New Patented Medicines Regulations Registered. Two Court Challenges Commenced.

  • September 23, 2019
  • Abigail Smith, Smart & Biggar LLP

On August 21, 2019, the long-awaited amendments to the Patented Medicines Regulations were published (SOR/2019-298). Together with the Patent Act, these regulations govern the Patented Medicines Prices Review Board’s oversight of the pricing of patented drugs in Canada.

The amendments represent the first substantive revision to the Regulations since their introduction in 1987 and a significant departure from the existing framework.

Major changes include:

  • The introduction of three new price regulatory factors: pharmacoeconomic value, market size, and gross domestic product (GDP) in Canada and GDP per capita in Canada;
  • Added reporting requirements relating to the three new price regulatory factors;
  • An updated list of the reference countries used to assess whether the price in Canada is excessive, notably excluding both the United States and Switzerland;
  • Reduced reporting requirements for medicines considered to be at low risk of excessive pricing; and
  • Added reporting requirements to take into account third party price rebates.

The Board is expected to release draft guidance on the application of the amended regulations and commence consultations in relation to this guidance in the coming weeks.

The amendments are expected to have a significant impact on the pricing of patented medicines in Canada: a cost-benefit analysis released by the Health Canada Strategic Policy Branch projects a 10-year total savings of $8.8 billion flowing from lower patented medicine costs.