Patented Medicines Regulations: UPDATE July 13, 2020

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As reported by Kelsey Rolfe of Benefits Canada, reforms to the Patented Medicines Pricing Review Board (PMPRB) have been upheld by the Federal Court. This decision followed an application for judicial review by Innovative Medicines Canada and 16 pharmaceutical companies who opposed the amendments which included:

  • In setting drug prices, a “basket” of 11 other countries (no longer including the US and Switzerland), that are similar to Canada’s population, economy and approach to health care, will be used to compare prices.
  • In establishing a price ceiling for a drug in Canada, the PMPRB will now have access to the actual market price of the medicines. In the past, they only had the list or “sticker” price of the drug which was an inflated price.
  • The PMPRB will also use economics-based price regulation factors (e.g., comparing the value of one pharmaceutical drug or drug therapy to another), intended to price drugs based on “demonstrably better health outcomes” and “Canada’s willingness and ability-to-pay for drugs”.

The Judge ruled “that a section of the amendments that would require patentees to report the market price of the medicine in Canada and other markets, including any possible rebates, instead of the inflated sticker price, falls outside of the scope of the act.”

Innovative Medicines Canada is said to be reviewing the decision.