C-265An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access)
Private member's bill, introduced in the House of Commons on March 11, 2026
- Status
- In committee in the House of Commons since June 10, 2026
What it does
Creates a pre-approved special access list for certain therapeutic products and sets new rules for emergency access to new drugs.
What it does
- Creates a Health Canada list of pre-approved, non-marketed therapeutic products for serious or life-threatening conditions, including rare diseases, and for cases where no comparable product is on the Canadian market.
- Lets the Minister add, limit, or remove products from the list, publish the list and removal reasons, and consult an expert advisory committee before changing it.
- Allows practitioners, pharmacists, hospitals, and medical non-profit groups to submit products for listing, and requires the Minister to decide within 120 days.
- Lets practitioners request listed products from manufacturers, and lets licensed importers bring them in and distribute them under set reporting and oversight rules.
- Sets rules for letters of authorization for emergency treatment with new drugs, including how the Minister must weigh evidence, give reasons for refusals, and keep emergency help available.
- Allows temporary emergency use of a new drug or listed product based on clinical judgment, with later notice to the Minister.
Who it affects
- Patients with serious conditions
- Practitioners
- Pharmacists
- Hospitals
- Medical non-profit organisations
- Drug manufacturers
- Licensed importers
- Minister of Health
Background
The bill builds on the Food and Drugs Act and the Food and Drug Regulations, which already provide special access and letters of authorization. It adds a statutory list and new rules for those processes.
Where it is
House of Commons
First reading
Completed.
Second reading
Completed.
Committee
Current stage. Now here
Report stage
Not reached.
Third reading
Not reached.
Senate
First reading
Not reached.
Second reading
Not reached.
Committee
Not reached.
Third reading
Not reached.
Royal assent
Royal assent
Not reached.
Introduced by an MP who is not a minister. These bills compete in a lottery for debate time, and most do not become law. How a bill becomes law
How the House voted
No recorded votes yet
What MPs said
Each party’s first speech on this bill in the House, from Hansard. Excerpts are the speaker’s opening sentences, unedited.
LiberalMarcus Powlowski· May 8, 2026
“Basically, it is similar to the pre-approved drug list in my bill, Bill C-265. They found that the program significantly reduced time-to-drug initiation from the time of request.”
Read the full speech on openparliament.caConservativeBurton Bailey· May 8, 2026
“I rise today to speak to Bill C-265, an act to amend the Food and Drug Act with respect to a list of therapeutic products pre-approved for special access. I want to start by telling the House about a child.”
Read the full speech on openparliament.caBlocMario Simard· May 8, 2026
“It is worth emphasizing that the intention behind this bill is a very noble one. Facilitating access to therapeutic products for patients seeking access to innovative drugs or therapies when that is their only remaining option is a highly commendable objective, it must be said.”
Read the full speech on openparliament.ca
Read the source
LEGISinfo status: At consideration in committee in the House of Commons. Bill data from LEGISinfo, votes from openparliament.ca and the House of Commons. Last updated October 13, 2026.