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Program directory · Patented Medicine Prices Review Board Canada

Patented Medicine Price Regulation Program

Program code
BVM01 (PMPRB)
Core responsibility
Regulate Patented Medicine Prices
In Departmental Plans
2018-19 – 2024-25 · Appeared and later dropped

What it does

Board Staff reviews introductory and ongoing price and sales information filed by patentees, for all patented drugs sold in Canada. When a price appears to be excessive, Board Staff conduct an investigation which could result in: 1) closure, where it is concluded that the price was not excessive; 2) a Voluntary Compliance Undertaking by the patentee to reduce the price and offset excess revenues obtained through a payment and/or a price reduction of another patented drug product; or 3) a public hearing to determine if the price is or was excessive. To make this determination a Hearing Panel of Board Members must consider the factors listed in the Patent Act namely: prices at which the medicine and other medicines in the same therapeutic class have been sold in Canada and the seven comparator countries; changes in the Consumer Price Index; and such other factors as may be specified in regulation. The Board may also consider the cost of making and marketing the medicine and other factors it deems relevant. In the event that the Hearing Panel finds a price is or was excessive, it may order the patentee to reduce the price and take measures to offset any excess revenues.

Source: the department's Program Inventory, via GC InfoBase.

History and lineage

First appears in GC InfoBase's actual spending by program in 2018-19. The data does not record when a program was created; it may be older than its first appearance here, which is limited by the sources (program spending starts in 2010-11, Departmental Plans in 2018-19).

2018-192019-202020-212021-222022-232023-242024-252025-262026-272027-282028-29Patented Medicine Price Regulation Program 2018-19: $5.7MPatented Medicine Price Regulation Program 2019-20: $7.7MPatented Medicine Price Regulation Program 2020-21: $8.9MPatented Medicine Price Regulation Program 2021-22: $7.3MPatented Medicine Price Regulation Program 2022-23: $6.9MPatented Medicine Price Regulation Program 2023-24: $7.9MPatented Medicine Price Regulation Program 2024-25: $7.6MPatented Medicine Price Regulation Program 2025-26: $12.1MPatented Medicine Price Regulation Program 2026-27: $12.1MPatented Medicine Price Monitoring Program 2025-26: $12.3MPatented Medicine Price Monitoring Program 2026-27: $11.3MPatented Medicine Price Monitoring Program 2027-28: $11MPatented Medicine Price Monitoring Program 2028-29: $10.7MPatented Medicine Price Regulation ProgramPatented Medicine Price Monitoring Program
Bars: spending by fiscal year (dark: actual; light: actual restated on the 2017-18 program structure; outlined: the latest plan's forecast; grey: related programs). Bands: each program in the lineage over the years it has data.
ProgramRelationYears with dataActual spending over those years
Patented Medicine Price Regulation ProgramThis program2018-19 – 2026-27$52.1M
Patented Medicine Price Monitoring ProgramLater program (name match, medium confidence)2025-26 – 2028-29—

Significant changes in scope and budget

Detected from the data: renames between plans, programs it appears to replace, merge with or split into (matched by name), year-over-year changes in spending of at least 25% and $5M, or in employees of at least 20% and 25 FTEs, linked budget measures, and results indicators added or dropped.

YearWhat changedSource
2025-26Appears to be replaced by Patented Medicine Price Monitoring ProgramCanada Spends name match across plans (an inference)

Success criteria

The program's indicators from its department's Departmental Results Framework: the target set in each year's plan, and the result reported the following year. Source: GC InfoBase.

Historical: targets against results

% decrease in the price of new patented drugs
Expected result: Prices charged by patentees for patented medicines sold in Canada are not excessive according to the factors of the Patent Act
Report yearTargetDueResultStatus
2020-21———
The PMPRB published its new Guidelines which operationalize the amendments to the Patented Medicines Regulations in November 2020. Given that the new Guidelines do not take effect until January 1, 2022, it is too early to establish targets and dates for achieving those targets.
No result reported
2022-23———
Amended Patented Medicines Regulations were brought into force July 1, 2022. As new Guidelines have not yet been implemented, it is too early to establish targets and dates for achieving those targets.
No result reported
2023-24———
The PMPRB is consulting on how to address the amendments to the Patented Medicines Regulations through its Guidelines. Given that the PMPRB’s new Guidelines have not been finalized it is too early to establish targets and dates for achieving those targets.
No result reported
2024-25——S.O.
In the absence of PMPRB Guidelines, this result was not calculable for 2024–25.
No result reported
% of Canadian patented drug prices below the median price of the PMPRB’s comparator countries
Expected result: Canadians pay their fair share for patented medicines sold in Canada
57.1%2018-19✓ met56.9%2019-20✓ met58.2%2020-21✓ met59.5%2021-22✓ met43.9%2022-23✗ not met39.1%2023-24✗ not met37%2024-25✗ not met

Bars: result reported. Dashed line: target.

Report yearTargetDueResultStatus
2018-19≥ 50%201957.1%
The 57.1% of patented medicine prices in Canada reported as being below the median international price includes a significant number of patented medicines being sold in fewer than five countries and therefore are not being compared to the actual median international price. Of the 1,399 patented medicines sold in Canada in 2018, only 830 were sold in five or more countries. Of this 830, only 395 p…
Met
2019-20≥ 50%202056.9%
The 56.9% of patented medicine prices in Canada reported as being below the median international price includes a significant number of patented medicines being sold in fewer than five countries and therefore are not being compared to the actual median international price. Of the 1,348 patented medicines sold in Canada in 2019, only 778 were sold in five or more countries. Of this 778, only 365 p…
Met
2020-21≥ 50%202158.2%
The 58.2% of patented medicine prices in Canada reported as being below the median international price includes a significant number of patented medicines being sold in fewer than five countries and therefore are not being compared to the actual median international price. Of the 1,272 patented medicines sold in Canada in 2020, only 746 were sold in five or more countries. Of this 746, only 353 p…
Met
2021-22≥ 50%202259.5%
The 59.5% of patented medicine prices in Canada reported as being below the median international price includes a significant number of patented medicines being sold in fewer than five countries and therefore are not being compared to the actual median international price. Of the 1,158 patented medicines sold in Canada in 2021, only 700 were sold in five or more countries. Of this 700, only 343 p…
Met
2022-23≥ 50%202343.9%
The result for 2022-23 compares patented medicine prices in Canada to the PMPRB11 schedule countries, reflecting a July 1, 2022, change in the allowable data collected by the PMPRB for price review under the Patented Medicine Regulations. As a result of this change, the result for 2022-23 is not directly comparable to those calculated for previous years, which used the PMPRB7 schedule countries f…
Not met
2023-24≥ 50%202439.1%
The results for 2022–23 and 2023–24 compare patented medicine prices in Canada to the PMPRB11 schedule countries, reflecting a July 1, 2022, change in the allowable data collected by the PMPRB for price review under the Patented Medicine Regulations. As a result of this change, the results for 2022–23 onward are not directly comparable to those calculated for previous years, which used the PMPRB7…
Not met
2024-25≥ 50%202537%
This indicator was introduced in 2015–16, under the premise that the PMPRB would continue to conduct its price reviews without significant changes in its regulatory framework. The results for 2022–23 onward compare patented medicine prices in Canada to the PMPRB11 schedule countries, reflecting a July 1, 2022, change in the allowable data collected by the PMPRB for price review under the Patented…
Not met
% reduction in the number of patented drugs priced above the international median
Expected result: Canadians pay their fair share for patented medicines sold in Canada
Report yearTargetDueResultStatus
2020-21———
The PMPRB published its new Guidelines which operationalize the amendments to the Patented Medicines Regulations in November 2020. Given that the new Guidelines do not take effect until January 1, 2022, it is too early to establish targets and dates for achieving those targets.
No result reported
2022-23———
Amended Patented Medicines Regulations were brought into force July 1, 2022. As new Guidelines have not yet been implemented, it is too early to establish targets and dates for achieving those targets.
No result reported
2023-24———
The PMPRB is consulting on how to address the amendments to the Patented Medicines Regulations through its Guidelines. Given that the PMPRB’s new Guidelines have not been finalized it is too early to establish targets and dates for achieving those targets.
No result reported
2024-25——S.O.
In the absence of PMPRB Guidelines, this result was not calculable for 2024–25.
No result reported

Current: the 2026-27 plan's targets

No indicators in the 2026-27 plan.

Future goals: targets due after 2026-27

No targets with a later due date.

Spending and employees: planned against actual

Spending

2018-19: $9.3M2018-19: $5.7M2018-192019-20: $11.3M2019-20: $7.7M2019-202020-21: $12.6M2020-21: $8.9M2020-212021-22: $13.6M2021-22: $7.3M2021-222022-23: $11.7M2022-23: $6.9M2022-232023-24: $11.8M2023-24: $7.9M2023-242024-25: $12M2024-25: $7.6M2024-252025-26: $12.1M2025-262026-27: $12.1M2026-27
Outlined bar: planned in that year's Departmental Plan (dashed: the latest plan, for years not yet reported). Filled bar: actual.
Show the numbers
Fiscal yearPlannedActual
2018-19$9.3M$5.7M
2019-20$11.3M$7.7M
2020-21$12.6M$8.9M
2021-22$13.6M$7.3M
2022-23$11.7M$6.9M
2023-24$11.8M$7.9M
2024-25$12M$7.6M
2025-26$12.1M*—
2026-27$12.1M*—

Employees (FTEs)

2018-19: 382018-19: 352018-192019-20: 462019-20: 452019-202020-21: 492020-21: 442020-212021-22: 462021-22: 412021-222022-23: 452022-23: 432022-232023-24: 432023-24: 452023-242024-25: 432024-25: 412024-252025-26: 432025-262026-27: 432026-27
Outlined bar: planned in that year's Departmental Plan (dashed: the latest plan, for years not yet reported). Filled bar: actual.
Show the numbers
Fiscal yearPlannedActual
2018-193835
2019-204645
2020-214944
2021-224641
2022-234543
2023-244345
2024-254341
2025-2643*—
2026-2743*—

Planned spending, plan by plan

Each row is one year's Departmental Plan and its forecast for the next three fiscal years; read a column down to see how the forecast for one year changed. The last row is what was actually spent. Click an amount for its source. Biggest changes in federal spending plans

Actual spending is from Departmental Results Reports and the Public Accounts, as published in GC InfoBase. FTEs are full-time equivalents.