Health committee  Yes. The other big ticket I think we can do is to take the intellectual property rights for the patient insert and the drug label and make it a public good. Health Canada can put this information up on the website, change it when it needs to, and send out alerts tied to that in

Health committee  Okay. Vis-à-vis the HPV issue, as I said before, this could be the best thing since sliced bread. Our position at the clinic has been that it's premature to have put it into the population base until we knew how long it lasted and whether or not the viruses that are in it actual

Health committee  I guess I'm a believer in mandatory reporting as a component. Partially why I put my energy into supporting the drug research and effectiveness network is it would be the backbone that would support researchers like Bruce, doing what I would call communities of practice; that is,

Health committee  I want to link it to the other question too. There are elements that we can learn around surveillance that I think Bruce has alluded to that have been a standard in public health. We do select doctors and nurses and pharmacists to report. We train them up. Sometimes it's on how m

Health committee  You're right. I think we need to be cognizant of the fact that we need to be managing our human resources in health care. We have some gaps, and we do need to develop a plan. I totally agree. People my age are all hoping to retire, I think, but the act of reporting, itself, is

Health committee  Well, I'm sure they would.

Health committee  Is that okay?

Health committee  You need to first start in animal models, and animal models are very helpful on the toxic effects of drugs on fetuses. That's one of the ways. The other way is for women who are now in clinical trials, one of the agreements, for example, is that they don't become pregnant, and if

Health committee  I actually think this is a step forward in our thinking. That being said, my remarks today were focused on two areas that I felt really needed enlightening. One was, of course, around sex and gender; but the other was about what that original bar was and what the risk management

Health committee  In a way I'm here because twenty years ago women sitting around this table and in the House thought that sex and gender mattered, and we needed to develop infrastructure and knowledge to help. Someone very wise, a mentor in my career, said, “Madeline, you've got to know that it t

Health committee  I don't think it's changed that much, hence my suggestions this morning around both enshrining a requirement for sex and gender analysis but also trying to now move to some kind of richer framework for the evaluation of drugs prior to their approval, because I think we can make s

Health committee  That's an excellent question, and I think it's one of the reasons why I suggested that we keep vaccines in the drug and health product field. Right now they run in a separate.... They come from a separate history in medicine, and because we are now using them so much more regular

Health committee  As you may know, vaccine and drug approval processes in Canada right now are private except for very extraordinary circumstances, so I can't really comment on what happened internally in the department. However, as you may know, my agency has been involved in thinking about the i

Health committee  Yes, that would be an example from my perspective. Also, young boys were not included in those trials either.

Health committee  I did spend a bit of time on the garbage-in, garbage-out issue. I actually feel strongly that what we need to be doing is looking at sex and gender at the beginning of the process--that is, what's going on in the clinical trials, what's the notice, what's the review, what's the n