第二章 TRIPS 協定中有關醫藥品之規定及對於開發中國家公共健
第四節 執行杜哈公共健康宣言第六段決議
依據杜哈公共健康宣言第六段，針對無或缺乏製藥能力國家，如何克服 TRIPS 協定 第f 款有關主要供應國內市場，及雙重補償問題，雖責成 TRIPS 理事會擬定方案予以解 決，然而亦引發新一波已開發國家與開發中國家之間的角力，已開發國家希望降低杜哈 公共健康宣言對於彈性機制肯定之衝擊，開發中國家則亦藉此重申在TRIPS 協定下解決 公共健康問題之重要性。
第一項 協商過程與爭點
依據杜哈公共健康宣言第六段，針對無或欠缺製藥能力國家利用強制授權機制，責 成TRIPS 理事會提出迅速的解決方式，此議題雖僅為開發中國家公共健康問題的一小部 分，然而已開發國家與開發中國家就諸多問題均爭論不休，見解相當分歧。
非洲集團認為就 TRIPS 協定第 31 條第 f 款形成會員利用強制授權制度的障礙，應 刪除、導入例外規定，或採取對於TRIPS 協定第 30 條為職權解釋。並認為醫藥產品範 圍應包括藥品、相關製程技術及技術設備，會員對於為解決無或欠缺製藥能力國家所面 臨之公共健康問題所採取之措施，應自制而避免提出爭端204。
美國則認為有關決議適用的範圍限於杜哈公共健康宣言第 1 段所示，又因宣言並未 就「無製藥能力」或「欠缺製藥能力」加以定義，決議應建立一套判斷標準；並著重透 明性要求，並要求出口國應將所製造之藥品全數進口至需要藥品之進口國，防止藥品自 市場中流出。
歐盟認為公共健康宣言第六段只要在處理有關無或缺乏製藥能力國家如何取得可 負擔藥品的問題，但也必須注意到兩個面向，即縱使藥物是基於強制授權而製造，所製 造的藥品仍可能為貧窮國家所無法負擔，另外縱使是強制授權製造藥品，仍有成本，而 藥廠也需回收成本205。修正的方式以修正TRIPS 協定第 31 條第(f)款的方案最為可採206。 經過長期的爭辯，WTO 於 2003 年 8 月通過「執行杜哈公共健康宣言第六段決議」。
第二項 內容
執行杜哈公共健康宣言第六段決議在體例上共分為 11 段，並附加附錄「Annex」。
總理事會在決議通過後，復宣讀一份聲明，稱之為「主席聲明」。茲分述重要內容如下：
204 WTO 文件：IP/C/W/351。
205 WTO 文件：IP/C/W/339。
206 WTO 文件：IP/C/W/353。
一、醫藥品之範圍
決議第1 段第 b 項規定所謂「醫藥產品」是指製藥領域所需，用來解決如杜哈公共 健康宣言第1 段所認公共健康問題的任何專利產品，或以方法專利製造之產品，包括製 造所需之活性成分（active pharmaceutical ingredient, API）及使用所需之診斷試劑
（diagnostic kits）207。
二、合格進口國之資格208
合格進口國資格包括全部低度開發國家，以及任何會員已經向TRIPS 理事會發出通 知，表示其欲實施強制授權以進口醫藥品。
三、TRIPS 協定第 31 條第 f 款主要供應國內市場要件之豁免209
在符合執行杜哈公共健康宣言第六段決議第2 條之要件下，可豁免 TRIPS 協定第 31 條第 f 款有關「主要供應國內市場需要」之義務。第 2 條之要件即如第四至第六所示 四、強制授權生產醫藥品之數量
強制授權製造之醫藥品數量必須符合合格進口國所需數量，強制授權製造之醫藥品 必須全部出口至合格進口國210。
207 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health art. 1(a):
“pharmaceutical product" means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address the public health problems as recognized in paragraph 1 of the Declaration. It is understood that active ingredients necessary for its manufacture and diagnostic kits needed for its use would be included.”
208 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health art. 1(b):
“"eligible importing Member" means any least-developed country Member, and any other Member that has made a notification208 to the Council for TRIPS of its intention to use the system as an importer, it being understood that a Member may notify at any time that it will use the system in whole or in a limited way, for example only in the case of a national emergency or other circumstances of extreme urgency or in cases of public
non-commercial use. It is noted that some Members will not use the system set out in this Decision as importing Members208 and that some other Members have stated that, if they use the system, it would be in no more than situations of national emergency or other circumstances of extreme urgency.”
209 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health art. 2:
“The obligations of an exporting Member under Article 31(f) of the TRIPS Agreement shall be waived with respect to the grant by it of a compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s) in accordance with the terms set out below in this paragraph.”
210 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health art.
2(b)(i): “only the amount necessary to meet the needs of the eligible importing Member(s) may be manufactured under the licence and the entirety of this production shall be exported to the Member(s) which has notified its needs to the Council for TRIPS.”
五、可資區別的特徵
授權製造之醫藥品必須清楚標示其係依照本決議所設置之制度而製造，並與專利權 人或其被授權人所製造之醫藥品在顏色或形狀上有足以區別之顯著不同211。
六、訊息公布於網站
出口前，被授權之廠商應將出口至特定會員之醫藥品數量，及醫藥品區隔特徵在其 網站或WTO 特定網站上公布。
七、補償金標準
應衡量專利權於進口國之經濟價值，又避免雙重補償，並規定如出口國已就相同產 品為補償，則進口國免除補償責任212。
八、其他防止再行出口措施213
進口國應採取合理措施，防止依本機制強制授權進口的醫藥品再行出口，已開發國 家並有義務協助開發中國家執行本機制。
九、再行出口之例外
區域貿易組織如有超過一半的成為為低度開發國家，在相當要件下依據決議進口之 醫藥品，得在該區域性貿易組織內部再行出口。
211 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health art.
2(b)(ii): “products produced under the licence shall be clearly identified as being produced under the system set out in this Decision through specific labelling or marking. Suppliers should distinguish such products through special packaging and/or special colouring/shaping of the products themselves, provided that such distinction is feasible and does not have a significant impact on price.”
212 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health art. 3:
“We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices.”
213 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health art. 4:In order to ensure that the products imported under the system set out in this Decision are used for the public health purposes underlying their importation, eligible importing Members shall take reasonable measures within their means, proportionate to their administrative capacities and to the risk of trade diversion to prevent re-exportation of the products that have actually been imported into their territories under the system. In the event that an eligible importing Member that is a developing country Member or a least-developed country Member
experiences difficulty in implementing this provision, developed country Members shall provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in order to facilitate its
implementation
十、附錄
決議附錄關於製藥能力的評估，將低度開發國家視為無或欠缺製藥能力，其他進 口國仍應由擬進口的產品逐項判斷。
十一、主席聲明
為了消除美國及製藥產業適用決議的疑慮，總理事會主席在總理事會核准該項決議 時發表一項獨立聲明，認為決議只是解決公共健康問題的一環，會員在採取決議相關機 制時，必須出於善意（good faith）。過去部分製藥公司發展出之防止產品再行出口相關 程序，應鼓勵會員適用這些最佳準則。
第三項 執行杜哈公共健康宣言第六段之影響
執行杜哈公共健康宣言第六項決議提供暫時性的豁免，決議通過後，美國、歐盟、
加拿大、南非、巴西等國表示贊同，認為該決議具有建設性的平衡，製藥產業亦肯認此 決議。但14 個 NGOs 則發表聯合聲明，認為前開決議具有重重障礙，必須許可 2 次強 制授權，又主席聲明使適用決議增加不確定性等，而質疑執行杜哈公共健康宣言第六段 決議。部分學者亦認為決議之機制在經濟上不具可行性214。亦有學者進一步以可近性
（Accessibility）、持續性（Sustainability）、經濟上可行性（Economic Feasibility）及透明 性（Transparency）來評價決議215。並有見解認為WTO 似乎認為強制授權為最可行的方 案，然而其實強制授權制度存在許多法律、經濟及政治上的缺點216，不可不慎重。
而決議帶來許多層面的影響，有關制度層面，重新定義TRIPS 理事會的角色，因 TRIPS 理事會必須整體審查決議執行狀況，因此扮演重要的角色217。在操作層面，決議 在開發中國家中帶來新層次的區別，並且帶來許多不確定性，並可能形成新的障礙218。 另一個影響，則是刺激其他替代方案219。
另外主席聲明可能帶來新的爭議，因依據主席聲明，是否將會直接限制學名藥出口
214 See Carlos M. Correa, TRIPS and Access to Drugs: Toward a Solution for Developing Countries without Manufacturing Capacity? 17 EMORY INT’L REV. 403 (2003).
215 See Haochen Sun, A Wider Access to Patented Drugs under the TRIPS Agreement, 21 B.U. INT’L L. J.
112-115 (2003).
216 See Amit Gupta, Patent Rights on Pharmaceutical Products and Affordable Drugs: Can TRIPS Provide A Solution?, 2 BUFF. INTELL. PROP. L. J. 150-151 (2004).
217 See Duncan Matthews, WTO Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: A Solution to the Access to Essential Medicines Problem? , 7 J. INT’L ECON. L. 97 (2004).
218 Id.
219 例如製藥公司捐獻必須藥品、差別定價及防止貿易轉向、public-private partnerships、世界基金（Global Fund）、the World Health Assembly。 Id. at 98-104. See also Jessica J. Fayerman, The Spirit of TRIPS and the Importation of Medicine Made under Compulsory License after the August 2003 TRIPS Council Agreement, 25 NW. J. INT’L L. & BUS. 271-276 (2004).
者獲取利潤的權利，或有其他的解釋方式220。有論者憂心如印度等學名藥出口國在執行 杜哈公共健康宣言第六段決議時受到拘束221。