• Title/Summary/Keyword: Hatch-Waxman Act

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The Pharmaceuticals Regime in the KORUS FTA and the TPP Agreement: A Comparative Analysis (한미FTA와 TPP협정의 비교분석을 통한 의약품 분야 국제통상규범에 대한 연구)

  • Yun, Mikyung
    • International Commerce and Information Review
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    • v.18 no.4
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    • pp.165-193
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    • 2016

  • This paper conducts a comparative analysis of the KORUS FTA and the TPP Agreement to assess the current state of affairs in international trade rules for the pharmaceutical industry. Intellectual property rights as well as public health related regulations have evolved to strengthen the position of innovator drug companies. In particular, the TPP Agreement which adopted data exclusivity for biologics for the first time, will set the standard for the future. Apart from this however, the TPP Agreement has not gone further than the KORUS FTA and in some respects, even contains greater policy flexibilities and provisions for market access than the KORUS FTA. Korea should take advantage of such differences when and if she must engage in negotiations to join the TPP Agreement or a renegotiation of the KORUS FTA.

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