Pangaea Express: PMPRB Scoping Paper to Start Guidelines Discussion

November 15, 2023

By Marla WeingartenSuzanne Solman

The PMPRB has posted its Scoping Paper that poses questions to stakeholders to start the first phase of consultations on its new Guidelines. New PMPRB Guidelines are required in order to implement the amendments to the Patented Medicines Regulations that came info force July 1, 2022.
The Scoping paper is centred around 6 themes:

  1. Efficient Monitoring of Prices without Price Setting
  2. Transition to PMPRB11 – New versus Existing Medicines
  3. Price Reviews during Product Life Cycle
  4. Investigations and Referral to Hearing
  5. Relation to pan-Canadian Health Partners, Insurers (Private and Public); and Alignment with Broader Government Initiatives
  6. Engaging with Patients, Health Practitioners, Pharmacy, and other Stakeholders

The PMPRB asks whether there are any elements of the 2010 Guidelines that should be retained as a way to kickstart discussion. For instance, the PMPRB is seeking input on categorizing medicines based on level of therapeutic improvement, a topic not touched on in recent Guideline revisions.

The Scoping paper also considers/asks:

  1. The use of MIP vs HIP for initial triaging measures - There may be much discussion around this topic as the interim guidance states that new medicines will be considered as reviewed if their list price is below the median international price (MIP) of the PMPRB11. There was feedback from stakeholders who argued the use of MIP vs HIP could be seen as regulating prices vs preventing excessive pricing. The scoping paper shows that 69% of all patented medicines had Canadian list prices higher than the median international price (MIP) of the PMPRB11 in 2022, representing 75% of the total sales.
  2. Whether the Guidelines should distinguish between medicines that existed as of July 2022 (existing medicines) and medicines introduced afterwards (new medicines).
  3. The possibility of co-ordinating decisions and timelines with those of CADTH, INESSS, the pCPA and insurers to understand what efficiencies may be gained as well as input on how the PMPRB can support a whole government approach within the bio/pharmaceutical ecosystem with respect to patented medicines.

These are just a few of the questions posed for discussion. Stakeholders may participate in a Policy Roundtable scheduled for December 5 (English session) and December 6 (French session) or provide a written submission by December 20, 2023. A What We Heard document will be released in early 2024.

For more information, please contact Suzanne Solman or Marla Weingarten