Proposed regulatory text of amendments to the Patented Medicines Regulations is published by the Governor-in-Council in Canada Gazette Part I (CG1) on December 2, 2017. Interested persons may submit comments on the proposed regulations within 75 days of publication in CG1 (by our estimate February 15, 2018). The Regulatory Impact Assessment Statement (RIAS) offers the rationale and justification for the proposed amendments.
It should be noted that the Regulations are distinct from both the enabling Patent Act and the Excessive Price Guidelines, the latter of which outlines the specific price tests and mechanisms for determining non-excessive prices. Proposed amendments to the Guidelines will be announced separately by the Patented Medicine Prices Review Board (PMPRB) and be subject to a separate notice and comment period pursuant to ss. 96 (5) of the Patent Act.
While some changes to regulatory language have changed in the text published, the policies are consistent with the initial announcement by the former Minister of Health in May 2017.
The proposed amendments to the Regulations include:
- Changes to Reference Countries:
- Addition of: Australia, Belgium, Japan, Netherlands, Norway, South Korea and Spain
- Removal of: United States, Switzerland
- Proposed List is: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden and United Kingdom
- Additional Economics-Based Price Review Factors – the Act at para 85(1)(e) allows the Governor-in-Council to identify additional price review factors the Board shall take into account in determining whether the price of a patented medicine in excessive. The proposed additional factors are:
- Pharmacoeconomic value of the medicine in Canada
- Size of the market for sale of medicine in Canada and countries other than Canada
- Market Size for sale of the medicine in Canada and countries other than Canada
- GDP & GDP per capita in Canada
- Reporting Requirements Related to Additional Factors:
- Information regarding pharmacoeconomic value
- Information respecting market size
- Reduced Reporting Requirements for patented generic, veterinary & over-the-counter drugs
- Reporting of third party price rebates
See the proposed regulatory text as published in Canada Gazette Part I for more details.