Evidence of meeting #25 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drugs.
A recording is available from Parliament.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
The provisions in our bill are inadequate, on the one hand because there is no effort being made to strengthen them, and on the other, because there is no indication as to how this information is being used.
What reservations do you have about the provisions in this bill?
Attorney and Specialist in Medical Law, Ménard, Martin, Avocats, As an Individual
If a mandatory reporting process is introduced, it must be effective. However, if there are no consequences as a result of non-reporting, we are not much further ahead.
Voluntary reporting has drawn very little attention because it is governed only by an administrative process. There is no legal process involved. There are no parameters for it. I think that it would be important to put it into the legislation so that it is more formal and better understood. That way, people would also be aware of it. Right now, you have to go on Health Canada's Internet site, which contains a lot of information. Lawyers are used to doing that, but it is not easy for the general public to find what they are looking for.
Mandatory reporting is something to look at. It is important to note that some provincial laws, like the Quebec legislation, already contain that kind of obligation. When something happens in a health care facility, it has to be reported. Do you introduce something that may be redundant, or is it better to try to cooperate to obtain the information from the provincial system? Those aspects need to be considered as well. There is no point creating two structures if there is already one that is working and can provide information through agreements or otherwise.
There is no magic formula. Even if the legislation calls for mandatory reporting, doctors and nurses have to be made aware of the requirements. Nurses need to be involved because they are often the ones who see the reactions. Doctors are paid on a fee-for-service basis. Generally speaking, there is no fee for this sort of thing, and many doctors therefore do not report them. It might be easier for nurses to do so. I do not have any magical answer, but it would be important to put in place a better structure for these processes.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Do we have things to learn from Quebec and Manitoba regarding implementation at the national level?
Attorney and Specialist in Medical Law, Ménard, Martin, Avocats, As an Individual
There are two issues that are significant. The notion of the right to medical safety is beginning to surface in all western health care systems. Ten years ago, this issue wasn't even discussed. We've only begun to talk about this in recent years, and it is becoming a major concern for the French, English, European and Canadian health care systems. Health care must not only be efficient and ethical, but also safe.
Quebec was the first province in Canada to legislate on this matter, and Manitoba followed suit in 2005. There is a current trend to begin acknowledging this principle. The principle must be part and parcel of a framework, something similar to section 3 of the Health and Social Services Act. In all decisions regarding the management and delivery of health care, safety must be guaranteed, among other things. A patient's right to drug safety must be exercised in several ways, such as quality control, advisories, or interruption of drug distribution. To my mind, a patient's right to drug safety must be provided for in the legislation proper, and not in the preamble. This strikes me as a significant step forward.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Merci.
Mr. Brogan, I'd like to ask you a couple of questions. First of all, where do you get your funding? Whom are you connected to? How do you make a living?
President and Chief Executive Officer, Brogan Inc.
We make our revenue by selling reports to drug companies, government, small clients, insurers.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Are you funded at all by drug companies in terms of your operations?
President and Chief Executive Officer, Brogan Inc.
If they need reports of some description, we produce those reports. It's not funding per se. It's earned income.
NDP
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
So you wouldn't have any conflict of interest in this, other than providing the services to drug companies and getting remuneration for that?
President and Chief Executive Officer, Brogan Inc.
We have the same rule that I had in government: the data show what the data show. If the client doesn't like it, the only thing that's certain is that they'll pay the bill. That's it.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
What is the difference between your database and the national prescription drug utilization information system?
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Is it your recommendation here that government should rely on your database in future?
President and Chief Executive Officer, Brogan Inc.
Well, I think there's an opportunity for us to work together, which I've offered up more than once. It doesn't make sense to me to have two independent data sources that are doing the same thing.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
You don't think this is something that should be fundamental to government, and part of the role of government?
President and Chief Executive Officer, Brogan Inc.
Oh, I think the government absolutely should have a database. My point is that they've gone out on their own and built something that we already had. If we had worked together, we would have had a bigger and better database much quicker.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Where do you see your proposal fitting in with regard to this broad study of post-market surveillance?
President and Chief Executive Officer, Brogan Inc.
Right now, if I understand the role of CIHI and others, they're not really into a patient-level analysis. That's the kind of work we've done, and I think there are probably some other private sector companies out there.
I don't think government can do all of the work that's necessary. I don't worry about competitors. There is so much to do in this area. The number of questions is just endless, so--
Conservative
The Chair Conservative Joy Smith
I'm sorry, Mr. Brogan, we're way over time. Thank you for your answer.
Mr. Brown.
Conservative
Patrick Brown Conservative Barrie, ON
Thank you, Madam Chairman.
Mr. Brogan, you mention in your brief, on the third page, that “only a minority of adverse events is reported”. Could you comment on that a little bit? How do you draw that information, and what percentage would that minority be? Are there any estimates?
President and Chief Executive Officer, Brogan Inc.
I've seen the estimate of around 10%. That's been pretty consistent. When I was in government, we used to look at figures like that. I think that figure has been around forever. And in talking to physicians and people in hospital...it's more impressionistic; no empirical analysis that I know of has ever measured that.
It's a very difficult figure to get a handle on, partly because what constitutes an adverse event? Is it the minor headache or is it the...? I mean, obviously a death would be a serious adverse event, but there's such a range in between. So getting a definition of that is quite....
Conservative
President and Chief Executive Officer, Brogan Inc.
Yes, it is, absolutely. Every time we ask that kind of question of physicians, the answers range from “I never report them” to “The really bad ones I'll call in”.