The Biden administration’s decision to support waiver of intellectual property rights for Covid-19 vaccines was hailed by campaigners and health officials on Thursday as a landmark move that could upend the warm relationship between rich countries and pharmaceutical giants and mark a crucial step in the fight against global inequality in vaccines.
However, the move has drawn strong criticism from major drugmakers and some experts, skeptical of its impact on the world’s efforts to fight the coronavirus.
And Washington’s sweeping shift has also raised questions about what will come next, with an emphasis on whether others will follow America’s lead.
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For months, the United States has been part of a group of wealthy countries that have resisted proposals by India and South Africa to relax some World Trade Organization protections related to vaccines against coronavirus.
On Wednesday, the Biden administration effectively crossed this divide between the haves and have-nots, reversing the course set by former President Donald Trump.
The landmark move suggests that pharmaceutical giants may need to share their vaccine know-how and allow third-party international manufacturers to start producing injections for poorer countries.
“These extraordinary times and circumstances call for extraordinary action,” said US Trade Representative Katherine Tai.
The debate has been highlighted by the crisis in India, where massive deaths, lack of oxygen supply and overwhelmed hospitals and crematoriums are made worse by the fact that only 2% of people have been vaccinated, compared to 30% in United States.
Washington has come under increasing pressure on the issue in recent weeks from more than 100 low- and middle-income countries, as well as a cavalcade of US and EU lawmakers, Nobel Laureates, former world leaders, human rights organizations and Pope Francis.
“The devastation caused by the pandemic is unprecedented and it is heartwarming to see the US government signal that it will put people’s lives and rights first,” said Aruna Kashyap, an India-based lawyer with the dog. guard Human Rights Watch.
The debate revolves around what is known as the Trade-Related Aspects of Intellectual Property Rights Agreement – or TRIPS Agreement – which governs how countries interact on the issue.
One immediate problem is that any decision to forgo parts of this WTO deal must be made by consensus, which means the United States needs other wealthy countries to support its decision.
Hours after Washington’s overthrow, Australia went from blocking to TRIPS waiver. And European Union President Ursula von der Leyen said Thursday she was “ready to assess how the US proposal might help” to immunize the world.
“In the short term, however, we call on all vaccine-producing countries to allow exports and avoid measures that disrupt supply chains,” she added.
The other resistance fighters – the UK, Japan and Brazil – have not said whether they will switch sides.
Crossing the floor from global north to global south, advocates say the United States has put itself “on the right side of history,” as the Doctors Without Borders charity said on Wednesday.
World Health Organization Director-General Tedros Adhanom Ghebreyesus called Biden’s decision a “monumental moment in the fight against Covid-19”.
Skeptics of this plan argue that the limiting factor in vaccine production is not a lack of knowledge, but rather a lack of raw materials and expertise.
Even armed with the vaccine recipe, manufacturers would still face shortages of the syringes, vials and nanoparticles needed to make them, they say.
“I doubt it will make any difference,” said Sir Robin Jacob, president of intellectual property law at University College London. He called the TRIPS campaign a “largely emotional reaction to an incredibly complex problem”.
Opponents also claim that forcing drugmakers to share their knowledge would mean companies have less incentive to make life-saving drugs in the future. Pfizer said this week that it expects to make $ 26 billion this year from its sales of Covid-19 vaccines alone.
“This short-sighted and ineffective decision by the Biden administration jeopardizes hard-won progress in the fight against this terrible disease,” said Nathalie Moll, CEO of the European Federation of Pharmaceutical Industries and Associations.
The federation is a powerful lobbying group whose board of directors is made up of figures from the world’s largest drug manufacturers, such as Pfizer and AstraZeneca.
“While we fully agree with the goal of protecting citizens around the world with vaccines,” said Moll, “waiving patents will make it even more difficult to win the fight against the coronavirus.”
The U.S. Trade Representative’s office said the waiver was only part of its strategy, and it was also trying to boost manufacturing not only of vaccines, but of raw materials as well. Amb. Tai said in his statement on Wednesday that negotiations at the WTO “will take time given the consensual nature of the institution and the complexity of the issues at stake.”
It’s not just the multi-billion dollar drugmakers who are skeptical.
Microsoft co-founder Bill Gates – who has invested mountains of money to get drugs to poorer countries – told Sky News last month he was against relaxing ownership rules intellectual for the same reasons. Sky News is owned by Comcast, the parent company of NBC News.
French President Emmanuel Macron said Thursday that while he was “fully in favor of this opening up of intellectual property” he had doubts about how this principle would work in practice, the Associated Press reported.
Advocates say drugmakers have a moral obligation to share because their injections have often been developed with billions of dollars in public money. Pfizer was keen not to accept public funds, but BioNTech, its partner, secured funding from the EU and the German government.
Even supporters know it won’t be easy to give more doses to the poorest countries and hasten the end of the pandemic.
They say the waiver is just one piece of a puzzle that must also include rich countries buying fewer vaccines and donating those they’ve bought, and drug makers making more voluntary deals to that others produce their vaccines.
“We need a multi-pronged approach,” said Siva Thambisetty, associate professor of law at the London School of Economics.
“The renunciation of intellectual property is a masters title – many types of actions must now be implemented.”