《生物多样性公约》对遗传资源国际交流政策的影响

《生物多样性公约》于1992年在巴西里约热内卢签订,1993年生效。该公约提出了“国家对生物遗传资源拥有主权、获取生物遗传资源须事先得到资源所有者的知情同意、利用生物遗传资源所产生的利益应由资源所有者和开发者公平分享”三项基本原则,其生效与实施促进了各国生物多样性保护的立法行动,在维护资源原产国利益方面发挥了积极的作用,同时也给遗传资源的国际交流增添了一些障碍。本文介绍了《生物多样性公约》中有关生物遗传资源获取和利益分享的条款及其对国际交流政策的影响,并提出了加强遗传资源国际交换的对策和建议。     

Vicissitudes of benefit sharing of crop genetic resources: downstream and upstream

In this article, we will first give a historic overview of the concept of benefit sharing and its appearance in official agreements, particularly with respect to crop genetic resources. It will become clear that, at present, benefit sharing is primarily considered as an instrument of compensation or exchange, and thus refers to commutative justice. However, we believe that such a narrow interpretation of benefit sharing disregards, and even undermines, much of its (historical) content and potency, especially where crop genetic resources are concerned. We argue that benefit sharing should not be based merely on commutative justice but rather on a broader model that is also grounded in the concept of distributive justice. This has repercussions for the application of benefit sharing, which we try to clarify by distinguishing between downstream and upstream benefit sharing. Upstream benefit sharing is not so much inspired by compensation for actions done, or the distribution downstream of benefits developed, but by the idea of shared decision-making on the research and development of resources fundamental to human welfare. Going upstream in the research process of crop genetic resources, and determining research agendas and improving crops according to the needs of the poor, benefit sharing may well be a tool to contribute to world food security and global justice. We concretize our ideas on upstream benefit sharing by introducing a set of criteria that determine the success of consultations on agricultural research agenda setting.     

Best practices for the use and exchange of invertebrate biological control genetic resources relevant for food and agriculture

The Nagoya Protocol is a supplementary agreement to the Convention on Biological Diversity that provides a framework for the effective implementation of the fair and equitable sharing of benefits arising out of the utilization of genetic resources, including invertebrate biological control agents. The Protocol came into force on 12 October 2014, and requires signatories and countries acceding to the Protocol to develop a legal framework to ensure access to genetic resources, benefit-sharing and compliance. The biological control community of practice needs to comply with access and benefit sharing regulations arising under the Protocol. The IOBC Global Commission on Biological Control and Access and Benefit Sharing has prepared this best practices guide for the use and exchange of invertebrate biological control genetic resources for the biological control community of practice to demonstrate due diligence in responding to access and benefit sharing requirements, and to reassure the international community that biological control is a very successful and environmentally safe pest management method based on the use of biological diversity. We propose that components of best practice include: collaborations to facilitate information exchange about what invertebrate biological control agents are available and where they may be obtained; knowledge sharing through freely available databases that document successes (and failures); cooperative research to develop capacity in source countries; and transfer of production technology to provide opportunities for small-scale economic activity. We also provide a model concept agreement that can be used for scientific research and non-commercial release into nature where access and benefit sharing regulations exist, and a model policy for provision of invertebrate biological control agents to other parties where access and benefit sharing regulations are not restrictive or do not exist.     

遗传资源获取与惠益分享: 背景、进展与挑战

本文回顾了《生物多样性公约》(CBD)有关遗传资源获取与惠益分享(access and benefit sharing, ABS)问题的谈判背景, 介绍了ABS问题特设工作组的工作历程。对《公约》第8次缔约方大会以来有关ABS问题的谈判进展进行了详细的分析, 特别是有关遗传资源来源证书制度的讨论与成果, 进而对当前ABS问题面临的挑战进行了分析研究, 包括国际层面上WTO体系和世界知识产权组织(WIPO)体系与CBD之间在遗传资源及相关传统知识在知识产权问题上的冲突, 国家层面上ABS问题的立法需求与焦点问题, 以及在确定遗传资源来源和实施惠益分享方面的技术限制等。     

Benefit Sharing in a Global Context: Working Towards Solutions for Implementation

Due to the state of globalized clinical research, questions have been raised as to what, if any, benefits those who contribute to research should receive. One model for compensating research participants is “benefit sharing,” and the basic premise is that, as a matter of justice, those who contribute to scientific research should share in its benefits. While incorporated into several international documents for over two decades, benefit sharing has only been sparsely implemented. This analysis begins by addressing the concept of benefit sharing, its historical development, and how it has been applied in the context of virus sharing for influenza research. The second portion of this analysis presents recommendations for ensuring benefit sharing. These recommendations are threefold: 1) an emphasis on social pressure, 2) the revision of international documents as means to ensure benefit sharing, and 3) greater collaboration between sponsor IRB and host country IRB. Because clinical research is a globalized industry, a global model will be proposed in the second that focuses on collaboration between the sponsor and host country. This collaboration is vital in order to ensure that proper forms of benefit sharing are accomplished as a matter of justice.     

Exchange of Natural Enemies for Biological Control: Is it a Rocky Road?—The Road in the Euro-Mediterranean Region and the South American Common Market

The access and benefit sharing (ABS) regulations from the Convention on Biological Diversity (CBD) for the use of natural resources became an important issue because the biodiversity of developing countries was heavily accessed and unilaterally exploited by pharmaceutical and seed companies. However, natural enemies used for biological control are living and unmodified genetic resources which cannot be patented and have been treated as resources such as drugs, seeds, or other commercial products. Consequently, the ABS requirements have limited not only the use of natural enemies but also the positive effects that scientifically supported biological control strategies have on the society, the environment, and the economy, reducing problems of pesticide residues, water and soil contamination, and non-target effects. During the last several years, the biological control scientific community has faced new and extremely complicated legislation dictated by a high and diverse number of governmental agencies at different levels, making the access to natural resources for biocontrol purposes a rocky road. Society at large should be aware of how the strict ABS regulations affect the use of natural enemies as biological resources to secure food production, food safety, and global environmental protection. We discuss in here the current difficulties derived from CBD for the exchange of natural enemies taking as example the Euro-Mediterranean region, Argentina, and Brazil to demonstrate how long and diverse are the steps to be followed to obtain the required permits for access and exportation/importation of natural enemies. We then argue that the public visibility of biocontrol strategies should be increased and their benefits highlighted in order to persuade legislators for the development of a less bureaucratic, more expedient, and more centralized regulatory frame, greatly favoring the practice and benefits of biological control. We finally propose a general framework in which ABS issues should be dealt in ways to attend the CBD, but also to make the use of natural resources for the biological control of pests to secure food production and security a possible alternative.     

From Norway to Novartis: cyclosporin from Tolypocladium inflatum in an open access bioprospecting regime

The Convention on Biological Diversity (CBD) introduces a new regime of source countries' national sovereignty over genetic resources, in which benefit sharing is a central factor. This article shows how Tolypocladium inflatum was collected in Norway in 1969 within an open access regime implying that there is no benefit sharing with the source country from Novartis' present sales of the derived medicines based on cyclosporin. We estimate source country's loss of benefits in comparison with present norms and expectations concerning bioprospecting. Two percent annual royalties would have been a reasonable claim in this case, and in 1997 this amounted to US$ 24.3 million. Such benefits could, for instance, have been targeted to conservation, scientific capacity building and health care. The study provides an indication of possible gains for source countries – countries with developed as well as developing economies – in a case of the finding of a blockbuster drug. Institutional prerequisites for benefit sharing are discussed, and the emphasis, which often is placed on the role of patents as the cause of lack of source country benefits, is in this case found to be misleading.     

Intra-consortium data sharing in multi-national, multi-institutional genomic studies: gaps and guidance

Growing investments in health research by governments and charitable organizations have fueled an increase in collaborative research projects between investigators from affluent and developing countries. Current international guidelines are silent on common intra-consortium data-sharing issues that arise in the context of such collaborations. A lack of guidance on intra-consortium data sharing threatens to undermine the success of crucial research ventures. In this work we outline some of the practical problems commonly faced by investigators working in multi-institutional, international genomic collaborations and offer recommendations on these issues. A data sharing policy should be prospectively negotiated and concluded between collaborators as early as possible. Sponsors of research, including those from developing countries, should issue detailed guidance on the above and related issues as doing so will facilitate research and catalyze scientific progress.     

Conducting Research with Human Subjects in International Settings: Ethical Considerations

Biomedical research in international settings is undergoing expansive growth and may potentially result in far-reaching benefits, such as direction of research resources toward solving basic health care needs of world populations. However, key ethical concerns surround this expansion and must be carefully considered by international researchers. International research is impacted by differences in language, culture, regulatory structures, financial resources, and possibly ethical standards. Local community leadership involvement in the planning stages of research is imperative. Especially in resource-poor countries, the research agenda must be designed to address local needs and provide local benefit. Capacity strengthening efforts, aimed at improving institutional support for ethical conduct of human subjects research, must continue to be supported by wealthier nations.     

What Do the Various Principles of Justice Mean Within the Concept of Benefit Sharing?

The concept of benefit sharing pertains to the act of giving something in return to the participants, communities, and the country that have participated in global health research or bioprospecting activities. One of the key concerns of benefit sharing is the ethical justifications or reasons to support the practice of the concept in global health research and bioprospecting. This article evaluates one of such ethical justifications and its meaning to benefit sharing, namely justice. We conducted a systematic review to map the various principles of justice that are linked to benefit sharing and analysed their meaning to the concept of benefit sharing. Five principles of justice (commutative, distributive, global, procedural, and compensatory) have been shown to be relevant in the nuances of benefit sharing in both global health research and bioprospecting. The review findings indicate that each of these principles of justice provides a different perspective for a different benefit sharing rationale. For example, commutative justice provides a benefit sharing rationale that is focused on fair exchange of benefits between research sponsors and communities. Distributive justice produces a benefit sharing rationale that is focused on improving the health needs of the vulnerable research communities. We have suggested that a good benefit sharing framework particularly in global health research would be more beneficial if it combines all the principles of justice in its formulation. Nonetheless, there is a need for empirical studies to examine the various principles of justice and their nuances in benefit sharing among stakeholders in global health research.     

Do new Access and Benefit Sharing procedures under the Convention on Biological Diversity threaten the future of biological control?

Under the Convention on Biological Diversity (CBD) countries have sovereign rights over their genetic resources. Agreements governing the access to these resources and the sharing of the benefits arising from their use need to be established between involved parties [i.e. Access and Benefit Sharing (ABS)]. This also applies to species collected for potential use in biological control. Recent applications of CBD principles have already made it difficult or impossible to collect and export natural enemies for biological control research in several countries. If such an approach is widely applied it would impede this very successful and environmentally safe pest management method based on the use of biological diversity. The CBD is required to agree a comprehensive Access and Benefit Sharing process in 2010, in preparation for which the IOBC (International Organization for Biological Control of Noxious Animals and Plants) Global Commission on Biological Control and Access and Benefit Sharing has prepared this position paper. Here, we first describe the practice of biological control in relation to the principles of ABS, illustrated extensively by case studies and successes obtained with biological control. Next, we emphasise the very limited monetary benefits generated in biological control when compared to other fields of ABS such as the collection of germplasm for development of human drugs, chemical pesticides or crop cultivars. Subsequently, we inform the biological control community of good ABS practice and challenges, and we hope to make clear to the community involved in ABS under the CBD the special situation with regard to biological control. Finally, based on the non-commercial academic research model, we make recommendations which would facilitate the practice of collection and exchange of biological control agents, propose a workable framework to assist policy makers and biological control practitioners, and urge biological control leaders in each country to get involved in the discussions with their national ABS contact point to take their needs into consideration.     

推进生物多样性保护与人类健康的共同发展——One Health

随着新冠肺炎(COVID-19)的暴发, 野生动物、生物多样性和人类健康的关系再次引起广泛讨论。近20年来, 国际社会对于生物多样性与健康的研究日益增多, 并将它作为生物多样性保护与研究的重要方向之一。One Health作为一个新的理念框架, 通过交叉学科的研究和行动来推动包括人、所有其他动物及环境的健康。这个理念被不同国家、国际组织及协定所接纳及推广, 包括《生物多样性公约》等。本文通过总结近些年生物多样性对健康的影响方式、One Health的定义与发展历史、进入生物多样性议程的过程, 提出中国应用One Health改进相关野生动物管理以降低公共卫生危机的可能性的建议, 以及One Health框架内增强生物多样性保护所需的研究方向。One Health在中国的应用与发展应重视生物多样性研究和保护在其中的作用, 利用在景观生态学、群落内物种关系动态变化、气候变化影响、土地利用变化模式与趋势的研究, 与人类健康相结合, 提高One Health在应对公共健康和环境健康风险方面的准确性与及时性。同时, 需要加强我国在野生动物管理方面的投入和力度, 增强生物多样性保护与公共健康的联系, 将预警与干预措施前移, 减少疾病暴发带来的社会经济成本。     

International research and just sharing of benefits in Mexico

International research enrolling human subjects has raised an ethical concern regarding the just distribution of benefits between the countries that design the research and the host communities. Although several universal declarations have expressed this concern, a gap between theory and practice continues to exist, as well as a significant divergence between the design of the research protocol and the social context where it will be implemented. Although institutional review boards have made a valuable effort to evaluate international research, their sensitivity to the just sharing of research benefits as well as their attention to the social context must be evaluated. This article analyzes the distribution of benefits in a review of international research in Mexico and produces an ethical reflection based on the results.     

Realizing benefit sharing - the case of post-study obligations

In 2006, the Indonesian government decided to withhold avian flu samples from the World Health Organization. They argued that even though Indonesian samples were crucial to the development of vaccines, the results of vaccine research would be unaffordable for its citizens. Commentaries on the case varied from alleging blackmail to welcoming this strong stance against alleged exploitation. What is clear is that the concern expressed is related to benefit sharing. Benefit sharing requires resource users to return benefits to resource providers in order to achieve justice. One benefit sharing tool within health research is the duty to provide a health care intervention which has been proven to be beneficial (or alternative benefits) to research participants after a study has been concluded. This duty is generally known as a post-study obligation. It was enshrined in the Declaration of Helsinki in 2000 and re-emphasized in 2008. Yet, there are few, if any, examples of good practice. In this article, we analyse the obstacles to giving more bite to benefit sharing provisions in health research through ethical review. We conclude that the provision of post-study access to healthcare interventions is not a promising mechanism when monitored through research ethics committees. Alternative benefit provision is preferable if one focuses on achieving compliance. However, even the latter faces challenges, which we address in specific recommendations.     

A human rights approach to an international code of conduct for genomic and clinical data sharing

Fostering data sharing is a scientific and ethical imperative. Health gains can be achieved more comprehensively and quickly by combining large, information-rich datasets from across conventionally siloed disciplines and geographic areas. While collaboration for data sharing is increasingly embraced by policymakers and the international biomedical community, we lack a common ethical and legal framework to connect regulators, funders, consortia, and research projects so as to facilitate genomic and clinical data linkage, global science collaboration, and responsible research conduct. Governance tools can be used to responsibly steer the sharing of data for proper stewardship of research discovery, genomics research resources, and their clinical applications. In this article, we propose that an international code of conduct be designed to enable global genomic and clinical data sharing for biomedical research. To give this proposed code universal application and accountability, however, we propose to position it within a human rights framework. This proposition is not without precedent: international treaties have long recognized that everyone has a right to the benefits of scientific progress and its applications, and a right to the protection of the moral and material interests resulting from scientific productions. It is time to apply these twin rights to internationally collaborative genomic and clinical data sharing.     

A global biodiversity fund to implement distributive justice for genetic resources

This article examines the question of who has a right to control and benefit from genetic resources globally. To this end it draws on different accounts in the resource rights literature with a focus on the specific features that distinguish genetic resources from other types of natural resources. It will be argued that due to the intangible and non‐territorial nature of genetic resources, territorial rights over these resources are difficult to maintain. Moreover, the vulnerability of genetic resources implies that much cost and effort is required to protect them. I will argue that not only benefits resulting from the use of genetic resources but also these costs associated with their protection should be an object of distributive justice. To accommodate these two points I will introduce the model of a global biodiversity fund that could replace the bilateral access and benefit sharing negotiations suggested by the Convention on Biological Diversity.     

遗传资源数字序列信息在生物多样性保护中的应用及对惠益分享制度的影响

遗传资源数字序列信息是近年来DNA测序技术的产物, 目前已经渗透到生命科学和环境科学等领域。遗传资源数字序列信息的应用有助于解释生命的分子基础和进化理论, 为生物多样性的保护和可持续利用提供新的技术手段。随着《名古屋议定书》的生效和履行, 各缔约方对遗传资源惠益分享的认识逐步提高, 并采取有效的立法、行政等措施对本国的生物遗传资源进行管制。遗传数字序列信息作为一种特殊的非实物性质的信息资源, 将会给获取与惠益分享制度带来挑战。近几年, 遗传资源数字序列信息已成为《生物多样性公约》缔约方大会谈判的焦点议题。中国是生物多样性大国, 也是近年来生物技术发展较快的国家之一。中国作为《名古屋议定书》的缔约方, 应积极参与遗传资源数字序列信息相关的研究, 并应对由此带来的各种挑战。     

Regulating access to genetic resources under the Convention on Biological Diversity: an analysis of selected case studies

In 1992 parties to the Convention on Biological Diversity (CBD) agreed to develop and implement policies to regulate and facilitate access to genetic resources (AGR). We examine regulations and agreements in Brazil, Colombia, and the Philippines in detail and discuss how these countries are implementing the AGR mandate. In particular, we evaluate progress toward achieving the CBD objectives of conserving biological diversity, using its components in a sustainable manner, and equitably sharing the benefits arising from the use of genetic resources. We highlight the difficulties in developing and implementing these policies, arising from the conflicting goals of regulating and facilitating AGR, as well as the special character of genetic resources, existing ex situ collections, issues of ownership and tenure, and the dearth of legal, institutional, and scientific capacity in many countries. We recommend (1) independent, multidisciplinary evaluation of the success of the access policy in achieving CBD objectives, (2) resolution of the conflict between traditional land tenure and legal property rights of genetic resources so as to match conservation obligations with benefit-sharing rights, (3) recognition that benefits obtained from AGR may be entirely non-monetary, and (4) that countries provide a 'two-track AGR application process separately for commercial and non-commercial users.     

Women in developing countries and benefit sharing

The aim of this paper is to show that any process of benefit sharing that does not guarantee the representation and participation of women in the decision-making process, as well as in the distribution of benefits, contravenes a central demand of social justice. It is argued that women, particularly in developing countries, can be excluded from benefits derived from genetic research because of existing social structures that promote and maintain discrimination. The paper describes how the structural problem of gender-based inequity can impact on benefit sharing processes. At the same time, examples are given of poor women's ability to organise themselves and to achieve social benefits for entire communities. Relevant international guidelines (e.g. the Convention on Biodiversity) recognise the importance of women's contributions to the protection of biodiversity and thereby, implicitly, their right to a share of the benefits, but no mechanism is outlined on how to bring this about. The authors make a clear recommendation to ensure women's participation in benefit sharing negotiations by demanding seats at the negotiation table.     

《名古屋议定书》在微生物领域的实施: 影响、最佳做法及我国立法选择

《名古屋议定书》继承了《生物多样性公约》在规范遗传资源的获取和惠益分享问题上采取的双边路径。但是, 这一路径不能完全按照《生物多样性公约》和《名古屋议定书》预设的前提和模式在微生物领域得到实施, 已有的旨在实施《名古屋议定书》的措施对微生物研究和开发活动产生了消极的影响。世界微生物菌种保藏联合会致力于推动《生物多样性公约》及其《名古屋议定书》在微生物领域的有效实施, 并为此制定了相关的行为守则和准则。2016年世界微生物菌种保藏联合会推出的TRUST准则代表了微生物领域的获取和惠益分享最佳做法, 该准则针对微生物遗传资源的原生境获取、保藏、非原生境获取以及惠益分享等问题提出了一系列务实的建议。为了实施《名古屋议定书》, 我国启动了遗传资源的获取和惠益分享立法进程, 当前立法已经进入到一个关键阶段。TRUST准则对我国遗传资源的获取和惠益分享立法具有重要的启示。立法机关可以借鉴TRUST准则提出的受规制活动类型及相对应的建议, 并结合我国国情构建一套适用于微生物遗传资源的获取和惠益分享法律规则。这套法律规则将由对植物、动物和微生物遗传资源都予以适用的法律规则和仅对微生物遗传资源适用的法律规则构成, 后者可被纳入我国获取和惠益分享立法的实施细则之中。