發(fā)布時(shí)間：2019-04-09 09:00

【摘要】：知識(shí)產(chǎn)權(quán)的保護(hù)是發(fā)達(dá)國家與發(fā)展中國家之間利益沖突的體現(xiàn)。烏拉圭回合首次在多邊貿(mào)易體制中觸及這一領(lǐng)域，并最終達(dá)成高保護(hù)標(biāo)準(zhǔn)的TRIPS協(xié)議。TRIPS協(xié)議第39條第3款明確要求對(duì)藥品數(shù)據(jù)提供保護(hù)。藥品數(shù)據(jù)保護(hù)是通過賦予品牌藥一定期限的市場壟斷使原研藥公司收回投資成本并獲取利益，從而刺激新藥研發(fā)。期限屆滿之后，仿制藥公司可使用這些藥品數(shù)據(jù)提出仿制藥的上市申請(qǐng)。嚴(yán)格的說，藥品數(shù)據(jù)保護(hù)的目的是原研藥與仿制藥之間的利益平衡。然而，藥品數(shù)據(jù)保護(hù)是一把雙刃劍。過強(qiáng)的藥品數(shù)據(jù)保護(hù)將滋生原研藥長期壟斷市場，從而導(dǎo)致藥價(jià)居高不下而嚴(yán)重影響藥品的可及性。相反，如果沒有有效的藥品數(shù)據(jù)保護(hù)將造成競爭者“搭便車”從而形成不公平競爭，其結(jié)果將挫傷新藥研發(fā)的積極性。 本文從影響美國藥品立法的兩件藥害事件入手，深層次地剖析了藥品數(shù)據(jù)對(duì)藥品審批的重要性，介紹了藥品數(shù)據(jù)保護(hù)的產(chǎn)生，評(píng)析了TRIPS協(xié)議與美國各自由貿(mào)易協(xié)定下的藥品數(shù)據(jù)保護(hù)以及若干國家的立法，并同時(shí)希望能為我國藥品數(shù)據(jù)保護(hù)提供借鑒。本文除緒言和結(jié)語外，共六部分。主要結(jié)構(gòu)如下： 第一章是藥品數(shù)據(jù)保護(hù)概論。首先，筆者闡述了藥品數(shù)據(jù)的來源及其價(jià)值。然后，闡述了藥品數(shù)據(jù)保護(hù)的誕生。 第二章是藥品數(shù)據(jù)保護(hù)的理論基礎(chǔ)及其意義。首先，筆者闡述了藥品數(shù)據(jù)保護(hù)存在的正當(dāng)性和必要性。然后，筆者揭露了藥品數(shù)據(jù)保護(hù)的本質(zhì)，并指出藥品數(shù)據(jù)保護(hù)對(duì)醫(yī)藥行業(yè)的影響，同時(shí)提出不建議仿制藥公司在藥品數(shù)據(jù)保護(hù)期屆滿前自行獲取藥品數(shù)據(jù)的觀點(diǎn)。 第三章是TRIPS協(xié)議以及美國自由貿(mào)易協(xié)定下的藥品數(shù)據(jù)保護(hù)。首先，，筆者介紹了TRIPS協(xié)議下藥品數(shù)據(jù)保護(hù)的立法背景，并對(duì)TRIPS協(xié)議下的藥品數(shù)據(jù)保護(hù)的五個(gè)條件進(jìn)行解析。然后對(duì)美國各自由貿(mào)易協(xié)定下的藥品數(shù)據(jù)保護(hù)進(jìn)行了簡單的介紹。 第四章是藥品數(shù)據(jù)保護(hù)在醫(yī)藥發(fā)達(dá)市場和醫(yī)藥新興市場中的立法情況。首先，筆者介紹了藥品數(shù)據(jù)保護(hù)在以美國、歐盟為代表的醫(yī)藥發(fā)達(dá)市場，以及以印度、墨西哥為代表的醫(yī)藥新興市場中的立法情況。此外，筆者還介紹了藥品數(shù)據(jù)保護(hù)在加拿大和中國臺(tái)灣地區(qū)中的立法情況。 第五章是藥品數(shù)據(jù)保護(hù)與公眾健康。 第六章是我國藥品數(shù)據(jù)保護(hù)的問題與對(duì)策。筆者介紹了有關(guān)我國藥品數(shù)據(jù)保護(hù)的立法現(xiàn)狀，同時(shí)指出我國藥品數(shù)據(jù)保護(hù)目前所存在的問題，并提出建議。
[Abstract]:The protection of intellectual property is the embodiment of conflict of interest between developed and developing countries. The Uruguay Round addressed this area for the first time in the multilateral trading system and culminated in a TRIPS agreement with high protection standards. Article 39 (3) of the trips Agreement specifically calls for the protection of drug data. Drug data protection is to stimulate research and development of new drugs by giving brand drugs a market monopoly for a certain period of time to recover investment costs and gain benefits from the original drug companies. After the expiry of the time limit, generic drug companies can use these drug data to apply for generic drugs to market. Strictly speaking, the purpose of drug data protection is to balance interests between original and generic drugs. However, drug data protection is a double-edged sword. Too strong drug data protection will breed the long-term monopoly market of original drugs, which will lead to high drug price and seriously affect the accessibility of drugs. On the contrary, the lack of effective drug data protection would create unfair competition by hitchhiking competitors, and the result would be a debilitating incentive to develop new drugs. In this paper, the importance of drug data to drug examination and approval is deeply analyzed, and the generation of drug data protection is introduced, starting with two drug damage events that affect the drug legislation in the United States. This paper reviews the drug data protection under the TRIPS Agreement and the free trade agreements of the United States and the legislation of several countries, and hopes to provide reference for the drug data protection in our country at the same time. In addition to the preface and conclusion, this paper consists of six parts. The main structure is as follows: the first chapter is the introduction to drug data protection. First of all, the author expounds the source and value of drug data. Then, the birth of drug data protection is expounded. The second chapter is the theoretical basis and significance of drug data protection. Firstly, the author expounds the legitimacy and necessity of the existence of drug data protection. Then, the author reveals the essence of drug data protection, and points out the influence of drug data protection on pharmaceutical industry. At the same time, the author puts forward the view that pharmaceutical companies should not obtain drug data by themselves before the expiration of drug data protection period. The third chapter is about drug data protection under TRIPS Agreement and American Free Trade Agreement. Firstly, the author introduces the legislative background of drug data protection under TRIPS protocol, and analyzes the five conditions of drug data protection under TRIPS protocol. Then a brief introduction is given to the drug data protection under the free trade agreements of the United States. The fourth chapter is about the legislation of drug data protection in medicine developed market and medicine emerging market. First of all, the author introduces the legislation of drug data protection in the developed pharmaceutical markets represented by the United States and the European Union, as well as in the pharmaceutical emerging markets represented by India and Mexico. In addition, the author also introduces the legislation of drug data protection in Canada and Taiwan. The fifth chapter is drug data protection and public health. The sixth chapter is about the problems and countermeasures of drug data protection in China. This paper introduces the legislative status of drug data protection in China, points out the problems existing in the protection of drug data in China, and puts forward some suggestions.
【學(xué)位授予單位】：中國社會(huì)科學(xué)院研究生院
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2012
【分類號(hào)】：D997.1

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