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Health committee  I can respond to that, Madam Chair. Our framework is as it is. We do look at risk. We look at risks to intended patients, the ones that the drug is supposed to be used by, and we ensure that it's labelled properly. We have a parallel set of regulatory frameworks that looks at the issue around diversion and abuse.

November 6th, 2013Committee meeting

Dr. John Patrick Stewart

Health committee  Madam Chair, my response would be this. In Canada, under the Food and Drugs Act and its regulations, a drug will be issued a market authorization if, after a risk-based decision-making process, Health Canada determines that the drug demonstrates safety, efficacy, and quality under its recommended conditions of use for the intended patient population.

November 6th, 2013Committee meeting

Dr. John Patrick Stewart

Health committee  I would just add that at more of an operational level, now when we approve an new opioid and it reaches the NOC stage, when it gets to notice of compliance, we're making sure that we're sending out information to a number of affected parties, provincial-level bodies as well as pharmacists and physician associations, so that they are aware that a new opioid or a new change in indication has hit the landscape of opioid medication.

November 6th, 2013Committee meeting

Dr. John Patrick Stewart

Health committee  I can speak from the licensing perspective around labelling. Certainly, when a drug comes in for approval and it's clear that it has addictive or abuse potential, we spend a fair bit of time looking at the labelling and ensuring that when the product is authorized on the market the labelling is clear to both the prescribers and the pharmacists, and that in part three of the product monograph for consumers or patients, the risks of abuse and the potential outcomes of that abuse are clear, so if they're looking for information around the product it's there in the product monograph.

November 6th, 2013Committee meeting

Dr. John Patrick Stewart