At the request of the U.S. Trade Representative, the U.S. International Trade Commission (USITC) is conducting an investigation and will issue an accompanying report concerning the TRIPS Agreement and a variety of issues related to COVID-19 diagnostics and therapeutics. According to USTR, the USITC report will inform future discussions within the United States and at the World Trade Organization (WTO) concerning potential TRIPS waiver expansion.
To oppose ideological calls to expand the TRIPS waiver and to underscore the essential role of intellectual property (IP) protections in driving U.S. innovation related to COVID-19 vaccines and treatments, PhRMA submitted comprehensive comments to the USITC on March 17 and provided testimony on March 29. These comments and testimony emphasize the following five points:
1. America’s world-leading biopharmaceutical industry innovated and produced safe and effective vaccines and treatments to combat COVID-19 in record time.
The industry developed multiple COVID-19 vaccines within the first year of the pandemic. By 2022, 20 companies were manufacturing enough doses to supply COVID-19 vaccines to the entire world’s population. These vaccines saved as many as 20 million lives and prevented over 80 million hospitalizations, and existing production capacity is more than sufficient to meet global demand. Similarly, over 70 million safe and effective COVID-19 antiviral treatment courses were produced by the end of 2022, an amount which far exceeded worldwide demand.
2. Industry’s success in combatting COVID-19 was founded on IP protections, including the baseline protections provided by the TRIPS Agreement.
IP protections ensured by the TRIPS Agreement also have facilitated hundreds of partnerships globally to enable this historic vaccine and treatment development and deployment. Considering treatments alone, IP has enabled more than 140 manufacturing partnerships spanning more than 30 countries, including such economically and geographically diverse countries as Brazil, India, Indonesia, Kenya, Singapore and South Africa.
3. Expanding the TRIPS waiver would jeopardize the innovation underway to develop new COVID-19 treatments.
Weakening IP protections for COVID-19 therapeutics would threaten not only innovation for medicines to treat COVID-19 but also innovation aimed at treating other diseases. Many COVID-19 therapeutics use ingredients and methods with additional applications, and 57% of COVID-19 treatments in the pipeline also are being developed for other conditions.
4. Expanding the TRIPS waiver would weaken American medical innovation and leadership, outsource American jobs and diminish our country’s ability to respond to future pandemics and health crises
Across the U.S. economy, the innovative biopharmaceutical sector supports more than 4.4 million jobs and fuels economic activity and exports, with biopharmaceutical goods exports exceeding $80 billion in 2021. Removing requirements for foreign countries to protect IP for COVID-19 treatments produced in the United States would jeopardize these jobs, reduce investment and leave us less prepared for future health crises. Further, any expansion of the TRIPS waiver poses significant threats to patient safety and supply chains and increases the risk of counterfeits.
5. Policymakers should focus on the evident issues impacting distribution and administration of COVID-19 vaccines and treatments.
Weak health systems, inadequate infrastructure and last-mile distribution and administration challenges, such as lack of cold storage, transportation and health care workers, are among the most important obstacles to accessing medicines in developing countries. These challenges have been exacerbated by regulatory delays, export restrictions and other trade-related barriers. Resolving these issues is the most effective way to ensure that COVID-19 vaccines and treatments can reach patients in need.
IP protections have never been a barrier in the fight against COVID-19. With more than enough COVID-19 vaccines and treatments for the world, it’s clear that IP rights have enabled the very collaborations necessary to deliver such innovation on a global scale. Policymakers should reject any efforts that undermine American innovation.