美國個人化醫學發展淺析－以法制問題暨其對策為中心

Analysis of Personalized Medicine in the U.S.A. Focused on Regulation and Policy

顏上詠(Shang-Yung Yen) ； 唐淑美(Shu-Mei Tang)

《醫事法學》 18卷1期 (2011/06) Pp. 21-31

摘要

個人化醫學(personalized medicine)的技術、商品與服務，結合近代的科學知識，如基因工程、分子生物學等，以及電腦與網路等資訊通訊科技設施，成爲在美國醫療與健康照護系統中快速興起的領域。根據定義，個人化醫學爲針對個別病患所特有的病徵，來進行專屬的治療，不僅提供專屬的藥品與醫療元件，以滿足醫師與病患於醫療與健康照護上的需求，同時也針對易罹患特殊疾病的次群體，提供適當的診斷與治療。本文擬從新興科技發展所可能出現的法律與制度上之影響、問題與可能的相關對應爲中心，對於身處尖端醫學發展中心的美國經驗，提出研究與探索。最後，對於該等科技發展尚處於探索與學步期的台灣而言，提供了未來可能遭遇的相關政策因應借鏡與可能之初步應變的法制對策。

關鍵字

個人化醫學 ； 反基因資訊歧視法案 ； 告知後同意

並列摘要

Personalized medicine and its related commodities and services, accompanying with modern science, such as genetic engineering, molecular biology, computer, networking and other IT facilities/equipments, have become a fast emerging field in the U.S. medical health-care system. By definition, personalized medicine refers to the specific treatments targeting at individual patient's symptoms. It not only can meet the needs of both the physician and patient by providing personal medication and treatment, but also provide diagnosis and treatments specially designed for the sub-group patients prone to special diseases. Based on the cutting-edge of U.S.'s experience, this paper intends to investigate the issues and impacts of legal and institutional system for this emerging technology. Finally, certain related policy and legal countermeasures are proposed for Taiwan's personalized medicine which is still in its initial stage.

並列關鍵字

Personalized Medicine ； Genetic Information Non-Discrimination Act of 2008 ； Informed Consent

參考文獻

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Genome. gov. (2011, January 16). Genetic Information Nondiscrimination Act (GINA) of 2008. Retrieved May 27 , 2011 , from http://www.genome.gov/24519851

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