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.
Canada working on solution for COVID-19 vaccine patent waivers, not ‘interfering or blocking,’ Trudeau says
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.
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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.
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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.”
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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.
Canada still undecided on vaccine patent waivers
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.”
© 2021 Global News, a division of Corus Entertainment Inc.
Coronavirus: What's happening in Canada and around the world Tuesday – CBC.ca
New Zealand’s government says it will expand a vaccine mandate to include thousands of workers who have close contact with their customers — including those at restaurants, bars, gyms and hair salons.
The changes will mean that about 40 per cent of all New Zealand workers will need to get fully vaccinated against the coronavirus or risk losing their jobs. Speaking with reporters on Tuesday, Prime Minister Jacinda Ardern said she didn’t believe the new rules were an overreach of government power, but would ensure customers and employees are treated equally.
The government had already introduced a vaccine mandate for workers in certain sectors, including those who operate in the health and eduction sectors.
New Zealand is aiming to get 90 per cent of all people aged 12 and up fully vaccinated to put an end to lockdowns. According to the health ministry, 71 per cent of the country’s eligible population is fully vaccinated.
As part of its plan to end lockdowns, New Zealand will also require people visiting high-traffic businesses to show vaccine passports to prove they’ve had their shots.
The island nation has seen a total of 28 related deaths and 5,822 cases of COVID-19 since the outbreak of the global pandemic.
-From The Associated Press and CBC News, last updated at 6:45 a.m. ET
What’s happening across Canada
What’s happening around the world
As of late Tuesday morning, more than 244.2 million cases of COVID-19 had been reported worldwide, according to Johns Hopkins University’s coronavirus case-tracking tool. The reported global death toll stood at more than 4.9 million.
Moderna said it will make up to 110 million doses of its COVID-19 vaccine available to African countries. Tuesday’s announcement says Moderna is prepared to deliver the first 15 million doses by the end of this year, with 35 million in the first quarter of 2022 and up to 60 million in the second quarter.
It said “all doses are offered at Moderna’s lowest tiered price.” The company called it “the first step in our long-term partnership with the African Union.” Africa and its 1.3 billion people remain the least-vaccinated region of the world against COVID-19, with just over five per cent fully vaccinated.
Meanwhile, Senegal and Rwanda have signed an agreement with German company BioNTech for the construction of its first start-to-finish factories to make messenger RNA vaccines in Africa.
BioNTech, which developed the Pfizer-BioNTech COVID-19 vaccine, said Tuesday that construction will start in mid-2022. It is working with the Institut Pasteur in Dakar, Senegal’s capital, and the Rwandan government, a statement said.
In the Middle East on Monday, health officials reported 7,516 new cases of COVID-19 and 140 additional deaths.
In Europe, the EU’s drug regulator said it has concluded in its review that Moderna’s COVID-19 booster vaccine may be given to people aged 18 years and above, at least six months after the second dose.
In the Americas, Venezuela reopened public schools and universities, which serve more than 11 million students, though some schools remained closed for repairs or because of lack of staff.
Kid-size doses of Pfizer’s COVID-19 vaccine may be getting closer in the U.S. as government advisers on Tuesday began deliberating whether there’s enough evidence that the shots are safe and effective for six- to 11-year-olds.
In a preliminary analysis last week, Food and Drug Administration (FDA) reviewers said that protection would “clearly outweigh” the risk of a very rare side effect in almost all scenarios of the pandemic. Now FDA advisers are combing through that data to see if they agree.
In the Asia-Pacific region, Indonesia is reportedly finalizing a deal with Merck & Co to procure its experimental antiviral pills to treat COVID-19 ailments.
-From Reuters, The Associated Press and CBC News, last updated at 11:05 a.m. ET
Overcoming scandal and PTSD, Japan’s Princess Mako finally marries college sweetheart
Japan‘s Princess Mako, the emperor’s niece, has married her commoner college sweetheart on Tuesday and left the royal family after a years-long engagement beset by scrutiny that has left the princess with post-traumatic stress disorder (PTSD).
Mako and fiance Kei Komuro, both 30, announced their engagement four years ago, a move initially cheered by the country. But things soon turned sour as tabloids reported on a money scandal involving Komuro’s mother, prompting the press to turn on him. The marriage was postponed, and he left Japan for law studies in New York in 2018 only to return in September.
Their marriage consisted of an official from the Imperial Household Agency (IHA), which runs the family’s lives, submitting paperwork to a local office in the morning, foregoing the numerous rituals and ceremonies usual to royal weddings, including a reception.
Mako also refused to receive a one-off payment of about $1.3 million typically made to royal women who marry commoners and become ordinary citizens, in line with Japanese law.
Television footage showed Mako, wearing a pastel dress and pearls, saying goodbye to her parents and 26-year-old sister, Kako, at the entrance to their home. Though all wore masks in line with Japan’s coronavirus protocol, her mother could be seen blinking rapidly, as if to fight off tears.
Though Mako bowed formally to her parents, her sister grabbed her shoulders and the two shared a long embrace.
In the afternoon, Mako and her new husband will hold a news conference, which will also depart from custom. While royals typically answer pre-submitted questions at such events, the couple will make a brief statement and hand out written replies to the questions instead.
“Some of the questions took mistaken information as fact and upset the princess,” said officials at the IHA, according to NHK public television.
Komuro, dressed in a crisp dark suit and tie, bowed briefly to camera crews gathered outside his home as he left in the morning but said nothing. His casual demeanour on returning to Japan, including long hair tied back in a ponytail, had sent tabloids into a frenzy.
Just months after the two announced their engagement at a news conference where their smiles won the hearts of the nation, tabloids reported a financial dispute between Komuro’s mother and her former fiance, with the man claiming mother and son had not repaid a debt of about $35,000.
The scandal spread to mainstream media after the IHA failed to provide a clear explanation. In 2021, Komuro issued a 24-page statement on the matter and also said he would pay a settlement.
Public opinion polls show the Japanese are divided about the marriage, and there has been at least one protest.
Analysts say the problem is that the imperial family is so idealised that not the slightest hint of trouble with things such as money or politics should touch them.
The fact that Mako’s father and younger brother, Hisahito, are both in the line of succession after Emperor Naruhito, whose daughter is ineligible to inherit, makes the scandal particularly damaging, said Hideya Kawanishi, an associate professor of history at Nagoya University.
“Though it’s true they’ll both be private citizens, Mako’s younger brother will one day become emperor, so some people thought anybody with the problems he (Komuro) had shouldn’t be marrying her,” Kawanishi added.
The two will live in New York, though Mako will remain on her own in Tokyo for some time after the wedding to prepare for the move, including applying for the first passport of her life.
(Reporting by Elaine Lies; Editing by Ana Nicolaci da Costa)
EU countries splinter ahead of crisis talks on energy price spike
Divisions have deepened among European Union countries ahead of an emergency meeting of ministers on Tuesday on their response to a spike in energy prices, with some countries seeking a regulatory overhaul and others firmly opposed.
European gas prices have hit record highs in autumn and remained at lofty levels, prompting most EU countries to respond with emergency measures like price caps and subsidies to help trim consumer energy bills.
Countries are struggling to agree, however, on a longer term plan to cushion against fossil-fuel price swings, which Spain, France, the Czech Republic and Greece say warrant a bigger shake-up of the way EU energy markets work.
Ministers from those countries will make the case on Tuesday for proposals that include decoupling European electricity and gas prices, joint gas buying among countries to create emergency reserves, and, in the case of a few countries including Poland, delaying planned policies to address climate change.
In an indication of differences likely to emerge at the meeting, nine countries including Germany – Europe’s biggest economy and market for electricity – on Monday said they would not support EU electricity market reforms.
“This will not be a remedy to mitigate the current rising energy prices linked to fossil fuels markets,” the countries said in a joint statement.
The European Commission has asked regulators to analyse the design of Europe’s electricity market, but said there was no evidence that a different market structure would have fared better during the recent price jump.
“Any interventions on the market and the decoupling of [gas and power] pricing are off the table,” one EU diplomat said, adding there was “no appetite” among most countries for those measures.
Other proposals – such as countries forming joint gas reserves – would also not offer a quick fix and could take months to negotiate. A European Commission proposal to upgrade EU gas market regulation to make it greener, due in December, is seen as the earliest that such proposals would arrive.
With less than a week until the international COP26 climate change summit, the energy price spike has also stoked tensions between countries over the EU’s green policies, setting up a clash as they prepare to negotiate new proposals including higher tax rates for polluting fuels.
Hungarian prime minister Viktor Orban has dismissed such plans as “utopian fantasy”, a stance at odds with other EU countries who say the price jump should trigger a faster switch to low-emission, locally produced renewable energy, to help reduce exposure to imported fossil fuel prices.
(Reporting by Kate Abnett; Editing by Bernadette Baum)
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