Forward Regulatory Plan 2021-2023: Consequential Amendments to the Patented Medicines Regulations for CETA
Title of Regulatory Initiative
Consequential Amendments to the Patented Medicines Regulations for CETA
Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act (subsection 138(5))
Amendments to the Patented Medicines Regulations are needed to provide the Patented Medicine Prices Review Board (PMPRB) with the authority to collect the same price, sales and other information from rights holders of medicines protected by Certificates of Supplementary Protection, or CSPs, as they currently do from patentees.
These proposed regulatory amendments are to be accompanied by an Order in Council that would bring into force the 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. The commitment to proceed with the Order in Council and accompanying regulatory amendments is included under the Intellectual Property chapter of Canada’s Statement on CETA Implementation.
Regulatory cooperation efforts (domestic and international)
Regulatory cooperation does not extend to drug pricing considerations. Each country is responsible for maintaining its own health care system, including decisions related to which treatments, procedures, drugs and devices will be eligible for coverage and under what conditions.
Potential impacts on Canadians, including businesses
These are consequential amendments that are needed as a result of the substantive amendments to the Patent Act that received royal assent on May 16, 2017.
Health Canada is seeking an exemption from Canada Gazette, Part I, from Treasury Board for these regulatory amendments on the grounds that significant consultations were held during development of the CETA Implementation Act.
The legislative amendments that create the need for these consequential 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 the spring 2021 session.
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.
Departmental contact information
Office of Pharmaceuticals Management Strategies
Strategic Policy Branch
Date the regulatory initiative was first included in the Forward Regulatory Plan
April 1, 2018
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