Patentees are required by law to file information about the prices and sales of their patented drug products in Canada at introduction and then twice a year until the patent expires. The Patent Act along with the Patented Medicines Regulations set out the filing requirements.
The PMPRB reviews the average price of each strength of an individual dosage form of each patented medicine. In most cases, this unit is consistent with the Drug Identification Number (DIN) assigned by Health Canada at the time the drug is approved for sale in Canada.
There are five factors used for determining whether a drug product is excessively priced, as outlined in section 85 of the Act:
- the prices at which the medicine has been sold in the relevant market
- the prices at which other medicines in the same therapeutic class have been sold in the relevant market
- the prices at which the medicine and other medicines in the same therapeutic class have been sold in countries other than Canada
- changes in the Consumer Price Index
- any other factors that may be set out in regulations
The Compendium of Policies, Guidelines and Procedures details the various price tests used to determine whether a price falls within the maximum allowable price.