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.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
We consider the marketing history of medical devices and how and where they were regulated by other trusted regulators. This would be part of the premarket scientific evaluation, these considerations.
Conservative
Ziad Aboultaif Conservative Edmonton Manning, AB
In the integration of making sure that the whole process is safe, it takes the industry, the department, Health Canada in general and the provinces, plus the practitioners. Where do you see the problem that is standing in the way of making sure we have a registry that is going to really solve the problem, as other countries have done?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
Well, we've touched on a number of challenges that we've been facing in Canada, should we be looking into implementing a registry for breast implants. They include data sharing, the privacy of data, identifying the purpose of this registry, and also identifying the federal institution that would be best placed for implementing and maintaining a registry like this one.
Conservative
Ziad Aboultaif Conservative Edmonton Manning, AB
This is a direct question.
If I'm listening today to all of this conversation and testimony, I would conclude that the industry is the problem, as far as standing in the way of making sure that we have a registry is concerned.
Is my conclusion correct? Do you think there is any truth to that?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
I can't really speak to the industry, but I don't think this is the case. In the context of previous conversations, I don't recall industry suggesting that a registry should not be implemented.
Liberal
The Chair Liberal Sean Casey
Thank you, Mr. Boudreau.
The last round of questions for this panel will come from Dr. Hanley for the next five minutes.
Liberal
Brendan Hanley Liberal Yukon, YT
Thank you, Chair, and thanks to the witnesses, all three of you, for appearing.
Looking at Mr. Thériault's original motion for this study, there are two parts. First is to look at the improvements that have been put in place since tightening Health Canada's rules. You've touched on some of those. Second is to look at the feasibility of establishing a central breast registry. I think both parts of this motion are important. We want to keep the focus on what the problem is that we are trying to solve and whether the solution is the registry or something else.
The key question is whether a registry could effectively add to our capacity to monitor and respond to safety issues around breast implants, if not other medical devices. I see the answer to that question is not straightforward due to the many limitations that you have brought forward.
I want to go back to the first part, mandatory reporting by hospitals and post-marketing surveillance.
Mr. Boudreau, can you give a brief overview on how much difference these provisions have made? Recognizing that we don't know what we don't know, is there a sense that the safety signal reporting has improved, that there's more exchange, that we're comparable to other nations with a registry? I'm sure this would have been the subject of the best brains exchange that you referred to. Maybe you could give me a sense of that.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
Yes. The system we have in place, I would say, is robust enough for the department to conduct risk assessments based on the information we're receiving through medical device incident reporting. Manufacturers are mandated to do this, and hospitals are as well. Not only are the manufacturers mandated to do this, but there are also conditions imposed on their licence, whereby they need to report on cases of breast implant cancer.
With all of this information, I believe the department is really in a position to conduct risk assessments. I would say this is highly comparable to other regulators in the world.
Liberal
Brendan Hanley Liberal Yukon, YT
Thank you.
Can you comment on the Health Canada email system? There's a notification system. How does that add to the effectiveness of the system?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
If we're talking about the subscription approach, basically, in this context, Canadians can subscribe to receive emails or notifications about changes to web pages and recalls related to breast implants, as well as changes to our data blog on breast implant cancer. It's a mechanism for receiving targeted information on breast implants and the risk profile of breast implants.
Liberal
Brendan Hanley Liberal Yukon, YT
What would be the subscription rate? Do you know? What's the sign-up compared to the denominator?
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
I could get back to the committee with this information.
Liberal
Brendan Hanley Liberal Yukon, YT
Thank you.
I want to turn to the foundational changes. I think, Ms. Carter-Langford, you referred to that.
This ties in very much with many of our studies, particularly our workforce crisis study and also recent budget commitments on modernizing our health care data system. Clearly, there's a lot of work to do.
I wonder if you could talk about some of the key steps and challenges, both in improving patient accessibility to their own medical information and in the exchangeability, the data-sharing mechanisms, either within a jurisdiction, within a region or, for that matter, across the country.
Chief Privacy and Security Officer, Canada Health Infoway
Thank you very much.
In Canada we've made a tremendous amount of progress in making sure that the tools used at the bedside directly with the patient are predominantly electronic. We've done a great job of getting that foundational layer of digital health information.
As you rightly note, we are at the point of starting to make those connections. There is a fair bit of practical work that can be done to ensure that, regardless of what system is being used in a physician's or a surgeon's office, the data is being codified and standardized in a way that it can then be connected. Those connections and that standards-based work can occur across provinces or within provinces.
We believe that creating that standardization and facilitating that standardization between tools is a critical part of building that foundation.
Another piece, as I've noted, is modernizing some of the legislative structures and implementing practical processes to get that one-third of Canadians who have access to their health information electronically closer to 100 per cent, which we think would be beneficial.
Those are the two areas of focus. There is also, certainly, further legislation optimization work around interoperability that would enhance.... We have digital information across this country. We now need to make sure it's standardized and connected.
Thank you.
Liberal
The Chair Liberal Sean Casey
Thank you very much, Ms. Carter-Langford.
That concludes the rounds of questions. I want to thank our witnesses for being here with us today. It gives us a good foundation as we embark on this study, and some sense of the areas that we want to pursue in more depth with the panels yet to come.
Thanks for being with us, and thanks for the patient way in which you've responded to the questions.
Mr. Boudreau, you're signalling that you might have something you wish to add. Go ahead.
Director General, Medical Devices Directorate, Health Products and Food Branch, Department of Health
Yes, if possible, Mr. Chair, thank you.
I just want to mention something else to the committee. The only way a registry would be beneficial to Canadians would be if it got full participation from all the different players. That would include provinces, territories, health authorities, private clinics, patients and manufacturers. Basically, it would need to have full participation. If you don't have a high participation rate, the registry won't be useful for signal detection or research purposes. Only individuals who have registered would be able to provide information through traceability.
Liberal
The Chair Liberal Sean Casey
Thank you, Mr. Boudreau.
I think that's a good note for us to end on. It will be a discussion that we will undoubtedly have with the witnesses who come to future meetings.
Colleagues, we will suspend while we go in camera for committee business.
Thanks again to our witnesses. The meeting is suspended.
[Proceedings continue in camera]