Legal and economic perspectives on fair and equitable benefit sharing in the Nagoya Protocol.

Adopted in 2010 as a supplementary agreement to the 1992 Convention on Biological Diversity, the Nagoya Protocol (NP) mandates the fair and equitable sharing of benefits arising from the use of genetic resources provided by Indigenous peoples. Member states must newly enact or amend domestic laws to align with the NP. Consequently, many countries are currently implementing legislative, administrative, and policy measures to ensure fair benefit sharing from the use of Indigenous genetic resources. We examined the inclusion of intellectual property (IP) protection in the sharing of benefits from research and development that utilizes Indigenous genetic resources. The NP does not specify guidelines for IP-related benefit sharing, leaving each member state to establish its own rules. We used an economics-based approach to explore the optimal scope and duration of IP protection for maximizing stakeholder interests, including those of Indigenous peoples, at the national level. The optimal duration of IP protection was when the marginal social cost and benefit of IP protection were equal. When this point occurred varied depending on various factors, such as the type of genetic resources in the country, existence of alternatives, number of users, and competing actors. The optimal scope of IP protection was when the social benefit of investment in fundamental research equaled the social benefit of application development. Likewise, this point of implementation also varied based on various factors, such as the type, uniqueness, potential for further discovery, and diversity of providers in the country.

Perspectivas legales y económicas del reparto justo y equitativo de beneficios en el Protocolo de Nagoya Resumen Adoptado en 2010 como un acuerdo complementario del Convenio sobre la Diversidad Biológica de 1992, el Protocolo de Nagoya establece el reparto justo y equitativo de los beneficios derivados del uso de los recursos genéticos proporcionados por los pueblos indígenas. Los Estados miembros deben promulgar o modificar su legislación nacional para adaptarla al Protocolo de Nagoya. En consecuencia, muchos países están aplicando actualmente medidas legislativas, administrativas y políticas para garantizar una participación justa en los beneficios derivados del uso de los recursos genéticos indígenas. Examinamos la inclusión de la protección de la propiedad intelectual (PI) en la participación en los beneficios derivados de la investigación y el desarrollo que utilizan recursos genéticos indígenas. El Protocolo de Nagoya no especifica directrices para la participación en los beneficios relacionados con la PI, dejando que cada Estado miembro establezca sus propias normas. Usamos un enfoque económico para estudiar el alcance y la duración óptimos de la protección de la propiedad intelectual con el fin de maximizar los intereses de los actores, incluidos los de los pueblos indígenas, a escala nacional. La duración óptima de la protección de la PI ocurría cuando el costo social marginal y el beneficio de la protección de la PI eran iguales. El momento en que se produce este punto varía en función de diversos factores, como el tipo de recursos genéticos del país, la existencia de alternativas, el número de usuarios y los actores que compiten entre sí. El alcance óptimo de la protección de la PI ocurría cuando el beneficio social de la inversión en investigación fundamental igualaba al beneficio social del desarrollo de aplicaciones. Asimismo, este punto de aplicación también varió en función de diversos factores, como el tipo, la singularidad, el potencial de nuevos descubrimientos y la diversidad de proveedores en el país.

Determining the legality of newly described CITES-listed species in the horticulture trade of tropical pitcher plants (Nepenthes).

Due diligence is a fundamental component of ensuring a sustainable and legal wildlife trade that is also supportive of the livelihoods and businesses that depend on the trade. This is particularly true with species listed on the Convention on International Trade in Endangered Species (CITES) that are considered threatened or may become threatened by trade. Undertaking due diligence exercises requires access to information on which to base such decisions; however, the extent to which information is available is unclear. We used the trade in tropical pitcher plants (Nepenthes) for horticultural purposes as a case study to determine the extent to which information is available. A systematic survey of online trade was conducted for species described from 1996 to 2016. For the species found in trade, these were cross-referenced with the CITES trade database, and inquiries were made to the relevant CITES Management Authorities and National Focal Points Access and Benefit Sharing (ABS). Of 83 newly described species, 61% were offered for sale online in 2018. Despite all Nepenthes species being listed on CITES, only 23% (n = 19) of the species being sold online were reported in trade on the CITES Trade Database, and only 3 were from the countries of origin. Thirty-two of these species had no international trade recorded according to the database. Management authorities of CITES for the countries of origin confirmed trade had been permitted for 5 of 32 species. Lack of CITES records may be explained by trade under "Nepenthes spp." or as exempt parts and derivatives. However, permits to collect and commercialize are likely to be required as part of the Nagoya Protocol on ABS from the Convention on Biological Diversity. The ABS National Focal Points were contacted to determine whether collection or commercialization permits had been issued for the remaining species. Only 2 of 7 focal points replied, and both stated no permits had been issued. Lack of traceability information or response related to the issuance of collection and commercialization permits is concerning and hinders the due diligence of businesses and consumers wanting to ensure their trade is legal, sustainable, and ethical.

Definición de la legalidad de especies recién catalogadas en CITES en la horticultura comercial de plantas de jarra tropicales (Nepenthes) Resumen La diligencia debida es un componente fundamental para garantizar un comercio de vida silvestre legal y sostenible que también apoye los medios de subsistencia y las empresas que dependen del comercio. Esto es especialmente cierto en el caso de las especies incluidas en la Convención sobre el Comercio Internacional de Especies Amenazadas de Fauna y Flora Silvestres (CITES) que se consideran amenazadas o pueden verse amenazadas por el comercio. La realización de ejercicios de diligencia debida requiere acceso a información con la cual fundamentar tales decisiones; sin embargo, no está claro hasta qué punto se dispone de información. Usamos como estudio de caso el comercio de plantas de jarra tropicales (Nepenthes) con fines hortícolas para determinar cuánta información hay disponible. Realizamos un estudio sistemático del comercio en línea de las especies descritas entre 1996 y 2016. Para las especies encontradas en el comercio, hicimos referencias cruzadas con la base de datos de comercio CITES y consultamos a las Autoridades Administrativas CITES pertinentes y a los Puntos Focales Nacionales de Acceso y Distribución de Beneficios. De las 83 especies con descripción reciente, el 61% se pusieron a la venta en línea en 2018. A pesar de que todas las especies de Nepenthes están catalogadas en CITES, sólo el 23% (n = 19) de las especies que se vendían en línea figuraban en la base de datos sobre comercio CITES, y sólo tres procedían de los países de origen. Treinta y dos de estas especies no tenían comercio internacional registrado según la base de datos. Las autoridades de gestión de CITES de los países de origen confirmaron que se permitió el comercio de 5 de las 32 especies. La falta de registros CITES puede explicarse por el comercio de «Nepenthes spp¼ o como partes y derivados exentos. Sin embargo, es probable que se exijan permisos de recolección y comercialización en el marco del Protocolo de Nagoya sobre Acceso y Participación en los Beneficios (APB) del Convenio sobre la Diversidad Biológica. Contactamos a los Puntos Focales Nacionales de APB para determinar si se habían expedido permisos de recolección o comercialización para las especies restantes. Sólo dos de los siete puntos focales respondieron y ambos afirmaron que no se había expedido ningún permiso. La falta de información de rastreo o de respuesta en relación con la expedición de permisos de recolección y comercialización es preocupante y obstaculiza la diligencia debida de las empresas y los consumidores que desean asegurarse de que su comercio es legal, sostenible y ético.

Benefit-Sharing by Design: A Call to Action for Human Genomics Research.

The ethical standards for the responsible conduct of human research have come a long way; however, concerns surrounding equity remain in human genetics and genomics research. Addressing these concerns will help society realize the full potential of human genomics research. One outstanding concern is the fair and equitable sharing of benefits from research on human participants. Several international bodies have recognized that benefit-sharing can be an effective tool for ethical research conduct, but international laws, including the Convention on Biological Diversity and its Nagoya Protocol on Access and Benefit-Sharing, explicitly exclude human genetic and genomic resources. These agreements face significant challenges that must be considered and anticipated if similar principles are applied in human genomics research. We propose that benefit-sharing from human genomics research can be a bottom-up effort and embedded into the existing research process. We propose the development of a "benefit-sharing by design" framework to address concerns of fairness and equity in the use of human genomic resources and samples and to learn from the aspirations and decade of implementation of the Nagoya Protocol.

How Can We Strengthen the Global Genetic Resources' Conservation and Use System?

Genetic resources serve as the foundation of our food supply and are building blocks for the development of new crop varieties that support sustainable crop production in the face of climate change, as well as for the delivery of healthy diets to a continuously growing global population. With the encouragement of the FAO and with technical guidance and assistance from the International Board for Plant Genetic Resources (IBPGR), almost 2000 genebanks have been established worldwide for the ex situ conservation of genetic resources since the middle of the last century. The global genetic resources' conservation and use system has evolved over several decades and presents apparent weaknesses, without a clear blueprint. Therefore, a Special Issue (SI) of Plants on 'A Critical Review of the Current Approaches and Procedures of Plant Genetic Resources Conservation and Facilitating Use: Theory and Practice' was initiated. This SI comprises 13 review and research papers that shed light on the history and the political dimensions of the global system; its current strengths, weaknesses, and limitations; and how the effectiveness and efficiency of the system could be improved to satisfy the germplasm users (plant breeders, researchers) and benefit consumers and society at large. This SI provides insight into new approaches and technical developments that have revolutionised ex situ conservation and the use of germplasm and related information. It also reflects on complementary conservation approaches (in situ, on-farm, home gardens) to ex situ genebanks, as well as how-through new forms of collaboration at national, regional, and global levels and through stronger links between public genebanks-synergies between the private breeding sector and botanic garden community could be achieved to strengthen the global conservation and use system. Special attention has also been given to the governance of genetic resources and access and benefit-sharing issues that increasingly hamper the needed access to a wide range of genetic resources that is essential for plant breeders to fulfil their mission.

Convention on Biological Diversity (CBD) and the Nagoya Protocol: Implications and Compliance Strategies for the Global Coffee Community.

The Nagoya Protocol on Access and Benefit-sharing (ABS) of the Convention on Biological Diversity (CBD) is a fundamental international agreement that plays a crucial role in the protection and equitable utilization of plant genetic resources. While this agreement is essential for conservation and sustainable use, it presents specific challenges to coffee research and industry. One major issue is the requirement to obtain prior informed consent (PIC) from the source country or community, which can be a complex and time-consuming process, especially in regions with limited governance capacity. Additionally, the mandates of this agreement necessitate benefit-sharing with the source community, a requirement that poses implementation challenges, particularly for small businesses or individual researchers. Despite these challenges, the importance of the Nagoya Protocol in the coffee sector cannot be overstated. It contributes significantly to the conservation of coffee genetic resources and the sustainable utilization of these resources, ensuring fair distribution of benefits. To address the complexities presented by this international framework, coffee researchers and industry need to engage proactively with source countries and communities. This includes developing clear and equitable benefit-sharing and implementing strategies for compliance. This article explores the impact of the Nagoya Protocol on the coffee industry, particularly emphasizing the need for balancing scientific investigation with the ethical considerations of resource sharing. It also discusses practical strategies for navigating the complexities of this agreement, including research focused on authenticity control and the challenges in conducting large-scale coffee studies. The conclusion underscores the potential for international collaboration, particularly through platforms like the International Coffee Organization (ICO), to harmonize research activities with the ethical imperatives of the Nagoya Protocol.

Application of the Nagoya Protocol to veterinary pathogens: concerns for the control of foot-and-mouth disease.

The Nagoya Protocol is an international agreement adopted in 2010 (and entered into force in 2014) which governs access to genetic resources and the fair and equitable sharing of benefits from their utilisation. The agreement aims to prevent misappropriation of genetic resources and, through benefit sharing, create incentives for the conservation and sustainable use of biological diversity. While the equitable sharing of the benefits arising from the utilisation of genetic resources is a widely accepted concept, the way in which the provisions of the Nagoya Protocol are currently being implemented through national access and benefit-sharing legislation places significant logistical challenges on the control of transboundary livestock diseases such as foot-and-mouth disease (FMD). Delays to access FMD virus isolates from the field disrupt the production of new FMD vaccines and other tailored tools for research, surveillance and outbreak control. These concerns were raised within the FMD Reference Laboratory Network and were explored at a recent multistakeholder meeting hosted by the European Commission for the Control of FMD. The aim of this paper is to promote wider awareness of the Nagoya Protocol, and to highlight its impacts on the regular exchange and utilisation of biological materials collected from clinical cases which underpin FMD research activities, and work to develop new epidemiologically relevant vaccines and other diagnostic tools to control the disease.

RDA-Genebank and Digital Phenotyping for Next-Generation Research on Plant Genetic Resources.

The National Agrobiodiversity Center under the Rural Development Administration (RDA) in Jeonju, Republic of Korea stands as the foremost national genebank in the country. Over the years, the National Agrobiodiversity Center has remained committed to enriching its collection with foreign genetic resources, elevating its status to a world-class plant genetic resources (PGR)- holding genebank. Currently, several steps are being undertaken to improve the accessibility of the collection to national as well as international researchers, improve the data available on the resources, and amend the passport information for the accessions. With the implementation of the Nagoya Protocol, the origin of genetic resources is being highlighted as an important input in the passport information. The RDA-Genebank actively responds to the Nagoya Protocol by supplementing passport data for resources lacking information on their origin. In addition, a large number of conserved resources are continuously multiplied, and agronomic traits are investigated concurrently. With the traditional methods of characterization of the germplasm requiring a significant amount of time and effort, we have initiated high-throughput phenotyping using digital techniques to improve our germplasm data. Primarily, we have started adding seed phenotype information followed by measuring root phenotypes which are stored under agronomic traits. This may be the initial step toward using largescale high-throughput techniques for a germplasm. In this study, we aim to provide an introduction to the RDA-Genebank, to adopted international standards, and to the establishment of high-throughput phenotyping techniques for the improvement of passport information.

Critical Review of the Increasing Complexity of Access and Benefit-Sharing Policies of Genetic Resources for Genebank Curators and Plant Breeders-A Public and Private Sector Perspective.

Plant breeders develop competitive, high-yielding, resistant crop varieties that can cope with the challenges of biotic stresses and tolerate abiotic stresses, resulting in nutritious food for consumers worldwide. To achieve this, plant breeders need continuous and easy access to plant genetic resources (PGR) for trait screening, to generate new diversity that can be built into newly improved varieties. International agreements such as the Convention on Biological Diversity (CBD), the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and the Nagoya Protocol recognised the sovereign rights of countries over their genetic resources. Under the CBD/Nagoya Protocol, countries are free to establish specific national legislations regulating germplasm access and benefit-sharing to be negotiated bilaterally. Consequently, access to PGR became increasingly restricted and cumbersome, resulting in a decrease in germplasm exchange. The ITPGRFA attempted to ease this situation by establishing a globally harmonised multilateral system (MLS). Unfortunately, the MLS is (still) restricted to a limited number of food and forage crops, with very few vegetable crops. Easy and continuous access to genetic diversity combined with equitable and fair sharing of derived benefits is a prerequisite to breeding new varieties. Facilitated access contributes to sustainable crop production and food and nutrition security; therefore, access to and, consequently, use of PGRFA needs to be improved. Thus, the authors recommend, among others, expanding the scope of the ITPGRFA to include all PGRFA and making them and all related information accessible under a Standard Material Transfer Agreement (SMTA) combined, if necessary, with a subscription system or a seed sales tax. Such a transparent, functional and efficient system would erase legal uncertainties and minimise transaction costs for conservers, curators and users of genetic resources, thus aiding plant breeders to fulfil their mission.

Improving awareness, understanding, and enforcement of responsibilities and regulations in Blue Biotechnology.

Blue Biotechnology is developing rapidly worldwide. However, the Nagoya Protocol (NP), Responsible Research and Innovation (RRI) and other regulatory requirements in this field are falling behind. This article identifies the main RRI, NP, and regulatory gaps and provides key recommendations to mitigate these challenges.

International agreements and the plant genetics research community: A guide to practice.

Plant genetic resources (PGR), including collections held in national and international gene banks, provide access to a wide array of genetic diversity and are critical to genomics research, conservation efforts, and applied breeding. Yet, there is a general lack of awareness in the research community about the rules and treaties that govern the use of PGR, about access and benefit sharing obligations contained in international treaties and/or national laws, and about how best to comply with potentially applicable requirements. This article provides a brief history and overview of three key international agreements, namely the Convention on Biological Diversity, the Nagoya Protocol, and the International Treaty on Plant Genetic Resources for Food and Agriculture, which collectively address responsibilities and obligations related to the use of much of the world's PGR. By highlighting the coverage and key considerations of each agreement, the article provides a guide for those who use PGR in plant genetics research to better understand when and how international agreements apply, and-where the rules are unclear-to suggest best practices for compliance with existing agreements.

Regulatory Frameworks for the Access and Use of Genetic Resources in Latin America.

The Nagoya Protocol is a legal framework focused on the Access and Benefit Sharing of genetic resources, including Biological Control Agents. In order to comply with the Nagoya Protocol, countries in Latin America are establishing legal frameworks for access to genetic resources. Scientists face the challenges of the bureaucratic and administrative burden to obtain the access permits to study the biodiversity present in Latin American countries, which include the evaluation of biological control agents that can be used in sustainable production programs. In order to avoid the demotivation of scientists and students to work on biological control by blocking the opportunities to get new bioproducts, it is important to increase the communication between the regulatory authorities and the scientific community, to ensure the establishment of an effective structure and mechanisms to facilitate the process and reduce the time needed to obtain the access permits. On the other hand, the establishment of regional platforms for the exchange of information and harmonization of procedures can contribute to reinforce the collaboration among Latin American countries and facilitate regional studies and biocontrol activities. In this article, the legal framework in place in different countries in Latin America will be discussed and some possible solutions and ways forward to the major challenges observed will be presented.

The Trouble Is, You Think You Have Time: Traditional Knowledge of Indigenous Peoples in Japan and India, the Reality of Biodiversity Exploitation.

This paper aims to illustrate the crucial role of preserving, protecting and managing the environment by Indigenous Peoples in Japan and India. Traditional Knowledge has provided the ability to detect, understand and respond to environmental changes. However, modern science and applied technology often fall short of sustainable practices, acquired through 'centuries of local observation'. Our consumer-centric world has unravelled a sad situation that has contributed to an irretrievable climate crisis. Multilateral instruments, however, have come to the rescue. In this journey, Japan and India have shown the world some constructive initiatives with positive outcomes which could go a long way in achieving the UN-SDGs.

Digital Sequence Information between Benefit-Sharing and Open Data.

Currently, parties to the Convention on Biological Diversity (CBD) are negotiating a strategic plan to save biodiversity. One crucial element of an agreement is the question of whether and how digital sequence information (DSI) is subject to access and benefit-sharing from the utilization of genetic resources, one main instrument of the CBD. In the EU, the Open Data Directive (ODD) of 2019 and the recently adopted Data Governance Act (DGA) already cover research data and to some extent DSI. An analysis of the ODD and the DGA throws a spotlight on the legal uncertainty of utilizing DSI and reveals systemic tensions between open data principles and benefit-sharing restrictions on non-commercial use. It also suggests that a future benefit-sharing mechanism for DSI should avoid distinguishing between commercial and non-commercial use upstream, but should instead favor a solution, which imposes benefit-sharing obligations further downstream or outside of the DSI life cycle.

Digital Colonialism and the Fourth Industrial Revolution - Preventing Exploitative Bio-economies.

As the traditional use of non-human genetic resources in research and development is increasingly ceded to computerised research activities, current frameworks for access and benefit-sharing face an impending identity crisis. The absence of international consensus on the regulation of digital sequence information presents a critical point of social division between the Global North and Global South, whereby a culture of "open data" promises immeasurable opportunity in high-income nations and threatens a wave of digital bio-piracy for vulnerable communities. This article critically evaluates these problems and considers solutions which draw on Indigenous Data Sovereignty principles. To do so, it uses the recent experience in Queensland to explore how the law might reconcile and balance these competing interests. Insofar as Queensland is one of the most mega biodiverse regions on earth, boasts a globally competitive life sciences sector, and has a vibrant and longstanding Indigenous population, it offers a unique case study.

Biodiscoveries within the Australian plant genus Eremophila based on international and interdisciplinary collaboration: results and perspectives on outstanding ethical dilemmas.

In a cross-continental research initiative, including researchers working in Australia and Denmark, and based on joint external funding by a 3-year grant from the Novo Nordisk Foundation, we have used DNA sequencing, extensive chemical profiling and molecular networking analyses across the entire Eremophila genus to provide new knowledge on the presence of natural products and their bioactivities using polypharmocological screens. Sesquiterpenoids, diterpenoids and dimers of branched-chain fatty acids with previously unknown chemical structures were identified. The collection of plant material from the Eremophila genus was carried out according to a 'bioprospecting agreement' with the Government of Western Australia. We recognize that several Eremophila species hold immense cultural significance to Australia's First Peoples. In spite of our best intentions to ensure that new knowledge gained about the genus Eremophila and any potential future benefits are shared in an equitable manner, in accordance with the Nagoya Protocol, we encounter serious dilemmas and potential conflicts in making benefit sharing with Australia's First Peoples a reality.

Responsible Research and Innovation Framework, the Nagoya Protocol and Other European Blue Biotechnology Strategies and Regulations: Gaps Analysis and Recommendations for Increased Knowledge in the Marine Biotechnology Community.

As the quest for marine-derived compounds with pharmacological and biotechnological potential upsurges, the importance of following regulations and applying Responsible Research and Innovation (RRI) also increases. This article aims at: (1) presenting an overview of regulations and policies at the international and EU level, while demonstrating a variability in their implementation; (2) highlighting the importance of RRI in biodiscovery; and (3) identifying gaps and providing recommendations on how to improve the market acceptability and compliance of novel Blue Biotechnology compounds. This article is the result of the work of the Working Group 4 "Legal aspects, IPR and Ethics" of the COST Action CA18238 Ocean4Biotech, a network of more than 130 Marine Biotechnology scientists and practitioners from 37 countries. Three qualitative surveys ("Understanding of the Responsible Research and Innovation concept", "Application of the Nagoya Protocol in Your Research", and "Brief Survey about the experiences regarding the Nagoya Protocol") indicate awareness and application gaps of RRI, the Nagoya Protocol, and the current status of EU policies relating to Blue Biotechnology. The article categorises the identified gaps into five main categories (awareness, understanding, education, implementation, and enforcement of the Nagoya Protocol) and provides recommendations for mitigating them at the European, national, and organisational level.

Sharing genetic resources fairly between nations.

The global governance of natural resources was established initially by Convention on Biodiversity(CBD) in 1992 followed by Nagoya Protocol(NP) in 2010 with an objective of ensuring fairness and equitable benefit sharing arising from the exploitation of genetic resources creating incentive at the same time for the conservation and sustainable use of such resources. The framework has been criticized for its inefficiency in achieving its objectives. Recently it has been the subject of debate on whether digital sequence information is covered by the term 'genetic resources'. There are divergent views in different countries on how digital sequencing information (DSI) should be defined and whether the information derived or non-tangible aspect of genetic resources should also fall under the ABS regime. The present paper analyses the Indian position on these points.