Japan and Taiwan in the wake of bio-globalization : drugs, race and standards

Abstract

This is a study of Japan and Taiwan's different responses to the expansion of the global drug industry. The thesis focuses on the problematic of "voicing," of how a state can make its interests heard in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a unique project that facilitates the formation of a single global market by creating universal standards for clinical trials and drug approvals. Tracing, through "slow motion" ethnography, step by step, why Japan claims a racial difference requires additional local clinical trials with "Asian bodies," this thesis rejects conventional interpretations of protectionism for Japan's resistance to globalization. It argues that more than protectionism is involved, and that a rich ethnographic understanding of Japan's medical infrastructure is required to understand the claim of biological, cultural, and national differences, as well as biostatistical arguments about the ambiguities of "extrapolation" of clinical data from one place to another.

(cont.) The inherent ambiguities of efforts to create "bridging" studies as a temporary solution to these problematics created a deadlock in the ICH, and provided an opening for Taiwan, another Asian state, which does not enjoy formal recognition from the world, to speak for itself to this conference, and to create the fragile, but politically critical, possibility of becoming a clinical trial center for Asian populations. The language of genomics and biostatistics become in the more recent period the vehicles for both Japanese and Taiwanese efforts at "voicing" their concerns. Both genomics and biostatistics look different in these contexts than they do from the United States or European Union. In sum, (1) Japan's and Taiwan's response, as well as "global ethnographic objects" such as the ICH, provide important tools to rethink the comparative method as well as universalizing claims of harmonization. (2) Race, culture, and the nation-state are transformed as categories through the contemporary reworkings of genomics and biostatistics. (3) The thesis demonstrates that abstract accounts of the spread of clinical trials and resistance in various parts of the world are not to be trusted unless they include detailed probings of local understandings, identity issues, and problems of voicing.