A Canadian company challenges vaccine rules to increase access 

For decades, the small Canadian company, Biolyse Pharma, has specialized in making injectable cancer drugs at its plant in St. Catharine’s Ontario.

When the pandemic hit, co-founder Claude Mercure watched from the sidelines as vaccine inequities unfolded globally. He wanted to help.

“We basically have the equipment. We have large bioreactors here that could deal with an industrial production. We should leave no stones unturned.”

“We basically have the equipment. We have large bioreactors here that could deal with an industrial production,” he said. “We should leave no stones unturned.”

By his own estimates, Biolyse could make at least 20 million COVID-19 vaccines a year, specifically the kind of effective, single-dose shot that Johnson & Johnson developed and has gained emergency approval for in several countries and through the World Health Organization.

Related: In Zimbabwe, vaccine hesitancy among front-line workers stalls rollout 

There’s just one catch: Johnson & Johnson holds the patent and the recipe — it controls who makes the vaccine, what to charge and where it goes. Biolyse wants to make the vaccine on its own, anyway, through what’s called a compulsory license under Canada’s Access To Medicines Regime. The company’s unconventional move is adding to a fierce global debate about who controls vaccine knowledge and production in a pandemic.

Earlier this year, Biolyse reached out to Johnson & Johnson by email to request permission to produce the vaccine, according to Mercure. Johnson & Johnson responded that they weren’t interested, he said.

That’s what led Biolyse to consider a compulsory license. In the mid-’90s, the World Trade Organization created rules that allow countries to issue compulsory licensing through their own legal and regulatory provisions. Canada’s specific rule has only been used once before — in the mid-2000s — to make HIV medicines to export to Rwanda.

Related: WHO draft report says animals likely source of COVID-19

If the Canadian government allows Biolyse to move ahead on this, it would mean the company could make the vaccine and export it — if they pay a fee to Johnson & Johnson. Mercure said it would be preferable to work directly with Johnson & Johnson, but this type of vaccine is based on a widely used technology and could be reverse engineered.

Jake Sargent, a Johnson & Johnson spokesperson, told The World in a statement that vaccine production involves “complex manufacturing processes,” and that there’s a limited number of places that can do this at quality and scale. Johnson & Johnson reviewed about 100 companies located around the world, he said, and selected 11 to enter into manufacturing agreements with, which would allow them to make more than a billion vaccine doses just this year, including doses directed to the global vaccine collaboration, COVAX, and the Africa Union.

Biolyse, which has never produced a vaccine before, is not one of those companies.

Biolyse’s efforts make for a powerful case study for testing out the global rules that were set up to respond to essential medicine shortages amid a public health crisis, according to Ana Santos Rutschman, an assistant professor of health law at St. Louis University.

“This means that something that was mostly a theory or legal framework that went unused, suddenly becomes a possibility. We sometimes just need one, you know, one to lead the pack and then we can resort to this mechanism, which really has been underused by developed countries.”

“This means that something that was mostly a theory or legal framework that went unused, suddenly becomes a possibility,” Rutschman said. “We sometimes just need one, you know, one to lead the pack and then we can resort to this mechanism, which really has been underused by developed countries.”

Related: Honduras and other countries at the ‘back of the line’ in global vaccine distribution

To date, no country has issued a compulsory license for a vaccine in the pandemic. But such licensing is not unheard of, according to Carlos Correa, executive director of the South Centre, an intergovernmental agency that works with 54 countries.

Take the 2009 H1N1 flu pandemic: “Some companies in developing countries started to produce the H1N1 vaccine because they were not available,” Correa said. “For instance, one in Argentina, in my own country, got an agreement with the government. The government supported the development of a plant in order for the production of H1N1 vaccines. So, this happens.”

Such a move faces a lot of opposition today from the European Union, the US, and drug developers themselves, who are mainly based in these regions, according to Rutschman.

“The concern is that if we do this with vaccines, what [is] next?” she said.

As in, could this challenge the model for developing drugs worldwide, which rewards companies with exclusive rights?

The deepening inequities in vaccine access and continuing surges in COVID-19 infections have prompted even more sweeping proposals. The World Health Organization created a system to encourage vaccine makers to voluntarily share their knowledge and technical know-how for making COVID-19 vaccines with other manufacturers. So far, no company wants to share.

South Africa and India have asked the World Trade Organization to lift all COVID-19 patents for the duration of the pandemic — a move that would more easily allow for compulsory licensing. While the proposal has gained support, many countries remain opposed, and it would require a consensus to advance.

In a recent letter to President Joe Biden, the Pharmaceutical Research and Manufacturers of America cautioned against lifting patents for vaccines: “Eliminating those protections would undermine the global response to the pandemic, including ongoing effort to tackle new variants, create confusion that could potentially undermine public confidence in vaccine safety, and create a barrier to information sharing. Most importantly, eliminating protections would not speed up production.”

Yet, other manufacturers around the world, from Pakistan to Bangladesh, have expressed interest in producing vaccines or vaccine components locally to improve access and be better situated for future disease outbreaks.

Related: Brazil saw its first COVID-19 death a year ago. Today the death toll nears 300,000.

The escalating vaccine shortages have leaders even in Europe assessing all options and taking notice of Biolyse, according to Kathleen Van Brempt, a Belgian member of the European Parliament and member of its trade committee.

“We need to learn from this crisis. That’s why the Biolyse case is also very interesting to me. It will not deliver so much vaccines for the rest of the world or the European Union, but it’s an interesting case, because I want to know whether compulsory licensing is working. How do we make the world health system pandemic-proof?”

“We need to learn from this crisis,” she said. “That’s why the Biolyse case is also very interesting to me. It will not deliver so much vaccines for the rest of the world or the European Union, but it’s an interesting case, because I want to know whether compulsory licensing is working. How do we make the world health system pandemic-proof?”

In Canada, it’s unclear whether Biolyse will have much success with their effort, or if they do get the green light, how long it will then take to manufacture and gain approval for their version. 

Mercure said he’s not giving up. The world needs all the support and vaccines it can get.

“I would pursue this until I stop working for sure,” he said. “We feel that we have to do something.”