2
Exploitable Raw Materials
“Genes were rapidly presented as a raw material for the industry of biotechnologies, one that is capable of modifying the living world to create new goods. Biodiversity, at its genetic level, is then defined as an economic resource” [AUB 05, p. 109].
Within a few decades, through the use of genetic engineering and biochemistry techniques, genes of terrestrial, aquatic and marine origin became an exploitable raw material, increasingly coveted by researchers and industrialists. Therefore, Article 2 of the CBD defines genetic resources as “genetic material [of plant, animal, microbial or other origin containing functional units of heredity] of actual or potential value”. Despite the ambiguity of this definition combining scientific and economic definition elements, the use of the term “containing” highlights the tangible and singular nature of genetic material, while the notion of value refers to a reductionist, utilitarian and commercial meaning.
In law, genetic resources are ab initio similar to natural things1, which are not produced by humans and can be used as “support” for the production of processed goods, among which are biotechnologies. The biotechnological R&D chain is now only marginally based on wild genetic resources. In this context of “confinement” of genetic material in laboratories or collections, marine genetic resources are still an exception, as their discovery and exploration are only just starting.
At present, neither marine genetic resources, nor the bioprospecting activity they are the object of, are clearly and consistently defined and framed by public international law or the majority of domestic laws. Yet, as illustrated by scientific practice, the multiplication of actual and potential uses of genetic resources questions the possibility and conditions of their appropriation: appropriation in the broader sense of reservation for the benefit of a few, namely preventing their common use, and appropriation in the sense of the civil law of taking possession or control. In the wake of the Cartesian mechanist rationalism [OST 03, pp. 35–38], legal systems considering living beings, apart from humans2, as legal things susceptible of appropriation on a singular basis3, are numerous. As natural tangible objects, marine genetic resources, like genetic resources in general, thus fall under the category of natural resources defined according to their appropriation (section 2.1). As actual or potential objects of use, they turn out to be marine biological resources of a new form and kind (section 2.2).
2.1. Genetic material: natural resources defined according to their conditions of appropriation
The legal distinction between a “thing” and a “good” arises from appropriation, which is excluded in the first case and is characteristic of the second case. The content of the category of marine natural resources changes according to the space and activity considered, which explains why the UNCLOS does not provide any definition for it. Only the two subcategories of mineral resources and biological resources are mentioned in it4. The general reference to natural resources can be interpreted so that it includes minerals, fauna and flora contained in the marine environment [MON 03, p. 162], including genetic material. The three domains of the living world (bacteria, archea and eukaryotes) are concerned, as well as a significant diversity of ecosystems (coastal, pelagic, benthic, etc.). The living or inert nature of the sought resources does not matter5.
Genetic resources have an intimate relationship, which reminds us of a natural form of accession, with their carrier specimen, on the one hand, and with the space where this specimen is located, on the other hand. This is all the more true regarding marine genetic resources, as their environment of origin is a decisive qualification criterion. For example, to access the DNA of a coral species, the researcher must first collect a few specimens or samples on a reef of Vanuatu, to then extract and analyze it in a laboratory onboard or ashore, in vivo, in vitro and/or in silico. In other words, the genetic resource is a “product” of the carrier specimen, which is itself an accessory of the principal marine space (“Accessorium non ducit, sed sequitur principalem”)6.
It is this closely interwoven relationship that makes the understanding of the legal nature of genetic resources difficult and suggests two approaches: first, that of the type of resource (national or private) and the degree of appropriation (total, partial); and then, that of legal systems (international, national, civil, customary or Common Law, etc.) relevant for marine genetic resources and the persons subject to it (States, natural or legal persons, public or private persons, local and indigenous communities).
The relationship between the concepts of ownership and sovereignty is not always clear. There is an overlapping and opposition between the sovereignty holder and the holders of property rights, as to the control of things which are the subject of appropriation7. Regarding biodiversity in international law, the lecturer in public law Betty Quéfellec inferred that “considering [the issue of appropriation] from the marine perspective makes it possible to observe a great number of variants regarding the notions of sovereignty and ownership. In fact, the sea benefits from unique schemes of appropriation, in particular with sovereign rights and the State jurisdiction in the Exclusive Economic Zone” [QUE 06, p. 52]. Most often, the biological specimen and, indirectly, the space where it is located determine the legal regime of the marine genetic resources, which are its accessory, the raw material arising from it8. Genetic material, provided it is incorporated in a living organism (animal, plant or microorganism), follows the regime of the latter. Sometimes it is res nullius (section 2.1.1), and sometimes it is res propria [in this sense, MAZ 88, p. 199].
2.1.1. Appropriable natural things
In the wild, the specimens of marine species and, by extrapolation, biochemical substances within them, are beyond the control and the hold of the owner, whether it is a public or private person. If abundant, they can be classified as res nullius (section 2.1.1.1), things which only exist, under public international law, in international marine areas (section 2.1.1.2).
2.1.1.1. Res nullius by accession9
Like game onshore, fish in the sea is the topical example of wild things appropriable by humans only because they can be caught. Since the time of the Romans, they belong to the category of res nullius, things which have no owner and therefore are available to all. The appropriable nature of the res nullius is a dual reality: it is defined by a freedom in principle in the face-to-face between the person and the property, and a true exclusivism allowing the owner to prevent any third party from using the thing [LIB 06, p. 3]. Appropriation is achieved by taking possession animo domini of specimens, a possession that derives from the right of occupation10. The fugacity of some wild specimens makes their catch even more difficult as their appropriation depends above all on the “technical” capacities to appropriate them11. In any event, they are temporarily non-appropriated things, which can perfectly be appropriated. Far from being opposite to the logic of appropriation, they are, on the contrary, its best example [OST 03, p. 60]12.
The category of res nullius is not limited to fish and wild animals. The content of this category varies according to the tangible utility of the fruits of nature at a given time and location, as well as the container, res communis, to which it relates (nature, sea, biodiversity, species) [REM 85, p. 29]. Generally, all material objects located in the sea likely to be occupied or appropriated can belong to this category [GID 81, p. 214 onwards]. Apart from fish, other marine organisms, such as molluscs, crustaceans and echinoderms, are res nullius for which occupation acts as an acquisition method. As for microorganisms, their appropriable nature is now clear, even if it was initially an issue for material and technical reasons, as these organisms are, by definition, intangible and invisible to the naked eye. They are appropriable, in situ and ex situ, whereas for a long time they were only useful in situ, as they could not be conserved outside their carrier specimen or separated from their environment of origin. According to the law professor Jean-Christophe Galloux, they are appropriated only if they are stably and durably linked to a carrier that is itself appropriated, with the owner being aware of it or having sought them out [GAL 98, p. 494]. Otherwise, on the basis of current knowledge and unlike traditional living resources, microorganisms are still objectively abundant and can be characterized as res nullius, or even as things with no existence for humans.
A similar reasoning is applicable to biochemical substances and, to a lesser extent, to genes, whose number is limited a fortiori in rare species. Unknown and with no practical existence, they have for a long time not benefited from any legal status or specific protection. The unveiling of their materiality, on the one hand, by the discovery of the double helix structure of DNA, and their discernible utility, on the other, thanks to the progress of bio-technoscience, placed them in the category of things seized by law. In the wild or if they are abundant, they became res nullius freely accessible to any individual or commerce, under the dual condition of appropriating their carrier (plant, animal, microbial or other) and of having the scientific and technical capacity to extract them from it.
2.1.1.2. International marine living resources
Beyond the limits of national jurisdiction, on the high seas, the space whose use is common to all (res communis), the living resources category in which genetic resources fall by default, is traditionally considered as res nullius in the extension of the centuries-old principle of fishing freedom13. Since ancient times, the exploitation of fishing resources rests on this principle, which is itself based on the false belief according to which “resources of the nurturing sea” are inexhaustible [in that sense, PRO 05, p. 97]. The absence of owner implies that everyone is free to capture them, subject to specific rules, such as the protection of the environment or the common or joint management of living resources. Unlike mineral resources of the Area belonging to the common heritage of mankind, no distinction is made between the living resources of the surface, of the water column, of the soil, whether they are sessile or vagile, and of the subsoil beyond the limits of the continental shelf. In principle, they indistinctly belong to the category of res nullius as well as, by accession, their components among other biochemical substances (DNA, RNA, proteins, etc.).
During the 20th Century, the scarcity of fish led to a widespread reconsideration of the characterization of res nullius and led “States” to resort to common or joint management forms such as the creation of regional fisheries bodies in parts of the high seas14. In fact, if a thing does not belong to anyone, no one can complain about its degradation [REM 89, p. 4]. Living things are no longer considered as fruits but as products whose collection affects the substance of the thing [REM 89, p. 84]. Consequently, genetic resources from commercial or threatened species are likely to lose their res nullius status as accessories of carrier specimens15. The genes of non-exploited species, such as nearly all microorganisms, are abundant from the biological point of view and could still be characterized as res nullius. However, one can also mention for them a subjective scarcity that depends on the perception of the law subjects: a scarcity of a technical nature, on the one hand, as genetic resources are only accessible and can only be used if one has the technical tools to use them16, and a potential scarcity, on the other hand, as scientific and technological progress make new uses possible, and is likely to change the substance of these things or justify the establishment of an activity regime. Therefore, it is highly doubtful that the res nullius characterization for genetic resources located beyond the limits of national jurisdiction will be maintained in the future.
The characterization of wild specimens as res nullius and the principle of free appropriation resulting from it have long been defended by Northern countries. The latter adhered to the idea that an isolated specimen had no value, because its collection did not deplete the reproducibility of the species it represented [HER 88, p. 259] and that it had no actual market value at the time of collection. In fact, genes per se are not consumable things since, as each cell of an organism contains the entire genome, the disappearance of a gene through the collection of cells or specimens does not affect the existence of the species genome. Only the disappearance of numerous individuals of the species is likely to lead to the actual and definitive disappearance of the genome via the extinction of the species.
During the CBD negotiations, Northern countries, especially Researching States whose nationals conducted bioprospecting activities, kept this position, which was reinforced by the absence or the late legal characterization of wild genetic resources as elements separate from their carrier specimens in the domestic laws of these countries17. This position was countered by Southern countries with the principle of permanent sovereignty over natural resources, which is included in the CBD. The res nullius status was, according to them, incompatible with their economic interests and with the objective of biodiversity conservation. In fact, it involved a risk of reservation of genetic resources for the benefit of a “scientific elite”, at the expense of States and local and indigenous communities from whose territory the genetic material was freely collected.
2.1.2. Things on the verge of exclusive appropriation
As they became useful and rare, marine genetic resources have gradually lost their res nullius status to become exclusively appropriated things, if not by private owners or communities (section 2.1.2.1), at least by the State in the spaces where they are located (section 2.1.2.2)18.
2.1.2.1. State appropriation objects
The first aspect of the exclusive appropriation of genetic resources is State appropriation. In national marine spaces, the sovereignty of the Coastal State is against the systematic application of the res nullius primo occupanti rule. The State appropriation of marine genetic resources arises from the reservation of marine spaces and natural resources therein, under State imperium and dominium. At sea, this reservation is reflected in territorial sovereignty19, sovereign rights20, exclusive or even creeping jurisdiction21 and the permanent sovereignty over natural resources22.
2.1.2.1.1. Genetic resources of the spaces under sovereignty and national jurisdiction
The principle of permanent sovereignty over natural resources, even though it was intended for peoples, resulted in the reservation, or even appropriation, by States of their natural resources23. Foreseen in the Law of the Sea following the geographical extension of Coastal States’ jurisdiction over marine biological resources, the reappropriation of biological diversity elements by States was clearly acknowledged in the preamble and Article 3 of the CBD, reaffirming in substance Principle 21 of the 1972 Stockholm Declaration [DES 04b]. Prevented from being used by all, because of fear of “biopiracy” and the will of developing countries to benefit from the exploitation of their own natural wealth, biodiversity elements, including biological and genetic resources, can therefore be considered as appropriated things (res propria) because of their real or actual economic value. Their exploitation implies the consent of the Coastal State, a discretionary power allowing it to exclude third States from its national spaces and to reserve the exploitation of its natural resources for its own nationals24. In addition, while fish was until recently considered as res nullius, it now tends to be assimilated de facto to a property [PRO 00, p. 647]. Unlike fishing resources, marine genetic resources are still, according to us, things that are certainly reserved but not property, since they only have a potential economic value at the time of their collection25.
It is understood that “reservation is not ownership”, even though the idea of exclusivity or reservation underlies the three concepts of ownership, sovereignty and exclusive jurisdiction26. According to Article 2 of the CBD, the country of origin is the country that possesses those genetic resources in in situ conditions. Despite the use of the ambiguous verb “possess”, the CBD does not give States an ownership right over genetic or biochemical resources as tangible elements. It only recognizes their sovereign rights over their natural resources and the authority for their governments to determine the conditions of access to these resources, whether they are the property of the State or any other person (see Article 15-1 CBD). It recognizes the national “quasi-appropriation” of biological diversity [DEK 96, p. 152].
The issue of the ownership of genetic resources is at the discretion of States. It is not clearly determined because ownership systems and national constitutions, with a few exceptions, do not refer to new genetic resources [GLO 96, p. 102, CAB 14]. This issue is however essential to determine the structure of the regimes relating to the access and benefit-sharing arising out of the utilization of genetic resources. As for the ownership of natural and biological resources, it can easily be determined in most States. What is “possessed” is generally the physical material incorporated into seeds, plants or animals for example [NNA 07, p. 5]. With no specific contrary legislation, the ownership of this physical material plausibly implies the ownership of the genetic one.
The idea according to which the recognition by the CBD of sovereignty over genetic resources is equivalent to State or public ownership is a widespread misconception. Some States, for example China for protectionist reasons27 or Norway for nature protection purposes28, assimilated ownership and State sovereignty or exclusive jurisdiction by considering their marine spaces and, by accession, the fauna and flora found therein, as property they allegedly owned. The legal systems of South American countries (Andean countries, Brazil, Costa Rica) differentiate the ownership of biological resources from that of genetic resources. Genetic resources and their by-products are inalienable public goods belonging to the heritage of the Nation or State (Article 6 Decision 391 of July 2, 1996 establishing the Common Regime on Access to Genetic Resources). When access is granted for specific uses, it does not confer ownership rights upon these resources or the genetic information they contain. As for Article XII section II of the Philippine Constitution, it induces that the flora and fauna inter alia are owned by the State and shall be not alienated. Their exploration, valorization and utilization shall be under the full control and supervision of the State. From the ownership of the flora and fauna, it is possible to deduce that the State also owns the genetic resources incorporated in them (in that sense [CAB 14]).
In practice, State appropriation is not more satisfactory than the res nullius status. It does not necessarily improve the protection of animal and plant species, and even less microbial species, because State ownership is often considered as belonging to everyone or no one. This change of status can weaken any sense of collective or social responsibility toward wild species [DEK 93, p. 18]29. Furthermore, this type of ownership can conceal the actual incapacity of some States to fully exercise their sovereignty over their natural resources and preserve their environment.
2.1.2.1.2. Genetic resources of national scientific collections
Unlike plant genetic resources, the main collections of marine genetic resources are still recent and in the process of being set up, particularly those of microorganisms and organisms from specific or extreme ecosystems30. These collections are important because they allow researchers to have easier access to marine genetic resources31. Collections of marine genetic resources are composed of material that was little modified due to human intervention, whereas the selection of terrestrial plants is ancient and still purely wild gene pools are rare. If, as universalities, collections are under the sovereignty of the State in which they are located, access to their components is subject to the consent of the right holder(s), subject to the rights of the country of origin, when these elements were collected after the entry into force of the CBD, on December 31, 1993. Under Article 9(b) of the CBD, States are relatively obliged (according to the expression “as far as possible and as appropriate”) to build collections for purposes of conservation ex situ, preferably in the country of origin of the resources32. Most of the time, these collections are in the territory of another State. This other “providing” country possesses them after collecting them in situ or obtains them from another collection, or even in rarer cases, holds them for the State of origin, as the latter does not have the technical or financial capacities to conserve them33.
At the national level, there are very diverse collection models which vary according to three main parameters: the person who established them or holds them (public or private legal persons), their content (origin of the material, more or less great exhaustiveness sought, the types of organisms, animal, plant, microbial organisms that it includes) and, finally, the objectives pursued (conservation, systematics, research work, biotechnological valorization, diffusion) [see NOI 04]. In France, Act No. 2016-1087 of August 8, 2016 to restore biodiversity, nature and landscapes (“loi pour la reconquête de la biodiversité, de la nature et des paysages”) defines a collection in a generic manner as “a set of collected samples of genetic resources and related information, gathered and stored, whether they are held by public or private entities” (Article L412-4-8°). Public collections include national collections of public museums, on the one hand, and those assigned to the public service of research, on the other, belong to the State. The law on museum collections, for example that of the Muséum National d’Histoire Naturelle (MNHN)34, is perfectly clear: the principles of inalienability and imprescriptibility of the public domain are applicable to the collections of public museums and are recognized by Act No. 2002-5 of January 4, 2002 on the museums of France (“loi sur les musées de France”)35. Article L. 451-8 of the French Heritage Code tempers the principle of inalienability: “a public legal person can transfer for free the ownership of all or part of its collections to another public legal person, if the latter undertakes to maintain the assignment to a museum of France”36. Collections assigned to the public service of research, namely set up by a public legal person, even though they are not protected by a specific law and their regime is not organized according to research need37, also fall within the public domain and are therefore inalienable. However, their samples, which are fungible things, can be totally or partially destroyed for the purposes of research.
Collections of genetic resources, which are generally of human origin, are commonly called gene banks, biobanks, culture collections, cryolibraries, chemical libraries or even target libraries38. Large infrastructures with greater resources emerged in 1999 at the initiative of the OECD under the name of Biological Resource Centers (BRCs)39. They simultaneously focus on tangible (physical resources) and intangible aspects (derived information or innovation) of genetic resources from any biogeographical origin. These collections are organized around the need for research and the commercialization of results.
In principle, the State owns the biological samples (cultivable or non-cultivable organisms of animal, plant, microbial or of other origins, tissues, cells or replicable parts of organisms, such as genomes, plasmids, viruses, DNA or RNA), which are stored in its national collections. Among these collections, one must however differentiate, at the international level, the genetic material collected within the framework of a fundamental or applied scientific research activity, on the one hand, and the material obtained before and after the entry into force of the CBD on December 29, 1993, on the other hand.
The interpretation of the UNCLOS provisions on the ownership of samples, data and results is different according to the characterization given to bioprospecting: a type of marine scientific research and, if so, fundamental or applied research. Under Article 241, “marine scientific research activities shall not constitute the legal basis for any claim to any part of the marine environment and its resources”, including the exclusive exploration of the natural resources of another State because it would be contrary to the principle of permanent sovereignty over natural resources. However, it seems entirely possible, by virtue of a physical ownership or intellectual property right, to claim exclusive rights over the exploitation of samples, data and results40. In the case of research for purely scientific purposes conducted in “normal circumstances” (fundamental, public, cooperative research) (see Article 246.3 UNCLOS), the rule seems to be the full ownership of the researching State, with, in exchange, the obligation to disseminate the results through publication. However, when the project “is of direct significance for the exploration and exploitation of natural resources, whether living or non-living” (applied, private, industrial research) (see Article 246.5 UNCLOS), the Coastal State can reserve for itself the full ownership of samples, data and results. The Doctor of Philosophy and specialist of marine scientific research, Gorinna-Ysern Montserrat concludes that “the [latter] implies degrees of shared ownership over marine scientific knowledge and its dissemination” [MON 03, p. 354].
Under Article 15.3, CBD rules on access to genetic resources are applicable, ratione temporis, only to collections established after the entry into force of the CBD on December 29, 1993 (see Article 15.3 CBD), except for genetic resources covered by the 2001 International Treaty on Plant Genetic Resources for Food and Agriculture41. Collections created before the entry into force of the CBD are in principle the property of the authority that collected them on the basis of animo domini taking of possession or physical holding42. Ownership and access rules remain unclear however. Numerous alternatives are possible, demonstrating the existence of various and changing situations revolving around the physical control of genetic material (possession, holding, ownership). After December 29, 1993, the ownership of samples goes to the bioprospector, following the issuance by the country of origin of a sampling authorization (fishing, catching, prospecting license) and/or the conclusion of a bioprospecting agreement with it (see Article 15 CBD). Technically, researchers and their institutions respectively become holders and owners by animo domini taking of possession, in the event that wild genetic resources are res nullius, or by transfer of holding and ownership, when they are the property of the State43. According to a similar logic, the recipient owns the genetic material if parties to material storage or to material transfer agreement concluded with the country that is providing the stipulator. Law can no longer remain silent about the nature of appropriation. Animo domini taking of possession and physical holding without authorization are illegal and constitute “biopiracy”.
By combining the CBD with the temporal scope of the NP which does not include any explicit ratione temporis delimitation44, it seem that the genetic material in ex situ collections collected before the entry into force of the CBD does not fall within the scope of Article 5.1 of the NP on benefit-sharing45. Each party implementing the protocol will have to carefully review the best way to address the issue of ex situ collections to secure access to genetic material and associated knowledge [see Volume 2 of this book]. Inevitably, the issue will be raised in future discussions under the NP, including those on the global multilateral benefit-sharing mechanism under Article 10 [BUC 11, p. 51].
2.1.2.2. Objects of private appropriation
The second aspect of the private appropriation of marine genetic resources as raw material is, in its natural state, the private appropriation by local and indigenous communities (section 2.1.2.2.1) and, in a confined environment, that of laboratories and private research companies (section 2.1.2.2.2).
2.1.2.2.1. Genetic resources of “customary territories”
Customary ownership constitutes a mode of representation of the world and a legal system, which is different from national and international systems. It establishes a specific relationship with the land and the environment, which is not really conceived, even though it results in a situation of private reservation by a group, as appropriation and absolute control, but rather as affiliation (ecological and cultural anchoring) and common use. Community ownership regimes give each individual or family of the collective body common title deeds and individual usufruct titles46. If it is relatively common to come across forms of community and customary ownership onshore, they are rare at sea47. The “ownership” of the land and the sea implies the management and fulfillment of responsibilities more than anything: it is not about having or possessing the land or the sea so that one can legally avail of it, or sell it, but about being an inseparable part of succession [RIE 97, p. 217].
The study of marine biodiversity law, which, in Melanesia, within the framework of the Coral Reef Intiatives for the South Pacific (CRISP), has underlined the existence of rights to “customary marine tenures” held by some chieftaincies over parts of the sea adjacent to their land [BEU 08]. The content of customary rights regarding the marine environment, as well as their ratione loci scope, is unclear. A special concept of customary fishing areas (qoliqoli) is provided for by Fijian law. Ni-Vanuatu and Salomon laws are far vaguer. The lack of clear definition of the “relationship” maintained with the territory and of the communities’ rights over their land and the natural resources therein poses a challenge in terms of “securing” the tenure system, use of natural resources and protecting the environment. The vertical delimitation of these rights (shore, soil, subsoil, water columns) is vague and often kept secret in compliance with the custom. This atypical form of ownership does not cover the same reality as in western-based societies. Melanesians do not perceive their relationship with the world as a relationship based on domination or control48. The conceptualization of the entire cosmos, which includes the spiritual world, is part of their practical life experience and takes place on and through the land [PAR 01, p. 168]. The rules of conduct toward the elements of their environment (tangible and intangible) therefore rely on beliefs associated with the sacred and a cosmogonic representation of the world.
The ancestral land dominates the things that are attached to it in space and over time. Its sacred nature and its physical vastness make it a “main asset”. As such, it is the subject of a customary ownership that could be said to be perpetual49. In practice, the owner only benefits from a usufruct right (usus and fructus, namely the right to use it and reap its benefits). This “relative” right, in comparison to full ownership, depends on the rights of third parties, members of the community, or foreigners50. Like the land, the ownership of water and coral reefs is generally collective. It can be understood as an extension of it. Access to natural resources is subject to the agreement of owners or customary chiefs, who are the only ones who can authorize access to the customary territory, the land, the water and the reef alike51.
Natural resources (domesticated and wild animals, plants) can be the subject of individual and temporary rights. The degree of power of control over these things, which are both real and spiritual, depends on their social utility, their influence on other assets or persons, the social relationship between owners and users and, finally, circumstances, namely the time, location, nature or reason for their use. Generally, fish are considered as wild animals, like other marine “creatures” used for food [NAR 83, p. 90 onwards]. For courtesy reasons, custom imposes a general rule of equitable sharing of the catch between users and customary owners. Some plants and animals or some of their parts (shells, teeth, etc.) are totems revered or consumed, as they symbolize the relationship uniting the living with the past and ancestors52. They are associated with the prestige and social rank of the person who owns them. When they are exchanged, they formalize the social link [PIL 98, p. 101]. They are ceremonial property whose ownership is generally individual and does not impede an excessive use. The relationship with time, as reflected by the rules of appropriation and the use of natural resources, is cyclical and temporary. It is punctuated by the seasons, customary rituals or weather conditions. Therefore, the life and actions of humans are subject to nature and the evolution of the living world. Oral tradition demonstrates it, as well as the circumstantial, ritualistic and sacred nature of customary law.
The CBD and the NP do not grant the State “ownership” over tangible genetic or biochemical resources. But under the principle of sovereignty, it still remains the main authority to decide on issues regarding the ownership and use of its natural resources. Its only obligations toward local and indigenous communities are to preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity (Article 8(j) CBD). Local and indigenous communities are often denied any right of use or enjoyment of tangible biological and genetic resources. They only benefit from a right over intangible traditional knowledge not connected to the practical use of the environment.
“The legal condition of indigenous peoples established by the sources of the current international regime is shaped by two contradictory dynamics: on the one hand, the undivided power of the sovereign State and, on the other hand, the abundant redefinitions of State prerogatives for the benefit of civil society in the balance of economic and political powers which are today structuring international relations” [FIL 07, p. 129]. The first dynamic still seems to prevail. When implementing the generic rights over customary territories, the State can vary the importance of the prerogatives linked to their holders, which reinforces legal uncertainty [FIL 07, pp. 61–62]. It also does not have to recognize custom as a source of right. Therefore, customary rules, if they continue to be applied by indigenous communities, coexist, and even come into conflict, with the law of general application enacted by the State (written law, Common Law) [see BEU 08]. However, it is encouraging to note that some States, such as the Melanesian States, recognize de facto or de jure some rights (participative, consultative, actual, intellectual) for the benefit of their communities in terms of access and use of the biodiversity of customary territories.
2.1.2.2.2. Genetic resources of private collections
“Most companies and research institutions manage private collections of genetic resources derived from microorganisms, plants, animals, mushrooms, bacteria and the products of these resources, such as enzymes, purified compounds and extracts. These collections are important, because they allow researchers to access marine genetic resources”53. For example, the company from Brittany, Polymaris Biotechnology, which is specialized in the research, characterization, and valorization of marine carbohydrate biomolecules (in particular bacterial exopolysaccharides used in cosmetics), has a private strain library with several hundred bacterial strains collected during oceanographic campaigns along the Brittany coast.
A similar logic to that of national collections applies to biological samples from collections held by private individuals. Pursuant to Article 15 of the CBD, they are the property of the latter on the basis of an animo domini taking of possession or physical holding before the entry into force of the CBD, or an animo domini taking of possession (sampling authorization paired with or without a bioprospecting agreement) or an ownership title (ownership transfer provided for by contract with the country of origin or the country providing the resource) after December 29, 1993. The origin and traceability of samples stored in private collections, such as those of national collections, are not always established, which poses problems in terms of benefit-sharing and conservation. Numerous marine genetic resources held in private collections are exempted from access to protect the profitability of investments and industrial secrets, as their access is only possible once the invention has entered the public domain or when it is no longer considered as commercially valuable.
2.2. Marine genetic resources: biological resources defined according to their destination
Despite the lack of legal definition in the Law of the Sea54, marine bioprospecting generally refers to “the exploration of marine biodiversity or commercially valuable genetic and biochemical resources; or the process of gathering information from the biosphere on the molecular composition of genetic resources for the development of new commercial products”55. The UNCLOS was not designed to integrate this form of use. CBD provisions are however applicable in accordance with the Law of the Sea (Article 22) in marine areas under State sovereignty or jurisdiction. The areas beyond the limits of national jurisdiction and the genetic resources found therein are excluded from its ratione loci scope56. Without any international legal regime applicable to marine bioprospecting, regardless of the space where it is conducted, it seems logical to refer to the legal regimes applicable to the activities of exploitation of marine living resources to determine the legal conditions of use of marine genetic resources57.
According to the UNCLOS, the main activity of exploitation is marine fisheries as marine living resources which are traditionally considered as raw material exploited for agro-food purposes (section 2.2.1). This traditional understanding of marine biological resources deviates in many ways from the terms and conditions and goal of marine bioprospecting, which consists of the search for genetic resources contained in marine biological resources for the purposes of scientific and biotechnological valorization (section 2.2.2).
2.2.1. Traditional marine living resources exploited for food and industrial purposes
The Law of the Sea considers fishing as the main activity of the harvesting of wild marine living resources. The UNCLOS established, in the wake of the Geneva Convention of April 29, 1958 on Fishing and Conservation of the Living Resources of the High Seas, an obvious link between marine living resources and fishing activity58. Without any legal definition, marine living resources are intended for food and industrial purposes, namely to satisfy vital (subsistence fishing) or economic (artisanal and industrial fishing) needs, which are direct and almost immediate59. This narrow traditional understanding does not make it possible to understand the marine living world in its entirety, or the multiple uses associated with it. It reduces marine living resources to fishing resources exploited in a quantitative manner, irrespective of kingdom, level (infra- or supraspecies) or size (section 2.2.1.1), and whose utility and value are for the “actual” present (section 2.2.1.2).
2.2.1.1. Quantitative resources
Marine fishing is the harvesting of a certain quantity of marine living resources or biomass to commercialize it on a market in the form of agro-food products. Harvesting concerns a stock of fungible things60; tangible entire bodies or parts (for example, shark fins) of commercial species. Fishermen catch fish so that it can be consumed for its flesh for human food or in the form of animal feed. Fishing is generally profitable only if the catch amount is significant. According to the fishing techniques used, quantities range from a few kilograms to several thousand tonnes of a given species and increase with global demand.
The UNCLOS and international marine fishing conventions partly reflect the productivist understanding of the prevailing liberal economy. Legal rules governing the management and conservation of fishing resources have for a long time aimed at maintaining a “maximum sustainable yield”61, moving toward the development of an “optimum sustainable yield”62 of the stocks of harvested species (below on the Schaefer curve). The search for yield, namely the quantity produced by unit of area or species, remains the main objective of management and conservation. The characterization of a species as a marine living resource implies the obligation for the Coastal State to determine, for this species, an allowable catch volume and to adopt conservation measures63. For example, the “Total Allowable Catch” (TAC), established by stock and by area, and then divided into national quotas between the member States, makes it possible to regulate access to the fishing resources of the European Union and to assess the quantities likely to be produced by a given species64.
The intensification of the fishing effort nearly caused the multiplication by five of catches between 1950 and the end of the 2000s65. This pressure on fishing resources led to the overexploitation and even the disappearance of commercial species66 – distrastrous continuing phenomenon. From the 1990s, the acceleration of the scarcity phenomenon induced a change of perspective in terms of the management and conservation of marine living resources. The 1995 Agreement on the Conservation and Management of Straddling and Highly Migratory Fish Stocks adopted innovating measures to ensure the long-term sustainability of stocks. It integrates inter alia the idea of uncertainty by recognizing the precautionary principle. Other conventions have adopted an ecosystem approach by considering species and their ecosystem67. The maximum sustainable yield has replaced the objective of optimum yield integrating the need to preserve the capacities of stocks reproduction. Nevertheless, the legal approach chosen by States in their relationship with fishing resources is still mainly quantitative, productivist and oriented toward the pursuit of immediate profit.
2.2.1.2. Actual resources
The marine living resources exploited in fisheries activity belong to the category of actual resources within the meaning of Article 2 of the CBD68. In theory, any marine species, regardless of its taxonomic origin (animal, plant, microbial or other) and its size (whether microscopic or not)69, can be considered as an actual resource, if it is consumed or useful for the agro-food sector. In practice, only some species are fishing resources (species of fish, molluscs, crustaceans, algae), as the content of this category is variable according to needs, location and time70. The UNCLOS provisions on the conservation of living resources in the EEZ seem to impose conservation measures only regarding “populations of harvested species” directly commercialized and not species likely to be exploited (Article 61.3). Provisions are also made in favor of species associated with or dependent on these stocks [DES 04b, pp. 276–277]. Marine fishing is an economic activity resulting nearly systematically in the commercialization of marketable goods. Although its conduct sometimes requires a phase to look for stocks or new species, called “fisheries research”71, the utility and value of fishing resources are proven before their collection. Commercial uncertainty is then relatively low. From the catch phase, the latter constantly decreases during a relatively short exploitation process, requiring little transformations (see Appendix 5).
In parallel with the traditional vision of living resources defined stricto sensu according to their actual economic value, the “conceptual and technological breakthrough” induced by the search for living resources for the purposes of scientific and biotechnological valorization gives rise to a new approach of the living world [in this sense, BEL 06b, pp. 50–51].
2.2.2. New marine biological resources searched for the purposes of scientific and biotechnological valorization
In a finite world where any nature component tends to be seen as an economic resource, at least potentially, new resources are only those whose exploitation is made possible by breakthrough technologies in the present context [DEP 00, p. 639]. Technical progress provides opportunities to exploit dormant, speculative or reserve resources72. It pushes back the limits of the finite world [REM 85, p. 29]. Paradoxically, as the knowledge and technologies to study and handle the living world are developing, the “field of possibilities” extends, giving the illusion of an infinite world. The living world, particularly the “infinitely small”, is thus similar to a “new frontier”, a kind of pioneering front generating successive discoveries and innovations.
From the 1960s–1970s, the technical advances of genetic engineering, biochemistry and bioinformatics, combined with the modern techniques of exploration of the living world, helped to reveal new objects in terms of knowledge, but also in terms of economic potential. These new objects are known as genetic resources in reference, no longer to individuals of species exploited for agro-food purposes, but to the “genetic material” of plant, animal, microbial or other origin containing functional units of heredity73 used for their genetic and biomolecular qualities (section 2.2.2.1). Even though their scientific and economic value was demonstrated as early as the 1970s, at the time of the third United Nations Conference on the Law of the Sea, marine genetic resources, in particular those of the deep seabed, did not draw the attention of the States74. Not considering these resources under the UNCLOS demonstrated the “the deepest of ironies” [GLO 00a], in light of the enormous potential with which marine genetic resources are now associated (section 2.2.2.2).
2.2.2.1. Qualitative resources
As recalled by the law professor Martine Rémond-Gouilloud, when it comes to natural resources, the usual tendency is to reason in terms of quantity, in units of measure, surface, weight or even volume. Biological sciences lead us to understand nature differently, in life units [REM 89]. They operate a gradual transition from a purely accounts-based understanding of natural resources to a qualitative understanding reflecting the current state of scientific knowledge. This form of representation of the living world is based on the idea that the value of species results from both their biomass and their genes, metabolic and biochemical functions, and their relationship within an ecosystem. For the purposes of bioprospecting, specimens are searched for and collected because they are the receptacle of functional biochemical substances (gametes, alleles, DNA, RNA, chromosomes, proteins, etc.), and not for themselves.
In contrast to fishing, this activity is, in principle, non-destructive and non-consumptive75. The quantities collected are most of the time extremely low and are generally not an obstacle to natural replenishment76. More than quantity and similarity (characteristics of fungible things), it is quality and qualitative diversity that are important for further laboratory research in laboratories [see SCO 04, p. 400]; yet qualifying diversity, whether it is genetic or biochemical, is more significant among marine organisms, which are however unknown, than in the terrestrial environment, as indicated by the higher probability of success based on marine molecules and the diversity of marine organisms eligible for the purposes of scientific and biotechnological valorization: microorganisms, rare species, symbiotic organisms, invertebrates, and phylums with no terrestrial equivalent.
The CBD was signed at a time when the unidirectional dogma of molecular biology (one gene encodes a protein; one gene, one function; the “everything is genetic” [ATL 99]) fell into disuse. However, in the mind of numerous commentators, the qualitative aspect of genetic resources still traditionally refers to genes of interest and their functions which allow a genetically modified organism to express one or more chosen traits: functions of weather or disease resistance, protein production (antifreeze), inhibition, bioluminescence, pollutants degradation, etc. Beyond this functional and simplistic meaning derived from the combined definitions of genetic resources and genetic material in the CBD, genetic material could also refer to any biochemical element resulting from the genetic or metabolic expression, without this element necessarily containing functional units of heredity, namely transmissible traits (DNA, RNA, chromosomes). As they depend on the genetic code and are derived from it, proteins, other biopolymers and small organic molecules with adaptation functions produced by genes, called secondary metabolites, can also be considered as marine genetic resources77.
The expression “functional units of heredity” is not defined in the CBD, which makes it somewhat difficult to determine the meaning to be given to the expression “genetic resources” and to transcribe into domestic and regional laws78. “The word 'functional' was basically used to distinguish genes/genetic material from the larger part of DNA in most eukaryote organisms which did not code for any protein, and at that time were called 'junk DNA', because nobody really understood what functions, if any, this DNA-material had in the total genome of a cell” [SCH 10, p. 13]. However, based on contemporary science, genetic material must include all the elements necessary to establish functional units of heredity, genes, their components (DNA), the factors governing their expression (messenger RNA, codons, introns), as well as their direct products (RNA, proteins). The functional units of heredity represent the sum of several interacting physical factors and not only pieces of DNA [BUR 04, p. 3]. “There is some confusion regarding the notion […], assimilated with genes, molecules, or even with the living world and its related ideological and political representations” [AUB 07a, pp. 23–24]. This inevitably poses problems of interpretation and application.
The evolution of knowledge and techniques (bioinformatics, genomics and postgenomics, synthetic biology, etc.), on the one hand, and the higher economic profitability of products and services derived from biodiversity in comparison to genetic resources stricto sensu, on the other79, led to an extension of the concept of “genetic resources” to derivatives and non-reproducible biochemical products since the CBD was signed80. Numerous patented biotechnologies use biological material that does not contain any functional unit of heredity, for example, active marine substances with antifungal, analgesic or anticancer virtues used in pharmaceutical chemistry (see Appendix 7).
Generally, most States with a law on access and benefit-sharing rely on the CBD definition of genetic resources, with sometimes a few adaptations that did not affect its scope. Other megadiverse States or regions make use of the vagueness of the Convention. They extended the ratione materiae scope of their access regime to by-products or hemisynthesized and synthesized products on which they would like to exercise sovereign rights. Thus, Article 3 (Title III) of Decision 391 of the Andean Community establishing the common regime on access to genetic resources is applicable “to genetic resources for which the Member Countries are the countries of origin, to their by-products, to their intangible components and to the genetic resources of the migratory species that for natural reasons are found in the territories of the Member Countries”81. These States want to protect against biopiracy, ensure fair and equitable benefit-sharing, and portray themselves as producers of a biological diversity intimately linked to their cultural diversity. Upstream, this leads to an extension of claims linked to the regime of access and benefit-sharing to substances not covered by the CBD, which diverts the spirit of Article 15. Downstream, it poses problems of compatibility with intellectual property law82.
The NP did not really solve these problems, leaving them de facto to the discretion of States. Of course, derivatives are defined in it 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 the scope of the text (Article 3)83. Nevertheless, numerous national delegates and researchers remain optimistic, seeing in the expression “utilization of such sources” a reference to derivatives. However, this deduction is not self-evident, transforming the expression used into a catch-all list [VOG 11, p. 55]. This may be a problem in the future, as users do not necessarily interpret the term “derivative” as an object likely to trigger the mechanism of access and benefit-sharing, unlike countries of origin or providing countries.
From the legal point of view, the same living or inert specimen may need to be treated differently according to its physical identity or the use for which it is intended, fishing or bioprospecting. In fact, should a salmon used as reproducer in a fish farm (genetic resource) be considered differently when it is used as food in a restaurant (biological resource)? Are different rules applicable for harvesting a flounder for food purposes or for isolating an anti-freezing gene to be inserted in a strawberry and patent the process? What about the algae used as food or as a natural source of omega 3? Should genetic resources be defined by their use, including their information and cognitive use, and/or by their physical identity84? Thus, the legal characterization and the status of the same resource can change according to circumstances85. In short, although they are merged with biological resources, genetic resources form a subcategory with a specific use in the sector of sciences and biotechnologies. The expressions bioresources or biogenetic resources, which are sometimes used by researchers, reflect this dual reality.
Differentiating genetic resources in the category of biological resources has become a key point of the debate on the patentability of living organisms. Marine genetic resources can then be defined from the perspective of their “materiality” or physical–chemical identity (we will then talk about natural substances, extracts, derivatives, molecules, compounds, natural, synthetic or hemisynthetic products) and from the information perspective (genes of interest, genetic codes, genomes), as is the case in Decision 391 of the Andean Community. In this last case, one will differentiate the information “contained in” (information encapsulated in the nucleotide sequence of the genetic material, which can be read and digitalized) from those “concerning” the genetic material (cognitive perspective: physiological, structural, taxonomic data, traditional and indigenous knowledge).
2.2.2.2. Potential resources
In the CBD, the word “value”, associated with biodiversity and its components, has a number of different aspects: of course, an economic aspect, as indicated by the utilitarian orientation of the text, but also intrinsic, environmental, genetic, social, scientific, cultural and aesthetic aspects86. During the CBD negotiations from 1989 to 1992, there was a general feeling of optimism linked to the potential benefits of the use of genetic resources in modern biotechnology, in particular by means of recombinant DNA techniques. Discussions on the CBD objectives were clearly orientated toward these new techniques and their expected benefits [SCH 10, pp. 12–13]. It is because biological diversity has potentially an economic value that States had to conserve it.
The potential of marine organisms for the production of useful compounds is however unknown, because very few of them were tested and the marine environment remains mostly unexplored. Yet, under Article 2 of the CBD, genetic material only becomes a “resource” if there is a utility and actual or potential value, namely a current or possible use [GLO 96, p. 28]. The distinction between actual and potential use is significant. It is the result of a compromise between two understandings of biodiversity, which are often seen as opposites. In the understanding defended by developing countries and new industrialized countries, biodiversity is a resource in itself, a profitable natural capital [NOI 97a, p. 188]. Like traditional natural resources, such as hydrocarbon and fish, it is an actual economic resource even before being collected87. In the understanding of developed countries and researchers, what gives its value to genetic material is not the genetic material per se, but the work transforming it88. The bryozoan or cnidarian are only potential resources, whose utility cannot be guaranteed with certainty before being developed. From the economic point of view, this position is closer to reality. The utility of marine genetic material is mainly potential, because generally bioprospecting is a contingent activity89.
Innovations commercialized from marine genetic material do exist, but they are rare compared to the thousands of species, molecules and genes studied for the last 40 years90. Studies confirm a faster and higher probability of success in marine organisms. Even though marine microbiology is only just starting, the rate at which new species are discovered and products likely to be used in pharmacology are developed is faster than for terrestrial organisms91. One molecule out of 10,000 identified molecules in the terrestrial environment would obtain a marketing authorization, whereas, in the marine environment, these predictions would be 10 molecules for 10,000 identified molecules [GUE 05b, p. 40].
From a practical point of view, the transformation of genetic material into a resource, and then into an economic good is based on a long, costly, complex and contingent process92. Generally, this process starts, after the negotiation with the country of origin, with the collection of wild species specimens conducted by researchers working for national research bodies and academic institutions. Because of its cost, the difficulties of access, or even the existence of well-stocked collections, bioprospecting stricto sensu or collection may not be achieved93. Only obtaining quantities of quality viable genetic material ensures the continuation of the valorization process. First, researchers, most of the time from public bodies (universities, laboratories), study and handle genetic material in laboratories, name it, classify it, characterize it, isolate it, modify it and scrutinize it. This first step in the scientific and biotechnological valorization can be inconclusive in the current state of knowledge and techniques and will hinder the performance of the next step of valorization by private laboratories or industrialists. Finally, nothing guarantees the commercialization of the innovation, as it will have to be profitable and presents no risk for human health and the environment94.
The development and commercialization of by-products of marine organisms are costly; approximately USD 800 million for the development of drugs alone [PHA 07]. The chance of success is low, sometimes between 15 and 20 years are needed to get through all the steps before commercialization. Only 0.001% of the products proposed are approved at the clinical level and then manufactured [SLA 07]. Bioprospecting thus remains subject to a significant random variable from an economic and practical point of view. During collection, the value of the genetic material is hard, or even impossible to determine. It can be non-existent or materialize in a carrier other than the one planned, such as symbiotic microorganisms. Having genetic material available is essential but not sufficient. A body of constantly evolving knowledge, know-how and techniques will be required to develop this material. Permanent at all steps, the fight against uncertainty is based on the ability of the successive users to artificially create new goods from a potential constantly worked on [KOO 05, p. 524].
Specialists disagree regarding the estimate of the economic impact of the marine bioprospecting activity, oscillating between myth and reality [POM 99, pp. 101–104, ROW 07]. Some key innovations in the medical and paramedical fields emerged95. It is obvious that marine biotechnologies have a significant actual and potential commercial interest; it is delicate to evaluate them due to the lack of transparent global data and truly significant examples. Evaluation must constantly be updated according to investments, lines of research, knowledge and technique evolution. It is even more delicate since the value of marine genetic resources does not only reside in the material part of the resource, but mainly in the information it contains or that concerns them96.
However, the discovery of new uses portends a significant increase [GRE 04, p. 3]. The potential market revenue for the industrial uses of marine genetic resources was cautiously estimated at USD 1 billion a year in 2000 [GLO 00, p. 79]. The European Union could become the world leader in marine biotechnology within the next 10 years. Blue biotechnology currently represents a market of 2 billion 800 million euros worldwide, with a growth potential that could reach 12% a year, if the industry and academics work together [see QUE 10]. However, we are far from the market expected by the CBD drafters. The actual and potential use of genetic material rather indicates an “attribution of a grant value”97.
The contingent nature of marine bioprospecting is again found from a legal point of view. With no legal definition, the question of whether it should be considered as a scientific or commercially orientated activity has not yet been decided within the UNCLOS framework. This raises the question of its legal regime, regardless of the marine space considered, with however a greater impact in the high seas and in the Area where marine biological resources can be openly accessed. Bioprospecting can be considered as an activity with an economic purpose comparable to mining98 or even fishing. According to us, on the contrary, there is an obvious factual link between bioprospecting and marine scientific research. As highlighted by the law professor Tullio Scovazzi, research conducted with the intention of increasing knowledge can very well lead to the discovery of commercially relevant information on genetic resources [SCO 10b, p. 312].
It is research that is the main vehicle of valorization of marine genetic resources and not bioprospecting assimilated with collecting, prospecting in situ. It would in fact be more appropriate to avoid semantic confusions to speak about “bio-valorization” rather than bioprospecting. Unlike mineral prospecting, bio-valorization is not just the current valorization of discovered marine genetic resource “deposits”. Innovations can emerge a long time after the collection of the carrier specimen. For example, a researcher can identify new active substances, therapeutic targets, thanks to the evolution of knowledge and techniques, years after the discovery of a carrier sponge. Therefore, marine bioprospecting should fall under the scientific research regime, as provided for by Part XIII of the UNCLOS99.
Bioprospecting, like modern marine scientific research, is a mixed hybrid activity driven by public and private interests, most of the time in cooperation, pursuing objectives that are both fundamental and applied100. It cannot, as an activity, represent the legal basis for any claim over sampled marine resources101. Genetic material is only the starting point of an R&D process102, the support of knowledge and pioneering technologies. In accordance with the UNCLOS objectives, there is however nothing to prevent the rights to exploit the results obtained from these resources from being claimed103. In the current context, obtaining such rights remains highly contingent, because they depend on the actual creation of new goods in the form of knowledge and industrial applications.