Tuesday, October 06, 2026
Ontario Clarifies Longstanding Out-of-Country Drug Funding Process
Regulatory amendment will protect Ontario patients’ access to affordable, life-saving medication here at home
In order to protect the province’s ability to provide affordable, publicly funded medication for Ontario patients here at home, the government has aligned Regulation 552 of the Health Insurance Act with Ontario’s long-standing out-of-country drug funding policy, which has been in place since 2011. This policy only funds drug treatments that have undergone Ontario’s rigorous, consistent, transparent, evidence-based and expert-led process that would otherwise be funded in the province but are subject to an unacceptable delay.
Maintaining the policy without clarifying it in regulation could cost the Ontario Health Insurance Plan $5.2 billion each year and would create a back door for global pharmaceutical companies to avoid negotiating directly with the province to achieve more competitive pricing.
“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 the recent decision of the Ontario Divisional Court concerning out-of-country drug funding, the government is exploring all available options, including an appeal and/or seeking a mutually satisfactory resolution of the matter with the applicant to the court. At the same time, the province has aligned Regulation 552 to its longstanding policy on out-of-country drug funding in order to protect and reinforce the importance of several critical objectives for Ontario’s health-care system, including:
- Ensuring pharmaceutical companies are incentivized to launch new products here in Ontario, rather than choosing to only market them outside of Canada, charging U.S. prices and in U.S. currency, which would dramatically increase the cost of treatment for Ontario patients who would only be able to access these drugs out of country.
- Protecting pan-Canadian negotiating leverage over pharmaceutical companies, which allows Canadian provinces and territories to work together to access life-saving drugs quickly and incentivizes pharmaceutical companies to lower medication costs for Canadian patients.
- Protecting the integrity of Ontario’s current drug approval process by ensuring any drugs funded in Ontario are fully tested and authorized by Health Canada to be administered here in Ontario.
- Limiting the significant increase in requests for out-of-country treatments that has occurred over the past few years, which would otherwise incur up to $170 million in additional annual costs.
Collectively, this decision will avoid up to $5.2 billion in additional annual costs for Ontario’s health-care system, preserving patients’ access to life-saving medications here at home and ensuring drugs administered in Ontario have been rigorously tested and approved in the province.
The amendments to Regulation 552 of the Health Insurance Act clarify that funding for out-of-country drug treatments would only be available when specific conditions are met, including that:
- The treatment is performed in Ontario
- The drug and the administration of the drug are publicly funded in Ontario
- Access to the drug in Ontario is temporarily unavailable,
- The delay in access to the drug makes it necessary that the insured person travel out of Canada to avoid death or medically significant irreversible tissue damage
Decisions about which drugs will be publicly funded will continue to be informed by Ontario's established review process, which includes regulatory approval, health technology assessment, negotiation and final funding decision.
Quick Facts:
- Since 2011, Ontario's Out-of-Country Prior Approval Program has required recommendations from the Executive Officer of the Ontario Public Drug Programs when considering requests related to out-of-country drug treatments.
- Ontario’s Funding Accelerated for Specific Treatments (FAST) pilot program encourages companies to bring new drugs and therapies to Canada and make them available to patients here. To date, access to nine innovative cancer therapies has been accelerated through the FAST pilot.
- The Ontario Drug Benefit (ODB) Program is one of the most generous drug benefit programs in Canada, providing coverage for approximately 5,900 drug products and therapeutic treatments on the ODB Formulary for approximately 9 million Ontarians in the community setting.
- Drugs that are not listed in the ODB Formulary may be considered for coverage on a case-by-case basis through the Exceptional Access Program, which includes nearly 1,500 drugs, upon meeting specified criteria.
Additional Resources:
Media Contacts:
Lily Barnes
Minister Jones’ Office
Lily.Barnes@ontario.ca
Media Relations
Communications Branch
media.moh@ontario.ca
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