政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/133208
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    Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/133208


    Title: 藥廠銷售合作、製藥產業競爭與公平交易法──歐盟產業調查的啟示
    Medical Commercial Co-operation, Competition within the Pharmaceuticals Industry and the Fair Trade Law-Insights from the Results of the EU`s Sector Inquiry
    Authors: 魏杏芳
    Wei, Hsin-Fang
    Contributors: 法律系
    Keywords: 原廠;學名藥廠;反向給付;商業化;共同推廣;共同銷售;域外結合
    Originator Company;Generic Company;Reverse Payment;Commercialization;Co-promotion;Co-marketing;Extraterritorial Merger
    Date: 2016-04
    Issue Date: 2020-12-22 09:42:48 (UTC+8)
    Abstract: 公平交易法原則禁止事業實施聯合行為，然依歐盟執委會 2009 年發布的製藥產業調查，藥廠透過締結協定進行合作的情形十分普遍，原廠尤其熱衷於商業化階段的共同銷售合作，包括共同推廣（co-promotion）、共同行銷（co-marketing）等。此外，原廠與學名藥廠間亦常以經銷（distribution）協議建立藥品銷售合作關係。競爭原廠間的銷售協議倘涉及金錢利益交換，以使協議當事人之一方不進市場為目的，即屬應予禁止的限制競爭，2013 年 Johnson & Johnson 與 Novatis 就止痛藥 Fentanyl 的合作即為著例。至於學名藥的銷售協議，則以「提早進入協議」（early-entry agreement）及涉及利益移轉的「延遲進入協議」（pay-for-delay agreement）或「反向給付」協議（reverse payment agreement）最受關注，其個案值得討論。本文試以歐盟調查報告所呈現的製藥產業特性為基礎，進而介紹歐盟製藥個案適用競爭法的分析；而我國並無類似歐盟的原廠，競爭法議題的本質也不相同，借鏡於歐盟經驗，本文認為我國製藥產業除了競爭之外，亦應有合作概念，而公平法有關聯合行為例外許可及結合管制的相關規定，提供了藥廠合作的法律依據，公平會有必要與衛福部共同致力於藥廠間的競爭與合作倡議，俾利於製藥產業未來發展。
    While the Fair Trade Law in Taiwan in principle prohibits concerted practices between competitors, the Final Report of the Pharmaceutical Sector Inquiry published in 2009 has shown that co-operation between pharmaceutical manufacturers is common in Europe, and encompasses the activities of R&D, manufacturing, and commercialization, although there is a particular focus on co-operation at the stage of drug commercialization. According to the Inquiry Report, distribution agreements concluded between originator companies and generic companies, or co-promotion agreements and co-marketing agreements between originators have been the most commonly seen scenarios, and certain types of co-operation agreements among them have given rise to competition concerns, including the “early-entry agreement” and the so-called “reverse payment”or“pay-for-delay” agreements. Only a limited number of cases with regard to the latter have been included in investigations by the European Commission and have finally benefited under Articles 101（1）or 102 of the Treaty on the Functioning of the European Union（TFEU.）The J&J blockbuster painkiller “Fentanyl” decision adopted by the Commission was such a case due to the agreement having an anticompetitive objective, i.e., value being transferred from one party in exchange for a promise from the other party to continue to stay out of the market.The pharmaceutical industry in Taiwan is different from that in Europe in terms of its level of industrialization and structure, turnover volume in the market and the nature of competition issues. Taiwanese drug companies are encouraged to cooperate in order to upgrade or enhance the industry`s competitiveness. The Fair Trade Law provides the pharmaceutical sector in Taiwan with the legal bases, including provisions related to concerted practices and merger controls, for the realization of co-operation between drug companies. With this purpose in mind, a campaign to increase knowledge and understanding of the Fair Trade Law among pharmaceutical companies should be necessary.
    Relation: 公平交易季刊, 24:2, 81-111
    Data Type: article
    Appears in Collections:[Department of Law] Periodical Articles

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