我国缺陷药品损害预防及救济研究

发布时间：2018-03-03 08:34

本文选题：缺陷药品　切入点：侵权责任　出处：《安徽医科大学》2017年硕士论文　论文类型：学位论文

【摘要】：药品自诞生以来,在治病救人,延年益寿方面发挥了不可替代的作用。然而,正如古人所说:“是药三分毒”,药品在治病的同时,也能致病,其存在的不良反应或副作用在目前乃至将来的很长一段时间都是无法根除的。20世纪以来,大量化学药品问世,新药种类层出不穷,但由于我国缺乏对新药有效的监督和管理,导致国内药害事件接连不断。药害轻则致病,造成伤害、残疾,重则使人丧失生命,其波及范围之广,影响之深远往往很难控制,极易引发公共事件。为了最大限度抑制缺陷药品带来的损害,有必要建立并完善相关的预防与救济体系。鉴于此,本文将在产品责任和侵权责任的基础上,结合我国现有的相关法律法规,将正文分四部分展开:第一部分“缺陷药品损害概述”。本部分由三节组成,第一节主要论述了何谓药品,缺陷的概念,并将缺陷进行简单分类,分析缺陷认定标准及方法,由此为整篇文章打下理论基础。第二节“缺陷药品侵权责任”。在归责原则上,我国实行的是严格责任,但经过分析,笔者认为应根据缺陷的类型设定不同的归责原则。严格责任下构成要件有:缺陷、损害事实及两者之间的因果关系。第三节“缺陷药品损害侵权责任的承担及免责事由”。本节需要解决的是缺陷药品损害责任主体有哪些,其中医疗机构的性质(是药品销售者还是药品使用者)是重点讨论的内容,此外发展风险抗辩是否可以作为免责事由也是有待解决的重要问题。第二部分“我国缺陷药品损害预防及救济方面存在的问题”。主要分析立法、司法、行政监管、法治教育、职业道德教育以及其他方面存在的问题,提出问题,理清思路,为问题的解决作铺垫。第三部分“完善我国缺陷药品损害预防及救济的建议”。针对第二部分提出的问题,并结合发达国家及地区的相关做法,对症下药提出相应的完善意见。立法方面,建议尽快出台《侵权责任法司法解释》,理清相关概念,解决相关问题;司法方面,对举证责任的分配、司法鉴定、专家辅助人的应用、判决的执行、公益诉讼的开展等提出相应的完善意见;行政监管方面,提出如何加强食品药品监督管理部门对药品的监管以及有关国家赔偿问题;教育方面,建议从学校和医药企业两个方面加强法治教育和职业道德教育;非诉方面,主要针对仲裁和调解方面存在的问题提出完善意见。第四部分“我国缺陷药品损害预防及救济中法治教育及职业道德教育的重要性”。该部分简要分析了缺陷药品损害预防及救济中法治教育及职业道德教育的重要性,以期能唤起人们对法治教育和职业道德教育的重视,更加关注药品安全。
[Abstract]:Since its birth, drugs have played an irreplaceable role in curing and saving people and prolonging life. However, as the ancients said, "it is a triple-drug poison." drugs can also cause diseases while treating diseases. Since the 20th century, a large number of chemicals have come out, and the kinds of new drugs have been emerging endlessly. However, due to the lack of effective supervision and management of new drugs in our country, the adverse reactions or side effects can not be eradicated at present or for a long time in the future. This has led to a succession of domestic drug incidents. If the drug damage is light, it causes illness, causing injury, disability, and heavy loss of life. The scope of its impact is so wide that it is often difficult to control its far-reaching effects. In order to minimize the damage caused by defective drugs, it is necessary to establish and improve the relevant prevention and relief system. In view of this, this article will be based on product liability and tort liability. Combined with the existing laws and regulations of our country, the text is divided into four parts: the first part is "Overview of defective drugs damage". This part is composed of three sections. The first section mainly discusses what is drugs, the concept of defects, and classifies defects simply. This paper analyzes the standards and methods of defect identification, which lays a theoretical foundation for the whole article. Section two, "liability for the infringement of defective drugs". In the principle of imputation, our country carries out strict liability, but after analysis, The author believes that different imputation principles should be set according to the types of defects. The fact of damage and the causality between them. Section III "liability and exemption for damages caused by defective drugs". What this section needs to solve is the subject of liability for damage caused by defective drugs. The nature of medical institutions (whether they are drug sellers or drug users) is the focus of discussion. In addition, whether the development of risk defense can be used as an excuse for exemption is also an important issue to be solved. The second part, "problems in the prevention and relief of defective drug damage in China", mainly analyzes legislation, judicature, administrative supervision, and education on the rule of law. Professional ethics education and other aspects of the problems, put forward problems, clear ideas, to pave the way for the solution of the problem. The third part, "improve the prevention and relief of defective drugs in China". The second part of the problem, And combined with the relevant practices of developed countries and regions, to put forward the corresponding improvement advice. In legislation, it is suggested that the judicial interpretation of the Tort liability Law should be issued as soon as possible, to clarify the relevant concepts and to solve the relevant problems; in the judicial aspect, To the distribution of the burden of proof, judicial expertise, the application of expert auxiliaries, the execution of judgments, the development of public interest litigation, and so on. How to strengthen the supervision of food and drug administration over drugs and the problems of state compensation; in education, it is suggested to strengthen the education of rule of law and professional ethics in schools and pharmaceutical enterprises; and in non-litigation, This part mainly aims at the problems existing in arbitration and mediation. Part 4th, "the importance of Rule of Law Education and Professional Ethics Education in the Prevention and Relief of defective Drug damage in China", is briefly analyzed. The importance of education in the rule of law and professional ethics in prevention and relief, In order to arouse people to the rule of law education and professional ethics education, pay more attention to drug safety.
【学位授予单位】：安徽医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D922.16;D923

【相似文献】