You're absolutely right that it is mandatory for manufacturers to report adverse events, but not so for health care professionals or, obviously, Canadians.
In the reporting of adverse events, there is a lot of underreporting, for a variety of reasons, going on in terms of barriers to reporting and communications channels. We've been looking at this issue actively, because that's a fundamental part of any kind of post-market surveillance activity. There's no question that, using a multi-pronged approach, we need to try to increase the reporting on these, because that's going to add to our information base in this progressive licensing or life cycle approach.
I'll let my colleagues who've been working on these issues much longer than I have speak to this, but in all our consultations in terms of looking at the international practices, looking across this country and talking to a variety of people, what was felt was that at this point in time there are many folks who are starting to work on putting systems in place to report these incidents. For example, a couple of the provinces—I think Manitoba and Saskatchewan—are putting into their hospitals or regional health authorities critical reporting systems. We have the Canadian Patient Safety Institute, as we know, trying to encourage that, so that it's not an individual who's held responsible and it's a system issue that we can all learn from.
During our consultations with all these folks, what came up was that at this point in time maybe the best place to start could be focusing on mandatory reporting by hospitals of serious drug adverse reactions to their regulated products, because we know that at some stage people will have to be, unfortunately, hospitalized if they've suffered a serious adverse event. What we're saying is that maybe as a first step we will try to have mandatory reporting within health care institutions. We're actively working with our colleagues in the provinces and territories, and there are a number of issues to be worked out, but I think the mood worldwide is to go in that direction, because we know we have to increase the reporting of these things using a variety of means.