Thank you, Madam Chair.
In terms of safety, that's a very, very important aspect of the new rare disease framework. Recognizing that the food and drug regulations themselves are somewhat older, we do have powers on market tracing and finding out what's going in the market, largely through the reporting of adverse drug reactions. That also happens through delivery and special access. The manufacturer and the physician would have to report back in if there's an incident through that transaction. So if the orphan drug is going out into the market on a one-by-one request, we do see it. The problem is that you don't get a population view of what's going on. The new framework would be much more deliberate. Safety would be a matter of trying to look out and understand what it is you need to follow if you've got any particular concern. If you start to detect something, you can put in further tests and studies and make sure you really follow what's going on with the drug, including utilization studies. So you can follow if it's being used outside of the labelled indication, which means that physicians are prescribing it, notwithstanding that it hasn't been completely demonstrated with us.
Basically, it would be a much more advanced way to follow out safety issues. That's not to say that pre-market there's any less of a look. We really want to make sure that as the drug—