Emergency access to unapproved drugs

Summary#

These are final amendments to the Food and Drug Regulations that change how unapproved drugs can be sold or imported for emergency human or animal treatment. The rules let manufacturers pre-position some products in Canada and reduce paperwork for repeat emergency requests. The amendments came into force on September 28, 2020.

What it does#

• Lets Health Canada issue a written authorization allowing a manufacturer to sell a specified quantity of an unapproved drug to a named practitioner for emergency treatment.
• Allows a practitioner to skip sending information on a drug’s use, safety and efficacy when all of these are true:
  • the drug was previously authorized under the emergency program for the same emergency;
  • the European Medicines Agency or the United States Food and Drug Administration has authorized the drug for the same use without terms; and
  • Canada has not cancelled the drug’s identification number (or suspended the product licence for natural health products).
• Creates a regulated process for manufacturers to “pre-position” a drug in Canada by importing it into the custody of a holder of a drug establishment licence (DEL) so it is already in the country if an emergency request is later made.
  • The DEL holder can store but cannot distribute the drug until an authorization is issued.
  • Many standard manufacturing and storage rules are relaxed for pre-positioned drugs, but basic storage and recall controls still apply.
• Expands where an emergency shipment can be sent: to a practitioner, to a pharmacist, or (for veterinary drugs) to a commercial medicated feed mill.
• Allows the practitioner to request a drug even if the patient’s identity is not known at the time (useful for first responders or emergency rooms).
• Extends annual sales-reporting requirements to veterinary emergency drugs that contain antimicrobials on List A. The rules require an annual report of total quantities sold and estimated quantities by species.
• Keeps a prohibition on issuing authorizations for drugs that are “restricted drugs” under existing rules.

Who's affected#

• Health Canada, which runs the programs and issues the authorizations.
• Practitioners who request emergency access to unapproved drugs, including physicians and veterinarians.
• Manufacturers of drugs that might be requested under the emergency programs.
• Holders of a drug establishment licence (DEL) who would store pre-positioned imports.
• Pharmacists and commercial medicated feed mills who may receive emergency shipments.
• Patients, especially those in rural or remote areas who may gain faster access to emergency medicines.
• Small health businesses such as physician offices, pharmacies and veterinary clinics (the government assessed only modest cost and paperwork changes for small businesses).

Why it matters#

• Faster access in emergencies: pre-positioning means some needed products can already be in Canada instead of shipped from abroad after a request, which can shorten delivery times.
• Less paperwork for repeat uses: practitioners may save time when requesting a drug that has been previously authorized and is approved by EMA or FDA for the same use.
• Better local access: allowing shipment to community pharmacies and other locations can help patients outside hospitals and in rural communities get emergency medicines more quickly.
• Safety trade-offs remain: drugs supplied under these emergency rules are not subject to the full pre-market review and manufacturing checks that apply to authorized drugs, so practitioners must still weigh risks and report outcomes or adverse reactions.
• Antimicrobial stewardship: veterinary emergency drugs with active ingredients on List A are now included in annual sales reporting to support tracking and responsible use; Health Canada estimated a small annual reporting cost of about $1,120 in its analysis.