Aligning intellectual property protection with public health to ensure access to medicines in Bhutan
Abstract Bhutan currently benefits from broad access to affordable generic medicines, supported by limited patent activity and an effective public procurement system. Although its patent law permits the protection of pharmaceutical inventions, enforcement remains minimal, allowing public health priorities to take precedence. However, Bhutan’s impending accession to the World Trade Organization (WTO), coupled with its recent graduation from Least Developed Country (LDC) status and the evolving landscape of global intellectual property (IP) norms, necessitates a critical assessment of its preparedness to balance IP protection with the constitutional mandate of ensuring universal access to essential medicines and healthcare for all its citizens. This paper examines the implications of the TRIPS Agreement for Bhutan’s pharmaceutical sector in the context of its prospective WTO accession and recent transition to a lower middle-income country (LMIC). While TRIPS compliance aims to strengthen IP protection, it also poses challenges to ensuring access to affordable medicines in developing economies like Bhutan. The analysis highlights Bhutan’s current dependence on pharmaceutical imports, primarily from India and Bangladesh, and underscores the need to strategically leverage TRIPS flexibilities to safeguard public health. The paper identifies critical legal and institutional gaps in Bhutan’s existing framework, including the absence of clear provisions for parallel importation, Bolar exceptions, and well-defined grounds for compulsory licensing. It recommends a series of policy actions to enhance institutional preparedness, strengthen IP and competition laws, and embed public health safeguards in the national IP regime. Furthermore, it emphasizes regional cooperation, garnering international technical assistance, and the avoidance of TRIPS-plus commitments in its future free-trade agreements.
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