In-Depth Review

Overview

An In-Depth Review is initiated when:

• the price of a patented medicine exceeds one or more of the identification criteria during its Initial or Annual Review; or
• a complaint is received from an approved individual or organization.

An In-Depth review includes review of any associated DINs of the medicine that is under the In-Depth Review.

Purpose

In-Depth Reviews are done to take a closer look at the price of a patented medicine. Regardless of the reason why the review is started, the scientific and price review processes are the same. At the conclusion of the In-Depth Review, Staff will make a recommendation to the Chairperson for closure or to issue a Notice of Hearing.

Process

In parallel with the Scientific Review, PMPRB Staff starts its Price Review of the patented medicine.

Once the Scientific Review is complete, Staff adds domestic and international pricing information to the TCC analyses. Accordingly, Staff reviews and analyses all information related to the patented medicine, namely:

• information relating to the price of the medicine in Canada;
• information relating to the price of the medicine in the Schedule Countries;
• information relating to the TCC selection and analysis; and
• information relating to changes in the CPI over the relevant period.

The information considered by Staff for each of these factors, and how the analysis relating to each factor may be weighted in the recommendation process, is described in the Appendices of the Guidelines. All recommendations arising from In-Depth Reviews are vetted for consistency by the Senior Director of Regulatory Affairs & Outreach and the Director General before they are presented to the Chairperson for consideration.

• More information on recommendations to the Chairperson and the hearing process

Rights Holder Input

Rights Holders may provide input to Staff on issues relevant to the subsection 85(1) factors of the Patent Act other than the TCC within three months of being notified that their patented medicine is subject to an In-Depth Review.

Timeline

The In-Depth Review process can take between 12 and 28 months to complete, depending on its complexity.