TRIPS灵活性有助于改变政策和实践,以增加获得药物的机会:从2001年到2024年的证据
Montgomery Dunn1,2, Ellen 't Hoen2,3, Pascale Boulet2
1University of Cambridge, Cambridge, UK montgomerydunn@aol.com.
BMJ global health
|January 28, 2026
概括
政府利用知识产权的灵活性,如强制许可 (CL),以改善获得负担得起的药物的机会. 最近的趋势显示,高收入国家对各种疾病的CL使用增加,突出显示其持续的重要性.
科学领域:
- 卫生政策 卫生政策
- 知识产权法 知识产权法 知识产权法
- 药品接入 药品接入 药品接入
背景情况:
- 由于成本和可用性,数百万人面临药品获取障碍,影响发展中国家和高收入国家.
- 知识产权 (IP) 管理,特别是通过与贸易有关的知识产权方面协议 (TRIPS),显著影响了医药的可访问性.
- 包括强制许可 (CL) 和最不发达国家 (LDC) 过渡条款在内的TRIPS灵活性为政府提供了提高医疗技术获取的工具.
研究的目的:
- 分析TRIPS灵活性,特别是强制许可 (CL) 和最不发达国家制药过渡措施的使用情况.
- 自COVID-19大流行以来,提供对CL和LDC过渡措施利用情况的全面分析.
- 评估TRIPS灵活性对全球药品获取的影响.
主要方法:
- 在三个医学和法律数据库中进行了范围审查.
- 在2001-2024年期间对强制许可 (CL) 和最不发达国家 (LDC) 制药转型措施的使用进行了时间分析.
- 检查了149个CL实例和最不发达国家过渡措施的潜在使用.
主要成果:
- 61%的确定的强制许可 (CL) 实例被执行.
- 强制许可 (CL) 的使用已经转移,高收入国家在过去十年中占据了超过一半的案例.
- 对于慢性,非传染性和罕见疾病,越来越多地考虑强制性许可 (CL),几乎所有符合条件的国家都使用了最不发达国家过渡措施.
结论:
- 自"多哈宣言"以来,TRIPS的灵活性显然促进了人们获得药物和疫苗的机会.
- 这些灵活性对于确保负担得起的新药至关重要,并且在不断变化的全球融资结构中仍然至关重要.
- 持续使用TRIPS灵活性强调了它们在解决全球制药获取挑战方面的作用.
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