Thank you.
The first question was on the legislative requirement. Perhaps it's because I'm a legislative lawyer and I draft legislation, but I believe legislation is generally a good thing, and yes, it's true, I believe for effective post-market surveillance you need legislation. I believe the government has accepted that principle in introducing today a bill on that very subject. I don't believe I have any disagreement with the government on this point.
Your second point was on the definition of an adverse reaction. There is, in the food and drug regulations, a definition of serious adverse drug reaction. I have that in my notes. The definition I gave is what I would call the ideal definition. I did not make this up myself; I got it from Dr. Ed Napke, who designed the first adverse reporting system in Canada. It included everything--devices, drugs, poison. So this is his recommendation that I'm passing along.
The first is that the drug, including its inactive ingredients, or the “incipients”, as they're often called, itself causes no therapeutic benefit, or no diagnostic benefit, no prophylactic benefit--no effect at all--or no injury, not just an injury that isn't known to be a side effect. So if bleeding ulcers are expected and people start having bleeding ulcers, that should also be reported. You're deemed to have assumed the risk, but I think most people in their heart don't believe they're going to get the side effect. It will be someone else, not them, who will be among the 10% who get the side effect.
Finally, with regard to the medical device regulations, I actually did prepare for that in case the question came up. These are even worse than for drugs. There's mandatory reporting only if there's death or serious deterioration of health. And that's only inside Canada. If these devices are causing death outside Canada, there's no obligation to report unless someone has started taking corrective action. If the industry is not correcting it, and no one else is aware of it or no one has taken steps, there is no obligation to even report deaths from medical devices outside Canada; it's only inside Canada.