PMPRB Updates: Proposed Interim Guidelines Published

Home PMPRB Updates: Proposed Interim Guidelines Published

PMPRB Launches Consultation on its Proposed Interim Guidance

Today, June 30, 2022, PMPRB published a proposed set of Interim Excessive Price Guidelines and has invited stakeholders to comment on the approach before July 18, 2022.

This Interim Guidance outlines PMPRB’s intentions for regulating the prices of patented medicines in the “interim period” between the coming-into-force date of the new regulations (July 1st 2022) and publication and implementation of a final set of guidelines.  

PMRPB is proposing to adopt a “status quo” approach, under which an investigation will NOT be triggered for a product provided:

  1. its national average transaction price (N-ATP) remains at or below its most recent non-excessive average price (NEAP) established under the existing Guidelines, and;
  2. its list price does not increase during the Interim Period. 

Investigation could possibly be triggered by either price test alone. However, PMPRB will not conduct price reviews of any new medicines until the final set of Guidelines come into effect.

PMPRB anticipates conducting consultation on a more permanent set of guidelines to begin in September, with a view to publishing final guidelines by the end of 2022.

Interested Stakeholders are invited to comment on this interim approach until July 18, 2022. For more information and to submit feedback, please see the Notice and Comment on PMPRB’s website.

This guidance leaves considerable uncertainty on the following points:

  • It appears that PMPRB11 price referencing will not be used to establish price ceilings during the interim. PMPRB needs to confirm whether a price that exceeds the Highest International Price but is otherwise compliant with the two identified price tests will be considered compliant.
  • It appears as though any List Price increase during the interim period will trigger an investigation, even if compliant with PMPRB’s CPI methodology. This is likely to impact many patentees if the interim period extends into 2023.
  • New Medicines must receive some guidance or assurances regarding their allowable launch price and any excess revenue penalties. At present, patentees are expected to launch completely blind to subsequent price limits.

Order in Council (OIC)

On June 29, 2022, the Government of Canada published the approved Order in Council (OIC) repealing several sections of the Patented Medicines Regulations, accessible here [PC Number: 2022-0822].

The order is brief and includes the following key points:

  1. As expected, the Provisions for Pharmacoeconomic and Market Size price factors are repealed
  2. As expected, the Provisions for allowing the PMPRB to collect information on 3rd party rebates are repealed
  3. Canada Gazette part II to be published on July 6, 2022 will detail the Regulatory Impact Analysis Statement (RIAS) and the Regulations regarding the repeal

The order does not mention any other elements of the reforms to PMPRB.

For additional information, please contact Mevin Mathew at Mevin.Mathew@pdci.ca

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