Pangaea Express: Announcement of Upcoming Patented Medicines Regulations Publication

August 9, 2019

By Suzanne SolmanMarla Weingarten

Health Canada Officials provided an update today regarding the final Patented Medicines Regulations. The government is not veering too far from the original December 2017 Canada Gazette I publication, but the Feds announced 6 changes from these original regulations:

  1. The Patented Medicines Regulations will come into force July 1, 2020
  2. The new factors (PE, market size and GDP) will only apply to new drugs that receive a DIN once the regulatory amendments are published in Canada Gazette II
  3. High-cost meds only will have HTA review (high-cost is defined as treatment cost that higher than 50% of Canadian GDP per capita)
  4. South Korea is out (PMPRB11 Basket of Countries: UK, France, Germany, Italy, Sweden, Japan, Spain, Norway, Australia, Belgium, and the Netherlands)
  5. All patented medicines will fall under new Regulations; there will not be reduced reporting for vaccines or biologics
  6. Enhanced cost benefit model as proposed by David Dodge

So, for any new drug that receives a DIN following the publication of the Canada Gazette II, the following changes will apply:

  • The 3 new price regulatory factors of: Pharmacoeconomics, market size, GDP and GDP per capita
  • The new basket of 11 countries for price comparison
  • Confidential rebates will be required

For patented drugs that obtained a DIN prior to the publication of the Amendments in the Canada Gazette, Part II, the new basket of 11 countries and confidential rebates will apply, but not the price regulatory factors. Further details will come with the publication of Gazette II on August 21, 2019.

The draft PMPRB Guidelines will be published in mid-September with a 90-day feedback period. Technical Working Groups will help walk through the Guidelines with stakeholders. The final Guidelines would be published by February 2020 to provide time for industry to apply the new pricing factors prior to the July 1, 2020 implementation date.

Looks like the Feds are stirring pre-election buzz on drug pricing in an effort to win the hearts of Canadians for lower drug prices. Will the Feds still feel the affection of Canadians when necessary new drugs are greatly delayed in their Canadian launch or don’t make it to this country at all?

For more information, please contact Suzanne Solman or Marla Weingarten.

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