《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。     

《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。     

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.     

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.     

《粮食和农业植物遗传资源国际条约》与《名古屋议定书》比较研究

《粮食和农业植物遗传资源国际条约》（简称《条约》）与《生物多样性公约关于遗传资源获取和公平公正地分享由遗传资源利用产生惠益的名古屋议定书》（简称《议定书》）是遗传资源获取和惠益分享领域两个重要的国际法律文书,建立了各自的获取和惠益分享机制。由于担忧两个法律文书之间存在监管重叠,以及对我国遗传资源的保护和利用现状不够了解,我国均未批准加入。本文从目标、范围、获取和惠益分享框架和模式及受益者等4四个方面比较了《条约》和《议定书》的差异,结合我国遗传资源的保护和利用现状,就是否加入《条约》与《议定书》提出了以下建议：（1）两个国际法律文书均应加入;（2）在履行《条约》时,需要加强作物野生近缘种的保护,防止资源流失;（3）在履行《议定书》时,监测和评估我国遗传资源应用能力,并适时提出修订《议定书》条款的要求。     

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.     

Fisheries tenure in an African floodplain village and the implications for management

Floodplain fisheries make an important contribution to the total freshwater catch of Africa. Rules and institutions controlling access to these fisheries have received little attention in the literature. This paper explores property regimes operating in the Hadejia-Jama'are floodplain fishery, Nigeria, with a focus on a case-study village. Private, communal property, and open-access tenure regimes exist. The physical characteristics of the resources under each of these categories are differentiated. The economic cost of making resources more exclusive appears to be a key factor affecting tenure. However, the social benefits of communal access are also extremely important. In a risky environment that is characterized by spatial and temporal variation in the distribution of resources, maintaining rights of access to a wide geographical portfolio of resources is an important consideration. This is especially true considering recent environmental changes in the floodplain caused by dams and drought. This suggests that recommendations to improve productivity of the fishery by making access more exclusive may not maximize overall benefits from the fishery, since gains in productivity may be outweighed by losses in social benefits.     

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。     

Regulatory challenges for GM crops in developing economies: the African experience

Globally, transgenic or genetically modified (GM) crops are considered regulated products that are subject to regulatory oversight during trans-boundary movement, testing and environmental release. In Africa, regulations for transgenic crops are based on the outcomes of the historic Earth Summit Conference held in Rio, Brazil two decades ago, namely, the adoption of the Convention on Biological Diversity (CBD) and the subsequent adoption of the Cartagena Protocol on Biosafety. To exploit the potential benefits of transgenic crops while safeguarding the potential risks on human health and environment, most African countries have signed and ratified the CBD and the Cartagena Protocol on Biosafety. Consequently, these countries are required to take appropriate legal, administrative and other measures to ensure that the handling and utilization of living modified organisms are undertaken in a manner that reduces the risks to humans and the environment. These countries are also expected to provide regulatory oversight on transgenic crops through functional national biosafety frameworks (NBFs). While in principle this approach is ideal, NBFs in most African countries are steeped in a host of policy, legal and operational challenges that appear to be at cross-purposes with the noble efforts of seeking to access, test and deliver promising GM crops for use by resource-limited farmers in Africa. In this paper we discuss the regulatory challenges faced during the development and commercialization of GM crops based on experiences from countries in Sub-Saharan Africa.     

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.     

Studies on monitoring and tracking genetic resources: an executive summary

The principles underlying fair and equitable sharing of benefits derived from the utilization of genetic resources are set out in Article 15 of the UN Convention on Biological Diversity, which stipulate that access to genetic resources is subject to the prior informed consent of the country where such resources are located and to mutually agreed terms regarding the sharing of benefits that could be derived from such access. One issue of particular concern for provider countries is how to monitor and track genetic resources once they have left the provider country and enter into use in a variety of forms. This report was commissioned to provide a detailed review of advances in DNA sequencing technologies, as those methods apply to identification of genetic resources, and the use of globally unique persistent identifiers for persistently linking to data and other forms of digital documentation that is linked to individual genetic resources. While the report was written for an audience with a mixture of technical, legal, and policy backgrounds it is relevant to the genomics community as it is an example of downstream application of genomics information.     

Interprofessional Education for Whom? — Challenges and Lessons Learned from Its Implementation in Developed Countries and Their Application to Developing Countries: A Systematic Review

Background

Evidence is available on the potential efficacy of interprofessional education (IPE) to foster interprofessional cooperation, improve professional satisfaction, and improve patient care. While the intention of the World Health Organization (WHO) is to implement IPE in all countries, evidence comes from developed countries about its efficiency, challenges, and barriers to planning and implementing IPE. We therefore conducted this review to examine challenges of implementing IPE to suggest possible pathways to overcome the anticipated challenges in developing countries.

Methods

We searched for literatures on IPE in PubMed/MEDLINE, CINAHL, PsycINFO, and ERIC databases. We examined challenges or barriers and initiatives to overcome them so as to suggest methods to solve the anticipated challenges in developing countries. We could not conduct a meta-analysis because of the qualitative nature of the research question and the data; instead we conducted a meta-narrative of evidence.

Results

A total of 40 out of 2,146 articles were eligible for analyses in the current review. Only two articles were available from developing countries. Despite the known benefits of IPE, a total of ten challenges or barriers were common based on the retrieved evidence. They included curriculum, leadership, resources, stereotypes and attitudes, variety of students, IPE concept, teaching, enthusiasm, professional jargons, and accreditation. Out of ten, three had already been reported in developing countries: IPE curriculum, resource limitations, and stereotypes.

Conclusion

This study found ten important challenges on implementing IPE. They are curriculum, leadership, resources, stereotypes, students'' diversity, IPE concept, teaching, enthusiasm, professional jargons, and accreditation. Although only three of them are already experienced in developing countries, the remaining seven are potentially important for developing countries, too. By knowing these challenges and barriers in advance, those who implement IPE programs in developing countries will be much more prepared, and can enhance the program''s potential success.     

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.     

Expresión sexual y regulación de la sexualidad en residencias de personas mayores

Objectives

The study had three objectives: (a) To determine how staff perceives the frequency of different sexual expressions in long-term care facilities for older people; (2) to quantify policies aimed at guaranteeing residents’ sexual rights in such institutions, and (3) to determine factors influencing the presence of these kind of policies.

主要利益相关方在履行《名古屋议定书》中的关系与义务

生物遗传资源及其相关传统知识的获取与惠益分享(Access and Benefit Sharing,ABS)涉及三个主要利益相关方,即提供方、使用方和监管方.在我国履行《名古屋议定书》的过程中,需深刻理解《名古屋议定书》中对于提供方、使用方和监管方的相关规定,分析三方关系内涵及各自义务,对有效履行《名古屋议定书》具有重...     

Towards Solutions for State vs. Local Community Conflicts Over Forestland: The Impact of Formal Recognition of User Rights in Krui, Sumatra, Indonesia

In 1998, a decree issued by the Indonesian government enabled communities in Krui, Indonesia, to register for concession rights over the area of state forest land planted with their agroforests. Registration would provide farmers with the legal right to manage and benefit from these agroforests. In 2005, we found that even though none of the Krui communities has ever formally applied for their concession rights, the decree has been instrumental in stopping outsiders’ attempts to appropriate these agroforests. Farmers within the state forest zone felt secure enough to continue investing in their complex agroforestry systems, while planting trees reinforced their feeling of security. We conclude that it is not the legal status of tenure, but the perception of tenure security that is of significance in people’s land-use decisions. These results are considered in the wider context of state–community conflicts over forest land in the tropics.

Why restricting access to abortion damages women’s health

Dr. Caitlin Moyer discusses the implications, for women globally, of restricting access to abortion care.

In late June, the landmark Roe v. Wade ruling was overturned by the United States Supreme Court, a decision, decried by human rights experts at the United Nations [1], that leaves many women and girls without the right to obtain abortion care that was established nearly 50 years ago. The consequences of limited or nonextant access to safe abortion services in the US remain to be seen; however, information gleaned from abortion-related policies worldwide provides insight into the likely health effects of this abrupt reversal in abortion policy. The US Supreme Court’s decision should serve to amplify the global call for strategies to mitigate the inevitable repercussions for women’s health.Upholding reproductive rights is crucial for the health of women and girls worldwide, and access to a safe abortion is central to this, yet policies in several countries either severely limit or actively prevent access to appropriate abortion care and services [2]. However, there is little to suggest that those countries and jurisdictions with abortion bans or heavily restrictive laws see fewer abortions performed. According to a modeling study of pregnancy intentions and abortion from the 1990s to 2019, rates of unintended pregnancies ending in abortion are broadly similar regardless of a country’s legal status of abortion, and unintended pregnancy rates are higher among countries with abortion restrictions [3]. Abortion is widely considered to be a low-risk procedure. Abortion-related deaths most likely occur in the context of unsafe abortion practices and are reported to account for 8% (95% UI 4.7–13.2%) of maternal deaths [4], making them a top direct contributor to maternal deaths globally, alongside hemorrhage, hypertension, and sepsis. Restrictive abortion policies may not lower the overall rates of abortion, but they can drive increasing rates of unsafe abortions, as women resort to seeking abortions covertly. Such abortions are often performed by untrained practitioners or involve harmful methods. Perhaps unsurprisingly, most abortions that take place in countries with restrictive abortion access policies are not considered safe [5], potentially contributing to maternal morbidity and mortality. A study of 162 countries found that maternal mortality rates are lower in countries with more flexible abortion access laws [6], suggesting that changes in abortion policies could have grievous implications for maternal deaths.It is not yet known if the reneging of federal protection of abortion rights will impact maternal deaths in the US; however, in the years following the 1973 Roe v. Wade decision, numbers of reported deaths associated with illegal abortions, defined as those performed by an unlicensed practitioner, declined, hovering between zero and 2 deaths from the 1980s to 2018, down from 35 in 1972 [7] and 19 reported in 1973 [8]. It is possible that limits on access to timely and safe abortion care could drive this number back up and add to the already unacceptably high maternal mortality rate in the US, potentially exacerbating the persistent disparities in maternal mortality based on socioeconomic deprivation, race and ethnicity, and other factors [9].Legal and social barriers that impede access to safe abortions are detrimental to the health and survival of women and girls; thus, constructing policies ensuring access to safe abortion services should be an urgent priority. Placing undue hurdles between women and access to abortion care is associated with undesirable health outcomes. For example, a 2011 change to medication abortion laws in one US state that involved increased medication costs and restricted the timing and location where abortion services could be provided was associated with an increase in rates of women requiring additional medical interventions [10]. Lending international weight to this argument, dissolution of barriers to safe abortion access was emphasized in the March 2022 update of WHO guidance on abortion care [11], echoing a 2018 comment on the International Covenant on Civil and Political Rights released by the United Nations Human Rights Committee [12] that called on member states to remove existing barriers and not enact new restrictions on provision of safe abortion services so that pregnant women and girls do not need to turn to unsafe abortions.In jurisdictions where prohibitive policies exist, more could be done to counter the impacts of new barriers by changing how abortion care is delivered and increasing accessibility. Protocols for the safe self-management of abortion can be implemented alongside provision of information and provider support. WHO guidance [11] suggests expanding the breadth of practitioners authorized to prescribe medical abortions to include nurses, midwives, and other cadres of healthcare workers. The guidelines also mention telemedicine as an approach to circumvent obstacles to seeking safe abortion services [11]. For those with access to the necessary technology, telemedicine services together with self-management of medication abortion can overcome travel-related barriers and ensure the privacy of those seeking treatment. Demands for telehealth services increased during the COVID-19 pandemic, and, according to one study, remote provision of abortion services in the US may be a promising option to counteract barriers and facilitate access [13].In 2022, restrictive policies or outright bans on abortion services are discriminatory against women, obstructing their right to maintain autonomy over their own sexual and reproductive health. A post-Roe legal landscape that renders abortion more difficult or impossible to obtain safely will exacerbate an increasingly bleak picture of maternal health in the US; however, the US is just one example where increased effort is needed to overcome barriers to improving women’s healthcare. The reality is that such barriers continue to represent a threat to the health of women worldwide. Evidence-based changes to policy and practice that break down barriers and build new roads are required to enable women to access the healthcare they need.     

Legal and Administrative Regulation of Palms and Other NTFPs in Colombia,Ecuador, Peru and Bolivia

Non-timber forest products (NTFPs) derived from palms and other plants are economically and culturally important to a large part of the more than 240 million people who live in the forest areas of developing countries. The sustainable extraction of NTFPs is increasingly regarded as an important part for forest conservation strategies. This paper provides an overview and comparison of existing statutory legislation with respect to the extraction and trade of NTFPs in four Andean countries and discusses its adequacy with respect to ensuring legal and sustainable extraction and trade of NTFPs. The related legal framework surrounding indigenous peoples’ rights, traditional knowledge and access to genetic resources is also reviewed. Forest laws are primarily concerned with the regulation of timber. Hence, legal and administrative frameworks to regulate the extraction and trade of NTFPs are fragmented and ambiguous. By providing an overview over the existing legal situation, this paper seeks to inform and open debates about ways to improve the regulation of the extraction and trade of NTFPs in the region.     

What alpine peasants have in common: Observations on communal tenure in a Swiss village

An ecological approach to the persistence of communal tenure in a Swiss village suggests that such rights are neither historical anachronisms nor aspects of the closed corporate community. The adaptive value of group holdings in alpine pasture, forest, water, and access routes is compared to that of individual rights in arable land, meadows, and buildings within the same community. The nature and exploitation of resources are related to communal acquisition, conservation, and distribution.This research was supported by a Guggenheim Fellowship, a grant from the University Museum, University of Pennsylvania, and National Science Foundation Grant No. GS-3318.This article is a revised version of a paper originally presented at the symposium, Cultural Adaptations to Mountain Ecosystems, given at the Annual Meeting of the American Anthropological Association, New Orleans, Louisiana, November 28, 1973.     

A need for recalibrating access and benefit sharing: How best to improve conservation,sustainable use of biodiversity,and equitable benefit sharing in a mutually reinforcing manner?

The upcoming UN Biodiversity Conference should address shortfalls of Access and Benefit Sharing systems inspired by the Nagoya Protocol to help improve sustainable use of biodiversity and equitable benefit sharing. Subject Categories: Economics, Law & Politics, Evolution & Ecology, Pharmacology & Drug Discovery

The 15^th UN Biodiversity Conference (COP‐15) in Kunming, China, presents an opportunity for transformative change to address the biodiversity crisis. However, a lack of consensus on two key issues—mobilization of the necessary resources; and the scope and functioning of regulatory regimes that govern access to genetic resources and the sharing of benefits resulting from their use—threaten progress under the next 10‐year strategic plan of the Convention on Biological Diversity. We highlight systemic misconceptions concerning the financing of biodiversity and the burden this places on the Access and Benefit Sharing (ABS) system. We caution that unworkable ABS regulatory frameworks and conflating ABS with resource mobilization could disrupt science policies built on open access, with potentially severe ramifications for research and innovation. To resolve these tensions, we call for a recalibration of ABS to maximize the value delivered by biodiversity for all of society, including indigenous peoples and local communities.