Abstract

This paper analyzes Taiwan's engagement with the standardization of pharmaceutical clinical trials at the turn of this century. Unlike approaches that treat local encounters with globalization as either reluctant acceptance or lasting resistance, this study calls attention to a complicated process of negotiation, the conceptual gap between the illusion of a unified world and the reality of persistently divided nation-states. To address this gap, an ethnographic investigation is required. Two concepts, "bridging" and "voicing" (fasheng), are introduced in order to capture Taiwan's unstable status, what I term "the voice on the bridge," in this process. Bridging emerged as a technical concept for evaluating pharmaceutical drugs' possible differential ethnic effects. But it also reflects the ambiguous reality of a world in which each state is an islet connected to others by imaginary bridges. Fasheng ("voicing") has to do with Taiwan's long-held desire for world recognition as a state. This paper is an ethnography of globalization and the state that traces how Taiwan created a regulatory resolution through the idea of bridging and how this "voice" was articulated through various social strategies. It explores not only the complexity of interactions in the technical field of regulatory science, but also argues that looking at such entanglements of science and society makes it possible to move beyond simple interpretations of globalization.

Abstract

本文探討臺灣如何在法規領域中, 從臨床試驗標準化趨勢的因應裡 開展自己的國家策略。在國際醫療法規協合會 (ICH) 的全球場域裡, 本文透 過種族差異要因爭議與「銜接性試驗」 (bridging studies) 概念的出現與落 實, 指出「世界大同」理想與各國分立現實之間的落差, 與法規作為探討標準 化進程例證的可能。另一方面, 本文利用「發聲」 (voicing) 概念, 深化過去 將科技引進僅為國家利益服務的看法, 嘗試理解非ICH 會員國並且長期孤立的 臺灣, 如何在提升法規標準時增加自己的國際可見度。本文無意指出在臨床 試驗上臺灣是因應全球化的「成功」案例。相反的, 當醫藥成為STS 研究的 新興課題之際, 它提醒傳統人文科學的議題, 如國際脈絡下的國家的重要。就 此意義而言, 在全球法規科學前沿上, 在國家定位中躑躅徘徊的臺灣的「橋上 之聲」 (voice on the bridge) , 具體呈現全球化下, 國家定位、科技政策與身 體管制間STS 研究的挑戰與可能性。

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