超越国界的信任:欧洲对药品获取的外部监管影响。

IF 1.7 4区 哲学 Q2 ETHICS
Pramiti Parwani, Katrina Perehudoff, Anniek de Ruijter
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引用次数: 0

摘要

人们普遍认为,欧洲机构在全球化市场上拥有监管权力,可以跨国界、跨部门地输出其标准。本文提出了什么样的制度动态催化了欧洲外部监管对中低收入国家(LMICs)药品治理的影响。这项研究的重点是两个欧洲监管机构,欧洲药品管理局(EMA)和欧洲专利局(EPO),并探讨了他们的技术官僚向欧洲以外的延伸的动态。我们发现,信任是促进某些形式的欧洲对外关系的关键潜在制度动力。这些机构通过与低收入和中等收入国家监管机构的技术援助、合作和工作分享来扩大其影响力,形成了一种片面的“技术官僚信任”关系。这种信任,通过将EMA和EPO定位为“值得信赖的”监管机构的国际监管框架加强,使这些机构能够将其监管影响力扩大到欧洲以外。通过严格审查这种信任建立对中低收入国家监管自主权的影响,本研究有助于更广泛地讨论欧洲在全球卫生治理中的监管权力,并强调了对中低收入国家药品市场和准入的潜在影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Trust Beyond Borders: European External Regulatory Influence on Access to Medicines.

European institutions are widely recognized as wielding regulatory power in a globalized market, exporting its standards across borders and between sectors. This paper asks what institutional dynamics catalyze European external regulatory impact on pharmaceutical governance in low- and middle-income countries (LMICs). The research focuses on two European regulatory bodies, the European Medicines Agency (EMA) and the European Patent Office (EPO), and explores the dynamics of their technocratic outreach beyond European borders. We find that trust is a key underlying institutional dynamic facilitating some forms of European external relations. The agencies extend their influence through technical assistance, collaboration, and work-sharing with LMIC regulators, fostering a one-sided relationship of "technocratic trust." This trust, reinforced by international regulatory frameworks that position the EMA and EPO as "trustworthy" regulators, enables these agencies to expand their regulatory influence beyond Europe. By critically examining the impact of this trust-building on LMICs' regulatory autonomy, this research contributes to the broader discourse on European regulatory power in global health governance and highlights potential implications for pharmaceutical markets and access in LMICs.

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来源期刊
Journal of Law Medicine & Ethics
Journal of Law Medicine & Ethics 医学-医学:法
CiteScore
2.90
自引率
4.80%
发文量
70
审稿时长
6-12 weeks
期刊介绍: Material published in The Journal of Law, Medicine & Ethics (JLME) contributes to the educational mission of The American Society of Law, Medicine & Ethics, covering public health, health disparities, patient safety and quality of care, and biomedical science and research. It provides articles on such timely topics as health care quality and access, managed care, pain relief, genetics, child/maternal health, reproductive health, informed consent, assisted dying, ethics committees, HIV/AIDS, and public health. Symposium issues review significant policy developments, health law court decisions, and books.
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