Public Accounts committee  Mr. Chair, our intent with the new cost recovery regime--as I said, we hope to begin consultations next month--is to bring additional resources into our regulatory system. So in that respect it's very important for us. The User Fees Act requires that we establish service standard

Public Accounts committee  Thank you, Chair. Yes, that's essentially correct. We have the pre-market review process. We approve conditions for products. If we're not satisfied that the benefits outweigh the risks, we will not approve them. We approve product labels that have indications for use, and so on

Public Accounts committee  Thank you, Mr. Chair. The member has hit upon a very important issue in terms of the future of food and drug regulation around the world. As you know, Vioxx was a global issue, and the action that was taken was global. We work closely with the FDA, in particular; one of our clos

Public Accounts committee  Thank you for that clarification. The reason I referred to the investment in performance review times is that we had developed a backlog in product reviews. The bottom line for us is that we never allow a product on the market without doing a thorough review. That's why a backlo

Public Accounts committee  Absolutely not.

Public Accounts committee  Thank you. Since the audit was done for these years in question, there have been two tranches of investment in the health product and the food regulatory regime. One was in 2003, and it focused on improving product review times. Canada had fallen way behind international standar

Public Accounts committee  Thank you, Chair. Yes, I can update you on that. We are working very hard on getting prepared to begin the consultation process on a new cost recovery regime. You're quite right, they were set in 1993-94 or so, and they're significantly out of date. There are two respects: th

Health committee  I guess that's over to me. Thank you for the question. We take our role to review health products extremely seriously. Our role is to do pre-market reviews. If we feel that the risk profile of a product is such that the risks outweigh the benefits, we will not approve it. That's

Health committee  All of the products for which we have pre-market approval responsibility have been reviewed. That's what we do.

Health committee  Certainly. Fees represent about 25% of our budget in the Health Products and Food Branch. They were set in the early to mid-1990s and have not been adjusted since, so there's been no accounting, even for inflation, during that time. We are preparing to launch a consultation proc

Health committee  Thank you for that question. I don't have a precise number with me in terms of the number of follow-up studies, but we can get that to you. The number of staff we have in our post-market area will be growing to around 190 next year. So it has grown fairly significantly from th

Health committee  They are mostly here in Ottawa. We do have regional adverse drug reaction reporting centres around the country. There are seven of those.

Health committee  The adverse reaction work we do is within our post-market area. Yes, that's part of the continuum.

Health committee  Yes.

Health committee  No, but they have the opportunity to do that, and we are looking at means of how we can increase reporting from the entire array of people who have an interest—practitioners, consumers, and so on.