Delay to PMPRB Amending Regulations

Summary#

The final regulation Regulations Amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), No. 4 (SOR/2021-273) delays when an earlier set of changes to drug-price rules takes effect. It pushes the start date from January 1, 2022 to July 1, 2022, and updates some reporting deadlines to match that new start date. The regulation was registered on December 21, 2021 and came into force the same day.

What it does#

• Delays the coming-into-force date of the earlier amending rules (the “Amending Regulations” published in 2019) from January 1, 2022 to July 1, 2022.
• Changes several deadline rules so that required reports tied to the new factors are due relative to the new start date (for example, many items must be filed within 30 days after the new coming-into-force date or within 30 days after a medicine first sells in Canada).
• Adds transitional timing for medicines already on the market so some analyses or market-size estimates for medicines offered before July 1, 2022 have specific submission dates (for example, some must be filed by July 30, 2022).
• Keeps the original exemption that medicines with a Drug Identification Number (DIN) before August 21, 2019 are not subject to the new factors or related reporting.
• Leaves in place an earlier suspension of the rule that would require rights holders to report prices net of third-party rebates. That particular provision remains delayed because courts have found it invalid and the matter is under appeal.

Who's affected#

• Drug manufacturers and their Canadian subsidiaries (often called rights holders).
• The Patented Medicine Prices Review Board (PMPRB), which uses the new factors and reports and enforces price rules.
• Health Canada, provincial drug programs, public and private insurers, and pharmacy/payor negotiators who deal with prices and listing agreements.
• Patients and taxpayers indirectly, because changes affect how much payers might spend on patented medicines.
• Small businesses are not expected to be affected, since most patented medicines are sold by large companies.

Why it matters#

• The delay gives industry and government more time to prepare and to keep focusing on COVID-19 response and other health priorities. The government said another six months of delay was needed for this reason.
• The original 2019 changes introduced new ways for the PMPRB to consider price — including market size and pharmacoeconomic value — and added reporting requirements. Pushing their start date postpones when those new rules begin to influence prices and negotiations.
• The federal analysis said the full Amending Regulations were expected to reduce patented medicine spending by about $8.8 billion (present value) over 10 years; a six-month delay may slightly reduce near-term savings, but most savings are still expected to occur.
• The rule about reporting prices net of third-party rebates remains on hold because of court rulings. That issue is still unresolved and could affect how price and sales data are reported in future.
• In practical terms, the delay is mainly about timing — it does not change which medicines will be covered by the new rules once they come into force.