由歐盟Avastin/Lucentis案談我國藥品標示外使用的若干問題【醫法新論】 試閱
EU Avastin/Lucentis Case and Several Issues on Drug Off-label Use in Taiwan
歐盟Avastin / Lucentis案涉及藥品標示外使用問題，羅氏與諾華兩藥廠分別在義大利、法國等國因違反競爭法而受處分。在競爭機關介入調查之前的相當期間，各國皆出現積極的社會倡議及辯論，要求癌症用藥Avastin若用於治療眼科「老年性黃斑部病變」，也就是將Avastin作標示外使用，國家衛生體系應予給付，以減輕持續支付高價Lucentis造成的財務負擔。法國2009年因Mediator案醜聞催生了陽光法案，同時也建立「暫時建議使用」制度，使主管機關有權力允許特定藥品作標示外使用，而有擴張藥品上市許可範圍的實效。即使Avastin/Lucentis案在歐盟持續爭議多年，但國內對該案卻十分陌生。我國現行規定藥品為標示外使用者，全民健保不予給付，亦不得申請藥害救濟，不過兩項藥品分別只應用於癌症及眼科疾病的治療時，則已納入健保給付等，有效地降低Avastin標示外使用的誘因。我國缺乏類似應將Avastin作標示外使用納入全民健保給付的社會倡議，故相關議題極少被討論。對於藥品標示外使用，多年來主管機關採取消極不禁止的立場，但法制上定位不明確，成為法規空白的區塊，運作的結果對患者並不友善。當前有關藥品廣告的法令，亦不足以涵蓋「貶抑」或「詆譭」競爭藥品的行銷行為，實有待公平交易委員會與衛生福利部相互合作，彼此支援執法必須的專業知識與資訊，共同實現藥品市場管理的目標。歐盟 Avastin / Lucentis案展示了跨領域、跨機關合作的典範模式，值得參考借鑑。
EU Avastin / Lucentis Case comes against the backdrop of off-label use for drug. Both pharmaceutical manufacturers, Roche and Novartis, were fined by competition authorities in Italy and France respectively due to the violation of competition law. Before the intervention of competition agencies, there were vigorous societal advocates in these two countries asking for including Avastin, originally authorized for the treatment of a certain kinds of cancers, in the list for drug to be reimbursed by the national health systems (NHS) when it is used off-label for the treatment of age-related macular degeneration (AMD), even though there is already an authorized drug, i.e., Lucentis, on the market as a therapeutic alternative for AMD. Because the pricing for Lucentis is usually several times higher than Avastin, it is believed that, by paying Avasin instead of Lucentis, the effect of alleviating the drug expenditure for NHS is possible. In France, the Mediator scandal in 2009 paved the way for introducing the temporary recommendation for use (RTU). RTU eventually allow the national authority to grant the RTU for a specific drug to be off-label used and de facto expands the drug’s indications. In 2015, the French drug safety agency granted Avastin the RTU status for the treatment of AMD for the first time. In contrast with the situation in the EU countries, Avastin / Lucentis Case is hardly heard in Taiwan and the relevant issues have been rarely discussed in our society. The existing rules and regulations, such as drug off-label use won’t get reimbursed by our National Health Insurance (NHI), and any injury resulting from drug off-label use is not allowed for drug injury relief, etc., have significantly lowered the incentives for off-label drug prescriptions and uses. The nature and status of off-label prescription in our legal system has not yet clarified, and there is an empty space when it comes to rules to be applied for drug offlabel use. The overall consequences due to the application of current policy and rules for drug off-label use are unfriendly for patients. For many years, our public health authorities have been passive for regulating the practice of off-label prescription. Our existing regulations for medicinal products advertisement are also insufficient to cover disparaging or denigrating competitors’ medicinal product, which is the type of promotional conduct by Roche and Novartis in the case under discussion in this paper. Avastin / Lucentis Case is an exemplary model for cross-discipline integration and cross-agency cooperation, which is the exact pattern that our respectively responsible authorities, i.e., both competition and health authorities, should learn together.
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