World reacts with hope over U.S. move to waive vaccine patent protections

Healthcare workers and relatives carry Shashikantbhai Parekh, a patient with breathing problem, out from an ambulance for treatment at a COVID-19 hospital, amidst the spread of the coronavirus disease (COVID-19) in Ahmedabad, India, April 28, 2021. REUTERS/Amit Dave

NAIROBI, Kenya – When South Africa and India proposed it in October, the idea seemed straightforward: waive intellectual property rights on coronavirus vaccine recipes and production technology so the world can produce as many doses as possible and end the pandemic as fast as possible.

Instead, wealthy, mostly Western nations including the United States with powerful pharmaceutical lobbies rejected the idea, and then cut deals with vaccine makers to effectively hoard doses. The World Health Organization’s head called it a “catastrophic moral failure” and other critics likened it to “vaccine apartheid.”

Seven months later, as the U.S. vaccine rollout nears its peak and life veers back toward normal, Washington has reversed its position to support a short-term waiver, angering drug companies while infusing hope into efforts to ramp up vaccine production as severe shortages coincide with enormous variant-driven waves of virus infections in India, Latin America and other parts of the developing world.

“The notion that ‘no one is safe until everyone is safe’ is true, and the Biden administration seems to have finally taken that to heart,” said Fatima Hassan, a South African human rights lawyer and founder of the Health Justice Initiative, which was part of a global campaign for a generically-produced, so-called “people’s vaccine.”

“Did it take them seeing people in India dying on television to make this decision?” she asked. “Maybe, but however late this comes, attention now needs to turn immediately to getting other vaccine-producing countries to follow.”

The statement issued Wednesday by U.S. Trade Representative Katherine Tai said the United States will now move forward with international discussions to waive the protections for the duration of the pandemic. But it did not appear to be a move coordinated with U.S. allies.

Canada and Britain’s trade ministers and the European Commission president issued statements indicating their willingness to continue discussions, but did not commit to any change of stance on the waiver issue.

“The European Union is also ready to discuss any proposal that addresses the crisis in an effective and pragmatic manner,” said Ursula von der Leyen, one of the continental bloc’s top officials, said in a speech to the European Union Institute in Florence. But she followed that line with a jab at the United States, which has largely limited vaccine exports at a time when E.U. factories have been supplying much of the rest of the world.

“In the short run, however, we call upon all vaccine-producing countries to allow exports and to avoid measures that disrupt supply chains,” she said.

The European Union’s top vaccine czar, Thierry Breton, also noted concerns about supply chains, expressing skepticism that it made sense to open up the patents immediately. He noted barriers to speeding up production, including access to raw materials.

“When will we be able to reach this without destabilizing the ramp-up and the supply chain . . . I could tell you, ‘Yes, the supply chains now are solid, the ramp-up is effective, so yes, it is the time to do it,’ ” Breton said. “Personally I think it will be good to do it quickly, but as I said always, everything at its time.”

French President Emmanuel Macron took time on the sidelines of a visit to a vaccination center to say that he favored “opening up intellectual property,” but that a waiver would not have much effect without a plan to transfer technology and know-how.

Europe’s hesitancy may be linked to a vaccine rollout at home that has lagged behind that of the United States.

More than 55% of the eligible U.S. population has received at least one dose, as opposed to around 30% across the European Union. In India and across Africa, however, vaccination rates have barely passed 2% of the general population.

The supply crunch has made it difficult for Covax – a World Health Organization-backed effort to equitably distribute vaccine – to get off the ground. The program aims to deliver up to 2 billion doses by the end of 2021, targeting 20% of the population of participating low- and middle-income countries, but under current conditions, they estimate, some countries could be waiting until 2023 to secure what they need.

So far, Covax has delivered only 53 million doses, with deliveries well behind schedule.

The huge wave of infections in India – where many of Covax’s doses are being manufactured – has slowed down its timeline, leaving many countries wondering when, or if, their next doses will arrive. For months now, foreign governments, public health experts and rights advocates have urged policymakers to address the growing gap by focusing not just on sharing available doses but on dramatically expanding supply.

Many of these voices now stress that a waiver is a helpful, but not sufficient, step toward ramping up vaccine production.

“The US must also demand that pharma companies that received significant amounts of US taxpayer funding to create these vaccines share the technology and know-how with other capable manufacturers to protect more people worldwide,” Doctors Without Borders said in a statement.

Public health officials largely lauded Washington’s reversal on vaccine intellectual property, which is broader than just the patents on the vaccines, but doesn’t include treatments, diagnostic kits, ventilators, protective gear and other products that India and South Africa had included in their initial proposal at the World Trade Organization last year.

Since October, at least 60 countries became co-sponsors with India and South Africa on the proposal, and at least 40 more voiced their support. Most of them are in the Global South, which includes Latin America, Africa and south and Southeast Asia.

“This development represents true leadership in a time of need,” said John Nkengasong, director of the Africa Centers for Disease Control and Prevention, the continent’s main public health body. “When the history of the covid-19 pandemic will be written, the decision of this waiver by the U.S. government will be remembered as pivotal in our fight against this terrible virus.”

South African president Cyril Ramaphosa praised the new U.S. stance in a statement and said the “anticipated temporary waiver provides a global response” to the pandemic.

“For countries that do not currently have manufacturing capacity on certain medical technologies, the waiver could open up more supply options and avoid countries being reliant on only one or two suppliers,” he said.

India’s Ministry of External Affairs welcomed the U.S. decision, calling it an “important step for enabling rapid scaling up of manufacture and timely availability of affordable Covid 19 vaccines and essential medical products.”

“We are hopeful that with a consensus based approach, the waiver can be approved quickly at the WTO,” the ministry said in a statement issued Tuesday.

The Indian government had been lobbying for a relaxation of the patent regime for coronavirus vaccines for months. Prime Minister Narendra Modi brought up the topic in a call with President Joe Biden in April and Indian diplomats have reportedly contacted U.S. senators to appeal for their support.

A spokesman for Serum Institute of India, one of the world’s largest vaccine makers, did not immediately respond to a request for comment on the move. Serum is manufacturing vaccines under licensing deals with large American and European pharmaceutical companies.

It is unclear what the Indian government’s position is when it comes to the intellectual property rights of vaccines created in India. For instance, Bharat Biotech, a company based in Hyderabad, is making a vaccine called Covaxin developed with government help.

Russian President Vladimir Putin said Thursday that he supports lifting patent protections from coronavirus vaccines, adding that the move prioritizes welfare over profits. “Safety can only be ensured if vaccines are used in an overwhelming majority of countries of the world,” Putin said. “Herd immunity in the broadest sense of the word will be created then.”

It remained unclear whether other countries that had been blocking the waiver, which include almost all of Europe as well as Japan, Canada, Brazil, Australia and Singapore, would follow suit. Those negotiations, which would take place under the auspices of the WTO, would determine whether Washington’s change of stance does in fact lead to the ramping up of production of generic vaccines.

The process to hammer out a deal could take months and result in a narrow interpretation of intellectual property rights. The WTO has met 10 times in the past seven months on the original waiver proposal. The organization’s rules stipulate that any decision has to be made by consensus, meaning any country could hold up a coordinated move on intellectual property waivers.

Ultimately, such a waiver might only come into effect later this year, once vaccine manufacturers in the West have boosted production.

Western pharmaceutical giants like Pfizer stand to make billions of dollars off coronavirus vaccines alone, and have received billions more in subsidies from the U.S. government.

Nevertheless, the announcement came as a win for South Africa, India, and the broad coalition they built at the WTO, where delegations of civil servants, and not politicians, persevered against a bloc of the world’s most powerful nations who seemed unready to budge.

“How could we have a situation with a global pandemic and you keep considering vaccines a commodity?” said Hassan, the South African campaigner. “It was and is absurd. In a sense, it was rich countries and their pharmaceutical companies saying that intellectual property claims and the interests of shareholders on a very narrow set of items mattered more than the lives of millions of people – people in the Global South in particular.”

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