發(fā)布時間：2018-03-22 22:28

  本文選題：藥品零售企業(yè)　切入點：行政監(jiān)管　出處：《華東師范大學(xué)》2014年碩士論文　論文類型：學(xué)位論文

【摘要】：近幾年,越來越多的藥品安全事件被媒體曝出。在2012年就連續(xù)曝光了“修正藥業(yè)毒膠囊事件”、“廣藥維C銀翹片事件”等等,藥品安全問題成了人們廣泛關(guān)注的熱點問題。藥品是一種特殊的商品,能夠幫助人們治療疾病、維護身體健康,但如果藥品的用法或者用量不當(dāng),將會給人們的身體健康帶來危害,甚至可能會威脅到人們的生命安全。不同于藥品生產(chǎn)企業(yè)和藥品批發(fā)企業(yè),藥品零售企業(yè)直接面向廣大的消費群體,所以在藥品安全的保障上,藥品零售企業(yè)具有更為直接的責(zé)任。隨著我國人民生活水平的提高,人們的自我保健意識不斷增強�！按蟛∪メt(yī)院、小病進藥店”成了社會的一種普遍現(xiàn)象,因此我國的藥品零售企業(yè)如雨后春筍般涌現(xiàn),如何保證這些企業(yè)的規(guī)范經(jīng)營,從而保障人們的用藥安全就成了藥品監(jiān)管工作中的關(guān)鍵任務(wù)。 本文從上海市藥品零售企業(yè)監(jiān)管的理論和實踐出發(fā),通過研究上海市藥品零售企業(yè)監(jiān)管體系,分析上海市藥品零售企業(yè)監(jiān)管中存在的立法問題和實踐問題,借鑒美國和日本的藥品零售企業(yè)監(jiān)管體系,從而對上海市的藥品零售企業(yè)監(jiān)管提出完善建議。本文正文共分為四個部分：第一部分介紹了上海市藥品零售企業(yè)監(jiān)管的體系,主要包括對藥品零售企業(yè)的性質(zhì)及分類的介紹、對上海市藥品零售企業(yè)監(jiān)管體系的介紹和對上海市藥品零售企業(yè)監(jiān)管現(xiàn)狀的介紹；第二部分分析了上海市藥品零售企業(yè)監(jiān)管的法律問題,主要包括權(quán)利義務(wù)均衡問題、市場準(zhǔn)入制度的法律問題、距離設(shè)限的法律問題、執(zhí)業(yè)藥師的立法問題和其他法律問題；第三部分介紹了美國和日本的藥品零售企業(yè)監(jiān)管體系,總結(jié)了美國在市場準(zhǔn)入制度、行政處罰機制、藥師協(xié)會作用和執(zhí)法人員構(gòu)成中的先進經(jīng)驗,并介紹了日本藥品零售企業(yè)距離設(shè)限的兩個違憲審查案例。第四部分提出對上海市藥品零售企業(yè)監(jiān)管立法和實踐的完善建議。立法建議主要包括制定統(tǒng)一規(guī)定,彌補法律空白,取消藥品零售企業(yè)開辦距離設(shè)限的規(guī)定,制定執(zhí)業(yè)藥師管理規(guī)范條例和加強法律責(zé)任制度；實踐工作的建議主要包括經(jīng)營資格準(zhǔn)入制度的并軌,監(jiān)管主體引入專業(yè)人才,監(jiān)管方式靈活化和引入公益訴訟制度。
[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.
【學(xué)位授予單位】：華東師范大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：D922.16;F426.72;F724.2
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本文編號：1650706