CSP Holders Must Report to PMPRB

Summary#

These are final regulations (SOR/2021-116) that extend the existing reporting rules so that holders of a certificate of supplementary protection (CSP) must report the same information to the Patented Medicine Prices Review Board (PMPRB) as patent holders do. The changes came into force on June 30, 2021 (with one sub‑section delayed to a later date).

What it does#

• Replaces references to “patentee” with the broader term rights holder so that both patentees and CSP holders must provide the same information to the PMPRB.
• Requires rights holders to report identity details and document details such as:
  • name and Canadian address for correspondence,
  • CSP number and the dates the CSP takes effect and expires,
  • the patent number listed in the CSP application.
• Requires the same price, sales, revenue and research-and-development (R&D) information already reported by patentees, including drug identification numbers, quantities sold, average price per package or net revenue, and publicly available ex-factory prices.
• Sets timing rules and some short deadlines for responding to Board requests (commonly 30 days in specific circumstances) and for providing estimates of expected use soon after a medicine is first offered for sale.
• Delays the rule that would require reporting prices net of third‑party rebates. That part was found invalid in court decisions (for example, Innovative Medicines Canada v. Canada (2020 FC 725) and a decision in Merck et al. v. Attorney General of Canada) and will come into force only after a future regulatory amendment fixes a date.
• Confirms the main amendments come into force June 30, 2021; one specific clause (noted in the text) will come into force on a day to be fixed later.

Who's affected#

• Rights holders: both existing patentees and companies holding certificates of supplementary protection (CSPs).
• Pharmaceutical companies that sell medicines in Canada (typically multinational firms or their Canadian subsidiaries).
• The Patented Medicine Prices Review Board (PMPRB), which will receive and use the additional reporting.
• Consumers and public payers are indirectly affected because the PMPRB uses this information to monitor prices. It is unclear that small businesses are affected; the government says the small business lens does not apply.

Why it matters#

• These rules make sure the PMPRB gets the same data for medicines protected by CSPs as it already gets for medicines protected by patents. That lets the PMPRB monitor prices during the CSP period, not just while a patent is in force.
• The regulations do not themselves change medicine prices. They change what information companies must report so the PMPRB can do its job.
• Administrative cost estimates are small: total annualized reporting costs were estimated at $5,869 across affected businesses and about $76.22 per business. Those figures assume tasks such as 26 hours of senior management time twice a year (valued at $62/hour) and a one‑time identity filing taking 1 hour (valued at $30/hour).
• One important data change — reporting prices after removing third‑party rebates — is on hold because of court rulings. That means the PMPRB cannot immediately collect rebate‑adjusted net prices until that issue is resolved.