Chapter

The Role of Domestic Administrative Law in the Accountability of Informal International Lawmaking: The Case of the ICH

Ayelet Berman

in Informal International Lawmaking

Published in print September 2012 | ISBN: 9780199658589
Published online January 2013 | e-ISBN: 9780191742248 | DOI: http://dx.doi.org/10.1093/acprof:oso/9780199658589.003.0022
The Role of Domestic Administrative Law in the Accountability of Informal International Lawmaking: The Case of the ICH

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In the framework of the informal international law (IN-LAW) project, this chapter examines the role domestic administrative law may or should play in the accountability of Transnational Regulatory Networks (TRN). Many TRNs are composed of domestic regulatory authorities, which triggers the role of domestic administrative law in the accountability of TRNs. The chapter develops an analytical framework which is applied to a case study of the International Conference on the Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) examined from a US administrative law perspective. It is argued that domestic law is significant in establishing the accountability of TRNs towards internal stakeholders, and has some role to play, albeit limited, in offsetting the problem of disregard towards external stakeholders.

Keywords: international law; informal law; lawmaking; regulatory networks; accountability; pharmaceuticals

Chapter.  13957 words.  Illustrated.

Subjects: Public International Law

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