国内制药企业药品说明书修改过程中的博弈及监管建议

Game and Regulatory Suggestions in the Revision Process of Drug Instructions for Domestic Pharmaceutical Companies

目的分析制药企业修改药品说明书时的理性行为,提出促进这些企业积极主动修改药品说明书的政策和建议。方法利用博弈论方法,分析我国制药企业修改说明书时与市场(患者及其代理人—医生)、政府有关部门之间的博弈均衡。结果基于成本考虑,企业不愿意主动修改药品说明书。结论我国药品监管部门应完善相关法律法规,制定明确可操作的药品说明书修改程序,并降低企业主动修改药品说明书的成本,激励患者(也可以是医生)积极报告因未修改说明书导致的药物不良反应问题,同时加大对不主动修改药品说明书行为的惩罚力度,促使制药企业及时、主动修改说明书。

OBJECTIVE To analyze the rational behaviors of pharmaceutical companies when modifying drug instructions, and puts forward policies and suggestions for promoting these enterprises to actively modify drug instructions. METHODS The game theo- ry is used to analyze the game equilibrium between enterprises and the market （patients and their agents -doctors） or the relevant gov- ernment departments when they modify the instructions of the pharmaceutical enterprises in China. RESULTS Based on cost considerations, enterprises are unwilling to modify drug instructions voluntarily. CONCLUSION The drug regulatory departments in China should improve the relevant laws and regulations, and formulate specific operational drug instructions to modify the program. These measures would reduce the cost of enterprises to take the initiative to modify the drug instructions, and encourage the patient （ and also be a doctor） to actively report the problem of adverse drug reactions caused by the unmodified instructions and increase penalties for not actively modify the behavior of drug instructions. At last the pharmaceutical companies could timely and actively modify instructions.