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 evaluated by using a variety of tools, not the least of which is ADR reporting, but also administrative data analyses, and running brand-new trials and other mechanisms.

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 because it builds relationships so the information can be more readily translated into new practices, let alone regulatory policies.

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 the bureaucrats and executives who run the system.

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 Canadians in fact face greater financial barriers to filling prescriptions than our comparable populations in many other countries, except for the United States.

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 organizations in the United States.

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 Century, otherwise nicknamed MOXXI.

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 surveillance and what is sometimes referred to as data mining.

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 front page of today's paper, however, the progressive licensing seems to be pitched as a mechanism for Canadians to get more rapid access to “breakthrough” drugs.

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 categories that seem to have a potential risk or a potential benefit that needs to be measured or better determined in the real world environment.

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 another drug to manage cholesterol faster in the name of access to medicines is not necessarily, in my opinion, appropriate.

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 increase reporting include possibly compelling and making it legislation, but are more likely to be active about it.

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, like the United States, France, the United Kingdom, Australia, and New Zealand, have all tried various regulatory frameworks using various forms of suasion other than strict regulation, to encourage firms to engage in these post-market studies.