假劣药品的风险来源与监管措施研究

Analysis of Sources of Counterfeit and Inferior Drugs and Supervision Measures

目的:针对当前药品市场上假劣药品的风险来源,分析原因,在现有监管措施的基础上提出合理化建议。方法:收集2005年至2014年期间性质恶劣、危害范围广的代表性假劣药品案件,运用鱼骨分析法分析其根源。同时,分析现有监管措施的有效性和适宜性。结果与结论:目前,监管部门主要通过完善标准和管理制度、开展监督检查和专项行动,以及创新监管措施来遏制制售假劣药品的行为。建议进一步完善假劣药品概念、建立药品企业责任义务制约机制、引入风险管理理念,从根本上遏制制售假劣药品的行为。

Objective： To analyze the risk sources and causes of counterfeit and inferior drugs in the market, and put forward reasonable suggestions based on the current regulation measures. Methods： The representative cases of counterfeit and inferior drugs from the year 2005 to 2014 were collected, the sources of those drugs were analyzed by fi shbone diagram. Meanwhile, the effectiveness and suitability of the current supervision measures were analyzed. Results and Conclusion： At present, producing and selling counterfeit and inferior drugs is restricted by the authorities mainly through improvement of standards and management, implementation of supervision and inspection activities and innovation of regulatory measures. It is suggested the authorities further perfect the defi nition of counterfeit and inferior drugs, establish a restricting system of enterprise responsibilities and obligations and introduce the concept of risk management so as to curb the behavior of producing and selling counterfeit and inferior drugs.