Benefit sharing of DSI (Digital Sequence Information on Genetic Resources) has been a long-standing controversial issue between parties of the Biodiversity Convention. After years of negotiations, the 2024-25 Conference of Parties (COP) marked a significant step by establishing a multilateral benefit-sharing mechanism (MLS) in the form of the Cali fund. While there are still questions about the exact scope of DSI, it is generally understood to mean genetic sequences and other related molecular biological data.
Achyuth B. Nandan explains the MLS and points out some inconsistencies between the Indian Biodiversity Rules and the Biodiversity Act which may affect effectively regulating DSI under the evolving multilateral framework. [Interested readers can also read relevant posts related to the regulation of biodiversity and benefit sharing, authored by Prashant, Adarsh, Gaurangi, and Alphonsa.] Achyuth is an LLM candidate at Rajiv Gandhi School of Intellectual Property Law, IIT Kharagpur, specializing in intellectual property law. He is also an advocate registered with the Bar Council of Kerala. [Long post ahead.]
COP 16 and the Digital Sequence Information Conundrum in Global ABS Governance: A Critical Appraisal of India’s Stance and Regulatory Gaps
By Achyuth B Nandan
Digital Sequence Information (DSI) encompasses genomic and molecular data such as DNA and RNA sequences and has become a key resource in biotechnological innovations. However, the absence of a universal definition and its limited presence in scientific literature create regulatory ambiguities, particularly for access and benefit-sharing (ABS) mechanisms.
After years of debate, COP16 (Cali, 2024) reached a landmark consensus on DSI governance, advancing a multilateral benefit-sharing framework. Central to this framework is the Cali Fund, which channels contributions from major commercial users of DSI to provider countries, particularly Low- and Middle-Income Countries (LMICs), ensuring equitable benefit-sharing while exempting academic and public research institutions.
This model seems aligned with the UN Food and Agricultural Organization (FAO)’s Treaty regarding Plant Genetic Resources multilateral system and the “High Seas Treaty”’s multilateral benefit-sharing model. The initial modalities of the COP 16 decision reflect a balanced approach to DSI governance, aiming to integrate national ABS measures with the emerging multilateral system. While the COP16 decision lays the foundation for DSI governance, it does not override national ABS laws (Paragraphs 1 & 21, Annex CBD/COP/16/L.32/Rev.1). Instead, it encourages harmonization to prevent duplicative benefit-sharing obligations (Paragraph 26).
DSI should generally remain publicly accessible, with restrictions only where explicitly permitted. However, critical aspects such as compliance, accountability, and exceptions to the multilateral approach remain unresolved, as outlined in Decision 15/9. Key questions such as monetary contributions, fund allocation, and data governance must be addressed at COP17 and COP18 to ensure transparency and equitable benefit-sharing, while also preventing the risk of “unaccountable sharing and use”.
Despite the global shift towards a Multilateral System (MLS) for Digital Sequence Information (DSI), India’s stance remains unclear. While the Biological Diversity Rules, 2024, attempt to regulate DSI, the Biological Diversity (Amendment) Act 2023 lacks explicit provisions, creating regulatory inconsistencies. In light of global discussions favouring a multilateral approach, this article critically examines India’s current position on DSI regulation and argues why aligning with the MLS would be a more strategic and effective pathway than attempting unilateral national control.
Use of DSI in a Patent Application
As highlighted by Chetali Rao and K M Gopakumar, researchers have developed products using DSI, such as therapeutics for viral diseases. For example, a monoclonal antibody for Ebola was created using the virus’ genetic sequence from GenBank, bypassing the need for physical samples from the country of origin, as seen in PCT application WO2016123019. Additionally, a vaccine for Ebola is under development (PCT application WO2000000617). These examples demonstrate how DSI enables global research without logistical constraints.
With DSI, researchers can develop biotechnological innovations without requiring physical samples, streamlining patent filings in fields such as virology and genetic engineering. DSI’s intangible nature allows seamless access and transfer of genetic information, facilitated by key open-access databases such as NCBI (GenBank), ENA (UK), and DDBJ (Japan). As a result, genetic sequences of viruses like SARS-CoV-2, Ebola, and Monkeypox have been cited in hundreds of patent filings, with SARS-CoV-2 alone appearing in 311 applications across major patent offices, including the USPTO (pdf), EPO, WIPO (PCT filings) and the Indian Patent Office (pdf). This underscores the growing role of DSI in biotechnology innovation.
Why the Multilateral System is the Future of DSI Benefit-Sharing
A multilateral benefit-sharing system for DSI offers a more effective and equitable alternative to a bilateral approach under the Nagoya Protocol. Articles 10 and 11 of the Protocol as well support this understanding. The bilateral model, based on Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT), is ill-suited for DSI, as genetic sequence data flows freely through open-access databases, making it nearly impossible to trace its origin or enforce bilateral benefit-sharing agreements. This issue arises because of a lack standardized metadata linking them to their origin. Additionally, as sequences are modified, fragmented, and integrated into new datasets, their provenance becomes increasingly difficult to trace. The lack of uniform global regulations on DSI documentation further exacerbates this issue, hindering equitable benefit-sharing. Furthermore, for tangible genetic resources, sovereign control is justified due to conservation risks. However, DSI is digital, and its regulation is primarily about equitable benefit-sharing, not conservation. Therefore, restrictive national measures on DSI could hinder scientific collaboration rather than advance biodiversity goals under the CBD-NP Framework.
Scholz et al. argue that a bilateral system, which requires individual permissions for each sequence transaction, would be overly complex, hinder data interoperability, and slow scientific progress. Moreover, it could lead to DSI forum shopping where users prefer data from countries with fewer restrictions (e.g., the USA and Germany) while avoiding Low- and Middle-Income Countries (LMICs), ultimately undermining global biodiversity conservation.
The proposed multilateral benefit-sharing model by Scholz et al. (illustrated in the figure) ensures DSI remains open-access while establishing a separate benefit-sharing mechanism to facilitate equitable revenue distribution. The multilateral fund would collect revenue from levies, contributions, and royalties, which is then allocated through national-level funding (dark green arrow), weighted by LMIC sequence deposits. This structure helps prevent DSI forum shopping, supports Low- and Middle-Income Countries (LMICs) in biodiversity conservation, and ensures compliance with Access and Benefit-Sharing (ABS) obligations while maintaining global research interoperability.
Margo A. Bagley advocates for a global multilateral benefit-sharing system as a fairer and more efficient approach to ensuring compliance while maintaining unrestricted access to sequence data. Currently, DSI is often patented and commercialized without acknowledging its country of origin. The Ebola drug case exemplifies this, where genetic sequences fueled pharmaceutical innovation without attribution. As Bagley highlights, industries from agriculture to therapeutics rely on sequence data without clear tracking, making equitable benefit-sharing nearly impossible. The lack of attribution mechanisms and effective monitoring exacerbates this issue, reinforcing the need for a robust multilateral solution.
DSI vis-à-vis Indian Biodiversity Governance
India seemed committed to align its stance with the evolving global framework in the COP 16. By endorsing the DSI global fund, it reaffirmed its commitment to equitable biodiversity governance. However, it played a pivotal and strategic role during the negotiations by securing last-minute amendments to uphold developing countries’ sovereign rights over DSI and fund utilization. The phrase “without prejudice to national legislation” was added to key provisions, reinforcing national authority within the multilateral benefit-sharing mechanism.
Inconsistent Terminology
Domestically, India’s approach to regulate DSI remains ambiguous. The Biological Diversity Act, 2002, and its 2023 amendment define “biological resources” in a way that appears limited to tangible components, lacking explicit recognition of DSI. Yet, provisions under Sections 2, 7, 21, and 5—covering “research,” “associated knowledge,” “information on biological resources,” and “transfer of research results”—hint at a potential legal basis for DSI governance. In its 2019 submission to the CBD, India suggested that “information on biological resources” under Section 6 could encompass DSI. The 2023 amendment streamlines terminology by consistently using “associated knowledge,” which, while conventionally linked to Traditional Knowledge (TK), is now interpreted more broadly to include digitized information. However, in line with the CBD-NP framework, “associated knowledge” remains fundamentally rooted in TK protection.
Biodiverse nations like India seek to regulate the conversion of physical bioresources into DSI at the national level, considering bioresources as state patrimony. Globally, regulatory approaches vary: for example, Costa Rica, Namibia, and Australia impose conditions on DSI use tied to physical genetic resource access; Bhutan, Bolivia, China, and Malaysia require PIC and MAT for DSI independently of physical access, while India, Brazil, and South Africa focus on benefit-sharing rather than regulating access.
The real challenge lies in effectively regulating DSI in a globally evolving multilateral framework.
Rules Superseding Act?
Rule 16 of the Biological Diversity Rules, mandates National Biodiversity Authority (NBA) approval for both foreign entities (Section 3) and Indian entities (Section 7) before securing intellectual property rights for inventions utilizing DSI accessed from India (Section 6). This move suggests an attempt to extend regulatory oversight over DSI, even though the Parent Act does not explicitly include it.
A critical legal concern arises: while the 2024 Rules attempt to regulate DSI, the Parent Act remains silent on it. The absence of statutory clarity creates a fundamental gap in India’s biodiversity governance and its alignment with international obligations.
Without a clear and enforceable legal framework, India’s approach risks regulatory contradictions, weakening its position in global biodiversity governance. Instead of uncoordinated national restrictions, India must align with the emerging multilateral ABS system, ensuring legal certainty, enforceability, and international collaboration.
Concluding Remarks
The Biological Diversity (Amendment) Act of 2023, along with its drafting, delegated legislation, and subsequent administrative actions, has faced widespread criticism, particularly from industries. A key concern is the drafting inconsistencies, as evidenced by the immediate corrigendum issued post-enactment, highlighting numerous significant errors. Furthermore, India’s approach to DSI regulation under the Biological Diversity Rules, 2024, raises concerns about whether it exceeds the Parent Act’s mandate.
Given the complexities of tracking and monitoring DSI, rigid national controls may be impractical and risk isolating India from emerging global frameworks. As COP 16 moves towards a Multilateral System (MLS) for benefit-sharing, India’s unilateral regulatory approach could lead to legal uncertainties and hinder international collaboration.
To effectively navigate the evolving global governance of DSI, India could consider developing a Traditional Knowledge Digital Library (TKDL)-like database for genetic resources to complement COP16’s initial modalities for an MLS. Such a model would enable transparent documentation and monitoring, ensuring inclusivity and equitable benefit-sharing without monopolization. Instead of ownership-based restrictions, integrating metadata tracking mechanisms could enhance accessibility and traceability, addressing concerns over the concentration of genetic resource databases in technologically advanced nations. However, its implementation comes with practical challenges, including data accuracy, access controls, and integration with global frameworks.
India must ensure its regulatory framework aligns with the Multilateral System (MLS) under COP16’s evolving global governance of DSI. Since Parties are encouraged to harmonize national ABS measures with the MLS to avoid duplication (Paragraph 26, Annex CBD/COP/16/L.32/Rev.1), India’s proactive engagement can streamline compliance, reduce conflicts, and enhance its influence in shaping DSI governance. While biodiversity-rich nations, including India, assert sovereign rights over digitized information from their bioresources, absolute sovereignty will inevitably shift toward a globally harmonized system. This transition, however, presents an optimal approach to DSI regulation, as it ensures no conservation threat while fostering research, innovation, and equitable benefit-sharing.
By constructively engaging with the MLS from its initial stages, India can strategically position itself to secure an effective ABS mechanism for DSI, both in monetary and non-monetary terms, while ensuring that its sovereign interests are safeguarded within the emerging global framework.