幹細胞運用之法律評析

Abstract

幹細胞是原來即已存在生命發展中某一階段的原始細胞，因其原始性，使幹細胞能進而分化成身體其他多種類型的細胞。其同時具有潛能，可形成真正人體的所有組織和器官，以供醫療之用。當1998年美國威斯康辛大學Dr. James Thomson分離出人類多能性幹細胞後，不啻宣告幹細胞將於生物技術發展上領一時風騷。近來更由於幹細胞技術的快速進展，用幹細胞治療許多疑難病症包括：巴金森氏症、阿茲海默症、脊柱損傷、中風、燒傷、心臟病、糖尿病、骨關節炎、類風濕性關節炎。未來提供器官移植，以及康復、保健，減輕老化、恢復青春活力等等廣泛應用於臨床似乎已為期不遠；此外藥物的安全性和有效性可以利用特定幹細胞進行分析和篩選，動物幹細胞可作類似桃莉羊之品種改良。但在這美好的願景下，相對地也隱藏著世人的不安，其爭議範圍也由倫理道德擴及至法律體系的衝擊。在幹細胞研究上最引發爭議的就是利用胚胎幹細胞之研究，由於要取得胚胎幹細胞必須摧毀或破壞所使用的胚胎，因此這項研究所引發的各方爭議如排山倒海洶湧而至。另外醫療性複製與生殖性複製(複製人)只有一線之隔，如何在倫理道德與法律上求其平衡，亦不斷地考驗著世人的思維。本研究利用比較外國及本國法律和文獻，針對幹細胞管制的相關可能產生之法律爭點，提出相關爭議並予以探討。此外成體幹細胞於臨床上運用，如何落實人體試驗中研究計畫的審查與告知後同意，以防止研究者利益衝突，同時對營利性幹細胞保存管理業者安全性的控管與風險與效益的評價，如何保護捐贈者(託付者)或病患的資訊，不使隱私外洩，均需事先防範，本文也同時也對幹細胞保存管理公捐或私營作了一番評析。最後對於幹細胞之可專利性，美國、歐盟與國內專利法制各有不同，本研究期藉由其間專利保護現況差異之研究，探討幹細胞給予專利保護之利弊、有關幹細胞未來專利保護可行性及其限制等議題。

A stem cell is a cell from the embryo, fetus, or adult that has a unique capacity to renew itself and to give rise to specialized cell types. It also can differentiate into any type of tissue or organ, presenting the enticing prospect that they could one day be used to replace diseased or damaged cells and tissue. In 1998 cultures of human pluripotent stem cells were first created in the laboratory of James Thomson at the University of Wisconsin-Madison (Science 282, 1145; 1998). Research using stem cells is an extremely active area of current biomedical inquiry. Research efforts have focused on spinal cord injury, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, diabetes, and other diseases or conditions. Scientists hope to use specialized cells to replace dysfunctional cells in the brain, spinal cord, pancreas, and other organs. Other potential applications for human stem cell cultures include uses for studying fundamental processes of human development or for toxicological testing and drug design. Non-human animal stem cell lines may also be used to produce genetically modified animals. However, the rapid march of stem cell research doesn’t give society much time to figure out a coherent response to its discoveries, both because of its extraordinary promise and because of relevant legal and ethical issues. Controversy surrounds the derivation of stem cells from human embryos and fetuses. In order to derive or extract the stem cells found within the embryo, the embryo is destroyed in the removal process. Given the moral implications of this extraction and the sanctity attached to embryos by many groups and individuals around the world, it is unsurprising that the question of how the research should proceed has spawned an energetic debate. This study employs the comparative method based on Laws and Regulations in Taiwan, foreign literature review and Anglo-American Law to discuss the likely disputes on using and regulating embryonic stem cells. Furthermore, there are many unresolved ethical issues related to the clinical and experimental use of adult stem cells such as umbilical cord blood. These issues include determination of ethical procedures for informed consent and institution review border for adult stem cell donation to public banks, to private banks, and for research and treatment. For example, legal and ethical issues related to privacy, confidentiality, and ownership of cord blood units are complex and controversial. There is also considerable debate regarding the ethics of commercial cord blood banking, particularly related to the availability of this potentially valuable resource for clinical use and research. Finally, the legal systems concerning patentability of stem cells are different in the U.S., Europe and Taiwan. This study discusses the advantages and disadvantages of grant of patent for stem cells, the feasibility and limitation to the protection for the patent of stem cells.