Sec. 2. Findings
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Congress finds the following: Section 8 of article I of the United States Constitution provides Congress with authority over international trade. Congress has used that authority to approve a number of trade agreements, including the WTO Agreement. Section 8 of article I of the United States Constitution provides Congress with authority to provide intellectual property protections in order to promote the progress of science and useful arts . People in the United States rely on those protections to support jobs and continue the highly successful leadership of the United States with respect to innovation.
The United States may not withdraw or otherwise alter the rights and obligations for the United States arising from a congressionally approved trade agreement without the consent of Congress. The United States is a global leader in containing and ending the COVID–19 pandemic. Innovators in the United States successfully and rapidly brought to fruition vaccines that provide highly effective protection against COVID–19. At facilities across the United States, thousands of United States workers are working around the clock to manufacture COVID–19 vaccines, contributing to the rapid, global scale up of manufacturing that is expected to reach at least 10,000,000,000 doses by the end of 2021.
The United States is a founding member of the World Trade Organization. The United States has secured and supported critical commitments in the WTO for protection of intellectual property of United States persons and globally, including under the Trade-Related Aspects of Intellectual Property Rights Agreement or the TRIPS Agreement. In implementing the Uruguay Round, Congress established under section 315 of the Uruguay Round Agreements Act ( 19 U.S.C. 3581 ) that it is the objective of the United States to accelerate the implementation of the TRIPS Agreement and to seek enactment and effective implementation by foreign countries of laws to protect and enforce intellectual property rights that supplement and strengthen the standards of the TRIPS Agreement.
Longstanding intellectual property protections are critical to efforts by the United States and the biopharmaceutical industry to develop and manufacture vaccines for both people in the United States and around the world. The United States is committed to providing global access to COVID–19 vaccines. In order to accelerate production and distribution of COVID–19 vaccines, biopharmaceutical manufacturers in the United States are collaborating at a scale that previously was unimaginable, including by entering into hundreds of voluntary manufacturing, production, and other partnerships around the world.
Manufacturing each of the COVID–19 vaccines involves highly specialized and unique infrastructure and equipment, as well as highly trained and experienced personnel. Manufacturing and distributing safe and effective COVID–19 vaccines on a global scale is incredibly challenging. Many experts on vaccine production and distribution are warning that waiving intellectual property protections will undermine the global response to the COVID–19 pandemic and compromise vaccine safety, including by disrupting the distribution of scarce raw materials for vaccines that existing vaccine makers with proven track records for delivering high-quality, safe, and effective vaccines need to continue their own production.
The United States Trade Representative announced without any consultation with Congress that the United States will support a waiver of intellectual property protections under the TRIPS Agreement for COVID–19 vaccines. That decision is not consistent with the intellectual property negotiating objectives of the United States set forth in section 315 of the Uruguay Round Agreements Act ( 19 U.S.C. 3581 ). That waiver announcement created confusion, and raised concerns that a successful effort to suspend protections will weaken already strained supply chains and foster the proliferation of ineffective and potentially dangerous vaccines.
The Trade Representative has not explained how a waiver of the TRIPS Agreement will expand vaccine production and access, particularly considering that the major impediments to vaccination efforts include the following: The difficulty in meeting the technical specifications of production and appropriately ensuring that finished vaccines are high-quality, safe, and effective. The scarcity of raw materials for the vaccines. Last-mile distribution and cold-chain storage. Trade barriers to the free flow of inputs and finished products.
The Government of the People's Republic of China and the Government of the Russian Federation are engaged in large scale industrial espionage and technology theft of intellectual property of United States persons. The Department of Justice has issued indictments in connection with attempts sponsored by the Government of the People's Republic of China to steal United States vaccine research with respect to COVID–19. The Government of the People's Republic of China and the Government of the Russian Federation are using their vaccines as part of diplomatic efforts that may be contrary to the national security interests of the United States.
Vaccines for COVID–19 manufactured by persons in the People's Republic of China and the Russian Federation appear to be less efficacious than those manufactured by producers in the United States. The Academy of Military Science, the scientific arm of the military of the People's Republic of China, is sponsoring the principal effort by the People's Republic of China to develop its own mRNA vaccine. At a hearing before the Committee on Finance of the Senate on May 12, 2021, the Trade Representative would not commit either— to ensure that any waiver of the TRIPS Agreement would exclude the People's Republic of China and the Russian Federation; or to ensure that Congress has advance access to the negotiating proposals of the United States for any such waiver.
The innovative biopharmaceutical companies in the United States contribute more than $1,100,000,000,000 annually to the United States economy, and employ more than 500,000 workers making 1.4 times the average earnings in the United States, including 153,000 workers who do not have a college degree. Waiving intellectual property protections, particularly of the mRNA technology platform in which the Defense Advanced Research Project Agency invested not less than $250,000,000, raises serious economic and national security concerns.
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