Health Committee on Nov. 21st, 2006

[Carolyn Bennett, Liberal, St. Paul's, ON]

Just following up on Dr. Dhalla's question, the whole issue of informed consent, I think, is what people are concerned about. Do people actually know enough to give informed consent? Certainly I think the medical-legal community has been interested in maybe a new innovative, creative thing. Maybe this would be the perfect area to look at it, because it's so controversial.

There was a CD that showed you three patients who loved it and three patients who hated it. You had to have seen the CD in order to sign and say that you actually knew enough to give informed consent. This comes out of the highly litigious American milieu.

I wonder if the department would be interested in looking into maybe a special kind of informed consent for something that's been so controversial.

[Dr. Supriya Sharma]

In terms of sharing information, once we've done the licensing, part of the reason that we have the focus groups is to see if the information we've provided adequately reflects the risks. Does it meet the requirements? The last time these were on the market was back in the early 1990s. As you mentioned, times have changed since then. Really, the idea is what would be the best way to share that risk information.

When we're talking about things in terms of the CDs and sharing of consent, that primarily comes from the practice community. It's the same way as clinical practice guidelines come about. It doesn't usually come from a federal regulator because of the nature of informed consent. We have no authority over informed consent and we have no authority over the practice of medicine.

So I think it's an interesting concept. I think it's an innovative approach. It will be interesting to see what comes up from the focus groups, but it isn't something we would be able to put in in terms of a condition of licensure.

[The Chair, Conservative, Rob Merrifield]

Just for the committee's information, Ms. Dhalla wants to make a point quickly.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

On behalf of all committee members, I just want to clarify something for the sake of Dr. Sharma, Dr. Bell, and Health Canada.

You mentioned that when the decision was released, we received information and website links in regard to the educational materials provided to patients and provided in addition to what's within the package inserts. I believe the day the decision was released was a Friday. I just want to clarify for the committee that the information was not received on that particular day. The information was received yesterday at about 4:30, at which time our gracious clerk here forwarded us the information at 5:30.

[Dr. Supriya Sharma]

Actually, on the press release that went through, it went out with a link to the Health Canada website and the decision, and then on that—

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

We all received the decision, but the information with regard to the educational materials--

[Dr. Supriya Sharma]

All the educational materials were linked to that decision, so we went through it. It's still on the Health Canada website. If you go on the Health Canada website, there's a big icon that says “Licensing Decision: Silicone Breast Implants”, and all of the links are then provided. We provided the major link, and then all the links with all the information.

Just to give you an idea, we have the hard copies here just to show you, but when you print it out it's this much information that has been publicly available. So that original link was actually provided.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

Just out of curiosity—and I'll end here—are patients actually going to read that link with that information?

[The Chair, Conservative, Rob Merrifield]

Let's move on.

We have your information. We appreciate your coming. We've had a fairly fulsome debate, and now we're going to go to the motion.

Madame Demers.

[Nicole Demers, Bloc, Laval, QC]

I promised victims of complications due to breast implants that I would ask the following question:

These people would like to know if you and your Health Canada colleagues who participated in making this decision would be prepared to be test subjects. You would receive next-generation breast implants. For the purpose of advancing science, of course, we would be sure to find out everything there is to know about them. We would monitor you very closely.

Would you be prepared to do this in order to advance science?

[The Chair, Conservative, Rob Merrifield]

All right. The question was asked. Let's move on.

We want to thank you very much for coming and presenting before the committee again.

I thank the committee for their very good questions. They were very probing and informative. Now we'd like to move on.

Madame Demers, you have a notice of motion that you have presented to committee. It's on our agenda. We need an indication from you as to whether you want to proceed with that or not.

[Nicole Demers, Bloc, Laval, QC]

Mr. Chair, I wish to introduce my motion.

[The Chair, Conservative, Rob Merrifield]

Do you want to speak to it? I'll allow you to introduce it very quickly.

[Nicole Demers, Bloc, Laval, QC]

Mr. Chair, I think enough has been said about breast implants. I am sure you understand why I want to introduce my motion. I am still very offended by the way Health Canada dealt with this issue. We are talking about a level 4 medical device, which means very high risk.

Health Canada's role is to protect the health of Canadians and Quebeckers, not to expose them to risk by approving a product that has not yet been proven safe. We absolutely have to report this to the House of Commons and have a debate on this issue.

[The Chair, Conservative, Rob Merrifield]

On the floor, we have the motion that is before us. We have it introduced by Madame Demers. We'll open the floor for debate on the motion.

Mr. Fletcher.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

I shall let the Liberal—

[The Chair, Conservative, Rob Merrifield]

Okay. Well, we'll close down the debate. I don't see any other hands. It's to be concurred in the House, so if there's—

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Well, I have a few comments, then, Mr. Chair.

With the preamble of Madame Demers' comment, there is certainly a problem. To suggest that proper diligence has not occurred is not correct. Due diligence has occurred. We have seen that Health Canada has proceeded through all the appropriate rules and regulations as outlined in the act.

We've also heard that the cost of bringing forward all the material to the committee is $55.9 million. I actually asked the member to repeat that, because that is an astronomical sum of money—$55.9 million—and I believe the taxpayers of Canada would prefer that kind of money spent on real issues, real things that can definitely improve the quality of life of Canadians.

[Hedy Fry, Liberal, Vancouver Centre, BC]

On a point of order, please, Mr. Chair, this motion has already been passed and debated as a substantive motion by this committee, and it was adopted. We are now discussing whether this should go to the House—

[The Chair, Conservative, Rob Merrifield]

That's right.

[Hedy Fry, Liberal, Vancouver Centre, BC]

—so any debate should be about the propriety of taking it to the House and not about the substance of the motion anymore. It's already been passed.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

And that's a fair point, so we'd like to do a consenting report.

Can you explain it to us?

[The Chair, Conservative, Rob Merrifield]

Fair enough. You mean a dissenting report.

So I think we're ready for the question.

Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

I only want to ask a question about what the parliamentary secretary just said.

What will cost $55 million? Translating all of those reports?

[The Chair, Conservative, Rob Merrifield]

No, I believe that question was asked to Ms. Sharma, and she said the documentation that was encompassed in this first motion would cost $55.9 million--to get the consent and the information. I believe that's what she said.