Study on Regulation of Tissue from Living Persons as the Biomaterials

• Main Authors: Ming-Wei Lee, 李明偉
• Other Authors: 李惠宗
• Format: Others
• Language: zh-TW
• Published: 2010
• Online Access: http://ndltd.ncl.edu.tw/handle/45778458701635719632

碩士 === 中興大學 === 科技法律研究所 === 98 === With the rapid development of biotechnology, many products or medical research are based on the tissue from living persons (in vitro tissue) as a raw material or test object. In view of the infringement cases involving in vitro tissue occurred in the recent decades and the regulations of in vitro tissue is insufficient, this study focuses on the legal nature and regulations of in vitro tissue, aiming to clarify whether in vitro tissue meets eligibility conditions for private property and discuss its theoretical foundation of regulations. Regardless of purposes for “public welfare,“ or “technological development,“ the guarantee of academic freedom under the constitution should safeguard the use of in vitro tissue for biomedical research. However, because in vitro tissue is derived from human body, to safeguard personal rights and human dignity, related research should be limited by the scope of researches, institutions, study objects and published results. The premise for such limits is based on the explicit authorization of law and the principle of proportionality. The legal protection of in vitro tissue should be based on its physiological, ethic and economic properties. We think that the value of in vitro tissue causes the creation of economic benefits. From the Locke’s labor theory, this study suggests that the creation of economic interests should be owed to researchers or biotech companies, while providers of in vitro tissue should be compensated through a reward system. On the other hand, in vitro tissue providers do not have the right of possession, use, usufruct and disposition. This study denies the potential of in vitro tissue becoming subjects of private property. Regulations regarding of the in vitro tissue for biomedical applications is based on principles of ethics. Early regulations suggested that principles of ethics include the consent, nonmaleficence and solidarity. Recently, the related law demanded the promotion of informed consent, ethical review, minority rights, researchers'' and sponsors'' obligations. In response to aims of technological growth, the UK and USA had practiced the related regulations of in vitro tissue or its derived objects. Conversely, in Taiwan, regulations on human tissue remain limited to medical purpose. In order to enhance biotechnology industrial competitiveness, Taiwan''s government should invest more resources to establish the comprehensive legal norms.