Daphne Lainson Nancy Pei October 19 2022 Draft revised PMPRB guidelines released for comment by 5 December 2022 Smart & Biggar | Healthcare & Life Sciences - Canada Daphne Lainson , Nancy Pei Healthcare & Life Sciences IntroductionInvestigation criteriaList pricesNew and existing medicinesWaiver of filing requirements for medicines believed to be at lower risk of excessive pricingIntroductionOn 6 October 2022, the Patented Medicine Prices Review Board (PMPRB) released its revised draft guidelines to give effect to the 1 July 2022 amendments to the Patented Medicines Regulations (for further details, see "New PMPRB regulations in force"). Submissions are due by 5 December 2022.The guidelines provide criteria that PMPRB staff will consider in determining whether the price of a patented medicine warrants an investigation, which could lead to a recommendation for a hearing to determine whether the price of the patented medicine is excessive. Neither the current guidelines (last updated in February 2017) nor the 2020 draft guidelines (for further details see "Final PMPRB guidelines released") address the final amended regulations. Pending the finalisation of the revised guidelines, the PMPRB is applying a "status quo" to pricing relating to the amended regulations (for further details, see "Patented medicines pricing – "status quo" during interim period").As described in the backgrounder that accompanied the draft guidelines, proposed changes include the following.Investigation criteriaInstead of separating patented medicines into different therapeutic categories with different excessive price tests, the guidelines introduce the concept of "investigation criteria". Staff may open an investigation into the price of a patented medicine when certain criteria are present. Different criteria would apply depending on whether the medicine is a "new" or "existing" medicine (see "New and existing medicines" below).List pricesUnder the draft guidelines, the proposed investigation criteria apply to list prices only and will not fluctuate annually based on average transaction prices (ATP) the year before and a formula derived from the consumer price index. While rights holders would still need to file their ATP with the PMPRB, the ATPs would only be taken into account in the context of proposed undertakings by rights holders to offset potential excess revenues from the sale of a patented medicine that is subject to an investigation.New and existing medicinesThe draft guidelines distinguish between "existing" medicines (those that received a notice of compliance prior to 1 July 2022 and line extensions thereof) and "new" medicines (all other medicines) and propose to apply less probing investigation criteria to the former. As this distinction does not arise from the PMPRB Regulations, once an investigation is opened, staff would apply the same level of regulatory scrutiny to all medicines in determining whether to recommend the commencement of a hearing.Waiver of filing requirements for medicines believed to be at lower risk of excessive pricingUnder the amended PMPRB Regulations, patented over-the-counter medicines, certain non-prescription controlled substances, and generic and veterinary medicines are not required to file pricing and other information with the PMPRB unless specifically requested to do so by the PMPRB. The draft Guidelines expand this list to biosimilars and vaccines. For all such medicines, a complaint would automatically result in the opening of an investigation.For further information on this topic please contact Daphne Lainson or Nancy Pei at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.