Health Canada has opened consultation on proposed amendments to the Patented Medicines Regulations including introducing new regulation factors, updated comparator countries, a complaints-based system for some products, and identification of pricing information and third party information required.

A discussion and rational for the proposed amendments to the regulations (link) is available from Health Canada (link). The consultation is open until June 28, 2017.

The Patented Medicine Prices Review Board (PMPRB) Vice-chairperson Dr. Mitchell Levine is quoted as saying, “The PMPRB welcomes the Minister of Health’s action to strengthen and modernize its pricing framework to reduce the cost of prescription drugs. We look forward to the outcome of this consultation process.”

Some background and commentary from the Toronto Star:

Health Minister Jane Philpott pledged action Tuesday to bring down “unacceptably high drug costs” as she announced consultations on a suite of proposed regulatory changes related to a drug prices board designed to protect consumers.

The Patented Medicine Prices Review Board — first created 30 years ago to ensure companies do not use monopolies to charge excessive costs — is now limited in its ability to protect consumers from high drug prices, Philpott said during lunchtime remarks hosted by the Economic Club of Canada.

“These consultations will help better equip the board to protect Canadians from excessive drug prices,” she said.