The story so far
In the wee hours of Thursday while most of India was asleep, U.S. President Joe Biden’s administration announced its support for waiving intellectual property protections for COVID-19 vaccines . About a dozen hours later, the European Union said it was ready to discuss the U.S.-backed proposal. This is a significant shift from their stated positions.
What is this debate about?
Following the onset of the pandemic in May 2020, the World Health Organisation proposed a COVID -technology access pool as a knowledge sharing initiative to rapidly scale up vaccine output around the world. The companies that develop vaccines, however, have not participated in the initiative.
As vaccine research progressed last year, wealthy and advanced countries like the U.S., the U.K. and the European Union members, placed huge advance purchase orders for vaccines to counter the debilitating impact of the pandemic faster in their respective domains. This meant that smaller, developing countries would take longer to get vaccines and find resources to pay for them.
In October 2020, India and South Africa floated a proposal at the World Trade Organisation’s TRIPS (Trade-Related Aspects of Intellectual Property Rights) Council to waive certain provisions of the WTO’s TRIPS pact till the pandemic subsides.
The proposal envisaged facilitating wider access to technologies necessary for the production of vaccines and medicines, so that local production could be scaled up quickly, and affordable as well as effective vaccines can be delivered to more people.
At the Council meeting, India said there is no doubt that Intellectual Property barriers limit ‘equitable’ access to tools such as diagnostics and vaccines. It pointed out the array of lawsuits filed across the world by companies over IP infringement on COVID-19-related products.
“It’s time for [the WTO] members to take collective responsibility and put people’s lives before anything else. History will not judge us kindly if we do not act immediately to save large scale loss of human life and health and allow global dysfunction to prevail over global cooperation. We hope that Members will support our proposal that will ensure that vaccines and treatments become truly global public goods,” India argued at the meeting.
While a majority of the least developed countries backed the proposal, some like China, Turkey and Thailand sought more clarity. However, the proposal was nixed with the E.U., the U.S., Switzerland, Norway, Australia, Canada, Japan and the U.K. rejecting it outright, along with Brazil. Among other things, the argument was that such waivers could dampen innovation and research in areas such as pharmaceuticals and diagnostic technologies.
What seems to have brought about a shift in the developed world stance?
Negotiations on the proposal have continued despite being blocked by the WTO Trips Council and subsequently, by its Ministerial Council. And the dynamics in support of the India-South Africa proposal, have been shifting, particularly after the second wave hit many countries. By February, 90 nations had backed the proposal, which swelled to 100 by the end of April. While the E.U. and the U.S. remained the key stumbling blocks towards attaining the necessary consensus, sections of lawmakers have been making a pitch for a rethink over the past month and a half.
While over 250 members of the European Parliament and member countries’ national parliamentarians backed the proposal in late March, last week, over 100 U.S. lawmakers wrote to President Biden to help the WTO temporarily lift certain intellectual property barriers and allow countries to locally manufacture COVID-19 diagnostics and vaccines.
The U.S. lawmakers, in the April 30 missive, stressed that the proposed TRIPS waiver is essential to ensure all global economies, including the U.S.’ own, recover from the pandemic and thrive. “Simply put, we must make vaccines, testing, and treatments available everywhere if we are going to crush the virus anywhere,” they pointed out.
However, till May 4, the President had been non-committal, stating that a decision can be taken “as we go along”. “As long as there is a problem anywhere in the world, we will get as many Pfizer and Moderna vaccines produced as is possible and export them,” he had said.
What exactly has the U.S. administration said now?
Stating that the extraordinary circumstances of the pandemic call for extraordinary measures, US Trade Representative Katherine Tai said though the U.S. government strongly believes in protecting intellectual property, it supports the waiver of those protections for COVID-19 vaccines in “service of ending this pandemic”. “The administration’s aim is to get as many safe and effective vaccines to as many people as fast as possible. 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,” she said.
The administration has also said it will increase the supply of raw materials needed to produce vaccines. In April, the Serum Institute of India (SII) had flagged issues with supply of vaccine raw material from the U.S. and the E.U. for that was affecting the planned output of the Covovax vaccines. The SII has a pact to produce 1 billion doses of the vaccine developed by U.S.-based Novavax, for India and other low and middle-income countries.
Taking a cue from the U.S., by Thursday afternoon, European Commission President Ursula von der Leyen said Brussels is ready to discuss the U.S.-backed proposal. “The European Union is also ready to discuss any proposal that addresses the crisis in an effective and pragmatic manner,” she said.
With the E.U. and the U.S. on board, does this mean developing countries can now expect quicker and wider access to vaccines and tools for their people?
Not just yet, say experts, despite the unprecedented U.S. move and the E.U.’s signal of support. Some E.U. countries, with large drug company headquarters such as Switzerland and the U.K may still not be enthusiastic. The strong pharmaceutical industry lobby in the U.S., which had told President Biden last month that waiving IP protections would not speed up vaccine production while endangering research on countering new virus variants, may still have some arrows in its quiver, while many operational details get fleshed out.
At the WTO itself, where these decisions need to be ratified, the process could take time. Hours before Mr. Biden’s change of stance, WTO Director-General Ngozi Okonjo-Iweala urged members at a General Council meeting on Wednesday to negotiate an IP waiver text that could temporarily allow easier access to COVID-19 vaccines and treatments.
“What was striking about today was this very strong declaration by all members on this shared objective — ramping up production and distribution of these vaccines and therapeutics and diagnostics in the developing world, where there is a great inequity in terms of distribution,” WTO spokesperson Keith Rockwell said after the meeting.
With the U.S. and the E.U. now open to negotiations, the challenge moves to the next level and needs to navigate fineprint consensus building through bureaucratic layers of WTO and member countries’ national governments.
The WTO’s TRIPS Council is tentatively expected to hold a meeting on the waiver proposal again later this month and further discussions are likely over June 8 and 9. If and when an agreement is reached here, the WTO’s Ministerial Council will also have to sign off. Since WTO decisions are based on consensus, all 164 members need to agree on every single aspect of the negotiated waivers and conditions attached.
As USTR Ambassador Tai has said, text-based negotiations under the WTO “will take time given the consensus-based nature of the institution and the complexity of the issues involved”. So while there’s room for cautious optimism, don’t hold your breath over this.
Can India do anything while this plays out?
The Indian government has yet to react formally. Former Minister of State for Commerce and Industry Jairam Ramesh suggested on Thursday afternoon that the Centre can take two steps immediately in consonance with its stance at the WTO, following the U.S.’ statement of support.
“The Union government must issue notification under Sections 92 and 100 of the Patents Act to freely licence all patents necessary for vaccine and drug production, including for equipment and all raw materials for vaccines, hospital equipment and drugs to treat COVID-19. Issues of the amount of royalties can be decided in due course as laid out in the Patents Act, but that should not come in the way of immediate licensing by the government,” he said.
Mr. Ramesh also urged the government to provide full support to companies to scale up vaccine production. “Indian industry has a well-respected expertise and capability to rapidly manufacture raw materials, consumables and equipment necessary to produce drugs, vaccines, medical devices and equipment if Intellectual Property barriers are removed,” the former Minister said.