Health Committee on May 16th, 2007

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

Thank you, Mr. Chairman.

Thank you very much for your presentation today. We've heard some things that I don't think I've heard before.

Dr. Morgan, I'm going to direct my comments to you first. You said in your presentation that the CDR has rapidly become a respected peer among review processes on the global stage. It's something I don't think I've heard before from the presenters we've had.

We're heard there's non-accountability, duplication, and no transparency. It's focused on cost containment rather than benefit. There's a lack of an appeal process. But in all fairness, they're not comparing it to the global stage. Could you make some comments in reference to that? Why is it looked at so much differently globally than it is internally?

[Dr. Steve Morgan]

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. But Canada's process is actually respected, and I think Canadian scientists who are engaged in these appraisals and assessments are respected.

On the lack of an appeal process, by default, the CDR has an appeal process because you can re-submit. Manufacturers are able to re-submit if there is new evidence brought to bear on a decision.

There are criticisms made of the CDR that are flatly not true.

On the international stage, Canada was invited to attend meetings of agencies like the CDR because Canada's process is respected. All processes around the world could use some improvement. Through actually collaborating and communicating with other processes, I think we're going to get there.

We learn from the success stories. For instance, I think the public participation on the Australian advisory committee truthfully informed the CDR's movement toward that kind of engagement. I think we could learn issues with respect to transparency and dialogue during a review process, for instance, from the process in the U.K.

I think I've written five papers on the CDR in the international context. Those are among the most requested papers internationally that I've written in my career, and I've probably written 50 or 60.

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

Can you tell me this? Do you think the CDR evaluations tend to focus more on cost containment than other countries do, or are they all done much the same way when it comes to cost?

[Dr. Steve Morgan]

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. Canada and the U.K. really stand alone in their nearly exclusive focus on relative effectiveness and then a secondary consideration of costs.

Although CDR is criticized for that, I think it's patently incorrect, because Canada is one of the exceptions to the extent that it focuses on science rather than economics.

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

In your presentation, you talked about Australia doing 100 drugs per year, including generics. Are other countries doing generic reviews as well as Australia? What percentage of the 100 drugs would be generics?

[Dr. Steve Morgan]

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. It's why they have such a big list of medicines that are vetted through their reviews.

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

Are they the only ones that do generics?

[Dr. Steve Morgan]

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

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

Could you do so, please?

[Prof. Devidas Menon]

I can't remember the exact number, but some European agencies look at generics as well.

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

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We'll now move to Ms. Kadis.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you, Mr. Chair.

Thank you, everyone, for coming today, as we move toward drawing up our interim report.

There's been a lot of witness discussion and concern regarding rare diseases and the issue of the expense, of course, and the fact that they're not getting their proper due. I would like to ask you this. In those other countries, in the U.K. and Australia, do they have a specialized process or a different set-up for rare diseases, and if so, what is it?

[Prof. Devidas Menon]

I can't answer extensively across all countries. The problem with rare diseases—and some of them will fall into the catastrophic disease category as well because of the cost—is that there is not a lot of scientific evidence that can be generated to help make the kinds of decisions that CDR has, because if a disease is very rare, there's going to be a small patient base for it, and so to do a trial to collect enough data to make meaningful conclusions is next to impossible. Add to that the fact that rare or orphan drugs, as they're called, will be much more expensive because typically they cost more to produce and they're produced for a smaller market. So all of that complicates the process.

Ultimately, one has to decide for such classes of drugs whether or not one is prepared to accept different levels of evidence. This is an argument that methodologists have. In the U.K., in NICE, they've tried to tackle this. They've even gone to look at what they call ultra-orphan diseases, which are even rarer. I mean, there are numbers in terms of prevalence. In fact, on the citizens jury that I talked about, one of the meetings I attended was when they were trying to decide how differently they would handle ultra-orphan drugs. The reality is that you can't have the same expectations for data or evidence. It just isn't possible.

In Canada, we've had similar discussions with drugs like Fabrazyme. I'm not exactly sure where CDR has ruled on any of those. As far as I know, both rare and catastrophic drugs are being discussed somewhat differently in terms of the amount of data needed to make these decisions.

[Susan Kadis, Liberal, Thornhill, ON]

Mr. Morgan, can you comment?

[Dr. Steve Morgan]

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. I think that owing to the unique ethical considerations and social responsibilities that we may have related to some of these conditions, you might argue for a national silo of funding, earmarked and capped in terms of budget, from which you would make a decision about rare diseases, using a slightly different algorithm with respect to cost-effectiveness.

I still believe that the phrase “globalize the evidence, localize the decision” should hold. These drugs should be subject to the same rigorous standards of proof. What we don't want to be doing is buying promise, hope, or hype. We want to be purchasing health outcomes here, and so we want to know whether these drugs work. In this context I believe “globalize the evidence, localize the decision” should begin to be taken literally. Oftentimes there are not enough patients in a given country to actually properly assess those drugs in one country, so we should be looking to partnerships with our colleagues around the world to figure out how we can develop the best possible approach to being ethical and responsible about these products and patients, showing compassion while also making sure that we're doing the right thing in terms of buying appropriate outcomes.

[Susan Kadis, Liberal, Thornhill, ON]

There's this disconnect that keeps reappearing with witnesses in terms of our hearing that it's working very well and it's been expanded, and yet other witnesses—health advocacy groups, industry—are saying that it is not working well, there are obstructions. What do you attribute this disconnect to? There is a running pattern through many of our sessions. Obviously we're trying to understand what we can attribute that to. Is it because they're not going to be happy, no matter what system we have, or because the system really isn't efficient and meeting their needs?

[Dr. Steve Morgan]

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. I'm not making a moral judgment here. They want entitlement to those scarce resources, and so they're going to want to contest and worry about the process.

I can say, as an outsider, that this process is very good. I would argue it's possibly one of the best drug policies that's happened at a national level in Canada ever, because we've had so few national drug policies, truthfully, aside from regulation.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Mr. Patrick Brown is next.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Mr. Chairman.

I have a few comments to make, and a few questions.

First of all, a comment I've heard today is that when we've heard comments, they might have come from industry. I'd just add that the comments I've been getting, the concerns over CDR, have not been coming just from the pharmaceutical industry; they have been from patients and from physicians I know in my own riding, and we've had individuals come up and tell their personal stories about some of the challenges they have faced with the process. We've had numerous deputations from various charitable groups that are raising funds and representing individuals who have various illnesses within Canada. There has certainly been a wide variety.

The one I found the most moving was a presentation by, I think, the Canadian Cancer Society about kidney cancer and some of the challenges they've had with the CDR. We are hearing a wide variety of opinions, and that's one of the tough things to reconcile. People have completely different images of the usefulness of CDR.

One thing I heard from previous proponents of the CDR is that one of the reasons it was created was to bring national standards to the drug approval process in Canada and get more commonality amongst the provincial drug plans. I asked that question. I asked if that has changed today, if we have that commonality, if we have those national standards. I wasn't satisfied with the answer, so I'd look for some comments on that today. If the purpose of this several years ago was to bring about that commonality, why do we have provincial drug plans completely ignoring what CDR is saying? Why do we see cancer drugs at the national level rejected by CDR and approved, for example, in British Columbia or Ontario? That is perplexing.

There is another question I wanted to throw out there. I haven't posed it from this perspective. We always talk about patient access. Prior to the CDR, how did this process hurt patients? How is the system better today than it was before? Can you tell this committee that Canada's health care system, its drug approval process, is serving patients better today than it was when this was created several years ago?

Could I please get comments from any of you three who would like to offer a perspective.

[Prof. Devidas Menon]

Those are very good points indeed. There is a difference of opinion, and we can't attribute it all to the industry.

I would step back first and ask a question that I think people tend to forget: why was the common drug review instituted in the first place? Did anyone ever say that the common drug review would make access to drugs common across the country? Everything I have read—

You might want to know that I was the first executive director of CCOHTA, the predecessor to CADTH, for the first seven years, so I have some idea of the provincial-federal play in this area. When the CDR was first talked about—and I think Dr. Morgan alluded to this—it was to make the review of drugs for formulary decision-making more efficient and to reduce duplication. Those were the first goals. To translate that into improved patient access or improved patient care, I would have to ask what one means by improved patient care. Was the assumption that decisions made previously jeopardized patients? Is that the assumption? Frankly, I don't know that.

To me, if anything, what the CDR has done is this. There's one submission, and there are standards for that submission. There are guidelines; they have to be met, so in that sense there's conformity with standards. The fear I have is that the standards are still so technical and clinical that other people's views and values don't get injected into it. I think that may be where the disconnect is coming, because you have standards that are based on very strong methodology.

I know you're running out of time, but I just want to make one comment. This just reminds me. My colleagues would hate me for this, but there's a joke that I like to tell: what's the difference between a methodologist and a terrorist? You can negotiate with a terrorist. In some cases I feel we're strapped because of the methodological development and we tend to forget that there are people. I think that's where really the disconnect comes.

As for the allegations that it isn't working, I would have to say, did we expect the common drug review would increase access to more drugs? Did we reasonably expect that? If we did that, we're making the assumption that we were denying people treatment before, and I just don't have the evidence to back that up. It may be the case. I think it now allows people to make decisions that are more defensible from a scientific point of view.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We'll move on now to Monsieur Malo.

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

Thank you, Mr. Chair.

Thank you for your presence this afternoon.

Professor Morgan, awhile ago, my colleague, Ms. Demers, asked you a question which you did not have time to answer. Do you have any studies that prove that more errors are committed in countries where there are more drugs approved under a faster review process, because of the fact that these drugs are approved more quickly and in larger numbers?

[Dr. Steve Morgan]

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. In part, it's part of the global licensing and marketing strategies of drug companies, and that is to get a drug into a market like France first, where they are able to secure higher prices and actually get approvals slightly more readily than elsewhere. That creates a precedent, if you will.

If they first attempt to license in a country that is deemed to have a difficult or tough regulatory stance—and arguably, the United States is actually one of those countries—and are turned down, it sets a poor international precedent for them.

There are lots of drugs in some countries, in part not because the consumers in those countries really need thousands of medicines, but because they need to get them on the market there first and then proliferate from there.

[Jean-Claude St-Onge]

There is one study, among others, that was done by the U.S. Government Accountability Office, which revealed that in the United States, before user fees were charged in 1992, 1.6% of drugs were taken out of circulation. User fees have meant that the approval time has been cut in half. It was shown that, towards the end of the decade, 5.4% of drugs were taken out of circulation because of the danger they posed.

A study appearing in Pharmacoepidemiology and Drug Safety in 1995 demonstrated that from 1974 to 1993, ten products were withdrawn from circulation in the U.S., while from 1997 to 2001, after the introduction of user fees, there were 12 withdrawals, including nine drugs that were approved after 1992. According to many observers, corners were probably cut and drugs approved a bit too quickly. One of the results was the worst medical catastrophe, namely the Vioxx catastrophe.