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监管科学视角下药品网络销售监督机制探讨
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篇名: 监管科学视角下药品网络销售监督机制探讨
TITLE: Discuss on Supervision Mechanism for Online Drug Sales from the Perspective of Regulatory Science
摘要: 目的:为完善我国药品电子商务政策和药品网络销售监督管理机制提供政策建议。方法:梳理我国药品网络销售政策沿革,基于监管科学视角分析2019年新修订的《药品管理法》和2020年11月发布的《药品网络销售监督管理办法(征求意见稿)》(以下简称《新征求意见稿》)关于网络药品销售监管机制的相关规定,并提出观点。结果与结论:我国药品电子商务经历了4个阶段的发展,目前处于鼓励创新、包容审慎的法律规范新阶段,新修订的《药品管理法》和《新征求意见稿》顺应新时代“互联网+”发展趋势,有条件地放开了网络处方药经营,构筑药品经营发展的新优势和新动能。新的药品网络销售监管机制是监管部门积极顺应社会发展的重要体现,是药品科学监管理念创新的具体实践,同时也为创新药品流通新业态提供了法律保障和政策空间。但是,笔者认为其在处方药的信息与药品广告的关系,网络处方传输与真实性、合法性审核,以及对销售行为和服务行为的概念界定方面还有值得商榷的地方,相关概念和术语应作出一定调整和重新界定。建议将药品网络销售者界定为“药品电子商务经营者”或“药品网络经营者”,将药品网络交易第三方平台界定为“药品电子商务平台经营者”或“药品网络交易平台经营者”等。
ABSTRACT: OBJECTIVE:To provide su ggestions for perfecting drug electronic commerce regulatory policy and online drug sale supervision mechanism in China. METHODS :The evolution of online drug sale policy in China were sorted out. The related regulations of online drug sale supervision mechanism stated in newly revised Drug Administration Law in 2019 and Measures for Online Drug Sale Supervision (Exposure Draft )in Nov. 2020(hereinafter referred to as New Exposure Draft )were analyzed on the basis of regulatory science to put forward the opinion. RESULTS & CONCLUSIONS :Drug e-commerce in China has experienced 4 stages of development ,and is now in a new stage of encouraging innovation ,inclusiveness and prudence. The newly revised Drug Administration Law and New Exposure Draft catch up with the trend of “Internet plus ”development in the new era ,and conditionally liberate the network prescription drug operation ,and build new advantages and new kinetic energy for the development of pharmaceutical business. The new network drug supervision mechanism is an important embodiment of the regulatory department ’s active adaptation to social development ,a specific practice of the innovation of scientific drug regulatory concept,and also provides legal guarantee and policy space for new business forms of innovation drug circulation. However ,the author thinks that the relationship between prescription drug information and drug advertising ,network prescription transmission and authenticity ,legitimacy audit ,as well as the concept definition of sales behavior and service behavior are still questionable. Relevant concepts and terms should be adjusted and redefined. It is suggested that online drug sellers should be defined as “drug e-commerce operators ”or“online drug operators ”. The third party platform of online drug trading is defined as “drug e-commerce platform operator ”or“online drug trading platform operator ”.
期刊: 2021年第32卷第07期
编辑: 徐敢,孙昱,朱文涛,王岳
AUTHORS: XU Gan,SUN Yu,ZHU Wentao ,WANG Yue
关键字: 药品;网络销售;电子商务;监管机制;监管科学
KEYWORDS: Drug;Network sales ;Electronic commerce ;Supervision mechanism ;Regulatory science
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