我國(guó)醫(yī)藥行業(yè)的政府規(guī)制研究 （碩士論文）
43000字

摘要
自改革開放以來，我國(guó)的醫(yī)藥行業(yè)一直采取的是政府監(jiān)管為主導(dǎo)，市場(chǎng)調(diào)節(jié)為輔導(dǎo)的運(yùn)作模式，醫(yī)藥行業(yè)中包含著制藥企業(yè)、經(jīng)營(yíng)企業(yè)、醫(yī)院等國(guó)家重要的經(jīng)濟(jì)主體，是我國(guó)社會(huì)發(fā)展必不可少的重要經(jīng)濟(jì)支柱。然而隨著社會(huì)主義市場(chǎng)經(jīng)濟(jì)的不斷深入，在最近幾年，我國(guó)的醫(yī)藥行業(yè)出現(xiàn)了許多質(zhì)量安全問題，尤其是一些重大的藥害事件更是讓人觸目驚心，這些事件不能不引起政府的反思，如何通過借鑒國(guó)外的先進(jìn)經(jīng)驗(yàn)，為我國(guó)政府對(duì)醫(yī)藥行業(yè)的規(guī)制提供一條可行的道路，以此來規(guī)范我國(guó)醫(yī)藥行業(yè)的發(fā)展，已成為當(dāng)前非常重要的課題之一。
本文從醫(yī)藥行業(yè)的基本特點(diǎn)出發(fā)，首先采取產(chǎn)業(yè)經(jīng)濟(jì)學(xué)的SCP范式分析法，從市場(chǎng)結(jié)構(gòu)、市場(chǎng)行為的角度對(duì)我國(guó)醫(yī)藥行業(yè)的現(xiàn)狀進(jìn)行分析，在此基礎(chǔ)上按照經(jīng)濟(jì)性規(guī)制與社會(huì)性規(guī)制的分類，對(duì)我國(guó)當(dāng)前醫(yī)藥行業(yè)政府的主要規(guī)制進(jìn)行了闡述，包括市場(chǎng)進(jìn)入規(guī)制、市場(chǎng)價(jià)格規(guī)制與質(zhì)量安全規(guī)制等，然后對(duì)我國(guó)醫(yī)藥行業(yè)政府規(guī)制當(dāng)前存在的問題進(jìn)行了分析，并指出產(chǎn)生問題的根源：一是由于政府對(duì)醫(yī)藥行業(yè)的進(jìn)入規(guī)制失靈；二是由于政府對(duì)醫(yī)藥行業(yè)價(jià)格規(guī)制的失靈；三是由于政府對(duì)醫(yī)藥行業(yè)質(zhì)量安全規(guī)制的失靈；之后在借鑒國(guó)外先進(jìn)政府規(guī)制經(jīng)驗(yàn)的基礎(chǔ)上，提出了針對(duì)我國(guó)具體國(guó)情的政府規(guī)制對(duì)策.
在現(xiàn)階段，我國(guó)政府必須在借鑒國(guó)外發(fā)達(dá)國(guó)家政府規(guī)制經(jīng)驗(yàn)的基礎(chǔ)上，通過以下手段提升我國(guó)現(xiàn)階段醫(yī)藥行業(yè)的政府規(guī)制水平，一是提高我國(guó)醫(yī)藥行業(yè)的GMP認(rèn)證執(zhí)行力、提升進(jìn)入標(biāo)準(zhǔn)等手段來加強(qiáng)醫(yī)藥行業(yè)進(jìn)入規(guī)制，并積極消除地方保護(hù)主義，打破陳舊退出壁壘；二是通過改革定價(jià)模式，引入競(jìng)爭(zhēng)機(jī)制，完善法律體系，進(jìn)行主體改革等措重點(diǎn)規(guī)制措施來完成與國(guó)際的接軌；三是通過完善質(zhì)量安全規(guī)制的事前控制、事中監(jiān)督、事后反饋的三步策略以及創(chuàng)新執(zhí)法手段的方式來加強(qiáng)我國(guó)政府的社會(huì)性規(guī)制；四是通過加強(qiáng)醫(yī)藥行業(yè)信息披露制度，深化醫(yī)療保險(xiǎn)改革等配套性措施來改善我國(guó)政府對(duì)醫(yī)藥行業(yè)規(guī)制的方式，使得國(guó)家對(duì)醫(yī)藥行業(yè)的規(guī)制走上合理化、制度化的軌道。
我國(guó)對(duì)醫(yī)藥行業(yè)的政府規(guī)制，是國(guó)家對(duì)醫(yī)藥行業(yè)采取的一項(xiàng)重要政策，旨在完善醫(yī)藥行業(yè)的市場(chǎng)制度，杜絕醫(yī)藥行業(yè)產(chǎn)生的不良影響，建立公平安全的醫(yī)藥消費(fèi)市場(chǎng)，為保證公民人身的健康和安全提供有力的保障。在這個(gè)過程中，不僅需要通過政府進(jìn)行規(guī)制改革，強(qiáng)化法律體系來完成，同樣需要社會(huì)公眾及輿論的監(jiān)督，以及各經(jīng)濟(jì)主體自身素質(zhì)的不斷提高，只有這樣，才能最大限度地保護(hù)我國(guó)人民的利益，使我國(guó)的醫(yī)藥市場(chǎng)朝著既快又好的方向發(fā)展。

關(guān)鍵詞：政府規(guī)制 醫(yī)藥行業(yè) 研究

Abstract
Since the china’s reform, our country pharmaceutical industry has adopted a government-led regulation, market regulation mode of operation for the counseling, pharmaceutical industry includes pharmaceutical companies, enterprises, hospitals and other important national economic agents, social development in China essential and important economic pillar. However, with the deepening of the socialist market economy in recent years, China's pharmaceutical industry there were many quality and safety problems, especially some major injury incident is shocking, these events can not but arouse the Government's reflection, How to learn the advanced experience of foreign countries, as our government regulation of the pharmaceutical industry to provide a viable path, in order to standardize the development of China's pharmaceutical industry, has become one of the very important issue.
This article from the pharmaceutical industry, the basic characteristics of the first to take industrial economics SCP Paradigm law, from the market structure, market conduct perspective of the pharmaceutical industry to analyze the situation, on this basis, in accordance with the economic regulation and social regulation classification of China's current pharmaceutical industry, major government regulations were introduced, including market access regulation, the market price regulation and quality and safety regulations, etc., then China's pharmaceutical industry, government regulation the current problems are analyzed and pointed out a problem of the source : First, as the government of the pharmaceutical industry into the regulation failure; Second, the Government of the pharmaceutical industry, price regulation system failure; Third, the Government of the pharmaceutical industry quality and safety regulation of the failure; after the draw on advanced foreign government regulation based on the experience,proposed specific conditions for the Regulation of countermeasures.
    At this stage, our government must learn from the experience of foreign countries on the basis of government regulation, through the following means of enhancing our current level of government regulation of the pharmaceutical industry, one of the pharmaceutical industry to improve execution of GMP certification, standards and other means to enhance access to to strengthen the pharmaceutical industry into the regulation, and actively eliminate local protectionism, breaking the old exit barriers; the second is through reform of the pricing model, to introduce competition, improve the legal system, the main reform measures focus on regulatory measures to complete with international standards; three by improving quality and safety regulation of the pre-control, a matter of supervision, after the feedback from the three-step strategy and innovative means of enforcement of the ways to strengthen our government's social regulation; Fourth, through the strengthening of the pharmaceutical industry information disclosure system and deepen the health insurance reform supporting measures to improve our government the way the pharmaceutical industry regulation, making the country took to the regulation of the pharmaceutical industry rationalization and systematic.
     Government regulation of the pharmaceutical industry, is state of the pharmaceutical industry to take an important policy, the pharmaceutical industry to improve the market system, to eliminate the adverse effect of the pharmaceutical industry, the safety of pharmaceutical consumption to establish a fair market, to ensure the citizens of the person provide effective health and safety protection. In this process, not only by government regulatory reform, strengthening the legal system to complete, also need the supervision of the public and the media, as well as economic agents own quality continues to improve, the only way to maximize the protection of the interests of our people , China's pharmaceutical market to move fast and a good direction.

KEYWORDS: Government Regulation  Medical industry  Study

目 錄
摘要 2
Abstract 4
第一章 導(dǎo)論 8
第一節(jié) 選題背景與研究意義 8
一、選題背景 8
二、選題意義 9
第二節(jié) 國(guó)內(nèi)外研究綜述 9
一、國(guó)外醫(yī)藥行業(yè)規(guī)制研究綜述 9
二、國(guó)內(nèi)醫(yī)藥行業(yè)規(guī)制研究綜述 11
第三節(jié) 研究?jī)?nèi)容與研究方法 14
一、研究?jī)?nèi)容 14
二、研究方法 14
第四節(jié) 研究思路與研究創(chuàng)新 15
一、研究思路 15
二、研究創(chuàng)新 15
第二章 醫(yī)藥行業(yè)政府規(guī)制的理論研究 17
第一節(jié) 醫(yī)藥行業(yè)概念及屬性 17
第二節(jié) 醫(yī)藥行業(yè)政府規(guī)制的必要性和可行性 18
一、醫(yī)藥行業(yè)政府規(guī)制的必要性 18
二、醫(yī)藥行業(yè)政府規(guī)制的可行性 19
第三節(jié) 醫(yī)藥行業(yè)政府規(guī)制的特征 20
第四節(jié) 醫(yī)藥行業(yè)政府規(guī)制的內(nèi)容 22
一、醫(yī)藥行業(yè)經(jīng)濟(jì)性規(guī)制的內(nèi)容 22
二、醫(yī)藥行業(yè)社會(huì)性規(guī)制的內(nèi)容 22
第三章 我國(guó)醫(yī)藥行業(yè)的政府規(guī)制現(xiàn)狀和主要問題 24
第一節(jié) 我國(guó)醫(yī)藥行業(yè)的發(fā)展?fàn)顩r 24
一、我國(guó)醫(yī)藥行業(yè)市場(chǎng)結(jié)構(gòu)分析 24
二、我國(guó)醫(yī)藥行業(yè)市場(chǎng)行為分析 25
三、我國(guó)醫(yī)藥行業(yè)市場(chǎng)績(jī)效分析 26
第二節(jié) 我國(guó)醫(yī)藥行業(yè)的政府規(guī)制制度及其發(fā)展 27
一、我國(guó)醫(yī)藥行業(yè)的市場(chǎng)進(jìn)入規(guī)制制度及其發(fā)展 28
二、醫(yī)藥行業(yè)的價(jià)格規(guī)制制度及其發(fā)展 29
三、醫(yī)藥行業(yè)的質(zhì)量安全規(guī)制制度及其發(fā)展 30
第三節(jié) 我國(guó)醫(yī)藥行業(yè)的政府規(guī)制存在的主要問題 31
一、我國(guó)醫(yī)藥行業(yè)在市場(chǎng)進(jìn)入規(guī)制存在的問題 31
二、我國(guó)醫(yī)藥行業(yè)在市場(chǎng)價(jià)格規(guī)制上存在的問題 32
三、我國(guó)醫(yī)藥行業(yè)在質(zhì)量安全規(guī)制上存在的問題 34
四、我國(guó)醫(yī)藥行業(yè)在政府規(guī)制上存在的其它問題 35
第四節(jié) 我國(guó)醫(yī)藥行業(yè)的政府管制問題的成因分析 36
一、醫(yī)藥行業(yè)市場(chǎng)進(jìn)入規(guī)制失靈，導(dǎo)致市場(chǎng)混亂不堪 36
二、醫(yī)藥市場(chǎng)價(jià)格規(guī)制失靈，醫(yī)藥價(jià)格成為擾亂市場(chǎng)源頭 37
三、醫(yī)藥行業(yè)質(zhì)量安全規(guī)制失靈，導(dǎo)致政府公信力下降 37
四、醫(yī)藥市場(chǎng)體系的不完善導(dǎo)致政府規(guī)制效力下降 38
第四章 國(guó)外醫(yī)藥行業(yè)政府規(guī)制的經(jīng)驗(yàn)借鑒 40
第一節(jié) 美國(guó)醫(yī)藥行業(yè)政府規(guī)制的特點(diǎn) 40
一、醫(yī)藥標(biāo)簽規(guī)制 40
二、醫(yī)藥廣告規(guī)制 40
三、信息披露規(guī)制 40
第二節(jié) 英國(guó)醫(yī)藥行業(yè)政府規(guī)制的特點(diǎn) 41
第三節(jié) 日本醫(yī)藥行業(yè)政府規(guī)制的特點(diǎn) 41
第四節(jié) 國(guó)外政府醫(yī)藥行業(yè)規(guī)制對(duì)我國(guó)的啟迪 42
一、政府規(guī)制比較注重引導(dǎo)性規(guī)制 42
二、政府有放松規(guī)制的傾向 42
三、國(guó)家醫(yī)療體制影響著醫(yī)藥行業(yè)的政府規(guī)制 43
四、政府價(jià)格規(guī)制手段多元化 43
第五章 醫(yī)藥行業(yè)政府規(guī)制的案例分析 44
第一節(jié) 案例背景 44
一、“亮菌甲素”假藥的發(fā)現(xiàn) 44
二、“亮菌甲素”假藥產(chǎn)生過程 45
三、“亮菌甲素”假藥事件的責(zé)任 45
第二節(jié) 案例的政府規(guī)制問題分析 46
一、市場(chǎng)進(jìn)入規(guī)制問題分析 46
二、價(jià)格規(guī)制問題分析 47
三、質(zhì)量安全規(guī)制問題分析 47
第六章 加強(qiáng)我國(guó)醫(yī)藥行業(yè)政府規(guī)制的對(duì)策建議 49
第一節(jié) 加強(qiáng)我國(guó)醫(yī)藥行業(yè)經(jīng)濟(jì)性規(guī)制 49
一、加強(qiáng)醫(yī)藥行業(yè)進(jìn)入規(guī)制，打破陳舊退出壁壘 49
二、抓住價(jià)格規(guī)制改革重點(diǎn)，積極完成與國(guó)際接軌 50
第二節(jié) 完善我國(guó)醫(yī)藥行業(yè)社會(huì)性規(guī)制 52
一、加強(qiáng)醫(yī)藥行業(yè)質(zhì)量安全規(guī)制，實(shí)行前中后三步策略 52
二、創(chuàng)新執(zhí)法手段，提升執(zhí)法效率 53
三、增強(qiáng)質(zhì)量安全規(guī)制的正向激勵(lì)方式 53
第三節(jié) 強(qiáng)化我國(guó)醫(yī)藥行業(yè)政府規(guī)制的配套性改革 54
一、設(shè)立醫(yī)藥類行業(yè)的信息披露制度，打破醫(yī)藥行業(yè)的隱蔽性 54
二、健全我國(guó)醫(yī)保制度，促進(jìn)醫(yī)藥市場(chǎng)繁榮 55
結(jié)論 57
參考文獻(xiàn) 58
致謝 60