REEP - A Human Rights Approach to Benefit-Sharing from the Use of Digital Sequence Information

Mariana Matamoros Cárdenas Randy Villalba Arango

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INDUSTRIA DE BEBIDAS ENDULZADAS EN COLOMBIA Alex Reep is an interdisciplinary researcher with a background in environmental science, urban planning, and sustainable development. She holds a master’s degree in development practice from the University of California, Berkeley. As a Fulbright researcher in Colombia (2023–2024), she studied what Indigenous and local communities consider to be fair and equitable benefit-sharing for the use of digital sequence information derived from genetic resources in their territories. She worked with Dejusticia as the strategist for the organization’s involvement in the 2024 United Nations Biodiversity Conference. This policy brief outlines a human rights-based approach to the design and implementation of the multilateral mechanism and Cali Fund for benefit-sharing from the use of digital sequence information on genetic resources. Drawing on research conducted in Indigenous, Afro-descendant, and farming territories in Colombia, it highlights the urgent need for a fair and inclusive benefit-sharing system that recognizes the rights and contributions of Indigenous people and local communities (IP&LCs). This brief outlines critical recommendations for decision-making and advocacy in the wake of the 2024 United Nations Biodiversity Conference in an effort to ensure fair compensation and reciprocity for IP&LCs while addressing structural inequalities. Public Policy and Law Series This series explores pressing issues in contemporary society that call for political and social action. Alex Reep

A HUMAN RIGHTS

APPROACH TO BENEFIT-SHARING

FROM THE USE OF DIGITAL

SEQUENCE INFORMATION

Public Policy and Law Series /

Law Series This series explores pressing issues in contemporary society that call for political and social action. Alex Reep

A HUMAN RIGHTS

APPROACH TO BENEFIT-SHARING

FROM THE USE OF DIGITAL

SEQUENCE INFORMATION Public Policy and Law Series / 2_PB_The Human Rights.indd Todas las páginas2_PB_The Human Rights.indd Todas las páginas 27/03/25 4:12 p. m.27/03/25 4:12 p. m.A HUMAN RIGHTS APPROACH

TO BENEFIT -SHARING

FROM THE USE OF DIGITAL SEQUENCE INFORMATION ALEX REEPThis policy brief outlines a human rights-based approach to the design and implementation of the multilateral mechanism and Cali Fund for benefitsharing from the use of digital sequence information on genetic resources. Drawing on research conducted in Indigenous, Afro-descendant, and farming territories in Colombia, it highlights the urgent need for a fair and inclusive benefit-sharing system that recognizes the rights and contributions of Indigenous people and local communities (IP&LCs). This brief outlines critical recommendations for decision-making and advocacy in the wake of the 2024 United Nations Biodiversity Conference in an effort to ensure fair compensation and reciprocity for IP&LCs while addressing structural inequalities.

Keywords: digital sequence information (DSI), multilateral mechanism, Cali Fund, benefit-sharing, genetic resources.

Este informe de política propone un enfoque basado en los derechos humanos para desarrollar el mecanismo multilateral y el Fondo Cali para la distribución de beneficios derivados del uso de la Información de Secuencia Digital de los recursos genéticos. Basándose en la investigación realizada con los pueblos indígenas y las comunidades locales (PICL) de Colombia, destaca la urgente necesidad de un sistema de distribución de beneficios justo e inclusivo que reconozca los derechos y las contribuciones de los PICL. Con naciones

pueblos indígenas y las comunidades locales (PICL) de Colombia, destaca la urgente necesidad de un sistema de distribución de beneficios justo e inclusivo que reconozca los derechos y las contribuciones de los PICL. Con naciones ricas en biodiversidad como Colombia a la vanguardia de estos debates, este informe esboza recomendaciones fundamentales para la toma de decisiones y la promoción, tras la Conferencia de las Naciones Unidas sobre la Diversidad Biológica COP16 de 2024, para garantizar una compensación justa para los pueblos indígenas y las comunidades locales, al tiempo que se abordan las desigualdades estructurales.

Palabras clave: Información de Secuencias Digitales, Mecanismo Multilateral, Fondo Cali, Distribución de Beneficios, Recursos Genéticos.

To cite this book: Reep, A. (2025). A Human Rights Approach to Benefit-Sharing from the

Use of Digital Sequence Information. Dejusticia.ALEX REEP Public Policy on Law Series /

A HUMAN RIGHTS APPROACH

TO BENEFIT -SHARING FROM THE USE OF DIGITAL SEQUENCE INFORMATIONisbn 978-628-7764-25-5 digital edition

Layout Diego Alberto Valencia Cover Diana Gonzalez Molina Copy Editing Morgan Stoffregen First English Edition Bogotá, Colombia, April 2025 This document is available at https://www.dejusticia.org Creative Commons Attribution-NonCommercial-ShareAlike 4.0 Dejusticia Calle 35 # 24-31, Bogotá, D.C., Colombia Telephone: (+57) 601 608 3605 www.dejusticia.org Alex Reep A Human Rights Approach to Benefit-Sharing from the Use of Digital Sequence Information / Alex Reep – Bogotá: Editorial Dejusticia, 2025. 38 pages; 22x13 cm. – (Public Policy on Law Series)

www.dejusticia.org Alex Reep A Human Rights Approach to Benefit-Sharing from the Use of Digital Sequence Information / Alex Reep – Bogotá: Editorial Dejusticia, 2025. 38 pages; 22x13 cm. – (Public Policy on Law Series)

ISBN 978-628-7764-25-5

1. Digital sequence information (DSI) 2. multilateral mechanism 3. Cali Fund 4. Benefit sharing 5. Genetic resourcesContents

Introduction 9 Background on the Multilateral Mechanism and the Cali Fund 11 The Current State of Benefit-Sharing Legislation in Colombia 13

Case Study: Research Findings from Colombian Indigenous and Local Communities 17

Recommendations from Indigenous and Local Communities in Colombia Regarding Ethical DSI Use 22

Proposed Framework: Benefit-Sharing for DSI Use 24

Conclusion 31 References 31The Author Alex Reep, is an interdisciplinary researcher with a background in environmental science, urban planning, and sustainable development. She holds a master’s degree in development practice from the University of California, Berkeley. As a Fulbright researcher in Colombia (2023–2024), she studied what Indigenous and local communities consider to be fair and equitable benefit-sharing for the use of digital sequence information derived from genetic resources in their territories. She worked with Dejusticia as the strategist for the organization’s involvement in the 2024 United Nations Biodiversity Conference.9 Public Policy on Law Series A Human Rights Approach to Benefit-Sharing from the Use of Digital Sequence Information Introduction A single sequence from a wild bean on an Indigenous reservation in Colombia could offer the key to resistance against a disease that threatens food crops across the world. Who owns and gains value from the digital sequence information (DSI) produced when genetic resources from plants, animals, or microbes are sequenced? The norm for centuries—the legacy of scientific colonialism, or “biopiracy”—has been to take genetic

disease that threatens food crops across the world. Who owns and gains value from the digital sequence information (DSI) produced when genetic resources from plants, animals, or microbes are sequenced? The norm for centuries—the legacy of scientific colonialism, or “biopiracy”—has been to take genetic resources without providing sufficient compensation to those who conserved and shaped these unique genomes. Biopirates extract knowledge or resources from communities without their consent, violating collective rights (Reid, 2009). The leading approach to addressing biopiracy is “benefit-sharing,” in which the benefits derived from the use of DSI are fairly distributed among the countries or communities of origin. Benefits might be monetary, such as royalties from pharmaceuticals and other commercial products made using DSI, or non-monetary, such as information exchange and technology transfer (Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity, 2011). Although benefit-sharing agreements are intended to recognize and compensate traditional knowledge holders and biodiversity stewards, they remain disconnected from the political and economic realities of local communities (Wynberg, 2023). How does scientific colonialism express itself—and how can we move toward justice—as genetic resources go from physical to digital? Benefit-sharing from the use of physi-10 Public Policy on Law Series Alex Reep cal genetic resources was established in the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization, the 2010 supplementary agreement to the United Nations Convention on Biological Diversity. However, these protocols were written before the cost of genome sequencing plummeted. Since that time, DSI from genetic resources has become increasingly accessible. Much of it is uploaded into open source databases in the Global North. Some argue that this is advantageous: it democratizes access to the primary tool in biodiversity conservation. Others argue that

of genome sequencing plummeted. Since that time, DSI from genetic resources has become increasingly accessible. Much of it is uploaded into open source databases in the Global North. Some argue that this is advantageous: it democratizes access to the primary tool in biodiversity conservation. Others argue that this is plunderous: it extends and facilitates a long legacy of using resources from the Global South for the benefit of the Global North. The lack of laws enforcing benefit-sharing risks a global free-for-all in which companies and institutions can use DSI without compensating any of the stewards of genetic resources, many of whom are from the biodiverse communities of the tropics and subtropics, located in the Global South. What constitutes “equitable” benefit-sharing from the use of DSI was up for debate for the fourth time at the 16th Conference of the Parties (COP16) to the Convention on Biological Diversity, hosted in Cali, Colombia, in October 2024. The results of the benefit-sharing debate at COP16 have implications for the future of biodiversity research and the global conservation movement. This brief, based on ten months of semi-structured interviews with genetic resource stewards from Indigenous and local communities in Colombia regarding their perception of “fair and equitable” benefit-sharing, in addition to a literature review on benefit-sharing from the use of DSI, offers considerations and actionable recommendations to guide policy makers in integrating a human rights perspective into the development and implementation of the new multilateral mechanism for benefit-sharing from the use of DSI on genetic resources, including the Cali Fund.11 Public Policy on Law Series A Human Rights Approach to Benefit-Sharing from the Use of Digital Sequence Information Background on the Multilateral Mechanism and the Cali Fund DSI, the data derived from genome sequencing an organism, drives breakthroughs in medical, agricultural, and environmental innovations. This information can include the details of an organism’s DNA and RNA, in addition to other “omics” (e.g.,

Background on the Multilateral Mechanism and the Cali Fund DSI, the data derived from genome sequencing an organism, drives breakthroughs in medical, agricultural, and environmental innovations. This information can include the details of an organism’s DNA and RNA, in addition to other “omics” (e.g., transcriptomics, metabolomics) and even associated traditional knowledge. The definition of DSI is still up for debate (DSI Scientific Network, n.d.). DSI has already proven invaluable in efforts such as the development of vaccines during the COVID-19 pandemic, advancing climate-resilient crop varieties, and safeguarding biodiversity (Meridian Institute, n.d. ). From diagnostic kits to conservation strategies, open access to DSI fuels global advancements, enabling responses to some of the most pressing challenges of our time. Despite the many uses of DSI, there exists a tense debate regarding where most sequence data come from and the ethicality of making those data open source if their origins are unknown. Companies and researchers in economically rich, biodiversity-poor nations benefit from using the genetic resources of low-income, biodiversity-rich countries, many of which are in the tropics and subtropics of the Global South. In “Myth-Busting the Provider-User Relationship for Digital Sequence Information,” Scholz et al. (2021) reject the idea that lowand middleincome countries are predominantly the providers of DSI from genetic resources and that high-income countries are predominantly the users . The United Kingdom, United States, China, and Canada provide the majority (67%) of the global DSI dataset (WiLDSI, 2024), meaning that institutions in these countries have uploaded and shared the most data. However, this does not necessarily reflect where the genetic material originally came from, as only 14.6% of all sequences in the International Nucleotide Sequence Database Collaboration database referenced in the Scholz et al. study include country-of-origin information

have uploaded and shared the most data. However, this does not necessarily reflect where the genetic material originally came from, as only 14.6% of all sequences in the International Nucleotide Sequence Database Collaboration database referenced in the Scholz et al. study include country-of-origin information (Scholz et al., 2021). The lack of country-level provenance information for the majority of sequences complicates any effort to draw conclusions regarding the current flow of global genetic12 Public Policy on Law Series Alex Reep information. This gap in provenance information contributes to a sensation among Indigenous people and local communities (IP&LCs) in both the Global North and Global South that their stewardship of genetic resources is unacknowledged, as DSI use is separated from the physical resources they are derived from and the permissions required to access these resources ( Golan et al., 2022). Historically, access to genetic resources has been regulated under the bilateral benefit-sharing model established in the Convention on Biological Diversity and its Nagoya Protocol. The Nagoya Protocol obliges the users of physical genetic resources to share benefits with the nations and communities from where these resources originate. However, DSI is being uploaded into databases with unregulated access and use, meaning that benefit-sharing mechanisms are often circumvented (Meridian Institute, n.d.). International laws vary significantly in terms of whether a “genetic resource” includes its derivatives and their DSI. Therefore, DSI is perceived as a loophole that inhibits fair and equitable benefit-sharing for the commercial use of genetic resources (Scholz et al., 2022). To address this gap and the transnational nature of DSI, governments at COP15 in 2022 agreed to establish a multilateral mechanism, including a global fund, to ensure that benefits derived from DSI are fairly shared (Conference of the Parties to the Convention on Biological Diversity, 2022). Under the traditional bilateral benefit-sharing system from the use of genetic resourcmechanism, including a global fund, to ensure that benefits derived from DSI are fairly shared (Conference of the Parties to the Convention on Biological Diversity, 2022). Under the traditional bilateral benefit-sharing system from the use of genetic resources, resource “users” (scientists and industry) establish mutually agreed terms (MAT) and obtain the free, prior, and informed consent (FPIC) of “providers” (resource stewards and traditional knowledge holders). In contrast, the new multilateral mechanism—rather than navigating individual FPIC and MAT procedures for each project—is intended to promote open access and limit complexity for companies and research institutions using DSI by encouraging them to contribute to a global fund. The multilateral mechanism may additionally address the unequal power dynamics between DSI users and providers in bilateral negotiations (Bagley, 2022). The multilateral mechanism and13 Public Policy on Law Series A Human Rights Approach to Benefit-Sharing from the Use of Digital Sequence Information global fund seek to not only redistribute financial benefits but also strengthen the capacity of these communities through technology transfer and equitable involvement in decision-making. At COP16 in 2024, governments adopted a decision on DSI that stipulates how the multilateral mechanism and global fund (referred to as the Cali Fund) will be operationalized (Conference of the Parties to the Convention on Biological Diversity, 2024). Under this agreement, qualifying businesses using DSI for commercial use are encouraged to contribute 1% of their profits or 0.1% of their revenue to the fund. Notably, half of the Cali Fund will be dedicated to supporting the self-identified needs of IP&LCs. This decision from COP16 will be essential to upholding global commitments to biodiversity, safeguarding the rights of IP&LCs, unlocking the benefits of DSI, and ensuring that all nations—particularly those rich in biodiversity—are compensated fairly for their contributions to global scientific advancement.

Several challenges remain: How will the multilateral

upholding global commitments to biodiversity, safeguarding the rights of IP&LCs, unlocking the benefits of DSI, and ensuring that all nations—particularly those rich in biodiversity—are compensated fairly for their contributions to global scientific advancement.

Several challenges remain: How will the multilateral mechanism function in practice, and how will funds be distributed transparently among those who steward genetic resources, particularly IP&LCs? Further, what type of benefits

(monetary vs. nonmonetary) will be shared for different types of DSI use, and how they will be shared? The Current State of Benefit-Sharing Legislation in Colombia The existing legal landscape in Colombia regarding benefit-sharing for the use of DSI derived from genetic resources is complex and evolving. While no regulation explicitly addresses DSI, existing agreements stipulate the responsibilities and conditions associated with access to and the use of genetic resources. For example, once a user accesses genetic resources and produces DSI, the user then controls how the information is managed—whether it is deleted, saved, or uploaded to public or private databases—unless otherwise specified in the access contract. If the DSI is uploaded to a public database, however, the14 Public Policy on Law Series Alex Reep user must clearly identify the geographical origin of the genetic resource from which the DSI was derived. In Colombia, genetic resources are recognized as a distinct category of goods, situated between the biological resource that contains them and the intellectual property derived from the discovery of genetic information (Colombian Government, 1997). More precise regulations are required to address the specific challenges posed by DSI within the broader context of access and benefit-sharing regulations. The Colombian Constitution contains several provisions related to genetic resources, which can be interpreted as covering DSI. Article 63 of the Constitution declares certain assets, such as national parks and communal lands, as inalienable, imprescriptible, and not subject to seizure. Article 81 manregulations. The Colombian Constitution contains several provisions related to genetic resources, which can be interpreted as covering DSI. Article 63 of the Constitution declares certain assets, such as national parks and communal lands, as inalienable, imprescriptible, and not subject to seizure. Article 81 mandates that the state regulate the entry, exit, and use of genetic resources in accordance with national interests, underscoring the state’s authority over genetic resources. While these articles do not explicitly address genetic resources, the Constitutional Court has interpreted genetic resources as part of the nation’s patrimony and thus protected under these principles. If the biologically active genes come from a species native to Colombia, genetic resources are considered “public domain assets,” making the Colombian state the exclusive owner of the genetic resources. Articles 8, 79, 80, 88, and 333 provide additional constitutional grounding for the state’s authority and responsibility over genetic resources as public goods. The Convention on Biological Diversity was ratified in Colombia through Law 165 of 1994, which reaffirms Colombia’s sovereign rights over its genetic resources. The law establishes that benefits derived from the use of the nation’s genetic resources—for research, technology, or commercial purposes— must be shared with the Ministry of the Environment and the IP&LC community of origin, if using the community’s traditional knowledge or if genetic information was derived from a native biological resource located within their territories. Sentencia C-519 of 1994 affirmed the constitutionality of the Convention on Biological Diversity and its domestic implementa-15 Public Policy on Law Series A Human Rights Approach to Benefit-Sharing from the Use of Digital Sequence Information tion through Law 165. In this ruling, the Constitutional Court emphasized the state’s duty to protect and conserve biodiversity, aligning with the convention’s objectives. Sentencia C-137 de 1996 reviewed the constitutionality of Colombia’s participation in the International Centre for Genetic Engineering and Biotechnology, affirming that while international cooperation

emphasized the state’s duty to protect and conserve biodiversity, aligning with the convention’s objectives. Sentencia C-137 de 1996 reviewed the constitutionality of Colombia’s participation in the International Centre for Genetic Engineering and Biotechnology, affirming that while international cooperation in biotechnology is permissible, the Colombian state has a constitutional duty to regulate and oversee genetic resources and to ensure that their use aligns with national interests and constitutional mandates. The Ministry of Environment is the national competent authority for granting access to genetic resources for which Colombia is the country of origin and provider (Decree 730 of 1997). Within the ministry, the Genetic Resources Group and the Sustainable and Green Business Office propose mechanisms for fair and equitable benefit-sharing, with support from the ministry’s Sub-Directorate of Education and Participation when traditional knowledge is involved (Decree 3570 of 2011). Any individual or institution intending to access genetic resources in Colombia must notify the Ministry of Environment and specify the following: the resource being accessed, the purpose of access (whether for research or commercialization), and how the resource will be used. If the activities are commercial in nature, a formal contract of access to genetic resources is created. If access is granted, the individual or entity must develop a contract with the Ministry of Environment that specifies the coordinates of where the resources will be collected, the duration of the agreement, the activities to be undertaken, sampling methods, and reporting requirements—in addition to the prior informed consent and mutually agreed terms with the contracting party providing genetic resources (CBD, 1992, art. 15). The contract also defines the portion of benefits that must go to the Colombian government, as the inalienable owner of the nation’s genetic resources. If DSI is deposited in a database, the contract details and origin of the genetic resource from which the DSI was obtained must be published (United Nations Convention on16 Public Policy on Law Series Alex Reep Biological Diversity Ad Hoc Technical Expert Group on Digital

genetic resources. If DSI is deposited in a database, the contract details and origin of the genetic resource from which the DSI was obtained must be published (United Nations Convention on16 Public Policy on Law Series Alex Reep Biological Diversity Ad Hoc Technical Expert Group on Digital Sequence Information on Genetic Resources, 2020). The right of the state to grant access to genetic resources, however, is conditioned by the constitutional rights of Indigenous, Afro-Colombian, and campesino communities to grant or deny access to their territories. Decision 486 of 2000 of the Andean Community recognizes the rights and authority of Indigenous, Afro-Colombian, and local communities over their “biological and genetic heritage” and traditional knowledge (Andean Community, 2000). Accordingly, the Ministry of Environment may issue an access contract only with the explicit consent of these communities. To reduce the bureaucratic burden on non-commercial DSI users, many scientific activities are exempt from the access contract requirement ( Minambiente, 2021). This allows scientists to conduct their work without acknowledging the Colombian origin when publishing DSI in public databases. In this case, the decision to attribute provenance information is left to the researcher or the institution responsible for the study. The researcher cannot patent the genetic resources, but DSI is considered part of the researcher’s discovery when it is made public, and they retain control over the discoveries made. In Colombia, there is currently no explicit legal requirement to share benefits if a company, individual, or institution uses DSI derived from Colombian genetic resources. Under Colombian law, DSI is not considered the same as genetic resources. Consequently, there is no legal obligation to contribute to benefit-sharing when using DSI. However, at the international level, the decision on DSI adopted at COP16 provides the most relevant legal basis for benefit-sharing from the use of DSI. According to paragraph 1 of the annex to the decision, the multilateral mechanism for benefit-sharing applies to DSI that

national level, the decision on DSI adopted at COP16 provides the most relevant legal basis for benefit-sharing from the use of DSI. According to paragraph 1 of the annex to the decision, the multilateral mechanism for benefit-sharing applies to DSI that is (i) publicly available in compliance with applicable national legislation; (ii) not subject to mutually agreed terms established at the time of access to the genetic resources from which the DSI is derived, unless those terms permit its public availability; and (iii) not already covered by other international access and17 Public Policy on Law Series A Human Rights Approach to Benefit-Sharing from the Use of Digital Sequence Information benefit-sharing agreements, unless those agreements opt to use the multilateral mechanism ( Conference of the Parties to the Convention on Biological Diversity, 2024). The outcomes of the COP16 negotiations may influence Colombia’s legal approach to benefit-sharing from the use of DSI, particularly if its national legislation evolves to align with the framework of the multilateral mechanism. Beyond the more DSI-specific regulations required to address how access and benefit-sharing regulations apply to DSI in Colombia, there also exists a significant gap in monitoring and surveillance. Colombia’s Ministry of the Environment, much like any nation’s access and benefit-sharing authority, lacks the capacity to ensure that entities using genetic resources fully comply with benefit-sharing. As regulations currently stand, compliance relies on the good faith of the genetic resources user. Further, Colombian regulations focus primarily on natural resources rather than on genetic resources or DSI specifically. Debates persist about whether such regulations adequately guarantee IP&LCs’ effective participation in decision-making and ensure fair and equitable benefit-sharing (Silvestri, 2016). A comprehensive consideration of the needs, opinions, and priorities of IP&LCs on the use of DSI derived from their territories will be essential to advancing global biodiversity conservation priorities.

Case Study: Research Findings from Colombian Indigenous and Local Communities Additional insights and on-the-ground context is proA comprehensive consideration of the needs, opinions, and priorities of IP&LCs on the use of DSI derived from their territories will be essential to advancing global biodiversity conservation priorities.

Case Study: Research Findings from Colombian Indigenous and Local Communities Additional insights and on-the-ground context is provided by research conducted by Alex Reep between October 13, 2023, and May 17, 2024, with twenty-two individuals from indigenous and local communities from five departments of Colombia. The research was conducted through Fulbright Colombia and was approved by the Institutional Review Board of the Alliance of Bioversity International and the International Center for Tropical Agriculture on July 27, 2023. Interviewees were18

Public Policy on Law Series Alex Reep asked about what they consider to be “fair and equitable” benefit-sharing for the use of DSI derived from the genetic resources on their territories. Data were analyzed using qualitative coding and AI Assist with MAXQDA 24 software. The Gioia et al. (2013) method supported the identification of themes by systematically recognizing patterns in interview and field note data. Key findings are discussed below. Understanding Local Context The way in which IP&LCs care for and relate to nature, their worldview, and their cosmovision all affect the way they conceptuali