遗传咨询中应用二代测序技术的法律边界
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摘要
飞速发展的医学遗传学和民众不断增长的专业医疗服务需求,为二代测序技术的科学研究和临床应用提供了广阔空间。伴随"健康中国"建设目标,精准医疗迅速融入我国民众生活和医疗服务体系。二代测序技术是精准医疗的核心,其在遗传咨询中广泛应用的同时,也产生知情同意、基因隐私和基因歧视等特殊法律问题。通过聚焦基因知情权、基因隐私权、基因平等权等三个层面,系统梳理我国法律和司法解释、行政法规、部门规章、其他规范性文件等的具体条款,揭示在现行法律体系下,如何依据相关法规对遗传咨询新技术所涉法律问题进行规制。
The rapid development of medical genetics and the growing demand for professional medical services provide a broad space for scientific research and clinical application of next-generation sequencing technology. Accompanied by the goal of"Healthy China",precise medical care is rapidly integrated into our public life and medical service system. Next-generation sequencing technology is the core of precision medicine treatment,which is widely used in genetic counseling,and it also causes special legal issues such as informed consent,genetic privacy and genetic discrimination. This paper focuses on three aspects: the informed right about gene,the right to geneprivacy and the right of gene equality. By systematically combing the specific provisions of laws and judicial interpretations,administrative regulations,departmental regulations and other normative documents in China,this paper revealed how to regulate the legal issues involved in the new genetic counseling technology according to relevant laws and regulations under the current legal system.
The rapid development of medical genetics and the growing demand for professional medical services provide a broad space for scientific research and clinical application of next-generation sequencing technology. Accompanied by the goal of"Healthy China",precise medical care is rapidly integrated into our public life and medical service system. Next-generation sequencing technology is the core of precision medicine treatment,which is widely used in genetic counseling,and it also causes special legal issues such as informed consent,genetic privacy and genetic discrimination. This paper focuses on three aspects: the informed right about gene,the right to geneprivacy and the right of gene equality. By systematically combing the specific provisions of laws and judicial interpretations,administrative regulations,departmental regulations and other normative documents in China,this paper revealed how to regulate the legal issues involved in the new genetic counseling technology according to relevant laws and regulations under the current legal system.
引文
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[3]李杰.患者知情同意制度的再解释---论《侵权责任法》第55条[J].法学杂志,2017,38(8):124-131.
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[8]黄宝醇,李利华.“中国基因歧视第一案”引发的法律思考[J].法制与社会,2014(13):74-76.
[9]林小毅.“基因歧视”与我国就业公平的立法完善[J].前沿,2011(7):97-100.
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[2]朱慧,凌勇武,黄松平,等.精神卫生法实施后知情不同意问题的再思考[J].现代医院管理,2013,11(4):90-92.
[3]李杰.患者知情同意制度的再解释---论《侵权责任法》第55条[J].法学杂志,2017,38(8):124-131.
[4]覃英.基因科技隐私法律问题[J].科技与法制,2009(13):770-771.
[5]季冬梅.精准医疗对基因隐私保护带来的法律挑战[J].中国医学伦理学,2017,30(8):936-939,944.
[6]洪伟,胡艳丽.基因隐私权保护所面临的问题探析[J].福建论坛(人文社会科学版),2013(10):171-177.
[7]秦天宝.论我国基因隐私保护的立法模式选择[J].政法论丛,2013(6):16-26.
[8]黄宝醇,李利华.“中国基因歧视第一案”引发的法律思考[J].法制与社会,2014(13):74-76.
[9]林小毅.“基因歧视”与我国就业公平的立法完善[J].前沿,2011(7):97-100.
[10]王康.基因平等权:应对基因歧视的私法政策[J].东方法学,2013(6):51-61.