U.S. drug-pricing policy linked to delayed Canadian launches

Nearly 50 medicines have had their Canadian launches cancelled or delayed in the past year, according to an EY survey of 31 pharmaceutical and life-sciences companies cited by CityNews.

The survey found 16 launches were cancelled directly because of the U.S. most-favoured-nation, or MFN, pricing policy, while 32 others were delayed. The policy aims to ensure Americans pay the lowest price offered in comparable countries, raising concerns that Canadian prices could become a reference point for U.S. pricing.

Dr. Michelle Hladunewich of Sunnybrook Health Sciences said the result could be reduced access to newer medicines, particularly for people with rare diseases. Industry representatives and legal experts said companies may instead seek higher Canadian prices or avoid markets where lower negotiated prices could affect their U.S. returns.

Canada’s process includes Health Canada approval, cost-effectiveness review by Canada’s Drug Agency, negotiations through the pan-Canadian Pharmaceutical Alliance and provincial formulary decisions. Novartis said it will not seek reimbursement for Vanrafia for IgA nephropathy at this time, citing the current Canadian access environment; it did not identify MFN as the reason.

A spokesperson for the federal health minister said the government is working to strengthen pharmaceutical capacity, support domestic manufacturing and streamline parts of the approval process. Experts said developments in the United States could make the next several months uncertain for Canadian drug access and pricing.