| 摘要: | 幹細胞研究可謂是目前生物技術、再生醫療領域最為熱門的話題。而胚胎幹細胞因為幾乎能分化為生命體任何型態的細胞，其所帶來的製藥、基因治療、醫療、專利等利益，頗為可觀。然，欲取得胚胎幹細胞必定要破壞胚胎，因此其中之法律、宗教與倫理相關爭議，亦隨研究的進行而持續多年。 iPS細胞雖遲於2006年始被科學家製成，卻迅速躍升為幹細胞研究領域的翹楚。因為其只需要摘取體細胞，透過誘導技術，即可將之轉變為豐富潛能幹細胞。由於iPS細胞之取得來源簡單、製作過程不涉及毀壞胚胎，分化能力又與胚胎幹細胞不相上下。對科學家來說此研究入門技術門檻低、成效佳；對反對胚胎幹細胞研究之論者來說，更是一種取代胚胎幹細胞研究的重要進展。惟iPS細胞並非毫無爭議，除分化效率與安全性等科學考量外，從製作到研究、應用等面向均存在著倫理與法律議題。 鑑於國內外的幹細胞文獻均以胚胎幹細胞為大宗，iPS細胞的探討通常僅止於科學介紹或倫理方面，法學討論甚少。因此筆者嘗試以本國憲法與法律的角度，探討iPS細胞與其衍生精卵的相關問題。就人類生殖細胞的定性而言，本論文以為，人類生殖細胞不受憲法上生命權之保障，而係兼具財產權與人格權性質。而在檢驗現行管制架構時發現，我國現行法規範並非針對iPS細胞而制定的，若切割適用恐會造成法體系間解釋的混亂，有違法律安定性之要求，因iPS細胞之研究和應用會涉及研究自由、當事者權益和重大公益，似有另行建立專門法規的必要性。再者，iPS細胞衍生人類精卵的技術在未來是可以做到的，為了防止該等精卵輕易遭到買賣或濫用，往後在適度開放研究的同時，必須採取限制研究用精卵來源、禁止精卵買賣，和相關監督機制等措施，以避免爭議。至於將該等精卵用於生殖的面向，本論文以為，若此政策將來有開放的可能，施行對象應限於有伴侶的不孕症患者和同性戀者，單身者宜排除在外；且考量到後代子女利益、安全性、人體基因庫多樣性等因素，亦不適合開放人類精卵的基因治療。 由於事涉複雜，相關當事人可能包含人民（體細胞提供者或病患）、主管機關、研究者（研究或醫療機構）。因此在全球iPS細胞研究熱潮中，筆者希望能藉此論文點出可能問題之所在，進而提出建立相關制度的建議，以期在倫理、法律和生物科技間找尋適當的平衡點。The stem cells research is regarded as the hottest topic in the field of biotechnology and regenerative medicine; inter alia, embryonic stem cells bring about large interests and benefits of medicine production, gene therapy, medical treatment and patents, due that they can be differentiated into every mode of cells of lives. Nevertheless, since it is necessary to break an embryo in order to attain embryonic stem cells, there are also many controversial issues in views of law, religion and moral debated along with progressive development of the relevant research. Although very late until 2006, the iPS cells were produced by scientists, they have soon become an outstanding invention in the field of research of stem cells, because they can be transformed from somatic cells into pluripotent stem cells merely by direct reprogramming. For the scientist, the threshold of this technique is low but with remarkable effects, for that the iPS cells are easily obtained, the productive process of them does not involve with breaking embryos, and their capacity of differentiation is equivalent to embryonic stem cells. Moreover, in the eyes of who are against the research of embryonic stem cells, the research of iPS cells has even been taken as a significant advance in substituting the original one. However, the iPS cells are not that undisputable. In fact, besides scientific concerns about the efficiency of differentiation and its safety, there have always been moral and legal controversies from the perspectives of their production, research and application. In light of that abundant treaties concerning stem cells mostly are related to embryonic stem cells, and that the discussions over iPS cells are usually limited to scientific introduction and moral debate; therefore, the author has tried to investigate on the relevant issues to iPS cells and sperm and eggs thereof from the angles of the Constitution and other domestic laws. As to the identification of human gametes, this article proposes that human gametes are characterized with the right to property and right to dignity under the Constitution, rather than being protected by the right to life. Further, in examining the existing regulatory framework, it is observed that the existing domestic legal norms were not codified for iPS cells, so if they are applied separately, it would cause such chaos of interpretation among jurisprudences application, and violation of the principle of legal stability; namely, it seems necessary to establish a set of specialized rules concerning the research of iPS cells owing to its interference with freedom of research, rights and interests of the parties concerned, and significant public interest. In addition, it is possible for the technique of deriving human gametes from iPS cells in the future, the restriction over source of sperm and eggs on the purpose of research, prohibition on trade of sperm and eggs and relevant monitoring mechanisms shall be taken, in process of moderate openness of research, in order to prevent such sperm and eggs from being traded or abused, and to avoid any dispute in question. With respect to the issue of application of such sperm and eggs to reproduction, this article proposes that if there is any probability of freedom thereof provided by policy in the future, the scope of the law at issue should be limited to the patients of infertility who have a spouse, and gay and lesbian couples; namely, the single persons are better excluded. Besides, taking the factors of the best interests of the future child, safety, diversity of human gene pool and so on into account, it is also inappropriate to accept germ line cell gene therapy. Because of complexities, the parties concerned might include people (cell providers or patients), authority and researchers (research or medical institutions); hence, in the global trend of iPS cells research, the author hope to point out the possible problems at issue in this article, then to propose such establishment of pertinent legal schemes and mechanisms, in order to properly balance among morals, laws and biotechnology. |
