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. There's a lot of research going on. Often patients are appearing and they're very hard to diagnose. You have to do some international collaboration to even understand if the disease is there, and then all of a sudden you're looking for a treatment.
That will start to involve us at the federal level, but there are many levels in play. There are funding levels. Getting a small research project off the ground is very important. At early stages you're not thinking about regulations when you're in your lab, trying to innovate and identify whether a therapy will work. But it's very important to approach the regulatory aspects early so that when you're doing your studies, you don't misfire. You can start to innovate, but if you don't start to build a case to get on the market, your research is not going to translate out.
I've been doing more work with Genome Canada and CIHR to go out and talk to researchers about what they're going to be expected to do as they work up their innovations. So that's one level of federal participation where we have to look at and talk with a lot of colleagues. That's both primary care physicians, research physicians, and academic physicians.
But really, there is an international discussion as well. One of the really interesting things about rare disease is that it does attract a lot of international cooperation. So part of what we need to do is look at the needs of our patients, our researchers, our provinces, and also see what we can draw from the international context and bring together. That's a good federal role because, as I mentioned, with things like trial advice, if we're setting up a global trial, that affects all those levels, but we're giving the advice. So we're trying to find ways to do that and build a framework so that people can have a voice at those early discussions.
It's not easy to design because we don't have a lot of good precedence in Canada. But we do get help from our international colleagues who have designed frameworks such as these, and they have been giving us very important advice on it. Putting it together is quite involved.