Health committee  I think it's important to recognize that these notions of pragmatic trials, or what are called designed delays, are typically applied in cases when we actually don't know if the new drug is in fact superior or if the new drug will cause more harm than good. They're also designed in such a way that is referred to as a designed delay, and all populations who would be eligible for the treatment will eventually get it.

Health committee  There's a period during which some people get a medicine and some people don't. It's random. It's basically a pragmatic way of running a randomized trial in the post-market world. It is a new idea. It's been explored for years, but it hasn't been applied very often. But there are provinces now looking into using these pragmatic trials in an environment where we don't know the value and the safety of the medicine.

Health committee  This is my last point. I just want to stress, as you've heard from several witnesses before this committee, that however important—and perhaps essential—post-market surveillance and vigilance is, it is not a substitute for due diligence pre-market. It would not be acceptable to lower the bar before medicines come to market simply because we think we have a safety net in the real world environment.

Health committee  Thank you very much for the invitation to speak on this important matter. My name is Steve Morgan. I'm an assistant professor at the University of British Columbia's Centre for Health Services and Policy Research. CHSPR, as it's known, is one of Canada's academic repositories for administrative health care data.

Health committee  For sure. Our research program spans the life course of pharmaceutical policy, from factors that influence pharmaceutical innovation and research and development, including the location thereof, through to factors that were associated with the coverage of pharmaceuticals, the design of public insurance plans, and, finally, through the analysis of the population's use of medicines, its outcomes both on health status and on the health care system.

Health committee  That's an important policy process, right—I mean, pointing people towards where the information is. That's what we might do. But I also think we should collaborate and cooperate and work with the manufacturers to say, what's a reasonable level of disclosure?

Health committee  Yes, it is, and I think we need to engage in dialogue, for instance, with people from the U.K., because the disclosure documents that NICE produces actually have a lot more information than the CDR is able to produce. And believe me, I've interviewed members of the CEDAC, and they'd love to put out more information.

Health committee  The answer is no, I don't. I'm not familiar enough with the literature around pre-market regulation, and so I would have to defer to my colleagues who are experts in regulatory process and impact. I would note, however, that there are reasons, for instance, why countries like France and elsewhere have lots of drugs listed.

Health committee  I would just add that, as Dr. Menon says, different countries take different approaches. In Australia and New Zealand, for instance, they actually vet drugs that are for rare/orphan diseases through their centralized process, but they also have, under political pressures, probably rightfully in some cases, created separate funding envelopes for drugs for rare diseases.

Health committee  Again, as an outsider, I would say this is a system that's working reasonably well. I went into my study, which was started a couple of years ago, expecting to find flaws, to be honest, and I was surprised at how well Canada's system runs. I think what you're finding is the inevitable politics of any program that has to allocate scarce resources—someone wins, someone loses, and the losers invariably have to complain.

Health committee  Although I've never been in the room and I'm not part of the process, from an outsider's perspective and having done candid interviews with the people involved in processes in five of these countries, I would argue that Canada actually focuses on costs less than all countries, except for NICE in the U.K.

Health committee  About half or so are generic medicines. The reason the Australian process vets their generics through the whole process is that, as I mentioned earlier, Australia uses a price negotiation and price setting system that's exceedingly complicated. Drugs have to go through the process to establish the therapeutic benchmarks that you're going to compare them against when doing price considerations.

Health committee  Of the five countries that I've studied, yes. Dev could probably speak to the 16 or more that they've looked at.

Health committee  I'll quickly jump in. I think it's essential. It's part of the original business case for the CDR. The Americans have a group that runs what's called the Drug Effectiveness Review Project, DERP, and their slogan is “globalize the evidence, localize the decision”. The CDR in many ways does that in the Canadian context.

Health committee  I think you've probably heard from industry and its various representatives with those comments. They would say that about any process that reviews medicines to make transparent, evidence-based coverage decisions. Industry doesn't like any of these processes around the world, because in some sense it's easier to have a free market for pharmaceuticals than to have an agency look at the science.