India is among a number of nations to have requested a relaxation of patent laws. Photo / Getty Images
India is among a number of nations to have requested a relaxation of patent laws. Photo / Getty Images
As the world stood still in lockdown in April 2020, a group of Oxford researchers packed the cell cultures needed to make their experimental coronavirus vaccine and quietly shipped them to India's Serum Institute.
The scientists were worried that the university's prospective partner, AstraZeneca, eager to control the intellectual propertybehind the shot, would stop them, and that their vaccine would never reach the poorer nations that most needed it, according to three people with knowledge of the matter.
In the case of AstraZeneca, their fears would prove to be unfounded. Oxford and the Anglo-Swedish drugmaker have since signed a licensing deal with Serum and produced hundreds of millions of doses of the cheap, portable jab for middle and lower-income countries.
But with hindsight, the covert shipment, intended to guarantee the mass production of Covid-19 shots at low costs, was an opening salvo in the fraught battle over intellectual property and technology transfer in which the world is now embroiled.
"We considered the risk of [Serum] going rogue and we didn't want that to happen," Oxford's Sandy Douglas, one of the researchers developing the shot, told the Financial Times. "But that doesn't mean we weren't conscious AstraZeneca might have had a different view and that it might have preferred to have total control."
The pharma group deserved "credit", Douglas said. "Once [AstraZeneca] got over their initial hesitance, they really did run with the tech transfer to poorer nations," he said. AstraZeneca, Oxford and the Serum Institute declined to comment.
But few other pharma companies have done the same, and when India and South Africa approached the World Trade Organization in October last year with a proposal to suspend intellectual property rights for all Covid-related drugs and technology, it was quickly shot down. Such a move would make it easier and cheaper for third parties to manufacture the most successful vaccines and treatments, thereby boosting and diversifying production, India and South Africa said.
The pharmaceutical industry has countered that waiving patents, which it says are necessary to protect the investment needed to bring drugs to market, would not lead to more doses. Pharma executives say they are already doing everything possible to scale up production and that third-party manufacturers lack the experience and know-how needed to produce complex vaccines without help.
Companies are really trying to see how much they can push for monopoly rights in the future
Hyo Yoon Kang, a senior law lecturer at the University of Kent, UKMost western governments had supported the companies' position until the US, in May, stunned the industry by backing the proposed patent waiver for Covid-19 vaccines.
But three months later little has changed. WTO talks over the proposed waiver were suspended without progress at the end of July as delegates dispersed for the European summer holidays. Despite a request from WTO director-general Ngozi Okonjo-Iweala for members to shorten the break given the urgency of the issue, they do not plan to reconvene until September.
Observers said the US move, while symbolic, had so far done little to address the technicalities needed to see it through and accused the EU, UK and other high-income countries of continuing to obstruct progress.
Despite encouraging rhetoric, the Biden administration has failed "the most obvious test of leadership" in not directly confronting those pharmaceutical companies "obstructing global access to life-saving vaccines", said Asia Russell, executive director at Health GAP, an advocacy group.
"This shirking of responsibility has led us to today's nightmare," she said. "Only 1.3 per cent of people in low-income countries are vaccinated, while the White House has no real strategy to deliver the 14bn doses the world needs to end this crisis."
Generic drug manufacturers say delays are proving costly. "The way these companies have restricted manufacturing because of their paranoia has actually seen vaccine shortages," said Kiran Mazumdar-Shaw, head of India's Biocon. "Pfizer and Moderna kept it all very closed, deciding to engage only with a handful of manufacturers."
India was one of the world's biggest vaccine suppliers, she said. "Why not make it a very important part of your global supply chain? You have excluded them because of IP and now the world is suffering. It's very myopic thinking."
Pfizer and its partner BioNTech have pledged to make 500 million doses of the vaccine available to 100 low-income nations next year. Photo / Getty Images
Pfizer and its partner BioNTech plan to fill and finish vaccines at a manufacturing hub in South Africa from next year. The two companies have pledged to make 500m doses available to 100 low-income countries but few other companies have promised substantial supplies.
Top global health officials have become increasingly exasperated with the industry's inability to boost access and clashed with pharmaceutical executives at a WTO meeting last month, according to two people familiar with what was said.
Pfizer told the FT that "weakening IP rules will not solve these [access] challenges nor will it get vaccines to patients any faster". Moderna did not respond to a request for comment.
It is not the first time the pharmaceutical industry and other stakeholders have been at loggerheads over patents. A battle over HIV drugs in the 1990s culminated, in 2001, with Indian pharma manufacturer Cipla's decision to offer generic medicines for US$350 per patient per year instead of the US$10,000-US$15,000 charged by the big pharma groups, sending shockwaves through the industry.
WHO director-general Tedros Adhanom Ghebreyesus has warned the HIV epidemic, which saw millions die in the 10 years it took to make drugs available to the poor, showed the world what not to do.
The current shortage was not a "momentary" problem, said Hyo Yoon Kang, a reader in law at the UK's University of Kent. "Companies are really trying to see how much they can push for monopoly rights in future pandemics."
Suerie Moon, the co-director of the global health centre at Geneva's Graduate Institute, added that the current regulatory framework for the global pharmaceutical industry had been found wanting.
"We don't have clear policy frameworks that articulate the social contract," she said. "If we don't find a solution, if we don't demonstrate that the rules can be flexible enough, that they can stretch to take into account the emergency, they become more fragile, they lose their legitimacy and become less acceptable overall."
