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研究生:楊一晴
研究生(外文):YANG, YI-CHING
論文名稱:論WTO對於公共衛生議題在國際法之發展與實踐─TRIPS協定與SPS協定之研究
論文名稱(外文):The Impact of WTO on the Development and Implementation of Public Health Issues under International Law- The Study of the TRIPS Agreement and the SPS Agreement
指導教授:牛惠之牛惠之引用關係
指導教授(外文):NIU, HUEI-CHIH
學位類別:碩士
校院名稱:東吳大學
系所名稱:法律學系研究所
學門:法律學門
學類:一般法律學類
論文種類:學術論文
論文出版年:2004
畢業學年度:92
語文別:中文
論文頁數:154
中文關鍵詞:公共衛生國際法健康權世界貿易組織與貿易有關之智慧財產權協定TRIPS協定TRIPS協定與公共衛生宣言食品安全檢驗與動植物防疫檢疫協定SPS協定風險評估
外文關鍵詞:Public Healthinternational lawRight to HealthWorld Trade OrganizationAgreement on Trade-related aspects of Intellectual Property Rights (TRIPS Agreement)Declaration on the TRIPS Agreement and Public HealthAgreement on Application of Sanitary and Phytosanitary Measures (SPS Agreement)Risk Assessment
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在國際社會中,各個國家都瞭解且承認公共衛生保障的重要性,且大部分國家的內國法律體系中亦有關於公共衛生法之規範,然而,在國際法架構下,卻尚未形成獨立的國際公共衛生法分支;因此,關於公共衛生議題在國際法下發展與實踐之研究,則必須藉由分析各種國際法法律分支中與公共衛生保障有關之規範,進而彙整出公共衛生議題在國際法律架構下「縱」向與「橫」向發展模式。
本文首先將說明國家公共衛生保障義務之國際法法源依據,並介紹目前影響國家公共衛生保障政策最深的國際組織活動及國際法律規範;透過對國際衛生組織、國際人權法、國際勞工法、國際環境法及世界貿易組織中公共衛生相關規範之分析,得以歸納出公共衛生議題在國際法架構下之發展,可分為「縱」向深度發展,在各種國際法領域中制定具體的公共衛生保障相關法規,以及「橫」向調和發展,促進各個國際法分支下公共衛生標準或規範間之協調與一致化。
其次,本文轉而針對WTO架構下TRIPS協定與SPS協定為案例與規範分析,檢討公共衛生議題在TRIPS協定與SPS協定下正面與負面發展狀況,並評析公共衛生議題在WTO法律中的「縱」「橫」發展成果。最後,則是提出本文對於公共衛生議題在國際法架構下之期許,期待未來國際法對於公共衛生保障,能朝向更綿密細緻之「縱」「橫」發展趨勢。
The importance of protection of public health is understood and recognized by states worldwide. In fact, most of states provide varies public-health-related legislatives and regulations in their domestic legal systems. However, there is lacking the existence of an independent legal branch of "international public health law" under international law system. Accordingly, in respect of studying the development and implementation of public health issues of international law, aiming to construct the "horizontal" and "vertical" development thereof, it is necessary to analyze all kinds of public-health-related regulations from different international law branches.
At the beginning of this article, the sources of international law about the states'' obligations on the protection of public health and the right to health will introduced. This article will also discuss about those international organization and international regulations, which are most effective and involved with the national public health protection policies. Based on the analysis of relevant public-health-related rules provided by World Health Organization, International Human Rights Law, International Labor Law, International Environmental Law and World Trade Organization (WTO), it is obvious that there are two dimensions of the development of public health issues under international law, one is the "vertical" development that the detailed health-related regulations will be enacted in various international law fields, and the other is the "horizontal" development to promote the accommodation and consistence among the regulations from different international branches.
The next step is turning to study all relevant dispute settlement cases and articles under the TRIPS Agreement and the SPS Agreement, to review the negative and positive impact and trend of public health issues thereunder, and to evaluate the effect of development of public health under the WTO legal system. Finally, it is focused on the future of the international protection of public health. In conclusion, the trend of further "horizontal" and "vertical" development on public health protection is expectable.
第一章 緒論 1
1.1 研究動機 1
1.2 研究目的 3
1.3 研究限制 3
1.4 研究方法 4
1.5 研究架構 5
第二章 公共衛生在國際法下之主要發展 7
2.1 公共衛生之內涵 8
2.1.1 公共衛生之定義與歷史 9
1. 公共衛生之定義 9
2. 公共衛生之歷史 10
2.1.2 公共衛生之法律意涵 12
1. 公共衛生法之涵蓋範圍 12
2. 公共衛生法之定義 13
2.1.3 公共衛生與國際法之關聯性 15
2.2 公共衛生在國際法下之主要法律基礎 16
2.2.1 健康權之意涵與公共衛生 17
2.2.2 健康權之違反與公共衛生 19
2.3 涉及公共衛生議題之國際法律規範 21
2.3.1 政策管理與指導功能之公共衛生國際法律規範 22
1. 世界衛生組織處理之公共衛生議題 22
2. 世界衛生組織對全球公共衛生發展之貢獻 24
2.3.2 基本權利與保障之公共衛生議題之國際法律規範 25
1. 國際人權法 26
2. 國際勞工法 28
2.3.3 人類活動所引發之公共衛生議題之國際法律規範 31
1. 國際環境法 31
2. 國際貿易法 34
2.4 小結 34
第三章 WTO架構下與公共衛生相關之規定 37
3.1 WTO之基本架構與原則 37
3.1.1 WTO之基本架構 37
3.1.2 WTO之基本原則與例外規範 39
1. 最惠國待遇原則 40
2. 國民待遇原則 40
3. 公共衛生原則與例外條款 41
3.2 涉及公共衛生議題之WTO多邊貿易協定 44
3.2.1 GATT 1994 44
1. GATT 1994簡介 44
2. GATT 1994之公共衛生相關規範 45
3. GATT 1994涉及公共衛生之議題 45
3.2.2 SPS協定 47
3.2.3 TBT協定 50
1. TBT 協定簡介 50
2. TBT 協定之公共衛生相關規範 51
3. TBT協定涉及公共衛生之議題 51
3.2.4 GATS 52
1. GATS簡介 52
2. GATS之公共衛生相關規範 53
3. GATS涉及公共衛生之議題 53
3.2.5 TRIPS協定 54
3.3 WTO架構下自由貿易目的與公共衛生保障之關係 54
3.3.1 由規範結構分析自由貿易目的與公共衛生保障之關係 54
3.3.2 由爭端解決案件比較自由貿易目的與公共衛生保障之關係 56
3.3.3 自由貿易原則為WTO之本質 59
3.4 小結 59
第四章 TRIPS協定對會員公共衛生之影響-TRIPS協定因應藥品取得困難所為之調整 63
4.1 開發中國家愛滋病問題引發藥品專利與藥品使用之爭端 63
4.1.1 美國與南非之爭端 65
4.1.2 美國與巴西之爭端 66
4.2 專利權與健康權之衝突與平衡 68
4.3 TRIPS協定簡介 70
4.3.1 TRIPS協定之成立目的與架構 70
1. TRIPS協定之成立與目的 70
2. TRIPS協定之架構 72
4.3.2 涉及公共衛生之藥品專利權保障之TRIPS協定相關規範 75
1. 第二十七條第二項:為保護公共秩序或道德而不予專利 76
2. 第七條、第八條:宗旨與原則 77
3. 第六條:耗盡原則 77
4. 第三十條:專利權之例外 79
5. 第三十一條:強制授權 79
4.4 杜哈部長會議「TRIPS協定與公共衛生宣言」 80
4.4.1 公共衛生宣言之內容 81
4.4.2 公共衛生宣言之法律地位 83
4.5 公共衛生宣言對解決TRIPS協定下藥品取得公共衛生危機之主要影響 84
4.5.1 強制授權 85
4.5.2 耗盡原則與平行進口 87
4.5.3 針對缺乏製藥能力之會員取得專利藥品之解決方針 88
1. TRIPS協定第三十條規定之解釋案 88
2. 修正TRIPS協定第三十一條第(f)項規定 90
3. 會員自制避免提出爭端 91
4.6 杜哈部長會議後TRIPS協定之發展-執行公共衛生宣言第六段決議 91
4.6.1 執行公共衛生宣言第六段決議之內容 92
4.6.2 本決議之象徵性意義 95
4.7 TRIPS協定對會員公共衛生之影響 96
4.8 小結 99
第五章 SPS協定對會員公共衛生之影響-SPS協定公共衛生相關案例與規範之分析 103
5.1 SPS協定簡介 103
5.1.1 SPS協定之成立與目的 103
1. SPS協定之成立 103
2. SPS協定之目的 104
5.1.2 SPS協定之範圍與主要規範 105
1. SPS協定之範圍 105
2. SPS協定之主要規範 107
5.2 SPS協定與國際公共衛生組織間衛生保障標準之調和 109
5.2.1 SPS措施對公共衛生之影響 109
5.2.2 SPS協定缺乏幫助會員維持或提升衛生水準之具體規範 109
5.2.3 SPS協定以採用國際標準之方式與其他國際公共衛生法規調和 110
5.3 SPS協定公共衛生議題相關案例介紹與規範分析 112
5.3.1 SPS協定下影響會員公共衛生水準自主權之相關規範 112
5.3.2 相關案例簡介 113
1. 歐體荷爾蒙案 114
2. 澳洲鮭魚案 115
3. 日本農產案 116
4. 日本蘋果案 117
5. 歐體生技產品案 119
5.3.3 相關規範分析 119
1. 充分的科學證據:第二條第二項 121
2. SPS措施不應造成歧視或隱藏性國際貿易限制:第二條第三項 122
3. 會員可選擇適當的保護水準(風險管理):第三條第三項 122
4. 風險評估:第五條第一、二項 124
5. 選擇適當的保護水準應考量之要素(風險管理):第五條第三項 127
6. 一致性:第五條第五項 128
7. 對貿易之限制以不超過達成適當的保護水準為限(風險管理):第五條第六項 130
8. 暫時性措施:第五條第七項 131
5.4 SPS協定對會員公共衛生之影響 132
5.5 小結 133
第六章 結論-從WTO看公共衛生議題在國際法之發展與趨勢 135
6.1 TRIPS協定對於公共衛生議題在國際法發展的意義 135
6.1.1 TRIPS協定之調整對公共衛生保障之「縱」向效果 136
6.1.2 TRIPS協定之調整對公共衛生保障之「橫」向效果 138
6.2 SPS協定對於公共衛生議題在國際法發展的意義 139
6.2.1 SPS協定對公共衛生保障之「縱」向效果 140
6.2.2 SPS協定對公共衛生保障之「橫」向效果 142
6.3 WTO對公共衛生議題在國際法下發展之啟發 144
參考文獻 147
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