Health committee  We have a whole process set out in guidance on our website on how that happens. What happens is that the manufacturer develops a package that meets our requirements for those criteria, and that sets up a meeting.

Health committee  We have a 30-day review period for those packages. Generally, we have a meeting with the manufacturer as well at that time, and point out any considerations we have. I'm talking about the drug side; the exact timeframes I'm more familiar with. Then there's a commitment for the manufacturer to file the submission within a certain time, between the decision that we grant them priority status and when they come in with the package.

Health committee  I won't be able to speak to the specifics of the Gilenya file. My apologies, but I don't have that information in front of me. What I can tell you is that the concerns around knowing the information that led us to a decision is why we went to the second phase of the summary basis of decision project, and we hope that responds to the needs of Canadians.

Health committee  All I can say is that Health Canada, at the health products and food branch, approves products. It doesn't approve medical procedures. I'm not aware of the specifics around that issue; however, we would have looked at any particular products that have that claim. We can go back and take a look at that particular one.

Health committee  Off-label use is actually not covered under the Food and Drugs Act and regulations specifically. That would be an issue for the practice of medicine, and the provinces have the jurisdiction in that area. To get things on labels, the manufacturers have to come forward with the information that supports the risks and benefits and the claims they wish to make, and we evaluate that information, so I can't speak to that.

Health committee  Plain language labelling is certainly one of the initiatives we are trying to move forward. It is something we feel is important for all Canadians. That's because it's important for Canadians to understand the risks and the benefits of the products they are taking. That is an initiative under the regulatory road map that I mentioned earlier.

Health committee  It's very difficult to give you a complete timeline for regulatory processes because they go through the formal Government of Canada process, the Canada Gazette, part I, and then the Canada Gazette, part II. My understanding is that we're hoping to have something in the Canada Gazette, part I, I believe this fall, which would mean prior to December, but I would rather not give you full dates on that because I might be off a bit.

Health committee  In these kinds of—

Health committee  This relates to openness and transparency on the part of our department and specifically our branch. We do have a number of initiatives to move forward in that area. At the moment, we already make available publicly product monographs for each drug that is approved. Those can be found on the Health Canada website.

Health committee  I'm sorry, could you repeat that part?

Health committee  If I could—

Health committee  Okay.

Health committee  Perhaps I could start and my colleagues could join in if they have additional comments.

Health committee  In terms of the impact of technologies, the Food and Drugs Act and regulations provide us with some ability to oversee especially the safety side and the adverse events that might happen with the use of new technologies, especially drugs and devices. We take that role very seriously.

Health committee  Thank you Madam Chair. I am pleased to be here today to speak about emerging technologies in health care and the important regulatory role played by Health Canada. I am the Director General of the Therapeutic Products Directorate within the Health Products and Food Branch (HPFB).