超药品说明书用药立法探讨

发布时间：2018-03-03 01:29

本文选题：超药品说明书用药　切入点：合理用药　出处：《福州大学》2014年硕士论文　论文类型：学位论文

【摘要】：关于超药品说明书用药的问题,国内研究关注较少,学术基础较为薄弱,缺乏系统的理论依据和规制体系。本文试图通过对超说明书用药立法的探讨,推动国内对超药品说明书用药的立法研究和体系构建,解决医疗机构及其从业人员超药品说明书用药行为与患者的生命权、健康权的冲突,缓和当前略显紧张医患关系。本论文对超药品说明书用药的立法问题进行研究,通过学校图书馆、互联网电子数据库、中国法律检索系统等途径,搜集期刊、报纸、学术论文、临床病历和法律法规等资料对该问题理论分析,主要分为三个部分进行研究。第一部分“超药品说明书用药立法探讨的必要性”。该部分笔者采用文献研究和案例分析的方法,从超药品说明书用药引发的法律问题出发,详细分析超药品说明书用药矛盾产生的原因,然后提出法律要解决的关键问题是平衡医患关系。第二部分“国内外规制超药品说明书用药的法律制度”。该部分笔者通过比较分析,阐明国内超药品说明书用药法律规制的现状,介绍一些国外的经验做法,为我国立法提供借鉴。第三部分“超药品说明书用药的法律规制构建”。该部分笔者立足法学、医学、药学、伦理学相关理论基础,从多学科角度展开交叉研究,对法律效力层级选择、确立法律原则、具体内容构建、明确责任归责、法律纠纷的解决、立法构想的不足六个方面详细展开分析与探讨。笔者认为,应先由国家卫生与计划生育委员会针对超说明书用药问题制定部门规章,建立起一整套的保障机制。该机制应涵盖超药品说明书用药的风险定级,分级知情同意流程,操作与监督程序,标准制定机构的设立,医疗机构及其从业人员减轻或免除法律责任的条件,药品说明书修改程序的改进,药品销售企业对其宣传资料应承担的法律责任等方面的内容。然后再逐步涉及修改完善,及时根据社情及医疗服务水平的变化不断调整,待条件成熟时再提请国务院制定行政法规。通过立法对超药品说明书用药进行管理与约束,可以有效避免药品滥用行为,约束商业因素导致的超药品说明书用药,促进开发新的药品适应证,使患者能用更低廉的费用得到更加有效的医疗服务,既保障医疗机构及其从业人员合法的合理用药权利,又保障患者健康权和知情权,平衡医患关系,构建和谐社会。
[Abstract]:On the issue of superdrug instruction, domestic research is less concerned, academic foundation is relatively weak, lack of systematic theoretical basis and regulatory system. To promote domestic legislative research and system construction on the use of superdrug instructions, and to resolve the conflict between the behavior of medical institutions and their practitioners and the right to life and health of patients. This paper studies the legislative issues of drug use in superdrug instructions, collects periodicals, newspapers, and academic papers through school libraries, Internet electronic databases, China Law Retrieval system, and so on. The theoretical analysis of the problem is mainly divided into three parts: the first part, "the necessity of discussing the legislation of drug use in the superdrug specification", the author adopts the methods of literature research and case analysis. Starting from the legal problems caused by the drug instructions for the use of superdrugs, the reasons for the contradiction between the instructions for the use of drugs and the drug use are analyzed in detail. Then the key problem to be solved by law is to balance the doctor-patient relationship. The second part is "the domestic and foreign legal system of regulating the use of superdrug instructions". This paper clarifies the current situation of the legal regulation of drug use in China's superdrug instructions, introduces some foreign experiences and practices, and provides reference for the legislation of our country. The third part is "Construction of legal Regulation of Super-drug instructions". This part is based on law, medicine, etc. On the basis of the related theories of pharmacy and ethics, we should carry out cross-research from a multi-disciplinary point of view, select the level of legal effect, establish legal principles, construct specific contents, make clear the responsibility imputation, resolve legal disputes. The author believes that the National Health and Family Planning Commission should first formulate departmental regulations to deal with the problem of over-prescribing drugs. Establish a complete set of safeguards. This mechanism should cover the risk classification of drug specifications, the hierarchical informed consent process, the operation and monitoring procedures, and the establishment of standard-setting bodies. The conditions under which medical institutions and their employees can mitigate or exempt from legal liability, the improvement of the procedures for revising drug instructions, the legal liability that drug sales enterprises should bear for their propaganda materials, etc., and then gradually involving revision and perfection, Timely adjustment is made according to the changes in the social situation and the level of medical services, and when the conditions are ripe, they will be submitted to the State Council for the formulation of administrative laws and regulations. Through legislation to administer and restrict the use of drugs in excess of drug instructions, drug abuse can be effectively avoided. The restriction of commercial factors on the use of superdrug instructions promotes the development of new drug indications, enables patients to obtain more effective medical services at a lower cost, and ensures the legitimate and reasonable use of drugs by medical institutions and their practitioners. Protect the patient's right to health and right to know, balance the relationship between doctors and patients, and build a harmonious society.
【学位授予单位】：福州大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95

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