Health Committee on May 2nd, 2007

[Durhane Wong-Rieger]

We had our first Canadian conference on rare disorders and an orphan drug policy program just last week. It was a two-day international conference. We had, in fact, some of the top international experts come to Canada to provide us with their expertise and advice. We also had, quite nicely, some representatives from provincial and federal governments there.

I hope that the idea has gotten some traction that people do recognize. I don't know if people are aware that in 1997 Health Canada came out and said, we don't need an orphan drug policy; we already have adequate access. And sadly enough, what was said was that other countries were already developing new drugs, so we didn't have to do that, and we didn't have to encourage that.

Of course, we think that's irresponsible. Canadians have every responsibility and every ability to contribute to it. We think it's an idea whose time has come. This has been discussed for a number of years now, ever since the U.S.—It hasn't gained a lot of support, but we're now beginning to feel that we're getting some attention and that it is gaining some traction. So actually, we're quite hopeful that we're going to be able to get some very positive response.

As Karen also indicated, we've had some very good response, for instance, in terms of how this program might fit in with the new drug legislation in Ontario in terms of their review process. Also, it fits in well with the kind of transparency that people like Helen Stevenson are promoting within the drug strategy secretariat.

We think there are things coming into place that are going to be much more supportive in making this happen now, whereas ten years ago the answer was categorically no.

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

Mr. Skinner, earlier on in your remarks, you stated that:

“There is a misguided war against medicines”.

Do you think this war will end some day, and how do you think it will end? Will people speak to each other? I think that the main problem lies within the lack of mutual understanding between players. Do you think it is possible to bring this war between the parties to a positive conclusion?

[Brett Skinner]

The point of calling it a misguided war against medicines is simply to draw attention to the fact that the focus on cost containment and the focus on what we spend our health care dollars on is really misguided. At various points in the history of medicare, costs have been focused on what we spend on doctors, and we have held their rates down to below market levels over time. After adjusting for inflation, for instance, Ontario doctors make no more today than they made in the early 1970s.

We have held down expenditures on hospitals. We have amalgamated hospitals. We have allowed them to deteriorate in terms of their modernization. Now, drugs are the latest—

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

You didn't answer my question.

[Brett Skinner]

I'm getting to that.

Drugs are now the focus of attention on cost, and that is misguided. We shouldn't be focusing on what we spend our health care dollars on, but on how we finance the system, because how we finance the system introduces incentives for how we prescribe and use medications, the kinds of medications that are demanded by patients, the decisions that are made in terms of efficient substitution between competing health care treatments.

Those kinds of things don't exist in our system. If we properly designed our public health plans, including our drug plans, with things like deductibles and co-payments, we could introduce proper economic incentives that would encourage the right decisions on those things. It would also free up spending to allow us to include a larger number of new health technologies, including new drugs, and give us the capacity to provide, under public plans, more of what is provided under private insurance. If you compare access to drugs under private insurance plans in the country, it's immediate and it's comprehensive, as soon as Health Canada says a drug is safe and effective. That does not occur under public drug plans. So if we simply mimic some of the things that are done in private plans, we could achieve the same thing.

[The Chair, Conservative, Rob Merrifield]

Thank you.

I will allow a very quick answer and then we'll move on.

[Dr. Karen Philp]

I have a quick point of clarification.

The CDR recommendations go to the participating plans, and except for—In all of the provincial plans, the only people who are really cover most of them are seniors and people on social assistance. The vast bulk of Canadians have private sector plans. So when we're talking about CDR recommendations, it's low-income seniors who are most affected by the decisions taken by CDR. Since Quebec is not participating, I think they have a far better program in Quebec than they do in provinces like Ontario or in Atlantic Canada.

I wanted to make sure you're clear that we are talking about a small group.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Mr. Fletcher, you have five minutes.

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

Thanks, Mr. Chair.

Thank you to the witnesses for coming here today.

I found it interesting that the Canadian Diabetes Association recommended an independent review. We've heard that. It seems to be a recurring theme here at the committee, and I'm sure the researchers are taking note of that.

I have a few questions. This is a very complicated issue and I only have five minutes.

One question that keeps coming up is having national standards. Madam Bennett suggested coordinating all the different plans. I wonder what the safeguard would be to preventing all the drug plans from going to the lowest common denominator versus the highest common denominator, and once you had established a highest common denominator over time, it would seem to be a lot more difficult to change the bar if you made it somehow compulsory for all the participants to agree on a certain standard. If a province, for example, wanted to exceed the standard, it would be very difficult for it to do so.

I'd like a comment on that.

This is the second question. I'd like the Canadian Diabetes Association to elaborate a little bit more on the proposal for conditional listing. It sounds like you want to replace the recommendations not to list with conditional listing recommendations. Would that not entail a lot more process at the level of the provinces, which then have to adjudicate each request on a case-by-case basis?

Finally, maybe for the Fraser Institute, if you had your wish, what is the cost estimate? You've said the CDR uses cost as a major consideration. If we removed that, what dollar figures are we actually talking about?

Those are my questions, Mr. Chair.

[Brett Skinner]

We'll start on the last question. It was directed to me.

My point was that the CDR was focused on cost and not on the actual value of the medications, that it's an exercise in cost containment, and for that reason I don't think it serves patients very well. So I'm providing an alternative approach to the CDR, something that would essentially say that if we do this, we don't need the CDR; we don't need central planning control over the kinds of drugs patients get. We can simply allow that decision to remain in the hands of patients and their physicians by redesigning our drug plans.

B.C., by the way, has a deductible for eligibility for drug coverage, and other plans have co-payments. Private sector plans have co-payments. The international jurisdictions of the OECD have co-payments and deductibles and user fees as part of their plans as well. So this is not radical stuff; it's being done all over the world quite successfully.

The point is that by introducing those things you create the financial capacity to pay for new expensive technologies and you allow people to pay for affordable things, which is what insurance is supposed to do. Insurance is supposed to cover those things that are impossible for individuals to afford on their own. So I'm simply suggesting that it would free up the capacity to pay for the things through the public programs we're talking about here today.

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

On the conditional listing and the common denominator issue?

[Dr. Karen Philp]

The conditional listing idea is Australian. Australia operates it, and they have a similar government structure to ours. So I think we could look at them in more detail and adapt it for the Canadian situation.

We think there are a lot of stakeholders at the table right now who aren't communicating through the common drug review process. A conditional listing would help get those drugs that have been approved as safe and effective by Health Canada, so it would still go through the safety review with Health Canada. It would be a drug that's also been given a price point by the Patented Medicine Prices Review Board.

At that stage, the company and the federal government—and if it were the common drug review, it would go to them to negotiate—would bring the company to the table, bring an organization like ours with the expertise that could help design a research program, work together, and identify the research program to identify the real-world health outcomes and the real-world costs. A lot of the cost estimates that are being made are based on clinical trials or other studies that aren't based on the real world or in the Canadian context. So we think there's a real gap here that needs to be addressed.

If we could do that, then government has ultimately the ability to ensure that the questions they want answered are asked. Industry knows they have a responsibility to pay for the research, but they also have an opportunity to have a contribution and input into the design of the research project. Organizations like ours can be assured that the expertise that needs to be there to ask those research questions is at the table. Right now, there's no ability for us to do any of that quality assurance.

We think the conditional listing is the way to go. It's also, I think, very similar to what Health Canada introduced back in February in its white paper on a progressive licensing model. Australia is the model we'd suggest you look at.

The other thing around national standards is that it really shouldn't matter where you live in Canada if you have diabetes, but it does. There are 17 diabetes medications that have been approved by Health Canada as safe and effective, and the Patented Medicine Prices Review Board has allowed them to be for sale. Right now if you have money you can go out and buy those drugs if your physician or doctor prescribes them, but if you're on a drug plan in Ontario, you have access to six of them; if you're in Atlantic Canada, it ranges. So every province has a different number. The national standard issue is very dear to our heart, and we want everybody to rise up.

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

I'm going to try to get in one more question quickly.

[The Chair, Conservative, Rob Merrifield]

It's too late. Your time has gone, Mr. Fletcher.

We'll move on to Ms. Chow now, for five minutes.

[Olivia Chow, NDP, Trinity—Spadina, ON]

I understand the CDR needs to be transparent and accountable—this would be to the Diabetes Association—and that it must coordinate with all the other reviews that are happening. I also know you agree that the CDR is the foundation for a national drug strategy, and that we want the highest level of coverage.

So how would we increase the role of CDR? It is supposed to be the first step. The provinces came together two years ago, saying they want a national drug formulary. It is a priority area. What is the status and the progress toward that push for a national drug formulary? That's number one.

Number two is, how would CDR get provincial drug plans to implement its recommendations, assuming the recommendations are faster, more transparent, better at peer processes, and all those things you're pushing for?

[Dr. Karen Philp]

We think the catastrophic drug plan...that's our ask, actually. There needs to be a national catastrophic plan that ensures that no Canadian pays more than 3% of their annual income on prescribed medications, devices, and supplies. Because the common drug review isn't working, we're arguing that any drug approved by Health Canada and given the opportunity to be sold in Canada through the Patented Medicine Prices Review Board should be covered. Right now we have this problem, with each of the provinces providing different levels of access.

When the common drug review was first introduced, we thought, well, here's the foundation; it's going to be open and transparent, it's going to engage the stakeholders, we're actually going to move forward, and we will get closer to a catastrophic drug plan or some sort of national pharmacare program. It's not happening with the common drug review.

We could go to the model where the federal and provincial and territorial governments sit down to try to negotiate, but that, I hate to say, takes forever. So we would really encourage this committee to look at what's happening with all the four steps in the review process and see if there's some way to either make the common drug review work or find another model.

We were just talking. We weren't sure if diabetes is the only disease, but there's not been a single diabetes medication reviewed by the CDR that has been approved since it started. We don't know why.

Secondly, there's so much coming down the pipeline in new therapeutic treatments and new research discoveries that we're really afraid that Canadians with diabetes are going to end up with lower health outcomes than people with diabetes in Australia or the U.K. or in parts of Europe.

We have to get this right, and that's what we would encourage the committee to do.

[Olivia Chow, NDP, Trinity—Spadina, ON]

Right now, because it's not coordinated—recently there's even been a new body to study the cancer drugs. There are many more layers, and then even if one is recommended, it's not mandatory that the drug plans respect it, so it's all over the map.

I think one of the recommendations you had was for the conditional listing for new medications, right? That would at least deal with the ones that are approved by Health Canada. Is that one of the recommendations?

[Dr. Karen Philp]

Yes. What could happen is that, for instance, it could be under special authority; that's what they do in Australia. Your physician makes the case that other treatments haven't been successful for you, so it might be a second- or third-line treatment. You could then apply to be part of this research program; you'd have to agree to be part of it.

If you're a Canadian with diabetes and you are not having the best health outcomes from your current treatment and your physician thinks this new drug might be useful, then you could enter the research program. That's what we were thinking.

[Olivia Chow, NDP, Trinity—Spadina, ON]

This is my last question.

Do you think this agency, CDR, can actually expand its mandate and recommend how long the drug should be protected under patent? If you make that recommendation, then—I'm thinking completely outside the box—the generics would be able to come in sooner, perhaps, therefore lowering the cost of some of these very expensive drugs. Is that a role this agency could play, possibly?

[Dr. Karen Philp]

I think you might find it such a big review that you would never get through it in the time you have allotted for it. That would be my concern.

It's a slightly separate issue, relating more to the innovation side of the question, and I would keep the common drug review focused on processes and on trying to streamline them so they're more effective.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We'll now move on to Mrs. Davidson.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thank you.

I would like to thank our presenters.

My first question is going to be for Ms. Wong-Rieger, please.

I have two constituents who suffer from Fabry disease , a mother and a son. The son underwent tests through a project in the States and is now undergoing one in Canada, and they're getting funded right now for the drug for a three-year period. Is this the test you were talking about?

[Durhane Wong-Rieger]

This is the disease we're talking about.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Yes, I know it's the disease, but you referred to—

[Durhane Wong-Rieger]

No, no, not at all.

Actually, here's the bizarre solution that came out of this with Fabry. Because there are two drugs available, one of which got an NOC, one got an NOC/c, etc., it added some confusion to the whole situation.

What happens now is that all of the health ministries agreed to make the drug available through a research protocol. The research protocol then allows those patients who have been on the treatment through the clinical trials that have been done to get it approved to continue it. Now, the mother and son—and I think I know who you're talking about—are on the treatment. The son is actually in an expanded clinical trial, so he's getting the treatment through the clinical trial process.

What Canada came up with, then, is a separate research protocol to say, okay, for those patients who were not on the treatment previously, we're now going to give them a chance to go on the drug. First of all, they set standards that were very different from the international standards—much more stringent standards. So a lot of people who would qualify internationally for funding and treatment in their countries would never get it in Canada. But beyond that, what happened is that they said, we will now randomize you to one of those two drugs, and we will then see whether or not, over the long term, one drug is more effective than the other, etc.

So they've introduced this other research protocol.