Introduction

In the recent past, due to rapid adoption of genome editing technology and its variants, several genome-edited crop products have been commercialized, including soybean with high oleic acid, pungency-free mustard greens, high-GABA (gamma-aminobutyric acid) tomato, and waxy corn with high amylopectin [11]. Many more genome-edited crops with improved traits are in the pipeline [4]. It is important for scientists engaged in genome editing to appreciate that the international community is currently engaged in highly dynamic negotiations to develop new rules for sharing benefits derived from the use of digital sequence information/genomic sequence data (DSI/GSD). Over the course of the past 10 years, this issue has grown in importance to the point where it is a key sticking point in negotiations taking place under the frameworks of four different United Nations fora. This short paper will briefly review why DSI benefit-sharing has gained so much attention in recent years, summarize the current state of international negotiations across four UN fora, and end with some consideration of the potential impact of the outcome of these negotiating processes.

Why has benefit sharing from DSI become such a hot issue?

At the risk of oversimplification, benefit sharing from the use of DSI became a hot issue as a result of five interrelated factors. The first baseline contributing factor is the fact that most of the world’s biodiversity has evolved in the global south. This is particularly true for crops [5] as illustrated in Fig. 1 and livestock [12].

Fig. 1
figure 1

Reproduced from Khoury et al. [5]

Primary regions of diversity of major agricultural crops worldwide.

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The second contributing factor, is that, long before DSI had entered the scene, developing countries were concerned that developed countries had an unequal, technological advantage to exploit genetic diversity for commercial advantage and economic development.

The third contributing factor is that the international access and benefit-sharing agreements that were negotiated in the 1990s and early 2000s to address this inequity–by redirecting benefits derived from the use of genetic diversity to developing countries–have generally not lived up to expectations. Particularly relevant in this regard are the Convention on Biological Diversity, 1993 (CBD) and its Nagoya Protocol on access and benefit sharing, 2010 (Nagoya Protocol), and the International Treaty on Plant Genetic Resources for Food Agriculture, 2004 (Plant Treaty). These international laws have not led to significant redirection of monetary benefit sharing to developing countries. So, ABS-related tensions were already there; the emergence of DSI has been like pouring gas on the fire.

The fourth factor of course, is the relatively recent, and extraordinary, scientific and technological advances in genome sequencing, genome manipulation/editing and gene synthesis. New generation sequencing technologies have dramatically increased the speed and lowered the cost of generating genetic sequence information. Genome editing and gene synthesis are creating unprecedented ways of using DSI as part of discovery research and crop and animal breeding [1, 8, 10].

Again, as in the case of biotechnologies in the 1990s, subject to a number of remarkable exceptions (e.g. China, India, Brazil) many developing countries lack capacity to fully exploit these new scientific and technological breakthroughs. There is widespread concern that DSI will contribute to widening, not closing, of the technology gap between north and south, and the ability of countries to exploit digital sequence information (and material genetic resources) for commercial benefit and economic development.

Finally, the CBD, its Nagoya Protocol and Plant Treaty were not built with DSI in mind. They regulate access to genetic resources [defined as ‘genetic material’ containing functional units of heredity (emphasis added)], not information derived from those resources. Under the Plant Treaty, monetary benefit sharing is triggered when accessed ‘genetic material’ is ‘incorporated’ in new, commercialized products. Under the Nagoya Protocol, access providers can potentially limit uses of data derived from genetic materials, but only as a condition that they set when they are making agreements to provide access to the genetic material in the first place.

Consequently, DSI has opened up the possibility that research and development organizations can benefit commercially from being able to access genetic sequence data on line which is free from the benefit sharing obligations that would otherwise apply to the underlying genetic material from which that data was derived [5]. They can use research leads based on that accessed DSI to synthesize genetic constructs, or edit genetic materials they already have, or which they can obtain from unregulated sources, to continue their product development [2].

In the end, as a result of these five combined factors, many countries—almost entirely from the global south—since the early 2010s have been calling for policy reforms, to close the gap in access and benefit sharing rules that has been opened up by the emergence of DSI.

DSI first got meaningfully forced onto the agenda of 13th meeting of the Conference of the Parties to the CBD (CBD/COP 13) in Mexico in 2013 when a group of contracting parties refused to adopt any other decisions during that meeting, unless there was an agreement to convene an intersessional process looking at how DSI affects conservation, sustainable use of genetic resources and benefit sharing. Since then, the issue has come to dominate the agendas of the CBD, Plant Treaty, UN WHO, and BBNJ.

What do we mean by ‘digital sequence information’?

Despite attracting so much attention, there is still no internationally agreed definition of digital sequence information. All of the countries involved in negotiations to create new benefit sharing rules for DSI under the four UN fora mentioned above have agreed, for the time being, to use ‘digital sequence information’ or ‘DSI’ as a place holder term until they can agree on (a) whether they actually need a definition, and (b) if they need a definition, what kinds of information should be included within its scope.

To help negotiators think-through what kinds of information could possibly be included within the scope of a definition of DSI, the CBD Secretariat published a very useful background paper setting out a framework for consideration options.

The paper presents a sliding scale of options as illustrated in Fig. 2. Here we see group 1 includes DNA and RNA. This is the narrowest range of information to include in the definition. Group 2 includes DNA, RNA and proteins. Group 3 includes DNA, RNA, proteins and metabolites. Group 4 includes all the forgoing, plus associated Traditional knowledge.

Fig. 2
figure 2

Framework of analysis for considering the scope of what is meant by ‘DSI’ [3]

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As highlighted in the next section, negotiators have been able to make some very significant interim decisions concerning DSI despite not having a definition 

The current state of play

In December 2022, the CBD/COP 15 adopted the Kunming-Montreal Global Biodiversity Framework. The COP also decided to establish, as part of the Kunming-Montreal Global Biodiversity Framework, a multilateral mechanism for benefit-sharing from the use of digital sequence information on genetic resources, including a global fund. This decision is very significant because it recognizes, for the first time in an international agreement, that there should be an equitable redistribution and sharing of benefits, worldwide, from commercial benefits derived from the use of DSI. However, the COP 15 decision left a lot of questions unanswered, for example, who should pay, under what circumstances, how money would be distributed from the fund and to whom. COP 15 launched a 2-year process for countries to negotiate/develop such terms by CBD/COP 16 in October 2024. The COP set out criteria for the development of the multilateral mechanism, stating that it must, among other things, generate more benefits than it costs; provide legal certainty; not hinder research and innovation and be consistent with open access to data. The COP also encouraged depositing DSI in public data bases. 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) was adopted in June 2023. One of its objectives is “fair and equitable sharing of benefits arising from activities with respect to marine genetic resources and digital sequence information …” (emphasis added). So, within 6 months of the COP 15 decision, a second international agreement recognized the need to share benefits from the use of DSI. However, the BBNJ also does not actually include details on who should share benefits, and how benefit sharing obligations should be calculated. That was left to be workedout in the future. In the meantime, contracting parties agree to make annual contributions to a central fund, calculated at 50% of their “assessed contribution to the budget adopted by the Conference of the Parties” (Article 14.6).

In October 2022, the Governing Body of the Plant Treaty relaunched a process to renegotiate the terms of the Plant Treaty’s multilateral system of access and benefit-sharing. (There had been an earlier round of negotiations from 2013 to 2019, but they were suspended without any agreement, partly because contracting parties disagreed so fervently over DSI). One of the ‘hot issues’ contracting parties have agreed needs to be addressed in the current round of negotiations is benefit-sharing from DSI (in addition to benefit-sharing from plant genetic resources, and expansion of the scope of crops and forages included in the scope of the multilateral system). It is hoped that the process will be wrapped up in November 2025, with the 11th Session of the Governing Body adopting/endorsing a revised package of measures to improve the effectiveness of the multilateral system.

The World Health Organizations (WHO) is currently hosting to two negotiations wherein new rules for benefit sharing from DSI are under consideration: (one) to develop WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response, and (two) to address/discuss amendments to the ‘International Health Regulations (2005)’. These two processes are scheduled to be finalized in May 2024.

Some higher-level outstanding issues concerning which there is still substantial disagreement between negotiating parties under the CBD, Plant Treaty, BBNJ and (to a lesser extent) WHO include the following:

  • Triggers for payments and the basis for calculating amounts to be paid. In this context fundamental decisions need to be made about whether payment obligations should be limited to commercializers of particular products that were developed through direct use of accessed DSI, or whether payments should be calculated on the basis of entire portfolios of products at the the end of R&D chains that are generally DSI-dependent regardless of whether the commercializer made direct use of DSI.

  • Whether in some exceptional cases, benefit-sharing payments should be directed to individual providers/sources of DSI, or must always be made to a centralized international benefit-sharing fund

  • Criteria for distributing payments from the international benefit-sharing funds created under the four UN fora

  • Whether it is necessary to develop a definition of DSI

  • Whether there needs to be some positive identification and listing of open access data bases that are ‘included’ in the new arrangements and if they should adopt some standardized governance arrangements

  • How legal certainty for DSI users and providers can be promoted or guaranteed

  • How to ensure that the DSI-related norms adopted by the four UN fora can be harmonized so that they are mutually supportive, and do not end up creating obstacles to open access to, and interoperability of, DSI data bases

  • How to effectively promote non-monetary benefit sharing in the forms of information exchange, capacity building and technology transfer to ensure that low-income countries are able to benefit from the use of DSI for economic development.

  • What to do about DSI users located in countries that decide not to participate in new benefit sharing arrangements

In light of these outstanding issues, the scheduled deadlines for adopting new DSI benefit sharing rules in all these fora are very ambitious. It is possible—likely even—that most, if not all, of these processes will need to be extended.

Conclusion: potential implications and ways forward

It is well established that countries are interdependent upon plant genetic resources for food and agriculture [9]. Indeed, that interdependence was one of the primary reasons for the creation of the Plant Treaty’s multilateral system of access and benefit-sharing [7]. DSI increases countries’ interdependence in all areas of research and development precisely because it increases our collective ability to compare information about genetic resources—regardless of where they are situated—at scales that were unimaginable before the emergence of new generation sequencing, phenotyping, gene synthesis and bioinformatics. As such, the stewardship of DSI as a collective common resource for use in R&D for sustainable development is becoming increasingly important.

The outcome of all these negotiations could profoundly affect, positively or negatively, how scientists are able to generate, access, use and share digital sequence information in the course of their work, and how benefits associated with that work is distributed. High tech breakthroughs can end up exacerbating the gaps in relative economic prosperity between high-and low-income countries. Consequently, benefit sharing systems need to be designed to ensure capacity sharing, so that resource poor countries are able to engage in, and take advantage of, the burgeoning fields of research that depend on DSI. At the same time, it is clear that open access digital infrastructures are essential for exploiting the power of DSI. So, it is critical that new benefit sharing systems are not set up in ways that interrupt or undermine open access [9]. In this context, it is important to underscore that DSI can be copied and sent anywhere in the world in seconds; as such, it is an even more challenging ‘object’ for ABS regulation than genetic material. Ultimately, a new form of benefit-sharing regulation is needed. This will require backing away from the sector-separated, transaction-based ABS systems we have had until now for genetic materials, and instead, developing a system (or systems) that calculate, collect and redistribute benefits at much higher (and much larger), aggregate levels [6]. The international community has an opportunity to develop such a harmonized system (or systems) across the four UN fora; to do so, negotiators will need to be creative, courageous, and willing and empowered to compromise.