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

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

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.