MAH制度是国际公认通行的药品上市审批制度，具有生产形式多样化、技术转让自由、节约市场资源以及提升政府行政监管质量等优点。2016年，我国在北京、上海等10个省（市）开展药品上市许可持有人制度（MAH）试点工作。本文根据我国药品上市制度变迁的路径依赖问题，构建演化博弈模型，分别对由药品研发机构、药品生产企业构成的内部制度变迁和由政府、消费者构成的外部制度变迁进行分析，深入研究博弈主体行为的演化路径。研究表明：内部制度和外部制度路径依赖是制约我国医药产业发展和新药研发动力不足的主要原因，药品上市内部制度变迁主要通过规模效应和适应性预期影响药品研发机构和药品生产企业，从而产生药品上市内部制度路径依赖；药品上市外部制度变迁主要通过学习效应和协调效应影响政府和消费者，从而产生药品上市外部制度路径依赖。在此基础上，运用Matlab数值分析对药品制度变迁过程中的最优稳定策略进行探讨，解释了我国MAH制度变迁过程中存在的路径依赖问题，为完善我国MAH制度、破除路径依赖提供了一定参考。
MAH system is a drug listing system, which is internationally recognized, features the diversification of production form, freedom of technology transfer, saving market resources, improving the quality of government administrative supervision and so on. In 2016, China carries out the drug marketing authorization holder system (MAH) in 10 provinces (cities), such as Beijing and Shanghai. Based on the path-dependence problem of China's drug listing system, an evolutionary game model is constructed, analyzing the internal institutional changes made up by drug research and development agencies, and pharmaceutical production enterprises, and external institutional changes made by governments and consumers, and the evolution path of game subject behavior is deeply studied. Research has shown that the internal system and the external system path dependence are the main reasons that restrict the development of China's pharmaceutical industry and the insufficient power of the new drug research and development. The internal institutional changes of drug listed companies mainly affect drug research and development institutions and drug production enterprises through scale effect and adaptability expectation, thus leading to the path dependence of the internal system of drug listing; The external institutional change of drug market is mainly influenced by the learning effect and the coordination effect of the government and consumers, thus generating the path dependence of the external system of drug listing. Based on this, Matlab is used to carry out numerical analysis to discuss the optimal stability strategy in the process of drug system change. And it has explained the path dependence of the village during the transformation of MAH system in China, which provides some reference for perfecting the path dependence of MAH system in our country.
[1] 尤晓敏,宋洋,杨悦.基于药品审评审批改革的药品上市许可转让程序构建研究[J].中国药学杂志,2016,51(3):248-252.
[2] 陈永法,伍琳,邵蓉. 药品上市许可与生产许可分离的新制度经济理论研究[J].中国医药工业杂志,2015,46(9):1034-1038.
[3] Tubach F, Lamarquegarnier V, Castot A. Role of the post-marketing authorisation studies in drug risk surveillance:Specifications and methodologies.[J]. Thérapie, 2011, 66(4):355.
[4] Song H, Yim D S. Problems within the post-marketing surveillance system in Korea:Time for a change[J]. 2016, 24(2):63-65.
[5] Swain E, Morgan S, Brewster W, et al. Early communication of drug safety concerns:a feasibility study on enhancing interaction between the pharmaceutical industry and regulators[J]. Pharmacoepidemiology & Drug Safety, 2010, 19(3):232-237.
[6] Jullian S, Jaskiewicz L, Pfannkuche H, et al. Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports[J]. Pharmacoepidemiology & Drug Safety, 2015, 24(9):971-979.
[7] David P A. Clio and the economics of QWERTY[J]. American Economic Review, 1985, 75(2):332-337.
[8] 时晓虹, 耿刚德, 李怀."路径依赖"论新解[J].经济学家, 2014(6):53-64.
[9] Arthur W B. Competing technologies, increasing returns, and lock-in by historical events[J].The Economic Journal, 1989, 99(394):116-131.
[10] Pierson P. Increasing returns, path dependence, and the study of politics[J]. American Political Science Review, 2000, 94(2):251-267.
[11] 李海东, 林志扬. 组织结构变革中的路径依赖与路径创造机制研究——以联想集团为例[J].管理学报, 2012, 9(8):1135-1146.
[12] 贾军, 张伟. 绿色技术创新中路径依赖及环境规制影响分析[J].科学学与科学技术管理, 2014,(5):44-52.
[13] 张生玲, 李跃, 酒二科,等. 路径依赖、市场进入与资源型城市转型[J].经济理论与经济管理, 2016, (2):14-27.
[14] Nash J. Non-cooperative games[J]. Annals of Mathematics, 1951, 54(2):286-295.
[15] Smith J M, Price G R. The logic of animal conflict[J]. Nature, 1973, 246(5427):15-18.
[16] Flesch J, Parthasarathy T, Thuijsman F, et al. Evolutionary Stochastic Games[J]. Dynamic Games and Applications, 2013, 3(2):207-219.
[17] Levinea D K, Pesendorferb W. The evolution of cooperation through imitation[J]. Games & Economic Behavior, 2007, 58(2):293-315.
[18] 张华.协同创新、知识溢出的演化博弈机制研究[J].中国管理科学, 2016, 24(2):92-99.
[19] 于涛, 刘长玉. 政府与第三方在产品质量监管中的演化博弈分析及仿真研究[J].中国管理科学, 2016, 24(6):90-96.
[20] 龚志文, 陈金龙. 基于演化博弈的企业集团内部资本转移激励机制研究[J].中国管理科学, 2017,25(4):26-32.
[21] 高照军, 武常岐. 制度理论视角下的企业创新行为研究——基于国家高新区企业的实证分析[J].科学学研究, 2014, 32(10):1580-1592.
