WASHINGTON – President Biden is facing increasing pressure from the international community and his party's left flank to advocate increasing vaccine supplies by advocating the protection of patents and intellectual property for coronavirus as the Covid-19 crisis in India and South America grows -Vaccines loosens.
Pharmaceutical and biotech companies, which were also under pressure, tried on Monday to prevent such a move, which could detract from future profits and jeopardize their business model. Pfizer and Moderna, two major vaccine manufacturers, each announced steps to expand the supply of vaccines around the world.
The issue came to a head when the General Council of the World Trade Organization, one of its highest decision-making bodies, met on Wednesday and Thursday. India and South Africa are pushing for the panel to renounce an international intellectual property agreement protecting the trade secrets of pharmaceuticals. The United States, Britain and the European Union have so far blocked the plan.
In the White House, the president's health advisors admit they're divided. Some say Mr. Biden has a moral imperative to act and that it is bad policy for the president to side with the pharmaceutical executives. Others say spilling closely guarded but highly complex trade secrets would do nothing to expand the global vaccine supply.
Having the prescription for a vaccine doesn't mean a drug company could make it, especially not quickly, and opponents argue that such a move would harm innovation and entrepreneurship – and harm America's pharmaceutical industry. Instead, it is said, Mr. Biden can address global needs in other ways, such as by urging companies that own patents to donate large quantities of vaccine or sell it at cost.
"That would be a terrible precedent for the industry," said Geoffrey Porges, an analyst at investment bank SVB Leerink. “It would be extremely counterproductive in the extreme because what it would tell the industry is, 'Don't work on something that is really important to us because if you do, we'll just take it away from you. & # 39; "
Dr. Anthony S. Fauci, Mr. Biden's senior medical advisor for the pandemic, said in an interview Monday that drug manufacturers must act themselves, either by significantly expanding their manufacturing capacity to serve other nations at "an extremely reduced price" or by transferring their technology to make cheap copies in the developing world. He said he was agnostic about giving up.
"I always respect the needs of companies to protect their interests in order to keep them in business, but we cannot do this fully if we don't allow life-saving vaccines to get to the people who need them," said Dr. Fauci, adding, "You can't let people around the world die because they don't have access to a product that rich people have access to."
For Mr Biden, the surrender debate is both a political and a practical problem. As a presidential candidate, he promised liberal health activist Ady Barkan, who suffers from amyotrophic lateral sclerosis [A.L.S.], to commit "absolutely positively" to technology sharing and access to a coronavirus vaccine if the US developed one first. Activists plan to remind Mr. Biden of this pledge during a rally scheduled for Wednesday in the National Mall.
"He's not brave," said Gregg Gonsalves, a Yale epidemiologist who fought similar battles during the AIDS crisis of the 1980s and 1990s and is expected to speak at the rally. “That's what you said during the AIDS epidemic. Still, the same excuses come from 20 years ago. "
India and South Africa's proposal would exempt World Trade Organization member countries from enforcing some patents, trade secrets or pharmaceutical monopolies under the agency's agreement on trade-related intellectual property rights known as TRIPS. The idea would be to allow pharmaceutical companies in other countries to make or import cheap generic copies.
Proponents say the waiver would allow innovators in other countries to pursue their own coronavirus vaccines without fear of patent infringement lawsuits. They also note that the proposed waiver goes beyond vaccines to include intellectual property for therapeutics and medical supplies.
"Lots of people say," Don't you need the secret recipe? "That's not necessarily the case," said Tahir Amin, founder of the Drugs, Access and Knowledge Initiative, a nonprofit dedicated to eliminating health inequalities. "There are companies that feel they can do it on their own, provided they don't have to look over their shoulder and feel like they are taking over someone's intellectual property."
The pharmaceutical industry counters that withdrawing intellectual property protection would not help boost vaccine production. It is said that other issues around the world act as barriers to shooting up, including access to raw materials and distribution challenges in the field.
May 3, 2021, 6:58 p.m. ET
Just as important as the right to manufacture a vaccine is the technical expertise that must be provided by vaccine developers like Pfizer-BioNTech and Moderna – a process known as technology transfer.
Sharon Castillo, a Pfizer spokeswoman, said the company's vaccine required 280 components from 86 suppliers in 19 countries. It also requires highly specialized equipment and personnel, as well as complex and time-consuming technology transfers between partners and global supply and manufacturing networks, she said.
"We just find it unrealistic to believe that doing without it makes startup easier so quickly that the supply problem can be addressed," she said.
On Monday, Pfizer CEO Albert Bourla announced on LinkedIn that his company will donate over $ 70 million worth of drugs to India immediately and is also trying to expedite the vaccine approval process in India. The company also posted on Twitter promising "the greatest humanitarian aid effort in the history of our company to help the people of India".
Moderna, which developed its vaccine with US taxpayer funding, has already announced that it will "not enforce our Covid-19-related patents against those who make vaccines to fight the pandemic." But activists are not only calling for a waiver, but also for companies to share their expertise in setting up and running vaccine factories – and for Mr. Biden to rely on it.
More than 170 former heads of state and Nobel Prize winners last month, including Gordon Brown, the UK's former Prime Minister; Ellen Johnson Sirleaf, the former President of Liberia; and François Hollande, the former President of France, issued an open letter asking Mr Biden to support the proposed waiver.
On Capitol Hill, 10 senators, including Bernie Sanders, independent of Vermont, and Elizabeth Warren, Democrat of Massachusetts, urged Mr. Biden to "give people priority over drug company profits" and to reverse the Trump administration's opposition to renunciation . More than 100 House Democrats have signed a similar letter.
"This is one of the most important moral questions of our time," said Representative Ro Khanna, Democrat of California. "Denying other countries the ability to make their own vaccines is just cruel."
Katherine Tai, Mr. Biden's sales representative, has held more than 20 meetings in the past few weeks with various stakeholders – including global health activists, pharmaceutical leaders, members of Congress, Dr. Fauci and the philanthropist Bill Gates – to find a way forward.
"Ambassador Tai reiterated that the Biden Harris administration's top priority is to save lives and end the pandemic in the United States and around the world," Ms. Tai's office said in a carefully worded statement Monday after she had spoken about the proposed waiver with the government director general of the World Intellectual Property Organization, an arm of the United Nations.
In a letter to Ms. Tai last month, the Biotechnology Innovation Organization, a trade group, warned against licensing other countries – some of them our economic competitors – to undermine our world-leading biotechnology base, export jobs overseas, and undermine incentives to invest in such technologies in the future. "
One of the pharmaceutical industry concerns about a patent waiver for coronavirus vaccines is that a precedent could be created that undermines intellectual property protection for other drugs that are central to making money.
"The pharmaceutical industry is extremely protective of its intellectual property," said Dr. Aaron Kesselheim, Professor of Medicine at Harvard Medical School and Brigham and Women & # 39; s Hospital. "This kind of violent resistance is a reflex from the pharmaceutical industry."
However, it is not seen that in the particular circumstances of the pandemic, such a move would have an impact on the protection of intellectual property for other treatments after the end of the coronavirus crisis, according to industry researchers.
In the 2000s, a handful of governments, including the Brazilian and Thai, bypassed patents of antiviral drug developers for H.I.V./AIDS, paving the way for lower-cost versions of the treatments.
HIV. However, drugs involve a much simpler manufacturing process than the coronavirus vaccines, especially those that use messenger RNA technology, which has never been used in an approved product before.
On a Twitter thread, Mr. Amin offered another example: In the 1980s, Merck and GlaxoSmithKline had developed recombinant hepatitis B vaccines and had a monopoly of more than 90 patents on manufacturing processes. The World Health Organization recommended vaccination for children, but it was expensive – $ 23 per dose – and most Indian families couldn't afford it.
The founder of Shantha Biotechnics, an Indian manufacturer, was told that "even if you can afford to buy the technology, your scientists cannot in the least understand the recombinant technology," wrote Amin.
But Shantha, he added, went on to "make India's first homegrown recombinant product for $ 1 a dose". This enabled UNICEF to run a mass vaccination campaign.