當西藥的新藥發展逐漸產生瓶頸下,全球各界無不看好藥界的明日之星---中草藥。然而,中草藥在台灣的發展環境卻呈現諸多不利的因素,包括:健保局對中醫門診實施總額預算制,使得中藥藥費每年只能以固定比例成長,從而也限制了產業的發展;中草藥產品品質的不穩定,使得民眾對於中藥的信心不夠;中醫所用的藥與十幾年前使用的藥品大同小異,可謂創新有限,這些情況都讓中草藥產業的發展猶如一個夕陽產業。 本研究的目的便在針對台灣中草藥產業發展的結構障礙,以及如何從產業政策與企業策略兩個層面解決這些發展困境等問題,提出探索性的研究,期能對於台灣中草藥產業的發展提供建言。首先,我們先概略性地描述中草藥在歐洲、美國、日本、大陸及台灣的發展現況;其次,再進一步分析台灣目前的中藥製劑業的發展環境;接著,我們選取台灣前三大傳統中藥製劑公司---勝昌、順天、港香蘭---作為台灣中藥製劑業的代表個案,結合另外兩個對比個案,一個是目前已經有產品通過美國FDA新藥上市的「友合生化」,另一個則是宣稱對於肺癌有相當療效的「華陽複方」,進行個案比較,期能透由多重個案的比較,歸納出中藥製劑廠商的發展策略與成長模式。 透由產業資料與質性的個案分析,本研究認為法規的明確性,對於中藥業產業與廠商的發展有重大的影響,所以,我們建議有關當局對於中藥業應該制訂出一套適合中醫邏輯的新藥開發程序,而非僅是跟隨西藥邏輯來制訂中藥界的遊戲規則;此外,中藥製劑廠商也應該轉換其研發的思維邏輯,跳脫傳統的中藥複方研發模式,以萃取物成分轉換、利基適應症為發開標的,來達到新產品品質及效果上的穩定;然而,對於現階段的中藥廠商而言,我們認為應該以較不受法令管制的保健食品及植物原料等領域來做為相關多角化的廠商成長規劃。
As pharmaceutical industry faces increasing difficulties of discovering new drugs, the commercial potentials of herbal medicines have received great attention by the worldwide pharmaceutical industry. However, the industrial development of herbal medicines in Taiwan reveals a somewhat disappointed profile for several reasons. The overall-budget system adopted by the National Health Insurance Plan in fact restricts the total reimbursement amount to herbal medicines and hence limits the income stream of providers. More fundamental limitation to a wide adoption of herbal medicine lies in the instability of herbal materials. Eventually, there is less innovation occurred in this industry, a fact which in turn forces it becoming a declining industry in Taiwan. The purpose of this research is to analyze the structural impediments to a healthy development of the Chinese herbal medicine industry in Taiwan. By so doing, we are able to further explore potential growth directions and strategies of realizing these potentials at both the industry policy and firm strategy levels. To be specific, we will focus on the Chinese herbal medicine industry, rather than a broadly defined herbal industry. To achieve the research goals, we first provide a general analysis on the herbal industries around major countries in the world. We then analyze the current development and structure of Chinese herbal medicine industry in Taiwan. Based upon these understandings, we undertake firm-level analyses on three indigenous Chinese herbal medicines companies, and two comparative cases of “Selected Vegetables” and “Sulbogin.” “Sulbogin” has been granted license by Food and Drug Administration of U.S.A., while “Selected Vegetables” has been in the phase III of drug evaluation at FDA. We argue that inappropriate regulatory system plays a key role limiting the development of Chinese herbal medicine industry in Taiwan. Especially, the current regulations on the Chinese herbal drug discovery are defined based on those for (chemical-based) pharmaceuticals while they in fact have different drug discovery logic. Chinese herbal medicine providers could adopt alternative approaches, e.g., finding niche indications, converting extracts to chemicals, to drug discovery. We suggest that the categories of health food and herbal products be the potential areas of development for these indigenous firms. Policy implications and growth strategies are also discussed.