本文選題：試驗數(shù)據(jù) + 藥品　； 參考：《復旦大學》2014年博士論文

【摘要】：本文旨在研究TRIPS協(xié)定下藥品試驗數(shù)據(jù)保護制度。引言提出本文研究的問題及其研究意義。正文各章主要內(nèi)容如下：第一章對藥品試驗數(shù)據(jù)保護涉及的理論問題進行了探討。第一節(jié)結(jié)合藥學科學與國際條約規(guī)定對藥品試驗數(shù)據(jù)的內(nèi)涵與外延進行界定,為全文探討藥品試驗數(shù)據(jù)保護問題奠定基礎(chǔ)。藥品試驗數(shù)據(jù)是制藥企業(yè)在藥品提出上市申請之前,為了證明藥品安全有效而進行的一系列實驗室試驗與臨床試驗所獲得的數(shù)據(jù)。根據(jù)TRIPS協(xié)定的規(guī)定,TRIPS協(xié)定中受保護的藥品試驗數(shù)據(jù)是作為成員政府批準藥品上市的條件,從含有新化學實體的藥品中,通過巨大努力而獲得的未披露試驗數(shù)據(jù)。第二節(jié)闡述了藥品試驗數(shù)據(jù)保護的知識產(chǎn)權(quán)屬性。TRIPS協(xié)定首次將藥品試驗數(shù)據(jù)保護納入知識產(chǎn)權(quán)國際保護范圍,將藥品試驗數(shù)據(jù)作為知識產(chǎn)權(quán)進行保護具有法理上的正當性。同時,藥品試驗數(shù)據(jù)保護是一種自成一體的知識產(chǎn)權(quán)保護形式,與傳統(tǒng)的知識產(chǎn)權(quán)既存在一致性又存在區(qū)別性。在藥品知識產(chǎn)權(quán)保護領(lǐng)域,藥品試驗數(shù)據(jù)保護發(fā)揮著不同于專利保護、商業(yè)秘密保護等傳統(tǒng)保護形式的作用,是一種特殊的未披露信息保護。這一保護制度的確立對藥品知識產(chǎn)權(quán)保護的完善具有重要意義。第三節(jié)探討了藥品試驗數(shù)據(jù)保護與公共健康的關(guān)系。藥品是具有生命關(guān)聯(lián)性的特殊產(chǎn)品,高標準的藥品知識產(chǎn)權(quán)保護可能與公共健康產(chǎn)生沖突,如何看待藥品試驗數(shù)據(jù)保護對公共健康造成的影響。應(yīng)當認識到實施藥品試驗數(shù)據(jù)保護對公共健康可能產(chǎn)生一定的負面影響,但同時也具有積極的推動與保護作用。尋求藥品試驗數(shù)據(jù)保護與公共健康協(xié)調(diào)統(tǒng)一的路徑是研究與實踐應(yīng)達到的目的。第二章著重對TRIPS協(xié)定確立的藥品試驗數(shù)據(jù)保護國際義務(wù)進行分析。第一節(jié)首先追溯了TRIPS協(xié)定中藥品試驗數(shù)據(jù)保護規(guī)定的由來。通過對作為TRIPS協(xié)定中藥品試驗數(shù)據(jù)保護規(guī)定藍本的《北美自由貿(mào)易協(xié)定》相關(guān)規(guī)定以及TRIPS協(xié)定談判歷史的回顧,梳理了TRIPS協(xié)定下藥品試驗數(shù)據(jù)保護制度的建立過程以及不同成員在TRIPS協(xié)定談判中對待藥品試驗數(shù)據(jù)保護的不同立場,為理解條款設(shè)立的目的與宗旨提供了幫助。其次分析了TRIPS協(xié)定第三十九條第三款與TRIPS協(xié)定其他條款的關(guān)系,為理解該條款規(guī)定的藥品試驗數(shù)據(jù)保護義務(wù)含義奠定了基礎(chǔ)。第二節(jié)討論了成員應(yīng)保護藥品試驗數(shù)據(jù)以防不公平商業(yè)使用的義務(wù)。保護試驗數(shù)據(jù)以防不公平商業(yè)使用的義務(wù)是藥品試驗數(shù)據(jù)保護義務(wù)中的關(guān)鍵。通過條約解釋的一般規(guī)則對“不公平商業(yè)使用”進行分析,可以認為政府藥監(jiān)機關(guān)依賴原創(chuàng)藥品的試驗數(shù)據(jù)批準仿制藥的行為屬于“不公平商業(yè)使用”。第三節(jié)探討了保護藥品試驗數(shù)據(jù)不被披露的義務(wù)。藥品試驗數(shù)據(jù)的不披露義務(wù)是試驗數(shù)據(jù)保護中的最起碼義務(wù),不披露試驗數(shù)據(jù)義務(wù)的保護期限和前提,與“不公平商業(yè)使用”的理解有直接的關(guān)系。第四節(jié)探討了由防止不公平商業(yè)使用義務(wù)引申出的保護藥品試驗數(shù)據(jù)不被依賴的義務(wù)。通過分析有關(guān)案例,得出政府在藥品試驗數(shù)據(jù)保護期間內(nèi)依賴原創(chuàng)藥品試驗數(shù)據(jù)批準仿制藥上市申請的行為應(yīng)當受到不依賴義務(wù)的規(guī)范。第五節(jié)分析了藥品試驗數(shù)據(jù)保護的例外,在出于保護公眾的必要以及已采取措施確保試驗數(shù)據(jù)不被不公平商業(yè)使用兩種情況下,WTO成員可以披露藥品試驗數(shù)據(jù)。第三章對部分WTO成員的藥品試驗數(shù)據(jù)保護制度進行比較法研究,以了解在相關(guān)國際義務(wù)下有關(guān)成員的具體法律實踐。第一、二節(jié)分別介紹了美國、歐盟兩個藥品試驗數(shù)據(jù)建立較早,制度相對成熟的WTO成員的域內(nèi)法律制度。這兩個WTO成員均采取了藥品試驗數(shù)據(jù)獨占保護模式,即在一定的試驗數(shù)據(jù)保護期內(nèi),不允許藥品監(jiān)管機關(guān)根據(jù)原創(chuàng)藥品提交的試驗數(shù)據(jù)批準仿制藥的上市申請。第三節(jié)介紹了加拿大的藥品試驗數(shù)據(jù)保護以及部分發(fā)展中國家采取的藥品試驗數(shù)據(jù)非獨占保護模式。發(fā)展中國家利用TRIPS協(xié)定的靈活度,采取這種保護模式,將藥品試驗數(shù)據(jù)保護義務(wù)要求盡量降到最低。第四節(jié)通過對制度的評價、鑒別和比較,對各成員在藥品試驗數(shù)據(jù)保護期限、保護范圍、規(guī)定淵源方面的差異進行了歸納,提出了其他WTO成員藥品試驗數(shù)據(jù)保護規(guī)定對完善我國有關(guān)制度的可借鑒之處。第四章探討了在TRIPS協(xié)定藥品試驗數(shù)據(jù)保護國際義務(wù)的基礎(chǔ)上,后TRIPS時期由WTO成員間簽訂自由貿(mào)易協(xié)定(FTA)的實踐催生的藥品試驗數(shù)據(jù)保護制度新的發(fā)展趨勢以及可能對國際義務(wù)產(chǎn)生的影響。第一節(jié)對比了TRIPS協(xié)定生效前后FTA中藥品試驗數(shù)據(jù)保護規(guī)定的區(qū)別,指出后TRIPS時期FTA中藥品試驗數(shù)據(jù)保護的范圍、方式等較TRIPS協(xié)定生效以前以及TRIPS協(xié)定的規(guī)定都有所變化。通過對比不同成員對FTA中規(guī)定藥品試驗數(shù)據(jù)保護的態(tài)度,初步得出一部分發(fā)展中國家因FTA中藥品試驗數(shù)據(jù)保護規(guī)定提高了其所承擔的數(shù)據(jù)保護義務(wù)的結(jié)論。第二節(jié)介紹了FTA中建立的藥品試驗數(shù)據(jù)獨占保護制度。以美國為典型代表的藥品試驗數(shù)據(jù)強保護國家,通過簽訂FTA的方式,向發(fā)展中國家推行了藥品試驗數(shù)據(jù)獨占保護模式。盡管FTA中的藥品試驗數(shù)據(jù)保護制度在客觀上削弱了發(fā)展中國家對TRIPS協(xié)定靈活度的利用,但有助于推動在全球范圍內(nèi)建立相對統(tǒng)一的藥品試驗數(shù)據(jù)保護標準。第三節(jié)介紹了后TRIPS時期生物藥品試驗數(shù)據(jù)保護制度的發(fā)展。生物藥品的試驗數(shù)據(jù)保護屬于超TRIPS協(xié)定的保護措施,但是隨著生物制藥在制藥產(chǎn)業(yè)中占據(jù)越來越重要的地位,藥品試驗數(shù)據(jù)保護在生物制藥領(lǐng)域的適用成為藥品試驗數(shù)據(jù)保護制度發(fā)展中備受關(guān)注的問題。在《跨太平洋伙伴關(guān)系協(xié)定》(TPP)談判中納入生物藥品試驗數(shù)據(jù)保護,是目前藥品試驗數(shù)據(jù)保護制度發(fā)展中討論最熱烈的問題之一。如果在這方面所有進展,將對藥品試驗數(shù)據(jù)保護國際義務(wù)的發(fā)展產(chǎn)生相當重要的影響。第五章對我國的藥品試驗數(shù)據(jù)保護制度進行研究。第一節(jié)介紹了我國根據(jù)所承擔的國際義務(wù)建立的藥品試驗數(shù)據(jù)保護制度。在分析我國制藥產(chǎn)業(yè)現(xiàn)狀與發(fā)展前景,藥品注冊審批程序法律規(guī)定以及藥品注冊審批實施情況的背景下,研究我國藥品試驗數(shù)據(jù)保護制度所能夠發(fā)揮的作用以及與藥品管理法律體系中其他藥品行政保護手段之間的關(guān)系。第二節(jié)指出目前我國藥品試驗數(shù)據(jù)保護制度存在的問題,以及完善和發(fā)展我國藥品試驗數(shù)據(jù)保護制度的必要性與可能性。在完善我國相關(guān)制度時,應(yīng)當始終在藥品創(chuàng)新和公共利益之間尋求平衡的原則下,設(shè)計、細化與改進藥品試驗數(shù)據(jù)保護制度,力求制度設(shè)計既能夠有效發(fā)揮藥品試驗數(shù)據(jù)保護制度激勵和促進藥品創(chuàng)新研發(fā)的效果,也能夠平衡和降低藥品試驗數(shù)據(jù)保護可能對公共健康造成的不利影響。從而使創(chuàng)新制藥企業(yè)與仿制藥企業(yè)都能受惠于藥品試驗數(shù)據(jù)保護制度。
[Abstract]:The purpose of this paper is to study the data protection system of drug test under the TRIPS agreement. The introduction puts forward the problems and its significance in this paper. The main contents of the main body of the text are as follows: the first chapter discusses the theoretical problems involved in the protection of drug test data. The first section combines the connotation of pharmaceutical science and international treaty provisions on the connotation of drug test data. It is the basis for the full text to explore the protection of drug test data. Drug test data is the data obtained by a series of laboratory tests and clinical trials in order to prove the safety and effectiveness of drugs before pharmaceutical companies apply for listing. According to the provisions of the TRIPS agreement, the TRIPS agreement is protected. The drug test data is the condition that the member government approves the drug listing, the undisclosed experimental data obtained from the drugs containing new chemical entities through great efforts. The second section expounds the.TRIPS agreement on the intellectual property property of drug test data protection for the first time in the protection of drug test data into the international protection of intellectual property rights. There is a legal justification for the protection of drug test data as intellectual property rights. At the same time, the protection of drug test data is a form of intellectual property protection, which is consistent with the traditional intellectual property rights. In the field of drug intellectual property protection, the protection of drug test data is not full. The role of traditional protection forms such as patent protection and trade secret protection is a special kind of undisclosed information protection. The establishment of this protection system is of great significance to the improvement of drug intellectual property protection. The third section discusses the relationship between drug test data protection and public health. The drug is a special product with life relevance. The protection of high standard drug intellectual property rights may conflict with public health, how to look at the impact of drug test data protection on public health. It should be recognized that the implementation of drug test data protection may have a certain negative impact on public health, but it also has a positive role in promoting and protecting. The second chapter focuses on the analysis of the international obligations of drug test data protection established by the TRIPS agreement. The first section first traces back to the origin of the provisions for the protection of drug test data in the TRIPS agreement. According to the review of the history of the North American Free Trade Agreement (NAFTA) and the negotiation history of the TRIPS agreement, the process of establishing the drug test data protection system under the TRIPS agreement and the different members of the different members on the protection of drug test data in the negotiation of the TRIPS agreement are reviewed. The second analysis of the relationship between the thirty-ninth sections and third sections of the TRIPS agreement with the other provisions of the TRIPS agreement laid the foundation for understanding the meaning of the obligation to protect the drug test data set out in the article. The second section discussed that members should protect the drug test data to prevent unfair commercial use. The obligation of commercial use is the key to the protection obligation of drug test data. Through the analysis of the "unfair commercial use" through the general rules of the treaty interpretation, it can be considered that the government drug supervision agency depends on the experimental data of original drugs to approve the behavior of the generic drug as "unfair commercial use". The third section discusses the protection of drug test. The non disclosure obligation of the test data. The non disclosure obligation of the drug test data is the minimum obligation in the test data protection, does not disclose the duration and premise of the protection of the experimental data obligations, and has a direct relationship with the understanding of "unfair commercial use". The fourth section discusses the protective drugs derived from the prevention of unfair commercial use obligations. The fifth section analyses the exceptions to the protection of drug test data in order to protect the public. Measures have been taken to ensure that experimental data are not used for unfair commercial use in two cases, WTO members can disclose drug test data. The third chapter makes a comparative study of the drug test data protection system of part of the WTO members to understand the practical legal practice of the members concerned under the relevant international obligations. The first, second section introduces the United States respectively Two EU drug test data have been set up early, and the legal system of relatively mature WTO members of the system. These two WTO members have adopted the exclusive protection model of drug test data, that is, within a certain period of test data protection, the drug regulatory agency will not allow the application of the experimental data submitted by the original drug to approve the application of the generic drug. The third section introduces the protection of drug test data in Canada and the non exclusive protection model of drug test data taken by some developing countries. Developing countries use the flexibility of the TRIPS agreement to take this protection model to minimize the requirements for the protection of drug test data. The fourth section is identified by the evaluation of the system. And compare the differences between the members of the drug test data protection period, the scope of protection and the origin of the provisions, and put forward the reference of the other WTO member drug test data protection regulations to improve the relevant system in our country. The fourth chapter discusses the international obligations of the data protection of the drug test data in the TRIPS agreement, and the post TRI The new development trend of drug test data protection system generated by the practice of the free trade agreement (FTA) between WTO members during the PS period and the possible impact on international obligations. The first section contrasts the difference between the drug test data protection regulations in FTA before and after the entry into force of the TRIPS agreement, and points out the protection of drug test data in the post TRIPS period FTA. The scope and mode of the TRIPS agreement have changed before the entry into force of the TRIPS agreement and the provisions of the TRIPS agreement. By comparing the attitudes of different members to the protection of drug test data in the FTA, a preliminary conclusion is drawn to the conclusion that some developing countries have improved their data protection obligations under the protection regulations of drug test data in FTA. The exclusive protection system of drug test data set up in FTA is introduced. The country which is a typical representative of the drug test data is strongly protected by the United States, and the drug test data exclusive protection model is carried out to developing countries by the way of FTA, although the protection system of drug test data in FTA objectively weakens the developing countries to TRIPS The use of protocol flexibility helps to promote the establishment of a relatively unified standard for the protection of drug test data around the world. The third section introduces the development of the data protection system for the post TRIPS biodrug test. The protection of the experimental data of biological drugs belongs to the protection of the super TRIPS agreement, but with the biopharmaceutical industry in the pharmaceutical industry The application of drug test data protection in the field of biopharmaceuticals has become a major concern in the development of drug test data protection system. The inclusion of data protection in biodrug test in the TPP negotiations is the most discussed in the development of the pre eye drug test data protection system. One of the hot issues. If all progress in this area will have a very important impact on the development of the international obligations for drug test data protection. The fifth chapter studies the system of drug test data protection in China. The first section introduces the system of drug test data protection established in China based on the international obligations undertaken. In the background of the current situation and development prospect of our pharmaceutical industry, the legal provisions of the approval procedure of drug registration and the implementation of the drug registration examination and approval, the study on the role of the drug test data protection system in our country and the relationship with other drug administrative protection means in the legal system of drug management are discussed in the second section. The problems existing in the national drug test data protection system and the necessity and possibility of improving and developing the system of data protection for drug test in China should be perfected in our country. Under the principle of balance between drug innovation and public interest, the system of data protection for drug test should be designed, refined and improved to make every effort to be made. The degree design can not only effectively give full play to the effect of drug test data protection system to stimulate and promote drug innovation and development, but also balance and reduce the adverse effects of drug test data protection on public health. Therefore, both innovative pharmaceutical enterprises and generic pharmaceutical enterprises can benefit from the drug test data protection system.

【學位授予單位】：復旦大學
【學位級別】：博士
【學位授予年份】：2014
【分類號】：D997.1

【引證文獻】

相關(guān)會議論文 前1條

1 陳兵;;試驗數(shù)據(jù)保護研究進展及展望[A];2011年中國藥學大會暨第11屆中國藥師周論文集[C];2011年

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