Page 11 - 2019年8月第30卷第16期

“互联网+”背景下完善我国网络药品经营监管的探索 Δ

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隋振宇 1，2＊ ，宋华琳 ，林长庆（1.国家药品监督管理局高级研修学院，北京 100073；2.南开大学法学院，天津
2 #
300350；3.国家药品监督管理局，北京 100037）

中图分类号 R951 文献标志码 A 文章编号 1001-0408（2019）16-2166-05
DOI 10.6039/j.issn.1001-0408.2019.16.02

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。
关键词 互联网+；网络药品经营；制度流变；监管措施

Exploration of Improving Online Drug Trading Regulation in“Internet Plus”Era
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SUI Zhenyu ，SONG Hualin ，LIN Changqing（1. Institute of Executive Development，National Medical Products
2
Administration，Beijing 100073，China；2. Law School，Nankai University，Tianjin 300350，China；3. National
Medical Products Administration，Beijing 100037，China）

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.
KEYWORDS Internet Plus；Online drug trading；Regulation evolution；Regulation measurements

目前，“互联网+”已经成为经济发展的新动力。而 品经营也迎来了高速发展时期，但同时也面临着问题与
随着消费者对高质量药品服务需求的不断增强，网络药 挑战，比如涉及网络药品的新型违法犯罪问题，互联网

Δ 基金项目：国家药品监督管理局资助项目（No.082018005） 的虚拟性以及其作为药品销售新兴市场的不成熟性，使
＊博士。研究方向：药品监管理论。电话：010-63467153。E- 得假药、劣药违法销售，处方药违规销售，保健品冒充药
mail：iamdanielsui@126.com
品夸大宣传，药学服务不到位等问题严峻。
# 通信作者：教授，博士。研究方向：行政法学、药品法学。电话：
022-83622496。E-mail：songhualin@vip.sina.com 现行规范性文件《互联网药品交易服务审批暂行规

·2166 · China Pharmacy 2019 Vol. 30 No. 16 中国药房 2019年第30卷第16期