發(fā)布時(shí)間：2018-03-31 08:42

  本文選題：缺陷藥品　切入點(diǎn)：藥品召回　出處：《西南政法大學(xué)》2014年碩士論文

【摘要】：近年來，隨著國家對藥品安全工作的逐步重視，安全有效用藥的理念越來越深入人心�，F(xiàn)代醫(yī)藥技術(shù)的發(fā)展促進(jìn)了制藥企業(yè)研發(fā)能力不斷提升，新研發(fā)的藥品數(shù)量逐年遞增，這對提高人類抵御疾病的能力、提升生活品質(zhì)具有重要意義。但是，藥品的復(fù)雜性與危險(xiǎn)性也與日俱增，缺陷藥品給消費(fèi)者造成損害的可能性也隨之大增。在藥品市場中，消費(fèi)者的不確定性和廣泛性決定了國家必須對藥品市場實(shí)施嚴(yán)格監(jiān)管。藥品召回作為一種強(qiáng)化企業(yè)責(zé)任的預(yù)警措施，在保障公眾安全用藥、維護(hù)社會公共利益方面發(fā)揮著重要作用。 2007年頒布實(shí)施的《藥品召回管理辦法》標(biāo)志著我國藥品召回制度的正式建立，這不僅可以在更大程度上強(qiáng)化制藥企業(yè)的誠信和責(zé)任意識，保障公眾用藥安全，而且通過政府和市場的雙重調(diào)節(jié)也可以更好地維護(hù)市場經(jīng)濟(jì)秩序。 但是，法律制度的完善是一個(gè)逐步推進(jìn)的過程，近年來很多與藥品相關(guān)的公共安全案件，如強(qiáng)生頻發(fā)的藥品召回事件、毒膠囊事件、康泰疫苗事件都告訴我們要重視藥品召回制度的完善和發(fā)展。在高度發(fā)達(dá)的市場經(jīng)濟(jì)條件下，只有建立更加完善的法律制度和安全保障機(jī)制，公眾才能享受到高科技帶來的物質(zhì)文明。新的醫(yī)療改革正在進(jìn)行，，對藥品市場的研究逐漸成為熱點(diǎn)。綜上，本文選擇藥品召回問題作為研究對象。 本文共分為四個(gè)部分： 第一部分主要是對美國強(qiáng)生頻發(fā)的藥品召回事件作出數(shù)據(jù)分析，從而引出藥品召回問題。通過分析強(qiáng)生連年出現(xiàn)的各類藥品召回事件和強(qiáng)生屢次將中國排除在藥品召回的范圍之外的事實(shí)得出：即便制藥水平不斷進(jìn)步，缺陷藥品仍然不能完全避免，我國雖然已經(jīng)實(shí)施了藥品召回制度，但與國外發(fā)達(dá)國家相比，我國的藥品召回制度及相關(guān)配套制度仍然存在不足。 第二部分主要是對藥品召回制度進(jìn)行概述。首先，對我國現(xiàn)行藥品召回的含義進(jìn)行解讀；其次，介紹藥品召回制度在國內(nèi)國外的起源與發(fā)展；最后，從維護(hù)公眾健康、企業(yè)信譽(yù)和市場秩序三方面總結(jié)藥品召回制度的意義。 第三部分主要是分析我國藥品召回制度在實(shí)踐中存在的三大問題：缺陷藥品的定義不明確、我國藥品召回主體結(jié)構(gòu)存在不足及我國藥品召回信息公開制度不健全。 第四部分主要是針對第三部分所提出的三大問題提出完善建議：首先，建立切實(shí)可行的缺陷藥品認(rèn)定標(biāo)準(zhǔn)，明確缺陷藥品的內(nèi)涵與外延；其次，完善藥品召回主體結(jié)構(gòu)，建立缺陷藥品管理系統(tǒng)。最后，統(tǒng)一藥品召回信息公開制度，加強(qiáng)與外部的溝通交流。 結(jié)語部分指出我國雖然已經(jīng)建立了藥品召回制度，但在實(shí)際運(yùn)行過程中仍然存在欠缺，藥品召回制度的完善過程任重而道遠(yuǎn)，需要社會各界的共同努力。
[Abstract]:In recent years, with the country pay more and more attention to drug safety, the concept of safe and effective drug use is more and more popular.The development of modern medicine technology has promoted the development of pharmaceutical enterprises'R & D ability and the quantity of new drugs has been increasing year by year, which is of great significance to improve the ability of human beings to resist diseases and improve the quality of life.However, the complexity and danger of drugs are increasing, and the possibility of damage caused by defective drugs to consumers is also increasing.In the pharmaceutical market, the uncertainty and universality of consumers determine that the country must strictly supervise the drug market.Drug recall, as an early warning measure to strengthen corporate responsibility, plays an important role in safeguarding the public safety of drug use and safeguarding the public interest.The "Drug recall Management measures" promulgated in 2007 marks the formal establishment of the drug recall system in China, which can not only strengthen the sense of honesty and responsibility of pharmaceutical enterprises to a greater extent, and ensure the safety of drug use by the public.And through the dual regulation of the government and the market can better maintain the order of the market economy.However, the improvement of the legal system is a gradual process. In recent years, many drug-related public safety cases, such as the frequent drug recalls by Johnson and the poison capsule incident,Kang Tai vaccine incident tells us to attach importance to the improvement and development of drug recall system.Under the condition of highly developed market economy, only by establishing a more perfect legal system and security mechanism can the public enjoy the material civilization brought by high technology.The new medical reform is under way, and the research on the drug market is becoming a hot spot.In summary, this paper chooses the drug recall problem as the research object.This paper is divided into four parts:The first part is mainly to make the data analysis to the American Johnson frequent drug recall event, thus leads to the drug recall question.Through the analysis of the various drug recalls that have occurred in successive years by Johnson and the fact that Johnson has repeatedly excluded China from the scope of drug recalls, it is concluded that even if the pharmaceutical level continues to improve, defective drugs still cannot be completely avoided.Although the drug recall system has been implemented in our country, compared with the developed countries, there are still some deficiencies in the drug recall system and related supporting system in our country.The second part is an overview of drug recall system.First of all, the meaning of current drug recall in China is interpreted; secondly, the origin and development of drug recall system at home and abroad are introduced; finally, from the maintenance of public health,The significance of drug recall system is summarized in three aspects: enterprise reputation and market order.The third part mainly analyzes the three problems existing in the practice of drug recall system in our country: the definition of defective drugs is not clear, the main structure of drug recall in our country is insufficient, and the disclosure system of drug recall information in our country is not perfect.The fourth part is mainly aimed at the three major problems put forward in the third part: first, to establish practical standards for the identification of defective drugs, to clarify the connotation and extension of defective drugs; secondly, to improve the main structure of drug recall.Establish defect drug management system.Finally, unified drug recall information disclosure system, strengthen communication with the outside.The conclusion points out that although the drug recall system has been established in our country, there are still deficiencies in the actual operation. The improvement process of the drug recall system has a long way to go and needs the joint efforts of all walks of life.
【學(xué)位授予單位】：西南政法大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：D922.16

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