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Abstract

In global bioethics, the concept beneﬁt sharing refers to the promotion of equitable access to and the sharing of beneﬁts derived from scientiﬁc and technological progress, with a focus on facilitating the transfer of beneﬁts from developed to developing countries and communities. This entry focuses on four beneﬁt-sharing aspects: international declarations, guidelines, and statements; contextual discourses to justify beneﬁt sharing; legal considerations of beneﬁt sharing; and international instruments to protect traditional knowledge and natural resources. The most important international declarations, guidelines, and statements include the Universal Declaration of Human Rights, the Universal Declaration on Bioethics and Human Rights, the CIOMS Guidelines, and the International Declaration on Human Genetic Data. The contextual discourses to justify beneﬁt sharing are the following: common heritage of humankind (justice-as-equality), beneﬁt sharing of genetic resources within the context of the Convention on Biological Diversity and the Nagoya Protocol (justice-as-exchange), and international clinical research (solidarity, reciprocity, fair beneﬁt, procedural justice, capacity building, maximin, humanitarian needs). The legal considerations of beneﬁt sharing focus on intellectual property systems, patents, compulsory licensing, and bio piracy. Lastly, the international instruments to protect traditional knowledge and natural resources are the Convention on Biological Diversity, the Nagoya Protocol, and the Doha Declaration.

Introduction

The concept beneﬁt sharing is prominent in international law, global bioethics, research ethics, and political philosophy (Dauda and Dierickx 2013). In research ethics, for example, some of the most important issues in this regard revolve around questions on whether and when participants in clinical research should receive extra beneﬁts in addition to the ethically acceptable ones that are offered to recruit participants, to collect data, and to reasonably protect research participants from potential harms and risks during and after the project (Hughes 2014). The principles of solidarity, equality, and justice are central to the current global bioethical discourse on beneﬁt sharing. As such, the beneﬁt-sharing focus in this entry is on global bioethics which ﬁrstly promotes the equitable access to and the sharing of beneﬁts derived from scientiﬁc and technological progress and secondly facilitates the transfer of knowledge from developed (high-income) to developing (low-income) countries and/or societies (UNESCO 2013a).

However, in many contexts, the beneﬁts of science, scientiﬁc knowledge, and technology are unevenly distributed, primarily as a result of power, economic, and structural imbalances between countries, communities, and individuals. This is today even more the case than previously due to the important role of scientiﬁc knowledge in wealth creation. The fact that only 10 % of the global spending on health research is directed at 90 % of the global disease burden illustrates the point; it is known as the “10/90 gap.” As a result, the principles of global justice should form an integral part of all scientiﬁc endeavors, including beneﬁt sharing (Galjaard 2009; Hughes 2014).

Some of the main areas of consideration about beneﬁt sharing are the following: who are the recipients of the beneﬁts – individual research participants, communities, societies, and/or the international community; when are the beneﬁts provided to the recipients – during the research project and/or post-research; what are the different forms of beneﬁt sharing; and who is responsible for the provision of the beneﬁts – researchers, research institutions, funding agencies, and/or governments (states). In short, who owes what to whom and why (Hughes 2014; Pratt and Loff 2014).

The ﬁrst part of the entry describes some of the important international declarations, guidelines, and statements that are linked to beneﬁt sharing. This is followed by a section that describes the various contextual discourses that are currently used to justify beneﬁt sharing. The third section brieﬂy touches on some legal considerations of beneﬁt sharing, speciﬁcally intellectual property systems, patents, compulsory licensing, and biopiracy. The last section describes three of the prominent international instruments that are used to protect traditional knowledge and natural resources in a context of beneﬁt sharing.

Benefit Sharing As A Global Principle: International Declarations, Guidelines, And Statements

The principle of beneﬁt sharing is explicitly addressed in a number of international declarations, guidelines, and statements. The following prominent documents, with the year in which it was formulated or implemented in brackets, are addressed in this section: the Universal Declaration of Human Rights (1948), Universal Declaration on Bioethics and Human Rights (2005), International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002), and International Declaration on Human Genetic Data (2003). However, due to the limited available space, the following documents are not explicitly addressed but should nevertheless be regarded as relevant to the topic: the Human Genome Organization (HUGO) Committee Statement on Beneﬁt Sharing (2000), Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of Beneﬁts Arising out of their Utilization (2002), and Singapore Statement on Research Integrity (2010).

The Universal Declaration of Human Rights (UDHR) (United Nations 1948) is one of the very ﬁrst international declarations to directly address beneﬁt sharing in the context of science and technology. Article 27(1) states the following: “Everyone has the right to freely participate in the cultural life of the community, to enjoy the arts and to share in scientiﬁc advancement and its beneﬁts” (emphasis added). Other prominent declarations, guidelines, and statements on beneﬁt sharing only followed in the ﬁrst decade of the twenty-ﬁrst century.

In line with current global bioethics discourse, the Universal Declaration on Bioethics and Human Rights (UDBHR) expanded the individual focus of the UDHR to include society and the wider international community, with a clear recognition of global inequalities. As such, it, inter alia, states the following in Article 15(1) (Sharing of Beneﬁts): “Beneﬁts resulting from any scientiﬁc research and its applications should be shared with society as a whole and within the international community, in particular with developing countries .. .” (UNESCO 2005) (emphasis added). Article 15(1) also indicates that the beneﬁts may include sustainable assistance to research participants (individuals, families, clans, and/or groups), provision of new diagnostic and therapeutic modalities or products stemming from research, access to scientiﬁc and technological knowledge, and capacity building facilities for research purposes (Galjaard 2009). An important aspect of Article 15(1) in the context of global inequalities is its reference to “developing countries” where the sharing of beneﬁts should particularly aim to address and/or reduce factors that contribute to the signiﬁcant gap between developing and developed countries. Some examples of this gap include access to health care (diagnostic methods, curative methods, essential medicines, and vaccines), education, clean water, safe shelter, and adequate nutrition (Galjaard 2009). In addition, Article 24(2) indicates that capacity building undertakings to generate and share scientiﬁc knowledge, as well as to develop the related skills, should be promoted in a context of international cooperation (UNESCO 2005).

The Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects (the so-called CIOMS Guidelines) has a narrower focus than the UDHR or the UDBHR, namely, biomedical research involving human participants. Note that the draft document for the revised CIOMS Guidelines is open for public consultation until March 1, 2016; it is envisaged that the ﬁnal document will be approved by the end of 2016. In the CIOMS context, several of the guidelines (2002 version) are linked to beneﬁt sharing, speciﬁcally Guidelines 10, 12, and 21. Guideline 10 (Guideline 2 in the 2016 draft version) addresses matters concerning biomedical research in populations and communities with limited resources, especially in those contexts where they are, or may be, vulnerable to exploitation by sponsors and/or researchers from high-income countries. This guideline indicates that research in such vulnerable populations and communities should be responsive to their health needs and priorities and should aim to improve their quality of life (so-called “public good” research). In addition, any intervention or product developed, or knowledge generated, should be made reasonably available for the beneﬁt of these populations and communities. The responsiveness requirement involves more than merely determining that the focus disease or health condition is prevalent in the population; it also requires that successful products and/or interventions, if any, or other kinds of health beneﬁt are reasonably made available to the population and/or community during and/or after the conclusion of the study. This should be especially the case where the host country has limited resources to enable access to such products and/or interventions. The implication of this guideline is that a research project in which the products, interventions, or other kinds of health beneﬁt will not be reasonably available during and/or after the conclusion of the study should be regarded as unethical (CIOMS 2002; Hughes 2014; Yassi et al. 2013; Pratt and Loff 2014).

Guideline 12 (Guideline 3 in the 2016 draft version) of the CIOMS Guidelines addresses matters concerning the equitable distribution of burdens and beneﬁts in the selection of research participant groups. On the one hand, the selection of particular communities, groups, and/or individuals to participate in biomedical research should be done in a way that ensures the equitable distribution of duly foreseen burdens and beneﬁts. On the other hand, the explicit non-selection (exclusion) of particular communities, groups, and/or individuals that might have reasonably beneﬁtted from study participation must be duly justiﬁed, either on methodological and/or ethical grounds, and not be based on unjust or arbitrary arguments related to race, ethnicity, economic status, or gender in particular. In this regard, the ethical principle of equity holds that no community, group, and/or individual should be required to accept more than its fair share of the burdens of participation in research. Similarly, they should not be deprived or restricted from opportunities to beneﬁt from a fair share of the potential research beneﬁts, especially in the case of therapeutic beneﬁts when no superior or equivalent therapeutic interventions are available, whether it be during or after conclusion of the research (CIOMS 2002).

Guideline 21 (Guideline 6 in the 2016 draft version) of the CIOMS Guidelines addresses matters concerning the ethical obligation of external sponsors to provide health-care services. It, inter alia, indicates that “external sponsors are ethically obliged to ensure the availability of … services that are a necessary part of the commitment of a sponsor to make a beneﬁcial intervention or product developed as a result of the research reasonably available to the population or community concerned” (CIOMS 2002). These obligations should be explicitly clariﬁed and/or negotiated prior to the onset of the actual research project, especially the following: the availability of beneﬁcial interventions or products during and after the research, the duration that it will be available, and the speciﬁc recipients (communities, groups, and/or individuals) (CIOMS 2002).

The International Declaration on Human Genetic Data (IDHGD) also has a narrower focus than the UDHR or the UDBHR, more speciﬁcally in its focus on the use and applications of human genetic data. Articles 18, 19, and 23 of the IDHGD are relevant in the context of beneﬁt sharing. Article 18 deals with data circulation and international cooperation. It is particularly concerned with the cross-border ﬂow and fair access to all kinds of genetic data and biological samples in a context of international cooperation and the sharing of scientiﬁc knowledge. In this regard, cooperation refers to medical, scientiﬁc, and cultural cooperation, particularly between developing and developed countries (UNESCO 2004). Article 19 explains that the beneﬁts resulting from all kinds of genetic data and biological samples collected for research purposes should in principle be shared with the international community. In addition, the communities, groups, and/or individuals who participated in the research should, inter alia, speciﬁcally beneﬁt in one or more of the following ways: access to medical care; access to new diagnostics, facilities for new treatments, or drugs originating from the research; and support for health services (UNESCO 2004). Lastly, Article 23 indicates that states (governments) should enter into international agreements to enable developing countries to build local capacity (infrastructure, human resources, skills, and knowledge) with regard to human genetic data endeavors (UNESCO 2004).

Contextual Discourses To Justify Benefit Sharing

A variety of contextual discourses to justify the beneﬁt-sharing concept is currently recognized. The following contextual discourses are addressed in this section: common heritage of humankind; genetic resources within the context of the Convention on Biological Diversity and the Nagoya Protocol; and international clinical research.

Beneﬁt sharing within the context of the common heritage of humankind. The fundamental argument of this discourse is that common heritage resources are not meant to be controlled, possessed, or owned by individuals, communities, or even states. Rather, such resources should be dealt with in terms of the rights and interests of all humankind, speciﬁcally in terms of the global, equitable sharing, and distribution of resources between developing countries and developed countries, in other words, justice-as-equality. Equality essentially means that every person enjoys the same human dignity and respect as all other humans. Beneﬁt sharing in this context extent beyond the sharing of tangible resources to include intangible resources, such as technology which is regarded as an inheritance of human ancestors irrespective of their nationalities. Ideally, this resource distribution approach relies on equality among all states with regard to the beneﬁts arising from the common heritage of humankind. However, this remains problematic due to the current status quo involving power and economic imbalances between many communities and states. One potentially negative consequence of this discourse is its use to justify exploitation and biopiracy by bioprospectors who might claim resources from low-income diversity-rich countries without seeking due permission or sharing any resultant beneﬁts with those countries or the local communities (Dauda and Dierickx 2013).

Beneﬁt sharing of genetic resources within the context of the Convention on Biological Diversity and the Nagoya Protocol. The fundamental argument of this discourse is that access to and the use of genetic resources should be based upon an exchange between the custodians who grant access to genetic resources or traditional knowledge and those who provide the beneﬁts, rewards, or compensations resulting from the use of the genetic resources, in other words, justice-in-exchange (commutative justice). Justice in this regard essentially requires that any exchange between countries or states be done in a fair and equitable way. The concept genetic resources refers in this discourse to both nonhuman genetic resources (animals, plants, and microorganisms) and human genetic resources (DNA, blood samples, and other human tissues). In contrast to the common heritage of humankind discourse, countries or states in this context hold a sovereign right over their genetic resources and act as gatekeepers to those who wish to utilize it under speciﬁc conditions and/or agreements. In the 1992 Convention on Biological Diversity (CBD), genetic resources are regarded as a “common concern” rather than a “common heritage” of humankind. The implication of this viewpoint is that genetic resources are a “concern” of all humankind with a clear state-based duty to use it in a way that is cognizant of humanity and future generations. For example, genetic research is increasingly a globally collaborative effort to identify the complex interactions between the genetic and environmental factors responsible for multifactorial disorders such as cardiovascular disease, cancer, and psychiatric disorders. The Nagoya Protocol, which was adopted in 2010, takes the CBD further by providing greater legal certainty in terms of country-speciﬁc laws for the providers and users of genetic resources. These laws must, inter alia, ensure that the use of genetic resources is done with prior informed consent and on mutually agreed terms. In addition, it must comply with beneﬁt-sharing legislation in other countries (Galjaard 2009; Dauda and Dierickx 2013).

Beneﬁt sharing within the context of international clinical research. The concept international clinical research refers to research involving human participants that is organized, sponsored, and/or conducted by pharmaceutical companies, contract research organizations, and other research institutions. The business entities of these companies, organizations, and institutions are predominantly based in developed countries, but the actual data collection procedures are predominantly conducted or outsourced in low-income developing countries. This came about due to various ﬁnancial and research methodological considerations, for example, patients who are treatment naïve, ease of patient recruitment, low trial costs, and less strict (in some cases even absent) ethics review and/or regulations in developing countries. In addition, many individuals, communities, and societies in developing countries live in abject poverty and have little or no access to even basic health-care services. As a result of all these factors, beneﬁt sharing to improve personal well-being and health-care services is considered to be an important aspect in international clinical research, especially in developing country contexts. However, the fact still remains that some individuals and communities in developing country contexts may be excluded from beneﬁt sharing which renders them vulnerable (Dauda and Dierickx 2013; Hughes 2014).

A number of ethics principles and concepts are recognized to duly justify beneﬁt sharing in the international research context: solidarity; reciprocity, fair beneﬁt, and procedural justice; capacity building; maximin approach; and humanitarian needs.

Solidarity. The principle of solidarity refers to an attitude or sense of responsibility toward others who would not necessarily have a claim to any direct beneﬁt; it is a humanitarian concern beyond or free from other ethical obligations in such contexts. Solidarity is often called upon to justify beneﬁt sharing in human genetic research. As a result, communities or societies outside the research context can also beneﬁt from the research outcomes and/or products. In other words, research participants contribute to research endeavors so that others may beneﬁt from it in an act of solidarity. This places an obligation on researchers who should in principle distribute the research outcomes to everyone. As such, the solidarity principle is the cornerstone of Article 15(1) in the UDBHR (Dauda and Dierickx 2013; Galjaard 2009; Yassi et al. 2013).

Solidarity in data sharing requires due consideration of privacy, conﬁdentiality, and informed consent matters. Data sharing agreements should ensure that the conﬁdentiality of participant information is duly protected and respected, while still allowing it to be shared with the scientiﬁc community. There is often a tension between academically oriented, publicly funded researchers who focus on openness, peer-reviewed publications, and public beneﬁt on the one hand and commercially oriented researchers who regard information as proprietary on the other hand. In a context of informed consent, research participants need to be duly informed whether their data will be shared and used for public health applications or will instead be used within a commercial for-proﬁt context (Alter and Vardigan 2015).

Reciprocity, fair beneﬁt, and procedural justice. The principle of reciprocity refers to a situation in which the contributions of research participants to society (e.g., improved health care) are reciprocated with outcomes, products, services, and/or information generated from the research endeavors for the inputs, efforts, time, inconveniences, and risks accepted by them during the research. In other words, reciprocity implies that some form of project-related beneﬁt is owed to the research participants or community in the aftermath of their participation in a clinical research project in which they were exposed to substantial risk or burden (Hughes 2014). One of the prominent forms of reciprocity in international clinical research is the provision of post-research outcomes of the proven intervention (e.g., a new drug), especially in developing country contexts (Dauda and Dierickx 2013; Pratt and Loff 2014).

This links with the “reasonably available” concept in Article 21 of the CIOMS Guidelines (2002), namely, that an intervention found to be effective during the research should be made available to the research participants and/or their community after the study. Clearly, this will only be reason- ably possible for research endeavors that were initially responsive to the health needs and priorities of the target populations and communities (see Article 10, CIOMS Guidelines).

Fair beneﬁt is closely linked to reciprocity in that the fair beneﬁt principle refers to the proportional accrual of beneﬁts with regard to the research-related risks and burdens that research participants are exposed to in the project. This means that the beneﬁts should proportionally increase as the risks or burdens of research participation increase. However, it differs from reciprocity in that the type of beneﬁts is not restricted to the direct outcomes or products of the speciﬁc research project; rather, it is concerned that a fair amount of beneﬁt should accrue to the research participants or their communities. In other words, the fair beneﬁt approach is not limited to the proven intervention of the clinical study but can also include a whole range of beneﬁts not directly linked to the research outcomes – employment, capacity building, long-term partnerships, and ﬁnancial rewards. Procedural justice refers speciﬁcally to the way that fair beneﬁts are negotiated between the research participants and communities on the one hand and the sponsors, research companies, contract research organizations, and/or research institutions on the other hand. This means that the negotiation processes and ultimate agreement must at the very least be transparent to all (Dauda and Dierickx 2013; Hughes 2014; Pratt and Loff 2014).

Capacity building. The development and strengthening of professional and community capacity building endeavors to address local needs and concerns in developing country contexts is an important beneﬁt-sharing aspect in international clinical research. It includes education and training, modern laboratory facilities, opportunities for international cooperation, and the provisioning of budgetary resources to maintain and expand infrastructure (Galjaard 2009; Yassi et al. 2013). Developed countries have a special responsibility to promote beneﬁt sharing in the form of capacity building in developing countries. This facilitates scientiﬁc and technological progress and the development of local expertise (UNESCO 2010). One negative consequence of effective capacity building is the emigration (so-called brain drain) of skilled and experienced local health professionals, technologists, scientists, and researchers from developing countries to developed countries; an important reason is the generally inadequate salaries and employment beneﬁts offered to skilled persons in developing country contexts (Galjaard 2009; Chetwood et al. 2015).

Maximin approach. The maximin principle seeks to maximize the welfare of those at the minimum level of society; it justiﬁes beneﬁt sharing in terms of global distributive justice. This approach argues that beneﬁt negotiations and agreements between research participants and communities on the one hand and the sponsors, research companies, contract research organizations, and/or research institutions on the other hand should not rely on procedural bargaining skills but should rather always favor the research participants and communities. The maximin approach recognizes the signiﬁcant power and economic imbalances between research sponsors and vulnerable research communities. As a result, maximin requires that these vulnerable communities should be offered the best possible macro level beneﬁts so that the communities’ economic and social progress, as well as health-care structures, can maximally beneﬁt from the planned research activities. In other words, the maximin approach, inter alia, aims to facilitate general improvements in health care for vulnerable communities through research endeavors; it represents global justice for health. An advantage of this approach is that it generates community beneﬁts irrespective of the development of effective postresearch interventions (Dauda and Dierickx 2013).

Humanitarian needs. The focus on humanitarian needs requires from international clinical research endeavors to direct its primary research goals away from pure market forces toward addressing humanitarian aims. This will result in mutual beneﬁt for research sponsors in terms of access to a low-income developing country’s population and health needs, as well as for communities in terms of access to health-care resources (Chetwood et al. 2015).

In summary, the contextual discourses to justify beneﬁt sharing include the following: justice-as-equality in the context of the common heritage of humankind; justice-in-exchange (commutative justice) in the context of the Convention of Biological Diversity; and solidarity, reciprocity, fair beneﬁt, procedural justice, capacity building, distributive justice (maximin), and humanitarian needs in the context of international clinical research.

Legal Considerations Of Benefit Sharing

The relationship between the law and ethics is complex. Some laws reﬂect the ethical features that are fundamental to maintain a good society and human interactions, while other laws can be in conﬂict with global ethics principles. Nonetheless, each country’s laws are meant to be taken seriously by all who live and work in that country, including scientists, researchers, and health professionals (Dauda and Dierickx 2013). This section brieﬂy addresses the following global legal considerations in the context of beneﬁt sharing: intellectual property systems, patents, compulsory licensing, and biopiracy.

Intellectual property systems. The current global intellectual property systems are predominantly guided and dominated by economic goals. It often restricts access to beneﬁt sharing of scientiﬁc ﬁndings and/or products, especially for communities in developing countries that need it to ensure optimal socioeconomic development. An element of global justice and equality is needed to positively link intellectual property (IP) concepts and regulations with socioeconomic development endeavors in developing countries. The global intellectual property systems do not truly adhere to global justice principles while its regulations in effect exclude or signiﬁcantly restrict access to its beneﬁts for most in developing countries. This situation calls for due recognition of IP holders’ rights to intellectual ownership and innovation on the one hand and the principles of global justice and respect for human dignity of those living in the developing world on the other hand. The innovative introduction of, for example, “fair use” ideas can add value to facilitate just and equitable applications of IP principles in developing country contexts (UNESCO 2013a).

Patents. The act of patenting secure privatization and exclusivity to the use of newly developed ideas and products. Two of the reasons for such exclusivity in the development of new medicines are its extremely high costs and long development process; the cost for pharmaceutical companies to ultimately release a new medicine is estimated to be several hundred million US dollars, and its development can take more than 10 years. Not surprisingly, these factors accumulate to make access to and affordability of new medicines almost impossible for low-income individuals and communities in developing countries (Galjaard 2009). As such, international patent law and economic forces severely restrict any beneﬁt sharing of scientiﬁc progress and technological developments by low-income communities. This can be even more problematic when it involves the patenting of traditional knowledge involving medicinal plants by commercial entities in the absence of beneﬁt-sharing agreements, especially when those commercial entities are based in developed countries. It can rightly be regarded as a form of “biopiracy” when patenting takes place without the permission of the indigenous community; it often coincides with no, very little, or much delayed fair compensation. The case of the San community in the Kalahari Desert (Southern Africa) and their traditional knowledge of the appetite suppressant properties of Hoodia is a good example.

Increasingly, pharmaceutical companies are targeting ethno botanical knowledge to potentially obtain the raw materials required to commercially develop and/or produce medicines and other natural health products. This poses a threat to fair beneﬁt sharing by traditional communities in countries where adequate legal regulations regarding indigenous knowledge systems and patenting of traditional knowledge products are not properly formulated, implemented, or enforced. Also, it poses a potential threat to the extinction or widespread plundering of endangered and protected species (UNESCO 2013b). However, licensing agreements and the production of generic medicines can be feasible ways to negotiate and deal with the availability of new biomedical or technological products and innovations in low-income settings (Galjaard 2009). One example of how this has been successfully achieved is the increased global access to antiretroviral drugs (ARVs) for HIV-positive individuals. The introduction of low-cost ARVs came about through the combined effect of the following: governments’ use of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) ﬂexibilities as administered by the World Trade Organization (WTO), policies of the patent holders, and increased funding from a variety of sources to support intervention programs (UNESCO 2014).

Compulsory licensing. Compulsory licensing involves government involvement to force a patent holder to grant a license to an appropriate third party for the use, production, and distribution of a speciﬁc patented product, intervention, or process at a lower cost to the end-user than previously. The patent holder is still entitled to royalties in terms of the compulsory license but again usually at a lower rate than would have been the case previously. Compulsory licenses contribute to global beneﬁt sharing in two ways: ﬁrstly to ensure wider access to the use, production, and distribution of a patented product, intervention, or process, especially in the context of developing countries and societies; and secondly to facilitate economic growth in developing countries (UNESCO 2014).

Biopiracy. In line with Article 17 (Protection of the environment, the biosphere, and the biodiversity) of the UDBHR (UNESCO 2005), all states need to duly protect and sustain the rich biodiversity across the globe for current and future generations but especially so in developing countries where biodiversity is often proportionally richer than in many developed countries. Its utilization, beneﬁt-sharing potential, and signiﬁcance for future generation cannot be underestimated. As such, the 1992 Convention on Biological Diversity and the 2010 Nagoya Protocol were agreed upon to provide greater legal certainty for the protection of global biodiversity against uncontrolled use and biopiracy on the one hand, and to facilitate global beneﬁt sharing of these resources on the other hand (Dauda and Dierickx 2013; Galjaard 2009).

International Instruments To Protect Traditional Knowledge And Natural Resources In A Context Of Benefit Sharing

Several international conventions, protocol, and declarations have been drafted, accepted, and/or ratiﬁed in the last two decades or so to enhance opportunities to protect traditional knowledge and natural resources, as well as to share the beneﬁts of scientiﬁc advances and research in the context of global justice. This section brieﬂy describes the intention and role of the following three instruments in these endeavors: the Convention on Biological Diversity; the Nagoya Protocol; and the Doha Declaration.

Convention on Biological Diversity. The CBD is a multilateral treaty that came into effect in 1993; it was ratiﬁed by all United Nations member states with the exception of the USA. This convention was primarily established to protect developing countries from the risk of exploitation of their traditional knowledge and biodiversity. In terms of the CBD, all researchers and multinational companies who seek access to these resources are required to obtain informed consent from the relevant communities and authorities. Traditional knowledge, innovations, and practices are thus regarded as a kind of communal property which should be treated with due respect. In addition, the beneﬁts that derive from the utilization of such knowledge, innovations, and practices should be fairly and equitably shared (UNESCO 2013b).

Nagoya Protocol. The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Beneﬁts Arising from their Utilization to the Convention on Biological Diversity is a supplementary agreement to the CBD; it was adopted in 2010 but only came into effect in 2014. It, inter alia, focuses on the fair and equitable sharing, transfer, and funding of beneﬁts arising from the utilization of genetic resources. The Nagoya Protocol provides more legal certainty regarding the sustainable use of genetic resources, including traditional knowledge associated with these resources, and enhances the role of biodiversity to development and human wellbeing. The protocol provides clear recognition that the principle of informed consent does not only apply to individuals but also includes collectives (e.g., communities) and the environment in which they live. Furthermore, it indicates that intellectual property rights cannot take priority in developing country contexts when public health protection is at stake; these states should make their decisions in this regard with due consideration of the 2001 Doha Declaration on the TRIPS Agreement and Public Health (UNESCO 2013b).

Doha Declaration. The Doha Declaration on the TRIPS Agreement and Public Health was adopted by the World Trade Organization in 2001. It encourages high-income developed countries to transfer technology to least-developed countries. Furthermore, it provides its member states with some ﬂexibility to circumvent patent rights within current intellectual property systems to ensure better access to essential medicines; in other words, the Declaration facilitates beneﬁt sharing in a global justice context. The ﬂexibilities, inter alia, give member states the right to grant compulsory licenses for the production and distribution of essential medicines and the freedom to determine the grounds upon which such licenses are granted. Also, it gives member states the right to determine what constitutes a national public health emergency or other circumstances of extreme urgency in which the circumvention of patent rights might be warranted. The Doha Declaration provides member states with a way to protect international intellectual property rights while at the same time ensuring that low-income communities and populations in developing countries have access to patent-protected products, procedures, and interventions when so warranted by public health circumstances (UNESCO 2013b).

Conclusion

The Universal Declaration on Bioethics and Human Rights has its origins based on the Universal Declaration of Human Rights. In both declarations, the ethical principle and responsibility to share the beneﬁts of science and technology for the common good of all are clearly enshrined, especially so in the context of global inequalities. Ultimately, this ethical responsibility is critical to facilitate and work toward sustainable development on a global scale and not just to the advantage of a few individuals, communities, or countries (UNESCO 2013a). A variety of contextual discourses are currently recognized to justify the beneﬁt-sharing concept in global bioethics. These rich discourses provide a multifaceted perspective of the concept (Dauda and Dierickx 2013). Lastly, the future vision of UNESCO’s Bioethics Programme anticipates an increase in the importance of the link between the basic health rights of citizens in low-income developing countries, sustainable development, and the imperative to share the beneﬁts of science and technology in a context of global justice (UNESCO 2013a).

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