Issue link: http://clhia.uberflip.com/i/406567
9 In addition, off-label use can drive up costs to the system. This is particularly true with higher cost drugs where their original price was established based on a small estimated potential market but which, through off-label prescribing, ultimately has a much larger volume of sales in the market. Prescribing off-label can be a valuable tool for physicians and is generally accepted medical practice. However, the life and health insurance industry believes that there should be greater oversight into the practice of off-label prescribing – not only to ensure patient safety but also to help with the financial sustainability of the system. THEREFORE, THE CLHIA RECOMMENDS THAT: • HEALTH CANADA IMPLEMENT A GOVERNANCE AND MONITORING FRAMEWORK FOR OFF-LABEL PRESCRIBING THAT FOCUSES ON THE HEALTH IMPLICATIONS FOR CANADIANS AS WELL AS THE IMPLICATIONS FOR THE FINANCIAL SUSTAINABILITY OF DRUG COVERAGE IN CANADA. B. ENSURING AVAILABILITY OF COST EFFECTIVE PRESCRIPTION DRUGS In order for Canadians to benefit from innovation in drugs, they need to have access, in a cost effective manner, to new drugs. The availability and relative cost of new drugs to Canadians is a function of a number of different factors. b.1 Role of the Patented Medicine Prices Review Board (PMPRB) The PMPRB is an independent quasi-judicial body established by Parliament in 1987 under the Patent Act. The PMPRB's mandate is primarily one of consumer protection and has two aspects: 1. Regulatory – to ensure that prices charged by patentees for patented medicines sold in Canada are not excessive.