I think the post-market aspect of this bill is important, because you need that capacity to be able to do the research, as my colleagues and I have pointed out. But when it comes to the pre-market portion of the bill, I get afraid. For example, as you mentioned with Vioxx, would Vioxx have been prevented if we lowered the standard for getting it on the market quicker? I don't think so. I think you're going to have more Vioxxes. Certainly we'll have post-market surveillance in place, but how that post-market surveillance will be done is very ambiguous right now. We don't know, actually.
It is great to set up a system of post-market surveillance, but right now there are a lot of questions as to how it will be done and the role that industry will play. So I would not lower the pre-market framework of phase one, two, and three trials. My sense is that there are consumer groups who step forward and say that patients want drugs at an earlier time, but I still think that there's a problem with getting them. They are not aware of the risks that are also associated with these drugs. The risk-benefit profile of these drugs is not completely clear. You're taking a much greater risk than I think is warranted.
Health Canada does take a longer time than other countries in reviewing drugs currently, and I think that is one of the pushes, but the fact is we have had a lower record of withdrawals than the United States and other countries have had. One of the reasons is that drugs are on the market in the U.S. and we get to see them, and when there's a Vioxx out there, we're not even going to approve it. We're not letting it out of the gate. Actually, I think that's a good thing. I'd rather be protected than take risks.
If you're talking about drugs that address life-threatening conditions like AIDS and cancer, we have a fast-track system already within Health Canada that allows those drugs to get on the market after only phase two trials, as far as I know. The drug companies are responsible for doing the post-market studies after the fact.
The problem with leaving industry in charge of the phase four trials, which are the post-market trials, is that there is no obligation for them to complete those trials. In the U.S. they found that less than half of the post-market studies that industry had agreed to conduct were ever begun. There is recent legislation, from the fall of 2007, that will give the FDA the power to compel industry to complete those phase four studies, but even in our current system, where we allow some fast-tracking, those studies are not necessarily completed, and there are no repercussions for industry; they just go on and market.
Just to summarize, I think I would not reduce the standards in the pre-market phase. We definitely need greater surveillance out there. So I laud the post-market portion of the bill, but the pre-market portion I would amend to strengthen it and not lower the standards.