“事先知情同意”制度在我国的适用

生物遗传资源是国家的战略资源之一。《生物多样性公约》首次引入事先知情同意制度,有关国际公约、国际准则及其他国家的立法实践都不同程度予以采纳。我国生物遗传资源流失严重,而国内有关生物遗传资源获取和保护的立法严重匮乏。我国应及早设立符合我国国情的PIC制度,完善相关申请、批准制度,保证惠益分享安排公正合理,维护国家利益和国家安全。     

我国遗传资源的获取和惠益分享立法研究

当前,我国遗传资源流失的问题非常严重,现有的法律存在较多的缺陷,无法有效阻止遗传资源的流失.因此,我国有必要遵照《生物多样性公约》的要求建立遗传资源的获取和惠益分享法律制度.我国应当采纳单独或专门立法的模式,未来立法应包括目标和原则、适用范围、国家主管部门、获取程序、事先知情同意和共同商定条件、惠益分享和监测机制等七个方面的核心内容.     

美国生物遗传资源获取与惠益分享法律制度介评——以美国国家公园管理为中心

生物遗传资源荻取与惠益分享法律制度的建立和完善,已经成为保障生态安全和可持续发展的重要内容.本文考察了美国在生物遗传资源获取与惠益分享实践中针对人工培育资源和自然资源所采用的不同模式与方法,并且通过对美国自然遗传资源最为丰富和集中的国家公园在此方面实践的研究,介绍和评述了美国生物遗传资源获取与惠益分享法律制度的基本框架和内容.     

生物基因资源获取和利益分享的国际法规制--兼论对我国基因资源保护的启示

在国际法上,基因资源的获取和利益分享涉及三个主要的国际公约,即《生物多样性公约》(CBD)、《粮食和农业植物遗传资源国际公约》和《TRIPS协议》,其中以CBD为核心,确立了基因资源的国家主权控制、事先知情同意和合理分享利益的原则和制度,确立了基因资源保护机制和产权设定的基本框架,对保护我国的基因资源具有重要的借鉴意义。     

印度遗传资源立法及其启示

为了阻止生物多样性的快速消失以及预防对生物资源和传统知识的不当利用,规范生物资源和传统知识的获取,确保公平分享因其利用而产生的惠益,印度于2002年制定了《生物多样性法》。目前,我国已经启动制定遗传资源的获取和惠益分享法律的立法程序。由于我国与印度在生物多样性和遗传资源的流失等方面具有类似的国情,因此,《生物多样性法》为我国制定遗传资源的获取和惠益分享的法律提供了许多重要的启示。     

遗传资源新型战略高地争夺中的“生物剽窃”及其法律规制

伴随着遗传资源成为后TRIPs时代国家知识产权战略的新制高点,生物剽窃正成为遗传资源新制高点争夺中凸现的亟待解决的重要问题。我们必须针对生物剽窃的特点与性质强化国家环境管制,推进来源披露与事先知情同意制度,借助共同商定条件等路径,加强生物剽窃的法律规制,进而推进遗传资源的可持续保护与知识产权惠益的公平分享。     

浅析遗传资源获取中的惠益分享机制

遗传资源是地球上一种极其重要的自然财富，在人类经济与社会的发展中发挥着不可替代的重要作用。针对获取到的遗传资源进行商业化利用，产生了各种惠益，如何分配这些惠益是一个关键的问题。《生物多样性公约》和《粮食和农业植物遗传资源国际条约》，均对遗传资源的惠益分享问题作出了规定。这些规定包括共同商定条件下的惠益分享和多边系统内的惠益分享等等。     

浅析遗传资源获取中的惠益分享机制

遗传资源是地球上一种极其重要的自然财富,在人类经济与社会的发展中发挥着不可替代的重要作用。针对获取到的遗传资源进行商业化利用,产生了各种惠益,如何分配这些惠益是一个关键的问题。《生物多样性公约》和《粮食和农业植物遗传资源国际条约》,均对遗传资源的惠益分享问题作出了规定。这些规定包括共同商定条件下的惠益分享和多边系统内的惠益分享等等。     

遗传资源的获取和惠益分享与知识产权

遗传资源的获取和惠益分享以及与其相关的知识产权问题是近年来国际间激烈争执的问题。为了因应人类所面临的共同挑战以及澄清法律上的不确定局面,以《生物多样性公约》、《粮食与农业植物遗传资源国际条约》为代表的国际法律文件,在遗传资源的归属上,确认各国对其自然资源拥有主权权利;在遗传资源的惠益分享上,主张对其公平合理分享。而知识产权作为一种从信息中获得奖励的方式,在因生物多样性的利用而产生的诸多问题中发挥着自身的作用,是调整遗传资源获取和惠益分享中利益相关者之间关系的一种重要法律机制。     

遗传资源获取管制和惠益分享制度的立法模式选择

建立遗传资源的获取管制和惠益分享法律制度是我国目前环境立法中的一个重要课题,如何确定立法模式、规范遗传资源的获取途径及惠益分享条件和内容是难点.制定以专门立法为主、修改既有法律为辅的双层立法模式体系,并对其中的主管机构、遗传资源的获取步骤、惠益分享等制度提出具体安排,是解决这个问题的有益尝试.     

病毒共享的国际法思考

从条约解释角度而言,病毒材料构成国家主权管辖范围内的“遗传资源”或“自然资源”,但其获取是否应遵循“事先知情同意”原则尚存在争议。国际专利体制激励基于病毒材料的医药研发,并不直接导致生物剽窃或医药可及性难题,但问题在于没有规定病毒材料的所有权和获取条件,故存在保护上的不对称性。从本质上说,病毒共享之争体现国际法上分配正义的缺失,故无法破解全球公共卫生难题,促进发展中国家履行健康权。为此,《国际卫生条例》需进一步明确健康权的国际责任,构建公平的“材料转移”机制。我国既要推动国际法上分配正义的实现和相关制度的非倾覆性变革,也可结合自身国情和优势发挥更大的建设性作用。     

The implementation of the Nagoya ABS Protocol for the research sector: experience and challenges

Over the years, researchers in public institutions and universities have accessed genetic materials from a variety of sources, freely exchanged them with fellow researchers and institutions and shared their research results with foreign and local collaborators. The 2010 Nagoya Protocol regulating access to genetic resources is set to change this scenario. This treaty requires country parties to put in place enhanced ABS measures regulating access to their genetic resources and to provide for the sharing of benefits arising from their utilization. These measures include minimum access standards, mandatory prior informed consent of indigenous and local communities, compliance with the domestic laws or requirements of the provider country and monitoring the utilization of genetic resources. This is aimed at commercial research. Non-commercial public research which contributes to the conservation and sustainable use of biological diversity is encouraged, particularly in developing countries, through simplified measures. There are undoubtedly practical challenges in operationalizing this provision without impeding research in the sector most potentially affected by ABS measures. This article presents the results of a survey of the practices of such researchers in one developing country, namely Malaysia. It examines the potential implications for the national implementation of the Protocol. Given country specificities, this study highlights and shows the importance of increasing knowledge about existing practices for an efficient design and implementation by developing countries of a complex legislation such as the Nagoya ABS Protocol.     

State secrets: access to information under the Human Reproductive Technology Act 1991 (WA)

Many Australian children have a biological father who gave his sperm so that the child's mother could conceive and raise them. Many of these children, and their parent(s), do not know who that biological father is. However, some want to know. The article examines the Western Australian law on access to information about the identity of parties in these arrangements. It is argued that there is an implied right to access identifying information where all parties consent to the exchange of information; that this right has been ignored in official and medical practice and opportunities for good record-keeping missed; and that the current law allows a parent to give consent to the exchange of identifying information on behalf of their child at any time after the child is conceived.     

司法何以如此尴尬——以一起医疗纠纷案件审理为例

不断增多的医疗纠纷及其引发的种种愤懑,使得各种利益纠葛、体制冲突、伦理诉求和法律管制之间形成了一种较之从前更为复杂而微妙的关系。对医患关系的社会调查显示,目前我国医患双方的关系并不融洽,双方缺乏高度的信任感,一旦患者未达到其预期的疗效,势必为双方的矛盾、冲突和纠纷埋下伏笔;医患双方在具体运用知情同意权法则时产生的强烈的错位,使得知情同意权在减少医患纠纷、构建高度信任基础上的医患和谐关系的功能大打折扣。而对实践中的一个真实案例的审理的剖析则反映出我国法律和司法在知情同意权方面是如此的苍白无力,使得知情同意法则的建立迫在眉睫。我国知情同意权法则的理想构架应该包括:知情同意权法则的基本原则,医生的告知义务,患者的同意以及违反告知义务的构成要件。     

Critical care research and informed consent

The doctrine of informed consent severely limits the ability of medical researchers to develop, evaluate, and refine investigational technologies for the treatment of patients suffering from heart attacks, strokes, and other "critical care" conditions. In this Article, Mr. Saver examines the current doctrine of informed consent as applied to critical care research and its various deficiencies. In addition, he analyzes recent reforms proposed by the Food and Drug Administration, which are intended to remove certain obstacles to critical care research posed by informed consent. While the proposed reforms address several of the current deficiencies, he asserts that they lack the breadth and scope necessary to advance the progress of critical care research in an ethical and sensible manner. Mr. Saver proposes several complementary and alternative reforms that would better accomodate the interests of all affected parties: the patients, their families, the researchers, and the general public.     

Consent to Treatment for Transgender Youth: The Next Chapter – Bell & Anor v The Tavistock and Portman NHS Foundation Trust & Ors

In September 2021, the Court of Appeal reversed the controversial decision of Quincy Bell v Tavistock and Portman NHS Trust in a victory for transgender rights. At first instance, the Divisional Court had set a high legal threshold for transgender children to attain Gillick competence to consent to treatment with puberty blockers – effectively restricting access to treatment for many. On appeal, the Court of Appeal held that children are capable in law of giving valid consent to treatment for gender dysphoria, and court authorisation would not be routinely required before children could access such treatment. This note considers the implications of the Court of Appeal decision for the law on minors and consent to medical treatment in the transgender health context.     

Misusing informed consent: a critique of limitations on research subjects' access to genetic research results

Express denials of access to genetic research results are being drafted into consent instruments. Some commentators suggest that the principle of beneficence can justify such a denial of access. This paper provides an ethical and legal critique of the use of consent instruments to disclaim responsibility for on-going disclosure by genetic researchers. Currently, the law of torts provides only weak protection for on-going disclosure for research subjects. The most substantive rights are to be found in the law of fiduciary obligations. The author concludes that, notwithstanding arguments to the contrary, there should be a presumption of disclosure in genetic research, unless the research subject elects otherwise. The author outlines one possible exception to this general presumption.     

Unwarranted variations in the quality of health care: can the law help medicine provide a remedy/remedies?

This Article reviews the essential findings of studies of variations in quality of care according to three categories of care: effective care, preference-sensitive care, and supply-sensitive care. It argues that malpractice liability and informed consent laws should be based on standards of practice that are appropriate to each category of care. In the case of effective care, the legal standard should be that virtually all of those in need should receive the treatment, whether or not it is currently customary to provide it. In the case of preference-sensitive care, the law should recognize the failure of the doctrine of informed consent to assure that patient preferences are respected in choice of treatment; we suggest that the law adopt a standard of informed patient choice in which patients are invited, not merely to consent to a recommended treatment, but to choose the treatment that best advances their preferences. In the case of supply-sensitive care, we suggest that physicians who seek to adopt more conservative patterns of practice be protected under the "respectable minority" or "two schools of thought" doctrine.     

The conflict of understanding the genetic make-up of man and his knowledge of it

The rapid development within the research of the human genome offers a great potential with regard to the diagnosis of genetic diseases but it also bears dangers of misuse. The starting point for avoiding these dangers is the autonomy of the individual, i.e. that the information about his genetic constitution should only be ascertained with his explicit consent. It is the duty of law to protect the individual and his relatives - who might also be concerned - without undermining the right to self-determination. Furthermore, it is discussed whether genetic tests should be limited to "health purposes" only. The problem of this limitation, however, is to define the term "health purposes" particularly when the criterion of "quality of life" is also taken into consideration. In order to assure a responsible handling of the genetic data, genetic analysis and especially the counselling of the subject should be reserved to the medical profession, since only a real understanding of the individual's genetic constitution with all risks and chances will enable him to make an informed and self-determined decision.