About the Patented Medicine Prices Review Board
Service Standard for the price review of new patented drug products
The PMPRB commits to a service delivery as follows:
- If the new patented drug product is first sold in the January to June period, the patentee can expect the results of the introductory price review between August and December, provided the scientific review has been completed.
- If the new patented drug product is first sold in the July to December period, the patentee can expect the results of the introductory price review between January and June of the following year, provided the scientific review has been completed.
Performance Target
The target for achieving this standard is set at 80%.
Performance Results
There were 86 new patented drug products reported in 2015, for 69 of these the scientific review was completed in 2015.
- For those first sold in the January to June 2015 period, 91.3% of patentees were advised in the July to December 2015 period.
- For those first sold in the July to December 2015 period, 87.0% of patentees were advised in the January to June 2016 period.
Annual service performance is measured over the course of the calendar year since the price review of new patented drug products is carried on the basis of a calendar year.
Annual service performance is measured over the course of the calendar year since the price review of new patented drug products is carried on the basis of a calendar year.
Submitting Prices of Patented Drug Products for Review
Context
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 requires that patentees file pricing information for new and existing patented drug products.
Application Process
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 once the scientific review has been completed:
- 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:
a. examines the information contained in Form 2,
b. 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.
Fee/Cost Recovery
There is no fee associated with the price review process of new patented drug products.
Departmental/Agency Contact
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
Box L40
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
E-mail: pmprb@pmprb-cepmb.gc.ca
Additional Information
Service Feedback
- A complaint can be lodged in writing at: pmprb@pmprb-cepmb.gc.ca.
- 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.