The Politics of Local Biology in Transnational Drug Testing: Creating (Bio)Identities and Reproducing (Bio)Nationalism through Japanese 'Ethnobridging' Studies

摘要

Next to the United States, Japan is the second-largest pharmaceutical market in the world in terms of expenditures. However, the regulatory issues and long clinical testing and approval time for drugs to be marketed in Japan continue to be stumbling blocks for foreign drugs in the Japanese market. In 1998, adoption of the International Conference on Harmonization (ICH) E5 guidelines by the United States, European Union, and Japan cleared the way for the use of data generated in one member region to be used in another for drug regulatory approval purposes－a prac-tice termed "bridging." In particular, the ICH E5 focused on a type of study termed "ethnobridging," studies conducted on a drug-by-drug basis to look at the sensitivities of a drug to "ethnic factors." Ethnobridging studies are drug trials specific to ethnic populations to assure safety, effectiveness, and dose specificity. In the last twenty years, such studies have almost always been required as part of the clinical data package needed for approval of Western drugs in the Japanese market. We examine the ways in which ethnobridging studies, based on an anthropologically questionable concept of ethnic factors as defined in ICH E5, have become a proxy for long-held cultural perceptions of "local biology" based on a notion of ethnic uniqueness and bioidentity in Japan. Ethnobridging studies, we argue, are more than venues for the production of scientific and clinical data. They produce data in concert with what Latour has termed "matters of concern," are techniques of governmentality that advance the nationalist agenda of the state in citizens' everyday lives, use pharmaceuticals as boundary objects and focal points of communication between researchers and policy makers in receptive environments, and justify state regulation of transnational flows of pharmaceuticals in a lucrative market. This is achieved through a renewed sense of bioidentity of what it means to be Japanese among both in-country and overseas Japanese. We also call attention to emergent patients' rights groups in Japan exerting pressure on the government to reduce the drug lag and provide wider access to lifesaving treatments available elsewhere but not in Japan because of its onerous clinical trials system and ethnobridging requirements.