“互联网+”背景下完善我国网络药品经营监管的探索
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篇名: “互联网+”背景下完善我国网络药品经营监管的探索
TITLE:
摘要: 目的:为我国完善网络药品经营监管政策提供参考。方法:梳理我国网络药品经营监管的制度流变,分析我国网络药品经营的特征和网络药品经营存在的问题,并提出监管建议。结果与结论:我国网络药品经营监管的制度经历了禁止网络药品经营、网络药品经营试点、网络药品经营监管改革探索、“互联网+医疗健康”时代对网络药品经营监管的挑战等4个阶段,药品监管从许可类的事前监管向事中/事后监管转型。目前网络药品经营具有高速发展和不均衡发展的特征。通过对网络药品经营企业和基层监管部门的调研发现,我国网络药品经营监管存在利用网络进行假药销售、利用互联网违规销售处方药、第三方药品物流及跨境物流存在监管盲区、药品信息展示缺乏规范性等问题。建议网络药品经营监管政策法规制定的思路应与《药品管理法》修订思路保持一致,明确网络药品经营监管与流通监管的关系,将处方药互联网销售与远程诊疗制度相匹配,通过建立“以网管网”的新模式、建立药品标准数据库、加强物流配送监管、发挥第三方平台的审查义务、加强一线监管人员对互联网药品监管能力的培训等监管手段,从而提升我国网络药品经营的监管水平。
ABSTRACT: OBJECTIVE: To provide references for perfecting online drug trading regulatory policy in China. METHODS: The online drug trading regulatory evolutions in China were summarized. The characteristics of network drug trading management in China and the existing problems were analyzed to put forward regulatory suggestions. RESULTS & CONCLUSIONS: The online drug trading regulation in China had gone through four stages including on-line drug selling prohibition, piloting, exploration of regulatory evolution and the regulation challenge under “Internet plus Health Care” era. It had been transited from prior-supervision of permission to in-process/post-supervision with a characteristic of high-speed and imbalanced development. The author participated in the investigation of the online-drug trading companies and basic level regulatory authority, found existing issues such as counterfeit drug selling by internet, the blind zone for regulation of third-party drug logistics and cross-border logistics, lacking of standardization for drug information display and so on. It is suggested that the legislation of online drug trading regulatory should be in accordance with the thinking of revising higher-level law as Drug Administration Law; the regulatory relationship between drug management and circulation needs to be defined; the prescription drug online sale should match remote diagnosis and treatment system; regulatory capacity was further expounded by exploring the new network technique to regulation, establishing a standard database of drug, strengthening logistics and distribution supervision, exerting the review obligations of third-party platforms, and strengthening the training of regulators to further improve  the management  of  online drug trading regulatory policy in China.
期刊: 2019年第30卷第16期
作者: 隋振宇,宋华琳,林长庆
AUTHORS: SUI Zhenyu,SONG Hualin,LIN Changqing
关键字: 互联网+;网络药品经营;制度流变;监管措施
KEYWORDS: Internet Plus; Online drug trading; Regulation evolution; Regulation measurements
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