Association raises concerns about proposed patented medicine guidelines

Innovative Medicines Canada, a national association representing the pharmaceutical industry, is raising the alarm about recently published draft guidelines governing the Patented Medicine Prices Review Board (PMPRB). The association says its initial interpretation is that the guidelines “will further reduce the availability of new medicines in Canada by exacerbating an already unpredictable regulatory environment.” 

The announcement follows the PMPRB’s publication of the draft guidelines for comment. The deadline for providing written submissions is December 5, 2022.

The PMPRB’s explanation of key changes from previous iterations of the guidelines and a high-level summary of the changes, made public in a background document, says the changes take into account feedback received from stakeholders as part of consultations on the 2020 guidelines and in response to a July 2022 comment period on the board’s interim guidance.

“On April 14, 2022, the Minister of Health announced the government would proceed with amendments to the Patented Medicine Regulations, resulting in a newly constituted schedule of comparator countries and reduced reporting requirements for medicines believed to be at the lowest risk of excessive pricing,” the PMPRB states. The amended regulations came into force on July 1, 2022.

“The PMPRB is proposing the new draft guidelines and is inviting its stakeholders and interested members of the public to provide feedback.” 

They add “while the guidelines, by definition, do not have the force of law, they have been held by courts to be useful both for the PMPRB and the public and may legitimately inform the board’s reasoning in an excessive price hearing.” 

The new guidelines, they say, are more pragmatic and less prescriptive, and better resemble modern guidance documents issued by other federal regulators.

The guideline revisions include the adoption of investigation criteria as an alternative approach to current price tests that change from year to year. It discusses investigation triggers, including pricing information, and distinguishes between new and existing medicines, proposing to apply less probing investigation criteria to existing pharmaceuticals.

“The board is of the view that the misalignment of Canadian and international prices is best addressed by applying more probing investigation criteria to new medicines on a go-forward basis,” they write, adding that once an investigation is opened, its staff will apply the same level of regulatory scrutiny, regardless of the medicine’s status.

The revisions also propose to waive the filing requirements for medicines believed to be at lower risk of excessive pricing. An investigation would only be opened in the event that a complaint is received regarding one of these products.

The board, they add, “has opted to expand this list of products for administrative purposes to include biosimilars and vaccines, as these are also thought to be at lower risk of excessive pricing. Biosimilars are, in many ways, subject to similar market conditions as generic medicines.” 

Created in 1987 to protect consumers from excessively priced patented medicines, the PMPRB is a five-member board, assisted by civil servants. Members are appointed for terms of up to five years, renewable once.

“These guidelines,” they write, “are intended to provide transparency to stakeholders regarding the procedures typically used by staff when monitoring the prices of patented medicines. In particular, they explain the criteria staff will consider in determining whether the price of patented medicine warrants a more in-depth review in the form of an investigation.”