PMPRB amendments delayed to Jan 1, 2022

Summary#

The final regulation Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), No. 3: SOR/2021-162 delays parts of an earlier package of PMPRB changes so industry has more time to prepare. It pushes the main coming-into-force date to January 1, 2022, and updates some reporting deadlines to match that new date.

What it does#

• Delays the coming-into-force of the August 2019 amendments to the Patented Medicines Regulations (the “Amending Regulations”) from July 1, 2021 to January 1, 2022.
• Updates reporting deadlines so information tied to the new factors (for example, cost‑utility analyses and estimated market size) must be filed in line with the new start date:
  • For medicines already being sold in Canada before January 1, 2022, certain analyses must be provided by January 30, 2022, or within 30 days after publication if published later.
  • Other deadlines tied to reporting periods were shifted so semi-annual reports still fall 30 days after each period end.
• Confirms that the provision allowing the Patented Medicine Prices Review Board (PMPRB) to collect price information net of third‑party rebates remains delayed (it was struck down by some courts and awaits further regulatory action).
• Leaves unchanged the original exemption cut-off: medicines with a Drug Identification Number (DIN) before August 21, 2019 remain exempt from the new factors.
• Does not change the June 30, 2021 extension of PMPRB jurisdiction to include holders of Certificates of Supplementary Protection (CSPs); those “rights holders” are already in scope as of June 30, 2021.

Who's affected#

• Patentees and other rights holders (including companies holding CSPs) who sell patented medicines in Canada.
• Patented Medicine Prices Review Board (PMPRB), which enforces the rules and collects the required reports.
• Drug manufacturers, including brand-name pharmaceutical companies and their Canadian subsidiaries.
• Public and private payers (provincial drug plans, insurers) and provincial health ministries that negotiate prices and coverage.
• Patient groups and health-care providers who watch medicine pricing and access.
• It is unclear whether small or niche industry players are affected differently; the regulation notes that manufacturers of patented medicines are generally not small businesses.

Why it matters#

• The delay gives drug companies and health-system partners extra time to prepare for new reporting and pricing rules while they manage COVID‑19 demands.
• There may be a small cost to payers because the full effects of the Amending Regulations (estimated earlier to save $8.8 billion in present value over 10 years) could be slightly reduced by this six‑month delay. Health Canada expects most of those savings to remain.
• The change mostly shifts timing rather than the substance of the rules: which medicines are subject to the new factors and the nature of the reporting obligations remain the same once the rules come into force.
• Administrative burden estimates were reduced slightly by the delay (previous estimates moved from $3,062 to $2,758, then $2,577, and now $2,388, with an annualized administrative cost reduction of $189).
• The rebate‑netting provision remains unresolved because court decisions found it invalid; that part will need a separate future fix before it can apply.