Health Committee on Jan. 31st, 2008

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Ballantyne.

Mr. Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you, Madam Chair.

Good afternoon. With your permission, I will take a specific case to find out how you deal with the information you receive. This morning, many women must have felt somewhat afraid when they read La Presse. This might even be the case for my colleague from Quebec, but I would not want to get into her more intimate secrets. In La Presse, this morning, we read that anti-ageing cream contains DMAE which affects cell division and can cause serious skin problems. Dr François Marceau drew this conclusion which was published in the British Journal of Dermatology.

What do you do when you receive or read this kind of information and when you are notified of a study?

[Meena Ballantyne]

I will ask Dr Turner to answer your question.

[Dr. Chris Turner]

I think what you're raising is that information can come to us from a variety of sources. For example, today there is a report of a Quebec citizen who had a fatal reaction to taking excessive doses of cold medications.

We don't limit the investigation or the creation of a report to someone actually sending us a report by fax—and we have toll-free fax and phone lines--by the online electronic reporting, etc. If there's a publication in a scientific journal, especially related to a Canadian, and we become aware of it, that can become a case.

So it depends, first of all, on whether it is a regulated product or not. If it's one of our products, for example, if it's a cosmetic, is it a cosmetic that's regulated by another part of Health Canada? It would depend then into which monitoring system it would go, and there are numerous monitoring systems—veterinary drugs, cosmetics, pesticides, etc.

But if it comes into our awareness and it's a regulated drug or product, then we will follow it and examine for trends. So if there is a concern such as was raised, then we would do a search of the database. And some of the fields of that database are public, so if you wanted to search it yourself, you would be able to. That's unique to Canada, actually, that we have that. Then it would be further investigated based on the trend.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Is there a process for changing the category of products? Currently, it is a cosmetic product, therefore it should be classified as a cosmetic. However, we have learned that this product penetrates the skin and that it can affect the cells. Therefore, it might be some other kind of product and not a cosmetic.

Is there a process to change product categories rapidly? As I listen to you, the process seems to me to be too long, given the fact that we are studying something that could very quickly change a person's whole life. Some women who read this in the morning newspaper may well panick.

[David Lee]

The department's interests clearly are to cover risk, no matter what the product line is. What we need to be stable about is how valid the risk is, because you don't want overreaction. So you want to really have the focus on what it should be to make sure that the risk is well managed, if there is one. So that's the study you want.

Dr. Turner was pointing to the kind of very complex analysis that has to go along, but what he's not getting now are the instruments to be able to do something effective once it's on the market, because the blunt instrument Ms. Ballantyne keeps pointing to is that we have to threaten to take it off to get more information; and it's a very old instrument.

Here you would be able to say, okay, we've identified a risk, we want to see more information, we want to see more studying to validate it. If we need quick intervention, because it's a very difficult risk to manage, then you get more direct ability to do that, including communicating well about the risk.

So what we're looking for is really being able, through the licence, to manage these various activities and make sure that you heighten the controls when you need to, and that's the life cycle governance. Once it's out there, you get the oversight that you need.

[Meena Ballantyne]

Can I just add something to answer your question? We're constantly scanning the media and other reports to see what's out there. As you can well imagine, a number of events and reports come to us.

We have people on the ground. For example, we have seven regional offices in the marketed health products. They're people out there in the provinces and territories working with those communities, trying to get Canadians and health care professionals to report more, encouraging everybody to report more.

The minute we get this data, we're looking at it quickly, making an assessment: is this an issue or not? If it's something that is a really huge issue or something we need to communicate to Canadians, we have a variety of risk communications. We have some criteria to trigger the appropriate risk communications, without, as Mr. Lee said, panicking the population.

Sometimes we will do an information update. If this is one of those cases, we would provide information, put it on our website, put it on our MedEffect website, if needed. Then the second stage would be getting out information to the physicians. We have a health care professionals advisory that goes out through the CMA, through direct mailings, to all doctors in this country. It goes out to pharmacists in this country. We work with the associations.

We use the media as well to get this information out. We recognize that in a crisis situation we would have to get this information out as quickly as possible. For example, there was the counterfeit toothpaste issue last summer. We thought there might have been something in it. Through our inspection programs, we found reports and confiscated this toothpaste based on, I think, a complaint that came up. We analyzed it in our labs. We had to act within a 24-hour period. We erred on the side of having people ask us why we reacted so soon as opposed to why we waited so long.

This branch does a balancing act on a constant basis. We're trying to do this in a much more effective, responsive way. We have to target our resources to the areas of greatest risk. This is what the action plan is talking about, active prevention, because it's in all our best interests to make sure health and safety is protected.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Ballantyne.

Mr. Tilson.

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

Thank you.

I'd like to return to an issue that was raised by Ms. Kadis and Ms. Davidson, and that has to do with reporting by health care professionals.

Your paper--I appreciate your giving it to us in writing, incidentally, it's been helpful--uses the word, as Ms. Davidson says, “encourages”. I don't understand that. Whether you're talking about the topic we were just dealing with, counterfeit toothpaste, or some genuine reaction, if citizens have a problem, they go to their doctor or dentist or health care professional or whoever you're talking about and ask why they have this rash after taking this drug. You're telling me they don't have an obligation to report it to Health Canada.

I don't understand that. Is there a jurisdictional issue? Why is that?

[Meena Ballantyne]

I'm going to ask Dr. Turner to respond to you, but I just wanted to say there are a number of issues related to mandatory reporting by health care professionals. In reporting adverse reactions, and particularly serious adverse reactions, it's more of an issue of quality rather than quantity, because you want to focus on the very serious areas. This is what I'm talking about in terms of targeting oversight on areas of greatest risk.

Which one would you rather be focusing on, the rash, which is painful for the person who's going through it--there's no question about it, and they're seeing their health care professional--or something you need to know about, as we talked about, under the criteria for a serious adverse event where it's a life and death situation? This is the philosophy we're talking about.

In terms of the health care professionals, you asked the question about enforcing it. It would create another burden on these doctors and health care professionals who are on the ground. We don't have enough of them in this country and worldwide. How do you encourage that, to report without--

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

If they prescribe the drug, I would think they'd be concerned about who told them to prescribe the drug, which gets to the issue of whether Health Canada.... Health Canada approves the drug, presumably.

[Meena Ballantyne]

Yes.

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

Then I don't know whether they have a guide or whatever you use that goes to the docs or the manufacturers. I assume you do.

[Meena Ballantyne]

Yes.

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

So they're tied into it already. I made the smart remark when Ms. Davidson was talking that if you have a problem that's serious enough, you call your lawyer. So what actions should a medical practitioner take? Surely they have an obligation. If there's a reaction.... It may not be the drug. It may be just that the particular person can't deal with that issue, but it may not be. Otherwise nobody will ever know if they don't do it, if they don't feel like it, you know, because it's a cloudy day out.

I just don't understand that.

[Meena Ballantyne]

You're right, there is a jurisdictional issue. As we all know, this is the practice of medicine, which is under provincial and territorial jurisdiction. I think the movement is that we're all trying to work together. The health care professional community, the industry, all levels of government, in terms of saying let's work together, collect as much information as we can; let's start somewhere where we can see how it works. As I said, there is a movement afoot in some of the provinces and territories to try to collect this information, get everybody to report this without assigning individual blame, taking a systems approach to health care.

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

I'd like to move to another area, and that has to do with cross-border shopping and other jurisdictions. It's been briefly mentioned in some of the issues that have been raised here. I am thinking particularly about the United States and the number of drugs that come across the border that people have access to.

Can you talk about that? It was mentioned already, but I would like you to elaborate on it.

[Meena Ballantyne]

In terms of the volume?

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

I don't know, someone gets on the Internet and calls Michigan and says send me such and such drug, and then it gets over here and there's a problem.

[Meena Ballantyne]

I don't think we have anybody here who can talk about the cross-border drug issue.

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

I assume that a health professional has recommended a particular drug and said that they can get it down in New York State. I don't know. I just know there is a certain exchange, and there has been an issue in the past number of years about people acquiring drugs on the Internet. I wonder whether that's another problem that Health Canada has had to deal with.

[David Lee]

There are probably a number of legal issues travelling through that conversation, and we would want to be very accurate with you.

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

So we're not going to talk about that.

[Meena Ballantyne]

We could provide you with some information, if you wish, at a later date.

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

No, that's all right. If you think of something, send it to the committee.