Marine Genetic Resources, R&D and the Law 1: Complex Objects of Use

By Bleuenn Guilloux

Advances in research and development reveal the immense diversity and potential of marine genetic resources. Under international law, no specific regime applies to these complex and paradoxical objects of use. The Law of the Sea Convention sets a framework that is partly inadequate for this new category of resources. The Biodiversity Convention and the Nagoya Protocol only address the genetic resources of national areas. Patents allow their holder to exercise a monopoly on exploiting biotechnological creations to extensive claims, questioning the common nature of biodiversity and related knowledge. They hinder research and the objectives of biodiversity law. The legal and practical rules of physical and functional access vary in geometry. They focus on the valorization of research results, crystallizing conflicts of interest between suppliers and users. Sustainable research and development is essential to the knowledge and protection of marine biodiversity. The qualification of marine genetic resources in common, standard contractual tools, distributed research and development infrastructures, negotiation of an agreement on sustainable use and conservation of biodiversity beyond the limits of national jurisdiction, would To remove these inconsistencies.

• Language: English
• Publisher: Wiley
• Release date: Jun 21, 2018
• ISBN: 9781119528166

Book preview

Foreword

Even though it is still relatively unknown, marine biodiversity is of considerable importance both at the scientific and technological levels. The continuous discoveries of sessile or vagile species demonstrate the complexity of marine ecosystem interactions, and the discoveries of genetic and biochemical properties of both sponges and plankton or cnidarians are beneficial to both pharmacopeia, cosmetics and biomaterials. This promising future could lead to what we could call a sea rush, whether it concerns the water column or the deep seabed. International law through the 1982 United Nations Convention on the Law of the Sea, the 1992 Convention on Biological Diversity, or subsequent conventions, did not anticipate the development of marine biology and its potential commercial consequences. The legal framework in force channels the exploration and exploitation of classical – mineral, fossil or halieutic fisheries – resources, but left a vagueness regarding the law applicable to marine genetic resources. It was then particularly interesting to guide legal work toward the research and development of marine genetic resources and their legal effects. This was the law PhD thesis of Bleuenn Guilloux, who did not hesitate to enter a multidisciplinary universe, which is certainly fascinating, but very difficult to capture between public international law, scientific research and intellectual property law, life sciences and related advanced technologies. This thesis, defended at the end of 2015, was rewarded in 2016 by the Paris Universities Chancellery-Sorbonne Mariani/Aguirre-Basualdo French national Prize 2016 in Law of the Sea.

In this book, based on the first part of her thesis, Bleuenn Guilloux studies the nature of marine genetic resources as complex objects of use. This high-quality work plunges the reader into a legal universe under construction, where the marine invertebrate or the cyanobacteria become natural resources within the meaning of the United Nations Resolution 1803, while they were formerly only objects of scientific investigation for biologists, with no legal status and therefore of free use. The study focuses on the relentless commodification of nature and scientific knowledge which becomes, according to the author, the cornerstone of the system of exchange and valorization of genetic material of any origin. This book covers both the marine scientific research regime through the expeditions of the last decade and the legal nature of genetic samples, like that of biological collections or related knowledge. The qualities of a legal expert, as well as the insightful curiosity of the author who has not hesitated to participate in marine biology work and to penetrate the very closed world of biomolecular engineering companies, mean that this high-quality work provides real answers on the nature of life, marine bioprospecting, and the commons thanks to its in-depth analyses and new ideas, but also and mainly with regards to the protection of the extraordinary marine biodiversity at the time of the sixth mass extinction of living species; a life source and a guarantee of survival for humankind.

Jean-Pierre BEURIER

Professor Emeritus

Law Faculty of the University of Nantes

Introduction

The ultimately unleashed Prometheus to whom science is hitherto giving unknown strengths and economics’ unresting drive calls for ethics that detains its power by voluntary reins from causing harm to others [JON 98, p. 15].

The marine world has always provoked fear and curiosity. In classical antiquity, some species which were hardly known were used as medicines or as poisons1. As fear receded due to the progress of knowledge, the curiosity of human societies regarding marine life has crossed the ages. Following the great collecting campaigns of the 19th and 20th Centuries and, under the impetus of a pool of scientists and increasingly efficient techniques, the quest for marine life experienced significant progress and a revival of interest at the end of the 1950s. The first drugs of marine origin date back to that time, with the discovery of two new compounds, spongothymidine and spongouridine, isolated from the Caribbean sponge Tethya crypta. These compounds gave rise to synthetic molecules commercialized in different antiviral medicines, such as AZT, the first drug used to treat HIV (Zidovudine®, Retrovir®), or Acyclovir (Zovirax®) used to treat herpes.

Thanks to the amazing progress of life sciences and new professional techniques (autonomous diving suits, submarines, sampling devices, etc.), the qualitative aspect of marine life has become, in barely 60 years, a specific object of interest for scientists and industrialists worldwide. Marine biotechnologies represent a limited portion of the numerous tangible and intangible results of scientific research on marine biodiversity that have been conducted since then. In a context favorable to scientific progress and economic development, the notion of genetic resources is an operational concept, which came to mean, from the 1980s to 1990s, these new forms of utilization of biological resources for Research & Development (R&D) purposes. If the exceptional biochemical and genetic qualities of marine biological resources had an impact on the number of marine scientific research campaigns conducted for over 30 years, the marine origin of these resources only gave rise to a late legal debate, which was for a long time limited to the definition of the conditions to access marine genetic resources in situ within the bioprospecting framework, neglecting the other forms of use that were upstream of the R&D chain. Thus, marine genetic resources remained for a long time (and still are, partly) in an uncertain legal and practical situation, with no legal status but with multiple legal regimes.

I.1. The notion of marine genetic resources

The case of marine genetic resources illustrates the phenomenon of the reservation and commodification of the living world. The biodiversity that these new kinds of resources belong to is a complex system, which is little known and paradoxically threatened by human activities and their consequences. Scientific research and bioprospecting activities related to genetic resources, whether they are of terrestrial, marine, aquatic or of another origin, are among the current uses of biodiversity. These activities, because of the means used and their scientific purpose, are generally considered less intensive and less destructive activities in comparison to fishing or mining. They symbolize the transition from an extraction economy to a knowledge economy.

The legal definition of genetic resources, while focusing on the commercial value of genetic material, combines scientific and economic definition elements. Generally, the notion of genetic resources involves several disciplinary and semantic fields. It is at the boundary between life sciences and human sciences. This polysemy will lead us to understand marine genetic resources as biological objects (section I.1.1), bio-technoscientific objects (section I.1.2) and legal objects still lacking clarity (section I.1.3).

I.1.1. Biological objects

The biodiversity from which genetic resources come is understood 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 a part of: this includes diversity within species, between species and of ecosystems" (Article 2 of the Convention on Biological Diversity, CBD). It is not limited to the sum of species. The diversity of the living world represents all the interactions between living beings and their environment. This concept implies the inclusion of all the organisms that belong to the living world and the abiotic factors covered by the inert world. Biodiversity is divided into three levels, including genetic diversity or intraspecific diversity. The latter is defined as the variability of genes within the same species, between individuals or populations. Genetic variability is essential so that species can adapt to the environmental pressures they experience2. Life has a history and a future which allows evolution, guided by randomness and need [MON 70].

In particular, marine life is characterized by its significant genetic diversity and chemo-diversity. As a life source, seas and oceans, which cover 71% of the planet’s surface, harbor 32 of the 34 phylums discovered on Earth, including 12 that are exclusively marine. The marine environment is very uniform and, in a zoological order, specific differentiation is low [KOR 05, p. 61]. It is a three-dimensional reservoir with metabolic forms, structures and organizations resulting from complexification and specialization throughout geological times, of which humans only see a very small part. If the gradient of terrestrial biodiversity is greatest in tropical areas, marine biological diversity, including genetic diversity, is concentrated in some tropical habitats (coral reefs, mangroves, hypersaline lagoons, etc.) and especially in temperate areas (grass beds, estuaries, etc.), abyssal areas (hydrothermal sources, sea bottom sediments, cold seeps of continental margins, microbial mats, etc.) and polar areas rich in plankton (Arctic, Antarctic). The genetic diversity part (DNA abundance and therefore cell abundance) is found in water columns and sediment [DEL 07] in connection with physical elements.

Scientists are divided on the number and hierarchy of life properties. However, they agree that variability, as well as auto-reproducibility and unity, are one of its main properties [DER 75, pp. 106–108, JAC 00, MOR 04c, BRI 01]. Living organisms are auto-reproducible, namely they are capable of generating new similar individuals without needing human intervention. Life is autopoiesis, meaning the property of a system to permanently reproduce itself by interacting with its environment [VAR 74]. For their reproduction, living organisms are derived from the duplication of DNA strands. This property ensures their permanence. According to French biologist, Jacques Monod (1910–1976), the unique, universal and essential characteristic of living beings is the possibility to keep the chemical structure (DNA) within which the genetic code is written [MON 88, p. 144].

Biological diversity hides unity at the genetic level. There is a scientific indifferentiation: genes and their material carriers DNA and RNA in the case of viruses, link all the regions of the living world, reconciling prokaryote organisms, such as bacteria, with eukaryote organisms, such as Homo sapiens. From the 1950s to the 1970s, molecular biology and the new techniques it created revolutionized our understanding of the living world by demonstrating the unique nature of the genetic system, the near-universality of its components and its operating mechanisms3. All the components of the genetic system, including coding nucleic acids (DNA, RNA) for proteins, do not have the ability to operate on their own per se. They are inert biological objects. Derived from the living world, they take part in it and result from its operation. Isolated from the organism or the cell, they lose the ability to reproduce without human intervention.

I.1.2. Bio-technoscientific objects

Until the 20th Century, the two properties of variability and auto-reproducibility were an obstacle for anyone who aspired to take over the living world, namely to master its offspring, predict characteristics and benefit from it [CHE 00a]. First generation biotechnologies and, mainly, second generation biotechnologies based on genetic engineering and molecular biology, made it possible to overcome this obstacle and disrupted the representation of the living world. Contemporary biotechnologies authorize the transfer of a foreign gene to a cell in culture or a tissue to obtain the appearance of a new property linked to the gene thus transferred [GRO 86, p. 180] (for example the transfer of an antifreeze-producing gene from a winter flounder to strawberries). Isolated from their host organisms in order to be modified, replicated and inserted in new living organisms, the components of the genetic system can again take part in life, in new and artificial forms.

In its modern sense, genetic resources, also called bioresources or biogenetic resources, thus refer to genetic information as much as its carrier specimen. This information, which is intangible by nature, can potentially be used in the entire living world, beyond the confines of species and biological reigns. Genes of any taxonomic and geographical origin, in other words of any biogeographical origin, acquire the status of genetic resources. Some scientists and industrialists speculate over their economic and strategic value as a virtual source of products and of new biotechnological processes [AUB 98b, p. 27]. The living world is turned into an instrumentum. Life sciences, which formerly focused on the study and passive representation of a given, real world, become technoscience, because they create worlds produced from reality [HOT 97, p. 160]4. The technosciences, whose archetype is biotechnology, adopts a materialistic, utilitarian and reductionist approach, in which nature and device, the living and inert world, become confused.

Biological resources in general and marine biological resources in particular are, from a biochemical and qualitative genetic point of view, useful and rare economic resources known as genetic resources. Biotechnology refers to any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use (Article 2 CBD). The notion of bioeconomy reflects this interference between life sciences, technologies and economy. If life is related to being, then the living world is now relating to having [BEL 06b]. The application of biotechnologies to marine organisms is described by some researchers as the blue revolution [SCH 10, p. 6].

The qualitative economic value of marine organisms, which was ignored until recently, represents a unique gene pool from a wide range of macroorganisms, microorganisms and biological associations. Marine biotechnologies that are multidisciplinary associate engineering with several fields of living sciences, as the objective is to produce and commercialize new products and processes5. Marine genetic resources, which are the foundation of biotechnologies, are divided into two categories: on the one hand, marine natural products, namely the chemical substances produced by marine organisms for pharmaceutical or biological purposes to be used in order to discover pharmaceutical medicines and model organisms; on the other hand, marine genes of biotechnological value, namely the coding genes of marine organisms for proteins with a potential commercial use in different fields (the production of pharmaceutical and cosmetic products, molecular biology, bioremediation, etc.) [ARR 13].

I.1.3. Ill-defined legal objects

The development of economic activities involving genetic resources of any biogeographical origin creates a need for a legal framework introducing, in turn, law in the semantic debate. Before the 1992 United Nations Convention on Biological Diversity (CBD), the concept of genetic resources was not a legal notion that was commonly used and did not represent clearly defined objects of use. This multilateral convention of 168 signatory countries enshrined, for the first time in the history of international law, the concept of biodiversity and then straight away desecrated it. Biodiversity, which is referred to as a common concern of humankind is considered as any economic resource exploited by States on the basis of the principle of permanent sovereignty over natural resources6 and a conditional access of a commercial nature.

The Framework Convention provides a binding definition, under which genetic resources are the genetic material [of plant, animal, microbial or other origin, containing functional units of heredity], of actual or potential value (Article 2 CBD). This definition includes genetic resources of marine origin. At first glance, genetic resources are included in the category of biological resources7. In practice, there is confusion between these two concepts8, confusion which is increased by an extension of the concept of genetic resources to non-self reproducible biochemical derivatives and products in the domestic law of some megadiverse countries to extend their exclusive rights9. At the request of these States, the 2010 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) in relation to the CBD (NP) defines derivatives as a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity (Article 2(e)), but without expressly including them in its ratione materiae scope (Article 3).

The main purpose of biological resources lato sensu is to be collected and then moved in order to be used as raw materials and related genetic information for research and industry. Despite the ambiguity of the expression genetic resources, combining scientific and economic defining elements, the notion of actual or potential value refers to a reducing and mercantile meaning of the living world. In exchange for the recognition of the State’s sovereignty, the CBD recognized the extension of intellectual property rights to biotechnologies and the intangible aspect represented by the genetic information carried by living organisms.

Fair and equitable access and the sharing of benefits, also called the access and sharing of benefits free of the fundamental notions of justice and fairness, became the cornerstone of the exchange and value system of the genetic material of any biological, but not geographic, origin. CBD provisions only cover the genetic resources located within the limits of the national jurisdiction (Article 4(a)), even though they also apply to activities, which include marine scientific research and bioprospecting, carried out under its jurisdiction or control, within the area of its national jurisdiction or beyond the limits of national jurisdiction, regardless of the location where the effects of these activities occur (Article 4(b)). If the ABS objective directly refers to genetic resources, limiting its ratione loci scope to areas under sovereignty or national jurisdiction, then the objectives of sustainable use and conservation concern genetic resources as a whole, whatever their biogeographic origin, through R&D activities that they are now the subject of.

Since its inclusion in the CBD, the expression genetic resources has appeared in numerous international treaties, national laws, scientific publications, etc., under various tangible and intangible, explicit and implicit, singular or global meanings. Some definitions do not take into consideration the informative aspect and only consider the genetic material of any biological origin containing functional units of heredity or the notion of functional unit of heredity. Yet, these two aspects are inextricably linked, because it is indeed the properties and functions of heredity molecules that have an economic value. Some specialists even understand genetic resources as natural information and therefore as intangible objects, whereas biological resources are both tangible and intangible10. Others sometime speak of bioresources or biogenetic resources to show the interference between biological and genetic, living and inert, tangible and intangible, informative and cognitive elements.

This notional vagueness is a source of legal uncertainty, in particular to achieve the objective of fair and equitable access and to share monetary and non-monetary benefits arising out of the utilization of genetic resources (Article 1 CBD), which is supposed to ensure the conservation of biodiversity. To this semantic vagueness is added the absence of a definition for marine genetic resources in the United Nations Convention of the Law of the Sea (UNCLOS), resources which belong by default to the category of marine biological resources forged in a tradition understanding of living natural resources. In an uncertain universe, fixed legal terminology might be out of step with bio-technoscientific developments [SCH 10, p. 2]. A dilemma arises between a dynamic and flexible definition, and a sufficiently precise and stable definition to be enforceable.

I.2. The increasing value of the knowledge associated with marine genetic resources in light of knowledge economy

If the debate regarding the use of marine genetic resources can be analyzed through the exploitation of tangible natural resources, the intangible characteristics of these resources raise new and specific questions in terms of legal frameworks [VIV 02]. Knowledge economy corresponds to specialized production and service industries based on intensive knowledge activities, dictated by the need for innovation, and characterized by the central role of science and technology [FOR 09, p. 3 and 5]. It sheds new light on knowledge by considering it as a specific economic good that partially escapes the market logic.

The growth of the marine biotechnologies sector depends on the knowledge economy and directly relies on a body of knowledge derived from bio-technoscience and bioinformatics,11 which acquired an economic value in itself. In this specific sector, as in terms of R&D in general, the own and shared knowledge produced by scientific and industrial laboratories of public institutions or private companies represents a body of knowledge, know-how and information with a use value, but whose exchange value is undefined. As a result, there is a dilemma between knowledge dissemination, knowledge which is a common good with high social benefits, or on the contrary, its use which can be partially and temporarily exlusively reserved under the effects of intellectual property rights.

The period in which knowledge economy emerged (1980–2000) coincided with the advent of neoliberal thinking. Legal regimes governing the conditions of ownership and redistribution of information and cognitive resources were influenced by market forces. The temporal and spatial expansion of intellectual property rights under the 1994 WTO agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is the result of economic globalization. By harmonizing rights at the global level in a manner favorable to the exclusive use of knowledge, the TRIPS reduced the ability of States, particularly in developing countries, to obtain existing knowledge and technologies, or to produce them on their own. Apart from protected technologies, including biotechnologies whose exploitation is dependent on the negotiation of bilateral agreements for licenses authorizing industrial exploitation, knowledge and related information can also be covered by trade secret and other intellectual property rights. In this context, the demarcation between industrial property and intellectual property tends to disappear [CHA 04a, p. 116].

The term knowledge is used to refer to two types of knowledge on marine life: on the one hand, so-called modern scientific and technical knowledge and, on the other hand, traditional and indigenous knowledge. Modern knowledge is obtained through the application of a scientific method based on observation and experimentation in the R&D field. It is fundamental (theoretical, abstract) knowledge and applied knowledge (know-how, techniques, technologies). On the other hand, the main characteristics of traditional and indigenous knowledge, as generally conceived, are that it is empirically produced, orally transmitted and collectively held12. Whether it is modern or traditional, its production, conservation and transmission are long and random processes whose social utility is important13.

Knowledge, even partial, is an interesting reference grid of the utilization of marine genetic resources. Without the taxonomic knowledge produced within the framework of R&D activities, the sustainable use of genetic resources is impossible. The uncertainty of modern knowledge explains the relativity and plasticity of classification outlines and the current scientific representation of the living world14. Traditional and indigenous knowledge associated with the utilization of marine genetic resources, such as traditional pharmacopeia, is also partial and limited in comparison to knowledge concerning terrestrial biodiversity15. However, even though it is insufficiently documented16, there is a vernacular knowledge that can guide R&D on marine genetic resources [DEM 10b].

I.3. The utilization of marine genetic resources: mixed and random R&D activities

The utilization of marine genetic resources implies the leverage or use of these elements for a specific R&D purpose, while the exploitation of biological resources generally refers to valuing and leveraging these elements by ensuring their production, which implies their destruction. With the use of the adjective sustainable, utilization has become a durable form of use of biodiversity components, including resources. According to the terms of the 1992 Convention on Biological Diversity, this use is made in a way and at a rate that does not lead to the long-term decline of biological diversity, thereby maintaining its potential to meet the needs and aspirations of present and future generations (Article 2 CBD).

The paradigm of sustainable development introduced a change in the regulative spatial and temporal framework of new activities using living resources. The 2010 Nagoya Protocol defines the utilization of genetic resources as a means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology […] (Article 2, (c)), showing the consubstantiality between sciences, technologies and economy. This consubstantiality is also represented by the concept of bio-technoscience, and the actual and potential use value of genetic resources and related benefits. Even though the definition of the genetic material is confusing, utilization concerns in practice all the use activities of genetic resources in and ex situ, in vivo, in vitro and in silico for R&D purposes.

In a general sense, the R&D definition encompasses, according to the OECD, any creative systematic activity undertaken in order to increase the stock of knowledge, as well as the use of this knowledge to devise new applications. It covers three activities: fundamental research, namely experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying foundations of phenomena and observable facts, without any particular application or use; applied research, in other words original investigation undertaken in order to acquire new knowledge […] towards a specific practical aim or objective; and experimental development that consists of systematic work, drawing on existing knowledge gained from research and/or practical experience, that is directed to producing new materials, products or devices; to installing new processes, systems and services; or to substantially improving those already produced or installed [OEC 15].

The expression R&D highlights the problem of demarcation between the activities of fundamental research, applied research and experimental development, and between these R&D activities and the activities of technological innovation and subsequent commercialization. This demarcation problem is still not resolved, as illustrated by the difficulty in defining marine bioprospecting. Without a binding legal definition, it refers, according to the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) and in a commercially oriented meaning, to the exploration of biodiversity for commercially valuable genetic and biochemical resources, or the process of gathering information derived from the biosphere, regarding the molecular composition of genetic resources for the development of new commercial products17.

Marine bioprospecting raises, pursuant to the UNCLOS and its Part XIII on Marine Scientific Research, the question of the distinction between marine scientific research and other activities (exploration, exploitation, prospecting) on the one hand, and between scientific research conducted in normal circumstances and research directly linked to the exploration and exploitation of biological resources, on the other hand. Again, we find that, regarding the activities not defined in the UNCLOS, the same conceptual vagueness about the resources they are the subject of. This conceptual vagueness is the result of the compromise found during the third United Nations Conference on the Law of the Sea (1973–1982), which excludes any restrictive definition of natural resources and marine activities to encompass various rights and obligations of States in the different marine areas. There are also still doubts as to the implicit content of the notion of marine scientific research under Part XIII of the UNCLOS, specifically dealing with the legal framework of this activity or the use type of marine living resources18.

Without trying to give a final definition to bioprospecting and R&D activities on marine genetic resources, the question of their legal characterization is raised because of the actual significance given to these unique activities using marine living resources. Pursuant to the CBD and the NP, the vagueness regarding the definition of bioprospecting and R&D activities questions the legal expert about the commercial and non-commercial purposes of the use of genetic resources and, indirectly, about the nature of benefits and the time when they are shared with the country providing genetic material. Based on the Law of the Sea, and with no specific regulation on the use of marine genetic resources, are R&D and bioprospecting activities considered as part of marine scientific research activities or as part of another kind of activity? What is the nature of the act of harvesting from the marine environment? Is bioprospecting limited to the collection of genetic material in situ? Is it similar to fishing, marine scientific research, or is it a new use type of marine living resources?

Considering its organization, funding, logic and directed purposes, marine bioprospecting looks like a mixed public or private activity. It is similar to an economic activity, by analogy with mining or fishing, for commercial purposes. Resources collected in specific ecosystems have a commercial and industrial potential, and therefore an economic value [JAR 06]. Bioprospecting may also be akin to marine scientific research, as it uses tools (hand, triangular, and Warren dredges; boring tools; epibenthic and beam trawls; plankton nets, etc.), technologies (oceanographic vessels; submarines; buoys; satellite tools; remote-controlled, towed, placed devices; imaging tools; etc.), knowledge (taxonomic, ecological, genetic, etc.) and similar know-hows. Ab initio, upstream of the R&D chain, the main users of marine genetic material are scientists from the public sector (universities, research institutions)19, as in most marine scientific studies.

Bioprospecting can also be understood as a mixed R&D activity, which relies on an approach and purposes that go beyond a simple economic aspect. The purpose of any bioprospecting can be theoretical research, but it can also result in the production of goods and market services. Thus, saying that the purpose of bioprospecting is only scientific or economic is a political stance and not a scientific approach. These extreme positions are the result of both ultraliberals and the Group of 77, and the disappearance of a difference between fundamental and applied research is a truism. R&D symbolizes the interference of science and market, as the prospects of commercial opportunities encourage innovation. However, the significance of the knowledge and the protection of the living world for the whole of humankind requires that scientific activities are not confused with economic activities.

Marine bioprospecting is not limited to physical access to genetic material. It encompasses the whole R&D chain, from in situ collection of specimens and samples to subsequent research work in the country of origin, on board research vessels and abroad, in laboratories and in collections in which genetic material is used and stored in vivo, in vitro, ex vivo and in silico. While R&D activities in vivo, in vitro and ex vivo require the supply of genetic material collected in situ and their conservation ex situ, the use of marine genetic resources in silico implies having access to the genetic and biomolecular data of marine organisms that were previously collected [BRO 14, p. 177], data held in databases, patent descriptions, scientific publications and R&D contracts, whose use is organized by intellectual property law and scientific research law.

The development of life sciences and information and communication technologies (ICTs), which made it possible to imagine new life forms and new goods and services, does not in any way make wild genes obsolete. In fact, if the R&D chain on genetic resources increasingly depends on the discovery of new compounds thanks to metagenomics and the screening of samples stored in collections, marine genetic resources are still an exception because of the lack of knowledge and the technical difficulties related to conserving some marine organisms ex situ. In the modern age of discovery of the marine environment, storing marine genetic material in collections complements scientific study, inventory and conservation activities of marine biodiversity in situ. The issue of access to samples, data, information, scientific information and, generally, to the results of marine scientific research on genetic resources is a key factor of progress for States and R&D actors.

Bioprospecting can be defined, lato sensu, as the use of genetic resources, namely a chain of R&D activities on genetic resources for commercial and non-commercial purposes. By analogy to the succession of rings composing a chain, bioprospecting is organized into activities or sequences of long, costly and uncertain stages. The first of them is the preparation of the mission that, if it takes place within the limits of national jurisdiction, requires the prior consent of the Coastal State of origin of the genetic resources and negotiation regarding the access and fair and equitable sharing of benefits (for up to 2 years). The second stage is the conduct of bioprospecting activities stricto sensu, namely the collection of specimens and biological samples in the natural environment (in situ), in order to identify, isolate and extract their components (cells, molecules,