Biological control and the Nagoya Protocol on access and benefit sharing – a case of effective due diligence

ABSTRACT

Biological control agents must be collected and utilised in compliance with the Nagoya Protocol on Access and Benefit Sharing (ABS) which is being implemented independently by each country that is signatory to the Protocol. By March 2018, 50 countries had legislation in place with an additional 54 designing their Legislative, Administrative or Policy Measures having become Party to the Protocol. Apart from the problem of dealing with the many different mechanisms countries are putting in place, it is often difficult to find relevant information on the ABS Clearing House and to access and receive appropriate responses from the National Focal Points or Competent National Authorities. We feel that a lot of time is lost on both sides (National authorities and scientists seeking information), and the process would benefit from streamlining. Also, open questions remain, such as how to deal with the generation digital sequence information and what specific activities are considered utilisation, especially for biological control. CABI has pro-actively developed an ABS policy and best practices for its staff to try and comply with the Nagoya Protocol. In addition, CABI has started negotiations with several provider countries, beginning with its member countries, to have its ABS policy and best practices recognised, considering the non-monetary benefits typically associated with biological control. The Nagoya Protocol was born out of the necessity to guarantee the fair and equitable sharing of benefits arising from the utilisation of genetic resources. However, it should not hinder the development of best practice solutions to protect exactly these genetic resources from threats like invasive species. It is important that research and development that addresses global societal challenges are not impeded and that science and its output are recognised as a way to preserve and use genetic resources in an equitable way.     

Patent portfolio-based indicators to evaluate the commercial benefits of national plant genetic resources

According to property rights theory, national plant genetic resources (PGRs) are sovereign properties rather than resources belonging to the common heritage of humankind. Consequently, provider states can claim compensation from users of their national PGRs, leading to the need for bilateral or multilateral agreements to share national PGRs' commercial benefits. However, as benefit-sharing agreements are made exante, estimating the potential profit is difficult. Thus, issues around asymmetric information about the commercial value of such resources have emerged. In this paper, we use a patent portfolio as a proxy to estimate the potential commercial benefits of national PGRs and propose new evaluation indicators. We propose a comprehensive evaluation process that covers constructing a patent portfolio for each PGR, establishing indicators in terms of marketability, technology, and exclusiveness, and assigning weights to the indicators using fuzzy analytic hierarchy. In addition, we illustrate this process using a case of Korean national PGRs based on the opinions of stakeholders and experts. This research is expected to help promote national PGR transactions with equitable access and benefit sharing agreements.     

Sharing the benefits of genetic resources: from biodiversity to human genetics

Benefit sharing aims to achieve an equitable exchange between the granting of access to a genetic resource and the provision of compensation. The Convention on Biological Diversity (CBD), adopted at the 1992 Earth Summit in Rio de Janeiro, is the only international legal instrument setting out obligations for sharing the benefits derived from the use of biodiversity. The CBD excludes human genetic resources from its scope, however, this article considers whether it should be expanded to include those resources, so as to enable research subjects to claim a share of the benefits to be negotiated on a case-by-case basis. Our conclusion on this question is: 'No, the CBD should not be expanded to include human genetic resources.' There are essential differences between human and non-human genetic resources, and, in the context of research on humans, an essentially fair exchange model is already available between the health care industry and research subjects. Those who contribute to research should receive benefits in the form of accessible new health care products and services, suitable for local health needs and linked to economic prosperity (e.g. jobs). When this exchange model does not apply, as is often the case in developing countries, individually negotiated benefit sharing agreements between researchers and research subjects should not be used as 'window dressing'. Instead, national governments should focus their finances on the best economic investment they could make; the investment in population health and health research as outlined by the World Health Organization's Commission on Macroeconomics and Health; whilst international barriers to such spending need to be removed.     

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.     

New regulations for accessing plant biodiversity samples,what is ABS?

In Rio de Janeiro, in order to preserve biodiversity a virtuous circle was set up in 1992: The sustainable use of biodiversity (genetic resources) will generate benefits which will then be used to preserve biodiversity. The Nagoya Protocol elaborated in 2010 was designed to bring clarification and allow the practical implementation of this virtuous circle of access and benefit sharing. The scope was clarified: research on genetic and biochemical content of plants, animals, fungi and microorganisms. Since many countries have now implemented access rules, it is important for academic and industrial users of biological resources to be fully aware of the regulations and to respect them.     

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.     

国家管辖范围外海域遗传资源获取和惠益分享机制构建建议

随着人类对海洋资源开发利用强度的增加, 海洋生物多样性的养护面临着更大挑战。《联合国海洋法公约》及其执行协定已不能较好地应对这些挑战。为此, 联合国大会决定成立工作组, 拟订新的国际协定, 以解决国家管辖范围外海域生物多样性的养护与可持续利用问题。建立国家管辖范围外海洋遗传资源的获取和惠益分享机制是该议题的焦点问题之一, 但是目前各国对新的国际执行协定应当包含哪些要素还缺乏共同理解。本文通过分析《生物多样性公约》、《名古屋议定书》及《粮食和农业植物遗传资源国际条约》等与遗传资源获取和惠益分享相关的国际条约在遗传资源的定义、管辖范围、获取条件及惠益分享要求等方面的异同, 提出对海洋遗传资源获取和惠益分享机制的构建建议: (1)国家管辖范围外的海洋遗传资源不可自由获取; (2)海洋遗传资源的定义应当涵盖海洋生物代谢生成的海洋天然产物; (3)惠益分享责任适用于在新执行协定生效前获取, 但在其生效后进行开发利用的遗传资源; (4)获取活动都应得到主管当局批准, 并签订材料转让协议或共同商定条件; (5)应为非商业化的获取活动制定简化程序, 在人类健康、粮食安全等受到重大威胁而急需获取海洋遗传资源时, 也应适用简化程序, 但后续商业化活动须分享惠益; (6)针对海洋遗传资源的不同研发环节, 设置惠益分享类型, 并就后续利用进行披露和监测, 确保惠益得到分享。     

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.     

中国作物种质资源引进与流出研究

引进国外种质、促进粮食生产,对中国至关重要。中国每年从世界各地引进大量的作物遗传资源,如水稻、小麦、玉米、马铃薯、甘薯,当然主要是从国际农业研究磋商组织(CGIAR)各中心引进的。同时,中国也向国际农业研究磋商组织各中心和其他国家提供了许多作物遗传资源(如大豆),为世界做出了巨大贡献。种质资源的流动有利于中国,因此中国应该与国际农业研究磋商组织各中心和其他国家加强合作,组织专家系统研究并争取尽快加入《粮食和农业植物遗传资源国际条约》,强化统一管理,规范种质资源引进与输出,建立共享机制,推进种质资源共享。     

巴西生物遗传资源获取与惠益分享管理制度研究

巴西是世界上生物多样性最丰富的国家之一,同时也曾一度是世界遗传资源的主要提供者。巴西很早就意识到保护本国生物遗传资源的重要性,巴西政府于2001年发布了《巴西保护生物多样性和遗传资源暂行条例》。随后又对《暂行条例》进行了数十次修订,直到2015年由总统签署以宪法修正案的形式通过了《生物多样性保护法》(第13.123号法律)。巴西立法对有关概念和术语做了比《名古屋议定书》更为详细的区分和解释,并分别对生物遗传资源与传统知识的获取、审批、转让、惠益分享、行政处罚等内容做出了规定。为了更好地管理生物遗传资源,巴西还成立了"遗传资源委员会(CGEN)",并建立了"国家惠益分享基金(FNRB)"。中国与巴西同属生物多样性大国,且国情相似,本文对巴西遗传资源立法过程及其在遗传资源获取程序、管理机构、惠益分享等方面的相关规定进行了系统整理分析,为国内立法提供参考依据。     

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.     

遗传资源数字序列信息问题刍议

遗传资源数字序列信息(DSI)是测序技术的产物,至少包括DNA、RNA等遗传物质的序列信息和天然产物化学结构信息等,其获取和利用以及由此产生的利益分配问题已经成为《生物多样性公约》等国际进程的热点和焦点。自2016年以来,《生物多样性公约》框架下各方对此虽然开展了卓有成效的讨论,但在DSI内涵和外延、与遗传资源的关系、开放获取、监测DSI的利用等领域仍然存在根本分歧。DSI获取与惠益分享问题面临政治博弈、技术障碍、国内法与国际法协调、多公约协同等多重挑战。我国作为全球DSI的主要提供国和利用国,为有效应对DSI获取与惠益分享所带来的挑战和机遇,有必要加强以下方面的相关工作:(1)加强DSI的相关基础研究工作,特别是需要强化跨学科研究,并开展惠益分享试点示范;(2)适时制定生物信息数据管理制度,系统构建生物资源数据分类、汇交、共享、研究、利用、跨境传输、惠益分享等关键制度;(3)加快建成开放、安全、共享、互惠的全球性生物资源数据生产和存储基础设施,加强生物资源数据国际合作;(4)充分发挥诸如中国生物多样性保护国家委员会等跨部门协调机制作用,持续加强我国参与DSI相关国际论坛讨论的协同增效。     

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.     

Commercial product exploitation from marine microbial biodiversity: some legal and IP issues

The biodiversity found in the marine environment is remarkable and yet largely unknown compared with the terrestrial one. The associated genetic resource, also wide and unrevealed, has raised a strong interest from the scientific and industrial community. However, despite this growing interest, the discovery of new compounds extracted from marine organisms, more precisely from microorganisms, is ruled by a complex legislation. The access and transfer of genetic resource are ruled by the Convention on Biological Diversity. One of the three core objectives of this convention is to ensure the fair and equitable sharing of benefits generated by the use of genetic resources and to split these benefits between the different stakeholders. From the discovery of a microorganism to the commercialization of a product, three main stakeholders are involved: providers of microorganisms, e.g. academic institutes, the scientists who will perform R&D on biodiversity, and the industrial companies which will commercialize the final product arising from the R&D results. This article describes how difficult and complex it might be to ensure a fair distribution of benefits of this research between the parties.     

Twenty-five years of international exchanges of plant genetic resources facilitated by the CGIAR genebanks: a case study on global interdependence

This article analyses 25 years of data about international movements of plant genetic resources for food and agriculture (PGRFA), facilitated by the gene banks hosted by seven centres of the Consultative Group on International Agricultural Research. It identifies trends in the movements of PGRFA for use in research and development, and describes the diversity of those resources transferred over time. The paper also presents data on the number of countries involved in the global exchanges, analyses their development status and describes their role as providers and/or recipients, providing a picture of the breadth of these global exchanges. We highlight that it is primarily developing and transition economies that have participated in the flows, and that the transferred germplasm has been largely used within their public agricultural research and development programmes. We conclude that, when provided the opportunity of facilitated access, countries will use a wide diversity of germplasm from many other countries, sub-regions and continents as inputs into their agricultural research and development programmes. We highlight the importance of enabling the continuation of the non-monetary benefits from international access to germplasm. We discuss the implications for the process of development and reform of the multilateral system of access and benefit sharing under International Treaty on Plant Genetic Resources for Food and Agriculture.     

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.     

Databases and Web Tools for Cancer Genomics Study

Publicly-accessible resources have promoted the advance of scientific discovery. The era of genomics and big data has brought the need for collaboration and data sharing in order to make effective use of this new knowledge. Here, we describe the web resources for cancer genomics research and rate them on the basis of the diversity of cancer types, sample size, omics data comprehensiveness, and user experience. The resources reviewed include data repository and analysis tools; and we hope such introduction will promote the awareness and facilitate the usage of these resources in the cancer research community.     

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.     

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.