Twenty years ago, Big Pharma’s reputation was in shreds. The drug manufacturers had pulled off an atrocious piece of PR. Just as the world was waking up to the growing death toll from Aids in Africa, the major companies took it upon themselves to launch legal action against Nelson Mandela’s government, which had been looking to buy cheaper versions of their patented medicines. As it happens, Aids drugs were then so prohibitively expensive that they were not on Mandela’s shopping list, while generic versions were not available. But that did not prevent a global outcry.
The drug giants hastily threw in the towel. But they have struggled ever since to convince the public of their serious good intent. Their story is that they spend billions of dollars researching and developing medicines and that their huge investment allows us all to live healthier, happier, longer lives. To claw back their massive financial investment, they say, they need patents that may run for 20 years on their medicines. These intellectual property rights prevent other companies from making cheap, generic versions. It guarantees Big Pharma a lengthy monopoly on sales.
Two decades on from that moment they’d like to forget in a court in Pretoria, the pharmaceutical companies want to make that same argument over vaccines against Covid-19. But the honeymoon they enjoyed when the first shots went into people’s arms and hope spread around the world is well and truly over. Only a tiny proportion of the populations of developing countries have been vaccinated, and very few doses have been supplied to them by the leading Covid vaccine companies. In the affluent nations of Europe and north America, millions are now getting booster jabs, while most Africans have had none. It is still true, in spite of the complacency of the well-jabbed nations, that none of us is safe until we’re all safe. That has just been dramatically demonstrated by the identification of the omicron variant in southern Africa, where vaccination rates are perilously low.
It was to forestall such a situation that the Biden administration made a shock announcement in May. The US would back international proposals for a temporary patent waiver for Covid vaccines. A delighted Tedros Adhanom Ghebreyesus, director general of the WHO, called it a “monumental moment in the fight against Covid-19… a powerful example of American leadership to address global health challenges.”
Campaigners for access to medicines who had battled long and hard for patent waivers for Aids drugs were astonished. The US, a home of Big Pharma, had been unmoved and unmovable over patents. Government officials and politicians had always recited pharma’s mantra that they were essential for companies to recoup their investment and pay for more R&D.
Biden’s bolt from the blue came at a meeting at the World Trade Organisation, where the waiver was originally proposed by South Africa and India, to allow generics companies to make copycat versions of the vital vaccines. Negotiations are ongoing. China, France, Russia and Spain support the idea of a waiver, as does Pope Francis, although some think it should go further than the US would countenance, to include all Covid tests and treatments. But no deal has been done.
“Moderna promised not to enforce its patents—but without revealing the ‘recipe’”
It’s no surprise the biggest opposition is from some of the other countries that host major drug companies and vaccine manufacturers. The UK, home to AstraZeneca, and Germany, which has Pfizer’s partner BioNTech, are not for budging.
While the negotiations stumble, the numbers getting vaccinated in the poorest countries hardly rise and the profits made by Big Pharma soar off the scale. According to the campaigning People’s Vaccine Alliance (PVA), the companies making the novel mRNA vaccines, Pfizer/BioNTech and Moderna, have together been clocking up something like $65,000 a minute in profit. That’s $1,000 a second. The companies are on course to make $34bn between them this year.
You might argue that you can’t put a price on human life. You might argue that the companies that have successfully developed these crucial vaccines deserve every cent. But, say campaigners, not only are the pharma companies selective over which lives are to be saved—by deciding where their products should go—but they didn’t do all the work themselves. They benefitted from government money.
In the US, another unprecedented event is unfolding: the National Institutes of Health, the US public health body, is taking Moderna to court. Moderna is trying to clinch a crucial patent on its vaccine. It claims its own scientists are the sole inventors. Not so, says the NIH: three of its scientists worked with Moderna, and must also be named on the patent.
This has been rumbling on for a year behind closed doors, but the NIH director Francis Collins has now confirmed that the institute will see Moderna in court. “I think Moderna has made a serious mistake here in not providing the kind of co-inventorship credit to people who played a major role in the development of the vaccine that they’re now making a fair amount of money off of,” said Collins to the global news agency Reuters.
It’s not just about the money, although NIH stands to share in the profits. Winning would also give the federal agency more of a say over which countries should receive supplies of the vaccine. In mid-November, PVA research showed Moderna had delivered just 0.2 per cent of production to low-income countries, while Pfizer had sent just under 1 per cent; 97 per cent of people in low-income countries have not been vaccinated.
These companies have received large amounts of public funds to develop their vaccines. The success of these and other vaccines is not, in spite of Boris Johnson’s reported but later withdrawn remarks (they were just a joke, he said), a triumph for greed and capitalism. The vaccines are saving lives thanks to taxpayers’ money—a public-private partnership involving expertise and cash. AstraZeneca’s vaccine owes its existence to Oxford University and was helped along with UK government funds. Pfizer and Moderna’s vaccines got $8bn between them from the US.
It is argued that AstraZeneca shows the way forward, with a philanthropic approach that stops short of undermining patents. Yet it is only thanks to the vaccine’s inventors, who made it a condition of partnership, that AstraZeneca’s vaccine has been not-for-profit during the pandemic. On 12th November, chief executive Pascal Soriot effectively declared the arrangement would end in 2022. AZ is now starting to sign lucrative commercial contracts like its rivals, although it pledges tiered pricing to keep the cost down for low-income countries.
Oxford and AZ aspired to vaccinate the world, but sadly they have fallen far short. AZ licensed the vaccine for manufacture in countries from Mexico to China, but the biggest supplier by far was intended to be the Serum Institute of India. And when India staggered under a huge surge of cases, the government temporarily banned all exports.
Big Pharma also argues that scrapping patents on the vaccines will not work because low-income countries don’t have the high-tech plants to make them. It’s another argument that has been heard before, over drugs for HIV at the turn of the millennium. India’s generics company Cipla proved that wrong. It’s said that making mRNA vaccines like Pfizer/BioNTech’s and Moderna’s is especially difficult, but there are companies in India and Thailand that are working on mRNA vaccines of their own. Other companies are being used to “fill and finish” Covid vaccines. In one instance, it was revealed that Aspen in South Africa was partly producing doses of the Johnson & Johnson vaccine for shipping to Europe.
Big Pharma is right that for most factories to scale-up and tech-up to make mRNA or other types of Covid vaccines, a patent waiver is not enough. Moderna, while not technically waiving its rights, generated good PR in October last year for promising not to enforce its patents during the pandemic. But no other company appears to have tried to make it, because Moderna will not reveal the “recipe.” The right technology and expertise are also needed, and investment is vital. Some believe that would all come, once the legal hurdles are out of the way.
There is already a facility to enable patent-sharing. The Medicines Patent Pool, backed by the UN, was born out of the Aids crisis. It’s been used for Covid, albeit as yet only with drugs. In October a US company, Merck, signed an agreement to license its antiviral drug against Covid, molnupiravir, to the pool, so that generics companies in low- and middle-income countries can make it. Pfizer has just agreed to put in its own antiviral Covid pill, which it calls Paxlovid, if it passes trials and is approved. Why then, said campaigners, won’t it do so with its vaccine?
On Covid vaccines, however, Big Pharma still resolutely defends the status quo, insisting enough are being made without recourse to other manufacturers. “With 7.5bn doses produced to date, 12bn by the end of the year, and 24bn by June 2022—supply is not the issue. Redistribution is what needs addressing,” said Thomas Cueni of the International Federation of Pharmaceutical Manufacturers and Associations at the end of September. He says the companies are fulfilling all the orders they have to the UN-backed global vaccine initiative Covax, as well as to low-income countries and high-income governments. Affluent countries should donate their surplus stocks to low-income countries in a timely manner, before the sell-by dates pass.
But as booster campaigns and childhood vaccination drives take off, the definition of surplus in Europe and America changes. And there’s no getting around the fact that many low-income countries are still not at first base. Campaigners, the WHO and many in public health believe the system has to change, not only for this pandemic but for fighting future diseases. Anna Marriott, health policy manager of Oxfam, which is a member of the People’s Vaccine Alliance, told me: “If you can’t learn from this and from the HIV crisis that we need a different approach, then you really have got the blinkers on.”
We’ve long known that it is an unequal world when it comes to health. As the pandemic continues to claim lives and the omicron variant spreads around the world, it is surely time to sort this out for good. Waiving patents, and helping low- and middle-income countries make vital drugs and vaccines, are in everybody’s interests.
