Some lawmakers are calling on the Biden administration to suspend patent protections on COVID-19 vaccines to help boost supply in other countries. And last week, they took a shot at pitching the idea to White House officials.
After House Speaker Nancy Pelosi sent a request to review proposals for breaking COVID-19 drug and vaccine patents, the White House held a meeting last week, CNBC reports, citing people familiar with the situation.
The prevailing view among supporters is that “we’re not safe until the world is safe," one source told CNBC. The United States has administered more than 143 million coronavirus vaccine doses, while some countries have yet to start vaccinations.
The lawmakers aren't the only ones questioning the effect of COVID-19 drug and vaccine patents on global supply. The talks come as Moderna faces renewed pressure to share its shot, and last month, Doctors Without Borders urged wealthy countries not to oppose a proposed intellectual property waiver at the World Trade Organization that would allow countries to ignore patents until the world reaches herd immunity.
Meanwhile, companies such as AstraZeneca and Novavax have inked large deals to allow their vaccine doses to make their way to countries worldwide.
It’s unclear whether the Biden team will move forward, and plenty of questions remain. For one, it’s not clear how the U.S. would boost access elsewhere simply by suspending intellectual property protections on COVID-19 drugs and vaccines. Some influential experts argue that seizing patents isn’t a realistic solution.
A spokesman for the Office of the U.S. Trade Representative told CNBC the agency is “evaluating the efficacy of this specific proposal by its true potential to save lives."
In a Wall Street Journal op-ed, former FDA commissioner Scott Gottlieb noted that manufacturing COVID-19 vaccines is complex and requires materials that are in very high demand.
“Allowing other manufacturers to appropriate the intellectual property wouldn’t increase the supply of the starting ingredients,” Gottlieb wrote. “It will make it harder for the current drugmakers to produce these vaccines.”
Under the proposal, worldwide COVID-19 vaccine production would decline, not increase, Gottlieb argued.
Instead, he recommends the Biden team look to the George W. Bush administration's AIDS response. Under the President’s Emergency Plan for AIDS Relief, or Pepfar, the U.S. government teamed with drugmakers to purchase and distribute trusted AIDS drugs in Africa, Gottlieb wrote.
In response to the global COVID-19 crisis, the government could boost manufacturing capacity by helping to produce raw materials and purchasing specialized equipment, Gottlieb wrote. Then, the U.S. could support donations of high-quality vaccines in low- and middle-income countries.
Aside from the practical concerns are legal questions. In a November op-ed in The Hill, law professor Sean M. O’Connor wrote that patent-breaking proposals “fatally misconstrue the law.” O’Connor, who serves as executive director of the Center for the Protection of Intellectual Property at George Mason University, was writing at the time about calls to seize patents on Gilead's COVID-19 antiviral Veklury.
Still, he argued the Biden administration would “do well to listen to experienced voices in drug development ... rather than follow these mistaken calls for seizing, breaking or bypassing drug patents.”
For many months as the pandemic has played out, patient advocates have focused on Moderna’s intellectual property because the U.S. government was a key research partner. In a letter last week, Public Citizen, AIDS group PrEP4All and others called on the government to leverage its power on a soon-to-be-issued patent to help scale up global supply for the vaccine.
Their proposal is different from simply bypassing drug company patents. Because Moderna’s vaccine uses technology in the U.S. government patent, the advocates are calling on the government to license its tech to Moderna. Under that license, the government could require “provisions to help increase global access” rather than just a royalty.
“This government-owned patent is an important policy tool that the U.S. government could use to facilitate scale up of production of mRNA-1273 and ensure rapid, equitable global access,” the group wrote.
Under the license, the government could bring more manufacturing partners on board and require tech sharing with the World Health Organization to boost capacity, the group wrote. The government could also require universal pricing.