药品缺陷责任研究

发布时间：2018-05-25 23:01

本文选题：药品缺陷 + 因果关系　；参考：《内蒙古大学》2015年硕士论文

【摘要】：药品虽然具有一定的特殊性但仍属于产品,药品缺陷责任适用无过错责任原则,构成要件有三：药品存在缺陷；受害人遭受损害；缺陷与损害具有因果关系。本论文立足我国的法律规定,借鉴国外相关立法、学说及判例,对如何认定和证明药品缺陷、缺陷与损害之间的因果关系以及药品缺陷责任承担主体范围进行探讨,以期对我国司法实践中药品缺陷责任认定提出建设性意见。论文主要分四部分展开。第一部分关于药品缺陷的界定。通过分析指明,药品缺陷是指药品具有的不合理危险。药品缺陷的本质涉及药品的安全性问题,由于药品标准并非药品的安全标准,药品符合标准并不能保证绝对安全,因此,合格药品仍可构成缺陷。第二部分关于药品缺陷的认定和证明。此部分探讨三个问题。—是缺陷的认定。药品缺陷在具体认定时应对处方药和非处方药适用不同的认定标准,并应区分设计、制造及警示缺陷适用不同的认定标准。二是药品不良反应是否构成缺陷的认定。药品不良反应以合格药品为基础,由于合格药品也可能具有缺陷,因而药品不良反应是否构成缺陷有探讨的空间。重点探讨药品不良反应在何种情形下可认定为缺陷。在第三个问题中将详述事实自证规则在缺陷证明中的作用。第三部分关于药品缺陷责任构成中的因果关系。药品缺陷责任因果关系的证明采盖然性因果关系规则,并辅助疫学因果关系理论。在盖然性规则下,有时需运用一些具体的方法,如市场份额理论和专家证人制度。此外,还将对最高院《关于审理食品药品纠纷案件适用法律若干问题的规定》第5条对因果关系证明规则的规定予以分析。第四部分则关于药品缺陷责任的承担主体。在责任主体上,有意义的探讨在于对生产者范围的界定以及医疗机构的责任承担问题。关于药品生产者范围的界定,主张将药品原材料的生产者、药品的准生产者认定为药品生产者,这对受害者赔偿请求的实现具有现实意义。对于医疗机构的责任承担则重点探讨医疗机构在药品缺陷责任承担中的法律地位,也即《侵权责任法》第59条有无归责基础。
[Abstract]:Although the drug has certain particularity, it still belongs to the product. The principle of no-fault liability is applicable to the liability for drug defects. There are three constitutive requirements: the drug has defects, the victims suffer damage, and the defects and damages have causality. Based on the laws and regulations of our country, this paper discusses how to identify and prove the defects of drugs, the causality between defects and damages, and the scope of the main body of liability for drug defects, drawing on the relevant legislation, theories and precedents of foreign countries. In order to put forward constructive suggestions on the cognizance of drug defect liability in judicial practice in our country. The thesis is divided into four parts. The first part is about the definition of drug defect. Through the analysis, it is pointed out that drug defect refers to the unreasonable danger of drugs. The essence of drug defect is related to the safety of drugs. Because the drug standard is not the safety standard of drugs, the conformity of drugs with the standard can not guarantee the absolute safety, so qualified drugs can still constitute defects. The second part is about the identification and proof of drug defect. This section discusses three problems.-is the identification of defects. Different identification standards should be applied to prescription drugs and over-the-counter drugs, and different identification standards should be applied to design, manufacture and warning defects. The second is whether adverse drug reactions constitute defects. Adverse drug reactions (ADR) are based on qualified drugs. As qualified drugs may also have defects, there is room for discussion on whether adverse drug reactions constitute defects. Emphasis is placed on the circumstances under which adverse drug reactions can be identified as defects. In the third question, the role of the fact-proof rule in the defect proof will be discussed in detail. The third part deals with the causality in the composition of liability for drug defects. The proof of causality of drug defect liability adopts the rule of causality and adjusts the theory of epidemic causality. Under the rule of probability, some specific methods, such as market share theory and expert witness system, are sometimes used. In addition, the article 5 of the Supreme Court "on the provisions of applicable Law on the trial of Food and Drug disputes" will also analyze the provisions of the rules of proof of causality. The fourth part is about the main body of the liability for drug defects. On the subject of responsibility, the meaningful discussion lies in the definition of producer scope and the responsibility of medical institutions. As to the definition of the scope of drug producers, it is proposed that the producers of raw materials and quasi-producers of drugs should be regarded as drug producers, which is of practical significance to the realization of victims' claims for compensation. For the liability of medical institutions, the emphasis is to discuss the legal status of medical institutions in the responsibility of drug defects, that is, whether Article 59 of the Tort liability Law has the basis of imputation.
【学位授予单位】：内蒙古大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：D922.294

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