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Biden administration to waive intellectual property protections for COVID-19 vaccines

The policy would suspend the IP rights of manufacturers, enabling developing countries to manufacture their own vaccines.

Jeff Lagasse, Editor

(Photo by Doug Mils-pool/Getty Images)

President Joe Biden's administration this week said it will support the waiver of intellectual property protections for COVID-19 vaccines, allowing developing nations to produce vaccines created by pharmaceutical companies in an effort to further limit the spread of the coronavirus.

Despite objections from the pharmaceutical industry, U.S. trade representative Katherine Tai said the U.S. supports the proposal and would actively participate in negotiations at the World Trade Organization, which is currently considering the proposal. 

The policy, in effect, would suspend the IP rights of vaccine manufacturers, thereby enabling companies in developing countries to manufacture their own versions of COVID-19 vaccines. Activists and lawmakers have said that waiving COVID-19 patent protection would expedite global vaccine production, said Tai -- which would be a boon to areas such as India and South America, which have been slammed with new cases in recent weeks.

While reiterating the Biden Administration's broader support of IP rights, Tai said in a letter Wednesday that negotiations with the WTO will take time given the complexity of the matter, and the fact that decisions at that level are made by consensus.

"The administration's aim is to get as many safe and effective vaccines to as many people as fast as possible," said Tai. "As our vaccine supply for the American people is secured, the administration will continue to ramp up its efforts -- working with the private sector and all possible partners -- to expand vaccine manufacturing and distribution. It will also work to increase the raw materials needed to produce those vaccines."

In India, it was recently reported that fewer than 2% of the population had been vaccinated, while globally, new COVID-19 cases are surging, particularly in poor and middle-income countries, according to The Wall Street Journal.

WHAT'S THE IMPACT?

As expected, the announcement prompted pushback from the pharmaceutical industry. Pharmaceutical Research and Manufacturers of America president and CEO Stephen J. Ubl said Wednesday that the move would undermine the global response to the pandemic and compromise safety. 

"This decision will sow confusion between public and private partners, further weaken already strained supply chains, and foster the proliferation of counterfeit vaccines," Ubl said.

Arguing that the change in policy would not save lives, he said removing IP protections would effectively hand over American innovations to countries who may be looking to undermine U.S. leadership in biomedical discovery. It would be better, he said, to focus on last-mile distribution of vaccines and the limited availability of raw materials.

"In the past few days alone, we've seen more American vaccine exports, increased production targets from manufacturers, new commitments to COVAX and unprecedented aid for India during its devastating COVID-19 surge," said Ubl.

"Biopharmaceutical manufacturers are fully committed to providing global access to COVID-19 vaccines, and they are collaborating at a scale that was previously unimaginable, including more than 200 manufacturing and other partnerships to date. 

"The biopharmaceutical industry shares the goal to get as many people vaccinated as quickly as possible, and we hope we can all refocus on that shared objective."

European Union Commission President Ursula von der Leyen said in a video address that the E.U., whose constituent nations all have votes in WTC policy, will consider the U.S. proposal, but have so far not committed to a specific course of action.

"We are ready to discuss how the U.S. proposal for waiver on intellectual property protection for COVID vaccines could help" she said. "In the short run, however, we call upon all vaccine producing countries to allow exports and to avoid measures that disrupt supply chains."

THE LARGER TREND

Nationally, vaccination efforts are trending in the right direction. As of April 15, the seven-day average number of COVID-19 vaccinations administered daily reached 3.3 million, a 10.3% increase from the previous week's average, according to data from the Centers for Disease Control and Prevention.

That translates to about 198.3 million total vaccine doses administered. Overall, almost 126 million Americans (37.9% of the U.S. population) have received at least one dose, while roughly 78.5 million (23.6%) have received two doses.

Yet vaccine hesitancy among many Americans is on the rise and threatening the goal of herd immunity, in which a critical mass of the population becomes inoculated and slows the spread of pathogens.

The vaccine push received a jolt last week as Walgreens announced it will activate multiple mobile clinics in Chicago. The traveling mobile clinics will focus on bringing COVID-19 vaccines directly to underserved communities and those with barriers to accessing the vaccine.

Over the next two months, additional mobile clinics will make stops in a number of locations across the country.

Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com