Health Canada delays drug-pricing reforms

Health Canada says it’s delaying its longawaited overhaul of drug-pricing regulations by another six months.

While pharmaceutical manufacturers and patient advocates welcomed the decision, they say the federal government needs to go back to the drawing board for Canada to stay competitive in the global marketplace for medical innovation.

A Health Canada spokesman confirmed to The Canadian Press that the rollout of regulatory changes that would give Canada's drug-pricing watchdog sweeping new powers has been pushed from Jan. 1 to July 1.

In an email, Geoffroy Legault-Thivierge said the delay is intended to give pharmaceutical companies more time to adjust to new reporting requirements while dealing with the challenges posed by the COVID-19 pandemic.

Stakeholders involved in the consultation process were notified of the change on Dec. 30, two days before the amendments were set to take effect, Legault-Thivierge said.

The postponement marks the latest setback in the years-long battle over the federal plan to recalibrate how the arm’s-length Patented Medicine Prices Review Board calculates fair drug prices.

Canada pays some of the highest prices in the world for patented medicines, LegaultThivierge said, and the new regulatory regime will allow the review board to rein in surging costs.

But drug manufacturers and patient advocates have condemned the changes on the grounds they could stifle scientific innovation and reduce access to medical therapies.

Dara Jospe, a lawyer who specializes in pharmaceutical regulation, says the fight is far from over as court challenges have quashed one of the three key tenets of the amendments to the federal framework.

“These changes are a really big deal to industry, and when they come into effect, there will be an overnight impact, which is why it’s being attacked on multiple grounds and through multiple channels,” Jospe said.

The prices review board was first created 30 years ago to ensure companies do not use monopolies to charge excessive costs for patented medicines.

To conduct these assessments, the board compares prices with those in a list of other countries. Under the new regime, two of the highest-paying countries, the U.S. and Switzerland, will be removed from the list, and new nations will be added.