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

Biolyse Pharma in St. Catharines, Ont., is hoping to obtain a compulsory licence. supplied by Biolyse Pharma

Biolyse Pharma says it could be producing as many as 20 million doses of COVID-19 vaccine for export annually, but it’s waiting for action from Health Canada.

The St. Catharines, Ont.-based company, which currently produces cancer medicines, 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.

But after a meeting with Health Canada on Wednesday, Biolyse is anticipating a lengthy process despite the urgency it says the pandemic poses.

“As I keep saying, it’s a war effort. You have to use the resources you have in your country and with your allies and bring your resources on the table and see who can do what and get things done,” Biolyse president Brigitte Kiecken told Global News.

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“And right now, I don’t really see how we can get anything done.”

On Wednesday, representatives for Biolyse say they met with officials with Health Canada; Innovation, Science and Economic Development Canada (ISED); the Canadian Intellectual Property Office, and others to discuss Biolyse’s request to amend the list of Schedule I drugs under the Patent Act to include COVID-19 vaccines.

Initially, the company was seeking a compulsory licence through Canada’s Access to Medicines Regime specifically for the Johnson & Johnson/Janssen vaccine.

After realizing the Patent Act list included “diphtheria vaccine” and “hepatitis B vaccine” without getting into more specifics, it is hoping to just get “COVID-19 vaccine” added to that list.

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“I think the government should help us with an interim order to expedite this process and just get simply a ‘COVID-19 vaccine’ added to the list to streamline this,” says John Fulton of BioNiagara, who’s been acting as a spokesperson for Biolyse.

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In response to a request for comment, Health Canada would only confirm that it and ISED met with Biolyse Canada “to discuss the Canadian Access to Medicines Regime (CAMR) and Health Canada submission related requirements particularly as they relate to vaccines.”

Health Canada also pointed to its guidance for market authorization requirements for COVID-19 vaccines, which states that measures have been introduced to expedite approval processes “while protecting the health and safety of Canadians.”

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Amending the Patent Act list is a major hurdle in pursuing a compulsory licence.

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The compulsory licence Biolyse is seeking is made possible through Canada’s Access to Medicines Regime, Canada’s legislation that reflects the World Trade Organization’s agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

According to a government website last updated in 2015, CAMR “provides a way for the world’s developing and least-developed countries to import high-quality drugs and medical devices at a lower cost to treat the diseases that bring suffering to their citizens.”

Luis Gil Abinader, senior researcher with Knowledge Ecology International (KEI), which is supporting Biolyse through the application process, says every low- and middle-income government he’s talked to has expressed interest in importing vaccine from Biolyse.

One country, which he says he cannot currently name, may soon step forward to express interest publicly “in a way that complies with the requirements by the WTO” and other provisions.

“I believe that if there is a country saying ‘I need help’ and they tell that to the Canadian government and to the world, I will hope that that will move people to action.”

Even if Biolyse succeeds in amending the Patent Act list of Schedule I drugs — which has previously taken as long as 15 months — it faces another lengthy hurdle with clinical trials, though it’s unclear if they’d need to conduct all trial phases or just the final phases.

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“It’s not treated like a generic where usually you just demonstrate chemical equality, that the products are bio-equivalent. And so it seems that if we do get that on the list as compulsory, it’s really not very helpful,” Kiecken says.

“The best would be for the patent holder to share their technology with diverse groups that can bring vaccines quite rapidly instead of waiting for the development of a new vaccine and new facilities.”

Biolyse previously sought a licence from Johnson & Johnson/Janssen that was rejected, according to Arianna Schouten with KEI.

Global News has reached out to Janssen Canada for comment but had yet to receive a response by publication time.

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Even outside of the push for a compulsory licence, Biolyse director Claude Mercure questioned why there has not been more government interest in utilizing its resources in the pandemic effort.

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Roughly a year ago, Biolyse says it asked Canada for about $4 million to prepare to produce COVID-19 vaccines, mostly for training, salaries and getting systems in place.

“The facility, the instrumentation that’s here, the tools that are here to fabricate injectable drugs, vaccines and so on — it’s all here, it’s all paid for. And it’s really unbelievable that they would refuse this offer,” Mercure says.

Fulton adds that companies pouring concrete now expecting to produce vaccines are “years away from helping us.”

Kiecken says during the meeting on Wednesday she asked what the government’s plan was for “immediate action” on domestic vaccine production.

“What is being done right now? I did not get an answer,” she says.

“Maybe they have a great strategy that we’re not aware of.”

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