我國人體組織利用管制架構之研究

Probe into the application and the control framework of human tissues in Taiwan

系所名稱：科技法律研究所 學位別：碩士 畢業學年：96年 指導教授：林昱梅、佘日新 生物科技發展瞬息萬變，在科技發展初期無法以法令管制規範，但法令規範可提供技術發展之穩定環境及遊戲規則，有促進技術發展之功能，法制與生物科技之發展應為互動性的，人體組織的利用在醫療技術發展和促進人類福祉上有極高成就，在這一波生物科技發展洪流中佔據重要的地位。我國人體組織利用規範，除了人體器官移植條例、去氧核醣核酸採樣條例及最近施行之人工生殖法規定外，相關法律規範極為欠缺，許多規範係以僅具內部規範的行政規則訂定，亦無規範架構及體系，如何建構法律架構體系及正確而有效之管制規範，有其迫切性及必要性。 人體組織在各種法規所使用之名稱或不相同，但其範圍至少包含器官、組織、細胞及其相關之衍生物。人體組織利用類型，大部分係以人體組織之摘除、儲存及使用行為做分類者，如英國之人體組織法。我國目前對於人體組織利用尚未完全法制化，本文將目前人體組織之利用之態樣，分為人體組織直接利用、人體組織間接利用及人體組織之資訊利用三部分，其中人體直接利用部分，又細分為器官移植、人工生殖與胚胎利用及人體試驗三部分；人體組織間接利用則又區分為人體組織銀行及人體組織輸出入二部分，及對人體組織資訊利用部分。探討國內外人體組織利用面臨之問題。 人體組織之利用應依循倫理準則，2000年10月7日通過之赫爾辛基宣言(Declaration of Helsinki)修正版，其中人體醫學研究倫理原則（Ethical Principles for Medical Research Involving Human Subjects），包括尊重生命；弱勢族群保護；保障受試驗者生命、健康、隱私及尊嚴；倫理審查委會之功能；尊重受試驗者自主權及告知後同意原則等，已成為國際上通用對人體組織試驗倫理規範的準則。人體組織利用上，人性尊嚴尊重應高於一切權利之保障。人體組織利用中，提供或接受人體組織之自然人，均應有自由決定之權利，其自主權應受到尊重。 美國人體組織利用技術較為先進，其立法規範依利用型態不同，分別訂定法規規範，與英國的人體組織法，提供一致的立法框架，規範人體捐贈、採集、貯存及使用人體器官和組織，明定使用同意的基本原則，使合法的採集、儲存和使用的人體器官和組織能有所遵循，立法模式雖有不同，均值我國參考。我國在人體組織利用之立法，較外國落後，且常未能遵守法律保留原則，以大量行政規則及政指導規範，未來在人體組織利用之法制化，有待努力。 建議我國應訂定人體組織利用基本法，就立法目的、人體組織的定義、人體組織利用之定義、主管機關、人體器官利用執行者之資格條件、倫理及基本原則規範、腦死之認定、許可制度的建立、定型化契約的法源依據、醫學倫理委員會之功能、爭議處理機制、人體組織利用類型之授權規範、人體資訊之保護及限制、補償制度、人體組織分配制度、罰則等事項 ，建構一個促進生物科技發展又適合研究者、醫療人員、人體組織提供者及利用人之遊戲規則。

The development of bio-technology varies from minute to minute. At the preliminary stage of technology development, it was unable to control the research by laws and decrees, but the laws and the decrees can provide the technical development with a stable environment and a game rule, and promote the development of technology. The legal system and the bio-technology should be interactive to develop. The application of human tissues has a very high achievement on the development of medical technique and the promotion of human happiness, and occupies an important position in this wave of bio-technology development. For the laws and the decrees on the application of human tissues in our country, in addition to the statute on the transplant of human organs and the statute of DNA sampling, there is a rule of law on artificial reproduction which was enforced recently. We are very short of relevant laws or rules. Many rules are of administrative rules with internal norms only. There is no framework or system for the norms. We have an urgency and a necessity as how to set up a framework and a system for the law, and how to set up a correct and effective control norm.Human tissues may be named differently in different laws or rules, but its range at least consists of organs, tissues, cells and the related derivatives. The application types of human tissues are mostly categorized into excision, storage and application behavior, such as the Human Tissue Act of UK. For the time being the application of human tissues is not completely legalized in our country. This essay divides the current applications of human tissues into three types – direct use of the human tissues, indirect use of human tissues and the application of the information on human tissues. The direct use of human tissues can be subdivided into the transplant of organs, the artificial reproduction and the application of embryo as well as human body experiments, total 3 parts. The indirect use of human tissues can be subdivided into (1) the human tissue bank, (2) the export and export of human tissues and (3) the application of information on human tissues. By means of this classification, the problems on the application of human tissues which we face either in our country or in foreign countries is probed.The application of human tissues should follow the ethical norm. On October 7, 2000 the revised version of Declaration of Helsinki was passed. In this declaration, Ethical Principles for Medical Research Involving Human Subjects, Includes “Respect Life”, “Protect the underprivileged groups” and “Protect the life, the health, the privacy and the dignity of the testees”. The function of Ethics Examining Committee is to respect testee’s decision-making power and provide a principle of giving a forewarning before testee’s agreement. It has become a general ethical norm to rule the human tissue experiments. For using human tissues, the dignity of human nature should be above the protection of all rights. Both the natural person provider and the natural person accepter of human tissues should have a self-decision right. His decision-making power should be respected.The USA has an advanced technology to apply human tissues. Its laws and rules are made depending on the type of application. It provides a legislative framework identical to the human tissue law of UK. It regulates the donation, the excision, the storage and the application of human body. It clearly regulates the basic principle of usage and agreement, and people can follow it to excise, store and apply human organs and tissues legally. The legislative modes are different, but it is worthwhile for our reference. We fall behind foreign countries on the legislation of the application of human tissues, and often not to follow the principle of legal reservation (Gesetzesvorbehaltprinzip). We use a large number of administrative regulations and directives instead. For legalizing the application of human tissues in the future, we have to work harder.This essay would suggest to draw up a basic law for The Application of Human Tissues Act. Depending on the legislative purpose, the definition of human tissues, the definition of applying human tissues, the authorities, the qualification of the executive who applies human organs, the ethics and the basic principles, the identification of brain death, established license system, the law source of the pattern-ized agreement, the function of medical ethic committee, the mechanism of solving disputes, the authorization range on the types of human tissue application, the protection and limitation of human body information, compensation system, the allocation system of human tissues and the punishment rules, make a game rule which can promote the development of bio-technology, and is also suitable for the researchers, the medical workers, the provider and the user of the human tissues.