上海市药品零售企业监管法律问题研究

发布时间：2018-03-22 22:28

  本文选题：药品零售企业　切入点：行政监管　出处：《华东师范大学》2014年硕士论文　论文类型：学位论文

【摘要】：近几年,越来越多的药品安全事件被媒体曝出。在2012年就连续曝光了“修正药业毒胶囊事件”、“广药维C银翘片事件”等等,药品安全问题成了人们广泛关注的热点问题。药品是一种特殊的商品,能够帮助人们治疗疾病、维护身体健康,但如果药品的用法或者用量不当,将会给人们的身体健康带来危害,甚至可能会威胁到人们的生命安全。不同于药品生产企业和药品批发企业,药品零售企业直接面向广大的消费群体,所以在药品安全的保障上,药品零售企业具有更为直接的责任。随着我国人民生活水平的提高,人们的自我保健意识不断增强。“大病去医院、小病进药店”成了社会的一种普遍现象,因此我国的药品零售企业如雨后春笋般涌现,如何保证这些企业的规范经营,从而保障人们的用药安全就成了药品监管工作中的关键任务。 本文从上海市药品零售企业监管的理论和实践出发,通过研究上海市药品零售企业监管体系,分析上海市药品零售企业监管中存在的立法问题和实践问题,借鉴美国和日本的药品零售企业监管体系,从而对上海市的药品零售企业监管提出完善建议。本文正文共分为四个部分：第一部分介绍了上海市药品零售企业监管的体系,主要包括对药品零售企业的性质及分类的介绍、对上海市药品零售企业监管体系的介绍和对上海市药品零售企业监管现状的介绍；第二部分分析了上海市药品零售企业监管的法律问题,主要包括权利义务均衡问题、市场准入制度的法律问题、距离设限的法律问题、执业药师的立法问题和其他法律问题；第三部分介绍了美国和日本的药品零售企业监管体系,总结了美国在市场准入制度、行政处罚机制、药师协会作用和执法人员构成中的先进经验,并介绍了日本药品零售企业距离设限的两个违宪审查案例。第四部分提出对上海市药品零售企业监管立法和实践的完善建议。立法建议主要包括制定统一规定,弥补法律空白,取消药品零售企业开办距离设限的规定,制定执业药师管理规范条例和加强法律责任制度；实践工作的建议主要包括经营资格准入制度的并轨,监管主体引入专业人才,监管方式灵活化和引入公益诉讼制度。
[Abstract]:In recent years, more and more drug safety incidents have been exposed by the media. In 2012, it was continuously exposed to the incident of "revising toxic capsules in the pharmaceutical industry", the "Yinjian tablet incident of wide drug", and so on. Drug safety has become a hot issue of widespread concern. Drugs are a special commodity that can help people treat diseases and maintain their health, but if they are used or used improperly, Will bring harm to people's health, and may even threaten people's life safety. Different from drug production enterprises and drug wholesale enterprises, drug and retail enterprises directly face the vast number of consumer groups. Therefore, the drug retail enterprises have a more direct responsibility in the protection of drug safety. With the improvement of our people's living standards, people's awareness of self-health care is constantly increasing. "going to the hospital with a serious illness," The introduction of minor diseases into pharmacies has become a common phenomenon in society. Therefore, drug retail enterprises in our country have sprung up like bamboo shoots. How to ensure the standardized operation of these enterprises? Thus, to ensure the safety of drug use has become a key task in drug supervision. Based on the theory and practice of drug retail enterprises supervision in Shanghai, this paper analyzes the legislative and practical problems in the supervision of drug retail enterprises in Shanghai through the study of the supervision system of drug retail enterprises in Shanghai. Based on the regulatory system of drug retail enterprises in the United States and Japan, the paper puts forward some suggestions to improve the supervision of drug retail enterprises in Shanghai. The text of this paper is divided into four parts: the first part introduces the supervision system of drug retail enterprises in Shanghai. It mainly includes the introduction of the nature and classification of the drug retail enterprises, the supervision system of the drug retail enterprises in Shanghai and the present situation of the supervision of the drug retail enterprises in Shanghai. The second part analyzes the legal problems in the supervision of pharmaceutical retail enterprises in Shanghai, including the balance of rights and obligations, the legal problems of market access system, the legal problems of distance limitation, the legislative problems of licensed pharmacists and other legal problems. The third part introduces the regulatory system of drug retail enterprises in the United States and Japan, and summarizes the advanced experience of the United States in the market access system, the mechanism of administrative punishment, the role of pharmacists' associations and the composition of law enforcement personnel. It also introduces two cases of unconstitutional review on the distance limit of pharmaceutical retail enterprises in Japan. The fourth part puts forward some suggestions to perfect the legislation and practice of the supervision of pharmaceutical retail enterprises in Shanghai. The legislative suggestions mainly include the formulation of unified regulations to make up the gaps in the law. The regulations on the distance between the establishment of pharmaceutical retail enterprises and the establishment of regulations for the management of licensed pharmacists and the strengthening of the legal liability system are abolished. The suggestions for practical work mainly include the integration of the admission system of business qualifications and the introduction of professional personnel into the main body of supervision. Flexible supervision and introduction of public interest litigation system.
【学位授予单位】：华东师范大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D922.16;F426.72;F724.2
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本文编号：1650706