Health committee  I'd echo that. One of the main issues here is that ADR reporting is one signal. It's a challenge sometimes to detect those rare occurrences and connect the dots. It's the reason why post-market surveillance and post-market drug safety and effectiveness have to be monitored and ev

Health committee  I see there also being an advantage in having regional centres of excellence. I think we've thrown the idea out there of having three to five centres in the country. Getting closer to the practitioners--those people who are prescribing and dispensing medicines--is important becau

Health committee  I would just reiterate that progressive licensing makes sense if it is to add to the existing rigour that is in pre-market. And you are right: I think Canada does have mechanisms in place to expedite access to medicines for people in dire circumstances.

Health committee  Perhaps what one needs to do is take the pressure off Health Canada by actually introducing legislation that requires a new degree of transparency with respect to clinical trials that are used to approve or not approve medicines. Right now the onus and the blame seem to lie with

Health committee  I appreciate your bringing up the question about access because it is an important issue as we discuss prescription drugs. Canada shares the distinction with the United States of being one of the only developed countries not to have universal pharmaceutical insurance coverage. So

Health committee  Fantastic. I would direct those questions to her. It's a particularly impressive Canadian success story.

Health committee  Canada could look south of the border, for instance, to the veterans administration in the United States. The VA runs an electronic system for tracking and monitoring prescription use and for helping physicians make prescribing choices. So do many of the major managed health orga

Health committee  I think maybe I'll leave this one to Andreas.

Health committee  The costs I don't, but I'll give you a Canadian example of an innovative system for bringing electronic prescribing assistance devices into the hands of physicians. It's from Montreal. Dr. Robyn Tamblyn, at McGill University, runs a project called the Medical Office of the 21st

Health committee  I think the other players would be provinces that, at the current time, are effectively data stewards as it relates to administrative data records around pharmaceutical use and other health care services. They're going to be a key player in terms of ongoing, active post-market su

Health committee  Very quickly, the notion of progressive licensing, which you have articulated--which is to maintain the status quo in terms of pre-market regulation but add a notion that a licence is deemed temporary--is, in my view, the ideal notion of a progressive licence. According to the

Health committee  Thanks. I'm a fan of the line of appreciative inquiry: begin with what you do well and build on that. I think there are a few things. An example would be Isis, a Toronto institute where they're doing excellent evaluation or pharmaco-vigilance work by choosing drugs or drug categ

Health committee  Very quickly, I think I would look to ensure that the progressive licences are only used in circumstances that are extremely dire, in which there are compelling and compassionate grounds for making access to a medicine early, on the basis of compassion. Making access to yet anoth

Health committee  That is a major question. How do we increase the degree to which adverse events are reported? Even when you compel a doctor, a pharmacist, or a hospital to report events, systems tend to report, in the best situations, on average about 10% of adverse events. Mechanisms to increas

Health committee  I think the key point I would like to make is that you have to design a regulatory framework that compels and actually mandates the manufacturer to complete phase four, or post-marketing trials. The penalty would be withdrawal of the product from the market. Several countries, li