論細胞治療產品之法律管制

The Legal Regulation of Human Cell Therapy Products in Law System

劉珮汶(Liu, Pei Wen)

指導教授 ： 陳仲嶙

國立清華大學/科技管理學院/科技法律研究所/碩士(2015年)

https://doi.org/10.6843/NTHU.2015.00292

摘要

再生醫學之發展，首重細胞治療。近年，細胞治療在臨床上之使用逐漸成熟，加上老化疾病議題開始受到重視，使細胞治療議題具有重要性和前瞻性。新興科技雖帶來突破性和進步性，但同時亦伴隨未知的風險與安全上的疑慮，因此，歐美各國皆針對細胞治療產品訂定法規規範加以管理。雖我國目前尚未出現細胞治療產品，但已累計有26件細胞治療產品臨床試驗申請案，為妥適管理此類產品，主管機關應建置完善之規範系統。經分析我國醫療產品相關之法規，雖已訂定人類細胞治療產品之相關準則，但立法保護尚未周全而有改善之處。除了定位尚處模糊外，細胞治療產品臨床試驗與查驗登記之管理亦未完備。此外目前細胞治療產品之規範依據係以行政規則組成，未來將如何重新定位細胞治療產品以及提升其規範之位階將是主要之課題。

因此，本文建議應進行醫療產品法規之整合並且檢視人類細胞治療產品於當我國醫藥產品管理架構之定位。其次，有關細胞治療產品之上市前之管理部分，應考量產品之特殊性調整適用現行之藥品加速產品審查程序，換言之，有條件地調整適用現行藥品加速產品審查程序，同時為確保產品之有效和安全性，應建立持續追蹤機制，並妥善履行風險告知義務。

最後，有關細胞治療產品管制密度之分級建議。本文認為在特定情況下，例如醫院使用或臨床試驗時，應可放寬管制之密度，然而，為保護病人安全同時促進研究之發展，未經核准之人類細胞產品若使用於治療疾病，應限於嚴重或威脅生命的情形，換言之，不經治療則疾病將會隨著時間日趨嚴重而顯著地影響病患日常生活功能者。若是為基礎研究而使用時，則應依細胞治療產品之風險高低管理，即隨細胞治療產品之風險高低，予以調整管制密。

關鍵字

再生醫學 ； 細胞治療 ； 人類細胞治療產品 ； 新興治療醫用產品 ； 人類 細胞組織治療產品

並列摘要

The development of regenerative medicine focuses on cell therapy. The application of cell therapy in clinical treatment, which provides a possibility to cure some diseases that used to be incurable, has come of age in recent years, and so it makes the issue of cell therapy become important and forward-looking. Although emerging technologies bring a breakthrough and progress, they are also accompanied with unknown risks and security concerns at the same time. In order to impose regulations on such products, European countries and the United States all engaged in establishing regulations for cell therapy products. Cell therapy products have not appeared in Taiwan yet, but there are 26 clinical trials of cell therapy product application in progress. It is of the utmost importance that authority establishes proper regulatory system for such products. After analyzing current Taiwan medical regulations, the legislation has not been comprehensive even if relevant criteria of human cell therapy products are set. In addition to the vague position of human cell therapy products in current medical legislation, the regulation for clinical trials and registration of cell therapy products remains incomplete. Moreover, existing regulation of human cell therapy product consists of administrative rules. To reposition the human cell therapy products and enhance regulation become the main subjects in the future.

That integrating the medical product regulations and examining the position of human cell therapy products in pharmaceutical products management should be firstly implemented is recommended in this thesis. Secondly, the management of human cell therapy products should base on the unique nature of those products to adjust existing drugs accelerate review process. In other words, conditional adjust current drugs accelerate review process for human cell therapy products. In the same time, to ensure the effectiveness and safety of the products, security tracking mechanism should be established, and inform concern should be properly fulfilled.

Finally, the density of human cell therapy products regulation should base on the purpose of usage. In particular circumstances that products are designed for certain patients in hospital or clinical research and not for sale in market, the regulation density should be loosened. However, in order to ensure the safety of patients while promoting the development of researches, using unapproved human cells products in treatment should be limited in cases of serious illness or illness posing threat to life.
. In other words, the disease will become increasingly serious and significantly affect the patient's activities in daily lives without treatment. On the other hand, if using unapproved human cells products in basic researches, those products should be managed in terms of the risk, namely adjusting the regulation density to the risk of the products.

並列關鍵字

Regenerative Medicine ； Cell Therapy ； Human Cell Therapy Products ； Cell and Tissue Cellular and Tissue-Based Products ； Advanced Therapy Medicinal Product

參考文獻

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