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At the direction of the U.S. Trade Representative, the U.S. International Trade Commission (USTIC) is investigating the impact of a proposed waiver of intellectual property (IP) protections for COVID-19 diagnostics and therapeutics under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). 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. 

Here is what pro-innovation and global health experts are saying: 

  • “The proposal to extend the World Trade Organization's current TRIPS waiver … is short-sighted and puts patients at risk. … [S]cientists succeeded at bringing COVID vaccines and therapeutics to patients in record time because of – not in spite of – strong and predictable intellectual property protections that reward innovation and create an incentive structure for drug companies to pursue future research and development.” – Andrew Spiegel, Esq., executive director, Global Colon Cancer Association

  • “The speed with which innovators responded to COVID speaks to the essential role of intellectual property rights. … A false narrative about patents [as a scapegoat to access] won the day, triggering the largest state-sponsored theft of intellectual property ever. It’s time to put this false narrative to bed.” – Marc Busch, Karl F. Landegger professor of international business diplomacy, Georgetown University

  • “The waiver stands in contrast to the agreement’s rule directing nondiscrimination of IP protections across technological fields. … The TRIPS waiver holds serious consequences for U.S. innovation leadership, economic and national security, and costing U.S. jobs in leading sectors of our innovation economy.”Mary Grealy, president, Healthcare Leadership Council

  • “As manufacturers work to address our most pressing challenges, robust IP protections will foster U.S. global technology leadership in emerging fields such as advanced healthcare, green technology, robotics and the digital economy.”Ken Monahan, vice president of international economic affairs, National Association of Manufacturers

  • “Waiving IP sets a terrible precedent, disrupts and disincentivizes innovation ecosystems, is a barrier to start-ups and SMEs generating capital, reduces R&D, results in fewer new uses and products, negatively impacts employment both within the pharmaceutical industry and the broader economy, and it does nothing to solve the real problems surrounding access to healthcare innovation in developing countries.”Stephen Ezell, director of global innovation policy, Information Technology & Innovation Foundation

  • “There can be no doubt that advancing this proposal will exacerbate risks to medical innovation – and future pandemic preparedness – while failing to address global medical access issues. … [S]trong IP systems – especially in the United States – incentivize the enormously expensive research, development, and global distribution of cutting-edge medicines. … IP protections conclusively did not pose a barrier to global COVID-19 vaccine access – rather, access disparities stemmed from severe supply chain roadblocks, international trade barriers, distribution challenges (particularly to underserved rural regions), and vaccine hesitancy. … [T]he waiver extension would continue a dangerous precedent … that jeopardizes biopharmaceutical innovation and patient access to new cures.” [Footnotes omitted] – Peter J. Pitts, president and co-founder, Center for Medicine in the Public Interest

  • “[T]he proposed waiver expansion would encourage the offshoring of pharmaceutical production, and therefore would have a direct, negative impact on the union workers who construct, retrofit, and maintain U.S. manufacturing facilities. ... Instead of allowing union jobs to be sent overseas, the Administration should prioritize U.S. workers by rejecting the proposed expansion of the TRIPS waiver.”Randy G. DeFrehn on behalf of the Pharmaceutical Industry Labor Management Association

  • “Handing over the recipe for COVID-19 treatments and diagnostics to other nations won't boost global public health. It will, however, punish the U.S. scientists, business, and workers who spearhead these life-saving breakthroughs. That’s especially true in Washington, where our state’s 1,100 life-science business and research organizations contribute over $30 billion in economic benefits annually and support more than 100,000 jobs.” Lori Punke, president, Washington Council on International Trade

IP protections have not been a barrier in the fight against COVID-19. There’s more than enough supply to vaccinate and treat the world. IP-enabled partnerships have helped to ensure product development and distribution, as well as find solutions to address access issues.  

Policymakers should reject any TRIPS waiver expansion and instead focus on administration and last-mile distribution challenges around the world. A strong IP ecosystem remains essential for American innovation leadership, economic development and preparedness for future pandemics. 

Megan Van Etten

Megan Van Etten is Vice President of Public Affairs. She is responsible for leading the association’s public affairs efforts on international issues, including trade, intellectual property and access to medicines. Prior to joining PhRMA, Megan was director of media and external communications at the U.S. Chamber of Commerce and communications director at the Beer Institute. She has also worked as a communications consultant for global public relations firms. When not at the office, Megan enjoys exploring new Washington, D.C. restaurants and traveling with her husband and friends.

Megan Van Etten

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What they are saying: Experts reinforce that TRIPS waiver expansion is harmful and unnecessary

Intellectual Property

Vaccines

Coronavirus

TRIPS Waiver

What they are saying: Experts reinforce that TRIPS waiver expansion is harmful and unnecessary

April 13, 2023

What they are saying: Experts reinforce that TRIPS waiver expansion is harmful and unnecessary

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