Health Committee on Oct. 18th, 2012

[Barbara Sabourin]

Yes, if I could. I'd like to point out that for both personalized medicine or pharmacogenomics and also for nanotechnology, these are areas that have the potential to change significantly the delivery of health care.

We've had a guidance document out on pharmacogenomics since 2008. I believe it's in the list of innovations that we provided. The intent of that is to provide information to manufacturers on the kind of evidence we would expect them to collect so that they can demonstrate that their products are safe and effective.

Nanotechnology is a very interesting file. What we've done there is to have a department-wide working definition of nanotechnology. When these kinds of technologies come along, we want to make sure that our regulatory system is adequate to cope with the technology. We are actively monitoring products of the developments so that we can make sure that is the case and that we're set up well to be proactive if there is a need to add any new requirements.

[Costas Menegakis, Conservative, Richmond Hill, ON]

How's my time, Madam Chair?

[The Chair, Conservative, Joy Smith]

It's very short, about 30 seconds.

[Costas Menegakis, Conservative, Richmond Hill, ON]

Okay.

Madam Sabourin, we often hear of medications, processes, some equipment and tools that are approved in other countries, but are not approved for use in Canada and vice-versa. Can you share with us how we share information with other friendly trading partners around the world?

[Barbara Sabourin]

Thank you for that question.

It's important to note that Health Canada, and specifically our branch, participates in many international initiatives with other regulators around the world. An example I mentioned was the International Conference on Harmonisation to set standards for the requirements for drugs. There's a similar group on the device side called the International Medical Device Regulators Forum. We also have arrangements with a variety of countries where we can share confidential information. As the industries are more global now, it's really important for us to do that. We have mechanisms to share the information, especially around safety issues with other jurisdictions.

[The Chair, Conservative, Joy Smith]

Thank you very much.

Ms. Duncan, you're up next.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

A recent study from the JAMA identified safety concerns about the fast-tracking of three drugs. One was Gilenya. I'm wondering if you could comment on that, Mrs. Sabourin.

[Barbara Sabourin]

I think the article you're referring to was in the CMAJ. Is that correct?

[Kirsty Duncan, Liberal, Etobicoke North, ON]

No, I think it's the JAMA.

[Barbara Sabourin]

I'm not familiar with that article.

What I can tell you is that the fast-tracking process, or the priority review process, is a way for us to put the products that have the potential to have a really significant impact on the lives of Canadians at the front of the queue. I want to make sure the committee is aware, however, that we go through the same review process, and we ensure that the data is there to support the claims for those products.

It's not surprising to us in one way to think that the products that have the potential to really change the lives of Canadians with severe life-threatening diseases would also carry some risk. The diseases themselves carry great risks. It is always the case that manufacturers continue developing their products even after licensing and approval. It's not unusual for us to have more than 100 interactions with companies during the life of their product on the market. Even with these therapies, we would expect that companies continue to develop information, provide that to us, and ensure that the appropriate risk and benefits are really provided to Canadians and to the prescribing health care professionals.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Are drugs for MS and certain cancers, for example, held to a lower safety standard when they're fast-tracked?

[Barbara Sabourin]

The priority review process in Canada—I think it's called fast-tracking in the United States, but ours is priority review—doesn't change the standards. Those standards are the same whether a drug is fast-tracked or not. What it does is it responds to a concern that was voiced by Canadians who were very ill when the HIV and AIDS crisis started. That was to find a way to provide medications to them more quickly. They voiced very clearly that they were willing to accept more risk for that. The standards are exactly the same.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Well, if we look at Tysabri, we fast-tracked a drug knowing that it caused a fatal brain infection. I see a real dichotomy between the way CCSVI has been treated and the way Tysabri has been treated. I have spoken to the researcher who created the molecule. If we go back to the 1990s, there were warnings that there could be infections. If you look at the adverse drug reactions on the Health Canada website, you will see spontaneous abortion and necrotizing fasciitis. I see a real dichotomy.

You explained there are no federal regulations for off-label use for a medical device. I'm going to look at stents. You said they fall under provincial jurisdiction. The question I have is why the federal government intervened for CCSVI.

[Barbara Sabourin]

CCSVI is a medical procedure. My group in my branch is responsible for approving different products. If a product was to be used and manufacturers wanted to come forward and advertise their product for use in a procedure such as CCSVI, they would have to come through us. To date, to my knowledge, there hasn't been such a claim made for any device. This is really about physicians and surgeons trying something, trying to innovate, trying to fix a problem they notice in their patients. That kind of thing is under the practice of medicine.

In terms of the federal intervention, I think there was a lot of work done across Canada and nationally to see how to handle this. I'm sorry I'm not able to speak to the specifics of that. That's not a regulatory intervention.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

That's fair enough. I'm going to come back to something I mentioned. I'm hoping you will be able to provide information to me, and I would ask if it could be sent, regarding the Gilenya reviews, since I was promised a briefing, which never happened.

I don't know if I said it earlier. When I pushed why I couldn't have my order paper question in the briefing, I was told they did not have the resources from the Minister of Health's office because of “government cuts”.

[The Chair, Conservative, Joy Smith]

Dr. Duncan, you're over the time. I know you would like to go on and on, but I have to cut you off.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you, Madam Chair.

[The Chair, Conservative, Joy Smith]

We'll go into another round of five minutes because we have some time to do that.

We're going to start with Mr. Kellway.

[Matthew Kellway, NDP, Beaches—East York, ON]

Thank you, Madam Chair. I too like to go on and on, so I appreciate this opportunity.

We were in the middle of a question before—

[The Chair, Conservative, Joy Smith]

You can only go on for five minutes, though, Mr. Kellway.

[Matthew Kellway, NDP, Beaches—East York, ON]

I'm sure you'll let me know when that's up.

We were in the middle of a question about maximizing the potential of research in the health care field.

Dr. Beaudet, you in particular had set out a very compelling argument about lowering health care costs and boosting the economy through this kind of investment. It would be a shame, obviously, to leave the potential of this kind of investment on the table, so to speak. I think you were in the midst of responding that about 25% to 30% of tests, etc., were in fact either useless or harmful.

[Dr. Alain Beaudet]

There are really two aspects to this. First of all, we not only have to introduce these new emerging technologies when they work— and they've been properly assessed and shown to work significantly and to be cost-effective—but we also have to develop a culture whereby we stop doing things that are not working. The problem with that is we need to better evaluate what works and what doesn't work. We tend to focus clinical research on the evaluation of new technologies, or new drugs, or new practices, but I think we also have to support clinical research that's evaluating what we're currently doing so that we can stop doing what's not efficient, what's not cost-effective, and what doesn't work.

In our patient-oriented research strategy, we really focus on, as I said, implementation and intervention research, on the one hand, ensuring that we change the behaviour and we modify practice. We also want to increase our capacity to do clinical research and evaluate what we are currently doing, what we call cost-effectiveness research, which is what works best and what's most cost-effective. That, I believe, is certainly the type of research that provinces are very interested in and are willing to invest in with us, because they see the direct benefit. I think there's a direct benefit for patients as well. It's a culture of evaluation that we have to develop.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Beaudet. I think Dr. O'Rourke wanted—

[Dr. Brian O'Rourke]

Yes, I'd love to speak to this as well. There's a new field within the type of work we do, and it's being referred to globally as disinvestment in health technologies. That's exactly what he was speaking to here. There are so many things we do in the health care system that were introduced without a good evidentiary platform for them.

Ontario and Alberta have some really wonderful initiatives in place right now. Ontario has created an appropriateness committee. They're looking very closely at a lot of these diagnostic tests, diagnostic imaging, and some surgical procedures to stop doing things where there really is no health benefit. That, hopefully, will create space for introducing technologies that do provide some health benefits.

[Matthew Kellway, NDP, Beaches—East York, ON]

Are there reliable authoritative estimates on that kind of waste in the health care system in terms of dollars?