For the third time in a row, the federal government is delaying long-awaited changes to Canada’s drug pricing regime for a further six months.
In an effort to give pharmaceutical companies more time to prepare for the impending changes, Health Minister Patty Hajdu announced Tuesday the regulations changing how the Patented Medicine Prices Review Board ensures new drugs are priced fairly now won’t take effect until Jan. 1, 2022.
The decision comes after more than three dozen pharmaceutical company executives sent Prime Minister Justin Trudeau a letter asking for another delay, arguing the coronavirus pandemic had prevented a real discussion about the impact the new regulations would have on drug accessibility and innovation in Canada.
In a statement on its website, Innovative Medicines Canada said it views the most recent delay as a renewed opportunity to examine the potential impact of these reforms, as well as affording time to generate more effective alternative solutions.
Conservative health critic Michelle Rempel Garner says the delay is a sign the government recognizes the regulations will hurt Canada and “need to be rethought. It makes no sense that the Liberals want to escalate tensions with pharmaceutical companies in the midst of a global pandemic, when Canadians still need access to vaccines and therapeutics.”
But some patient advocacy groups have said the new regulations are required to protect Canadians who already pay among the highest prices in the world for new medicines still protected by patents. The new regulations are expected to cut drug prices by $13 billion over the next decade, with adjustments to the countries used for comparison purposes and new economic conditions guiding decisions on whether proposed prices are excessive.
Many of the companies lobbying against the regulations are supplying the coronavirus vaccines Canada desperately needs. “I have no doubt the pandemic has been used, explicitly or implicitly,” to threaten Ottawa to back off on the regulations, said NDP health critic Don Davies in an interview with The Canadian Press.
Trudeau is in the midst of trying to rebuild Canada’s domestic pharmaceutical industry after being left entirely reliant on foreign production for coronavirus vaccines. The industry has warned the regulations could hurt that effort.
Davies says that’s hogwash, noting many European countries with lower mandated drug prices have very strong pharmaceutical industries. He says delaying the regulations, which would save money for Canadians who need life-saving drugs, is both “cowardly and misinformed.”
Sharon Batt, a bioethics professor at Dalhousie University in Halifax, says these regulations are needed to establish a national pharmacare program, which Canada badly needs. “It’s way overdue that we take this step and I think it would make a huge difference to patients who need drugs and can’t afford them and to the provinces that are trying to cover essential drugs with their limited budgets.”
The PMPRB first published its initial draft guidelines back in November 2019. After an 85-day consultation period, it released a revised draft of the guidelines, which was subject to a further 30-day consultation in June 2020. The new rules were announced in 2019 and were set to take effect in 2020 but were first delayed until Jan. 1 and then again until July 1 this year.