The United States, as well as other wealthy countries, have faced pressure to support a proposal under the World Trade Organisation (WTO) that would temporarily waive intellectual property protections for Covid-19 vaccines – at a time when cases are surging in parts of the world like India.
Under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, pharmaceutical companies are awarded monopoly control over vaccine production. This has sparked a backlash amid the pandemic, though, because it could impact poor countries from ramping up their own supplies.
Now the WTO has reportedly urged member nations to each temporarily ease the rules protecting intellectual property for vaccinations in an effort to make vaccines more accessible for struggling countries.
The WTO decision would be based on a consensus from member nations, which means that all 164 members must agree.
On Wednesday, the Biden administration indicated it would support temporarily easing rules protecting intellectual property for vaccinations – a move that sent a shockwave among big pharmaceutical companies and caused the stocks of companies like Moderna, BioNTech and Pfizer to sharply drop.
"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," said United States Trade Representative Katherine Tai in a statement.
Who is asking for the waiver of these patent rights?
The waiver was first proposed by India and South Africa in October 2020 and has since garnered support from more than 100 developing countries.
Humanitarian aid groups and more than 400 government officials across the EU, including the World Health Organisation's director general, have also urged the WTO to lift intellectual property provisions on vaccines and equipment.
"Flexibilities in trade regulations exist for emergencies, and surely a global pandemic, which has forced many societies to shut down and caused so much harm to business – both large and small – qualifies," Dr Tedros Adhanom Ghebreyesus, the director general of the World Health Organisation, wrote in a recent op-ed.
"We need to be on a war footing, and it's important to be clear about what is needed," he added.
The proposed temporary waiver only applied to Covid-19 vaccines, but other technologies related to the pandemic like diagnostics, treatments and PPE could also receive a waiver – which may help speed up access for developing countries as the work to manage the novel virus.
While the United States, for example, has purchased more than 600 million vaccine doses and vaccinated about 44.7 per cent of its total population with at least one dose to date, developing countries have struggled to vaccinate their elderly and vulnerable residents.
Instead, most developing countries have turned to Covax – the Covid-19 Vaccine Global Access programme under the World Health Organisation – to access vaccine doses.
What would be the short and long term effects of the temporary waiver?
Health experts remain divided on whether waiving these patent rights would offer relief to developing countries as quickly as needed.
In India, for example, the country is battling a staggering number of new coronavirus infections, with reports of 400,000 new daily cases over the weekend.
Stanford law professor Lisa Larrimore Ouellette argued in the school's law blog that countries like India need available doses from the current vaccine supply over the ability to access intellectual property.
"Vaccines are complex biologics that are more difficult to replicate than small-molecule drugs, so a new manufacturer that wanted to create its own version of the Pfizer-BioNTech vaccine would need to run its own clinical trials to demonstrate that its vaccine is safe and effective," she said.
"And even with the involvement of the original developer, building new manufacturing capacity takes time – time that India doesn't have. That's why sharing existing vaccine supply is so critical right now."
In the longer term, waiving the temporary patent rights could assist countries in their vaccine development. But the exact impact would likely not be seen in the immediate future.
Critics have instead argued that the move would harm pharmaceutical companies' incentives to innovate while also not addressing the central issue that developing countries face when accessing vaccines.
"This is a huge misstep by the Biden Administration that will do nothing to increase vaccine distribution and will endorse China's ability to piggyback on US innovation to further its vaccine diplomacy aims," Clete Willems, a former attorney at the Office of the US Trade Representative, said of the decision, CNBC reports.
He recommended for the Biden administration to improve vaccine production in the United States and then export the supply to other countries in need.
Billionaire philanthropist Bill Gates, a major supporter of global Covid-19 vaccine equity through the Bill & Melinda Gates Foundation, has also previously criticised the move when speaking to Sky News.
"There's only so many vaccine factories in the world and people are very serious about the safety of vaccines," Mr Gates said.
"The thing that's holding things back in this case is not intellectual property. There's not, like, some idle vaccine factory with regulatory approval that makes magically safe vaccines. You've got to do the trials on these things and every manufacturing process has to be looked at in a very careful way."
Pharmaceutical companies fight hard to protect their intellectual property rights, not least because astronomical sums of money are involved in developing drugs and vaccines.
These days new advancements from pharmaceutical companies come, in part, from public funding. For example, the United States alone provided $18bn of taxpayer money to companies in their development of an effective Covid-19 vaccine under the Trump administration’s Operation Warp Speed.
What happens next?
India and South Africa are expected to put a revised proposal before the WTO national members next month, WTO spokesman Keith Rockwell said in a media briefing. The details of what this revised proposal could look like were not revealed, but it could garner more support among members now that it has the anticipated approval of the United States.
This proposal would then be voted on by the 164 members, with all needing to reach a consensus for it to move forward. Already the proposal has been blocked by a select number of WTO nation members in March.
If approved, then intellectual property rights as well as other pandemic-related technologies must be transferred to new production sites, Mr Rockwell said. Countries would also be required to have a transparent regulatory infrastructure in place to manufacture the vaccines.
Wealthier countries, in the meantime, were urged to donate surplus vaccine doses to Covax as well as other equipment and technologies that would assist other nations in their battle against Covid-19.