Regulatory Process

The PMPRB monitors the prices charged by patentees for patented drugs on an ongoing basis. Under the Patent Act, patentees are required to file price and sales information about their patented drug products at introduction and twice a year thereafter for each strength of each dosage form of each patented drug product sold in Canada.

However, patentees are welcome to consult with the PMPRB on the application of the Guidelines at any time. Patentees are not required to obtain approval of the price before a drug is sold.

If you are a patentee, please visit Are You a Patentee? for more information about your reporting obligations.

Scientific Review

The PMPRB’s scientific review is an evidence-based process that considers clinical, pharmacoeconomic and other relevant information about the patented medicine for the purpose of determining its Therapeutic Criteria Level.

The scientific review of a patented medicine is based on information from a variety of sources such as patentee submission, research by a Drug Information Centre (DIC), research by Staff or the PMPRB Human Drug Advisory Panel (HDAP)

Price Review

The price review process consists of a series of steps whereby (i) patented medicines are categorized based on their date of introduction and market characteristics and (ii) ceiling prices are identified and used to assess the patented medicines’ prices. Price reviews are normally conducted by Staff using the methods and tests set out in these Guidelines based on the information filed by the patentees and/or obtained by Staff from relevant outside sources such as public formularies.

New Patented Medicines Reported to the PMPRB

The PMPRB publishes information on the price review of all new patented drug products in a searchable table format. This format was introduced in January 2012 as part of the ongoing implementation of the 2010 Guidelines.

The table is updated as the review of each new patented drug product is completed. Each new patented drug product from 2010 onward that has a status classified as “Within the Guidelines” or “Does Not Trigger an Investigation” has a link from the brand name to an individual Price Review Record.

Price Review Records are currently available for almost all new drug products reported in 2010 and will be gradually populated for 2011. Summary Reports are available for new drug products reported prior to 2010.


An investigation is an in-depth review of the price of a patented medicine conducted by Board Staff. Board Staff will open an investigation into the price of a patented drug product when any of the following criteria are met:

  • the list price of any dosage form or strength of a medicine appears to be above the corresponding applicable “interim Maximum List Price” (iMLP) or the “Maximum List Price” (MLP) by more than 5%; or
  • the potential excess revenues appear to exceed $50,000 for the medicine (i.e., across all dosage forms and strengths) in a calendar year; or
  • A complaint is received.

Voluntary Compliance Undertakings

At any time prior to the issuance of a Notice of Hearing, a patentee may submit a VCU to Staff. A VCU is a promise by the patentee to reduce its price(s) and/or offset any potential excess revenues from the sale of a patented medicine that is subject to an investigation. A proposed VCU does not constitute an admission by the patentee that the price of the patented medicine is excessive.


PMPRB hearings are public proceedings. During a hearing, submissions and evidence from the parties are heard by a Hearing Panel consisting of at least two Board members. The Hearing Panel determines whether a patented medicine is being or has been sold at an excessive price in any market in Canada by taking into consideration the available information relating to the factors set out in section 85 of the Act.

Advance Ruling Certificates

Under the Patent Act, the Board may issue a non-binding Advance Ruling Certificate on the price of a patented drug product at the request of the patentee. This requires the patentee to clearly establish that the proposed price of the patented drug product would not exceed the maximum average potential price as provided by the Board's Compendium of Policies, Guidelines and Procedures.

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