Health committee  Those countries were determined...and I've asked this question since I've been there. Those European countries were determined.... They're in the Patent Act, actually.

Health committee  That also includes the SPA. These funds are set aside exclusively to hold hearings. Therefore, if there are no hearings, we will not spend this money.

Health committee  Mr. Malo, our budget was increased by 80%. You are right in saying that it has almost doubled. However, one must remember that our workload practically doubled as well, and we were not responsible for that. This is a result of the fact that more patented drugs were introduced into the Canadian market and we had to conduct investigations to determine if prices were consistent with our guidelines.

Health committee  Indeed, our mandate is focused on excessive pricing. To determine whether or not a price is excessive, all of the issues surrounding a particular product must be examined. We have a very complex comparative analysis system for drugs that are used to treat the same disease. This allows us to determine what their prices are, etc.

Health committee  The Patent Act clearly stipulates that we are to review net prices, or, to be more precise, discounted prices, etc. We are currently holding consultations with both provincial and industry representatives to identify and assess these rebates. Certain pharmaceutical companies seek to postpone their discounts because this reduces their average prices; on the other hand, there are many others, perhaps even the majority, that do not.

Health committee  We act in full compliance with the Patent Act, a federal statute. We fully recognize that health care falls within provincial jurisdiction, but we are acting under the Patent Act. Our mandate is a federal one.

Health committee  No, I wouldn’t say that. We comply with rather stringent regulations that have not been amended for 15 years because they work rather well. We are often called before the courts by pharmaceutical companies that don’t like the decisions we hand down during our hearings, or for other reasons.

Health committee  It is because of the marked increase in our workload. All of the things you mentioned are part of our workload.

Health committee  We can say that half of the supplementary amount we requested and received will be spent on hearings.

Health committee  Approximately 90% of drugs are in compliance with our guidelines, so let us say that 10% are priced too high. Let's look at the issue from another angle: I would say that this is a sign that our system works very well.

Health committee  Suppose that only 10% of drivers exceed the speed limit. If 90% of drivers respect the speed limit, does that mean that the police should not pull over the 10% who exceed the speed limit?

Health committee  Well, Dr. Bennett, if I could ask the question back, has that Institute on Governance report been distributed to the members of this committee? I ask because we were provided with this report in September of last year. The document that we received is dated April of 2008 and is marked as confidential, and we were assured by Rx&D;, the organization that mandated this report, that we would be permitted, if the report were to be made public, to respond to some of the questions, one of which you're presenting today.

Health committee  I'll give you a short answer. Right at the moment our price regulations apply at introduction. We are currently asking for discussions and proposals regarding a real-world efficacy after the drug has been on the market for a few years. But at the moment, we don't look at the price after introduction--

Health committee  --except for the consumer price index every year. They're allowed a small percentage.

Health committee  I think this whole initiative is great. In my opinion, it's long overdue. But you have a lot of work to do in terms of how you're going to implement it. You have different organizations; you have CIHI that can collect the data, if it's obligatory that it be reported to them. I'm not sure what our role in this would be exactly.