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Biden confronts Coronavirus vaccine patents

WASHINGTON – President Biden is facing severe Covid-19 crises in India and South America, is under intensifying pressure from the international community and his party’s left flank to commit to increasing vaccine supply by loosening patent and intellectual property protection on coronavirus vaccines.

Pharmaceutical and biotech companies, which also feel pressured, on Monday sought to ward off such a move, which could cut future profits and jeopardize their business model. Pfizer and Moderna, two major vaccine manufacturers, each announced steps to increase the supply of vaccine around the world.

The issue comes to the fore when the World Trade Organization’s General Council, one of its highest decision-making bodies, meets on Wednesday and Thursday. India and South Africa are pushing for the body to renounce an international intellectual property agreement 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 that Mr. Biden has a moral imperative to act and that it is bad policy for the president to sit with pharmaceutical leaders. Others say that the spill of closely guarded but highly complex trade secrets in the open would do nothing to expand the global supply of vaccines.

Having the prescription for a vaccine does not mean that a drug manufacturer could produce it, certainly not quickly, and opponents claim that such a move would harm innovation and entrepreneurship – and harm America’s pharmaceutical industry. Instead, they say that Mr. Biden can meet global needs in other ways, such as forcing companies that have patents to donate large amounts of vaccine or selling it at cost.

“For the industry, this would be a terrible, terrible precedent,” said Geoffrey Porges, an analyst at investment bank SVB Leerink. “It would be extremely counterproductive, extremely, because what would say to the industry is, ‘Do not work on something that we really care about, because if you do, we’ll just take it away from you. ””

Dr. Anthony S. Fauci, Mr. Biden’s chief medical adviser on the pandemic said in an interview on Monday that the drug manufacturers themselves must act, either by greatly expanding their production capacity to supply other nations at “an extremely reduced price” or by transferring their technology to let developing countries make cheap copies. He said he was an agnostic over a waiver.

“I always respect the needs of companies to protect their interests in order to keep them in business, but we can not do it completely at the expense of not allowing a life-saving vaccine to get to the people who need it,” said Dr. Fauci added: “You can not make people die all over the world because they do not have access to a product that rich people have access to.”

For Mr Biden, the debate on renunciation is both a political and a practical problem. As a presidential candidate, he promised liberal health activist Ady Barkan, who has amyotrophic lateral sclerosis, or ALS, that he would “absolutely positively” commit to sharing technology and access to a coronavirus vaccine if the United States developed one first. Activists plan to commemorate Mr. Bite about this promise during a demonstration scheduled for Wednesday at the National Mall.

“He’s not bold on this,” said Gregg Gonsalves, a Yale epidemiologist who fought similar battles during the AIDS crisis in the 1980s and 1990s and is expected to speak at the demonstration. “They also said this during the AIDS epidemic. All the same excuses come from 20 years ago. ”

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

Proponents say the waiver will free up 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 will also include intellectual property rights to therapy and medical devices.

“Many people say, ‘Do they not need the secret recipe?’ “That’s not necessarily the case,” said Tahir Amin, founder of the Medicine, Access and Knowledge Initiative, a nonprofit dedicated to eliminating health inequalities. “There are companies that feel they can go it alone, provided they don’t have to look over their shoulder and feel like they want to take someone else’s intellectual property.”

Pharmaceutical industry counteracts that returning intellectual property protection will not help increase vaccine production. It says other problems serve as barriers to firing guns around the world, including access to raw materials and on-site distribution challenges.

And just as important as having the rights to make a vaccine is having the technical know-how that was to 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 requires 280 components from 86 suppliers in 19 countries; it also needs highly specialized equipment and personnel and complex and time-consuming technology transfers between partners and global supply and production networks, she said.

“We just think it’s unrealistic to think that a dropout would make it easier to ramp up so quickly to solve the supply problem,” she said.

On Monday, Pfizer’s CEO Albert Bourla told LinkedIn that his company would immediately donate more than $ 70 million of medicine to India and is also trying to speed up the vaccination approval process in India. The company also posted on Twitter, promising “the greatest humanitarian relief effort in the history of our company to help the people of India.”

Moderna, which developed its vaccine with funding from U.S. taxpayers, has already said it would not “enforce our Covid-19-related patents against those who manufacture vaccines designed to combat the pandemic.” But activists have called not only to give up, but for companies to share expertise in setting up and operating vaccine factories – and that Mr. The bite leans 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 François Hollande, the former French president, issued an open letter urging Mr Biden to support the proposed derogation.

On Capitol Hill, ten senators, including Bernie Sanders, independent of Vermont, and Elizabeth Warren, Democrat from Massachusetts, called on Mr. Bite to “prioritize people over pharmaceutical company profits” and turn the Trump administration’s opposition to the waiver. More than 100 House Democrats have signed a similar letter.

“This is one of the most important moral issues of our time,” said Representative Ro Khanna, a Democrat in California. “Denying other countries the opportunity to make 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 leaders, members of Congress, Dr. Fauci and philanthropist Bill Gates – to try to map a way forward.

“Ambassador Tai reiterated that the highest priority of the Biden-Harris administration is to save lives and end the pandemic in the United States and around the world,” Ms. Tai said in a carefully worded statement Monday after talking about the proposed exemption with the CEO for 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 erode our world-leading biotechnology base, export jobs abroad and undermine incentives to invest in such technologies in the future. ”

One of the pharmaceutical industry’s fears of a patent exemption for coronavirus vaccines is that it could set a precedent that would weaken its intellectual property protection for other drugs, which is crucial to how it makes money.

“The pharmaceutical industry is extremely protective of its intellectual property rights,” said Dr. Aaron Kesselheim, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital. “This kind of fierce resistance is a reflex in the pharmaceutical industry.”

However, it is not clear that such a move in the unique circumstances of the pandemic would have implications for the protection of intellectual property rights to other treatments after the coronavirus crisis has passed, industry researchers said.

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

However, HIV drugs involve a much simpler manufacturing process than the coronavirus vaccines, especially those that use messenger RNA technology that has never been used in an approved product before.

In a Twitter thread, Mr. Amin offered another example: By the 1980s, Merck and GlaxoSmithKline had developed recombinant hepatitis B vaccines and had a monopoly of more than 90 patents covering manufacturing processes. The World Health Organization recommended vaccination for children, but it was expensive – $ 23 a dose – and most Indian families could not afford it.

The founder of Shantha Biotechnics, an Indian manufacturer, was told that “even if you can afford to buy that technology, your researchers may not understand recombinant technology in the least,” Amin wrote.

But Shantha, he added, “continued to produce India’s first home-grown recombinant product at $ 1 a dose.” This enabled UNICEF to run a mass vaccination campaign.

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