In December 2017, the Governor-in-Council published in Canada Gazette Part 1 the most comprehensive changes affecting patented medicines since Bill C-91 was passed by the Government of Canada more than 25 years ago. These regulatory changes proposed by Health Canada are anticipated to have significant detrimental effects for Canadians and the innovative pharmaceutical industry which have not been adequately considered in Health Canada’s Regulatory Impact Assessment Statement or its accompanying cost-benefit analysis.
This report, commissioned by Innovative Medicines Canada, was conducted independently by PDCI Market Access. It provides additional perspectives and analysis with the aim of helping policy-makers and all Canadians to critically assess the cost–benefit analysis that Health Canada prepared, and which supports implementation of the proposed changes. This report investigates the extent to which the proposed changes will impact the balance among three key factors: the affordability of medicines, their availability in Canada, and the need to support a vibrant life-sciences sector.