India’s WTO proposal on Covid-19 vaccine IP waiver gets key backing

NEW DELHI: In a potential global breakthrough, the United States, European Union, India and South Africa are closing in on a draft “compromise agreement” on waiving intellectual property (IP) rights for Covid-19 vaccines, according to a tentative text that arrived at last week which HT has reviewed.

The text was first circulated among representatives of the US, EU, India and South Africa, and then to all World Trade Organization (WTO) members, an official said on conditions of anonymity.

A key condition in the draft text is that a waiver could apply to a “developing country member that exported less than 10 % of world exports of Covid-19 vaccine doses in 2021”. Most developing nations have not crossed the threshold.

Developing countries, including India, have been negotiating for long at the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) for waiving IP rights to universalise access to Covid-19 vaccines.

The WHO has repeatedly warned that vaccine inequities – richer countries have more vaccines and vaccination rates – are the biggest hurdle in ending the pandemic and protecting millions of the world’s poor.

It’s still uncertain if the proposal will go through because it must be approved by WTO’s all 164 member nations.

India’s waiver application was not limited to just vaccines but includes “diagnostics and therapeutics in relation to prevention, containment or treatment of Covid-19”. But, the draft text proposes a waiver for only vaccines .

On 17 May 2021, HT had reported in detail the complexities of Covid-19 vaccine IPs and India’s stand on the matter. If the proposal moved by India and South Africa jointly on 2 October 2020 at WTO goes through with US’ backing, it would prevent countries from implementing patents, trade secrets or other monopolies on Covid-19 vaccines under the WTO’s agreement on TRIPS.

The draft text permits access to the “patented subject matter required for the production and supply of Covid-19 vaccines without the consent of the right holder to the extent necessary to address the Covid-19 pandemic”.

A surprising US decision on 5 May 2021 had stirred hopes of bridging the great vaccine gap. The Joe Biden administration said at the time that it will support temporarily waiving IP protections for coronavirus vaccines, something India and South Africa are pushing for.

“Still, it has come too late and doesn’t seem to be strong,” Madhu Pai, the Canada Research Chair of Epidemiology & Global Health at McGill University, told HT, adding “I have not had time to study this in detail.”

According to the World Health Organization, nearly 80% of Covid-19 vaccines had been administered in just 10 rich countries last year, while more than 2.5 billion people await their first shots.

Tahir Amin, an IP expert, said the draft text this week over the waiving of IP rights on Covid-19 vaccines shows “it’s a half-baked solution that the global north and its pharma lobbies will be content with”.

The text is limited to allowing the use of patents, which is “not enough”, according to Amin, because it doesn’t cover waivers for full trade secrets and “undisclosed clinical trial data”.

Currently, pharma companies enjoy patents, which legally protect their products from being copied or cheaper generic versions being made. This allows developers of original products a monopoly to earn profits, for at least 20 years.

“Whether America’s support of the waiver will have impact on people’s lives in India depends on a number of factors, such as how quickly the negotiations move and what the terms of the final waiver are,” said Priti Radha Krishtel, co-founder of Initiative for Medicines, Access & Knowledge (I-MAK).

“Just having access to a patent does not mean all countries are equipped with the technological infrastructure to scale up manufacturing of generic counterparts. Companies like Moderna and Pfizer will need to establish helpful partnerships and collaborations with companies, say in India,” said Bhramar Mukherjee, professor of global public health at University of Michigan.

In a paper, scholars Mario Gaviria and Burcu Kilic in the first analysis of mNRA vaccine patents in the journal ‘Nature’ published on 12 May 2021, stated that this vaccine platform uses multiple technologies, including the main mRNA technology, lipid nanoparticle technology and a delivery system.