幹細胞研究與再生醫療產品之法律規範

Abstract

幹細胞相關議題，大致可分為研究方面及醫療應用方面。研究方面又可分為可否研究及來源管制，此部分在先前文獻多所論及，學者多採贊成開放胚胎幹細胞的研究。醫療應用方面可能面臨的法律問題又分為四個重點，包括：再生醫療產品商業化、研究成果保護、研究成果利益歸屬及新生技產品的品管規範問題。現有文獻不足之處在於受限於期刊篇幅，學者只對於特定議題作討論，且多所著重在幹細胞研究議題。碩士論文亦多著重於幹細胞研究容許性之前階段問題，甚少論及幹細胞再生醫療產品之相關爭議，從品質管制角度切入則付之闕如。 因此筆者採取與一般文獻不同的切入點，本論文之研究重點在於我國人民如何使用幹細胞產品獲得治療？是否會由於法規之不足而造成取得之困難？政府應如何介入管制才能帶給人民最適之幹細胞再生醫療照護？此過程涉及複雜之問題，包括人民(病患)、政府(醫療主管機關)及醫院三個主體之公私法問題。本論文擬將重點放在新生技產品商品化所產生之爭議，包括來源取得、儲存與加工及人體利用等，並將提供關於幹細胞再生醫療之研究面、應用面及品質管制提供觀察及分析。本論文亦採用與傳統法學研究所不同之研究方法，除分析近十年的美國法院判決，更以社會學研究方法中之質性研究，對相關人士做深度訪談，並提出實證資料，以期能對幹細胞醫療產品之相關法議題，提出建議並利後續之研究。

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.