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COVID-19 | US support for waiving vaccine patents, India’s role and other questions answered

What does the US decision to support an initiative at WTO for temporary waiver of patent protection for COVID-19 vaccines mean for India? Below is a primer.

May 06, 2021 / 11:28 AM IST

On May 5, the United States said that it will support an initiative at the World Trade Organisation (WTO) for a temporary waiver of Trade Related Intellectual Property Rights (TRIPS) protection for Covid-19 vaccines.  Here’s a lowdown.

Why is it a big deal?

This would help quickly ramp up the production of Covid-19 vaccines across the world. The US’s move will help rally support for temporarily removing patents on Covid-19 vaccines and making these eligible for production by drugmakers across the world.

Vaccines, like most other so-called “innovator” drugs, are subject to patent protection under the World Trade Organisation’s (WTO) TRIPS agreement.

The TRIPs agreement, to which India is a signatory, makes it mandatory for member countries to guarantee 20-year patent protection to companies that produce “new drugs.”

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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A temporary waiver on Covid-19 vaccines’ IP rights would mean that tens of drugmakers across the world can be contacted simultaneously by sharing know-how with them to rapidly produce these vaccines.

To inoculate 7 billion people, the world would need to produce about 14 billion vaccines (two doses for each individual). At the current pace, it will take several years to reach that volume of production. Mass vaccination remains the only potent tool to deal with the ferocity of Covid-19, for which more and more vaccine production centres will have to be opened up to make these jabs by billions.

What has been India’s role in rallying support for a waiver of Covid-19 vaccine patents?

Last year, in October, India and South Africa moved a joint proposal at the WTO seeking a temporary waiver of the IP rights (patents) on Covid-19 vaccines and drugs.

Both the countries have argued that when production of vaccines needs to be scaled up to meet demand, WTO should recommend “a waiver from the implementation, application, and enforcement of” certain provisions of the TRIPS Agreement (waiving intellectual property rights like patents, copyright, and trademarks) for prevention, containment or treatment of Covid-19.

The proposal has since been co-sponsored by Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group, the Least Developed Countries (LDC) Group, and most recently Maldives, Fiji and Namibia — a total of 60 WTO members.

On April 16, ten Democratic Senators led by influential Bernie Sanders have urged US President Joe Biden to support India and South Africa's proposal to the WTO to temporarily lift certain intellectual property barriers and allow countries to locally manufacture COVID-19 diagnostics and vaccines, arguing that this is key to end the pandemic and a strong American recovery.

What has the Joe Biden administration said on the matter?

On May 5, the US Trade Representative (USTR) Katherine Tai issued a statement stating that the US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic. “We’ll actively participate in WTO negotiations to make that happen,” the USTR said. “These extraordinary times and circumstances call for extraordinary measures”.

When will the WTO decide on this matter?

At a meeting of the TRIPS Council on April 30, WTO members agreed to continue consideration of the proposal for a temporary waiver of certain TRIPS obligations in response to COVID-19 and tasked the chair to report to the General Council on this decision at its 5-6 May meeting.

The WTO General Council is currently meeting over two days (May 5-6) to discuss the matter. On May 5, WTO Director General Okonjo-Iweala underlined the urgent need to address equitable access to vaccines, describing it as the “moral and economic issue of our time”.

Supporters of the proposal were of the view that the current challenges posed by the pandemic can only be effectively addressed by waiving certain TRIPS obligations. Other delegations remained unconvinced about the necessity for a waiver at the international level, with some members arguing that a waiver might undermine ongoing collaborative efforts.

The USA's decision to support a temporary waiver on IPs of Covid-19 vaccines will likely embolden the cause for making the vaccines more equitably available in rapid time across the world.

How soon can we expect a patent waiver, if it happens, to take place?

A decision can be expected as early as June, provided those supporting a proposal can hammer out a broad consensus among WTO member nations in wake of a surge in the pandemic and its devastating consequences.

The proponents of the TRIPS waiver proposal, mainly driven by India and South Africa, will submit a revised text initially submitted in October 2020 in a bid to reconcile positions.

A meeting open to all members in the second half of May to discuss the revised proposal before the next formal TRIPS Council meeting scheduled for early June.
Gaurav Choudhury is consulting editor, Network18.

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