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Health committee  Madam, I can tell you that last year there were 74 new drugs introduced in Canada, which is a little bit more than in the years before. As we've said, previously these investigations and hearings and so on have led to the determination of excessive revenues in certain cases and those moneys have actually been collected back for the federal treasury.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  A lot of that is part of a voluntary compliance undertaking.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  As I was trying to answer to this side of the table, the volume of work has increased. We have 22 drugs of the 1,100 that are deemed to be non-compliant. This is more than in the past. There has been a trend towards relative non-compliance. You may say that 90% are compliant and that's really great.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  Now, the Patent Act was written in 1987. You might ask, well, what about Japan? What about Australia? But they're not in our comparator countries.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  There are a lot of economies and health care systems that are similar to Canada's that are not included in the seven comparators. I understand that the seven were chosen because their health care systems were similar to Canada's.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  I'll answer the last part of the question first. We have no mandate to regulate how much percentage of gross revenues are invested in R and D in Canada; we simply report that. The figures come from the companies themselves. We have not audited the R and D expenditures of any company, and I'm not sure it's in our mandate to do that.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  First of all, we have various price tests. If you have a new cancer drug, let's say the cure for lung cancer, that would be deemed a breakthrough drug. The price that would be permitted under our concurrent guidelines would be the median international price. We would go to the publicly available price in those seven countries and determine the median of that, and this would be the price that would be permitted in Canada.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  That'd be nice to have.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  We are fulfilling our mandate. As you know, we are updating our guidelines, in view of addressing some of the problems raised during our hearings. We believe that modernizing our guidelines will provide increased flexibility to pharmaceutical companies so that they can set slightly higher prices.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  We hope that it will conclude in June. We were hoping that it would be completed in December 2008, but there were delays. Consultations with pharmaceutical companies are underway. Two weeks ago, in fact, we met with a small committee from Rx&D.; Discussions are ongoing.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  Actually, that's one of the items we can look at if we cannot decide by other factors whether the price is excessive or not. We've not yet done that. Going into the costs of making and marketing would be extremely difficult from a financial point of view. We're advised that companies would basically have to open their books and tell us how much it costs and so on.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  Yes, they often do.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  Madam, we do actually look at that. We have a price test called the “reasonable relationship” test. For instance, if it's $1 for a 5-milligram pill, should it be $2 for a 10-milligram pill? At the moment, this is one of the things being discussed in our revision of our guidelines.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  No, that is one of our tests.

February 12th, 2009Committee meeting

Dr. Brien Benoit

Health committee  I couldn't tell you an exact number, but I can tell you that we have about 90 investigations. That doesn't mean that 90 of them are going to result in a determination of excessive pricing, but it means that something in their reporting has triggered a red flag and our staff is looking into it in more detail.

February 12th, 2009Committee meeting

Dr. Brien Benoit