Proposed “Regulations Amending the Patented Medicines Regulations” have been published in the Canada Gazette for a 75 day consultation. According to the Regulatory Impact Analysis Statement, “This proposal would amend the Patented Medicines Regulations (“Regulations”) so that the PMPRB’s regulatory framework includes new price regulatory factors and patentee price information reporting requirements that will help the PMPRB to protect Canadian consumers from excessive prices.”

The proposed amending regulations were published in the Canada Gazette Part 1 on December 2, 2017 (link). From the RIAS, the changes have five elements:

(1) Providing the PMPRB with three new price regulatory factors to enable it to consider the price of a patented medicine in relation to its value to patients and impact on the health care system.

(2) Updating the schedule to the Regulations that sets out the countries (now the PMPRB7) on which patentees report pricing information to include countries with similar consumer protection priorities, economic wealth, and marketed medicines as Canada. This would provide the PMPRB with the information needed to regulate prices based on comparisons that are more closely aligned with the PMPRB’s mandate and Canada’s domestic policy priorities.

(3) Reducing reporting obligations for patented veterinary, over-the-counter and “generic” medicines (i.e. those authorized for sale by the Minister of Health through an Abbreviated New Drug Submission [ANDS]). As these products pose a lower risk of asserting market power and charging excessive prices, this reduction would enable the PMPRB to focus on medicines at higher risk of excessive pricing.

(4) Amending patentee price information reporting requirements to include reporting in relation to the new factors.

(5) Requiring patentees to report price and revenue information net of all price adjustments such as direct or indirect third party discounts or rebates. This would ensure that the PMPRB is fully informed of the actual prices for patented medicines in Canada and enhance the relevance and impact of domestic price comparisons.