequence-related data (estimated at over 1.5 billion sequences) (WiLDSI, 2020WiLDSIFinding compromise on ABS & DSI in the CBD: requirements & policy ideas from a scientific perspective.https://www.dsmz.de/fileadmin/user_upload/Presse/WILDSI/Final_WiLDSI_White_Paper_Oct7_2020.pdfDate: 2020Google Scholar) facilitate the sharing and use of digital sequence information (DSI) (Ad Hoc Technical Group on Digital Sequence Information, 2020Ad Hoc Technical Group on Digital Sequence InformationSynthesis of Views and Information Relating to Digital Sequence Information on Genetic Resources CBD/DSI/AHTEG/2020/1/2.2020: 11Google Scholar). The scientific value of public databases largely comes from the aggregation of data that allow scientists to identify patterns across the stored sequences (WiLDSI, 2020WiLDSIFinding compromise on ABS & DSI in the CBD: requirements & policy ideas from a scientific perspective.https://www.dsmz.de/fileadmin/user_upload/Presse/WILDSI/Final_WiLDSI_White_Paper_Oct7_2020.pdfDate: 2020Google Scholar). The ability for scientists to work on sequence data independently of physical genetic material fundamentally changed the nature of plant-related research. The uncoupling of immaterial sequence data from their material form also challenged the legal regimes that regulate how genetic resources are accessed and used. Specifically, the availability of open access sequence data is said to undermine the benefit-sharing regimes established under the CBD and the Nagoya Protocol, which require users of physical genetic resources to share benefits with access providers. As a recent report suggested, ‘rapid advances in sequencing and synthesizing DNA means that “digital” piracy is now possible, circumventing rules on access and benefit sharing’ (The International Civil Society Working Group on Synthetic Biology, 2016The International Civil Society Working Group on Synthetic BiologySynthetic biology and the CBD: five key decisions for COP 13 & COP-MOP.. 2016; 8: 5Google Scholar). This is because, except in limited cases, such as Brazil, where national access and benefit sharing (ABS) laws cover derived sequence data, it is possible to access and use sequence information from CBD-protected plants without triggering benefit-sharing obligations. The fact that sequence information can be ‘generated and shared without applying benefit-sharing obligations has led to concerns that “developing country governments, farmers, and indigenous peoples that created and nurtured that diversity will lose out. National genetic resources and Indigenous Peoples’ plants will be privately “mined” for profitable sequences with little or no recompense’(The International Civil Society Working Group on Synthetic Biology, 2016The International Civil Society Working Group on Synthetic BiologySynthetic biology and the CBD: five key decisions for COP 13 & COP-MOP.. 2016; 8: 5Google Scholar). The status of DSI under the CBD has been discussed at a series of recent international meetings. Given the negotiating history of the CBD, it is not surprising that the parties have been unable to agree on whether DSI falls within the scope of the CBD or should be subject to ABS obligations (Ad Hoc Technical Group on Digital Sequence Information, 2020Ad Hoc Technical Group on Digital Sequence InformationSynthesis of Views and Information Relating to Digital Sequence Information on Genetic Resources CBD/DSI/AHTEG/2020/1/2.2020: 11Google Scholar). Despite this, there is common ground. For example, there is agreement that the placeholder term DSI is neither clear nor helpful and that it needs to be replaced (there is, however, no consensus on what its replacement should be). There is also agreement that sequence data should be openly accessible (Houssen et al., 2020Houssen W. Rodrigo S. Jaspars M. Digital Sequence Information in Genetic Resources: Concepts, Scope and Current Use, 5; Ad Hoc Technical Group on Digital Sequence Information Synthesis of Views and Information Relating to Digital Sequence Information on Genetic Resources CBD/DSI/AHTEG/2020/1/2.2020Google Scholar) and that access should not be unduly compromised (Gaffney et al., 2020Gaffney J. Tibebu R. Bart R. Beyene G. Girma D. Kane N.A. Kane Mace E.S. Mockler T. Nickson T.E. et al.Open access to genetic sequence data maximizes value to scientists, farmers, and society.Glob. Food Secur. 2020; 26https://doi.org/10.1016/j.gfa.2020.100411Crossref Google Scholar). While concerns about the pace of change at the CBD explain why member states have begun to clarify the status of DSI under domestic laws, for a long-term workable solution to be developed it must be a global solution, because local solutions only “entrench the lack of harmonization and legal uncertainty” (Bagley, 2015Bagley M. Digital DNA: The Nagoya Protocol, Intellectual Property Treaties, and Synthetic Biology. Wilson Centre, 2015Google Scholar). While the question of whether the ABS laws include DSI is unsettled, and will be for some time, people have begun to consider what a possible solution to the policy conundrum might look like (Table 1). In this context, policy makers are asking, if DSI falls under the CBD, how should it be regulated? This is important given that the schemes proposed to regulate how sequence data are used not only reveal something about the way priorities are being set, they may shape discussions about the status of digital sequence data under the CBD.Table 1Options for balancing access to DSI with access and benefit sharing solution.ProsConsExtension of CBD arrangementswidely acceptednot suitable for multilateral DSI useMicro-levySimpleoverheads/distributionAnnual membership paymentSimpleoverheads/distributionNational levySimpleoverheads/distributionTriggered by commercial useSimplecompliance Open table in a new tab In developing a scheme that ensures that benefits are shared equitably when sequence data are used, policymakers need to balance different policy goals. They need to deter the misappropriation of sequence data (digital biopiracy); ensure that providers of genetic resources can control how their resources are used and are compensated for that use (digital biodiscovery); and, at the same time, ensure that access to sequence data is not restricted or scientific research impinged. In thinking about how these policy goals might be navigated, different models have been mooted. One possibility is to simply extend the existing benefit-sharing schemes—which requires access providers to enter into legally binding agreements with the party accessing the genetic resources that specify how the materials will be used and the compensation (benefits) to be provided in return for that use—to include DSI. There has been little support for using the individualized bilateral ABS system of the CBD to regulate DSI (WiLDSI, 2020WiLDSIFinding compromise on ABS & DSI in the CBD: requirements & policy ideas from a scientific perspective.https://www.dsmz.de/fileadmin/user_upload/Presse/WILDSI/Final_WiLDSI_White_Paper_Oct7_2020.pdfDate: 2020Google Scholar). This is because there are “clear limitations to taking a bilateral approach to dealing with DSI through contracts, particularly when DSI is published in publicly accessible databases.” While the bilateral ABS system assumes there is a direct linear relationship between the providers and users of genetic material and that there are a limited number of actors who need to negotiate an ABS agreement, the digital sequence landscape is much more decentralized: there are a growing number of actors in the DSI supply value chain that are dispersed and often invisible. The scale of access and use of DSI is also “at a different scale and complexity than [physical resources]” (WiLDSI, 2020WiLDSIFinding compromise on ABS & DSI in the CBD: requirements & policy ideas from a scientific perspective.https://www.dsmz.de/fileadmin/user_upload/Presse/WILDSI/Final_WiLDSI_White_Paper_Oct7_2020.pdfDate: 2020Google Scholar; Contribution by the Government of the Netherlands FAO, Eighth Session of the Governing Body, 2019Contribution by the Government of the Netherlands FAO, Eighth Session of the Governing Body (2019). IT/GB-8/19/16.1/Inf.1 Add. 1.Google Scholar). Sequences may not be unique to particular organisms, sources, or countries, which makes it difficult to trace where a sequence came from, to track when and where it has been used, and who “deserves credit for a particular stretch of DNA bases” (WiLDSI, 2020WiLDSIFinding compromise on ABS & DSI in the CBD: requirements & policy ideas from a scientific perspective.https://www.dsmz.de/fileadmin/user_upload/Presse/WILDSI/Final_WiLDSI_White_Paper_Oct7_2020.pdfDate: 2020Google Scholar). Faced with these problems, policy makers and commentators have begun to explore what an alternative regulatory scheme might look like. One model being explored imposes a charge or fee for accessing sequence data. There are a number of ways fees could be collected, including imposing a micro-levy on a sequence-related purchase such as DNA sequencing or synthesis services, sequencing machines, or molecular biological reagents (WiLDSI, 2020WiLDSIFinding compromise on ABS & DSI in the CBD: requirements & policy ideas from a scientific perspective.https://www.dsmz.de/fileadmin/user_upload/Presse/WILDSI/Final_WiLDSI_White_Paper_Oct7_2020.pdfDate: 2020Google Scholar). Alternatively, users (or governments) could make annual payments to a central agency based on pre-agreed criteria such as GDP, data use, or seed sales (Halewood et al., 2018Halewood M. Chiurugwi T. Sackville Hamilton R. Kurtz B. Marden E. Welch E. Michiels F. Mozafari J. Sabran M. Patron N. et al.Plant Genetic Resources for Food and Agriculture: opportunities and challenges emerging from the science and technology revolution.New Phytol. 2018; 217: 6-17Google Scholar) Another option is for governments to make direct payments to a central fund to allow citizens to access the sequence data (WiLDSI, 2020WiLDSIFinding compromise on ABS & DSI in the CBD: requirements & policy ideas from a scientific perspective.https://www.dsmz.de/fileadmin/user_upload/Presse/WILDSI/Final_WiLDSI_White_Paper_Oct7_2020.pdfDate: 2020Google Scholar). There is much to recommend about schemes of this nature. They would, all being well, reduce transaction costs, increase certainty, facilitate access, and ensure that funds are available to distribute to access providers. Given that, under this model, payment is disconnected from use, it needs to be decided how the pooled funds will be distributed and who those funds will be distributed to. There is a danger that pooled funds may not be equitably or transparently distributed, or a large proportion of the funds will be eaten up in running the central collection/distribution agency. It could also be said that fee-based models take what is an exceptional situation, namely when research leads to a commercial outcome, and elevate it to something that it is not. While it is important that provider countries share in the financial benefits of commercial use, it may be a mistake to use this relatively rare occurrence as the norm to shape the models used to regulate all research on genetic resources. By monetarizing all transactions, these schemes risk subtly altering the research process (in much the same way as the pursuit of intellectual property in universities has); they also downplay non-monetary benefits (although this could be captured by ensuring that sequence data remain openly accessible). Another suggested model shifts the focus of regulatory attention away from the time when the sequence data are accessed to a point further down the research-to-outcome pathway. While many jurisdictions, such as Australia, Ecuador, and Peru, have adopted aspects of this model, Brazil offers the most complete example of a scheme of this nature (Brazil’s Position on DSI, 2019Brazil’s Position on DSI (2019). Notification 2019-102, 8.Google Scholar). Under this type of scheme, rather than entering into ABS agreements or paying a fee for use at the start of the research process, users can freely access sequence data for whatever purpose they want. The only obligation imposed on users, which could occur via a click-wrap license agreement entered into when users link with public databases (WiLDSI, 2020WiLDSIFinding compromise on ABS & DSI in the CBD: requirements & policy ideas from a scientific perspective.https://www.dsmz.de/fileadmin/user_upload/Presse/WILDSI/Final_WiLDSI_White_Paper_Oct7_2020.pdfDate: 2020Google Scholar), is a promise to negotiate a benefit-sharing agreement when, and only when, a specific event occurs in the future. These trigger-points could arise when users apply for intellectual property protection, develop or finish a product, they derive economic benefit as a result of having accessed sequence data, or when users disclose sequence-related research results in scientific publications. Importantly, the user's promise to return to negotiate benefit sharing when certain trigger points occur is monitored by downstream checks and balances. These include the requirement that, when applying for intellectual property, parties have to disclose the origin of any genetic resources and sequence data that underpin their application. Similar obligations could arise when parties export products overseas or obtain approval to sell products to the public. This could be reinforced by journals requiring acknowledgment of the source of genetic resources and sequence data as a pre-condition for publication. To reduce transaction costs and increase certainty, the negotiation of the ABS agreement under this model could be streamlined by mandating how monetary benefits are calculated. In Brazil, for example, “the percentage of monetary benefit sharing from products or reproductive material derived from the use of genetic resources is established at 1% of net revenues from the product or reproductive material sales: there is no speculation of values and no surprises for genetic resources users” (Brazil’s Position on DSI, 2019Brazil’s Position on DSI (2019). Notification 2019-102, 8.Google Scholar). Monetary benefits would be paid into a central fund tasked with redistributing the benefits arising from the use of genetic resources for certain predefined purposes. There is merit in a simple, declaratory, and transparent system buttressed by effective tracking and tracing tools that monitor compliance. By shifting attention away from access toward the exploitation of sequence data, a scheme of this nature should reduce upfront transaction costs. It should also protect access to sequence data. However, a range of subsidiary issues need to be resolved, including ensuring that the click-wrap agreement is valid across jurisdictions, and working out the type of relationship between sequence data and downstream research there must be for the obligation to negotiate an ABS agreement to kick-in. The issues with the centralized collection and distribution of pooled funds under the fee-based model also arise here. Perhaps the biggest stumbling block to the success of this model as a global solution is that it is unlikely that the secondary compliance measures, such as the requirement to disclose the origin of genetic resources in intellectual property applications, will be taken up on a scale needed for it to be effective. Balancing different policy goals inevitably leads to compromise. The key issue that needs to be decided is what we are willing to compromise, what we want to prioritize, and what are we willing to concede. The different models outlined above represent different responses to these questions. Given that the way that these questions are answered will shape plant science in the future, it is important that scientists play a role in these discussions and contribute to the development of effective and equitable approaches. No conflict of interest declared.