公共健康危机下TRIPs豁免的困境及其启示  

TRIPs Waiver as Tackling Public Health Crisis:To be,or Not to be?

作　　者：马乐[1] 卢吕静 Ma Le;Lu Lvjing(School of International Law,East China University of Political Science and Law,Shanghai 200042,China)

机构地区：[1]华东政法大学国际法学院,上海200042

出　　处：《科技与法律（中英文）》2022年第4期123-135,共13页Science Technology and Law（Chinese-English Version）

基　　金：Significant Project of NPSS:International Rule of Law of Free Trade Port with Chinese Characters(20&ZD205);Research Project of East China University of Political Science and Law:Study on Compulsory Licensing of Phar⁃maceutical Patents in Response to Public Health Crisis(20HZK011)。

摘　　要：作为应对新冠肺炎疫情的方案,印度和南非在WTO提出的TRIPs豁免提案一经公布便引来争论。该项TRIPs豁免提案旨在通过免除WTO成员就TRIPs协定第二部分相关知识产权的保护义务,确保这些知识产权不会成为应对疫情所需医疗产品及时获取和可负担性的障碍,或者阻碍实现研发、生产和提供这些医疗产品规模化的实现。但是,疫情全球肆虐的严重性并没有使得TRIPs豁免的正当性和必要性共识更容易达成。相反,TRIPs豁免遭到了以欧盟为代表的WTO部分发达成员以及制药企业等知识产权所有者的强烈抵制。支持者和反对者在TRIPs豁免究竟能否起到应对疫情的功能上各执一词,针锋相对。这种矛盾揭示了TRIPs豁免所遭遇的现实困境,包括前提性共识难以达成、功能性认知差异甚巨以及程序性障碍十分明显。这种困境再次证明,在国际交往与合作的意义上,知识产权的战略资源角色以及TRIPs协定保护知识产权的根本目标未曾改变。这也是TRIPs豁免面临困境的根本原因。作为多边主义重要成果的TRIPs灵活性条款更显难能可贵,或可发挥更大作用。WTO第12届部长级会议就新冠疫苗专利权有限豁免达成的部长决定并未改变上述困境,而是对以强制许可为代表的TRIPs灵活性不得已而为之的回归。TRIPs waiver proposal was controversial as soon as it was presented as a response to COVID-19.TRIPs waiver aims to exempt WTO members'obligations to protect intellectual property rights related to Part 2 of the TRIPs Agreement to ensure that these IPRs do not create barriers to the timely access to affordable medical products or to the scaling-up of research,development,manufacturing,and supply of medical products essential to combat COVID-19.Unfortunately,the severity of the global ravages of the pandemic did not make it easier to reach a consensus on the legitimacy and necessity of the TRIPs waiver.On the contrary,the TRIPs waiver has been strongly resisted by some developed members of WTO and IP holders.The opinions of proponents and oppo‐nents are opposed on whether the TRIPs waiver can perform the function of dealing with COVID19 or not.The contradiction reflected in this discussion reveals the practical dilemmas the TRIPs waiver encountered,including the difficulty of reaching a prerequisite consensus,the significant divergence in functional perceptions,and the obvious procedural hurdles.The dilemma proves that the strategic role of IPRs and the fundamental objective of the TRIPs Agreement in protecting IPRs have not changed,which is the real cause of the hardships faced by the TRIPs waiver.As an important multilateralism achievement,the TRIPs flexibilities are even more valuable and may play a more significant role.The Ministerial Decision on the TRIPs Agreement of WTO MC12,which ends up partly waiving the patent right of COVID-19 vaccines,is more like a forced comeback to compulsory licensing rather than a way out of the dilemma mentioned above.

关 键 词：TRIPs豁免 公共健康 新冠肺炎疫情 TRIPs灵活性 强制许可 

分 类 号：D923[政治法律—民商法学]