Certainly. Thank you, Mr. Chair.
On the first point, when we started discussing some of the text in the bill, this was raised by health care professionals. It's the first time you've had mandatory recall. It's very important that the threshold language be able to deal with the kind of event that we saw, a failure of a birth control pill to work.
So we went back and we pulled in our inspectors; we pulled in our legal team; and we really made sure that this new threshold, which we've never had before, would work for that. So we were satisfied that the language “serious and imminent” would do it. That was a very serious concern for us. We really made sure we looked at it.
On this other language, “injury to health”, that's a phrase that occurs in the existing act in different places and in other parts of what we're trying to amend through the bill. It's very important to understand how this language would operate throughout those, so any vagueness that this would introduce could prospectively be very troubling. It's something you'd have to be very careful about in introducing brand new language.
I will say that for NDP-1.1, we would include “in an adverse event or an injury to health”. Really what we're looking for there, especially if it's serious, if somebody is permanently debilitated or there's a life-threatening event to them, no matter how it happened, whether it was a package that went wrong, or the labelling, we would pick that up as a serious event.
And basically, the other thing I should mention is that in our label-change power later on, in that proposal it does contemplate changing package. So if there is a mistake around the package, if we do see that, then there's a decisive action that can be taken.