In terms of your first point, about balancing the benefits and risks of any health product, you're absolutely right that it's a call we make in terms of providing timely access to innovative products but also assuring health and safety first and foremost.
That leads into the CDR. We are currently in the process of reviewing the standing committee's report on CDR. We are taking a very serious look at that, looking at the linkages between your recommendations and this new approach that is being proposed, because there are some linkages. We will be tabling that before the April deadline.
In terms of the CDR, absolutely, the access and timely access to products is what CDR is most concerned with. We look at safety, quality, and efficacy. CDR basically takes that information and puts in another criterion, which is, as you know, the cost-effectiveness. We need to look at that very closely in terms of how we build that into the life cycle approach as we move forward. At this time, I am not able to provide you with a precise answer on that.
Your third point asked what we do once a drug is on the market and is used for another purpose. I'll invite my colleagues to speak to that, but my understanding is that it would have to come back in, because if it's being used for another purpose then that really is off-label use. The company would have to resubmit it through the regulatory process because it is being used for another purpose.
I know that off-label use, particularly in the case of children, where this is.... We know that the clinical trials are often done on adults. Sometimes some of these medications are provided to children without adequate testing being done. That is off-label use, which poses its own challenges. We need to look at that.
I'd like my colleagues to add to that, if they wish.