Quo vadis Nagoya Protocol? Access-and-benefit sharing of genetic resources of biodiversity in times of digitalization

For decades, Indigenous representatives have fought for acknowledgement of their people’s knowledge of genetic resources—that is, genetic material steaming from plants, animal, microbials, or other origins—and demanded fair compensation for the benefits that may arise from their commercial utilization. The first United Nations Convention on Biological Diversity (1992) and the ensuing Nagoya Protocol (2010) have been hailed as victories that have established an access-and-benefit sharing mechanism (ABS). As a bilateral system, ABS is the core mechanism of the Nagoya Protocol between the so-called users (researchers and corporations, for instance) and providers (local peasants and Indigenous peoples) of genetic resources, based on prior informed consent between both parties. (For a detailed explanation of ABS and the Nagoya Protocol, its achievements, and criticisms see our first blog post.)

Nevertheless, these accomplishments in international law are being questioned nowadays due to digitalization: biotechnological innovations foster the digital and dematerialized availability of sequence information on genetic resources, a process that is called digital sequence information (DSI). Even though the term has been declared “inappropriate” (Ad Hoc Group on DSI, 2018), it is maintained due to the lack of alternative concepts. The digital access to sequence data by DSI has put two core ideas and, with them, the original intention of the Nagoya Protocol at stake. The first concerns the characteristic of a genetic resource as a material entity. The second concerns the bilateral ABS mechanism itself, which is based on that materiality. As we show in this post, DSI appears to be a real game changer for the global governance of biodiversity protection and could render current ABS mechanisms obsolete.

The materiality and bilaterality as established principles in access-and-benefit sharing

There are two basic principles in the implementation of the Nagoya Protocol that have structured the way of thinking about genetic resources for decades. The first is that genetic resources are somehow material entities, or at least dependent on a material carrier: a plant, a fungus, a frog (materiality). The second basic principle is that of bilateral agreements that permits traceability of the genetic resource, the identification of holders of traditional knowledge, and finally the compensation towards the providers of genetic resources (bilaterality). Materiality and bilaterality compose a logical link and have been developed as two interconnected principles of biodiversity governance. They reflect the aspirations, plans and technical realities of the early days of the global environmental governance prevalent in the early 1990s.

Let us delve a little bit more in detail into this materiality-bilaterality nexus. First, the materiality of genetic resources. For the Convention on Biological Diversity (CBD)-era negotiators, genetic resources meant a material being: a plant, a fungus, a frog. The CBD defines, for instance, both genetic resources and genetic material as “genetic material of actual or potential value” and “any material plant, animal, microbial or other origin containing functional units of heredity.” The materiality of the genetic resources drew on the factual perception that research and development on biotechnology was to be conducted specifically with samples, seeds, bacterial cultures, etc., and this physicality is reflected in general terms in the Nagoya Protocol guidelines.

The materiality of genetic resources could be then ascribed into fixed relationships between users and providers of genetic resources, fostering the traceability of the resources. The bilateral system was then introduced in which countries, companies, and researchers—users of genetic resources—are required to achieve prior informed consent and mutually agreed terms of use. Potential benefits must then be shared with providers.

What is biodiversity? From a colorful frog to a data sequence

The bilateral architecture was designed for the age of material genetic resources and corresponded to outdated views on biotechnological research that were prevalent until the early 2000s. Back then, the view on genetic resources as a sort of rivalrous resource (a subtractable thing that is diminished through its use) bore some resemblance to the biological world and, perhaps, to the experience of most people on Earth. Of course, the Convention on Biological Diversity and Nagoya Protocol’s options for the materiality of genetic resources involved many interests and strategies (for an overview of non-state actors’ influence on the Convention on Biological Diversity and Nagoya Protocol, see Orsini 2013), but it also reflected a worldview dominated by material biological resources. In Ruíz-Müller’s words, “ABS was never intended to be about access to biological materials but, rather, about the application of modern biotechnology” (Ruíz-Müller 2018: 8).

Departing from this insight, one should argue that Indigenous peoples’ and peasants’ views found some refraction in the early negotiations—especially through the joint interests of southern nations like Brazil in exerting a firm grip on their own natural resources. To be more accurate, Irma Klünker’s (2023) view that genetic resources have been conceived between the immaterial (as information, that is, non-rival and thereby closer to the perspectives of intellectual property rights) and the material (the carrier of information, which in the case of genetic resources seems relatively close to the protection of new plant varieties) seems quite pertinent. This ambiguity is not a novel thing, though; the Brazilian Constitution (1988, Art. 225, II) defined its sovereign claim to genetic diversity through the concept of genetic heritage, which addresses both the material carrier and non-material genetic information.

With the onset of the digital age and technological capabilities that enabled widespread sequencing (and, therefore, sharing) of genetic structures such as DNA, the material dimension of genetic resources currently corresponds neither to research and development nor to scientific investigation. It has become clear—not only to Global North countries, corporations and scientists—that nature is not exclusively about colorful frogs and exquisite plants, but is also accessible through digital files that portray genetic structures and other useful components for the biotechnological sector such as DNA sequences of Stevia in order to develop a chemical replication of the herbal sweetener.

In a nutshell: for nature to be scientifically and commercially appropriated, it is currently irrelevant whether nature is physical or non-material. One point of access (it is still access!) suffices to get an element of biodiversity, to sequence it, and get it uploaded to some relevant database like the International Nucleotide Sequence Database Collaboration (INSDC), to enable the provision and use of genetic information. Once converted into a digitalized file bearing the non-rivalrous qualities typical of immaterial goods and, thereby, sharing the inherent challenges of non-excludability, genetic resources become digital sequence information. Then comes the big trouble: the digitalization of genetic information, its dematerialization and non-rivalrous features endangers the whole structure of the access-and-benefit sharing global system based on the material-bilateral nexus. As the regulated access through providers becomes obsolete, no prior-informed consent, no acknowledgement of particular traditional indigenous knowledge (e.g. about the sweetness of Stevia, the ways to cultivate the plant and its medical effects) are acknowledged anymore, and no benefit-sharing is likely to happen. The pure fact that digital information alone is necessary to develop research and development therefore bears the risk of weakening the providers, many of them Indigenous and traditional communities in the Global South whose knowledge is less likely to be acknowledged.  

Digital sequence information as the new normal—ending or modifying benefit sharing?

What is DSI? Digital sequence information is a placeholder that entails DNA, protein sequences, or molecular data that might be accessed virtually and used for scientific ends, research, and development, and ultimately for the commercialization of products developed on the basis of this information. DSI enables access to genetic resources detached from the material sample, seed, tissue, etc. Just to give the reader an example, by using DSI instead of a material sample, users of genetic resources who until December 2022 circumvented the Nagoya Protocol—Indigenous peoples and local communities as well as national governments (in the role of providers)—faced the risk of having their rights to ABS not recognized and, thereby, not receiving benefits of their traditional knowledge associated with genetic resources, or sovereignty. In December 2022, the COP in Montreal agreed on the decision 15/9 which changed that fact. The utilization of DSI is, for now, subject to benefit sharing. However, point 4 of the decision states “that the distribution of digital sequence information on genetic resources and distinctive practices in its use require a distinctive solution for benefit-sharing.” Access-and-benefit sharing (ABS) for DSI was endangered up to 2022, and now a multilateral system will either replace the ABS in the Nagoya Protocol or coexist with it (as a hybrid solution, which is less likely).

Even though DSI since the 09/15 decision is supposed to be regulated with ABS, the challenge of the DSI is still of huge concern for Indigenous peoples. They argue that any DSI may hide traditional knowledge that may never be traced back due to the immateriality and digital availability of the sequence information. Additionally, under the proposed change towards a multilateral system in which access to genetic resources might be decoupled from benefit sharing (see details in Scholz et al 2022), Indigenous peoples and local communities might lose their recognition as well as the promised material benefits. Their fear that traditional knowledge may be concealed behind a never-ending exchange of DSI and that the bearers of such knowledge may be never found (the argument for traceability) is understandable. A positive feature of all those discussions lies in the acknowledgement of Fair and Care principles for Indigenous data sovereignty in the 9/15 decision. Initiatives like the Biocultural Labels (“BC Labels”) presented in December 2022 by Indigenous representatives also reflect Indigenous digital sovereignty concerning traditional knowledge associated with DSI. The labels permit Indigenous peoples and local communities to ascribe provenance, origin and even ownership claims over data that is stored in digital repositories.

In addition, some experts argue that DSI may frustrate the core objectives of the Convention on Biological Diversity and of the Nagoya Protocol whose goals were to harmonize conservation, sustainable use, and benefit sharing, instances that reflect a more material and localized view of nature. By using DSI, scientists and corporations no longer necessarily interact with the world out there—with frogs, plants or people living within natural surroundings, but can just rely on data. DSI—so the argument goes—is doomed to colonize environmental policy, being itself a subject of scientific policy that is replacing the proper environmental issues at stake. As we can tell from these arguments, DSI is a serious issue.

DSI was first mentioned at the Conference to the Parties to the Biodiversity Convention (COP-13) (2016). Until now, the 9/15 decision made in Montreal at the COP-15 remains the cornerstone of DSI governance in the realm of biodiversity under national jurisdiction. The first open-ended working group meeting on DSI took place in Geneva in November 2023 in order to frame the negotiations for the coming COP-16 that will take place in Columbia in late 2024. Unresolved pressing issues regarding DSI and its relationship to the Nagoya Protocol are the following: a) the need for an official designation of DSI, inasmuch as the term designates a placeholder; b) whether there will be (or not) a hybrid solution (both bilateral-material and multilateral-immaterial access-and-benefit-sharing systems working simultaneously); c) whether the envisioned benefit-sharing mechanism for DSI will be of a voluntary or mandatory nature, inasmuch as delegates from northern countries are proposing a specific agreement for DSI in the latter case, given the wide scope of the agreement developed at the COP-15 and the consequences for basic and applied research; d) last but not least, the triggers and indicators for DSI benefit-sharing, the disputed question of geographic information on DSI, and whether Indigenous groups and local communities would have the option of accessing resources from the multilateral fund. These items are, of course, not exhaustive.

The turn towards the immaterial/informational nature of genetic resources has been caused by massive technological changes. In the realm of policy, DSI also marks a transformation of research practices in biotechnology and the life sciences. Value is no longer expected to be won by accessing a determined plant, traditional knowledge, and establishing a single ABS agreement with Indigenous populations. The value in biotechnology is more prone to be generated out of the association of several DSIs, irrespective of the bearer of information. That is the main issue discussed today regarding the future of access and benefit sharing. However, DSI is only one chapter of ongoing technological changes, as the prospects of artificial intelligence for biotechnology are immense and might render DSI obsolete very soon. DSI is still indirectly linked to access to a material biological being and traditional knowledge; artificial intelligence does not need direct or indirect access, since multiple streams of biological data may replace the need for DSI in significant ways (Halewood et al 2023). Time will show how experts and negotiators within the material-nature governance structures of the Convention on Biological Diversity and Nagoya Protocol will develop against this background.