基于制度变迁均衡分析模型-中国药房.PDF

我国建立药品上市许可人制度的必要性与可行性分析——基于 制度变迁均衡分析模型 ＊ 邵 蓉 ，郑 澜，胡晨希，陈永法（中国药科大学医药产业发展研究中心，南京 211198） 中图分类号 R95 文献标志码 A 文章编号 1001-0408（2014）33-3076-05 DOI 10.6039/j.issn. 1001-0408.2014.33.02 摘 要 目的：探讨我国是否有必要建立药品上市许可人（MAH ）制度，及在我国实施该制度是否可行。方法：依托制度变迁理论 中的均衡分析模型，分析MAH 制度的潜在收益与需求及其建制过程中面临的成本与供给情况，并结合制度弹性进行分析。结果： 国内强大的制度需求使建立MAH 制度成为必要；政府供给MAH 制度的阻力主要在于适应成本和脱序成本；若政府致力于降低 这些制度成本，将同时催生更大的内部需求，由此强力推动我国有效实现由合并管理制度向MAH 制度的变迁。结论：有必要在我 国建立MAH 制度，且现阶段允许在我国某些地区先行试点推行MAH 制度。 关键词 药品上市许可人制度；制度变迁理论；均衡分析；制度需求；制度供给 Necessity and Feasibility Analysis of Establishing Marketing Authorization Holder System in China ：Based on an Institutional Change Demand-Supply Model SHAO Rong ，ZHENG Lan ，HU Chen-xi ，CHEN Yong-fa （Research Center of Pharmaceutical Industry Develop- ment ，China Pharmaceutical University ，Nanjing 211198，China ） ABSTRACT OBJECTIVE ：To explore the necessity of establishing marketing authorization holder （MAH ）system in China ，and the feasibility of MAH system. METHODS ：Based on demand-supply model of institutional change theory ，the potential profit and demand of MAH system and the cost and supply of system construction were all analyzed ，combined with the flexibility of system. RESULTS ：The establishment of MAH system was necessary due to strong domestic system demand ；adaption cost and disorder cost mainly blocked the implementation of MAH system. If the government gets involved with trying to reduce the system cost ，it will at the same time result in greater internal demand ，so as to forcefully promote the system to change from combined manage- ment system to MAH system in China. CONCLUSIONS ：It is necessary to establish MAH system in China. At present ，MAH sys- tem is permitted to be first piloted in some areas in China. KEYWORDS Marketing authorization holder system ；Institutional change theory ；Demand-supply analysis ；System demand ；Sys- tem supply