Forward Regulatory Plan 2021-2023: Consequential Amendments to the Patented Medicine Prices Review Board Rules of Practice and Procedure
Title of Regulatory Initiative
Consequential Amendments to the Patented Medicine Prices Review Board Rules of Practice and Procedure
Enabling Act
Patent Act
Description
Amendments to the Patented Medicine Prices Review Board Rules of Practice and Procedure are needed to reflect the fact that the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) has been expanded to include rights holders of medicines protected by Certificates of Supplementary Protection (CSPs).
These proposed regulatory amendments are to be consistent with amended sections of the Patent Act, which extend the PMPRB’s jurisdiction to include CSP-protected medicines. These amendments to the Patent Act were part of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) Implementation Act, which received Royal Assent on May 16, 2017.
Regulatory cooperation efforts (domestic and international)
Regulatory cooperation does not extend to this consequential amendment.
Potential impacts on Canadians, including businesses
These are miscellaneous amendments that are needed as a result of the substantive amendments to the Patent Act that received royal assent on May 16, 2017.
Consultations
Health Canada will seek an exemption from pre-publication in the Canada Gazette, Part I, on the grounds that the amendments are minor and are expected to have no impacts beyond the consistency of terminology with the enabling legislation. The legislative amendments that create the need for these accompanying miscellaneous regulatory amendments were set out in this Act, which received Royal Assent on May 16, 2017.
The publication of the amendments to the regulations in the Canada Gazette, Part ll, is expected to take place in winter 2021.
Further information
More information on the Government of Canada’s CETA commitments can be found in the Intellectual Property chapter of Canada’s Statement on CETA Implementation.
Additional information on this proposal can be requested from the departmental contact.
Departmental contact information
Isabel Jaen Raasch
General Counsel and Director of Legal Services
Patented Medicine Prices Review Board
Email address: Isabel.jaenraasch@pmprb-cepmb.gc.ca
Date the regulatory initiative was first included in the Forward Regulatory
February 2021
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