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About the Book As a least-developed-country (LDC) member of the World Trade Organization, Nepal is not required, under the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), to provide patent protection for pharmaceutical products. With no patent restrictions in force, Nepal’s domestic pharmaceutical industry has expanded over the years to meet an increasing share of the country’s medicine needs. This growth is now under threat, however, as Nepal is set to lose its LDC status – and, with it, the TRIPS exemption – in 2026. This paper assesses how the Nepali pharmaceutical sector can face the challenges posed by implementation of the WTO intellectual property rules after the country’s graduation from the LDC category. It calls for full utilization of policy flexibilities allowed by the TRIPS Agreement and strengthened government support to boost the local pharmaceutical industry and enhance access to affordable medicines. South Asia Watch on Trade, Economics and Environment (SAWTEE) is a non-government organization registered in Nepal with a vision of ensuring fair, equitable, inclusive and sustainable growth and development in South Asia. Established in 1999, SAWTEE has been actively engaged in research, advocacy, capacity building, sensitization and alliance building on issues of trade, economics and environment. The SAWTEE team is comprised of highly skilled and experienced professionals who are passionate about contributing to informed and inclusive policymaking. Researchers at SAWTEE have provided inputs to regional and global organizations, besides the Government of Nepal and the Nepali private sector. Contents 1. Introduction 2. Brief History of Nepal’s Pharmaceutical Sector and Intellectual Property System 3. Characteristics of Nepal’s Pharmaceutical Sector 3.1 Overview 3.2 Major medicines consumed in Nepal 3.3 Domestic production 3.4 Consumption and production of patented medicines in Nepal 3.5 Import and export 3.6 Price controls 4. Institutional and Policy Structures 5. The Use of TRIPS Flexibilities 6. Conclusion and Recommendations References
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