我国药品安全“黑名单”制度探析

近年来,我国药品安全事件不断发生,人员伤亡和经济损失难以估计。如何建立严重违法者的市场退出与重点监控机制,增加责任人的违法失信成本,促进该领域的健康可持续发展,已逐步成为当前药品监管法制工作中亟待解决和备受关注的焦点问题。应推行药品安全＂黑名单＂制度,对不守法的涉药单位,加大惩治力度,严惩蓄意违法行为、完善市场禁入和退出机制,积极营造褒奖守信、惩戒失信的社会氛围,不断促进药品安全诚信体系建设和法制建设。

A Probe on the System of Drug Safety Blacklist in China

In recent years drug safety cases often occur in China and it is difficult to estimate the loss of life and economy. How to establish a market exit mechanism for serious offenders and a supervision mechanism, adding credit cost to the offenders and promoting the sustainable development of drug market have become the focal issues which need to be dealt with urgently and paid more attention to for current legislation of drug supervision. The system of drug safety blacklist shall be promoted to reinforce the power of punishment to those illegal units in- volved with drugs, perfect market entry and exit mechanism and actively construct the social atmosphere of praising trustworthy and punishing faith breaking activities. The drug safety credit system and legal system shall be im- proved.