中国药品安全规制研究
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摘要
随着社会发展和人类健康意识的增强,药品安全问题受到广泛重视,近年来成为经济学、法学等各学科共同关注的课题。药品安全规制即从公共利益角度出发,在法律授权范围内,对药品研发、生产、经营和使用全过程进行的行政监督与技术监督。在这一过程中,如何调整政府、企业与消费者三者关系,确定各自利益合理阈值成为改革的难题。
中国自1998年以来,药品安全规制共历经两次较大的体制变革。2008年政府机构改革,将原有药品监管体制由省以下垂直管理改为地方政府分级管理。这种旨在强化地方政府责任、确保药品监管部门相对独立执法的改革思路,在实践中取得了突出成绩。然而,诸如假劣药品、ADR以及不合理用药等药品安全问题却并未因此而得到有效解决,特别是近年来,出现的“齐二药”、“山西疫苗”等药害事件,给公众健康、生命安全和社会稳定造成了极大的损害和负面影响。为此,中国亟需加强药品安全监管,提高规制能力,以改善药品安全现状,保障消费者健康免遭损害、确保公众用药安全。
文章从规制经济学的视角,在对药品安全规制国内外文献梳理、评价的基础上,着重对药品安全规制进行了经济学分析,构建了药品安全规制博弈模型,对政府与企业、企业与药品消费者之间的博弈关系进行了深入探讨,揭示出了药品安全规制改革的制约因素,从而分析得出结论：(1)政府与企业之间纯策略纳什均衡的结果是理想状态,虽然在法律框架内,以及舆论和医药行业协会等社会中介组织的监督与制衡下,规制部门持续进行药品安全监管执法表现为一种常态,但理性人假设条件下,双方都会依据对方策略前提下采取最优策略,致使只能存在混合策略纳什均衡。(2)规制机构与企业合谋情况下的最优监督概率比没有合谋的提高；企业的违规概率也相应增大。规制机构致命性的罚款,能够有效的震慑企业违规行为；同时迫于舆论压力、考虑长期发展的需要,企业会积极配合规制机构的监管。(3)在企业与药品消费者博弈过程中,消费者信息劣势地位决定了n(消费者购药可能性)尽可能大、而α(企业以次充好概率)尽可能小的理想状态无法实现。长期下去,易导致整个市场“劣药驱逐良药”的逆向选择,使社会总福利降低。理论分析解释了中国药品安全规制的历史轨迹及其发展成效。同时也反映出中国药品安全规制存在的主要问题：多部门规制、政府行政执法不作为、中介组织不尽责等药品安全规制体制问题；法律体系不健全、药品市场准入制度实施不严格、药品价格规制失效以及药品标准与ADR监测等技术监督不足等药品安全规制体系问题。药品安全规制博弈分析也揭示了当前中国药品安全规制问题的主要原因,主要表现为规制主体、客体以及体系等方面的原因,具体包括规制主体责任不明确、地方保护主义盛行、规制机构执法资源配置不合理、被规制者自律性差、医药卫生体制改革影响价格规制、多环节供应链导致药品供应效率下降等。
文章还运用比较研究方法,剖析典型发达国家药品安全规制体制以及规制实践,并加以借鉴。发达国家比较完善的药品安全规制体制、法律体系、健全的药品召回制度等为中国规制改革提供了经验：建立独立、高效的药品安全规制机构,完善法规体系,严格执法,发挥专家咨询委员会的作用,健全药品召回制度,提高技术支撑能力等。同时,也要认识到发达国家药品安全规制也存在一定的缺陷,有些规制经验也不一定适合中国国情。
另外,文章结合中国发展实际,依据博弈分析结果,提出了完善中国药品安全规制的主要对策：(1)健全药品安全规制体制。如选择恰当的药品安全规制机构改革方案,改善规制效果；加快培育市民社会,充分发挥中介组织的补充监管作用。
(2)完善药品安全规制体系。如完善法律体系建设,提高规制效率；注重药品质量安全规制,提高规制水平；加强农村药品安全规制,改善农村药品市场环境；深化医药卫生体制改革,确保规制质量；鼓励公众参与,加强社会监督；健全药品安全责任体系,提高政府公信力。
With the social development and strengthening of people's health consciousness, drug safety has been widely taken seriously and become common concerned subject in fields as economics and laws. Regulation of drug safety is the administrative and technical supervision, originated from public benefits and legally entitled, of the whole process of drug research and development, produce, sale and appliance. It becomes a hard problem for the reform to confirm each reasonable benefit threshold in adjusting the relationship among government, enterprises and consumers during this course.
Since 1998, China has experienced two big system reforms of drug safety regulation. The 2008 reform of governmental organizations turned the former drug supervision structure from line management below province to management at different local levels. Aiming at strengthening the government responsibilities and ensuring the relative independent law enforcement of drug supervision department, this reform has gained outstanding achievement in practice. However, there are still drug safety problems unsolved, such as counterfeiter and low quality drugs, ADR and unreasonable use of drugs. In recent years, harmful events like counterfeiter medicine of Qiqihar NO.2 pharmaceutical company and Shanxi vaccine made great injuries and negative impact to public health, life safety and social stability. For all these reasons, it is urgent for China to enhance drug safety supervision and improve regulation ability to make a better drug safety, safeguard consumers'health from injuries and ensure public drug use safety.
From the view of regulation economics, the dissertation collects and evaluates the international and national literatures on drug safety regulation, makes economic analysis of drug safety regulation, constructs a game theory model of it, deeply discusses the relationship between government and enterprises, enterprises and drug consumers, discloses the conditional factors of drug safety regulation reform, and further makes conclusions that:(1) the result of pure strategy Nash equilibrium between government and enterprises is an ideal state. Although under the legal frame and supervision of social intermediary organizations as public opinion and pharmaceutical industrial associations, each side will take the optimal strategy based on the other side's strategy, thus only mixed strategy Nash equilibrium could exist. (2) The optimal supervision probability is greater under the collusion of regulatory organizations and enterprises than the noncollusion situation; the violation probability increases too. The fatal penalty of regulation organizations can effectively frighten enterprises, and meanwhile enterprises, thinking of long run development necessity, could positively cooperate the supervision under the pressure of public opinion. (3) During the course of game between enterprises and drug consumers, the inferior position of consumers decides that the ideal state which maximizes n* (consumer purchase ability) and minimizes a* (shoddy probability of enterprise) can't be realized. In the long run, the reverse choice of "counterfeiter drives out effective medicine" in whole market decreases the total social benefit. Theoretical analysis explains the historical trace and effectiveness of Chinese drug safety regulation, and reflects main problems in this field:unsound system of drug safety regulation laws, omission of governmental administrative enforcement, lax implementation of market entrance system for drugs, imperfect reform of medical care system, and undutiful industry associations, etc. The game theory analysis of drug safety regulation also reveals the deep-rooted reasons - the responsibility of mainstay of regulation is uncertain, the enforcement resource allocation of regulation institutions is unreasonable, the regulated has weak self-discipline, the multi-linked supply chain results in decrease in drug supply efficiency, regulation departments is captured by enterprises, the self-supervision system is weak, and technologies of ADR monitoring is inefficient, etc.
Using comparative study method, the dissertation analyzes typical drug safety regulation system and regulation practice of developed countries. The rather complete drug safety regulation system, law system and sound drug recall system of developing countries offer experiences for Chinese regulation reform. Perfect law system is the basis, building independent and highly effective drug safety regulation institutions, strict enforcement and highlighted regulating emphasis is the key. The role of expert consultation committee should be emphasized, recall system should be improved, and the supporting role of technologies should be stressed. At the same time, it should be seen that this regulation in developing countries is not perfect either; sometimes they may not suit Chinese nation conditions.
Besides the above, the dissertation also advances some countermeasures for improving drug safety regulation, based on the developing reality of China and the analysis result of the game. Countermeasures include:(1) improving the structure of drug safety regulation. Such as choosing the appropriate regulatory agency reform program to improve the effect of the regulation; accelerating the development of civil society and fully playing the role of industry association. (2) improving the system of drug safety regulation. Such as improving statutes construction and regulation efficiency to improve regulatory efficiency; laying stress on drug quality safety regulation and heightening regulation level; enhancing this regulation in countryside and improving its drug market environment; deepening medical care system reform and upgrading the effectiveness of drug safety regulation; encouraging general public to join in and enhancing social supervision; improving drug safety responsibility system to improve the credibility of the government.
中国自1998年以来,药品安全规制共历经两次较大的体制变革。2008年政府机构改革,将原有药品监管体制由省以下垂直管理改为地方政府分级管理。这种旨在强化地方政府责任、确保药品监管部门相对独立执法的改革思路,在实践中取得了突出成绩。然而,诸如假劣药品、ADR以及不合理用药等药品安全问题却并未因此而得到有效解决,特别是近年来,出现的“齐二药”、“山西疫苗”等药害事件,给公众健康、生命安全和社会稳定造成了极大的损害和负面影响。为此,中国亟需加强药品安全监管,提高规制能力,以改善药品安全现状,保障消费者健康免遭损害、确保公众用药安全。
文章从规制经济学的视角,在对药品安全规制国内外文献梳理、评价的基础上,着重对药品安全规制进行了经济学分析,构建了药品安全规制博弈模型,对政府与企业、企业与药品消费者之间的博弈关系进行了深入探讨,揭示出了药品安全规制改革的制约因素,从而分析得出结论：(1)政府与企业之间纯策略纳什均衡的结果是理想状态,虽然在法律框架内,以及舆论和医药行业协会等社会中介组织的监督与制衡下,规制部门持续进行药品安全监管执法表现为一种常态,但理性人假设条件下,双方都会依据对方策略前提下采取最优策略,致使只能存在混合策略纳什均衡。(2)规制机构与企业合谋情况下的最优监督概率比没有合谋的提高；企业的违规概率也相应增大。规制机构致命性的罚款,能够有效的震慑企业违规行为；同时迫于舆论压力、考虑长期发展的需要,企业会积极配合规制机构的监管。(3)在企业与药品消费者博弈过程中,消费者信息劣势地位决定了n(消费者购药可能性)尽可能大、而α(企业以次充好概率)尽可能小的理想状态无法实现。长期下去,易导致整个市场“劣药驱逐良药”的逆向选择,使社会总福利降低。理论分析解释了中国药品安全规制的历史轨迹及其发展成效。同时也反映出中国药品安全规制存在的主要问题：多部门规制、政府行政执法不作为、中介组织不尽责等药品安全规制体制问题；法律体系不健全、药品市场准入制度实施不严格、药品价格规制失效以及药品标准与ADR监测等技术监督不足等药品安全规制体系问题。药品安全规制博弈分析也揭示了当前中国药品安全规制问题的主要原因,主要表现为规制主体、客体以及体系等方面的原因,具体包括规制主体责任不明确、地方保护主义盛行、规制机构执法资源配置不合理、被规制者自律性差、医药卫生体制改革影响价格规制、多环节供应链导致药品供应效率下降等。
文章还运用比较研究方法,剖析典型发达国家药品安全规制体制以及规制实践,并加以借鉴。发达国家比较完善的药品安全规制体制、法律体系、健全的药品召回制度等为中国规制改革提供了经验：建立独立、高效的药品安全规制机构,完善法规体系,严格执法,发挥专家咨询委员会的作用,健全药品召回制度,提高技术支撑能力等。同时,也要认识到发达国家药品安全规制也存在一定的缺陷,有些规制经验也不一定适合中国国情。
另外,文章结合中国发展实际,依据博弈分析结果,提出了完善中国药品安全规制的主要对策：(1)健全药品安全规制体制。如选择恰当的药品安全规制机构改革方案,改善规制效果；加快培育市民社会,充分发挥中介组织的补充监管作用。
(2)完善药品安全规制体系。如完善法律体系建设,提高规制效率；注重药品质量安全规制,提高规制水平；加强农村药品安全规制,改善农村药品市场环境；深化医药卫生体制改革,确保规制质量；鼓励公众参与,加强社会监督；健全药品安全责任体系,提高政府公信力。
With the social development and strengthening of people's health consciousness, drug safety has been widely taken seriously and become common concerned subject in fields as economics and laws. Regulation of drug safety is the administrative and technical supervision, originated from public benefits and legally entitled, of the whole process of drug research and development, produce, sale and appliance. It becomes a hard problem for the reform to confirm each reasonable benefit threshold in adjusting the relationship among government, enterprises and consumers during this course.
Since 1998, China has experienced two big system reforms of drug safety regulation. The 2008 reform of governmental organizations turned the former drug supervision structure from line management below province to management at different local levels. Aiming at strengthening the government responsibilities and ensuring the relative independent law enforcement of drug supervision department, this reform has gained outstanding achievement in practice. However, there are still drug safety problems unsolved, such as counterfeiter and low quality drugs, ADR and unreasonable use of drugs. In recent years, harmful events like counterfeiter medicine of Qiqihar NO.2 pharmaceutical company and Shanxi vaccine made great injuries and negative impact to public health, life safety and social stability. For all these reasons, it is urgent for China to enhance drug safety supervision and improve regulation ability to make a better drug safety, safeguard consumers'health from injuries and ensure public drug use safety.
From the view of regulation economics, the dissertation collects and evaluates the international and national literatures on drug safety regulation, makes economic analysis of drug safety regulation, constructs a game theory model of it, deeply discusses the relationship between government and enterprises, enterprises and drug consumers, discloses the conditional factors of drug safety regulation reform, and further makes conclusions that:(1) the result of pure strategy Nash equilibrium between government and enterprises is an ideal state. Although under the legal frame and supervision of social intermediary organizations as public opinion and pharmaceutical industrial associations, each side will take the optimal strategy based on the other side's strategy, thus only mixed strategy Nash equilibrium could exist. (2) The optimal supervision probability is greater under the collusion of regulatory organizations and enterprises than the noncollusion situation; the violation probability increases too. The fatal penalty of regulation organizations can effectively frighten enterprises, and meanwhile enterprises, thinking of long run development necessity, could positively cooperate the supervision under the pressure of public opinion. (3) During the course of game between enterprises and drug consumers, the inferior position of consumers decides that the ideal state which maximizes n* (consumer purchase ability) and minimizes a* (shoddy probability of enterprise) can't be realized. In the long run, the reverse choice of "counterfeiter drives out effective medicine" in whole market decreases the total social benefit. Theoretical analysis explains the historical trace and effectiveness of Chinese drug safety regulation, and reflects main problems in this field:unsound system of drug safety regulation laws, omission of governmental administrative enforcement, lax implementation of market entrance system for drugs, imperfect reform of medical care system, and undutiful industry associations, etc. The game theory analysis of drug safety regulation also reveals the deep-rooted reasons - the responsibility of mainstay of regulation is uncertain, the enforcement resource allocation of regulation institutions is unreasonable, the regulated has weak self-discipline, the multi-linked supply chain results in decrease in drug supply efficiency, regulation departments is captured by enterprises, the self-supervision system is weak, and technologies of ADR monitoring is inefficient, etc.
Using comparative study method, the dissertation analyzes typical drug safety regulation system and regulation practice of developed countries. The rather complete drug safety regulation system, law system and sound drug recall system of developing countries offer experiences for Chinese regulation reform. Perfect law system is the basis, building independent and highly effective drug safety regulation institutions, strict enforcement and highlighted regulating emphasis is the key. The role of expert consultation committee should be emphasized, recall system should be improved, and the supporting role of technologies should be stressed. At the same time, it should be seen that this regulation in developing countries is not perfect either; sometimes they may not suit Chinese nation conditions.
Besides the above, the dissertation also advances some countermeasures for improving drug safety regulation, based on the developing reality of China and the analysis result of the game. Countermeasures include:(1) improving the structure of drug safety regulation. Such as choosing the appropriate regulatory agency reform program to improve the effect of the regulation; accelerating the development of civil society and fully playing the role of industry association. (2) improving the system of drug safety regulation. Such as improving statutes construction and regulation efficiency to improve regulatory efficiency; laying stress on drug quality safety regulation and heightening regulation level; enhancing this regulation in countryside and improving its drug market environment; deepening medical care system reform and upgrading the effectiveness of drug safety regulation; encouraging general public to join in and enhancing social supervision; improving drug safety responsibility system to improve the credibility of the government.
引文
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