Public Accounts Committee on March 29th, 2012

[Joyce Bateman, Conservative, Winnipeg South Centre, MB]

Oh, it is on your website.

So that link that we're all going to get has that information? Joe Q. Public can access that information?

[Paul Glover]

Yes. We don't post those hundreds of thousands of adverse events. We sift through that information to what the real events are—what the things are that we've followed up on.

[Joyce Bateman, Conservative, Winnipeg South Centre, MB]

Why don't you post the hundreds of thousands of adverse events? If I were putting my child on medication and I knew that there were hundreds of thousands of adverse events, I would want you posting them.

[Paul Glover]

What we post is the specific summaries of those, as we've investigated them. Otherwise, you're swimming in a sea of data, with hundreds of thousands year after year.

[Joyce Bateman, Conservative, Winnipeg South Centre, MB]

Fair enough; but you utilize all this information.

[Paul Glover]

Yes, and that is what is summarized in the adverse event newsletters, warnings to health professionals, etc.

[Joyce Bateman, Conservative, Winnipeg South Centre, MB]

Is your newsletter available by a link as well?

[Paul Glover]

Yes.

[Joyce Bateman, Conservative, Winnipeg South Centre, MB]

From this link that we're going to get, we could get not only the summary piece, but the newsletter as well?

[Paul Glover]

We'll provide several links. We'll provide a link to all of the drugs that are available for sale in Canada. We'll also provide a link to our adverse events, the MedEffect, and Canadian adverse reaction newsletter. So you will have both those, all drugs and all adverse events, and health and safety updates.

[Joyce Bateman, Conservative, Winnipeg South Centre, MB]

And we can share this with the public?

[Paul Glover]

It is already shared with the public.

[Joyce Bateman, Conservative, Winnipeg South Centre, MB]

Excellent.

Thank you so much.

[The Chair, NDP, David Christopherson]

There you go.

You're very welcome.

Moving on over to Madam Blanchette-Lamothe. You have the floor.

[Lysane Blanchette-Lamothe, NDP, Pierrefonds—Dollard, QC]

Thank you very much.

I have a question for Ms. Yeates, because I would like a clearer answer.

The report states that Health Canada sometimes takes more than two years to identify safety-related issues. I would like to know if you think that it would be relevant to increase the efficiency of the process even further, to reduce the time frames for identifying safety-related issues.

[Glenda Yeates]

Thank you.

It's a very important question. What we would try to reassure the committee and to communicate to the committee is that when we are trying to assess the time between getting some piece of information and putting out a communication.... If we assess this to be a real and serious signal that affects the health of Canadians, obviously two years will be far too long. We don't wait. Those are prioritized and those are done immediately.

There are some signals where we would say more information needs to be gathered. We would take the time to make sure that we are confident the advice we would be giving to Canadians is, in fact, the right advice. We would say that the standard operating procedures—the clarification, which the Auditor General suggested, that we are very clear about how we prioritize that work, and set ourselves timelines.... We are meeting those timelines, as my colleague mentioned, and these signals are so unlike each other that one timeline in a sense wouldn't be appropriate for all of them. What's important is that they are done in the priority that reflects their seriousness. So for some, 24 hours would be the right timeline, and for others much longer, and different mechanisms and tools would be used.

We are comfortable that we are addressing those in a timely way, and that's, I think, the prioritization that my colleague was flagging. We always want to be making sure that we are doing a better job, though, and that's why we look to these system improvements, these process improvements, and these procedures to help us ensure that we are always catching the important ones early and that we are, in fact, setting timelines for all of them. I think that's the spirit of the way in which we're looking at this.

[Lysane Blanchette-Lamothe, NDP, Pierrefonds—Dollard, QC]

Thank you, Ms. Yeates.

I have another question for you.

You still have a lot of challenges to overcome. I am aware that you are doing everything you can to improve your services, with the resources available to you. Could other resources be made available to you to help you respond to all these challenges you will face in the coming months?

[Glenda Yeates]

I think we are at the moment. Because of the significant increase in resources that's come to us at this time through the user fee proposal, we are busily staffing up, in a sense, to those levels. So at this time I think we're feeling that we are simply trying to work through that process of getting the new reviewers and the new inspectors, getting everyone trained up, getting our computer systems updated in some cases. We are working with that, and at this point, managing the complexity of this change is really the focus of our efforts.

[Lysane Blanchette-Lamothe, NDP, Pierrefonds—Dollard, QC]

Thank you.

Mr. Maxwell, I'll give you the opportunity to wrap up. Based on what you have heard today and the action plans that are being implemented, would you like to add anything with respect to your audit and your positions?

[Neil Maxwell]

Yes, thank you. You read my mind.

I was hoping someone might ask that question. I have maybe three quick points, being conscious of time. I'll speak in English, since I can speak more quickly.

Concerning the two years it has taken, I listened with interest and I'm encouraged by the fact that the department is now meeting its timelines. But I would emphasize that it is a multi-step process, and there are timelines only for certain parts. So that's improvement, but we found—and it was a large number—almost 50% of the cases took more than two years, when they had to go from evaluation through to the actual communication to the medical professionals and Canadians. We found things such as breakdowns in communication between the different sections, between the people dealing with brand name and generic.

We found as well that quite often there were delays because it was easier to batch a number of label changes, if there were a number of different generics. So I think there are more structural things that will also need to be looked at with regard to that.

I have two other quick points. There's been a lot of discussion on clinical trials today, and a lot of encouraging action. Auditors always reserve judgment until they can go back and re-audit, but encouraging indeed.

The one thing that I think remains the largest gap is the question of the availability of information on specific clinical trials. As we sit here now, you could find many of those clinical trials by going to the FDA site or the European Medicines Agency. So I'm encouraged by the actions that Health Canada's taking, but a gap still exists today in terms of the information Canadians have.

Maybe I'll stop there.

[The Chair, NDP, David Christopherson]

That's fine, and that exhausts our time.

Thank you very much, Madame and Monsieur.

We'll now go to Mr. Byrne.

[An hon. member]

No. Chair....

[The Chair, NDP, David Christopherson]

The final thing I said was one from each. One, two, three.

[Some hon. members]

No. Two and two....

[The Chair, NDP, David Christopherson]

You're both going to go with two then? That's not what I said, but if that's your understanding, that's more important. So go ahead then....

That's fine. I stand corrected.

Mr. Kramp, then over to Mr. Byrne.