| 摘要: | 細胞基因之生物科技法律風險，因違法性侵害隱私權和專利權，可能造成個人無法彌補之損失，生物科技進步之細胞基因法律風險包括：違法性基因檢測、基因治療、基因採集過程和基因資料庫儲存。就民法、刑法和行政法之觀點，隱藏於生物材料之法律風險，包括：血液、器官、精卵細胞、胚胎、幹細胞、再生組織，複製人和人造基因組活細胞，就其取得之程序切勿讓法律程序阻礙科技進步，然其法律風險評估時需要依據科學證據加以斷定風險存在之因果關係，誠如處理基因資料檢測、治療、採集和儲存過程中，就因法律規範疏失可能面臨到多數卻彼此分歧科學觀點與薄弱證據，或因少數法律專家總結出法律之共通見解以及科學證據不充分甚至不存在之情形等阻礙科技進步。我國相關指導性法律防範規定，侵入性採集樣本程序將細胞基因檢測法規範法律風險預防原則，防範法律風險發生時難以控制，應著眼於保護合法性。此一基因檢測法所可能引發不確定科技風險，須防患未然，法律風險控制之議題值得主管機關慎思。
Legal risks of cellular genes’ biotechnology, due to illegal invasion of personal in-formation privacy and patent rights, may cause immediately and irreparably harm to in-dividuals, including the legal risks of cellular genes: illegal genetic testing, gene therapy and genetic data collection process and storage. From the civil, criminal and administra-tive laws’ point of view, the legal risks implied in biological materials include blood, organs, sperms, eggs, embryos, stem cells, tissue regeneration, reproduction and imple-menting a synthetic genome in a modern cell. The legal procedures are not allowed to hinder technological progress when the biological materials are collected. Legal risks are assessed on scientific evidence to determine the causal relationship between the ex-istence of risks, just as dealing with genetic data detection, treatment, collection and storage process. However, because of the negligence of legal norms, we may face a lot of evidence that has different scientific perspectives with weak proof. Or because few legal experts conclude with the common opinion of the law and contend that scientific evidence is insufficient or even not existent, the laws would impede technological pro-gress. Taiwan’s relevant laws and guidance prevent the provisions of invasive sampling procedures to assay cell gene precautionary principle from the legal risks. The occur-rence of the legal risk prevention is difficult to control, and detection of this gene may lead to uncertain scientific and technological risk, so we should take preventive meas-ures. The competent authorities should consider the issue of legal risks deliberatively. |
