Health Committee on Nov. 21st, 2006

[Dr. Supriya Sharma]

Okay.

Second of all, in terms of the special access program, the special access program is very much an exception program. The reason we prefer to have products that have gone through the rigorous review is that we do have the ability to put conditions on them in terms of the licensure to be able to regulate them. For the special access program, there's limited monitoring because it's an exception program. But as a result of the special access program, we have not received any complaint reports submitted from the cohort of patients who have been examined.

In terms of the comparison, the comparison was not being made between risks associated with aspirin and risks associated with breast implants. What I'm saying is that something on a very low level of risk, such as an aspirin, still carries risk, as well as something on a high level of risk.

This is a surgically implanted device. There are risks to surgery. There are risks to putting a foreign body into your body. We know the risk. We've studied the risk. We've informed people of the risk. We've labelled the products. We've done an intensive review. So what I'm saying is that everything we do has a certain amount of risk associated with it, and we have to consider both the risks and benefits of anything we do in terms of our health care.

What we're doing is saying that these devices have passed the bar in terms of safety, effectiveness, and quality, and just to remind everyone again, that's mandated by the Food and Drugs Act and regulations, the medical devices regulations, put in place by Parliament, which forms the basis of our regulatory decisions. They've made that submission. Those submissions have been reviewed and they've met those criteria.

To continue to meet those criteria, there are conditions that are put on their sale. But all medical devices have risks associated with them. They are not 100% safe, they are not 100% effective, and we need to continue to monitor them. We need to know about the risks. We need to know about the benefits. Practitioners need to inform their patients. Patients need to inform themselves, and people need to make educated, informed decisions about their health.

[The Chair, Conservative, Rob Merrifield]

Just as a correction--and correct me if I'm wrong--I understand that the regulations are not set by Parliament; they're set by the department. Is that accurate?

[Dr. Supriya Sharma]

Well, they're passed in Parliament.

[The Chair, Conservative, Rob Merrifield]

The research team are saying they're not passed in Parliament, they're set by the department. I'm not sure. I'm not going to debate it.

Maybe just for the committee, from our research team, we'll allow this.

[Nancy Miller Chenier, Committee Researcher]

I'd like to go on the record on this, because you have scolded the committee a couple of times.

The Food and Drugs Act is a piece of legislation that was passed by Parliament. The regulations are gazetted through a special gazetting process that Parliament sees as any member of the public would see. The only regulations that the health committee sees are the tobacco regulations and the assisted human reproduction regulations.

[Dr. Supriya Sharma]

Right. I was referring to the Food and Drugs Act, and the act is actually an act of Parliament, right?

[Nancy Miller Chenier]

Just drop the regulations part of it.

[The Chair, Conservative, Rob Merrifield]

The act we see; the regulations we don't. Fair enough. That's just for the information of the committee.

Ms. Dhalla.

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

I just want to build upon something that you were saying at the end, about the responsibility for physicians to be able to educate their patients and for patients to make an informed decision. In your particular decision that has been made by Health Canada, what types of initiatives or steps have you taken to ensure that patients do receive the right information? Building, I think, upon what Mr. Batters was saying earlier on, what type of educational tools and resources are going to be provided to these women to make an informed choice?

I know you talked a number of times, both in your report and in your discussion, about there being a mandatory reporting requirement. But from everything that you've told the committee, it's the manufacturers that are required to report adverse reactions. First, there are no restrictions on patients reporting those reactions to their surgeons or physicians; and second, there is no mechanism there for the surgeons and physicians to actually go out and report those to the manufacturer. So if a woman out there is experiencing an adverse reaction, the manufacturer may never, ever know about it, and the physician and surgeon may be very hesitant, as this is their bread and butter, to go out and actually report that.

So I would like to know what initiatives Health Canada has taken, in light of all the information available, over a period of four years, to ensure that women in Canada are going to be able to make an informed choice?

[Dr. Supriya Sharma]

In terms of the informed consent process, the process by which a physician or a practitioner actually exchanges information to make those decisions, that's regulated at the provincial and territorial level. So the actions of the physicians are actually governed by the Colleges of Physicians and Surgeons--

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

I know that, but what has Health Canada done?

[Dr. Supriya Sharma]

So that's that.

So the role of Health Canada is to provide information to inform that decision, and it's done in a number of ways. I mentioned the “It's Your Health” document, which is written in lay language, and the background on the file in terms of all the decisions that have gone up into this point on the file. The decisions are actually posted publicly. So for each breast implant that has been licensed, there's a summary basis of decisions that summarizes all the information that went into the review, and that's actually listed on the website for every single product.

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

Not everyone has a computer, and not everyone is literate in medical language to be able to actually disseminate the information. So has there been any initiative by Health Canada to make a--

[Dr. Supriya Sharma]

I'm getting to that.

Just to go back to before I was interrupted, all that information is there. In addition, what's also there is all the patient labelling and all the patient information that goes along with the product. The patient labelling and decision aids are included. There are actually booklets that go to the patients, which they can go through and which have all the questions for them to ask themselves. There are also questions provided that you can ask the surgeons: How many surgeries have they performed? What are the side effects? What are the adverse events? There's a whole decision-making aid that goes along with the product for the patient. Then there's information for the practitioner to be able to make this decision.

All that information is mandated. It's part of the patient labelling. It's been reviewed. It was part of the rigorous review. It's available not only publicly on the website, but with the product. If anybody writes in at any point in time to Health Canada and says they don't have a computer, we copy it all off and send it out to them. We've made all of that information available.

All that information is just part of the information that's out there. There's a wealth of information out on breast implants, from a variety of different sources, with a variety of different opinions. It is then up to the patient and the practitioner to sit down and go through the information. All patients and all practitioners view risks and benefits in different ways. So you really have to cater that discussion to the person you have in front of you.

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

Can you just, for the sake of this committee, submit that information, those tools that are made available to patients, please?

[Dr. Supriya Sharma]

Actually, they've already been submitted. As part of the notice that went out to parliamentarians, there was a package that went out when we made the decision. It identified all of the links. Those links have also been provided to the committee, so the committee actually has all that information.

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

I actually never received it. So if you can forward it to the committee, that would be great.

[The Chair, Conservative, Rob Merrifield]

I just want to remind the committee that we have a considerable amount of business to do. We had scheduled the first hour for this. There is limited time. But I see a couple of hands going up now. We'll allow that.

Madam Gagnon, did your hand go up?

[Christiane Gagnon, Bloc, Québec, QC]

I just wanted to say that Ms. Sharma is talking too fast and that the interpreters are having a hard time following her. She should slow down.

[The Chair, Conservative, Rob Merrifield]

Okay, thank you.

Ms. Priddy, do you have a quick question?

[Penny Priddy, NDP, Surrey North, BC]

Yes, thank you. I wasn't sure if we were going in order. It seemed as though we were just all of a sudden asking.

[The Chair, Conservative, Rob Merrifield]

No, I was hoping to start it.

[Penny Priddy, NDP, Surrey North, BC]

I was trying to be polite. So much for that.

I just have a comment that if we'd had at some stage an agreement to have a national breast implant registry, a number of the questions we are dealing with today would have been dealt with in a national registry, and though some of our discussion today would still have been necessary, some of it would not have been. So at some stage, I expect that I and others I work with will still go back to the national registry, because it gets at a number of the issues around reporting, confidentiality, and our ability to see a trend when there's something happening, without necessarily relying on a manufacturer or a physician who may--I say “may”--have a vested interest.

Thank you.

[Dr. Supriya Sharma]

Just to address the implantation registry, it's something that we did consider in the review. Specifically, the panel recommended that Health Canada consult with the Canadian Institute for Health Information on the subject of a registry. We did that. We actually went back to CIHI because they're the national experts in terms of data collection and database and registries, and they went through all the information that we have with breast implants. Their opinion--and we actually have that in writing--would be that a national registry would not be the best way to follow these patients.

There were a number of different reasons that they actually signified that it wasn't. One was that for a registry you actually a priori usually identify the events that you're looking for, and that for a registry to work we would have to mandate reporting. As an interesting point, the U.K. breast implant registry was operable for a number of years. They closed it down for two reasons. One was that they didn't actually get a very high level of participation, and the second was that they didn't actually get any meaningful clinical data out of the registry.

So we did consult with CIHI on the issue, and they went through all of the reasons why it wouldn't be the best way to monitor the patients, which is why then we began to think of what would be the best way to monitor these patients. What conditions could we put on? The way we structured the clinical trials not only met the outcomes of what people were looking for in a registry, but it surpassed them.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

I'm a little reluctant to do this, but Ms. Bennett has asked for a very quick question. I've got to see this, so we'll try.