本文關(guān)鍵詞： 藥品平行進口 權(quán)利窮竭原則 TRIPs靈活性 公共健康　出處：《中國政法大學(xué)》2011年碩士論文　論文類型：學(xué)位論文

【摘要】：自20世紀(jì)70年代起,伴隨著經(jīng)濟全球化,傳染性疾病迅速地在欠發(fā)達(dá)國家蔓延,使這些國家陷入了公共健康危機。在面對公共健康危機時,發(fā)展中國家顯得無能為力,關(guān)鍵在于由TRIPs協(xié)議對藥品專利權(quán)的高標(biāo)準(zhǔn)保護導(dǎo)致了國民難以承擔(dān)高昂的醫(yī)藥費用。藥品平行進口,作為公共健康與藥品專利權(quán)的一個平衡點,一方面對增加藥品的可及性、解決公共健康危機起到舉足輕重的作用,而與此同時也備受國際社會爭議。本文通過對TRIPs協(xié)議進行詳細(xì)分析,闡明其對藥品平行進口的態(tài)度以及發(fā)展中國家應(yīng)當(dāng)如何援引TRIPs協(xié)議的靈活性條款實施藥品平行進口。 在結(jié)構(gòu)上,本文分為四章: 第一章是關(guān)于藥品平行進口的概述,界定了何為藥品平行進口、其構(gòu)成要件以及對公共健康的意義,并詳細(xì)闡述了藥品平行進口的理論基礎(chǔ)——權(quán)利窮竭原則,為后面的論述做好鋪墊。 第二章則通過法條分析,對TRIPs協(xié)議下藥品平行進口的合法性進行了詳細(xì)的論述。首先,第6條關(guān)于權(quán)利用盡的規(guī)定將權(quán)利窮竭原則交由各國自行決定,也就說說藥品平行進口的合法性問題屬于各國的主權(quán)裁量事項。其次,第7條和第8條表明了TRIPs協(xié)議的宗旨和原則并非僅僅為了保護藥品專利權(quán),也要兼顧公共健康,允許成員國在必要時實施藥品平行進口,但須與TRIPs協(xié)議的規(guī)定相符合。多哈宣言后通過的TRIPs第31條修正案雖然對成員國實施藥品平行進口設(shè)置了諸多限制,但它第一次明確地將藥品平行進口納入了協(xié)議中,得到了正面肯定。可見TRIPs協(xié)議對藥品平行進口給予了一定的認(rèn)可度,但由于條款的模糊性往往也給發(fā)展中國家?guī)砹艘欢ǖ淖璧K。 第三章主要從TRIPs協(xié)議的角度評析了三個具有代表性的關(guān)于藥品平行進口案例,包括39個跨國醫(yī)藥公司訴南非政府案、美國和加拿大炭疽危機以及菲律賓2008年頒布的《廣泛獲得的價廉物美藥品法》,反映了發(fā)展中國家與發(fā)達(dá)國家在藥品平行進口問題上對TRIPs協(xié)議的不同理解與斗爭,進一步闡明了TRIPs協(xié)議在實際糾紛中對解決藥品平行進口合法性發(fā)揮著何種作用。 第四章先總結(jié)了目前的TRIPs協(xié)議在實踐上究竟賦予了藥品平行進口多大的認(rèn)可度以及目前存在的不足,從而闡述了發(fā)展中國家應(yīng)當(dāng)如何援引其靈活性條款應(yīng)對公共健康危機。筆者認(rèn)為成員國在遵循TRIPs協(xié)議的前提下可以實施國際權(quán)利窮竭原則,允許藥品平行進口合法化。同時,在對本國藥品專利法進行修改或制訂時應(yīng)當(dāng)以保障公共健康為目的,并需要采取多種措施防止藥品平行進口的濫用。
[Abstract]:Since 1970s, with the globalization of the economy, infectious diseases have spread rapidly in less developed countries, plunging these countries into public health crises. In the face of public health crises, developing countries seem powerless. The key lies in the high standard protection of drug patents by the TRIPs agreement, which makes it difficult for the people to bear the high medical expenses. As a balance point between public health and drug patent rights, the parallel import of drugs, on the one hand, increases the availability of drugs. Solving the public health crisis plays an important role, but at the same time it is also controversial in the international community. This paper analyzes the TRIPs protocol in detail. This paper expounds its attitude towards parallel import of drugs and how developing countries should invoke the flexibility clause of TRIPs agreement to implement parallel import of drugs. Structurally, this paper is divided into four chapters:. The first chapter is an overview of parallel import of drugs, which defines what is parallel import of drugs, its constituent elements and its significance to public health, and expounds in detail the theoretical basis of parallel import of drugs-the principle of exhaustion of rights. Lay the groundwork for the following discussion. The second chapter discusses in detail the legality of parallel import of drugs under the TRIPs Agreement through the analysis of articles of law. Firstly, the provisions of Article 6 on exhaustion of rights refer the principle of exhaustion of rights to the discretion of each country. Secondly, articles 7 and 8 show that the purposes and principles of the TRIPs Agreement are not only to protect drug patents, but also to take into account public health. Allow member States to import drugs in parallel if necessary, subject to the provisions of the TRIPs agreement. The amendment to Article 31 of the TRIPs, adopted after the Doha Declaration, imposes a number of restrictions on the implementation of parallel imports of medicines by member States. But for the first time, it explicitly incorporated parallel drug imports into the agreement, which was positively affirmed. It can be seen that the TRIPs agreement has given a certain degree of recognition to parallel drug imports. However, the ambiguity of the provisions often brings some obstacles to the developing countries. The third chapter analyzes three representative cases of parallel drug import from the perspective of TRIPs agreement, including 39 multinational pharmaceutical companies v. the Government of South Africa. The anthrax crisis in the United States and Canada and the widely available and inexpensive Medicines Act of 2008 in the Philippines reflect the differences in understanding and struggle between developing and developed countries over the issue of parallel importation of drugs to TRIPs. This paper further expounds the role of TRIPs protocol in resolving the legality of parallel import of drugs in practical disputes. Chapter 4th summarizes how much recognition the current TRIPs protocol has given to the parallel import of drugs in practice and the shortcomings of the current agreement. The author thinks that the member countries can implement the principle of exhaustion of international rights and legalize the parallel import of drugs under the premise of following the TRIPs agreement, and how to invoke its flexibility clause to deal with the public health crisis. The purpose of the revision or formulation of national drug patent law should be to protect public health, and various measures should be taken to prevent the abuse of parallel drug imports.
【學(xué)位授予單位】：中國政法大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2011
【分類號】：D997.1

【引證文獻(xiàn)】

相關(guān)碩士學(xué)位論文 前1條

1 肖珍珍;專利藥品平行進口與公共健康[D];吉林大學(xué);2012年

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本文編號：1504180