Patented Medicines Amendments Delayed

Summary#

These final regulations (registered as SOR/2020-298) push back when earlier Patented Medicines rules will take effect. They delay the start date from January 1, 2021 to July 1, 2021, and put off the specific rule that would let regulators collect prices net of third‑party rebates until a later date.

What it does#

• Delays the coming-into-force date of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), No. 2: SOR/2020-298 to July 1, 2021 (the delaying regulations were registered on December 29, 2020 and published in the Canada Gazette on January 20, 2021).
• Leaves the subsection that would require reporting prices net of third‑party rebates (the rebate-adjusted price rule) without a start date; its coming-into-force is postponed until a future regulatory amendment fixes a date.
• Moves some reporting deadlines so they line up with the new start date. For example:
  • Cost‑utility analyses and similar reports must be provided by July 30, 2021 if they were published before July 1, 2021, or within 30 days after publication if published later.
  • The most recent estimated maximum use of a medicine must be submitted by July 30, 2021 in certain cases, or within 30 days after a drug identification number is assigned in others.
• Keeps the original exemption rule that medicines with a drug identification number (DIN) obtained before August 21, 2019 are not subject to the new factors and related reporting.

Who's affected#

• Drug manufacturers and patentees — especially companies that market medicines in Canada and will have to report more information when the new rules take effect.
• The Patented Medicine Prices Review Board (PMPRB), which uses the new information and factors to assess whether patented medicine prices are excessive.
• Health Canada, which sponsored the amendments and coordinates the timing.
• Public and private drug payers and plans, who may see pricing and listing decisions influenced by the changed timeline.
• Innovative Medicines Canada and other industry groups that asked for the delay.

If it’s unclear who else will notice the change, that reflects the document: the core impacts are on patentees and the regulator.

Why it matters#

• It gives the drug industry more time to prepare while COVID‑19 disruptions continue. Regulators said the delay reduces short‑term administrative pressure and lets stakeholders learn the PMPRB’s final Guidelines (published October 23, 2020).
• There may be a small cost to payers from the six‑month delay. Health Canada originally estimated first‑year savings of Can$220 million from the rules; it says most of that saving is still expected, but some short‑term impact is possible.
• The paperwork burden is slightly reduced by timing: estimated annualized administrative costs fell from $3,062 to $2,758, and with this further six‑month delay to $2,577, a net reduction of about $181 (all figures in constant 2012 dollars as reported).
• The specific rule about collecting rebate‑adjusted prices was already challenged in court. The Federal Court decision on June 29, 2020 and a Quebec Superior Court decision on December 18, 2020 found problems with that provision; the government has delayed putting that part into force pending further regulatory action and ongoing appeals.
• In short: this is a temporary, legally binding postponement, not a repeal. The underlying rules will take effect later, and the courts are still deciding part of the reporting changes.