Health Committee on April 25th, 2007

[The Chair, Conservative, Rob Merrifield]

Okay, go ahead.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Last Monday our chair said that one solution may be to come up with one form. Do you think that that may help us bring the two parties together?

[John Wright]

Mr. Chair, Saskatchewan is actually taking the lead on the development of a common formulary for a national basis. This is part of the national pharmaceutical strategy, one of the five key priorities, and work is well under way.

[The Chair, Conservative, Rob Merrifield]

Thank you.

Mr. Brown, the floor is yours.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Mr. Chairman.

When the CDR was set up and the decision-makers decided that it was an appropriate route to take, were there any drugs being approved that shouldn't have been approved? When this extra layer of review was put in, were there cases that sparked the decision? Was there a case where a provincial body was approving a drug prematurely? Was giving the best possible drug to those patients in need somehow inhibited? Are there any cases like these that merited the creation of this body?

I just want to know whether there were any actual errors that might have sparked this extra layer of review.

[Robert Nakagawa]

I could respond.

As somebody who was involved in that process, I can say there was no specific triggering event. Our current drug regulation process is based on the experience that came out of thalidomide. The latest round looking at post-marketing surveillance is from Vioxx. There was no such triggering event for the common drug review. There was, I guess, just the experience of all of us doing exactly the same thing in trying to review the same medical literature for the same drug. The larger provinces had very rigorous, evidence-based, critical appraisal systems similar to the CDR. The smaller provinces didn't have that capacity, and so we were looking at ways to share that and to be able to improve the quality of the drug reviews in those provinces that didn't have the capacity.

But to answer your question directly, no, there was no precipitating event to lead us down this path.

[Patrick Brown, Conservative, Barrie, ON]

Just to play the devil's advocate, one thing I get in my riding is the general belief, I guess among some Canadians, that government is too big. What do you say to people with concerns that there are overlapping jurisdictions here, in the sense of relevancy, where you might have a provincial body deciding to approve a drug that has been rejected federally, and you're at cross purposes and have duplication? What explanation is there that we're not duplicating government resources in these instances?

[Robert Nakagawa]

Well, I would respond that the common drug review is doing the opposite. It's allowing us to share resources across the country. I think Dr. Sanders referred to the 18 different reviews that would have been undertaken prior to this, and now the resources are pooled, the experts are pooled, and we can do one review, which is then shared across the country. So there's a lot of efficiency being generated by this across the country, rather than additional redundancy, because it could have happened 16 or 18 times before and now it happens once.

[Patrick Brown, Conservative, Barrie, ON]

Is there any evidence on that front that we've actually expedited timelines? From a patient access perspective, I have concerns from constituents that the CDR has actually delayed their access to needed drugs. Is there any evidence that we've actually made it faster?

[Mike Tierney]

There was an independent study published in the Provincial Reimbursement Advisor in November that looked at the time taken from Health Canada approval to decision-making by drug plans: pre-CDR it was 471 days, post-CDR it's 479 days. So there really hasn't been any change.

Along the way, we've added opportunities for the manufacturers to receive and comment on our reviews, which they did not have prior to the CDR.

[The Chair, Conservative, Rob Merrifield]

Is it possible that you could provide the committee with that study?

Thanks.

[Patrick Brown, Conservative, Barrie, ON]

Two other areas where I've had concerns brought to me in my riding are, one, on the front of rare diseases, where the delays are perceived to be excessive; and two, on drugs relating to cancer. Is there any information you can share with us on how the CDR handles these two areas? Is there any concern that because of the smaller patient samples, CDR isn't currently best able to handle the approval or disapproval of drugs for rare diseases? And could you comment on the cancer front as well?

[Mike Tierney]

I'll take the cancer one first.

In the first three and some years of the CDR, we've received over 90 submissions, and six of those drugs were for the treatment of cancer. The reason that's relatively low is that most cancer drugs are given by injection, and they're given in cancer centres or hospital settings. That's outside the mandate of the CDR. So the joint oncology drug review process was an opportunity for the provinces. And we are collaborating with that process to work together to provide a review of not just the oral drugs, but also the injectable drugs—not just the drugs given in the community, but also those given in hospitals and cancer centres.

[John Wright]

With respect to rare diseases, again, this is another element and another priority of the national pharmaceutical strategy. As I mentioned, Saskatchewan leads the common formulary. Alberta is leading work on how we can address expensive drugs for rare diseases. So work continues on that.

The deputies just met these last several days in Montreal, and this was an issue that came up. A friend of mine and Bob and I were talking earlier about the need to expedite our review processes on that.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Mrs. Bennett.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Thank you very much.

I think I'm still having trouble with the context of where the national pharmaceutical strategy is. Maybe you could update me, from what the deputy ministers have agreed to.

The EU has a common formulary, and we heard from the five formularies that are in the federal government. Where does the CDR fit, in moving towards a common formulary? And what timeframe are we looking at in terms of generics and the other pieces? I know about the budget and the mandate you have, but where do you, as deputy ministers, see this in the process, and how long will it take for us to actually not have these little bits and be able to get on to an actual national pharmaceutical strategy that includes an approach to expensive drugs for rare diseases, catastrophic drug coverage, and our moving as a country beyond what was there in the Canada Health Act, when everything happened by doctors and in hospitals and drugs weren't as important?

[John Wright]

Very quickly and briefly, Mr. Chair, there are five elements to the national pharmaceutical strategy that the provinces are currently working on: catastrophic coverage, a common formulary, pricing and purchasing, real world effectiveness and safety, and expensive drugs for rare diseases. Again, the deputies just met for the last couple of days in Montreal.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Is post-market surveillance on that list?

[John Wright]

That would be real world effectiveness. In fact, that was another major topic for discussion, as to how to expedite it. Ontario is responsible for that area.

We look forward to meeting again, and with ministers in June of this year in sunny Saskatchewan. At that time we expect that officials will have presented to the deputies, and through the deputies to the ministers, a solid update on the national pharmaceutical strategy.

[Carolyn Bennett, Liberal, St. Paul's, ON]

I understand that in other countries people look at international evidence with stakeholders, particularly around cancer. Patient groups and provider groups have a sort of green light committee that will green-light stuff based on an international—whether it's Japan or the EU or the FDA—standards, so that if those stakeholders are comfortable that the science has been done properly, the drug could be fast-tracked. Then they move to whether you pay for it or not in terms of whether it is effective and then whether it is worth paying for in that sort of way.

I think all of us as parliamentarians are concerned as to where the choke points are in all of this in terms of the science. If it resides with Health Canada, then the 491 days that it takes in your shop to actually get drugs to market—And then, I think the far more important thing that Canada should be doing is finding out what happens when it gets out in practice.

In our looking at safety and efficacy and tax dollars—there's a huge spectrum there—is there something that you see? In how many cases of the drugs you look at do you also look at what international groups have done? And just from your gut—and maybe it's not fair to ask the agency, but rather any of the deputy ministers—how many drugs would we be sitting waiting for Health Canada to approve when internationally you knew they were going to be fine? It seems a rather odd thing for us to do here in Canada, when other people are taking other scientists' points of view on this and you could just get to work.

[Mike Tierney]

One of the things we have initiated in collaboration with Health Canada is the capacity for a CDR to start our review process in the latter stages of the Health Canada review process, so that for those drugs that offer the potential for treatment of life-threatening or very serious conditions, we could expedite the CDR review process and also bring forward the learnings from the Health Canada review into the CDR. We've completed one such drug review and were able to reach a recommendation within two months of the market approval by Health Canada.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Let me change the way I'm asking this. What is the value added—I mean in terms of you people who do this every day—if you look at the international evidence? We as a committee are supposed to look at how we get Canadians what they need. How often would you be surprised to find the Health Canada review different from the FDA review or the EU review or the Japan review? What would be your gut instinct of the value added by doing this domestically in Canada for drugs that have been in the marketplace in other countries?

[Mike Tierney]

I'm not sure I can comment. I believe what you're asking is, are there—

[Carolyn Bennett, Liberal, St. Paul's, ON]

Was value added?

[Mike Tierney]

—efficiencies in having Health Canada repeat the review that other regulatory agencies have done internationally?