Following the publication of the PMPRB Draft Guidelines on Nov 21, 2019, PDCI undertook an analysis to critically assess the impact of the PMPRB regulatory changes published in August 2019, as proposed to be implemented in the Draft Guidelines.

Top-Line Summary

• The PMPRB regulatory changes and Draft Guidelines changes will have estimated revenue impacts to industry of up to $41.8 billion net present value (NPV) over 10 years.
  • This far exceeds Health Canada’s estimate of $8.8 billion (NPV) over the same period.
• In most years, at least 50% of new medicines will likely be classified by PMPRB as high-priority (high-risk) Category I.
• Future launches of innovative medicines in Canada will be at risk due to significant price reductions associated with the proposed implementation of the new economic factors to Category I new medicines, including:
  • 82.8% average price reductions for rare disease medicines; and
  • 60.8% average price reductions for oncology medicines.
• The proposed use of a median therapeutic class test will push Canadian list prices toward the lowest international price, which is inconsistent with Canada’s economic standing and previous Health Canada assessments.
• Product launch impacts are also foreseeable due to the proposed use of a median therapeutic class test and the risk of disclosing confidential price information.
• Given the projected impact, policy makers should reset the implementation process for the PMPRB reforms to allow for the development of more appropriate, practical and balanced Guidelines.