Law and Marine Genetic Resources

Abstract

From a legal perspective, these are exciting times for marine genetic resources (MGR). After years of debate about MGR beyond national jurisdiction, famously encapsulated in the idea of the “deepest of ironies” in ocean affairs, a United Nations process began, focused on drafting an Agreement on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction (BBNJ) and with a clear mandate to address MGR. This agreement has the capacity to unravel issues that remain to be solved, particularly when linking MGR with the marine scientific research regime established by the United Nations Convention on the Law of the Sea and with the provisions of the Nagoya Protocol and the TRIPS Agreement, or when addressing MGR under national jurisdiction.

This chapter will consider the web of legal regimes for MGR, including the complexities surrounding marine spaces, such as the extended continental shelf. After providing a comprehensive analysis of both international law—UNCLOS, CBD, the TRIPS Agreement and the upcoming BBNJ Agreement—and national legislation, the chapter will conclude that an all-encompassing approach is required when dealing with MGR.

1 Introduction

“Le développement des biotechnologies s’était jusqu’alors déroulé dans une sorte de Far West juridique, dans les interstices du droit de la mer, de l’environnement et de la propriété intellectuelle” (Coutansais 2010, p. 208).

In his work Mare Liberum, Hugo Grotius famously stated that “if many hunt on the land or fish in a river, the forest will soon be without game and the river without fish, which is not so in the sea” (Grotius 1916).¹

This is now known to be untrue and resources depletion is a serious problem in the ocean. But it is also now clear that the variety of resources in the ocean is greater than ever imagined; new species and organisms are being discovered every day, and a significant number of these are microorganisms. Research in this field has led to an important finding: the genetic potential of marine resources.

Marine genetic resources (MGR) are “informational biological resources” (Marques 2007, p. 380). As natural resources, they are distinct from classic natural resources such as fisheries, because the value of a genetic resource is not the physical substance in itself but the genetic information of the resource, which means that without technological manipulation, the resource has little or no economic value beyond its obvious intrinsic environmental value and as a component of biodiversity.

The knowledge offered by MGR and their associated potential make them increasingly important in present-day societies. However, legal gaps remain, in areas both beyond and under national jurisdiction. At the international level, the United Nations Convention on the Law of the Sea (UNCLOS, 1982/1994), which created a “new regime for the ocean”, does not address genetic resources, despite containing some pertinent provisions on marine scientific research. The Convention on Biological Diversity (CBD, 1992/1993), the related 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 (Nagoya Protocol, 2010/2014) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement, 1994/1995) also apply, in part, to marine genetic resources. At the national level, many States have not yet outlined legal regimes.

The characteristics associated with marine genetic resources—their location in a fluid environment, sometimes simultaneously in spaces subject to and exempt from national jurisdiction, and the aim of evolving from research to exploration or exploitation—mean that a comprehensive and cohesive legal regime is required. Consequently, negotiations with a view to establishing a legal regime for marine genetic resources are currently taking place at the United Nations. At the same time, at the national level, countries need to address issues of borders and transboundary resources, sovereignty and ownership, access to and sharing of benefits, and intellectual property issues.

2 UNCLOS, CBD, Nagoya Protocol, TRIPS and the New BBNJ Agreement: An Intricate Web of Legal Regimes

2.1 Relevant Treaties and Protocols

The codification and development of the law of the sea received a decisive boost with the adoption of the United Nations Convention on the Law of the Sea, the so called “constitution of the oceans”.²

The new regime, of unusual magnitude and complexity, introduced numerous innovations, such as the concept of Exclusive Economic Zones (EEZ), changes in the legal definition of the continental shelf, the establishment of a comprehensive regime for marine scientific research, unprecedented rules for environmental protection, and a broad dispute settlement system—including a specialised International Court. It also created the regime of the Area, as common heritage of mankind, as well as an Authority to manage it.

The regime of the Area, corresponding to a space occupying about 30% of the total surface of the planet,³ is established in Part XI of the Convention and in the Agreement on the implementation of Part XI (1994). It sets out that mineral resources on the seabed and subsoil, i.e. beneath the water column, beyond national jurisdiction, belong to mankind and should be used for the benefit of mankind. Meanwhile, progress in scientific research has made it possible to detect the presence of living resources at great depths and in hostile environments, where genetic resources gain prominence as the focus of research and commercial interest.

MGR have significant biotechnological potential (Marques 2007, pp. 25–26),⁴ particularly those organisms that survive in environments with extreme pressure, acidity, darkness, temperature, heavy metal concentration or radioactivity. These resources are therefore called extremophiles or hyperthermophiles, or chemosynthetic organisms, because they chemosynthesize rather than photosynthesize.

The isolation of bioactive marine compounds from a Caribbean sponge (spongouridine and spongothymidine) in the 1950s allowed scientific research to conclude that these had anti-tumour and anti-viral characteristics (Luna 2015, p. 652).⁵ Since that time, the relevance of marine genetic resources has grown exponentially and science continues to demonstrate that the potential of these marine resources is vast, especially in the light of health challenges that have now become blatantly clear (Leary et al. 2009). Although they are still undervalued in commercial terms (Pearce and Moran 1994; Ngo et al. 2011; Newman and Cragg 2012), marine compounds are beginning to be developed from deep-sea resources, producing corresponding scientific and economic potential for the marine biotechnology market (Hunt and Vincent 2006).

The Convention on the Law of the Sea employs the terms “natural resources”, “non-living” and “living”, the latter being biological resources which in general “encompass all resources of or dependent on the sea that can be considered ‘living’ in UNCLOS terminology” (Dupuy and Vignes 1991, p. 993). It should be noted, however, that several of the UNCLOS living resources provisions explicitly target fish resources and that the concept of living marine resources is dynamic.⁶ As such, the application of UNCLOS to marine genetic resources may give rise to some difficulties of interpretation (Dupuy and Vignes 1991; Lawson and Downing 2002; Lallier et al. 2014).

The Convention on Biological Diversity is a positive step towards recognition of sovereignty and the conservation, use, access to and sharing of biological resources, including MGR.

Article 2 of the CBD states that the term “Biological resources” includes “genetic resources, organisms or parts thereof, populations, or any other biotic component of ecosystems with actual or potential use or value for humanity”. Biological resources thus include genetic resources, which the same article defines as “genetic material of actual or potential value”. The distinction between the two, although the latter is part of the first, is based fundamentally on teleological or functional criteria.

The CBD also defines “biological diversity” (or “biodiversity”) as “the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems” (Article 2).

While the UNCLOS to some extent represented a “quantitative” concept of resources, focused mainly on fisheries, the Convention on Biological Diversity recognises the plurality and diversity of resources, including genetic resources.

Despite explicitly recognising the hierarchical superiority of the UNCLOS (Article 22.2 of the CBD), the CBD, a framework convention, and later the Nagoya Protocol, enhanced and added detail to the regime for marine biological resources (including genetic resources), in particular with respect to access and benefit sharing.

Activities related to genetic resources fall along a continuum from scientific research to bioprospecting and commercial development. This distinction has occupied much of the doctrinal work in this area. The CBD’s Subsidiary Body on Scientific, Technical and Technological Advice, which has addressed the topic on several occasions, clearly describes the fuzzy nature of MGR-related activities:

“While marine scientific research is primarily undertaken with a view to furthering knowledge of the evolutionary relationship between various organisms or of the adaptive mechanisms allowing organisms to thrive in an extreme environment with unique characteristics, some prospective activities are run to discover commercially useful information and resources for subsequent industrial, chemical, agricultural or medical purposes. However, what may have been, in the first place, an expedition with scientific purposes, where intent of economic gain was absent, may result in the genetic resources being transferred to industry for biotechnological applications.”⁷

The entry into force of the CBD introduced into the debate the issue of access to MGR and the sharing of benefits arising from them in areas under the jurisdiction of States, which was duly followed by discussions on intellectual property rights over biotechnological innovations (Marques 2007, p. 376).

In this regard, Article 15 is among the most relevant provisions on access to MGR and should be read in the light of Article 3. Article 15 is a clear example of the duality of the Convention, guaranteeing both the sovereignty of States over their genetic resources (paragraph 1) and, simultaneously, the presumption that access to these resources should be provided (paragraph 2). Article 15(2) sets out the CBD’s objectives of facilitated access to resources and equitable and fair benefit sharing. The importance of Article 15 is at odds with the absence of a consistent effort to explore the links between this article and Part XIII of the UNCLOS (marine scientific research), with both frameworks creating prior consent obligations that should be articulated. Access to genetic resources is not guaranteed de jure but the Convention hints that it should be granted de facto, reflecting the attempt to balance sovereignty and access to genetic material (Noiville 1998).

Article 15 emphasises that access is subject to prior informed consent, and is granted on mutually agreed terms. It refers to a duty to seek to involve the Contracting Parties who have supplied genetic resources in any scientific research based on those resources, and also the duty of Contracting Parties to take legislative, administrative or policy measures to bring about a fair and equitable sharing of the results and benefits achieved, with proactivity of States being explicitly called for. The reference to “mutually agreed terms” alludes to a preference for bilateral contracts (Scheiber 1999; Marques 2007, p. 509).⁸

The Nagoya Protocol, adopted at COP 10, seeks to build on the foundations established by Article 15 of the CBD. Its generic formulation is the outcome of difficult negotiations, and distinguishing between genetic and biological resources proved to be complex: for the purposes of the Nagoya Protocol, resources are only biological resources used as genetic resources.

The issue of access is particularly relevant, and one of the challenges is to understand how exactly “access” should be defined and under what circumstances supplier countries are in breach by “denying” access—a particular concern for some countries. Article 6 of the Protocol regulates this aspect, establishing the sovereignty of States over their resources, and defining that access is subject to prior information and consent of the provider country.

The Protocol additionally establishes that benefits arising from the utilization of genetic resources and their applications shall be shared in a fair and equitable way, and on mutually agreed terms, with the provider of the resources (Article 5). Again, this is a concern for some countries, often those that are “resource-rich” and “technologically-poor”. The aforementioned benefits may be monetary or non-monetary, including access to and transfer of technology, and collaboration and cooperation in research and development programs (Article 23). The Nagoya Protocol further details provisions on compliance, monitoring and measures to deal with non-compliance, prior informed consent and mutually agreed terms requisites.

One of the main novelties of the regime introduced by the Protocol was the caveat that Parties must take into consideration the “intention” or “purpose” of the research, reflected in Article 17, pointing to the blurred line between non-commercial and commercial use (Lallier et al. 2014).⁹

The Protocol relates not only to the UNCLOS, but also to the TRIPS Agreement, with the three of them forming the research/exploitation triangle (UNCLOS—CBD/Nagoya—TRIPS) for genetic resources. Intellectual property rights have a direct and effective link with the Protocol, in particular through Article 27 of the TRIPS Agreement, and there has been an in-depth debate on the relationship between these instruments, notably concerning whether or not there is an obligation to disclose the country of origin of the resource when a patent application is submitted.

The debate around MGR, in marine scientific research and bioprospecting, is clearly related to intellectual property.¹⁰

Intellectual property rights are essentially territorial, and determined by States, although conditioned by applicable international conventions. Thus, whether it relates to marine genetic resources located under national jurisdiction or to those beyond national jurisdiction, intellectual property is regulated by the State where that right is sought, regardless of its origin.¹¹

Several patent law dilemmas arise in the debate about genetic resources: the distinction between invention and discovery, the exclusion criteria of public policy, the patentability of living organisms, and the trade-off between patents and plant and species protection (OECD 2002, p. 74). And the current circumstances, in the aftermath of a pandemic outbreak, raise further questions regarding patent law and its role in society. Nevertheless, what is indisputable is that the genes of marine organisms are the subject of an increasing number of patent applications.

The Doha Ministerial Declaration recognised the need to further study the TRIPS Agreement and the CBD, and the Council for TRIPS was mandated to review Article 27(3)(b).¹² The relationship between the TRIPS Agreement and the CBD, including on the important issue of “disclosure”, has been the subject of much debate regarding the proper fora to address this matter—national legislation, the WTO, the CBD or another forum—but as yet no agreement exists (Plahe et al. 2021).

2.2 The Relevance of the Future BBNJ Agreement

In recent years, one of the stages where this debate has taken place is at the negotiating table for an international legally binding instrument under the United Nations Convention on the Law of the Sea on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction.

In 2012, at the United Nations Conference on Sustainable Development (Rio +20), States made a commitment to address “the issue of the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction, including by taking a decision on the development of an international instrument under the United Nations Convention on the Law of the Sea”, in the document “The Future we Want” (endorsed by General Assembly Resolution 66/288 of 27 July 2012).

This decision was followed by a two-year process, led by a Preparatory Committee (established by Resolution 69/292 adopted on 19 June 2015), after which the United Nations General Assembly adopted Resolution 72/249 (24 December 2017), convening an Intergovernmental Conference (IGC) to develop an international legally binding instrument on marine biodiversity in areas beyond national jurisdiction.

The agreement aims to strengthen the governance framework for areas beyond national jurisdiction, including MGR, and the related sharing of benefits, but also for area-based management tools, environmental impact assessments and capacity-building and the transfer of marine technology.

MGR are among the most complex issues in the BBNJ Agreement. During the negotiations, divisions became visible, mirroring other processes such as that of the Nagoya Protocol, and highlighting the divide between developed and less developed countries, or between the so called “Global North” and “Global South”.

Several contentious issues related with the MGR regime persist, including issues of access and the sharing of benefits. The nature of such benefits involves, once again, consideration of monetary and non-monetary benefits (including training and sharing of data, among others) or the removal of this binary divide, on the grounds that non-monetary benefits also carry “costs”.

Similarly, there is also the question of commercial vs. scientific research, connected with the major topic of bioprospecting, which raises questions of access to data and intellectual property rights, and requires an understanding on the use of MGR, either for research and development or for exploitation. The connection with the Nagoya Protocol, albeit within different jurisdictions, is evident (Bonfanti and Trevisanut 2011).

3 The Extended Continental Shelf Case: Interconnection Between National and International Law

The regime of the continental shelf and the circumstances of its extension have given rise to an area that, to some extent, can be considered “hybrid”: the continental shelf beyond 200 nautical miles. In this instance, there is the need to articulate the powers exercised in an area under national jurisdiction, the outer continental shelf, with an overlying area where there is freedom of the high seas, taking into account that the two spaces are necessarily interconnected. The UNCLOS establishes that the exercise of the rights of the coastal State on the continental shelf must not affect the regime of freedom that exists in the water column (nor in the overlying air space, according to Article 78). However, the coastal State is also entitled to protect its space and resources. The question is thus one of striking a balance, which is not always clear, between the interests of the coastal State and those of the States as beneficiaries of the freedom of the seas (Molenaar 2007; Mossop 2007).

The fact that, in this space, the seabed and subsoil are under the jurisdiction of the coastal State, while the overlying water column belongs to the high seas, marks a real difference from the shelf under the 200-mile limit where, in principle, the water column corresponds to the EEZ of the same coastal State. Although the freedoms of the high seas are not challenged, in principle it is easy to foresee situations where this is de facto the case, when navigation or fishing activities, to cite the main examples, affect the activities carried out on the seabed, or vice versa. Furthermore, beyond the 200 miles lay several deep-sea ecosystems, where the richness of biological resources is vaster.¹³

The interrelationship between different maritime spaces has been confirmed by additional advances in scientific knowledge, and as research intensifies, so does the pressure for and emergence of new economic opportunities. Several States have established delimitation and sharing agreements in this sense, demonstrating through joint development schemes that interconnection is critical (Becker-Weinberg 2014), particularly when considering MGR.

4 Genetic Resources Under National Jurisdiction

The international debate concerning a legal regime for marine genetic resources also arises under national legal frameworks.¹⁴

MGR often straddle legal and political boundaries. Organisms found within areas of national jurisdiction at some point may later be found beyond areas of national jurisdiction and vice-versa.¹⁵

National legislation is required to pursue the objectives set forth in the CBD and the Nagoya Protocol, since most of the CBD provisions are not “self-executing”, and many depend on “further and eventual densifying legislative activity of the contracting States” (Marques 2007, pp. 404–405). The European Union, for its part, approved Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April, on measures relating to user compliance with the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization. Following this Regulation, in Portugal Decree-Law 122/2017, of 21 September, was subsequently passed. The Decree-Law addresses several aspects related to the identification, access, use, conservation and sharing of the benefits of MGR.

In addition to the relevant international treaties and agreements, Decree-Law 122/2017 is key to the regulation of MGR, and specifically highlights the potential of MGR located under national jurisdiction (territorial sea, EEZ and the continental shelf) in terms of “scientific research, bioprospecting and exploration/exploitation”.

Despite the legal framework in place, a few key issues remain uncertain. The first pertains to access. With different specificities, both the UNCLOS and the CBD are based on a delicate balance between protecting the sovereignty of States and the duty of these States to give, under normal circumstances, their consent to scientific research and access to resources. Since sovereignty over resources belongs to the States where they are located, regulated by national law, the CBD recognises that the “source nations” may also be entitled to the benefits of the resources to which they have ceded access (McLaughlin 2003). Patents on marine genetic resources may therefore include, in addition to the patent holder, the State providing the resource. This principle, allowing benefits to the State of origin of the resources i.e. the “source State”, entails some difficulties, as previously stated. The first concerns the non-obligation to disclose the origin of the patented resource. The second relates to transboundary resources and issues of endemism, given that organisms found in different ocean spaces—which also introduces border delimitation implications—have been found to have similar genotypes. This has implications for patents on genetic resources—specifically those located in different national spaces and border areas—and for disclosure requirements.

This is particularly important for Portugal, as a “resource-rich country” where numerous scientific cruises from foreign countries take place (Gonçalves and Gameiro 2018).

In this connection, disclosure issues are also relevant. Portugal, like several other States, defines an obligation of disclosure of origin (through sampling or filing) when it comes to biotechnological inventions. The nature of intellectual property rights makes this a key issue. Indeed, while the obligation of disclosure exists in Portugal, it may not exist in another jurisdiction where a sample collected in Portugal is registered and non-disclosure of the origin of the resource makes it difficult to share any ensuing benefits.

The Nagoya Protocol recommends that Parties create mechanisms to address potential complications, but these are often voluntary, at best. Decree-Law 122/2017 also details monitoring tools, including disclosure of research funding (Article 8), considering the “intent” or “purpose” of the research, i.e. non-commercial or commercial.

Finally, there is the question of geographical divisions. While the legal framework for spaces under national jurisdiction can be considered to be broadly set, despite relevant gaps, the same cannot be said for “hybrid spaces”, i.e. the extended continental shelf, particularly considering the high seas regime, and its entailing freedoms on the water column above.

5 Conclusion

The ocean is a physical ecosystem where the law reveals its plasticity, promoting a dialogue between different areas, both nationally and internationally, as well as a favourable ground for interaction with other sciences.

Although traditionally dominated by lege ferenda, the international community has defined a lege data instrument in this field, including a dispute settlement system and a judicial building. However, despite its many achievements, the established regime (and the subsequent instruments) remains at odds with the very specific nature of such a space and particularly, in the case of MGR, the very specific nature of such resources.

The new challenges posed by the discovery of and growing interest in MGR are widening gaps in the established structure of the law of the sea. But they are also opening new fields of inquiry.

There is a clear demand for regimes that address MGR in a comprehensive manner—articulating marine scientific research and bioprospecting, exploration and exploitation, sovereignty, and intellectual property rights, at the international and national levels. However, the path is not a clear one, as evidenced by the BBNJ Agreement negotiations rounds.

The characteristics associated with marine genetic resources—the fact that they have no intrinsic commercial value (despite having ecological value), being dependent on laboratory transformation and a patentability regime that affects them, the legal uncertainty that surrounds them at international and national level, accentuated by the particular environment in which they live (the ocean), with clear differences in relation to the terrestrial environment—result in challenges that a watertight legal approach cannot solve when confronted with the ecological, economic and political realities under development in this field.

And yet, in an area where the interconnectedness between national and international jurisdictions is so evident, an international solution is paramount.

It should be noted that the main concerns raised in relation to MGR have been the same over the last decades. Issues of origin and disclosure were raised in the Doha Declaration of 2001 and are among the most contentious issues of the BBNJ Agreement negotiations, as they were at the Nagoya Protocol negotiations.

The boundaries between scientific research and commercial interests, and the ensuing intellectual property regime and royalties’ issues, were the subject of heated debate between 1973 and 1982, during the negotiations for the UNCLOS. These issues remain under scrutiny today.

Despite the different agreements and negotiations currently in existence, a consensus on the BBNJ Agreement will—we believe—unlock the Gordian knot of MGR, fostering greater consensus in other fora, such as the TRIPS Agreement or national legislation.

This explains the key relevance of the new agreement on the law of the sea, where MGR play a prominent role. Conversely, the international negotiations for an agreement with a clear focus on MGR also highlight the importance of such resources in years to come. The journey appears to be just beginning.