Biden Administration details inadequate protection of American intellectual property and foreign barriers to innovation abroad

More than two years into the COVID-19 pandemic, the world has witnessed the immense value of biopharmaceutical innovation. With numerous safe and effective vaccines and treatments developed in record time, PhRMA member companies are facilitating an unprecedented response to the pandemic. It took years of investment, collaboration across companies and borders, and the right public policies to encourage the risk-taking and research and development necessary to deliver the new treatments and vaccines.

Unfortunately, as two recent reports from the office of the U.S. Trade Representative (USTR) lay out, many countries fall short of the right policy environment for innovation and patient access.

In its recent 2022 Special 301 Report, USTR identified markets that deny adequate and effective intellectual property (IP) protection or fair and equitable market access to American industries that rely on IP protection. Urgent action is required to address the serious IP and market access barriers to discovering and bringing new treatments and cures to patients around the world. As PhRMA detailed in its submission to USTR on the Special 301 Report, it is necessary to address damaging IP policies in Brazil, China, Europe Union, Indonesia and Saudi Arabia and discriminatory medicine pricing policies in Canada, Japan and Korea.

The 2022 Special 301 Report follows USTR’s 2022 National Trade Estimate Report, released in March, showing significant foreign barriers to trade in dozens of markets and industries, including biopharmaceuticals. The U.S. government should use all available tools to address these important concerns for American manufacturers and workers.

At the same time, the Biden Administration should pursue policies that uphold America’s innovation leadership and do not authorize or incentivize foreign governments to weaken protection of American IP. Despite clear evidence that IP rights have not been a barrier to COVID-19 vaccine access, but rather have enabled the very collaborations necessary to produce vaccines on a global scale, the 2022 Special 301 Report reaffirms that the Biden Administration “supports a waiver of intellectual property protections for COVID-19 vaccines.” This policy position constitutes a reversal of longstanding U.S. policy under both Democratic and Republican administrations concerning the protection of American IP rights. It is being pursued despite the reality that the remaining barriers are last-mile distribution and administration.

As Seth Berkley, CEO of the Global Alliance for Vaccines and Immunization said this week, “global [COVID-19 vaccine] supply has ramped up and access to doses is no longer the issue…patents have not been the blocking factor here.” UNICEF’s head of advocacy, Lily Caprani, even said that the IP waiver “is probably neither necessary nor sufficient” to address the remaining barriers to vaccination, including distribution, health care capacity and vaccine hesitancy.

Harmful policies abroad, and misguided multilateral attacks like the proposed waiver of international IP commitments, threaten the 4.5 million American jobs and $1.4 trillion in economic output supported by the U.S. biopharmaceutical industry and patient access to the latest treatments and cures. Biopharmaceutical companies will continue working to deliver innovative medicines – for COVID-19 and other harmful diseases – to patients around the world.

To view PhRMA’s complete 2022 Special 301 submission, please click here. PhRMA’s 2022 NTE submission can be found here.