Health committee  Yes. Just to add, in terms of the Health Canada assessment around the Alysena issue, we did actually deem it to be a serious risk when we did do the risk assessment. When the testimony was given, I think the issue was that when the company had made the assessment, they had not r

Health committee  The lack of effectiveness would have consequences. When we're looking at the definitions, we're really focusing on the consequence. Regardless of the upstream cause of it, you're looking at something that could have an impact on patient safety or endangering patient safety. Then

Health committee  To start, I think you're absolutely right. When the bill first came in, there was no Twitter; there was no Facebook. People got information in very different ways. It's still that way, I think. When we're talking with practitioners and physicians out in the community, people want

Health committee  Certainly the provisions in the bill, as we mentioned, give us more flexibility in terms of collecting data. It really comes down to two parts of it. One is that there are powers in the bill that actually ask companies to do reassessments. You can have a situation that's going on

Health committee  There are a number of parts of the legislation that would have helped in both those situations. The first part is really what we talked about in terms of the recall. Again, for the vast majority of companies when Health Canada said they would like a recall, they do recall. The

Health committee  In terms of the Public Health Agency of Canada report or the fact sheet, I think you would probably have to direct that to them. If there's a question for Health Canada, I'd happily be able to take that.

Health committee  We are talking about the reuse of single-use devices. If it sounds like an oxymoron it's because it is. The idea from our perspective is that if a product is for single use there should be good reasons that it's for single use and it should be labelled as such. We do have symbol

Health committee  They are.

Health committee  They are. The concerns that we have right now are.... For example, let's say we have a product that's for single use and it's going out and it's being reused and there are concerns about that. We don't have a way to then compel the manufacturer to study that or to change the labe

Health committee  Yes.

Health committee  Absolutely. In terms of the definition of serious, it is dependent on the situation. As you know, for an individual patient an adverse reaction can be quite serious...for a group of patients, because they are predisposed to that. The bill actually allows us to collect that type o

Health committee  Good morning. I think I have the longest title of anyone here. I'm the acting associate assistant deputy minister of the health products and food branch and also the senior medical adviser for the branch.