Editor's Note
There is an inherent tension between the accessibility of COVID-19 vaccines and intellectual property (IP) protection. From the perspective of global public health, ensuring the worldwide availability of COVID-19 vaccines is imperative to effectively curb the pandemic. However, under the TRIPS Agreement and national IP systems, vaccine manufacturers are required to obtain authorization from IP rights holders and pay licensing fees.
In June 2022, the 12th WTO Ministerial Conference reached a compromise by adopting the Ministerial Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics and the Ministerial Decision on the TRIPS Agreement, which granted a temporary patent waiver for COVID-19 vaccines. This compromise seeks to balance the incentive for technological innovation with the goal of expanding vaccine accessibility as part of building a global health community.
Against this backdrop, Professor Xu Chunming and his master's student Chen Xue'ni from the Shanghai International College of Intellectual Property at Tongji University conducted an in-depth study of the WTO's COVID-19 vaccine patent waiver texts. Their research explored the impacts of the waiver on pharmaceutical innovation incentives, the balance between vaccine accessibility and IP protection, and the uncertainties surrounding the effectiveness of the waiver. They further examined the implications for China. The research was published in Science, Technology and Law (Chinese-English Edition), Issue 4, 2022. The following is an abstract of the article.
Abstract
Since the outbreak of COVID-19 in 2019, vaccines have become the most effective tool in combating the pandemic and the greatest hope for restoring normalcy in global social and economic order. However, limited manufacturing capacities of vaccine developers worldwide have made it difficult to meet global demand. Additionally, the complex outbreak situation in countries like India prompted calls from many nations for a temporary waiver of IP rights related to COVID-19 vaccines.
In June 2022, after several days of negotiations, the 12th WTO Ministerial Conference adopted the Ministerial Decision on the TRIPS Agreement and the Ministerial Declaration on the WTO Response to the COVID-19 Pandemic and Preparedness for Future Pandemics, allowing developing country members to issue domestic authorizations to waive patents for necessary ingredients and processes for manufacturing COVID-19 vaccines, thereby expanding global vaccine accessibility.
While the waiver undoubtedly impacts IP protection—given that the pharmaceutical sector is one of the most R&D-intensive industries—the decision also sets a precedent for waiving pharmaceutical patents not only for COVID-19 but also for other public health emergencies. This may reduce innovation incentives for pharmaceutical companies.
On the other hand, increasing global vaccine supplies and relaxing IP protections can help curb the pandemic. The patent system remains indispensable for vaccine protection and improvement. The waiver aligns with the ultimate goal of the IP system—to maximize global public interest by balancing innovation incentives with public health and economic development.
The WTO decision carefully balances the relationship between vaccine accessibility and IP protection by limiting the scope, subjects, and duration of the waiver, thereby enhancing accessibility without excessively infringing upon patent holders' rights. However, the actual increase in vaccine supply resulting from the waiver remains uncertain due to factors such as material scarcity, high production learning curves, and the fact that essential know-how often lies beyond published patent documents.
Regarding China, as both a beneficiary and subject of the waiver, the country has actively supported the WTO's efforts to achieve consensus on the COVID-19 vaccine patent waiver. Although China has not issued any compulsory licenses for COVID-19-related patents, the WTO decision provides broader and more flexible options for member states than China's existing compulsory licensing system. The decision permits both manufacturing and export of vaccines, sets guidelines for reasonable compensation based on humanitarian and non-profit principles, and prohibits members from challenging the decision under GATT Article 23, enhancing enforceability during emergencies.
Given its vaccine development and manufacturing capabilities, China can assist eligible WTO members in implementing the waiver, expanding vaccine accessibility, and building a more robust vaccine manufacturing system. Simultaneously, China should use this opportunity to enhance its pharmaceutical innovation capacity, narrow the technology gap with developed countries, and improve its IP legal system, including the refinement of compulsory licensing mechanisms, as no such licenses have yet been issued domestically.
In conclusion, the IP system and technological innovation play vital roles in controlling and eliminating COVID-19. The Ministerial Declaration and the TRIPS Decision provide a critical first step in overcoming patent-related barriers, while also laying the groundwork for balancing IP protection with responses to global public health crises. As a responsible major country, China should further participate in global IP governance and promote the construction of a multilateral system for managing IP during public health emergencies.
Author Profiles
Xu Chunming, Professor, Shanghai International College of Intellectual Property, Tongji University; Ph.D. in Management; Principal Investigator of the National Social Science Fund Major Project "Strategic Research on China's Participation in Global Intellectual Property Governance under New Circumstances" (21&ZD165).
Chen Xue'ni, Master's Student, Shanghai International College of Intellectual Property, Tongji University.
