通过国际监管途径促进疫苗正义
Katrina Perehudoff1,2,3,4, Pramiti Parwani1,2,3,4, Seraphine Bruinsma1,2
1Law Centre for Health and Life, University of Amsterdam, Amsterdam, Netherlands.
Global public health
|November 13, 2025
概括
监管依赖加速疫苗批准,增强全球疫苗正义. 这种方法,特别是南南合作和欧洲药物署的依赖,通过加速获得安全有效的疫苗,有利于低收入和中等收入国家 (LMICs).
科学领域:
- 全球卫生政策 全球卫生政策
- 关于疫苗的规定 疫苗法规
- 国际法 国际法 国际法
背景情况:
- 公平的全球接种疫苗对公共卫生至关重要,但受到资源密集型监管流程的阻碍.
- 及时的监管批准是疫苗正义的关键决定因素,但经常面临重大延迟,特别是在低收入和中等收入国家 (LMICs).
- 现有的国际制药监管政策往往忽视了历史上被边缘化的LMICs的需求.
研究的目的:
- 通过"第三世界对国际法方法" (TWIL) 的视角,批判性地检查疫苗监管政策.
- 通过集中LMICs的观点,挑战国际制药监管中占主导地位的叙述.
- 为了说明现代监管依赖趋势如何与疫苗正义的"第三世界方法"保持一致.
主要方法:
- 对当前国际监管依赖趋势进行批判性分析,包括南南依赖以及对全球卫生产品依赖欧洲药品署 (EMA) 意见.
- 应用"第三世界国际法方法" (TWIL) 框架来评估疫苗监管政策.
- 检查这些趋势如何影响疫苗正义和历史上被边缘化LMICs的获取.
主要成果:
- 监管依赖的现代趋势,特别是南南合作和EMA对全球健康的依赖,正在越来越多地采用"第三世界方法"来实现疫苗正义.
- 这些依赖机制表明,有潜力拥抱那些挑战主流国际监管规范的原则.
- 加强国际监管途径可以帮助克服已经被认为是安全和有效的疫苗的批准瓶.
结论:
- 监管依赖,特别是以南南和EMA为基础的全球健康模式,为加速疫苗批准和加强全球疫苗正义提供了有希望的途径.
- 这些方法可以帮助缓解监管瓶,简化注册流程,改善获得基本疫苗的机会,特别是在卫生紧急情况下.
- 通过国际监管合作建立能力,对于实现全球公平疫苗接种至关重要.
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