- 學位論文
台灣參與國際生物製劑藥品捐贈經驗-新流感疫苗與國血製劑案例
Taiwan Experiences in International Biologics Drug Donation -Two Local Products, H1N1 Vaccine and Factor VIII and IX
摘要
中文摘要 背景 藥品捐贈為國際間常見的援助活動，為減少不適當藥品捐贈現象，世界衛生組織遂於西元1996年制定藥品捐贈準則，內容重視捐贈藥品品質與雙方溝通；台灣生物製劑僅於台灣上市，如何參與國際藥品捐贈，克服產品未於其他國家上市障礙，並克服台灣於國際上的特殊情勢，本研究將深入探討台灣生物製劑國光新流感疫苗及國人濃縮凝血因子成功捐贈案例，省思台灣生物製劑參與國際藥品捐贈之侷限與契機。 目的 1. 分析台灣生物製劑如何進行國際藥品捐贈; 2. 探討民國99年國血製劑益康成功捐贈案例，比較與國光疫苗捐贈案例之異同與成功關鍵 方法 本研究為質性研究，採個案研究法 結果 國光新流感疫苗與國血製劑益康皆為極具公共衛生價值生物製劑，於產品面，國內核准基礎符合國際要求，製造廠達GMP標準，科學性證據可支持捐贈產品品質；於過程面，兩者參與者皆包括藥廠與政府，不同處在於前者為以政府與國際間政府組織合作模式進行，後者則透過非政府組織與國際非政府組織合作，並由法規專業積極協助，成功達到捐贈預期目標。 結論 臺灣生物製劑具備參與國際藥品捐贈潛力，因產品未於其他國家上市，法規專業的加入協助，以及透過熟悉產品的國內非政府組織與國際非政府組織合作，可增加台灣生物藥品成功跨國捐贈機率。國際上藥品捐贈制度已行之有年，隨著國內生技產業發展，期待將來能有更多台灣上市產品積極從事國際藥品捐贈，開拓國際知名度，建立台灣製藥業於國際上之聲譽形象，政府並可建立一法規專業平台協助進行，並利用台灣產品進行國際援助，開展我醫療技術援外之外的另一優勢契機。
並列摘要
ABSTRACT Introduction Drug donation is common in international aid. To reduce inappropriate drug donations, World Health Organization (WHO) announced “ Guidelines for Drug Donations” in 1996. The contents focus on donated drug quality and communication process. However, for biologics only approved by the regulatory agency in Taiwan intending for international drug donations, there are certain barriers such as regulatory status and the unique international situation of Taiwan. By analyzing Taiwan experiences in international biologics drug donation and studying two local products: AdimFlu-s(A/H1N1) and ‘TBSF’ High Purity Factor VIII and IX Concentrate, the study is expected to explore the limitations and opportunities of Taiwan biologics intending for international drug donation activities. Objectives 1. Analyze Taiwan experiences in international biologics drug donation 2. Study the successful case of ‘TBSF’ High Purity Factor VIII and IX Concentrate donation in contrast to the failed experience of AdimFlu-s(A/H1N1) donation Results AdimFlu-s(A/H1N1) for pandemic influenza and ‘TBSF’ High Purity Factor VIII and IX Concentrate for hemophilia are both valuable biologics in public health. When looking into the quality of donated products, they were manufactured under GMP standards and the regulatory bases for approvals are both line with the international practices. About the donation process, the former adopted a cooperation of government and international government organization, but unfortunately failed. However, the latter adopted a cooperation of non-government organization (NGO) in Taiwan and international non-government organization (INGO) with great help from regulatory professions and succeeded. Conclusions Biologics approved by regulatory agency in Taiwan actually have potential in intending international drug donation. The challenge of regulatory status should solicit support from regulatory professions. Besides, by a successful cooperation model of NGO and INGO cooperation, the possibility of successful donation will be higher. International drug donation has been popular for years. By proactive support from regulatory professions and cooperation between NGO and INGO, local products in Taiwan are capable of successful donation. The booming pharmaceutical industries in Taiwan will have more capability to involve in this endeavor. For local pharmaceutical industries, attending for international drug donation is helpful in building international brands and establishing good images. Taiwan government could offer regulatory resources for supports and use local products as foreign aids in the future.