COVID-19 Drug Licence Fee Repeal

Summary#

The federal government cancelled the temporary fee-remission rule that had waived certain drug establishment licence fees for activities tied to COVID‑19 drugs. The repeal was registered on December 22, 2021 and took effect the same day; the Canada Gazette published it on January 5, 2022.

What it does#

• Repeals the Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug).
• With the repeal, fees set in the Fees in Respect of Drugs and Medical Devices Order apply again to any drug establishment licence application, licence amendment, or annual licence review for activities linked to COVID‑19 drugs.
• Notes that the earlier temporary rule worked alongside the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, which already expired on September 17, 2021. The remission order had no expiry date and therefore needed to be repealed to end the fee relief.
• Offers numbers from Health Canada’s review of the temporary measure: seven licence holders made interim-order amendments; six companies received partial fee remissions in 2021, averaging $7,000 each and totalling about $42,000.

Who's affected#

• Drug establishment licence holders — companies that manufacture, import, package, test, distribute or wholesale drugs in Canada.
• The small group of licence holders that used the interim order (seven firms, six of which received partial remissions). One small business chose not to continue its COVID‑19 activities.
• Health Canada, which will again collect the full fees for these licence activities.
• It is unclear that any large group of Canadians will be directly affected by this change.

Why it matters#

• It ends a temporary, pandemic-era fee break and clarifies which fee rules apply going forward.
• Financial impact is small: Health Canada estimates at most about $42,000 per year in additional fees collected because of the repeal.
• Health Canada says the repeal is unlikely to reduce the supply of COVID‑19 drugs in Canada. Most affected companies chose to keep their COVID‑19 activities after the interim order expired.
• Fees recovered are used to pay for regulatory work. Existing processing standards remain the same (reviews are to be completed within 250 calendar days; annual licence materials should be submitted before April 1 to allow review by August).
• If fees are not paid, Health Canada may take enforcement action under its existing guidance.