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    题名: 生醫產業環境轉變下台灣罕藥代理商因應策略之研究
    Research on Response Strategies of Taiwan’s Orphan Drug Agents Under the Changing Environment in the Biomedical Industry
    作者: 葉秋香
    Yeh, Chiu-Hsiang
    贡献者: 詹文男
    葉秋香
    Yeh, Chiu-Hsiang
    关键词: 罕見疾病防治及藥物法
    罕病
    罕藥
    PEST
    五力分析
    價值鏈
    Rare Disease and Orphan Drug Act
    rare disease
    orphan drug
    PEST
    Five Forces analysis
    Value Chain
    日期: 2024
    上传时间: 2024-03-01 11:53:59 (UTC+8)
    摘要: 90年代末，台灣社會在患者家屬、醫藥人員、大眾媒體、輿論壓力與政府的努力之下，《罕見疾病防治及藥物法》以創台灣有史以來最快立法之姿，於民國89年1月14日通過，成為全世界第五個立法保障罕病患者用藥權利兼具保障罕病防治效益的專法。
    然而，該法時至今已超過二十幾年，國際間生醫藥產業已大不相同，各國陸續推出罕見疾病藥物(罕藥)開發的獎勵措施、生醫技術也隨著人類基因圖譜的解碼而突飛猛進，從此，罕藥的開發有了蓬勃發展的面貌。對於一開始不著眼於小眾市場的大藥廠，為了能快速進入罕見疾病的領域，紛紛以授權、併購的方式開展研發管線，近年來，罕藥的新藥開發，已逐漸轉變由大藥廠所主導; 此外，中國也因為經濟的起飛，政策上的激勵，也促使藥企以授權引入的方式投入罕藥市場，授權代理的區域常見以「大中華」的範圍將台灣納入其經銷範圍，但在地緣政治不確定的因素下，即使握有台灣的經銷權，是否能被優先開發經營，有其不確定性。
    另外，在國內，罕病法在專家、學者、社會大眾的認同與推動下，有了豐碩的成果，近年來，新興技術開發出來的藥物昂貴，加上罕藥專款的成長不足，已讓罕藥的健保給付面臨到給付不易、審查時程延長、台灣有藥而患者無法醫治的困境。
    本研究利用PEST分析、五力分析探討國內外總體環境與生醫產業的轉變，利用訪談的方式了解台灣罕藥代理商，在其公司經營發展的不同階段，如何利用架構在現有罕病發展的基礎上，仍能保有經營罕病的初心，利用不同階段發展出的核心價值來因應現今的挑戰，以讓公司能達到永續經營的理念。
    In the late 1990s, thanks to patients' families, healthcare professionals, mass media, public pressure, and the government's efforts, the "Rare Disease and Orphan Drug Act" was the fastest legislation in Taiwan's history. It passed on 14th Jan. 1989; it became the fifth legislation in the world to protect the rights of patients with rare diseases to use orphan drugs while ensuring the effectiveness of rare disease prevention and treatment.
    However, the macro environment of the international biopharmaceutical industry has changed over 20 years since this law was passed. Countries have successfully introduced incentives for developing orphan drugs, and biomedical technology has evolved due to human genomic projects. Rapid progress has been made, and since then, the development of orphan drugs has flourished. Big pharmaceutical companies that did not initially focus on niche markets quickly entered the rare diseases field to develop their R&D pipelines through licensing, mergers, and acquisitions. In recent years, the development of orphan drugs has gradually shifted to big pharmaceutical companies. In addition, China's economic boom and policy incentives have also prompted pharmaceutical companies to enter the rare disease market through licensing. Regions of market authorization to the agent often include Taiwan in their distribution scope under "Greater China." However, due to geopolitical uncertainties, even if they hold the distribution rights for Taiwan, it is still being determined whether it can be prioritized for market development.
    In addition, in our country, the Orphan Drug Act has achieved fruitful results with the recognition and promotion by experts, scholars, and the general public. In recent years, the orphan drugs developed by emerging technologies have been expensive, and the need to grow orphan drug budgets has become more difficult. The health insurance benefits for orphan drugs are faced with the difficulty in reimbursements, the prolonged review process, and the fact that Taiwan has orphan drugs, but patients cannot be treated.
    This study uses PEST analysis and Five Forces analysis to explore macroenvironment and microenvironment changes in the biomedical industry in Taiwan and abroad. It uses professional interviews to understand how Taiwan's orphan drug agents are based on current achievements in developing rare diseases and to develop their core values at different stages of their company's development, with the original aspiration of managing business in rare diseases and using the core values developed at different stages to respond to today's challenges so that the company can achieve sustainable management.
    參考文獻: 中文:
    1.司徒達賢，(2016) 策略管理新論：觀念架構與分析方法(三版)。台灣:元照出版。
    2.行政院衛生署食品藥物管理局，(2013)。罕藥彌補愛無憾。 台北市
    3.朱璿尹，(2022)。台灣健保引進罕見疾病用藥的挑戰。2022罕見疾病用藥可近性論壇。
    4.吳昭軍署長國健署，(2022)。罕見疾病防治及藥物法22年來之醫療照護成果。2022 罕見疾病用藥可近性論壇。
    5.黃育文組長健保署，(2023)。歷年罕藥、癌藥及新藥費用之歷年藥費佔率。第106屆藥事論壇「高價、新興藥品暨罕藥支付現況與挑戰」。
    6.黃育文組長健保署，(2023)。罕病藥費專款執行率。第106屆藥事論壇「高價、新興藥品暨罕藥支付現況與挑戰」。
    英文：
    1. Aguilar J. F, (1967). Scanning the Business Environment,” MacMillan Co., New York.
    2. European Commission. (2020) Evaluation of the medicines for rare diseases and children legislation.
    3. EvaluatePharma®. (2015) Orphan Drug Report 2015
    4. Kato T, (2020). The Case of CAR-T Cell Therapy, Mitsui & Co. Global Strategic Studies Institute Monthly Report.
    5. Levine A J, Stemitsiotis C. (2023). De-risking rare disease acquisitions: a win–win–win for patients, biotech and investors, Nature Reviews Drug Discovery.
    6. Porter E.M, (1980). Industry structure and competitive strategy: keys to profitability, Financial Analysts Journal, 36(4), 30-41.
    7. Porter, M.E, (1985).Competitive Advantage: Creating and Sustaining Superior Performance, The Free Press, New York.
    8. United States Government Accountability Office, (2017). Drug Industry: Profits, Research and Development Spending, and Merger and Acquisition Deals.
    網際網路:
    1.中國醫藥創新促進(PhIRDA)，2021年中國創新藥license in 交易Top 10, 上網日期:2021/12/16，檢自: http://www.phirda.com/artilce_26293.html?cId=1
    2.全國法規資料庫，罕見疾病防治及藥物法，檢自：https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0030003
    3.罕病基金會，罕病法歷法大事紀，檢自：https://www.tfrd.org.tw/tfrd/library_a/content/category_id/1/id/15
    4.罕病基金會，歷年公告罕見疾病通報人數，檢自：https://www.tfrd.org.tw/tfrd/rare_b
    5.罕病基金會，公告罕藥、健保給付與涵蓋罕病統計，檢自：https://www.tfrd.org.tw/tfrd/rare_b
    6.罕病基金會，健保給付與涵蓋罕病統計，2023國際罕病日【呼籲貫徹健保罕病新藥執行效率】記者會，檢自: https://www.tfrd.org.tw/tfrd/library_e/content/id/215
    7.張鑫，2020年全球及中國孤兒藥市場現狀分析，我國是全球罕見病單一最大市場，上網日期2021年8月30日，檢自: https://www.huaon.com/channel/trend/743991.html
    8.邱家琳，中國鎖藥危機步步逼近，罕藥首當其衝，上網日期:2022/03/23，檢自: https://www.tfrd.org.tw/tfrd/library_d/content/id/6127
    描述: 碩士
    國立政治大學
    經營管理碩士學程(EMBA)
    106932187
    資料來源: http://thesis.lib.nccu.edu.tw/record/#G0106932187
    数据类型: thesis
    显示于类别:[經營管理碩士學程EMBA] 學位論文

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