Drug-pricing regulator contemplates “significant changes” in light of heavy industry pushback
The Patented Medicine Prices Review Board (PMPRB) is considering how it will apply a new set of pricing guidelines introduced last year as drugmakers blame it for delays in the introduction of new medicines into Canada as well as workforce reductions.
As reported by Reuters, the PMPRB is changing the index of countries on which it bases its drug price-capping decisions in August, effectively basing Canadian prices on those from jurisdictions with lower drug prices.
The new regulations for medicines under patent protection, which were passed in August despite heavy lobbying from drug manufacturers, also bestow the power on regulators to review new medicines based on cost-effectiveness.
Following the introduction of the new rules, Reuters said, Swiss drugmaker Roche pulled out Tecentriq, an immunotherapeutic drug it presented as a treatment for breast cancer, from evaluation; the company cited “significant uncertainty and complexity” around the new regulation. In November, Merck blamed the new policy as it announced plans to cut 145 jobs, which represented 30% of its Canadian workforce.
In a statement to Reuters, the PMPRB said that its draft pricing guidelines, which would help determine the ultimate impact of the new rules, could still be revised. “The PMPRB is contemplating significant changes to the document in light of stakeholder feedback,” the regulator said.
Speaking to the news outlet, PMPRB Executive Director Doug Clark said that it could extend an 18-month grace period for companies to comply with parts of the regulation. Cost-effectiveness measures may be imposed on fewer treatments, he added.
When asked whether pulled applications and objections from pharma industry players had anything to do with the changes being considered, Clark said “absolutely not,” adding that there is no evidence to support their suggestion that lower prices lead to reduced access to new drugs.
“No amount of reassurance can be expected to persuade the pharmaceutical industry to support these reforms,” PMPRB said in a statement, “given that the inevitable end result will still be lower ceiling prices for many patented medicines in Canada.”
There are also concerns that lower prices resulting from the Canadian changes would ripple out into the United States, where some policymakers have suggested either importing less expensive drugs from Canada or taking cues from jurisdictions in other countries with lower drug prices, including its neighbour to the North.
The former proposal does not sit well with numerous Canadian policy experts, who point to a growing problem of drug shortages in the country.
