Notice and Comment - PMPRB Price Review Approach During the Interim Period following publication of Amendments to the Patented Medicines Regulations
June 30, 2022 – The Patented Medicine Prices Review Board (PMPRB) invited stakeholders to comment on its proposed approach for conducting interim price reviews while the PMPRB consults its stakeholders on new guidelines.
The Board announced the decision resulting from this consultation on August 18, 2022.
All submissions are now available.
On April 14, 2022, the Minister of Health announced that the Government will proceed with amendments to the Patented Medicines Regulations which will result in a new basket of comparator countries and reduced reporting requirements for medicines believed to be at the lowest risk of excessive pricing. The Minister also announced that the Government would not proceed with the amendments related to new price regulatory factors and to the requirements on rights holders to file information net of all price adjustments.
The regulatory amendments were made on June 24, 2022 and rights holders are required, by operation of law, to begin reporting price information to the PMPRB based on the new basket of countries as of July 1, 2022.
The PMPRB currently administers its regulatory framework based on the existing Regulations and Guidelines. In anticipation of the coming into force of the Amendments to the Patented Medicines Regulations that were published in Part II of the Canada Gazette on August 21, 2019, the Board issued revised Guidelines in October 2020 which have never come into effect.
As neither the existing nor the October 2020 Guidelines address the set of regulations which will come into force on July 1, 2022, it is necessary for the Board to consult on a new set of guidelines later this year. At this time, the Board expects to begin consulting on the new guidelines in September, with a view to having a final set of guidelines in place by the end of the calendar year.
Proposed Interim Guidance
In the period between the coming into force of the new Patented Medicines Regulations and the final publication of a corresponding set of guidelines (“Interim Period”), the PMPRB is proposing to adopt a “status quo” approach to carrying out its regulatory mandate. Under this approach, an existing patented medicine will not trigger an investigation 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.
In cases where the N-ATP of an existing patented medicine is above the NEAP, the PMPRB will only open an investigation if this results in excess revenues greater than $50,000, as is currently the case.
The PMPRB will not conduct a price review of any new patented medicines or open any investigations in respect of them until the new guidelines come into effect.
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