COVID-19 Drug Order and US Entry Ban

Summary#

This Canada Gazette item records two pandemic-related orders. It approves an emergency drug rule to speed the import, sale and advertising of COVID-19 drugs, and it renews a border rule that mostly bars foreign nationals coming from the United States. The emergency drug measure was made on September 16, 2020 and approved by order on September 25, 2020; the border rule runs until October 21, 2020.

What it does#

• Approves the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. In plain terms this:
  • Creates faster, temporary pathways to authorize drugs (human and veterinary) for COVID-19 use.
  • Allows "rolling" applications so companies can send data as it becomes available.
  • Lets regulators consider foreign approvals when deciding whether to allow a drug in Canada.
  • Permits existing Canadian drugs to be sold or advertised for a COVID-19-related use not currently on their label, via a special list.
  • Provides a quicker process to issue or amend drug establishment licences (the permits needed to make, package or import drugs), with flexibility on some manufacturing requirements while still monitoring safety.
  • Lets the Public Health Agency of Canada (PHAC) or other designated licence holders pre-position (import and store) promising drugs in Canada before full Canadian authorization, if the government has a procurement contract and an application has been filed.
  • Keeps requirements for bilingual labelling, adverse-reaction reporting, recalls and shortage reporting.
  • Says authorizations under the Interim Order only last while the Interim Order is in effect (up to one year unless repealed or replaced).
  • Removes review fees for drug applications submitted under this Interim Order and waives certain annual market fees for these COVID-19 drugs.
  • Requires Health Canada to publish the non‑confidential clinical evidence used to authorize drugs under the Interim Order.
• Replaces and extends the border rule as the Minimizing the Risk of Exposure to COVID-19 in Canada Order (Prohibition of Entry into Canada from the United States). In plain terms this:
  • Prohibits most foreign nationals from entering Canada from the United States for optional or discretionary reasons (for example tourism).
  • Allows exceptions for immediate family members of Canadians who can show they will stay at least 15 days, certain refugee claimants at designated land ports, U.S. citizens in many cases, Indigenous people registered under the Indian Act, and others specifically listed.
  • Keeps people with COVID‑19 symptoms out even if otherwise exempt.
  • Is in force from the moment it was made until 23:59:59 Eastern Daylight Time on October 21, 2020 and repeals the previous similar order made in August 2020.
  • Notes penalties for breaking Quarantine Act measures of up to $1,000,000 and/or three years in prison.

Who's affected#

• People crossing the Canada–U.S. border:
  • Most foreign nationals travelling from the United States for optional reasons (tourists, short-term visitors) will be blocked.
  • Immediate family members of Canadian citizens or permanent residents may be allowed if staying at least 15 days.
  • U.S. citizens, some refugee claimants, and certain other categories have narrow exceptions.
• Drug makers and suppliers:
  • Manufacturers, importers and distributors of medicines for COVID-19 use will notice faster and different application options.
  • Veterinary drug producers are included because of possible animal cases and to be cautious.
• Health agencies and hospitals:
  • Health Canada and PHAC will run the expedited reviews, pre-positioning and monitoring.
• The public more broadly:
  • People hoping for faster access to COVID-19 treatments may be affected by the new pathways and by any drugs pre-positioned in Canada.

Why it matters#

• Faster access to treatments: The drug measures aim to get potentially useful COVID-19 medicines into Canada more quickly by accepting less-complete data up front and using foreign approvals when appropriate. That could speed treatment options in a fast-moving crisis.
• Trade-offs and monitoring: Faster authorization increases the need for active safety monitoring. Health Canada keeps the ability to suspend or cancel authorizations if problems arise.
• Border and family impacts: The entry order keeps strict limits on who can travel from the United States. That affects tourism, some cross-border work and short family visits, while allowing certain close family reunifications and essential exceptions.
• Enforcement risk: Non-compliance with quarantine and entry rules can lead to large fines and criminal penalties.