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由競爭法觀點談「藥品標示外使用」-以歐盟 Avastin/Lucentis 案為中心(Competition Law Perspectives on Off-Label Drug Use--The EU Avastin/Lucentis Case Study and Its Implications)
編著譯者: 魏杏芳
出版日期: 2023.04
刊登出處: 台灣/醫藥、科技與法律第 28 卷 第 1 期/1-40 頁
頁  數: 40 點閱次數: 107
下載點數: 160 點 銷售明細: 權利金查詢 變更售價
授 權 者: 國立清華大學科技法律研究所 授權者指定不分配權利金給作者)
關 鍵 詞: 標示外使用Avastin/Lucentis案「目的」限制競爭集體支配地位貶抑行為
中文摘要: 「藥品標示外使用」(off-label use)意指醫師未依照已核准標示之藥品適應症而為處方用藥的行為,這在醫療實務上十分普遍,除了對患者可能造成健康風險之外,「藥品標示外使用」也引發是否違反競爭法的爭議。Avastin(癌思停)原適用於特定腫瘤疾病的治療,羅氏藥廠擁有 Avastin 在歐盟從事商業利用的權利;Lucentis(樂舒晴)的主要適應症則是「新生血管型老年性黃斑部病變」(AMD),其在歐盟上市許可的權利人則是諾華集團。醫療實務發現,如果以 Avastin 治療 AMD,也會有正面效果,歐美多項臨床研究皆顯示,Avastin 作標示外使用與 Lucentis 效果是相同的,故此種用法被廣泛應用在眼科,使 Avastin 與 Lucentis 彼此有競爭關係。但在價格方面,用於眼科注射,在美國 Lucentis 的價格比 Avastin 貴 20 倍以上,在歐洲兩藥品也有極高的倍數價差,另外各國健保給付制度也會影響醫師開藥的選擇。
2014 年 2 月,義大利競爭機關認定羅氏與諾華兩大集團違反歐盟運作條約第 101 條,處以鉅額罰鍰。理由是兩事業在科學上仍不明確的情況下,共謀對醫藥界及患者散布 Avastin 用於眼科治療的風險訊息,目的在降低對 Avastin 的需求,以便從 Lucentis 的銷售中獲利。2018 年 1 月歐盟法院以「先決判決」作成法律解釋,認定羅氏與諾華兩事業散布誤導資訊的行為,其性質屬於歐盟運作條約第 101(1)條所稱的「目的」限制競爭。就相同的基礎事實,法國競爭機關則是將諾華、羅氏及羅氏子公司 Genentech 三家藥廠視為單一主體,以其濫用「集體支配地位」違反歐盟運作條約第 102 條為由裁罰。
歐盟一向重視積極執行競爭法以促進藥品市場競爭,統計顯示,羅氏與諾華兩大藥廠 2020 年在我國的銷售金額高居首位及次位,為我國藥品市場的主要廠商,兩藥廠在我國是否也有散布貶抑競爭者資訊的行為,值得公平交易委員會及醫藥主管機關正視,兩機關應密切合作,共同提升藥品市場的競爭法執法力度。
英文關鍵詞: off-label useAvastin/Lucentis Caserestriction of competition“by object”collective dominancedisparagement practice
英文摘要: An approved drug for an unapproved use, i.e. off-label drug use, is quite common in health and medical practices globally. Accepting off-label drug use and including those drugs into national health insurance system are highly controversy among interest parties including drug makers and pharmaceutical society, particularly when the off-label drugs are equal in terms of efficacy to the approved medicines for the approved indications whereas cost much less in price than the latter. The EU Avastin/Lucentis Case highlights the relevant substantial issues from the perspectives of competition law.
Avastin, whose commercial exploitation in the EU was entrusted to the Roche group, was authorized for the treatment of certain kind tumorous diseases since 2005. In 2007 the EU Commission granted a marketing authorization to Lucentis for the treatment of neovascular age-related macular degeneration (AMD) and the right holder for Lucentis’ commercialization in Europe was the Novartis group. The prescription of Avastin for the treatment of AMD, i.e., the off-label use of Avastin, was established among ophthalmologists and began to spread worldwide. Several large-scale empirical researches revealed that the unregistered use of Avastin has the equal efficacy as Lucentis used for its approved indication while there was a striking cost-difference between the two medicines.
In 2014 the Italian Competition Authority (ICA) imposed fine on Roche and Novartis respectively for their conduct contrary to Article 101 TFEU on the ground that those two pharmaceutical companies concluded an agreement to disseminate the information, in the context of scientific uncertainty, over the safety of the use of Avastin for the treatment of eye diseases and to create doubts among doctors and patients. In a preliminary ruling granted by the European Court of Justice on January 2018 for the matters referred to by the Italian court, the Court ruled that an arrangement between two undertakings marketing two competing medicinal products but disseminating misleading information relating to adverse reactions resulting from the off-label use of one of those products with a view to reducing the competitive pressure it exerts on the other product, constitutes a restriction of competition “by object”. In September 2020, based on the similar background and facts as the Italian case but with different analytical approach, the French Competition Authority fined Novartis, Roche and Genentech for abusing their collective dominant position by implementing disparagement practices in the French market for the treatment of AMD and infringing Article 102 TFEU.
European Commission has used vigorous competition enforcement as a tool for the fulfillment of EU policy, e.g., affordable drug price and incentives for innovation, in pharmaceutical sector. After studying the Avastin/Lucentis Case, reconsidering and reflecting the medicinal product market in Taiwan, the author suggests, given the fact that multinational pharma companies such as Roche and Novartis are competitive and important participants in our domestic market, the similar strategies and practices like the disparagement practices discussed in this article might be deployed in Taiwan and probably do harm to our industry and ultimately to consumers. The competent authorities, i.e., Taiwan Fair Trade Commission (TFTC) and Taiwan Food and Drug Administration (TFDA), should cooperate closely and comprehensively monitor this sector in order to upgrade the competition enforcement and therefore enhance the competition of pharmaceutical market in Taiwan.
目  次: 壹、前言
貳、歐盟 Avastin/Lucentis 案的「藥品標示外使用」爭端
  一、與 Avastin/Lucentis 案有關的「藥品標示外使用」概況
  三、歐盟法院對 Avastin/Lucentis 案適用競爭法的解釋
參、歐盟 Avastin/Lucentis 案適用競爭法評析
肆、歐盟 Avastin/Lucentis 案對我國的啟示-代結論
  一、貶抑行為(disparagement practices)為藥廠常見的反競爭行為類型,值得關注
魏杏芳,由競爭法觀點談「藥品標示外使用」-以歐盟 Avastin/Lucentis 案為中心,醫藥、科技與法律,第 28 卷 第 1 期,1-40 頁,2023年04月。