Public Accounts committee  Yes. Thank you to the member for his question. I'll begin and then very quickly—I'm thoughtful of the time—hand it to my colleagues, who in fact are the experts doing this day to day. It is very much the case that we work to make sure, right through the clinical trial approva

Public Accounts committee  Thank you very much, Mr. Chair, and I'll begin, and then turn it over to my colleagues on the specifics of clinical trials. But it does strike me that there are two components in the question. One is what do the people who are in the clinical trials—and again one of the things

Public Accounts committee  Thank you very much, Mr. Chair. It's a pleasure to be able to speak to the user fee initiatives. In some ways I think it was a huge undertaking for the department and I think it is very important. I know the user fees were set in the mid-nineties, and at that point they were ab

Public Accounts committee  There are five actions that I would bring to the committee's attention. First, if someone gets an approval from us in a clinical trial, we encourage them to register the clinical trial at a publicly available registry endorsed by the WHO. As the business becomes increasingly inte

Public Accounts committee  It's an aggregate report that has been published. It's the first one we've done of that type. Perhaps I'll ask my colleague to speak more to that.

Public Accounts committee  There is a searchable database where Canadians can see individual drugs.

Public Accounts committee  Maybe I'll ask my colleagues to speak to this, but yes.

Public Accounts committee  I'll ask my colleagues to speak to the specific latter part of the question. But I want to reassure the committee on the point that we have learned of some of these issues from elsewhere. I actually think that is a mark of the system working well. I'll just say that although we

Public Accounts committee  I will ask my colleague, but I would say the fact that the foreign regulators are sharing information—and much bigger populations may see more signals earlier. We may have one or two cases. They may have 20 or 30. That, in fact, is the system working well. The fact that we're l

Public Accounts committee  I guess I will just say there are two things and I'll turn it over to my colleague to speak to the consultant's or the external report. I would say that the first part that we did immediately was actually to do the—

Public Accounts committee  No. The Auditor General did not find one, although as they point out, that wasn't the focus of their audit, but certainly they did not identify anything. As we've gone through this process of having our staff reconfirm their commitment, we have not discovered anything in that pro

Public Accounts committee  I was a former provincial deputy minister and this is not an area wherein the provinces, although we do look to them on many other fronts, would necessarily have that kind of expertise, although they may in some regulatory areas. We certainly would look to them in many cases, but

Public Accounts committee  I appreciate the question. I think it's a very important issue, as the Auditor General pointed out. The department was in keeping with Treasury Board policy, but I think raised a very valid question about whether that is sufficient in this very sensitive area. We did have a mec

Public Accounts committee  Yes. The only thing I would comment to the committee is that in some cases we are in consultations. If we're actually talking to the public, consumers, and experts, we may not be in a position to pre-empt those discussions and say precisely the outcome of those consultations. We

Public Accounts committee  Yes. Certainly, as I say, one of the things that is part of our consultation is to understand where it is we want to head. I mentioned in my opening remarks that we were looking at guidance and possibly regulatory changes if that is required to enable us to do this. I would say t