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題名 個人使用藥品進口管制之比較法研究
A Comparative Legal Study on the Import Control of Medicine for Personal Use作者 黃意晴
Huang, Yi-Ching貢獻者 楊培侃
Yang, Pei-Kan
黃意晴
Huang, Yi-Ching關鍵詞 個人自用
無證藥品
藥品進口
藥事法
藥物樣品贈品管理辦法
Personal use
Unlicensed drugs
Drugs import permission
Pharmaceutical Affairs Act
Regulations on Management of Medicament Samples and Gifts日期 2023 上傳時間 9-Mar-2023 18:55:49 (UTC+8) 摘要 我國部分患者因無法負擔昂貴的原廠藥，選擇辦理申請個人自用藥品進口， 以取得較便宜的國外學名藥，而此等藥品或已取得或尚未有我國衛生主管機關核 發之藥品許可證。儘管這些進口的國外藥品較為便宜，但伴隨而來的是此等藥品 可能不具藥物相等性、且有帶來國內公共衛生安全之風險與侵害原廠藥品專利權 等疑慮。我國衛生福利部曾因上述疑慮未核准此類藥品進口申請案，但此舉遭認 為不當擴張《藥事法》、《藥物樣品贈品管理辦法》之要求。為使患者得以適當利 用我國個人使用藥品進口制度，本文建議應借鑒英國、澳洲以及美國之法制並考 量相關國際規範後進行適度的調整，以解決個人使用藥品取得與進口管制問題。
Given that the brand drugs are too expensive to afford, some patients in Taiwan choose to apply for special permission to import foreign generic drugs that are cheaper than brand drugs but with or without drug permit license for personal use. Despite the unlicensed drugs are cheap, they often accompanied with the doubts such as dissatisfaction with pharmaceutical equivalence, involvement of public health risks and infringement of pharmaceutical patents. The Ministry of Health and Welfare in Taiwan once disapproved the import application of special permission because of legal and policy issues mentioned above. But the Ministry’s decision of disapproval was criticized to be an overreaching of its authority in interpreting and implementing the Pharmaceutical Affairs Act and Regulations on Management of Medicament Samples and Gifts. 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國立政治大學
國際經營與貿易學系
107351041資料來源 http://thesis.lib.nccu.edu.tw/record/#G0107351041 資料類型 thesis dc.contributor.advisor 楊培侃 zh_TW dc.contributor.advisor Yang, Pei-Kan en_US dc.contributor.author (Authors) 黃意晴 zh_TW dc.contributor.author (Authors) Huang, Yi-Ching en_US dc.creator (作者) 黃意晴 zh_TW dc.creator (作者) Huang, Yi-Ching en_US dc.date (日期) 2023 en_US dc.date.accessioned 9-Mar-2023 18:55:49 (UTC+8) - dc.date.available 9-Mar-2023 18:55:49 (UTC+8) - dc.date.issued (上傳時間) 9-Mar-2023 18:55:49 (UTC+8) - dc.identifier (Other Identifiers) G0107351041 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/143908 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 國際經營與貿易學系 zh_TW dc.description (描述) 107351041 zh_TW dc.description.abstract (摘要) 我國部分患者因無法負擔昂貴的原廠藥，選擇辦理申請個人自用藥品進口， 以取得較便宜的國外學名藥，而此等藥品或已取得或尚未有我國衛生主管機關核 發之藥品許可證。儘管這些進口的國外藥品較為便宜，但伴隨而來的是此等藥品 可能不具藥物相等性、且有帶來國內公共衛生安全之風險與侵害原廠藥品專利權 等疑慮。我國衛生福利部曾因上述疑慮未核准此類藥品進口申請案，但此舉遭認 為不當擴張《藥事法》、《藥物樣品贈品管理辦法》之要求。為使患者得以適當利 用我國個人使用藥品進口制度，本文建議應借鑒英國、澳洲以及美國之法制並考 量相關國際規範後進行適度的調整，以解決個人使用藥品取得與進口管制問題。 zh_TW dc.description.abstract (摘要) Given that the brand drugs are too expensive to afford, some patients in Taiwan choose to apply for special permission to import foreign generic drugs that are cheaper than brand drugs but with or without drug permit license for personal use. Despite the unlicensed drugs are cheap, they often accompanied with the doubts such as dissatisfaction with pharmaceutical equivalence, involvement of public health risks and infringement of pharmaceutical patents. The Ministry of Health and Welfare in Taiwan once disapproved the import application of special permission because of legal and policy issues mentioned above. But the Ministry’s decision of disapproval was criticized to be an overreaching of its authority in interpreting and implementing the Pharmaceutical Affairs Act and Regulations on Management of Medicament Samples and Gifts. In order to enable the patients to properly use special permission scheme in Taiwan, this thesis suggest that current regulations governing the import control of medicines for personal use can be revised accordingly based on the regulatory scheme adopted by the UK, Australia, USA and related international regulations such as Convention Concerning Customs Facilities for Touring. en_US dc.description.tableofcontents 第一章、緒論 1第一節、研究動機與目的 1第二節、研究方法 3第三節、研究範圍與侷限 4第二章、個人使用藥品取得與進口管制問題 5第一節、問題緣起與爭議彙整 6第二節、取得個人使用藥品相關之法制問題 13第三章、各國藥品個案核准進口制度及國際規範 15第一節、各國個案核准進口之管理架構與制度概說 15第二節、各國個案核准進口管理法制之內容 26第三節、各國個案核准進口法制之借鏡與不足之處 72第四章、各國對個人攜帶藥品入境之管理與國際規範 74第一節、各國之海關規定 74第二節、個人攜帶藥品議題之國際規範 80第三節、各國攜帶藥品入境規範之借鏡及問題 83第五章、我國個人使用藥品規定及其問題之檢討 85第一節、我國現行個人使用藥品進口制度與個人攜帶入境規範 85第二節、我國現行制度與規範對個人使用藥品所衍生之問題 89第三節、個人使用藥品進口管理問題之解決途徑:以外國法制與國際規範為借鏡 92第六章、結論 97參考文獻 99 zh_TW dc.format.extent 2391039 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0107351041 en_US dc.subject (關鍵詞) 個人自用 zh_TW dc.subject (關鍵詞) 無證藥品 zh_TW dc.subject (關鍵詞) 藥品進口 zh_TW dc.subject (關鍵詞) 藥事法 zh_TW dc.subject (關鍵詞) 藥物樣品贈品管理辦法 zh_TW dc.subject (關鍵詞) Personal use en_US dc.subject (關鍵詞) Unlicensed drugs en_US dc.subject (關鍵詞) Drugs import permission en_US dc.subject (關鍵詞) Pharmaceutical Affairs Act en_US dc.subject (關鍵詞) Regulations on Management of Medicament Samples and Gifts en_US dc.title (題名) 個人使用藥品進口管制之比較法研究 zh_TW dc.title (題名) A Comparative Legal Study on the Import Control of Medicine for Personal Use en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 中文文獻書籍傑瑞米．葛林（Greene, Jeremy A.），便宜沒好藥？一段學名藥和當代醫療的糾葛，2018年7月。法規藥事法，第22、27-2、39、48-2、55條。藥物樣品贈品管理辦法，第2、4、13、14條。特定藥品專案核准製造及輸入辦法，第3條。入境旅客攜帶行李物品報驗稅放辦法，第4條。網際網路林以璿，肺癌藥物1天5000元病友吃不消 深圳「廁所牌」假藥流竄全台，Cancer，2019年9月18日，網站：https://cancer.heho.com.tw/archives/56679（最後瀏覽日：2022年12月19日）。財政部關務署台北關稽查組，藥物及醫療器材，財政部關務署台北關，2022年8月24日，網址：https://taipei.customs.gov.tw/singlehtml/3392?cntId=cus2_3392_3392_1347（最後瀏覽日：2022月14日）。黃文鴻，【專文】為什麼我們需要一個C肝治療的國家級政策，民報，2016年8月10日，網址：https://www.peoplemedia.tw/news/ce1d4cd6-9add-4396-87d3-c1ca0f7657f4（最後瀏覽日：2022年12月19日）。衛生福利部食品藥物管理署，申辦說明—個人自用藥品專案進口申請，衛生福利部食品藥物管理署，最後更新日：2022年3月30日，https://oap.fda.gov.tw/B101/B101_2?ItemSEQ=11。英文文獻國際協定Convention Concerning Customs Facilities for Touring art. 1, June 4, 1954, 276 U.N.T.S. 191.General Agreement on Tariffs and Trade, Oct. 30, 1947, 61 Stat. 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