基于博弈论分析中药饮片质量监管策略

Game Theory-based Strategies for Quality Supervision over Chinese Herbal Pieces

目的:探讨中药饮片质量监管存在的主要问题,并找出有效策略。方法:首先分别构建中药饮片生产经营企业与地方药监部门之间的静态与动态博弈模型,并对其进行纯策略纳什均衡分析和混合策略纳什均衡分析;然后,构建上级监管部门与基层监管部门间的博弈模型,并对此模型进行混合策略分析,以找出与饮片质量相关的监管因素。结果与结论:结合中药饮片质量监管的现状和博弈模型的分析结果,建议现阶段我国中药饮片监管部门应着力推动监管体制改革,降低监管成本(包括引导规模化、集中化的中药材生产和对中药饮片统一实施批准文号管理)、建立系统全面的奖惩体系、建设一支专业化的监管队伍(包括加强基层监管队伍建设和提高人员素质、规范监管部门的执法行为、适当放权与"硬"监督结合起来),并理顺政府监管工作与公众的关系,培养公众的责任意识。

OBJECTIVE:To find out the main problems about quality supervision over Chinese herbal pieces and effective supervision strategies. MEDTHODS:First,static and dynamic models of the game between the enterprises engaged in the production and business of Chinese herbal pieces and local food and drug administration were respectively established,to which pure strategy Nash equilibrium analysis and mixed strategy Nash equilibrium analysis were made. Next,the model of the game between the superior regulatory authorities and the basic-level regulatory authorities was established,to which mixed strategy analysis was made to find out the supervision factors relevant to the quality safety of Chinese herbal pieces. RESULTS & CONCLUSIONS:Based on the current situation of quality supervision over Chinese herbal pieces and the analysis results of the game models,it is suggested that at present the Chinese herbal medicine regulatory authorities of China should work hard to promote the reform of the supervision system,reduce supervision cost(including the guidance of the large-scale and centralized production of Chinese medicinal materials and unified appliance of approval number to the administration of Chinese herbal pieces),establish a systematic and comprehensive system of rewards and punishments,create a professional supervisor staff(including the strengthening of basic-level supervisor staff creation and the improvement of personnel's quality,the standardization of the law enforcement of regulatory authorities and the combination of proper power delegation to lower levels and strict supervision),and balance the relationship between the government and the public in supervision to increase the public's awareness of responsibility.