台灣健保制度下專利到期藥品之競合策略︰以抗憂鬱藥品為例

Abstract

憂鬱症是造成全球成人失能（disability）的第一大負擔，也是世界衛生組織（WHO）預測將成為全球第二大疾病負擔的來源。過去五十年來，全球專利藥廠莫不卯足全力開發抗憂鬱藥物，以在專利保護下享受獨占的利潤。然而，隨著藥品研發創新出現瓶頸，大多數原廠抗憂鬱藥品的專利保護傘已經逐漸失效，而學名藥品（generics）則逐漸取得市場佔有率。為因應此一競爭情勢的轉變，維護專利到期藥品的持續優勢，將是專利藥廠得以存活與持續研發的重要挑戰。 本研究旨在針對在台經營之專利藥廠，因市場受到抗憂鬱學名藥品侵蝕，提供一個兼顧學理基礎與實務可行性的決策思考架構，以管理保護專利到期藥品銷售的策略。文中首先整理我國醫療政策與健保制度中對專利藥品銷售具有影響之因素，包括醫療分層、藥品核價、給付限制、進藥流程與藥價利益分配；其次則進行抗憂鬱藥品市場和產業結構分析，作為規劃競合策略的依據。 最後，針對抗憂鬱學名藥品已然成形的衝擊，本文整理專利藥廠現有的兩類策略行為：聚焦策略和價值基礎策略，並發現其不足建構長期優勢，進而利用價值網概念，發展出七種價值創造之競合策略，分別為產品線延伸、層次型創新、DTC行銷、專利佈局、授權副品牌、結盟研發、以及代工製造，並逐一檢視各種策略可能面臨之學名藥廠競爭反應與在台灣實作之可行性。本研究結果期能提供作為規劃具體可行的長期競合策略之依據，並希望能對於減緩專利藥廠淡出台灣市場的趨勢。

Depression is the disease that has brought the most serious burden of disability of adults in the world. WHO also claimed depression to be the second largest source of costs of disease treatment. During the past 50 years, the majority of pharmaceutical companies were striving to develop antidepressants and becoming prosperous by earning monopolistic profits trough patent protection. However, as time goes, their patent protection have been gone through the end and generic drugs gradually replaced the original ones and gain lion share in the antidepressant market. For the patented drugs, making strategic effort to prolong the monopolistic advantages so as to continuously harvest their blockbusters becomes a critical challenge for major pharmaceutical companies to survive and sustain researches. Through various phased of field work, this study provides an analytical framework of formulating ex-patent strategies for the major multinational pharmaceutical companies in Taiwan who are in antidepressants drug market. To achieve our research goals, we first explore factors that affect sales of patented antidepressants within the institutional context of Taiwan health policy and reimbursement system. These factors include medical classification, approved pricing, limit of indication, purchasing process, and allocation of drug benefit, among others. Next, market and industrial analyses of antidepressants were conducted to create a basis for developing the ex-patent co-opetition strategies. Based on the field interviews, we conclude two types of ex-patent strategies that are adopted by the existing players, focused and value-based strategies, and found that few of them would be sustainable in the nearly future. We then adopt the value net framework and develop seven value-based strategies, including product line extension, layer innovation, direct-to-customer marketing, patent arrangement, secondary brand license, localized R&D alliance, and outsourcing, for the major multinational pharmaceutical companies operating in Taiwan. Evaluations of generics’ responses and strategy feasibility are also discussed.