Aligning intellectual property protection with public health to ensure access to medicines in Bhutan

Aligning intellectual property protection with public health to ensure access to medicines in Bhutan | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Aligning intellectual property protection with public health to ensure access to medicines in Bhutan Thupten Tshering, Dorji Tshering This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8597770/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 11 You are reading this latest preprint version 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. Bhutan Intellectual property Access to medicines TRIPS flexibilities Pharmaceutical patents Essential medicines WTO accession Trade agreement Figures Figure 1 INTRODUCTION Intellectual Property (IP) protection is intended to safeguard investments in research and development (R&D), stimulate innovation and support economic growth (1). It serves as a vital mechanism to safeguard investments in R&D, fostering innovation and enhancing commercialization, and broader economic progress. While the protection of IP rights has become an important means of providing safeguards to investments in innovation and creativity, it has inevitably become an important component of international trade policies (2). While IP protection is purported to foster innovation and enhance investment in R&D, its broader implications on trade and access to commodities have been far-reaching (3). The most significant impact of IP protection has been on the global public health, where the enforcement of patent protection under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) has often impeded medicines access, especially in low- and middle-income countries (LMICs). Stronger pharmaceutical monopolies have been linked to increased drug costs, delays in availability, and increased operational costs to governments (4). Bhutan, a small landlocked economy in South Asia, graduated from the least developed country (LDC) status in 2023, becoming only the seventh nation in recent history to achieve this milestone (5). Among its most notable achievements is the provision of free and universal healthcare, which ensures equitable access to essential medicines largely supported by affordable generic imports (6). While the country has made commendable progress toward the Sustainable Development Goals, its economy remains modest in scale and highly vulnerable to external shocks (7). The country faces unique challenges in ensuring access to medicines. It depends heavily on imports for its pharmaceutical needs, primarily from India and, to a lesser extent, Bangladesh. Domestic pharmaceutical production is minimal, making Bhutan susceptible to fluctuations in international supply and pricing. The Industrial Property Act of the Kingdom of Bhutan (IPA) 2001 permits granting of pharmaceutical patents in line with the international IP standards(8). However, there are currently no pharmaceutical patents in enforcement, which has effectively enabled unrestricted access to generic medicines. This has allowed continued importation and use of generic medicines, creating a policy environment that, although unusual, has thus far supported a healthy balance between IP protection with public health priorities. Bhutan is also one of the few remaining countries yet to accede to the WTO (9). The country’s WTO accession is currently under deliberation, weighing the prospects of economic integration and expanding trade opportunities against the imperative to safeguard national interests guided by the principles of Gross National Happiness (GNH) (10). Although the broader implications of WTO membership have been extensively debated, there has been little focus on how accession may affect access to medicines. This paper examines Bhutan’s IP framework and its enforcement landscape, with a focus on the potential implications of IP protection on access to medicines in Bhutan, in light of its recent graduation from the LDC status, its small domestic market, limited pharmaceutical manufacturing capacity, and prospective accession to the WTO. METHODS This study involved a doctrinal analysis of Bhutan’s IP laws and regulations alongside review of policy framework on IP protection and access to medicines. It assessed the coherence and adequacy of national laws with the TRIPS Agreement and their potential implication on access to medicines, in the context of its prospective WTO accession and the recent LDC graduation. The analysis is structured around the following domains: Legal coherence of Bhutan’s IP regime with TRIPS obligations and flexibilities; Access to affordable medicines in Bhutan and the potential impact of IP enforcement; Policy and legislative reform opportunities to align the IPA 2001 with the TRIPS obligation/flexibilities and harmonize IP, competition and health policies. Literature Sources This study reviewed the following primary and secondary literatures relevant to IP regulation and access to medicines in Bhutan, available in the public domain: Primary legal document reviewed include the Industrial Property Act (2001) , the Medicines Act (2003) and Consumer Protection Act (2012) , and their associated rules and regulations. International legal instruments such as the TRIPS Agreement (1994), the Doha Declaration (2001) form the normative reference points. Secondary sources include policy papers and agency reports from the World Intellectual Property Organization (WIPO), World Health Organization (WHO), WTO, United Nations Conference on Trade and Development (UNCTAD) and the World Bank; the national agencies including the Department of Media, Creative Industries and Intellectual Property (DoMCIP) under the Ministry of Industry, Commerce and Employment MoICE); and the Ministry of Health (MoH). Bilateral trade agreements including India-Bhutan Trade, Commerce and Transit Agreement (1972), Bangladesh-Bhutan Preferential Trade Agreement (2022) and Thailand-Bhutan Free Trade Agreement (2026) were also reviewed. Literature review of relevant peer-reviewed articles was also conducted using Google Scholar employing search terms related to TRIPS flexibilities, regional IP enforcement and access to medicines in combination with “Bhutan”. The status of pharmaceutical patent filings and enforcement was verified through direct communication with DoMCIP over an email. Analytical framework The study applied an analytical framework linking patent protection, TRIPS obligations and flexibilities, health system characteristics with medicines availability and affordability. Findings were interpreted in the context of Bhutan’s status as small, non-producing economy with a publicly financed healthcare system juxtaposed against potential WTO accession. No primary data collection involving human participants were undertaken. RESULTS 1. Bhutan’s IP law and its alignment with TRIPS: The IPA 2001 broadly aligns with the TRIPS standards. It covers patents, trademarks, industrial designs, and copyrights. It defines patentability requirements including novelty, inventive step, and industrial applicability, and establishes a 20-year term of protection. No pharmaceutical patents are currently in enforcement, allowing unrestricted import and distribution of generic medicines. Enforcement mechanisms exist in law but institutional capacity remains limited. 2. Use of TRIPS flexibilities : Bhutan’s IP law incorporates certain TRIPS flexibilities relevant to access to medicines, but misses out on key relevant safeguards, as outlined below: Compulsory Licensing: Government can use patent without consent but the grounds for issuing such licenses are unclear, limiting utility during public health emergencies. Parallel Importation: Not included. Exemptions: Includes experimental use, but no Bolar exception, necessary for pre-grant generic development. Patentability Standards: No explicit safeguards against frivolous patents and evergreening. 3. Access to medicines: Bhutan has maintained good availability of medicines provided free of cost through the public healthcare system. Access is dominated by generic medicines primarily imported from India and Bangladesh. Government manages centralized bulk procurement, ensuring price control, efficiency, and equitable distribution. The National Drug Policy (NDP) 2007 provides a framework for procurement and rational use across all levels of the health system. However, generic availability could be impacted with future patent enforcement while heavy dependence on imports leaves the country vulnerable to supply disruptions. Inclusion of TRIPS-plus provisions in trade agreements could also restrict generics. 4. Trade agreements and regional context: Bilateral and regional trade agreements significantly shape Bhutan’s pharmaceutical supply chain, as outlined below: India-Bhutan (1972): Ensures duty-free trade and transit, with India serving as the dominant source of medicines. Bangladesh-Bhutan (2022): Expands preferential access to medicines, helping diversify supplies. Thailand-Bhutan (2026): Expected to broaden trade relations, though care must be taken to avoid TRIPS-plus obligations that could restrict generic imports. 5. Policy implications and strategic considerations: Bhutan’s experience highlights the importance of balancing IP protection with the public health priorities: Non-enforcement of pharmaceutical patents has ensured access to low-cost generics. Centralized procurement supports equitable distribution and cost control. Legislative reforms are required to ensure effective use of TRIPS in view of the impending WTO accession. Vigilance in trade negotiations is necessary to prevent restrictive IP commitments. Strengthening local pharmaceutical capacity could reduce supply vulnerabilities DISCUSSION TRIPS Agreement and its impact on access to medicines Access to medicines is influenced by global patent policies, supply chain disruptions, or price changes in exporting countries (4). The WTO administered TRIPS Agreement, is known to have a profound impact on access to medicines, particularly in LMICs (4,11). It sets minimum standards for IP protection among WTO members, including for pharmaceuticals. Prior TRIPS, many countries did not patent medicines allowing free production and import of generics. TRIPS framework was designed to promote innovation by rewarding pharmaceutical R&D, with the expectation that the benefits would eventually percolate to LMICs. However, in practice, pharmaceutical patents have become a means to extend monopoly leading to delay in the entry of affordable generics (4,12). As a result, many LMICs face significant challenges in accessing patented medicines, including life-saving treatments for diseases including HIV/AIDS, hepatitis and cancer (13). LMICs face a dual challenge: a growing demand for new and effective treatments alongside limited public health budgets. The restrictions arising from TRIPS obligations have further compounded their struggle to balance the need for affordable access to medicines and health technologies (14). Nevertheless, it does provide safeguards, referred to as TRIPS flexibilities, which allows countries to mitigate the negative effects of IP protection on public health. Some of these flexibilities include compulsory licensing, parallel importation, the Bolar exception and LDC transition waiver. Further, the 2001 Doha Declaration on TRIPS and Public Health reaffirms the right of the member countries to prioritize public health over IP rights and to use these flexibilities (15). Larger economies have successfully leveraged these safeguards. India, for example, used TRIPS-compliant provisions within its national laws to foster a robust generic pharmaceutical industry, enabling it to become a global leader in generic medicine supply (16). Thailand effectively applied compulsory licensing for antiretroviral drugs, significantly reducing the cost of HIV/AIDS treatment (17). However, smaller and less-developed economies face considerable challenges in utilizing these flexibilities (14). The legal and technical complexity involved in issuing compulsory licenses often deters governments from pursuing this route (18). Most critically, limited domestic manufacturing capacity in many LMICs forces reliance on imported generics, rendering many of the TRIPS flexibilities practically ineffective in improving local access to affordable medicines (19,20). IP framework in Bhutan Bhutan is a member of the WIPO and a signatory to the Berne Convention (21). Its accession to WIPO in 1994 marked a pivotal step in the development of IP protection in the country. Since then, Bhutan has established a relatively comprehensive legal framework governing various forms of IP. WIPO Lex identifies 27 laws relevant to IP protection of which three constitute primary IP legislation and further three are other IP related statutes (22). Among these, the key legislative instruments for IP protection includes The Industrial Property Act of the Kingdom of Bhutan 2001 and The Copyright Act of the Kingdom of Bhutan 2001 (8,23). The IPA 2001 provides for the protection of patents, industrial designs, and trademarks, in line with the Paris Convention for the Protection of Industrial Property (24). It lays out the procedures for registration, the exclusive rights conferred to IP holders, and penalties for infringement, thereby providing the legal and operational backbone for industrial property protection in Bhutan. The Civil and Criminal Procedures Code Act 2011 and the Penal Code of Bhutan 2004 provide civil and criminal mechanisms for enforcement of IP infringements including injunctions, seizure of infringing goods, claim for damages and penalties for willful infringement and counterfeiting (25,26). Administrative oversight and enforcement of IP laws fall under the purview of DoMCIP, which operates under the MoICE. The department is mandated to review patent applications and grant patents, including those of pharmaceuticals, as per the provisions of the IPA 2001 and its associated rules. It seeks to leverage the national IP system as a tool for fostering socioeconomic development and technological innovation (27). Efforts are ongoing to enhance IP enforcement in Bhutan through legislative reforms and capacity building of IP officials. The National Intellectual Property Policy 2018 outlines a vision for establishing a legislative framework that aligns with Bhutan’s socio-economic conditions while promoting collaboration with industries and academic institutions to promote R&D and technological innovation (28). Whilst the country is actively seeking to move from basic legal framework and WIPO membership to a comprehensive IP protection, significant gap remains in enforcement capacity and public awareness (29). The department continues to face significant technical capacity challenges, particularly in conducting independent patent examinations. As a result, it relies heavily on technical collaboration with WIPO and other international partners. The examination and review of patent applications are outsourced to WIPO due to the limited availability of specialized expertise within the country (27). Bhutan and the WTO conundrum Bhutan currently enjoys broad access to affordable generic medicines due to limited patent activity and a reliable public procurement system. While the IPA 2001 allows pharmaceutical patents, enforcement is minimal, and public health remains prioritized. Continued vigilance, however, will be required to ensure access to medicines is not impacted, especially in the context of future WTO accession and evolving global IP norms. Bhutan is not yet a member of the WTO, but it has been in the process of accession since 1999 (9). It holds the status of an observer and has engaged in accession negotiations over the years. The accession process has been slow and cautious, reflecting Bhutan’s desire to ensure that WTO membership aligns with its national development priorities and values (10). A Working Party was established to oversee its accession. It has submitted documentation, answered queries, and engaged in bilateral market access negotiations, but has not finalized its entry. Bhutan pursues a unique development philosophy centred on GNH, which prioritizes social well-being, environmental conservation, cultural preservation, and good governance over purely economic growth. In this context, prospective WTO membership, which emphasizes market liberalization and trade competitiveness, must be in keeping with the GNH priorities. Debate over Bhutan’s WTO accession has persisted for years. Proponents argue that membership would facilitate greater integration into the global trading system, improving market access for Bhutanese exports and attracting foreign investment (30). Conversely, critics point to Bhutan’s small, agrarian, and aid-dependent economy with limited export diversification, warning that rapid trade liberalization could undermine local industries and threaten economic self-reliance (31). The risk of joining a free-trade regime for a small economy like Bhutan, such as import surges that could affect local producers and livelihoods and loss of policy flexibility, is well known (31,32). However, the potential impact on healthcare and medicine access due to patent rules and pharmaceutical IP protections under TRIPS has been largely overlooked. Nevertheless, concerns about the sustainability of access to essential medicines in Bhutan in the context of its WTO accession had been raised as early as 2008 (33). The NDP 2007 explicitly references IP rights, urging the government to ‘keep the health of the public and access to medicines in the forefront’ while signing any bilateral or international treaties (34). However, to date, no comprehensive assessment has been undertaken on how TRIPS compliance could affect access to essential medicines, should Bhutan join the WTO. WTO membership will require Bhutan to align its domestic legislation with WTO agreements and to strengthen its administrative capacity for trade compliance, dispute resolution, and negotiation. This process entails substantial legal reforms and bureaucratic investment. Amid these preparatory efforts, concerns related to access to medicines risk being overshadowed by broader trade priorities. Given Bhutan’s longstanding commitment to universal healthcare, it is essential that the country carefully assesses the potential implications of joining a free-trade regime on public health. IP protection and access to medicines in Bhutan Bhutan’s Constitution guarantees free access to essential public health services (35). Government bears the sole responsibility for meeting the healthcare needs of the population, ensuring that the essential medicines, along with the other healthcare services, are provided free of cost. The NDP 2007 guides the selection, procurement, storage, distribution and promotion of rational use of medicines in Bhutan (34). A centralized public procurement system underpins the efficiency and equity of medicine distribution. Although private pharmacies exist, they are largely confined to urban centres, and their influence on the overall medicines supply chain is minimal, given the dominance of the public healthcare system (36). While the IPA 2001 allows pharmaceutical patents, none are currently enforced in Bhutan. At the time of writing of this paper, DoMCIP had received 5 pharmaceutical patent applications: 2 were under review, 2 other applications had been withdrawn and the only pharmaceutical patent in enforcement had also elapsed. This information was furnished by DoMCIP in response to a request from the authors via email. The low pharmaceutical patent activity reflects the generally limited patent filings in Bhutan. As per the WIPO statistical country profile, only 7 patients had been filed in 2024 (37). Patent filings are typically driven by local R&D or by the multinational companies seeking market exclusivity, neither of which are significant in Bhutan. Pharmaceutical manufacturing is at a nascent stage, while pharmaceutical research is virtually non-existent. As a small market economy with a relatively low purchasing power, there is poor commercial incentive for multinational pharmaceutical companies, for filing and enforcing patents in Bhutan. Although the limited pharmaceutical patents in Bhutan have been viewed as a limitation, it has offered important public health advantages. With minimal patent protection, Bhutan has had the freedom to procure generic medicines without legal barriers. It has allowed the government to source medicines at competitive, non-exclusive prices from countries with LDC waiver manufacturing generics of patented products. On the other hand, as a non-producing country, it has not fully benefited from the lack of patent filings. Its access to generic alternatives still depends on external suppliers and the policies of producing countries. Even with the patent protection system in place, Bhutan has been able to maintain consistently a good availability of essential medicines at its healthcare facilities. The average availability of essential medicines at the public healthcare facilities was reported to be over 95% of the items listed on the National Essential Medicines List (NEML) between 2020 and 2024 (38). Availability of essential medicines may not likely deteriorate even if Bhutan accedes to the WTO as most of the medicines on NEML consist primarily of off-patent generics, which can continue to be sourced from India. However, affordability and access to medicines on patent in India, which are procured on named-patient basis could be impacted significantly. At the same time, government expenditure on medicines and vaccines have been increasing steadily over the years raising concerns about the sustainability of public health care financing in Bhutan (39). Inference can be drawn from the Annual Audit reports of the Bhutan Health Trust Fund, on the increasing public expenditure on medicines including vaccines. The annual expenditure had increased from Ngultrum 380 million in 2021 to 558 million in 2025 (40). This trend underscores the growing fiscal pressure and highlights the importance of reliance on generics. Graph 1 depicts the upward trend of annual expenditure on essential medicines and vaccines. Alignment of Bhutan’s IP law with the TRIPS agreement The IPA 2001 was enacted to protect patents, trademarks and industrial designs. While Bhutan is not yet a member of the WTO and therefore not legally bound by the TRIPS Agreement, the act already covers most of the standards set out in the TRIPS Agreement. It provides for the grant of patents for inventions that are novel, involve an inventive step, and are industrially applicable, for a term of 20 years, consistent with the TRIPS standards (8). Similar to that of TRIPS, subject matters such as discoveries, scientific theories, methods for medical treatment, and plant/animal varieties have also been excluded from patentability. The Act also incorporates certain TRIPS flexibilities (8). Under section 15 of the Act, the “Exploitation by Government” provision allows the state to use patent without owner’s consent. This mechanism, akin to compulsory licensing under the TRIPS Agreement is crucial in ensuring access to affordable medicines, particularly during emergencies. However, the absence of a clearly defined ground for issuing compulsory licenses and its weak linkage to public health emergencies could constrain the practical use of TRIPS flexibilities. Bhutan’s IP laws and regulations further do not include any provision on parallel importation, a flexibility particularly relevant to Bhutan given its heavy dependence on imported pharmaceuticals. While providing an exception for experimental use, it omits the Bolar exception, which enables generic manufacturers to begin the regulatory approval process before patent expiry. The Act also lacks a clear patentability criterion that will be useful to prevent frivolous patents and evergreening practices. Alignment of the IPA 2001 with the TRIPS Agreement is summarized under Table 1 . These gaps are significant and amendment of the IPA 2001 will be required to be able to enable effective use of TRIPS flexibilities, should Bhutan accede to the WTO. Further alignment may also be required, particularly in areas such as undisclosed information and test data protection. The alignment of Bhutan’s legislative framework with TRIPS obligations should be complemented by the strengthening of institutional capacity for effective implementation, monitoring, and enforcement. In advancing its WTO accession negotiations, Bhutan should ensure that public health safeguards form a part of its negotiation agenda. In the interim, Bhutan should leverage its non-WTO member status to fully utilize the available policy space for prioritizing public health objectives. This position allows the country to adopt regulatory and legislative measures that facilitate access to affordable medicines and health technologies without being bound by the full constraints of TRIPS compliance. Regional context and implications for Bhutan While the TRIPS Agreement will definitely shape medicine accessibility and affordability in Bhutan, the pharmaceutical policies of its neighbors will likely have a more immediate impact. Bhutan’s near-total reliance on imports makes strong trade ties, especially with India, crucial. Closely monitoring policy and market developments in India and Bangladesh, particularly in patent laws, generic medicine production, and export regulations, will be crucial. In the long term, lessons should also be drawn from its neighbors on effectively leveraging TRIPS flexibilities to stimulate domestic pharmaceutical manufacturing and improve access to affordable medicines. India has effectively leveraged TRIPS flexibilities since joining the WTO in 1995. It used the ten-year transition period to align its patent laws with the TRIPS Agreement (41). The Indian Patent Act 1970 was amended to incorporate provisions to prevent evergreening while also allowing patent opposition (42). As a result, India has been able to develop a robust generic pharmaceutical industry, becoming the world’s largest producer of generic medicines and a global supplier of affordable drugs (43). Bhutan continues to benefit from India’s thriving generic sector due to its geographical proximity and strong economic ties. Bangladesh, as an LDC is exempt from enforcing pharmaceutical patents and data protection under the TRIPS Agreement until 2034, allowing manufacture and export generic versions of patented medicines without legal constraints (41). These flexibilities have enabled it to develop a robust pharmaceutical sector, achieving self-sufficiency in essential medicines. Bhutan has the liberty to import these generics without the TRIPS obligation. Although limited medicines imports have occurred from other neighbors including Thailand, the pharmaceutical landscapes of India and Bangladesh will continue to exert the greatest influence on Bhutan’s access to medicines. While Bhutan’s current non-WTO status offers greater policy space, any future alignment with global IP norms must be approached with careful foresight. The experiences of India and Bangladesh underscore the importance of balancing IP protection with the right to health. Bhutan can draw lessons from India’s legal innovations, and the proactive use of TRIPS flexibilities, as well as from Bangladesh’s strategic use of its LDC status. There is also an opportunity for regional cooperation through joint procurement mechanisms, regulatory harmonization, and shared IP strategies to enhance collective bargaining power and improve access to affordable medicines across South Asia. Bhutan and its LMIC status paradox Another challenge that may hinder Bhutan’s ability to fully utilize TRIPS flexibilities arises from its recent designation as a Lower-Middle-Income Country (LMIC) (5). While this transition would grant Bhutan a 10-year adjustment period to align its domestic laws with TRIPS requirements, it would no longer qualify for the LDC-specific waivers related to pharmaceutical patents and data exclusivity. Losing access to these exemptions could further constrain Bhutan’s already limited pharmaceutical manufacturing capacity and exacerbate its dependence on pharmaceutical imports. Given the country’s small market size, large-scale domestic production is economically unviable, while public health budget constraints would limit the government’s ability to procure a broad range of medicines. To mitigate the potential price shocks arising from shifts in patent regimes in the event Bhutan joins WTO, remedial measures such as price regulation, pooled procurement, and regional manufacturing collaboration should be explored. If necessary, Bhutan should also be prepared to invoke TRIPS flexibilities, including compulsory licensing and parallel importation, to ensure uninterrupted access to essential medicines during public health emergencies. Given the absence of domestic generic production, Bhutan may have to rely on flexible international mechanisms, such as Article 31bis of the TRIPS Agreement, which allows the import of patented medicines produced under a compulsory license in another country. However, this mechanism entails significant procedural and administrative complexities, and will require institutional preparedness and capacity building for effective implementation. Bilateral trade agreements and TRIPS-plus provision “TRIPS-plus” refers to IP commitments in bilateral or regional trade agreements that go beyond TRIPS minima. Evidence from other countries shows free trade agreements (FTAs) with TRIPS-plus rules reduce generic competition and raise medicine costs (44,45). TRIPS-plus clauses, which are known to impede generic competition, include patent term extensions, data exclusivity and limits on compulsory licensing. Overview of Bhutan’s bilateral trade agreements: India-Bhutan Agreement on Trade, Commerce & Transit (Free-trade regime, 1972, last revised 2016) : India is Bhutan’s dominant trade partner and the principal source of medicines and pharmaceutical imports. The bilateral trade arrangement establishes effective duty-free trade and duty-free transit for Bhutan (46). Bangladesh-Bhutan Preferential Trade Agreement (1 July 2022) : It is a PTA that reduces tariffs on selected goods and is being discussed for upgrade to an FTA. It creates additional import avenues but currently covers limited product lists (47). Thailand-Bhutan FTA (effective 1 January 2026) : The recent FTA gives Bhutan an opportunity to diversify trade partners beyond India. It appears primarily focused on goods trade with focus on agriculture and niche Bhutanese goods and does not publicly emphasize IP provisions (48). Bhutan’s existing agreements do not yet embed major TRIPS-plus standards, but future upgrades could import TRIPS-plus obligations. Further, Bhutan’s small market and near-total import dependence make it especially vulnerable to TRIPS-plus spillovers originating in supplier or transit countries. Future FTAs should explicitly exclude pharmaceuticals from TRIPS-plus provisions. Table 2 provides a comparative summary of the provisions of Bhutan’s bilateral agreement with its trading partners Access to medicines and competition law Bhutan does not have a stand-alone competition law; instead, matters about competition are guided by the National Competition Policy 2020 (49). The policy provides a general framework for fair market practice and protection of consumer welfare. The policy emphasizes removing ‘unreasonable barriers to entry’ and preventing monopolistic practices, which could be applied to pharmaceutical distributors and importers engaged in price fixing and abuse of market dominance. However, the policy does not necessarily address IP-related market barriers concerning access to medicines. Nevertheless, Bhutan’s Consumer Protection Act 2012 provides safeguards against exploitative trade practices including price manipulation and unfair mark ups (50). Effective enforcement of this act could also complement broader efforts to control of anticompetitive practices in the market including that of pharmaceuticals. Both competition and consumer protection affairs are looked after by the Competition and Consumers Affairs Agency (CCAA) under the MoICE. Future competition law should incorporate provisions to prevent the misuse of IP rights and abuse of market dominance. Competition safeguards could also be integrated into pharmaceutical procurement and related health policies. CONCLUSION As Bhutan moves toward potential WTO accession and greater integration into the global trade and intellectual property system, it faces the dual challenge of aligning its laws with TRIPS obligations while safeguarding public health interests. The transition from LDC to LMIC status will narrow the policy space currently available to leverage TRIPS flexibilities, making proactive legal and institutional measures imperative. Strengthening the IPA, building administrative capacity, and ensuring inter-agency coordination will be crucial for Bhutan to effectively navigate the evolving pharmaceutical landscape. Equally important will be the strategic use of competition law, regional cooperation, and partnerships with international organizations to mitigate the risks of monopolistic practices and ensure sustained access to affordable medicines. Bhutan’s approach should be guided by the principle of balancing innovation with equity, upholding the right to health while fostering a fair and resilient intellectual property regime to align with the country’s broader development philosophy of GNH. The country is well positioned to draw lessons from other nations and to craft pre-emptive, strategies well suited to its needs in leveraging TRIPS flexibilities and negotiating future bilateral free trade agreements in a manner that safeguards public health and national interests. Key recommendations for safeguard of access to medicines in Bhutan is summarized under Table 3 . Declarations Ethics approval: Not applicable Conflict of Interest: None Funding: No funding was received. Author Contribution TT conceived the study framework and wrote the initial draft. DT reviewed and provided critical feedback on the manuscript. Both the authors read and approved the manuscript. Acknowledgement Authors would like to thank Industrial Property Division, Department of Media, Creative Industry and Intellectual Property (DoMCIP), Ministry of Industry, Commerce and Employment (MoICE) for furnishing the information on status of pharmaceutical patents in Bhutan, for the purpose of this study. Data Availability Graph 1 depicting the trend of annual government expenditure on medicines and vaccines was generated using Microsoft Excel. The Excel worksheet is available for deposit in the repository. The expenditure for each financial year was captured from the Financial Audit Report of the Bhutan Health Trust Fund. The reports are available on its website: [https://www.bhtf.bt/?page\_id=3285](https:/www.bhtf.bt/?page_id=3285) References WIPO. World Intellectual Property Report 2024: Making Innovation Work for Development. [Internet]. Geneva; 2024 [cited 2026 Jan 8]. 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Compulsory Licences: Law and Practice in Thailand. In 2015. p. 61–77. Pogge T. Pharmaceutical Patents and Economic Inequality. Health Hum Rights. 2023 Dec;25(2):199–204. Kerry V, Lee K. TRIPS, the Doha declaration and paragraph 6 decision: what are the remaining steps for protecting access to medicines? Global Health. 2007;3(1):3. Hoen EFM ’t.. The global politics of pharmaceutical monopoly power : drug patents, access, innovation and the application of the WTO Doha Declaration on TRIPS and public health. AMB Publishers; 2009. 136 p. World Intellectual Property Organization. Berne Convention for the Protection of Literary and Artistic Works: Accession by the Kingdom of Bhutan. . WIPO. WIPO Lex Database - Bhutan [Internet]. [cited 2026 Jan 6]. Available from: https://www.wipo.int/wipolex/en/members/profile/BT?activeCollection=laws&collection=laws&collection=treaties&collection=judgments Royal Government of Bhutan. The Copyright Act of the Kingdom of Bhutan 2001. 2001. United Nations. Paris Convention for the Protection of Industrial Property. 1967. Royal Government of Bhutan. Penal Code of Bhutan 2004. 2004. Royal Government of Bhutan. Civil and Criminal Procedures Code (Amendment) Act 2011. 2011 Department of Intellectual Property M of EAB. Annual IP Magazine 2019 [Internet]. 2019 [cited 2026 Jan 9]. Available from: https://www.moice.gov.bt/wp-content/uploads/2023/03/Annual-IP-Magazine-2019.pdf Department of Intellectual Property. National Intellectual Property Policy 2018 [Internet]. 2018 [cited 2026 Jan 8]. Available from: https://www.moenr.gov.bt/?p=4521 Lack of awareness and resources hinder intellectual property growth. Kuensel [Internet]. 2018 Nov 9 [cited 2026 Jan 8]; Available from: https://kuenselonline.com/news/lack-of-awareness-and-resources-hinder-intellectual-property-growth Biswas AK. Foreign trade policies and WTO accession in Bhutan. International Journal of Multidisciplinary Trends. 2025 Apr 1;7(4):240–2. Wangyel Tashi. Rhetoric and Reality: An Assessment of the Impact of WTO on Bhutan. Centre for Bhutan Studies. 2013. FAO. Issues at stake relating to agriculture development, trade and food security [Internet]. [cited 2026 Jan 8]. Available from: https://www.fao.org/4/x4829e/x4829e04.htm Dorji T. Effect of TRIPS on Pricing, Affordability and Access to essential medicines in Bhutan. Centre of Bhutan Studies. 9(1). Ministry of Health. National Drug Policy 2007 [Internet]. 2007 [cited 2026 Jan 8]. Available from: https://moh.gov.bt/wp-content/uploads/2025/01/National-Drug-Policy-2007.pdf?utm_source=chatgpt.com The constitution of the Kingdom of Bhutan. 2008. Choden T. Private sector participation in pharmacy services in Bhutan for better consumer service [Internet]. [cited 2026 Jan 8]. Available from: https://ccaa.gov.bt/wp-content/uploads/2025/06/Final-Private-Sector-Participation-in-Pharmacy-Services-in-Bhutan.pdf WIPO IP Statistics Data Center. Intellectual Property Statistical Country Profile 2024. 2024. [Internet]. [cited 2026 Jan 8]. https://www.wipo.int/edocs/statistics-country-profile/en/bt.pdf The World Bank Group. Primary Health Care in Bhutan Findings from the Primary Health Care Performance Initiative Assessment [Internet]. 2023 [cited 2026 Jan 9]. Available from: https://documents1.worldbank.org/curated/en/099042624133516182/pdf/P17054414014ae0b61a154156f3f80a11f7.pdf Thinley S, Sharma G, Wangmo K. Sustainability of Bhutan’s Health Services. 2015 [cited 2026 Jan 8]; Available from: https://drukjournal.bt/sustainability-of-bhutans-health-services/ Royal Audit Authority. Financial Audit Report of the Bhutan Health Trust Fund 2021 [Internet]. 2021 [cited 2026 Jan 8]. Available from: https://www.bhtf.bt/?page_id=3285 World Trade Organisation. Developing countries’ transition periods [Internet]. [cited 2026 Jan 8]. Available from: https://www.wto.org/english/tratop_e/trips_e/factsheet_pharm04_e.htm Government of India. The Patent Act of India 1970. 1970. Bjerke L. Antibiotic geographies and access to medicines: Tracing the role of India’s pharmaceutical industry in global trade. Soc Sci Med. 2022 Nov;312:115386. El Said M. The Impact of ‘TRIPS-Plus’ Rules on the Use of TRIPS Flexibilities: Dealing with the Implementation Challenges. In: Access to Medicines and Vaccines. Cham: Springer International Publishing; 2022. p. 297–327. Kessomboon N, Limpananont J, Kulsomboon V, Maleewong U, Eksaengsri A, Paothong P. Impact on access to medicines from TRIPS-Plus: a case study of Thai-US FTA. Southeast Asian J Trop Med Public Health. 2010 May;41(3):667–77. Agreement on Trade, Commerce and Transit Between the Royal Government of Bhutan and the Government of Republic of India. 2026. Agreement on Trade Between the Royal Government of Bhutan and the Government of the Peoples Republic of Bangladesh. 2022. The Government Public Relations Department. 2025. Thailand and Bhutan signs Free Trade Agreement. Ministry of Economic Affairs. National Competition Policy 2020. 2020. Royal Government of Bhutan. Consumer Protection Act 2012. 2012. Tables Table 1: Alignment of IPA 2001 with TRIPS Sl No TRIPS Obligation/flexibilities IPA Status 1 Patent scope & 20-year term Fully aligned 2 Patentability criteria Does not define ‘inventive step’ in manner that would prevent frivolous patent and evergreening 3 Exclusion from patentability Excludes discoveries, scientific theories, methods for medical treatment, and plant/animal varieties; does not explicitly mention exclusion of new uses of known substance 4 Registration and rights clarity Clear provisions for registration, priority, rights, and infringement enforcement 5 Enforcement mechanisms Remedies, injunctions, damages and criminal penalties in place 6 Parallel importation No provision on parallel importation 7 Compulsory license / government use Covered under “Exploitation by government”; Permits use for public interest, emergency and on anti‑competitive grounds 8 Bolar & experimental use exception Exception for experimental purpose but no provision on bolar/ early working exemption 9 LDC waiver Not applicable as a non-member of WTO; transition will not be applicable as Bhutan joins WTO post LDC graduation 10 Patent opposition Post grant “Invalidation” incorporated Table 2: Comparative summary of the provisions of Bhutan’s agreement with the major trading partners. India Bangladesh Thailand Agreement Name India-Bhutan Agreement on Trade, Commerce & Transit Bangladesh-Bhutan Preferential Trade Agreement Bhutan-Thailand Free Trade Agreement Year signed First signed in 1972; current version valid until 2026. Signed December 2020; in force from July 2022 Signed April 3 2025; implementation targeted January 1 2026. Nature of Agreement Bilateral Free Trade & Transit Agreement Preferential Trade Agreement (tariff-reductions) Bilateral Free Trade Agreement (goods) Key features Duty-free trade in goods between India and Bhutan Transit rights through India for Bhutan’s trade with third countries. Tariff concessions on selected goods Facilitates imports/exports, supports transit cooperation. Elimination of tariff on general goods on both sides Special quotas for certain Bhutanese agricultural products for duty-free export Relevance to Pharmaceuticals India is Bhutan’s main source of pharmaceuticals; duty-free imports facilitate access. Bangladesh, as an LDC with generic manufacturing, can export generics to Bhutan under this preferential regime. Opens up new market access for Bhutan, possibly lowers cost of medicines produced in Thailand. Table 3. Key recommendations to safeguard access to medicines in Bhutan No. Strategic Area Key Recommendation 1 Strategic use of non-WTO status Leverage Bhutan’s current non-WTO membership and absence of enforced pharmaceutical patents to procure generic medicines from TRIPS-waiver eligible countries (e.g., Bangladesh) through strategic procurement arrangements until WTO accession. 2 Institutional preparedness Enhance readiness to utilize TRIPS flexibilities through policy gap analysis and administrative capacity building, including preparedness to operationalize compulsory licensing and Article 31bis mechanisms. 3 Legal embedding of health safeguards Amend the Industrial Property Act 2001 to explicitly incorporate public health safeguards, including compulsory licensing, parallel importation, Bolar exception, appropriate exhaustion regimes, and stricter patentability standards. 4 Institutional strengthening and coordination Strengthen the capacity of key institutions (DoMCIP, BFDA, Office of Consumer Protection, and MoH legal division) and establish a multi-agency core team to coordinate TRIPS-related policy formulation and negotiations. 5 International technical assistance Seek legal and technical support from international and regional organizations such as the WTO, WIPO, WHO, UNDP, and UNCTAD to align IP implementation with public health objectives. 6 WTO accession strategy Preserve public health policy space during WTO accession by negotiating explicit carve-outs, transition periods, or interpretative safeguards comparable to LDC flexibilities. 7 Stakeholder engagement Engage public health experts, legal scholars, civil society organizations, and other stakeholders to ensure IP policy coherence with national health goals and Bhutan’s GNH philosophy. 8 Regional cooperation Strengthen regional collaboration through joint procurement, regulatory harmonization, and shared IP strategies to enhance bargaining power and improve access to affordable medicines in South Asia. 9 Avoidance of TRIPS-plus obligations Avoid adopting TRIPS-plus provisions such as data exclusivity, patent term extensions, or enhanced protection in domestic laws or trade agreements that could restrict generic competition. 10 Competition law strengthening Strengthen national competition law to prevent abuse of IP rights, monopolistic practices, cartels, and deceptive conduct, ensuring IP protection does not undermine access to affordable medicines. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8597770","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":589414460,"identity":"c3d04b68-ff8e-49f8-a386-c98a8ec706e9","order_by":0,"name":"Thupten Tshering","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABC0lEQVRIiWNgGAWjYDACCQSTjYGhwAYhwoZDBw9IwQGICqAagzTStRxGsRcrsJfuMXv8oeKOXf/89mcPPhicT+yf3XzwAUONDQOfdAN2W2TOmBscOPMsecYxHnPDGQa3E2fcOZZswHAsjYFN5gAOh+WYSRxsO5zMcIyHTZoHqKXhBlCEseEwA5tEAh4t/w4nyx9jfyb9x+Bc4nzitDQctjM4xmAmzWBwIHEDQS030soNzhw7nGB4LMdMsscg2XjjjbRkg4RjaTy4tLDPSN72oKLmsL3c4ePPJH5U2MnOu5F88MGHGhs5+RnYtTBAoyyxAcpzBDOAinlwqYdpsYfx7HErHAWjYBSMgpEKABTtXdglAgUXAAAAAElFTkSuQmCC","orcid":"","institution":"Phuntsholing General Hospital","correspondingAuthor":true,"prefix":"","firstName":"Thupten","middleName":"","lastName":"Tshering","suffix":""},{"id":589414461,"identity":"042cf35c-279d-4c34-b9c1-5ab5bac766d1","order_by":1,"name":"Dorji Tshering","email":"","orcid":"","institution":"Phuntsholing General Hospital","correspondingAuthor":false,"prefix":"","firstName":"Dorji","middleName":"","lastName":"Tshering","suffix":""}],"badges":[],"createdAt":"2026-01-14 05:38:54","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8597770/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8597770/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":102526331,"identity":"481a55be-0efa-4cac-96fb-868c08b93044","added_by":"auto","created_at":"2026-02-12 15:33:33","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":37146,"visible":true,"origin":"","legend":"\u003cp\u003eGraph 1. Trend of annual expenditure on essential medicines and vaccines based on the Annual Financial Audit Reports of the Bhutan Health Trust Fund from 2022-2-25.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8597770/v1/517ad8a93d8f65ecd52e3c49.png"},{"id":102746818,"identity":"dbf66b90-1da2-4eea-a765-946d4c269aeb","added_by":"auto","created_at":"2026-02-16 09:01:39","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1047903,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8597770/v1/b1d4bccc-a196-46ca-969c-1aec64bee801.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Aligning intellectual property protection with public health to ensure access to medicines in Bhutan","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eIntellectual Property (IP) protection is intended to safeguard investments in research and development (R\u0026amp;D), stimulate innovation and support economic growth (1). It serves as a vital mechanism to safeguard investments in R\u0026amp;D, fostering innovation and enhancing commercialization, and broader economic progress. While the protection of IP rights has become an important means of providing safeguards to investments in innovation and creativity, it has inevitably become an important component of international trade policies (2).\u003c/p\u003e \u003cp\u003eWhile IP protection is purported to foster innovation and enhance investment in R\u0026amp;D, its broader implications on trade and access to commodities have been far-reaching (3). The most significant impact of IP protection has been on the global public health, where the enforcement of patent protection under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) has often impeded medicines access, especially in low- and middle-income countries (LMICs). Stronger pharmaceutical monopolies have been linked to increased drug costs, delays in availability, and increased operational costs to governments (4).\u003c/p\u003e \u003cp\u003eBhutan, a small landlocked economy in South Asia, graduated from the least developed country (LDC) status in 2023, becoming only the seventh nation in recent history to achieve this milestone (5). Among its most notable achievements is the provision of free and universal healthcare, which ensures equitable access to essential medicines largely supported by affordable generic imports (6). While the country has made commendable progress toward the Sustainable Development Goals, its economy remains modest in scale and highly vulnerable to external shocks (7).\u003c/p\u003e \u003cp\u003eThe country faces unique challenges in ensuring access to medicines. It depends heavily on imports for its pharmaceutical needs, primarily from India and, to a lesser extent, Bangladesh. Domestic pharmaceutical production is minimal, making Bhutan susceptible to fluctuations in international supply and pricing. \u003cem\u003eThe Industrial Property Act of the Kingdom of Bhutan (IPA) 2001\u003c/em\u003e permits granting of pharmaceutical patents in line with the international IP standards(8). However, there are currently no pharmaceutical patents in enforcement, which has effectively enabled unrestricted access to generic medicines. This has allowed continued importation and use of generic medicines, creating a policy environment that, although unusual, has thus far supported a healthy balance between IP protection with public health priorities.\u003c/p\u003e \u003cp\u003eBhutan is also one of the few remaining countries yet to accede to the WTO (9). The country\u0026rsquo;s WTO accession is currently under deliberation, weighing the prospects of economic integration and expanding trade opportunities against the imperative to safeguard national interests guided by the principles of Gross National Happiness (GNH) (10). Although the broader implications of WTO membership have been extensively debated, there has been little focus on how accession may affect access to medicines.\u003c/p\u003e \u003cp\u003eThis paper examines Bhutan\u0026rsquo;s IP framework and its enforcement landscape, with a focus on the potential implications of IP protection on access to medicines in Bhutan, in light of its recent graduation from the LDC status, its small domestic market, limited pharmaceutical manufacturing capacity, and prospective accession to the WTO.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003eThis study involved a doctrinal analysis of Bhutan\u0026rsquo;s IP laws and regulations alongside review of policy framework on IP protection and access to medicines. It assessed the coherence and adequacy of national laws with the TRIPS Agreement and their potential implication on access to medicines, in the context of its prospective WTO accession and the recent LDC graduation.\u003c/p\u003e \u003cp\u003eThe analysis is structured around the following domains:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eLegal coherence of Bhutan\u0026rsquo;s IP regime with TRIPS obligations and flexibilities;\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eAccess to affordable medicines in Bhutan and the potential impact of IP enforcement;\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePolicy and legislative reform opportunities to align the IPA 2001 with the TRIPS obligation/flexibilities and harmonize IP, competition and health policies.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eLiterature Sources\u003c/h2\u003e \u003cp\u003eThis study reviewed the following primary and secondary literatures relevant to IP regulation and access to medicines in Bhutan, available in the public domain:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003ePrimary legal document reviewed include \u003cem\u003ethe Industrial Property Act (2001)\u003c/em\u003e, \u003cem\u003ethe Medicines Act (2003) and Consumer Protection Act (2012)\u003c/em\u003e, and their associated rules and regulations. International legal instruments such as the TRIPS Agreement (1994), the Doha Declaration (2001) form the normative reference points.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eSecondary sources include policy papers and agency reports from the World Intellectual Property Organization (WIPO), World Health Organization (WHO), WTO, United Nations Conference on Trade and Development (UNCTAD) and the World Bank; the national agencies including the Department of Media, Creative Industries and Intellectual Property (DoMCIP) under the Ministry of Industry, Commerce and Employment MoICE); and the Ministry of Health (MoH).\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eBilateral trade agreements including India-Bhutan Trade, Commerce and Transit Agreement (1972), Bangladesh-Bhutan Preferential Trade Agreement (2022) and Thailand-Bhutan Free Trade Agreement (2026) were also reviewed. Literature review of relevant peer-reviewed articles was also conducted using Google Scholar employing search terms related to TRIPS flexibilities, regional IP enforcement and access to medicines in combination with \u0026ldquo;Bhutan\u0026rdquo;. The status of pharmaceutical patent filings and enforcement was verified through direct communication with DoMCIP over an email.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eAnalytical framework\u003c/h3\u003e\n\u003cp\u003eThe study applied an analytical framework linking patent protection, TRIPS obligations and flexibilities, health system characteristics with medicines availability and affordability. Findings were interpreted in the context of Bhutan\u0026rsquo;s status as small, non-producing economy with a publicly financed healthcare system juxtaposed against potential WTO accession. No primary data collection involving human participants were undertaken.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003e\u003cstrong\u003e1. Bhutan’s IP law and its alignment with TRIPS:\u0026nbsp;\u003c/strong\u003eThe IPA \u0026nbsp;2001 broadly aligns with the TRIPS standards. It covers patents, trademarks, industrial designs, and copyrights. It defines patentability requirements including novelty, inventive step, and industrial applicability, and establishes a 20-year term of protection. No pharmaceutical patents are currently in enforcement, allowing unrestricted import and distribution of generic medicines. Enforcement mechanisms exist in law but institutional capacity remains limited.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2. Use of TRIPS flexibilities\u003c/strong\u003e: Bhutan’s IP law incorporates certain TRIPS flexibilities relevant to access to medicines, but misses out on key relevant safeguards, as outlined below:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003e\u003cstrong\u003eCompulsory Licensing:\u003c/strong\u003e Government can use patent without consent but the grounds for issuing such licenses are unclear, limiting utility during public health emergencies.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eParallel Importation:\u003c/strong\u003e Not included.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eExemptions:\u003c/strong\u003e Includes experimental use, but no Bolar exception, necessary for pre-grant generic development.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003ePatentability Standards:\u003c/strong\u003e No explicit safeguards against frivolous patents and evergreening.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003e3. Access to medicines:\u0026nbsp;\u003c/strong\u003e Bhutan has maintained good availability of medicines provided free of cost through the public healthcare system. Access is dominated by generic medicines primarily imported from India and Bangladesh. Government manages centralized bulk procurement, ensuring price control, efficiency, and equitable distribution. The National Drug Policy (NDP) 2007 provides a framework for procurement and rational use across all levels of the health system. However, generic availability could be impacted with future patent enforcement while heavy dependence on imports leaves the country vulnerable to supply disruptions. Inclusion of TRIPS-plus provisions in trade agreements could also restrict generics.\u003c/p\u003e\n\u003ch3\u003e\u003cstrong\u003e4. Trade agreements and regional context:\u0026nbsp;\u003c/strong\u003eBilateral and regional trade agreements significantly shape Bhutan’s pharmaceutical supply chain, as outlined below:\u003c/h3\u003e\n\u003cul\u003e\n \u003cli\u003e\u003cstrong\u003eIndia-Bhutan (1972):\u003c/strong\u003e Ensures duty-free trade and transit, with India serving as the dominant source of medicines.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eBangladesh-Bhutan (2022):\u003c/strong\u003e Expands preferential access to medicines, helping diversify supplies.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eThailand-Bhutan (2026):\u003c/strong\u003e Expected to broaden trade relations, though care must be taken to avoid TRIPS-plus obligations that could restrict generic imports.\u003c/li\u003e\n\u003c/ul\u003e\n\u003ch3\u003e\u003cstrong\u003e5. Policy implications and strategic considerations:\u003c/strong\u003e Bhutan’s experience highlights the importance of balancing IP protection with the public health priorities:\u003c/h3\u003e\n\u003cul\u003e\n \u003cli\u003eNon-enforcement of pharmaceutical patents has ensured access to low-cost generics.\u003c/li\u003e\n \u003cli\u003eCentralized procurement supports equitable distribution and cost control.\u003c/li\u003e\n \u003cli\u003eLegislative reforms are required to ensure effective use of TRIPS in view of the impending WTO accession.\u003c/li\u003e\n \u003cli\u003eVigilance in trade negotiations is necessary to prevent restrictive IP commitments.\u003c/li\u003e\n \u003cli\u003eStrengthening local pharmaceutical capacity could reduce supply vulnerabilities\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"DISCUSSION","content":"\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\n\u003ch2\u003eTRIPS Agreement and its impact on access to medicines\u003c/h2\u003e\n\u003cp\u003eAccess to medicines is influenced by global patent policies, supply chain disruptions, or price changes in exporting countries (4). The WTO administered TRIPS Agreement, is known to have a profound impact on access to medicines, particularly in LMICs (4,11). It sets minimum standards for IP protection among WTO members, including for pharmaceuticals. Prior TRIPS, many countries did not patent medicines allowing free production and import of generics.\u003c/p\u003e\n\u003cp\u003eTRIPS framework was designed to promote innovation by rewarding pharmaceutical R\u0026amp;D, with the expectation that the benefits would eventually percolate to LMICs. However, in practice, pharmaceutical patents have become a means to extend monopoly leading to delay in the entry of affordable generics (4,12). As a result, many LMICs face significant challenges in accessing patented medicines, including life-saving treatments for diseases including HIV/AIDS, hepatitis and cancer (13).\u003c/p\u003e\n\u003cp\u003eLMICs face a dual challenge: a growing demand for new and effective treatments alongside limited public health budgets. The restrictions arising from TRIPS obligations have further compounded their struggle to balance the need for affordable access to medicines and health technologies (14). Nevertheless, it does provide safeguards, referred to as TRIPS flexibilities, which allows countries to mitigate the negative effects of IP protection on public health. Some of these flexibilities include compulsory licensing, parallel importation, the Bolar exception and LDC transition waiver. Further, the 2001 Doha Declaration on TRIPS and Public Health reaffirms the right of the member countries to prioritize public health over IP rights and to use these flexibilities (15).\u003c/p\u003e\n\u003cp\u003eLarger economies have successfully leveraged these safeguards. India, for example, used TRIPS-compliant provisions within its national laws to foster a robust generic pharmaceutical industry, enabling it to become a global leader in generic medicine supply (16). Thailand effectively applied compulsory licensing for antiretroviral drugs, significantly reducing the cost of HIV/AIDS treatment (17).\u003c/p\u003e\n\u003cp\u003eHowever, smaller and less-developed economies face considerable challenges in utilizing these flexibilities (14). The legal and technical complexity involved in issuing compulsory licenses often deters governments from pursuing this route (18). Most critically, limited domestic manufacturing capacity in many LMICs forces reliance on imported generics, rendering many of the TRIPS flexibilities practically ineffective in improving local access to affordable medicines (19,20).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n\u003ch2\u003eIP framework in Bhutan\u003c/h2\u003e\n\u003cp\u003eBhutan is a member of the WIPO and a signatory to the Berne Convention (21). Its accession to WIPO in 1994 marked a pivotal step in the development of IP protection in the country. Since then, Bhutan has established a relatively comprehensive legal framework governing various forms of IP.\u003c/p\u003e\n\u003cp\u003eWIPO Lex identifies 27 laws relevant to IP protection of which three constitute primary IP legislation and further three are other IP related statutes (22). Among these, the key legislative instruments for IP protection includes \u003cem\u003eThe Industrial Property Act of the Kingdom of Bhutan 2001\u003c/em\u003e and \u003cem\u003eThe Copyright Act of the Kingdom of Bhutan 2001\u003c/em\u003e (8,23). The IPA 2001 provides for the protection of patents, industrial designs, and trademarks, in line with the Paris Convention for the Protection of Industrial Property (24). It lays out the procedures for registration, the exclusive rights conferred to IP holders, and penalties for infringement, thereby providing the legal and operational backbone for industrial property protection in Bhutan.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eThe Civil and Criminal Procedures Code Act 2011\u003c/em\u003e and the \u003cem\u003ePenal Code of Bhutan 2004\u003c/em\u003e provide civil and criminal mechanisms for enforcement of IP infringements including injunctions, seizure of infringing goods, claim for damages and penalties for willful infringement and counterfeiting (25,26).\u003c/p\u003e\n\u003cp\u003eAdministrative oversight and enforcement of IP laws fall under the purview of DoMCIP, which operates under the MoICE. The department is mandated to review patent applications and grant patents, including those of pharmaceuticals, as per the provisions of \u003cem\u003ethe IPA 2001\u003c/em\u003e and its associated rules. It seeks to leverage the national IP system as a tool for fostering socioeconomic development and technological innovation (27).\u003c/p\u003e\n\u003cp\u003eEfforts are ongoing to enhance IP enforcement in Bhutan through legislative reforms and capacity building of IP officials. The National Intellectual Property Policy 2018 outlines a vision for establishing a legislative framework that aligns with Bhutan\u0026rsquo;s socio-economic conditions while promoting collaboration with industries and academic institutions to promote R\u0026amp;D and technological innovation (28). Whilst the country is actively seeking to move from basic legal framework and WIPO membership to a comprehensive IP protection, significant gap remains in enforcement capacity and public awareness (29).\u003c/p\u003e\n\u003cp\u003eThe department continues to face significant technical capacity challenges, particularly in conducting independent patent examinations. As a result, it relies heavily on technical collaboration with WIPO and other international partners. The examination and review of patent applications are outsourced to WIPO due to the limited availability of specialized expertise within the country (27).\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eBhutan and the WTO conundrum\u003c/h3\u003e\n\u003cp\u003eBhutan currently enjoys broad access to affordable generic medicines due to limited patent activity and a reliable public procurement system. While \u003cem\u003ethe IPA 2001\u003c/em\u003e allows pharmaceutical patents, enforcement is minimal, and public health remains prioritized. Continued vigilance, however, will be required to ensure access to medicines is not impacted, especially in the context of future WTO accession and evolving global IP norms.\u003c/p\u003e\n\u003cp\u003eBhutan is not yet a member of the WTO, but it has been in the process of accession since 1999 (9). It holds the status of an observer and has engaged in accession negotiations over the years. The accession process has been slow and cautious, reflecting Bhutan\u0026rsquo;s desire to ensure that WTO membership aligns with its national development priorities and values (10). A Working Party was established to oversee its accession. It has submitted documentation, answered queries, and engaged in bilateral market access negotiations, but has not finalized its entry.\u003c/p\u003e\n\u003cp\u003eBhutan pursues a unique development philosophy centred on GNH, which prioritizes social well-being, environmental conservation, cultural preservation, and good governance over purely economic growth. In this context, prospective WTO membership, which emphasizes market liberalization and trade competitiveness, must be in keeping with the GNH priorities.\u003c/p\u003e\n\u003cp\u003eDebate over Bhutan\u0026rsquo;s WTO accession has persisted for years. Proponents argue that membership would facilitate greater integration into the global trading system, improving market access for Bhutanese exports and attracting foreign investment (30). Conversely, critics point to Bhutan\u0026rsquo;s small, agrarian, and aid-dependent economy with limited export diversification, warning that rapid trade liberalization could undermine local industries and threaten economic self-reliance (31).\u003c/p\u003e\n\u003cp\u003eThe risk of joining a free-trade regime for a small economy like Bhutan, such as import surges that could affect local producers and livelihoods and loss of policy flexibility, is well known (31,32). However, the potential impact on healthcare and medicine access due to patent rules and pharmaceutical IP protections under TRIPS has been largely overlooked.\u003c/p\u003e\n\u003cp\u003eNevertheless, concerns about the sustainability of access to essential medicines in Bhutan in the context of its WTO accession had been raised as early as 2008 (33). The NDP 2007 explicitly references IP rights, urging the government to \u0026lsquo;keep the health of the public and access to medicines in the forefront\u0026rsquo; while signing any bilateral or international treaties (34). However, to date, no comprehensive assessment has been undertaken on how TRIPS compliance could affect access to essential medicines, should Bhutan join the WTO.\u003c/p\u003e\n\u003cp\u003eWTO membership will require Bhutan to align its domestic legislation with WTO agreements and to strengthen its administrative capacity for trade compliance, dispute resolution, and negotiation. This process entails substantial legal reforms and bureaucratic investment. Amid these preparatory efforts, concerns related to access to medicines risk being overshadowed by broader trade priorities. Given Bhutan\u0026rsquo;s longstanding commitment to universal healthcare, it is essential that the country carefully assesses the potential implications of joining a free-trade regime on public health.\u003c/p\u003e\n\u003ch3\u003eIP protection and access to medicines in Bhutan\u003c/h3\u003e\n\u003cp\u003eBhutan\u0026rsquo;s Constitution guarantees free access to essential public health services (35). Government bears the sole responsibility for meeting the healthcare needs of the population, ensuring that the essential medicines, along with the other healthcare services, are provided free of cost. The NDP 2007 guides the selection, procurement, storage, distribution and promotion of rational use of medicines in Bhutan (34). A centralized public procurement system underpins the efficiency and equity of medicine distribution. Although private pharmacies exist, they are largely confined to urban centres, and their influence on the overall medicines supply chain is minimal, given the dominance of the public healthcare system (36).\u003c/p\u003e\n\u003cp\u003eWhile \u003cem\u003ethe IPA 2001\u003c/em\u003e allows pharmaceutical patents, none are currently enforced in Bhutan. At the time of writing of this paper, DoMCIP had received 5 pharmaceutical patent applications: 2 were under review, 2 other applications had been withdrawn and the only pharmaceutical patent in enforcement had also elapsed. This information was furnished by DoMCIP in response to a request from the authors via email. The low pharmaceutical patent activity reflects the generally limited patent filings in Bhutan. As per the WIPO statistical country profile, only 7 patients had been filed in 2024 (37).\u003c/p\u003e\n\u003cp\u003ePatent filings are typically driven by local R\u0026amp;D or by the multinational companies seeking market exclusivity, neither of which are significant in Bhutan. Pharmaceutical manufacturing is at a nascent stage, while pharmaceutical research is virtually non-existent. As a small market economy with a relatively low purchasing power, there is poor commercial incentive for multinational pharmaceutical companies, for filing and enforcing patents in Bhutan.\u003c/p\u003e\n\u003cp\u003eAlthough the limited pharmaceutical patents in Bhutan have been viewed as a limitation, it has offered important public health advantages. With minimal patent protection, Bhutan has had the freedom to procure generic medicines without legal barriers. It has allowed the government to source medicines at competitive, non-exclusive prices from countries with LDC waiver manufacturing generics of patented products. On the other hand, as a non-producing country, it has not fully benefited from the lack of patent filings. Its access to generic alternatives still depends on external suppliers and the policies of producing countries.\u003c/p\u003e\n\u003cp\u003eEven with the patent protection system in place, Bhutan has been able to maintain consistently a good availability of essential medicines at its healthcare facilities. The average availability of essential medicines at the public healthcare facilities was reported to be over 95% of the items listed on the National Essential Medicines List (NEML) between 2020 and 2024 (38). Availability of essential medicines may not likely deteriorate even if Bhutan accedes to the WTO as most of the medicines on NEML consist primarily of off-patent generics, which can continue to be sourced from India. However, affordability and access to medicines on patent in India, which are procured on named-patient basis could be impacted significantly.\u003c/p\u003e\n\u003cp\u003eAt the same time, government expenditure on medicines and vaccines have been increasing steadily over the years raising concerns about the sustainability of public health care financing in Bhutan (39). Inference can be drawn from the Annual Audit reports of the Bhutan Health Trust Fund, on the increasing public expenditure on medicines including vaccines. The annual expenditure had increased from Ngultrum 380\u0026nbsp;million in 2021 to 558\u0026nbsp;million in 2025 (40). This trend underscores the growing fiscal pressure and highlights the importance of reliance on generics. Graph 1 depicts the upward trend of annual expenditure on essential medicines and vaccines.\u003c/p\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n\u003ch2\u003eAlignment of Bhutan\u0026rsquo;s IP law with the TRIPS agreement\u003c/h2\u003e\n\u003cp\u003e\u003cem\u003eThe IPA 2001\u003c/em\u003e was enacted to protect patents, trademarks and industrial designs. While Bhutan is not yet a member of the WTO and therefore not legally bound by the TRIPS Agreement, the act already covers most of the standards set out in the TRIPS Agreement. It provides for the grant of patents for inventions that are novel, involve an inventive step, and are industrially applicable, for a term of 20 years, consistent with the TRIPS standards (8). Similar to that of TRIPS, subject matters such as discoveries, scientific theories, methods for medical treatment, and plant/animal varieties have also been excluded from patentability.\u003c/p\u003e\n\u003cp\u003eThe Act also incorporates certain TRIPS flexibilities (8). Under section 15 of the Act, the \u0026ldquo;Exploitation by Government\u0026rdquo; provision allows the state to use patent without owner\u0026rsquo;s consent. This mechanism, akin to compulsory licensing under the TRIPS Agreement is crucial in ensuring access to affordable medicines, particularly during emergencies. However, the absence of a clearly defined ground for issuing compulsory licenses and its weak linkage to public health emergencies could constrain the practical use of TRIPS flexibilities.\u003c/p\u003e\n\u003cp\u003eBhutan\u0026rsquo;s IP laws and regulations further do not include any provision on parallel importation, a flexibility particularly relevant to Bhutan given its heavy dependence on imported pharmaceuticals. While providing an exception for experimental use, it omits the Bolar exception, which enables generic manufacturers to begin the regulatory approval process before patent expiry. The Act also lacks a clear patentability criterion that will be useful to prevent frivolous patents and evergreening practices. Alignment of \u003cem\u003ethe IPA 2001\u003c/em\u003e with the TRIPS Agreement is summarized under Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n\u003cp\u003eThese gaps are significant and amendment of \u003cem\u003ethe IPA 2001\u003c/em\u003e will be required to be able to enable effective use of TRIPS flexibilities, should Bhutan accede to the WTO. Further alignment may also be required, particularly in areas such as undisclosed information and test data protection. The alignment of Bhutan\u0026rsquo;s legislative framework with TRIPS obligations should be complemented by the strengthening of institutional capacity for effective implementation, monitoring, and enforcement. In advancing its WTO accession negotiations, Bhutan should ensure that public health safeguards form a part of its negotiation agenda.\u003c/p\u003e\n\u003cp\u003eIn the interim, Bhutan should leverage its non-WTO member status to fully utilize the available policy space for prioritizing public health objectives. This position allows the country to adopt regulatory and legislative measures that facilitate access to affordable medicines and health technologies without being bound by the full constraints of TRIPS compliance.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n\u003ch2\u003eRegional context and implications for Bhutan\u003c/h2\u003e\n\u003cp\u003eWhile the TRIPS Agreement will definitely shape medicine accessibility and affordability in Bhutan, the pharmaceutical policies of its neighbors will likely have a more immediate impact. Bhutan\u0026rsquo;s near-total reliance on imports makes strong trade ties, especially with India, crucial. Closely monitoring policy and market developments in India and Bangladesh, particularly in patent laws, generic medicine production, and export regulations, will be crucial. In the long term, lessons should also be drawn from its neighbors on effectively leveraging TRIPS flexibilities to stimulate domestic pharmaceutical manufacturing and improve access to affordable medicines.\u003c/p\u003e\n\u003cp\u003eIndia has effectively leveraged TRIPS flexibilities since joining the WTO in 1995. It used the ten-year transition period to align its patent laws with the TRIPS Agreement (41). The \u003cem\u003eIndian Patent Act 1970\u003c/em\u003e was amended to incorporate provisions to prevent evergreening while also allowing patent opposition (42). As a result, India has been able to develop a robust generic pharmaceutical industry, becoming the world\u0026rsquo;s largest producer of generic medicines and a global supplier of affordable drugs (43). Bhutan continues to benefit from India\u0026rsquo;s thriving generic sector due to its geographical proximity and strong economic ties.\u003c/p\u003e\n\u003cp\u003eBangladesh, as an LDC is exempt from enforcing pharmaceutical patents and data protection under the TRIPS Agreement until 2034, allowing manufacture and export generic versions of patented medicines without legal constraints (41). These flexibilities have enabled it to develop a robust pharmaceutical sector, achieving self-sufficiency in essential medicines. Bhutan has the liberty to import these generics without the TRIPS obligation. Although limited medicines imports have occurred from other neighbors including Thailand, the pharmaceutical landscapes of India and Bangladesh will continue to exert the greatest influence on Bhutan\u0026rsquo;s access to medicines.\u003c/p\u003e\n\u003cp\u003eWhile Bhutan\u0026rsquo;s current non-WTO status offers greater policy space, any future alignment with global IP norms must be approached with careful foresight. The experiences of India and Bangladesh underscore the importance of balancing IP protection with the right to health. Bhutan can draw lessons from India\u0026rsquo;s legal innovations, and the proactive use of TRIPS flexibilities, as well as from Bangladesh\u0026rsquo;s strategic use of its LDC status. There is also an opportunity for regional cooperation through joint procurement mechanisms, regulatory harmonization, and shared IP strategies to enhance collective bargaining power and improve access to affordable medicines across South Asia.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n\u003ch2\u003eBhutan and its LMIC status paradox\u003c/h2\u003e\n\u003cp\u003eAnother challenge that may hinder Bhutan\u0026rsquo;s ability to fully utilize TRIPS flexibilities arises from its recent designation as a Lower-Middle-Income Country (LMIC) (5). While this transition would grant Bhutan a 10-year adjustment period to align its domestic laws with TRIPS requirements, it would no longer qualify for the LDC-specific waivers related to pharmaceutical patents and data exclusivity. Losing access to these exemptions could further constrain Bhutan\u0026rsquo;s already limited pharmaceutical manufacturing capacity and exacerbate its dependence on pharmaceutical imports. Given the country\u0026rsquo;s small market size, large-scale domestic production is economically unviable, while public health budget constraints would limit the government\u0026rsquo;s ability to procure a broad range of medicines.\u003c/p\u003e\n\u003cp\u003eTo mitigate the potential price shocks arising from shifts in patent regimes in the event Bhutan joins WTO, remedial measures such as price regulation, pooled procurement, and regional manufacturing collaboration should be explored. If necessary, Bhutan should also be prepared to invoke TRIPS flexibilities, including compulsory licensing and parallel importation, to ensure uninterrupted access to essential medicines during public health emergencies.\u003c/p\u003e\n\u003cp\u003eGiven the absence of domestic generic production, Bhutan may have to rely on flexible international mechanisms, such as Article 31bis of the TRIPS Agreement, which allows the import of patented medicines produced under a compulsory license in another country. However, this mechanism entails significant procedural and administrative complexities, and will require institutional preparedness and capacity building for effective implementation.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n\u003ch2\u003eBilateral trade agreements and TRIPS-plus provision\u003c/h2\u003e\n\u003cp\u003e\u0026ldquo;TRIPS-plus\u0026rdquo; refers to IP commitments in bilateral or regional trade agreements that go beyond TRIPS minima. Evidence from other countries shows free trade agreements (FTAs) with TRIPS-plus rules reduce generic competition and raise medicine costs (44,45). TRIPS-plus clauses, which are known to impede generic competition, include patent term extensions, data exclusivity and limits on compulsory licensing.\u003c/p\u003e\n\u003cp\u003eOverview of Bhutan\u0026rsquo;s bilateral trade agreements:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eIndia-Bhutan Agreement on Trade, Commerce \u0026amp; Transit (Free-trade regime, 1972, last revised 2016)\u003c/strong\u003e: India is Bhutan\u0026rsquo;s dominant trade partner and the principal source of medicines and pharmaceutical imports. The bilateral trade arrangement establishes effective duty-free trade and duty-free transit for Bhutan (46).\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eBangladesh-Bhutan Preferential Trade Agreement (1 July 2022)\u003c/strong\u003e: It is a PTA that reduces tariffs on selected goods and is being discussed for upgrade to an FTA. It creates additional import avenues but currently covers limited product lists (47).\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eThailand-Bhutan FTA (effective 1 January 2026)\u003c/strong\u003e: The recent FTA gives Bhutan an opportunity to diversify trade partners beyond India. It appears primarily focused on goods trade with focus on agriculture and niche Bhutanese goods and does not publicly emphasize IP provisions (48).\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eBhutan\u0026rsquo;s existing agreements do not yet embed major TRIPS-plus standards, but future upgrades could import TRIPS-plus obligations. Further, Bhutan\u0026rsquo;s small market and near-total import dependence make it especially vulnerable to TRIPS-plus spillovers originating in supplier or transit countries. Future FTAs should explicitly exclude pharmaceuticals from TRIPS-plus provisions. Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e provides a comparative summary of the provisions of Bhutan\u0026rsquo;s bilateral agreement with its trading partners\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\n\u003ch2\u003eAccess to medicines and competition law\u003c/h2\u003e\n\u003cp\u003eBhutan does not have a stand-alone competition law; instead, matters about competition are guided by the National Competition Policy 2020 (49). The policy provides a general framework for fair market practice and protection of consumer welfare. The policy emphasizes removing \u0026lsquo;unreasonable barriers to entry\u0026rsquo; and preventing monopolistic practices, which could be applied to pharmaceutical distributors and importers engaged in price fixing and abuse of market dominance. However, the policy does not necessarily address IP-related market barriers concerning access to medicines.\u003c/p\u003e\n\u003cp\u003eNevertheless, Bhutan\u0026rsquo;s \u003cem\u003eConsumer Protection Act 2012\u003c/em\u003e provides safeguards against exploitative trade practices including price manipulation and unfair mark ups (50). Effective enforcement of this act could also complement broader efforts to control of anticompetitive practices in the market including that of pharmaceuticals. Both competition and consumer protection affairs are looked after by the Competition and Consumers Affairs Agency (CCAA) under the MoICE.\u003c/p\u003e\n\u003cp\u003eFuture competition law should incorporate provisions to prevent the misuse of IP rights and abuse of market dominance. Competition safeguards could also be integrated into pharmaceutical procurement and related health policies.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eAs Bhutan moves toward potential WTO accession and greater integration into the global trade and intellectual property system, it faces the dual challenge of aligning its laws with TRIPS obligations while safeguarding public health interests. The transition from LDC to LMIC status will narrow the policy space currently available to leverage TRIPS flexibilities, making proactive legal and institutional measures imperative. Strengthening the IPA, building administrative capacity, and ensuring inter-agency coordination will be crucial for Bhutan to effectively navigate the evolving pharmaceutical landscape.\u003c/p\u003e\n\u003cp\u003eEqually important will be the strategic use of competition law, regional cooperation, and partnerships with international organizations to mitigate the risks of monopolistic practices and ensure sustained access to affordable medicines. Bhutan\u0026rsquo;s approach should be guided by the principle of balancing innovation with equity, upholding the right to health while fostering a fair and resilient intellectual property regime to align with the country\u0026rsquo;s broader development philosophy of GNH. The country is well positioned to draw lessons from other nations and to craft pre-emptive, strategies well suited to its needs in leveraging TRIPS flexibilities and negotiating future bilateral free trade agreements in a manner that safeguards public health and national interests. Key recommendations for safeguard of access to medicines in Bhutan is summarized under Table \u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e\n"},{"header":"Declarations","content":"\u003cp\u003e \u003cstrong\u003eEthics approval:\u003c/strong\u003e \u003cp\u003eNot applicable\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConflict of Interest:\u003c/strong\u003e \u003cp\u003eNone\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding:\u003c/h2\u003e \u003cp\u003eNo funding was received.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eTT conceived the study framework and wrote the initial draft. DT reviewed and provided critical feedback on the manuscript. Both the authors read and approved the manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eAuthors would like to thank Industrial Property Division, Department of Media, Creative Industry and Intellectual Property (DoMCIP), Ministry of Industry, Commerce and Employment (MoICE) for furnishing the information on status of pharmaceutical patents in Bhutan, for the purpose of this study.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eGraph 1 depicting the trend of annual government expenditure on medicines and vaccines was generated using Microsoft Excel. The Excel worksheet is available for deposit in the repository. The expenditure for each financial year was captured from the Financial Audit Report of the Bhutan Health Trust Fund. The reports are available on its website: [https://www.bhtf.bt/?page\\_id=3285](https:/www.bhtf.bt/?page_id=3285)\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003e WIPO. World Intellectual Property Report 2024: Making Innovation Work for Development. [Internet]. Geneva; 2024 [cited 2026 Jan 8]. Available from: https://www.wipo.int/web-publications/world-intellectual-property-report-2024/en/index.html\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e WIPO. World Intellectual Property Report 2011: The Changing Face of Innovation [Internet]. World Intellectual Property Organization; 2011 [cited 2026 Jan 8]. 186 p. Available from: https://www.wipo.int/publications/en/details.jsp?id=227\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Correa CM. Innovation of the Global Expansion of Intellectual Property Rights: Unfulfilled Promises. South Centre. 2016 Aug; Research Article No. 70.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Tenni B, Moir HVJ, Townsend B, Kilic B, Farrell AM, Keegel T, et al. What is the impact of intellectual property rules on access to medicines? A systematic review. Global Health. 2022 Apr 15;18(1):40.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e United Nations. Bhutan graduates from LDC status [Internet]. [cited 2026 Jan 8]. Available from: https://www.un.org/development/desa/dpad/2023/bhutan-graduates-from-ldc-status/\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Thinley Sangay. The Kingdom of Bhutan health system review. World Health Organization, Regional Office for South-East Asia on behalf of the Asia Pacific Observatory on Health Systems and Policies; 2017. 226 p.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Turner M, Wangchuk D. National Development Planning and Sustainability: The Case of Bhutan. Sustainability. 2025 Apr 6;17(7):3261.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Royal Government of Bhutan. Industrial Property Act of the Kingdom of Bhutan 2001.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e WTO. Accession status: Bhutan [Internet]. [cited 2026 Jan 8]. Available from: https://www.wto.org/english/thewto_e/acc_e/a1_bhoutan_e.htm\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Lhadon K. Expert consultation underway to assess WTO membership. Bhutan Broadcasting Service [Internet]. 2024 Dec 10 [cited 2026 Jan 8]; Available from: https://www.bbs.bt/221584/\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Islam MdD, Kaplan WA, Trachtenberg D, Thrasher R, Gallagher KP, Wirtz VJ. Impacts of intellectual property provisions in trade treaties on access to medicine in low and middle income countries: a systematic review. Global Health. 2019 Dec 30;15(1):88.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e DrugPatentWatch. The Dark Reality of Drug Patent Thickets: Innovation or Exploitation? [Internet]. [cited 2026 Jan 11]. Available from: https://www.drugpatentwatch.com/blog/the-dark-reality-of-drug-patent-thickets-innovation-or-exploitation/\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Yenet A, Nibret G, Tegegne BA. Challenges to the Availability and Affordability of Essential Medicines in African Countries: A Scoping Review. Clinicoecon Outcomes Res. 2023;15:443\u0026ndash;58.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Motari M, Nikiema JB, Kasilo OMJ, Kniazkov S, Loua A, Sougou A, et al. The role of intellectual property rights on access to medicines in the WHO African region: 25 years after the TRIPS agreement. BMC Public Health. 2021 Dec 11;21(1):490.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e World Trade Organization. Ministerial Declaration of 14th November, 2001.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Tenni B, Lexchin J, Phin S, Kittitrakul C, Gleeson D. Lessons from India and Thailand for Cambodia\u0026rsquo;s future implementation of the TRIPS Agreement for pharmaceutical patents. J World Intellect Prop. 2023 Jul 7;26(2):166\u0026ndash;94.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Kuanpoth J. Compulsory Licences: Law and Practice in Thailand. In 2015. p. 61\u0026ndash;77.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Pogge T. Pharmaceutical Patents and Economic Inequality. Health Hum Rights. 2023 Dec;25(2):199\u0026ndash;204.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Kerry V, Lee K. TRIPS, the Doha declaration and paragraph 6 decision: what are the remaining steps for protecting access to medicines? Global Health. 2007;3(1):3.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Hoen EFM \u0026rsquo;t.. The global politics of pharmaceutical monopoly power : drug patents, access, innovation and the application of the WTO Doha Declaration on TRIPS and public health. AMB Publishers; 2009. 136 p.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e World Intellectual Property Organization. Berne Convention for the Protection of Literary and Artistic Works: Accession by the Kingdom of Bhutan. .\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e WIPO. WIPO Lex Database - Bhutan [Internet]. [cited 2026 Jan 6]. Available from: https://www.wipo.int/wipolex/en/members/profile/BT?activeCollection=laws\u0026amp;collection=laws\u0026amp;collection=treaties\u0026amp;collection=judgments\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Royal Government of Bhutan. The Copyright Act of the Kingdom of Bhutan 2001. 2001.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e United Nations. Paris Convention for the Protection of Industrial Property. 1967.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Royal Government of Bhutan. Penal Code of Bhutan 2004. 2004.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Royal Government of Bhutan. Civil and Criminal Procedures Code (Amendment) Act 2011. 2011\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Department of Intellectual Property M of EAB. Annual IP Magazine 2019 [Internet]. 2019 [cited 2026 Jan 9]. Available from: https://www.moice.gov.bt/wp-content/uploads/2023/03/Annual-IP-Magazine-2019.pdf\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Department of Intellectual Property. National Intellectual Property Policy 2018 [Internet]. 2018 [cited 2026 Jan 8]. Available from: https://www.moenr.gov.bt/?p=4521\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Lack of awareness and resources hinder intellectual property growth. Kuensel [Internet]. 2018 Nov 9 [cited 2026 Jan 8]; Available from: https://kuenselonline.com/news/lack-of-awareness-and-resources-hinder-intellectual-property-growth\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Biswas AK. Foreign trade policies and WTO accession in Bhutan. International Journal of Multidisciplinary Trends. 2025 Apr 1;7(4):240\u0026ndash;2.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Wangyel Tashi. Rhetoric and Reality: An Assessment of the Impact of WTO on Bhutan. Centre for Bhutan Studies. 2013.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e FAO. Issues at stake relating to agriculture development, trade and food security [Internet]. [cited 2026 Jan 8]. Available from: https://www.fao.org/4/x4829e/x4829e04.htm\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Dorji T. Effect of TRIPS on Pricing, Affordability and Access to essential medicines in Bhutan. Centre of Bhutan Studies. 9(1).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Ministry of Health. National Drug Policy 2007 [Internet]. 2007 [cited 2026 Jan 8]. Available from: https://moh.gov.bt/wp-content/uploads/2025/01/National-Drug-Policy-2007.pdf?utm_source=chatgpt.com\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e The constitution of the Kingdom of Bhutan. 2008.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Choden T. Private sector participation in pharmacy services in Bhutan for better consumer service [Internet]. [cited 2026 Jan 8]. Available from: https://ccaa.gov.bt/wp-content/uploads/2025/06/Final-Private-Sector-Participation-in-Pharmacy-Services-in-Bhutan.pdf\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e WIPO IP Statistics Data Center. Intellectual Property Statistical Country Profile 2024. 2024. [Internet]. [cited 2026 Jan 8]. https://www.wipo.int/edocs/statistics-country-profile/en/bt.pdf\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e The World Bank Group. Primary Health Care in Bhutan Findings from the Primary Health Care Performance Initiative Assessment [Internet]. 2023 [cited 2026 Jan 9]. Available from: https://documents1.worldbank.org/curated/en/099042624133516182/pdf/P17054414014ae0b61a154156f3f80a11f7.pdf\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Thinley S, Sharma G, Wangmo K. Sustainability of Bhutan\u0026rsquo;s Health Services. 2015 [cited 2026 Jan 8]; Available from: https://drukjournal.bt/sustainability-of-bhutans-health-services/\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Royal Audit Authority. Financial Audit Report of the Bhutan Health Trust Fund 2021 [Internet]. 2021 [cited 2026 Jan 8]. Available from: https://www.bhtf.bt/?page_id=3285\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e World Trade Organisation. Developing countries\u0026rsquo; transition periods [Internet]. [cited 2026 Jan 8]. Available from: https://www.wto.org/english/tratop_e/trips_e/factsheet_pharm04_e.htm\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Government of India. The Patent Act of India 1970. 1970.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Bjerke L. Antibiotic geographies and access to medicines: Tracing the role of India\u0026rsquo;s pharmaceutical industry in global trade. Soc Sci Med. 2022 Nov;312:115386.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e El Said M. The Impact of \u0026lsquo;TRIPS-Plus\u0026rsquo; Rules on the Use of TRIPS Flexibilities: Dealing with the Implementation Challenges. In: Access to Medicines and Vaccines. Cham: Springer International Publishing; 2022. p. 297\u0026ndash;327.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Kessomboon N, Limpananont J, Kulsomboon V, Maleewong U, Eksaengsri A, Paothong P. Impact on access to medicines from TRIPS-Plus: a case study of Thai-US FTA. Southeast Asian J Trop Med Public Health. 2010 May;41(3):667\u0026ndash;77.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Agreement on Trade, Commerce and Transit Between the Royal Government of Bhutan and the Government of Republic of India. 2026.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Agreement on Trade Between the Royal Government of Bhutan and the Government of the Peoples Republic of Bangladesh. 2022.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e The Government Public Relations Department. 2025. Thailand and Bhutan signs Free Trade Agreement.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Ministry of Economic Affairs. National Competition Policy 2020. 2020.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e Royal Government of Bhutan. Consumer Protection Act 2012. 2012.\u003c/span\u003e\u003c/li\u003e \u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1: Alignment of IPA 2001 with TRIPS\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"623\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSl No\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTRIPS Obligation/flexibilities\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIPA Status\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003ePatent scope \u0026amp; 20-year term\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003eFully aligned\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003ePatentability criteria\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003eDoes not define \u0026lsquo;inventive step\u0026rsquo; in manner that would prevent frivolous patent and evergreening\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e3\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eExclusion from patentability\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003eExcludes discoveries, scientific theories, methods for medical treatment, and plant/animal varieties;\u0026nbsp;does not explicitly mention exclusion of new uses of known substance\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e4\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eRegistration and rights clarity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003eClear provisions for registration, priority, rights, and infringement enforcement\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e5\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eEnforcement mechanisms\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003eRemedies, injunctions, damages and criminal penalties in place\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e6\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eParallel importation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003eNo provision on parallel importation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e7\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eCompulsory license / government use\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003eCovered under \u0026ldquo;Exploitation by government\u0026rdquo;; Permits use for public interest, emergency and on anti‑competitive grounds\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e8\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eBolar \u0026amp; experimental use exception\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003eException for experimental purpose but no provision on bolar/ early working exemption\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e9\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003eLDC waiver\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003eNot applicable as a non-member of WTO; transition will not be applicable as Bhutan joins WTO post LDC graduation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 47px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e10\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 227px;\"\u003e\n \u003cp\u003ePatent opposition\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 350px;\"\u003e\n \u003cp\u003ePost grant \u0026ldquo;Invalidation\u0026rdquo; incorporated\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 2: Comparative summary of the provisions of Bhutan\u0026rsquo;s agreement with the major trading partners.\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"614\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 109px;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 178px;\"\u003e\n \u003cp\u003e\u003cem\u003eIndia\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003e\u003cem\u003eBangladesh\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003e\u003cem\u003eThailand\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 109px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAgreement Name\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 178px;\"\u003e\n \u003cp\u003eIndia-Bhutan Agreement on Trade, Commerce \u0026amp; Transit\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003eBangladesh-Bhutan Preferential Trade Agreement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003eBhutan-Thailand Free Trade Agreement\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 109px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eYear signed\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 178px;\"\u003e\n \u003cp\u003eFirst signed in 1972; current version valid until 2026.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003eSigned December 2020; in force from July 2022\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003eSigned April 3 2025; implementation targeted\u0026nbsp;January 1 2026.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 109px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNature of Agreement\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 178px;\"\u003e\n \u003cp\u003eBilateral Free Trade \u0026amp; Transit Agreement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003ePreferential Trade Agreement (tariff-reductions)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003eBilateral Free Trade Agreement (goods)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 109px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eKey features\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 178px;\"\u003e\n \u003cp\u003eDuty-free trade in goods between India and Bhutan\u003c/p\u003e\n \u003cp\u003eTransit rights through India for Bhutan\u0026rsquo;s trade with third countries.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003eTariff concessions on selected goods\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eFacilitates imports/exports, supports transit cooperation.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003eElimination of tariff on general goods on both sides\u003c/p\u003e\n \u003cp\u003eSpecial quotas for certain Bhutanese agricultural products for duty-free export\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 109px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRelevance to Pharmaceuticals\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 178px;\"\u003e\n \u003cp\u003eIndia is Bhutan\u0026rsquo;s main source of pharmaceuticals; duty-free imports facilitate access.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003eBangladesh, as an LDC with generic manufacturing, can export generics to Bhutan under this preferential regime.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 164px;\"\u003e\n \u003cp\u003eOpens up new market access for Bhutan, possibly lowers cost of medicines produced in Thailand.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003eTable 3. Key recommendations to safeguard access to medicines in Bhutan\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"623\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eNo.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eStrategic Area\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eKey Recommendation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eStrategic use of non-WTO status\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003eLeverage Bhutan\u0026rsquo;s current non-WTO membership and absence of enforced pharmaceutical patents to procure generic medicines from TRIPS-waiver eligible countries (e.g., Bangladesh) through strategic procurement arrangements until WTO accession.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eInstitutional preparedness\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003eEnhance readiness to utilize TRIPS flexibilities through policy gap analysis and administrative capacity building, including preparedness to operationalize compulsory licensing and Article 31bis mechanisms.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eLegal embedding of health safeguards\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003eAmend the Industrial Property Act 2001 to explicitly incorporate public health safeguards, including compulsory licensing, parallel importation, Bolar exception, appropriate exhaustion regimes, and stricter patentability standards.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eInstitutional strengthening and coordination\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003eStrengthen the capacity of key institutions (DoMCIP, BFDA, Office of Consumer Protection, and MoH legal division) and establish a multi-agency core team to coordinate TRIPS-related policy formulation and negotiations.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eInternational technical assistance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003eSeek legal and technical support from international and regional organizations such as the WTO, WIPO, WHO, UNDP, and UNCTAD to align IP implementation with public health objectives.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eWTO accession strategy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003ePreserve public health policy space during WTO accession by negotiating explicit carve-outs, transition periods, or interpretative safeguards comparable to LDC flexibilities.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eStakeholder engagement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003eEngage public health experts, legal scholars, civil society organizations, and other stakeholders to ensure IP policy coherence with national health goals and Bhutan\u0026rsquo;s GNH philosophy.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eRegional cooperation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003eStrengthen regional collaboration through joint procurement, regulatory harmonization, and shared IP strategies to enhance bargaining power and improve access to affordable medicines in South Asia.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eAvoidance of TRIPS-plus obligations\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003eAvoid adopting TRIPS-plus provisions such as data exclusivity, patent term extensions, or enhanced protection in domestic laws or trade agreements that could restrict generic competition.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eCompetition law strengthening\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 444px;\"\u003e\n \u003cp\u003eStrengthen national competition law to prevent abuse of IP rights, monopolistic practices, cartels, and deceptive conduct, ensuring IP protection does not undermine access to affordable medicines.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pubh","sideBox":"Learn more about [BMC Public Health](http://bmcpublichealth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/pubh/default.aspx","title":"BMC Public Health","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Bhutan, Intellectual property, Access to medicines, TRIPS flexibilities, Pharmaceutical patents, Essential medicines, WTO accession, Trade agreement","lastPublishedDoi":"10.21203/rs.3.rs-8597770/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8597770/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBhutan 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\u0026rsquo;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.\u003c/p\u003e \u003cp\u003eThis paper examines the implications of the TRIPS Agreement for Bhutan\u0026rsquo;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\u0026rsquo;s current dependence on pharmaceutical imports, primarily from India and Bangladesh, and underscores the need to strategically leverage TRIPS flexibilities to safeguard public health.\u003c/p\u003e \u003cp\u003eThe paper identifies critical legal and institutional gaps in Bhutan\u0026rsquo;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.\u003c/p\u003e","manuscriptTitle":"Aligning intellectual property protection with public health to ensure access to medicines in Bhutan","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-12 15:33:29","doi":"10.21203/rs.3.rs-8597770/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"24624134545343296565075860132397732877","date":"2026-02-20T15:24:00+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-02-20T10:10:51+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-02-19T01:29:30+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"88795968398288305330243646394868092391","date":"2026-02-15T22:48:03+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"224390473190727926684179841290650357803","date":"2026-02-14T05:52:33+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"63004964921077334708364401394555459519","date":"2026-02-11T05:10:38+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-02-09T05:06:28+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-01-19T10:57:56+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-01-19T08:53:35+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-19T08:49:43+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Public Health","date":"2026-01-14T05:27:03+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pubh","sideBox":"Learn more about [BMC Public Health](http://bmcpublichealth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/pubh/default.aspx","title":"BMC Public Health","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"a8281165-6ba9-453d-84a6-8bc62b9fc9ce","owner":[],"postedDate":"February 12th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-02-12T15:33:29+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-12 15:33:29","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8597770","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8597770","identity":"rs-8597770","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}