傳統中草藥方法專利性之研究

生物科技的發展已掀起顛覆傳統社會的浪潮，根據「哈佛商業評論」的報導，未來 20年最重要的四大產業為：生物科技、中草藥現代化、網際網路及行動通訊。近年來，西方醫藥在藥物的開發上逐漸遭遇瓶頸，中草藥已儼然成為全球醫藥產業的重要趨勢。我國政府於近年來積極推動中草藥產業，並將此列為國家重要政策之一。1 故歐美諸多先進國家有鑑於傳統醫療及替代醫學之重要性，近年來紛紛提出相關法制規範草案，準備予以立法保護之。其中影響較為廣泛者包括美國FDA植物性產品規範草案（the Draft Guidance For Botanical Drug Products），歐洲議會和理事會關於修定2001/83/EC 指令之歐盟傳統草藥產品指令2004/24/EC指令（the proposal For a Directive of the European Parliament and of the Council amending the Directive 2001/83/EC），加拿大藥物食品法規之自然健康產品規範，大陸藥品管理法，WHO傳統醫藥品策略方針2002-2005。由於上述法案在全球中草藥藥品及保健食品具重要地位，因此對於台灣未來制定相關中草藥法規上是重要的參考指標。中草藥產品是否能夠朝全球產業化發展，其關鍵點在於管理執行面及法制規範面，而在現代化醫藥品產業的發展上，智慧財產權往往扮演最關鍵的角色。在研究中草藥之相關科學研發時，必須創造新的傳統知識或新的製造方法，始能符合智慧財產權保護之要件，或特別針對保護傳統知識方面設計新的法律架構，以維持中草藥研究之進行。多數國家對於此皆極盡努力，除了確保所有人和全部族群能在此類傳統知識上享有利益外，亦確保研究者和發展者個人權益。台灣可利用本身文化上之傳統加以發展中草藥，就整體而言，唯有經由良好法律規範始能使中草藥於智慧財產權與公眾利益之間取得平衡。本文會先對中草藥的發展去探究，現行的制度與這傳統醫學會有什麼樣的問題需要被關注，再從中分析若要發展傳統草藥醫學會有什麼難題、如何解決為恰當，並想如何預防問題的產生，最終是跟現行法制作一配合。

關鍵字

中藥；草藥；植物藥；專利制度；經營策略；傳統知識；傳統醫療；生物多樣性

並列摘要

Raditional Chinese medicine, which encompasses many different practices, is rooted in the ancient philosophy of Taoism and dates back more than 5,000 years. Today, TCM is practiced side by side with Western medicine in many of China’s hospitals and clinics. TCM is widely used in the United States. Although the exact number of people who use TCM in the United States is unknown, it was estimated in 1997 that some 10,000 practitioners served more than 1 million patients each year. According to the 2007 National Health Interview Survey, which included questions on the use of various CAM therapies, an estimated 3.1 million U.S. adults had used acupuncture in the previous year. In addition, according to this same survey, approximately 17 percent of adults use natural products, including herbs, making it the most commonly used therapy. In another survey, more than one-third of the patients at six large acupuncture clinics said they also received Chinese herbal treatments at the clinics. In spite of the widespread use of TCM in China and its use in the West, scientific evidence of its effectiveness is, for the most part, limited. TCM’s complexity and underlying conceptual foundations present challenges for researchers seeking evidence on whether and how it works. Most research has focused on specific modalities, primarily acupuncture and Chinese herbal remedies. The fast growing demand worldwide for traditional medicines calls for harmonized monographic standards tosafeguard the safety and quality of CMM products.