Order Fixing June 30, 2021 as the Day on Which Sections 45 to 58 of that Act Come into Force: SI/2021-25

Canada Gazette, Part II, Volume 155, Number 12

Registration
SI/2021-25 June 9, 2021

CANADA–EUROPEAN UNION COMPREHENSIVE ECONOMIC AND TRADE AGREEMENT IMPLEMENTATION ACT

Order Fixing June 30, 2021 as the Day on Which Sections 45 to 58 of that Act Come into Force

P.C. 2021-465 June 1, 2021

His Excellency the Administrator of the Government of Canada in Council, on the recommendation of the Minister of Health, pursuant to subsection 138(5) of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, chapter 6 of the Statutes of Canada, 2017, fixes June 30, 2021 as the day on which sections 45 to 58 of that Act come into force.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

In accordance with subsection 138(5) of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (CETA Implementation Act), this Order fixes June 30, 2021, as the day on which sections 45 to 58 of that Act come into force. Those sections amend the Patented Medicines section of the Patent Act to extend the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) to include medicines that are protected by the new period of “patent-like” protection, called a Certificate of Supplementary Protection (CSP).

Objective

This Order brings into force amendments to the Patent Act that were part of the CETA Implementation Act. As part of Canada's domestic implementation of CETA, changes to the Patent Act created the CSP regime. At the same time, the Government of Canada committed to ensure that Canadians continue to be protected against excessive prices during the period of time that a medicine benefits from the CSP period of protection. Those amended sections of the Patent Act received royal assent, but were not brought into force due to the need for accompanying changes to the Patented Medicines Regulations that would require CSP holders to report equivalent price, sales and other information to the PMPRB as is required by patentees. Therefore, the amended sections of the Patent Act will be brought into force at the same time as the Regulations Amending the Patented Medicines Regulations and the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements).

Background

The PMPRB was created in 1987 as the consumer protection “pillar” of a major set of reforms to the Patent Act that significantly strengthened Canada's patent protection for medicines. The regulatory mandate of the PMPRB is to protect consumers against excessive prices of patented medicines. The PMPRB also has a mandate to report on medicine prices, sales and research and development.

The CSP, a new and additional period of “patent-like” protection for patented medicines, was implemented pursuant to the Canada-European Union Comprehensive Economic and Trade Agreement (CETA). For qualifying patented medicines, the CSP may provide up to two years of additional “patent-like” protection following the expiration of the eligible patent, to partly compensate for time spent in research and obtaining marketing authorization. The CETA Implementation Act, which included amendments to the Patent Act that provided for the creation of CSPs in Canada, received royal assent on May 16, 2017. The CSP regime came into force in September 2017. Since then, a number of CSPs have been issued, though none have yet taken effect.

The CETA Implementation Act also included changes to introduce CSP-related terminology to existing clauses of the Patent Act (sections 79 to 103, which establish the PMPRB and its authorities) that extend the PMPRB's jurisdiction from medicines that are protected by a patent to also include medicines that are protected by a CSP. Examples of these amendments include introduction of the definition of the term “rights holder” to represent a patentee or a holder of a CSP, and changes to replace the term “patentee” with “rights holder” throughout. These amendments to the Patent Act did not come into force upon royal assent, but were to come into force on a date fixed by the Governor in Council due to the need for the supporting regulations to be developed.

Implications

Expansion of the PMPRB's jurisdiction to include CSP-protected medicines will provide consistency for Patent Act protection of pharmaceuticals in Canada. This will ensure that Canadian consumers continue to receive the same level of protection from excessive prices during the period of time that a medicine is protected by CSP as they would if the medicine is protected by patent.

These changes are unlikely to create significant incremental regulatory burden to the PMPRB, as the patents set out in the CSPs would already fall under PMPRB's jurisdiction. Therefore, no additional financial resources are being allocated for this Order.

By fixing the coming-into-force date of these amendments to the Patent Act as June 30, 2021, the PMPRB's jurisdiction over CSP-protected medicines will be established prior to any CSP taking effect. Currently, the earliest possible date for a CSP to take effect is June 2022; however, an application could be received at any time that could result in one taking effect at an earlier date.

Consultation

The creation of CSPs in Canada and the accompanying extension of PMPRBs jurisdiction to include CSP-protected medicines were included as part of extensive Government of Canada consultations with multiple stakeholder groups, including provinces and territories and the pharmaceutical industry, during the development of the CETA Implementation Act. No objections were raised during these consultations.

Contact

Michelle Boudreau
Executive Director
Office of Pharmaceuticals Management Strategies
Strategic Policy Branch
Health Canada
Telephone: 613‑710‑7663
Email: michelle.boudreau@Canada.ca