Canadian firm seeks mandatory licence to produce COVID-19 vaccines for poorer countries

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Whenever he needs motivation for his fight to expand vaccine production, John Fulton thinks of a family member: a 67-year-old woman in Kenya who died of COVID-19 this month.

“They tried to get her to hospital, but all the hospitals in her area were full,” said Mr. Fulton, a consultant at Biolyse Pharma in St. Catharines, Ont.

“It’s a war zone there,” he said, describing the surge of pandemic deaths in Kenya. “This is what drives us.”

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As global shortages become more severe and vaccine inequities grow sharper, Biolyse believes it could help bridge the gap by producing up to 20 million doses of COVID-19 vaccines annually.

But to do so, it needs to win approvals from the federal government – a difficult challenge so far, and an example of the bureaucratic and corporate obstacles that hinder the task of expanding vaccine supplies globally.

“We have the equipment and facilities and the engineering and the staff,” Biolyse president Brigitte Kiecken said. “We could have done this quite rapidly. But it’s been brick wall after brick wall, and lots of confusion and not knowing what’s going on.”

Federal officials say the problem is that Canadian companies such as Biolyse are too small to be of interest to the major manufacturers of COVID-19 vaccines.

With the exception of factories that are already making critical products such as polio vaccines, “Canadian biomanufacturing assets were of a scale which was not of interest to these firms,” said John Power, a spokesperson for François-Philippe Champagne, the federal Minister of Innovation, Science and Industry.

“Manufacturing capacity for vaccines is often purpose-built, and pivoting production capacity takes time,” he said in an e-mailed response to questions from The Globe and Mail.

The global needs are stark and extreme. While many wealthy countries are rapidly vaccinating their populations, most poorer countries are far behind. Of the 690 million vaccine doses administered worldwide so far, for example, less than 2 per cent have been in Africa.

“Limited stocks and supply bottlenecks are putting COVID-19 vaccines out of reach of many people in this region,” said Matshidiso Moeti, the Africa director for the World Health Organization, in a statement on Thursday.

Kenya has been engulfed in a tidal wave of COVID-19 cases and deaths in recent weeks, but it has struggled to obtain vaccines in the midst of the global shortage. It expects to vaccinate only 22 per cent of its population by the middle of next year.

“How many more mothers-in-law are going to die in that period of time?” Mr. Fulton asked, thinking of his brother’s relative.

Biolyse, which normally produces cancer drugs, believes it is one of the few companies in Canada with the capacity to produce COVID-19 vaccines this year. If it wins approval, it could be manufacturing the vaccines within six months. A number of lower-income countries have already expressed interest in buying vaccines from Biolyse, the company says.

But the company has been trying to catch the attention of Ottawa and the major vaccine manufacturers for nearly a year – with almost no success. When it approached Johnson & Johnson, the U.S.-based company said it was not interested.

It may have finally made a breakthrough this week when it won a meeting with about 20 officials from four federal departments. “Someone is finally listening,” Mr. Fulton told The Globe in an interview on Thursday. “I found it encouraging.”

Biolyse is hoping to use the provisions of Canada’s Access to Medicines Regime, or CAMR, a rarely used law that was introduced in 2004 to help Canadian companies produce life-saving medicine such as HIV drugs for humanitarian use in lower-income countries, even when these drugs are under patent by other companies.

If Biolyse can persuade the federal government to add COVID-19 vaccines to a required list under the Patent Act, it could proceed with making vaccines for export under a compulsory licence from the CAMR system, possibly using the vaccine technology that was patented by Johnson & Johnson or AstraZeneca.

This would create jobs in Canada, while helping the government fulfill its promise of helping poorer countries that have limited access to vaccines, Ms. Kiecken said in a letter to federal officials in late March.

The CAMR law has “basically been forgotten,” Mr. Fulton said. “The phone number was disconnected, and it took us a month to find someone. But if you can’t do this in the middle of a pandemic, when can you do it? People are dying. We don’t have time for niceties.”

Knowledge Ecology International, a U.S.-based non-profit group that focuses on social justice in intellectual property issues, said the CAMR process is “rife with unanswered questions and dead ends.”

It noted that the federal CAMR website contains only two contact numbers, of which one is an invalid number and the other did not respond. Application forms for compulsory licences under CAMR are not readily available, it said, and the entire application process is “convoluted and difficult.”

Riyadh Nazerally, a spokesperson for the Innovation, Science and Economic Development department, confirmed that federal officials met with Biolyse this week to discuss the compulsory licensing process.

The government has provided details to the company on the “regulatory and technical requirements” for applications under the CAMR process, he said.

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