The precautionary principle was taken in that–for instance, one of the conditions. There are two studies already ongoing, and one very large study will be undertaken by the companies that monitor these patients. In that context, there is mandatory reporting because it's a clinical trial. Not only is there mandatory reporting, but there's all the patient information that goes along with mandatory reporting.
What we find when we're doing even active surveillance, which encourages reporting, is that it's not the number of reports you get, it's not just the quantity; it's the quality of reports. So mandatory reporting may give you a piece of paper that says this was the adverse event, but to put that in context you really need the rest of the information around the patient. The best way to get that is through a clinical trial.
We had that discussion internally about the best way to monitor these products, given the context, the history, and the concerns that have been expressed by the Canadian public. The best way we found was to continue the mandatory reporting by the manufacturers and then put in very stringent conditions so we're not just getting the adverse reaction reports; we're getting all the clinical information associated with these patients so we can interpret the reports. It happens all the time that we get adverse reaction reports and we can't interpret them because there's not enough information in them.