About the Patented Medicine Prices Review Board
Service Standard for the scientific review of new patented drug products
The PMPRB commits to a service delivery standard of three (3) weeks:
- Following the Human Drug Advisory Panel (HDAP) meeting where its drug product is discussed, the patentee will receive a copy of the HDAP report within three (3) weeks of the date of the HDAP meeting.
Performance Target
The target for achieving this standard is set at 100%.
Performance Results
In 2014, 100% of the HDAP reports were sent to patentees within three weeks of the date of the HDAP meeting.
Annual service performance is measured over the course of the calendar year since the scientific review of new patented drug products is carried on the basis of a calendar year.
Submitting new patented drug products for scientific review as part of the price review process
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 new and existing patented drug products.
Application Process
The Compendium of Policies, Guidelines and Procedures is intended to assist patentees with the scientific review process for purposes of the price review.
Prior to completing the price review of a new patented drug product, it may require scientific review by the Human Drug Advisory Panel, a committee of experts who assesses the level of therapeutic improvement of the new drug product and recommends appropriate drug products and dosage regimens to be used for comparison. The level of therapeutic improvement of a patented drug is used to determine the ceiling price, the Maximum Average Potential Price, at introduction.
The following steps comprise the typical submission process:
- Electronic submission of product monograph or information similar to that included in the product monograph (if product has not yet been approved by Health Canada) and the proposed level of therapeutic improvement.
- 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 the submission,
- assigns scientific literature research to a Drug Information Centre,
- forwards the documentation to the HDAP for review.
- The HDAP completes its review, finalizes its report and makes recommendations.
If the patentee disagrees with the recommendation of the HDAP , it may file a revised submission.
Once the scientific review is completed, the Regulatory Affairs and Outreach Branch proceeds with the price 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 scientific 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.