"The price thing is a red herring," says former Patented Medicine Prices Review Board head, calling out delays in drug approvals
Doug Clark, former executive director of the Patented Medicine Prices Review Board (PMPRB), has raised concerns over delays in Canada’s drug approval process, calling the system “fragmented, cumbersome, onerous.”
The Globe and Mail reported that, speaking publicly for the first time since stepping down in 2023, Clark said there are too many steps and described the regulatory journey as “like a relay race.”
Clark led the PMPRB for a decade, during which he often faced criticism from drug makers.
While he rejected claims that cost containment was to blame for delays—calling it “a red herring”—he said industry groups are “quite right” about how long the system takes, noting that “we really don’t stack up well.”
The drug approval process begins with Health Canada reviewing new pharmaceuticals for safety and efficacy. Canada’s Drug Agency (CDA) then assesses cost-effectiveness.
Afterward, the pan-Canadian Pharmaceutical Alliance (pCPA) negotiates prices on behalf of public plans covering about 40 percent of the market.
Within 30 days of a drug’s first sale, the PMPRB may step in if a price is deemed “excessive.”
Innovative Medicines Canada reported that it takes 1,301 days on average for a drug to go from global launch to public reimbursement in Canada.
Of that, 732 days are spent evaluating whether a drug should be reimbursed. By comparison, the same process takes 379 days in Germany, 679 in the United Kingdom, and 725 in France.
Clark proposed that regulators run evaluations in parallel, not sequentially.
He also urged the pCPA—which he briefly led as CEO in 2023 before retiring—to gain decision-making autonomy and added resources.
“I did see from the inside how difficult it is when you are a consensus-driven organization with 14 members,” he said.
He further recommended that private insurers, who also cover about 40 percent of drug spending, be allowed to pay the same rates as public plans for patented drugs, mirroring the current approach for generic medicines.
Clark's concerns echo recent commentary published by Benefits and Pensions Monitor, where experts questioned the efficiency of the current system.
According to a Benefits and Pensions Monitor interview, Gary Walters, chief actuary at GroupHEALTH Benefit Solutions, argued that Canada's new national pharmacare framework may not be the best way to fix drug access issues.
Walters said, “We may end up with a lot of money to pay for coverage that only less than a quarter of the population needs.”
Also speaking with Benefits and Pensions Monitor, Carolyne Eagan, spokesperson for the Smart Health Benefits Coalition, called for a focus on targeted coverage for the uninsured and underinsured.
She stated that this approach would be a “lower-cost, more efficient” solution than creating a new universal plan.
Clark pointed out that even reform efforts have moved slowly. The Trudeau government first proposed PMPRB rule changes in 2015.
By 2019, Ottawa planned to implement them in 2020.
However, the COVID-19 pandemic, legal challenges, and repeated rounds of consultation delayed the effort.
“I was consulted out by that point. I had no more bandwidth for consultation,” Clark said, reflecting on his decision to leave the PMPRB after the government announced yet another round of consultations.
