Evidence of meeting #36 for Health in the 39th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was fasd.
A recording is available from Parliament.
Associate Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
When we're talking about immediate, the side effects that actually happen in the first six months to a year, most of them are actually self-limiting and don't require additional surgeries in terms of the numbers we're seeing.
Liberal
Susan Kadis Liberal Thornhill, ON
Okay. So I'm assuming that fundamentally it is erring on the side of caution.
Thank you, Mr. Chair.
Conservative
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
Thanks very much, Mr. Chairman.
I have a couple of other quick questions. We've talked quite a bit about the tracking and the surveillance and so on. What happens if new information surfaces showing that there are new problems. What happens then? What is the process that's in place? And what happens if a manufacturer doesn't comply with the licensing?
Assistant Deputy Minister, Health Products and Food Branch, Department of Health
I can start on that one, Member.
When new information becomes available, we assess its significance in terms of what action we might want to take. We have various levels of action. They stem from providing an information update on a product, perhaps a change in the label in terms of the use, to issuing an advisory of some kind--warnings or removal of the product. We have that entire continuum of actions available to us, depending on the nature of the information. In this case we have the large-scale follow-up study. That's going to be a very important source of information, one way or the other. That's basically how we would assess things from the information that comes to us.
Sorry, once again I forgot the second part of your question.
Conservative
Assistant Deputy Minister, Health Products and Food Branch, Department of Health
It would depend on how serious that is. We always retain the authority to remove a product licence. That would be the ultimate action we would take. There are many steps before that. At the end of the day, that option is available to us if we're not satisfied that we are getting the kind of compliance we feel is needed.
We should say that in the case of these applications we had very good cooperation from the companies involved.
Associate Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
I have maybe one additional point.
This was a licence with conditions. Those conditions must be fulfilled within a year of licensure. If those conditions are not fulfilled, then the licence will be suspended for these products.
Conservative
Patricia Davidson Conservative Sarnia—Lambton, ON
Are the conditions an ongoing thing, or do they meet them once? How does that work?
Associate Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
The conditions placed on it are from a year perspective. But these conditions actually continue to provide information for a longer period of time, so they're basically renewed on a yearly basis.
Conservative
Bloc
Christiane Gagnon Bloc Québec, QC
I am listening to answers given to questions, and it seems to me that you are dealing with this issue in a very reckless manner.
For example, when you talked about the risk, you said that it is a fact that there is always some risk involved in any surgery. It seems to me that you are playing down the risk in this issue of breast implants. Even if there is only one or two persons who die because of this, it still remains that two persons have died because of a punctured breast implant.
How many victims would you need for Health Canada to withdraw some implants from the market? One, two, three or one thousand? A physician said that out of 1,000 persons, 50% had either suffered a punctured implant after 10 years or that some harm had been caused to women. How far will it have to go before Health Canada show some courage and withdraw some licences from the market?
Assistant Deputy Minister, Health Products and Food Branch, Department of Health
Member, I think that's actually unanswerable. I don't think there is a particular number. We would have to assess the information. We would have to assess the cause and effect. Often it's difficult to establish the cause and effect with adverse event reports. That's just the complexity, I think, of what we're dealing with.
Clearly if we felt there was a clear causal relationship and it was serious, then we would remove the product. That's what we do now.
Bloc
Christiane Gagnon Bloc Québec, QC
What I understood is that physicians in the different provinces will have the responsibility, together with their patients, to ascertain to what degree the patients have fully understood what they were getting into. In case of a punctured implant, who is responsible for compensating the patients? For example, if a patient is suing her physician, what is the responsibility of Health Canada who authorized the marketing of an implant that was questionable in terms of its safety for women?
Assistant Deputy Minister, Health Products and Food Branch, Department of Health
That, I guess, would remain for the courts to determine. As you may know, Health Canada is from time to time involved in lawsuits in and around products, and we may be taken to court on our regulatory action. We're named as a party in various suits.
In the situation you described, it sounded to me like you may have an issue of malpractice by a physician, potentially. But of course these are always controversial.
And there could be issues in and around the role we've played as a regulator, and those cases do occur from time to time. But again, that's really the nature of the business we're in. There are thousands and thousands of products that we review and approve--some 50,000 medical devices or so, 20,000 pharmaceuticals, and 40,000 natural health products. We have a very broad scope of responsibility, and these risks are out there. But we take our role in taking responsibility for the review process extremely seriously. In this case, yes, we are satisfied that the conditions for quality, effectiveness, and safety have been met. That may change in the future if new information becomes available, as it might for any product that we oversee and regulate.
Conservative
The Chair Conservative Rob Merrifield
Okay, thank you very much.
Just on that, for the information of the committee, when an individual or client decides to use the silicone gel-filled breast implant, does she have to actually sign off that she knows it's only adequate for seven to ten years and that the risks are there?
For every procedure we do, we know that there are some risks. I think we all understand that. My concern, particularly, is whether the patient understands the risk and is totally aware of it. How are we addressing that?
Assistant Deputy Minister, Health Products and Food Branch, Department of Health
Well, our part of that has been to ensure that in the material that's provided with the product, there are decision aids and so on so that the patient and the physician have the material available that clearly outlines the risks and benefits. What the physician and the patient actually do is up to them. That's not something we regulate. That is the practice of medicine.
If somebody is having surgery, I think that basically, yes, they are required to sign a consent for surgery, but that is not something we oversee in Health Canada. That would be up to the hospital, the surgeon, and so on.
Conservative
The Chair Conservative Rob Merrifield
But with the controversy around this one, and the potential for liability--I know we talked about it, and they're all hypothetical--you'd think it would be an easy thing to do as a government. We're there to regulate, to make sure that the individual, whoever is going to accept the risk--and that's what we're asking a person to do--is aware of the risk before having the procedure. It just seems to me that it would be a very easy thing to do. I just wondered why we wouldn't have put that in.
Assistant Deputy Minister, Health Products and Food Branch, Department of Health
I think, very fundamentally, it's because we feel that this is not the role of the Government of Canada. That really is the practice of medicine, and that's up to the colleges of medicine and the physicians and so on.
As I say, we approve tens of thousands of products, and to me, it's a slippery slope in terms of seeking consent for that array of products. There are many products with risks attached to them, many pharmaceuticals, for example. So it's not something I think we could do for a single device, Chair.
Conservative
The Chair Conservative Rob Merrifield
Yes, we're seeing the same problem with pharmaceuticals and so on. That's fine. It's not for us to debate it. I just asked the question as to why we wouldn't have considered it. I'm not sure I'm satisfied with the answer, but I have your answer.
Seeing no other questions, I want to thank you very much for coming in and presenting again to us. We appreciate the opportunity to have input on this issue. It's very important for many people in Canada, so thank you very much.
And thank you to the committee for their good questions.
With that, I will call the meeting adjourned.