Access to and use of marine genetic resources: understanding the legal framework

Societal Impact StatementSeaweed cultivation is the fastest‐growing aquaculture sector, with a demonstrable potential to drive development in some of the poorest coastal populations worldwide. However, sustainable exploitation, fair access and equitable benefits from marine genetic resources, such as seaweeds have yet to be fully realised. Patchy fundamental knowledge on the genetic diversity and metabolic potential of algae limits their exploitation; scant practical skills and low investment in breeding restricts germplasm availability and the Nagoya protocol has only partially remediated insufficient governance. Further developments and the addressing of knowledge gaps in relation to biosecurity, breeders’ rights and conservation of genetic resources are needed for progress.SummaryWe review how seaweed genetic resources are currently used in aquaculture, in relation to the diversification and rapidly increasing use of marine resources. Using a revealing case‐study, we summarise the potential for positive societal change, underpinned by the cultivation of eucheumatoid carrageenophytes (species of the red algal genera Eucheuma and Kappaphycus), an activity which has been successfully initiated in many tropical countries to support their economic development. We also review the challenges currently faced by this industry and identify potential threats to the seaweed cultivation sector. Accordingly, we suggest new directions to support the continued development of an economically resilient and environmentally sustainable industry based on the utilisation of genetic resources.

The legal landscape regulating the access to and utilisation of genetic resources has changed with the entry into force of the Nagoya Protocol in 2014 and the adoption of the related EU Regulation on user compliance in 2014. Moreover, many countries are now adopting laws that regulate access to their genetic resources and thier utilisation. This has clear implications for scientists working on genetic resources, including those doing biotechnology research on marine organisms, as well as any user of genetic resources along the biodiscovery pipeline. This chapter informs users on their obligations under the access and benefit-sharing legal framework, with a focus on their application to marine genetic resources, for which the United Nations Convention on the Law of the Sea (1982) is also relevant. The difference between (domestic) access legislation to genetic resources and the compliance mechanisms, such as the Nagoya Protocol and the EU Regulation 511/2014, is explained in detail. A more practical description is then presented in a step-by-step approach, which can serve as a basic guideline for scientists.

Objective: We seek to understand the definition of marine genetic resources and marine biological resources, placing it in the historical context of narratives of international law of the sea. We seek to look into the content of common heritage of mankind towards MGRs. We seek to analyze the international legal framework of extraction and use of MGRs while securing easy access to them in accordance with the concept of common heritage of mankind. We seek to investigate the international legal regulation of biopiracy in legal research. The authors consider the importance of necessity to fulfil the lack of the universal definition of biopiracy in relation to MGRs in International Law of the Sea.Methodology: The research uses general scientific and special cognitive techniques wherein legal analysis and synthesis, systemic, formal-legal, comparative-legal, historical-legal and dialectical methods are applied.Results: We found out that for the first time ever, the legal protection of the intangible MGR heritage belonging to indigenous peoples and local communities is going to be universally fixed by maritime law. The law will also establish a special mechanism to control the concerned parties’ access to this knowledge. The traditional knowledge of indigenous peoples falls within the definition of intangible cultural heritage. This fact raises a question about an overlap between the future Agreement and the Convention for the Safeguarding the Intangible Cultural Heritage. Though the sphere that is going to be regulated by the future Agreement is very specific, many of its provisions build upon the previously adopted international legal instruments like the UN Convention on the Law of the Sea, the Convention on Biological Diversity, and the IOC Criteria and Guidelines on the Transfer of Marine Technology. Moreover, the scope of the Agreement might overlap with the scope of other international instruments, which have nothing to do with marine law, marine ecology, and marine biodiversity, e.g. the Convention for the Safeguarding the Intangible Cultural Heritage. All the aforementioned aspects should trigger further studies of the legal framework of marine genetic and biological resources. The authors came to the conclusion to extend the concept of the common heritage of mankind to marine genetic resources and we found out the fact that the lack of international legal regulation of the extraction and use of marine genetic resources while securing facilitated access to them in accordance with the concept of the common heritage of mankind, which may lead to an increase in the commission of acts of biopiracy.Contributions: Following a review of the content, we raised possible problems, strategies, suggestions and guidelines for the marine genetic resources and biopiracy.The authors conclude that the implication of the principle of the common heritage of mankind to MGRs may further generate conflicts of law because it is impossible to imply this principle to the high seas. On top of it, the simplified access to MGRs together with the lack of protection of intellectual rights to MGRs and genetic information may result in the overexploitation of marine and oceanic resources as well as the spread of biopiracy. We also point out that it is necessary to find a balance between the freedoms of the high seas, the safeguard of MGRs, and the protection of intellectual property rights to genetic information or marine biotechnologies. The researches considered the distinction between the concepts of marine biological and marine genetic resources and revealed the problems of international legal regulation of the use of marine genetic resources. The authors conclude that generalization of the international legal framework for regulating the use of marine genetic resources needs legal improvement. The authors encourage the complement to the international legal regulation of the universal definition of marine genetic resources and biopiracy.

The Expansion of National Sovereignty and China's Legal System on Genetic Resources The tenth Conference of Parties of Convention on Biological Diversity adopted the Nagoya Protocol on the Access to Genetic Resources and the Fair and Equitable Sharing of Benefits on 29 October 2010 in Nagoya, Japan. In accordance with its Article 32, The Nagoya Protocol was opened for signature by Parties to the Convention from 2 February 2011 until 1 February 2012. In total, 92 countries have signed the Nagoya Protocol and 26 have already ratified it. The Nagoya Protocol will enter into force after ratification by fifty states. Recently EU has shown a move of ratifications for the Nagoya Protocol and Bolivia, Brazil, China, Colombia, Costa Rica, Democratic Republic of the Congo, Ecuador, Kenai, Madagascar, Malaysia, Peru, the Philippines, Venezuela, and the LMMC(Like-Minded Mega-diverse Countries) that have not ratified the Nagoya Protocol are increasing probability to ratify. Also, Many countries interested in ABS(access to genetic resources and benefit-sharing) has shown a move of ratifications. After the CBD in 1993, the objective of fair and equitable sharing of benefits arising from the utilization of genetic resources has been a big issue. To negotiate the international regime for ABS of genetic resources is a main mandate for in the past years and ABS becomes an inevitable international norm by the adoption of the Nagoya Protocol. The objective of the Nagoya Protocol is the fair and equitable sharing of the benefits arising from the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and thereby contributing to the conservation of biological diversity and the sustainable use of its components. According to the Protocol, the main principles of ABS include that 1) it should approve the sovereign right of the nation-states on genetic resources, 2) it is required to obtain PIC(prior informed consent) from provider countries, and 3) users and providers of genetic resources should share benefits equally from the utilization of genetic resources, with the contract on the basis of MAT(mutually agreed terms). Parties to the Nagoya Protocol are required to enact related domestic laws and necessary administrative and politic actions, in order to enforce the principles of ABS. In these circumstances, each country is increasing the level of public awareness about Nagoya Protocol and protection of genetic resources through taking domestic measures. In particular, China that our largest trading partner is trying for protection of genetic resources and traditional knowledge associated with genetic resource and be watched intently foreign legislation and measures. If Nagoya Protocol will enter into force, With China that share the traditional knowledge associated with genetic resources of the same type, genetic resources dispute is foretold. And seen the entry into force of the Nagoya Protocol is a matter of time, can be seen to have reached the desired point in time to respond to this.

The legal landscape regulating the access to and utilization of genetic resources has changed with the entry into force of the Nagoya Protocol in 2014, and the adoption of the related EU Regulation on user compliance in 2014. Moreover, many countries are now adopting laws that regulate access to their genetic resources. This has clear implications for scientists working on genetic resources, including those doing taxonomic and biotechnology research on marine microorganisms. The first part of this chapter informs the scientific community on the Access and Benefit-Sharing (ABS) legal framework, including a focus on their application to marine genetic resources, for which the United Nations Convention on the Law of the Sea (1982) is also relevant. The difference between (domestic) access legislation to genetic resources, and the compliance mechanisms, such as the EU Regulation 511/2014 is explained in detail. A more practical description of ABS related obligations is then presented in a step-by-step approach, which can serve as a basic guideline for scientists.

This article examines the legal challenges associated with the utilization of marine genetic resources (MGR) at both the national level and beyond national jurisdiction (BBNJ). The legal challenges addressed are as follows: 1) MGR are located across various jurisdictions, encompassing both national and international domains. The analysis starts with an overview of the international regulations that govern the utilization of genetic resources (GR) and their influence on national legislation. It emphasizes the principle of state sovereignty over natural resources while defining MGR and determining ownership; 2) It further highlights the intersection of national and international laws, particularly in transboundary contexts and within Indigenous and Afro-descendant peoples (IADP) territories, analyzing how these regulations are interpreted and applied in such scenarios; 3) The legal challenges related to the use of MGR in international waters are examined. Special emphasis is placed on the recent United Nations (UN) Agreement concerning this issue. This includes an analysis of its impact and specific provisions related to the utilization of MGR, such as the quantity to be collected, the methodology employed, collection sites, among others. The article concludes by asserting that the equitable distribution of benefits from the use of GR should begin at the earliest stages of access to these resources, including project planning and sample collection, rather than being delayed until the patenting and commercialization phases. Early benefit-sharing is essential for promoting fairness and equity in the use of MGR.

The object of research of this article is interstate relations in the field of legal regulation of the use of marine genetic resources. The author presents a detailed analysis of the concept of "marine genetic resources", draws a distinction with other similar concepts used in international legal acts. The current international legal acts in this area are considered in detail, as well as the draft of an International legally binding Document on the conservation and sustainable use of marine biological diversity in areas beyond the limits of national jurisdiction. A number of problems related to the international legal regulation of the use of marine genetic resources are identified. Comparative legal analysis, formal legal, formal logical and system methods, methods of analysis and generalization were used as the main methodology of the study. The novelty of this study lies in the fact that at the moment there is no universal international legal act that would regulate the use of marine genetic resources. It is also necessary to note a small number of scientific papers, mainly by foreign authors, devoted to this topic. At the same time, such resources have found wide application in various branches of science and production. Taking into account the above, it seems relevant to conduct additional scientific research aimed at studying the international legal regime of marine genetic resources. As a result of the presented research, the analysis of the concepts of "marine genetic resources", "genetic material", "marine biological resources", "living marine resources" was carried out. A number of problems in the international legal regulation of this sphere have been identified. So, in particular, the extension of the principle of the common heritage of mankind to marine genetic resources, if it is impossible to extend this principle to the open sea, may further generate legal conflicts. The author comes to the conclusion that it is necessary to further study the international legal regime of marine genetic resources.

Marine genetic resources other than fish and mammals are of increasing commercial interest and importance in genetic engineering, but fail being properly addressed in the law of the sea and in international economic law. The paper analyses the implication of the United Nations Convention on the Law of the Sea, the Convention on Biodiversity, the WTO Agreement on Trade Related Aspects of Intellectual Property Rights and related instruments under the auspices of WIPO. The paper argues that the triangle of these agreements does not adequately address marine genetic resources in particular in the high seas. Neither concerns of protecting biodiversity nor of access and benefit sharing find appropriate answers commensurate to the commercial potential of marine genetic resources. The paper suggests developing an instrument inspired by, and comparable to, the mechanisms developed by the International Treaty on Plant Genetic Resources for Food and Agriculture. The instrument would grant facilitated access to marine genetic resources and offer a more detailed set of rules with respect to the sharing of benefits resulting from their use, thereby addressing the existing legal gaps in a comprehensive way.

With the advent of synthetic biology, scientists are increasingly relying on digital sequence information, instead of physical genetic resources. This article examines the potential impact of this shift on the access and benefit-sharing (ABS) regime of the Convention on Biological Diversity (CBD) and the Nagoya Protocol. These treaties require benefit-sharing with the owners of genetic resources. However, whether “genetic resources” include digital sequence information is unsettled. The CBD conceives genetic resources as genetic material containing functional units of heredity. “Material” implies tangibility, and for some scholars, “functional units of heredity,” undefined in both treaties, mean full-coding sequences. This article argues that digital sequence information obtained from physical genetic resources, full-coding or not, should be treated as genetic resources. Literal construction of the CBD risks eroding its usefulness and the ABS regime. This is because through bioinformatics, sequence information can easily be obtained from genetic resources for utilization, without physically moving them or concluding ABS agreement with owners. The CBD must evolve with scientific progress also because sequence functionality depends on the state of knowledge. These arguments are vindicated by domestic ABS laws equating genetic information with genetic resources; Nagoya Protocol provisions deeming research exploiting the genetic composition of genetic resources as utilization of genetic resources; and CBD provisions requiring the sharing of benefits from the utilization of genetic resources. Moreover, treaty interpretation and case law demand that generic, scientific terms, such as “genetic resources” and “functional units of heredity” be interpreted in an evolutionary manner to capture scientific developments.

This study attempted to predict the effectiveness of prior informed consent (PIC) as a mechanism under the Nagoya Protocol (NP) through the case of Japan, a developed country with a wealth of genetic biodiversity. The NP to the Convention on Biological Diversity (CBD) aims at creating a virtuous cycle between biodiversity conservation and the utilization of genetic resources through fair and equitable benefit sharing. As PIC is a crucial component of the NP for promoting fair and equitable sharing, this study investigated whether introducing PIC creates a virtuous cycle. Considering the limitations of empirical data, this study adopted a policy Delphi comprising experts in an iterative group communication process that used consecutive questionnaires to reveal diverse issues as input for policymaking. We identified six related issues that were evaluated for the case of introduction and three for the case of no introduction of PIC. Their relative importance as a policy concern was measured through best–worst scaling to narrow down policy-relevant issues. This study revealed that contrary to the NP's intent, the overall contribution to the virtuous cycle is limited. In designing PIC mechanisms, policymakers must pay particular attention to bequest and research and development. This study identified three paths through which the negative impacts on research and development further negatively affect bequest, that is, slackening the identification of important genetic resources and ecosystems to conserve, disincentivizing biodiversity conservation for genetic resource use, and dampening ex-situ conservation efforts.

Advocates for conventional intellectual property systems argue that intellectual property rights create effective incentives for innovative use of biodiversity and lead to benefit-sharing arrangements with the holders of genetic resources and biodiversity. This chapter suggests that how intellectual property systems can protect and preserve marine genetic resources (MGRs), by reviewing relevant provisions of the Convention on Biological Diversity (CBD), Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Agreement) and the UN Convention on the Law of the Sea (UNCLOS) respectively. Recent advances in bio-science have created an enormous potential market for unique genetic material from MGRs. Developed countries are pursuing various policies to create high added value by combining genetic resources and science technology and they also emphasize transparent and easy access to genetic resources. Keywords:convention on biological diversity (CBD); marine genetic resource (MGR); trade-related aspects of intellectual property (TRIPS); United nations Convention on the Law of the Sea (UNCLOS)

Longstanding negotiations on the status of marine genetic resources beyond national jurisdiction under a new UN treaty oscillated between the common heritage of mankind and the freedom of the high seas. The final text of the new Biodiversity Beyond National Jurisdiction (BBNJ) Treaty bridges the normative dissonance by crafting a freedom of marine scientific research juxtaposed with the common heritage of humankind. This article argues that the principle is a specific carve‐out from the freedom of scientific research in the United Nations Convention on the Law of the Sea (UNCLOS), enumerated as one of the freedoms of the high seas. The principle of freedom of marine scientific research is best conceived as a property‐protected activity tethered to marine genetic resources where the scope and consequences of the activity demarcate the commons resource. It derives legitimacy and content from the common heritage regimes in UNCLOS as well as the operative elements of Part II of the BBNJ Treaty that address the equitable use of marine genetic resources and digital sequence information on marine genetic resources. As such, this element in the Treaty and the explanation set out here introduces a new and unprecedented constitutionalising norm in global biodiversity governance.

Protection of the Associated Traditional Knowledge on Genetic Resources: Beyond the Nagoya Protocol

This report examines whether it is possible for the research and use of marine genetic resources in areas beyond national jurisdiction (ABNJ) to follow an approach based on the system that is being used with plant genetic resources in areas within national jurisdiction, as developed by the Food and Agriculture Organization. Part IV of the International Treaty on Plant Genetic Resources for Food and Agriculture contains the multilateral system of access and benefit-sharing. In addition, the report considers the implications of relevant provisions as contained in the Law of the Sea Convention, the Convention on Biological Diversity, the Antarctic Treaty System, as well as instruments on intellectual property rights. The report concludes with an assessment of the options within existing legal frameworks for accommodating an access and benefit-sharing system for marine genetic resources originating from ABNJ, and provides suggestions to move the international debate forward.

The Agreement on Marine Biodiversity of Areas Beyond National Jurisdiction (BBNJ) is poised to play a critical role in regulating access to and benefit-sharing from Marine Genetic Resources (MGR) located in areas beyond national jurisdictions. MGR are increasingly valued for their potential in biotechnology, pharmaceuticals, and other scientific advancements, raising urgent questions about equitable benefit-sharing from these resources. The BBNJ Agreement introduces specific measures aimed at addressing these issues, but its effectiveness depends on harmonizing with other international frameworks, notably the Trade-Related Aspects of Intellectual Property Rights (TRIPS), the Convention on Biological Diversity (CBD), and the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (GRATK). This paper explores these intersections and identifies challenges to ensuring that benefits derived from MGR flow equitably to all parties, including developing nations and indigenous communities.First, the BBNJ Agreement brings to light the unique legal status of MGR in areas beyond national jurisdiction, where no single state holds sovereignty. Unlike the CBD, which primarily covers genetic resources within national territories, the BBNJ must address MGR in international waters, requiring cooperative frameworks among states. However, the agreement does not fully resolve the question of access rights or the distribution of benefits from MGR, which could result in exploitation by entities from wealthier nations unless robust regulations are established.Furthermore, while the CBD has advanced mechanisms for benefit-sharing, it focus on resources within national borders. The BBNJ will need to create parallel mechanisms suited for international waters, yet compatible with existing CBD and other instruments, to ensure a seamless integration of benefit-sharing practices. An additional challenge lies in identifying and recording the origin of genetic material in international waters to enable fair benefit distribution. Advances in traceability and transparency technologies, as well as international cooperation, will be essential for implementing effective monitoring under the BBNJ.In Latin America, and specifically in Brazil, the implementation of benefit-sharing for MGR presents unique challenges, especially where MGR are connected to traditional knowledge. In Brazil, many marine genetic resources are intertwined with the cultural practices and traditional knowledge of Indigenous and local communities, who have preserved and utilized these resources for generations. Additionally, regional cooperation within Latin America could foster a collective approach to these challenges, creating aligned benefit-sharing frameworks and reinforcing protections for traditional knowledge.In conclusion, implementing effective benefit-sharing mechanisms under the BBNJ Agreement will require addressing the legal and procedural gaps among BBNJ, TRIPS, CBD, and GRATK. It demands concerted international cooperation, regulatory innovation, and the deployment of new traceability technologies. Only through harmonization of these frameworks can the BBNJ’s goals be realized, ensuring that MGR from international waters serve as a shared resource and source of equitable benefits, particularly for those nations and communities historically marginalized in global resource-sharing arrangements. This paper proposes potential policy recommendations for navigating these complex intersections and ensuring that the promise of the BBNJ Agreement is fulfilled through fair, transparent, and inclusive benefit-sharing practices.