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药品安全事件中生产者刑事责任研究

发布时间:2018-04-16 17:55  文章来源:笔耕文化传播

  本文选题:药品安全事件 + 生产者 ; 参考:《成都中医药大学》2014年硕士论文


【摘要】:改革开放以来,我国社会主义市场经济得到蓬勃发展,医药行业的市场化程度亦随之不断加深。在医药行业迅速发展的同时,大大小小的药品安全事件屡见不鲜。这些药品安全事件不但严重破坏了国家对于医药行业的监管制度、扰乱了社会经济秩序,也极大地损害了公众的生命健康与财产权利。 制药企业,即药品生产者,低效率管理和秩序混乱的现象仍然存在。因药品生产者在药品生产与流通过程中的故意或过失行为致使缺陷药品进入消费市场从而引发药品安全事件的情形,在诸多包括医生和患者不合理用药等因素在内从而引发的药品安全事件中占有很大比例。因此,依靠国家强制力有效打击不良生产者对于保护药品市场秩序和公众的合法权益是十分重要的。 本文以“药品安全事件中生产者刑事责任研究”为选题,从药品研发、生产、流通等环节分析生产者存在的问题,挖掘其中涉及的刑事责任和法律适用,在现有理论的基础上,提出一些具有实践意义的建议和措施,以维护公众的生命、健康、财产权益和医药行业有序发展。 药品安全管理系统而复杂,涉及白药品研发到临床用药后观察等系列过程,且在药品安全事件中可能涉及刑事责任的主体也不仅仅只有生产者,还包括专门的药品销售者等。因而,对于药品安全事件中生产者的刑事打击也只是从整个安全监管体系中的一个方面遏制药品安全事故的发生。增加药品生产厂商的违法成本,使之远远高于其非法所得,以严厉的惩治力度震慑违法生产者,从源头上加强对药品质量的保障。 考虑到药品作为特殊的产品,近年来具有公害性质的药品安全事件又逐渐呈现出涉案金额高、涉案范围广、受害人较多、危害后果严重,社会影响恶劣,有些甚至演变为社会公共事件的趋势,而生产者大都牵涉其中,因此,如何在药品安全事件中,正确适用《刑法》等有关强行法的规定追究药品生产者的刑事责任,提出一些具有实践意义的建议措施是本领域需要迫切解决的问题,这也是本文重点研究的内容。
[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.
【学位授予单位】:成都中医药大学
【学位级别】:硕士
【学位授予年份】:2014
【分类号】:D924.3

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