Evidence of meeting #63 for Health in the 44th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was implants.
A recording is available from Parliament.
11:45 a.m.
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
Mr. Chair, that's a really long “no”.
Ms. Wu, you haven't done anything....
11:45 a.m.
Director, Acute and Ambulatory Care Information Services, Canadian Institute for Health Information
That's right.
11:45 a.m.
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
Forgive me, but this has been a private member's bill issue since 2004. You would think that at least somebody would have done an economic analysis on what this potentially could cost. I'll just leave that for you. We're going to write a report on this and essentially submit that.
In a media report in 2019, the then president of the Canadian Society of Plastic Surgeons said that the CSPS believed a tracking system for breast implants was needed.
I'll start with you, Mr. Boudreau. Do you think this is an issue? Do you think there are women who are suffering right now because of this issue? A simple yes or no is also....
11:45 a.m.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
We're certainly preoccupied by the health of Canadians and women with breast implants.
11:45 a.m.
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
I think that's yes. I'll go with yes.
Ms. Carter-Langford, do you think that this is an issue that women are facing?
11:45 a.m.
Chief Privacy and Security Officer, Canada Health Infoway
I don't know that I have sufficient expertise specifically in breast implant registries to comment on the relationship between a breast implant registry and the health of Canadians. There's no question that Canada Health Infoway is concerned about the health of women and Canadians generally.
11:45 a.m.
Conservative
11:45 a.m.
Director, Acute and Ambulatory Care Information Services, Canadian Institute for Health Information
I've heard from patients with lived experience, but a connection to a registry or other measures is to be determined.
11:45 a.m.
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
I'll go with yes from everyone, I guess.
I think that most people around this table agree that there are women suffering, and it's unfortunate that there's not something in place or hasn't been something in place. Regardless of the reasons within government, jurisdictionally or whatever, I think that, from a compassionate level, there are women who are suffering right now because of this, and we have been, I guess as a Parliament, bringing issues like this forward since 2004 to try to find some path forward.
When it comes to some of your opening comments, Mr. Boudreau, on the purpose of this being research-based or tracking-based—I think of patient safety notifications—both of those seem legitimate to me. I would think either of those, preferably both, would be sufficient reasons for this to be set up.
There is support from, obviously, the association. CSPS, as was said, back in 2019, indicated that this would be helpful. It seems that since 2018, Health Canada has embarked on a number of these reforms.
I'm curious as to your opinion first, Mr. Boudreau, on the fastest way to implement something like this. Is it to go right to the CSPS and say, like in the U.S., that they are responsible for this and that we will help with what we can, or is it going to the provinces? What is the best and fastest way to do this?
11:45 a.m.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
I'd like to make a clarification.
When the committee indicated here that we haven't done anything, that's not the case. We've been able to provide more information on the Health Canada website about the risks. We've been able to meet with the scientific advisory committee on women's health products and then make some clear updates, for instance, a data blog, on breast implants and on cancer. We were also able to provide work on the checklist for patients.
To this question that is also asked about what would be needed for us to implement a registry, we were able to discuss before all the complexities related to data sharing related to privacy of information, as well, that my colleagues also mentioned to the committee.
11:50 a.m.
Conservative
Matt Jeneroux Conservative Edmonton Riverbend, AB
There are a blog and a checklist, all this since 2004. I don't think it's necessarily Mr. Boudreau's fault, and I don't mean to take it out on you, Mr. Boudreau, but this has been going on for a long time, and the fact is that those are the only things that seem to have been done on this.
Kudos to Mr. Thériault for bringing this forward.
11:50 a.m.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
Mr. Chair, it's not only that. I could expand on it, but I was also instructed to give very short answers. If you'd like me to expand, I could also expand and provide more information—
11:50 a.m.
Liberal
The Chair Liberal Sean Casey
Mr. Jowhari can give you that opportunity.
Mr. Jowhari, you have the next five minutes.
11:50 a.m.
Liberal
Majid Jowhari Liberal Richmond Hill, ON
Thank you, Mr. Chair, and thank you to the witnesses.
Building on the same theme, we heard from Madam Wu the fact that we need to do so many foundational things before we start looking at the registry.
Then I heard from you, Mr. Boudreau, the fact there are two different purposes a registry could have. One is for research and the other one is for what is called track and trace, for recalls.
Then we heard from you, Madam Carter-Langford, the fact we need to make sure we look at the integration of all these data between the private practitioners and the patients, who hopefully will opt in so it will increase the numbers, and from the provinces that are gathering that information and sharing it.
It looks like between all three organizations, a lot of conversation and a lot of thought has gone into this, yet we haven't had any, let's say, real action taken on it.
When I look at the fact that we've only had one registry and that's for joint replacement.... I look at many other implants that we use, as human beings. I went through cataract surgery. I had a new lens put in my eye. It got recalled, so I had to go back and do another one. There was nothing from the government. I just got a call and my eyesight had started deteriorating.
Having said all of that as a background and with the fact that we really need a clear objective, why do those two objectives seem to be in so much conflict, as far as track and trace and research, that they can't join hands and start working on this registry for both purposes? What is so fundamentally different about those two that a single registry cannot handle it?
Any of you can comment on that.
11:50 a.m.
Director, Acute and Ambulatory Care Information Services, Canadian Institute for Health Information
I can go first.
I think a single registry with both purposes could happen. The fundamental question is around how the information and the data are going to flow. That requires a legislative and privacy review. That would also determine which organization can hold it.
The challenge between safety recall versus research.... Using CIHI as an example, CIHI as an organization can potentially host a registry focused on research and system performance reporting. We are not in the world of patient safety recalls, so depending—
11:50 a.m.
Liberal
11:50 a.m.
Director, Acute and Ambulatory Care Information Services, Canadian Institute for Health Information
Yes, that might be one option. I think determining the pathway of how this is going to be implemented, who can hold it and who can govern the registry would depend on the objectives.
11:50 a.m.
Liberal
Majid Jowhari Liberal Richmond Hill, ON
What's the barrier to those two objectives coming together and working across all those levels? At the end of the day, we live in Canada, so there should be some co-operation.
Go ahead.
11:50 a.m.
Chief Privacy and Security Officer, Canada Health Infoway
There is a fundamental legislative structure issue. The way our historical privacy legislation and the provinces have been built considers the delivery of health care—with one governance structure, one oversight and one set of permissions—and research and health system use entirely separately.
We see some really great work in progress at the provincial level to recognize that we're looking at our legislative structures the wrong way. It needs to be from the patient outward. Right now, with the way our health system privacy legislation is structured, it's not built to enable that. It's built to treat those two functions not as a continuum, but as two very separate activities. That's why you'll see, as Juliana described, registries in research in one area very separate and segregated from clinical use, like track and trace.
11:50 a.m.
Liberal
Majid Jowhari Liberal Richmond Hill, ON
Mr. Boudreau, you were talking about some of the jurisdictions and said you'd had an opportunity to explore and get their feedback. You talked about how the jurisdictions that were successful were successful because they had a single patient registry.
If I understood you correctly, that means all the health information of an individual is carried in that record, whether it's for medical, for implant or for anything else. Did I understand you right?
11:55 a.m.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
Maybe I can clarify.
In the U.K., the approach that has been taken is one where there is centralized patient information. There is one file for an individual, as opposed to having this decentralized, as it is here in Canada. It's easier in that context when it comes to implementing a registry and ensuring data sharing, because it's all coming from one source, as opposed to here in Canada where we have a decentralized health care system, with each province having authority over patient information.
Within a province, there is also the complexity or the notion around private clinics versus hospitals. This is another area. For instance, some provinces might actually have to look into regulation or legislation to even have access to private clinic information.
That comes back to the complexity we were talking about. If we were looking into implementing a registry for patient notification purposes in Canada, these would need to be addressed.
11:55 a.m.
Liberal
The Chair Liberal Sean Casey
Thank you, Mr. Boudreau.
Mr. Thériault, you have two and a half minutes.
11:55 a.m.
Bloc
Luc Thériault Bloc Montcalm, QC
Thank you, Mr. Chair.
Mr. Boudreau, earlier you talked about recalls and, when I listen to you, I get the impression that you are more responsible for the devices than for the health of patients.
You tell me that currently we don't have the data we need, but 85% of procedures are done in private settings and only 15% of procedures, those in hospitals, must be reported. So you're saying that, as a Canadian, you can't see the basis for the U.S. Food and Drug Administration, or FDA, statement on September 8, 2021, that all types of implants, whether they're filled with saline or silicone, and whether they have a smooth or textured surface, cause cancer. You say you don't know, but you are only collecting data from 15% of the settings that do procedures.
Don't you find that's not very reassuring for women? Do you really think a woman who wants to get implants for reconstruction and has dealt with cancer would have a substantive objection to participating in a registry?
11:55 a.m.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
I'm not in a position to say what patients think. What I can say is that we also have a subscription system in place so women can receive alerts and information about recalls. The system also gives them information about our data blog, as well as any new or increased risks relating to breast implants.