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Sen. Warren presses PhRMA foyer group on efforts to dam vaccine patent waivers

Sen. Warren presses PhRMA lobby group on efforts to block vaccine patent waivers

Sen. Elizabeth Warren, D-Mass., conducts a news conference outside the Capitol to reintroduce the Universal Child Care and Early Learning Act, on Tuesday, April 27, 2021.

Tom Williams | CQ-Roll Call, Inc. | Getty Images

Democratic Sen. Elizabeth Warren is pressing the CEO of a major pharmaceutical trade group on its lobbying efforts against a proposal to waive intellectual property rights for Covid-19 vaccines that would help boost production of the shots for poorer nations.

Warren and other lawmakers asked how much money the Pharmaceutical Research and Manufacturers of America, or PhRMA, and its member companies spent this year lobbying Congress and White House officials in opposition to the waiver, in a letter sent Wednesday to PhRMA CEO Stephen Ubl that was obtained by CNBC.

The Biden administration said in early May it would support waiving the World Trade Organization’s Trade Related Intellectual Property Rights, or TRIPs, agreement. PhRMA, whose members include Covid vaccine makers AstraZeneca, Pfizer and Johnson & Johnson, is trying to block the waiver.

Removing patent protections on Covid vaccines would allow other drug companies to manufacture the lifesaving shots. Drugmakers worry that could set a precedent for future products and end their lucrative monopolies over sales of their new medicines.

Warren also asked the trade group about its attempts to block a bill from House Democrats that would allow Medicare to negotiate directly with manufacturers for lower drug prices.

“PhRMA and other pharmaceutical companies have pushed the Biden Administration to oppose the TRIPS waiver, arguing that it would “undermine the global response to the pandemic,”‘ Warren and other lawmakers wrote. The industry also said drug pricing provisions of the American Rescue Plan would “lead to fewer new cures and treatments,” and it opposed Medicare Part D price negotiation, the letter reads.

“While taking credit for the development of new COVID vaccines — which were developed with massive infusions of federal funds — the pharmaceutical industry has not backed off of its efforts to block drug pricing proposals and maintain the status quo,” the lawmakers added.

The lawmakers gave the trade group until June 30 to respond.

In a statement to CNBC, PhRMA spokesman Brian Newell said the trade group was reviewing the letter.

“We will continue our efforts to work with policymakers on solutions to lower what patients pay out of pocket for prescription medicines and ensure equitable global access to COVID-19 vaccines,” he said.

Warren’s letter comes as global groups, including the World Health Organization, are urging wealthy countries and drugmakers to get Covid shots to low-income and lower-middle-income countries, some of which are witnessing an increasingly worrying rise in new infections.

Ken Frazier, chairman and chief executive officer of Merck & Co., from left, Stephen Ubl, chief executive officer of Pharmaceutical Research and Manufacturers of America (PhRMA), and Robert Hugin, chairman of Celgene Corp., arrive to a news conference outside the White House following a meeting with U.S. President Donald Trump, not pictured, in Washington, D.C., U.S., on Tuesday, Jan. 31, 2017.

Andrew Harrer | Bloomberg | Getty Images

Many countries and drugmakers have made pledges to share millions of doses around the world. President Joe Biden announced last week that his administration would donate 500 million vaccine doses produced by Pfizer to other nations.

The pharmaceutical industry has previously said the TRIPS waiver would compromise safety, weaken supply chains and sow confusion between public and private partners.

In the first three months of this year, pharma companies have spent a record $92 million on lobbying, according to data compiled by the Center for Responsive Politics, a nonpartisan campaign finance research group in Washington. PhRMA spent $8.6 million this year on lobbying after spending $25.9 million in 2020, according to its data.

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Patent waivers and influence on world vaccine provide shortages

Patent waivers and impact on global vaccine supply shortages

Losing intellectual property protection for Covid-19 vaccines will not help address global supply bottlenecks, the co-founder of a Massachusetts-based biopharmaceutical company told CNBC.

The demand for patent waivers is “political theater” and does not inherently allow others to make safe and effective vaccines that are already very difficult to make, said Jake Becraft, CEO and co-founder of Strand Therapeutics.

His company doesn’t make Covid-19 vaccines, but is developing a platform to develop programmable messenger RNA drugs that can trigger the body’s immune response to fight disease.

“We have to commit ourselves to what we already manufacture and scale this worldwide as much as possible,” Becraft said Monday in CNBC’s “Squawk Box Asia”.

Lack of vaccine

Due to the global shortage of Covid-19 vaccines, some countries have searched for supplies to launch their vaccination programs. Indeed, India – the world’s largest vaccine maker – is facing domestic shortages in the midst of a devastating second wave.

Health experts, rights groups and international medical charities have argued that there is an urgent need to abandon intellectual property rights in order to address the global vaccine shortage and avoid prolonging the health crisis. It is because many countries, especially in Asia, are affected by new waves of infections due to mutated Covid variants.

However, vaccine makers argue that such a move could disrupt the flow of raw materials and result in less investment by smaller biotech innovators in health research.

Last year India and South Africa submitted a joint proposal to The World Trade Organization waives intellectual property rights in Covid vaccines.

Known as Trips Waiver – or trade-related intellectual property rights – the plan has been blocked by some high-income countries, including the UK, Switzerland, Japan, Norway, Canada and the European Union. France, for example, argued that the way to step up global vaccination is for vaccine-producing nations to increase their exports.

While the United States initially blocked the proposal, the Biden government said earlier this month it supports the waiver of intellectual property rights for Covid-19.

Increase in the supply chain

Becraft said the vaccines have to be made in very controlled, high-tech facilities and that the technology required doesn’t exist around the world. This means that despite a patent waiver, some countries do not have the expertise to manufacture their own vaccines.

Instead, Becraft suggested incentivizing pharmaceutical companies like Moderna, Pfizer, and BioNTech to roll out the technology to manufacturing facilities around the world.

“If we want vaccines that are safe and effective, we need to encourage these companies to actually build manufacturing capacities around the world,” he said.

“We have to go to Moderna, we have to go to BioNTech and say, ‘What do you need to transfer your technology to these developing countries?'” Becraft said.

When vaccines aren’t available to everyone around the world, there’s always a risk of a variant of Covid that makes vaccines ineffective, he added. “All of our progress up to this point will be in vain.”

Nisha Biswal, president of the US-India Business Council, agreed that waiving a patent will not resolve the issue of increasing vaccine supply to the rest of the world.

With a patent waiver, it would take months or years for the technology, raw materials and production capacity to meet the required standard So that countries can manufacture their own vaccines, she told CNBC’s Squawk Box Asia on Monday.

Instead, the focus should be on helping countries that already make vaccines increase their production.

“Many of these (vaccine) manufacturers are already in discussions with India and Indian companies about how they can try to make some of these products in India,” said Biswal. “This is probably a faster and more efficient way than talking about no trips.”

Strand Therapeutics’ Becraft added that longer term, world governments need more funding and infrastructure support to provide pharmaceutical companies with manufacturing facilities around the world.

Last week BioNTech announced that it would set up a manufacturing facility in Singapore to manufacture its mRNA-based vaccines.

– CNBC’s Silvia Amaro contributed to the coverage.

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Health

WHO chief urges world to observe U.S., waive Covid vaccine patent protections

WHO chief urges world to follow U.S., waive Covid vaccine patent protections

World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus attends a press conference organized by the United Nations Union of Geneva Correspondents Association (ACANU) during the COVID-19 outbreak on July 3, 2020 at WHO headquarters in Geneva, Switzerland has been.

Fabrice Coffrini | Pool | Reuters

The Director General of the World Health Organization, Tedros Adhanom Ghebreyesus, on Friday called on other countries, in particular the Group of the Seven Industrialized Nations, to follow the example of the US and support a request by the World Trade Organization to temporarily waive patent protection for Covid-19 vaccines .

“The US announcement on Wednesday to support a temporary waiver of intellectual property protection for Covid-19 vaccines is an important declaration of solidarity and support for vaccine justice,” Tedros said at a press conference. “I know that this is not easy politically, so I really appreciate the US leadership and we urge other countries to follow suit.”

The USA, which is strongly committed to the enforcement of intellectual property rights around the world, has previously spoken out against the waiver of patent protection for Covid vaccines.

President Joe Biden personally made the decision to change the US stance, White House deputy press secretary Karine Jean-Pierre told reporters aboard Air Force One on Thursday. As a presidential candidate, Biden had supported the abandonment of the intellectual property of Covid vaccines.

The Pharmaceutical Research and Manufacturers of America, whose members include vaccine manufacturers AstraZeneca, Pfizer, and Johnson & Johnson, firmly oppose the Biden government’s decision.

WHO chief Tedros on Friday also called on the G7 industrialized nations – Canada, France, Germany, Italy, Japan and Great Britain, as well as the USA – to do more to facilitate the equitable distribution of Covid vaccines worldwide.

“For G-7, vaccines and vaccine equity are now the most important and immediate support we need,” said Tedros. “I think everyone knows what we should do to increase production capacity and then increase vaccination rates in all countries.”

According to the WHO chief, more than 80% of the more than 1 billion Covid vaccine doses distributed worldwide went to high-income countries, while low-income countries received 0.3%.

“That kind of gap is unacceptable,” said Tedros. “It is not only unacceptable on moral grounds, but also because we will not defeat the virus in a divided world.”

“It is in the interests of every country in this world to exchange vaccines and to contribute in every possible way to ensure the justice of the vaccines,” said the WHO chief. “Vaccine equity is not a charity. Vaccine equity is in everyone’s interest.”

The demand for the revocation of patent protection proposed by India and South Africa last October is facing an uphill battle at the WTO, which takes decisions by consensus among its 164 member states.

Germany, Europe’s largest economy, has spoken out against the attempt to temporarily forego vaccination patents. BioNTech, which developed a Covid vaccine in collaboration with Pfizer, is based in Germany.

“The US proposal to lift patent protection for Covid-19 vaccines has a significant impact on vaccine production as a whole,” said a spokesman for the federal government on Thursday. “The limiting factor in vaccine production is the production capacity and high quality standards, not the patents.”

After the US reversal, the governments of Canada, Italy, Japan and Great Britain did not take any clear public positions for or against the renunciation of the protection of intellectual property. French President Emmanuel Macron supported the US position.

The President of the European Commission, Ursula von der Leyen, who heads the executive body of the European Union, did not accept the waiver plan and declared in a speech that she was “ready to discuss proposals for effective and pragmatic management of the crisis”.

Russia, which developed the Sputnik vaccine, has expressed support for the move and China is open to further discussion. The WHO announced on Friday that it has approved the emergency vaccine developed by China’s Sinopharm.

According to The Associated Press, which quoted a Geneva-based trade official, around 80 WTO countries, mostly developing countries, have expressed support for the proposal.

“It’s also important to remember that abandoning intellectual property must go hand-in-hand with a transfer of technology and expertise for these elusive vaccines,” said Tedros.

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Biden-backed Covid vaccine patent waiver will trigger issues

Biden-backed Covid vaccine patent waiver will cause problems

Sergeant Jennifer Callender (L) of the Illinois Air National Guard administers a vaccine for Pfizer Covid-19 to Virginia Persha on February 3, 2021 at a vaccination center at Triton College in River Grove, Ill.

Kamil Krzaczynski | AFP | Getty Images

Pfizer CEO Albert Bourla warned on Friday that waiving patent protection for Covid vaccines – a proposal just endorsed by President Joe Biden – would spark a global race for raw materials that would allow the safe and efficient manufacture of Covid- Shots at risk.

The Biden government said Wednesday it supports the limited intellectual property rule waiver in the service of expanding vaccine distribution to the lower-income countries currently hit by the pandemic.

But Bourla, whose company makes one of three vaccines approved for use in the United States, “categorically” believes the waiver will “cause more problems.”

“Right now, the infrastructure is not the bottleneck for us to produce faster,” wrote Bourla in a letter from a dear colleague published on LinkedIn. “The limitation is the lack of highly specialized raw materials needed to make our vaccine.”

Pfizer’s vaccine requires 280 different materials and components, sourced from 19 countries around the world, Bourla said. He claimed that companies with much less experience than Pfizer would compete for the same ingredients in making vaccines without patent protection.

“Currently, virtually every gram of the raw material produced is immediately delivered to our manufacturing facilities and is instantly and reliably switched to vaccines that are immediately shipped around the world,” wrote Bourla.

He predicted that the proposed waiver “threatens to disrupt the flow of raw materials”.

Albert Bourla, CEO of Pfizer, speaks after attending a press conference to monitor the production of the Pfizer-BioNtech COVID-19 vaccine at the factory of the US pharmaceutical company Pfizer in Puurs, Belgium, on April 23, 2021.

John Thys | Pool | Reuters

“It will create a mess for the critical inputs we need to make a safe and effective vaccine,” wrote Bourla.

“Companies with little or no vaccine manufacturing experience are likely hunting the very raw materials we need to scale our production, putting everyone’s safety at risk,” the CEO wrote.

The White House referred CNBC’s reach to Bourla’s post to the US sales representative’s office, which did not immediately respond to a request for comment.

The leaders of the World Trade Organization recently called on member states to reach an agreement on possible waivers for vaccination patents. But even with the support of the US, an agreement is hardly guaranteed, since the decisions of the WTO are based on consensus and require the consent of all 164 members.

Germany, a WTO member and the largest economy in Europe, spoke out against the waiver proposal on Thursday. BioNTech, which worked with Pfizer to develop the vaccine, is based in Germany.

Bourla on LinkedIn also expressed concern that potential vaccination waivers “will discourage others from taking great risks”.

“The latest rhetoric isn’t going to stop us from continuing to invest in science. However, I’m not sure if the same is true of the thousands of tiny biotech innovators who are totally dependent on access to capital from investors who just do investing provided their intellectual property is protected, “wrote the CEO.

PhRMA, the pharmaceutical industry advocacy group that includes Pfizer and Johnson & Johnson, another US vaccine company, described the waiver as “an unprecedented move that will undermine our global response to the pandemic and put safety at risk”.

Meanwhile, Moderna CEO Stephane Bancel, maker of the other U.S.-approved Covid shot, said he wasn’t concerned about the possible exemptions.

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Covid vaccine makers’ shares seesaw after U.S. says it would again patent waivers

Covid vaccine makers' shares seesaw after U.S. says it will back patent waivers

A healthcare worker fills a syringe with the Moderna COVID-19 vaccine. At the Giorgio Companies site in Blandon, PA where the CATE Mobile Vaccination Unit was on site to deliver Moderna COVID-19 vaccines to workers on Wednesday morning April 14, 2021.

Ben Hasty | MediaNews Group | Getty Images

Stocks of two Covid vaccine makers fluctuated Thursday after the Biden government announced it would support a motion before the World Trade Organization to forego patent protection for the mRNA technology used to manufacture the vaccines.

Pfizer was down as much as 5% on Thursday from Wednesday’s close of trading, while Moderna fell nearly 12% before both stocks made up for most of those losses. The companies use the same mRNA technology to make their recordings.

Pfizer, which makes its Covid-19 vaccine with German pharmaceutical company BioNTech, closed about 1% that day, while Moderna lost about 1.4% that day.

South Africa and India are urging US officials and the WTO to temporarily forego patent protection so developing countries can manufacture life-saving vaccines until world leaders can bring the pandemic under control. Human rights organizations such as Doctors Without Borders, Oxfam and Amnesty International have all signed letters in support of the proposal.

US sales representative Katherine Tai released a statement Wednesday evening in support of the waiver.

“This is a global health crisis and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” she said. “The government firmly believes that protecting intellectual property, but in the service of ending this pandemic, supports the removal of this protection for COVID-19 vaccines.”

Moderna CEO Stephane Bancel told investors on a earnings call Thursday that he had “not lost a minute of sleep” on the news and said traders’ concerns were false.

Johnson & Johnson and AstraZeneca both use an adenovirus, a common type of virus that typically causes mild cold symptoms, to make their Covid vaccines. The stocks of these two companies barely changed on Thursday.

President Joe Biden made an election promise last year to “absolutely positively” renounce vaccination patents. The waiver of patent protection can take months or even years.

Critics of the move say that developing countries do not have the infrastructure to produce the vaccines, others disagree.

Analysts largely shook off the news.

“We believe a new manufacturing operation can take 6 to 9 months to scale up, effectively limiting the impact of other manufacturers. While we expect the headlines to put pressure on MRNA, we don’t see any significant practical impact from this news,” said the Morgan Stanley analysts said in a research report Thursday.

Bank of America analysts cited “obstacles to vaccine development, including sourcing raw materials, developing manufacturing and engineering know-how.” They also note that “US support does not mean approval when WTO decisions require consensus and other members such as the EU, UK, Japan and Switzerland are currently opposed to surrendering intellectual property.”

The German Chancellor Angela Merkel spoke out against the exemptions together with these countries on Thursday. “The limiting factor in the manufacture of vaccines is the production capacity and high quality standards, not the patents,” a Merkel spokeswoman said in a statement.

The President of the European Commission, Ursula von der Leyen, did not accept the waiver plan and stated in a speech that she was “ready to discuss proposals that would address the crisis in an effective and pragmatic way”.

Both Pfizer and Moderna already have plans to produce billions of cans in the meantime, leaving essentially all competitors far behind in the manufacturing process.

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U.S. to debate wider distribution, India calls to waive patent protections

U.S. to discuss wider distribution, India calls to waive patent protections

Ground staff unload coronavirus disease (COVID-19) supplies from the United States at the cargo terminal of Indira Gandhi International Airport on April 30, 2021 in New Delhi, India.

Prakash Singh | Reuters

WASHINGTON – White House Chief of Staff Ron Klain said Sunday that the Biden government plans to distribute the coronavirus vaccine to India and other countries after millions of Americans received their doses.

In the past few weeks, India has been grappling with a staggering surge in new coronavirus infections. Over the weekend, India reported 400,000 cases a day for a cumulative total of 19,557,457 cases. This is evident from numbers compiled by Johns Hopkins. The spike may have been triggered by a highly contagious variant of Covid known as B.1.617, which was first identified in the country.

The variant has since been identified in other countries, including the United States.

On Friday, the White House announced it would limit travel from India as the country works to counter the rise in Covid-19 infections.

“We are rushing to help India,” said Klain during an interview on CBS’s Face the Nation program.

Klain said the US has sent therapeutics, rapid diagnostic test kits, ventilators and protective equipment to the world’s largest democracy, as well as raw materials that are vital to vaccine production.

“Our US Trade Representative, Katherine Tai, will go to the WTO next week to begin talks on how we can further distribute, license and distribute this vaccine,” he said when asked if the Biden administration would protect patents The coronavirus vaccine would loosen up.

Klain added that he expected the White House to have more to say on the matter in the coming days.

Earlier this month, Indian Prime Minister Narendra Modi discussed with Biden about the revocation of patent protection for the coronavirus vaccine. The relaxation would give governments faster and more affordable access to the life-saving doses.

Last week, the Biden government announced that it would immediately provide the raw materials needed to manufacture coronavirus vaccines in India. The US response came after Britain, France and Germany pledged aid to India, the world’s largest democracy. Rich nations have come under fire in the past few days for hoarding the raw materials needed for the shots.