Canada’s Patented Medicine Prices Review Board (PMPRB) is a federal administrative body created under the Patent Act1 with a mandate of ensuring that the price of patented medicines sold in Canada are not excessive2. PMPRB’s jurisdiction over a medicine does not currently extend through the period of time afforded by a Certificate of Supplementary Protection (CSP) and, for that reason, legislative amendments are planned for 2021.
What you need to know
- Patent Act amendments that explicitly extend the PMPRB’s price-review powers to include CSP-protected medicines have still not come into force3.
- Amendments to the Patented Medicine Prices Review Board Rules of Practice and Procedure4 (the PMPRB Rules) and to the Patented Medicines Regulations5 are planned for 2021. The related Patent Act amendments may come into force at the same time.
- These amendments, which are not yet law, would explicitly extend PMPRB’s jurisdiction over a CSP-protected medicine to the end of the CSP term.
- The federal government does not intend to publish these amendments for comment, which is unusual. Instead, it is expected that these amendments will become law without pre-publication for consultation in Canada Gazette, Part I.
In 2017, Canada entered into and provisionally accepted most provisions of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA). To fulfil Canada’s commitments under CETA, the CETA Implementation Act6 amended the Patent Act to create a Certificate of Supplementary Protection (CSP) regime that provides up to two years of sui generis “patent-like protection” for new drug products protected by an eligible patent after the patent expires.
Related Patent Act amendments found in sections 45 to 58 of the CETA Implementation Act that explicitly extend the PMPRB’s price-review powers to include CSP-protected medicines have still not come into force. The explanatory note to the CETA Implementation Act states that the government intends to “bring these provisions into force together with corresponding amendments to the PMPRB-related regulations”7.
The Patent Act amendments introduce the terms “rights holder” and “medicine” to the sections dealing with the PMPRB’s activities8:
- “Rights holder” is defined as including both patentees and people entitled to the benefit of a CSP for medicine.
- “Medicine” is defined as “a drug, as defined in section 104”, and a medicinal ingredient.
Aside from the addition of these definitions, the amendments replace the word “patentee” with “rights holder”, and “patent” with “patent or certificate” in order to expressly extend the PMPRB’s jurisdiction throughout a CSP term9.
Health Canada previously indicated in its Forward Regulatory Plan that it intends to amend the Patented Medicines Regulations to explicitly extend the PMPRB’s jurisdiction to include CSP-protected medicines10. In February 2021, Health Canada announced that it will additionally implement “minor” amendments to the PMPRB Rules to reflect the extension as well11.
Health Canada’s proposed amendments to the Regulations and the PMPRB Rules have not yet been published. Health Canada intends to seek an exemption from usual pre-publication of proposed amendments in the Canada Gazette, Part I, enabling it to circumvent the public consultation stage.
The timeline for the coming into force of the jurisdictional provisions of the CETA Implementation Act, and the corresponding regulatory amendments, is currently unclear. Health Canada anticipates that the amendments will be published in the Canada Gazette, Part II sometime in winter 2021, which suggests that the jurisdictional provisions in the CETA Implementation Act may come into force at that same time. It is not known whether the amendments will be retroactive to the date the Certificate of Supplementary Protection Regulations12 came into force in 2017.
Based on current Register of Certificates of Supplementary Protection, the extent of PMPRB’s jurisdiction over CSP-protected medicines will not be a live issue until 2022, when the CSP term for some CSP-protected medicines will begin.
1 Patent Act, R.S.C. 1985, c. P-4.
3 Update: the amendments will come into force on June 9, 2021.
6 Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, SC 2017, c 6.
8 SC 2017, c 6, ss. 46(2).
9 SC 2017, c 6, s. 47-58.
11 See: https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/forward-regulatory-plan/plan/consequential-amendments-patented-medicine-prices-review-board-rules-practice-procedure.html.
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