It’s been five months since the Bolivian government called on Canada to allow COVID-19 vaccines to flow from a manufacturer in St. Catharines, Ont., to the Global South.
Now, the country, where fewer than thirty per cent of people are fully vaccinated, is repeating its request for Canada to override the patent waiver and issue a compulsory license to allow manufacturing to begin.
“It is time to make decisions in the name of humanity,” said Benjamin Blanco, Minister of Foreign Trade and Integration, Ministry of Foreign Relations for Bolivia in an interview with Global News.
In May, Bolivia signed an agreement with Biolyse Pharma, a St. Catharines-based pharmaceutical company, which is prepared to manufacture the Johnson and Johnson one-dose vaccine. The deal would ensure Bolivia received the first 15 million doses produced by Biolyse. However, the company still has not been approved to begin manufacturing by the Canadian government, leaving the Bolivian people in the lurch.
“We continue to wait,” said Blanco. “We have been waiting too long.”
Currently, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement protects Johnson and Johnson’s patent on their vaccine and prohibits Biolyse from producing it. The TRIPS waiver, if put into effect, would allow for member states like Canada to scale-up their manufacturing of patent-protected COVID-19 vaccines.
Biolyse has also made a formal appeal to the Canadian government to amend a list of Schedule I drugs under the Patent Act to include COVID-19 vaccines under the Canadian Access to Medicines Regime, a separate entity from the TRIPS waiver. The Canadian manufacturer also approached Johnson and Johnson to help them in producing their vaccine, but were turned down.
Multiple attempts by Global News to reach Johnson and Johnson went unanswered.
A spokesperson for the Ministry of Innovation, Science and Economic Development Canada wrote in an email to Global News they are “aware of the interest in exploring IP flexibilities to increase COVID 19 vaccine production.” The spokesperson did not directly answer concerns from the Bolivian government or about Canada not issuing a compulsory license to Biolyse.
They’ve said that companies like Biolyse can apply for Canada’s Access to Medicines Regime (CAMR) to acquire a compulsory license to produce and export the COVID-19 vaccine, which the company has already done. The vaccine has not been added to Schedule 1 and even if added would not itself result in a compulsory licence.
Canada lacking 'political will' on TRIPS waiver
Canada’s lack of movement on the TRIPS waiver has left Blanco stunned. The Bolivian cabinet minister said Canada, where more than 75 per cent of people are fully vaccinated, is looking out for companies, not people.
“What we need is political will,” said Benjamin Blanco. “We need the governments of developed countries to be able to think of life before the interests of a few transnational pharmaceutical companies.”
In May, then-Minister of Small Business, Export Promotion and International Trade of Canada, Mary Ng said Canada will “actively participate” in negotiations to waive intellectual property patents for COVID-19 vaccines as part of a World Trade Organization (WTO) agreement.
“We have been a leader in the global effort to ensure there is equitable access to successful vaccines,” she said.
Ng’s comments were reiterated by Prime Minister Justin Trudeau who said his government was “working with others around the world to come up with a solution.”
“We’re engaged wholeheartedly in these discussions on various proposals,” he said at a press conference in May. “I can assure you that Canada is not interfering or blocking. Canada is very much working to find a solution that works for everyone.”
In many ways, Blanco said he is “disappointed” in Canada’s lack of decision-making to how the country positions itself as a global champion for equity and public health.
“We are confused. Canada in multilateral organizations uses one discourse, but in practice, we see another action,” he said.
Biolyse prepared to create vaccines
While it seems like initiating the TRIPS waiver might be a major move for Canada to undertake, the country did exactly that in 2007 when it approved Apotex to produce TriAvir, an HIV drug, to be sent to Rwanda.
“It was for a good cause, but it was a bureaucratic headache for all,” said Richard Gold, a law professor at McGill University who specializes in patent law and the biomedical field.
Biolyse is going down the more process-intensive and bureaucratic method of CAMR, according to Gold.
In 2006, the company won approval to produce the drug Oseltamivir, better known as Tamiflu during the bird flu pandemic. The process took seven months, but during that wait, the demand dwindled.
John Fulton, executive vice president at Biolyse, oversaw the process in 2007, so knew it would take some time. But, he still admitted the constant jumping through hoops the past several months has him “losing sleep” and it’s hard to stomach given the depths of the current global situation. He thinks that Canada could’ve approved the drug through CAMR or supported the TRIPS waiver, but has done neither.
“In some ways, I’m embarrassed as a Canadian that the government is not jumping on this opportunity,” he said.
Biolyse is in the midst of preparing to handle vaccine manufacturing, which Fulton said would require about four to six months and an injection of cash from the federal government.
Fulton said Biolyse checks off most of the boxes needed to produce the vaccine, but he alleges it is bureaucracy that is causing the delay, not the financial shortcomings or lack of experience. Over the past several months, Fulton claims he has been passed back-and-forth from different ministries and spoken to well over 50 government employees, none of whom can give him a clear answer on when he can expect an approval.
A spokesperson for the Ministry of Innovation, Science and Economic Development Canada told Global News that “federal government officials have met with Biolyse on a number of occasions to discuss their manufacturing capabilities, the process for Schedule 1 listing, and subsequent authorization requirements.”
Even if Canada did approve the vaccine to be on Schedule 1, Biolyse would still need to conduct trials to meet Health Canada safety requirements. According to Fulton, if all went well and Johnson and Johnson worked with them, that timeline could be four months, but if they have to reverse-engineer the vaccine, which is doable, it would take 8-12 months.
Blanco said in many respects, Canada has talked about making vaccines available to everyone, about the need for global vaccination, and now when presented with an option to follow through, the country has not moved on the opportunity.
“We thought that the Canadian government was going to be much faster,” said Blanco. “The days go by at the diplomatic level, we have no answer.”
What to do about the TRIPS waiver?
In March 2020, the Government of Canada amended the Patent Act and the Drugs Act in direct response to the COVID-19 pandemic. The changes would allow the government to use and authorize the use of patented inventions on a time-limited basis to address drug shortages.
At the time, Srinivas Murthy, a Faculty of Medicine member at the University of British Columbia, thought it would be a sign of things to come, but noted that we’ve trended the wrong way.
“I don’t think we’ve even moved the needle in wanting to waive patents,” he said.
According to both Murthy and Gold, some of the arguments to uphold patents, mainly around innovation, lack empirical evidence. But, to Gold, part of the reason why Canada could be hesitant around touching the intellectual property (IP) of big pharma is the desire to have them invest and build in the north. The desire to drive investment coupled with buying vaccines from the companies in question is another reason Gold thinks Canada is mum on the TRIPS waiver.
“Any time that the government worries about exporting or decreasing IP, they’re going to get attacked by certain sectors, including the pharmaceutical sector,” he said.
In May, 62 member states at the WTO supported a TRIPS waiver proposal brought forth by India and South Africa, with almost 100 low-income countries throwing their support behind the idea. But, wealthier nations like the U.K., Japan and Australia opposed it. While the U.S. announced support for re-negotiations, they have yet to sign onto the proposal.
To Murthy, Canada and other rich countries tend to be “chipper” about how much they do for smaller nations, but in reality, he thinks the pandemic has shown the gaps in global public health. Now, while rich countries have an abundance of vaccines and are able to have nuanced conversations like overcoming hesitancy or whether a third booster dose is needed, the rest of the world is still struggling to get even first doses.
In Bolivia, only 27.9 per cent of their people have received a full set of COVID-19 doses while the entire continent of Africa has only 2.2 per cent of their population vaccinated, according to Our World in Data, which tracks global vaccination rates.
“We’ve all realized that supply of these vaccines isn’t enough to meet demand globally,” said Murthy in an interview with Global News. “Rich countries have vaccinated their populations and poor countries have not. And that is almost exclusively because of supply and distribution on the supply side of things.”
Murthy knows there will be some arguments against citing a potential ‘loss of innovation’ if Canada moves to remove patents, but said a significant part of the COVID-19 vaccines were developed in part due to the work of researchers from the University of British Columbia. The technology used by the Pfizer-BioNTech vaccine can be “traced back to research pioneered in the lab of Dr. Pieter Cullis in the late 1970s,” according to UBC. In Murthy’s view, it’s clear that innovative public health research is being used for-profit, but the public isn’t always reaping the benefits.
“People don’t have access to supply of the lifesaving intervention purely because of patents,” he said.
Gold thinks big pharma has enough profits off the vaccine and now it’s time to ensure people across the world can get the jab.
“They’ve profited, a lot. It’s time to share.”