由歐盟孤兒藥案件談競爭法與藥品超額定價問題【醫法新論】 試閱
EU Orphan Drug Cases and Tackling Excessive Drug Pricing by the Enforcement of Competition Law
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。
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.
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