Health Committee on April 16th, 2007

[Dr. Daniel Billen]

Yes, I would like to take this one. One of the things that would be our recommendation on the JODR is to make absolutely sure that we don't repeat the same mistakes we made with CDR. Our point of view is it's not who's at fault in the process; it is who suffers. At the end of the day it is the patient who is denied access. That's the way we have to look upon it. When a patient is denied access, we rob that patient of any new hope that this potentially important medication could bring to the table.

Our point of view is that CDR had asked to expand into oncology products. I think it was the provinces' recommendation to go with the JODR approach. In reality, in principle, both approaches are fine, to say let's have a common denominator of knowledge to make some decisions. The important part, though, is if we look at the end result. The end result is, will CDR or JODR provide access to important medical breakthroughs? For CDR we can say the answer is no. For JODR, we still have to wait and see. I think the focus of us as Canadians has to be on making sure that patients who need access to important, innovative products get that access. That's the job.

[Bonnie Brown, Liberal, Oakville, ON]

Mr. Brenders I think wanted to comment.

Could somebody comment on this rare diseases issue?

[Peter Brenders]

I will. I think the short answer to your question is there are concerns in terms of whether a CDR process can effectively deal with rare diseases, unmet needs. The former chair, as I mentioned, Dr. Laupacis, has gone on the record as saying that the CDR process as it was set up could not adequately deal with the unmet needs. The structure as it's defined doesn't work. It seems to have set itself up as an adequate review for common drugs, but as a technology process to take a look at unmet needs, rare diseases treatments, clearly with what we're starting to see from provinces that are doing their own reviews or setting up other things like the JODR, you have to wonder, is there a question of confidence in the competence of what is the CDR?

[Bonnie Brown, Liberal, Oakville, ON]

As you know, we're partway through a vision that came out of a federal-provincial process, which had a national pharmaceutical strategy as part of it, but it seems to me one of their end goals was to have a national drug formulary as opposed to provincial formularies. It seems to me that this is where those thinkers were going at the time this was set up. My concern is if we ever got there, does it concern you that we might end up with a list based upon the CDR experience on a national formulary that essentially is the lowest common denominator?

Would anybody like to comment on that?

[Russell Williams]

As to your question, again it sounds interesting and quite positive when you throw out a simple idea: wouldn't it be nice if we...? But in reality, our greatest concern is that we would be moving to the lowest common denominator.

As to your earlier point, I find it difficult to imagine how you're going to create a national formulary, possibly driven by a strategy very oriented to cost containment and that at a certain level will be making decisions about which drugs are available for which patients. Ultimately it will be the provincial level that will be paying for the consequences of those decisions, because I passionately believe that in fact good utilization of innovative medicines not only saves and improves lives but also saves money within the health care system.

So the concern is that the current movement would be towards a reduction of access versus an increase in access.

[Bonnie Brown, Liberal, Oakville, ON]

Thank you.

Thank you, Madam Chair.

[The Vice-Chair, Bloc, Christiane Gagnon]

Mr. Keon would like to add some information.

[Jim Keon]

Yes, thank you.

On the last issue, we deal with the drug program managers and health ministries in all the provinces, and I think as long as they are paying for the drugs, there is virtually no chance they are ever going to cede authority back to some other agency as to which drugs they pay for.

I would comment again that the common drug review, as Mr. Williams said, is not a creation of the federal government; it was actually coming from the federal-provincial-territorial groups that have been meeting. In many ways, it's actually the desire of the provinces, in particular the smaller provinces, who simply don't have, or feel they don't have, adequate resources to review the cost-effectiveness and therapeutic value of all of these new medicines.

[Bonnie Brown, Liberal, Oakville, ON]

Thank you, Madam Chair.

[The Vice-Chair, Bloc, Christiane Gagnon]

Thank you.

Should I have questions for the witnesses, I would ask the members of the committee to give me the permission to remain seated in my chair to do so, rather than moving, which would be time-consuming.

We will now move on to our second round of questions. I will give the floor first to our colleague Mr. Malo. I will have some questions later. Thank you.

Mr. Malo, you have the floor.

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

Thank you very much, Madam Chair. Before I put my questions to the witnesses, allow me on this special day to offer you my best wishes for a happy birthday. And may I take this opportunity to wish you the best of health in the coming year.

[The Vice-Chair, Bloc, Christiane Gagnon]

The floor is yours, Mr. Malo.

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

Thank you, Madam Chair.

Gentlemen, thank you for having come here today.

What I understand from the fairly substantial presentations we have heard today is that you have been following this file for a number of years. I conclude that some of the elements of the current program could stand for some improvement, in your opinion.

Mr. Williams, in your presentation you seemed to be saying that for certain patients this program constitutes an obstacle to access to certain drugs. In your work in the field, did you have an opportunity to collect figures, to observe specific cases where this program proved very, very problematical for some patients or groups of patients?

[Russell Williams]

Thank you for your question.

I think that the Quebec model answers your question for the most past. Because Quebec does not use the CDR, there are a larger number of drugs listed in Quebec. Up to 62% of drugs are listed and are thus accessible and available to Quebec men and women. Unfortunately, in the other provinces—and each province is different—because of the duplication of the work done by the CDR, these drugs are not accepted or are placed on a waiting list because a decision has not yet been made.

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

Is it because there exists in Quebec a desire to list a greater number of drugs, regardless of their cost, or is this due to other reasons, reasons that involve the effectiveness of the program?

[Russell Williams]

I will begin to reply to your question, and Mark will complete my answer.

I think that Quebec has understood that the proper use of innovative drugs and better access to them is a good health intervention because in this way one can improve the health of the population, save money and reduce the number of hospitalizations. There does indeed exist a will to use innovative drugs as a health strategy. In my opinion, the population and patients are the better for it.

Mr. Ferdinand wants to add something to my reply.

[Mark Ferdinand, Vice-President, Policy, Research, Regulatory and Scientific Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)]

Mr. Malo, I would point out that it is not only a question of access, but a question of choice. Basically, when the health care professionals who prescribe drugs have more choice, they are the ones deciding whether or not their patients will have access to certain drugs. So neither the provinces nor the federal government are deciding whether such-and-such a medicine is good for you or me. It is actually the health care professionals—as is the case in Quebec—who have more choice in curing and treating their patients. In my view, we must understand the following: when we see the number of rejected or negative recommendations from the common drug review, we realize that, regrettably, that is where choice is being interfered with.

[Russell Williams]

And it's not just the CDR: in more and more decisions, a barrier is being erected between doctor and patient. I think that Mr. Ferdinand has raised an important point because it seems quite clear in the case of new drugs, which are the ones we are talking about here. If the list is longer, you won't use it all, but there will be more choice. At the moment, it is practically impossible to decide if one medicine is good for everyone at all times. Each province, even each region, as well as each doctor can make the best decisions for their patients.

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

Following that train of thought, Mr. Billen—

[The Vice-Chair, Bloc, Christiane Gagnon]

Your question will have to be a short one.

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

Mr. Billen, just now you were heading precisely in that direction when you said that we often hear doctors saying that they are sorry but that there is nothing more they can do.

Is that because they are not telling their patients that Health Canada recommends a number of drugs that are not yet approved by the common drug review?

[Dr. Daniel Billen]

Yes, meaning that I think the answer is that at the end of the day patients go through their diseases. Our objective at Amgen is to make sure we find solutions for these very severe patients. That doesn't mean the solutions we are going to come up with are going to help everybody, but it is our mission statement to make sure we provide alternative approaches to very severe diseases. And by doing that you're giving physicians and patients more options.

I think especially in the area of cancer, in the area of rheumatoid arthritis, in the area of kidney disease, there are too many times that the physician has to say there's nothing more we can do, while in other countries around the world there are still other things that can be tried. I think we want to make sure that Canadians have the same opportunity as patients with these very debilitating diseases have in the rest of the world. It is their right, from my point of view, to get that same option that potentially could make a difference from a quality- or a quantity-of-life point of view.

[The Vice-Chair, Bloc, Christiane Gagnon]

Thank you.

Mr. Fletcher.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Thank you, Madam Chair.

I have three questions for Mr. Williams and one for Mr. Keon. But before I get to the questions, there was a very helpful suggestion that was provided by Mr. Williams in his speech. That was that there should be an independent, comprehensive review of the objectives, accountability, value for money, and health outcomes as they relate to the common drug review and the Canadian Agency for Drugs and Technologies in Health. That may be something the researchers and the other members of the committee may want to consider in the final report.

First I will lay out my questions, and then I'll let you answer them as you wish.

Mr. Williams, you also say that it is your recommendation that the federal government freeze funding to the CDR. The federal government only provides a portion of the funding, and I wonder what goal that would accomplish, because this is not going to change immediately. What would the goal of that be?

I also wonder if you could explain the statement that you believe the CDR places too much emphasis on cost containment and not on patient outcomes. There is also a complaint that the process is not transparent—you don't have access to information, and it seems to be a bit of a black box. I would be interested in what you have to support that statement and what you estimate are the costs we're talking about. What is the difference between what has been provided and what you would like to have provided, and what would the cost of that be?

Finally, for Mr. Keon, on your suggestion that we substitute generics where possible and maybe increase the substitution for patented drugs, could you explain for us why generic drugs in Canada tend to be more expensive than they are for our neighbours to the south?

Those are my questions, Madam Chair.

[Russell Williams]

Thank you for your three questions. I will attempt to answer them, and Mr. Ferdinand would like to add further comments.

On the first point about the message about freezing funding, you're absolutely right that the federal government does not control the overall funding. But I think it would send a very clear message that we need to have this independent review. We need to make sure, because as Mr. Williams said, we're talking about access to innovative medicines, life-saving medicines, for patients. This is not just a study about a government agency.

What we have to do is pass the message clearly that asks what it is doing, what it is supposed to do, and whether it is fundamentally flawed. I actually believe that the model we have in Canadian society is that ultimately these decisions, as for the first questions, are going to be made at a provincial level. So why are we building in duplication throughout that that questions, on one hand, some of the clinical trial information from Health Canada, and then adds in other criteria that maybe other international jurisdictions don't add and that second-guesses pricing? The message would be that it's time for a review.

When I look at a body that makes decisions that aren't binding, that seems to be duplicating information, and that is not accountable, what better mechanism is there than to send a message saying that we're freezing the funding until we actually understand that it is doing what we want it to do? That is a lot better than announcing a week before parliamentary hearings that there is an expansion of the mandate.

In terms of the CDR and cost containment, when you try to understand, when you look at the decision-making process, you come to the conclusion that they're using cost containment. Again, as I mentioned, if you're taking a product that is the same molecule and you're putting it to the same scientific scrutiny but coming up with entirely different responses, it seems to me that there are other ingredients being entered, including cost containment versus patient outcome. But to your point, you're absolutely right, it is difficult to find out the decision-making process.

This is one of the things we're hearing more and more. Canadians, having confidence in our health care system and in our drug system, are saying that they hear that a certain drug, a life-saving drug, has been available for x number of months or years somewhere else, and now they hear that Health Canada has approved it, it has gone to this other body that doesn't really seem to be accountable to anybody, it's either been rejected—which is a very mixed message—or it's been recommended again by another level, and it goes to provincial bodies and sits there for a few hundred days. It is very difficult for citizens to understand what's going on. To your point, we have to really open up in terms of transparency.

To your actual questions on the specifics of cost containment, Mr. Ferdinand wants to add some points.