I agree.
Evidence of meeting #26 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A recording is available from Parliament.
Evidence of meeting #26 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was information.
A recording is available from Parliament.
12:20 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
And so that also can come down into the licensing.
12:20 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
But I'm wondering where in the legislation is an equivalent requirement to what you now have for health care institutions. Where does it say that pharmaceutical companies “shall” report immediately any adverse reactions?
12:20 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
It doesn't say that as a provision in the act. We would make regulations about that, so that it's a standing term and condition of every authorization.
12:20 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
But why wouldn't it be in the act? Why is this in the act and not drug companies?
Let me ask it this way: how are you going to prevent a Vioxx from happening, either through this legislation or your scheme or plan?
12:20 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
We think we could walk you through that at the appropriate time, should the bill come to committee. It's a very important dialogue. I'd want to really make sure that you can build confidence around that. We think we can do that.
12:20 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Are you prepared anywhere—in regulation, legislation, or this plan you presented today—to require drug companies like Merck Frosst to immediately get information to you upon learning of any side effects, so that something can be done with it?
12:20 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
Yes, we're putting in a very strong, direct ability to do that. And we can speak—
12:20 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
But if it's that important, why wouldn't you put it in law?
12:20 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
It is. Well, it's proposed, anyway.
12:20 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Is there a provision in the bill that says that drug companies “shall” present any information that's important to reactions to a drug?
12:20 p.m.
Conservative
The Chair Conservative Joy Smith
On a point of order here, Ms. Wasylycia-Leis, are you talking about Bill C-51 in terms of the “shall”?
12:20 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
I'm talking generally: the plan they presented today—the nice fancy document on post-market surveillance—the bill, anything.
12:20 p.m.
Conservative
The Chair Conservative Joy Smith
I'm just going to tell you the parameters. We can't talk about the wording of the bill, because it hasn't been referred to the committee. We can talk about the subject matter, because it is related to post-market surveillance. I just want to clarify that. So I will give you a couple of extra minutes.
12:20 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Right, but given the fact, Madam Chair, that we're in the middle of a study that is really redundant.... We have legislation from the government that deals with post-market surveillance. We have a plan before us, the plan for post-market surveillance from 2007 to 2011, I believe it says. So it makes our work pretty frivolous and ridiculous—
12:20 p.m.
Conservative
The Chair Conservative Joy Smith
Ms. Wasylycia-Leis, I'd like to continue, but we cannot talk about the bill until it's referred to the committee. I'm trying to be fair with you, but please continue properly.
12:20 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
All right. Is there somewhere in the government's plans to require that from drug companies—for example, Merck Frosst, which is now under investigation for misrepresenting information or not conveying information on a timely basis, which did lead to hundreds of thousands of people dying? That's a simple, straightforward question for which there should be an answer from government.
12:20 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
There is an answer, that for the last couple of years we've been having very close stakeholder meetings and studying what it is that we need. Yes, absolutely, that has been a topic of discussion; there's no question. We have tried to study what information we need, when in the cycle we need it, and how best to ask for it. That's both domestically and internationally. So we've really studied these things, and—
12:25 p.m.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Okay, but I'm asking, if you studied it a lot, are you prepared to say somewhere that pharmaceutical companies “shall”—just like you say with proposed section 20.7—report adverse reactions?
12:25 p.m.
Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
Yes, we are.
12:25 p.m.
Conservative
The Chair Conservative Joy Smith
Ms. Wasylycia-Leis, your time is up.
Now we'll go to Mr. Temelkovski.
12:25 p.m.
Liberal
Lui Temelkovski Liberal Oak Ridges—Markham, ON
Thank you very much, Madam Chair.
Thank you to all the presenters. I think I have the same 10 minutes as Robert had.
Let's look at it in this fashion: there are reporting elements on a national basis, and not one but many ways that people can report adverse reactions. There are also international avenues where people report adverse reactions; and there are people, as well as stakeholders, reporting directly to the pharmaceutical companies.
Is all of this information being compiled anywhere, in one unit, or is it reported back in as many facets as it is reported inward?
May 1st, 2008 / 12:25 p.m.
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
If we take the post-market adverse event report for pharmaceuticals, from any source, whether they come from the manufacturers or consumers or health care professionals, they will all end up in the same area, which is the Canada Vigilance database. This is where the Canadian reports will be collated. It's also in that same area that the international reports are kept in the records. So if we're talking about drugs, it all ends up in the same place.
12:25 p.m.
Liberal
Lui Temelkovski Liberal Oak Ridges—Markham, ON
Then Health Canada will report them back to Canadian sources, to the stakeholders, I'm assuming, on a quarterly basis, on a newsletter basis, as you mentioned earlier, right?
12:25 p.m.
Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health
Yes, there are numerous tools used to report back. This is one of the tools we use to identify emerging safety signals. So in that sense, if we take action, that's some kind of retroaction to the Canadian public and to the reporters. It's indirect, but that's one source of retroaction.
There is the availability of the Canadian adverse drug reaction database, or Canada Vigilance, as it's called now, and that's searchable. So that's another retroaction.
And as I've mentioned before, the Canadian Adverse Reaction Newsletter is another way to report back.