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Public Health Must Be the Highest Law

Public Health Must Be the Highest Law

A healthcare worker gives a dose of Covishield to a woman inside a school converted into a temporary vaccination centre, in New Delhi, May 4, 2021. Photo: Reuters/Adnan Abidi

Africa has 17% of the world’s people but has only administered 2% of all COVID-19 vaccine doses given worldwide. By early April, more than 700 million vaccine doses had been administered around the world – more than 87% of them in upper-middle-income countries, versus only 0.2% in low-income countries.

Currently, eight vaccines are being used overall. No country is using all of them but the richer nations have access to three or four, having placed advance orders. The vaccine makers are also typically based in these countries, and have patents that prevent others from manufacturing them. As a result, the US is expected to have a stockpile of 300 million excess doses by July 2021, while many countries will have to wait for years before they can vaccinate a significant fraction of their populations.

At the same time, wealthy nations have recognised that if COVID-19 has to be effectively and quickly tackled, everyone everywhere must be vaccinated. This is not a healthy argument, of course.

One vetoed solution

To correct the discrepancy, the WHO in March asked companies to “waive patents temporarily” (emphasis added). Subsequently, 100 countries joined India’s and South Africa’s chorus, along with organisations like Médecins Sans Frontières.

But this effort has thus far been blocked at the WTO by the US, the EU and the UK, with a crucial role played by the self-appointed czar of the vaccine world, Bill Gates.

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With the TRIPS meeting set to take up the issue in just a few days, global demands to temporarily relax monopolies gained momentum. Initiatives like the WHO’s COVID-19 Technology Access Pool called for “shared knowledge, intellectual property and data”. At the same time, these calls were challenged a similarly coordinated barrage of articles advocating corporate philanthropy, like Gates’s ACT-Accelerator and COVAX – without addressing how insufficient and feeble on the ground these efforts are.

One particular article published in STAT News, entitled ‘No evidence that patents slow access to vaccines’, by Andrei Iancu was eye-catching.

Iancu served as the under-secretary of Commerce for Intellectual Property and director of the US Patent and Trademark Office in 2017-2021. His is an influential voice.

“President Biden is reportedly weighing whether to back the waiver,” Iancu wrote. If this were to occur, there will be major repercussions for Big Pharma. Iancu should know, after all: he was the under-secretary of commerce for intellectual property – which is a gentle term for monopoly.

He is also a senior adviser to the Renewing American Innovation Project (RAIP) at the Center for Strategic and International Studies (CSIS). This is notable.

According to the CSIS website, its “purpose is to define the future of national security.” It should be no surprise then that CSIS is funded by the US and the UAE governments, weapons manufacturers, defence contractors and oil companies. Its president and CEO John Hamre has been associated with the US Department of Defence.

RAIP is a CSIS initiative concerned with restoring and maintaining the US’s “postwar status as the world’s foremost centre of innovation and advancement in science and technology… [It] recognises the growing challenges the US faces from robust competition in this space – from China and elsewhere.”

Further, according to RAIP, “IP is more important than ever… But America’s patent system is lagging in dealing with important developments that are now affecting the ability to exploit the insights needed for future products and services – meaning that broad awareness of these issues is needed for technological advancement and economic security.”

In line with its mandate, CSIS/RAIP launched a campaign, including seminars and awareness programmes, to promote IP; his STAT News article is one link in this chain. In an online session conducted by the CSIS in March 2021, Iancu and others described how urgent the IP question has become and spoke about expanding IP’s scope to other hitherto patent-unprotected areas like diagnostic methods as well.

If the demand to waive patents for COVID-19 treatments gathers steam, we will see an avalanche of “scientific” papers, articles, discussions and roundtables strengthening the role of IP and broadening its scope. Otherwise, there will be grave consequences for Big Pharma, even if this threat has been presented as a national security issue. In short, Iancu’s article didn’t arise from a vacuum but is part of a deeper plan to ensure Big Pharma’s hegemony stays unchallenged.

Half-truths, half-lies

As a technology-dependent country, India’s patents Act discourages patenting frivolous inventions and excludes patenting software, plants, animals or their parts and known chemical molecules. Photo: Reuters

Iancu continues, “Proponents of the idea say it would boost vaccine supply and access. The problem is, there is no evidence for this claim.”

It is unlikely that ignorance could have led to this assertion. One Google search later, I’m reading a Harvard University study showing patents have a negative effect on access to anti-HIV drugs.

Perhaps more important, do we need any evidence at all? More than a third of the world’s population doesn’t have regular access to medicines, with poverty as the most important cause. It is a well-known fact that monopolies allow patent-holders to charge high prices, leading to lack of access among poorer nations. The WHO has been pointing this out for decades.

Third, patents restrict access to products and also prevent other scientists from improving on patented inventions, thus discouraging innovation and widespread adoption. There is enough historical evidence regarding steam engines, aeroplanes, software, even drugs, to back this up. Many life-saving drugs, including insulin, penicillin, the polio vaccine, ORS, etc., were never patented.

Finally, it is also well-known that companies spend more to market medicines than on R&D. They also try to extend the patent lives of their medicines through evergreening techniques. Many companies also focus more on financial operations rather than drug-discovery and development. Stress on less risky me-too drugs leads to important diseases missing out on new drugs. All of these are correlated with patents-profits.

Back to Iancu: “the push by India and South Africa appears to be disingenuous, aimed not at curbing the pandemic but at allowing domestic companies to make money off of others’ IP.”

India and South Africa did not “push” for manufacturing only in their countries but around the world. Even if this wasn’t the case, the originator companies still get royalties even as the vaccines available increases. This is an important consideration because viruses circulating in communities are likely to mutate, rendering existing vaccines ineffective in a year or so.

Nevertheless, it might have been if India had walked its talk at the WTO, and licensing other manufacturers to produce vaccines.

Iancu then regurgitates Big Pharma’s arguments about drug development being risky, expensive and patents being the excuses to invest in research. Iancu even threatens that there will be “worse trouble when the next pandemic comes around, in five, 10, or 20 years” if governments revoke patents now. “On the contrary, IP rights made it possible for research scientists to make the decades of investments required to develop and deliver safe and effective COVID-19 vaccines in record time. Companies would not share such critical technology with competitors if the law didn’t protect their investments.”

These arguments have more holes than Swiss cheese. The riskiest part of new drug discovery is when scientists try to gain insights into disease pathophysiology and look for proteins and receptors to target for treatment. According to Iancu, the success rate on these fronts is lower than 12%. This is also why such research is often left to government-funded institutions. A recent study stated, “NIH funding contributed to published research associated with every one (emphasis mine) of the 210 new drugs approved by the FDA from 2010-2016.”

Others have come to similar conclusions, as I discussed for The Wire in 2019.

Big Pharma turns up once a public institute has completed the risky part, exploring the possibility of developing new drugs with relatively high chances of success, and thus swiftly appropriates decades of public-funded academic work.

Consider the mRNA vaccines for COVID-19. The story of Katalin Kariko, who got her PhD from the Hungarian University of Szeged, a public-sector institution, is particularly instructive – and also the norm.

She spent many years studying mRNA at the University of Pennsylvania, funded by government money, and her findings led to the Pfizer-BioNTech and Moderna vaccines. Other components of these vaccines were developed by scientists at yet other universities, also using tax money, including using lipid nanotechnology and the use of the spike protein as the antigen.

Let’s also not forget that Chinese scientists disclosed the viral genome on an open-access platform as early as January 2020.

Moderna received $955 million from the US government’s Biomedical Advanced Research and Development Authority, before securing a $1.5-billion government deal for 100 million doses. All this led to a demand to call it “the people’s vaccine”.

In 1986, the US government passed the Vaccine Injury Act, following heavy pharma lobbying, to remove the financial liabilities of vaccine manufacturers due to vaccine injury claims. Patients remain entitled to compensation but from the government’s coffers, through an excise tax on each dose of the vaccines. This is a classic example of wealth transfer.

Closer home, although Bharat Biotech has said it didn’t receive any government funding in the development of Covaxin, we can’t deny the crucial roles (virus isolation, pre-clinical and clinical studies) that the National Institute of Virology, Pune, and the Indian Council of Medical Research essayed. The Central government’s Department of Biotechnology also chipped in with another Rs 65 crore for a BSL-3 facility while the finance ministry offered Rs 1,500 crore. Covaxin is also the people’s vaccine.

Human Rights Watch’s criticism is therefore appropriate:

“Throttling vaccine production globally by blocking the TRIPS waiver … is a scandal that affects us all. It’s galling to hear pharma moan that a temporary waiver would ‘disincentivise’ them from making future vaccines. Apart from bordering on extortion, it’s ahistorical. What incentivised them last time was our taxes. Our governments poured billions into developing vaccines. They could be thus incentivised again in future, obviously.”

But then there is a clever bit of illusion composed of half-truths and half-lies. Iancu:

“So before governments take the risk of waiving patents, they should evaluate whether intellectual property rights are really standing in the way of vaccine manufacturing and distribution. To do that, they need to answer two questions:

Is there evidence that a broad range of Covid-19 vaccine developers have been asked for, and unreasonably refused, licenses to their IP?

Are there more facilities that could manufacture a vaccine in short order if they just had the intellectual property?

The answers are no and no. The issues about making more vaccines and distributing them to every country are far more complex than those proposing to waive intellectual property rights on these vaccines would have us believe. Manufacturing and distributing these vaccines is extremely complicated, posing issues well beyond patents.”

The last bit is clearly half-true. No one can deny that issues of production and distribution are significant in ensuring access to vaccines – but they don’t make the patent issue go away!

Several manufacturers are ready to produce vaccines; they only need permission from the monopoly regime. While Iancu says there are no facilities that could manufacture vaccines quickly, he also writes, “Almost every factory on the planet that can make these vaccines is already doing so”. One of these statements is therefore false, or they’re both half-false.

The czars

Bill Gates in 2008. Photo: World Economic Forum/Flickr, CC BY NC SA 2.0

Iancu goes on to quote the two people least likely to say anything contradicting his thesis: Serum Institute CEO Adar Poonawalla and Bill Gates. “Believe me, IP did not limit anything,” Gates had already said in a podcast published earlier.

Gates also proposed in an article published in the New England Journal of Medicine in April 2020 that rich countries “can help low- and middle-income countries prepare for this pandemic. … By helping African and South Asian countries get ready now, we can save lives.”

As it happens, he also stressed the need for “larger systemic change” to meet the pandemic but one that is driven by the public sector: “Government funding is needed because pandemic products are extraordinarily high-risk investments; public funding will minimise risk for pharmaceutical companies and get them to jump in with both feet.”

Using his immense wealth and power, plus his widely-publicised stature as a humanitarian, this modern-day czar is perhaps the single most important figure in the way of patent waivers, letting public interest to lose to the for-profit Big Pharma.

Iancu finally acknowledges that “those advocating for patent waivers have their hearts in the right place” but concludes that it shouldn’t be done. Ordinarily, we may be able to ignore one article, even by a high-profile author, but this isn’t the case here. Here, something deeper lurks.

It could be about Big Pharma wanting to avoid creating a precedent for IP waivers. But even should a one-time concession be given, international and national courts may not allow more instances of such “IP violation” in the future.

Or it could be about pandemic profiteering, but this isn’t likely. Big Pharma already stands to make enough. For example, Pfizer-BioNTech is expected to make $7.5-12.5 billion in profits in 2021-2022. These figures will increase if other companies around the world are allowed to manufacture their vaccines well, thanks to licensing fees.

Precedence and profiteering are fairly straightforward, but they exist in another, more treacherous form.

The first real reason lies in the mRNA technology, which has a big future. Financial Times recently reported how industry lobbyists had started to warn officials in Washington about the “dangers” of passing the technology on to Russia or China, as these countries could use the technology to develop new vaccines (say, for malaria) as well as drugs for cancer and heart disease.

Words desert me. Do monopoly-protected, US-based Big Pharma endeavours have monopolies on finding the cures for many of the world’s most important diseases as well? Where do the hearts of Big Pharma, Iancu and the organisation he represents lie?

The second real issue lies with monopolists’ plan to expand to hitherto unpatentable areas, like diagnostic methods. We know that diagnostic equipment, kits and chemicals are patentable, but the methods are not. Efforts to undermine IP using COVID-19 as an excuse could create a powerful, undesirable precedent. Any defeat related to IP, however inconsequential, will in turn make it harder to include more categories under IP.

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Big Pharma’s IP concerns promoted by influential lobbyists, supported by organisations capable of turning it into a ‘national security’ issue and backed by powerful philanthropists are necessary to distract from the real issues, to evade public reaction. The author is but a minor irritant, or as Gates has said, a “spoiled child demanding ice cream before dinner”.

The historian Frank Snowden ends his 2019 book Epidemics and Society: From the Black Death to the Present thus: “In the ancient but pertinent wisdom, salus populi suprema lex esto – public health must be the highest law, and it must override the laws of the marketplace.” This pandemic has shown that whatever, if any, utility patents provided in the past, the time has come for us to let them go.

Dr Samir Malhotra works at the Post-Graduate Institution of Medical Education and Research, Chandigarh.

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