Evidence of meeting #56 for Health in the 39th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was process.
A recording is available from Parliament.
4:20 p.m.
Conservative
The Chair Conservative Rob Merrifield
Thank you very much.
We'll move on now to Madame Demers. It's good to have you back to the committee. You have five minutes.
4:20 p.m.
Bloc
Nicole Demers Bloc Laval, QC
Thank you, Mr. Chair.
I am also very pleased to be with you. I have missed you all.
Gentlemen, thank you for being with us. It has been a long time since I sat on the Health Committee; I have not taken part in the studies completed. However, as a consumer and an individual, I have often needed drugs. We are always worried when we are given drugs. I can understand the concerns of my colleague, Ms. Brown, because when we need drugs we want to be sure that the drugs provided are the right ones.
From listening to your presentations, I noted that there seemed to be a bit of dissension among the various perceptions. It was said that in countries like Sweden, Switzerland and France, about 50% more drugs are approved and recognized than here, in Canada. Is there a greater frequency of error in those countries, because more drugs are approved? This worries me. Should we focus more on the Common Drug Review of new drugs? I remember that, on the Health Committee, we heard people with HIV who were demanding access to a drug that was under review. Unfortunately they could not have access to that drug, which might save their lives. Because this drug was being reviewed and it was taking a long time to be approved, these people were not given the possibility of obtaining it. Is that also part of the problem? If the Common Drug Review does not report to Health Canada, who determines the value of the information and the reviews? Who reports to government? Who determines whether a drug should be marketed or not?
Mr. St-Onge, you talk about the large number of drugs on the Quebec list. It is true that I have benefited from them. I had cancer six years ago and I was very pleased to have various choices so that I could take the appropriate drug for the type of cancer I had. I have a hard time taking a position on such an important subject. I know that in Quebec reviews take place more quickly.
4:25 p.m.
Bloc
4:25 p.m.
Bloc
Nicole Demers Bloc Laval, QC
Is less attention being paid? Is less care being taken? I do not know why it is like this. I am asking you.
4:25 p.m.
Author and Professor at Lionel-Groulx College, As an Individual
I am not sure where to begin, but I want to take the example of a cancer drug called Iressa. I went to the Health Canada site, among others, which are quite good with regard to the undesirable effects of drugs. This is a drug used for lung cancer. Now it is also being used outside of indications to treat such things as neck and head cancer.
The reviewers at Health Canada specify that this drug, for instance, has not succeeded in reducing mortality or in increasing survival without the disease progressing and without the symptoms becoming worse.
To come back to what Dr. Morgan said awhile ago, this is a drug that was approved using surrogate endpoints. It was observed that this drug reduced cancerous tumours and that is the basis on which it was accepted.
At least four clinical studies were done and they all demonstrated that the drug did not improve survival without disease progression or any of these things. Consequently the consumer protection organization in the U.S., Public Citizen, drafted a petition now circulating in the U.S. for this drug to be taken off the market. In addition it had some very serious undesirable effects. Go to the Health Canada site and you can see which ones; I do not wish to give them to you.
Perhaps these are things that should not exist. When a drug is approved on the basis of a surrogate endpoint, we should be very, very cautious about this drug and demand that the company that makes it conduct clinical trials to demonstrate that it is truly important and it actually decreases mortality, that it improves quality of life, etc.
4:30 p.m.
Conservative
The Chair Conservative Rob Merrifield
Thank you very much.
We'll now go to Mr. Jaffer for five minutes.
4:30 p.m.
Conservative
Rahim Jaffer Conservative Edmonton Strathcona, AB
Five minutes. That's fine.
Thank you to all the presenters for being here today. I'm sort of new to this common drug review. I joined the committee just recently.
Dr. Menon, I was interested in particular in what you mentioned in your summation points—the fourth point, I believe—the idea of the public participation, public representatives, in the jurisdictions in the U.K. and Australia. I think they were called the citizens jury or citizens council. It seems to me an interesting process, and I know we have, to some extent, something like that here, but in those particular jurisdictions, to what extent are the public involved in the process of their drug reviews? Are they quite extensively asked for their advice? Are they involved in the process? And how are they selected or appointed in those particular jurisdictions?
4:30 p.m.
Prof. Devidas Menon
I can speak more knowledgeably about the U.K. situation, so let me focus on it. When NICE, the National Institute for Health and Clinical Excellence, was created, it was with the view that priority setting for such things as health technology assessment reviews ought to involve a broader sector than what was traditionally driving the system, which was technical, clinical, and methodology experts. Experts reviewed, experts designed, experts made recommendations, and the public essentially bore the results or the brunt of those decisions.
They created something called the citizens council. I should point out that the citizens council does not get involved in review of individual products. What they do is look at the classes of drugs or technologies that are important to them, that ought to be examined, at the aspects, other than the very technical and scientific things that are measured in trials, that ought to be considered.
It was a nationwide advertisement that went out. People were invited to apply. I can't remember now whether it's 20 members that the citizens council has. They were selected on the basis of that process to represent the population of the U.K. I've attended two of their meetings. They include everything, to be representative, from an ethnic mix to unemployed, employed, age—all of that.
They've come together, and it's phenomenal watching them work. They don't make any decisions about what ought to be listed or not. There was one in particular where they were dealing with orphan diseases. It was important for NICE, before it went out to commission trials, to understand what that meant to families of people with orphan drugs and what citizens felt.
What was important and good to see was that citizens, through this process, began to understand that all of these decisions are trade-off decisions. In a sense, the Health Canada licensing process is not a trade-off process; you can add any number, if you think it meets scientific standards. But the formulary coverage, CDR decisions, are trade-offs. When people in general understand that they are trade-offs, I think they're more accepting of these decisions.
4:30 p.m.
Conservative
Rahim Jaffer Conservative Edmonton Strathcona, AB
On that note, then, I think you mentioned that the CDR has public representatives. I'm not as familiar with that. You mention that the process for appointment in the U.K. is quite broad and that they try to touch on different backgrounds. Is that your impression of what's happening here?
You mentioned as well that they could enhance their role or public consultations. Maybe you could tell us what you think that role should be.
4:30 p.m.
Prof. Devidas Menon
Dr. Morgan might know more about the process. I believe there are two public members on the CEDAC. As far as I know, it was a call that went out on the website. I'm not sure about the process that was used to select them.
4:30 p.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
It was a call. There are two members who sit on CEDAC. They're non-voting public representatives of CEDAC.
I think the public representation is an important question, and I just want to highlight some work about coverage processes in general—pharmaceuticals in health care and technology more broadly.
There is an interesting ethical framework referred to as the accountability for reasonableness, which sounds like a reasonable framework. It suggests that there are four criteria you would want to have for a decision-making process. First is that it has relevance, that it is using relevant criteria to make decisions. That, which Dr. Menon is referring to, is precisely when public engagement is important: engage the public in helping us determine what the criteria are for making a decision, but don't necessarily involve them in direct democracy, in the sense of making them make those tough choices. That's the responsibility of public servants and experts, frankly.
Publicity is another criterion in this framework; that is, that the rationale for decisions needs to be public. After you've made them, you should be able to defend them. The limiting factor on that criterion right now is confidentiality clauses enforced by the manufacturers. I don't think, frankly, Canada can go it alone on this one. We are going to have to cooperate internationally with other countries on how to develop what you might call a minimum data set, a minimum standard of transparency for decision-making processes, and require that manufacturers and other groups participate to that level of publicity or transparency.
The next question with respect to these criteria or this decision-making framework is revision. There should be opportunities, effectively, for appeals and for a reconsideration of decisions if there have been procedural problems.
Then finally there is enforcement. The decisions should be binding; there should be some mechanism by which they are enforced.
Canada's CDR does fairly well, or as well as it can in the context of our jurisdictional issues around drugs and the transparency limits due to confidentiality. Canada's CDR lives up pretty well to the others. The question of relevance of criteria and the involvement of patients in establishing those criteria is definitely worth pursuing.
They've done some work to include people in the committee. You might want to have a national citizens jury or panel to establish a list of criteria. In New Zealand, there are nine of them that they must consider. In Canada, maybe there would be 16, since that's how many drug plans we have.
4:35 p.m.
Conservative
4:35 p.m.
NDP
Penny Priddy NDP Surrey North, BC
Thank you, Mr. Chair.
My first question would be that one of the goals the national pharmaceuticals strategy talks about is the development of a national drug formulary. Some of us would see this as a first step toward establishing a national drug plan, which has also been called for. Can you offer me very briefly--because I have a couple of other questions--your thoughts on a national drug formulary? Yes, no, good, bad, maybe.
4:35 p.m.
Prof. Devidas Menon
Maybe, I would say.
Looking at what the common drug review has or has not achieved, I think people tend to forget, when they criticize the common drug review, that prior to the common drug review each province had some mechanism, as everybody knows. Has that changed decision-making? I'm not so sure. So how would we ever get to a situation where the provincial governments would agree to a common formulary when they can't make the same decision based on common evidence and recommendations right now?
To me, the best I would hope for—and maybe I'm a cynic—is to have a certain basket of pharmaceuticals in a common formulary. It would be hard to judge what they may be. There would have to be criteria to decide, because then there would be advantages to bulk purchasing and so on, as a result.
4:35 p.m.
Prof. Devidas Menon
But I cannot see how there would be one single formulary that all provinces would deal with in a similar way.
4:35 p.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
Yes, I'm a policy pragmatist. I realize that in the Canadian context a national pharmacare program is still a way off—or yes, pragmatist, or pessimist, I suppose.
I think the national formulary is a way forward. Dr. Menon just alluded to a recommendation that Bob Evans and I have recently written about in a book forthcoming from the IRPP on policy challenges in Canada. We wrote the chapter on drugs and health care more generally. Our recommendation for Canada is to start with a national drug plan based on the five leading chronic diseases in Canada: diabetes, hypertension, high cholesterol—you can pick your favourites.
If you started with the big classes and had a national formulary around those essential medicines, within those classes exactly as Dr. Menon is referring to, I think you'd build toward a national pharmacare program, and I don't think the issues around what would go into the basket of drugs to treat hypertension, cholesterol, diabetes, etc., would be as hotly contested.
4:40 p.m.
Author and Professor at Lionel-Groulx College, As an Individual
This would indeed by desirable, if only for the sake of efficiency. If such an agency is created, it will have much greater negotiating power, provided it is given negotiating power. I know that the RAMQ, for example, does not have the power to negotiate with the pharmaceutical companies.
There are some fairly absurd things sometimes. I was talking with the pharmacist in a big hospital in the Montreal region not too long ago, and she told me that the hospitals have the right to negotiate with the pharmaceutical companies. They receive PPIs, proton pump inhibitors, antiulcerants. They pay one cent a pill for them, and the RAMQ pays $1.80 for them in reimbursement. The difference between the two prices is quite incredible. And this does not apply just to PPIs; there are lots of other examples.
Obviously we know why the manufacturers do that. They do it to accustom doctors to prescribing drugs and to accustom patients to taking them. But if there were an organization that could make purchases and negotiate prices, it would be excellent for both patients and the public purse.
The Quebec issue is a different one.
4:40 p.m.
NDP
Penny Priddy NDP Surrey North, BC
Thank you.
One thing that is obviously up for consideration and is being done is the expansion of the current role of CDR, which is to look at existing drugs. I don't know what you've said about other countries, but could you very quickly give me your opinion on the expanding role of looking at existing drugs as opposed to only new ones?
4:40 p.m.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
I'll quickly jump in.
I think it's essential. It's part of the original business case for the CDR. The Americans have a group that runs what's called the Drug Effectiveness Review Project, DERP, and their slogan is “globalize the evidence, localize the decision”.
The CDR in many ways does that in the Canadian context. Right? It nationalizes the evidence and it keeps localized decision-making, which might be right for Canada, but to do this appropriately and to deal with the whole spectrum of pharmaceutical agents on the market, as Dev was referring to earlier, we need to think now about looking at classes of medicines, new and old medicines, and establishing, if you will, what might be considered the drugs of first choice in Canada.
So absolutely, yes, I think it's going to require a significant resource commitment. I believe the federal government can take a leadership role in this, but it's going to be non-trivial, because the science involved is costly in terms of assessing and appraising in a transparent fashion, and I think involving the public in whatever way in that process would be quite useful.
4:40 p.m.
Conservative