SummaryOn May 5, the Biden administration announced its support for waiving World Trade Organization (WTO) intellectual property regulations with respect to COVID-19 vaccines, in an effort to increase supply and worldwide access to the vaccines.
Since that announcement, the European Union Commission has expressed a willingness to discuss waiver provisions or other proposals that might effectively address the ongoing pandemic. However, some member states have voiced concern about waiving provisions, or that such action would not address the problem of vaccine access. If other WTO member countries agree, negotiations can begin on waiving specific provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). Waiver negotiations could take several months and would require unanimous agreement among the WTO’s 164 member countries.
“During this pandemic, ensuring a sufficient and timely vaccine supply is critical for patient access, as is public confidence in the safety and efficacy of the vaccines being delivered globally,” said Jason Hall, Managing Director at Avalere. Through public/private partnerships, manufacturers and other global organizations have built capacity and distribution capabilities, and these collaborations are best positioned to continue expanding vaccine access in timely and efficient ways.”
“There could be a significant delay between WTO agreement on the waiver details and the increased supply of vaccines. It may take time to scale up manufacturing capacity, supply the needed raw materials, hire and train experienced employees on novel technology platforms, and manage other barriers like import and export challenges,” added Thomas Hess, Principal at Avalere. “Manufacturers should be prioritized based on a proven record of demonstrating expertise in vaccine manufacturing and regulatory affairs.”
“Waiving patents sets an unfavorable precedent for continued innovation and investment in the next generation of pandemic countermeasures and is unlikely to deliver more vaccine doses faster,” said Gillian Woollett, Principal Research Scientist at Avalere. “Effort should be placed behind expanding capacity, improving access to raw materials, and donating existing supplies to areas of need.”
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