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.
We are keeping a very close eye on what's going on in the research community. One of the things we're doing is outreach for this new framework. With those involved in diagnosing and trying to find drugs to treat these diseases—and a lot of it is genetically based work—we're meeting with them early to try to understand what they're doing. We're doing that to try to take away uncertainties about what they need to look at for a potential regulatory filing in the future. You don't want the research to stall in the clinic. Eventually you want to achieve a market presence to make sure that you're translating your research into the most benefit for Canadian patients.
One of the uncertainties we can reduce and that can cause risk aversion is asking what the regulator needs. What is the pathway to taking this research into what the market will require? We're working on that part.
From a risk aversion point of view, I think that the costs of some failures, given the costs of development, are recognized by regulators. We do try to understand why we require data in the way that we do, because some of the expensive work is what you need to do to present the regulatory filing to the USFDA and Europe.
We do have some working groups and some initiatives worldwide. They are not only trained on rare diseases, but we're also trying to understand how to focus our data requirements better. We're on a group with the USFDA and Europe, trying to come to ground on that discussion. We have participants such as industry—a lot of very excellent scientists—trying to think that through.
It doesn't displace risk entirely, but it tries to bring more innovation to that research climate and how it might translate into the development of drugs.