人體分離物及其衍生物之權利歸屬與法律屬性研究-以細胞治療產品為中心

Abstract

近來新興生物技術快速進展，細胞治療(Cell therapy)技術被寄予厚望，特別是對癌末或疾病無法醫治的病人而言更是，該項技術可以提供給醫師及病患更多元的選擇。 本文所指稱人體分離物及其衍生物係指自人體分離之人體組織以及人體組織衍生物本身、人體組織胞器製造之產物以及人體上所攜帶之資訊，細胞治療則是指使用人體細胞組織物重建人體構造、機能或治療疾病之技術，將細胞經體外增殖再輸回病患體內以治療特定疾病，可見人體分離物或衍生物在細胞治療中扮演著極重要的來源角色。 然而自古以來，中西方都將與身體分離的細胞、組織、器官視為身體的延長，而各國對於人體分離物及衍生物在法律上的權利歸屬認知不一，以美國來說，聯邦法律或州法律上並沒有明確規定人體細胞、組織或器官與人體分離後之所有權歸屬，早期德國通說見解則認為人體之一部分與身體分離後屬於法律上之「物」，視為「權利客體」，而日本，在實務見解與學說上，則僅有所有權說一種見解。 而我國多數學者見解與德國通說相同，認為人體之一部與人體分離後應屬於「物」，是為「權利客體」，並肯定人體組織具有所有權與財產權，此外，亦同時具有人格權，只要不違反法律與公序良俗，與身體分離的部分，得為物權客體，屬於該人所有，即便是經由加工自人體分離取出的細胞為全新物質。依據我國民法第814條規定，加工物之所有權原則上仍屬於材料所有人，但若因加工物所增之價值超過材料之價值者，其加工物之所有權應屬於加工人，而決定有無顯逾材料之價值，應依加工物之特性、社會觀念以及約定契約等具體情形而決定。因此，於醫療過程中所有人可主張自我決策的權利，此與人格、人性尊嚴的自律主權概念一致。 病人既對於人組織分離物及衍生物具有所有權與自主之權利，欲應用於現今細胞治療，卻面臨法制規範的束縛。我國細胞治療法規管理採取雙軌制，以醫療產品與醫療技術分別加以管理，然而不論是大量生產或為特定個別病人量身訂作細胞治療產品，抑或自體細胞移植或異體細胞移植，都是需要向主管機關申請臨床試驗及查驗登記，再者，目前制度對於細胞治療之風險性均未能分級管理，相較於其他各國來說規範嚴格許多，審查所耗費的時間也無法縮短，並不符合民眾對於所謂「開放」的期待。 因此建議應廣泛比較分析各國現有立法規範與實踐情形，以健全我國細胞治療管理法制與技術，才能加速發展國內細胞治療技術與產品。

Cell therapy, one of biotechnology technologies, has recently been considered as a new medical hope, especially for patients with cancer disease who cannot be treated. This technique can provide an additional treatment for physicians and patients. Human body parts or derivatives have been playing a very important source role in cell therapy. However, diverse views on the legal ownership of human body parts and derivatives generally exist among countries. In the United States, federal laws or state laws do not clearly stipulate the ownership of human cells, tissues, and organs after separated from human body. In German, any parts of the human body, separated from body, was considered as a legal 'thing' and an 'object of rights'. In Japan,” ownership” is the only point of view practically and theoretically. Most domestic scholars believe that separated parts of human body should be considered as 'things' and 'object of rights' and that human tissues have ownership and property rights. According to Article 814 of the Civil Law, the ownership of the processed product belongs to the owner of the original material, even if the processed product is completely new substance originally separated from human body. If the value of the processed product, however, exceeds that of the raw material, the ownership should be under the processor. The values of the raw material and processed product are determined by the feature of processed product, social concept, and agreed contract. In addition, if it does not violate the law and public order and moral, the parts separated from body can be the object of property rights and claim the right of self-decision in the medical process, which is consistent with the concept of autonomy for personality and human dignity. Patient has the right of ownership and autonomy for separated tissues and derivatives, but it is bound by current regulation to cell therapy. In Taiwan, a two-track system, including medical products and medical technologies, is used to manage the related law and regulation. Both mass production and tailor-made products for specific individual patients and autologous or allogeneic cell transplantation should be registered and approved by the competent authority. Furthermore, the current system fails to manage the hierarchical risks of cell therapy. Compared with international law and regulation in cell therapy, our system is much more regulated and tedious review process. Our competent authorities should extensively evaluate the available international legislative norms and practical experiences to refine domestic legal system of cell therapy management and improve the development of the related technologies and products.