本文選題：藥品安全事件 + 生產(chǎn)者��； 參考：《成都中醫(yī)藥大學(xué)》2014年碩士論文

【摘要】：改革開放以來,我國(guó)社會(huì)主義市場(chǎng)經(jīng)濟(jì)得到蓬勃發(fā)展,醫(yī)藥行業(yè)的市場(chǎng)化程度亦隨之不斷加深。在醫(yī)藥行業(yè)迅速發(fā)展的同時(shí),大大小小的藥品安全事件屢見不鮮。這些藥品安全事件不但嚴(yán)重破壞了國(guó)家對(duì)于醫(yī)藥行業(yè)的監(jiān)管制度、擾亂了社會(huì)經(jīng)濟(jì)秩序,也極大地?fù)p害了公眾的生命健康與財(cái)產(chǎn)權(quán)利。 制藥企業(yè),即藥品生產(chǎn)者,低效率管理和秩序混亂的現(xiàn)象仍然存在。因藥品生產(chǎn)者在藥品生產(chǎn)與流通過程中的故意或過失行為致使缺陷藥品進(jìn)入消費(fèi)市場(chǎng)從而引發(fā)藥品安全事件的情形,在諸多包括醫(yī)生和患者不合理用藥等因素在內(nèi)從而引發(fā)的藥品安全事件中占有很大比例。因此,依靠國(guó)家強(qiáng)制力有效打擊不良生產(chǎn)者對(duì)于保護(hù)藥品市場(chǎng)秩序和公眾的合法權(quán)益是十分重要的。 本文以“藥品安全事件中生產(chǎn)者刑事責(zé)任研究”為選題,從藥品研發(fā)、生產(chǎn)、流通等環(huán)節(jié)分析生產(chǎn)者存在的問題,挖掘其中涉及的刑事責(zé)任和法律適用,在現(xiàn)有理論的基礎(chǔ)上,提出一些具有實(shí)踐意義的建議和措施,以維護(hù)公眾的生命、健康、財(cái)產(chǎn)權(quán)益和醫(yī)藥行業(yè)有序發(fā)展。 藥品安全管理系統(tǒng)而復(fù)雜,涉及白藥品研發(fā)到臨床用藥后觀察等系列過程,且在藥品安全事件中可能涉及刑事責(zé)任的主體也不僅僅只有生產(chǎn)者,還包括專門的藥品銷售者等。因而,對(duì)于藥品安全事件中生產(chǎn)者的刑事打擊也只是從整個(gè)安全監(jiān)管體系中的一個(gè)方面遏制藥品安全事故的發(fā)生。增加藥品生產(chǎn)廠商的違法成本,使之遠(yuǎn)遠(yuǎn)高于其非法所得,以嚴(yán)厲的懲治力度震懾違法生產(chǎn)者,從源頭上加強(qiáng)對(duì)藥品質(zhì)量的保障。 考慮到藥品作為特殊的產(chǎn)品,近年來具有公害性質(zhì)的藥品安全事件又逐漸呈現(xiàn)出涉案金額高、涉案范圍廣、受害人較多、危害后果嚴(yán)重,社會(huì)影響惡劣,有些甚至演變?yōu)樯鐣?huì)公共事件的趨勢(shì),而生產(chǎn)者大都牽涉其中,因此,如何在藥品安全事件中,正確適用《刑法》等有關(guān)強(qiáng)行法的規(guī)定追究藥品生產(chǎn)者的刑事責(zé)任,提出一些具有實(shí)踐意義的建議措施是本領(lǐng)域需要迫切解決的問題,這也是本文重點(diǎn)研究的內(nèi)容。
[Abstract]:Since the reform and opening up, China's socialist market economy has been booming, the degree of marketization of the pharmaceutical industry has been deepened.The rapid development of the pharmaceutical industry at the same time, large and small drug safety incidents are common.These drug safety incidents have not only seriously damaged the national supervision system of the pharmaceutical industry, disturbed the social and economic order, but also greatly damaged the public's right to life, health and property.The phenomenon of inefficient management and disorder in pharmaceutical enterprises, that is, drug producers, still exists.A situation in which a defective drug enters the consumer market as a result of intentional or negligent behavior of a drug producer in the course of drug production and circulation, thereby causing a drug safety event,It accounts for a large proportion of drug safety incidents, including irrational use of drugs by doctors and patients.Therefore, it is very important to protect the order of the drug market and the legal rights of the public by relying on the national coercive power to effectively crack down on the bad producers.Based on the topic of "Research on producer Criminal responsibility in Drug Safety events", this paper analyzes the problems existing in producers from the aspects of drug research and development, production and circulation, and excavates the criminal responsibility and legal application involved in them, based on the existing theories.Some practical suggestions and measures are put forward to safeguard the public life, health, property rights and interests and the orderly development of the pharmaceutical industry.The drug safety management system is complex, involving a series of processes, such as the development of white drugs to the observation after clinical use, and the subject of criminal responsibility in drug safety incidents is not only producers, but also specialized drug sellers and so on.Therefore, the criminal attack on producers in drug safety incidents is only one aspect of the whole safety supervision system to curb the occurrence of drug safety accidents.Increase the illegal cost of drug manufacturers, make it far higher than their illegal income, with severe punishment to deter illegal producers, strengthen the quality of drugs from the source to ensure the quality.Considering that drugs are special products, in recent years, drug safety incidents of a public hazard nature have gradually shown a high amount of money involved, involving a wide range of victims, more victims, serious harmful consequences and adverse social effects,Some have even evolved into a trend of social and public events, and most of the producers are involved. Therefore, how to correctly apply the relevant provisions of the mandatory law, such as the Criminal Law, to investigate the criminal responsibility of drug producers in drug safety incidents,To put forward some practical suggestions is an urgent problem to be solved in this field, which is also the focus of this paper.
【學(xué)位授予單位】：成都中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：D924.3

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本文編號(hào)：1759985