Health committee  That's not going to tell you. I think the heart of your question is that most studies are not powered to find adverse events, because they're very, very rare in the grand scheme of things. Most studies are powered to find out whether or not they work and whether or not there are

Health committee  That's right.

Health committee  I'll make a quick comment.

Health committee  If I go with Carol's proposal of, say, $20 million—and I don't know what it is because we haven't costed it out—I will say we allocated $2 billion in compensation for people infected with hepatitis C. I think the cost of not investing up front is going to be much greater, and the

Health committee  I think part of it, though, comes back to the level of uncertainty. The more uncertain the data, the more innovative the product, the more you have to put in a robust surveillance system. In some cases, as a condition to having that drug approved, you have to set up a very robust

Health committee  I go back to saying that everybody has a bias. When we look at Health Canada, at the government, at the drug review agencies, at the provincial governments, and at industry, everybody comes with a bias. I think the challenge is to put that bias out there and to be very clear. Unf

Health committee  I think one has to talk about the different patient populations. When we're talking about very small patient populations—hemophiliacs, or people who have other kinds of conditions—patient registries become really important. Again, you're dealing with very small databases, you're

Health committee  For the most part, we see that a lot of the studies are in fact international. I go back also to some of our work with new and innovative therapies for rare disorders. Certainly for many of our patients, having no access to medicine is a much greater harm than not. And many patie

Health committee  Can I make one additional comment on that? I think it's a perfect question and it's a perfect example of the disconnect between what happens in terms of Health Canada and their approval for marketing and what actually happens in terms of the availability and marketing. It goes

Health committee  Yes, we do.

Health committee  We have it in terms of any time there's a conflict of interest.... We work with a number of organizations, including organizations that deal with us on anemia. We deal with organizations that deal with us in terms of blood. I also get some funding from--

Health committee  I get money from pharmaceutical companies.

Health committee  That's a loaded question, as you know. We believe that it is in fact a national issue, recognizing again that health is funded at both levels. Carol made a comment about FPTs, and we do know how difficult it is for FPTs to work. We know that even the simplest FPT agreement take

Health committee  If you had asked me this five years ago, I would have said definitely. Many of us have been very pleased with the kind of progress Health Canada has been able to make. Certainly they've demonstrated it, as we look at something like the progressive licensing framework, as we look

Health committee  Thank you very much. I really appreciate the opportunity to be here. I am here as the president of the Anemia Institute for Research and Education. I will also speak, though, in my role as president of the Canadian Organization for Rare Disorders. Let me just put into the cont