Introduction The pricing and reimbursement process in Canada is considered to be challenging to pharma. Furthermore, Health Canada takes longer to award marketing approval for new drugs than the European Medicines Agency (EMA). Also, while the intellectual property environment in Canada has improved in recent years, it is still considered to be behind that of other G7 countries. Features and benefits Assess the key factors facing pharma in terms of regulatory issues, pricing and reimbursement. Review the insurance and healthcare system in Canada including recent health reforms. Gain insight into regulatory and intellectual property issues in Canada. Review important pricing and reimbursement issues in Canada.
Highlights The pricing and reimbursement process in Canada is considered to be challenging to pharma, and although the Patented Medicines Prices Review Board, the Common Drug Review, and the public drug plans have their distinct strategies for regulating drug prices, there is substantial variation in reimbursement between provinces. In terms of the drug approval process, Health Canada takes longer to award marketing approval for new drugs than the European Medicines Agency (EMA). Consequently, in order to speed up the process, user fees were increased in April 2011, and from April 2012 all fees will be increased annually by 2%. Canada lacks any workable right of appeal under its linkage system and it is the only G7 nation that does not offer any form of patent term restoration. Because of this, Canada is on the PhRMA Special 301 Watch List and major reform of the intellectual property system has been called for. Your key questions answered Contains 39 pages and 8 tables/figures.
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