Faster Access to Unapproved Treatments

Summary#

• This bill would change Canada’s Food and Drugs Act to speed up access to certain drugs and medical devices for people with serious or life‑threatening conditions, including rare diseases.

• It creates a public “List of Therapeutic Products Pre‑approved for Special Access” and sets clear rules for emergency access to new drugs.

• Key changes:

  • Health Canada must create and publish a list of non‑marketed treatments (not approved or not sold in Canada) that doctors can access for serious conditions when no comparable option is available here.
  • Clear criteria for adding items to the list, including prior Canadian authorization, comparable foreign approval, or clinical evidence and guidelines.
  • Doctors can request products on the list for a patient, and may request supply even before a patient is identified; licensed importers and manufacturers can sell or import these products under streamlined rules.
  • An expert advisory committee must be consulted before the list is created or changed; doctors, pharmacists, hospitals, and medical non‑profits can propose additions; the Minister must decide within 120 days.
  • Oversight includes reporting by doctors, manufacturers, and importers; the Minister can limit or stop use and can remove products from the list for safety or misuse.
  • For new drugs in emergencies, the Minister must follow published guidelines, consider all types of medical evidence, and generally issue authorization if two expert clinicians support a treatment plan, unless it risks public harm.
  • A 24/7 help line for emergency authorizations; in a true emergency, a doctor may give a new drug without prior authorization but must notify Health Canada.
  • Annual public reports on how the list and emergency access system are working.
  • Takes effect one year after it becomes law.

What it means for you#

• Patients and families

  • You could get faster access to certain drugs or devices that are not sold in Canada if you face a serious or life‑threatening condition and have no good alternative.
  • Your doctor may be able to obtain and stock a treatment in advance, so care can start sooner.
  • In an emergency, your doctor can give you a new drug right away, then report it to Health Canada.
  • Safety is still monitored. Health Canada can limit use, require expert training, or remove a product from the list if risks arise.
  • This bill does not change who pays for treatment. Public or private coverage rules stay the same.

• Practitioners (like doctors) and pharmacists

  • You can request products on the list for a patient, even if the patient’s name is not yet known.
  • You must report to Health Canada within 90 days after making a request; manufacturers and importers must also give notice within 90 days of sale or import.
  • For emergency new‑drug use, Health Canada must weigh benefits and risks using all available evidence. If two expert clinicians support a plan and the patient consents, the Minister should generally authorize, unless there is likely public harm.
  • Some products may be limited to certain training, specialties, or care settings.
  • A 24/7 help line should assist with urgent authorizations.
  • You, your hospital, or your professional organization can propose additions to the list; Health Canada must respond within 120 days.

• Hospitals

  • Hospital pharmacies with the right federal licences can import, store, and distribute listed products, including in anticipation of a doctor’s request, following any conditions set by Health Canada.
  • Expect tracking, record‑keeping, and reporting requirements.
  • You can help propose products for the list and will be consulted in annual reviews.

• Manufacturers and importers

  • You may sell or import listed products under exemptions from many usual rules, subject to conditions and reporting.
  • If Health Canada believes you are using the list to avoid full approval, you may be required to explain why; a product can be kept on the list only until approval is obtained or can be removed.
  • Products can be removed for safety issues, diversion or misuse, if marketed in Canada, or if withdrawn internationally. Health Canada will publish reasons for removal.

• General

  • “Therapeutic products” include drugs and medical devices.
  • “Non‑marketed” means not approved or no longer sold in Canada.
  • “Comparable” treatments are judged by factors like cost, how the product is made, how well it works, safety warnings, and side‑effect rates in certain groups.

Expenses#

No publicly available information.

Proponents' View#

• Speeds up access to treatments for people with urgent or rare conditions, reducing delays when no good Canadian option exists.
• Gives doctors clearer rules, a 24/7 help line, and the ability to act in emergencies, which could save lives.
• Uses all types of evidence, including real‑world and foreign data, to make timely decisions.
• Keeps safety checks in place with reporting, expert input, limits on use, and the power to remove risky products.
• Improves transparency by publishing the list, decision guidelines, and annual reports.
• Sets timelines (120 days for list decisions) and reduces red tape for hospitals and clinicians.

Opponents' View#

• Allowing sales and imports under exemptions could weaken usual safety oversight and increase the risk of side effects or misuse.
• Doctors and hospitals face new reporting and record‑keeping duties, which could add workload.
• Companies might rely on special access instead of seeking full Canadian approval, limiting broader access and long‑term safety data.
• Uneven access could arise if some hospitals or regions can import and stock products more easily than others.
• The advisory committee is unpaid, which may affect participation and depth of review.
• A 24/7 help line and new systems may require resources and staffing that are not yet defined.