Wed., May 5, 2021
BBC
A healthcare worker prepares a dose of the Pfizer/BioNTech coronavirus disease
The US has thrown its support behind an initiative at the World Trade Organization (WTO) to waive intellectual property protections for coronavirus vaccines.
India and South Africa proposed the move, which they said would increase vaccine production around the world.
But drugs manufacturers argue it may not have the desired effect.
US Trade Representative Katherine Tai said that "extraordinary times call for extraordinary measures".
And she warned that it would take time for WTO members to reach a consensus decision on the matter.
India and South Africa were the leading voices in a group of about 60 countries which for the last six months has been trying to get the patents on vaccines set aside.
However, they met with strong opposition from the previous US administration of Donald Trump, the UK and the EU.
But Mr Trump's successor as US President, Joe Biden, has taken a different tack. He backed a waiver during the 2020 presidential campaign and reiterated his support on Wednesday.
The head of the World Health Organization (WHO) called the move a "monumental moment" in the fight against Covid-19.
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Biden backed a waiver during the 2020 presidential campaign
What would the waiver mean?
If approved, supporters say, the waiver would allow production of vaccines to be ramped up and provide more affordable doses for less wealthy countries.
Many developing countries have argued that rules requiring countries to protect patents and other forms of intellectual property are an obstacle to ramping up the production of vaccines and other products needed to tackle the pandemic.
The US had previously helped block WTO negotiations about the waiver proposal led by India and South Africa aimed at helping developing countries to produce vaccines using the intellectual property of pharmaceutical companies.
Ms Tai said the US would now embark on negotiations at the WTO to try and secure the waiver. This could take time as WTO decisions require a consensus of all 164 members.
An extraordinary moment
Analysis box by Faisal Islam, economics editor
It is a truly extraordinary moment.
President Biden's trade representative released a statement saying the White House would support a waiver on the intellectual property rights owned by the makers of Covid-19 vaccines during the pandemic.
The campaign for this has been going on amongst NGOs, some US Congressional Democrats and some developing countries such as India and South Africa. And as recently as March the US, the UK and the EU were resisting the moves in negotiations at the WTO in Geneva.
Katherine Tai has been seeing top pharmaceutical companies and also raised the issue with UK International Trade Secretary Liz Truss at a virtual meeting last month.
In an interview with the BBC last month, WTO chief Ngozi Okonjo-Iweala told the BBC that if vaccine manufacturers failed to supply the world, they would have to transfer the know-how.
Drugs companies are adamant that the patents are not the bottleneck here, it is manufacturing capacity. But the Indians and South Africans have disagreed, with South African President Cyril Ramaphosa decrying what he called "vaccine apartheid", saying his country and some in South America could ramp up production.
The US move does tilt the balance of power in the WTO towards a waiver. But the position of both the UK and the European Union will now also come under careful scrutiny.
What has the reaction been?
Tedros Adhanom Ghebreyesus, head of the WHO, called the US decision "historic" and marked "a monumental moment in the fight against Covid-19".
But pharmaceutical companies have voiced their opposition, insisting that patents are not the primary obstacle, and cautioned that the move could stifle innovation.
The International Federation of Pharmaceutical Manufacturers and Associations called the move "disappointing".
"A waiver is the simple but the wrong answer to what is a complex problem," the Geneva-based lobby group said.
Dr Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, told the Reuters news agency that the waiver "amounts to the expropriation of the property of the pharmaceutical companies whose innovation and financial investments made the development of Covid-19 vaccines possible in the first place".
Wed., May 5, 2021,
The head of the World Health Organization says the US backing of a proposed waiver of intellectual property rights for COVID vaccines is a "monumental moment" in the fight against the virus.
The waiver could significantly boost vaccine production around the world by lifting patents, copyrights and protections for industrial design and confidential information.
This could mean easier access to vaccines for those in poorer and middle-income countries, many of whom have been at the back of the queue while others such as the US and UK have been able to vaccinate large numbers of their own people.
It is an issue that has become more urgent with the surge of cases in India, the world's second-most populous country.
WHO's director-general, Tedros Adhanom Ghebreyesus, has repeatedly urged the world to support the proposal, which was initially brought to the World Trade Organisation by India and South Africa in October last year.
After the announcement by the Biden administration, he said on Twitter: "This is a monumental moment in the fight against COVID-19.
"The commitment by (Joe Biden and US trade representative Katherine Tai) to support the waiver of IP protections on vaccines is a powerful example of United States leadership to address global health challenges."
More than 100 countries support the proposal and Mr Biden had been under growing pressure from a group within Congress - all fellow Democrats who backed the waiver.
Those in favour of the move say it is already among the WTO's tools and there is no better time to use it than during a pandemic that has killed 3.2 million people, infected more than 400 million more, and ruined economies around the world.
Earlier Ms Tai said: "This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.
"The administration's aim is to get as many safe and effective vaccines to as many people as fast as possible."
But those against it say producing the vaccines is difficult and the process of vaccinating the world cannot be sped up simply by easing intellectual property laws.
Adam John Ritchie is senior project manager and vaccine scientist at the Jenner Institute and was one of the key people involved in setting up manufacture for the AstraZeneca vaccine.
He said: "It feels like trying to fight the HIV drug battle all over again.
"The manufacturing of these vaccines is much more complex, thus tech transfer becomes more important.
"Supply chains are the real bottleneck right now anyway."
They also say that lifting such intellectual property protections could hurt future innovation - companies can spend a lot of money researching such breakthroughs and they rely on the protections to make sure their work is not then copied by others for easy profit.
Ms Tai has also warned it will take time to reach the global consensus needed to waive the protections under WTO rules and officials have said any effect on vaccine supply will not be immediate.
Also on Wednesday, WTO director-general Ngozi Okonjo-Iweala spoke to a gathering of ambassadors from developing and developed countries about the issue.
WTO spokesman Keith Rockwell said the countries agree on the need for wider access to COVID-19 vaccines and a panel has been set up to discuss the proposal at a "tentative" meeting later this month before a formal gathering in early June.
A consensus could take some time but Mr Rockwell said there had been a recent change in tone after months of arguing, adding that the discussion was now "far more constructive, pragmatic".
"It was less emotive and less finger pointing than it had been in the past," he said.
"I think that this feeling of everyone-being-in-it-together was being expressed in a way that I had not heard to this point."
U.S. backs giving poorer countries access to COVID-19 vaccine patents, reversing stance
Reuters
By Andrea Shalal, Jeff Mason and David Lawder
WASHINGTON (Reuters) -President Joe Biden on Wednesday threw his support behind waiving intellectual property rights for COVID-19 vaccines, bowing to mounting pressure from Democratic lawmakers and more than 100 other countries, but angering pharmaceutical companies.
Biden voiced his support for a waiver - a sharp reversal of the previous U.S. position - in remarks to reporters, followed swiftly by a statement from his top trade negotiator, Katherine Tai, who backed negotiations at the World Trade Organization.
“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures," Tai said in a statement, amid growing concern that big outbreaks in India could allow the rise of vaccine-resistant strains of the deadly virus, undermining a global recovery.
Shares in vaccine makers Moderna Inc and Novavax Inc dropped several percent in regular trade, although Pfizer Inc stock fell only slightly.
The head of the World Health Organization, Tedros Adhanom Ghebreyesus, called Biden's move a "MONUMENTAL MOMENT IN THE FIGHT AGAINST #COVID19" on Twitter, and said it reflected "the wisdom and moral leadership of the United States."
Pharmaceutical companies working on vaccines have reported sharp revenue and profit gains during the crisis. The industry's biggest lobby group warned that Biden's unprecedented step would undermine the companies' response to the pandemic and compromise safety.
One industry source said U.S. companies would fight to ensure any waiver agreed upon was as narrow and limited as possible.
Robert W. Baird analyst Brian Skorney said he believed the waiver discussion amounted to grandstanding by the Biden administration and would not kick off a major change in patent law.
"I'm skeptical that it would have any sort of broader long- term impact across the industry," he said.
Biden backed a waiver during the 2020 presidential campaign in which he also promised to re-engage with the world after four years of contentious relations between former President Donald Trump and U.S. allies. Biden has come under intensifying pressure to share U.S. vaccine supply and technology to fight the virus around the globe.
His decision comes amid a devastating outbreak in India, which accounted for 46% of the new COVID-19 cases recorded worldwide last week, and signs that the outbreak is spreading to Nepal, Sri Lanka and other neighbors.
NEGOTIATIONS TO TAKE TIME
Wednesday's statement paved the way for what could be months of negotiations to hammer out a specific waiver plan. WTO decisions require a consensus of all 164 members.
Tai cautioned deliberations would take time but that the United States would also continue to push for increased production and distribution of vaccines - and raw materials needed to make them - around the world.
The United States and several other countries previously blocked negotiations at the WTO about a proposal led by India and South Africa to waive protections for some patents and technology and boost vaccine production in developing countries.
Critics of the waiver say producing COVID-19 vaccines is complex and setting up production at new facilities would divert resources from efforts to boost production at existing sites.
They say that pharmaceutical companies in rich and developing countries have already reached more than 200 technology transfer agreements to expand delivery of COVID-19 vaccines, a sign the current system is working.
The WTO meets again on Thursday, but it was not immediately clear if the U.S. decision would sway other opponents, including the European Union and Britain.
The U.S. government poured billions of dollars into research and advance purchases for COVID-19 vaccines last year when the shots were still in the early stages of development and it was unclear which, if any, would prove to be safe and effective at protecting against the virus.
Wednesday's move allows Washington to be responsive to the demands of the political left and developing countries, while using WTO negotiations to narrow the scope of the waiver, said one source familiar with the deliberations. It also buys time to boost vaccine supplies through more conventional means.
Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, said such a patent waiver “amounts to the expropriation of the property of the pharmaceutical companies whose innovation and financial investments made the development of COVID-19 vaccines possible in the first place.”
But proponents say the pharmaceutical companies would suffer only minor losses because any waiver would be temporary - and they would still be able to sell follow-on shots that could be required for years to come.
Pfizer said on Tuesday it expects COVID-19 vaccine sales of at least $26 billion this year and that demand for the shots from governments around the world fighting to halt the pandemic could contribute to its growth for years to come.
(Reporting by Andrea Shalal, Jeff Mason and David Lawder; Additional reporting by Steve Holland, Michael Erman, Patricia Zengerle and Stephanie Nebehay; Editing by Peter Cooney)