PMPRB jurisdiction extended to CSPs

Summary#

This order fixes June 30, 2021 as the day when sections 45 to 58 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act come into force. In practice, it brings changes to the Patent Act so the Patented Medicine Prices Review Board can also cover medicines protected by a Certificate of Supplementary Protection (CSP).

What it does#

• Brings into force sections 45 to 58 of the CETA implementation law on June 30, 2021.
• Amends the Patent Act so the Patented Medicine Prices Review Board (PMPRB) has jurisdiction over medicines protected by a Certificate of Supplementary Protection (CSP), not just by patents.
• Puts that expansion in place at the same time as related changes to the Patented Medicines Regulations that will require CSP holders to report price, sales and other information to the PMPRB.
• Notes that the CSP regime was created after the CETA changes in 2017, and that several CSPs have been issued but none had taken effect at the time of this order.

Who's affected#

• Patented Medicine Prices Review Board — its formal jurisdiction is expanded.
• Holders of CSPs and pharmaceutical companies that apply for them — they will be subject to PMPRB oversight and reporting rules during the CSP period.
• Consumers and patients — price oversight that applies while a medicine is patented will also apply during the CSP period.
• Health Canada, provinces and territories, and the pharmaceutical industry — they were involved in consultations and may notice the regulatory change.

If it is unclear who else might be affected, the order does not add more detail.

Why it matters#

• It ensures the same price oversight now applies during the extra, “patent-like” protection that a CSP provides. That aims to protect Canadians from excessive medicine prices during that additional protection period.
• The change is timed so the PMPRB has jurisdiction before any CSP can take effect (the earliest possible CSP effective date noted in the source was June 2022, though applications could change timing).
• The government indicated this will not require extra funding to the PMPRB, because the medicines covered would largely already have been within its scope.