药品不良反应损害救济制度探究

发布时间：2018-04-20 03:13

本文选题：药品不良反应 + 损害　；参考：《山东大学》2014年硕士论文

【摘要】：药品作为治疗疾病必不可少的一种手段,其不良反应也是如影随形。本文讨论的药品不良反应是指由合格药品引起的,在正常用法用量下出现的与用药目的无关的有害反应。近几十年来药品不良反应造成损害的事件频频出现在人们视线中,例如反应停事件、DES事件、“斯蒙病”事件等,这使人们认识到了药品在带给人们健康的同时也可能带来灾难,而不良反应造成的后果往往很严重,轻者致残、致畸,重者要付出生命的代价,这使得建立健全药品不良反应损害救济制度具有极强的必要性和紧迫性。在认识到这些情况之后,我国相继制定了一系列法律对药品质量严格把关,例如《疫苗流通和预防接种管理条例》和《药品管理法》。《药品不良反应报告和检测管理办法》也加强了药品不良反应的监测工作,起到了一定的预防作用。然而,我国药品不良反应救济制度却是一片空白。反观国外及我国台湾地区,美国对制药企业苛以严格的产品责任来救济受害者,德国和瑞典构建了与其社会保障制度相配套的保险制度,日本和我国台湾地区则建立了较为完善的基金救济制度。本文通过了解药品不良反应的概念,分析我国药品不良反应救济制度的现状及存在的问题,剖析建立药品不良反应损害救济制度的重大意义,结合对美国、德国、瑞典、日本以及我国台湾地区的药品不良反应损害救济制度的比较分析,总结相关经验教训。在此基础上探索适合我国现阶段国情的药品不良反应损害救济制度,提出可行性建议。
[Abstract]:Drugs as an essential means of treatment of disease, its adverse reactions are also accompanied. The adverse drug reactions discussed in this paper refer to harmful reactions caused by qualified drugs and not related to the purpose of drug use. In recent decades, adverse drug reactions have frequently caused damage to people's eyes, such as the "des" incident, the "Smon disease" event, etc., which make people realize that drugs not only bring people health, but also bring disaster. However, the consequences of adverse reactions are often very serious, the light people are disabled, teratogenic, and the heavy ones have to pay the cost of their lives, which makes it necessary and urgent to establish and improve the relief system of adverse drug reactions damage. In recognition of these circumstances, China has formulated a series of laws to strictly control the quality of drugs. For example, the regulations on the Administration of Vaccine Circulation and Preventive vaccination and the Law on Drug Administration. The methods for reporting and detecting adverse Drug reactions have also strengthened the monitoring of adverse drug reactions and played a preventive role. However, the relief system of adverse drug reactions in China is a blank. On the other hand, in foreign countries and Taiwan, the United States has imposed strict product liability on pharmaceutical companies to help the victims. Germany and Sweden have established insurance systems that complement their social security systems. Japan and Taiwan have established more perfect fund relief system. Through understanding the concept of adverse drug reactions, this paper analyzes the present situation and existing problems of the relief system of adverse drug reactions in China, analyzes the great significance of establishing the system of adverse drug reaction damage relief, and combines with the United States, Germany, Sweden, the United States, Germany, Sweden, the United States, Germany, Sweden, The comparative analysis of adverse drug reaction (ADR) damage relief system in Japan and Taiwan is carried out, and the relevant experiences and lessons are summarized. On this basis, this paper explores the relief system of adverse drug reaction damage suitable for the present situation of our country, and puts forward some feasible suggestions.
【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

【参考文献】