比较法视野下药品不良反应所致损害的救济之路

发布时间：2018-06-10 05:41

本文选题：药品不良反应 + 民事责任　；参考：《山东大学》2014年硕士论文

【摘要】：药品是一种特殊的产品,在治愈疾病的同时,又因其自身的危险性给人们带来危害。在现代工业模式下,药物的风险得以空前的扩散。20世纪,世界上多个国家先后发生多起大规模的药害事件。德国的“反应停事件”、美国的“DES事件”、日本的"SMON病风波”等一系列惨剧令人震惊。而随着我国医药事业的发展和进口药物的不断涌入,我国的药物不良反应事件也日益显现。2000年因常用感冒药中的PPA导致脑中风的“PPA事件”；2001年因德国拜耳公司生产的心血管药拜斯亭导致横纹肌溶解综合症和急性肾衰竭事件；2003年的“龙胆泻肝丸事件”。可以说,药品的天然风险性所产生不良反应之损害,任何国家都难以置身事外。我们要做的是如何更好的预防和如何对受害者进行充分的救济。我国对药品不良反应损害的应对与救济机制很不完善。行政干预仅停留在对药物不良反应信息的获取和控制上,还没有涉及到对受害者的补偿问题。在司法领域,由于我国的《产品责任法》、《医疗事故处理条例》、《侵权责任法》等法律均将合格药品所致不良反应造成的损害排除在外,导致受害者的诉讼之路步履维艰。由于没有明确的法律规定,司法判例可谓五花八门,法院或因无法可依而驳回诉讼请求,或依据公平原则,判决一定数额的补偿,却不能从根本上对受害者进行救济。国内相当一部分学者已经关注药品不良反应事件,并思考如何救济的问题。本文在大量论证的基础上,也旨在寻求一条在我国现阶段可行的药品不良反应救济之路。全文从药品不良反应的定义、与相近概念的区别入手,进而分析药品不良反应所具备的法律特征,因其所具备的特殊性而在我国侵权法上所面临的救济困境。本文对几个典型国家的药品不良反应的立法制度、救济模式进行了考察,分析其经验与教训,以资借鉴。药品不良反应损害应建立多元化救济机制,是目前学界与实务界达成的共识。但对建立何种模式的救济机制却见仁见智。本文通过比较侵权法、责任保险、基金救助三种救济方式的优劣,对目前盛行的两种观点即修改侵权法之归责原则和建立以责任保险为主的救济模式进行了可行性分析论证。本文最后,作者构建了一条金字塔模式的救济之路。以侵权法损害赔偿为塔尖,基金救助制度为塔基,多种救济方式相互配合,构成一个统一的体系。在侵权法框架下,作者对如何进行侵权法的内部完善提出了建议。包括改进对于药品缺陷的认定标准、采纳新的因果关系证明理论、加强对药企违反药品安全观察义务之过错追究三个方面,以期充分发挥侵权法惩戒与激励功能。对于基金制度的构建,本文从基金的单独立法、机构的设立、资金的筹集和赔偿的范围、标准等四个方面进行了构思。希望本文对于我国药品不良反应救济机制的构建能提供一些有益探索。
[Abstract]:Medicine is a special product, which not only cure disease, but also bring harm to people because of its own danger. In the modern industrial model, the risk of drugs can spread unprecedented in the 20th century, many countries in the world have occurred a number of large-scale drug damage events. A series of tragic events in Germany, des in the United States and Smon disease in Japan are shocking. And with the development of our country's medical industry and the continuous influx of imported drugs, "PPA event" caused by PPA in common cold medicine in 2000, and rhabdomyolysis syndrome and acute in 2001 due to Baxtin, a cardiovascular drug produced by Bayer Company in Germany. Kidney failure event; 2003 Gentian Xiegan Pill event. It can be said that any country can hardly stay away from adverse reactions caused by the natural risks of drugs. What we should do is how to better prevent and how to provide adequate relief to the victims. Administrative intervention only focuses on the acquisition and control of adverse drug reaction information, and does not involve the compensation of the victims. In the judicial field, due to the "Product liability Law", "Medical malpractice treatment Regulation", "Tort liability Law" and other laws, the damage caused by adverse reactions caused by qualified drugs is excluded, resulting in the victims' litigation difficult. In the absence of clear legal provisions, judicial precedents can be described as varied. The court either dismissed the claim because it could not be followed, or decided a certain amount of compensation on the basis of the principle of fairness. However, it is impossible to provide relief to the victims fundamentally. A considerable number of domestic scholars have paid attention to adverse drug reactions and considered how to remedy them. On the basis of a great deal of argumentation, this paper also aims to find a feasible way to remedy adverse drug reactions in our country. This paper starts with the definition of adverse drug reaction and the difference between the similar concepts, and then analyzes the legal characteristics of adverse drug reaction and the relief dilemma in tort law of our country because of its particularity. In this paper, the legislative system and relief mode of adverse drug reactions in several typical countries are investigated, and their experiences and lessons are analyzed. Is the current academic and practice reached a consensus. However, there are different opinions on what kind of relief mechanism should be established. By comparing the advantages and disadvantages of tort law, liability insurance and fund relief, this paper analyzes the feasibility of modifying the principle of liability imputation of tort law and establishing a relief mode based on liability insurance. Finally, the author constructs a pyramid model of relief road. The compensation for damages in tort law is the top, the fund rescue system is the base, and various relief methods cooperate with each other, forming a unified system. Under the framework of tort law, the author puts forward some suggestions on how to improve the tort law. It includes improving the identification standard of drug defects, adopting the new theory of causality proof, and strengthening the investigation of drug enterprises' fault of violating the duty of drug safety observation, in order to give full play to the disciplinary and incentive functions of tort law. For the construction of the fund system, this article has carried on the conception from four aspects: the separate legislation of the fund, the establishment of the institution, the scope of raising funds and the compensation, and the standard. It is hoped that this paper can provide some useful exploration for the construction of relief mechanism for adverse drug reactions in China.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D923;D922.16;D922.294

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