生命物質相關之法令規章   全文下載

Regulatory Aspects of Living Biological Material

任何有生命的物質像一個小工廠，具有精密的運作系統，和潛在的產業資源。生物技術即應用此生命材料及其運作系統（即遺傳信息和生化功能）來製造有用的產物、造福人群。提到生物技術，人們對它的認識往往局限于新近發展的重組基因技術、融合瘤技術、及其相關之製造過程和產品，殊不知它是包括製造非重組生物物體諸如微生物、植物、動物，生理活性物質，以及各種化學品，醫藥品，飲食品和嗜好品。近年來，由於生產技術革新，經濟高度成長，以及社會急劇變化，生物技術已由知識積累科學邁向成為一新興工業。因此而造成了眾多問題，包括遺傳與生化資源之所有權和智慧財產權。現在生物產業多元化、自由化、國際化的發展，世界市場競爭要求我們要特別注意遵循生命物質相關的法令規章。這些法規的範圍包括專利生命物質的寄存、生命物質的移轉協定、和生命物質的包裝與郵寄托運。

Any living biological material is, in effect, a biotechnology factory complete with sophisticated process designs and its own source of venture capital. Biotechnology is the application of living material and its process system to obtain useful products or services. It is not limited to the recent developments in recombinant DNA techniques, monoclonal antibodies, and related processes and products, aspects with which it is most often identified, but includes the manufacture of nonrecombinant biological material, such as microorganisms and plants and animals from traditional breeding methods; biologically active compounds; and a variety of foods and drugs. Due to complex economic, social, and technological changes, biotechnology is in a state of transition from a knowledge-building science to a new industry. Among the many issues and concerns contributing to this is the emergence of ownership and intellectual property rights of biological material. Since the biotechnology industry is becoming increasingly global in nature, competition in world markets requires that special attention be paid to regulations concerning deposit requirements for patent purposes, transfer agreements, and the packing and shipping of biological material, both nationally and internationally.