PITTS: The Biden Admin Is Poised To Kill US Medical Innovation

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Peter Pitts Contributor
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The Biden administration is considering a World Trade Organization proposal to waive crucial intellectual property protections for Covid-19 treatments and tests. 

Allowing the IP waiver to move forward risks extinguishing life-saving medical innovation happening across the nation and the world. It’s time for President Biden to kill the misguided plan once and for all. 

The proposal relates to the WTO’s “TRIPS” agreement, which provides global protection for patents, trademarks, copyrights, and other exclusive rights behind many of the central features of modern life — from medications and textiles to audio recordings and integrated circuits. 

The TRIPS agreement, a pact made between the United States and 163 other countries, ensures that no one around the globe can copy inventors’ exclusive discoveries without permission. Its the same respect for IP that has undergirded the U.S. innovation system from our countrys founding and helped us become an economic powerhouse. 

The TRIPS agreement functioned just fine from its start in 1995 until June of 2022. That’s when the WTO, with the Biden administration’s consent, waived the TRIPS agreement for COVID-19 vaccines. Proponents of the waiver claimed it was necessary to increase vaccine access in developing countries. 

The truth is that patent protections have nothing to do with low vaccination rates in developing countries. The truth is that barriers to widespread vaccination were logistical, including poor transportation, lack of storage infrastructure, and shortages of medical facilities and personnel. In 2021, the Democratic Republic of Congo returned 1.3 million COVID vaccine doses because it didn’t expect to administer them before they expired. Global vaccine hesitancy was another obstacle. If people refuse to take the shot, it doesn’t matter how many you ship. 

In other words, a TRIPS waiver for vaccines wasn’t just a bad prescription, it was a false promise. Yet, never satisfied with doubling down on a bad idea, opponents of intellectual property kept pushing to extend the waiver even further, to include COVID-19 diagnostics and therapeutics. 

Whether or not to back an extended IP waiver is the decision the White House now faces. The WTO has put a decision on that extension off twice now. In the interim, the Biden administration has asked the U.S. International Trade Commission, a nonpartisan agency, to conduct a “fact finding investigation” on the merits of a waiver extension before the U.S. government decides whether to support or oppose it.

The final USITC report, released in the fall, offered no serious evidence of a need to waive patents for treatments and tests. It is common sense, considering the pandemic is behind us and demand for diagnostics and therapeutics has plummeted. 

The Biden administration ignored the best available evidence when it supported the TRIPS waiver for vaccines, so it’s plausible that, despite facts to the contrary, U.S. officials will decide to support a patent waiver for diagnostics and therapeutics at the WTO’s next meeting. If they do, medical innovation will be in grave jeopardy. A pandemic of stupidity.

The research and development behind cutting-edge cures, not to mention the work that goes into distributing them globally, is enormously time-consuming and expensive. It takes on average about 10 years and upwards of $3 billion in private-sector funds to take a drug from the initial breakthrough phase to final FDA approval. Many failures occur along the way. Only about 10 percent of drug candidates make it through clinical trials.

Investors are willing to take that risk because they know if they manage to back a winner, the IP protections guaranteed under TRIPS mean theyll have a chance to recoup their investment from global sales. Why on earth would we want to destroy this crucial incentive?

The current waiver is already sending a dangerous signal to drug companies and private investors: if you rise to meet the next public health crisis, prepare to be robbed at the WTO with the help of your own government. 

Doubling down on that message would be wildly unnecessary. It would also be a nail in the coffin of U.S. medical innovation as we know it. The Biden administration must oppose any extension of the TRIPS waiver.

Peter Pitts is a former associate commissioner of the Food and Drug Administration and President of the Center for Medicine in the Public Interest.

The views and opinions expressed in this commentary are those of the author and do not reflect the official position of the Daily Caller.