Thank you very much, Madam Chair.
I am going to move into a different line of questioning. I want to talk about clinical trials. Given that the cohort group in clinical trials is so small because it's about rare diseases, there is a problem that I have heard about. People have come to me with this problem many times.
As you're looking at clinical trials, access to the clinical trial group is usually a very difficult thing. If you have two people in New Brunswick, for instance, they may need to come to Ottawa because there's a larger group in Ottawa, etc., and the problem they face is having somebody pay for them so that they are able to come to Ottawa and spend time here. There are costs for staying in a hotel, etc.
These costs of the clinical trials are often a burden for a lot of people, and I wondered if you would talk about how much greater that would be in regard to a rare disease, because we're really talking about small amounts going into one big place. That's the first thing.
Ms. Davies talked about drug safety. It is becoming a major problem for us here in Canada. What I like about your concept is that if, because of new communications technologies, we're suddenly going to work with places such as the United States and Europe now, and if it turns out that the FDA is doing a far better job of drug safety than we are, I would be prepared for the FDA to tell me that “this is a good drug to use in this kind of environment”. I think that's a great piece. I think it's good because we don't have to reinvent wheels and do that kind of stuff.
However, there is the problem of diversity, given that many rare diseases have a genetic component. Given that Canada has such a diverse population—very much unlike Europe in terms of ethnicity, race, and those kinds of diversities, which as we know do have certain DNA components and genetic components to them—and given that the United States also has, but has a difficult time breaking down that information because of their multiple insurance agents and privacy issues, how do you see us getting around that?
The final piece of the question may be more directed to the European Union. Dr. Carrie asked about how difficult it would be here in a federation where there are other jurisdictions, but I see the European Union mandating things for probably 50 countries that are all autonomous nations with their own things going on. They manage to do that relatively well, so maybe we could also learn about how to look at multiple jurisdictions and then come up with a good idea and some innovative ways of dealing with that. I'd like the presenter from Europe to answer that.
For the other questions on cohort size and trials and so on, could you please answer?