Health Committee on Feb. 7th, 2008

[Robert Thibault, Liberal, West Nova, NS]

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you very much.

We will now go to Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

I have a few questions for the panellists today. I first wanted to ask what you think of the life cycle approach, in terms of regulating the health products. It was suggested in the blueprint for renewal in 2006 that this might be a way to have better surveillance. Also, do you expect that progressive licences will be subject to phase four clinical trials? And do you have any idea, on a broader level, of what types of costs would be involved with that?

[Glenda Yeates]

As an agency responsible for collecting national statistics from the provinces and territories, essentially from not a voluntary but from a consensus point of view, this is not a question we've looked at, in a sense. We very much view ourselves as a body that provides information for others to have those kinds of policy debates, as opposed to entering into them ourselves, so I'm afraid it's not a matter we've considered nor have a view on.

[Dr. Brien Benoit]

I can honestly say that our mandate is to regulate prices, but we currently have a discussion paper out there for all our stakeholders, which goes to re-benching, re-looking at the price of a medication once it's been on the market for a number of years.

As you alluded, Mr. Brown, after the drug's been out there for several years, obviously, some of the things that have not been picked up in the clinical trials come to the surface: either the drug becomes less effective or it becomes more effective for perhaps another indication. Would that be an occasion when the pharmaceutical manufacturer might ask for an increase in his price? Conversely, we might determine that the drug is not as effective as projected and lower the price.

One of the things we're currently discussing is post-market surveillance. We're in the process of looking at our guidelines, which are almost 15 years old, and if necessary, changing them to adapt to the modern environment.

[Patrick Brown, Conservative, Barrie, ON]

I think Mr. Tilson alluded to my next point. One figure we've heard mentioned is 10%, in terms of adverse reactions that are reported. How could we get a better picture of that? Would hospitals have the ability to do mandatory reporting? How much would that assist in making the picture less murky?

Additionally, in terms of manufacturers, if there were a requirement for them to report as well, would they even have the ability to track that? What mechanisms would you suggest would give your organization a better ability to have the full picture of what the accurate percentage is?

[Glenda Yeates]

We tend to have very complete data sets at the moment, so we are blessed, in a sense, in this country with very complete data sets from hospitals. In the discharge abstract database, for example, we have information on virtually every hospital encounter; it's a very high percentage. We have very high percentages for some of our other databases as well.

I think it's clear one can have less complete, less comprehensive databases that can be used to pinpoint issues. From a data and statistical point of view, I think you usually start these things in stepwise motions. You want to start collecting data in a certain sector. That would give you information you could then use to improve safety and reach conclusions.

If the question is if we started in hospitals, if we started in a certain place, would that be helpful, I think the answer would be yes. Certainly we have data collection systems for hospitals, for example. The technical means of doing that, certainly, is--

[Patrick Brown, Conservative, Barrie, ON]

So you have data assistance collections from hospitals. Do you have a fair degree of data from hospitals?

[Glenda Yeates]

We have data from hospitals. I should be clear, it's not about adverse drugs events, that's not one of the things reported to them, but there is a very comprehensive and clear data submission process. If there were a consensus or a regulation or something that required additional reporting, there is a vehicle currently in existence for hospitals to report data.

[Patrick Brown, Conservative, Barrie, ON]

Would that be helpful?

[Glenda Yeates]

Would a regulator find that helpful? My assumption is you would find out certain things from in-hospital use. They would be different from the things you would find out from community use, but they would nonetheless, I presume, be quite useful.

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Yeates.

Monsieur Malo.

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

Thank you for joining us today.

Over the course of the last three meetings, we have met with organizations and departmental officials all of whom are connected in some way with the study under way on post-marketing surveillance of pharmaceutical products.

First of all, I wonder what proportion of their budget and how much time each organization spends on post-marketing surveillance of pharmaceutical products?

Secondly, I am curious as to how all of the organizations responsible for post-marketing surveillance of pharmaceutical products work together and how information is shared? What happens when an agency receives information that could require more in-depth studies on its pharmaceutical products and their effects?

[Glenda Yeates]

Thank you for the question.

Currently we do not have a mandate, essentially, or a request to be in the field of post-marketing surveillance. So when you ask about how much of our budget...that's not an area we have been asked by our governors to pursue.

There are many possibilities in health information. They've given us their priorities, but thus far this has not been a priority.

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

Why were you invited here this morning?

[Glenda Yeates]

I think it's the fact that we have databases under development in the pharmaceutical area that give us the potential tool, if there is a desire to use them.

There is some potential from the databases that we have, and it's useful for people to know.... We don't want to duplicate databases; they're expensive to build. From our point of view, it's useful for people to understand what now exists, and if that is something that can be built on, added to, or in fact could be useful in some way to others, I think that would be helpful.

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

Therefore, at present, none of the data that you collect is used for post-marketing surveillance.

[Dr. Brien Benoit]

Mr. Malo, I would have to give you the same answer. None of our budget is tied to post-marketing surveillance. All I can say—and Ms. Ouellette has just supplied the figures to me— is that our participation in the National Prescription Drug Utilization Information System will cost $805,000 over the next year. As you know, the NPDUIS has many other participants, including the Canadian Institute for Health Information. We have no funding for post-marketing surveillance. We are not involved in this field at the moment.

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

Would you like to see your mandate expanded to include post-marketing surveillance?

[Dr. Brien Benoit]

Our mandate is set out in the Patent Act and pursuant to section 90 of this legislation, Health Canada can ask us to participate in certain inquiries. A request to get involved in this area would need to come from the Minister of Health.

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

Earlier, you were telling us that pharmaceutical companies are not spending the portion of their budget that they should be spending on R&D.

How can you get pharmaceutical companies to spend the money in order to reach these targets?

[Dr. Brien Benoit]

There is nothing we can do to force them to meet these targets. They simply tell us how much they invest in R&D, and we draw up a report. You claim it would be ideal if they spent a minimum of about 10% of their budget on R&D. I believe this is in line with a voluntary agreement concluded between the government and the industry 20 years ago.

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

Would the marketing of pharmaceutical products that present some problems post-marketing be avoided if companies met the 10% target?

[Dr. Brien Benoit]

As I see it, there is no easy answer to that question.

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

You seem to be smiling, Ms. Yeates.