not used title
not used title
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.
Kevin Haninger
Kevin Haninger is Senior Vice President of International Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA), where he manages market access, intellectual property, trade and global health policy advocacy in key markets. Prior to joining PhRMA, Kevin was Senior Economist in the Office of the Secretary at the U.S. Department of Health and Human Services. Kevin received an undergraduate degree with distinction from Stanford University and a Ph.D. from Harvard University.
Kevin Haninger
Bayh-Dole: The fuel for America’s innovation engine
September 2, 2026
Why smart vaccine policy matters
August 3, 2026
New study: HPV vaccination helps prevent cervical cancer deaths
July 21, 2026
Setting the record straight: 3 facts about drug patents
July 13, 2026
New PBM principles don't change the fundamental challenge: Access to lower-cost medicines
July 10, 2026
MFN could disrupt the affordable medicines patients depend on
June 18, 2026
Intellectual Property and Hatch-Waxman: A blueprint for American leadership and patient savings
June 2, 2026
New research reinforces the importance of hepatitis B vaccination at birth
May 21, 2026
World Immunization Week: Putting preventable diseases in the past
April 24, 2026
ICYMI: Measles resurgence could cost U.S. nearly $8 billion over five years
April 15, 2026
Argentina sets course to enable innovation by rejecting failed patent rules
March 26, 2026
16 years later: How BPCIA continues to expand competition and lower costs
March 23, 2026
Key context is often missing from the debate over the Patent Trial and Appeal Board
March 20, 2026
MFN undermines U.S. biopharmaceutical innovation
February 25, 2026
Why shifting childhood vaccines to “shared clinical decision-making” puts kids at risk
February 23, 2026
Updated Analysis Underscores the Need for Brazil to Address Patent Backlogs
February 2, 2026
Changes to America’s childhood vaccine schedule fail to protect our nation's kids
January 13, 2026
How post-approval innovation keeps delivering for patients
December 9, 2025
PhRMA calls on USTR to ensure foreign nations pay their fair share
November 4, 2025
New study: Measles setbacks harm health and America’s economy
October 28, 2025
Why the hepatitis B vaccine matters
October 21, 2025
Three things to know about Bayh-Dole: Innovation that pays off for taxpayers
October 9, 2025
Vaccines and autism: Decades of scientific evidence find no link
September 22, 2025
Delivering breakthroughs and lower costs for patients
September 8, 2025
Why the vaccine injury program matters
August 18, 2025
Recognizing the importance of vaccination for American health and security
August 4, 2025
PBMs, not patents, are blocking access to lower-cost medicines
July 23, 2025
Answering common questions on mRNA technology
July 17, 2025
New report: How intellectual property drives U.S. innovation and biopharma's impact
June 30, 2025
What to know about vaccine ingredients: Aluminum and thimerosal
June 24, 2025
New report: Post-approval innovation delivers substantial patient benefits
June 2, 2025
The biopharmaceutical industry is one of the highest contributors to America’s economy among all manufacturers
April 30, 2025
USTR 2025 Special 301 Report corrects course
April 29, 2025
World Immunization Week: Highlighting the importance of vaccines for public health
April 28, 2025
From sound to science: How IP powers innovation in music and hearing
April 25, 2025
How the IRA is impacting the generic drug market
April 8, 2025
3 myths critics get wrong about intellectual property
March 28, 2025
ICYMI: PhRMA submits comments to White House on artificial intelligence
March 17, 2025
What you need to know: Measles and the MMR vaccine
March 10, 2025
Improved treatments continue to lead to declining cancer mortality rates in the U.S.
February 25, 2025
Preventing and fighting disease: A look at the biopharmaceutical progress made for patients in 2024
February 3, 2025
Recognizing the value of disease prevention with Dr. Len Friedland from GSK
December 12, 2024
Leveraging the power of vaccines to prevent antimicrobial resistance
October 31, 2024
From the emergency department to the CDC Advisory Committee: Key takeaways from ACIP’s recent meeting
October 30, 2024
The Patient Perspective: Vaccines
October 23, 2024
PhRMA submission calls for USTR to correct course on trade policy, enforcement
October 18, 2024
40 Years of Hatch-Waxman: How Can We Secure its Legacy?
September 24, 2024
40 Years of Hatch-Waxman: How does the Hatch-Waxman Act help patients?
September 23, 2024
40 Years of Hatch-Waxman: What is the Hatch-Waxman Act?
September 19, 2024
New research: American biopharmaceutical investment in R&D drives transformational innovation
September 16, 2024
Biden Administration report debunks myths around patent “evergreening” and “thickets”
September 3, 2024
How to protect your children’s health this school year
August 22, 2024
What to know about the latest effort to break patents using a legally dubious avenue
August 21, 2024
WTAS: Proposed Unsubstantiated USPTO Rule Change is a Threat to American Innovation
August 12, 2024
New Report: Vaccines continue to drive improved health outcomes
July 16, 2024
Showcasing the promise of biopharma at ASCO 2024
June 28, 2024
PhRMA launches education campaign on the benefits of America's IP system
June 26, 2024
ICYMI: Innovation transforms lives but misguided federal policies threaten patient outcomes
May 30, 2024
Experts discuss the value of IP at Senate Judiciary Committee hearing
May 28, 2024
World Trade Week 2024: Time for a more ambitious U.S. trade agenda
May 23, 2024
World IP Day 2024: Supporting an innovative and sustainable future
April 26, 2024
World Vaccine Congress: Building on vaccine success
April 1, 2024
International meetings hold big implications for Americans and our innovation ecosystem
February 26, 2024
Proposed march-in framework would chill American innovation
February 7, 2024
PhRMA 2024 Special 301 submission: USTR needs to support American innovation, global access to medicines
January 31, 2024
Powering the next generation of therapies: A conversation with Astellas US President Mark Reisenauer
January 30, 2024
New poll: Americans agree that expanding the TRIPS waiver will harm U.S. global manufacturing and innovation leadership
January 29, 2024
What they are saying: Experts agree that proposed march-in framework would jeopardize innovation
January 25, 2024
The Biopharmaceutical Industry Still Needs Clarity from the FDA on Orange Book Listings
December 19, 2023
The White House continues to attack American innovation
December 15, 2023
Biden Administration’s Indo Pacific trade dialogue is a missed opportunity to bolster American exports, innovation
November 29, 2023
Misuse of march-in could stifle innovation
November 27, 2023
WHO Pandemic Agreement offers opportunities and risks for American innovators
November 20, 2023
New Report: 1,600 cancer treatments and vaccines in clinical development
November 9, 2023
Word of the Month: The Bayh-Dole Act
November 8, 2023
PhRMA submission: USTR needs more ambition to combat unfair trade barriers
October 24, 2023
What you should know about protecting your health this fall
October 16, 2023
It’s PBMs, not patents, blocking competition
September 14, 2023
What you need to know: COVID-19 public health emergency is over, but ideological attacks on IP remain
September 12, 2023
WTAS on reasonable pricing and public-private partnerships
August 8, 2023
Key considerations as Congress works towards PAHPA reauthorization
July 12, 2023
A conversation with Dr. Mike Ybarra on the current state of COVID-19
June 27, 2023
Reject efforts to undermine America’s R&D ecosystem
June 15, 2023
Four ways that America’s biopharmaceutical industry supports jobs and fuels economic growth
May 18, 2023
Setting the record straight on the Bayh-Dole Act and March-in
May 10, 2023
World IP Day 2023: Celebrating women leaders in innovation
April 26, 2023
What they are saying: Experts reinforce that TRIPS waiver expansion is harmful and unnecessary
April 13, 2023
New global analysis shows patient access challenges around the world
April 12, 2023
Celebrating the success of the COVID-19 vaccines, and looking to the future
March 27, 2023
PhRMA submits comments to OSTP on enhancing clinical trial diversity
March 21, 2023
U.S. biopharmaceutical exports support jobs, innovation
March 20, 2023
What we’ve learned from three years of fighting COVID-19
March 20, 2023
Will the administration capitalize on the Indo-Pacific Economic Framework to drive medical innovation?
March 13, 2023
PhRMA submits comments to USPTO highlighting important role of patent system in medicine development
February 23, 2023
U.S. must address IP and market access barriers abroad to protect American innovation
January 31, 2023
Biden administration should prioritize innovation in U.S.-Taiwan Initiative on 21st-Century Trade
January 17, 2023
Word of the Month: What is TRIPS?
November 29, 2022
Expanding TRIPS waiver would jeopardize biopharmaceutical research and development
November 17, 2022
Six ways I-MAK is lying about biopharma patents
November 16, 2022
What you should know about RSV
November 15, 2022
TRIPS waiver expansion risks public health
November 14, 2022
Expanding the WTO intellectual property waiver will hurt American jobs
November 9, 2022
PhRMA submission to USTR calls for urgent defense of American innovation abroad
November 1, 2022
The law driving technology transfer and fostering innovation
October 24, 2022
Word of the Month: Long COVID
October 19, 2022
Don’t take anti-innovation, activist funded academics at their word
October 18, 2022
Protecting against influenza: A conversation with David Ross, Vice President, Commercial Operations, North America, CSL Seqirus
October 13, 2022
New report ignores benefits of patent system to innovation and patients
September 30, 2022
Partnerships are driving global COVID-19 treatment access
September 22, 2022
The dangers of expanding the TRIPS waiver
September 19, 2022
ICYMI: New research builds upon growing body of evidence on value of COVID-19 treatments and vaccines
August 16, 2022
Patent policy changes proposed by USPTO and FDA would leave patients behind
July 22, 2022
ICYMI: PhRMA’s Ubl pens op-ed on IP waiver for COVID-19 technologies
July 15, 2022
Increase in drug-resistant superbugs during COVID-19 highlights need for policy reforms to address antimicrobial resistance
July 14, 2022
COVID-19 vaccines and treatments helped save millions of lives and billions in health care costs
July 7, 2022
ICYMI: Antimicrobial resistance spotlighted as growing public health threat
July 6, 2022
Intellectual Property waiver on COVID-19 innovation is unnecessary and harmful
May 23, 2022
ICYMI: PhRMA CEO Stephen J. Ubl spotlights lessons learned during COVID-19
May 13, 2022
ICYMI: PhRMA COO Lori Reilly spotlights efforts to improve health care in 2022 and beyond
May 9, 2022
A conversation with Barry Greene, CEO of Sage Therapeutics
May 4, 2022
Biden Administration details inadequate protection of American intellectual property and foreign barriers to innovation abroad
April 29, 2022
ICYMI: New resource catalogs biopharmaceutical industry lessons learned from COVID-19
April 28, 2022
PhRMA encourages Biden administration to pursue ambitious Indo-Pacific Economic Framework
April 13, 2022
New Data: COVID-19 vaccine global production capacity projected to exceed 20 billion doses this year
February 24, 2022
What you need to know about newly authorized COVID-19 antiviral treatments
February 22, 2022
Guest post: Joining forces to combat the COVID-19 mental health crisis
February 17, 2022
Guest Blog: COVID-19 vaccines are the key to keeping kids healthy
February 16, 2022
Research and development continues long after a medicine is initially approved
February 1, 2022
Protecting U.S. innovation abroad to support economic and pandemic recovery
February 1, 2022
ICYMI: New report demonstrates growing global impact of antimicrobial resistance
January 24, 2022
Legislation threatens patent protections and future innovation
January 12, 2022
Navigating the patient experience in the time of COVID-19
December 6, 2021
Global COVID-19 vaccination matters now and for the future
November 29, 2021
Understanding breakthrough COVID-19 infections
November 11, 2021
New report highlights importance of IP-intensive manufacturing industries to the U.S. economy
November 1, 2021
PhRMA submission to 2022 National Trade Estimate Report underscores need for pro-innovation U.S. trade policy to combat COVID-19
October 29, 2021
The important role of antivirals in the fight against COVID-19
October 6, 2021
Understanding Long COVID-19
September 29, 2021
A year and a half later: The biopharmaceutical industry remains committed to beating COVID-19
September 8, 2021
Patients and innovators lose if the government pursues ‘march-in’
September 7, 2021
The impact of monoclonal antibodies and COVID-19 recovery
September 2, 2021
Recognizing National Immunization Awareness Month
August 31, 2021
Driving further innovation is critical to global vaccine equity
August 24, 2021
Supporting country readiness to boost global vaccine access
August 12, 2021
Ensuring global vaccine equity requires eliminating trade and regulatory barriers
August 5, 2021
Setting the record straight: Addressing common misconceptions about the COVID-19 vaccine
August 4, 2021
Increasing global access to vaccines by optimizing production
July 29, 2021
Guest post: Retired medics return to the field to take on vaccine delivery and disaster relief
July 23, 2021
Guest Post: A patient’s story of the long-term health impacts of COVID-19
July 21, 2021
Dose sharing as a part of the COVID-19 global vaccine equity strategy
July 20, 2021
Promoting global vaccine equity while protecting innovation
July 15, 2021
Data shows COVID-19 vaccines are creating a pathway to a strong U.S. recovery
July 2, 2021
PhRMA awards $75,000 to fund initiatives to reduce health inequities
July 1, 2021
More than 800 medicines are in development for diseases that disproportionately affect racial and ethnic communities
June 22, 2021
Americans 12 years of age and older are eligible for COVID-19 vaccines
June 17, 2021
PhRMA hosts first stakeholder workshop on clinical trial diversity
June 11, 2021
Coming together to fight COVID-19: A conversation with Barry Greene, CEO of Sage Therapeutics
June 9, 2021
A year later: Reflections on the meaning of equity
May 25, 2021
ICYMI: PhRMA president and CEO Stephen J. Ubl joins other industry leaders for a conversation on COVID-19 vaccines with Axios
May 21, 2021
Supporting India during the devastating coronavirus surge
May 20, 2021
New polling shows Americans are sounding the alarm on the TRIPS IP waiver
May 14, 2021
The Biden Administration allows politics to upend a pragmatic pandemic response
May 14, 2021
New report demonstrates development of new medicines relies on private sector expertise and investment
May 10, 2021
PhRMA CAREs Grant request for proposals: Addressing inequities in access to COVID-19 testing, therapeutics and vaccines
May 6, 2021
Ron Busby, Sr., President and CEO of the U.S. Black Chambers, Inc. on improving vaccine confidence in community
May 5, 2021
Reflecting on Mental Health Awareness Month
May 4, 2021
American leadership on innovation policy is essential to global health progress
May 4, 2021
Patient safety is at the heart of COVID-19 vaccine R&D
April 26, 2021
Data shows that Americans are relying on vaccines to get us through the pandemic
April 22, 2021
ICYMI: New CBO Report highlights biopharmaceutical leadership in the development of new treatments and cures
April 12, 2021
Diversifying clinical trials and fighting disease requires equity and trust
April 12, 2021
Key excerpts: PhRMA submits comments to NIST in effort to safeguard intellectual property protections
April 9, 2021
Building confidence in the COVID-19 vaccine through education
March 22, 2021
ICYMI: WSJ showcases breakthrough science of COVID-19 vaccines and implications for future medicines
March 8, 2021
Intellectual property is the key to vaccine development, manufacturing and technology sharing
March 5, 2021
Coming together to fight COVID-19: A conversation with Paul Perreault, CEO and Managing Director of CSL
February 24, 2021
Fighting variants of COVID-19
February 22, 2021
ICYMI: Report provides actionable recommendations to strengthen America’s preparedness and future health crises response
February 22, 2021
Top five issues voters want addressed in the administration’s first 100 days
February 18, 2021
The latest: What they are saying: Intellectual property protections vital to COVID-19 research, development and manufacturing
February 12, 2021
Lessons learned from COVID-19: The way we develop new medicines is changing
February 10, 2021
Preserving U.S. innovation worldwide is more important than ever
January 29, 2021
Growing trend: Increased vaccine confidence
January 28, 2021
Election insights: Common ground areas to address Americans’ health care concerns
January 26, 2021
Paper finds gaps in health data are a barrier to health equity
January 11, 2021
New research shows hotspots of inequity relate to increased COVID-19 hospitalizations
January 8, 2021
American biopharmaceutical manufacturing: Fueling economic growth now and for years to come
December 21, 2020
Election insights: Voter priorities in the states
December 17, 2020
Strengthening a culture dedicated to patients and equity: A conversation with Percival Barretto-Ko, President of Astellas US
December 16, 2020
Insights from the election: Meeting voters where they are on health care
December 15, 2020
Coming together to fight COVID-19: A conversation with Kabir K. Nath, President & CEO of Otsuka North America Pharmaceutical Bu
December 9, 2020
Guest post: How COVID-19 underscores the importance of public confidence in vaccines
December 7, 2020
Guest Post: Bringing our best to the fight against COVID-19
December 3, 2020
An unprecedented year and the road ahead: A conversation with Giovanni Caforio, PhRMA Chairman and CEO of Bristol Myers Squibb
November 18, 2020
Deep dive: The issues that drove the 2020 vote
November 13, 2020
Understanding the emergency use authorization process for COVID-19 vaccines
November 12, 2020
New video: See how strong IP protections lead to stronger treatments for patients
November 9, 2020