Regulation 552 now mirrors a 2011 policy the province says shields $5.2 billion in OHIP costs
Ontario has capped public funding for out‑of‑country drug treatments at medications already publicly funded within the province, under an amendment to Regulation 552 of the Health Insurance Act announced on October 7.
The Ontario government said in its announcement that the amendment aligns the regulation with an out-of-country drug funding policy in place since 2011.
The province put the cost of rising out‑of‑country requests at up to $170m annually.
Funding is available only where the drug and its administration are publicly funded in Ontario, access to the drug is temporarily unavailable, and the delay makes it necessary for the patient to travel outside Canada to avoid death or medically significant irreversible tissue damage.
Allowing the previous regulation to stand “could cost the Ontario Health Insurance Plan (OHIP) $5.2bn each year and would create a back door for global pharmaceutical companies to avoid negotiating directly with the province to achieve more competitive pricing,” the health ministry said in a statement reported by CTV News.
Alex Shved, a 37‑year‑old father of two with Stage 4 melanoma, took the province to court over OHIP rejections, The Canadian Press reported.
OHIP had denied his oncologist’s request for tumour‑infiltrating lymphocyte therapy in Florida at an approximate cost of US$600,000, largely citing the fact that the therapy is under consideration for public funding in Ontario.
Routinely funding out‑of‑country drug therapies while they are undergoing review in Ontario would “undermine the incentive structure that encourages manufacturers to participate in Canada’s drug review processes,” the executive officer of Ontario public drug programs wrote in the denial.
A Divisional Court ruling found OHIP offered no real basis for that reasoning and ordered the plan to reconsider.
OHIP rejected Shved’s request a third time, and Health Minister Sylvia Jones announced the regulatory amendment.
“The courts concluded that the government’s actions were unlawful, and the government’s response was to change the law to make those same actions now lawful,” Shved said in an interview with The Canadian Press.
Jones wrote in a statement, “We’re protecting Ontario patients and taxpayers from price‑gouging and protecting their access to life‑saving medications that would otherwise only be available in the United States or overseas.”
The government is exploring a “mutually satisfactory resolution” in Shved’s case, she wrote, though Shved said he remains unclear on what that would entail.
Adil Shamji, a physician and Ontario Liberal health critic, told The Canadian Press the clarified rules amount to a catch‑22.
“The risk with that is that in order for a drug to be funded here it has to go through years of regulatory approvals and the challenge with that becomes we have patients who don’t have years to wait,” he said.
Holly Wardlow, a Toronto resident with NRG1 fusion cholangiocarcinoma, has spent close to half a million dollars on a drug costing $78,000 a month, CTV News reported on October 11.
Her drug, Bizengri, the brand name for zenocutuzumab, was approved under Health Canada’s Special Access Program for her treatment but has not received wider approvals.
Health Canada approved lifileucel, a version of TIL therapy, for sale in 2025, and it is undergoing reviews for possible funding by provincial drug plans, a process that could take years, The Canadian Press reported.
