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題名 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作者 吳詩婷
Wu, Shih-Ting貢獻者 翁燕菁<br>許耀明
Weng, Yen-Ching<br>Hsu, Yao-Ming
吳詩婷
Wu, Shih-Ting關鍵詞 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日期 2021 上傳時間 2-Sep-2021 17:03:35 (UTC+8) 摘要 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. 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Available at https://www.winston.com/en/legal-glossary/BPCIA-Hatch-Waxman-Act-differences.html. 描述 碩士
國立政治大學
法律學系
107651049資料來源 http://thesis.lib.nccu.edu.tw/record/#G0107651049 資料類型 thesis dc.contributor.advisor 翁燕菁<br>許耀明 zh_TW dc.contributor.advisor Weng, Yen-Ching<br>Hsu, Yao-Ming en_US dc.contributor.author (Authors) 吳詩婷 zh_TW dc.contributor.author (Authors) Wu, Shih-Ting en_US dc.creator (作者) 吳詩婷 zh_TW dc.creator (作者) Wu, Shih-Ting en_US dc.date (日期) 2021 en_US dc.date.accessioned 2-Sep-2021 17:03:35 (UTC+8) - dc.date.available 2-Sep-2021 17:03:35 (UTC+8) - dc.date.issued (上傳時間) 2-Sep-2021 17:03:35 (UTC+8) - dc.identifier (Other Identifiers) G0107651049 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/136984 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 法律學系 zh_TW dc.description (描述) 107651049 zh_TW dc.description.abstract (摘要) 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。 zh_TW dc.description.abstract (摘要) 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. en_US dc.description.tableofcontents 第壹章、前言 1第一節、研究動機 4第二節、研究目的與方法 13第三節、章節安排 15第貳章、健康人權與藥品近用 19第ㄧ節、經社文公約下之健康人權與藥品近用 19ㄧ、健康人權：超越病患接受治療之基本權利 20（一）國際多邊條約揭示的健康人權：歷史與發展 20（二）經社文公約施行後的健康人權發展與補充 25二、人權、衛生與經貿國際法規範下的藥品近用權 35（一）健康人權、公共衛生與經貿秩序下的藥品近用權 36（二）自HIV/AIDS藥品近用爭訟觀察藥品近用權之挑戰與修正 41三、小結：在我國以經社文公約主張藥品近用權的挑戰 48（一）藥品近用權之學說補充修正：基本能力說 48（二）經社文公約中藥品近用在我國內國法化後的挑戰 54第二節、憲法下之健康基本權與藥品近用 60ㄧ、釋憲實務中的健康基本權 60（一）早期釋憲實務中隱晦的健康基本權 61（二）近期釋憲實務所肯認之健康基本權 65二、憲法下藥品近用權的解釋空間再商榷 71（一）釋憲實務下藥品近用權解釋的侷限 71（二）藥品近用權憲法解釋之建構方向芻議 78三、小結：憲法下藥品近用的內涵與界限 82（一）基本能力健康權與合理審查之操作芻議 83（二）國家保護義務之待商榷 84第參章、自藥品近用權出發再訪專利連結制度 87第ㄧ節、專利連結制度：發展、運作與爭議 87ㄧ、國際貿易下專利連結制度的推廣 88（一）TRIPS-plus之興起與美國雙邊自由貿易協議 89（二）美國專利連結制度 94二、我國專利連結制度的發展與運作模式 96（一）啟動專利連結程序的第四款聲明 98（二）專利連結程序開啟後的通知義務與12個月暫停核發藥證程序 100（三）學名藥藥品許可證申請人的12個月銷售專屬期間 103三、小結：對美貿易利益與我國專利連結制度 105第二節、專利連結制度與藥品近用權利 107ㄧ、專利連結制度下的藥品近用權 108（一）以藥品近用權抗拒專利連結制度之國際案例 108（二）專利連結制度爭訟：學名藥證核發延誤是否侵害藥品近用權？ 112二、專利連制度對於人民憲法下藥品近用的侵害 117（一）以化學藥品Sorafenib（商品名稱Nexavar）為例 117（二）以生物藥品Trastuzumab（商品名稱Herceptin）為例 123三、小結：藥品近用權之救濟與《憲法訴訟法》 128第肆章、結論＿兼論COVID-19疫苗相關爭議 133參考文獻 139 zh_TW dc.format.extent 2793306 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0107651049 en_US dc.subject (關鍵詞) 藥品近用權 zh_TW dc.subject (關鍵詞) 專利連結 zh_TW dc.subject (關鍵詞) 憲法訴訟 zh_TW dc.subject (關鍵詞) 經濟社會文化權利公約 zh_TW dc.subject (關鍵詞) TRIPS-plus zh_TW dc.subject (關鍵詞) Right to access to medicines en_US dc.subject (關鍵詞) Patent linkage en_US dc.subject (關鍵詞) Constitutional litigation system en_US dc.subject (關鍵詞) ICESCR en_US dc.subject (關鍵詞) TRIPS-plus en_US dc.title (題名) 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 zh_TW dc.title (題名) Right to access to medicines under the ROC Constitution and the ICESCR: lessons from patent linkage system en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 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， 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