台灣學名藥廠之發展趨勢與政策探討

Abstract

台灣製藥產業在2022年達到新台幣961億元營業額，年成長率約4.80%。其中，學名藥在西藥製劑中占據主要營收來源。近年政府也推出不少政策，旨在鼓勵國內學名藥廠增加生產及研發動能，推動學名藥產業蓬勃發展。自2013年二代健保上路後，政府開始實施全民健康保險藥品價格調整作業辦法（Drug Expenditure Target，DET），逐年調整藥品價格以增加新藥可近性。然而，這對於競爭逐漸激烈的學名藥市場產生了深遠影響，再加上2020年COVID-19疫情爆發，加劇全球原料藥供應問題，促使台灣政府正視學名藥品供應問題，在2023年承諾研議輔導獎勵措施，更開始草擬健保藥品政策改革方案相關法規修正草案，鼓勵國內藥廠投入或擴充生產，以達到扶植國產學名藥，確保民眾用藥無虞的目標。

本研究旨在探討台灣學名藥廠在市場中的發展現況及未來經營趨勢。通過比對現行學名藥相關政策及草案規劃，並進一步參考其他國家的作法，以提出建議。研究方法採用文獻分析法，了解具規模的台灣學名藥廠在現行健保制度和政策環境下的研發及代理策略，並分析藥廠獲利較高的經營模式與目前發展趨勢。期望透過對學名藥廠的深入分析，為政府及產業界提供有價值的參考，幫助台灣學名藥產業永續發展。

In 2022, Taiwan's pharmaceutical industry achieved a revenue of NT$96.1 billion, with an annual growth rate of approximately 4.80%. Among these, generic drugs accounted for the major revenue share in the Western pharmaceutical preparations sector. Over the years, the government has introduced numerous policies aimed at encouraging domestic generic drug manufacturers to enhance their production and research capabilities, thereby promoting the robust development of the generic drug industry. Since the launch of the second-generation National Health Insurance (NHI) in 2013, the government has implemented the Drug Expenditure Target (DET) system, adjusting drug prices annually to improve the accessibility of new medications. However, this has had a profound impact on the increasingly competitive generic drug market. Additionally, the outbreak of COVID-19 in 2020 exacerbated global active pharmaceutical ingredient supply issues, prompting the Taiwanese government to address the generic drug supply problem. In 2023, the government pledged to consider incentive measures and began drafting amendments to regulations related to the NHI drug policy reform plan, encouraging domestic manufacturers to invest in or expand production to support domestic generic drugs and ensure a stable supply of medications for the public. This study aims to explore the current development status and future business trends of generic pharmaceutical companies in Taiwan. By comparing existing policies and draft plans related to generic drugs, and further referencing practices from other countries, we seek to provide specific recommendations. The research employs a literature analysis method to understand the R&D and agency strategies of Taiwanese generic pharmaceutical companies under the current health insurance system and policy environment. Additionally, it analyzes profitable business models and current development trends. Through an in-depth analysis of generic pharmaceutical companies, this study hopes to offer valuable insights to the government and industry, supporting the sustainable development of Taiwan's generic pharmaceutical industry.