政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/143908
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    Please use this identifier to cite or link to this item: https://nccur.lib.nccu.edu.tw/handle/140.119/143908


    Title: 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
    Authors: 黃意晴
    Huang, Yi-Ching
    Contributors: 楊培侃
    Yang, Pei-Kan
    黃意晴
    Huang, Yi-Ching
    Keywords: 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
    Date: 2023
    Issue Date: 2023-03-09 18:55:49 (UTC+8)
    Abstract: 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. 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.
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    Description: 碩士
    國立政治大學
    國際經營與貿易學系
    107351041
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0107351041
    Data Type: thesis
    Appears in Collections:[Department of International Business] Theses

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