Repeal of PMPRB New Pricing Factors

Summary#

The final rule Regulations Amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), No. 5 removes some planned reporting and pricing rules that were part of the 2019 update to Canada’s drug-price regime. It keeps the revised list of comparator countries and reduced reporting for low‑risk products, which will take effect on July 1, 2022; the new regulation was registered on June 24, 2022 and published July 6, 2022.

What it does#

• Repeals the parts of the 2019 Amending Regulations that would have added new price‑setting factors (such as pharmacoeconomic value and market size) and the associated reporting demands.
• Removes the rule that would have required rights holders to report prices net of third‑party rebates.
• Confirms that the updated schedule of comparator countries and the smaller reporting burden for medicines considered lowest risk (for example, veterinary, over‑the‑counter, and certain generics) will come into force on July 1, 2022.
• Changes the coming‑into‑force wording so this repeal takes effect the day the new regulation was made.

Who's affected#

• Rights holders (patentees and holders of Certificates of Supplementary Protection) and the pharmaceutical companies that sell patented medicines in Canada.
• The Patented Medicine Prices Review Board (PMPRB), which enforces price rules and collects reporting.
• Public and private drug plan payers, provincial and territorial health ministries, and patient groups: they may notice effects on price reviews, negotiations and information available about drug prices.
• Some industry groups and academics that had prepared for the now‑repealed reporting and assessment rules.
  If it is unclear who will feel the biggest impact, say so plainly: the ultimate effect on drug prices and access is uncertain because the PMPRB will still use the new comparator country basket but will not use the repealed factors.

Why it matters#

• It reduces the new data companies would have had to submit and removes some ways the PMPRB could have judged whether a medicine’s price was excessive. That lowers reporting burden on industry.
• It preserves a change (the revised basket of comparator countries) that can change how the PMPRB compares Canadian prices to other countries. That may influence price negotiations, launch timing, or public plan costs.
• The government previously estimated the full 2019 package would have produced both benefits and costs of about $8.8 billion (present value) over 10 years; because parts were repealed, only the effects tied to the comparator basket and reduced reporting will be realized. The 2017 breakdown attributed about $3.8 billion, $2.9 billion, and $2.1 billion to the new factors, revised basket and net‑price reporting respectively.
• The change also responds to recent court rulings that found parts of the 2019 package invalid in some jurisdictions, so this repeal avoids having rules that would apply unevenly across Canada.
• Bottom line: fewer reporting requirements for industry, but a key pricing comparison tool (the comparator basket) still takes effect on July 1, 2022, so the PMPRB’s work and drug‑price outcomes may still change.