【作者】 李宁；

【导师】 熊进光；

【作者基本信息】 江西财经大学 ， 民商法学， 2025， 博士

【摘要】 21世纪以来,生物科技研究取得了卓越的成果,人体生物样本在医学研究和临床应用中的价值日益凸显。由人体生物样本利用引发的事件和纠纷逐渐增多,如2018年“贺建奎基因编辑婴儿”事件,通过基因编辑技术使一对双胞胎婴儿获取对HIV的天然抵抗力的这类研究是否符合法律规范和伦理要求、对后代的潜在影响等引发广泛争议。又如我国2014年“江苏宜兴冷冻胚胎案”,是我国首例冷冻胚胎权属纠纷,涉及失独老人对子女遗留的冷冻胚胎是否享有权属以及何种权属、如何实现等问题。再如2020年湖南长沙“丧偶妇女是否有权要求移植与丈夫已受精完成的胚胎进行生育案”等均引发广泛讨论。此外,民间机构大量开展基因检测服务的合法性与规范性、生物样本库中样本利用的隐私保护、利益共享等诸多伦理难题同样引起广泛关注和思考。人体生物样本利用的主要方式是医疗和研究。在利用过程中,均应以尊重和保障人权和人性尊严原则、不伤害原则、人类利益可持续性原则、尊重生命价值和风险防范原则为基础。人体生物样本利用中的民事权利保护主要应通过规范和平衡样本提供者、使用者、管理者和利益相关者的权利冲突来实现。人体生物样本兼有实体性和信息性、人格权益和财产权益双重性、利益多元性的特点,决定了人体生物样本法律属性的特殊性和对其利用中产生的民事权利进行系统保护的复杂性。人体组织利用中,人体健康权、隐私权和个人信息权益保护问题是核心。应建立人体组织利用中“二次同意”制度和保持知情同意的持续性原则,以及完善权利主体“同意后撤回”制度。明确人体组织利用中,产生纠纷较多的人体胚胎的法律属性为具有人格权权益的伦理物。对人体胚胎利用的保护应遵循生命伦理道德规范,应保障单身女性生育权与所生子女权益,平等保护夫妻间生育权冲突,依照“儿童最大利益”来确定丧偶女性、失独老人等的胚胎移植和处置权。人体基因利用主要方式为基因诊断、基因治疗、基因编辑等,由此产生的民事权利有基因隐私权、自主权和财产权。在基因隐私权保护中,应注重保护提供者的知情同意权,平衡隐私权和公共利益。确保人体基因科技成果公平分享、合理利用。在基因编辑侵权案件中,对救济方式、归责原则、侵权赔偿金额和赔偿范围、法定免责事由作出准确认定。各国生物样本库建设、发展和完善过程中,均产生诸多有关样本利用的伦理难题。尽管我国《生物安全法》《人类遗传资源管理条例》等已有原则性规范,但对样本采集、数据保护、知识产权及商业利用等规定仍不完善。因此,应确立知情同意、隐私保护、知识产权保护和利益公平分配等原则,完善知情同意书的内容,推动生物样本库的健康发展,保障科研创新和样本提供者等权利主体各方权益。域外人体生物样本利用的保护模式分为如下几类,一类是以规制技术为中心的专门立法模式。如英国针对人体胚胎利用专门制定《人类受精与胚胎学法》,对胚胎的创建、使用、储存和处置等进行全面细致的规定,建立专门的监管机构(人类受精和胚胎管理局),对相关活动进行许可和监督。这种专门立法模式使胚胎研究和应用有法可依,监管明确。另一类是以权利保护为中心的分散立法模式。如美国在人体胚胎和基因利用的法律规制上,分散于宪法、联邦法律、州法律以及众多的判例之中。这种模式虽然灵活性强,但可能导致法律之间的不协调和冲突。此外,欧洲部分国家在遵循欧盟指令的基础上,结合本国国情制定具体的法律措施。无论采取何种保护模式,都应强调尊重生命与保护人权,既要保障医疗和科研的合理需求,又要防止对生物样本的滥用和伤害,同时加强对权利主体所有权、利益分享权、知情同意权、隐私权与个人信息保护。我国对人体生物样本利用保护主要采用分散式的立法模式。我国《民法典》人格权编虽对人体基因、人体胚胎等医学、科研活动作出原则性规定,但对生物样本的法律属性、权利类型及权利归属、侵权责任等核心问题缺乏具体规范。更多具体的规定散见在各类行政法规和部门规章乃至行业自律性指导规范中。我国缺乏单行、统一的专门法,对人体生物样本利用中的权利保护缺乏顶层设计,达不到应有的规制效果。因此,应在民法框架内制定专门的人体生物样本利用保护法,对人体生物样本利用进行规范,对人体生物样本的概念和受保护范围、法律属性做出界定,细化知情同意制度和确立知情同意退出制度、建立侵权损害的惩罚性损害赔偿制度、界定样本提供者、利益相关者等相关权利人的权利类型和保护机制、样本利用符合限制性商业利用原则和比例原则,明确人体生物样本利用中的民事权利保护应遵循的法律原则为公序良俗原则、权利保障原则、公平原则、互利原则和禁止权利滥用原则。构建人体生物样本利用的完整民事法律规范体系。同时,在《民法典》人格权编中增加、完善相应的条款来规范人体生物样本利用中的权利保护机制,与人体生物样本利用保护法相呼应。完善医疗卫生法规和规章,明确医疗机构在人体生物样本管理中的具体职责和操作规范,加强对医疗机构的监管。在《生物安全法》中,增加对人体生物样本跨境流动等监管的规定,防止因生物样本的不当流动引发国家安全和法律问题。同时辅以行政、刑事的相关规范,构建有中国特色的、系统的人体生物样本利用保护的法律体系。最后,在人体生物样本利用的民事权利保护中,应重点构建、完善五个制度。一是人体生物样本所有权归属。准确界定人体生物样本与人体分离后,样本所有权并不天然地因为物理“分离”的事实而自然地发生转移和变更。如人体胚胎属于夫妻双方一方或者双方所有。其他人体生物样本实体(包括人体基因物质)所有权则可以由提供者和使用者进行约定。但人体基因信息所有权不能通过签署知情同意书等方式发生转移,所有权应归属于样本提供者。二是合理的利益分享制度。虽然研究人员等样本使用者应享有利用样本在医疗、研究中产生的专利权,但人体生物样本提供者、利益相关者乃至国家应共同参与分配专利权收益,以及设置明确的利益分享机制。三是完善知情同意制度。从完善知情同意撤回制度、改进持续同意制度以及建立代际同意制度来保障权利主体的知情同意权。四是构建以隐私权保护为基础和敏感个人信息保护为框架的双层保护制度。对样本提供者的隐私权、敏感个人信息进行双重保护。五是建立生物样本利用中的合理使用制度,平衡个人利益、社会公共利益和国家利益。更多还原

【Abstract】 Since the 21st century,the research of biotechnology has achieved excellent results,and the value of human biological samples in medical research and clinical application has become increasingly prominent.Incidents and disputes caused by the use of human biological samples have gradually increased,such as the"gene edited babies"case of He Jiankui in 2018.Whether such research on the acquisition of natural resistance to HIV by gene editing technology meets legal norms and ethical requirements,and the potential impact on future generations has aroused widespread controversy.Another example is the"Jiangsu Yixing Frozen embryo case"in 2014,which is the first dispute over the ownership of frozen embryos in China,involving whether the elderly lost their adult kids can enjoy the ownership of the frozen embryos left by their children,what kind of ownership and how to achieve it.In 2020,in Changsha,Hunan Province,"Whether widowed women have the right to request the transfer of embryos that have been fertilized with their husbands for reproduction"triggered widespread discussion.In addition,many ethical problems,such as the legality and standardization of genetic testing services carried out by non-governmental organizations,privacy protection arising from the use of biobanks,and sample sharing,have also aroused widespread concern and reflection.The main ways of utilizing human biological samples are medical treatment and research.In the process of utilization,it should be based on the principles of respecting and safeguarding human rights and human dignity,the principle of non-harm,the principle of sustainability of human interests,the principle of respecting the value of life and the principle of risk prevention.The utilization of human biological samples should be realized mainly by standardizing the rights and obligations of sample providers,users,managers and beneficiaries.Due to the characteristics of both substantiality and information,duality of personality rights and property rights,and diversity of interests,the particularity of legal attributes of human biological samples and the complexity of systematic legislative protection of human biological samples are determined.The protection modes for the use of extraterritorial human biological samples are generally divided into the following categories.One is the special legislative mode with regulation technology as the center.For example,the United Kingdom formulated the Human Fertilization and Embryology Act specifically for human embryos,which provides comprehensive and detailed regulations on the creation,use,storage and disposal of embryos,and establishes a special regulatory body,the Human Fertilization and Embryology Authority,to license and supervise related activities.This special legislative model provides legal basis for embryo research and application,and clear supervision.The other kind is the decentralized legislation model with the protection of rights as the center.For example,in the United States,the legal regulation of human embryo and gene utilization is scattered among the Constitution,federal laws,state laws and numerous precedents.Although this model is highly flexible,it may lead to incoordination and conflicts between laws.In addition,some countries in Europe have formulated specific legal measures in accordance with their national conditions on the basis of following EU directives.No matter what kind of protection model is adopted,it should emphasize respect for life and the protection of human rights,ensure the reasonable needs of medical treatment and scientific research,prevent the abuse and harm of biological samples,and strengthen the protection of privacy,personal information and the right to know.In the use of human tissue,the protection of human health,privacy and personal information rights are most important.Therefore,a"secondary consent"system should be established in the use of human tissue and the continuity of informed consent should be maintained,and the"withdrawal after consent"system should be clearly protected.The legal attribute of human embryos,which cause more disputes in human tissue,should be defined as ethical objects with personality rights and interests.Protection should follow the code of bioethics and morality,should protect the reproductive rights of single women and the rights of their children,equal protection of the reproductive rights conflicts between couples,in accordance with the"best interests of children"to determine the right of embryo transfer and disposal of widowed women,the loss of only elderly.The main ways of human gene utilization are gene diagnosis,gene therapy,gene editing,etc.The resulting civil rights include gene privacy,autonomy and property rights.In the protection of gene privacy,attention should be paid to the right of informed consent of the provider,and the right of privacy and public interest should be balanced.We should ensure the fair sharing and rational utilization of human genetic science and technology.In cases of gene editing infringement,the means of relief,the amount and scope of infringement,and the legal reasons for exemption should be accurately determined.In the process of construction,development and improvement of biobanks in various countries,many ethical problems have arisen.Although China’s Biosafety Law and Regulations on the Management of Human Genetic Resources have established principles,regulations on sample collection,data protection,intellectual property rights and commercial utilization are still incomplete.Therefore,the principles of informed consent,privacy protection,intellectual property protection and fair distribution of interests should be established,the contents of informed consent should be improved,and the material transfer agreement should be included in the contract of the Civil Code as a typical and well-known contract,so as to promote the healthy development of biobank,and protect the rights and interests of scientific research and innovation and sample providers.At present,the protection of human biological samples in China is mainly based on a decentralized legislative model.Although the Personality rights Compilation of the Civil Code makes principled provisions on medical and scientific research activities such as human genes and human embryos,it lacks specific norms on core issues such as the legal attributes,rights ownership and responsibilities of biological samples.More specific provisions are scattered in various administrative regulations,departmental rules and even industry self-discipline guidance norms,lacking a single and unified special law.The protection of rights in the use of human biological samples lacks top-level design and fails to achieve the due regulatory effect.Therefore,the use of human biological samples should be regulated in the form of a special human biological sample protection law within the framework of civil law,and the concept,scope of protection and legal attributes of human biological samples should be defined.Refine the informed consent system,establish the informed consent withdrawal system,establish a punitive damage compensation system,define the rights of relevant right holders such as the sample provider’s heirs,the principle of restrictive commercial use,the principle of proportionality and the liability for tort damage,etc.,and build a complete civil legal norm for the utilization of human biological samples.At the same time,in the"Civil Code"personality rights to add and improve the corresponding provisions to regulate the use of human biological samples,in line with the human biological sample protection law.Improve medical and health laws and regulations,clarify the specific responsibilities and operational norms of medical institutions in the management of human biological samples,and strengthen the supervision of medical institutions.In the Biosafety Law,provisions on the cross-border flow of human biological samples and other regulations should be added to prevent the improper flow of biological samples from causing safety and legal problems.At the same time,a systematic legal system for the protection of human biological samples with Chinese characteristics should be established,supplemented by relevant administrative and criminal norms.更多还原