Drug companies won't sell life-saving medicines approved in Canada, Novartis case shows

Novartis got Health Canada approval for Vanrafia, a drug that can slow progression of IgAN, a rare kidney disorder — but the company won't pursue reimbursement, meaning Canadians won't be able to buy it.

Ruchi Ambike, a Mississauga resident with IgAN, was ecstatic when the approval came through. "It's exciting because we have no IgAN drugs in Canada," she said. In the United States, there are six FDA-approved IgAN medications, with two more coming this year. None are available here.

Novartis said the decision reflects economics, not safety: "Under the current Canadian access environment, the likelihood of successfully securing reimbursement for Vanrafia is limited."

This is not isolated. Dr. Michelle Hladunewich, a nephrologist at Sunnybrook Health Sciences Centre and a trial participant, said the pattern is becoming routine. "It doesn't sit well with me as a physician, but it seems to be the way it's happening lately, especially with new drugs in Canada."

Canadians have access to only 18 per cent of all innovative medicines available globally, according to Dr. Bettina Hamelin, president and CEO of Innovative Medicines Canada. Americans have access to over 90 per cent. Other OECD countries average 28 per cent.

The bottleneck is process and time. After Health Canada approves a drug, the Patented Medicine Prices Review Board sets a price ceiling by comparing with OECD countries. The Canada Drug Agency makes a recommendation on coverage. The Pan-Canadian Pharmaceutical Alliance negotiates prices nationwide. Then provinces decide if they can afford to list it. The entire sequence can take years — long enough that companies may exhaust patent exclusivity in Canada while still waiting for a reimbursement decision. A single drug costs $3.5 billion to develop and takes 10-20 years of research, Hamelin noted.