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Explained: Why US statement on waiving vaccine patents is important in fight against Covid-19

Why is there a demand to do away with vaccine patents, and what is the importance of the statement by the Biden administration that it would support relaxing intellectual property rights of vaccines?

A syringe is loaded with the Pfizer-BioNTech Covid-19 vaccine at a clinic in Richmond, British Columbia, Canada. (Jonathan Hayward/The Canadian Press via AP)

The Biden administration on Wednesday said it would support waiving patents on Covid-19 vaccines. The statement has important implications because doing away with intellectual property rights will pave the way for cheaper versions of the vaccine to enter the market and also scale up production.

While signaling its intention to do away with patents, US Trade Representative Katherine Tai in a statement said, “The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines…The Administration’s aim is to get as many safe and effective vaccines to as many people as fast as possible.”

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The statement also mentioned that in view of the global health crisis now, “extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures”.

India has been leading a push from lower- and middle-income countries at the World Trade Organisation (WTO) to do away patents on vaccines against Covid. The demand had also been raised by human rights bodies and global advocacy groups. However, the appeals to do away with intellectual property rights have been unsuccessful so far in the face of lobbying by powerful pharmaceutical companies.

So, why is there a demand to do away with vaccine patents and what is the importance of the statement by the Biden administration that it would support relaxing intellectual property rights of vaccines? We explain.

Why is the demand to waive patents on Covid vaccines important?

At present, only drug companies which own patents are authorised to manufacture Covid vaccines. A lifting of patent will allow the recipes to be shared and there will no longer be an embargo — basically once the formula is shared, any company which possesses the required technology and infrastructure can produce vaccines. This will lead to cheaper and more generic versions of Covid vaccines. It will also mean two things — vaccines will be more affordable and this will be a big step in overcoming vaccine shortage.

At a time when many people across India are struggling to get vaccines and shortages are being reported from many states, there is a unanimous agreement on the fact that there is a need to scale up production. An important talking point in recent times has also been the need to have more equitable distribution of the vaccine doses available. For instance, the United States has been reportedly sitting on tens of millions of AstraZeneca vaccines even when Pfizer and Moderna are estimated to deliver 400 million doses by the end of May and 600 million by the end of July. Combined with the 20 million doses Johnson & Johnson is also expected to deliver this month, the United States may have an excess of over 80 million doses.

Inequitable distribution of vaccines has opened up a glaring gap between developing and wealthier countries now — while countries where vaccine orders ran into billions of doses have already given the shot to a considerable percentage of their population and are getting ready to welcome a semblance of normalcy back into their lives, poorer nations that continue to face shortages have overburdened healthcare systems and hundreds dying daily.

But this is against the interests of the world at large. Vaccine experts and human rights groups, including Médecins Sans Frontières and Amnesty International, have warned that the longer Covid circulates in developing nations, there is a greater chance of more vaccine-resistant, deadly mutations of the virus emerging. An Oxfam International report published in March this year states that during a survey of 77 epidemiologists from 28 countries, carried out by The People’s Vaccine Alliance, two-thirds warned that mutations could render current COVID vaccines ineffective in a year or less.

“Unless we vaccinate the world, we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them… We all have a self-interest in ensuring that everyone around the world, no matter where they live have access to Covid-19 vaccines,” Gregg Gonsalves, Associate Professor of Epidemiology at Yale University, was quoted as saying in the report.

The report further stated, “Nearly three-quarters of those surveyed—who included epidemiologists, virologists and infectious disease specialists from institutions including Johns Hopkins, Yale, Imperial College, London School of Hygiene and Tropical Medicine, Cambridge University, the University of Edinburgh and The University of Cape Town—said that open sharing of technology and intellectual property could increase global vaccine coverage.”

Who is demanding that patents on Covid vaccines be lifted?

In October last year, India and South Africa submitted a proposal to WTO to suspend vaccine patents for the duration of the pandemic and share the formula for jabs prepared by AstraZeneca and Pzifer. The proposal argued this would make vaccines more affordable and allow poorer countries to acquire more doses easily. The proposal was supported by more than 100 countries, mostly lower- and middle-income nations, and strongly opposed by some of the world’s largest economies including the European Union and the United States.

World Health Organization (WHO) chief Tedros Adhanom Ghebreyesus in March called for vaccine patent rights to be waived until the end of the pandemic, stating that these “unprecedented times” warrant the move. Countries with their own vaccine capacity should “start waiving intellectual property rights” as provided in special emergency provisions from the WTO, Tedros said at a press briefing.

In April, WHO in one of its online newsroom posts stated that it wants to facilitate the establishment of technology transfer hubs for producing mRNA vaccines. “It is essential that the technology used is either free of intellectual property constraints in LMICs (low- and middle-income countries), or that such rights are made available to the technology hub and the future recipients of the technology through non-exclusive licenses to produce, export and distribute the COVID-19 vaccine in LMICs, including through the COVAX facility,” the WHO post stated. However, the open call issued by WHO has so far received very little expression of interest from the owners of vaccine technology and intellectual property rights.

Human rights bodies and advocacy groups have also been at the forefront of the demand to waive patents and make vaccines more readily available to end the pandemic. For instance, in Australia, more than 700 medical officials and academics signed a letter, supported by Medecins Sans Frontieres and the Public Health Association of Australia, calling on the federal government to throw its support behind the intellectual property waiver proposal.

“Health professionals across the country are urging the Australian government, which is one of a small group of governments opposing the patent waiver, to stand on the right side of history,” Associate Professor Deborah Gleeson, from the Public Health Association of Australia, told the Sydney Morning Herald.

In the United States, senators, House of Representatives Speaker Nancy Pelosi, nearly 100 members of the House, 60 former heads of state, 100 Nobel Prize winners and nonprofit groups who came up with a petition signed by 2 million people have all raised the demand for patent on Covid vaccines to be waived. In Africa, more than 40 charities, including Amnesty International and Christian Aid, have said that the move by Western nations to prevent manufacture of generic vaccines in poorer nations was “an affront on people’s right to healthcare”.

Apart from politicians, civil society members, human rights bodies and health professionals, pharmaceutical companies that have the required infrastructure to produce millions of vaccines if patents are waived have been also raising the demand. Abdul Muktadir, the chief executive of Bangladeshi pharmaceutical maker Incepta, had emailed executives of Moderna, Johnson & Johnson, and Novavax offering his company’s help but never heard back from them, The Washington Post reported. Incepta reportedly has the capacity to produce 600-800 million doses per year to distribute throughout Asia.

There’s more to the story. Biolyse Pharma, a small Canadian drug manufacturer, reached out to Johnson & Johnson seeking permission to produce its Covid vaccine. Biolyse, which has a capacity of producing 20 million doses per year, wanted to produce the vaccine on its own through a compulsory license under Canada’s Access To Medicines Regime, a legislation under which there is an emergency provision for the federal government to waive patent rights. However, Johnson & Johnson wrote back saying it was not interested — it wanted the vaccine doses to be produced only by 11 companies that it had entered into an agreement with.

A nurse fills a syringe with the Johnson & Johnson Covid-19 vaccine in New York. (AP Photo: Mary Altaffer)

Who are opposing the lifting of patents on Covid vaccines and why?

The issue of waiving intellectual property rights is one of conflict between human rights and commercial interests of powerful pharmaceutical companies. Drug manufacturers and governments in the US, UK and Europe have been strongly opposing the patent waiver. This, despite the fact that WHO chief Tedros had said that lifting patents do not mean the innovators will not get anything — they stand to get royalty for the products they manufacture.

The pharmaceutical industry has been arguing that innovation as well as vaccine quality and safety depend on maintaining exclusive intellectual property rights. They have been further arguing that intellectual property rights are important because of the money and effort that goes into research and development — they feel lifting of patents would be a huge deterrent to their investing heavily on vaccine development during pandemics in the future.

They have been also pointing out that lifting of patents would be a compromise on control of safety and quality standards for vaccine manufacturing. They argue that the move would disincentivise pharmaceutical companies and allow countries such as Russia and China to exploit the mRNA technology to their advantage.

Many of these drug companies, which enjoy a monopoly on individual Covid vaccines worth billions of dollars in annual sales, have been lobbying the Biden administration not to do away with the intellectual property rights.

In a recent letter to President Joe Biden, the Pharmaceutical Research and Manufacturers of America, while opposing the lifting patents on vaccines, stated, “Eliminating those protections would undermine the global response to the pandemic, including ongoing effort to tackle new variants, create confusion that could potentially undermine public confidence in vaccine safety, and create a barrier to information sharing. Most importantly, eliminating protections would not speed up production.”

In March, four Republican Senators —Mike Lee, Tom Cotton, Joni Ernst and Todd Young — wrote to President Biden urging him not to accept the proposal to have patents on Covid vaccines waived. “Waiving all rights to intellectual property would end the innovation pipeline and stop the development of new vaccines or boosters to address variants in the virus… Even if the waiver may temporarily result in a few copycats attempting to produce what American companies developed, it would introduce major quality control problems,” they wrote in the letter.

Moderna said in February that its vaccine is expected to bring in $18.5 billion for the company this year. Pfizer has stated that conservative estimates suggest that it would gain $15 billion from sales. Faced with the possibility of losing out on their profit margins and the monopoly, drug companies have been lobbying the US administration to block India’s push for a patent waiver at the WTO. The US Chamber of Commerce, the Business Roundtable and the International Intellectual Property Alliance — all of which receive money from drug companies — had reportedly dispatched lobbyists to oppose the move.

When the WTO’s Trade-Related Aspects of Intellectual Property Rights (Trips) met in March, the proposal to waive off vaccine patents was struck down by Britain, Switzerland, EU nations and the US. The WTO has a consensus-based system, as opposed to a majority voting system.

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What does Biden’s statement mean for India now?

The announcement by US Trade Representative Katherine Tai on Wednesday came after administration officials met important stakeholders in the vaccine patent debate. Biden, in line with his campaign pledge, has supported the patent waiver.

However, the announcement does not mean that patent rules will be waived right away. The decision has to be taken by members of the WTO.

White House Chief of Staff Ron Klain has acknowledged that intellectual property rights are a part of the problem of vaccine shortages that the world is facing today.

If patents are ultimately waived, it will definitely be a shot in the arm to increase the scale and speed of vaccine rollout across the world. For India, which has had the bulk of the vaccine doses it is producing being taken up by foreign countries which could pay more for the doses, this move can help scale up production to meet demand besides making the vaccines more affordable for everyone.

Had the proposal been accepted at the WTO last year, it could have played a crucial role in preventing vaccine shortage in India and preventing the number of daily deaths the country is witnessing now.

However, the crisis is far from over, with Dr K V VijayRaghavan, Principal Scientific Advisor to the Prime Minister, stating on Wednesday that a third wave of the pandemic is inevitable. Once the number of cases and deaths plateau, addressing shortages and making more affordable vaccines readily accessible could be the best way to prepare for the surge once again.

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