Health Committee on Oct. 18th, 2012

[Barbara Sabourin]

I won't be able to speak to the specifics of the Gilenya file. My apologies, but I don't have that information in front of me.

What I can tell you is that the concerns around knowing the information that led us to a decision is why we went to the second phase of the summary basis of decision project, and we hope that responds to the needs of Canadians.

On the FDA, my understanding is that there is information published through the equivalent of the Access to Information and Privacy Acts. There's a process whereby those kinds of things go on a public website. In Canada, there is also the opportunity for people to apply through the ATI Act as well. From our perspective we think there is reasonably equivalent access to information.

In terms of the—

[The Chair, Conservative, Joy Smith]

Thank you.

I'm sorry. Your time is just about up.

Now we'll go to—

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Isn't it seven minutes?

[The Chair, Conservative, Joy Smith]

I'm sorry, go ahead and finish. You have two more minutes. I was mistaken; my apologies to you.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Sorry, Mrs. Sabourin, I'll move on. It's okay. You've given me something so at least I understand the rationale.

I'd like to get in one more question. You may not be able to answer, but I'm wondering why Health Canada approved renal denervation surgery under its access to care programs when the one study that looked at safety and efficacy was funded by the company that makes the $6,000 catheters that are used in the procedure.

[Barbara Sabourin]

All I can say is that Health Canada, at the health products and food branch, approves products. It doesn't approve medical procedures. I'm not aware of the specifics around that issue; however, we would have looked at any particular products that have that claim. We can go back and take a look at that particular one.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Great. If you could table that, or send that information to me, I'd be grateful.

What are the federal regulations that control off-label use of a medical device that's already approved in Canada?

[Barbara Sabourin]

Off-label use is actually not covered under the Food and Drugs Act and regulations specifically. That would be an issue for the practice of medicine, and the provinces have the jurisdiction in that area.

To get things on labels, the manufacturers have to come forward with the information that supports the risks and benefits and the claims they wish to make, and we evaluate that information, so I can't speak to that.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you.

[The Chair, Conservative, Joy Smith]

We'll now go to Mr. Lobb.

[Ben Lobb, Conservative, Huron—Bruce, ON]

Thanks, Madam Chair.

Dr. Beaudet, you diagnosed the two things that are truly holding me back from greatness: mental health and lower back pain. I thank you for that.

You have mentioned a number of different pieces that you study, and a number of different grants that go out to researchers from coast to coast. What percentage of your research would be applied research, at least what I would call applied research, where there is an issue identified, and industry, academia, and government may come together to work on the issue?

What percentage would be what I would call blue-sky research, where they are trying to fix something or create something that may be many years down the road?

Can you tell us that?

[Dr. Alain Beaudet]

First of all, that's terminology. Blue-sky research is roughly 70% of our budget; 70% of our budget is what we call open. In other words, it's investigator-driven. May the best win in terms of best idea, best mind. It is totally open. You're coming with your best ideas; it doesn't mean that it's not applied.

Very often people think if it's open, it's basic science. Not necessarily. If we look at what we fund through our open grants competition that you call blue-sky research, we have some very basic research in there, but we also have very applied research.

In addition to that we have a number of strategic investments that can be specifically in applied research. That would account roughly for the remaining 30%, although some of our strategic investments may also be for more fundamental research. We cannot equate what we call top-down or strategic with being entirely applied and the rest entirely basic.

We often try through our strategic investments to encourage partnership with industry. For instance, in some cases, we have a program with NSERC that is totally focused on applied research and research that stems from the collaboration between the biological side and engineers.

[Ben Lobb, Conservative, Huron—Bruce, ON]

Fair enough.

I think the number you mentioned was $900 million a year. Was it $900 million a year?

[Dr. Alain Beaudet]

That's correct. Our total budget is $1 billion and what's going to grants....

[Ben Lobb, Conservative, Huron—Bruce, ON]

Is it fair to say that $250 million or $260 million would go towards applied research then?

[Dr. Alain Beaudet]

Again, I wouldn't say applied research.

[Ben Lobb, Conservative, Huron—Bruce, ON]

Okay. Of that, how much can you leverage when you have other people in the industry willing to—is that something you do? I know in the auto industry they do that.

[Dr. Alain Beaudet]

It is something we're doing, and we're doing it increasingly.

For instance you may have seen last week's announcement of our leveraging $12.5 million from a private donor to support a clinical research network in mental health in adolescents. That's really a fifty-fifty leverage. We're putting $12.5 million and the donor's putting $12.5 million.

We leverage money from industrial partners for certain types of programs. We leverage money from charities for other types of programs. By and large, we try to partner and leverage federal funds for everything that is strategic, that is targeted research.

[Ben Lobb, Conservative, Huron—Bruce, ON]

One other question I had was for Ms. Sabourin. In your report on page 3 you talked about priority review time of 45 days as opposed to 90. Does everything get classified as priority review, or are there different review levels? A priority review would seem to me to get the quickest treatment. Are these things triaged?

What would be another term other than priority review? What would be lower down the scale? What would you classify that, and how many days would it take to have that reviewed?

[Barbara Sabourin]

The priority review process is for products that have substantial evidence of significant improvements for severe diseases, life-threatening or severely debilitating diseases. Those are the high-level ones.

[Ben Lobb, Conservative, Huron—Bruce, ON]

How do you make that claim? If I have a product that I say should be priority reviewed, how do I convince you of that?

[Barbara Sabourin]

We have a whole process set out in guidance on our website on how that happens. What happens is that the manufacturer develops a package that meets our requirements for those criteria, and that sets up a meeting.

[Ben Lobb, Conservative, Huron—Bruce, ON]

How long would it take to go through that process to get to priority review?

[Barbara Sabourin]

We have a 30-day review period for those packages. Generally, we have a meeting with the manufacturer as well at that time, and point out any considerations we have. I'm talking about the drug side; the exact timeframes I'm more familiar with. Then there's a commitment for the manufacturer to file the submission within a certain time, between the decision that we grant them priority status and when they come in with the package.

Generally, there's no requirement for companies to come in at a certain time after the presubmission meeting. Then we go through the process.

[Ben Lobb, Conservative, Huron—Bruce, ON]

How many devices per year would be in priority review? How many and what percentage of total submissions? Would it be 50 a year that get priority review, or how many would it be?