Can I make one additional comment on that? I think it's a perfect question and it's a perfect example of the disconnect between what happens in terms of Health Canada and their approval for marketing and what actually happens in terms of the availability and marketing.
It goes back to the federal-provincial divide. At the federal level they approve it for safety, approve it for efficacy. I think when Health Canada does that approval it means something, and it means something significant. The problem is that then when we talk about making it available, that information is not necessarily carried over in the right way, but as other people have said, the availability becomes totally disconnected. And it's almost impossible to call it post-market surveillance anymore, because as we're talking about progressive licensing and continuous licensing renewals, we have to be talking about ongoing surveillance.
So this is a perfect opportunity to ask, based on the uncertainty of the information—there is always some uncertainty—based on, as you say, the patient populations it's been tested on, what else do we need to do in order to be assured that if we're going to roll out the program, we're going to collect, in a continuous way, the information that is going to feed back into that decision?
And again, Health Canada, in their progressive licensing framework, has set it up perfectly to say that as we get more information, we can re-evaluate where we are. So as this program rolls out, as we collect not only safety information but efficacy information, we should be able to feed it back into the approval process to ask, where are we, and do we agree? And that should also feed back into the accessibility or the marketing process to ask, is it still being marketed in the right populations?
So it's an ideal opportunity to set up that integrated framework, and this is really where we do have to have that close cooperation between all of the stakeholders, including the patients and the clinicians, but also between the various levels of government.
As we're looking at it, it's an example where we can really take advantage of what we're trying to do in terms of setting up a much more robust, continuing surveillance of both efficacy and safety, but also the appropriate patient populations. And I would agree that I don't think it has been done.