基于委托代理理论的我国药品安全监管研究

发布时间：2018-12-29 09:14

【摘要】：现代社会中,药品对人们来说并不陌生,已然成为缓解病痛的有效工具。药品具有与其他物品不同的特性,一般是指用于诊断、预防、治疗人的疾病,有目的地调节人的生理机能并规定有适应症或者主治功能、用法用量的物质。其能够通过药理作用达到防治结合的疗效,对病患的健康有一定的促进作用。每种药品都对应一种病症,并具有靶向作用,不同药物同时服用或者滥用药物都可能危及生命。所以就人民群众而言,药品的安全使用至关重要。药品安全直接关系到经济社会的长足发展,同时也与监管息息相关。因此为了确保药品的安全性、有效性、适用性和经济性,对药品研制、生产、经营、销售、使用的全过程进行监管是十分必要的。国家有关部门通过制定、颁布药品管理法律、法规和药品标准,对药品质量和药事机构的质量保证体系等进行强制性的监督管理。20世纪以来,世界各国纷纷将药品监督管理权通过立法授权的形式赋予政府的卫生监管部门。在药品安全监管中引入委托代理理论,首先必须明确其所涉及的相关利益主体。一般可将具有代表性的利益主体分为广大药品消费者、政府(监管机构)、以及受监管企业(药品生产厂家),从而形成一个多层次的监管链条,即“消费者--政府(监管机构)--受监管企业”的多重委托代理结构。由此可以看出药品安全监管中涉及的主体众多,其中存在复杂的委托代理关系链条。针对目前我国药品行业存在的诸多问题,将委托代理及相关理论应用其中具有一定的积极意义。本文首先阐述了药品安全监管涉及的相关理论,将我国药品安全监管现状与欧盟、美国发达国家作以比较,以委托代理的视角审视我国药品安全监管环节中的各利益相关主体,并将其界定为多重委托代理关系,通过分析药品安全监管中各利益主体间的关系,发现委托代理链条中存在的问题,并探寻其根源所在,旨在设计出有效加强药品安全监管的激励相容机制,真正使人民群众享受到良心药、放心药带来的益处。
[Abstract]:In modern society, medicine is no stranger to people and has become an effective tool to alleviate the pain. Drugs have different characteristics from other articles, and generally refer to substances used in diagnosis, prevention, treatment of human diseases, purposeful regulation of human physiological function and regulation of indications or main therapeutic functions, usage and dosage. It can reach the curative effect of prevention and cure by pharmacological action, and it can promote the health of patients to some extent. Each drug has a disease and is targeted, and taking or abusing drugs at the same time can be life-threatening. So as far as the people are concerned, the safe use of drugs is very important. Drug safety is directly related to the rapid development of economy and society, but also closely related to supervision. Therefore, in order to ensure the safety, effectiveness, applicability and economy of drugs, it is necessary to supervise the whole process of drug development, production, sale, sale and use. Through the formulation and promulgation of laws, regulations and standards for drug administration, the relevant state departments carry out mandatory supervision and administration over the quality of drugs and the quality assurance system of pharmaceutical agencies. Since the 20th century, Countries all over the world have given the authority of drug supervision and administration to the government's health supervision department by way of legislative authorization. To introduce the principal-agent theory into drug safety supervision, it is necessary to clarify the relevant stakeholders involved in it. In general, representative stakeholders can be divided into a broad range of drug consumers, governments (regulatory agencies), and regulated enterprises (pharmaceutical manufacturers), thus forming a multi-level regulatory chain. That is, "consumers-government (regulatory bodies)-regulated enterprises" multi-agency structure. It can be seen that there are many subjects involved in drug safety supervision, among which there is a complex chain of principal-agent relationship. In view of the problems existing in the pharmaceutical industry in China, it is of positive significance to apply the principal-agent and related theories. This paper first expounds the related theories of drug safety supervision, compares the current situation of drug safety supervision in our country with that of the European Union and the developed countries of the United States, and examines the relevant stakeholders in the link of drug safety supervision in China from the perspective of principal-agent. It is defined as the multi-principal-agent relationship. By analyzing the relationship among the stakeholders in drug safety supervision, the problems existing in the principal-agent chain are found, and the root causes are explored. The purpose of this paper is to design an effective incentive and compatibility mechanism to strengthen drug safety supervision so as to make the people enjoy the benefits of the medicine of conscience and rest assured of the medicine.
【学位授予单位】：陕西师范大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95

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