How Significant is US’ Proposal to Waive COVID-19 Vaccine Patents?

Had the patents been waived last year, a larger vaccine basket could have changed India’s current COVID trajectory.

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The Joe Biden administration on Wednesday, 5 May, threw its support behind the proposal to waive intellectual property protections for COVID-19 vaccines, which will help poor nations accelerate their vaccination programmes, as more drug makers will be able to manufacture the vaccine.

US Trade Representative Katherine Tai, in statement released on Wednesday, stated on Twitter that “these extraordinary times and circumstances call for extraordinary measures.”

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. 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,” Tai said in her statement.

So, why has it taken so long for the protections to be lifted given multiple countries are witnessing spikes in cases? What does the proposal from India and South Africa exactly state? And how significant is the US’ move to waive the IP protections for vaccines? Lets discuss.

What Does the Proposal for Lifting Vaccine IP Protections State?

The proposal, which is being spearheaded by India and South Africa, was filled on 2 October 2020, which called for “global solidarity, and the unhindered global sharing of technology and know-how in order that rapid responses for the handling of COVID-19.”

The proposal asked for a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in relation to prevention, containment or treatment of COVID-19.

Temporary relaxation of these sections of the TRIPS Agreement will allow more countries to produce or import generic versions of coronavirus vaccines, rather than wait months or years for enough doses to immunise their populations against the deadly virus.

Why the Delay in Waiving the IP Protections?

The debate around the lifting of protections has been fought between activists who back the lifting of the protections and pharmaceutical companies and lawmakers who believe that sharing the patents could backfire.

The petition in the past was also blocked by the United States under former president Donald Trump’s administration and by other nations, including Britain and Canada, fearing that the sharing of patents may throw global vaccine productions into disarray.

A majority of the House Democrats had put pressure on the Biden Administration on 30 April to “restore America’s public health leadership on the world stage.”

In an interview with US-based activist Ady Barkan in July 2020, six months before he took office, Biden stated that he will be lift the waivers on vaccine patents, adding that it is the “humane thing to do.”

How Significant is the Move of US Backing Waiving of Patents for India?

The US announcement comes at a time when India is witnessing large scale devastation brought on by the second wave of COVID-19, which has severely impacted its healthcare system and economy.

At a time when rich countries have been accused of hoarding vaccines, the move could help other nations in their vaccination programmes, as more drug makers will be able to manufacture the vaccine.

India has appreciated the Biden administration's decision to support the proposal moved by India and South Africa.

India's Ambassador to the US Taranjit Singh Sandhu said, “We appreciate the US administration's announcement today of its support for waiver of IPR for COVID-19 vaccines,” PTI reported.

Not only India and South Africa, but World Health Organisation (WHO) chief Tedros Adhanom has also been pleading for patent waivers. He has, in the past, lashed out against perceived vaccine-hoarding by richer nations.

For example, the US has been sitting on millions of AstraZeneca vaccines, which are branded as Covishield in India, even as other vaccines manufactures like Pfizer and Moderna have confirmed deliveries of 400 million doses by May and 600 millions doses by July of their vaccines. Plus, Johnson and Johnson is also expected to deliver close to 20 million doses by May end, thus leaving US with 80 million doses in excess.

According to Dr Anant Bhan, Adjunct Professor & Researcher in Bioethics at Mangaluru’s Yenepoya University, even if the proposal is passed, it will take a lot of time in the technology transfer and setting up of the facilities.

“Its obviously an important step but till you tech transfer, you need hand holding to be able to set up facilities. That’s only one of the steps. Especially for more complex platforms, like mRNA platforms. It is an important step and it’s time that we look at some of these models that give us the ability to scale of vaccine production. However, there needs to be more done. But it’s good to see that this is moving forward,” said Dr Bhan, in an interview with FIT.

How Has the US' Move Been Received?

The move to waive patent protections for COVID-19 vaccines has prompted ire from the Pharmaceutical Research and Manufacturers of America (PhRMA), who in a statement on 5 May stated that the “unprecedented step will undermine our global response to the pandemic and compromise safety.”

“This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines,” the PhRMA statement read.

However, elsewhere, the decision has come in for praise. The WHO chief has commended the Biden-Harris administration for the move, adding that it “is a powerful example of American leadership to address global health challenges.”

“I commend the United States on its historic decision for vaccine equity and prioritising the well-being of all people everywhere at a critical time. Now let's all move together swiftly, in solidarity, building on the ingenuity and commitment of scientists who produced life-saving COVID-19 vaccines,” he said.

Support for the move has also come from Medecins Sans Frontieres (MSF) Access Campaign and it has also appealed to other countries to stop stalling the waiver.

"India like the United States has witnessed a frightening rise in infections and deaths from COVID-19 with its healthcare system reaching breaking point. Numbers have never been so large anywhere in the world before. MSF welcomes the US government's bold decision to support the waiving of intellectual property on COVID-19 vaccines during this time of unprecedented global need. It is crucial that this waiver not just apply to preventative vaccines, but it should also cover other medical products for COVID-19, including treatments for people who fall ill and diagnostics to help curb the spread, as originally proposed by India and South Africa seven months ago,” said Leena Menghaney, Head South Asia, MSF.

“MSF appeals to Norway, UK, Canada, EU and Japan to join the US in the negotiations and stop stalling the proposal to waive of all intellectual property restrictions that may be faced in expanding the number of manufacturers to meet the needs of the developing world,” she added.

Will the Vaccine Patents be Waived Off Immediately?

The patents will not be waived immediately since the final decision rests upon the members of the WTO. If the waivers are lifted, it will signal a shot in the arm for India’s vaccination drives and help scale up production to meet the demand of vaccines.

According to a Washington Post report dated 1 May, the final agreement could differ significantly from the current proposal and deliberation could fall apart entirely.

“Text-based negotiations are important. It just takes a long time to get consensus in the WTO around specific language,”reported The Washington Post, quoting Nao Matsukata, who served in the George W Bush administration’s trade office and helped work on the 2001 agreement which set the base for the existing intellectual property protections.

After the US cleared path for the vaccine patents, European Union President Ursula von der Leyen announced on 5 May that the bloc of nations is also ready to discuss the now US-backed proposal.

“The European Union is also ready to discuss any proposal that addresses the crisis in an effective and pragmatic manner," she said. “And that’s why we are ready to discuss how the US proposal for waiver on intellectual property protection for covered vaccines could help achieve that objective."

Had the proposal been accepted last year, a larger vaccine basket could have changed India’s trajectory and prevented the spike in cases and deaths we are witnessing right now.

(With inputs from Washington Post)