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利益集团与中国药品安全规制制度变迁
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摘要
近年来,药品安全事故时有发生,药品安全规制成为社会大众和学术界非常关心的问题。已有的媒体报道和学术研究大多只关注药品安全事故本身、药检高官腐败以及监管体制问题,鲜有跳出药品安全监管行为本身,从经济发展背景和具体的制度着手,深入分析制度对药品安全规制的相关利益者行为的影响。本文回顾了中国药品安全规制的历史沿革和机构重组,试图用经济学的基础理论来解释中国药品安全规制制度演变逻辑,目的是为了增进人们对药品安全规制政策结果、政策效果的理解,并为当前中国药品安全规制出现的问题提供理论见解。
     本文采用新制度经济学方法来研究中国药品安全规制制度问题。具体而言,本文采用利益集团规制理论最前沿的研究成果,即利益集团政治委托——代理理论来解释药品安全规制改革。在本文的分析框架中,制药企业和消费者集团是两个具有冲突利益的委托人,政治家则是代理人。制药企业和消费者集团都试图通过相应途径给政治家施压,从而影响制度安排结果。
     本文的分析框架强调信息在利益集团政治压力函数中所起的重要作用。总体来看,消费者成员数量庞大,不易于组织,并且个人参与政治活动的成本也非常高昂,收益却微乎其微,因此消费者集团的成员通常没有参与政治活动的积极性,而是选择搭便车,最终导致其对政策结果的影响微乎其微。反之,制药企业集团由于其成员数量少,搭便车问题易于解决,集团的凝聚力强,容易形成集体行动,因此它们在集团政治活动方面更具有优势。经济理论通常也认为政府规制往往受到特殊利益集团的控制。然而,这一政治结果趋势却因媒体市场的变化正在悄悄的发生改变。因为,媒体提供的信息交流和舆论监督平台,大大降低了消费者参与政治活动的成本。因此,媒体参与制度变革,改变了利益集团对制度结果的相对影响力,克服了抵制规制结构改变的政治和经济力量。同时,媒体通过改善发布信息、监督、评估政策效果的方法,降低了新制度的制度交易成本,从而支持新制度的采用和实施。
     本文分析表明,高昂的信息成本使得消费者对投票采取懈怠行为,从而在影响药品安全规制方面,对规制决策者没有形成足够的压力,致使很长一段时间里,中国药品安全规制制度都倾向于保护制药企业的发展,而没有对消费者权益给与应有的关注。但如果成本能被转移到第三者,消费者就会倾向于获取更多选举信息,积极参与投票,从而给规制决策者施加更多压力,最终使得制度的安排有利于他们。媒体正是通过向广大公众提供信息的作用而降低了消费者的投票成本。并且,媒体还通过监督政府官员的不端行为,减少了消费者的监督成本。因此,媒体参与药品安全规制制度安排,使得消费者在影响药品安全规制制度安排方面具有相对成本优势,从而改变了消费者集团与制药企业集团在影响药品安全规制方面的相对优势,最终促使药品安全规制朝着有利于消费者的方向发展。
In recent years, drug safety incidents have occurred sometimes, and drug safety regulation becomes the issue that the public and the academic community concern about very much. Media coverage and academic studies have mostly focused on drug safety incidents themselves, corruption of officials in the regulatory agency and regulatory system issues, rarely out of drug safety supervision act itself, from an economic development background and specific institution to analyze that institution impact on the stakeholders'behaviors of drug safety regulation. This paper reviews history and restructuring of the drug safety regulation in China, trying to use economic basic theory to explain the evolutional logic of the Chinese drug safety regulation institution, which purpose is to make people understand the policy outcomes, the effectiveness of the drug safety regulation and provide a theoretical insight for problems that arise in current drug safety regulation.
     This paper employs new institutional economics approach to study on Chinese drug safety regulation institution. In detail, this paper uses frontline research results of interest group regulation theory, that is, interest group politics principal-agent theory to explain the reform of drug safety regulation. In this analytical framework, the pharmaceutical enterprise and consumer's groups are two principals with conflicting interests, and politicians are agents. Pharmaceutical enterprise and consumer groups are trying to put pressure on politicians through the corresponding channels, thus affecting the result of institutional arrangements.
     Analytical framework of this article stresses that the information plays an important role in the interest group political pressure function. Overall, the large number of consumers is not easy to organize and the cost of individual participation in political activities is also very high, but their benefits are negligible, so the members of consumer groups usually do not participate in political activities with enthusiasm, and chose free-rider, eventually leading to its minimal impact on policy outcome. On the contrary, the pharmaceutical enterprise group, because of their small number, free-rider problem is easy to solve, group cohesion is very strong, and easy to form a collective action, so they are more advantageous in political activities. Economic theory generally believes that government regulation is often controlled by special interest groups. However, this political results trend is changing quietly because the media market changes. For the media greatly reduce the cost of consumers participating in political activities by providing a platform for exchange of information and supervision by public opinion. Therefore, the media participates in institutional reform, changing the relative power of influence that interest groups impact on institutional outcome, overcoming political and economic power that resists to reform of regulatory structure. Meanwhile, the media reduce institutional transaction costs of the new institution by improving methods of the information released, monitoring, evaluation the effectiveness of policies, thus supporting the adoption and implementation of the new instituion.
     This analysis shows that the high information cost makes consumers take slack behavior in voting, and the do not put enough pressure on regulatory decision-makers in affecting drug safety regulation, a very long time, resulting in Chinese drug safety regulation institution have tended to protect the development of the pharmaceutical enterprises, but do not give attention to the interests of consumers that it should. However, if the cost can be transferred to a third party, consumers will tend to get more election information, actively participate in voting, and put more pressure on the regulatory decision-makers, finally, institution arrangement is in their favor. The media lower the cost of consumers'voting by providing information to the general public. And the media reduce the monitoring costs to consumers by overseeing misconduct of government officials. Therefore, the media involved in institutional arrangement of the drug safety regulation, making consumers has a comparative cost advantage in influencing the institutional arrangements of drug safety regulation, thus changing the comparative advantage between consumer group and pharmaceutical enterprise group in influencing drug safety regulation, leading to drug safety regulation to develop in favor of consumer direction.
引文
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