强制许可与药品获取:美国和巴西的案例研究  

Compulsory license and access to drugs:A case study of the USA and Brazil

作　　者：黄灿[1] 徐戈 张玉蓉[2] 李兰花 郑素丽 Huang Can;Xu Ge;Zhang Yurong;Li Lanhua;Zheng Suli(Institute for Intellectual Property Management,School of Management,Zhejiang University,Hangzhou 310058,Zhejiang,China;Intellectual Property Academy,Law School,Shanghai University,Shanghai 200444,China;China Institute for SMEs(Zhejiang Provincial New Key Professional Think Tank),Zhejiang University of Technology,Hangzhou 310023,Zhejiang,China;School of Economics and Management,China Jiliang University,Hangzhou 310018,Zhejiang,China)

机构地区：[1]浙江大学管理学院知识产权管理研究所,浙江杭州310058 [2]上海大学知识产权学院,上海200444 [3]浙江工业大学中国中小企业研究院(浙江省新型重点专业智库),浙江杭州310023 [4]中国计量大学经济与管理学院,浙江杭州310018

出　　处：《科研管理》2022年第12期125-134,共10页Science Research Management

基　　金：国家自然科学基金面上项目:“企业专利组合战略与创新绩效:基于专利组合结构特征的新视角”(71572187,2016.01-2019.12);国家自然科学基金面上项目:“基于专利交易数据的中国高校和科研院所技术转移的机制和政策分析”(71874152,2019.01-2022.12);教育部人文社会科学青年项目:“FRAND原则下标准必要专利许可费率的确定研究”(17YJCZH253)。

摘　　要：运用强制许可威慑开展降价谈判是获取抗疫特效药的一种重要方式,然而各国的实践结果却存在明显差异,强制许可在哪些情况下能够发挥积极作用尚不清晰。新冠肺炎等短期突发疫情全球爆发背景下,疫情类型变得更加复杂、药品需求主体拓展,本文突破已有研究针对发展中国家抗击长期疫情的思路,探讨强制许可在不同情境中发挥的异质性作用。通过对美国和巴西运用强制许可获取特效药的案例进行分析,区分长短期疫情特征,以及发展中与发达国家运用强制许可面临的挑战,本文提炼出了不同情境下影响强制许可威慑有效性的七项重要因素。其中,本国制药水平、进口仿制药的可能性是强制许可发挥威慑作用的基础,运用强制许可威慑次数和其他国家运用强制许可分别作用于长、短期疫情,本国制药行业和经贸部门的反对影响发达国家的决策,原研药企业与所在国的经济报复则会削弱发展中国家强制许可的威慑效果。基于以上结论,本文为发达国家和发展中国家应对短期和长期疫情提供了针对性建议。Using compulsory license as a threat in price negotiations is an important way to obtain anti-epidemic drugs.However,the results of implementing compulsory license threats vary a lot across different countries.Since the adoption of the Declaration on the TRIPS Agreement and Public Health(Doha Declaration) in 2001,there have been twenty-four cases which implemented compulsory license as a threat in anti-epidemic drug price negotiations by seventeen countries.Among those twenty-four cases,only nine successfully got a discount on the drug price.It is still not clear that under what circumstances compulsory license threat can play a positive role.With the global outbreak of short-term epidemics and pandemics,such as the "Covid-19" pneumonia pandemic,the context in which compulsory license is applied has changed significantly.On the one hand,new types of short-term epidemics have emerged,making the implementation and enforcement of compulsory license more complex.On the other hand,the number and scope of countries in need of anti-epidemic drugs have also expanded,not only developing countries face shortages of anti-epidemic drugs,developed countries also need to obtain anti-epidemic drugs in sudden epidemic outbreaks.Existing literature has been intensively focusing on whether compulsory license can help developing countries obtain drugs in long-term epidemics such as AIDS.Although the results of those studies provide valuable implications for developing countries to combat long-term epidemics,their applicability to the growing presence of sudden global epidemic is limited.To take full advantage of compulsory license under the new development of epidemics,it is necessary to extend the scope of existing literature and explore the specific role of compulsory license in different situations.In this study,we try to divide the context of implementing compulsory license into two dimensions.The first dimension is the epidemic,including short-term such as "Covid-19" and long-term epidemics such as AIDS.The second dimension is

关 键 词：药品专利 强制许可 TRIPS协定 公共卫生 知识产权 

分 类 号：G311[文化科学]