Abstract
For decades, there has been a concerted push for legal mechanisms to encourage, if not compel, those who access and use genetic resources (GRs) to recognize that countries (along with Indigenous people and local communities) from which these GRs originate have certain rights in those resources. This recognition of rights would entail things like prior informed consent (PIC) for accessing and using the resource and a sharing of benefits derived from the use of the resource. The push has come primarily from developing countries and indigenous communities that have characterized the use of their resources by developed countries and corporations as exploitative, at times amounting to “biopiracy.” Pharmaceutical and biotechnology companies have pushed back, at least against some of the more aggressive and coercive proposals, arguing that they are unduly burdensome and will impede research and innovation, ultimately to the detriment of biodiversity and public health. Developed countries, particularly the United States, have echoed these concerns.
In recent years, proponents of this recognition of rights in GRs have made significant progress. Notably, the Convention on Biological Diversity (CBD), as updated by the Nagoya Protocol and more recently the post-2020 Global Biodiversity Framework, impose requirements of PIC and access–benefit sharing (ABS) on countries that are party to the CBD. Other international treaties, including the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA, i.e., the “Plant Treaty”) and 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 Agreement), incorporate their own ABS requirements for GRs. The Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (GRATK), adopted by WIPO Member States in 2024, requires signatories to mandate that patent applicants disclose the origin/source of a GR, or associated traditional knowledge (TK) provided by Indigenous Peoples or local communities, in certain circumstances. In addition, a number of countries have already incorporated ABS and disclosure requirements applicable to the patenting or commercialization of products incorporating GRs into their laws.
An important question to be addressed is the extent to which these requirements of PIC, ABS, and disclosure apply to digital sequence information (DSI), e.g., DNA sequence information available on publicly accessible digital databases. As initially conceived, the GRs subject to these requirements were physical, tangible materials. But as biotechnology has evolved, research and commercial development have increasingly employed DSI rather than physical materials, which has raised the question as to the extent to which these requirements are applicable in the digital context, if at all. In most cases, the treaties themselves do not explicitly address the question—this applies, for example, to the CBD, the Plant Treaty, and the GRATK—but developing countries argue that DSI should be treated no differently than physical materials, particularly given that the DSI originated in physical materials derived from a source country. Indeed, some countries have already started treating DSI as a form of GR, subject to the same requirements as the use and access of physical embodiments of genetic material. Biopharmaceutical companies and developed countries, in contrast, have generally pushed back that DSI is not encompassed by the same regulations that apply to physical materials, arguing that imposing requirements of PIC, ABS, and patent disclosure on DSI could create a substantial impediment to research and product development. In particular, they could cripple the ability of science to respond to another pandemic or other public health emergency.
This Holman Report looks at this issue. It begins with some background on treaties. Then looks at DSIs and how the treaties are being applied to DSIs. It ends with a brief discussion of the implications for biotechnology research and product development.
I. CONVENTION ON BIOLOGICAL DIVERSITY AND NAGOYA PROTOCOL
In November 1988, in response to a growing recognition that biological diversity is a global asset of tremendous value to present and future generations, the United Nations Environment Programme (UNEP) convened the Ad Hoc Working Group of Experts on Biological Diversity to explore the need for an international CBD. Soon after, in May 1989, it established the Ad Hoc Working Group of Technical and Legal Experts to prepare an international legal instrument for the conservation and sustainable use of biological diversity. The experts were to take into account, inter alia, “the need to share costs and benefits between developed and developing countries” as well as “ways and means to support innovation by local people.”
The group’s work culminated in 1992 with the Nairobi Conference for the Adoption of the Agreed Text of the Convention on Biological Diversity, i.e., the CBD. The CBD was opened for signature on June 5, 1992, at the United Nations Conference on Environment and Development (the Rio “Earth Summit”). It remained open for signature until June 4, 1993, by which time it had received 168 signatures. The Convention, which currently has 196 members, entered into force on December 29, 1993. 1 The Conference of the Parties (“COP”) is the governing body of the CBD and makes decisions at periodic meetings to advance implementation of the Convention.
Although President Bill Clinton signed the CBD in 1993 on behalf of the United States, the U.S. Senate has never ratified the Convention, in large part due to concerns about the potential impact on intellectual property rights (“IP”) and constraints on the U.S. biotech and agricultural industries. Despite not being a party, the United States generally supports the goals of the CBD and participates as an observer in its processes. 2
The CBD has three primary stated objectives: (1) the conservation of biological diversity, (2) the sustainable use of the components of biological diversity, and (3) the fair and equitable sharing of benefits arising from the use of GRs. 3 The CBD defines “GRs” as “genetic material of actual or potential value” and “genetic material” as “any material of plant, animal, microbial, or other origin containing functional units of heredity.” 4 Although human GRs are not explicitly excluded from the definition of “genetic resources,” it has been clearly established that the CBD does not apply to human GRs. 5
Article 3 of the CBD provides that “States have the sovereign right to exploit their own resources pursuant to their own environmental policies.” Thus, countries own the GRs found within their borders and can determine access conditions. Article 12 states that the Convention’s objectives include the promotion and encouragement of research that contributes to the conservation and sustainable use of biological diversity, particularly in developing countries.
Article 15 directly addresses access to GRs and provides that access is subject to national legislation and based on the user receiving PIC from the provider country. Access to the GR and benefit sharing (ABS) are to be on “mutually agreed terms” (MAT) between the user and the country providing those resources. Article 15 emphasizes facilitated access for environmentally sound uses and promotes cooperation in scientific research. Article 15(7), in particular, provides:
Each Contracting Party shall take legislative, administrative or policy measures… with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources…
The CBD thus laid the foundation for what has come to be referred to as the ABS framework.
The Nagoya Protocol, a supplementary agreement to the CBD, was adopted in 2010 and entered into force in 2014. 6 The Nagoya Protocol seeks to provide greater legal clarity and transparency for access to GRs and traditional knowledge associated with GRs and for the sharing of benefits. In particular, the agreement expands and operationalizes the CBD’s third objective, i.e., “the fair and equitable sharing of benefits arising from the use of genetic resources.” To that end, the Nagoya Protocol established transactional procedures, compliance mechanisms, and checkpoints that are intended to monitor and ensure benefit-sharing (BS).
While the CBD encouraged parties to adopt ABS laws, such laws were not mandated by the treaty. The Nagoya Protocol, in contrast, made ABS operational, requiring parties to establish clear national rules on how PIC is granted, how MATs are negotiated, and who owns or controls GRs. It turned the CBD’s general principles into enforceable procedures.
More particularly, Articles 5 and 6 of the Protocol require countries to take legislative, administrative, or policy measures to ensure that benefits arising from the utilization of GRs are shared fairly and equitably, on MATs with the country of origin and/or indigenous or local communities. Access must be based on PIC from the provider country and compliance with domestic access legislation or regulatory requirements.
Countries that are parties to the CDB and Nagoya Protocol are expected to implement national legislation for access, use, and compliance monitoring. Articles 15 through 18 set forth the scope of these compliance obligations. For example, countries must ensure users of GRs comply with PIC and MAT of the provider country. Checkpoints (e.g., patent offices, research funders) must monitor use of GRs. Documentation, such as Internationally Recognized Certificates of Compliance (IRCCs), may be required. Article 8 calls for simplified access for non-commercial research and for emergency response (e.g., pandemics) and also requires parties to the CBD to consider the importance of GRs for agriculture and their special role in food security.
The Nagoya Protocol defines “utilization of genetic resources” as “[t]o conduct research and development on the genetic and/or biochemical composition of GRs, including through the application of biotechnology.” 7 Significantly, the definition does not exclude non-commercial research. Article 2 of the CBD defines “biotechnology” as any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. The Protocol expands coverage to “derivatives” of GRs (like proteins or metabolites), which were not clearly included under the CBD.
The Protocol calls for support for developing countries in building ABS infrastructure, cooperation in research, technology transfer, and capacity building, and a Global Multilateral Benefit-Sharing Mechanism for cases where GRs cannot be traced to a single provider (e.g., transboundary or pooled resources). Article 10 provides:
Parties shall consider the need for and modalities of a global multilateral BS mechanism to address the fair and equitable sharing of benefits derived from the utilization of GRs and traditional knowledge associated with GRs that occur in transboundary situations or for which it is not possible to grant or obtain PIC. The benefits shared by users of GRs and traditional knowledge associated with GRs through this mechanism shall be used to support the conservation of biological diversity and the sustainable use of its components globally.
Countries that are parties to both the CBD and Nagoya Protocol are expected to implement national legislation for access, use, and compliance monitoring. The European Union (EU) ABS Regulation (Regulation EU No. 511/2014), applied uniformly across Member States, enforces user-side due diligence, ABS compliance, and institutional monitoring of GR use, in line with the Nagoya Protocol. Note that even though the United States is not a party to the CBD, U.S.-based researchers and companies must still comply with the ABS laws of countries that have implemented the Nagoya Protocol if they access GRs from those countries. In practice, this means setting up contractual arrangements before material is collected from the field, to guarantee that a fair portion of any resulting profits or other benefits, such as scientific research, is shared with the country or community providing the access. 8 While well-intentioned, this system has proven to be inefficient and often incurs high transaction costs to obtain the necessary permits. 9 The United States has advocated for voluntary and flexible BS models and strong IP protections, often diverging from more restrictive approaches favored under the CBD framework.
II. DSI
In the context of the Nagoya Protocol to the CBD, “digital sequence information (DSI) on genetic resources” is an intentionally non-defined policy term used by the CBD COP to address whether, and to what extent, BS obligations associated with access to GRs should extend to digitized genetic sequence data derived from those resources. 10 In practice, the proposed scope of the term has ranged from a narrow conception limited to nucleotide sequence data (DNA, and in some discussions RNA), to broader formulations encompassing amino acid (protein) sequences and, in the most expansive interpretations, annotations, metadata, and other digital information functionally linked to GRs. 11 Despite repeated consideration under the Protocol’s ABS framework, no single, legally operative definition of DSI has been adopted, and parties have instead advanced BS arrangements while expressly acknowledging unresolved questions of scope.
Although neither the CBD nor the Nagoya Protocol explicitly mention DSI, for the last decade developing countries have been arguing for the inclusion of DSI within the scope of ABS obligations. DSI is typically held in online open-access databases, where use is disconnected from physical access, as well as the permits generally required for access to physical GRs. Biodiverse nations, many of which are low- and middle-income countries (LMICs), believe their sovereign rights have been undermined because any potential monetary gains from DSI through commercialization are not shared with them, as would be required in the case of the use of physical GRs. DSI is perceived as a loophole that inhibits fair and equitable BS. Moreover, the political pressure to close this loophole is high. On the other hand, the EU and its Member States, along with other developed parties to the CBD like Australia, Japan, and South Korea, have taken the position that DSI is not equivalent to physical GRs, and thus PIC should not be required for access to digital data (especially from open-access databases). 12
A number of commenters have identified significant problems with any attempt to impose the bilateral ABS framework that is currently being applied to physical GRs, i.e., individual agreements between providers and users, in a digital context. For example, it has been pointed out that the core infrastructure for storing sequence data, the International Nucleotide Sequence Database Collaboration (INSDC), contained 228 million annotated sequences at the time that the 2020 report was prepared. 13 The dataset is downloaded partially or completely 34 million times per year, used by more than 10–15 million unique users, and 99.5% of the 750 downstream sequence databases that pull and push DSI through the scientific ecosystem directly rely on the INSDC system. 14 The data are linked to a further 1200 databases and hundreds of thousands of publications that, on average, cite 44 sequences per publication. Clearly, a bilateral system, modelled on the principles of the Nagoya Protocol, that required permission between the end user and the country of origin for every sequence and user transaction, would be prohibitively complex, affect data interoperability, and be ill-suited for generating knowledge.
The DSI statistics above make clear that a human-based system would not work. Technological approaches to track and trace DSI usage would be expensive, complex, and could have a significant environmental footprint. Most importantly, a loss of open access would adversely impact the analytical capacities, data infrastructures, and academic systems in LMICs that rely on these open data infrastructures and make collaboration with researchers based in countries that enforce DSI use restrictions very unattractive.
A bilateral DSI system would also inadvertently create a competitive marketplace that would perversely incentivize the use of DSI from countries where no restrictions exist (e.g., United States, Germany), leading to DSI “forum shopping.” Ironically, DSI from LMICs that are needed most for global monitoring and protection of biodiversity would often be avoided, which, in turn, would severely impede progress on the Global Biodiversity Framework (which is discussed below). 15
In view of the problems attendant to a bilateral approach to DSI ABS, life science researchers and policy writers have called for a multilateral framework for ABS. In March 2020, Laird et al. made a compelling case for multilateralism, calling on the scientific community to work together to develop policy options. 16 Members of the DSI Scientific Network, a group of scientists from different countries and economic settings, proposed a multilateral framework for DSI that will support biodiversity monitoring and conservation, maintain open access, improve the scientific record, share both non-monetary and monetary benefits, and enable green growth. 17 They emphasize that any future BS system must guarantee open data access, a necessary prerequisite to the use of DSI and the creation of any tangible benefits. Only open access enables efficient and broad-scale knowledge-generation and capacity building. The existing core DSI infrastructures already fulfills these requirements. They propose a multilateral DSI BS framework where access to DSI is “decoupled” from BS, and BS is accomplished by mechanisms that do not limit access to DSI. This is a fundamental shift away from traditional control-oriented ABS to a new idea of OA (open access) and BS. The authors of that article argue that this is necessary in order to protect the many benefits of openness and recognize that BS can be accomplished without dramatically altering real-world access. The proposal that new monetary mechanisms can be put into place upstream of DSI generation (e.g., a micro-levy on DSI-generation reagents and disposables), downstream of DSI use (e.g., a user fee on bio-based products), and/or outside the DSI life cycle (e.g., payment from high-income nation international development funds).
III. CBD/NAGOYA AND DSI
Recently, i.e., post-Nagoya Protocol, the CBD COP has begun to explicitly address DSI. In particular, the Kunming-Montreal Global Biodiversity Framework (GBF), adopted in 2020 during the fifteenth meeting of the COP (COP-15), following a four-year consultation and negotiation process, acknowledges that DSI is integral to achieving the objectives of the Convention. This historic Framework, which supports the achievement of the Sustainable Development Goals and builds on the CBD’s previous Strategic Plans, sets out an ambitious pathway to reach the global vision of a world living in harmony with nature by 2050. Among the Framework’s key elements are four goals for 2050 and 23 targets for 2030. 18
The GBF highlights that DSI supports research, innovation, and sustainable use, thereby contributing to biodiversity conservation and sustainable development. The Framework sets out key criteria for any future policy on DSI BS. These include: (1) the policy must be efficient, feasible, practical, and effective; (2) it should generate monetary and non-monetary benefits that outweigh the costs; (3) it must provide legal clarity for both providers and users; it should not hinder research or innovation, and must be consistent with open access to data; (4) it must to be compatible with existing international obligations (e.g., Nagoya Protocol) and support other ABS instruments; and (5) it must respect the rights of Indigenous Peoples and local communities (IPLCs).
The GBF emphasizes that a purely bilateral approach is unlikely to meet these criteria. Instead, it favors a multilateral BS mechanism for DSI as more efficient and effective. The framework encourages global sequence databases (e.g., INSDC) to tag sequence records with geographical origin metadata and to promote greater deposits of DSI with proper traceability information. Recognizing global disparities, the Framework calls for targeted capacity building, technology transfer, and technical-scientific cooperation. It especially supports developing countries, IPLCs, and less-resourced parties to generate, access, and utilize DSI effectively. The GBF mandates a clear, inclusive process (involving stakeholders and rights-holders) to analyze policy options against the established criteria. The plan is to eventually develop an adaptable, global multilateral BS mechanism for DSI, with regular review and improvement.
In 2021, the CBD Secretariat published a document outlining potential monetary BS options to be considered for DSI. 19 These options range from a bilateral system similar to the CBD and its Nagoya Protocol, with access tightly coupled to BS, to multilateral mechanisms in which access is facilitated through standardized global rules for BS.
In February 2025, at its sixteenth meeting (COP 16, held in Cali, Colombia), the COP took significant steps toward addressing the DSI issue by adopting “Decision 16/2 on digital sequence information on genetic resources.” 20 With Decision 16/2, the COP adopted modalities for operationalizing a multilateral mechanism for the fair and equitable sharing of benefits from the use of DSI on GRs, including a global fund, as set out in the annex to the decision. 21 The COP decided that the global fund will be known as the Cali Fund for the Fair and Equitable Sharing of Benefits from the Use of Digital Sequence Information on Genetic Resources (the “Cali Fund”). This is a global financial mechanism designed to collect contributions from private sector users of DSI (e.g., biotech, pharmaceuticals). It is intended to ensure that benefits flow to biodiversity-rich countries, IPLCs, and support CBD’s three core objectives: conservation, sustainable use, and equitable benefits.
The Cali Fund is administered by the UN Multi-Partner Trust Fund Office (MPTFO) with strategic support from UNDP, UNEP, and the CBD Secretariat. A Steering Committee and Ad Hoc Technical Expert Group oversee governance, fund allocation, and the development of equitable methodologies. Companies in sectors like pharmaceuticals, agricultural and industrial biotechnology, cosmetics, food production, artificial intelligence, and lab equipment that benefit from DSI are invited to contribute. Entities like public research institutions and purely academic users are exempt. Contribution guidelines suggest that companies meeting at least two of the following thresholds contribute either 1% of profits or 0.1% of revenue: (1) total assets of ≥USD 20 million, (2) sales of ≥USD 50 million, and (3) profit of ≥USD 5 million (averaged over 3 years). COP 17, scheduled for October 2026 in Yerevan, Armenia, will further refine these rates and thresholds. Contributors will receive a certificate acknowledging compliance and exempting them from additional monetary sharing for that year. The funds are to be used to support the following functions:
Implementation of National Biodiversity Strategies and Action Plans (NBSAPs) in developing and transition economies. Capacity building for research and sustainable management of DSI. Promoting biodiversity conservation, sustainable use, and research on DSI storage, access, and usage. Supporting IPLCs directly to strengthen their role as biodiversity custodians.
The mechanisms underpinning the Cali Fund are to be guided by:
Inclusivity, equity, and transparency. Complementarity with existing ABS instruments like the Nagoya Protocol and the Plant Treaty. Emphasis on both monetary and non-monetary BS, including knowledge exchange and capacity support. Embedding in broader aid frameworks like NBSAPs and existing biodiversity finance mechanisms.
The Cali Fund invites industry participation while directing tangible benefits to biodiversity hosts and IPA communities. Although currently voluntary, countries are encouraged to integrate contributions into national legislation—potentially making participation more systemic and impactful.
COP17 will adopt a detailed funding allocation formula, as mandated by the Cali Fund modalities. A technical expert group (Allocation Methodology) has been assembled to propose these criteria. Parties are requested to designate or establish national entities—such as biodiversity funds—to receive and distribute Cali Fund resources at the local level using country- or community-driven processes. At least 50% of the Cali Fund’s resources must be allocated to the self-identified needs of IPLCs, including women and youth.
COP17 may also set aside additional proportions for capacity-building support, particularly for least developed countries, small island developing states, and economies in transition. Parties are encouraged (via national policy or legislation) to incentivize contributions, establish transparency measures, and support the Fund’s operation at both global and national levels. The Steering Committee, already being constituted, will begin operational functioning. COP17 will likely reinforce its mandate and oversight functions. A review of the Fund’s effectiveness, to be conducted at COP18 (2028), must include key indicators drawn from the adopted methodology.
The COP also decided to explore possible additional modalities of the multilateral mechanism, including, in the context of paragraph 7 of decision 15/9 and the annex to decision 16/2, to take products and services into account. The COP further decided to explore possible new tools and models, such as databases, for making DSI on GRs publicly available and accessible in a transparent and accountable manner to all Parties.
The COP invited Parties, other Governments, indigenous people and local communities, and relevant organizations to submit views on possible additional modalities as well as new tools and models (including databases). It also requested that the Executive Secretary, subject to the availability of resources:
Synthesize the views submitted; Commission a study to examine options for making DSI on GRs publicly available and accessible in a transparent and accountable manner; Submit the synthesis of views and the study to the Subsidiary Body on Implementation for consideration at its sixth meeting; Prepare a study on national and international standards for the identification of the small, medium and large entities referred to in paragraph 3 of the annex to decision 16/2; and Commission a study on contribution rates, including implications for revenue generation and economic competitiveness.
The COP requested the Subsidiary Body on Implementation to consider the synthesis of views and the study mentioned in subparagraphs 6 (a) and (b) of the decision and to make recommendations to the COP at its seventeenth meeting on:
Possible additional modalities for the fair and equitable sharing of benefits from the use of DSI on GRs; and Possible tools and platforms, such as databases, for making DSI on GRs available and accessible in a transparent and accountable manner.
The effectiveness of the multilateral mechanism, including the global fund, will be reviewed by the COP at its eighteenth meeting and at every second subsequent meeting against the principles established in decision 15/9, taking into consideration the factors set out in enclosure VI and a methodology to be adopted by the COP at its seventeenth meeting, noting also the relevance of the global reviews of collective progress in the implementation of the GBF due to be conducted for the seventeenth and nineteenth meetings of the COP further to decision 15/6.
Although contributions are voluntary, making them early can mitigate future regulatory risks, particularly if nations move toward mandatory implementation. So far, there has not been a rush to contribute to the fund. 22 On November 19, 9 months after the fund officially launched, UK start-up TierraViva AI put forward the first contribution. The company expressed an intent that its nominal $1,000 payment to the fund would serve as an “ice-breaker” and encourage others “who may be hesitating” to pay in. 23
IV. OTHER TREATIES IMPLICATING DSI
The issue of ABS in the context of DSI has also come up in other international treaties, as briefly summarized in this section.
A. The GRATK Treaty
The GRATK Treaty, adopted by WIPO in May 2024, implements a mandatory disclosure requirement in patent applications that are “based on” GRs or associated traditional knowledge (TK). Applicants must disclose the country of origin of the GR or TK—or state that the origin is unknown—when GRs were necessary for the invention. However, the Treaty’s definitions focus on physical genetic material such as plant, microbial, or animal materials—at this time, DSI is not explicitly included under the GRATK Treaty. Nonetheless, it would not be surprising to see some countries implement the Treaty in a manner that does encompass DSI. For example, national laws could be drafted to define “genetic resources” in a manner that encompasses DSI, and require a patent application disclosing a synthetic gene designed solely from published sequence data to disclose the origin of that sequence. Implementing statutes could require patent applicants to disclose not only the origin of physical GR but also the database accession number of DSI used, and possibly any associated metadata, e.g., country of origin or indigenous knowledge linkage.
Countries could also leverage patent examination guidelines. For example, national patent offices could adopt examination guidelines instructing examiners to check whether inventions relying on DSI disclose their source/origin. The WIPO Secretariat has prepared a useful document entitled “Disclosure Requirements Table related to GRs and/or traditional knowledge,” which provides a non-exhaustive selection of extracts from existing legislative texts that include specific disclosure requirements related to GRs and/or traditional knowledge. 24
B. The International Treaty on Plant Genetic Resources for Food and Agriculture
The International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)—also known as the Plant Treaty—was adopted in 2001 under the UN’s Food and Agriculture Organization framework to conserve and sustainably manage plant GRs, promoting Farmers’ Rights and a global system for sharing genetic material for food security. It is intended to facilitate access to plant GRs for food and agriculture (PGRFA) through a Multilateral System (MLS). The Plant Treaty covers 64 crops and forages essential to food security. Users must share benefits from commercial use, often via a standard material transfer agreement. The Treaty assumes access to physical genetic materials—not digital information.
The Eleventh Session of the Plant Treaty’s Governing Body (GB-11) met in Lima, Peru, on November 24–29, 2025, and several DSI-related issues were discussed, but no final decisions were adopted that directly resolve how DSI will be treated within the MLS. Although DSI was a central part of the MLS enhancement agenda going into the meeting, GB-11 did not reach agreement and therefore deferred detailed DSI BS measures to further intersessional work. Key contentious elements—such as monetary BS arrangements, payment structures, and potential expansion of the MLS to include DSI-related BS provisions—remained unresolved. 25
C. The BBNJ Agreement
The Agreement under 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 Agreement) was adopted by consensus on June 19, 2023, at the further resumed fifth session of the Intergovernmental Conference on Marine Biodiversity of Areas Beyond National Jurisdiction, convened under the auspices of the United Nations. Under the BBNJ Agreement, Marine Genetic Resources (including their DSI) are to be governed through a framework ensuring conservation, sustainable use, and equitable BS. Notably, this treaty explicitly includes DSI in its scope and contemplates ABS mechanism. 26
V. NATIONAL IMPLEMENTATION OF ABS LAWS ENCOMPASSING DSI
A number of developing countries (e.g., India, Brazil, Peru) have decided not to wait for the CBD to resolve the DSI issue and have enacted and/or interpreted ABS laws aligned with CBD Article 15 in a manner that encompasses DSI. While recognizing that DSI is not explicitly mentioned in the CBD or the Nagoya Protocol, many parties interpret DSI as covered under the concept of “derivatives,” which, as mentioned above, were specifically introduced into the CBD by the Protocol. Domestic legislation implementing the Nagoya Protocol can impose BS requirements to DSI, particularly when there is commercial use of DSI.
For example, in Brazil Law No. 13,123/2015, i.e., the Law on Access to Genetic Heritage and Associated Traditional Knowledge, implements ABS standards aligned with the Nagoya Protocol. It sets ABS obligations for GRs and associated TK, requires ABS agreements before access, and incorporates PIC where relevant. Law 13,123/2015 defines GRs (or genetic heritage) as the genetic information from plants, animals, and microbial species, or any other species, including substances originating from the metabolism of these living organisms (Article 2, I). Furthermore, Decree No. 8,772/2016, which addresses registration in the National System for Genetic Heritage (“SisGen”), requires that the origin of the genetic heritage found in in situ conditions be informed, even if obtained from ex situ or in silico sources. Therefore, the Law and Decree that regulate ABS in Brazil have already recognized access to dematerialized GRs in its framework, without the need for access to the physical sample as such. Law 13,123/2015 provides that research utilizing genetic information obtained in silico is to be carried out freely, and that registration is required only at the time of publication of the results, or upon application for a patent, or before introduction of a product on the market.
Under Article 47 of Law 13,123, patent grants involving Brazilian genetic heritage or associated traditional knowledge require prior registration or authorization by the Genetic Heritage Management Council (CGEN). Article 47 mandates prior CGEN authorization; patent applications filed without the access code may be rejected. The Brazilian Patent Office (BRPTO) issues formal objections if patent applications fail to declare involvement of genetic heritage or traditional knowledge—prompting applicants to produce required approvals. Regulatory interpretations declare that both Law 13,123 and its implementing Decree 8,772 treat DSI (in silico genetic data) as within scope—subject to ABS and potential BS.
Regarding DSA, Brazil has taken the position that:
even if genetic information obtained digitally is to be considered as excluded from the concept of genetic material, a systemic interpretation of the Convention on Biological Diversity and the Nagoya Protocol leaves no doubt that the use of this information is subject to benefit sharing. The means of transmission of genetic information, whether in the form of matter from a DNA sample or as information stored in silico, is irrelevant to the fulfillment of this obligation. Since there was a “utilization” of a physical sample to access this type of information, its application and subsequent commercialization should be shared in a fair and equitable way, in line with Article 5 of the Nagoya Protocol[.]
It is also worth mentioning that, in the context of the Brazilian regulatory framework, this issue is considered settled. It is also important to highlight that the CBD and the Nagoya Protocol, especially its Article 8, recognize the need for access facilitation for the progress of science. The exchange of digital sequence information is essential to achieve the objectives set out in Article 12 of the CBD, which are to promote and encourage research which contributes to the conservation and sustainable use of biological diversity, particularly in developing countries, inter alia, in accordance with decisions of the Conference of the Parties taken in consequence of recommendations of the Subsidiary Body on Scientific, Technical and Technological Advice. In order to contemplate the provisions of Article 12 of the CBD and Article 8 of the Nagoya Protocol, the benefit sharing obligation should not impact the speed of research and development using digital sequence information. Parties should consider facilitated rules for access and use of these sequences in the development of their national legislation, so as to provide for the fair and equitable sharing of the benefits that originate from the commercialization of new products obtained from the utilization of genetic information. 27
Brazil has also emphasized the importance of traceability:
For provider countries and countries of origin of genetic resources, traceability is crucial for the full implementation of the Nagoya Protocol in the context of the utilization of digital sequence information. Traceability is also fundamental for countries that utilize this information, since a consolidated legal framework is considered favorable by institutions that study the possibility of investing in research in their domestic contexts. Although genetic sequence databases require the provision of several different pieces of information regarding the submitted sequences, in many cases the necessary data for its traceability is not required or the requirement of information is not mandatory, which makes the precise determination of its source very difficult. Therefore, once rules for the use of digital sequence information are established in the context of the CBD and the Nagoya Protocol, it is important to ensure the traceability of sequences submitted in databases. Thus, it is necessary to: (i) establish mechanisms to ensure that the genetic databases require standardized information necessary to the traceability of submitted sequences; (ii) establish differentiated treatment for cases of sequences submitted in genetic databases prior to the definition of this mechanism and whose traceability is not possible. The implementation of “disclosure of origin or source” in both patent applications and the deposit of digital sequences in databases could make possible the creation of verification points, as envisioned in Article 17 of the Nagoya Protocol. Although this mechanism has not yet been established as a rule for all databases, it could potentially facilitate the establishment of prior art for the analysis of patent applications, inhibit misappropriation, create mutual trust among all stakeholders and make traceability possible.
…
It remains to be further analyzed how benefit sharing should be carried out in the cases of: (i) access to multiple genetic resources, including cases in which the genetic information was obtained from genetic databases, and may come from different species or regions, and (ii) use of conserved sequences, since these sequences can be found in hundreds or even thousands of different species, which makes traceability difficult. 28
India has likewise taken steps to extend its ABS and related laws to cover DSI.
Responding to the CBD, in 2002, India enacted the Biological Diversity Act, which requires prior approval for foreign entities and individuals before accessing Indian biological resources. The 2002 Act established the National Biodiversity Authority (NBA), which is responsible for regulating access to biological resources and associated knowledge and ensuring fair and equitable BS with local communities.
The Biological Diversity (Amendment) Act, 2023, introduced significant changes to align India’s law with international practices and reduce compliance burdens. Some of the key features are:
Replaced imprisonment with monetary penalties for most violations in order to encourage compliance. Simplified compliance for Indian entities. Explicit inclusion of DSI under ABS obligations. Streamlining of processes for obtaining IPRs, including clarification of disclosure timelines and the availability of conditional ABS approval for intellectual property rights. Broadened definitions of key terms to include modern applications like value-added products and digital knowledge.
The Biological Diversity Rules, 2024, notified on October 22, 2024, and effective as of December 22, 2024, operationalize the 2023 Amendment Act and explicitly provide that DSI, when used in inventions, is included within the purview of the Act. Foreign entities are subject to specific obligations when accessing research results based on Indian biological resources or using foreign biological resources within India. The rules outline obligations for both foreign and Indian entities regarding the commercialization of intellectual property rights based on biological resources.
The 2025 NBA Regulations, officially titled the Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulations, 2025, were introduced to implement the amended 2024 Act. They provide DSI regulations that bring genomic data users under ABS, ensuring companies using sequence information also share benefits. Thus, Indian law now explicitly treats DSI as part of “biological resource,” subjecting it to ABS obligations:
“…NBA approval will be required for the commercialisation of IPR for any invention based on DSI accessed from India. Further, the new Regulation of 2025 explicitly includes DSI within the ambit of ‘biological resource’ for the purpose of ABS obligations…” 29
Regulation 3 of the 2025 Biological Diversity Regulations, which pertain to foreign entities accessing Indian resources for research or bio-utilization, includes DSI in its scope and potentially imposes upfront payments unless waived for academic research. Regulation 4, which concerns commercialization of biological resources and establishes tiered BS percentages tied to annual turnover and product value, explicitly treats DSI in the same manner as tangible resources.
In view of these regulatory developments, any invention based on DSI sourced from India now requires prior approval from the NBA before filing for intellectual property rights. Patent applications must thus demonstrate compliance through ABS documentation and the agreed BS processes. Filing a foreign patent application without NBA approval can lead to penalties, and the patent may be challenged or invalidated later.
South Africa’s ABS framework under its biodiversity law likewise mandates PIC and MAT for commercial access to both biological resources and associated traditional knowledge. Its national ABS regulations embed DSI utilization within the same legal structure as tangible GRs. In particular, South Africa’s 2013 amendment to its National Environmental Management: Biodiversity Act, 2004, contains a definition of GRs that includes any genetic material, or the genetic potential, characteristics or information of any species, whether gathered from the wild or accessed from any other source. 30 On this basis, South Africa requires benefit sharing from uses of DSI on GRs, whether stored in public or private databases. 31
VI. IMPLICATIONS FOR BIOTECHNOLOGY
Biotechnology developers must integrate ABS compliance into upstream R&D, particularly when using GRs or knowledge from these countries—even if synthetic or digital. Multiple overlapping obligations are possible, such as having to make payments in bilateral ABS deal after paying into the Cali Fund, or multiple, overlapping demands of BS in multiple jurisdictions, perhaps in connection with a plurality of treaties, e.g., CBD/Nagogya, the Plant Treaty, and the BBNJ Agreement.
A World Health Organization (WHO) Secretariat report from 2016 stressed that the manner in which the Nagoya Protocol is implemented will significantly affect the ability of biopharmaceutical researchers in both the public and private sectors to respond to public health crises in a timely manner. 32 Delays or legal barriers in accessing DSI (e.g., pathogen genetic data) could critically slow vaccine or diagnostic development. GSK issued a public policy position article in 2025 making the same point and emphasizing the need for clear, proportional ABS rules and special treatment for pathogens and their genetic data in order to facilitate timely access during public health emergencies. 33
Biotechnology companies are responding by crafting jurisdiction-responsive ABS compliance mechanisms and employing centralized databases to track the use of GRs and related DSI used, jurisdictions, permits, IRCCs, and MAT contracts, thereby facilitating audits and declarations. They often employ R&D contracts that include ABS clauses referencing DSI policies in various jurisdictions, enabling automated red flags when DSI from high-interest regions is utilized. Company and trade groups have also actively engaged in international policy dialogues to shape norms on DSI and ABS, aiming for clarity and global harmonization.