药害事故防范与救济制度研究

【作者】 齐晓霞；

【导师】 刘士国；

【作者基本信息】 复旦大学 ， 民商法学， 2011， 博士

【摘要】 药品可“治病”也可“致病”,会“强身”也会“戕身”,能“活命”也能“祸命”,其治疗作用与副作用必然同存、有效性与危险性必然并在。为最大限度地抑制其危险性、发挥其有效性,建立并完善相关的防范和救济制度殊为必要。近年来,我国药害事故时有发生,引起了有关方面的高度重视,并着手从立法层面研究解决,但由于对药害事故的防范和救济缺乏体系性、前瞻性思考,出台的法律往往只针对具体问题,难以从根本上解决问题。有鉴于此,本文尝试对药害事故的防范和救济制度作系统研究,立足于我国法制和制药产业发展现状,根据对美、德、日等法制发达国家相关立法、判例、学说的考察、分析,从加强保护药害事故受害人和促进制药产业平衡发展的角度,对药品行政管制、药品缺陷认定、缺陷药品损害侵权救济、药品不良反应损害特殊救济等问题进行通盘思考,有针对性地提出构建和完善我国药害事故防范和救济制度的系统建议。本文除导论外,共有五章和结论,主要内容如下：第一章基本概念及问题的引入。首先对全文研究的药品范围和药害事故范围予以界定,通过对与此问题相关的基本概念的探析和对数起严重药品致害事件的历史考察,明确了建立完善药害事故防范和救济制度的重要性和必要性,在对药品特点和药害事故特点深入分析的基础上,提出了建立药害事故防范和救济制度的总体思路框架：发挥政府行政管制的主导作用,加强事先防范；严格界定、科学确定药品质量标准和缺陷认定标准；完善药品损害的侵权法救济,加强事后惩戒；建立药品不良反应损害救济制度,作为重要补充。第二章政府职能的发挥：强化行政管制。药品领域技术复杂、信息专业、产业化程度高,为了防范药品危害,最大限度地提升药品效用,需要政府充分发挥主导作用,对药品从研发到生产,从销售到使用,乃至上市后的不良反应监测,实行全过程、无缝隙的严密管制。鉴于美国食品药品管理局(FDA)在药品监管领域的成就有目共睹,其成功的监管经验可以为我国提供有益借鉴,本章首先介绍了其药品监管制度和管制实践,总结其制度经验,然后介绍我国的药品管制现状,最后提出为最大限度防范药害事故,我国应完善药品标准,加强对制药企业的信息披露、药品上市许可,以及药品上市后的监视等方面的监管。第三章药品缺陷的认定：完善标准要求。药品缺陷的认定是防范和处理药害事故的关键性环节和基础性工作,但由于其不仅是技术难题,又涉及价值取向、利益定位等诸多难题,所以历来是观念冲突、观点交锋的焦点领域。本章首先分析药品缺陷认定中争议较大的符合国家标准的药品是否也可能为缺陷药品、引发不良反应能否认定药品存在缺陷、药品缺陷认定的时间基准等问题；然后分析认定药品缺陷的几项重要标准、几种主要药品缺陷类型的不同认定要求,以及药品缺陷认定中最难处理的行政规范与侵权法救济的关系问题；提出我国应完善药品缺陷认定标准,不将法定标准视为药品缺陷认定的唯一标准,只应将其视为“底线标准”,但从我国现在制药产业现状出发,应将药品缺陷的时间判定标准规定为药品上市流通时,同时应对各种药品缺陷的认定标准予以细化,并明确区分药品缺陷和药品不良反应。第四章侵权责任的适用：完善现有规则。首先,从比较法角度探析药害事故侵权救济的合理归责原则：为强化对受害者权益的保护,各国药害事故侵权救济的归责原则均经历了从过错责任原则到无过错责任原则的发展演变：但现在美国一些药品责任的判例以及侵权法重述中的相关规定,却呈现出另一发展趋势,即对药品损害适用无过错责任进行适当限制,并对不同类型的药品缺陷适用不同的认定标准,体现不同的归责要求,出现了类型化发展趋向。其次,分析了药害事故侵权救济的构成要件：主要结合药品损害的特点探讨对受害人造成损害的赔偿范围问题,包括对其造成的精神损害是否应当赔偿、如何适用惩罚性赔偿；以及如何认定药品缺陷与受害人所受损害之间存在因果关系,介绍分析了盖然性因果关系说、疫学因果关系理论、市场份额理论等特殊因果关系理论,《德国药品法》中的法定因果关系推定规则、受害者知情请求权规则、美国法中的专家证言规则。最后,分析了药害事故侵权责任的承担与免除问题,主要包括：责任主体问题,重点分析医疗机构是否应当对缺陷药品造成的损害承担无过错责任；免责条款问题,重点分析对于缺陷药品造成的损害是否应当适用科技现状免责抗辩事由,如果适用该免责抗辩事由,如何对受害者予以救济；诉讼时效与除斥期间问题,比较德国、日本基于药品损害的累积性和潜伏性特点作出的两种不同规定,提出我国应当作出的立法选择。第五章药品不良反应损害的救济：构建可行制度。对药品不良反应造成的损害应如何救济,各国的立法态度、制度设计等存在较大差异：有令制药企业对受害者承担侵权责任；有制定药害救济法,建立专门的救济基金；也有强制制药企业向保险公司投保责任险或建立专门的药品保险制度。而我国目前除针对疫苗接种不良反应损害作出特例性的补偿规定,药品不良反应损害救济制度基本付之阙如。本章首先考察美国有些州对药品不良反应适用侵权责任救济的模式,以及其为弥补该种模式不足在疫苗领域尝试进行的疫苗伤害补偿计划,分析并总结了该补偿计划可为完善我国疫苗损害救济制度提供的有益经验。其次,通过对瑞典、德国法保险救济模式的考察,发现其之所以在本国获得成功,是以其发达的社会保障体系和健全的保险制度为基本前提,而且保险救济并不是唯一手段,同时还辅有其他方式。再次,考察日本法、我国台湾地区法的基金救济模式,从其实践结果看,虽然存在一些问题和不足,但相对而言优势明显。因此,主张从我国实际情况出发,对保险和基金两种模式兼收并蓄,建立以基金方式为主辅之以保险救济的混合模式的药品不良反应损害救济制度。更多还原

【Abstract】 Drugs could cure or cause an illness, could strengthen or hurt a body, and could also rescue or harm a life. The coexistences of their active and adverse reactions, and effectiveness and danger make it necessary to establish and improve prevention and relief systems related. It is only in recent years that China has attached importance to the problem because of the frequently happened drug-induced injury accident. However, legislations are only aimed at solving concrete problems and lack systematic and proactive thought. Therefore, I would try to make a systematic study on prevention and relief systems of drug-induced injury accident in the dissertation. Based on analysis of legislation, cases and theory of U.S.A., German, Japan and other developed countries, Chinese legal systems, and development status of our pharmaceutical industry, I study systematically on administrative regulation of drugs, determination of defective drugs, relief of defective drugs and special relief of adverse drug reaction, and provide integral suggestions for constructing Chinese prevention and relief systems of drug-induced injury in aspects of protecting the injured and promoting the even development of pharmaceutical industry. Besides of the part of introduction, there are five chapters and a conclusion, the main contents of which are:ChapterⅠBasic Concepts and Introduction of Problems. I firstly limit the concepts of "drugs" and "drug-induced accident". According to a study on related concepts and a historic analysis of several serious drug-induced accidents, I specify the importance and necessity of establishing and improving prevention and relief systems of accidents. On basis of analyzing characters of drugs and drug-induced accidents, I promote my suggestions of establishing prevention and relief systems of the accidents, which are to let government play a main role to emphasize prevention, to determine strictly the standards of drug quality and defects, to improve the tort relief system of drug damages, to strengthen ex post punishment and to establish the relief systems of adverse drug reactions.ChapterⅡRole of Government:To Strengthen Administrative Regulation. Because of the complication of pharmaceutical technology and its high extent of specialization, it is necessary to make government to play a main role and regulate the whole process of research, development, sale, consumpation and adverse reaction supervision. In view of the achievement of FDA in field of drug supervision and regulation, we could learn from their successes. Therefore, I introduce the supervision and regulation systems and practices of U.S.A. and conclude their experiences firstly. Then I describe the status quo of Chinese drug regulation, and conclude that China should improve drug standards and strengthen supervision of information disclosure of pharmaceutical industries, permission before entering into market and regulation afterwards to prevent drug-induced accident as possible as we can.ChapterⅢDetermination of Defective Drugs:To Improve Standards. Determination of Defective Drugs, which is critical and basic to prevent and solve drug-induced accident, has always been a focus of discusses since it is not only a technological problem, but related to value tendency and interest orientation. In this chapter, I make a study on several controversies, i.e. whether drugs matching country’s standards could be defective, whether drugs could be regarded as defect because of causing adverse reaction, and the time bases of determining defective drugs. Then I analyze several standards of determining defective drugs, different requirements of the main defects and relation between administrative regulations and relief according to tort law. We should not regard the standards stipulated in law as unique, but "basic", should take the time drugs enter into market as one to judge whether they are defective, clarify standards of different defects and distinguish drug defect and its adverse reaction.ChapterⅣApplication of Tort Liability:To Improve Rules. I firstly probe into the rational liability rules in aspect of comparative laws and conclude that the rules of drug-induced accidents have all experienced a development from negligent liability to no-negligent liability to protect interests of the injured. However, a new tendency has come into being according to some cases of U.S.A. and rules of the Restatement of Tort Law, that is, to restrict the application of no-negligent liability and to apply different standards on different defects. Then I study the components of tort relief in drug-induced accidents, which are emphasized on limits of damages, including whether moral damages should be compensated and how to apply punitive compensation, and the determination of causation between drug defects and damages. I analyze probability theory of causation, theory of epidemic causality, theory of market share, and other special causality, rules of statutory presumption of causation in German Drug Law, rules of the victims claim knowledge and expert testimony rules in American law. Lastly, I study the accountability and exclusion of tort liability of drug-induced accidents, including bodies of responsibility, the emphasis of which is whether medical institutions should bear no-negligent liability for damages because of defective drugs; exclusion clauses, emphasizing on whether exclusion claims of technology status should be applied to damages of defective drugs, and ways to protect the injured if applied; problems of litigation limitation and scheduled period, which are based on different stipulations in German and Japan to improve Chinese rules.ChapterⅤRelief for Damages of Adverse Drug Reactions:To Establish Applicable Institution. There are many differences of legislative attitudes and institutions design among countries:some stipulate that pharmaceutical industry should bear tort liability; some enact Drug Relief Act and set up special relief fund; some force pharmaceutical manufacturer to insure or establish drug insurance system. However, there only exist special stipulations on adverse vaccine reaction, but no relief systems of adverse drug reaction. In the chapter, I firstly probe into the tort relief model of drug adverse reaction and Vaccine Injury Compensation Program used to make up its defects in several states of U.S.A., and conclude the experiences we could learn from. Secondly, I find reasons of its success by studying the model of insurance relief in Sweden and German, that is, there are advanced social relief systems, wholesome insurance system and other ways. Thirdly, I study the model of relief fund in Japan and Taiwan. There is notable superiority in spite of some problems. Therefore, we should absorb the above two models and establish a system mainly based on fund relief and supplemented by insurance relief.更多还原