【作者】 沈秀芹；

【导师】 肖金明；

【作者基本信息】 山东大学 ， 宪法学与行政法学， 2010， 博士

【摘要】 21世纪人类进入生物技术时代。基因科技,尤其是人体基因科技,是生物技术的核心,对人类生活产生巨大影响。随着基因检测、基因治疗、胚胎干细胞研究、基因复制器官以及克隆技术的不断发展与应用,人们可以根据基因偏好选择新的生命；目前被视为绝症的遗传性疾病和癌症有可能被治愈；通过体细胞研究可以复制任何需要的器官,器官移植的来源不再紧缺；长生不老不再是梦想,死去的人也可以“复活”。人体基因科技能够对人的出生直至死亡的全过程进行干预和操控,人类将僭越“上帝”的权力,人人健康长寿,生活质量大大提高。然而,与此同时,人性尊严、生命权、健康权、平等权、身体完整权、隐私权、知情同意权、专利权等为宪法所保护的基本权利以及基本的宪政秩序也受到了前所未有的挑战。科学家们问的是：什么是能够做的?而伦理和法律问的则是：什么是应该做的?允许做的?显然,技术上能做到的并不都是应该做的,需要伦理和法律对行为设定边界,进行规范。只是伦理属于道德范畴,主要靠内心自律,而法律则具有国家强制力,更为有效,属于他律。在人体基因科技研究中,有两大对垒的宪法法益发生了巨大的冲突：一方面是人体基因科技研究的自由；另一方面是公民的各项基本权利。究竟如何进行规制才能够使人体基因科技的良性发展与保障公民基本权利之间保持一种动态平衡?这已经成为当代法学面临的重要课题之一。规制,具体可分为立法规制、行政规制以及司法规制,其中立法规制无疑是首要前提,并且决定着其他规制的实施。各个国家和地区在重构符合人体基因科技发展的伦理规范进行约束的同时,纷纷制定相应的人体基因科技法律、法规等进行规制。其路径有二：一是对传统的法律进行调整和修改,以适应人体基因科技的发展要求；二是制定专项人体基因科技法,以对某项基因技术的实际研究和应用进行规范和保障。我国也于20世纪90年代开始基因科技立法规制建设。但是,随着人体基因科技的飞速发展,已有法律越来越滞后于技术的发展；并且已有的法律、法规多关注于动物、植物、转基因食品、农业等的安全问题,而很少注重对关涉生命和健康的人体基因科技立法；并且,已有人体基因科技的法律层次比较低,多数是法规或规章,需要提高法律位阶。随着人体基因科技在现实生活中的大量应用,又带来很多新的伦理、法律问题,很多领域产生了新的社会关系,存在大量“法律调整的真空”,不利于社会秩序的稳定和人民基本权利的保障。在这种背景下,本文尝试着对人体基因科技的立法规制进行系统研究,分析人体基因科技对法律的挑战及其立法规制的必要性；阐述人体基因科技立法规制的伦理基础与法理基础；在考察国外人体基因科技立法规制和我国人体基因科技立法规制现状的基础上,尝试构建我国人体基因科技规制法律体系,拟定其核心内容《人体基因科技基本法》的基本框架和主要内容。本论文由导论、正文和结语三部分组成,其中正文部分共分为六章：导论部分,主要叙述基因科技的历史发展及其对人类医疗、素质以及寿命带来的影响,提出研究问题和意义；介绍我国目前研究的现状、本文研究范围与文章整体思路；最后说明研究方法和几个创新点。人体基因科技的发展在给人类健康带来巨大福祉的同时也可能带来毁灭性的灾难后果,如何进行规范和控制才能促进其良性发展的同时最大限度的造福人类减少负面影响?各国在重构相适应的伦理规范的同时,纷纷立法进行规制。本论文专门对人体基因科技的立法进行水平层面的系统研究。第一章,关于人体基因科技对法律的挑战及其立法规制必要性。首先,人体基因科技由于在分子水平上实现了对人类遗传物质的修饰和操纵,它对法律最根本、最深层次的挑战体现在对人性尊严方面；其次,在人体基因科技研究条件下,享有权利承担义务的法律主体“自然人”不再是毫无争议,什么是“人”?人的生命始于何时?胚胎是否享有尊严和权利等都需要作出明确界定；再次,生命健康权、平等权、隐私权、知情权、专利权等各项基本权利和法律秩序都遇到前所未有的冲击,为了应对新型生命社会关系、促进人体基因科技良性发展、防范人体基因科技的滥用,迫切需要对其进行立法规制。第二章,关于人体基因科技立法规制的伦理基础。首先,分析人体基因科技发展带来的伦理问题及论争,主要围绕着基因生殖、基因检测与治疗以及基因克隆技术引起的优生、基因隐私与歧视、技术异化等问题展开。指出对人体基因科技进行伦理调节的必要性和对其问题解决的伦理途径；其次,分析人体基因科技立法规制中的伦理价值冲突及选择；再次,用康德义务论、功利主义后果论等伦理学基础理论,以克隆人为例进行伦理分析,指出对克隆人进行立法的伦理依据；最后,提出了适应人体基因科技发展的伦理原则。第三章,关于人体基因科技立法规制的法理基础。首先,介绍了人体基因科技研究自由的涵义及结构；其次,分析人体基因科技发展引发的法益之间的冲突,主要包括人体基因科技研究自由与人性尊严之间的冲突,人体基因科技研究自由与生命权、健康权、身体权等其他基本权利之间的冲突,以及基因本身引起的财产法益与人格法益之间的冲突；再次,分别阐述对人体基因科技研究自由的保障和对其限制的宪法和法律依据及界限,主要包括维护人性尊严的内在限制、遵守法律保留原则、比例原则和目的原则等。第四章,关于人体基因科技立法规制的国外考察。首先,分析国外对基因科技进行立法规制的几种模式,包括单独立法模式、制定管理标准和规则模式、结合立法模式和无单独立法,依其他部门法规范模式；其次,以基因治疗、胚胎干细胞和克隆三种人体基因科技为例对国外的立法规制进行了考察；最后,对国外立法模式和立法内容进行比较分析与借鉴。第五章,关于我国人体基因科技立法规制现状及不足。首先,介绍我国人体基因科技的历史发展及其立法概况；其次,介绍我国目前几个核心人体基因科技法律规范的主要内容；最后,分析我国目前人体基因科技立法存在的不足,主要是缺乏核心理念、立法层次低、系统性不强、新型权利保护缺位及存在法律漏洞等五个方面。第六章,关于我国人体基因科技规制法律体系构建。首先,应确立人性尊严为人体基因科技立法规制的核心理念,在宪法中明确人性尊严保护条款,以及保护人体基因科技引起的新型相关权利规定,并以此为指导构建人体基因科技规制法律体系；其次,应当制定专门的《人体基因科技基本法》作为人体基因科技规制法律体系的核心内容,并指导其他人体基因科技专门法律、行政法规以及规章的制定,以刑法为最后底线共同构成我国人体基因科技规制法律体系；最后,规划和设计《人体基因科技基本法》的基本架构和主要内容,拟定《人体基因科技基本法》的主要条款。更多还原

【Abstract】 The 21 century is an era of biotechnology, with gene technology as the core of it. Human gene technology (gene technology related to human, abbreviated HGT hereafter in the dissertation) is the most important part of the core, in the sense that it brings about significant influence to human life. With the application and development of genetic testing, genetic therapy, stem cell research, genetic organ copy and gene cloning technology, people can choose descendants with excellent gene "borne"; genetic diseases and cancer viewed as incurable in the past could be cured; people can obtain any requisite organs through the research of body cell, and the shortage of transplantable organs is no longer a problem; longevity is no more a dream of human beings, and dead people could "come back to life" again; with the capability of intervening and controlling human’s whole life, from birth to death, humans are going beyond the power of "God"; everyone enjoys longevity and health, and quantity of life is highly enhanced too. However, in the meanwhile, the basic human rights and constitutional orders, as well as interests protected by constitution, such as dignity, life, health, equality, body’s integrity, privacy, informed consent and patent, are all faced with unprecedented threat. While scientists ask "what can we do", scholars in the field of ethics and law ask, "what should we do and what is permitted to do?" Obviously, what people can accomplish technically is not necessarily what they are permitted to do. We need ethics and law to define and regulate such behavior. The main difference lies in this:ethics belongs to moral scope, relying on inside control mainly, while law is more effective with the national power behind, belonging to the category of the control outside. In the research of HGT, there are two kinds of constitutional interest in conflict: the freedom right of HGT research and the basic right of citizens. How to, by means of regulation, keep dynamic balance between the healthy development of HGT and the basic constitutional right of citizen? It is a very important subject for modern legal system. Regulation could be divided into three aspects, legislation, administration, and justice. Legislation definitely is the necessary prerequisite among them, and decides the enforcement of other regulation activities. Many countries and districts have established corresponding human gene technology laws and regulations to govern respectively the development of HGTwhile at the same time reconstructing ethical norms to restrain. Two ways are generally adopted:to adjust and rectify traditional law to meet the demand of developing HGT, and/or to formulate specific law of HGT to regulate and protect the practical research and application of any gene technology. The construction of HGT’s legislation in china starts in the 1990’s. However, with the rapid development of HGT, existent legal system has fallen behind of the development of gene technology. In addition, most current laws focus on such categories as the safety of food from animal, plant, modified food and agriculture application, and rarely pay attention to the HGT legislation which is most related to people’s life and healthy. Furthermore, the efficency of HGT law are to be improved, most of which are regulations or rules. With improved application of HGT in reality, many new ethical and legal problems have followed, as well as a variety of new types of social relationships in different fields. This results into a "vacuum of legal regulation", which is disadvantageous to the stability of social order and the protection of people’s basic rights. Thus, in consideration of such background, the author of this dissertation tries to do some systematic research on the legislative regulation of HGT to analyze the challenge to law from HGT and the necessity of legislative regulation, and elaborate on the ethical and legislative bases of HGT regulation. In addition, on the basis of a comprehensive study of international legislative regulation on HGT and the domestic situation in China, the dissertation attempts to constitute the legislative regulation system on HGT in China, with the framework and major content of Basic Law of Human Gene Technology as the focus.This dissertation is composed of introduction, body text and epilogue, and the body text consists of six chapters.In the introduction, the author mainly describes the history of gene technology and its influence on medical science, human quality and human longevity, to foreground the focus and the significance of the research. The author also introduces the present research circumstance, research scope and the framework of the whole dissertation, and further on defines methodology and several innovations of this dissertation finally. The development of HGT brings about huge healthy benefit for people and the possibility of catastrophic outcome at the same time. How to regulate and control HGT so that it can benefit human beings to the maximum and reduce its negative influence to the minimum? In this dissertation, the author has carried out specific systematic study on the legislation of HGT, which is one of the first comprehensive studies on the legislation of HGT.The first chapter elaborates on the challenges to law from HGT and its necessity to legislative regulation. First, owing to its realization of decorating and manipulating human’s inheritance on the level of molecule, HGT has brought about a most fundamental and profound challenge to legal system - the challenge to human dignity. Second, in the context of HGT, the legal subject "natural person" who enjoys rights and takes responsibility is no longer a concept without controversy. What is "human being"? When does a person’s life begin? Does embryo possess dignity and rights"? All these questions need to be clarified definitely. Third, the basic rights of human life such as health, equality, privacy, informed consent, patent and legal order are all confronted with unprecedented impact. Thus, it is urgent to enforce legislative regulation to secure a new type of social relationship of human life, as well as to guarantee the right orientation of HGT development and to defend against the abuse of HGT.The second chapter discusses the ethical foundation of legislative regulation of HGT. Firstly, this chapter analyzes the ethical problems and arguments which HGT puts forth. These mainly include the problems of eugenics, genetic privacy and discrimination, technical alienation which are brought about respectively by genetic reproduction, genetic test and therapy, gene cloning technology. The dissertation therefore points out the necessity of ethical regulation for HGT and the possible ethical solutions to the problems. Secondly, it puts forward the ethical value conflict and choice of HGT legislative regulation. Thirdly, taking human cloning as an example, it provides ethical foundation for human cloning legislation on the basis of the theories of Kant’s Deontology, Benthamic Consquentialism and Confucianism. Last but not least, this chapter also tries to constitute ethical principles applying to HGT development.The third chapter is the legal foundation of HGT. First, it introduces the meaning and construction of the freedom right of HGT research, then it analyzes the interest conflict resulted from the development of HGT, namely the conflict between freedom of HGT research and some basic human rights, such as human dignity, life right, health right, and body right. This chapter also respectively elaborates on the protection, as well as constitutional and legal restriction of HGT and the validity of restriction, including the inner restriction for human dignity, and the legal observation of reservation principle, proportion principle and purpose principle.The forth chapter is the foreign investigation of legislative regulation for HGT. First, it analyzes several models of legislative regulation concerning gene technology from aboard, including independent legislation, the establishment of administrative criteria and rules, the combination of specific legislation, and some relevant legal regulation without independent legislation. Then, it investigates the foreign legislative regulation for HGT, based on three of HGT, gene therapy, stem cell research and gene cloning, and finally carries out a comparative analysis and study with foreign legislation as a contrast.The fifth chapter is the current situation and deficiency of legislative regulation of china’s HGT. First, it mainly introduces the history and overview legislation situation of gene technology, and then introduces central contents concerning HGT legislative regulation. Finally the dissertation analyzes the current situation and deficiency of legislative regulation for HGT. Main problem are expresses as absence of core idea, lower level of legislation, weaker systemization, lack of new right protection and insufficient legal coverage.The sixth chapter is the system construction of legislative regulation. First, it points out that human dignity should be taken as the core idea of legislative regulation of HGT, which should also be added as a new provision in the constitution, as well as other basic right protection formulating in the constitution related with HGT. All these efforts might help to guideline the construction of legislative regulation system of HGT. Second, the special basic law of HGT should be enacted as core content of the legislative regulation system of HGT, together with other special law, regulation, rules and criminal law as the bottom line also. Finally, it introduces the framework and main content of the core legislation, "basic law of HGT", and tentatively designs some items of the law.更多还原