生物資料所存人體組織權力歸屬之探討

我國雖於2010年新訂定人體生物資料庫管理條例，然於2011年修定其應適用之對象範圍，復於2012年公布刪除第29條之一般資料庫準用規定，致適用本條例之對象範圍大幅縮減。由於本條例之原始立法目的即非處理人體組織物之財產權問題，加上並無其他法規或判解可資遵循之，實難據以妥適處理當事人間關於人體組織之民事法上利益衝突。為釐清一般人體生物資料中人體組織之所有權歸屬，本文先介紹我國人體生物資料庫管理條例之立法與修法，次觀察一般生物銀行人體組織財產權歸屬之比較法，再藉本條例現行規定內容指出人體組織財產權歸屬上之問題點，最後說明人體組織之物權取得，除須依本條例所規定取得「告知後同意」外，尚必須基於人體組織之財產權性質而踐行民事財產法上之法律行為，以針對一般人體生物資料庫（包含舊條例第29條之「非以人口群體為基礎之生物學研究所採集之人體組織」），提供既存檢體之合法取得方法，盼能解決現今之困境並為生物資料庫之建置與永續經營提供完整穩定之法律基礎。

關鍵字

人體組織；人體生物資料庫管理條例；生物資料庫；生物檢體；告知後同意；自己決定；財產權

並列摘要

Failing to recognize the major difference between informed consent and transfer statement, our Human Bio-bank Management Act (2010) certainly does not cope well with the conflicts of interest raised by the establishment of bio-bank between the tissue provider and the bio-bank, and definitely will show awkwardness in handling the legal disputes already existed. Based on the general rules of the civil law, this article, stressed that the informed consent given by the participant who provides biological specimen, though legitimatize the collecting behavior performed by the human tissue collector, yet the ＂consent＂ itself does not necessarily implicate the ownership and other related civil rights on the biological specimens has already been legally transferred to the collector, and accordingly the bio-bank can utilize them at will, unless the participant has otherwise made an explicit transfer statement of property right on human specimen.