OTTAWA — Critics of a major drug-price overhaul hope a fresh federal cabinet will put a temporary stop to the new regulations set to take effect in January.

The Patented Medicine Prices Review Board (PMPRB) is set to change the way it sets a price cap on medicines in Canada in an effort to lower excessively expensive drug costs. 

The overhaul has drawn the disapproval of patient groups and drug manufacturers, as well as some pharmacists, doctors, academics and even provincial governments.

On Tuesday, Prime Minister Justin Trudeau put a new minister, Jean-Yves Duclos, in charge of Health Canada, which oversees the file. 

“I think it's premature and even irresponsible for anybody to be making any decisions until the new senior policy-makers for government are in place and have a chance to settle in and be briefed and to hear from stakeholders,” said John Adams, the volunteer board chair of the Best Medicines Coalition.

The coalition lobbies on behalf of 29 patient groups for access to safe, effective medicines.

While most welcome more affordable drugs, some critics fear a drastic drop in the sticker price for medicines will make Canada an unattractive place to launch new products, which could leave life-saving new therapies out of reach for Canadian patients.

The changes could also put pressure on the supply of existing drugs to Canada, Adams said. 

Health Canada first announced the changes in 2019 as a means to protect Canadians from excessive prices and make patented medicines more affordable.

The department expects the amendments will save Canadians billions of dollars over the next 10 years on patented drugs.

Adams calls it a "hazardous public policy experiment."

Health Canada said there is no evidence lower drug prices will reduce access to medicines. 

"With these changes, Canada will continue to be an important market for new medicines," a Health Canada spokeswoman wrote in a statement to The Canadian Press. 

"New medicines are launched in major markets in very similar time frames, including in countries with prices below those in Canada."

Since the policy was announced, the agency has become embroiled in court challenges against pharmaceutical companies and even the Quebec government, which claims the regulations are unconstitutional. Those cases are ongoing.

Other critics worry about stifling effects on innovation in the biomedical field.

A coalition of eight Canadian life-sciences organizations have written to government ministers to ask them to put off the changes pending further consultation, input from the new federal cabinet, and resolution of the legal challenges.

"We strongly recommend waiting until new ministers and other political appointments have been made, mandate letters have been issued, and decision-makers have been briefed on this issue before moving forward," the life-science organizations wrote in their letter earlier this month.

The organizations said the changes run contrary to the federal biomanufacturing and life sciences strategy, announced last summer, which strives to enable innovation by ensuring “world class regulation.”

One of the signatories, Jason Field, president and CEO Life Sciences Ontario, said he was encouraged by the strategy and the impact it could have on the government's decisions on the PMPRB changes.

"I am hopeful and optimistic a new cabinet will want to prioritize that life sciences strategy," Field said in an interview with The Canadian Press. 

Minister of Innovation, Science and Industry Francois-Philippe Champagne said he's open to speaking to CEOs about it. 

"I'll be happy to engage with them to see what more we can do to attract more investment, create jobs in this country, and make Canada more resilient to face whatever may come next," he said after the cabinet swearing-in ceremony Tuesday.

The new regulations were initially supposed to take effect in July 2020, but the implementation has been delayed three times due to the COVID-19 pandemic.

"Health Canada is mindful of the impact the COVID-19 situation has on industry to adapt to these new reporting obligations and had delayed the coming into force of these amendments," the Health Canada spokeswoman wrote.

Health Canada would not say if it plans to bring the regulations into force in January as planned, only that the government remains committed to increase the affordability, accessibility and appropriate use of medicines for Canadians.  

This report by The Canadian Press was first published Oct. 28, 2021.

Laura Osman, The Canadian Press