Health Committee on Jan. 31st, 2008

[Meena Ballantyne]

Okay.

[David Tilson, Conservative, Dufferin—Caledon, ON]

In your presentation you talk about two new regional adverse reaction offices. Can you tell us where they are?

[Meena Ballantyne]

Alberta and Manitoba is where they are. So we have one in every province. I think there's one for all of the Atlantic.

[David Tilson, Conservative, Dufferin—Caledon, ON]

So they are right across the country?

[Meena Ballantyne]

Yes, there are seven of them now.

[David Tilson, Conservative, Dufferin—Caledon, ON]

What happens at those offices?

[Dr. Chris Turner]

They're primarily responsible for two big jobs. The first is to collect and process the initial adverse reaction report from their local area. Second is to promote and encourage reporting in the area.

A third one is perhaps encouraging appropriate use of adverse reaction information, because people tend to abuse it, for example the media, which tends to sensationalize it and scare Canadians away from using products that may actually be beneficial to them. There may be an issue with the subpopulation, etc., but they don't adequately explain it and put things into context.

So they have a huge job in working with their local constituencies to submit those reports to the national database.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Turner.

Ms. Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you, Madam Chairperson.

I want to try to zero in on what specifically the government is proposing with respect to this new approach around post-market surveillance, because I don't get those specifics from the paper, other than some talk about a life cycle approach.

I'm wondering what mechanism is in place or is being contemplated that will provide independent assessment of a drug, or any product, once it is on the market. Or is it all industry based? Is there any proposal for an independent post-market surveillance body?

[Meena Ballantyne]

We currently have an expert advisory committee on the vigilance of health products, which has just been struck a few months ago, which includes patient-consumer groups and health care professionals. They're there to provide advice to me in terms of post-market surveillance issues related to health products. This is a new expert advisory committee.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Yes, but that's a body that's not going to look at the actual drugs or the products and provide independent advice. I am asking, in terms of this whole scheme you've given us of the life cycle approach, where the independent analysis is. Once a product reaches market and there are problems identified, what do you do? Who is doing it?

[Meena Ballantyne]

I'll let David answer in a minute, but I was going to say that what we've said, and encouraged, and put on our website in terms of inviting public input into policy-making, into decision-making, is one way of doing this. We have a whole marketed health products directorate, which Dr. Turner heads up, which is designed specifically to make sure we monitor the situation, we strike expert advisory committees as needed when we hear of signals--

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Okay, but you're not getting my question, which is this. For consumer safety, there has to be a body that is independent of drug companies. Anyone with a stakeholder interest, who actually has a role in assessing the adverse reactions of drugs or whether or not this drug should stay on the market, should be pulled. I don't see that anywhere in this scheme of things, anywhere.

We used to have an independent drug research bureau. We don't have that. We were told, oh, we're going to give this to third parties, universities. I remember that coming from the Minister of Health. I've never seen any evidence of a body being set up.

You've now presented us with this new framework and this new plan around a life cycle approach. Where is the independent analysis, pre- and post-market?

[David Lee]

Could I start with the first part of your question, which is, what are the precise instruments we're actually talking about?

What we've been proposing over the last years is an array of tools, and they include, for example, an ability to get companies to do studies, but others to do studies too. In terms of requiring changes on label, making sure that we have nice clear powers...and that's really the information about how to use the drug.

Reassessment. Reassessment is a really important component. In Europe, for example, they require reassessment every five years for every product. It's hard to know, after five years, what you now know about a drug right across the board. So what we're trying to do is study that tool, for example, and figure out how from a data point of view, how from a safety point of view, it is valuable to do a reassessment.

Those are the kinds of tools that we're studying, how they work in other jurisdictions, and then coming back and talking to Canadians—patient groups, academics, and others—about how those tools could work. So once they're hooked into the licensing situation, and you can make them obligations on market and then bring them back into our analysis, that's really where we have this conversation going on. So there are precise tools that you can lay in to do that.

I mentioned pharmacovigilance plans and risk management plans, which are commitments you make—

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

That's great, but you're not looking at an independent body at all, free of any market, free of any drug company influence.

Go ahead.

[Michael Vandergrift, Director General, Policy, Planning and International Affairs Directorate, Department of Health]

The federal government has been working with provincial and territorial colleagues, as well as networks of academic centres, in developing what's been called a real world drug safety and effectiveness network, which will be used to collect data about real world impacts, tapping into administrative databases and the like. There has been a business case developed on that. That's under continuing discussion between governments, with hopes to advance that. That would also form another source of data that can be used and tapped into by the regulator in terms of looking at real world impacts of pharmaceuticals.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

To help us, then, is it—

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Vandergrift.

I'm sorry your time is up, Ms. Wasylycia-Leis. My apologies.

Mr. Fletcher.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Thank you, Madam Chair.

I'd like to thank the guests for coming. I'm going to try to rapid-fire my questions so that I can get them all in.

What I'm hearing from my colleagues is really the balance between risk and benefit. If you have an approval process that's too long, there would be an adverse event in not providing access to drugs to the people who need it. That's a bad thing in itself, but you don't want it to be so fast that you're putting the population at risk. That's a tough thing to do.

The Standing Committee on Health just completed a study on the common drug review, as I'm sure you all know. What role, if any, would you expect the common drug review to have in relation to the life cycle of any particular drug, and what effect will Health Canada's proposal with the life cycle approach to drug safety have on the common drug review?

As well, how do you propose to deal with different indicators? Once a drug is in the market and it's found to help another ailment, how does that work? And how do you propose to deal with those types of situations?

[Meena Ballantyne]

In terms of your first point, about balancing the benefits and risks of any health product, you're absolutely right that it's a call we make in terms of providing timely access to innovative products but also assuring health and safety first and foremost.

That leads into the CDR. We are currently in the process of reviewing the standing committee's report on CDR. We are taking a very serious look at that, looking at the linkages between your recommendations and this new approach that is being proposed, because there are some linkages. We will be tabling that before the April deadline.

In terms of the CDR, absolutely, the access and timely access to products is what CDR is most concerned with. We look at safety, quality, and efficacy. CDR basically takes that information and puts in another criterion, which is, as you know, the cost-effectiveness. We need to look at that very closely in terms of how we build that into the life cycle approach as we move forward. At this time, I am not able to provide you with a precise answer on that.

Your third point asked what we do once a drug is on the market and is used for another purpose. I'll invite my colleagues to speak to that, but my understanding is that it would have to come back in, because if it's being used for another purpose then that really is off-label use. The company would have to resubmit it through the regulatory process because it is being used for another purpose.

I know that off-label use, particularly in the case of children, where this is.... We know that the clinical trials are often done on adults. Sometimes some of these medications are provided to children without adequate testing being done. That is off-label use, which poses its own challenges. We need to look at that.

I'd like my colleagues to add to that, if they wish.

[David Lee]

I would just add that in advancing the large framework, we've been trying to be very mindful about how the rest of the system works. This has been urged on us by many participants. We have been in close conversation with CDR about just what data they use and what we need to look at to make sure that there are no slippages in the system and that we all understand at least our own roles and the extent to which we can be efficient together as decision-makers or as people who recommend decisions.

We've been trying to do this very close analysis together. I think that was one of the things the committee urged us to do. We're trying to understand how to have earlier conversations to make sure we get a lot of efficiencies built into the system.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Do I have time for another question, Madam Chair?

[The Chair, Conservative, Joy Smith]

I'm sorry, Mr. Fletcher, there are only about three seconds left.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

In three second or less, since the last report of the standing committee on “Opening the Medicine Cabinet”, what has Health Canada done?

[The Chair, Conservative, Joy Smith]

I'll let you briefly answer that.