Health Canada is proposing changes to its prescription drug pricing regulations with the establishment of a risk-based approach, applying new economic factors in the decision framework, and updating the list of countries it uses for average price comparisons.
The proposal includes a complaint-based oversight system for patented generic products, detailed pricing information required from patent holders, and mandating holders to provide Canada’s price review board with domestic rebate and discount information.
Health Canada has not significantly updated its pricing regulations in over 20 years, and newer, higher cost drugs, biologics and gene therapies continue to put pressure on spending, the agency said. In addition, the discrepancy between public list prices and lower market prices is increasing due to the use of confidential discounts and rebates.
The agency is currently taking public comment on the new regulations through June 28.