美国药品安全监管机制研究及启示

摘要

OBJECTIVE:To provide references for perfecting the drug safety supervision mechanisms in China. METHODS:Based on the theory of“market failure”“contract failure”and“government failure”,representative drug safety supervision mecha-nisms were selected from USA for analysis and evaluation. RESULTS & CONCLUSIONS:USA has made some achievements in the implementation and application of drug safety supervision mechanisms. The representative drug safety supervision mechanisms included prescription drug applicant payment mechanism,drug safety information communication mechanism,punishment and in-centive mechanism, public-private partnership mechanism, passive monitoring and active monitoring combination mechanism. These mechanisms relieved“government failure”of FDA,and solved the problems of“market failure”and“contract failure”to cer-tain extent. In China,drug safety supervision mechanisms should be perfected from refining the legal guarantee,mobilizing exter-nal forces completely,absorbing and applying modern information technology,focusing on both prevention and disposal,paying at-tention to the coordination of different mechanism,striving for open procedure and transparent result.%目的：为我国药品安全监管机制的完善提供参考。方法：基于市场失灵、合约失灵和政府失灵理论，选取美国具有代表性的药品安全监管机制进行分析和评价。结果与结论：美国在药品安全监管机制的实施和运用方面取得的成效显著，其具有代表性的药品安全监管机制有处方药申报者付费机制、药品安全信息沟通机制、惩罚与激励机制、公私合作伙伴机制以及被动监测和主动监测相结合机制，这些机制缓解了FDA的政府失灵，在一定程度上破解了市场失灵和合约失灵的难题。我国在完善药品安全监管机制时应细化法律保障、充分调动外部力量、吸收利用现代信息技术、预防与处置并重、注重不同机制之间的协调、力求过程公开和结果透明。