Please use this identifier to cite or link to this item: https://ah.nccu.edu.tw/handle/140.119/136984


Title: 憲法及經濟社會與文化權利國際公約下之藥品近用權:以專利連結制度中暫停核發藥品許可證為中心
Right to access to medicines under the ROC Constitution and the ICESCR: lessons from patent linkage system
Authors: 吳詩婷
Wu, Shih-Ting
Contributors: 翁燕菁
許耀明

Weng, Yen-Ching
Hsu, Yao-Ming

吳詩婷
Wu, Shih-Ting
Keywords: 藥品近用權
專利連結
憲法訴訟
經濟社會文化權利公約
TRIPS-plus
Right to access to medicines
Patent linkage
Constitutional litigation system
ICESCR
TRIPS-plus
Date: 2021
Issue Date: 2021-09-02 17:03:35 (UTC+8)
Abstract: 藥品已成為當代工業社會中治療或預防人類疾病之必需品,亦已成為經濟市場上左右人類身體結構及生理機能之產品。藥品之近用涉及國際經貿法、衛生法及人權法,尤其在國際藥品專利保護體制興起下,國際社會已逐步建立相關規範與原則。反之,我國憲法同樣以保障人民健康為社會國宗旨之一,相關內涵卻仍有待發展。本文旨在藉由藥品專利連結制度下的藥品近用爭議,嘗試平衡智慧財產權與健康基本權之法益衝突,以論證並發展憲法訴訟制度下可行之藥品近用請求權。

藥品近用權與經濟社會不平等息息相關,因此本文認為分配正義應為保障之首要重點。其中,《經濟社會文化權利國際公約》第12條保障之健康人權,經過多年解釋與發展,已然建構出可操作之藥品近用權內涵。同時,在世衛組織與世貿組織之框架下,近年亦以保障藥品近用為目的嘗試規範國家行為。至於我國憲法,司法院晚近始初步肯認健康基本權為憲法第22條保障,並認定國家制定相關制度時負有「最低限度之保護義務」,但藥品近用權是否為憲法所保障及如何保障,至今司法院大法官未曾有機會闡釋。然而,國際公約或憲法對藥品近用權之解釋是否已足以回應根本之經濟社會不平等問題,不乏疑慮。尤其基於藥品近用權的給付請求性質,使其可裁判性備受質疑,徒使權利難以行使。是故本文主張,於未來憲法訴訟制度下,藥品近用權應以基本能力說為審查依據,就個案研判其可裁判性。司法院亦應考慮適用舉證責任適度反轉之寬鬆審查,以有效課責國家保障義務。

本文以專利連結制度下行使藥品近用權為例,驗證本文對藥品近用權憲法保障之主張。國家同時負有保障智慧財產權與藥品近用權之雙重義務,且於兩者之法益可能發生衝突時,須盡力加以平衡。全民健保係我國保障藥品近用權之基礎,並非所有對健康有益之用藥皆為健保給付,是以本文將分別以實際案例討論健保給付藥品與非健保給付藥品之近用權,藉以檢視未來於憲法訴訟制度下,兩者可能採取之救濟。
Medicines are not only necessary for the treatment or prevention of human diseases in the contemporary industrial society, but are also products that affect human health and physiological functions. The issue of access to medicines now involves international economic and trade law, health law and human rights law; and under the rise of the patent protection system, the international community has gradually established relevant norms and principles in these areas. On the contrary, although the ROC Constitution (“the Constitution”) has protection of people's health as one of its aim, the content of the right to health is still poorly developed. In this regard, the purpose of this article is an attempt to balance the conflict between intellectual property rights and the right to health through the issue of access to medicines under patent linkage system, with the hope to develop the arguments for right to access to medicines under the constitutional litigation system in Taiwan.

The right to access to medicines is closely related to economic and social inequalities, of which distributive justice is the main issue to be addressed. Article 12 of the ICESCR protects right to health, which has been interpreted and developed over the years, and has already established a viable right to access to medicines. Additionally, under the framework of the World Health Organization (WHO) and the World Trade Organization (WTO), attempts to regulate state behavior for the purpose of safeguarding access to medicines were carried out. As for the Constitution, the Judicial Yuan has recently recognized that right to health is guaranteed by Article 22 of the Constitution and that the state has a "minimum obligation to protect" when formulating relevant system. Nonetheless, the Grand justices of Judicial Yuan has not yet had the opportunity to address the issue of whether and how the right to access to medicines is protected by the Constitution. Further, regardless of whether international conventions or constitutional interpretations of access to medicines as they are now are adequate to address the issue of economic and social inequality, this paper argues that the right to access to medicines should be examined on the basis of the " basic capabilities" and the justiciability of such right should be analyzed in the context of each particular case. Besides, the Grand justices of Judicial Yuan should also consider applying a lenient review with an appropriate reversal of the burden of proof, in order to confer the obligation to the state.

Finally, this paper will use patent linkage system as an example to support the claim for constitutional protection of access to medicines. The state has a dual obligation to protect both intellectual property rights and the right to access to medicines, and must strive to strike a balance between the two when they conflict. However, not all medicines that are beneficial to health are covered by health insurance; this article will therefore discuss the right to access to medicines that are covered by health insurance and those that are not covered by health insurance with practical cases, and the possible remedies under the constitutional litigation system in the future.
Reference: 一、中文文獻

(一)專書

李震山(2014),多元、寬容與人權保障─以憲法未列舉權之保障為中心, 2版,元照。
湯德宗(2016),對話憲法憲法對話(下冊),修訂3版,新學林。
蔡墩銘(2000),生命與法律,翰蘆圖書。

(二)專書論文

吳全峰(2011),從健康人權角度論國際藥品智財制度之發展,載:歐盟與美國生物科技政策,頁581-693,中央研究院歐美研究所。
---------(2013),從經濟社會文化權利國際公約論健康人權與健康平等—兼論全民健康保險給付機制之健康人權困境,載:中華民國施行聯合國兩權利公約的意義:接軌國際,頁200-242,深化民主,財團法人臺灣民主基金會。
---------(2012),跨國製藥企業保障藥物近用權利之人權責任,載:2011科技發展與法律規範雙年刊-健康、科學與人權,頁131-297,新學林。
李震山(2002),論憲法未列舉之自由權利之保障—司法院大法官相關解釋之評析,載:憲法解釋之理論與實務第三輯上冊,頁355-394,中研院中山人文社會科學研究所。
孫迺翊(2015),社會法的憲法基礎,載:社會法,頁69-93,元照。
張文貞(2009),憲法與國際人權法的匯流-兼論我國大法官解釋之實踐,載:憲法解釋之理論與實務第六輯上冊,頁223-272,新學林。
湯德宗(2009),違憲審查基準體系建構初探-「階層式比例原則」構想,載:憲法解釋之理論與實務第六輯下冊,頁1-38,新學林。
湯德宗、吳信華、陳淳文(2015),論違憲審查制度的改進-由「多元多軌」到「一元單軌」的改制方案,載:憲法解釋之理論與實務第四輯,頁523-598,中央研究院法律學研究所。
黃昭元(2002),司法消極美德的積極實踐-評Sunstein教授的「司法最小主義」理論,載:當代公法新論(上)翁岳生教授七秩誕辰祝壽論文集,頁875-918,元照。

(三)期刊論文

牛惠之(2019),當「杜哈公共衛生宣言」遇上TRIPS-Plus——藥品專利連結是否會阻礙強制授權的實施?,經貿法訊,246期,頁10-36。
何娜瑩、林均郁(2019),論生物藥品準用專利連結制度對我國藥廠智慧財產權策略之影響,全國律師,23卷5期,頁51-59。
吳全峰、黃文鴻(2007),醫藥人權之發展與權利體系,月旦法學雜誌,148期,頁128-161。
吳東哲(2019),專利連結的另一半-談以專利法明定擬制侵權與確認訴訟之必要性與爭議,專利師,39期,頁21-33。
吳秦雯(2021),強制預防接種之健康權保障,月旦法學雜誌,222期,頁10-13。
李秉燊(2019),專利有效性判斷雙軌制下臺灣專利連結制度觀察及建議,交大法學評論,5期,頁125-188。
沈宗倫(2018),簡評我國專利連結制度之相關立法-以藥事法之解釋適用為中心,月旦法學雜誌,278期,頁165-177。
林明昕(2004),原住民地位之保障作為「基本權」或「基本國策」?,憲政時代,29卷3期,頁335-358。
林明昕(2005),健康權—以「國家之保護義務」為中心,法學講座,32期,頁26-36。
孫迺翊(2012),社會給付權利之憲法保障與社會政策之形成空間:以德國聯邦憲法法院關於年金財產權保障及最低生存權保障之判決為中心,國立臺灣大學法學論叢,41卷2期,頁445-516。
---------(2006),憲法解釋與社會保險制度之建構-以社會保險「相互性」關係為中心,國立臺灣大學法學論叢,35卷6期,頁241-290。
徐揮彥(2014),「公民與政治權利國際公約」與「經濟、社會與文化權利國際公約」在我國最高法院與最高行政法院適用之研究,國立臺灣大學法學論叢,43卷特刊,頁839-909。
翁燕菁(2011),私人與家庭生活的歐洲共識與善良風俗-《歐洲人權公約》體系求同存異之道,中研院法學期刊,9期,頁179-269。
---------(2017),對話與爭議:從歐洲人權法圖像論臺灣施行人權公約之實質意涵,國立臺灣大學法學論叢,46卷特刊,頁1115-1201。
張文貞(2012),NGO與跨國憲政主義的發展:以台灣加入國際人權公約的實踐為例,台灣國際法季刊,9卷3期,頁47-72。
---------(2012),演進中的法:一般性意見作為國際人權公約的權威解釋,台灣人權學刊,1卷2期,頁25-43。
許志雄(1995),司法消極主義與司法積極主義,月旦法學雜誌,2期,頁40-41。
許宗力(2002),基本權利:第二講基本權的功能,月旦法學教室,2期,頁72-80。
---------(1996),基本權的功能與司法審查,人文及社會科學研究彙刊,6卷1期,頁23-34。
許忠信(2016),TPP著作權與其TRIPS PLUS,台灣國際法季刊,13卷1期,頁27-51。
陳俞沛(2019),論醫療損害風險社會化分擔-以全民健康保險之國家責任為核心,東吳法律學報,31卷2期,頁83-122。
陳隆志、廖福特(2002),國際人權公約與國內法化之探討,國家政策季刊,1卷2期,頁33-56。
黃昭元(2004),憲法權利限制的司法審查標準:美國類型化多元標準模式的比較分析,國立臺灣大學法學論叢,33卷3期,頁45-148。
黃舒芃(2006),社會權在我國憲法中的保障,中原財經法學,16期,頁1-43。
---------(2016),國際及區域人權公約在憲法解釋中扮演的角色,臺灣民主季刊,13卷1期,頁85-129。
楊智傑(2018),美國與臺灣專利民事侵權訴訟爭點效之發展與爭議-兼論臺灣專利無效雙軌制之困境,交大法學評論,3期,頁97-158。
靳宗立(2014),我國藥物安全管理法制與刑事規制現況之探討,刑事政策與犯罪研究論文集,10期,頁37-62。
廖福特(2009),批准聯合國兩個人權公約及制訂施行法之評論,月旦法學雜誌,174期,頁223-229。
---------(2011),法院應否及如何適用《經濟社會文化權利國際公約》,台灣人權學刊,1卷1期,頁3-25。
---------(2010),法院應否及如何適用公民與政治權利國際公約,台灣法學雜誌,163期,頁45-65。
廖瑋婷(2019),臺美TIFA對藥品核准前專利爭端解決程序之要求——以美國 BPCIA 之專利舞蹈為中心,貿易政策論叢,29期,頁89-128。
劉宏恩(2020),評我國食藥署關於 COVID-19 疫苗臨床試驗受試者徵求及緊急授權使用(EUA)之政策,生物醫學,13卷4期,頁237-239。
劉亞明、高雅慧、謝啟瑞(2010),財務動機對醫師處方原廠藥與學名藥選擇的影響,成大研發快訊,14卷8期。
劉建宏(2007),吸菸者與非吸菸者之人權保障:「吸菸自由」?-兼論「健康權」之內涵,台灣本土法學雜誌,94期,頁59-67。
蔡孟翰(2014),論個人以健康權為基礎對菸害防制提起救濟之可能,中華國際法與超國界法評論,10卷2期,頁177-200。

(四)學術研討論文與碩士論文

吳東哲(2015),藥品的核准前專利爭端解決程序-美國專利連結為借鏡,政治大學法學院法律科際整合研究所碩士論文。
張耕豪(2005),醫藥品專利與強制授權制度之探討,東吳大學法學院法律學系碩士班碩士論文。
陳美利(2005),專利制度與公共衛生需求之調和-以醫藥品專利相關制度之發展為核心,東吳大學法學院法律學系碩士班碩士論文。
賴炫羽(2000),有關全民健保支付規定與藥品價差問題之研究,東吳大學法律學系法律專業碩士班碩士論文。
譚令蒂、洪乙禎、謝啟瑞(2005),論藥價差,中央研究院經濟研究所學術研討論文。

(五)法院判決

高雄高等行政法院109年度簡上字第26號判決。
高雄地方行政法院108年度簡字第21號判決。
智慧財產法院110年度民專抗字第2號裁定。
智慧財產法院109年民專訴字第46號判決。
最高行政法院107年度判字第516號判決。
新北地方行政法院109年度簡字第155號判決。

(六)其他

1. 政府公告、研究報告以及人權公約之國家報告

公民與政治權利國際公約及經濟社會文化權利國際公約第二次國家報告(2016),https://www.humanrights.moj.gov.tw/media/12222/4272004131850eed8d.pdf?mediaDL=true。
公民與政治權利國際公約及經濟社會文化權利國際公約第三次國家報告(2020),https://www.humanrights.moj.gov.tw/media/14756/03中文版-兩公約第三次國家報告經濟社會文化權利國際公約執行情形.pdf?mediaDL=true。
李素華、吳全峰、林道通(2017),藥事法建置專利連結制度相關子法規研擬,衛生福利部食品藥物管理署106年度研究期末報告,頁10, 46。
李素華、吳全峰、謝季峰(2015),自由化法規鬆綁落實藥品智慧財產保護之法規修訂,衛生福利部食品藥物管理署104年度研究成果報告,頁51。
健保審字第1090050844號公告。
衛授食字第1081410630號公告。
藥字第1061411895號公告。

2. 電子期刊

王亞蕾(2018),疫苗研發的臨床參考要點,當代醫藥法規月刊,98期,頁1-10。
張哲倫(2014),專利權之無體性質對專利侵權訴訟程序之影響,智慧財產權月刊,192期,頁5-20。
黃庭筠(2020),資料專屬期及國內外臨床試驗資料表之介紹,當代醫藥法規月刊,117期,頁13-21。
葉庭佑(2020),運動傷害用藥,台大醫網,180期,頁14-16。

3. 衛生福利部網路資訊

行政院衛生署中央健康保險局(2013),國際藥價政策與管理制度讀書會會議資料,https://www.nhi.gov.tw/Resource/webdata/23978_1_1020715國際藥價政策與管理制度讀書會會議資料.pdf。
衛生福利部(2016),「我國新藥與疫苗研究開發、上市流程及相關法規之妥適性」專案報告。
---------------(2019),西藥專利連結制度於108年8月20日正式上路,https://www.mohw.gov.tw/cp-4254-49000-1.html。
---------------(2019),「研討生物相似性藥品準用專利連結可行性」公聽會(書面報告),https://www.mohw.gov.tw/dl-52702-36852ffd-3e81-43a0-bffc-e02161c9d0f0.html。
---------------(2021),中華民國108年國民醫療保健支出。
---------------(2019),全民健康保險新收載品項明細表,http://www.capa.org.tw/upfiles/1574138481.pdf。
---------------(2020),全民健康保險新收載品項明細表,http://www.capa.org.tw/upfiles/1584417989.pdf。
---------------(2020),全民健康保險新收載品項明細表,http://www.capa.org.tw/upfiles/1594957820.pdf。
---------------(2021),全民健康保險新收載品項明細表,http://www.capa.org.tw/upfiles/1611732662.pdf。
---------------(2016),全民健康保險辦理藥品給付、價格訂定及調整Q&A,https://www.nhi.gov.tw/Resource/webdata/31549_1_藥品給付、價格訂定及調整QA.pdf。
---------------(2018),全民健康保險藥物給付項目及支付標準共同擬訂會議藥品部分第31次(107年4月)會議紀錄。
---------------(2021),全民健康保險藥品已收載品項異動明細表,https://webcache.googleusercontent.com/search?q=cache:KoDDShSTT5QJ:https://ws.nhi.gov.tw/Download.ashx%3Fu%3DLzAwMS9VcGxvYWQvMjkyL3JlbGZpbGUvNzU5NS80MDQ2L%252BmZhOS7tjMt5YWo5rCR5YGl5bq35L%252Bd6Zqq6Jel5ZOB5bey5pS26LyJ5ZOB6aCF55Ww5YuV5piO57Sw6KGoLnBkZg%253D%253D%26n%3D6ZmE5Lu2My3lhajmsJHlgaXlurfkv53pmqrol6Xlk4Hlt7LmlLbovInlk4HpoIXnlbDli5XmmI7ntLDooagucGRm+&cd=3&hl=zh-TW&ct=clnk&gl=tw&client=safari。
---------------(2019),西藥專利連結制度於108年8月20日正式上路,https://www.mohw.gov.tw/cp-4254-49000-1.html。
---------------(2020),修訂抗癌瘤藥物 Lenvatinib(如Lenvima)及Sorafenib(如Nexavar)部分規定,http://webcache.googleusercontent.com/search?q=cache:5SmjzX2c-i0J:www.tsim.org.tw/helth/hel338_m744.html+&cd=3&hl=zh-TW&ct=clnk&gl=tw&client=safari。
---------------(2019),健保藥價調整、藥價黑洞與壟斷查處情形書面報告,https://webcache.googleusercontent.com/search?q=cache:bIFQyo_Z1NwJ:https://www.mohw.gov.tw/dl-57926-f4608033-1f94-4c9e-8d60-aebb63021c82.html+&cd=1&hl=zh-TW&ct=clnk&gl=tw&client=safari。
---------------(2018),細說從頭,https://www.mohw.gov.tw/cp-7-7-1.html。
---------------(2009),標靶藥物「賀癌平」用於早期乳癌將列入健保給付,https://www.mohw.gov.tw/cp-3162-26971-1.html。
---------------(2021),衛生福利部核准「臺灣清冠一號濃縮製劑」專案製造,應經中醫師處方,民眾勿自行購買服用,https://www.mohw.gov.tw/cp-16-60830-1.html。
---------------(2012),學名藥與原廠藥之療效及品質均符合政府要求之標準,https://www.mohw.gov.tw/cp-3159-23887-1.html。
---------------(2018),藥事法部分條文修正草案之專利連結制度(Patent Linkage ),https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f636694189498129515。
衛生福利部社會保險司(2020),投資健康,110年健保費率調整為5.17%,https://www.mohw.gov.tw/cp-4624-57420-1.html。
衛生福利部食品藥物管理署(2018),1070423本署回應,https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f636694364438478130。
------------------------------------(2018),公告修正「藥事法第二十七條之二必要藥品清單」,https://www.mohw.gov.tw/cp-3795-41840-1.html。
------------------------------------(2017),專利資訊查詢,https://plls.fda.gov.tw/PatentList?r=1502999088。
------------------------------------(2018),專利資訊查詢,https://plls.fda.gov.tw/PatentList?r=2070965050。
衛生福利部疾病管制署(2021),我國疫苗政策兩大原則:由中央政府與原廠簽約採購並統籌分配執行,https://www.cdc.gov.tw/Bulletin/Detail/PHfk6o4BpcxNWZRfEQ8Hvw?typeid=9。
-------------------------------(2005),侯署長籲羅氏藥廠共同協議克流感藥劑製造權許可,以確保國人生命,https://www.cdc.gov.tw/En/Category/ListContent/AHwuigegBBBmuDcbWkzoGQ?uaid=GzYQBpW0a3Wtqr1tNs_9lQ。

4. 其他網路資訊

王昶閔(2012),肝癌標靶藥物健保給付了,肝病防治學術基金會,https://www.liver.org.tw/journalView.php?cat=22&sid=329&page=3。
李樹人、張益華(2018),鼓勵生技製藥創新與國際接軌,聯合報, http://www.irpma.org.tw/zh_TW/education2_content/id/483。
立法院國會圖書館(2017),管制藥品管理條例,法規資源引介,147輯。
光田綜合醫院(2021),Nexavar(蕾莎瓦膜衣錠),http://www.ktgh.com.tw/Medicament_tbDrug_Look.asp?CatID=65&ModuleType=&NewsID=1339&Ordid=20541。
好險在這裡(2016),抗肝癌五大療法,樣樣燒大把錢,https://goodins.life/bt/24202/anticancer-5therapy。
行政院經貿談判辦公室(2016),第10屆臺美TIFA會議相關資訊,https://www.ey.gov.tw/otn/5C2DCF56C7DDD197/328ff503-e0e5-411b-97b7-23d3af648931。
拜耳(2020),蕾莎瓦®膜衣錠200毫克,https://www.bayer.com.tw/zh-hant/nexavar。
科學人(2011),新藥來源告急,https://sa.ylib.com/MagArticle.aspx?id=1828。
黃心瑩(2021),台灣死亡率偏高需觀察。張上淳:瑞德西韋不是救命藥,健康醫療網,https://www.healthnews.com.tw/news/article/50375。
翁國彥(2018),大法官釋字第767號解釋映照司法審判者的人性與血淚,公視新聞議題中心, https://pnn.pts.org.tw/project/inpage/997/56/73。
連珮如(2021),乳癌新標靶藥物治療之自我照護,臺北榮民總醫院乳房醫學中心, https://wd.vghtpe.gov.tw/cbhc/Fpage.action?muid=8526&fid=9371。
臺北市立聯合醫院(2018),中藥處方集,https://tpech.gov.taipei/News_Content.aspx?n=7717FE40F153EFC6&sms=7A5AA85AB0074BE6&s=3635D3B7545FAFAE。
趙大中(2021),化療+賀癌平有效預防腋下淋巴結陰性HER2陽性的小型乳癌復發,臺北榮民總醫院乳房醫學中心,https://wd.vghtpe.gov.tw/cbhc/Fpage.action?muid=8669。
嘉義長庚肝癌團隊(2020),嘉義長庚肝癌自費治療簡介,https://www1.cgmh.org.tw/intr/intr5/c61200/嘉義長庚肝癌治療(民眾版)(20200318).pdf。
劉錦鳳(2021),乳癌標靶藥物皮下注射新劑型,高醫資訊,http://www.kmuh.org.tw/www/kmcj/data/10901/8.htm。
蔣士棋(2021),提升新冠肺炎疫苗全球普及率專利強制授權是唯一解?,聯合新聞網, https://udn.com/news/story/6871/5487211。
鄭凱元(2020),世衛組織宣布「武漢肺炎不構成PHEIC」引爆親中爭議──談防疫政治與黑洞效應,換日線,https://crossing.cw.com.tw/article/12898。
羅氏公司(2020),Herceptin®賀癌平®,https://www.roche.com.tw/zh/products/products01/herceptin.html。
羅志華(2021),中央擋地方政府採購疫苗不合理!桃市議員舒翠玲告衛福部,ETtoday新聞雲,https://www.ettoday.net/news/20210531/1995215.htm。

二、英文文獻

(一)專書

Sen, Amartya. (1997). Choice, Welfare, and Measurement, Cambridge: Harvard Univ. Press.
- (2000). Development as Freedom, New York: Anchor Books.
- (1992). Inequality Reexamined, Cambridge: Harvard Univ. Press.
Saul, Ben et al. (2014). The International Covenant on Economic, Social and Cultural Rights: Commentary, Cases, and Materials, Oxford: Oxford Univ. Press.
Saul, Ben. (2016). The International Covenant on Economic, Social and Cultural Rights: Travaux Préparatoires, Volume I, Oxford: Oxford Univ. Press.
Sunstein, Cass R. (1999). One Case at a Time: Judicial Minimalism on the Supreme Court, Cambridge: Harvard Univ. Press.
Rose, Geoffrey Rose et al. (2008). Rose's Strategy of Preventive Medicine, Oxford: Oxford Univ. Press.
Rawls, John. (1999). A Theory of Justice, Cambridge: Harvard Univ. Press.
- (2001). Justice as Fairness: A Restatement, Belknap Press.

(二)專書論文

Nussbaum, Martha (2001). Capabilities and Human Rights, in Patrick Hayden ed., The Philosophy of Human Rights.
- (1999). Capabilities, Human Rights, and the Universal Declaration, in Burns Weston and Stephen Marks eds., The Future of International Human Rights.
Rägo, Lembit & Santoso Budiono. (2008). in Chris J. van Boxtel et al. eds., Drug Regulation: History, Present and Future, Drug Benefits and Risks.
Wing, John K. (2018). Severe Mental Illness, in Andrew Stevens et al. eds., in Health Care Needs Assessment: The Epidemiological Based Needs Assessment Reviews, Vol. 2.

(三)期刊論文

AbouZahr, C. (2003). Safe Motherhood: A Brief History of the Global Movement 1947–2002. British Medical Bulletin 67(1):13-25.
Ahmadiani, S., & Nikfar, S. (2016). Challenges of Access to Medicine and the Responsibility of Pharmaceutical Companies: A Legal Perspective. Journal of Faculty of Pharmacy 24(1):1-7.
Bashford, A. (2006). Global Biopolitics and the History of World Health. History of The Human Sciences 19(1):67-88.
Eiland, ML. (2007). Patenting Traditional Medicine. Journal of the Patent and Trademark Office Society 89(1):45-90.
Feldman J. (2009). Compulsory Licenses: The Dangers behind the Current Practice. Journal of International Business and Law 8(1):137-167.
Gostin, LO. (2001). The Human Right to Health: A Right to the "Highest Attainable Standard of Health". The Hastings Center Report 31(2):29-30 (2001).
Grover A, Citro B, Mankad M, Lander F. (2012). Pharmaceutical Companies and Global Lack of Access to Medicines: Strengthening Accountability under the Right to Health. J Law Med Ethics 40(2):234-250.
Gruszczynski, Lukasz & Wu, CH. (2021). Between the High Ideals and Reality: Managing COVID-19 Vaccine Nationalism. European Journal of Risk Regulation 1-9.
Hestermeyer, HP. (2004). Access to Medication as a Human Right. Max Planck Yearbook of United Nations L. 8:101.
Heywood, M. (2003). Preventing Mother-to-Child HIV Transmission in South Africa: Background Strategies and Outcomes of the Treatment Action Campaign Case against the Minister of Health. South African Journal on human Rights 19(2):278-315.
Hoen, E. '., Berger, J., Calmy, A., & Moon, S. (2011). Driving a decade of change: HIV/AIDS, Patents and Access to Medicines For All. Journal of the International AIDS Society 14, 15.
Hogerzeil HV, Samson M, Casanovas JV, Rahmani-Ocora L. (2006). Is Access to Essential Medicines as Part of the Fulfilment of the Right to Health Enforceable through the Courts?. Lancet 368:305-311.
Idris, R. (2016). Patent Linkage: Possible Impact on Malaysia’s Access to Medicine. Scholars Journal of Applied Medical Sciences 4(5C)1672-1676.
Ingrid T. Katz, M.H.S., Rebecca Weintraub, Linda-Gail Bekker, and Allan M. Brandt. (2021). From Vaccine Nationalism to Vaccine Equity — Finding a Path Forward. The England Journal of Medicine 384:1281-1283.
Kinney, ED. (2001). The International Human Right to Health: What Does this Mean for our Nation and World. Indiana Law Review 34(4):1457-1475.
Kogan, LA. (2011). The U.S. Biologics Price Competition and Innovation Act of 2009 Triggers Public Debates, Regulatory/Policy Risks, and International Trade Concerns. Global Trade and Customs Journal 6(11)(12):513-546.
Ladonnikov, A. (2018). The Biosimilar Patent Dance - If You Don't Dance, You're No Friend of Mine. Santa Clara High Technology Law Journal 35(1):135-154.
Lopert, R & Gleeson, D. (2013). The High Price of Free Trade: U.S. Trade Agreements and Access to Medicines. J Law Med Ethics 41(1):199-223.
Magaisa, AT. (2017). CASE NOTES: Minister of Health and Others v. Treatment Action Campaign and Others (2002). Journal of African Law 47:117-125.
Maybarduk P., Rimmington S. (2009). Compulsory Licenses: A Tool to Improve Global Access to the HPV Vaccine?. American Journal of Law & Medicine 35:323-350.
Mehl, AB. (2006). The Hatch-Waxman Act and Market Exclusivity for Generic Manufacturers: An Entitlement or an Incentive?. Chicago-Kent Law Review 81(2):649-677.
Meier, BM & Yamin AE. (2011). Right to Health Litigation and HIV/AIDS Policy. The Journal of Law, Medicine & Ethics 39(1):81-84.
NG, Elizabeth Siew Kuan Ng. (2009). Balancing Patents and Access to Medicine. Singapore Academy of Law Journal 21: 457-484.
Ngwena, C. (2003). Access to Health Care Services as a Justiciable Socio-Economic Right under the South African Constitution. Med Law Int 6(1):13-23.
No authors listed. (2021). A patent waiver on COVID vaccines is right and fair. Nature 593:478.
Ruger, JP. (2006). Toward a Theory of a Right to Health: Capability and Incompletely Theorized Agreements. Yale J Law Humanit 18(2):1-47.
Sachs, A. (2000). Social and Economic Rights: Can They Be Made Justiciable?. SMU Law Review 53(4):1381-1392.
Sage Publications, Inc. (1921) International Sanitary Convention: Proces Verbal of the Deposit of the Ratifications by the United States and Other Governments, October 7, 1920, of the International Sanitary Convention Signed at Paris January 17, 1912. Public Health Reports 36(2):36-38.
Scheuring, S. (2009). Is There a Right to Water in International Law. UCL Jurisprudence Review 15:147-171.
Schrijver, NJ. (2006). The Future of the Charter of the United Nations. Max Planck Yearbook of United Nations L 10:1-34.
Sell, SK. (2003). Trade Issues and HIV/AIDS. Emory International Law Review 17(2):933-954.
Shalev, Carmel. (2004). Access to Essential Drugs, Human Rights and Global Justice. Monash Bioethics Review 23(1)56-74.
Son, KB, Lopert R, Gleeson D & Lee TJ. (2018). Moderating the Impact of Patent Linkage on Access to Medicines: Lessons from Variations in South Korea, Australia, Canada, and the United States. Globalization & Health 14:101.
Sotto, LJ. (1986). Undoing a Lesson of Fear in the Classroom: The Legal Recourse of Aids-Linked Children. University of Pennsylvania Law Review 135:193-221.
Tarantola, D. (2008). A Perspective on the History of Health and Human Rights: From the Cold War to the Gold War. Journal of Public Health Policy 29(1):42-53.
Tsui, M. (2011). Access to Medicine and the Dangers of Patent Linkage: Lessons from Bayer Corp v. Union of India. J Law Med 18(3):577-588.
Urias, E., & Ramani, S. V. (2020). Access to Medicines after TRIPS: Is Compulsory Licensing an Effective Mechanism to Lower Drug Prices? A Review of the Existing Evidence. Journal of International Business Policy, 1–18.
Weiswasser, ES & Danzis SD. The Hatch-Waxman Act: History, Structure, and Legacy. Antitrust Law Journal 71(2):585-608.

(四)法院判決

Bayer Corporation & Anr v. Union of India & Ors, LPA 443/2009 (2010).
Durisotto v. Italy App nos 62804/13 (ECHR 152 May 2014).
Government of the Republic of South Africa and Others v. Grootboom and Others (CCT11/00) [2000] ZACC 19; 2001 (1) SA 46; 2000 (11) BCLR 1169 (4 October 2000).
Hristozov and Others v. Bulgaria App nos 47039/11 and 358/12 (ECtHR 13 November 2012).
Minister of Health and Others v. Treatment Action Campaign and Others (No 2) (CCT8/02) [2002] ZACC 15; 2002 (5) SA 721; 2002 (10) BCLR 1033 (5 July 2002).
Soobramoney v. Minister of Health (Kwazulu-Natal) (CCT32/97) [1997] ZACC 17; 1998 (1) SA 765 (CC); 1997 (12) BCLR 1696 (27 November 1997).
Tribunal Supremo de Justicia de Venezuela, Cruz Bermúdez v. Ministerio de Sanidad y Asistencia Social, Case No. 15.789, Decision No. 916 (1999).

(五)國際多邊/單邊條約與憲章

Charter of the United Nations, Oct. 24, 1945, 1 U.N.T.S. XVI.
Constitution of the World Health Organization, Jun. 19-Jul. 22, 1964, 14 U.N.T.S. 186.
International Covenant on Civil and Political Rights, Dec. 16, 1966, 999 UNTS 171.
International Covenant on Economic, made and Cultural Rights, Dec. 16, 1966, 993 U.N.T.S. 3.
Universal Declaration of Human Rights, Dec. 10, 1948, UN Doc. A/RES/217 A (III).

(六)國際組織文件

CCPR. (2018). General Comment No. 6, UN Doc CCPR/C/GC/36.
CESCR. (2000). General Comment No. 14, UN Doc E/C.12/2000/4.
European Generic Medicines Association. (2008). Patent-related Barriers to Market Entry for Generic Medicines in the European Union.
OHCHR. (2008). Fact Sheet No. 31, The Right to Health.
----------(2012). Normative Standards in International Human Rights Law in Relation to Older Persons.
UNDP. (2000). Human Development Report 2000.
UN Economic and Social Council. (1947). International Bill of Rights Documented Outline, E/CN.4/AC.1/3/Add.1.
UN General Assembly. (2003). Access to Medication in The Context of Pandemics such as HIV/AIDS, Tuberculosis and Malaria, A/RES/58/179.
---------------------------(1990). Resolution Adopted on the Report of the Ad Hoc Committee on the Seventeenth Special Session, A/RES/S-17/2.
---------------------------(2013). Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, Anand Grover, on Access to Medicines, A/HRC/23/42.
---------------------------(2010). Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, A/65/255.
United Nations Office on Drugs and Crime, Demand Reduction: A Glossary of Terms, https://www.unodc.org/pdf/report_2000-11-30_1.pdf.
WHO. (2002). Access to Medication in the Context of Pandemics such as HIV/AIDS: Report Of The Secretary-General, E/CN.4/2002/52.
--------(1981). Global Strategy for Health for All by the Year 2000.
--------(2001). Meeting Report: Network for Monitoring the Impact of Globalization and TRIPS on Access to Medicines, 20, WHO/EDM/PAR/2002.1.
--------(2002). Strengthening Mental Health, EB109.R8.
--------(1985). the Role of the WHO Action Programme on Essential Drugs and Vaccines, WHO/CONRAD/WP/2.5.
--------(2017). Towards access 2030: WHO essential medicines and health products strategic framework 2016-2030, WHO/EMP/2017.01.
--------(1981). WHO Action Programme on Essential Drugs, WPR/RC32/16.
--------(2003). Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, WT/L/540.
--------(2021). Waiver from Certain Provisions of The Trips Agreement for The Prevention, Containment and Treatment of Covid-19, IP/C/W/669/Rev.1.

(七)其他

American Occupational Therapy Association. (2021). What is Occupational Therapy?. Available at https://www.aota.org/Conference-Events/OTMonth/what-is-OT.aspx.
American Psychiatric Association. (2019). What is Psychotherapy?. Available at https://www.psychiatry.org/patients-families/psychotherapy.
Americcan Physical Therapy Association. (2021). Becoming a PT. Available at https://www.apta.org/your-career/careers-in-physical-therapy/becoming-a-pt.
Baker Mckenzie. (2019). Global Guide to Patent Linkage. Available at https://f.datasrvr.com/fr1/819/62093/Global_Guide_to_Patent_Linkage_Handbook_5_November_2019.pdf.
Branswell, Helen. (2021). How the Covid pandemic ends: Scientists look to the past to see the future. Available at https://www.statnews.com/2021/05/19/how-the-covid-pandemic-ends-scientists-look-to-the-past-to-see-the-future/.
Brown, Mayer. German Federal Court of Justice Denies Compulsory License on Anti-Cholesterol Drug Patent. Available at https://www.mayerbrown.com/en/perspectives-events/blogs/2019/06/german-federal-court-of-justice-denies-compulsory-license-on-anticholesterol-drug-patent.
Council on Foreign Relations. (2021). What Does the World Health Organization Do?. Available at https://www.cfr.org/backgrounder/what-does-world-health-organization-do.
Drew, Catherine. (2017). EU Unlikely to Follow US with 'Patent Linkage' System, Says Expert. Available at https://www.pinsentmasons.com/out-law/analysis/eu-unlikely-to-follow-us-with-patent-linkage-system-says-expert.
European Commission. (2021). Questions and Answers on COVID-19 Vaccination in the EU. Available at https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans/questions-and-answers-covid-19-vaccination-eu_en.
FDA. (2019). Abbreviated New Drug Application (ANDA). Available at https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda.
- (2019). COVID-19 Vaccines. Available at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines.
- (2019). Generic Competition and Drug Prices. Available at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices.
Fletcher, E.R. (2019). WHO Essential Medicines Review: Cancer Drugs, Insulin Analogues Draw Controversy. Available at https://healthpolicy-watch.news/who-essential-medicines-review-cancer-drugs-insulin-analogues-draw-controversy/.
Ibrahim, Imad Antoine. (2021). Overview of Export Restrictions on COVID-19 Vaccines and their Components. Available at https://www.asil.org/insights/volume/25/issue/10.
Medicines for Europe. (2019). Position Paper: the Anti-Competitive Effects of Patent Linkage (May 2019). Available at https://www.medicinesforeurope.com/wp-content/uploads/2021/03/Medicines%20for%20Europe%20Position%20Paper%20On%20Patent%20Linkage%20-%20May%202019.pdf.
Meredith, Sam. (2021). Rich Countries are Refusing to Waive the Rights on Covid Vaccines as Global Cases Hit Record Levels. Available at https://www.cnbc.com/2021/04/22/covid-rich-countries-are-refusing-to-waive-ip-rights-on-vaccines.html.
Mikulic, Matej. (2020). Comparison of the Wholesale Acquisition Cost (WAC) Of Herceptin Vs Biosimilars in the United States as of Q2 2020. Available at https://www.statista.com/statistics/1186607/comparison-wac-herceptin-vs-biosimilars-us/.
Office of The United States Trade Representative. (2017). The United States Officially Withdraws from The Trans-Pacific Partnership. Available at https://ustr.gov/about-us/policy-offices/press-office/press-releases/2017/january/US-Withdraws-From-TPP.
Office of the United States Trade Representative. (2017). The United States Officially Withdraws from the Trans-Pacific Partnership.
OHCHR. (2017). Access to Essential Medicines is a Fundamental Element of the Right to Health. Available at https://www.ohchr.org/EN/NewsEvents/Pages/Accessessentialmedicines.aspx.
Riedel, Eibe. The Human Right to Health: Conceptual Foundations. Available at https://www.eda.admin.ch/dam/eda/en/documents/aussenpolitik/menschenrechte-menschliche-sicherheit/01_453_Riedel.pdf.
Shipman, Matt. (2020). Vaccine Q&A: How Long Does It Take to Make Vaccines?. Available at https://news.ncsu.edu/2020/12/vaccine-manufacturing-q-and-a/.
UNAIDS. (2018). Kofi Annan’s AIDS legacy. Available at https://www.unaids.org/en/resources/presscentre/featurestories/2018/august/kofi-annan-aids-legacy.
United Nation. (2021). Unequal Vaccine Distribution Self-Defeating, World Health Organization Chief Tells Economic and Social Council’s Special Ministerial Meeting. Available at https://www.un.org/press/en/2021/ecosoc7039.doc.htm.
Victoria's Hub for Health Services & Business. (2020). Pharmacotherapy Treatment. Available at https://www2.health.vic.gov.au/about.
WHO. (2020). Access to Essential Medicines as Part of the Right to Health. Available at https://www.who.int/medicines/areas/human_rights/en/.
- (2017). Data Exclusivity and Other “Trips-Plus” Measures. Available at https://apps.who.int/iris/handle/10665/272979.
- (2020). Essential Medicines and Health Products. Available at https://www.who.int/medicines/services/essmedicines_def/en/.
- (2021). HIV/AIDS. Available at https://www.who.int/news-room/fact-sheets/detail/hiv-aids.
- (2021). International Health Regulations. Available at https://www.who.int/health-topics/international-health-regulations#tab=tab_1.
- (2021). Medicines. Available at https://www.who.int/health-topics/medicines#tab=tab_3.
- (2005). Mental Health Atlas: 2005, Rev. ed. Available at https://apps.who.int/iris/bitstream/handle/10665/43230/924156296X_eng.pdf?sequence=1&isAllowed=y.
- (2019). Poliomyelitis. Available at https://www.who.int/news-room/fact-sheets/detail/poliomyelitis.
- (2020). WHO Director-General's Opening Remarks at the Media Briefing on COVID-19. Available at https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020.
- (2021). Severe Acute Respiratory Syndrome (SARS). Available at https://www.who.int/health-topics/severe-acute-respiratory-syndrome#tab=tab_1.
- (2021). Smallpox. Available at https://www.who.int/health-topics/smallpox#tab=tab_3.
Winston & Strawn. (2021). What Are the Patent Litigation Differences Between the BPCIA and Hatch-Waxman Act?. Available at https://www.winston.com/en/legal-glossary/BPCIA-Hatch-Waxman-Act-differences.html.
Description: 碩士
國立政治大學
法律學系
107651049
Source URI: http://thesis.lib.nccu.edu.tw/record/#G0107651049
Data Type: thesis
Appears in Collections:[法律學系] 學位論文

Files in This Item:

File Description SizeFormat
104901.pdf2727KbAdobe PDF7View/Open


All items in 學術集成 are protected by copyright, with all rights reserved.


社群 sharing