從美歐植物藥管理之法制趨勢探討我國中草藥產業發展之機會與挑戰

黃慧嫺

《科技法律透析》 19卷1期 (2007/01) Pp. 24-46

https://doi.org/10.7062/STLR.200701.0024

摘要

近年來，西方主流醫體系逐漸承認其醫療觀念的侷限，因此開始正視並檢視他國傳統醫學的價值。在傳統醫學範圍內，草藥治療的方式有千年以上的經驗，至今仍爲許多國家或地區的醫療實踐所採用，而世界各國對於傳統知識的發掘與重視，無疑已爲植物藥的發展奠立利基。中草藥知識原即我國醫藥文化的一部份，在華人世界更具有數千年的傳統文化和臨床實踐，隨世界發展觀（以人爲本的可持續發展）、消費觀（重視生活品質）和醫療保健觀（重視整體醫療保健和提高人類自身免疫力的變化）的轉變，中藥走向國際的條件基本上已經成熟，中草藥的發展更面臨前所未有的機遇。
有鑑於製藥產業具有高度管制與全球化發展之特色，此在植物藥產業亦然，因此，發展中草藥產業實需密切掌握先進國家對於植物藥的規管態度及其所制訂之相關法令、政策可能對產業發展之影響，本文爰從探討中草藥於國際間之定位出發，介紹美國與歐盟對於植物藥管理之最新規範，並提供因應建議以供我國中草藥業者與相關政府機關參考。

關鍵字

中草藥 ； 植物藥 ； 營養補充品

並列摘要

Most of the new drugs we use today are chemical drugs. Since late 1990s, the marketing numbers of new drugs have been declined, although the R&D spending on new drug doubled in comparison to the 1980s. This ”gap” between supply and need has forced government officials to develop new or alternative healthcare policies to meet the need in an approaching ageing society. In 2002, the WHO published the ”WHO Traditional Medicine Strategy 2002-2005”. In this study, the WHO emphasized the healthcare value of herbal medicine and encouraged his member countries to adopt policies and measures to take full use of its advantages.
Along with the trend, another WHO report in 2005 revealed that many countries acknowledge the benefits herbal medicine may bring. Some countries even considered legalize the herbal medicine; that is to say to include the herbal medicine in their national healthcare system. Not long ago, the US FDA finalized the ”Guidance for Industry-Botanical Drug Products (July 2004)”. In the EU, a new Directive on Traditional Herbal Medicinal Products became effective on 31 0ctober 2005, which introduced an abbreviated marketing procedure for traditional herbal medicine. The aforesaid development has made herbal drug/herbal medicine to be the next ”star industry”.
From the viewpoint of western medicine, herbal drug or herbal medicine is a kind of herbal therapy. It is one of the most use means in traditional medicine. In Taiwan, the society has a long use history of herbal medicine. Several valuable codex remains exist. Internationally, the laws & regulations on the R&D and marketing of herbal drug become more and more clearly in recent years. Since Taiwan stands at an advantageous starting point to develop herbal drug industry, the Taiwan government has invested a lot of resources in order to transform such ”traditional knowledge” into real benefits. This article introduces the laws & regulations on herbal drugs, taking USA and EU as examples. After the review and analysis on the regulatory details, this article also provides some suggestions with the intention to help research institutions and industries to take the challenges and make good use of any opportunities.

並列關鍵字

botanical drug ； chinese herbal medicine ； dietary supplements, CAM