Kyla Cavaliere, centre, with her parents Katerina and Marco Cavaliere. Kyla, 16, relies on pork insulin and her mother Katerina is cautiously optimistic that SAP would provide a way to get the product.Photography by Sammy Kogan/The Globe and Mail
A small group of Canadian Type 1 diabetes patients who were about to lose access to the only type of insulin they can tolerate may soon be able to obtain the medicine through a special Health Canada program, but the product will likely not be available for regular sale as they had hoped.
The patients at the heart of the case rely on Hypurin, an old-fashioned insulin derived from the pancreases of pigs.
Health Canada announced in March of 2025 that Hypurin would be discontinued in Canada because Wockhardt Ltd., the Indian pharmaceutical company that makes the product at a factory in Wales, is switching its distribution method from vials to cartridges for injection pens.
The format change required Wockhardt, the last remaining maker of porcine insulin, to reapply for Health Canada approval, something the federal drug regulator said the company refused to do.
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Health Canada also told patients – and The Globe and Mail – that Wockhardt also declined to participate in the department’s special access program, or SAP, a long-standing route for unlicensed drugs to be brought into the country for individual patients with serious or life-threatening medical conditions.
Wockhardt did an about-face after The Globe asked it about the Canadian situation last month.
Bhakti Kamble, the export manager for Wockhardt UK, told The Globe in a March 27 e-mail that the company would, in fact, participate in SAP, and would apply for market authorization of Hypurin cartridges if Health Canada waived the application fees.
Diabetes Canada and Breakthrough T1D Canada say that somewhere between 60 and 100 Canadians use animal insulin.
Nearly two weeks later, Health Canada responded to say it won’t forgo the fees, which range from $44,269 to nearly $320,000, depending on the data a company submits.
Marie-Pier Burelle, a spokeswoman for the regulator, said in a statement Thursday that, “based on the information available to Health Canada at this time, it does not appear that Wockhardt would be eligible for a fee waiver.”
The regulator can waive, reduce or defer fees in some cases, such as when the applicant is a small business or is addressing an urgent public-health need, she explained, but Wockhardt’s porcine insulin doesn’t appear to fit either bill.
However, Ms. Burelle wrote that Health Canada is now in discussions with Wockhardt about providing Hypurin through SAP, providing a glimmer of hope for patients who’ve been rationing their remaining vials.
Katerina Cavaliere, whose 16-year-old daughter Kyla relies on pork insulin, was cautiously optimistic that SAP would provide a way to get the product.
“We’re in a slightly better position than we were the whole past year with Health Canada, because SAP was not on the table,” said Ms. Cavaliere, who lives with her family in Kleinburg, Ont., north of Toronto.
Still, she worries SAP won’t be a long-term solution for her daughter or others who need animal insulin. The program requires a doctor to reapply every three months on behalf of individual patients, and the paperwork can be onerous.
It was a “punch in the gut,” to learn that Health Canada wouldn’t take the more straightforward route of waiving the application fee, Ms. Cavaliere added.
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Patient advocacy groups Diabetes Canada and Breakthrough T1D Canada say that somewhere between 60 and 100 Canadians still use animal insulin. Ms. Kamble of Wockhardt said it heard from the federal regulator that the figure was less than 20.
The vast majority of Type 1 diabetes patients thrive on either human insulin, produced using recombinant DNA technology inside E. coli cells or baker’s yeast, or newer, genetically modified analogue insulins.
Despite their small numbers, the group that depends on Hypurin embodies a dilemma that patients with other diseases face whenever pharmaceutical companies discontinue old drugs that are no longer profitable, said Matthew Herder, a professor of health law at Dalhousie University.
“If we know there are these predictable market failures, we need to take this out of the for-profit realm for these older medications, or at least create options, especially for a scale like this,” he said.
Colleen Fuller, a Vancouver health researcher and advocate who has relied on porcine insulin for decades, argued that a fee waiver for Hypurin, “is not some kind of outlandish or unheard of proposition.”
Health Canada, she added, “has become an obstacle to accessing an essential medicine, which is not what they are mandated to do.”