The Patented Medicine Prices Review Board will publish a new draft of its guidelines on June 15, followed by a written consultation period for 30 days.
As a result, the amended regulations will be delayed from July 1, 2020 to Jan. 1, 2021. The PMPRB said more details on the next and final phase of its consultations will be announced closer to the date of publication of the revised draft guidelines.
The reforms, announced August 2019, aim to update the reference countries Canada uses to compare its prices internationally. They’ll also provide the PMPRB with the market price of medicines in Canada, adding any possible rebates, instead of the inflated sticker price to allow the board to better assess whether a drug price is reasonable when setting its ceiling price, and give the board the ability to consider whether the drug’s price reflects its value to patients.
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“The PMPRB will continue to work with its stakeholders and interested members of the public to ensure that a fully operational set of guidelines is ready in time for the coming into force of the regulatory amendments in January 2021,” said a letter from the organization’s chairperson.
“The final guidelines will include transitional measures which will provide patentees sufficient time to take the necessary steps to come into voluntary compliance with the relevant price ceilings for both new and existing patented medicines.”
Delaying the implementation means the PMPRB has more time to adequately consult industry on the guidelines and to evaluate the impact on the Canadian health-care system, said Innovation Medicines Canada in a statement.
“The innovative medicines sector remains deeply concerned about the impact the amendments to the patented medicines regulations, as they are currently drafted, will have on Canadians’ access to new medications and treatments, and on Canada’s ability to attract investment to the life sciences sector. We look forward to more details about the PMPRB’s next steps regarding the consultation process.”
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