中国药品监管收费制度及其改革  

Drug Regulation Fee Regime and its Reform in China

作　　者：李鸻[1] 宋华琳[2] 

机构地区：[1]上海交通大学凯原法学院 [2]南开大学法学院

出　　处：《宏观质量研究》2013年第2期52-65,共14页Journal of Macro-quality Research

基　　金：国家社会科学基金课题(09CFX020)的阶段性成果

摘　　要：目前我国药品监管收费的水平较低,未能为药品监管活动提供成本补偿,未能通过监管收费改进监管效率。对于私人物品、公共物品和准公共物品,分别适合通过价格、税收和收费机制来提供,行政监管很大程度上是准公共物品。监管收费的设计应秉承公平、效率和合法的原则。从药品监管活动的性质、药品监管机构的地位、受益者受益、改进药品审批绩效及实现药品监管目标的角度,在我国引入药品监管收费制度具有可行性。为此应依法设定药品监管收费,确定药品监管收费范围、收费标准,完善药品监管收费的形成和调整程序,明确监管收费用途,修订法律规则,推进我国药品监管收费制度的发展与改革。Now the level of drug regulation fee in China is very low, it cannot provide cost reimbursement for drug regulatory activities, cannot improve regulatory performance via fees. It can provide private goods by price mechanism, provide public goods by tax, and provide quasi-public goods by regulation fee.To some extent regulation is quasi-public goods.The design of user fee system should comply with the rationale of fairness, efficiency and legality.To explore the nature of drug regulatory activities and the role of drug regulatory agencies, to find identifiable beneficiaries and identifiable interests,to improve drug review performance, to achieve regulatory goal, it is practical to introduce drug regulation fee system to our country. So we should establish regulation fee regime in laws, to define the scope and standard of regulation fee, improve formation and adjustment procedure in drug regulation fee regime. The usage of fees should be clarified. It also needs to revise related laws and regulations, to accelerate the development and reform of drug regulation fees regime in China.

关 键 词：药品监管 监管收费 行政收费 行政法 

分 类 号：R95[医药卫生—药学]