The Architecture of Compulsory Licensing: Historical Evolution and Structural Limits

Author

Shaily Navadia, Priyasha Mishra


Abstract

 Compulsory licensing under TRIPS Article 31 and the Doha Declaration is a reactive, product-specific remedy that has proved procedurally cumbersome and underused, as COVID-19 demonstrated. This paper examines whether the 2025 WHO Pandemic Agreement can operate as a “Compulsory Licensing 2.0” for future threats such as “Disease X”. It finds that, despite genuine advances in the One Health principle and the PABS system, the Agreement depends on voluntary, “willingly undertaken” technology transfer, is silent on trade secrets, and cannot enter into force until the PABS annex is finalised. Because Disease X demands proactive rather than reactive architecture, the paper proposes automatic PHEIC-triggered licensing, pre-committed licences for platform technologies, a TRIPS Article 31ter, a binding technology transfer provision in the PABS annex, and model domestic legislation.



Keywords

Compulsory licensing; TRIPS Article 31; Doha Declaration; WHO Pandemic Agreement; PABS annex; Disease X



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References


Abbott, F. M. (2002). The TRIPS Agreement, access to medicines, and the WTO Doha Ministerial Conference. Journal of World Intellectual Property, 5, 15.

Agreement on Trade-Related Aspects of Intellectual Property Rights. (1994). 15 April 1994, 1869 UNTS 299.

Baker, B. K., & Thrasher, R. (2023). From business as usual to health for the future: Challenging the intellectual property regime to address COVID-19 and future pandemics. Boston University International Law Journal, 23, 1.

Braimoh, T., et al. (2024). Intellectual property licensing of therapeutics during the COVID-19 crisis: Lessons learnt for pandemic preparedness and response. Globalization and Health, 20, 52.

Convention on Biological Diversity. (1992). 5 June 1992, 1760 UNTS 79.

Council of the EU. (2025). Crisis preparedness: Council approves framework for compulsory licensing in crisis situations. 27 October 2025. Retrieved 10 March 2026, from https://www.consilium.europa.eu/en/press/press-releases/2025/10/27/crisis-preparedness-council-approves-framework-for-compulsory-licensing-in-crisis-situations/

Drahos, P., & Braithwaite, J. (2000). Global business regulation. Cambridge University Press.

Eccleston-Turner, M., & Harris, J. (2025). The new WHO Pandemic Treaty and global health governance: Incorporating common but differentiated responsibilities into PABS. Georgetown Journal of International Affairs.

Eccleston-Turner, M., Rourke, M., & Switzer, S. (2025). Fate unknown: The Pandemic Agreement’s pathogen access and benefit sharing. Think Global Health, 20 May 2025. Retrieved 10 March 2026, from https://www.thinkglobalhealth.org/article/fate-unknown-pandemic-agreements-pathogen-access-and-benefit-sharing

Governing Pandemics Initiative. (2025). Governing Pandemics Snapshot. Graduate Institute Geneva. Retrieved 10 March 2026, from https://www.governingpandemics.org/gp-snapshot

Gurgula, O. (2021). Compulsory licensing v the IP waiver: What is the best way to end the COVID-19 pandemic? SSRN Working Paper. doi: 10.2139/ssrn.3944192

Hollis, A., & Pogge, T. (2008). The Health Impact Fund: Making new medicines accessible for all. Incentives for Global Health.

Huang, L., & Jiang, G. (2025). Compulsory licensing of pharmaceuticals during public health crisis: A TRIPS framework analysis. Frontiers in Public Health, 13, 1630586.

Inside EU Life Sciences. (2025). What companies should know about the WHO Pandemic Agreement. 18 April 2025. Retrieved 10 March 2026, from https://www.insideeulifesciences.com/2025/04/18/what-companies-should-know-about-the-who-pandemic-agreement/

IPI Global Observatory. (2025). How the landmark Pandemic Agreement addresses technology transfer and access to pandemic response products. 23 May 2025. Retrieved 10 March 2026, from https://theglobalobservatory.org/2025/05/how-the-landmark-pandemic-agreement-addresses-technology-transfer-and-access-to-pandemic-response-products/

Jain, S. (2025). The WHO Pandemic Agreement: A contested step beyond Doha. SpicyIP, 17 July 2025. Retrieved 10 March 2026, from https://spicyip.com/2025/07/the-who-pandemic-agreement-a-contested-step-beyond-doha.html

Katz, A., & Reichman, J. H. (2022). Fulfilling the promise of TRIPS Article 31bis. University of Pennsylvania Law Review, 170, 1.

Kinyon, B. (2022). IP waivers in a pandemic: Great in theory, wrong in practice. Minnesota Journal of Law, Science and Technology, 23, 485.

Matthews, D. (2004). WTO Decision on implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health: A solution to the access to essential medicines problem? Journal of International Economic Law, 7, 73.

Musungu, S. F., & Oh, C. (2006). The use of flexibilities in TRIPS by developing countries: Can they promote access to medicines? South Centre.

Paris Convention for the Protection of Industrial Property. (1883). 20 March 1883, 828 UNTS 305.

’t Hoen, E. (2009). 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.

’t Hoen, E. (2025a). Transfer of technology and know-how for the production of pandemic-related health products in the WHO Pandemic Agreement: The proverbial half glass. Medicines Law and Policy, June 2025. Retrieved 10 March 2026, from https://medicineslawandpolicy.org/2025/06/transfer-of-technology-and-know-how

’t Hoen, E. (2025b). WHO members meet to finalise the pathogen access and benefit sharing instrument. Medicines Law and Policy, September 2025. Retrieved 10 March 2026, from https://medicineslawandpolicy.org/2025/09/who-members-meet-to-finalise-the-pathogen-access-and-benefit-sharing-instrument/

WHO Framework Convention on Tobacco Control. (2003). 21 May 2003, 2302 UNTS 166.

WHO Pandemic Agreement. (2025). 20 May 2025, WHA78 Res.

World Health Organization. (2018). Managing epidemics: Key facts about major deadly diseases. WHO.

World Health Organization. (2025a). Countries make progress on WHO Pandemic Agreement annex on pathogen access and benefit sharing system. 7 November 2025. Retrieved 10 March 2026, from https://www.who.int/news/item/07-11-2025-countries-make-progress-on-who-pandemic-agreement-annex

World Health Organization. (2025b). World Health Assembly adopts historic Pandemic Agreement to make the world more equitable and safer from future pandemics. 20 May 2025. Retrieved 10 March 2026, from https://www.who.int/news/item/20-05-2025-world-health-assembly-adopts-historic-pandemic-agreement

World Health Organization. (2026a). Seventy-ninth World Health Assembly – Daily update: 19 May 2026. 19 May 2026. Retrieved 12 October 2026, from https://www.who.int/news/item/19-05-2026-seventy-ninth-world-health-assembly---daily-update--19-may-2026

World Health Organization. (2026b). WHO Member States agree to extend negotiations on Pathogen Access and Benefit Sharing annex. 1 May 2026. Retrieved 12 October 2026, from https://www.who.int/news/item/01-05-2026-who-member-states-agree-to-extend-negotiations-on-pathogen-access-and-benefit-sharing-annex

World Trade Organization. (n.d.). TRIPS and public health: Compulsory licensing of pharmaceuticals and TRIPS. WTO. Retrieved 10 March 2026, from https://www.wto.org/english/tratop_e/trips_e/pharmpatent_e.htm

WTO General Council. (2003). Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health (WT/L/540). 30 August 2003.

WTO Ministerial Conference. (2001). Declaration on the TRIPS Agreement and public health (WT/MIN(01)/DEC/2). 20 November 2001.

WTO Ministerial Conference. (2022). Ministerial Decision on the TRIPS Agreement (WT/MIN(22)/30). 17 June 2022.

 

 

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