全球监管合作的问责:国内行政法的角色?医疗产品案例

Ayelet Berman
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引用次数: 0

摘要

全球监管合作,或国内监管机构之间超越国界的合作,正在成为21世纪国际关系的主导特征。然而,它因问责不足而招致批评。这些文献大体上集中于在国际一级改进问责制的措施。本文认为,国内行政法在提高问责制方面也具有一定的作用。此外,鉴于传统形式的行政法与监管合作的现实之间的差距(以及随之而来的对问责制的新挑战),行政法需要适应。文章提出了可以进行这种调整的四个领域:建立“自下而上”的程序、法定授权、监督机制和纳入全球监管的程序。本文以医疗领域的监管网络为例,展示了这种方法在美国和欧盟的实践中是如何开始显现的,并指出了总体趋势。
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The Accountability of Global Regulatory Cooperation: What Role for Domestic Adminsitrative Law? The Case of Medical Products
Global regulatory cooperation, or cooperation among domestic regulators beyond national borders, is becoming a dominant feature in 21st century international relations. It has, however, drawn criticism for its accountability deficits. The literature has focused, by and large, on measures to improve accountability at the international level. This article argues that domestic administrative law too has a role in improving accountability. Moreover, in light of the gap between administrative law in its traditional form and the reality of regulatory cooperation (and the consequent new challenges to accountability), administrative law needs to adapt. The article proposes four areas where such adaptation could take place: setting “bottom up” procedures, statutory authorization, oversight mechanisms and procedures for incorporating global regulation. Applied to the case of regulatory networks in the medical field, the article demonstrates how this approach has already started manifesting itself in practice in the U.S. and EU, and points to general trends.
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