自由貿易協定中各種有利於製藥產業的規定

FTA 的談判可謂是一場開發中國家由杜哈宣言所確立的權利遭受蠶食鯨吞的歷 程。這些條文除了與海關等相關的邊境執行措施以外，⁶⁹有相當大的比例是在製藥產業

“Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement.”

66 Peter K. Yu, TRIPS協定 and It’s Achilles Heel, 18 J.INTELL.PROP.L.479,519-520(2011).

67 TRIPS Art. 1.1.

68 Henning G. Ruse-Khan, The International Law Relation Between TRIPS and Subsequent TRIPS-PLUS Free Trade Agreements: Towards Safeguarding TRIPS: Toward Safeguarding TRIPS Flexibilities, 18 J.INTELL.PROP. L. 325, 338-341 (2010-2011).

69 參閱本論文表八──2000 年後簽訂之部分自由貿易協定中超 TRIPS 協定條款示意表。

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70 WHO, WTO and the TRIPS Agreement, http://www.who.int/medicines/areas/policy/wto_TRIPS 協定 /en/index.html (last visited June 21, 2012).

71 World Trade Organization, Ministerial Declaration of 14 November 2001, WT/MIN(01)/DEC/1, 41 I.L.M.

746 (2002) [hereinafter Doha Declaration].

72 Id., at paragraph 5.

73 General Council, Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WT/L/540 (Aug. 30, 2003).

74 See e.g. AUSFTA, Art. 17.9(7); U.S. – Singapore FTA, Art. 16.7(6).

75 See e.g. AUSFTA, Art. 17.9(6); U.S. – Singapore FTA, Art. 16.9(5).

76 TRIPS Art. 6 states:

“For the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4 nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.”

77 Doha Declaration, paragraph 5(d) states:

“the effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge, subject to the and national treatment provisions of Articles \ 3 and 4.”

78 See e.g. AUSFTA, Art. 17.9(4); U.S. – Singapore FTA, Art. 16.7(2).

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其他非常有利於專利藥廠的規定涉及資料專屬之保護（data protection; data

exclusivity）。雖然 TRIPS 協定第 39 條規定，會員國必須保護權利人的未公開資訊以防 止不公平競爭的發生。⁷⁹而在烏拉圭回合談判中，美國與某些國家曾經爭取專利申請人 向管制機關遞交據以申請的資料應受到五年之保護，然而這樣的要求並未被納入 TRIPS 協定最後拍板定案的條文中。⁸⁰在美國專利藥廠享有五年資料專屬之保護，無論該資訊 是否已經公開。最後這些條款被納入了 FTA 中，⁸¹如果允許專利藥廠恣意行使將使得藥 商形同享有「市場專有」（marketing exclusivity）。⁸²這些關於資料專屬性的條款意義在 於防止學名藥廠依靠專利藥廠在申請資料中的效用資料，而主張生體相等性

（bioequivalence）。資料專屬性並非專利體制中固有的保障，將會對學名藥的競爭造成 傷害，並且箝制了國家的管制主權。⁸³

美國與澳洲簽訂的 FTA 對澳洲而言影響最大的莫過於必須修正 1948 年建立的「藥 物福利計劃」（pharmaceutical benefit scheme, PBS），大幅影響澳洲政府對於醫藥專利的 管制主權。藥物福利計劃的目標在管理藥價與確保必要藥物的使用，以嚴格的成本定價 評估審核藥價補貼，將藥物以可承擔的價格提供給國民。⁸⁴但這樣的體系對於美國藥業 聯盟（the Pharmaceutical Research and Manufacturers of America, PhRMA）而言必然是芒 刺在背，而不希望該體系為任何開發中國家所模仿。在美國藥業聯盟與美國貿易代表署 施壓之下，藥物福利計劃被要求加入多項修正。依據美澳自由貿易協定，澳洲政府在涉 及藥業管理決定時，必須與美國食品藥物管理委員會（the United States Food and Drug Administration, FDA）討論是否會傷害該藥物的創新；⁸⁵也必須為藥商增設爭端解決機 制，⁸⁶即使澳洲方未有違規行為時，美國也可以隨時提出爭訟與抗議。就有研究指出，

在澳洲與美國簽訂 FAT 以後，超 TRIPS 協定條款造成了學名藥的延遲上市，導致了消

79 TRIPS Art. 39.3. states:

“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use.

In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

80 Abbott, Contradictory Trend in Bilateral and Regional FTA, at 6.

81 See e.g. AUSFTA, Art. 17.10(1); U.S.-Singapore FTA, Art. 16.8(1).

82 Frederick M. Abbott, Toward a New Era of Objective Assessment in the Field of TRIPS協定 and Variable Geometry for the Preservation of Multilateralism, 8 J.INT’L ECON.L. 77, 90-93 (2005) [hereinafter Toward a New Era of Objective Assessment].

83 Sell, TRIPS was Never Enough, at 453.

84 See generally Peter Sainsbury, Australia-United States Free Trade Agreement and the Australian

Pharmaceutical Benefits Scheme, 4 YALE J.HEALTH POL'Y L.&ETHICS 387 (2004). See also Thomas A Faunce et al., Trans-Tasman Therapeutic Products Authority: Potential AUSFTA Impacts on Safety and

Cost-Effectiveness Regulation for Medicines, 37 VICTORIA U.WELLINGTON L.REV. 365 (2006).

85 AUSFTA, annex 2C.4.

86 AUSFTA, Art. 21.7.

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費者損失了約一億五千萬美元。⁸⁷澳洲的學者也認為，澳洲本身就可以歸為智慧財產權 保護標準較高的國家，在與美國簽訂的 FTA 中增加對智慧財產權的保護，其損失大於 利益。⁸⁸