後杜哈時代開發中國家公共健康問題與TRIPS協定彈性機制之研究--兼論我國修法方向

Abstract

許多開發中國家（包含低度開發國家）面臨如愛滋病、肺結核及瘧疾等傳染病所導致之嚴重公共健康危機，其中因專利等智慧財產權制度，賦予權利人市場獨占權利，所導致之高藥價，影響醫藥品可近性，則為重要因素。

WTO成立後，TRIPS協定一體適用在各會員，設定最低程度之保護標準，均須將醫藥品列為專利權保護之對象，更使問題雪上加霜。而TRIPS協定中雖亦規定TRIPS彈性機制（TRIPS flexibilities），然南非及巴西利用TRIPS協定彈性機制欲解決公共健康問題時，卻被跨國製藥公司及美國認為違反TRIPS協定，而提出訴訟，引發國際關切，WTO於是檢討TRIPS協定，陸續通過杜哈公共健康宣言、執行杜哈公共健康宣言第六段決議、TRIPS協定第31條修正案。

然縱使TRIPS協定經過檢討修正，所得出之結論並不會自動在各會員中生效，仍須會員將之落實在內國法中始能成為引用之依據。則在後杜哈時代，最新發展為何值得進一步研究。本文即分為供應者、需求者及權利人面向，探討各國就執行杜哈公共健康宣言第六段決議實踐狀況，開發中國家適用TRIPS協定彈性機制時所遭遇之問題，及美國近年來密集與開發中國家簽署自由貿易協定，其中包含許多TRIPS-plus條款，增加權利人權利，限制TRIPS協定彈性機制，其影響又為何。

最後回歸我國，分析我國現行與醫藥品相關之智慧財產權制度及其沿革，並以TRIPS協定之合致性、TRIPS協定彈性機制，及TRIPS-plus角度觀察我國法制之光譜，輔以檢視我國製藥產業狀況，分析我國在開發中國家公共健康議題所得以扮演的角色，並提出修法之建議。

Many developing countries, including least-developed countries, face serious public health crises caused by infectious diseases such as HIV/AIDS, tuberculosis, and malaria. High pharmaceutical prices, the result of intellectual property systems, is one of the most important factors in these crises.

The TRIPS agreement, which establishes minimum standards for the protection of intellectual property, including patents for pharmaceuticals, worsened the situation by allowing increased levels of patent protection, affecting pharmaceutical prices. Developing countries where patents are in place sought to reduce drug prices via measures accorded by TRIPS flexibilities, but pharmaceutical companies and the United States claimed patent infringement. WTO members began to negotiate revisions to the TRIPS agreement, eventually resulting in the “Declaration on the TRIPS Agreement and Public Health”, “Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health” and “Decision on the Amendment on the TRIPS Agreement”.

Even though the TRIPS agreement has been examined and revised, those efforts will not be self-executed. This dissertation reviews the development of this issue in the post Doha era from three perspectives: suppliers, users, and the United States. The current intellectual property system in Taiwan related to medical products is analyzed from the standpoints of legitimacy, TRIPS flexibilities, and TRIPS-plus to determine what role the country can play in this issue.