Categorization and Development: The Political Economy of New Drug Regulation in China

• In Event: 1549 - The Rhetoric of Development

Abstract

The paper presents how states in the Global South can redefine the category of innovation against international convention to promote late development in the face of Northern hegemony. Research on innovation primarily focuses on the question of what is conducive to innovation, treating innovation as an outcome to be explained, yet less attention has been paid to what counts as innovation, who gets to define and categorize it, or how and why that matters, especially in the context of North-South norm convergence/divergence. Meanwhile, existing literature has examined categorization as a ubiquitous force that informs political, economic, and social order, but few studies have explored the role of categorization in state-led late development. Drawing on 113 interviews and extensive historical data, this research seeks to fill these gaps by studying the political economy of new drug regulation in China. Specifically, my analysis traces 1) how the Chinese state redefined the category of new drug in its drug regulation regime from “new to the local industry” (1984) to “new to the domestic market” (2002), and eventually to “new to the global market” (2015) to promote domestic industry growth and upgrading under the pressure of Northern-based Big Pharma, and 2) how such audience-based recategorization (on the principle of “new to whom”) was driven by a counterproductive innovation fever stemming from the gap between guidance on paper and practice on the ground, which has produced mixed consequences for local industrial performance and access to medicines in the past decades. In doing so, this in-depth case study aims at deepening our understanding of categorization, innovation, development, and globalization.

Author

• Lantian Li, Northwestern University