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系統識別號 U0002-0102201213112600
中文論文名稱 歐盟醫藥業適用競爭法中「濫用市場優勢地位」之研究
英文論文名稱 A Study on Abuse of Market Dominant Position under EU Competition Law-Case of Pharmaceutical Industry
校院名稱 淡江大學
系所名稱(中) 歐洲研究所碩士班
系所名稱(英) Graduate Institute of European Studies
學年度 100
學期 1
出版年 101
研究生中文姓名 莊喬燕
研究生英文姓名 Chiao-Yen Chuang
學號 698290292
學位類別 碩士
語文別 中文
口試日期 2012-01-11
論文頁數 114頁
口試委員 指導教授-曾秀珍
共同指導教授-林立
委員-陳麗娟
委員-蘇宏達
中文關鍵字 優勢地位  歐盟競爭法  醫藥業 
英文關鍵字 Dominant Position  EU Competition Law  Pharmaceutical Industry 
學科別分類 學科別社會科學區域研究
中文摘要 歐盟競爭法中禁止企業濫用優勢地位,為維護內部市場秩序的重要規範之一,適用於歐盟各項產業;但由於醫藥業因為具有其經濟、社會保險、安全與健康等重要影響,所以受到會員國國家的嚴格管制,也因此造就歐盟藥品市場為一受到國家干預的不完全競爭市場;在此情形下,歐盟又受限於條約賦予的有限職權,無法有效的協調整合會員國在醫藥規範之分歧,加上藥品專利保護的強烈需求作用下,使醫藥業具有不同於其他的特殊性。
而且根據本文對於目前相關案例的判決過程之分析,證明歐盟醫藥業仍然適用競爭法的規範,但在滿足歐盟運作條約第102 條之法定構成要件時,容易產生判別上的困難;除此之外,檢驗相關案例的判決結果,第一起醫藥業濫用市場優勢地位的AstraZeneca 案現階段仍未有終局判決,而Syfait 案與Lélos案又以「非當然濫用市場優勢地位」作結,證明醫藥業的行為是否能確實構成濫用優勢地位實屬不易。
英文摘要 The law of prohibition from abusing of dominant position under the EU competition law is one of the most important rules to maintain the order of the internal market and applied to all sectors in Europe. But owing to the great influence on economics, social security, national safety and health insurance, the pharmaceutical industry in Europe is close confined by most member states, which forming the medicines trade an incomplete competitive market with state intervention; besides, EU cannot integrate the differences between the member states effectively with restricted competence by treaties, plus the strong needing of the patent rights, leading the pharmaceutical industry to have its specific characteristics.
According to the analysis of the judgments of relative cases in this article, EU pharmaceutical industry still applies the regulation of competition law. For all that, there are lots of difficulties when satisfying the legal conditions of article 102 TFEU; nonetheless in light of the judgments of these cases: the case Astrazeneca, which the first abuse dominant position case by pharmaceutical undertakings, doesn’t given the final judgment currently; and the result of the cases Syfait and Lélos as “company of GSK AEVE didn’t violate the regulation of abusing market dominant position.” in conclusion, the conducts of pharmaceutical industry indeed constituts abuse of dominant position is not that easy.
論文目次 第一章 緒論 .........................................................................................................1
第一節 研究動機與目的.............................................................................1
第二節 研究方法.........................................................................................2
第三節 文獻評論.........................................................................................3
第四節 研究範圍與限制.............................................................................6
一、研究範圍.......................................................................................6
二、研究限制.......................................................................................7
第五節 研究架構.........................................................................................7
第二章 歐盟藥品市場之建立與發展.................................................................9
第一節 歐盟醫藥品市場概況.....................................................................9
一、醫藥業之發展...............................................................................9
二、醫藥業之特色.............................................................................12
三、藥品管制之必要.........................................................................17
第二節 醫藥業之相關規範.......................................................................18
一、會員國之藥價管制.....................................................................19
二、歐盟之共同規範.........................................................................24
第三節 歐洲藥品專利規範的調和.........................................................28
一、會員國專利法規之分歧.............................................................29
二、歐洲藥品專利規範之整合.........................................................29
第四節 小結 ...............................................................................................39
第三章 醫藥業適用競爭法中「濫用優勢地位」之分析.................................41
第一節 競爭法之「濫用市場優勢地位」要件.......................................42
一、「企業」與「相關市場」...........................................................43
二、「優勢地位」與「濫用行為」...................................................47
三、醫藥業中處方藥品的適用情況.................................................54
第二節 醫藥業適用「濫用優勢地位」...................................................55
一、醫藥相關市場.............................................................................55
二、專利之優勢地位.........................................................................61
三、專利權濫用行為.........................................................................62
第三節 藥品專利與市場競爭的法律關係...............................................63
一、智財權與競爭法之法律關係.....................................................64
二、藥品專利與關鍵設施.................................................................66
三、藥品平行貿易與競爭法.............................................................67
第四節 小結 ...............................................................................................69
第四章 醫藥業濫用優勢地位之案例分析.......................................................73
第一節 AstraZenenca 案..........................................................................73
一、事實 .............................................................................................74
二、法律爭點.....................................................................................74
三、普通法院判決.............................................................................77
四、評析 .............................................................................................79
第二節 Syfait 案/Lélos 案.........................................................................82
一、Syfait 案......................................................................................83
二、Lélos/ Syfait II 案.......................................................................84
第三節 小結 ...............................................................................................89
第五章 結論 .......................................................................................................91
一、不完全競爭下的歐洲藥品單一市場.........................................92
二、專利藥品仍適用歐盟競爭法的規範.........................................93
三、公眾健康權(生命權)與專利權(財產權)的法益平衡.....94
參考文獻 .............................................................................................................96
附錄一 歐盟會員國醫藥法規與主管機關.....................................................104
附錄二 歐盟會員國藥品定價(供給面:定價、預算、產業與給付) .......107
附錄三 歐盟會員國藥品定價(需求面:醫師、病患與藥劑師) ...............108
附錄四 歐盟人類用藥相關規範(依時間序) .............................................109
附錄五 歐盟會員國專利法規......................................................................... 111

圖目錄
圖 1:全球醫藥業發展(2010 年)(依地區)(%) .......................................... 11
圖 2:全球醫藥業成長率(2004-2009 年) (%) ................................................ 11
圖 3:全球醫藥業新藥銷售(2005-2009 年) (%).............................................. 11
圖 4:歐盟醫藥業研發投資成長率(2008 年) (%) .........................................13
圖 5:美國與歐盟藥品研發投資成長率(1996-2010 年) (%) ........................14
圖 6:歐盟會員國藥品平行貿易成長(2004-2008 年) (%) ............................15
圖 7:藥品平行貿易供應途徑(線條較深者) ..............................................17
圖 8:醫藥業跨領域發展..................................................................................18
圖 9:藥品市場供需流程..................................................................................21
圖 10:歐盟藥品取得上市許可程序................................................................28
圖 11:學名藥生產成本組成(%) ....................................................................33
圖 12:全球學名藥生產(2007 年) (%) ...........................................................34
圖 13:學名藥發展影響之層面........................................................................35
圖 14:歐盟執委會專利爭端解決監督機制....................................................36
圖 15:執委會兩階段專利爭端解決及監督(2010-2011 年) (%) ..................37
圖 16:歐盟運作條約第102 條(企業濫用優勢地位)之法律構成要件....42
圖 17:優勢地位之定義....................................................................................48
圖 18:處方藥供應............................................................................................55
圖 19:醫藥業濫用優勢地位之構成要件........................................................70
圖 20:AstraZeneca 案企業濫用優勢地位之判別..........................................80
圖 21:Syfait 案與Lélos/ Syfait II 案企業濫用優勢地位之法律構成要件88
圖 22:歐盟醫藥業適用競爭法中「濫用市場優勢地位」之法律分析........92

表目錄
表 1:歐盟有關公衛醫藥政策之權限..............................................................26
表 2:歐盟人類用藥專利權相關規範(依時間序) ......................................32
表 3:Glaxo Wellcome/Smithkline Beecham 案相關產品市場.....................58
表 4:Glaxo Wellcome/Smithkline Beecham 案抗病毒型藥物(J5B)市佔率61
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