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C-265 — An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access)
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C-265
An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access)
5
LPC
In progress
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BILL C-265
An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access)
Last activity : At consideration in committee in the House of Commons
LPC
In progress
Commons · 1st2026-03-11Commons · 2nd2026-06-10Commons · 3rdSenate · 1stSenate · 2ndSenate · 3rdRoyal assent
Sign-in required — one request per person, no anonymous requests
What it does, in plain language
- Creates a "List of Therapeutic Products Pre-approved for Special Access" that the Minister of Health must build, maintain and post on the Health Canada website, covering non-marketed products used to treat serious or life-threatening conditions, including rare diseases.
- Sets out what can go on the list: products that previously held an authorization not cancelled for safety reasons, products approved by a foreign regulator the Minister considers comparable, or new drugs already covered by a letter of authorization.
- Requires the Minister to consult a non-partisan committee of medical research and clinical experts, including specialists working with children, before creating or changing the list; members serve unpaid and without expense reimbursement.
- Lets practitioners, pharmacists, hospitals or medical non-profits nominate a product for the list, with the Minister required to decide within 120 days.
- Allows a practitioner to order a listed product directly from the manufacturer for a patient, with a report to the Minister due within 90 days; manufacturers and importers must also notify the Minister of sales and imports within 90 days.
- Sets rules for emergency letters of authorization for new drugs: evaluation criteria, published guidelines, written reasons for any refusal, and a ban on refusing solely for certain reasons, such as an ongoing clinical trial.
- Permits a doctor, in an emergency, to temporarily give a product based on clinical judgment without prior authorization, requires Health Canada to keep a help line staffed at all times, mandates annual public reports, and takes effect one year after royal assent.
🤖 AI-generated from the bill’s official text as introduced — may not reflect amendments adopted since.
Registered lobbying
5 communications · 1 organization
as of Sep 10, 2026
the 5 most recent +
Canadian Organization for Rare Disorders5
2026-06-04 · House of Commons
Canadian Organization for Rare Disorders
Met with : Tom Kmiec — Member of Parliament
2026-05-27 · Health Canada (HC)
Canadian Organization for Rare Disorders
Met with : Daniel MacDonald — Director General, Office of Pharmaceutical Management Strategies
2026-05-26 · House of Commons
Canadian Organization for Rare Disorders
Met with : Helena Jaczek — Member of Parliament
2026-05-26 · House of Commons
Canadian Organization for Rare Disorders
Met with : Marcus Powlowski — Member of Parliament
2026-05-26 · Health Canada (HC)
Canadian Organization for Rare Disorders
Met with : Sandenga Yeba — Director of Policy & Deputy Chief of Staff · Justine Frame — Policy Advisor
Communications reported to the Office of the Commissioner of Lobbying that name this bill. Lobbying is a lawful, publicly registered activity — this count is a fact, not a verdict. Only communications whose description names both the bill number and its title are counted, so the real total may be higher. Registry archive read on September 10, 2026; the Commissioner republishes it about monthly, and we refresh it by hand.
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