Evidence of meeting #85 for Health in the 41st Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drugs.
A recording is available from Parliament.
Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Madam Chair, if I could clarify, is it the question on the cooperation, or the ethnicity issue?
Liberal
Hedy Fry Liberal Vancouver Centre, BC
Yes, the fact that unlike Europe, we have a proportionately larger ethnic and—
Is that the one you meant, Mr. Wilks?
Conservative
The Chair Conservative Joy Smith
We don't have much time, Mr. Wilks.
Ms. Fry does have another question, so she could bring that up herself and have more time, if she chooses to do that.
I'm going to have to cut you off in about 30 seconds because the time is running out, and I hate to do that.
Mr. Wilks, you are a very generous man. Are you finished your question?
Conservative
The Chair Conservative Joy Smith
You did a great job.
I just didn't want to cut you off because you can't answer that in such a short period of time.
We'll now go into our five-minute rounds, and we will begin with Dr. Sellah.
Ms. Fry, you can be ready to go.
NDP
Djaouida Sellah NDP Saint-Bruno—Saint-Hubert, QC
Thank you, Madam Chair.
I want to thank our guests for joining us.
As it is stated on the Orphanet website, “There is no disease so rare that it does not deserve attention”.
Dr. Wong-Rieger, we know that 80% of those orphan diseases are linked to genetic factors. You also said that Canada is a leader in genome research, but it has unfortunately not been able to use that technology for a prevention or treatment program.
Why has Canada been lagging behind in that area even though we have world-renowned minds and scientists? As you said, we are almost 10 years behind the U. S. and Europe. Unfortunately, Canada now has to learn from that European and American Orphanet.
Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Thank you, Madam Chair.
In terms of timing I will acknowledge that we are doing our best to catch up. I'm not sure it's—
Conservative
The Chair Conservative Joy Smith
I was saying Dr. Wong. I should have said Dr. Wong-Rieger. I'm sorry about that.
Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Pardon me, Madam Chair.
Conservative
The Chair Conservative Joy Smith
I know she's on the telephone.
Dr. Wong-Rieger, I think it was directed to you, was it not?
Okay. Go ahead.
President and Chief Executive Officer, Canadian Organization for Rare Disorders
Yes. Thank you.
Let me give you an example and it may help provide the answer. We have a very important drug that was discovered at the University of Montreal by a physician there, for treatment of a very rare bone disease. At the time the drug became ready for clinical trial, the company in fact moved to the U.S. to host those clinical trials, even though we had the first clinical site in Canada. At the time we did not have a designation for orphan drugs, and we didn't have a regulatory framework that would support and provide the kind of support that's necessary in order to foster a climate there. That's why the regulatory framework is so important.
That drug is now currently in late phase 2 clinical trials. One of the major sites is in Canada. But quite frankly, the benefits of that research and development are taking place in the States. That is one of the reasons why we have been pushing so hard to get this orphan drug ready for a [Inaudible--Editor] in Canada, to provide the supports, including the supports for how to design the trials; the critical inputs of those trials; as well as some of the research incentives, including in the U.S., and some of the supports in terms of rebates for the clinical trials, as well as future market exclusivity. It has been the case that we did not create an environment that was very supportive of it, and that was unfortunate. But if somebody will remember, back in 1996, Health Canada said that we didn't need it, that the drugs were being developed elsewhere and that Canada was able to live off other people's research and development. It has taken us, quite frankly, 13 years behind these [Inaudible—Editor]. But we are very happy. I think what we're going to get is very nice too, what we call coming to the front of the pack.
NDP
NDP
Djaouida Sellah NDP Saint-Bruno—Saint-Hubert, QC
Thank you.
Thank you for those clarifications, Dr. Wong-Rieger.
If I have understood correctly, you are asking the government to show some leadership and possibly create a regulatory framework, so that Canadians can at least benefit from the research carried out by our scientists.
President and Chief Executive Officer, Canadian Organization for Rare Disorders
That is exactly right. As you rightly said, we have the intellectual capacity here, but this is just one example. Over and over again we see companies leave Canada for the U.S. and Switzerland. We have not really focused on the capacity that we thought in order to bring these drugs to market.
Conservative
Conservative
Wladyslaw Lizon Conservative Mississauga East—Cooksville, ON
Thank you, Madam Chair.
Thank you, witnesses, for appearing before the committee.
Mr. Lee, I have a very simple question. Of course, I'm not very familiar with all of the aspects of rare diseases. In terms of numbers, what are we talking about in Canada? Can you give some examples of rare diseases and the number of people affected, whether x number per thousand or in gross numbers?
What are we talking about? What are the proportions?
Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Madam Chair, I would defer on that question to my colleague, Dr. Wong-Rieger.
I will answer, though, that some of it is hard to measure. It will be inexact because diagnosing some of these diseases is very hard to do. We may not be picking up every patient in the country. But we think there are just under 7,000 diseases that have been identified internationally. How many Canadians have them? Again, there's not a specific count, but we do think, as I mentioned in my opening remarks, that there's reason to believe that one out of 10 Canadians is affected by a rare disease.
I don't know if Dr. Wong-Rieger would have more exact statistics on that.
President and Chief Executive Officer, Canadian Organization for Rare Disorders
It isn't just that there are statistics. You're absolutely right that we would extrapolate to Canada the international figures, so you're looking at maybe 28 million Canadians who could be affected.
Very important as to why we need this regulatory framework and why we need to focus the research and development is that there are, as I think Dr. Fry was mentioning, ethnic pockets in Canada, and there are also geographically isolated pockets in Canada. So we are actually the host of some rare diseases that are most prevalent or most well identified in Canada. So unless we're doing the research on treatments for these diseases, these treatments aren't going to be developed elsewhere, and we offer a great opportunity to do the research here.
The bone disease I was talking about is prevalent among Amish communities. A small community outside of Winnipeg is actually the site for one of the clinical trials. So it's not just the sheer numbers but the recognition that many of these diseases will become prevalent because of the geographic isolation. We in Canada are actually home to some very unique rare diseases, or we have a large population, because of ethnic migration, of some of these rare diseases. So it's a great opportunity for us not just to deal with numbers, but also to deal specifically with some of those diseases that are either overrepresented or easily identified in Canada.
Conservative
Wladyslaw Lizon Conservative Mississauga East—Cooksville, ON
The reason I'm asking that question is that I had a friend who had a vary rare form of cancer—unfortunately he passed away—and from what I remember there were only three places in the entire world where he could receive treatment: one was in the United States; I think one was in Sweden; and one in Rome, Italy.
Mr. Lee, can you maybe give us some examples of new inventions in medicine that can be adopted to treat rare diseases in others, or do they have to be strictly developed for a particular medical condition?
President and Chief Executive Officer, Canadian Organization for Rare Disorders
I think one of the things that's certainly happening in the rare disease community is that it's a very internationally linked community. So as you say, even though there may be only three sites in the world that can treat that particular disease, in fact many of these clinicians will know each other. Now, because we are also part of Orphanet and we're part of those international communities, we are also listing our clinical sites and listing our experts on there, and we have access to others. We have diseases, as David was saying, for which we may have only a dozen people in Canada with that disease, but they actually can be followed and supported by international sites—
Conservative
The Chair Conservative Joy Smith
I'm sorry, something has happened with the connection, Dr. Wong-Rieger, and I don't know if we can correct it or not.
