Public Accounts Committee on March 29th, 2012

[Gerry Byrne, Liberal, Humber—St. Barbe—Baie Verte, NL]

Will that be okay? Will we be able to get in a full—?

[The Chair, NDP, David Christopherson]

You won't get a whole round, if you do five, no. You would get a minute each, if you're going to do the whole thing.

I'll throw this out, colleagues. If we were to cut it at the end of Mr. Byrne's normal rotation, that would have given the government two more questions, the official opposition two more questions, and Mr. Byrne would still get his chance to have the floor.

Are you open to that? We'll truncate the time. We'll make it, say, three minutes. That would mean there would be six more speakers.

[Andrew Saxton, Conservative, North Vancouver, BC]

Why don't we say it's four more speakers, two from the government and one from each of the opposition parties—four more questions? Maybe we'll finish early.

[The Chair, NDP, David Christopherson]

Let's not be kids in the parking lot and spend more time on the rules than playing the game.

[Malcolm Allen, NDP, Welland, ON]

I think Mr. Byrne wants an opportunity to speak. As the official opposition, I'm happy to accept Mr. Saxton's suggestion.

[The Chair, NDP, David Christopherson]

Do you mean one each?

[Malcolm Allen, NDP, Welland, ON]

Yes, that's one each.

[The Chair, NDP, David Christopherson]

Are you saying one each for the whole time, five minutes?

[Malcolm Allen, NDP, Welland, ON]

It would be ten, five, and five.

[The Chair, NDP, David Christopherson]

Okay, so it would be five minutes each, and I reserve the right to make a couple of comments at the end.

You have the floor.

[Andrew Saxton, Conservative, North Vancouver, BC]

Thank you, Mr. Chair.

Health Canada has the duty and legal responsibility to ensure the safety of pharmaceutical drugs on the Canadian market, and we know that rigorous tests are done before a drug is approved for use in Canada. But the responsibility does not end there. There is also a need to continue monitoring drugs once they are on the market. Indeed, should safety concerns be identified once a drug is available to the public, the need for a quick response is essential to ensure that as few people as possible are exposed to health or safety risks.

Can you explain what steps are being taken to ensure the safety of Canadians in this regard?

[Glenda Yeates]

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 approval stage, through the drug approval stage, and then in the post-market stage, that we are looking at safety at every step. We post, as my colleague mentioned, the product information on the web so that individual practitioners and Canadians can see it. We post advisories, wherever we have concerns. We have mechanisms to determine which signals might be ones we should be prioritizing.

I'll turn to my colleagues for a more complete answer.

[Paul Glover]

Once a product is on the market, adverse events are the most important signal for us. We follow those up very actively. To provide the committee with some specific numbers, there were over 30,000 domestic adverse events reported to Health Canada in the last year—that is in addition to more than 300,000 international adverse events. We pool that together, we look for common safety signals, and we investigate those.

Out of those several hundred thousand safety signals and events that were reported to us, we narrow the focus down. In the last year, it was about 1,600 particular investigations that we did. That further narrows down to about 125 specific events that we felt were really worthy of further investigation.

Of those, there were between 60 and 90 risk communications, and that could be a label update, it could be a warning to the public, or it could be a withdrawal of a drug. There's a range of things in those activities. It's a case of constantly going from large volumes of data down to something very specific.

Just to respond to one of the questions earlier, for which we ran out of time, we would acknowledge that in those areas of the report card, which was mentioned by one of the members, we were not meeting performance targets. With the new fees, with the new changes in processes, we're pleased to report that we are meeting our performance targets on post-market surveillance and safety. The signals are being assessed in the timeframes that we have, they're being assigned, and the investigations are concluding.

We're very pleased that not only have we set those performance standards, but we are now able to meet them and to deal with sifting through those large amounts of data.

[Andrew Saxton, Conservative, North Vancouver, BC]

Most of that information comes from the drug companies themselves. They supply you with that information. Is that right?

[Paul Glover]

The drug companies supply us with adverse events from other jurisdictions. They also supply us with adverse events reported to them. We also take adverse events from physicians directly—there is a form that they fill out—and from individual patients themselves.

So we get it from the health community, from those receiving the drugs, the drug companies, and international colleagues. We try to make sure that we get adverse event reports from as many sources as possible.

[Andrew Saxton, Conservative, North Vancouver, BC]

Thank you.

[The Chair, NDP, David Christopherson]

Thank you.

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

Does he have one tiny second left of his time?

[The Chair, NDP, David Christopherson]

He has more than a tiny second. You're welcome to it, if you'd like.

[Andrew Saxton, Conservative, North Vancouver, BC]

I'd be happy to share it with my colleague.

[The Chair, NDP, David Christopherson]

I think that was her inference.

The clock is going. Talk.

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

This is so silly. We're in the parking lot again.

Are all of those adverse reports that we were talking about earlier put on the website?

[Paul Glover]

That goes back to the MedEffect and the Canadian adverse event reporting newsletter. We have several thousand people who subscribe to it.

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

So it could go on your website. It doesn't—

[Paul Glover]

It is on it.