Health committee  Good morning, I'm David Lee. I'm the director of the office of legislative and regulatory modernization within the branch.

Health committee  Mr. Chair, technically what's in is both drugs and devices and what's excluded is natural health products as it's defined in those regulations. We are certainly looking at some products that would apply under the drug definition, like disinfectants, and so on. Again, that's also part of our regulatory road map as we work on regulations under the act as well, so we can speak to that.

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 regulations.

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.

Health committee  Yes. Recall is usually when we need to reach into the market and say something is so dangerous right now we need to remove it from supply. It usually comes back to the manufacturer usually from pharmacy and from retail. That's different from suspension. Suspension just says don't sell any more into the system.

Health committee  Usually when there's a suspension we will advise the whole drug system and people will appreciate that there is a stop. Sale includes distribution, so technically speaking, you shouldn't see more of the drug going out to any one particular patient when we suspend. Having said that, sometimes it is so dangerous you really need to remove it from pharmacy shelves and that would be recall.

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 would also constitute grounds for a recall.

Health committee  That's what we would do.

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 approved for kids initially, we can put in some measures that we want to see if we think it's going to be used in that population.

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 and do a reassessment.

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 go in and they're taking a number of medications, seeing that very early is very important, so if there is a reaction between a new drug coming out and other drugs that are already out there, we can try to pick that up.

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 list....

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 then they have to give it to a third-party regulator, as it they wouldn't normally disclose that to competitors.

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 kind of event that we saw, a failure of a birth control pill to work.

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 serious moment as a regulator.