October 05, 2017
Partner and chair of the Intellectual Property and Food and Drug Regulatory practices Eileen McMahon has told Law Times the proposed changes to Canada’s patented drug prices could in fact have an effect on pharmaceuticals in the U.S.
Health Canada has released a number of suggested amendments to the Patented Medicines Regulations in an attempt to stop drug prices becoming excessive. One of the most notable amendments is a change to the basket of comparator countries the Patented Medicine Prices Review Board uses when setting its price ceiling.
Traditionally, drug companies are required to submit wholesale prices in the basket of seven comparator countries. The basket has now increased to 12 and no longer includes the U.S.
Eileen told Law Times American drug companies are worried that the change will reignite old fears about a black market in cheaper Canadian versions of drugs.
“Given Canada’s close proximity to the U.S., the chance that some of these drugs will leak back into the U.S. market is something that is concerning to companies,” Eileen told Law Times.
She said the focus on lowering drug prices could turn the regulations into an international issue due to the upcoming renegotiation of NAFTA.
With much of the research and development into innovative drugs going on in the U.S., Eileen told Law Times “discontent may grow if Canadian drug price ceilings come down even further below American levels.”
You can read our recent bulletin on this topic here.