我国药品侵权责任强制保险制度构建研究

发布时间：2018-09-18 19:08

【摘要】：第32届世界卫生大会通过的《阿拉木图宣言》明确指出:“健康权是人的一项基本人权。”人非神灵,百毒不侵,药品在人类绵延发展的历史上扮演着极其重要的角色。古有神农尝百草、李时珍著《本草纲目》,无一不强调着药草及药理的重要。但伴随着经济的飞速发展与科技水平的迅猛提高,药品非但没有让我们远离人间苦疾、伤病的困扰,反而日趋严重的药品侵权事件威胁着我们的生命安全、挑动着“健康权”的每一根神经。因为药品不同于一般的商品,它是由复杂化学成分构成的物质,如果没有正确的标签和说明书,即便拥有一双慧眼,也无从知晓药品的副作用和不良反应。一旦药品没有达到预定的治疗功效,那产生的危害后果往往是药品使用者难以承受的。近年来,因缺陷药品导致使用者人身损害的案例不断增加,一系列触目惊心的药品侵权案件让国人越来越担心药品的安全问题。药品这把“双刃剑”在治病救人的同时也在威胁着使用者的生命安全。2010年的“素比伏”事件中,受害人李立力在服用诺华抗乙肝病毒药物替比夫定一年后,因横纹肌溶解导致多种脏器衰竭死亡。死者家属将北京诺华制药有限公司诉至法院,虽然最终认定李立力的死亡是服用替比夫定(商品名“素比伏”)直接导致的,但是损害的后果已经无法挽回。2016年3月20日发生的“山东毒疫苗”事件,再一次拉响了药品安全的警钟。面对日益严重的药品侵权事件,如何构建药品侵权事件受害者的救济体系是当今社会面临的严峻问题。药品侵权案件的不断发生,在拷问我们药品企业的良心的同时也质疑着我国现有的相关法律、制度。如何最大化的保护药品侵权受害者的利益,实现社会整体价值?新《药品管理法》在社会关心的损害救济方面没有任何突破,保护消费者的合法权益需要国家相应法律法规的完善,但是法律的滞后性在救济重大灾害性事件或者紧急性损害的时候不能够及时的发挥作用,在经历周期漫长的诉讼之后,且不说受害者能否真正的得到赔偿或者补偿,即使胜诉,获得事后的补救也无法弥补受害者承受的伤害。因此仅有法律规定不能够满足消费者对高品质药品的需求;同时对药品的生产者来说,一旦发生大范围严重的药品侵权事件,等待企业的将是巨额罚款,甚至一些方兴未艾的企业骤然间破产。面对诸如此类的药品侵权事故,各国有不同的应对措施,或依靠市场,或依靠国家,或者二者相结合。对比分析各国发生药害事件时采取的救济措施,同时参考我国药品侵权案件的境况,不难发现药品侵权责任强制保险制度,是目前最契合我国发展需要的。该制度的构建不能够简单的照搬他国经验,药品的特殊性让我们在探讨药品侵权责任强制保险的设计理念的同时要考虑更多的问题,本文通过理论与实践相结合提出规范药品侵权责任强制保险制度运行的建议,以期对我国的保险制度与药品管理制度的完善有所裨益。
[Abstract]:The Almaty Declaration adopted by the 32nd World Health Assembly clearly states that "the right to health is a basic human right." Human beings are not gods, poisonous and non-invasive, and drugs have played an extremely important role in the history of human development. But along with the rapid development of economy and the rapid improvement of science and technology, drugs not only keep us away from human suffering and injury, but also threaten our life and safety and stir up every nerve of the right to health. Substances made up of ingredients, even if they have a pair of eyes, can't be aware of the side effects and adverse reactions of drugs without proper labels and instructions. Drugs are a "double-edged sword" that threatens the lives of users as well as cures illness and saves lives. Li Lili, the victim of the 2010 Subivo incident, took the Novartis anti-HBV drug Tebivo. Relatives of the deceased filed a lawsuit against Beijing Novartis Pharmaceutical Co. Ltd. and eventually decided that Li's death was a direct result of taking tibivudine, but the damage was irreversible. The "Shandong Toxic Epidemic" occurred on March 20, 2016. The Miao Incident has once again sounded the alarm bell of drug safety. In the face of increasingly serious drug infringement, how to construct the relief system for the victims of drug infringement is a serious problem facing the society today. Law, system. How to maximize the protection of the interests of victims of drug infringement and realize the overall value of society? The new Drug Administration Law has no breakthrough in the relief of damages of social concern. The protection of the legitimate rights and interests of consumers requires the perfection of relevant laws and regulations of the state, but the lag of the law in the relief of major disasters or tight. Acute damage can not play a timely role, after a long period of litigation, and do not say whether the victim can really be compensated or compensated, even if the victim wins the lawsuit, access to ex post remedy can not make up for the victim's injury. At the same time, for drug producers, once a large-scale and serious drug infringement incident occurs, waiting for enterprises will be a huge fine, or even some of the rising enterprises suddenly bankruptcy. It is not difficult to find out that the compulsory insurance system of drug infringement liability is most suitable for the development of our country at present. The construction of this system can not simply copy the experience of other countries. The particularity of drugs makes us explore the liability of drug infringement. The design concept of compulsory insurance should consider more problems at the same time. This paper puts forward some suggestions to standardize the operation of the compulsory insurance system of drug tort liability through the combination of theory and practice in order to benefit the perfection of the insurance system and the drug management system in China.
【学位授予单位】：华东政法大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：D922.16

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