Health committee  The Institute on Governance document was paid for by Rx&D;, was never published on the Rx&D; website, was never published on the Institute on Governance website, and reflects ideas that are at least two years old. The thing was published in April 2008. We were provided with a copy in September 2008, which was supposed to be confidential, but obviously was distributed to members of this committee.

Health committee  The industry, the pharmaceutical environment. The compliance rate in 2004 was something like 95%. It has now gradually drifted down, and you're going to see it in our annual report, to about 89%. You say it's only 5%, but that 5% may represent many companies, may represent many drugs, each one of which deserves its own investigation.

Health committee  First of all, we have not discussed this with the minister. We have a new minister. We've met her, and this has not been part of the original consultation between us. We are driven and controlled and mandated by the Patent Act. So if a generic product doesn't have a patent, we have no jurisdiction.

Health committee  But if you have a breakthrough drug, I think the last time—

Health committee  Your comments are multi-pointed, I might say. I know you have an interest in the generics.

Health committee  Well, you said the cost of drugs is skyrocketing.

Health committee  The amount spent on drugs in Canada--for you, as an individual Canadian citizen--is the second-highest in the world. The people in the United States spend I don't know how much. We spend roughly $900 per person in Canada on drugs of all kinds—not all prescription, not all patented.

Health committee  They're very few, but the last time we talked in February, you referred to cancer drugs, for example. If you have a drug that's going to cure breast cancer and there's no competitor in Canada, there's nobody that does the same treatment, then we go to the median international—

Health committee  Madam, they will never get higher than the highest-priced competitor in the same therapeutic class. So if you have a new drug—

Health committee  Well, the thing is we don't have the mandate to do that because—

Health committee  Yes. When a patentee appeals one of our decisions to the Federal Court, rulings are rarely against us. We did get one negative ruling from the Federal Court concerning jurisdiction. It involved a drug being sold in Canada with limited distribution to specific patients. The case went on for several years.

Health committee  About $2 million out of a total budget of a little over $11 million.

Health committee  You have just summed up the goal of our consultations. We hope that, with the new categories and all of the changes to our guidelines, compliance rates will rise and we will have fewer investigations and hearings.

Health committee  The process will be finalized in June, and we will begin to enforce the new guidelines in January 2010. Mr. Malo, we really hope that the new guidelines will significantly reduce the number of appeals.

Health committee  I cannot answer your technical question specifically, Mr. Malo, but I will ask Mrs. Ouellet to address it. Right now, we are spending that money. We have eight hearings underway, one of which has been going on for 10 years. This is an unfortunate way to have to resolve certain issues.