| 摘要: | 近年隨著生物科技的迅速發展，特別是在人工智慧（Artificial Intelligence，縮寫為 AI）和資訊和通訊技術（Information and Communication Technology，縮寫為ICT）結合的醫材領域，新興技術如基因編輯（Gene Editing）在診斷和治療中的應用正在迅速擴展。這些技術的進步雖為醫療治療帶來前所未有的可能性，但同時也對現有的法律框架提出重大的挑戰。現行法律需要不斷更新和調整，以確保能夠有效保護患者權益、數據隱私以及維護道德倫理標準。臺灣現有的法律框架是以《藥事法》為首，後因一些產品如醫療器材與藥品的差異越來越大，所面臨必須進行調整的壓力，後修訂《醫療器材管理法》訂立的特別法或補充性規範，已具有針對性、彈性高，但應受限於母法架構或與其協調。
當今科技快速演進深刻影響社會結構、環境資源分配與企業的再投資意願，特別是在生技醫藥領域，科技進步既帶來巨大的經濟效益與醫療創新，也伴隨著倫理爭議、智慧財產壟斷與社會不平等等問題。如何在追求產業創新與經濟成長的同時，妥善回應生物倫理的挑戰、維護資源公平性、保障個人權益，以及兼顧智慧財產權的保護與知識的合理共享，已成為法律制度面臨的重大考驗。這些問題著測試法律規範的彈性與調適能力，更對制度如何支撐企業永續經營與公共利益保障提出挑戰。透過對制度設計與產業實務的綜合分析，本研究旨在提供具彈性、正當性與前瞻性的法制建議，作為主管機關修法與施政參考，協助引導臺灣生技醫藥產業穩健成長。;In recent years, the rapid development of biotechnology—particularly in the field of medical devices integrating Artificial Intelligence (AI) and Information and Communication Technology (ICT)—has significantly expanded the application of emerging technologies such as gene editing in diagnosis and treatment. While these advancements offer unprecedented possibilities for medical innovation, they simultaneously pose serious challenges to existing legal frameworks. Continuous updates and adjustments to current laws are necessary to ensure the protection of patient rights, data privacy, and ethical standards.
Taiwan’s existing regulatory system is primarily based on the Pharmaceutical Affairs Act. However, due to the increasing divergence between product types—such as pharmaceuticals and medical devices—there has been growing pressure to revise existing regulations. This led to the enactment of the Medical Devices Act, a special or supplementary law offering greater specificity and regulatory flexibility. Nevertheless, such laws must still align with, or remain subject to, the overarching structure of the parent legislation.
The rapid pace of technological innovation is profoundly reshaping social structures, resource allocation, and corporate reinvestment incentives. In the biotech and pharmaceutical sector in particular, technological progress brings both substantial economic benefits and transformative medical advancements, yet also raises concerns surrounding bioethics, intellectual property monopolies, and social inequality. Balancing industrial innovation and economic growth with the ethical challenges of
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biotechnology, equitable distribution of resources, protection of individual rights, and the tension between intellectual property protection and knowledge sharing has become a pressing legal issue.
These developments not only test the flexibility and adaptability of legal norms, but also challenge the capacity of regulatory systems to simultaneously support sustainable business development and protect public interests. By analyzing the interplay between legal design and industry practices, this study aims to offer legal recommendations that are flexible, legitimate, and forward-looking—providing a valuable reference for regulators in future legislative reform and policy planning, and contributing to the steady growth of Taiwan’s biotech and pharmaceutical industry. |
