Institute of Social Science, The University of Tokyo
Abstract
本稿は,EUの制度的発展の経済的論理を解き明かすために,製薬産業における統合を分析した.まず,経済学文献における制度の取り扱いをサーベイしたうえで,従来の研究の特徴と限界を指摘した.それに統いて,EU製薬産業の統合経緯について,医薬品販売承認手続の統合に即しながら具体的に概観した.そこから明らかになった三つの特徴,即ち,1980年代半ば過ぎからの統合の進展,統合過程における二つの制度の並存,バイオ医薬品の中央申請方式義務付けについて,その説明を試みた.そこからは,不確実性・不完全情報,世界的競争条件,そして,産業的利害と社会的利害の補完・緊張関係が制度生成・発展に大きな影響を及ぼすことが示された.最後に,本稿の分析から得られた知見を他の統合局面,並びに,EU全体の統合分析にどの程度生かすことができるのか,ということを今後の課題として示唆したThis paper analyses the EU integration in the pharmaceutical industry, which has three features. The first is that the integration process began to develop since the mid-1980\u27s. The second is that the two systems, i.e. the ""Decentralised System"" and the ""Centralised System"", co-exist in the development process of the integration. The final one is that the bio-technology products are obliged to use only the ""Centralised System"". The integration process with these features has been influenced very much by the combination of the uncertainty and the imperfect information, the global competitive conditions, and the unique relation-ships between the industrial and social interests. This paper makes clear, to a certain extent, the appropriateness of the Comparative Institutional Analysis (CIA) to examine the institution more than the orthodox economics, but also showed the limit of the CIA to analyse the regional institution such as the European Union
