Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016
Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016
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DOI：
10.2471/blt.17.199364
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发表时间：
2018-03-01
影响因子：
11.1
通讯作者：
Hogerzeil, Hans V.
中科院分区：
文献类型：
--
作者：
't Hoen, Ellen F. M.;Veraldi, Jacquelyn;Hogerzeil, Hans V.
数百万人，特别是中低收入国家的人，无法获得有效的药品，往往是因为他们买不起。2001年世界贸易组织（世贸组织）部长级会议通过了《关于与贸易有关的知识产权协定和公共卫生的多哈宣言》。宣言承认知识产权对新药开发和药品价格的影响。该宣言概述了WTO成员国为确保所有人都能获得药品而可以采取的措施，即所谓的TRIPS灵活性。这些措施包括药品专利的强制许可和最不发达国家药品过渡措施。这项研究的目的是记录2001年至2016年期间利用TRIPS灵活性获得低价仿制药的情况。总体而言，89个国家确定了可能使用TRIPS灵活性的176个实例：100个（56.8%）涉及强制许可或公共非商业性使用许可，40个（22.7%）涉及最不发达国家的药品过渡措施。其余为：1宗平行进口案件; 3宗研究例外; 32项与专利无关的措施。在这176个案例中，152个案例（86.4%）得到执行。它们涵盖了治疗14种不同疾病的产品。但是，137份（77.8%）涉及治疗人类免疫缺陷病毒感染和获得性免疫缺陷综合征或相关疾病的药物。人们发现，TRIPS灵活性的使用比通常认为的更为频繁。鉴于当今各国在采购高价专利药品方面面临的问题，《与贸易有关的知识产权协议》的灵活性为获得较低成本的仿制药提供了切实可行的法律的途径，这一点越来越重要。
Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.