Delay of New Patented Medicines Rules

Summary#

These final regulations delay parts of the August 2019 changes to the Patented Medicines Regulations that would add new pricing factors and reporting rules. The delayed rules will now take effect on January 1, 2021 instead of July 1, 2020 and some reporting deadlines are moved to align with that date.

What it does#

• Changes the coming-into-force date of the August 2019 amending rules (the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements)) from July 1, 2020 to January 1, 2021.
• Updates deadlines for new information requirements so they match the new start date, including deadlines of January 30, 2021 or within 30 days after publication or assignment in certain cases.
• Clarifies that medicines with a Drug Identification Number (DIN) assigned before August 21, 2019 remain exempt from the new factors and related reporting obligations.
• States that the new pricing factors will not apply to sales made before January 1, 2021.
• The instrument that makes these changes was registered and came into force on June 1, 2020.

Who's affected#

• Pharmaceutical companies that hold patents on medicines in Canada and must report price and sales information (patentees).
• The Patented Medicine Prices Review Board (PMPRB), which uses these rules to assess whether patented medicine prices are excessive.
• Public and private drug payers and listing negotiators, who may be affected by any change in timing of pricing information and ceilings.
• Patient groups and industry associations such as Innovative Medicines Canada, which asked for a delay because of COVID-19 pressures.
• Small businesses are generally not affected, since patented medicines in Canada are sold by large companies; the government did not identify small business impacts.

Why it matters#

• The delay reduces near-term administrative work for drug companies while many are dealing with COVID-19 supply and response efforts.
• It gives stakeholders more time to review and comment on the PMPRB’s draft Guidelines that explain how the new rules will be applied.
• There may be a small short-term effect on drug spending: the government estimated earlier that the 2019 changes could save Can$220 million in the first year, and delaying the start by six months could slightly reduce those savings.
• The estimated administrative cost impact of the change was adjusted from $3,062 to $2,758, with an annualized reduction shown as $304 (and about $4 per business in the government’s 2012-dollar accounting).

If you want more detail on the exact reporting deadlines or exemptions for particular medicines, say so and I can pull the specific clauses from the official text.