Removal from the Forward Regulatory Plan 2016-2018: Regulations Amending the Patented Medicines Regulations

Title or working title of the regulatory initiative:
Regulations Amending the Patented Medicines Regulations

Description of the objective:
The goal of the previously announced initiative to amend the Patented Medicines Regulations had been to align with the key priority of the 41st Canadian Parliament for the Patented Medicine Prices Review Board (PMPRB), namely, alignment with the Government’s Red Tape Reduction Plan and Economic Action Plan. Accordingly, PMPRB examined its price review process to identify possible ways to reduce the regulatory burden on patentees and increase efficiency. The PMPRB developed a plan to decrease filing requirements by replacing semi-annual regulatory filing of Form 2 – Identity and Prices of the Medicine, by an annual filing for existing drug products. The proposed regulatory change would also have eliminated the requirement to submit Form 2 information for the first day of sales of a patented drug product in Canada and add a section in the Form 1 – Medicine Identification Sheet to report the publicly available ex-factory price in Canada on the date of first sale. Consultations with patentees occurred through a Notice and Comment from May to June 13, 2013. The Notice and Comment is available at PMPRB Notice and Comment May 2013 and stakeholder submissions are available at Submissions to the May 2013 Notice and Comment on Regulatory Burden Reduction.

In response to the emergence of several key trends in the Canadian and international pharmaceutical environment, the PMPRB released its Strategic Plan 2015-2018, in which broader framework modernization and consultation with stakeholders are identified as priorities. A more thorough modernization of its activities is necessary than that envisioned in previous Forward Regulatory Plans if the Board is to effectively defend Canadian consumers from excessive patented medicine prices. Accordingly, Staff resources have been directed toward the implementation of this modernization agenda, and the previously consulted changes to the Regulations has been cancelled. This announcement does not preclude changes to the Regulations in the 2016-2018 period, but if such changes are announced for consultation, they may be of a fundamentally different nature than those previously envisioned.

Enabling Act:
Patent Act

Indication of business impacts:
There will be no business impacts – the previously established Regulations will continue to be enforced without change.

Public consultation opportunities:
Stakeholders had been consulted on the initiatives in a Notice and Comment from May to June 13, 2013. It was announced in previous Forward Regulatory Plans that Canadians would have the opportunity to provide further input on the proposal during the Canada Gazette, Part I public comment period in the winter of 2016, but this opportunity for comment has been cancelled.

Departmental contact:

Jeffrey Biggs
Manager of Policy Development
Policy and Economic Analysis Branch
Patented Medicine Prices Review Board

Telephone number:613-948-9220

Email address:

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