Patents off as India gets US, EU backing

WASHINGTON/NEW DELHI: The Biden administration on Wednesday announced the US will support temporary waiver of intellectual property rights to Covid-19 vaccines, accepting a key element of a joint proposal by India and South Africa at the World Trade Organization (WTO), and said it will “actively participate” in negotiations to “make that happen”.

The decision, also backed by French President Emmanuel Macron, reversed former president Donald Trump’s opposition to the proposal in its entirety. It was welcomed as a “monumental moment” by WHO director general Tedros Adhanom Ghebreyesus and was a called a “bold decision” by Doctors Without Borders (Médecins Sans Frontierè — MSF).

The UK and the European Union, too, indicated a change in their posture, but the German government opposed the move, saying it would create “severe complications” for future vaccines.

People familiar with the matter said it is a “limited waiver” that the US is supporting, as it covers only vaccines and not therapeutics and related technologies as proposed by India and South Africa. And, given the consensus-based approach of the WTO, it will not happen overnight.

“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,” US trade representative Katherine Tai said. “We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen.” Following US announcement, the EU and the UK also indicated a change in their posture, or a willingness to do it. European Commission president Ursula von der Leyen said “we are ready to discuss how the US proposal for a waiver on intellectual property protections for Covid-19 vaccines could help achieve that objective” of addressing the global crisis.

French President Emmanuel Macron, too, reversed his previous stance and said he is “absolutely in favour”. In London, a government spokesperson said, “The UK is working with WTO members to resolve this issue. We are in discussions with the US and WTO members to facilitate increased production and supply of Covid-19 vaccines.”

The proposal will now be discussed and cleared by the general council, which is the highest decision-making body of WTO. The council will lay down conditions under which member countries will be allowed to “violate” the agreement on TradeRelated Aspects of Intellectual Property Rights (TRIPS), which protects patents and copyrights. This could take weeks and months or years as it did when WTO dealt with patented drugs and HIV/AIDS that was the last time it confronted similar policy challenges, according to people familiar with ongoing negotiations.

Officials in India welcomed the decision. “We welcome the statement of the US government of 5th May announcing their support for this initiative. We are hopeful that with a consensusbased approach, the waiver can be approved quickly at the WTO,” the external affairs ministry said in a statement. “The waiver is an important step for enabling rapid scaling up of manufacture and timely availability of affordable Covid-19 vaccines and essential medical products,” it said.

In the joint proposal filed in October, India and South Africa had sought a waiver of TRIPS provision “in relation to prevention, containment or treatment of COVID-19”, covering, in other words, vaccines, diagnostic kits and technologies and therapeutics such as remdesivir. The US support for waiver is only for vaccines.The Biden administration was under mounting pressure from lawmakers of the ruling Democratic Party, rights groups at home and a growing number of WTO member nations — more than 100 at last count — to reverse US opposition to the waiver proposal ordered by Trump, who was in office when India and South Africa moved their joint proposal last October. The US was joined in its opposition to the waiver by the EU, the UK, Japan and Switzerland, essentially developed countries that had built up sizable stockpiles of vaccines and therapeutics.

“The administration’s aim is to get as many safe and effective vaccines to as many people as fast as possible,” Tai said. “As our vaccine supply for the American people is secured, the Administration will continue to ramp up its efforts – working with the private sector and all possible partners – to expand vaccine manufacturing and distribution.”

“I warmly welcome her willingness to engage with proponents of a temporary waiver of the TRIPS agreement to help in combating the Covid-19, pandemic,” Ngozi Okonjo-Iweala, World Trade Organization chief , said in a statement, read to reporters by her spokesperson Keith Rockwell.

India and South Africa moved the proposal before WTO calling for temporary waiver of the agreement on TRIPS to protect patents and copyrights, with the goal of ensuring easy and affordable access globally, and specially to developing countries, to Covid-19 vaccines, therapeutics and related technologies till the pandemic had been crushed.

GAVI, the global vaccine alliance said: “We recognise also the significance of the (Biden) administration’s commitment to work towards increasing raw material production which will have an immediate impact on alleviating current global supply constraints.

Gavi urges now that in the interests of global equitable access the US supports manufacturers to transfer not only IP but also know-how in a bid to urgently boost global production.”The proposal secured the support of the majority of the members of the WTO but ran up against a small group of developed countries led by the US.

The pharmaceutical companies were opposed as well and remain so. “This change in longstanding American policy will not save lives,” said Stephen Ubl, the president and CEO of PhRMA, a lobbying group for the biopharma industry. “This decision does nothing to address the real challenges to getting more shots in arms, including lastmile distribution and limited availability of raw materials.” Opponents of the waiver have argued that IP rights to the vaccines do not pose a barrier to equitable distribution, but scalability of production.

“The decision probably wasn’t made lightly,” said Atman Trivedi, an Obama administration official, who was on Biden’s presidential transition team, pointing to the centrality of intellectual property safeguards to the American economy. “But the strong humanitarian case, as infections surge in India, throughout South Asia, Latin America, and other parts of the developing world, is compelling.”

The second wave of Covid-19 in India added a sense of urgency to the debate on whether or not the US should support the waiver, as the tragedy unfolding in overcrowded, ill-equipped and understaffed hospitals and overwhelmed cremation grounds was depicted in graphic details in words and visuals in the US media.

Rick Rossow, who holds the India chair at the Center for Strategic and International Studies, a leading tank, welcomed the US’s decision but said, “India and other nations have the right to break patents anyways under Compulsory License rules... But proactively announced American support further helps repair the damage caused by the noticeable period of American inaction from mid-April.”