Evidence of meeting #17 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drug.
A recording is available from Parliament.
Conservative
Conservative
David Tilson Conservative Dufferin—Caledon, ON
Everybody.
And then you get into issues of privacy. Let's say you have other people do it other than government. Are there issues of privacy? I don't know. And finally, does anyone have a vague idea of what this is all going to cost?
Let's start with the Professor.
Associate Professor, Faculty of Pharmacy, Université de Montréal
There's a difference between who should do it and who should pay for it. Actually, what we've seen things evolving into is that regulatory authorities set up departments of risk management where they negotiate the plan with the companies very early on and then they agree that such a study needs to be done.
There has to be monitoring of how the study is done because we have to ensure that high-quality data will be generated. What we've seen and what could be very applicable in Canada is to create a network of centres for excellence in, for example, pharmaco-epidemiology or observational studies. I think this is already on the map. Certainly the studies could be conducted through that network and funded by the companies, and we've seen that this model is actually taking place in both the U.S. and the EU.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
Professor, you've looked at this issue, I gather, in other countries. Do you have any idea what such a process would cost Health Canada? I assume you're going to say “Well, the government should pay for it all”.
Associate Professor, Faculty of Pharmacy, Université de Montréal
Actually, no. That's the thing. Now the model is such that in the U.S. they're thinking about a user fee to evaluate the plans just to administer departments of risk management within regulatory authorities, but the individual studies are paid for by the industry as part of their commitments. Otherwise the drug approval is denied.
Conservative
David Tilson Conservative Dufferin—Caledon, ON
How do we know industry is going to report things? Right now the industry reports. They're the only ones, and I think we're talking about the hospitals joining in, but there's no obligation for the doctors to do it or the pharmacists to do it. So how do we know? Let's say some doctor fills out a report and sends it off. How do we know it goes anywhere?
Associate Professor, Faculty of Pharmacy, Université de Montréal
But this is the current system—the passive pharmaco-vigilance.
What we're evolving into is not to rely only on the passive, spontaneous reporting, but to introduce new tools, like registries, epidemiologic studies, database studies, active surveillance, prescription event monitoring. All these activities do not rely on spontaneous reporting.
Conservative
Chair of the Board, Cancer Advocacy Coalition of Canada
In terms of the cost, I'm not in that field, but I would think that the cost should not be that great. If you take the example of one computer screen to put this information into and then the information is all collected electronically, it's really setting up the program that would be the major cost. I would have no idea, but I think the analysis in the end, particularly in cancer drugs, could be taken up by the National Institute of Cancer and academic organizations like that.
It's making the data available. There will be an upfront cost in organizing the electronics, but once that's there.... As I said in my presentation, if you ask physicians like me and my colleagues to fill in 18 pages, forget it, it just won't happen. The technology is there to collect this data, and I think very inexpensively.
Vice-President, Institute for Safe Medication Practices Canada
Yes, and thank you for your question.
I think Health Canada's approach to collaborating with partners and coordinating efforts of different groups interested in safety and pharmaco-vigilance is the way to go, and I think it's to be commended. As was mentioned before, there are various pockets of information in different databases, and their outputs can be coordinated. We've heard about claims databases, we've heard before about coroners' offices reports, and there are poison information centres, so there will always be pockets of information that we can analyze differently and coordinate in terms of outputs. I understand that Health Canada is considering the idea that there are various databases that we can pool together and learn from together.
With regard to privacy and transparency, I also think Health Canada's efforts to bring the adverse reaction reports online are to be commended. Yes, they are planning to improve the database and the searchability of that information; however, there is now information online, and it's transparent. Transparency is the way to go; in terms of privacy legislation, provided the information is de-identified and factual, it can be shared. There are ways to share important information in a transparent way that falls under the umbrella of privacy legislation and privileged acts.
As has been stated, we are moving in the right direction, and working together is the approach.
Conservative
The Chair Conservative Joy Smith
Thank you, Ms. Hyland, for your very insightful answers.
I'm sorry, but we're out of time. Please accept my apologies.
We're now going into the second round, and I would remind members that this is a five-minute round. We'll begin with Ms. Kadis.
Is Ms. Kadis not here? Well, then, would anyone like to go first?
Dr. Bennett, would you like to go ahead?
Liberal
Carolyn Bennett Liberal St. Paul's, ON
Thank you so much.
Quite often what the committee really would like to know is what would be in the report for you if you were writing the report. What would you like the recommendations to be that would just make our job easier, so that you'd say the committee got it--that this is the infrastructure that needs to be in place and this is the role of the federal government in how they would interact with the provinces, industry, and clinicians? How could this work? Have you seen it done well anywhere else?
Past Chair, Cancer Advocacy Coalition of Canada
I could bring it down to a very practical approach, to answer the previous questioner.
It's never the cost; it's whether you want to do it and how much you want to do. If you had a pilot study of expensive cancer drugs for two years, sampling major cancer centres' use of those drugs for adverse events and efficacy, and learned from that pilot study as a start, you would have a major step forward in addressing the issue in respect of these expensive but effective cancer drugs.
Chair, Expert Advisory Committee on the Vigilance of Health Products
I'm going to add a comment to that.
One of the recommendations from the Expert Advisory Committee at our last meeting was exactly that statement. Instead of going very broad to begin with, let's start small; let's try to work through the bugs and see what will work and what won't work. We hadn't actually....
We don't identify specifics; we just give broad recommendations in terms of policy, but we did feel that in order to make this as efficient and effective as possible, you can't attack everything at the same time, because every aspect of the care in medicine is so complex and so patient-specific. If you target a small group, you can at least identify the bugs that will prevent you from working through the process.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
I actually thought that's what the cancer agencies did across the country. What are the cancer agencies doing, and what happened to the cancer strategy, if we aren't actually keeping track of the drugs that work and those that don't?
Past Chair, Cancer Advocacy Coalition of Canada
I don't think the strategy is concerned with that, because of its mandate.
But to answer your question, the specific program we're talking about isn't being done, but it could easily be done. All the western provinces now have electronic data systems, which could easily be interrogated—to answer a previous questioner—and have the data drained off and the adverse effects and failure to respond also made immediately available. This isn't a big deal for the western provinces.
For the provinces that don't have cancer agencies and don't have electronic data systems, it is a big deal. But as I said earlier, if you want to start small, with a pilot study for these expensive cancer drugs, go to the systems that have electronic data systems, drain off the information, and see what you have.
Conservative
Vice-President, Institute for Safe Medication Practices Canada
In terms of the report and recommendations, I think our organization would like to see, where there are databases that do contain reports about preventable harm from medications, that there is a method for analysis that considers the practice concerns, the clinical significance, the systems issues, and the potential preventative measures, because there are two different ways of analyzing the information that comes to us around adverse drug events.
Associate Professor, Faculty of Pharmacy, Université de Montréal
My recommendation would be to recognize that Canadians deserve more and that you should start thinking about introducing guidelines. Start with the guidelines and follow up with the legislation to effectively monitor drug safety in the post-marketing setting.
Conservative
Liberal
Carolyn Bennett Liberal St. Paul's, ON
My point is that it's not only adverse effects; it's whether things work or not, and whether something would work better.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
So I think we get a bit confused when we keep talking about adverse drug reactions but actually want to know more broadly than that what's out there and cost effective—the benefit-risk; that's right.