英國胚胎及胚胎幹細胞研究之管制體系 －兼論英國經驗對我國之啟發

The Regulation of Embryo and Embryonic Stem Cell Research in the UK:The Inspiration to Taiwan from the Regulatory Experiences of the UK

謝秉孝(Ping-Hsiao Hsieh)

指導教授 ： 陳英鈐

國立中央大學/客家學院/法律與政府研究所/碩士(2011年)

摘要

英國為全世界胚胎及胚胎幹細胞研究位居領先地位之國家，此與其管制之策略有關，這也是本文研究之重點，希冀英國經驗對我國之管制有所啟發。英國管制體系之建立，實應歸功於英國當初選擇明智之作法，尋求Warnock委員會專家之建議，其內容蘊含著道德哲學與功利主義之精神，而許多寶貴之建議也成為日後「人類受精暨胚胎學管制法」管制規範之具體內容，並成為全世界其他各國取經之對象，這也是為何英國管制經驗值得汲取的原因之一。
英國並以「人類受精暨胚胎學管理局」作為獨立管制機關，具體的執行人類受精暨胚胎學管制法所交付之管制任務，而在嚴格的許可程序背後竟能造就出研究領先的成果，關鍵的因素之一在於英國科學家願意鼎力配合管制規範，此外，集中的管制能夠減少研究申請的不確定性，增加管制的穩定性，正立研究的合法性，並能增加民眾對於管制機關之信任，使得科學家能在無後顧之憂的環境下專心的進行研究。再者，人類受精暨胚胎學管理局肩負起管制之樞紐，上溯能具體的落實嚴格的管制規範，下溯能與幹細胞庫合作使得寄存幹細胞株作為獲得許可之條件，大大降低胚胎破壞之數量，減少倫理之爭議。
英國管制體系建立後，雖然面臨著「細胞核取代」與「混合胚胎」兩階段之挑戰，但由於原始的管制體系英國視為一種典範，因此其採行的是種溫和性的管制體系變革—即修補舊制以符現狀之合用，而非革命式的顛覆過往之管制體系與成果，否則易造成管制的不穩定性，間接地也影響到研究的進展，也會造成人民信賴崩盤恐懼再起。這也提醒我國在建立管制體系之初時須審慎為之，建立一個能長久運行且經得起挑戰的體系，遇有新興技術挑戰時，仍應從原始建立的核心理念加以修補調整，始能持續的受到人民的信任，使得管制具有一定之威信。

關鍵字

胚胎幹細胞 ； 細胞核取代 ； 混合胚胎 ； 幹細胞庫

並列摘要

United Kingdom (UK) is regarded as the top country in the field of studying the embryo and embryonic stem cell, which is related to its good regulatory policy of embryos and embryonic stem cell research. And we hope that the regulatory experience of UK can inspire Taiwan to improve the regulation of this field. Establishment of UK’s regulation of this field is due to its wise strategy about adopting the advisement of Warnock Committee, it includes the spirit of moral philosophy and utilitarianism and this become the norm of the Human Fertilisation and Embryology (HFE) Act. Besides, part of norm from HFE Act is the learning direction of other countries in the world, and this is one of the reasons we think the regulatory experience of UK is deserved to be learned.
The Human Fertilisation and Embryology Authority (HFEA) in UK is as an independent regulatory agency, mediating the task of the HFE Act. The great achievement in the field of the embryos and embryonic stem cell research is produced by strict permissive procedure of the regulation. And one of the key elements is UK’s scientists volunteer to follow the norm of regulation. Furthermore, centralized regulation can reduce the uncertainty of researching applications, promote the stability of regulation, ensure the legitimacy of study, and increase public confidence. It makes scientists can focus on research in a worry-free environment. In addition, HFEA is responsible for being a key position of regulation, which not only can achieve the mission of the HFE Act but also can cooperate with the UK Stem Cell Bank to make deposit the stem cell line as one of the permissive condition. All of these actions significantly minimum the destroying number of embryos and decrease the controversy of ethics.
Although there are two step challenges, including cell nuclear replacement (CNR) and hybrid embryos, after establishing the regulatory system of UK. They adopt moderate alteration, which means modifying the original regulatory system to fit the need of present situation, rather than chooses overthrowing the past regulatory system and effort, owing to the initial regulatory system is regarded as a good model by UK. In contrast, if they adopted revolutionary change, it would easily lead to instability of regulation, indirectly influence the progress of the research in this field, and cause the collapse of the public confidence. It reminds we should be cautious on establishing the regulatory system, which can withstand the challenges of emerging technologies, and moderately modifying it when our regulatory system faces the challenges above to make it continually wins the public confidence and owns the reliance.

並列關鍵字

embryonic stem cells ； CNR ； hybrid embryos ； stem cell bank

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