我国临床试验中人类遗传资源政府规制研究
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摘要
目的:介绍我国临床试验中人类遗传资源的规制现状,提出一些完善建议,以期实现更好的规制效果。方法:采用政府规制理论,从市场失灵角度分析规制的必要性,并从规制目的、规制主体、规制客体、规制手段、规制环境五个要素全面梳理规制现状。结论:我国临床试验中人类遗传资源的规制取得了显著成绩,但规制细节仍有待完善。
Objective: To introduce the regulation of human genetic resources of clinical trials in China, and to put forward some suggestions for its improvement so as to achieve better regulatory effects. Methods: The necessity of regulation was analyzed from the perspective of market failure with the government regulation theory. The current status of regulation was comprehensively analyzed from the five factors: the regulatory purpose, the regulatory subject, the regulatory object, the regulatory means and the regulatory environment. Results and Conclusion: The regulation of human genetic resources of clinical trials in China has achieved remarkable achievements, but some details of regulation still need to be improved.
Objective: To introduce the regulation of human genetic resources of clinical trials in China, and to put forward some suggestions for its improvement so as to achieve better regulatory effects. Methods: The necessity of regulation was analyzed from the perspective of market failure with the government regulation theory. The current status of regulation was comprehensively analyzed from the five factors: the regulatory purpose, the regulatory subject, the regulatory object, the regulatory means and the regulatory environment. Results and Conclusion: The regulation of human genetic resources of clinical trials in China has achieved remarkable achievements, but some details of regulation still need to be improved.
引文
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[15]科技部.中国人类遗传资源管理办公室撤销两项行政许可决定[EB/OL].(2018-02-12)[2018-03-10]. http://www.most.gov.cn/tztg/201802/t20180206_138051.htm.
[2]张涛.聚焦生物多样性:中国遗传资源大流失[EB/OL].(2006-5-22)[2017-10-26]. http://www.bioon.com/biology/Class422/182802.shtml.
[3]李恒.论我国遗传资源的法律保护[D].武汉:华中科技大学,2005.
[4]科技部办公厅.关于实施人类遗传资源采集、收集、买卖、出口、出境行政许可的通知[EB/OL].(2015-09-30)[2017-12-13]. http://www.most.gov.cn/fggw/zfwj/zfwj2015/201509/t20150930_121849.htm.
[5]科技部办公厅.关于优化人类遗传资源行政审批流程的通知[EB/OL].(2017-10-26)[2017-10-27].http://www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2017/201710/t20171027_135781.htm.
[6]植草益.微观规制经济学[M].北京:中国发展出版社,1992.
[7]王洪会.基于市场失灵的美国农业保护与支持政策研究[D].长春:吉林大学,2011.
[8]刘海龙.人类遗传资源的特性思考—研发与保护的视角[J].中国科技论坛,2018,8(8):104-108.
[9]郭鹏鹏.基因专利与人类遗传资源保护[D].成都:西南政法大学,2005.
[10]《人类遗传资源管理条例(送审稿)》公开征求意见[EB/OL].(2016-02)[2018-03-02]. http://www.gov.cn/xinwen/2016-02/05/content_5039517.htm
[11]苏月,何蕊,王跃,等.加强我国人类遗传资源保护和利用[J].中华临床实验室管理电子杂志,2017,5(1):9-11.
[12]王雪.政府规制的要素研究[J].价值工程,2013,32(24):325-329.
[13]黄海.论政府规制体制的本质属性、构成要素及运行机制[J].当代经济科学,2010,32(3):61-68.
[14]彭晶.我国人类遗传资源专门立法中的知识产权问题研究[D].武汉:华中科技大学,2010.
[15]科技部.中国人类遗传资源管理办公室撤销两项行政许可决定[EB/OL].(2018-02-12)[2018-03-10]. http://www.most.gov.cn/tztg/201802/t20180206_138051.htm.