Two different ethical notions of benefit sharing of genetic resources and their implications for global development

Nazi eugenics is one of the main historical events influencing current popular as well as scholarly discussions of reproductive genetics. This influence, however, is open to different interpretations and social constructions. Based on 44 open interviews with Israeli and German genetic counselors, conducted in 2000–2003, our findings suggest that while the majority of German counselors reflected on Nazi eugenics as setting moral limits for contemporary repro-genetics, many Israeli counselors detached their contemporary practice from the wrongdoings of the past. Correspondingly, German counselors were far more sensitive towards the disability critique of repro-genetics than their Israeli counterparts. We conclude with a discussion of these two opposite positions, suggesting that the comparison of German and Israeli professionals reveals a profound complexity and involvedness in coming to terms with the “eugenic” lessons of the Holocaust, on both sides. In Germany, potential benefits of repro-genetics might be rejected due to an emphasis on a more universalistic lesson of the Holocaust regarding the value of human life and dignity. In Israel, a more particularistic lesson of the Holocaust regarding national Jewish survival, combined with a lack of public debate regarding medicalization and geneticization, might have promoted the advent of unregulated commercially and consumer-driven repro-genetics.     

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。     

North-South benefit sharing arrangements in bioprospecting and genetic research: a critical ethical and legal analysis

Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy is conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of 'community' presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments' responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.     

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。     

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.     

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.     

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 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.     

The benefit sharing vision of H3Africa

One of the central ethical tenets of research in developing countries is the sponsor's obligation to benefit host participants and communities. Two known models of benefits provision dominate the ethical discourse of research in developing countries. The first model, known as the “reasonable availability,” endorses the obligation to provide interventions proven to be effective at the end of a study. This contrasts with the second model, known as “fair benefits,” which endorses other forms of benefits that host communities may deem as fair beyond those derived directly from the study's findings. This paper explores a third benefit model consistent with the writings of the Human Hereditary and Health in Africa (H3Africa) research initiative. The H3Africa—a North‐South collaborative initiative predicated by U.S. National Institutes of Health, the Wellcome Trust and the African Society of Human Genetics upholds a benefit model that endorses capacity building as the primary obligation of its research agenda. This is evident by the endorsement of mechanisms to strengthen capacity building in its research projects. While capacity building remains a plausible means of improving the expertise, quality and independence of research in Africa, sustainable measures are needed to realizing the full potential for African‐led research on the continent.     

Genetic diversity and conservation and utilization of plant genetic resources

Biodiversity refers to variation within the living world, while genetic diversity represents the heritable variation within and between populations of organisms, and in the context of this paper, among plant species. This pool of genetic variation within an inter-mating population is the basis for selection as well as for plant improvement. Thus, conservation of this plant genetic diversity is essential for present and future human well-being. During recent years, there has been increasing awareness of the importance of adopting a holistic view of biodiversity, including agricultural biodiversity, conservation for sustainable utilization and development. These principles have been enshrined in the Convention on Biological Diversity and the Global Plan of Action of the Food and Agriculture Organization of the United Nations. The emphasis is now to understand the distribution and extent of genetic diversity available to humans in plant species, so that the genetic diversity can be safely conserved and efficiently used. It is generally recognized that plant genetic diversity changes in time and space. The extent and distribution of genetic diversity in a plant species depends on its evolution and breeding system, ecological and geographical factors, past bottlenecks, and often by many human factors. Much of the large amount of diversity of a species may be found within individual populations, or partitioned among a number of different populations.A better understanding of genetic diversity and its distribution is essential for its conservation and use. It will help us in determining what to conserve as well as where to conserve, and will improve our understanding of the taxonomy and origin and evolution of plant species of interest. Knowledge of both these topics is essential for collecting and use of any plant species and its wild relatives. In order to mange conserved germplasm better, there is also a need to understand the genetic diversity that is present in collections. This will help us to rationalize collections and develop and adopt better protocols for regeneration of germplasm seed. Through improved characterization and development of core collections based on genetic diversity information, it will be possible to exploit the available resources in more valuable ways.     

遗传资源获取和利益分享与知识产权保护

随着人类对遗传资源开发利用程度的加剧、物种资源不断减少以及国际交流合作的日益频繁,遗传资源获取和利益分享中的知识产权问题日益受到国际社会的关注。为了保护和持续利用遗传资源,本文根据《生物多样性公约》第15条的规定,以及国际社会在遗传资源获取和利益分享方面的做法,分析了我国遗传资源保护和利用以及知识产权保护的现状,提出建立和完善保护遗传资源知识产权的专利制度,遗传资源的管理制度以及遗传资源保护和利用的市场化机制等管理措施,最后,对中国和阿根廷NIDERA公司在大豆遗传资源交换,合作研究和利益分享的案例进行了分析。     

保障国家公园体制试点区社区居民利益分享的公平与可持续性——基于社会-生态系统意义认知的研究

建立国家公园旨在保护生态系统完整性并为民众提供多样化的使用机会,保障利益相关者利益分享的公平与可持续性。对国家公园社区居民的资源使用而言,需要他们认可保护地管理中的利益分享规则,从而规范行为,促进系统的稳健性。影响规则认可与相应行为的关键在于各个资源使用者如何评估资源价值,以及如何形成价值共识。基于社会-生态系统理论,研究利用一个界定资源价值与形成使用规则的分析框架,通过对资源价值界定的情境认知、对生态系统的意义认知和对可能规则的态度进行分析,研究武夷山国家公园体制试点建设进程中社区对"利益"的动态认知与形成原因、潜在行为变动对系统"稳健性"的影响和促进利益分享规则形成的路径。分析发现,①在保护地管理发展过程中,社区认为其以往存在和国家公园的出现有利于资源的生计带动;②武夷山生态系统的意义首先在于其多样化的物质供给,其次是作为文化遗产和商品所带来精神满足,同时具有生态保护价值;③社区对利益分享规则的态度取决于规则在时空上的应用是否影响他们对生态系统意义所认定的优先次序。因此,研究提出一个用于规则形成的协商空间,从不同资源使用者利益认知角度引导其认知趋同,最终提高社区对规则的接受程度与行...     

云南省作物种质资源的研究现状及利用前景

云南是中国作物种质资源最为丰富的省份之一,已收集保存各类作物种质资源2万余份,并在水稻、小麦、玉米、甘蔗、茶叶、油料、花卉等资源的利用方面开展了一系列的研究,取得了丰硕的成果。本文将在分析云南作物种质资源利用研究的基础上,论述云南作物种质资源在育种、科研、国际交流等方面的利用途径与发展前景。     

小麦族遗传资源的多样性及其保护

禾木科小麦族中包含了三种世界最重要的粮食作物,即：小麦、大麦和黑麦以及许多具有重要经济价值的牧草种类。小麦族植物种类繁多、分布广泛、生态多样,具有极其丰富的形态和遗传变异类型。作为巨大的基因资源库,小麦族植物在通过现代生物技术而导入外源有益基因的麦类作物育种程序中,具有重要和特殊的价值。然而对于小麦族植物的生物多样性的研究和了解还远远不足。同时在全球环境的不断改变和遭到破坏的今天,一些小麦族的物种已处于濒危的状态而面临灭绝,因此对于小麦族丰富的遗传多样性制定有效的措施进行保护是摆在我们面前亟待解决的课题。     

Importance of genetic characterization and conservation of plant genetic resources: The breeding system and genetic diversity of wild soybean (Glycine soja)

Abstract Plant genetic resources play an important role in the improvement of cultivated plants. To characterize and evaluate the ecological and reproductive features of wild soybean ( Glycine soja Sieb. et Zucc.), which is the most probable ancestor of cultivated soybean ( G. max (L) Merr.), the breeding system and genetic diversity of G. soja were investigated. The extent of natural cross-pollination of G. soja was estimated in four populations along the Omono River in Akita Prefecture, Japan by examining allozyme variation. Although it has been previously believed that G. soja is autogamous, as is cultivated soybean, the mean multilocus outcrossing rate ( t m) estimate was 13%. These values are much higher than the outcrossing rate previously reported for both G. soja and G. max . Frequent visits by honeybees and carpenter bees to flowers were also observed, which supported this conjecture. Furthermore, to evaluate the genetic variation of G. soja as a genetic resource, the genetic structure of 447 populations over Japan were analyzed. Wild soybean populations had a higher degree of variation of isozyme loci. The G ST coefficient of gene differentian values among the sites within the district were particularly high, revealing that the isozyme genotype was greatly different among site populations and homogeneous within the sites. The genetic differentiation among nine districts was observed in the allele frequencies of a few loci, indicating that geographic isolation in the wild soybean population was effectively created through the distance between the districts. The difference in the allele frequency among the districts may be produced under genetic drift. Finally, the importance of the preservation of natural plant populations and the habitats of wild progenitors (i.e. the in situ conservation of plant genetic resources) was emphasized.     

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。     

Ex-situ conservation of wheat genetic resources from Saudi Arabia

Wheat (Triticum L.) is one of the major food crops of the world, and an important component of food security. The aim of this study was to collect and preserve seeds of wheat growing in eight regions of the Kingdom of Saudi Arabia (Al-Qassim, Asir, Al-Taif, Najran, AL-Baha, Jazan, Al-Madinah and Wadi Al-Dawasir) where wheat has been cultivated since ancient times. Sixty-one accessions/samples of wheat (Triticum aestivum) were collected and placed in dry storage (ex-situ conservation) at −18 °C (i.e. permanent storage). The accessions of local wheat have the ability to grow under harsh environmental conditions such as (high temperature, drought and salinity). Most of these samples were collected directly from farms, but a few were collected from markets. The most important criteria for ex-situ conservation is that seeds need to have a low moisture content (MC) and a high percentage viability. Seed MC was measured for all 61 accessions by the oven-drying method and seed viability was tested in three ways: percentage of germination, tetrazolium chloride testing, and X-ray radiography.The seed MC of the 61 accessions was uniformly very low (0.10–0.12%), and 97 to 100% of the seeds were viable. Thus, all 61 wheat accessions collected in this study have the initial requirements to remain viable for long periods of time in ex-situ conservation in the gene seed bank.     

稻种遗传资源多样性的开发利用及保护

由于近年来栽培稻众多改良品种的育成和大面积推广,使之在很大程度上取代了地方品种,造成栽培稻基因源的大量基因流失,导致栽培稻品种的遗传基础越来越狭窄以至不能承受新病、虫害和不利环境的袭击。同时,由于人们长期施用杀虫剂、灭菌剂和除草剂等化学农药,严重地恶化了农业生态环境。要改变这种恶性循环的局面,开发和利用稻种的遗传资源,以丰富栽培稻品种的遗传基础是非常必要的。稻种基因源包括了亚洲栽培稻、非洲栽培稻、杂草稻、稻属的野生物种以及稻族内的近缘属种,它们是栽培稻品种进一步改良所不可缺少的遗传资源。但是,由于农业生产模式的改变,社会经济和工业化水平的迅速发展和提高,稻种基因源的多样性受到了严重的影响和威胁。一些野生稻种的居群已经迅速地缩小甚至从原产地消失。因此,对稻种基因源及其多样性进行及时有效的保护,并对其进行合理的开发和利用,是保证栽培稻进一步改良和持久生产的最有效方法。