About the Patented Medicine Prices Review Board
Service Standard for the price review of existing patented drug products
The PMPRB commits to a service delivery standard of 45 days for the following:
- The templates for the Form 2 (Information on the Identity and Prices of the Medicine) regulatory filing will be sent to a patentee 45 days prior to the filing deadline.
- The results of price review of existing patented drug products will be sent to a patentee no later than 45 days after the filing deadline.
The target for achieving this standard is set at 90%.
Drug prices of patented medicines sold in Canada are reviewed to ensure that they are not excessive. The review is based on a calendar year. In 2015, 100% of templates for the Form 2 regulatory filing were sent 45 days prior to the filing deadline and 100% of the results of the price review of existing patented drug products were sent no later than 45 days after the filing deadline to patentees.
Annual service performance is measured over the course of the calendar year since the price review of existing patented drug products is carried on the basis of a calendar year.
Submitting Prices of Patented Drug Products for Review
Section 80 of the Patent Act and sections 3 and 4 of the Patented Medicines Regulations pertain to the patentees' filing requirements regarding the identification and price information for new and existing patented drug products.
The Compendium of Policies, Guidelines and Procedures and the Patentee's Guide to Reporting are intended to assist patentees with the price review process and facilitate their compliance with the filing requirements of the Patent Act and the Patented Medicines Regulations. Section 80 of the Patent Act requires that patentees file pricing information for new and existing patented drug products with the Patented Medicine Prices Review Board for review purposes, to ensure that prices of patented drug products sold in Canada are not excessive. Also, sections 3 and 4 of the Patented Medicines Regulations set out in detail the information that is to be submitted by patentees identifying the medicine, its approval status as determined by Health Canada, its patent status, the quantity of the medicine sold, the publicly available ex-factory price for each dosage form, strength and package size at which the medicine is sold in Canada and in the seven comparator countries (listed in subparagraph 4(1)(f)(iii)).
The following steps comprise the typical submission process:
- Submission of Form 2 electronically.
- Reception, administrative validation and electronic notification of the applicant of completeness or deficiency of its application.
- The Regulatory Affairs and Outreach Branch:
- examines the information contained in Form 2,
- determines whether the price of the patented drug product is within the Board’s Guidelines
- Informs the patentee of the results of the review.
If the price is not within the Guidelines, Board Staff initiates an investigation into the price. An investigation can result in:
- Closure, if the price is subsequently found to be within the Guidelines;
- Voluntary Compliance Undertaking, to bring the price down to a non-excessive level and reimburse any excess revenues accrued due to an excessive price;
- The issuance of a notice to hold a public hearing into the price of the patented drug product.
There is no fee associated with the price review process of existing patented drug products.
Please contact the Director of Board Secretariat and Communications to make any general inquiries or comments:
Board Secretariat and Communications
Patented Medicine Prices Review Board
Standard Life Centre
333 Laurier Avenue West, Suite 1400
Ottawa, Ontario K1P 1C1
Telephone: (613) 954-8299
Fax: (613) 952-7626
Teletypewriter: (613) 957-4373
- A complaint can be lodged in writing at: firstname.lastname@example.org.
- The complaint will be acknowledged within 48 hours of receipt and answered within five (5) working days of its receipt by the Director, Regulatory Affairs and Outreach.
For More Information
To learn about upcoming or ongoing consultations on proposed federal regulations, visit the Canada Gazette and Consulting with Canadians websites.