The Food and Drugs Act is a federal statute regulating the safety, production, importation, and sale of food, drugs, cosmetics, and medical devices. It helps protect Canadians from unsafe products and deceptive marketing.
This special statement has been prepared to support proposed changes to the Act’s Special Access Program section. These changes could give people experiencing serious or life-threatening conditions faster access to medications that aren’t yet approved by Health Canada. Some of these medications could help people living with lung conditions.
On March 11, Minister Marcus Powlowski introduced in Parliament Bill: C-265, An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access).
Through evidence and by patient and clinician advocacy, Bill: C-265, An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access) (the “Bill”) is an essential step to promoting better access to essential lung health medicines. The Bill reforms the Special Access Program (SAP) which allows Canadian physicians to use medications not approved by Health Canada when there is an unmet, and essential, need.
Example
Linda is being treated for Stage IV non-small cell lung cancer. She’s tried several therapies, but her condition continues to be serious and life-threatening. Her oncologist knows about a new medication that could give Linda more time and quality of life, but it is not yet approved for marketing by Health Canada, though is approved in other countries. Through the reformed Special Access Program, her oncologist can apply for emergency access to the medication with approval from the supplier.
The Bill reduces the red tape associated with this program and leaves the decision in life-threatening situations as to whether to use a drug not yet approved by Health Canada to the clinicians and their patients. In so doing, the Bill will reduce the wait-times experienced by patients in need. The main requirement for an SAP is that the drug is requested for a patient with a serious or life-threatening condition for whom conventional therapies (available in that country) have failed, are unsuitable, or are unavailable. SAP authorized sales are considered exempt from the usual Food and Drugs Act regulations, on strict emergency and case-by-case bases, meaning the SAP itself does not constitute a full, formal safety and efficacy approval, but rather an emergency authorization.
Example
Every Special Access Program case is unique. Linda’s specific circumstances mean that she gets to use the medication, but this does NOT mean that the same medication would be available to everyone until it is formally approved by Health Canada. The medication would still need to be thoroughly reviewed to make sure it’s safe and effective enough.
The Bill will receive its second reading in the House of Commons on Thursday, March 19, 2026 before its consideration in committee, whereupon it will be open for public consultation. The Lung Health Foundation welcomes its lung health advocates, clinicians, and partners to share their thoughts with respect to the Bill at this time.
The Lung Health Foundation, on behalf of patients Canada-wide navigating lung health morbidities, also thanks SickKids Hospital and the staff at the SickKids Child Health Policy Accelerator who worked closely with the Hon. Minister Marcus Powlowski in drafting the bill, children’s hospitals Canada-wide for their contributions, and Conservative MP Dr. Matt Strauss for seconding the bill.
Read more here: https://www.parl.ca/LegisInfo/en/bill/45-1/C-265
