Forward Regulatory Plan 2019-2021: Consequential Amendments to the Patented Medicines Regulations for CETA

Title of Regulatory Initiative

Consequential Amendments to the Patented Medicines Regulations for CETA

Enabling Act

Patent Act

Description

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 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 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 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 the fall 2019 session.

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.

Departmental contact information

Karen Reynolds
Executive Director
Office of Pharmaceuticals Management Strategies
Strategic Policy Branch
Health Canada

Telephone: 613-957-1692
Email address: karen.reynolds@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 1, 2018

Consult Health Canada’s acts and regulations web page for:

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada’s implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

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