Health committee  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.

Health committee  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.

Health committee  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.

Health committee  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.

Health committee  Mr. Thibault, I work primarily in a hospital. I'm in a tertiary care hospital, so we have a quality assurance program that is quite intrusive. Even a minor medication error creates what we call an incident report. The incident report is then reviewed by the unit manager, and, if it is minor, dealt with.

Health committee  The answer, regrettably, is not as far as I know.

Health committee  That's exactly what I've just said. Most of the minor adverse reactions are not reported. If this committee is to make a recommendation—I'm going to speak for our particular organization—we would like to know what your objective is, and then we could say how we would fit into that objective, because at the moment, adverse reaction is not part of our business.

Health committee  First of all, the PMPRB's role in reporting has primarily a financial impact implication. Our interest in collecting or using a lot of the CIHI data is to analyze it so that we can help the public drug plans better manage their operations. We tell them what's coming in the future—

Health committee  I'm just trying to say that our particular mandate at the moment is primarily financial. If we were to take on something like the mandatory reporting of adverse events, we would have to create a different structure. I'm also a practising physician, so I know many—or most, I would say—adverse reactions don't ever get reported.

Health committee  Thank you, Madam. I can answer that question. First of all, the role of the PMPRB is to protect Canadian consumers from excessive prices. The meaning of the word “excessive” is poorly understood by the public because drug companies will tell you—as they no doubt did last time they appeared before you—that they spend a considerable amount of money on R&D.; Our role, however, is to define the word “excessive” and we do that in several ways.

Health committee  I would not say they spend “heavily”, Madam.

Health committee  They do invest in research and each year, we do an analysis, since they are required to disclose how much money they have invested in their research efforts. When Parliament created the PMPRB in 1987, it called on the pharmaceutical industry to invest 10% of its gross revenues in research.

Health committee  Thank you, Madam Chair. Good morning. Bonjour. On behalf of the Patented Medicine Prices Review Board--and we will call ourselves the PMPRB from here on out, as it is a lot easier--I am pleased to have this opportunity to appear before this committee to discuss the work of the National Prescription Drug Utilization Information System, also called NPDUIS.

Health committee  A significant difference.

Health committee  The easy answer is that we regulate the prices only as they leave the factory gate. As I said earlier, there are a lot of add-ons between the factory gate and the actual consumer. Those add-ons we have absolutely no jurisdiction over. We can have an idea of what the add-ons are, but we have absolutely no authority to change it.