Health Committee on April 10th, 2008

[Patricia Kosseim, General Counsel, Office of the Privacy Commissioner of Canada]

Thank you, Mr. Chair.

Certainly the challenge of dealing with federal, provincial, and territorial realities is a real one, and we commend the leadership of Infoway for the great work they do in that area.

From a regulatory perspective, juggling those different regulatory frameworks is also quite challenging. Not only are there 14 jurisdictions and laws, but within each jurisdiction there are different laws, some dealing with the private sector, some with health information, and some with general personal information.

One example of where leadership can come to bear on these sorts of challenges is how, over time, the regulatory frameworks have either adapted or evolved or have been amended to enable the reality of electronic health records to work with the Canadian public to an acceptable and agreeable solution for implied consent within a circle of care, so that when individuals go to see their physicians, they understand that the information in the electronic health care arena can be shared with other health professionals engaged in their circle of care or their treatment without necessarily having to go back to get their informed consent every time. That concept has grown to be acceptable and workable.

However, there are other concepts that remain very distinct in each jurisdiction, that have yet to be resolved and harmonized. For instance, the rules for using personal health information to support research or surveillance or other secondary purposes outside that circle of care are not harmonized around a certain agreeable standard.

There is still work to be done. We're pleased to work with Canada Health Infoway and the privacy forum to begin to address those challenges. As well, Infoway senior officials have come to our FPT privacy commissioners meetings in recent years to give us regular updates.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Madam Kosseim.

Now we'll move to the second round, a five-minute round, with Mr. Thibault.

[Robert Thibault, Liberal, West Nova, NS]

Thank you very much, Mr. Chairman.

Thank you all for your presentations.

I understand the complexities of privacy issues and provincial legislation and regulations and of trying to work your way around those, but it seems to me, as a simple citizen, that if the Canada Health Infoway or the health providers out there are using the information about me for the purposes it was gathered, then it's being done on my behalf to improve my outcomes. So it would seem to me that for most of the users of this information, if you could separate their data from their personality, then I wouldn't have any problem with it. It wouldn't matter to me if anybody in this country, any researcher, etc., knows there is a Canadian of a certain weight with certain medical conditions, and of a certain age. I don't want my insurance people to know that; I don't necessarily want all this information out there, but as far as the medical practitioners are concerned, they can know there's such an individual.

I want the people who will have to work with me to have my identity and all of that information immediately. I'm willing to take a little bit of a risk for that; I'm taking a little bit of a risk that maybe somebody would get some information I'd rather they not have, provided that the people who do need it will have it. I don't know if that's the same risk as my medical records flying off a movie set.

So I hope that we will be able to find such an accommodation and that the provinces are working with the federal government in modifying their regulations and legislation in a way that we can get that one day.

Are you seeing any progress in that area, Madam Stoddart?

[Jennifer Stoddart]

Yes, we are. We're seeing continuous progress.

Everybody, I think, is trying very much, in good faith, to work through concepts that predate the electronic health records and the possibilities these have for improving the health of Canadians. They are working through a lot of these complex legal, organizational, and societal issues, because you mentioned that it's not just about me and my doctor, me and my nurse, me and my family; there is the whole industry, there's the infrastructure, there's the increasing blurring of the public and the private sectors, there's the cost of developing effective specialized drugs, there's the pharmaceutical industry, and there are international considerations as well.

So we are all working intently at trying to move definitions forward in a way that preserves values while making the definitions workable to all, and I think everybody is cooperating in this very intense discussion quite well.

[Robert Thibault, Liberal, West Nova, NS]

Thank you.

Mr. Alvarez, pretty well every practitioner who has appeared at the committee, when they talked about the reporting of adverse drug events—and I think we're generally hearing that 10% of serious adverse events are being reported now—they told us that they'd be willing to report every, or pretty well every, adverse event if there were a simple, efficient method that fed back to them. I don't know how you would define that, but it should tell them: this is what you should have expected; what you got is reasonable, and you should have expected it; or these are the alternatives you can use. So it would require participation by the practitioner, by Health Canada, but also by the industry, by the manufacturers of these pharmaceuticals and the people who have experience with them.

I'm very pleased to hear of the advances you're making, but will they get us there? Will they result in a two-way dialogue with practitioners?

[Richard Alvarez]

Mr. Chair, before I answer your question directly, I should say that we have a primary role, and the primary role is basically to provide better care at the point of service. The primary role includes the prevention of adverse drug events.

Earlier on, we had a comment about the cost. There have been studies done in Canada that show that between 9,000 and 24,000 Canadians are killed or suffer serious injury every year. Many of these are preventable, and 70% of them are because of fluids and drugs, adverse effects from drugs. Seniors are generally on a minimum of 12 medications, so--in terms of preventing--the systems that we're funding are systems that, at the time of prescribing, will enable you to see medication histories and to see what you're prescribing, and whether it will in fact have a likely adverse event with what the individual is on already. So that's the prevention side.

In terms of adverse events occurring--or in some cases, unexpected results where you're trying to kill one ailment and it increases cardiovascular risk, etc.--that's certainly possible to do on a population basis. When you start to look at people who are on a particular drug, and what their outcomes have been all the time, and why their outcomes have...or how their lab tests have spiked, that is certainly possible in terms of the secondary uses of data.

We've really just dipped our toe in, in terms of the reporting aspects in B.C., where I believe four out of the six health regions are reporting adverse events from neonatal units. From my understanding--and certainly that of the clinician who's running it--it is relatively easy to do, and it does really increase the numbers that are reported and the feedback mechanism that steps in to stop that from occurring.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much.

[Robert Thibault, Liberal, West Nova, NS]

Mr. Chair, I have 20 minutes left.

[The Vice-Chair, Liberal, Lui Temelkovski]

I'll let you know the next time you have 20 minutes.

[Some hon. members]

Oh, oh!

[The Vice-Chair, Liberal, Lui Temelkovski]

Mr. Tilson, please proceed.

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

Thank you, Mr. Chairman.

My questions or comments are directed towards Commissioner Stoddart.

I always enjoy your comments because there are many challenging issues with respect to privacy. I'm looking forward to reading this decision that you have given in your comments--this Federal Court decision--particularly the comment where it says that privacy is paramount over the access to information, which we've heard before. I'm always amused by that, particularly coming from a small community, as many of us do, because in small communities there are no secrets. It's impossible to keep secrets in small communities. However, I understand that.

I want to canvass this, though, because we're told that for Health Canada to look at serious adverse reactions, we need to look at a whole slew of things. There may have been a practitioner who goofed in his or her prescription. Someone may have said, “Oh well, instead of taking four pills, I'll take eight pills.” There may be some genetic issues. There may be all kinds of things that deal directly with the individual. We know that when doctors discover that someone has a communicable disease, they have an obligation to tell the spouse. We know that when a teacher, for example, finds that some child may have been abused or may be bruised, they have the law and they have to go and report that.

I guess I get to the question: how can the government properly study serious adverse reactions if they don't know the identity of the individual?

[Jennifer Stoddart]

Mr. Chair, perhaps I could tell the committee a bit more about the facts of the case I was talking about in which this came up. As a general principle, privacy trumps access.

The case had to do with a request to the Information Commissioner. It was my colleague's case, in fact, a request from a CBC producer who was interested in accessing the results of this CADRIS database about adverse drug reactions. I can ask Ms. Kosseim to supplement my remarks, because she actually worked on this case.

As I understand it, Health Canada had all the personal information. The issue was not that Health Canada didn't have many fields; I think there were 60 or 80 fields, and most of these fields could be released to the journalist. The issue was with the fields the Information Commissioner did not release. The debate was about the province field. “Province” is not generally thought of as being personal information, but Health Canada's position--with which we concurred--was that if you released the province field, in certain cases that field, coupled with obituary notices, would allow journalists to understand who exactly had died and just release their information.

I don't think, Mr. Chairman, that any of this hampers Health Canada or the scientific study of adverse drug reaction in any way. In fact, they did have the name.

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

Except, of course, as someone said, we're now into talking about events beyond the borders of this country, which are aspects we probably should be studying. Drugs are coming from other countries. For Health Canada to adequately study something, to adequately discover whether there's a problem with a specific drug, I believe there may be circumstances in which Health Canada may at least want to know the identity of that person to properly determine whether or not it's safe.

We all have Canada Revenue Agency problems in our offices, so we stick a consent form in front of them, and they have to sign it. What if the person doesn't want to sign the consent? I assume that would happen with drugs. If they come in with a reaction and see the pharmacist or the doctor or whoever, and they say they'll report it, then I assume they'll stick a consent in front of them. I don't know whether they will or not. What if they don't, and what if they don't want anybody to know they had this reaction? If Health Canada doesn't know what that is, then how is it a benefit to the general public?

[Jennifer Stoddart]

Mr. Chair, the honourable member raises a very good question about public interest as compared to individual privacy interests. There's no one answer that does it for all. I think in those kinds of contexts you would have to set up the legislation framework. If you're trying to monitor something as important as adverse drug reactions to drugs being administered to a large population, it would be necessary for the regulatory agency to have as much personal information as it needs to adequately monitor the drug; otherwise, there are going to be unsafe drugs on the market.

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

Do I have time?

[The Vice-Chair, Liberal, Lui Temelkovski]

You have to say thank you.

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

Thank you.

[The Vice-Chair, Liberal, Lui Temelkovski]

We have to move on to Madame Thi Lac.

[Ève-Mary Thaï Thi Lac, Bloc, Saint-Hyacinthe—Bagot, QC]

Good morning. I want to start be telling you that I am not a permanent member of this committee. I am standing in today for my colleague Ms. Gagnon. I will likely be sharing my time with Mr. Malo. I also stood in for a colleague at last Tuesday's meeting.

No one is disputing that Health Canada's current warning or advisory system has shortcomings. Let me give you an example. I was floored to learn last August that a warning had been issued about a prescription drug that I use. In November, I went to have the prescription renewed, but I was not informed of this drug advisory. Obviously, if the advisory warned people not to go out in the sun while on the medication, then the adverse effects I might be facing would not be as serious as, say, cardiovascular problems.

It is important for the consumer to be alerted. Protecting people's privacy should be the overriding consideration. Right now, users of certain prescription drugs are unaware that warnings or advisories have been issued by Health Canada.

Here is another simple example. If your automobile is singled out by a manufacturer's recall, you will be notified by mail to bring your vehicle to the dealer or to a mechanic to have the necessary repairs done. However, in this case, if people are not even informed that taking a certain drug may pose a health risk, it is clear that there is something wrong with the warning and advisory system, that it fails to protect consumers.

[Sheila Fraser]

Mr. Chairman, as I already noted, we looked into the regulation of medical devices in 2004 as well as the overall communications plan and strategy for warning consumers. In its report, the Medical Devices Review Committee noted that in the early years of this decade, the communications strategy left a lot to be desired. It was also noted that Health Canada had neither a communications plan nor a strategy in place to assess the situation. Of course, the department had various ways and means of communicating with consumers, but no way of verifying if these means were effective.

At the time, we conducted interviews in 19 hospitals and asked people to share with us their thoughts on Health Canada's communications strategies. We were told that with respect to issues of some concern, Health Canada was not people's main source of information, that HC warnings were often issued much too late to be of use.

I found your example of automobile recalls quite interesting. We also used it as an example of a process that could be put in place. Other possibilities are also mentioned in the report.

[Ève-Mary Thaï Thi Lac, Bloc, Saint-Hyacinthe—Bagot, QC]

Thank you.

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

Do I have any time left?

[The Vice-Chair, Liberal, Lui Temelkovski]

You have one minute.

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

Madam Auditor General, how much would it cost to put in place an effective post-market surveillance program?