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초록

영어

Since the 1995 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) there has been a growing tension in developing countries between the right of patients to access affordable medicines and the obligation to protect the patent rights of the pharmaceutical companies. This tension has arguably led to a growing crisis in public health in developing countries. This article examines this issue in six parts; following an introduction, part Ⅱ summarizes the tension between patent rights and patient rights. Part Ⅲ highlights the flexibilities created by TRIPS and its subsequent amendment that aim to mitigate the potentially negative consequences of patenting on access to medicines. This part explains the system of compulsory licensing that allows third parties to produce and sell patented drugs without the consent of the rights holder, so long as governments follow certain procedures. In addition, the system of parallel imports is examined under TRIPS. Despite these flexibilities, many developing countries have failed to take advantage of this flexibility by not incorporating the appropriate provisions into national law. Parts Ⅳ and Ⅴ examine three of the reasons constraining access to medicines in developing countries. The first is a problem over Article 31(f) of TRIPS that is restricted to domestic market supply. The second is a problem of the uncertainty over the scope of Article 31 of TRIPS. It appears that through a combination of political pressure, legal challenges and other tactics, the pro-pharmaceutical company lobby has sought to prevent developing countries from exercising their rights under TRIPS. To address these problems, the "Doha Declaration on TRIPS and Public Health" and an unprecedented subsequent amendment to TRIPS in 2005 reinforced the original agreement. The third reason is the threat to compulsory licensing via regional or bilateral pressure, particularly when exerted through free trade agreements (FTAs). Such agreements have introduced so-called "TRIPS-plus" measures such as "data exclusivity" and "marketing approval/patent linkage" provisions that have the potential to constrain the ability of developing countries to use compulsory licensing. This section also looks at these TRIPS-plus measures within the recent Korea/US FTA. Part Ⅵ concludes that without a greater sense of global responsibility by developed countries and pharmaceutical companies, the combination of TRIPS and FTAs could prove a hindrance to improving public health in the developing world.

목차

I. 머리말
 II. 의약품에 대한 접근 vs. 의약품에 대한 특허권
  1. 의약품에 대한 접근이 문제되는 2가지 경우
  2. 의약품 접근에 대한 권리의 근거
  3. 의약품에 대한 특허권
  4. 의약품에 대한 특허권과 의약품에 접근할 권리간의경합 현상
 Ⅲ. 특허권의 제한
  1. 강제실시에 의한 특허권의 제한
  2. 병행수입에 의한 특허권의 제한
 IV. 특허권의 제한에 대한 TRIPS 협정 규정상의 문제점들
  1. 문제점 1: TRIPS 협정 제31(f)조 국내실시 규정
  2. 문제점 2: TRIPS 협정 제31조의 불명확한 범위와적용
  3. 문제점 3: TRIPS-plus와 FTA
 V. FTA상의 강제실시제도의 실효성에 영향을미칠 수 있는 조항들
  1. 의약품 시판허가/특허 연계: 식약청과 특허청 업무의연계
  2. 자료독점권
 VI. 맺음말
 참고문헌
 ABSTRACT

키워드

TRIPS 협정 공중보건 의약품에 대한 접근 도하선언 특허권 강제실시 병행수입 의약품 시판허가/특허 연계 자료 독점권 TRIPS-plus TRIPS Agreement public health access to medicines Doha Declaration patent rights compulsory licensing parallel imports marketing approval/patent linkage date exclusivity

저자

• 이윤주 [ Yunjoo Lee | 한국싸이버대학교 법학부 교수 ]

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