After three years of negotiations, the WHO was finally able to come up with a final version of the Pandemic Agreement last month. SpicyIP Intern Riddhi Yogesh Bhutada takes a look at the key provisions of the Agreement and highlights how the instrument might not be able to overcome the challenges it originally aimed to resolve. Riddhi is a final-year law student at School of Law, CHRIST (Deemed to be University), with a focused interest in Intellectual Property Law and Media and Entertainment Law. She enjoys reading and writing on how intellectual property interacts with other disciplines. Her previous post can be accessed here.
Preparedness Without Power? Analysing IP and Access in the WHO Pandemic Agreement
By Riddhi Yogesh Bhutada
In May 2025, the 78th World Health Assembly put together more than three years of intensive negotiation in a WHO Pandemic Agreement as a response to the impact faced by pharmaceutical industries and various nations during Covid-19 pandemic. This document born out of Covid-19 aftermath (see here) seeks to provide global legal framework for future pandemic prevention, preparedness and response. The intergovernmental negotiating body (INB) held 13 meetings to substantively complete the draft of the Agreement (Clause 4 of the Annex). This Agreement is a comprehensive framework aimed at fostering global cooperation to prevent, prepare for, and respond to pandemics. As per Article 4, the Agreement offers or claims to offer international collaboration to strengthen pandemic prevention and surveillance, consistent with the International Health Regulations (2005). It also promotes mutually agreed technology transfers to enhance production of pandemic-related health products, particularly for developing countries. It does not mandate but encourages reasonable royalties to improve affordability and access particularly for developing countries (Article 11). The Agreement enters into force on the 30th day following the deposit of the 60th instrument of ratification, acceptance, approval, formal confirmation, or accession with the Depositary (Article 33). It shall be open for signature after the adoption of the Pathogen Access and Benefit Sharing system (PABS) Instrument at WHO Headquarters in Geneva and then at UN Headquarters in New York, dates for which will be determined by the Health Assembly (Article 31.2).
The Agreement essentially focuses to prepare developing and under developed nations for any future pandemic that may arise. This is due to the technological know-how and financial gap between high- and low-income nations (see here). This Agreement can be considered a historic breakthrough in global health and governance as it focuses on equitable global response. Yet the intellectual property dimensions of global health give a sense of déjà vu.
The said déjà vu, is the repetition non-binding language (see here) relating to intellectual property in international health frameworks. This looks like a settlement for diplomatic middle path hoping that global pharmaceutical companies act in goodwill and volunteer for sharing data or comply with the Agreement provisions. For instance, the Agreement introduces PABS and emphasizes equity in access, however, the implementation of the same can be questioned due to lack of firm commitments. The PABS and technology transfer under the Agreement reflects demands of developing countries for fair benefit-sharing based on vaccine inequity faced during COVID-19. It focuses on parties developing the infrastructure and collaborating but it misses to highlight explicit provisions, vaccine mandates, or global protocols. PABS acts as a cornerstone of the treaty’s equity framework, aimed at ensuring rapid sharing of pathogens with pandemic potential. As per Article 12, during a pandemic emergency, participating manufacturers are to provide 20% of their real-time production of safe, quality, and effective vaccines, therapeutics, and diagnostics for pathogens causing pandemic emergency to WHO, with 10% as donations to and 10% at affordable prices.
The Agreement encourages voluntary licensing, technology transfer, flexibilities under the intellectual property regime. Though the Agreement acts as a step towards recognition of equitable access to essential and life-saving medicines, the lack of clear mandating and IP waivers puts low-income nations in the same position. Despite the intensive debate over access to essential medicines during Covid-19 by developing countries the key issue remains unaddressed. This is worsened by withdrawal of the United States from the World Health Organisation as key pharmaceutical players from the US are no longer obligated by the provisions of this Agreement (see here) (paywalled). This is striking as despite global debate over TRIPS waiver and repeated requests from low- and middle-income countries, the Agreement does not address most of these concerns. Additionally, pharmaceutical companies efforts to reduce the technological know-how and financial gap remains questionable (see here). Though various pharmaceutical companies are now focusing on low- and middle-income countries but the efforts stand limited owing to the voluntary nature of this focus. The Agreement mirrors this approach by skipping any clear provision for compulsory licensing or providing any explicit power to the World Health Organisation. This lack of scrutinising power creates only voluntary form of help which is increasing but still remains inadequate. The Agreement, shows diverse reactions from countries, shaped by their health priorities, economic interests, and geopolitical stances. Supporters include South Africa which believes the treaty’s PABS system to address inequities in pathogen-sharing benefits, reflecting the African region’s push for equitable access. The European Union, Germany, and Ireland endorse the treaty for its One Health approach and mechanisms like the global supply chain and logistics network, though Germany sought stronger prevention measures. Hungary, despite ties to U.S. leadership, supports the treaty. Iran and Paraguay reserved support, awaiting PABS details, while Slovakia insisted on a vote, signalling resistance.
The Agreement places heavy reliance on voluntary mechanisms, which fall short in times of crisis. Though such voluntarism is politically comfortable, it is rarely effective or affordable for the middle- and low-income nations. In avoiding commitments around accessibility, the Agreement lays down emphasis on role of parties during such crisis. The Agreement lays down provisions on sustainable financing, international cooperation and implementation by providing what the parties should do in situation of a pandemic. What the Agreement skips is many of these parties do not have the know-how or the financial aid to follow the provisions. Pharmaceutical companies and high-income nations will remain committed to preserving their intellectual property in order to generate incentive for the research and development undertaken. This is an effect of lack of mandatory or compulsory provisions.
The global medicine industry cannot work on goodwill or voluntariness of companies as public-private cooperation will not be enough if there are no mechanisms to ensure actual assistance during pandemic. The Agreement does not give the WHO any authority to mandate public health responses. Lack of authority will result in enforcement and compliance to the Agreement being governed by domestic will of the parties.
The WHO pandemic Agreement though cautious shows a potential constructive step towards equitable pandemic governance in near future. Technology transfer is a step forward but might be insufficient. With no binding measures and absence of one of the key pharmaceutical superpowers, the Agreement feels more like a framework for future negotiation than a decisive solution.