CAR-T細胞治療技術之法律管理制度

TMUIR > College of Humanities and Social Sciences > Graduate Institute of Health and Biotechnology Law > Dissertations/Theses > Item 987654321/64970

Please use this identifier to cite or link to this item: http://libir.tmu.edu.tw/handle/987654321/64970

Title:	CAR-T細胞治療技術之法律管理制度 The legal and regulatory framework for CAR-T cell therapy technology.
Authors:	林語婕 LIN, YU-JIE
Contributors:	醫療暨生物科技法律研究所碩士班何建志
Keywords:	CAR-T細胞治療;細胞治療製劑;個體化醫療;病人權益;受託開發製造生產(CDMO);不良反應;救濟措施 CAR-T cell therapy;Cell therapy products;Patient rights;Contract Development and Manufacturing Organization (CDMO);Adverse reactions;Remedial measures
Date:	2024-01-16
Issue Date:	2025-01-06
Abstract:	CAR-T細胞治療，近幾年引起了廣泛關注，是一種新興的癌症治療方法，透過採集患者的免疫細胞，經過體外擴增或基因改造後，製成生物製劑，重新注入到患者體內，強化其免疫系統，對抗或消滅癌細胞，主要針對個別患者的癌細胞特性，提供量身訂做的個體化細胞治療藥物，提高治療效果。本論文藉由相關文獻回顧，並以第一個取得FDA許可的諾華藥廠Kymriah藥物為案例，從CAR-T醫療技術的發展原理跟應用現況開始，施行時的風險與可能發生的爭議，討論台灣目前對於CAR-T細胞治療的管理，以及CAR-T細胞治療技術實施時，應注意的法律規範，同時探討細胞治療藥物的製造標準與管理、跟長期風險監測的必要性，對於病人權益的影響。鑑於CAR-T細胞治療乃新興的醫療技術與藥物，整體發展過程中曾經有一系列的智財權紛爭，於此同時，在不斷的專利訴訟跟商業併購過程中，形成藥物的關鍵技術集中於特定藥廠，為了降低此類高價藥物的生產成本，促進藥物更可及，逐步發展出技術授權，受託開發製造生產的「CDMO」（Contract Development and Manufacturing Organization）商業模式，法規跟產業之間，透過多方合作的互動，對於藥品的可及性產生實質性的影響，但也由於契約多層化，造成法律關係複雜，可能發生系統化管理的困難跟長期違約風險，再者，施行CAR-T細胞治療臨床技術的資格管制，到個體化生物藥劑的生產許可與查核，目前仍以醫事法跟藥事法進行雙向監理，落實於產業發展前，法規上需要更深化的審查，並持續釐清專業醫療機構跟生技產業各方參與時的法律關係與責任，才能落實對病人權益的保障；文末，針對美國、日本、韓國，以及台灣對CAR-T細胞治療技術的健保給付政策提出探討，期待藉由本研究，對CAR-T細胞治療的法規管理後續發展，提出參考與建議。 "CAR-T cell therapy” has garnered widespread attention in recent years as an emerging cancer treatment method. This approach involves collecting a patient's immune cells, expanding or genetically modifying, creating a biopharmaceutical product, and reinfusing it into the patient's body. This process strengthens the immune system to combat or eliminate cancer cells, targeting the specific characteristics of individual patients' cancer cells and providing personalized cell therapy drugs to enhance treatment effectiveness. This thesis conducts a comprehensive review of relevant literature, using the first FDA-approved drug from Novartis, Kymriah, as a case study. It starts by exploring the development principles and current applications of CAR-T medical technology, discussing the risks and potential disputes during its implementation. Furthermore, the paper delves into Taiwan's current regulatory management of CAR-T cell therapy, considering aspects such as the legal and regulatory framework for CAR-T cell therapy, standards and management of cell therapy drugs, and the necessity of long-term risk monitoring for patient rights. Key drug technologies in CAR-T therapy are concentrated in specific pharmaceutical companies due to ongoing patent litigation and commercial mergers. The emergence of the Contract Development and Manufacturing Organization (CDMO) business model, involving technology licensing and outsourced manufacturing, aims to reduce production costs and enhance drug accessibility. The interplay between regulatory relaxation and industry development, facilitated through collaborations, significantly impacts drug accessibility. Complex contractual relationships pose risks of systemic management issues. Simultaneously, qualification control for implementing CAR-T cell therapy, from permits to personalized biopharmaceutical production, is regulated by both the Medical Act and the Pharmaceutical Affairs Act in Taiwan. Full implementation in the medical institute and biotech industry requires a deeper examination, emphasizing the need to clarify legal relationships and responsibilities to safeguard patient rights. The paper concludes with a discussion on health insurance reimbursement policies for CAR-T cell therapy in the United States, Japan, South Korea, and Taiwan, aiming to provide reference and suggestions for the future regulatory management development of CAR-T cell therapy.
Description:	碩士指導教授：何建志口試委員：賈文宇口試委員：李崇僖口試委員：何建志
Note:	論文公開日期：2024-01-26
Data Type:	thesis
Appears in Collections:	[Graduate Institute of Health and Biotechnology Law] Dissertations/Theses

Files in This Item:

File	Description	Size	Format
index.html		0Kb	HTML	164	View/Open

Loading...