COVID‑19 Drugs Interim Order and Notices

Summary#

This Canada Gazette notice (Part I, Vol. 154, No. 40, published October 3, 2020) collects several government announcements. Key items include new 2021 employment insurance premium rates, Environment and Health Canada decisions and draft assessments about certain new substances, an emergency Health Canada Interim Order to speed access to COVID‑19 drugs, and pandemic‑related extensions of several legal deadlines.

What it does#

• Sets the 2021 employment insurance premium under the Employment Insurance Act at $1.58 per $100 of insurable earnings. For Quebec residents covered by the Quebec Parental Insurance Plan the reduction is $0.40, making their rate $1.18 per $100.
• Announces waivers under the Canadian Environmental Protection Act, 1999 allowing some companies to skip certain test data requirements when notifying the government about new living organisms or chemical substances. The annex lists specific firms given waivers.
• Publishes a draft screening assessment for four polymers (the “Other Polymers Group”) and proposes:
  • Concluding that DGEBA-DA resin, soya alkyd resin, and polyurethane‑33 do not meet the harmfulness criteria in the act, so no further action is proposed for those three.
  • Concluding that PHMB (polyaminopropyl biguanide) does meet the criteria and proposing to recommend adding PHMB to Schedule 1 of the act. A risk‑management scope document for PHMB has been released and public comments are invited for 60 days.
• Publishes the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID‑19 made under the Food and Drugs Act. Main features:
  • Creates an expedited authorization route for drugs (human and veterinary) related to COVID‑19, including reliance on some foreign approvals when appropriate.
  • Allows “rolling” submissions (applicants can provide some data later), temporary flexibility for establishment licences, and a process to allow pre‑positioning (importing and storing) promising COVID‑19 drugs before full Canadian authorization if the government has a procurement contract.
  • Lets the Minister impose terms, require extra information, or suspend/revoke authorizations if safety concerns arise. The order was signed on September 16, 2020.
• Extends pandemic‑affected deadlines under the Time Limits and Other Periods Act (COVID‑19), including:
  • Extending some firearms licence validity periods under the Firearms Act that end before December 31, 2020 until that date. (The firearms order came into force September 23, 2020.)
  • Extending a range of superannuation, pension and other administrative time limits by 180 days or to December 31, 2020 in several separate orders.

Who's affected#

• Employers and workers: payroll deductions will use the new 2021 EI premium rates.
• Chemical, biotech and pharmaceutical companies that notify or plan to import/manufacture new living organisms or substances: some were granted waivers (examples named in the Gazette include AstraZeneca Canada Inc., Glaxosmithkline Inc., Janssen Inc., Merck Canada Inc., and others). Those waivers mean certain tests or data were not required in their notifications.
• Manufacturers, importers, hospitals, pharmacies, veterinarians and public health agencies involved with COVID‑19 treatments and vaccines: they may use the faster authorization pathway under the Interim Order. Foreign makers whose products are already approved abroad may be able to support faster Canadian access.
• Consumers and users of products containing PHMB (used as a preservative or antimicrobial in some cosmetics and health‑care products): the government proposes that PHMB meets health‑risk criteria and may move to regulate it.
• Firearms licence holders whose licences would have expired in 2020: certain expiry dates were extended to December 31, 2020.
• Pensioners, public servants and administrators: many deadlines under pension and superannuation rules were extended by 180 days or to December 31, 2020.
• The general public: there is a 60‑day comment window on the draft screening assessment for the four polymers and on the proposed measures for PHMB.

Why it matters#

• The EI rate decision affects how much employers and workers pay into the system in 2021. Small changes in the rate affect payroll calculations for millions of workers.
• Waivers for test data can speed product development and market access, but they also mean less publicly available test information at the time of notification. That can matter to communities concerned about environmental or health impacts of new substances.
• The draft finding on PHMB signals possible restrictions or controls on a chemical used in cosmetics and other products. If added to Schedule 1, PHMB could face regulatory limits or risk‑management measures that change product formulations or availability.
• The Health Canada Interim Order is aimed at faster access to COVID‑19 drugs and allows the government to pre‑position supplies. That can help hospitals and public health planners get treatments sooner. At the same time, the order keeps safeguards (conditions, monitoring, and the ability to suspend or revoke authorizations) because evidence on benefits and risks can be limited in an emergency.
• Deadline extensions for licences and pension matters reduce administrative pressure on people and agencies during the pandemic. They give individuals and organizations more time to comply with requirements interrupted by COVID‑19.