Yes, thank you.
The progressive licensing concept is an attractive concept, because I think we know from our experience and the drugs we've talked about—Vioxx, Cisapride, and there's a long list of drugs that we've had over the last 20 years—that we really only truly learn about drug safety through use. Conceptually, there's lots of attraction around just getting the drug into the market as soon as we feel it's reasonably safe, and then monitoring its use in 10,000, 20,000, or 30,0000 patients in order to know whether it's truly safe or not.
So I think the concept of progressive licensing is probably where we need to go. I think the challenges are around actually making sure the systems are in place at a practice level to ensure that we can effectively collect all of the relevant data to make sure we can make a good assessment of safety. And then further, on top of that, there is this need to really better develop systems that support the safe and effective use of drugs.
We've just published a book written by a Canadian who won the Harkness Scholarship this year. It is called Safe and Effective. The Eight Essential Elements of an Optimal Medication-Use System. It deals with issues around the evaluation of drugs prior to marketing, but more importantly, it deals with what needs to actually be done in practice to make drug use safe. We can make a copy of this available to committee members.
I think that conceptually, progressive licensing is probably the way we need to go. But a lot of work has to be done in terms of building the systems that would actually support that in the practice environment.