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Pressure mounts to lift patent protections on coronavirus vaccines

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WASHINGTON – President Biden, facing mounting Covid-19 crises in India and South America, comes under increasing pressure from the international community and his party’s left flank to pledge to increase vaccine supply by relaxing patent and intellectual property protections on coronavirus vaccines.

Pharmaceuticals and biotech companies, also under pressure, on Monday sought to prevent such a move, which could reduce future profits and jeopardize their business model. Pfizer and Moderna, two leading vaccine makers, have each announced measures to increase vaccine supply around the world.

The issue comes to a head as the General Council of the World Trade Organization, one of its highest decision-making bodies, meets on Wednesday and Thursday. India and South Africa are pushing for the agency to drop an international intellectual property deal that protects pharmaceutical trade secrets. The United States, Britain and the European Union have so far blocked the plan.

Inside the White House, the president’s health advisers admit they are 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 leaders. Others say that the disclosure to the general public of closely guarded but extremely complex trade secrets would do nothing to increase the global supply of vaccines.

Having a recipe for a vaccine doesn’t mean a drug maker could produce it, certainly not quickly, and opponents argue that such a move would hurt innovation and entrepreneurship – and hurt the American pharmaceutical industry. Instead, they say, Biden can meet global needs in other ways, such as lobbying companies that hold patents to donate large quantities of the vaccine or sell them at cost.

“For the industry, this would be a terrible and terrible precedent,” said Geoffrey Porges, analyst for investment bank SVB Leerink. “That would be extremely counterproductive, in the extreme, because what it would say to the industry is, ‘Don’t work on something that is really close to our hearts, because if you do, we’ll just get you there.’ to take off. . ”

Dr Anthony S. Fauci, Mr Biden’s chief medical adviser for the pandemic, said in an interview on Monday that the drugmakers themselves must act, either by dramatically expanding their manufacturing capacity to supply other countries. at “an extremely low price”, or by transferring their technology to enable the developing world to make cheap copies. He said he was agnostic on a waiver.

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“I always respect the needs of businesses to protect their interests to keep them in business, but we cannot do this completely at the expense of not allowing life-saving vaccines to reach the people who need them,” he said. said Dr Fauci. , adding: “It is impossible for people all over the world to die because they do not have access to a product that the rich have access to.”

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For Biden, the waiver debate is both a political and a practical issue. As a presidential candidate, he promised liberal health activist Ady Barkan, with amyotrophic lateral sclerosis, or ALS, that he would make an “absolutely positive” commitment to sharing the technology and accessing to a coronavirus vaccine if the United States develops one first. Activists plan to remind Biden of the promise at a rally scheduled for Wednesday at the National Mall.

“He’s not daring about it,” 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. “They said that too during the AIDS epidemic. All the same excuses come from 20 years ago. “

India and South Africa’s proposal would exempt member countries of the World Trade Organization from enforcing certain patents, trade secrets or pharmaceutical monopolies under the body’s agreement on property rights trade-related intellectual property, known as TRIPS. The idea would be to allow pharmaceutical companies in other countries to manufacture or import cheap generic copies.

Supporters 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 exemption goes beyond vaccines and would also encompass intellectual property for therapeutic and medical products.

“A lot of people say, ‘Won’t they need the secret recipe?’ This is not necessarily the case, ”said Tahir Amin, founder of the Medicines, Access and Knowledge Initiative, a non-profit organization dedicated to eliminating health inequalities. “There are companies that think they can go it alone, as long as they don’t have to look over their shoulder and feel like they’re going to take someone’s intellectual property. . “

The pharmaceutical industry retorts that removing intellectual property protections would not help speed up vaccine production. He says other issues serve as barriers to getting gunfire around the world, including access to raw materials and the challenges of field distribution.

And just as important as having the rights to manufacture a vaccine is having the technical know-how, which should be provided by vaccine developers like Pfizer-BioNTech and Moderna – a process known as technology transfer. .

Sharon Castillo, a spokesperson for Pfizer, said the company’s vaccine requires 280 components from 86 suppliers in 19 countries; it also needs highly specialized equipment and personnel, as well as complex and time-consuming technology transfers between partners and global supply and manufacturing networks, she said.

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“We just think it’s unrealistic to think that a waiver will facilitate a ramp-up so quickly that it will solve the supply problem,” she said.

On Monday, Pfizer chief executive Albert Bourla said on LinkedIn that his company will immediately donate more than $ 70 million worth of drugs to India and is also trying to speed up the vaccine approval process in India. The company also published on Twitter promising “the greatest humanitarian relief effort in the history of our company to help the Indian people.”

Moderna, which developed its vaccine with funding from US taxpayers, has already said it “will not enforce our patents related to Covid-19 against those who make vaccines intended to fight the pandemic.” But campaigners have called for not only the waiver, but also for companies to share their expertise in building and running vaccine factories – and for Mr Biden to rely on them to do so.

Last month, more than 170 former heads of state and Nobel laureates, including Gordon Brown, the former British Prime Minister; Ellen Johnson Sirleaf, former President of Liberia; and Francois Hollande, the former president of France, issued an open letter calling on Mr. Biden to support the proposed waiver.

On Capitol Hill, 10 Senators including Vermont Independent Bernie Sanders and Massachusetts Democrat Elizabeth Warren urged Biden to “put people first over drug company profits” and topple the opposition from the Trump administration to the waiver. More than 100 House Democrats signed a similar letter.

“This is one of the main moral issues of our time,” said Representative Ro Khanna, Democrat of California. “Denying other countries the possibility of making their own vaccines is just cruel.”

Katherine Tai, Mr Biden’s trade representative, has held more than 20 meetings with various stakeholders – including global health activists, pharmaceutical executives, members of Congress, Dr Fauci and philanthropist Bill Gates – these past few weeks to try to chart the way forward. .

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“Ambassador Tai reiterated that the top priority of the Biden-Harris administration is to save lives and end the pandemic in the United States and around the world,” Ms. Tai’s office said Monday in a statement. carefully crafted release, after discussing the proposed waiver with the Director General of the World Intellectual Property Organization, a branch of the United Nations.

In a letter to Ms. Tai last month, the Biotechnology Innovation Organization, a commercial group, warned against granting a “license to other countries – some of which are our economic competitors – to empty our base. biotechnology, exporting jobs abroad and undermining incentives to invest in such technologies in the future. “

One of the pharmaceutical industry’s fears about a patent waiver for coronavirus vaccines is that it could set a precedent that would weaken its intellectual property protections for other drugs, which are central to how she earns 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’s Hospital. “This type of fierce resistance is a reflex of the pharmaceutical industry.”

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It is not clear, however, that such a decision in the unique circumstances of the pandemic would have implications for the protection of intellectual property for other treatments after the coronavirus crisis, industry researchers have said. .

In the 2000s, a handful of governments, including those in Brazil and Thailand, circumvented patents held by developers of antiviral drugs for HIV / AIDS in an attempt to pave the way for cheaper versions of treatments. .

Anti-HIV drugs, however, involve a much simpler manufacturing process than coronavirus vaccines, especially those using messenger RNA technology, which has never been used before in an approved product.

In one Twitter feedMr. Amin gave another example: in the 1980s, Merck and GlaxoSmithKline had developed recombinant hepatitis B vaccines and held a monopoly with over 90 patents covering manufacturing processes. The World Health Organization has recommended childhood immunizations, but it’s expensive – $ 23 a dose – and most Indian families can’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 understand the recombinant technology in the slightest bit,” Amin wrote.

But Shantha, he added, continued “to produce the first recombinant grown in India at $ 1 a dose.” This enabled UNICEF to carry out a mass vaccination campaign.

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