發(fā)布時間：2018-03-18 11:12

  本文選題：藥品試驗數(shù)據(jù)　切入點：數(shù)據(jù)公開　出處：《大連海事大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

【摘要】：目前,國際上對藥品試驗數(shù)據(jù)的保護(hù)制度以TRIPS協(xié)議第三十九條第三款作為最低標(biāo)準(zhǔn),其保護(hù)原則為"不披露和不依賴",即不得將藥品試驗數(shù)據(jù)披露給未經(jīng)授權(quán)的第三方,不得依賴等數(shù)據(jù)進(jìn)行生物等效性試驗批準(zhǔn)具有競爭力的仿制藥品的上市申請。從制藥商的角度,此種模式能夠完全地保護(hù)其因擁有藥品試驗數(shù)據(jù)所帶來的經(jīng)濟(jì)利益,但是這與公眾尤其是用藥者的知情權(quán)相悖。藥品由于具有特殊商品的性質(zhì),其與公共健康權(quán)息息相關(guān),如果公眾對藥品的知悉權(quán)僅停留在其成分和作用機(jī)理等基礎(chǔ)之上,而不知悉藥品的產(chǎn)生過程的話,對于公眾可能不公平,尤其是近年來國際投資中的腐敗現(xiàn)象和新藥安全性事故頻繁發(fā)生,TRIPS協(xié)議中藥品試驗數(shù)據(jù)的"不披露"規(guī)定之正當(dāng)性面臨質(zhì)疑,其與公眾對藥品的知情權(quán)之沖突為筆者研究藥品試驗數(shù)據(jù)的法律保護(hù)制度提供了一個新的思路,即能否在披露數(shù)據(jù)的前提下做到"不依賴",可否構(gòu)建一個以公開為基礎(chǔ)的藥品試驗數(shù)據(jù)專用權(quán)保護(hù)制度?對于這個問題,本文以藥品試驗數(shù)據(jù)為研究對象,運用價值分析法探討藥品試驗數(shù)據(jù)是否具有公開性的法律性質(zhì),并選取國際上最具代表性的TRIPS協(xié)議中有關(guān)藥品試驗數(shù)據(jù)保護(hù)的規(guī)定加以分析,將其與TPP協(xié)議中有關(guān)于藥品試驗數(shù)據(jù)保護(hù)的規(guī)定對比研究,在此基礎(chǔ)上,根據(jù)我國藥品試驗數(shù)據(jù)保護(hù)制度的發(fā)展歷程,分析我國藥品試驗數(shù)據(jù)保護(hù)制度的缺陷,提出構(gòu)建以公開為基礎(chǔ)的藥品試驗數(shù)據(jù)專用權(quán)保護(hù)制度的建議。第一章概述藥品試驗數(shù)據(jù)的法律性質(zhì)、藥品試驗數(shù)據(jù)法律保護(hù)的目的和意義以及藥品試驗數(shù)據(jù)法律保護(hù)的立法范例。藥品試驗數(shù)據(jù)從法律性質(zhì)上看,其在藥品研發(fā)過程中屬商業(yè)秘密,一旦制藥商提交試驗數(shù)據(jù)于一國政府以此獲得藥品上市審批許可,該數(shù)據(jù)應(yīng)當(dāng)具有公開性并為公眾所知悉。藥品試驗數(shù)據(jù)保護(hù)制度的目的在于防止仿制藥品的不正當(dāng)競爭。藥品試驗數(shù)據(jù)法律保護(hù)的意義則在于維護(hù)制藥商的利益及維護(hù)公共利益和制藥商利益的平衡。第二章探討TRIPS協(xié)議下藥品試驗數(shù)據(jù)的法律保護(hù)。TRIPS協(xié)議對藥品試驗數(shù)據(jù)的保護(hù)規(guī)定由"受保護(hù)的數(shù)據(jù)類型"、"新化學(xué)個體"、"經(jīng)過相當(dāng)?shù)呐?、"未公開"四要件組成,筆者對此依次分析并提出自己的看法,認(rèn)為四要件與藥品試驗數(shù)據(jù)公開性并不沖突。對于TRIPS協(xié)議下藥品試驗數(shù)據(jù)法律保護(hù)的例外規(guī)定,即"公共利益之例外"和"禁止不正當(dāng)商業(yè)使用",內(nèi)含公益性與公開性的統(tǒng)一,在公共利益出現(xiàn)緊急危機(jī)時,本國政府可直接使用并公開試驗數(shù)據(jù),而無需考慮各項利益的平衡。試驗數(shù)據(jù)在國內(nèi)予以公開后,本國政府應(yīng)當(dāng)采取法律方式對其加以保護(hù),防止出現(xiàn)"不正當(dāng)商業(yè)使用"的情況。第三章闡述跨太平洋伙伴關(guān)系協(xié)議(TPP)中藥品試驗數(shù)據(jù)保護(hù)條款與TRIPS協(xié)議相比的不同之處,具體表現(xiàn)為保護(hù)對象的擴(kuò)張、保護(hù)期限的規(guī)定和救濟(jì)程序的特定化。第四章介紹了 TRIPS協(xié)議對我國藥品試驗數(shù)據(jù)法律保護(hù)制度的啟示以及我國對TPP協(xié)議藥品試驗數(shù)據(jù)法律保護(hù)制度的借鑒和應(yīng)對,以及我國藥品試驗數(shù)據(jù)保護(hù)制度存在的缺陷,對此提出應(yīng)當(dāng)構(gòu)建以公開為基礎(chǔ)的藥品試驗數(shù)據(jù)專有權(quán)保護(hù)制度。
[Abstract]:At present, the drug test data protection system in the world in the third paragraph of article thirty-ninth of TRIPS agreement as the minimum standard, the principle of protection of "non disclosure and independent", which may not be the drug test data disclosed to unauthorized third parties, are listed for the bioequivalence test approved generic drugs may not be competitive rely on data from manufacturers. The point of view, this model can fully protect the drug because it has brought the test data and the public economic interests, but this particular use of the right drug contrary. Due to the nature of a special commodity, and the right of public health are closely related, if the public right to know only the drug stay on the basis of its composition and mechanism, and the process is not aware of the drug, the public may be unfair, especially corruption in international investment in recent years. And the phenomenon of drug safety accidents occur frequently, the TRIPS protocol of pharmaceutical test data "disclosure" provisions of the legitimacy of the question, which provides a new way of thinking and the public's right to know the drug on the conflict for the legal protection system of the study of drug testing data, whether in the premise of the disclosure of the data to achieve "do not rely on", will build a public based drug test data of special right protection system? For this problem, taking the drug test data as the research object, using the value analysis method to study the drug test data is not the legal nature of publicity, and select the relevant provisions of data protection and drug test representative the international TRIPS protocol analysis, the comparative research on regulations on drug data protection test and TPP protocol, on this basis, according to the drug test data of insurance in China The development of nursing system, analyze defect data protection of China's drug test system, and proposes to construct the public based drug test data exclusive right protection system. The first chapter outlines the legal nature of drug testing data, the legal protection of drug test data of the purpose and significance of the legal protection of drug test data. Examples of drug legislation the test data from the legal nature, it is a commercial secret in the drug development process, once the drug makers to submit test data on a country's Government in order to obtain the approval of the drug, the data should have open and available to the public. The drug test data protection system is to prevent unfair competition of generic drugs. The legal protection of drug test data significance lies in the maintenance of the drugmaker's interests and safeguard the public interests and the interests of the pharmaceutical manufacturers balance. The second chapter discusses the TRI The legal protection of.TRIPS protocol PS drug test data on drug test data protection provisions of the "protected data type", "new chemical entity", "after considerable effort", "unpublished" four elements of composition, the author successively analyzed and put forward their own views, that the four elements and drug test public data does not conflict. With the exception of law protection of drug test data under the TRIPS protocol, namely the "exceptional" public interest "and prohibit unfair commercial use, unified and open with the public, the public interest in the emergency crisis, the government can be used directly and openly test data, without need to consider the balance of interests. The test data to the public at home, the government should take the legal way to protect them, to prevent the emergence of" unfair commercial use ". The third chapter of the trans Pacific The partnership agreement (TPP) drug test data protection provisions compared with TRIPS protocol differences, specifically for the protection of the object expansion, specific provisions on the protection period and relief procedures. The fourth chapter introduces the inspiration of the TRIPS agreement on China's drug test data protection legal system and China's legal protection of TPP agreement drug test data reference system and response, and the defects of Chinese drug data protection test system, this paper should be built in the open based drug test data exclusivity protection system.

【學(xué)位授予單位】：大連海事大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：D997.1

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