What to Expect When you are Expecting to Launch a Drug in Canada – Regulatory Overview
March 2, 2015
Author: Noel Courage
The brand name has been picked out. The patents have issued. The new drug submission is ready to go into Health Canada. It's not just the Great White North landscape that is unique. Many of our regulations can catch unwary companies by surprise. This article provides a very concise summary of some key issues for brand name pharmaceutical companies launching a product in Canada.
Price Regulation and Reimbursement
Canada regulates the price of patented medicines. The federal Patented Medicines Prices Review Board (PMPRB) is the body that has been empowered to review and limit price. It may review prices even where a Canadian patent is not being commercialized, such a patent on an alternate formulation or process of manufacture. The patent need only be related to a medicine by the “slenderest thread”, according to Canadian courts, to trigger price review jurisdiction. Pharmaceutical companies typically negotiate price with the PMPRB in advance of product launch by providing comparative pricing data and other information to justify proposed pricing. The PMPRB can trigger an administrative price review hearing if no agreement is reached. A PMPRB decision can be appealed to a court.
For reimbursement, drug manufacturers can look to each of the separate provincial formularies and private insurers. There is a single review process, called the common drug review, that streamlines the process of drug review for the participating governments. It reviews efficacy, safety, cost-benefit analysis etc. There are also specialized review processes for cancer and HIV drugs. Irrespective of the review process followed, obtaining a formulary listing for reimbursement remains a discretionary province-by-province decision-making process.
Canada has 8 years of data protection for innovative drugs not previously approved in Canada. There is a potential extension of 6 months if pediatric clinical trials trials are conducted.
There is no orphan drug regulatory exclusivity in Canada.
The first generic drug approved in Canada does not get a six month market exclusivity period.
Patents and Patent Linking
Canada has a Health Canada Patent Register here, analogous to the US FDA Orange Book for ANDA Proceedings. It provides a useful tool for patent owners to list their patents with the regulator to prevent patent infringement and keep generic drugs off the market. The Register is limited to patents specific to the approved medicine, dosage forms, formulations and uses. The Register also has very strict timing requirements.
There is no patent term extension, though it is expected to arrive in the next year or two because Canada signed a free trade agreement with Europe (CETA). The treaty requires patent term extension to be available to an applicant with an innovative medicine that is experiencing drug regulatory delays by Health Canada. The government says the system will not be retroactive to already-approved drugs.
There tends to be less competition law (antitrust) scrutiny in Canada. The Canadian government sees intellectual property and competition law as complimentary. Mere exercise or licensing of an IP right will not attract government review. The Canadian Competition Bureau has typically been less aggressive in reviewing and commenting on emerging competition issues than its US counterparts.
The Competition Bureau published a position paper in 2014 stating that it could review certain reverse payment pharma settlements using its civil or criminal powers. We are not aware of any such cases. Canada does not have a settlement notification system, unlike the FTC requirements in the US.
Information on this website is for information only. It is not, and should not be taken as, legal advice. You should not rely on, or take or not take any action, based upon this information. Professional legal advice should be promptly obtained. Bereskin & Parr LLP professionals will be pleased to advise you.