Health Committee on April 16th, 2007

[Russell Williams]

I don't believe, as Mr. Brenders has responded, that there would be a negative consequence at this point. Obviously freezing the funds and not doing anything isn't what we are recommending. One message is to freeze the funds and then do a complete review so that we can build a system that actually does move innovative medicines to patients more quickly in an effective way, a transparent way, and an accountable way, and first and foremost avoid that duplication.

Right now we have checks—review upon review upon review. The first part about the freeze would be to give the signal to do the review, and then do the review that has a more effective system. That, frankly, I think is built on provincial decision-making versus a duplicated decision-making.

[Dave Batters, Conservative, Palliser, SK]

Thanks.

For me the issue here today is that it's all about patient access, and the CDR seems to be involved in cost containment. Duplication does exist; the CDR does the same work that provincial plans do and that Health Canada does. There are significant delays, there's lack of accountability, there's non-transparency, and in the end patients suffer.

CDR and CADTH tout evidence-based decision-making. Why is it that other countries such as Sweden, Switzerland, and the U.K. are providing much greater access—more than 50% more—to innovative medicines for their people, given that they are reviewing the same drugs, the same science, the same evidence-based approach? Mr. Williams, why is CDR blocking access to these same innovative therapies for Canadians?

[Russell Williams]

Let me start, and Mr. Ferdinand will jump in.

That concerns me a great deal. My belief is that they are building in a cost-containment strategy that allows them to make decisions about cost versus patient outcomes.

I have the darndest time, and I think you would too. How do you look a patient in the eye and say that something approved in the rest of the world, something available in those countries you mentioned, something approved by Health Canada, is not acceptable to CDR? Worse, once it gets through a six-month delay—and we're talking about life-saving medicines, so every day counts—there's a further delay at the provincial level. Your question is exactly the question Canadians are asking.

On the precision of some of the decision-making, Mr. Ferdinand, do you want to add a comment?

[Mark Ferdinand]

The only thing I'd add is that it is very difficult to understand. When we did the international comparison, we looked at two jurisdictions, France and Canada, to see if we could look at the reasons for decision. In other words, what were the reasons that resulted in a negative recommendation here in Canada for some medicines, and what were the reasons in France, let's say, for positive recommendations for the same drugs?

One of the things we found was, again, the question of what the role is. We found that it seems as though in France there is a value placed on the therapeutic value of the medicine, which means that if this works better for you because you can tolerate it, or if it works better for you because it has fewer side effects for a specific patient subpopulation, then those are the reasons that maybe France can recommend that drug for approval. Unfortunately, we just didn't see the same types of reasons—the same type of thought, I would say—going into the recommendations that resulted in negative listing here in Canada.

[Dave Batters, Conservative, Palliser, SK]

Thanks, gentlemen.

[The Vice-Chair, Bloc, Christiane Gagnon]

Madame Beaumier.

[Colleen Beaumier, Liberal, Brampton West, ON]

Thank you.

I think my colleague Bonnie Brown has zeroed in on one of the problems for many of us. I am one of the members who hasn't been here on drug review or drug pricing. And not being that familiar with CDR, according to what I've heard today, I think there's no contest; you should make the recommendation and we should follow it.

We will be hearing from Health Canada. We will be hearing from CDR. I would like to get a commitment from each of you that when we have questions—I for one certainly will have questions—we can call upon you individually to answer some of these questions. As you know, you're amongst the first; there are going to be people coming after you, countering your arguments.

Dr. Billen, you're a scientist. You are so passionate about this, you very well may be the last one to talk to all of us.

[Dr. Daniel Billen]

I would love to.

[Colleen Beaumier, Liberal, Brampton West, ON]

I don't have any intelligent questions to ask right now, but I do appreciate your presentations.

[The Vice-Chair, Bloc, Christiane Gagnon]

Mr. Lunney.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Thank you, Madam Chair. Félicitations on your birthday.

[The Vice-Chair, Bloc, Christiane Gagnon]

Oh, yes—

[James Lunney, Conservative, Nanaimo—Alberni, BC]

It's been well publicized.

[The Vice-Chair, Bloc, Christiane Gagnon]

We're not going to talk about my age.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

My first question deals with the concern that exists around the cost of health care delivery. We are all concerned about escalating costs. We're over $103 billion, I guess, in terms of what's spent just on the publicly administered health care delivery.

Currently drugs represent one of the highest and most rapidly escalating costs of health care delivery, and governments have a legitimate interest in managing those costs. But one of the other things is making sure that publicly reimbursed programs include verifying that they're good value, relative to the benefits, over existing therapies.

I would say that one of the challenges in evaluating the value of new therapies is the lack of, or limitations of, evidence that these drugs work for the patients in the long term and fulfill the provinces providing better health and quality of life. In relation to cost containment, we're worried about adverse drug effects and reactions. Often it takes time to evaluate the full effects of medications on patients, particularly those who have chronic conditions.

In my home province of British Columbia, the provincial government has taken the innovative approach of actually paying pharmacists double the prescription fee, or subscription fee, or—what do we call it now?

[Penny Priddy, NDP, Surrey North, BC]

Dispensing fee.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Yes, dispensing fee; thank you, former health minister Priddy.

So they actually pay them a double fee—in the last year, that amounted to some $750,000—for not prescribing when there was evidence that the prescription could harm the patient, could be ineffective, or could conflict with other medications they were taking. In the rush to bring in new drugs, although it's great that they may be very innovative, we want to make sure that we're not in fact contributing to other costs when drugs fail if they're not adequately scrutinized before they come in.

What in fact is your industry doing to strengthen evidence of safety and effectiveness of therapies over the life cycle of the products?

[Russell Williams]

I'll start, and Mr. Ferdinand can add to it.

We are deeply committed to health and safety and to making sure that the drugs that come out are safe every step along the way. I could spend the rest of the hearings going through each of the various steps.

To my understanding, with regard to the new and innovative types of drugs that are first in class, with no comparators in this country, the very rules of CDR are going to make them not available. I think what we have to do is make sure that we build in a proper surveillance system and continue to monitor those.

So there are risks, and there are risk benefits. We have to monitor all of those. But—

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Sir, could you expand on what you just said? Why is that? You said that the very rules under which CDR operates currently would not make innovative drugs available. What do you mean by that?

[Russell Williams]

On the specifics, I'll let Mr. Ferdinand go through the details of the process.

[Mark Ferdinand]

As I understand the CDR process—and again I encourage members to ask this question of CDR representatives—if there is no active comparator in Canada for a drug, their process, which is a chart, defaults to a cost-effectiveness or budget impact analysis. This means that the drug will only be evaluated based on its budget or cost impact. That's just the way the process seems to work.

The challenge is that if you're first in class, you have no active comparator in this country against which to measure the drug. So what do you have left but the budget impact analysis?

[James Lunney, Conservative, Nanaimo—Alberni, BC]

May I pick up on that? Wouldn't it seem likely that in developing new products, at least some of them would cost less and still be effective? Certainly in the automotive industry, it's very competitive today. Cars that used to cost a fortune are suddenly coming down, in some areas at least, because of changes in technology, and so on.

Anyway, that's another discussion, but you could make a case, if you examined certain aspects of the automotive industry.

Wouldn't it make sense that at least some of the new drugs being developed would come out with lower costs?

[Dr. Daniel Billen]

I'll go back to your first question, since I'm a bit behind here. It always has to be a balance concerning the appropriate use of a drug. There's no doubt about it. We are not advocating that new is the best, which often is the most expensive drug for every given situation. But when it comes down to life and death, or to a product that definitely can change a life, it's not all right to take that option away from patients.

I want to congratulate B.C. for being one of the very innovative provinces from a cancer access point of view. One of our opinions on JODR was that if you have to pick a province to align behind, why not pick the best rather than the worst? That said, British Columbia has better access to cancer therapeutics than any other province in this country. Why not give that province the lead in saying, okay, let Canada go in this direction?

It all comes down to what we are talking about. If we're talking about small things where it doesn't make much difference, I'm totally with you. But when we talk about end-of-life decisions, or products that will potentially make an enormous difference in someone's life, I think access has to be the number one goal. Patients have to come first.

[Sean Thompson]

I'd like to offer a comment on your previous question, if I may, about the cost of developing drugs. YM Biosciences is one of the group of very small companies that are in the business of taking risks in developing products, which may not be appropriate for a large pharmaceutical company.

For example, I mentioned the drug nimotuzumab, which we're developing for a very small population of patients. This is a risk that a large pharmaceutical company would not take. It's not appropriate for an organization that size.

We've been in business for 13 years. Over this history we've raised about $200 million, and all the money goes into research and development. We have no revenues at this point in time. It is critical for us to get that first drug across the goal line, so that we can continue to exist, and develop and license products coming out of universities.

There are limitations to the resources that would be made available to us, in terms of doing gigantic studies before products are approved. We do what is required by regulatory authorities here in Canada, the United States, Japan, and elsewhere to ensure the safety and effectiveness of our drugs.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Can I ask another question?