The Ontario government has aligned Regulation 552 of the Health Insurance Act with the province’s long-standing out-of-country drug funding policy, which has been in place since 2011, in order to protect the province’s ability to provide affordable, publicly funded medication for Ontario patients at home.
The policy only funds drug treatments that have undergone Ontario’s evidence-based, expert-led approval process and would otherwise be funded in the province but are subject to an unacceptable delay. The province says maintaining the policy without clarifying it in regulation could cost the Ontario Health Insurance Plan $5.2 billion each year and create a back door for global pharmaceutical companies to avoid negotiating directly with the province.
“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,” said Sylvia Jones, deputy premier and minister of health. “This change supports a consistent, fair and transparent approach to funding decisions, protects the integrity of Ontario’s world-class drug approval process and will help avoid up to $5.2 billion in additional costs to Ontario’s health-care system every year.”
With respect to a recent Ontario Divisional Court decision concerning out-of-country drug funding, the government says it is exploring all available options, including an appeal or a mutually satisfactory resolution with the applicant.
The province says the amendments protect several objectives, including incentivizing pharmaceutical companies to launch new products in Ontario rather than marketing them only outside Canada at U.S. prices, preserving pan-Canadian negotiating leverage over drug companies, and ensuring any drugs funded in Ontario are fully tested and authorized by Health Canada. The province also says the increase in requests for out-of-country treatments in recent years could otherwise cost up to $170 million annually.
Under the amendments, funding for out-of-country drug treatments will only be available when the treatment is performed in Ontario, the drug and its administration are publicly funded in the province, access to the drug is temporarily unavailable, and the delay makes it necessary for the patient to travel out of Canada to avoid death or medically significant irreversible tissue damage. Decisions on which drugs are publicly funded will continue to be informed by Ontario’s established review process.
