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

Health committee  Thank you, Madam Chair. Predictive technologies are a very important innovation in this space. Some of them will become regulated as medical devices, but some of them are a matter of hospital-based research. Identifying predictively when a disease is going to appear or what its symptoms and natural history might look like is very important work.

Health committee  Thank you. Madam Chair, we at Health Canada would very strongly support the idea of cooperating in international registries. This is a very key aspect of the rare disease world. How you enter very important information into registries is a key question. So coordinating internationally is a very important issue.

Health committee  Madam Chair, I would defer on that question to my colleague, Dr. Wong-Rieger. I will answer, though, that some of it is hard to measure. It will be inexact because diagnosing some of these diseases is very hard to do. We may not be picking up every patient in the country. But we think there are just under 7,000 diseases that have been identified internationally.

Health committee  Thank you, Madam Chair. In terms of timing I will acknowledge that we are doing our best to catch up. I'm not sure it's—

Health committee  Pardon me, Madam Chair.

Health committee  Madam Chair, if I could clarify, is it the question on the cooperation, or the ethnicity issue?

Health committee  Thank you for that question. In terms of uncertainties, there are some uncertainties that Health Canada is able to address. I think others would be in the hands of entities like Genome Canada and CIHR, which are on the ground working with those who have proposed to conduct research.

Health committee  Off-label is a very important concept in our realm. Label indications mean that you've come to Health Canada and you have demonstrated, as a company, that the product works and it's safe for that indication or that claim. So we put that on the label. It then goes out into the prescribing environment, and we don't, as Health Canada, tell physicians how to prescribe.

Health committee  Thank you. Clinical trials are a key aspect of the new framework. This actually is a very international discussion as well. A number of features will be uniquely Canadian. One is our geography. I think it's quite right to say that the disparity of where patients live and whether they have access to a trial site will be a uniquely Canadian factor.

Health committee  Yes, I've certainly learned that making regulatory frameworks is not for the faint of heart. For a framework like this, at the federal level you really have to go out and first listen and understand the needs across country, because it is quite true that there is a lot going on in the hospitals.

Health committee  That would very much be included.