Substantial changes to Medicine regulations in Canada from July 2020

Significant changes have been published, due to come into force in 2020, affecting the countries used by Canada in international reference pricing, and how prices are reported to the PMPRB for value assessment.

Reforms have been agreed by the Canadian Government to the Patented Medicines Regulations, which are implemented by the Patented Medicines Prices Review Board (PMPRB). Health Canada have reported that the reforms include changes to the way international reference pricing (IRP) is calculated, the aim being to use a set of countries more similar to Canada “in terms of population, economy and approach to health care”. The countries to be used in Canada’s IRP methodology are: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden and the UK.

The PMPRB will be required to factor the value to consumers of a medicine into its determinations, and manufacturers will be required to adjust what they report to the Board. Companies must:

“…report price and revenue information that is net of all price adjustments such as direct or indirect third party discounts or rebates. This will ensure that the PMPRB is informed of the actual prices for patented medicines in Canada and enhance the relevance and impact of domestic price tests.”

Dr Mitchell Levine, Chairperson of the PMPRB, said in a statement:

“With these amendments, the PMPRB now has the tools and information needed to meaningfully protect Canadian consumers from excessive prices today and into the future. We would like to thank the Minister of Health for placing her confidence in our ability to deliver on the Government’s commitment to make prescription drugs more affordable and accessible for all Canadians.”

MAP will continue to monitor the Canadian market, and track how the Regulations are effected through the creation of new PMPRB Guidelines. Read the amendments to the regulations in full here, and a Q&A on the changes here. The amended Regulations come into force on 1st July 2020.

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Published 21. August 2019 in News, News Canada