【摘要】：現(xiàn)代社會中,藥品對人們來說并不陌生,已然成為緩解病痛的有效工具。藥品具有與其他物品不同的特性,一般是指用于診斷、預(yù)防、治療人的疾病,有目的地調(diào)節(jié)人的生理機(jī)能并規(guī)定有適應(yīng)癥或者主治功能、用法用量的物質(zhì)。其能夠通過藥理作用達(dá)到防治結(jié)合的療效,對病患的健康有一定的促進(jìn)作用。每種藥品都對應(yīng)一種病癥,并具有靶向作用,不同藥物同時服用或者濫用藥物都可能危及生命。所以就人民群眾而言,藥品的安全使用至關(guān)重要。藥品安全直接關(guān)系到經(jīng)濟(jì)社會的長足發(fā)展,同時也與監(jiān)管息息相關(guān)。因此為了確保藥品的安全性、有效性、適用性和經(jīng)濟(jì)性,對藥品研制、生產(chǎn)、經(jīng)營、銷售、使用的全過程進(jìn)行監(jiān)管是十分必要的。國家有關(guān)部門通過制定、頒布藥品管理法律、法規(guī)和藥品標(biāo)準(zhǔn),對藥品質(zhì)量和藥事機(jī)構(gòu)的質(zhì)量保證體系等進(jìn)行強(qiáng)制性的監(jiān)督管理。20世紀(jì)以來,世界各國紛紛將藥品監(jiān)督管理權(quán)通過立法授權(quán)的形式賦予政府的衛(wèi)生監(jiān)管部門。 在藥品安全監(jiān)管中引入委托代理理論,首先必須明確其所涉及的相關(guān)利益主體。一般可將具有代表性的利益主體分為廣大藥品消費(fèi)者、政府(監(jiān)管機(jī)構(gòu))、以及受監(jiān)管企業(yè)(藥品生產(chǎn)廠家),從而形成一個多層次的監(jiān)管鏈條,即“消費(fèi)者--政府(監(jiān)管機(jī)構(gòu))--受監(jiān)管企業(yè)”的多重委托代理結(jié)構(gòu)。由此可以看出藥品安全監(jiān)管中涉及的主體眾多,其中存在復(fù)雜的委托代理關(guān)系鏈條。針對目前我國藥品行業(yè)存在的諸多問題,將委托代理及相關(guān)理論應(yīng)用其中具有一定的積極意義。 本文首先闡述了藥品安全監(jiān)管涉及的相關(guān)理論,將我國藥品安全監(jiān)管現(xiàn)狀與歐盟、美國發(fā)達(dá)國家作以比較,以委托代理的視角審視我國藥品安全監(jiān)管環(huán)節(jié)中的各利益相關(guān)主體,并將其界定為多重委托代理關(guān)系,通過分析藥品安全監(jiān)管中各利益主體間的關(guān)系,發(fā)現(xiàn)委托代理鏈條中存在的問題,并探尋其根源所在,旨在設(shè)計出有效加強(qiáng)藥品安全監(jiān)管的激勵相容機(jī)制,真正使人民群眾享受到良心藥、放心藥帶來的益處。
[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.
【學(xué)位授予單位】：陜西師范大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R95

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