The Biden Administration should follow the facts: Undermining IP rights will deter innovation, harm patients and leave the world vulnerable to future global health challenges.

PhRMA's final written submission to the U.S. International Trade Commission's (USITC)Section 332 investigation titled "COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities."

Public submissions to the USITC from experts across patient groups, academia, public health, labor and the private sector make clear that, much like the original TRIPS waiver for COVID-19 vaccines, the proposed expansion of the waiver to diagnostics and therapeutics is harmful and unnecessary.

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.

PhRMA Vice President for International Policy Kevin Haninger prepared an oral statement for the March 30, 2023 U.S. International Trade Commission (USITC) hearing concerning its Section 332 investigation titled “COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities.”

It is no coincidence that the United States has developed leading COVID-19 treatments.

Expanding the TRIPS waiver to COVID-19 treatments and diagnostics would compromise global public health.

Expansion of the TRIPS waiver would jeopardize the 97% of medicines in development for COVID-19 that have yet to be launched.

Any expansion of the TRIPS waiver would damage the global innovation ecosystem, stifle American innovation and undermine the more than 140 partnerships expanding access to COVID-19 treatments today.

World Trade Organization (WTO) members are considering waiving commitments to honor certain intellectual property (IP) rights on COVID-19 treatments, following a harmful and unnecessary decision to do the same for COVID-19 vaccines. This is referred to as the TRIPS waiver. Any expansion of the TRIPS waiver would: 1.) Compromise global public health and harm patients; 2.) Cede American IP to foreign countries, sending research and manufacturing jobs overseas; 3.) Undercut American innovation and jeopardize our ability to respond to future pandemics; and 4.) Harm global collaboration and undermine U.S. leadership in the biopharmaceutical sector. Biopharmaceutical manufacturers are already sharing their IP and remain committed to providing timely global access to safe and effective COVID-19 vaccines and treatments.

Waiving commitments to protect intellectual property (IP) rights on COVID-19 technologies is unnecessary and harmful, with medicine supply far exceeding global demand. Any expansion of the TRIPS waiver would outsource America’s manufacturing jobs, weaken our biopharmaceutical leadership and undercut medical innovation. Learn more in the full report.

Policymakers should reject any expansion of the TRIPS waiver and focus on last-mile distribution and administration challenges around the world to make a real impact.

The Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubl released the following statement on the announcement that a TRIPS waiver was agreed to for COVID-19 technologies.

TRIPS laid the foundation for the policy environment that has propelled the world’s technological advancement over the last three decades.

Across the industry, biopharmaceutical companies are working around the clock to meet the demands of COVID-19 vaccine manufacturing. Even prior to knowing the efficacy of particular vaccine candidates, companies have proactively been increasing their own manufacturing capabilities as well as partnering with other manufacturers who are sharing available capacity to support production. These partnerships have been key to manufacturing ramp-up following vaccine authorization.

Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl made the following statement after the United States Trade Representative expressed support for a proposal to waive patent protections for COVID-19 medicines.

PhRMA sent a letter to President Biden on March 5, 2021, signed by 31 PhRMA board members, welcoming his Administration’s focus on the pandemic, underscoring the unprecedented collaboration underway and warning that undermining intellectual property would impede our collective response to COVID-19 and emerging variants.