Global environmental issues such as climate change and the loss of biodiversity are being addressed through the Multilateral Environment Agreements (“MEAs”) by nearly all countries. MEAs impose various obligations on each country to achieve the objectives of the agreement¹. The obligations imposed by the Convention on Biological Diversity (CBD), for example, are implemented within countries by legislative measure (for example, law), administrative measure (for example, regulation and guideline), and/or policy measure (for example, public awareness). While it is important to identify the phenomena and causes of the phenomena in order to effectively address such measures, the CBD recognizes the general lack of information and knowledge on biodiversity and oblige Parties to promote the exchange of scientific knowledge and technology or scientific cooperation. However, such scientific knowledge is generated by the United Nations (“UN”) Agency, Industry, Intergovernmental Organization, Non-Governmental Organizations/Non-Profit Organizations, and academia such as universities and research institutes. Therefore, without the cooperation of such sectors, the central government as a Party with decision-making authority cannot achieve the objectives and implementation of the obligation, of CBD. Scientific knowledge generated by various sectors not only interacts at the national and global levels directly and/or indirectly, but also between the national and global levels (Figure 1). With regard to the relations with other MEAs, at the global level they may also interact between MEAs as they may be indirectly affected in the process of coordination with the Secretariat of agreement as a UN Agency and coordination within the central government. However, it is up to the Party with final decision-making authority to decide whether such interactions will work or not. MEAs and scientific knowledge are interrelated in circumstances such as the following: (1) when scientific knowledge raises questions regarding the draft of an agreement (Glowka et al., 1994) (2) when Parties attempt to come to consensus on terms, definitions, scope, and actions regulated by the agreement, (3) when reconsideration of matters regulated by the agreement is warranted due to new knowledge or technologies (in some cases, this may escalate to circumstance 1), and (4) when implementation of the agreement requires scientific knowledge (e.g., for example, Article 6 of CBD and Article 5 of International Treaty on Plant Genetic Resources for Food and Agriculture). In other words, agreements require scientific knowledge not only during the drafting process but also throughout the process of implementation. Scientific knowledge refers to the objective knowledge accumulated by experts in the scientific community. Accumulating knowledge in this manner occurs in various academic fields; in particular, for global-scale environmental protection, the Intergovernmental Panel on Climate Change has been developed in the climate change field and platforms such as the representative Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services are being built in the biodiversity field. Apart from these examples, scientific knowledge is expected to play a critical role from the agreements in various biodiversity related fields, and there is a trend toward making agreements on these (Mauerhofer, 2019; Nishimura, 2019).

In recent years there have been technological advancements and innovations in various fields, including artificial intelligence. In the field of biotechnology, these advances include genome editing and synthetic biology technologies that enable the artificial creation of, e.g., enzymes and cells. Concerns about the impact of such technological developments on the objectives of the CBD, in particular the third objective of fair and equitable sharing of the benefits arising out of the utilization of genetic resources, were raised by the African region at the 13th meeting of the Conference of the Parties held in Mexico in November 2016. With the advent of synthetic biology technologies, users of genetic resources can directly access publicly available sequences in databases such as GenBank, where they obtain the data from genetic resources while remaining exempt from benefit-sharing obligations (Kobayashi, 2017) instead of coordinating with the developing countries where the former are found. This issue, which applies to all genetic resources, was not only raised at the CBD but also by the governing body of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGR)², which regulates the use of plant genetic resources for food and agriculture (PGRFA), and the Pandemic Influenza Preparedness Framework (PIPF) of the World Health Organization (WHO) regarding the sharing of influenza viruses, access to vaccines, and other benefits. Unlike the CBD, which delegates regulation to the laws of each country and does not set substantive rights and obligations regarding the acquisition of genetic resources, the ITPGR established a Multilateral System (MLS) and Standard Material Transfer Agreement (SMTA) (Manzella, 2013). Although issues related to digital sequence information (DSI) on genetic resources were considered during the discussions on enhancing the functioning of the MLS in the ITPGR meeting, several Parties were opposed to the Chair’s proposal regarding the handling of DSI at the 8th session of the governing body held in November 2019, and no consensus was reached³. However, the PIPF stipulates that—in addition to the mechanism of global sharing of genetic resource of H5N1 and other influenza viruses with human pandemic potential—the framework should share genetic sequence data (GSD) obtained from viruses⁴. The PIPF defines genetic sequences as ‘the order of nucleotides found in a molecule of DNA or RNA. They contain the genetic information that determines the biological characteristics of an organism or virus.’ However, the handling of GSD including the benefit sharing in the context of PIPF was relegated to future discussions, and these PIP Advisory Group and PIP Review Group discussions were still in progress as of February 2020⁵. Ever since the handling of DSI was proposed at the 13th meeting of the Conference of the Parties to the CBD, related agreements seem to be becoming further integrated via information sharing between these agreements⁶. A common point of discussion at these international forums is the use of the provisional term ‘DSI.’ In the notes of the decision of the 13th meeting of the Conference of the Parties to the CBD, it is stated that the terminology for DSI is ‘subject to further discussion in the study and the expert group.’ Defining terminology not only benefits a single agreement, whether CBD as the umbrella Convention, ITPGR as a specialized ABS instrument or not, but also contributes to development of other international treaties discussing the same topic. Replacing and defining DSI with the appropriate term will also be advantageous for implementation of the agreement and can be an opportunity to incorporate scientific knowledge in the implementation process from the view of the international environment law.

In addition, as the terms GSD and DSI are used, each agreement has a system or a provision for data or information. Article 17 of ITPGR requires Parties to work together to develop the Global Information System on Plant Genetic Resources for Food and Agriculture (GLIS) and facilitate information exchange. Regarding the relationship with PIPF, the Global Initiative on Sharing All Influenza Data (GISAID) is an existing database, although it is not a system built under the framework. GISAID has initiated a mechanism to promote global sharing of all influenza virus data and to jointly publish results and is recognized as an essential mechanism for sharing influenza gene sequences and metadata⁷. GSD of new coronaviruses originating in China and occurring in various countries are also shared through GISAID⁸. Although the relationship between PIPF and GISAID is not necessarily the same as GLIS in ITPGR from a legal point of view, GISAID was developed in 2008 through discussions within the scientific community and negotiations with national governments around data sharing (Elbe and Buckland-Merrett, 2017). When considering alternative terms to the DSI, it is inevitable to discuss how to position the relationship with information sharing systems or existing databases established under the agreement.

To date, studies dealing with DSI can be broadly divided into those that address approaches to regulation and management of DSI acquisition and use (e.g., material transfer agreements, open access) and those that focus on DSI from a legal or policy-related perspective (Bagley et al., 2020). Common across these studies is the mention of what the term ‘DSI’ used in these negotiations refers to. Terminology used includes ‘natural information,’ ‘genetic resource information,’ and ‘genetic sequence data’; these terms were also mentioned in the report of the Ad Hoc Technical Expert Group (AHTEG) established in accordance with decision XIII/16 adopted at the Conference of the Parties to the CBD held in 2018. The discussion processes of the PIPF (the Intergovernmental Meeting on Pandemic Influenza Preparedness and the Open-Ended Working Group of Member States on Pandemic Influenza Preparedness) are still at the stage of discussing specific handling provisions using the term ‘GSD’; therefore, it cannot be confirmed whether there were opportunities to integrate scientific knowledge, such as through the submission of views or opinions from the government, relevant organizations, and stakeholders such as academia and industry. However, according to Gostin et al. (2014) and Hay and McCauley (2018), a wide range of Parties including government and public health officials, scientists and intellectual property experts, as well as GISRS and WHO, have participated in these discussions. Past research results have also identified the existence of uncertainties in the scientific knowledge (Dovers et al., 1996). However, the role expected of the AHTEG established under the CBD and other expert groups is to address the issue through the process of reducing and removing such uncertainties, while the Conference of the Parties to the CBD serves to unify knowledge and make decisions. In that sense, the Conference of the Parties is also a process of learning for governments. Therefore, the discussion of Conference of the Parties—and by extension, analysis of opinions by Parties to the CBD used as a basis for discussion—are necessary components for integrating scientific knowledge and policy, and it is possible to understand the intentions and strategies of each Party as to whether it intends to accept various types of knowledge and reflect them in policy decisions. In recent years, attention has been paid to the role of “uncertainty.” According to Knaggård (2014), the role is first, to the need to decrease uncertainty in order to enable policy-making (e.g., Shukla et al., 2009); second, to the need to communicate uncertainty to enable policy-making (e.g., Ascher, 2004; Kandlikar et al., 2005; Smith and Stern, 2011); and third, to policy strategies to cope with uncertainty (e.g., Mearns, 2010; Funke and Paetz, 2011; Smith and Stern, 2011). These three points do not seem to indicate a role but rather a step toward policy-making. Not many studies have analyzed how scientific knowledge is translated into actual discussions and negotiations in multilateral agreements on specific issues at these three stages (Choi et al., 2009). This is probably because it is difficult to grasp the position of each government in relation to the debate. However, in this study, it is possible to supplement it by the documents submitted by each government to the Secretariat in advance and the open negotiation meeting, and it is considered that the value as a substantive study can be found. Such research can also provide the scientific community with an overview of the roles expected of the practical research community.

The base sequence database referred in the statement by developing countries was established in 1980 and has been used by researchers and companies. Each database has promoted a policy of free acquisition and use⁹. However, it has been pointed out that the implementation of this policy also ignores issues related to inequalities in access and capacity to assess DSI (Aubry, 2019). In addition, if the discussion on the term DSI discussed in this study is not properly addressed, there is a possibility that uncertainty will remain in the future use of data, and there are concerns over its long-term impact. Therefore, it is expected that key stakeholders such as researchers and companies will actively participate in and contribute to the discussions. However, when actively participating, it is considered to be necessary to sort out the content to bridge the understanding and recognition of each Party.

In this study, we focused on international negotiations related to DSI/GSD in MEAs, analyzed the changes of terminology for DSI/GSD in the opinions or views of the Parties with decision-making authority in the supreme decision-making bodies from the perspective of implementation of MEAs, and suggested the way forward to solve the challenges in relation with integration of scientific knowledge.