The Regulation of Stem Cell Research and Regenerative Medicinal Products

• Main Authors: Ying-Chieh Chiu, 邱映潔
• Other Authors: Shang-Jyh Liu
• Format: Others
• Language: zh-TW
• Published: 2008
• Online Access: http://ndltd.ncl.edu.tw/handle/anh26a

碩士 === 國立交通大學 === 科技法律研究所 === 96 === The relevant issues of stem cell could be divided into medical research and clinical practice. Medical research includes permission of research and the control of resources which has been mentioned repeatedly in previous articles. Most scholars agree to open up the research of embryonic stem cell. The legal issues of clinical practice includes four parts, the commercialization of regenerative products, the protection of R&D results, the interest sharing and the quality control of new biological products. Scholars and present theses put emphasis on the research of stem cell and the front stage issues. Therefore, it appears in itself legally a brand new issue both on the reproductive medicinal products and the quality control of stem cell. The study focuses on the usage of therapeutic stem cell products of people in Taiwan and whether the shortage of regulations raises the difficulty of therapy access. Furthermore, how should the government regulate to bring people the best stem cell medicinal care? The process involved people(patients), government and hospital-based issues of public and private law. Following, the present thesis discussed the legal issue of commercialization of new biotechnology products including the resources, storage and process, and human use. The study was set out by the research, application and quality control of reproductive medicine of stem cell. This thesis analyzed the U.S. court decisions of the recent decade. Moreover, it adopted the depth interview of qualitative research and provided empirical information. Finally, this thesis makes some advices for regenerative medicinal products of stem cell for further study.