Health committee  Thank you, Madam Chair.

Public Accounts committee  We do a number of foreign inspections, and we also have what we call mutual recognition agreements, where we have gone through confidence-building and rather than constantly going all around the world, we work with our international partners and exchange information. For those th

Public Accounts committee  Mr. Chair, I'll try to be as clear as I possibly can, perhaps it was my miscommunication. Sandoz has a plant in Boucherville, Quebec, and two in the U.S. The FDA inspected all of those. The FDA was concerned with what it saw in the Boucherville plant in Quebec, with respect to

Public Accounts committee  No. We were monitoring and watching that. The ultimate issue, if I may, was a business decision by Sandoz, in terms of responding and how they chose to respond, that has resulted in this. They could have responded to both the FDA warning letter and to our reports differently tha

Public Accounts committee  The drug companies supply us with adverse events from other jurisdictions. They also supply us with adverse events reported to them. We also take adverse events from physicians directly—there is a form that they fill out—and from individual patients themselves. So we get it fro

Public Accounts committee  That goes back to the MedEffect and the Canadian adverse event reporting newsletter. We have several thousand people who subscribe to it.

Public Accounts committee  It is on it.

Public Accounts committee  Yes. We don't post those hundreds of thousands of adverse events. We sift through that information to what the real events are—what the things are that we've followed up on.

Public Accounts committee  What we post is the specific summaries of those, as we've investigated them. Otherwise, you're swimming in a sea of data, with hundreds of thousands year after year.

Public Accounts committee  Yes, and that is what is summarized in the adverse event newsletters, warnings to health professionals, etc.

Public Accounts committee  Yes.

Public Accounts committee  We'll provide several links. We'll provide a link to all of the drugs that are available for sale in Canada. We'll also provide a link to our adverse events, the MedEffect, and Canadian adverse reaction newsletter. So you will have both those, all drugs and all adverse events, an

Public Accounts committee  It is already shared with the public.

Public Accounts committee  Once a product is on the market, adverse events are the most important signal for us. We follow those up very actively. To provide the committee with some specific numbers, there were over 30,000 domestic adverse events reported to Health Canada in the last year—that is in additi

Public Accounts committee  Thank you very much, Mr. Chair, for the member's question. With respect to safety, first and foremost, the design of all clinical trials is subject to a review and approval by the department to ensure that the trial both achieves its objective in its design and that the patient'