It’s been five months since Bolivia’s government asked Canada to allow COVID-19 vaccines to be streamed to the Granthshala South from a manufacturer in St. Catharines, Ont.
Now, the country, where less than thirty percent of people have been fully vaccinated, is reiterating its request for Canada to revoke the patent exemption and issue a mandatory license to allow manufacturing to begin.
“It is time to make decisions in the name of humanity,” Benjamin Blanco, Minister of Foreign Trade and Integration of the Bolivian Ministry of Foreign Relations, said in an interview with Granthshala News.
In May, Bolivia signed a deal with Biolyse Pharma, a St. Catharines-based pharmaceutical company, to make a Johnson & Johnson one-dose vaccine. The deal will ensure that Bolivia receives the first 15 million doses produced by Biolis. However, the company is yet to get approval from the Canadian government to start construction, which has put the Bolivians in trouble.
“We continue to wait,” said Blanco. “We’ve been waiting too long.”
Currently, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement protects Johnson & Johnson’s patent on the vaccine and prevents Biolyse from producing it. The TRIPS exemption, if taken into effect, would allow member states such as Canada to increase their manufacturing of patent-protected COVID-19 vaccines.
Biolyse has made a formal appeal to the Canadian government to send a list of Schedule I drugs under the Patent Act, which includes COVID-19 vaccines, to a separate entity from the TRIPS exemption, under the Canadian Access to Medicines arrangement. The Canadian manufacturer also approached Johnson & Johnson to help with the production of their vaccine, but was turned down.
Multiple attempts by Granthshala News to reach Johnson & Johnson went unanswered.
A spokesman for Canada’s Ministry of Innovation, Science and Economic Development wrote in an email to Granthshala News that they are “aware of interest in exploring IP flexibility to increase COVID 19 vaccine production.” The spokesperson did not directly respond to concerns about the Bolivian government or Canada not issuing mandatory licenses to Biolis.
He said companies like Biolyse can apply for Canada’s Access to Medicines arrangement (CAMR) to obtain a mandatory license for the production and export of a COVID-19 vaccine, which the company has already done. The vaccine has not been added to Schedule 1 and, even if added, will not result in compulsory licensure.
The lack of Canadian movement on the TRIPS exemption has stunned Blanco. The Bolivian cabinet minister said Canada, where more than 75 percent of people have been fully vaccinated, is looking for companies, not people.
“We need political will,” Benjamin Blanco said. “We need the governments of developed countries to be able to think of life before the interests of some international pharmaceutical companies.”
In May, Canada’s then Minister for Small Business, Export Promotion and International Trade, Mary Ng, said Canada was in talks to waive intellectual property patents for COVID-19 vaccines as part of a World Trade Organization (WTO) agreement. “will actively participate”. .
“We have been at the forefront of the Granthshala effort to ensure 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 are whole-heartedly engaged in these discussions on various proposals,” he said at a news conference in May. “I can assure you that Canada is not interfering or blocking. Canada is working very hard to find a solution that works for everyone.”
In many ways, Blanco said he is “disappointed” at Canada’s lack of decision-making on how the country establishes itself as a Granthshala champion for equity and public health.
“We are confused. Canada uses one discourse in multilateral organizations, but in practice, we see another action,” he said.
While it seems like introducing the TRIPS discount could be a big step for Canada, the country did exactly that. 2007 when it approved Apotex to produce TriAvir, An HIV drug, to be sent to Rwanda.
“It was for a good reason, but it was a bureaucratic headache for everyone,” said Richard Gould, a law professor at McGill University who specializes in patent law and the biomedical field.
According to Gould, Bioliss is moving down from the more process-intensive and bureaucratic method of CAMR.
In 2006, the company gained 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.
Biolis’ executive vice president John Fulton oversaw the process in 2007, so knew it would take some time. But, he still admitted that he has been “losing sleep” from constantly jumping through hoops over the past several months and that it’s hard to stomach given the depth of the current Granthshala situation. He thinks that Canada could have approved the drug through CAMR or supported the TRIPS exemption, but did not.
“In some ways, I am ashamed as a Canadian that the government is not jumping to the occasion,” he said.
Biolis is in the middle of preparing to take over vaccine manufacturing, which Fulton said would require about four to six months and an injection of cash from the federal government.
Fulton said Bioliss checks most of the boxes needed to produce the vaccine, but he alleges that it is bureaucracy that is causing the delay, not financial deficiencies or lack of experience. Over the past several months, Fulton claims to have been swung back and forth with various ministries and spoken to more than 50 government employees, none of whom could give him a clear answer as to when. ..