第五章 多哈公共健康宣言的分析
第二節 多哈公共健康宣言第六段決議內容
WTO 會員最終於 2003 年 8 月 30 日打破談判僵局，就如何執行多哈公共健 康宣言第六段問題達成共識，作出決議，採取暫時性豁免義務之解決方案，使欠
502 Id..
503 Id.
504 Id.
505 Id.
缺完全製藥能力及製藥能力不足之會員，較容易以進口之方式取得廉價之學名 藥，消弭在現行 TRIPS 協定下進口學名藥之障礙。
第一項 適用範圍
決議之第一段係就適用解決方案之客體及主體為規範。在客體方面，係以「醫 藥產品」(pharmaceutical product)為限，至所謂「醫藥產品」係指製藥領域所需，
用以因應多哈公共健康宣言第一段所肯認公共健康問題之任何專利產品，或以方 法專利製造之產品，包括製造所需之有效成分和使用所需之診斷試劑506，而排除 設備之可適用性。
在主體方面，「適格之進口會員」將全數低度開發國家包含在內，並包括任 何向 TRIPS 理事會發出通知，表示其希望使用此制度作為進口者之會員，會員 得隨時將其欲全部或有限制性地（例如：僅在國家緊急危難，或其他其他極度危 急情況，抑或基於非營利之公益目的等事由存在時方使用此制度）使用此制度之 事宜通知 TRIPS 理事會，必須注意者為，部分會員聲明將不會使用決議中確立 之制度作為進口者，而部分會員聲明僅在國家緊急危難或其他特別極度危急狀況 下方使用本制度507。至於「出口會員」則係指使用決議中確立之制度製造醫藥產 品，並將其出口至適格進口會員之會員508。
506 Decision, supra note 8, P 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.＂
507 Id. P 1(b): “eligible importing Member means any least-developed country Member, and any other Member that has made a notification 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 Members 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.＂
508 Id. P 1(c): “exporting Member means a Member using the system set out in this Decision to
從上述內容不難發現多哈公共健康宣言第六段問題決議之適用範圍相當寬 廣，除了於客體方面排除技術設備之適用外，其餘均已符合多數開發中國家的要 求，而未予以嚴格限制。
第二項 製藥能力之評估
關於製藥能力之評估，決議是在附件之部分處理，將低度開發國家會員視為 在製藥領域製造能力不足，或不具製藥能力。就其他適格之進口會員而言，對系 爭醫藥產品是否存有製造能力不足或不具製造能力之情狀，可由以下所列方式之 一確認：第一、系爭會員已確認其在製藥領域不具製造能力；第二、該會員在該 領域有部分製造能力，但對此能力進行審查後發現，倘若排除專利權人所擁有及 控制之能力，其能力尚不足以滿足自身需求509。是以，除了低度開發國家被視為 當然不具充分製藥能力外，其他適格進口國是否具有充分之製造能力仍須由進口 國就擬進口之產品進行逐項之判斷，而未能一概而論。
第三項 出口會員許可強制授權供給藥品予適格進口會員 之要件
依據決議第二段內容，出口會員為將醫藥產品進口至適格之進口會員，而 許可強制授權製造醫藥產品時，在符合下列要件之情形下，可豁免遵守 TRIPS 協定第三十一條第(f)款規定所負之義務510。
produce pharmaceutical products for, and export them to, an eligible importing Member.＂
509 Id. ANNEX.
510 Id. P 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 …＂
第一、 適格之進口會員已向 TRIPS 理事會就下列事項發出通知：特定所需藥品
511 Id. P 2(a):“the eligible importing Member(s) has made a notification to the Council for TRIPS, that:
(i) specifies the names and expected quantities of the product(s) needed;
(ii) confirms that the eligible importing Member in question, other than a least developed country Member, has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question in one of the ways set out in the Annex to this Decision; and (iii) confirms that, where a pharmaceutical product is patented in its territory, it has granted or intends to grant a compulsory license in accordance with Article 31 of the TRIPS Agreement and the provisions of this Decision.＂
512 Id. P 2(b): “the compulsory licence issued by the exporting Member under this Decision shall contain the following conditions:
(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;
(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; and
(iii) before shipment begins, the licensee shall post on a website the following information:
- the quantities being supplied to each destination as referred to in indent (i) above; and - the distinguishing features of the product(s) referred to in indent (ii) above.＂
第三、 出口會員應向 TRIPS 理事會通報許可強制授權之事宜，包含附加之條 件。提供之資訊應包括被授權人之名稱及地址、被授權之產品、數量、
供給產品之對象國、授權之期間及上述網站位址513。
依據上開內容，出口國無論在進口國是否許可強制授權之情形下，均應許可 強制授權方得製藥產品出口。關於出口國方強制授權補償金之計算方式，決議第 三段指出，當出口會員依據決議所確立之制度許可強制授權時，應一併考慮該授 權為進口會員帶來之經濟價值，依據 TRIPS 協定第三十一條第(ｈ)款之規定，給 予專利權人適當之補償金514。至於當適格之進口會員擬進口之產品同時於進、出 口國受有專利保護時，如何克服專利權人收取雙重補償金之不公平情形？決議指 出，當適格之進口會員對同一產品許可強制授權時，如果出口國已依照上開方式 就該產品支付補償金，進口會員履行 TRIPS 協定第三十一條第(h)款之義務應被 豁免515。
由此部分之決議內容可知悉 WTO 最終是採取以 TRIPS 協定第三十一條規定 為基礎之解決方案，在適格進口會員擬進口之產品同時於進口國及出口國境內受 專利保護時，必須由雙方分別許可強制授權，但設有解決雙重補償金問題之配套 措施，化解開發中國家所持之疑慮。另一方面，由於歐體及其會員等已開發國家
513 Id., P 2(c): “(c) the exporting Member shall notify the Council for TRIPS of the grant of the licence, including the conditions attached to it. The information provided shall include the name and address of the licensee, the product(s) for which the licence has been granted, the quantity(ies) for which it has been granted, the country(ies) to which the product(s) is (are) to be supplied and the duration of the licence. The notification shall also indicate the address of the website referred to in subparagraph (b)(iii) above.＂
514 Id. P 3: “Where a compulsory licence is granted by an exporting Member under the system set out in this Decision, adequate remuneration pursuant to Article 31(h) of the TRIPS Agreement shall be paid in that Member taking into account the economic value to the importing Member of the use that has been authorized in the exporting Member.＂
515 Id.:“Where a compulsory licence is granted for the same products in the eligible importing Member, the obligation of that Member under Article 31(h) shall be waived in respect of those products for which remuneration in accordance with the first sentence of this paragraph is paid in the exporting Member.”
仍堅守對防止貿易轉向防衛措施之要求，決議要求出口會員對產品為特別之標
516 Id. P 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.＂
517 Id. P 5: “Members shall ensure the availability of effective legal means to prevent the importation into, and sale in, their territories of products produced under the system set out in this Decision and diverted to their markets inconsistently with its provisions, using the means already required to be available under the TRIPS Agreement. If any Member considers that such measures are proving insufficient for this purpose, the matter may be reviewed in the Council for TRIPS at the request of that Member.＂
第五項 促進會員利用強制授權制度自行製造醫藥產品之
518 Id. P 6: “With a view to harnessing economies of scale for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products:
(i) where a developing or least-developed country WTO Member is a party to a regional trade agreement within the meaning of Article XXIV of the GATT 1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and Fuller Participation of Developing Countries (L/4903), at least half of the current membership of which is made up of countries presently on the United Nations list of least developed countries, the obligation of that Member under Article 31(f) of the TRIPS Agreement shall be waived to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory licence in that Member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. It is understood that this will not prejudice the territorial nature of the patent rights in question;
(ii) it is recognized that the development of systems providing for the grant of regional patents to be applicable in the above Members should be promoted. To this end, developed country Members undertake to provide technical cooperation in accordance with Article 67 of the TRIPS Agreement, including in conjunction with other relevant intergovernmental organizations.“
用決議所確立之制度時，宜朝向此目標邁進。又依據TRIPS 協定第六十
519 Id. P 7: “Members recognize the desirability of promoting the transfer of technology and capacity building in the pharmaceutical sector in order to overcome the problem identified in paragraph 6 of the Declaration. To this end, eligible importing Members and exporting Members are encouraged to use the system set out in this Decision in a way which would promote this objective. Members undertake to cooperate in paying special attention to the transfer of technology and capacity building in the pharmaceutical sector in the work to be undertaken pursuant to Article 66.2 of the TRIPS Agreement, paragraph 7 of the Declaration and any other relevant work of the Council for TRIPS.＂
520 Id. P 8: “The Council for TRIPS shall review annually the functioning of the system set out in this Decision with a view to ensuring its effective operation and shall annually report on its operation to the General Council. This review shall be deemed to fulfill the review requirements of Article IX:4 of the WTO Agreement.＂
521 Id. P 11: “This Decision, including the waivers granted in it, shall terminate for each Member on the date on which an amendment to the TRIPS Agreement replacing its provisions takes effect for that Member. The TRIPS Council shall initiate by the end of 2003 work on the preparation of such an amendment with a view to its adoption within six months, on the understanding that the amendment will be based, where appropriate, on this Decision and on the further understanding that it will not be part of the negotiations referred to in paragraph 45 of the Doha Ministerial Declaration.＂