Scholarship on the applicability of the ABS regime to digital sequence information mostly engages with the CBD, the Nagoya Protocol, and domestic ABS provisions. However, as a further contribution to the scholarly heritage, this article incorporates treaty interpretation and case law. Doing so significantly guides the interpretation of the contested terms, “genetic resources” and “functional units of heredity.” As treaties, the CBD and the Nagoya Protocol come within the realm of public international law. A pertinent question is how they should be interpreted amid uncertainty. The CBD provides that disputes over its interpretation or application shall be resolved through negotiation,86 conciliation,87 or arbitration.88 These provisions also apply to disputes over the interpretation or application of the Nagoya Protocol.

Despite their acknowledged merits, those alternative dispute resolution methods have limited value for the present purposes. Generally, the outcomes of negotiation or conciliation proceedings do not bind the parties concerned. Arbitral awards are binding, but only on the parties to the arbitration proceedings. Hence, they have limited precedential value. Consequently, arbitral tribunals presiding over disputes with substantially similar facts and legal questions may make directly opposite awards.89 Nevertheless, Article 4, Annex II, Part 1 of the CBD provides that arbitration proceedings shall be in accordance with the provisions of the Convention, any relevant protocols and, importantly, international law. According to Article 27(3)(b) thereof, disputes over the interpretation or application of the instrument can also be settled by the International Court of Justice (ICJ).

Under international law, treaty interpretation is governed by customary international law as the established practices among states; the Vienna Convention; judicial decisions; and the teachings of the most highly qualified publicists.90 Articles 31–33 of the Vienna Convention state the general principles of interpretation. Under Article 31(1), “a treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.”91 While a treaty provision is to be given its ordinary meaning, based on Article 31(1), such meaning may change over time. The Vienna Convention does not tell whether the ordinary meaning of a provision, as understood at the time of its adoption, or at the time of its interpretation, should apply ([58], p. 131).

Yet, to remain relevant, laws must metamorphose with changes in the times and circumstances of their adoption ([88], p. 365), although adaptability, itself, must be integrated with the imperative of legal certainty ([89], p. 4). A key device for ensuring such adaptability is evolutionary interpretation. This requires a treaty term to be interpreted in a dynamic manner in line with changing situations. Evolutionary interpretation assumes that parties may intend a treaty or some of its provisions to evolve in meaning with “changes in factual or legal circumstances ranging from scientific or technical developments to the emergence of new legal regimes” ([90], p. 18).

Evolutionary interpretation of a treaty term may also be justified by the requirement in Article 31 of the Vienna Convention to interpret a treaty in good faith, consistent with its object and purpose, taking into account relevant international law rules ([63], pp. 8, 14–16).92 Publicists also acknowledge that the terms, objects, and purposes, as well as intentions of a treaty may justify evolutionary interpretation ([58], pp. 168–169). Moreover, ICJ opinions, which encapsulate customary international law, support evolutionary interpretation, where the terms of a treaty imply that the text may admit of “factual or legal evolution after its conclusion.”

In Namibia Legal Consequences,93 for example, the ICJ stated that where the terms of a treaty are “by definition evolutionary,” their “interpretation cannot remain unaffected by the subsequent development of law.”94 Hence, the Court concluded that the terms, “strenuous conditions of the modern world,” “‘the wellbeing and development’ of the peoples concerned,” and “sacred trust” used in the Covenant of the League of Nations,95 were evolutionary, not static.96 Again, in AegeanSea,97 the Court held that the term, “rights” was “generic” and must, consequently, “evolve in meaning” consistent with “the development of international relations.”98 In Gabcikovo-Nagymaros Project,99 the Court also stressed that a 1977 Hungary-Slovakia treaty for the construction of barrages on the River Danube, traversing both countries, was not static, but “evolving” and, therefore, amenable to newly emerged peremptory norms of general international law. Thus, “current standards” of environmental protection were relevant to its implementation.100

In giving evolutionary interpretations to the treaties involved in the foregoing three cases, the ICJ considered the parties’ intention. They were presumed to have used the relevant treaty terms intending them to evolve with time ([90], p. 20). In Namibia Legal Consequences, for example, the Court first alluded to “the primary necessity of interpreting an instrument according to the intention of the parties at the time of its conclusion.”101 It then proceeded to hold that they “must be deemed to have accepted” that the treaty should evolve,102 unless there was unmistakable evidence suggesting otherwise. Therefore, the Court concluded that South Africa’s obligations toward the Namibian people under the “sacred trust” had been affected by changes occurring after the Covenant of the League of Nations was made.103 The Court continued that “the objective of the sacred trust was the self-determination and independence of the peoples concerned,” even though such a right was probably not contemplated when the Covenant was concluded.

In Dispute Regarding Navigational and Related Rights,104 the ICJ crystallized the above principles into a “general rule” for determining when parties’ intention must be presumed to be evolutionary.105 According to the Court, when generic terms are used in a treaty and that treaty is meant to have a “continuing duration,” the parties “must” be deemed to have intended such terms to be given an evolutionary interpretation. Impliedly, a term would most likely be considered evolutionary because it is generic and there is further “indication that the term was supposed to connote a perpetual obligation whose meaning would have to be keyed to changing factual or legal circumstances to remain relevant as a right over time” ([90], p. 22). Thus, in the above case, the Court considered the treaty term, “comercio,” to be generic and the 1858 Costa Rica-Nicaragua treaty to have been intended to have a perpetual duration.106 On both grounds, it concluded that the parties intended “comercio” to evolve so as to include activities that were not viewed as “comercio” when the treaty was adopted. Instead of limiting the term to its original 1858 meaning of trade in goods, the Court adopted a broad interpretation covering trade in goods and services, including tourism.107

In Aegean Sea, the ICJ similarly ruled that the generic term, “territorial status,” used in an instrument intended to have a “continuing duration,”108 must be presumed to have been intended to “follow the evolution of the law.” The International Law Commission’s Conclusions on the Fragmentation of International Law clarifies that, based on Article 31(3)(c) of the Vienna Convention, this new meaning of a generic term shall be determined from the international law applicable in relations between the parties at the time of the treaty’s application ([63], pp. 15–17). In effect, generic terms are to be interpreted based on their international law meaning at the time of their application.109

Parties’ intention need not be explicit ([90], p. 20). As the ICJ stated in Dispute Regarding Navigational and Related Rights, it may be presumed.110 According to the Court, “there are situations in which the parties’ intent upon conclusion of the treaty was, or may be presumed to have been, to give the terms used—or some of them—a meaning or content capable of evolving, not one fixed once and for all.”111 In the above case, the ICJ noted that “generic terms” “[refer] to a class of [something].”112 They mean an indefinite category of referents that “share some particular trait(s)” ([58], pp. 177–178; [91], pp. 178, 194). It would be recalled that, in Aegean Sea, as well as Dispute Regarding Navigational and Related Rights, the terms, “territorial status” and “comercio,” were respectively considered as generic. In both cases, the referents were indefinite; the former, “a class of issues” and the latter, “a class of activity” ([58], p. 178).113 Since both terms had evolved, they were given an evolutionary interpretation based on the ICJ’s general rule. Generic terms may be viewed as vague in that the reference may remain the same, while its scope may vary with changing times: this makes it reasonable to infer that a text was intended to evolve with the changing scope of the reference, hence justifying evolutionary interpretation ([58], p. 181). Thus, in Dispute Regarding Navigational and Related Rights, the reference, “comercio,” was vague, and the ICJ resolved this vagueness by giving that term an evolutionary interpretation. That helped to align it with changes that had occurred in its scope ([58], p. 182).

Decisions of quasi-judicial bodies similarly reflect evolutionary treaty interpretation. In United States-Import Prohibition of Certain Shrimp and Shrimp Products,114 the Appellate Body of the World Trade Organization (WTO) ruled that “exhaustible resources’ used in exception XX(g) of the General Agreement on Tariffs and Trade (GATT) 1994, covered not only non-living resources, such as minerals, which are finite, but also living or biological resources, such as sea turtles, which are renewable.115 This is because, although reproducible and therefore renewable, living species could be depleted and endangered by human activities.

Instructively, the Appellate Body emphasized that, although the GATT language, “resources,” was used over 50 years ago and subsequently transplanted in an unmodified form into the WTO Agreements in 1994, that term was not static in reference, but “by definition evolutionary.”116 It, therefore, warranted evolutionary interpretation in line with international concerns for environmental protection and conservation, which had subsequently emerged since that time. The Appellate Body thus resolved the vagueness of the contested term, “exhaustible resources,” with the aid of evolutionary interpretation, which considered changes that had since occurred in its scope. In doing so, the Appellate Body tellingly drew upon other international instruments, particularly the CBD, which uses terms, such as “biological resources” and “marine living resources.”

In interpreting “exhaustible resources” to include living and non−living resources, the Appellate Body also referred to Namibia legal Consequences, as well as the United Nations Convention on the Law of the Sea (UNCLOS) 1992,117 the latter of which refers to both “living” and “non−living” resources. It observed that the UNCLOS provisions on fisheries largely reflected customary international law. Deploying Article 31(3)(c) of the Vienna Convention, the Appellate Body stressed that “our task here is to interpret the language of the chapeau [of Article XX of GATT], seeking interpretive guidance as appropriate, from the general principles of international law.”118

In its Conclusions on the Fragmentation of International Law, the International Law Commission similarly maintains that a treaty term may be presumed to have been intended to have an evolutionary meaning where it requires taking into account subsequent changes of technical, legal, or economic nature or where that term is of such a general character as to necessitate taking into consideration changing situations ([63], p. 16). It referred to the ICJ’s remark in Gabcikovo-NagymarosProject that the parties’ use of technical terms in the treaty at issue showed that they “recognized the potential necessity to adapt the Project.” Consequently, the treaty was not static.119 In United States-Import Prohibition of Certain Shrimp and Shrimp Products where the parties used the generic term, “exhaustible natural resources,” the Appellate Body followed the same approach when it stated that, “we note that the generic term ‘natural resources’ in Article XX(g) is not ‘static’ in its content or reference, but is rather ‘by definition evolutionary.’”120 Thus, where parties have used a scientific term or one expressed in such a general way, it may be concluded that they “did not intend to fix its meaning and thereby potentially ground their future obligations on outmoded or falsified scientific concepts, but intended the terms to connote obligations keyed to the evolving meaning of their terms” ([90], p. 21).

Altogether, the real essence of evolutionary interpretation is to ensure that a treaty effectively achieves its object and purpose, having regard to changes in its circumstances. Thus, in Iron Rhine Arbitration,121 even though the dispute between the parties did not concern generic terms, but technical problems over the rail route connecting them, the Permanent Court of Arbitration insisted that, “but here too, it seems that an evolutive interpretation which would ensure an application of the treaty that would be effective in terms of its object and purpose, will be preferred to a strict application of the intertemporal rule.”122 Reiterating the principle of effectiveness articulated in Iron Rhine Arbitration, the European Court of Human Rights similarly stressed the importance of interpreting the European Convention on Human Rights “in a manner which renders its rights practical and effective, not theoretical and illusory. A failure by the Court to maintain a dynamic and evolutive approach would risk rendering it a bar to reform and improvement.”123

From the foregoing analysis, the following conclusions can be drawn with regard to the CBD. “Genetic resources” and “functional units of heredity” are scientific terms. Also, they are generic in that they merely refer to an indefinite category of referents. Further, they are vague because, as argued earlier, despite the references remaining the same, there is potential for their scope to evolve with changing times. Based on ICJ’s jurisprudence, such terms must, by definition, be deemed evolutionary. Even if this contention fails to hold, those terms would still warrant evolutionary interpretation based on the ICJ’s general rule. Not only are they generic, but also, the relevant treaties in which they are used, the CBD and the Nagoya Protocol, have continuing durations. It is, therefore, reasonable to presume an intention by the parties thereto that both texts should evolve with those changing references, thus justifying evolutionary interpretation of both terms.

Digital sequence information was most likely not contemplated when the CBD was adopted in 1992. However, since that time, profound changes have occurred in the life sciences, stirred by rapid technological advances across diverse fields. As a result, genetic resources now regularly assume an informational form, including genome sequences stored in public online databases, rendering them far more ubiquitous and accessible to the global public ([51], p. 26). Consequently, in line with the jurisprudence already analyzed, the vague term, “genetic resources,” must be interpreted in an evolutionary manner to reflect developments that have occurred since 1992. Equally important, the Appellate Body’s ruling in United States-Import Prohibition of Certain Shrimp and Shrimp Products shows that the term, “resources,” applies not only to living, but also non-living things, such as minerals and, analogously, digital sequence information ([92], p. 106).124

Despite controversies over whether a treaty may have only one or several objects and purposes ([93], pp. 5–7), three objectives can be identified for the CBD. According to Article 1 thereof, these “are the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources.” These complementary goals may be read conjointly to mean that the CBD’s overall object and purpose is the establishment of a system of unimpeded access to genetic resources, while also ensuring their sustainable use, as well as fair and equitable flow of benefits to providers.

Preamble 12 of the CBD recognizes the dependence of indigenous and local communities on such benefits. This benefit-sharing component of the treaty’s object and purpose is the reward that provider states expect from the treaty to compensate them as custodians of biodiversity and support their conservation efforts ([10], p. 6). Failure to achieve it would jeopardize the durability of this system of access to and conservation of biodiversity. Erosion of benefit-sharing would discourage provider states from concluding ABS agreements, even for non-commercial research of potential value to biodiversity conservation, which is also connected to the achievement of the UN’s 2030 Agenda for Sustainable Development ([24], pp. 2, 4). Provider states may become concerned that their resources would eventually be sequenced and distributed for commercial use, without any benefits accruing to them ([8], p. 15). Since the 1990s, there has been an expanding list of genome sequencing projects providing sequence information on diverse genetic resources ([51], p. 33; [94], p. D475). By 2019, there were more than 1600 biological databases ([18], pp. 2, 17).125 Most of the standard sequences are lodged with the leading nucleotide sequence database, the INSDC, which comprises the DNA Data Bank of Japan, the European Bioinformatics Institute [EMBL-EBI], and the U.S. National Center for Biotechnology Information that hosts the GenBank ([18], pp. 2, 24). By April 2019, GenBank, which has over 5.8 million users across the world, had over 212 million sequence data entries, 76% of them from plants, animals, bacteria, fungi, and viruses of relevance to Article 15 of the CBD ([18], pp. 28–29, 31). The EMBL-EBI, itself, records over 38 million requests every week ([24], p. 6).

As a whole, the INSDC has users from every country in the world. Most of them are, however, from developed countries, although Brazil, India, and Singapore are also emerging ([18], p. 31).126 Along with its three partner institutes and many other databases that access sequence data from its databases, the INSDC maintains a policy of open, unrestricted access to every user across the world, who has Internet connectivity ([18], pp. 26–27). Without login or registration requirements, users, including firms and research institutes, access INSDC entries “hundreds of thousands of times a day” ([18], p. 25). Together with its open access and no use restriction policy, the INSDC does not require depositors to furnish ABS-related information, such as proof of prior informed consent and mutually agreed terms ([95], p. 5; [24], pp. 5, 6).127 Users can obtain sequence data without ABS obligations or any means of tracing their origin, absent accession numbers. Moreover, even though accession numbers may enable traceability, this is not always fail-safe, once data leaves INSDC databases ([8], p. 11; [18], pp. 3, 35). In any case, INSDC-generated accession numbers are essentially meant to foster scientific publication, rather than serve regulatory purposes.

The INSDC databases contain a metadata tag for “/country,” which permits depositors to report the country of origin of nucleotide sequence data, but, as Study 2/3 observes, this term does not perfectly correspond to “country of origin.” Even at that, reporting of country of origin of INSDC entries remains poor. Despite a gradual increase in reporting, in 2018, barely over 40% of nucleotide sequence data deposited indicated a country of origin, which suggests that potentially thousands to millions of sequences do not carry country of origin information ([18], pp. 4, 65). Further, in jurisdictions, such as India and South Africa, country of origin is required for patent applications, yet such information is not disclosed when nucleotide sequence data related to patents is deposited with the INSDC ([18], p. 5).

While it may be possible to trace sequence data to the underlying genetic resource and country of origin, this is only if a depositor reports it ([18], p. 4). Depositors may, by error or willful intent, omit or enter incorrect country of origin. There may, in fact, be cases of fraudulent reporting. A maleficent INSDC user could develop a lucrative product by using “an NSD entry from a CBD Party and, although aware of ABS obligations, country of origin and, conceivably even access permits, in the process of patenting, lie about the AN [accession number] associated with this piece of NSD or lie about the presence of ABS obligations” ([18], p. 56). Likewise, other information that could provide legal certainty for both providers and users, such as “date of sampling/primary access” and “date of sequencing/utilization” do not always accompany sequence data submissions ([18], pp. 46, 65).

Surely, open access to digital sequence information is supportable and consistent with CBD requirements, particularly with regard to biodiversity conservation ([96], pp. 3–4; [97], p. 1). Open access obviates the need for physical access to genetic material and facilitates reproducibility, validation, and improvements on results, as well as research collaboration in a field like taxonomy that demands collectivism ([3], p. 26; [24], p. 6). Equally important, however, are the conditions for such access. Allowing access to information on the biodiversity of provider states, without benefit-sharing obligations, is difficult to justify. After all, as some have argued, genome sequencing projects may eventually charge rents, whether described as maintenance costs or otherwise, for access to their databases by parties ([95], p. 5)128 who also could use accessed sequences to develop profitable inventions and patent them ([24], p. 17).

It is reported, for example, that strain C15 of the Ebola virus, isolated from a sample obtained from Guinea, in West Africa, was sequenced and deposited in GenBank by European researchers. From there, it was accessed by U.S. firm, Regeneron Pharmaceuticals, which used it to develop an anti-Ebola drug that it patented in Nigeria and South Africa, two of the largest markets on the African continent ([86, p. 17; 105, pp. 1–3]. The costs of such products are usually unaffordable in many states that are ironically the providers of the underlying genetic resources. During the Indonesian bird flu (H5N1) crisis, for example, Indonesian strain of the virus shared by the country with WHO’s Global Influenza Surveillance Network, was accessed and used by foreign pharmaceutical firms to develop vaccines. Those vaccines were patented and sold at prices beyond the reach of afflicted Indonesians, leaving scores of them dead ([98, 99]).

States like Japan and Costa Rica view open access to digital sequence information derived from physical genetic resources as a non-monetary form of benefit-sharing; they support the deposit of sequence data in openly accessible databases to promote scientific development ([11], p. 27). This arrangement is, however, more likely to benefit states that have the necessary technological, human, and organizational capacities to exploit accessed data ([24], p. 6; [83], p. 10). The mostly developed user states are far better equipped in these areas than many provider states in the developing world. For example, most file transfer protocol downloads from the INSDC are by developed states, ostensibly because they have the facilities required for such purposes ([18], p. 32).129

Additionally, the INSDC partner institution, GenBank, allows depositors to claim intellectual property rights, including patents, in all or aspects of deposited data ([18], p. 27), potentially placing restriction on use. Also, data deposited with the INSDC may be accessed by private databases and combined with their in-house generated data for research and development. Yet, access to private databases is generally restricted [18], p. 36). Mindful of those factors, states, such as Brazil and South Africa, insist that “there is no national benefit from such international work and it is very difficult to trace the benefits that are being generated without an internationally agreed standard” ([11], p. 27). They argue that, even if open access to digital sequence information were to benefit society, there should also be concrete monetary benefits. Otherwise, provider states may be discouraged from cooperating with non-commercial research projects or compelled to tighten access conditions. In that case, the goal of orderly access and biodiversity conservation critical to sustain present and future generations would be undermined.130 Scientists would be unable or reluctant to engage in otherwise beneficial research, thus stifling scientific progress ([8], pp. 17–18). During its thirteenth meeting in December 2016, COP similarly acknowledged that digital sequence information on genetic resources is a cross-cutting issue, which is relevant to the three objectives of the CBD [12], in addition to the 2030 Agenda for Sustainable Development.

It is worth recalling that, in establishing the international ABS regime, CBD parties sought to ensure fair and equitable sharing of benefits from the utilization of genetic resources so as to promote access to sustainable use and conservation of biodiversity. To effectively pursue these goals and fully achieve the CBD’s object and purpose, “genetic resources” and “functional units of heredity” should be construed in such a dynamic manner as would include digital sequence information ([100], p. 3), regardless of intangibility, and whether full-coding or not. Current synthetic biology research typically replicates and tinkers with natural sequences and processes, aided by CRISPR-Cas 9 and other tools, to produce useful biological functions ([8], p. 9).

It is untenable that the genetic composition of a genetic resource utilized in such a way, even if transformed through biotechnology, should be excluded from the ABS regime, simply because it was accessed digitally or is non-coding. To give “genetic resources” its original, restrictive meaning would rob the ABS regime of the potential value of genetic material utilized in synthetic biology or other future biotechnologies ([7], p. 22). As Schei and Tvedt conclude, and in conformity with the jurisprudence earlier examined, “since potential value and the level of knowledge regarding functionality in biology change, the wording of the legally binding definition suggests being dynamic in the sense that it captures the evolving knowledge and technological state of the art” ([68], p. 10). This approach is needed to ensure that provider states benefit fairly and equitably from the use of digital sequence information derived from their regular genetic resources ([101], p. 9).