Keywords

1 Introduction

Covering almost 70% of the Earth, marine environments have extraordinary ecological, socioeconomic, scientific, cultural, recreational, and aesthetic value. They serve humans in global trade, transportation, tourism, and energy. Furthermore, marine organisms are a source of food for humans and contribute significantly to the health of the planet by absorbing great amounts of carbon dioxide.Footnote 1 Technological innovation and developments in marine equipment and laboratory technology have enabled cost-effective exploration and sampling of unexplored areas and sophisticated research on sampled organisms in laboratory settings (Krabbe 2021, p. 25). This evolution has meant that, for the first time in history, it is possible to explore the deep oceans and other previously inaccessible remote and frontier areas, and to extract resources from them (Leary 2007, p. 158ff; Scovazzi 2007, p. 16; Ramirez-Llodra 2020, p. 38ff).Footnote 2 Furthermore, advances in science, especially in the fields of marine biology, genomics, oceanography and bioinformatics, have increased understanding about marine organisms (Matz 2002, p. 280f; Arico and Salpin 2005, p. 8; Leary et al. 2009, p. 188; Doussis 2017, p. 87). This technological and scientific development has revealed that, along with their pure scientific value, marine organisms have an extended commercial value. They produce a variety of secondary metabolites that are useful in product development, especially in medicine, agriculture, chemistry, and cosmetics (Leary 2007, p. 158ff; Leary et al. 2009, p. 185).

As a result of recent developments and the increasing commercial interest in marine organisms, new activities have emerged. One of them is Marine Bioprospecting (MB), a promising, yet hotly debated, activity concerning the commercial exploitation of Marine Genetic Resources (MGR).Footnote 3 MB has been described as the activity of identifying unique properties of marine organisms for the purpose of product development (Mossop 2015, p. 825). On the one hand, MB is expected to experience significant growth in the next decades, leading to vast economic and commercial profits. On the other hand, it raises several issues regarding environmental protection, scientific research, and equity. The lack of a comprehensive legal framework and the limited experience and systematic knowledge regarding its exercise, possible implications, and long-term consequences complicate things further. Therefore, it is necessary to develop a thorough understanding of MB, define its potential and limitations, and regulate it effectively. This will enable maximum gains to be achieved, while minimising the risks and potential harm associated with its uncontrolled exercise. Within this context, this paper aims to briefly present some challenges connected with the exercise of MB. The first part will explore the activity itself, while the second one will provide an overview of the environmental, scientific, ethical, and legal challenges.

2 Understanding Marine Bioprospecting

This section aims to shed more light on MB by defining it, distinguishing it from Marine Scientific Research (MSR), describing its main characteristics, and presenting its commercial aspect and the interests connected to it.

2.1 Definition of Marine Bioprospecting

Since MB has only recently been developed as an activity, a unified definition of the concept is lacking. In fact, different understandings have been expressed over time regarding the number and kinds of processes that MB covers (Arico and Salpin 2005, p. 15; Leary 2007, p. 157; Hemmings and Rogan-Finnemore 2009, p. 535; Leary et al. 2009, p. 184; Mossop 2015, p. 826; Yu 2020, p. 7; Krabbe 2021, p. 41).

In a narrow sense, MB is defined as 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 products” (Subsidiary Body on Scientific and Technical and Technological Advice 2003, para 49; See also Matz 2002, p. 282; Arico and Salpin 2005, p. 15; de La Fayette 2009, p. 228; Broggiato 2013, p. 248; Mossop 2015, p. 827; Tvedt 2020, p. 245f; Ganashree 2021, p. 199). It includes the access to and exploration of marine environments, the sampling of organisms, and the initial process of scientific investigation and sampling analysis in laboratories. The aim is to indicate biological compounds of actual or potential value to commercial applications (Moran et al. 2001, p. 505; Matz 2002, p. 282; de La Fayette 2009, p. 228; Harvey and Gericke 2011, p. 325). In this sense, MB constitutes the first step towards future commercial exploitation of MGR and ends with the isolation and characterisation of the desired compound or property (UN Secretary General 2007, para 150).

In a broad sense, MB includes in-situ exploration and sampling as well as the entire research and development process. It is defined as the “process whereby commercially useful products are technologically derived, processed and developed based on the collection of marine genetic resources” (Krabbe 2021, p. 41). Here, MB does not cover only the initial process of sampling and laboratory analysis but also the product development and full-scale commercialisation (Farrier and Tucker 2001, pp. 213, 231; Arico and Salpin 2005, p. 15; Leary 2007, pp. 158, 164f; Leary et al. 2009, p. 184; Wales 2015, p. 46; Krabbe 2021, p. 41ff). It involves a number of actions divided into four stages in a linear sequence: first, the exploration and discovery, which includes the investigation and in-situ collection of samples and data from the environment; second, the isolation, characterisation, and culture of bioactive components in laboratories; third, the screening of components for useful quantities that may result in products; fourth, the full scale commercialisation, which includes patenting, product development, marketing, and selling (Jabour-Green and Nicol 2003, p. 85ff; Leary 2007, p. 164ff; Heafey 2014, p. 496; Bhatia and Chugh 2015, p. 178; Krabbe 2021, pp. 20, 43, 104). In the last stage, the natural component may represent a source of inspiration for the product development or it may be a large part or the whole of the final product. The latter case presupposes the harvesting of large quantities of organisms in bulk (Jabour-Green and Nicol 2003, p. 85; Krabbe 2021, p. 100).

Furthermore, based on a different understanding, bioprospecting describes the initial stage of exploration including sampling in small quantities, while biodiscovery covers the subsequent stage of recollection, isolation, characterisation, culture, screening, product development, and commercialisation (Hemmings and Rogan-Finnemore 2009, p. 536. See also Matz-Lück 2017, p. 1611). Moreover, for some scholars, MB does not only refer to organisms but also includes the associated traditional knowledge. This is usually possessed by indigenous coastal communities and is related to medical and other applications of marine resources and the management of biodiversity (Compare Shiva 2007, p. 307; Demunshi and Chugh 2010, p. 3018; Eritja 2017, p. 225). This knowledge constitutes an essential complement in order to pursue effective research and discover useful properties and applications, especially in case of drug development.

In order to provide a comprehensive understanding of the complexity and inherent challenges of MB, this paper accepts the broad definition. The following analysis has practical value only if the activity is considered within its natural complexity and is not seen only from a theoretical and simplified perspective. Before entering the main analysis, it is necessary to briefly outline three characteristics of MB. First, MB is a highly risky, long-lasting and expensive activity and requires wide-ranging technological and scientific expertise (Farrier and Tucker 2001, p. 227; Krabbe 2021, p. 105). The process between sampling and selling may last up to 15 years. The most costly and burdensome phase is in laboratories (Farrier and Tucker 2001, p. 227; Krabbe 2021, p. 29). Second, exploration and resource extraction take place in areas within and beyond national jurisdiction. However, the main focus in the future is expected to be on some unique and valuable organisms of deep oceans. Third, MB shows a high degree of complexity, diversity of purposes, methods, and processes, and may vary significantly from case to case (Tvedt 2020, p. 246; Krabbe 2021, p. 104). Different needs and practical requirements have led to the development of various means of conducting MB. Furthermore, it is not very common for the whole process to be conducted exclusively by a single entity or bioprospecting group (Krabbe 2021, pp. 30, 104). On the contrary, the current trend is to establish collaborations between scientific and bioprospecting groups or use data collected from other groups. This complexity creates challenges and uncertainties that have to be considered when regulating the activity.

2.2 Marine Bioprospecting VS Marine Scientific Research

Scholarship and praxis are often unclear about the nature of MB and whether it should be considered as MSR. MSR is fundamental research undertaken for purely scientific purposes and carried out with the intention of open publication (Matz 2002, p. 282; de La Fayette 2009, p. 270; Scovazzi 2013, p. 121; Doussis 2017, p. 89). It is described as ‘an activity that involves collection and analysis of information, data or samples aimed at increasing mankind’s knowledge of the environment, and is not undertaken with the intent of economic gain’ (Scovazzi 2004, p. 401f; See also Leary 2007, p. 183ff).

A comparison between MB and MSR shows that they both relate to the exploration of marine environments and include sampling, laboratory investigation, and research. Furthermore, both focus on the exploration of the same kind of marine organisms and hotspots and make use of similar technologies, research and investigatory methods (Krabbe 2021, p. 198). However, they pursue different purposes (Compare Caflisch and Picard 1978, p. 850; Mossop 2015, p. 832; Matz-Lück 2017, p. 1611; Yu 2020, p. 9). While MB investigates marine organisms in order to develop products and make profit, MSR aims to increase scientific knowledge and understanding for the benefit of humankind. The latter researches marine environments in order to describe and understand oceans, the functions and processes of marine ecosystems, and the role of genetic resources within biological diversity (Matz 2002, p. 283; de La Fayette 2009, p. 270; Krabbe 2021, pp. 49ff, 198).Footnote 4 In order to enhance knowledge, MSR is characterised by openness, exchange of samples, and dissemination of data and research outcomes (Scovazzi 2004, p. 402). Although the knowledge produced may later be used in commercial and non-commercial applications, the exclusive goal of MSR is scientific discovery and the expansion of scientific knowledge.

The different purposes pursued by MB and MSR have practical and legal implications. At a practical level, sampling methods, the selection of organisms, and the frequency and intensity of sampling may differ significantly. Sampling in scientific projects usually takes place randomly and in small quantities and the applied methods focus on screening and understanding marine environments. On contrary, sampling in MB projects is often more invasive and manipulative of the environments. It targets exclusively habitats and organisms with increased commercial value, and may occur repeatedly and in large quantities. As a result, the two activities may affect marine organisms and environments on a different scale. Especially when product development in MB requires the intensive harvesting of organisms, there is a higher risk of causing significant and irreversible harm. At the legal level, the different purposes are fundamental in determining the regime that regulates the exploration, sampling, and in-situ research and the conditions for the protection, publication, and use of research data and outcomes (Matz 2002, p. 283; Scovazzi 2004, p. 401, 2020, p. 223; Drankier et al. 2012, p. 416; Yu 2020, p. 6).

Despite the clear lines in theory, the boundaries between MB and MSR are often blurred in praxis as a result of an increasing trend of mutual interaction and integration (Farrier and Tucker 2001, p. 228; Wales 2015, p. 46; Yu 2020, p. 8f; Krabbe 2021, p. 103). This usually happens when a project is partly scientific and partly commercial or when the same data and research outcomes are used in science and for commercial applications. The requirements for scientific and technical expertise and the high costs of sampling and research often give rise to close collaboration between scientific research institutions and bioprospecting groups (Farrier and Tucker 2001, p. 228f; Jabour-Green and Nicol 2003, p. 78; Leary et al. 2009, p. 184; Heafey 2014, p. 496; Harden-Davies 2017, p. 505; Yu 2020, p. 9; Krabbe 2021, p. 107).Footnote 5 In some collaborative projects, bioprospecting groups do not participate in sampling, only becoming involved during laboratory research (Krabbe 2021, p. 112). Moreover, it may happen that non-commercially orientated collaborations begin with the aim of describing new species or exploring the biodiversity of a certain region and their outcomes are later used for commercial purposes (Krabbe 2021, p. 108). In other cases, bioprospectors skip the in-situ investigation and use publicly available information and samples collected earlier by scientific and other bioprospecting groups and preserved in ex-situ collections, databases, and libraries (Hemmings and Rogan-Finnemore 2009, p. 536; Leary et al. 2009, p. 184; Krabbe 2021, pp. 51, 108f). Sometimes, although a project begins as a fundamental research project, commercial motives are added at a later stage, altering its initial character. This often happens after the in-situ operation is completed (Krabbe 2021, p. 103). In the aforementioned cases, the mix of scientific and commercial elements creates confusion about the character and legal qualification of a project and causes uncertainty about the applicable rules.

2.3 The Commercial Aspect of Marine Bioprospecting

Marine environments contain some of the most valuable and biodiverse ecosystems on Earth. While in the past commercially valuable organisms were supposed to live in coastal areas, recent expeditions have discovered new and rare species in deep oceans and especially on hydrothermal vents and cold seeps. These species have developed some unique and commercially valuable genetic and biochemical properties as a response to the extreme conditions of high pressure and temperature, darkness, toxicity, and absence of oxygen (Matz 2002, p. 281; Leary 2007, p. 159ff; Scovazzi 2007, p. 16, 2010, p. 50, 2020, p. 217; de La Fayette 2009, p. 228ff; Matz-Lück 2010, p. 61; Mossop 2015, p. 827; Ramirez-Llodra 2020, p. 37; Krabbe 2021, pp. 26ff, 53ff). Compared with organisms in coastal areas, organisms of deep oceans are genetically, metabolically, physiologically, and taxonomically very diverse (Subsidiary Body on Scientific and Advice 2005: paras 24ff; Leary 2007, p. 159; de La Fayette 2009, p. 228f; Harden-Davies 2017, p. 505; Krabbe 2021, p. 53). Marine biotechnology recognises in them a high potential for developing new products and processes (Compare de La Fayette 2009, p. 231; Leary et al. 2009, p. 189ff; Scovazzi 2010, p. 51; Harvey and Gericke 2011, p. 323f; Scheiber 2011, p. 95; Harden-Davies 2017, p. 506f; Humphries et al. 2020, p. 2). At the moment, a very small percentage of them have been explored. The likelihood of discovering previously undescribed species with commercial value is estimated to be 500 times higher in comparison with terrestrial counterparts (Arrieta et al. 2010, p. 18320; Mossop 2015, p. 827; See also Arico and Salpin 2005, p. 27; Leary et al. 2009, p. 185. See also Krabbe 2021, p. 53f). This increases the interest of the biotechnological industry in commercially exploiting ocean resources (Leary 2007, p. 159; de La Fayette 2009, p. 231).

In this framework, MB constitutes a key activity in the discovery of novel bioactive properties of marine organisms with potential uses for humans. This is expected to foster innovation, solve current social problems, and improve our quality of life. Findings from MB can be used in various industrial and commercial sectors, such as medicine and pharmacology, agriculture and aquaculture, chemistry, manufacturing and the cosmetic industry, as well as in the fields of eco-toxicology, bioremediation, and bio-fuel production (Farrier and Tucker 2001, p. 215f; Arico and Salpin 2005, pp. 20f, 25, 27; Subsidiary Body on Scientific and Advice 2005, para 21; Leary 2007, p. 160; de La Fayette 2009, p. 231; Leary et al. 2009, p. 189f; Arrieta et al. 2010, p. 18320; Scovazzi 2010, p. 52; Broggiato 2013, p. 249; Broggiato et al. 2014, p. 176177; Mossop 2015, p. 828; Wales 2015, p. 44; Papastavridis 2020, p. 585). The significance of MB is reflected in the number of discoveries based on MGR, the number of patents filed to protect these discoveries, and the number of applications developed from biotechnological discoveries. Since 1999, the number of patents originating from MGR has increased 12% per year on average. (Arrieta et al. 2010, p. 18319; See also Arico and Salpin 2005, p. 25; Leary et al. 2009, p. 189; Krabbe 2021, p. 125).

2.4 Interests Connected to Marine Bioprospecting

Besides the interest of the biotechnological industry in commercially exploiting marine organisms in order to develop new products and foster innovation, several other interests are at play regarding MB.

Human presence and the investigatory and sampling techniques used can harm organisms and endanger biodiversity. This risk is higher in case of the unique and fragile ecosystems of the deep oceans. Coastal states and the international community have a strong environmental interest in protecting marine organisms and conserving biodiversity (Leary et al. 2009, p. 188; Gjerde et al. 2016, p. 47). Along with the establishment of technical and scientific frameworks, strict rules are required in order to control and reduce harmful bioprospecting activities. Although environmental protection does not necessarily imply the total prohibition of MB, this may be indispensable, especially when activities can harm rare and vulnerable species.

Furthermore, the scientific community has a double interest in MB. Firstly, scientists need to collaborate with bioprospectors in order to cover the immense technological, scientific, and financial requirements. Secondly, scientists have a general interest in the applied methods and the research outcomes of MB as a means of increasing understanding about marine environments (Leary et al. 2009, p. 184; Doussis 2017, p. 87f). Beside purely academic purposes, the gained knowledge may have practical applications, helping scientists and decision makers to develop sustainable mechanisms and policies, manage resources effectively, and address climate change and anthropogenic pollution (Doussis 2017, p. 88). However, it should be mentioned that the commercially-oriented outcomes of MB can only partially serve scientists who follow broader, non-commercial purposes. Moreover, the contribution of MB to science is restricted when data and research outcomes remain undisclosed and protected by intellectual property rights (Leary et al. 2009, p. 184; Drankier et al. 2012, p. 396; Krabbe 2021, p. 112).

Along with the industrial sector, the international community and coastal states have increased economic interest in exploiting marine resources. However, technological, financial, and scientific requirements enable only a small number of developed states to conduct MB. At the moment, three states (Germany, Japan, US) control 70% of MGR, while the majority of other states lack access (Arnaud-Haond et al. 2011, p. 1521; Krabbe 2021, p. 124). This fact generates inequalities between rich and poor states regarding the sharing of benefits from the commercial exploitation of MGR.

Finally, in the case of MB within national jurisdiction, several, often contradictory, interests are involved. Interest in MB is related to the freedom of coastal states to decide whether, to what extent, and under which conditions they will permit resource exploitation. This affects the interests of other states, private entities, and the international community in exploiting marine resources. Furthermore, MB may influence other activities and interests, such as tourism, fisheries, transportation, local communities, and indigenous groups. All these interests have to be identified, described, and fairly balanced.

3 Marine Bioprospecting Challenges Related to Environmental Protection, Scientific Research, Ethics, and the Law

MB is a recently emerged and little understood activity that is in the process of development. It is characterised by a high level of complexity and variability, its boundaries and processes are not sufficiently clear, and various interests are connected to it. MB promises to revolutionise the field of biotechnology, yet, at the same time, it raises environmental, scientific, ethical, and legal challenges that will need to be effectively addressed. This section will provide an overview of some of the important challenges.

3.1 Challenges Related to Environmental Protection

In-situ bioprospecting activities can significantly harm marine organisms and their environments in various ways. One way relates to the adopted investigatory and sampling techniques. Noise, light, and heat from vessels, the movement of submersibles, accidental oil spills, hazardous waste, and ballast water discharge can cause physical and structural harm (de La Fayette 2009, p. 233; Leary et al. 2009, p. 188; Hubert 2011, p. 330; Broggiato 2013, p. 249). In addition, MB often requires the application of invasive, manipulative, and destructive techniques, such as the clearing of fauna for experimental studies, transplantation of fauna between locations, or the placement of instrument packages. The aim of the techniques used is not merely to describe and understand environments and organisms but rather to identify commercially valuable resources.Footnote 6

Collection of marine organisms can also cause harm, especially when this takes place in large quantities. Researching, identifying, and isolating commercially valuable compounds often require the sampling of large quantities for repeated experiments in laboratories. The exact quantity depends on the research purpose (Krabbe 2021, p. 106). Moreover, it is often economically more profitable to harvest resources in large quantities than to produce them synthetically (Jabour-Green and Nicol 2003, p. 108). In addition, massive, intensive, aggressive, and often uncontrolled harvesting for product manufacturing may destroy organisms and their communities (Farrier and Tucker 2001, p. 218f; Arrieta et al. 2010, p. 18321). Harm is also caused by the collection of resources beyond industrial and scientific needs or when large quantities are required for profitable use. Frequent repeated collection in areas with recognised commercial value adds to the harm, as do simultaneous or successive activities in the same area by various scientific and bioprospecting groups. In fact, repetitive harvesting can threaten species even if it is controlled and moderate (Arico and Salpin 2005, p. 22; Warner 2008, p. 416; Arrieta et al. 2010, p. 18321; Mossop 2015, p. 829). In this context, it is worth noting that the environmental impact of in-situ activities is currently assessed in very few projects (Dhillion et al. 2002, p. 492; Leary 2007, p. 190). Finally, in addition to the destructive factors, it is also necessary to consider the increasing pressure caused by other anthropogenic activities that have a cumulative impact on marine environments (de La Fayette 2009, p. 232).Footnote 7

In the aforementioned cases, MB can disturb fauna, harm the target organisms, and cause second order effects, such as changes in water flows, alteration of the community structure, biological contamination, and the introduction of exotic species. Long-term effects, such as alteration or destruction of marine ecosystems, decreases in population, and species extinction are also possible (Arico and Salpin 2005, p. 22; Subsidiary Body on Scientific and Advice 2005, para 27; Leary 2007, p. 189; Matz-Lück 2010, p. 64; Hubert 2011, p. 330; Scheiber 2011, p. 95). The level of harm depends on a number of factors, including the structure of the ecosystems, the specific circumstances of the targeted area (e.g. environmental conditions, level of pollution, other activities), the uniqueness and vulnerability of the sampled organisms, the characteristics of the project, the methods used, and the quantity and frequency of sampling.

The effects of MB are even more significant in the case of organisms in deep oceans. Due to specific environmental conditions, these organisms grow very slowly, have a slow rate of regeneration, and lack the ability to adapt to changes in their environment Some unique forms of life like trenches that form less than 1% of the oceans have evolved over millions of years. (Compare Harden-Davies 2017, p. 506; Humphries et al. 2020, p. 2). Oceanic organisms tend to recover slowly from disturbances and in some cases damage can be irreversible or take a very long time to reverse.Footnote 8 Some organisms are unique, live in small communities, and can be found only in one place. Any intervention during MB and the continuous harvesting of large amounts can seriously harm them or cause their extinction. The risk is higher for small and rare populations with limited distribution.

In-situ bioprospecting activities constitute a major threat to these organisms and environments. This fact cannot be ignored for the sake of commercial profit. On the contrary, a comprehensive analysis of all risks and long-term effects is required in order to establish the appropriate scientific, technical, and regulatory frameworks that will effectively manage MB, control its impact, and ensure biodiversity conservation and a high level of environmental protection.Footnote 9 This is not only in the interest of marine environments. It also benefits MB, given that the activity itself depends on the good condition of marine ecosystems and a future decline of biodiversity will adversely affect it in the long term (Compare Hughes and Bridge 2010, p. 17). Although the effective management of the impacts from MB seems easy in theory, several challenges complicate it in practice. Some of the difficulties include its complexity, the limited experience in the field, the numerous competing interests, the impact of the techniques used on ecosystems and the lack of comprehensive knowledge about this impact. Other challenges are related to the specific conditions of marine environments, the complexity and limited understanding of the marine realm, the connectivity among ecosystems, the characteristics of the collected organisms, the reaction of organisms to human presence and interventions, and the cumulative and long-term effects. Finally, in addition to the challenges mentioned above, the environmental regulatory framework is insufficient and fragmented, there is a lack of effective monitoring and enforcement as well as knowledge gaps, and the cooperation between actors (states and private entities) is limited (Rayfuse and Warner 2008, p. 402; de La Fayette 2009, p. 257; Leary et al. 2009, p. 183; Matz-Lück 2010, p. 67f).

3.2 Challenges Related to Scientific Research

Research constitutes the most significant part of MB and seeks to reveal commercially valuable properties of marine organisms for product development. In order to protect their economic interests, bioprospectors keep important information and data produced during research strictly confidential. Confidentiality covers a wide spectrum of information regarding marine resources and environments, the geographic origin of the samples, the methods used, the scientific outcomes, the frequency and intensity of sampling, and other details about the project (Compare Leary et al. 2009, p. 184; Scovazzi 2010, p. 52; Arnaud-Haond et al. 2011, p. 1522; Chiarolla 2014, pp. 178, 180f; Mossop 2015, p. 832; Wales 2015, p. 45; Krabbe 2021, p. 117). In many cases, the deposition of specimens to collections is delayed or bypassed in order to meet confidentiality requirements (Hughes and Bridge 2010, p. 16). At the same time, confidentiality affects the freedom of scientific research and deprives academic scientists and policy makers of useful information (Jabour-Green and Nicol 2003, pp. 78, 97ff; Leary and Walton 2010, p. 2; Wales 2015, p. 45). Furthermore, confidentiality may reduce trust and interaction between scientists, who avoid sharing data before licensing arrangements are made. Hence, there are negative consequences for the conducting of research, fostering of cooperation, and production of novel research outcomes (Hughes and Bridge 2010, p. 15f). Moreover, confidentiality impedes precise and comprehensive assessment of the project in question, understanding of its environmental impact, monitoring of its long-term effects, and the collection of experience. This, in turn, complicates the establishment of effective scientific, technical, and legal frameworks to control MB.

In light of the above, the following questions need to be addressed: What are the limits of confidentiality? To what extent does confidentiality really promote innovation when data sharing is hindered (Compare Chiarolla 2014, p. 178)? Does confidentiality comply with principles of fairness and reciprocity, given that bioprospectors use publicly available data from scientific groups, while they keep their own data strictly confidential? How could transparency of research outcomes and access to information be guaranteed? Based on the answers to these questions, it is necessary to redefine confidentiality with regard to MB and establish a more appropriate framework.

Besides this issue of confidentiality, MB can also harm academic research in another way. Specifically, the current trend whereby governments and investors provide support to commercially significant projects indirectly forces academic researchers to commercialise their work, produce commercially relevant outcomes, and collaborate with industrial partners in order to get sufficient funding. In the long term, this pressure may influence the quality of academic research, lead to shrinking or loss of scientific areas with little commercial value, and affect the production of a more holistic understanding of marine environments (Hughes and Bridge 2010, p. 15). In this respect, it is necessary to increase awareness and take measures to prevent such outcomes.

3.3 Challenges Related to Ethics

As explained above, MB can foster innovation and product development in numerous industrial sectors. Industries and biotechnology companies invest years and millions of USD in research and product development. As the primary goal is the commercial exploitation of marine resources, bioprospectors are willing to bear the costs and risks if a significant profit is guaranteed. Currently, the potential monetary benefits are estimated to be in billions of USD, and this rate should continuously increase (Arnaud-Haond et al. 2011, p. 1521; Mossop 2015, p. 828). Contracts of exclusive access to and exploitation of marine resources, as well as intellectual property rights, provide incentives and foster innovation, research, and product development (Jabour-Green and Nicol 2003, pp. 78, 87; Leary 2007, p. 170ff; Leary et al. 2009, p. 189; Drankier et al. 2012, p. 396; Chiarolla 2014, p. 172; Heafey 2014, p. 511; Bhatia and Chugh 2015, p. 182; Krabbe 2021, p. 116ff; See also Moran et al. 2001, p. 513). Each year, the number of patents derived from MGR is growing at around 12%. Ten countries own 90% of patents on marine genes while the top three own 70% (Arnaud-Haond et al. 2011, p. 1521; Broggiato 2013, p. 248). Based on studies of the records of genetic sequences associated with patents, the majority of MGR belong to a few corporations (Scovazzi 2010, p. 51; Arnaud-Haond et al. 2011, p. 1521; Blasiak et al. 2018, p. 2). One single company (BASF) has registered 47% of all oceanic marine sequences. Although the commercial exploitation of resources has significant monetary benefits, can foster innovation and improve the quality of life, it raises a number of ethical issues.

The first issue relates to the ownership of genetic resources and the right to control and dispose of them (Compare Bhatti et al. 2009, p. 18; de La Fayette 2009, p. 255; Barnes 2010, p. 83; Fedder 2013, p. 71; Ganashree 2021, p. 199). This raises several questions. What does it mean to “own the resources”? What is the scope of ownership? Who is the owner? To what extent are resources capable of being owned? Do ownership and commercialisation foster growth for the benefit of humankind or for a small number of states leaving biodiversity-rich regions financially and environmentally poor (Shiva 2007, pp. 307, 312)? Other questions relate to the rights and obligations of the owner and the practical and environmental implications of recognising ownership. In line with the United Nations Convention on the Law of the Sea (UNCLOS), the Convention on Biological Diversity (CBD) recognises the right of coastal states to own and utilise genetic resources within their jurisdiction and to grant access (Farrier and Tucker 2001, p. 222; Harvey and Gericke 2011, p. 323f; Mossop 2015, p. 830; Krabbe 2021, p. 326). In the case of ocean resources, the situation is more complicated, given that no state can claim sovereignty rights and neither UNCLOS nor CBD provide specific rules (Compare Jabour-Green and Nicol 2003, pp. 95, 106ff; Scovazzi 2007, p. 18, 2020, p. 218; Matz-Lück 2010, p. 62; Mossop 2015, p. 836; Krabbe 2021, p. 330). Currently, the question is the subject of negotiations under the Biodiversity Beyond National Jurisdiction (BBNJ) agreement, which aims to establish a framework for biodiversity conservation and fair exploitation (Matz-Lück 2010, p. 65; Scovazzi 2010, p. 53, 2020, p. 218ff; Chiarolla 2014, p. 172f; Mossop 2015, p. 830; De Santo et al. 2020, p. 4). In fact, various regulatory regimes are available (Mossop 2015, p. 837f; Ganashree 2021, p. 203).Footnote 10 Some states interested in exploiting MGR endorse the right to free access, while others regard ocean resources as common heritage of humankind.

A second issue relates to the sharing of monetary and non-monetary benefits derived from commercial exploitation of MGR. As explained above, only a few states from the developed north have the capacity to conduct MB, while the vast majority have no access (Scovazzi 2007, p. 19; Wales 2015, p. 45; Blasiak et al. 2018, p. 2). Furthermore, the granting of exclusive rights enables corporations to make significant profits using resources and associated traditional knowledge, while excluding indigenous coastal communities from similar use (Shiva 2007, p. 312; Demunshi and Chugh 2010, p. 3017). Ultimately, MB is seen as ‘the expropriation of the collective and cumulative innovation’ of the indigenous population, which has been used, protected, and conserved for centuries (Shiva 2007, p. 307). This situation perpetuates the gap between rich and poor states, reinforcing inequalities at the expense of developing states. In this respect, issues of fairness arise with regard to benefit sharing (Jabour-Green and Nicol 2003, p. 80; Rosendal 2006, p. 437; Guyomard 2010, p. 31; Jabour 2010, p. 25; Leary and Walton 2010, p. 2; Arnaud-Haond et al. 2011, p. 1521; Harvey and Gericke 2011, p. 325; Heafey 2014, p. 512; Ganashree 2021, p. 200). The CBD and the Nagoya Protocol address inequalities by introducing a system of sharing the benefits from resource exploitation within national jurisdiction (Moran et al. 2001, p. 516f; Drankier et al. 2012, p. 412, 416; Chiarolla 2014, p. 191; Mossop 2015, p. 830; Ganashree 2021, p. 213). However, this regime includes several legislative, contractual, procedural, and practical uncertainties and controversial issues.Footnote 11 Regarding oceanic resources, the issue is under negotiation within the framework of the BBNJ agreement (Scovazzi 2007, p. 24, 2020, p. 226ff; Tvedt and Jørem 2013, p. 151; De Santo et al. 2020, p. 4; Tvedt 2020, p. 238; Ganashree 2021, p. 201). Finally, in addition to issues of ownership and benefit sharing, ethical considerations arise with regard to genetic engineering, public safety, and patentability of life forms (Bruce and Bruce 1998; Leary 2007, p. 171; Drankier et al. 2012, p. 388; Chiarolla 2014, p. 175).

3.4 Legal Challenges

The aforementioned challenges and open questions at the environmental, scientific, and ethical level are reflected in the existing legal framework related to MB. As MB is still in its infancy, a unified and well established framework regulating all issues concerning the commercial exploitation of MGR is missing. Depending on the issue in question, several rules are applicable. (Compare Scovazzi 2007, p. 18, 2010, p. 57; de La Fayette 2009, p. 263; Matz-Lück 2010, p. 64; Bhatia and Chugh 2015, p. 180; Krabbe 2021, p. 131). This section does not aim to list the applicable regulatory regimes but rather to highlight the complexity and identify challenges to be addressed promptly in order to establish legal certainty.

As explained, different regimes are applicable in different zones depending on the subject matter, the stage of the process, and the physical location of the resources.Footnote 12 These regimes, characterised by complexity, cover general issues without considering the specific characteristics and challenges of MB. They pursue different goals and apply during different stages of the process, simultaneously or successively, complementarily or concurrently (Krabbe 2021, p. 130; See also de La Fayette 2009, p. 234ff; Demunshi and Chugh 2010, p. 3018; Bhatia and Chugh 2015, p. 180; Ganashree 2021, p. 202). Some rules regulate issues related to in-situ research, such as environmental protection and impact assessment, resource management, the rights of coastal states to grant access, and administrative issues of sampling permissions. Other rules concern contractual issues in the case of research collaborations and funding, the code of conduct for responsible research, acceptable scientific methods, the conditions for ex-situ access to resources preserved in libraries, and the sharing of data and research outcomes. Other rules relate to the use of MGR, benefit sharing, biotechnology issues, intellectual property rights, marketing and product commercialisation.

Application of the appropriate rules presupposes the correct ad hoc legal qualification. However, this may be difficult given the complexity of MB, the various forms it may take, and the blurred boundaries. For example, the relationship between MB and MSR raises questions as to whether MB should be legally treated as MSR (Scovazzi 2007, p. 18, 2010, p. 57f, 2020, p. 223f; de La Fayette 2009, pp. 254, 260ff; Drankier et al. 2012, p. 416; Heafey 2014, p. 509; Mossop 2015, p. 832ff; Matz-Lück 2017, p. 1611; Yu 2020, p. 9; Krabbe 2021, p. 198ff). The situation is more complex in the case of collaborations between bioprospecting and scientific groups or when bioprospectors use data produced in academia (Farrier and Tucker 2001, p. 229f; Matz 2002, p. 283; Guyomard 2010, p. 36f). Qualification issues also arise during laboratory research. In some cases, sophisticated genetic engineering technology modifies the natural components in a way that the final function differs from the original one. In this respect, it is unclear whether this process and the resulting product constitute MB or purely synthetic development (Krabbe 2021, p. 110).

In addition, it is common for different international, regional, and national regulatory frameworks to apply to the same legal issue. These frameworks lack a holistic approach, coordination, harmonisation and normative consistency, and cause confusion and legal uncertainty. For instance, issues regarding patentability or confidentiality are regulated differently within domestic patent law and at international level.Footnote 13 Similarly, several international, regional, and national environmental rules may apply simultaneously in a certain area, introducing different conditions on all or some activities. The fact that most of the time the applicable rules are not harmonised leads to problems during implementation, challenging their effectiveness and reducing environmental protection. Furthermore, identifying the applicable regime is often complicated when bioprospecting activities transcend the conventional UNCLOS division in maritime zones and take place partly beyond and partly within the national jurisdiction of one or more states.

Moreover, rules applicable to MB are characterised by a high level of fragmentation, complexity and incoherence, with ambiguities and disconnection, in addition to overlapping rules and legal gaps (de La Fayette 2009, p. 253; Gjerde et al. 2016, p. 47).Footnote 14 These characteristics result from ideological differences (different values and goals) and different logics across the regimes, lack of coordination during drafting, and regulatory gaps in science and technology.Footnote 15 For instance, while resource management, biodiversity protection and benefit sharing for resources within national jurisdiction are regulated under the CBD and the Nagoya Protocol, there is currently no similar framework for ocean resources (Chiarolla 2014, p. 191; For further information, see Matz 2002, p. 285). In these cases, it is very common for disputes to arise as to which rules and legal principles are applicable (de La Fayette 2009, p. 253). Furthermore, in sui-generis regimes like Antarctica and Arctic, the legal framework is more complex and the available regimes are inadequate to respond to the specific needs and requirements (More in Jabour-Green and Nicol 2003, p. 77ff; Guyomard 2010, p. 31; Jabour 2010, p. 19; Mossop 2015, p. 840; Eritja 2017, p. 229ff). Moreover, simultaneously applied regulations that serve different goals may introduce competing obligations and conditions, creating conflicts of rules. Such conflicts exist between patent law and environmental law with regard to confidentiality (Wales 2015, p. 45). While the former promotes confidentiality of information until patents are granted, the latter encourages transparency and free access to data as a means of promoting knowledge and environmental protection (Rosendal 2006, p. 436; Chiarolla 2014, p. 108f; Wales 2015, p. 45).Footnote 16 In addition, various regulatory regimes introduce seemingly incoherent obligations, although they are part of international law (Compare Krabbe 2021, p. 271).

The aforementioned characteristics of the legal framework related to MB make it difficult to identify the applicable rules, create conflicts of rules and confusion, and jeopardise legal certainty. In addition to these, two more parameters should be considered. Firstly, the characteristics of marine organisms and environments complicate the establishment of a suitable regulatory framework. Secondly, science and technology in the marine sector are developing so rapidly that legislators are unable to keep pace (Tladi 2019, p. 490f).

Besides challenges at the regulatory level, problems emerge regarding effective enforcement and monitoring.Footnote 17 In the case of international agreements and non-legally binding frameworks, their effective implementation depends mainly on the willingness of the state. In addition, enforcement gaps result from the lack of effective compliance and enforcement mechanisms and the lack of standing of states and organisms to protect the interests of the international community (Rayfuse 2010, p. 189). Moreover, rules in international law do not usually impose obligations on private entities and cannot be implemented and enforced in relation to them. At the same time, states are not always able to effectively control them (Rayfuse 2010, p. 189; Tvedt 2020, p. 247). Furthermore, effective implementation depends on scientific evaluations resulting from a thorough analysis of MB. However, this is not always feasible due to the limited experience and available information. Besides, rules often introduce obligations qualified by phrases such as “as far as possible” or “where applicable” (e.g. Article 6 (b), 7 and 8 CBD. See also Mossop 2015). This offers room for manoeuvre, allowing states and corporations to undermine significant obligations. Due to the lack of harmonisation, the implementation of one rule may undermine obligations introduced in other rules. Finally, the multiplicity of regimes, the regulatory gaps, and the conflicting obligations give states and companies a certain discretion to implement rules selectively, or control the system, avoiding to apply of the prohibitive rules of one regime by referring to the permissive rules of another (Krabbe 2021, p. 19).

4 Conclusion

MB is a relatively new activity and a product of recent biotechnological and scientific advances. It is a promising and challenging activity. On the one hand, it can contribute to improving the quality of life through the development of products and applications. On the other hand, it can cause detrimental and irreparable damage to marine environments, adversely affect scientific research, and increase inequalities. At the same time, the available regulatory framework is characterised by a high level of fragmentation, complexity, ambiguities, and disconnection that hinder proper control of the activity and its impacts.

In order to gain maximum advantage in the long term and mitigate the detriments of MB, it is necessary to become aware of the overall impact of this activity and take measures accordingly. The first step is to understand MB thoroughly. This involves considering it holistically at two levels. At micro-level, it is essential to analyse all challenges and open questions arising from its exercise. Some of these have been briefly presented in this paper. At macro-level, it is necessary to regard MB as part of a big picture that includes other activities and anthropogenic factors, the current state of the marine environment, the needs of current and future generations, and the requirements for biodiversity conservation and environmental protection. Based on the results of this analysis, a comprehensive regulatory framework should be established. This should introduce strict conditions that prioritise environmental protection and ensure the right balance between the interests of all stakeholders. However, given that MB is a complex and dynamic activity, mere regulation is not sufficient. It is also necessary to establish institutions and groups of experts who will be tasked with continuously monitoring the activity and its impacts and ensuring effective implementation of the regulatory framework, in addition to adapting the latter to specific needs and conditions.

Like every other human activity, MB has the potential to affect humans and the natural environment in a positive or negative way. It is in the hands of the current generation to define the footprint that it will leave for humans and our planet. Biodiversity conservation and environmental protection are of critical importance in order to meet the needs of present and future generations. All decisions should be taken on this basis.