法學期刊
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論著名稱:
由歐盟孤兒藥案件談競爭法與藥品超額定價問題(EU Orphan Drug Cases and Tackling Excessive Drug Pricing by the Enforcement of Competition Law)
文獻引用
編著譯者: 魏杏芳
出版日期: 2023.06
刊登出處: 台灣/月旦醫事法報告第 80 期/116-136 頁
頁  數: 13 點閱次數: 258
下載點數: 52 點 銷售明細: 權利金查詢 變更售價
授 權 者: 魏杏芳
關 鍵 詞: UB測試罕見疾病孤兒藥超額定價銷售專屬權
中文摘要: 由於孤兒藥的市場特性以及法定銷售專屬權保護,使藥廠有超額定價誘因,傷害了消費者及國家利益。近年歐盟數會員國接續對同一孤兒藥藥廠以違反競爭法裁罰,是為 Leadiant 案;歐盟執委會也查處安沛(Aspen)藥廠的血癌用藥,是否有違法超額定價情事,此顯示歐盟以競爭法介入藥價管制的趨勢。在個案中歐盟採「UB 測試」,即先「量」後「質」的分析模型,已具有通案性。歐盟競爭法設有禁止支配事業不公平定價的榨取式濫用條款,我國公平法亦有主旨相同的規範,歐盟的執法作為值得參考。
英文關鍵詞: UB testrare diseaseorphan drugexcessive pricingmarket exclusivity
英文摘要: The unique characteristics of orphan drug market and the right of exclusivity provide the incentives for pharmaceuticals to adopt excessive pricing. In recent years, three EU member states' competition authorities had fined the same orphan drug company, Leadiant, due to illegal excessive prices. European Commission also sanctioned Aspen because the medicine manufacture had imposed unfair prices, abused its dominant position and violated the EU competition law. All these facts reflect the trend that EU competition law has been used as a tool to tackle the exorbitantly high drug prices. The "UB test", i.e., cumulatively quantitative and qualitative analyses, is applied in those cases. The rules for prohibiting abuse of dominance in both EU and Taiwan have the common purposes and principles, therefore the practices and enforcement experiences in EU are valuable for use to learn.
目  次: 壹、前言
貳、荷蘭、義大利及西班牙競爭機關處罰 Leadiant 案概述
一、CTX、CDCA 與 Leadiant
二、各國競爭機關展開執法行動
(一)荷蘭
(二)義大利
(三)西班牙
參、歐盟以競爭法處理藥品超額定價的觀察及法律分析
一、執委會對指定 CDCA 為孤兒藥的檢討
二、歐盟以競爭法處理藥品超額定價的趨勢
三、藥品超額定價的競爭分析-「UB 測試」
(一)市場界定與藥廠支配地位
(二)「UB 測試」-「過度定價」與「不公平定價」
四、歐盟以競爭法處理藥品超額定價的省思及其對我國的借鑑意義-代結論
相關法條:
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相關論著:
魏杏芳,由歐盟孤兒藥案件談競爭法與藥品超額定價問題,月旦醫事法報告,第 80 期,116-136 頁,2023年06月。
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