Drug companies are abandoning Canada after Health Canada approval, leaving patients without life-saving medicines
Novartis rejected its own approved IgAN drug. Six FDA-approved treatments exist in the U.S.; zero in Canada. The approval process is the barrier.
The day's top stories, food & events — every morning at 7. Unsubscribe anytime.
Novartis received Health Canada approval for Vanrafia, a drug that can slow kidney disease progression in patients with IgAN, a rare autoimmune disorder. Then the company decided not to pursue it.
In a statement, Novartis said it determined "the likelihood of successfully securing reimbursement for Vanrafia is limited" under Canada's current access environment. The company is not alone. According to Innovative Medicines Canada, Canadians have access to just 18 per cent of all innovative medicines available worldwide. Americans access over 90 per cent. OECD countries — the world's richest nations — average 28 per cent.
The bottleneck is not Health Canada approval; it's the reimbursement process that follows. After approval, the Patented Medicine Prices Review Board sets a price ceiling by comparing costs in other OECD countries. The Canada Drug Agency then recommends whether federal and provincial health plans should cover it. The Pan-Canadian Pharmaceutical Alliance negotiates prices on behalf of the entire country. Finally, each province decides whether to list the drug on its formulary.
The entire process can take years. Drug companies typically recoup development costs through patent exclusivity — usually 10 to 20 years of research and $3.5 billion in investment per drug. In Canada, that exclusivity window may last fewer than five years after approval, according to Innovative Medicines Canada's President and CEO Bettina Hamelin. "Right now, Canadians wait an average of two and a half years before they can access innovative medicines," Hamelin said.
For IgAN patients like Ruchi Ambike, the gap is stark. There is no cure for IgAN, and some patients progress to end-stage kidney disease requiring dialysis or transplant. Six FDA-approved medications exist in the United States, with two more expected this year. None are available in Canada. "It's exciting because we have no IgAN drugs in Canada," Ambike said from her Mississauga home after learning of Vanrafia's approval — before learning the company would not sell it here.
Which other Health Canada-approved drugs has Novartis or other manufacturers declined to pursue reimbursement for?
How many Canadian patients currently need IgAN or similar treatments unavailable here?
We'll update this story as answers emerge.
The facts
Why did Novartis reject its Health Canada-approved drug Vanrafia?
Novartis determined that the likelihood of securing reimbursement for Vanrafia was limited under Canada's current access environment.
How long does the reimbursement process typically take in Canada?
The entire reimbursement process after Health Canada approval can take years, with Canadians waiting an average of two and a half years before accessing innovative medicines.
What percentage of innovative medicines are available to Canadians compared to Americans?
Canadians have access to 18 per cent of innovative medicines available worldwide, while Americans access over 90 per cent.
