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U.S. backs waiver on vaccine patents. What it means and what Canada thinks

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WATCH: U.S. supports proposal to waive vaccine patents to boost supply – May 5, 2021

The world may be inching closer to lifting patent protections for COVID-19 vaccines, and experts in Canada are keen to see the country jump on board.

The U.S. announced Wednesday it now supports a proposal to waive intellectual property (IP) protection to help boost the global COVID-19 vaccine supply. The European Union is also willing to discuss the waiver.

Read more: U.S. IP waiver support rocks COVID-19 vaccine makers

The sudden support could kick off a complex — and potentially bristly — set of negotiations over sharing patents for the life-saving shots. Patents currently prevent the vaccines from being copied, allowing the originator to be financially rewarded.

“The idea that places like the U.S. and EU — strong patent holders — will recognize that there are times when the intellectual property rights need to be superseded by larger global public interest issues… I think it signals something,” said Myra Tawfik, a professor at the University of Windsor and an expert in intellectual property law.

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“I do think it’s a moment of reckoning for Canada.”

What does it mean?

Richer nations like the U.S. have faced pressure to put weight behind this waiver for months now.

The pleas have come from 100 other countries, led by India and South Africa. They’ve asked fellow World Trade Organization (WTO) members to agree to a time-limited lifting of COVID-19-related IP rights.

Read more: Canada should ‘join forces’ with U.S. to support waiving COVID-19 vaccine patents, expert says

American support is a “signal that IP rights can legitimately be limited in these kinds of situations,” like a public health catastrophe, said Tawfik.

The goal is ultimately to allow nations to produce more vaccines using the formulas and manufacturing techniques that have already been established by pharmaceutical companies. The countries argue that the world’s leading vaccine supplies should share their knowledge so that more countries can start producing domestically and for the lowest-income nations.

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The World Health Organization welcomed U.S. President Joe Biden’s backing of a waiver. Its head, Tedros Adhanom Ghebreyesus, called it a “monumental moment in the fight against COVID-19.”

However, there are hurdles to cross before something like this comes to fruition.

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What stands in the way?

Experts caution that negotiations could take weeks or months.

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“Getting something — anything — through the WTO takes ages,” said Tawfik. “So there will be that issue of how long it will take to actually implement.”

Even if they’re successful, it remains unknown if developing countries could quickly start manufacturing the complex vaccines.

It’s one of the key criticisms coming from the pharmaceutical industry — that freeing up patents won’t magically produce vaccines.

“I am the first one to admit that what we are leaning into is a process that is not going to be easy,” U.S. trade representative Katherine Tai said in an interview Wednesday with Bloomberg.

Read more: World mulls next step after U.S. supports waiving COVID-19 vaccine patents

Tawfik agrees it’s not an immediate solution.

“It’s not an easily implementable approach but it speaks volumes,” she said. “It puts pressure on the patent holders to work within this understanding that they might need to do better.”

The other bridge to cross is unanimity. Technically, any single country could block a decision at the WTO to agree to a waiver.

Canada still hasn’t offered direct support of the waiver of IP protections on COVID-19 vaccines, but there is a precedent here.

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In 2003, WTO members agreed to waive patent rights and allow poorer countries to import generic treatments for HIV/AIDS, malaria and tuberculosis.

“Canada reacted first, we wanted to do the right thing and got stymied at every turn,” said Tawfik.

“Here’s an opportunity to challenge the orthodoxy around the patent system, especially the patent system through the trade agreement.”

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Will it impact Canada?

It depends on the stance Canada chooses to take, Tawfik said. Canada has previously been accused of being too slow to act on this issue.

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Trade Minister Mary Ng tweeted following the U.S. announcement, saying Canada actively supports the WTO efforts to accelerate global vaccine production and distribution.

Mark Lievonen, co-chair of Canada’s federal COVID-19 vaccine task force, said Tuesday that the transfer of technology would be “time-consuming.”

“It certainly wouldn’t have gotten us vaccines this year. I don’t think it would’ve gotten us vaccines next year. It is something that’s being looked at, as what I would call a medium-term or long-term solution,” he said during a committee hearing.

“There were not facilities sitting idling by in Canada that could make the mRNA vaccines.”

Read more: Biolyse suggests Health Canada lacks urgency over its ask to produce COVID-19 vaccines for export

Biolyse Pharma, an Ontario-based manufacturer, has been waiting many months to help.

While it’s not equipped to make mRNA vaccines, it believes it has the potential to produce up to 20 million doses of a viral-vector vaccine per year — but it needs access to a patent of an already-approved vaccine to do so.

Biolyse asked Johnson & Johnson in March, but the company declined.

The company says the U.S. support for IP waiving is encouraging.

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“Canada needs to get on the plate,” Claude Mercure, director of production at Biolyse, told Global News.

“We have difficulty here acquiring vaccines and so on, if anything, they should empathize with other countries facing the same issue.”

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The company is seeking a special, rarely sought licence that would allow it to essentially override a patent and manufacture a generic version of vaccines on its own in order to export them to countries in need. Even if it succeeds in amending the Patent Act list of Schedule I drugs — which has previously taken as long as 15 months — it could face another lengthy hurdle with clinical trials.

Mercure said the company has an “open channel of communication” with the federal government, but feels it has “been ghosted more than anything.”

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“We’re a little bit tired, we feel like we wasted time,” he said. “Six months ago we could’ve been producing vaccines for countries in need and we’ve lost a little bit of the energy.”

Tawfik said Canada’s support for waiving IP rights would “certainly help” a company like Biolyse.

She said it could allow countries like Canada to “fill the gap” and make generic drugs to help poorer countries, addressing pharmaceutical companies’ concerns about some lower-income nations being unequipped to ramp up production quickly.

Read more: Johnson & Johnson’s vaccine won’t be the ‘workhorse’ in Canada’s rollout

What have vaccine makers said?

So far, drugmakers have argued that the plan is ineffective and that too few countries have the capacity to make more vaccines — even if they knew the formulas.

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Moderna, whose two-dose shot is circulating in many countries worldwide, said Thursday that waiving IP rights on COVID-19 vaccines won’t help boost supply this year or next.

The International Federation of Pharmaceutical Manufacturers and Associations told The Associated Press that a waiver would invite new manufacturers that lacked essential know-how and oversight.

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Countries like Britain and Switzerland, home to large pharmaceutical companies, have opposed the waiver. They argue it would undermine incentives for manufacturers — which have produced coronavirus vaccines in record time –- to do so in a future pandemic.

Pharmaceutical companies also point to a limited global supply of the materials needed to produce these shots.

Tawfik, whose studies focus on the historical evolution of patent laws, said the system is designed to “encourage socially beneficial outcomes.”

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“If patent holders are not going to adjust to provide meaningful options to help resolve the pandemic, then governments will step in.”

— with files from The Associated Press, Reuters and Global News’ Jacquelyn LeBel and Jackson Proskow

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