Health committee  If they were carrying out that function and it was for that function, yes.

Health committee  We didn't want to narrow it. “A person who sells” does get you that widest group in the chain. As Mr. Young just said, it goes all the way down through the company—which is typically the holder of the authorization—into wholesale and into pharmacy. So the minister would be able t

Health committee  Thank you, Mr. Chair. The word “prescribed” next to “health care institutions” indicates that we would use a regulation to say which ones they would be, so “prescribed” just points to the fact that the regulations will tell you which ones. If the list is up at the act level in a

Health committee  It would certainly make that exercise quite difficult.

Health committee  Mr. Chair, what I can say, again, is that in our discussions on prospective language, health care professionals, among others, and patient groups brought up this issue. They raised it very profoundly with us. As a regulator, we want to have this right. It's a threshold for a very

Health committee  Certainly. Thank you, Mr. Chair. On the first point, when we started discussing some of the text in the bill, this was raised by health care professionals. It's the first time you've had mandatory recall. It's very important that the threshold language be able to deal with the k

Health committee  Yes, typically it would. If you look at article 39 in TRIPS and its equivalent article 1711 in NAFTA, it does contemplate that companies have to invest quite a bit of money to get the data that they would submit—and this is health-related, so it's safety and efficacy data—but the

Health committee  Mr. Chair, the inclusion of a list in this definition may be a very vulnerable way to introduce what the member is suggesting. There is a commonly understood international approach to what is protected, and that's really expressed in this definition. By saying what is not on that

Health committee  This is where a number of clauses in the bill can really work together very valuably. You can start with approval. There is a section in the proposals that would allow us to put conditions on authorizations, so to plan out what to look for as a drug goes out. If it's not approv

Health committee  Oh, sorry. If we start to see adverse events occurring and we see that kids are being harmed, then we can pick that up and try to understand it and figure out if it's the drug and if we need to do something, and we can use these powers to very immediately get at that analysis an

Health committee  On the second question about a new drug coming in and a person taking many drugs, that can happen. Clinical trials don't always tell us how the therapies will react together. I think one of the big promises from the proposals is the institutional reporting, because as patients

Health committee  We've taken this question up and really searched carefully through the language, the threshold that you need to use for recall, and we absolutely think that, looking at Alesse, we would be able to effect recall on the language that we've proposed. A failure to work in that case w

Health committee  That's what we would do.

Health committee  Mr. Chair, on the first issue about suspension, when putting in measures at either the legislative or regulatory level, you need to look at what the instrument does. Recall is introduced at the act level. Suspension is something that Health Canada can do under the current regulat

Health committee  No. Suspension does mean that it can't be sold anymore. The authorization allows you to sell. There's a prohibition in law that says that you don't sell unless you have an authorization.