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Results: 1 - 15 of 20
View Tracy Gray Profile
CPC (BC)
Thank you, Madam Chair, and thank you to all of the speakers for being here today.
Something that I hear about quite often, whether it's ventilators or testing kits, is delays with Health Canada for approving products that might be similar in the United States or in the United Kingdom. Things seem to take longer here.
First of all, I'd like to ask Mr. McDonald. Is this something that your team has faced, and do you have any concerns with red tape as you've been going through your processes?
Arthur McDonald
View Arthur McDonald Profile
Arthur McDonald
2020-06-01 12:19
No. Actually, it's just the opposite. Health Canada has been very helpful as we've gone forward. There are some small differences between what the approval that we already have from the FDA is and what Health Canada will be looking for, but in particular, Health Canada will be providing authorization for our Canadian manufacturers. You authorize a final product in this case, so it's important for us to manufacture and test specifically what is being manufactured here in Canada and submit it to them for the final approval.
We've had guidance on the characteristics they're looking for, and they have offered us a three- to five-day turnaround once we have submitted the device for authorization. I've found Health Canada to be very good.
View Majid Jowhari Profile
Lib. (ON)
Thank you, Madam Chair. I will be splitting my time equally with MP Lambropoulos.
Thank you to the witnesses for all the great information. Thank you as well for all the great work you've done. You've made us proud and you've made Canada proud. You're also putting the health of many citizens of the world at the forefront.
Dr. McDonald, you talked about the fact that you started the Canadian research on March 21, and you recently submitted the Canadian design to Health Canada for approval. You also heard feedback, in around three to five days, in approval. Can you tell us when you actually submitted? When do you expect to have the approval from a timing point of view?
Arthur McDonald
View Arthur McDonald Profile
Arthur McDonald
2020-06-01 12:24
No, I'm sorry, I must have misspoken earlier. We are planning to submit to Health Canada in a couple of weeks' time.
Arthur McDonald
View Arthur McDonald Profile
Arthur McDonald
2020-06-01 12:24
At that point, they have committed to giving us a three- to five-day turnaround.
View Majid Jowhari Profile
Lib. (ON)
You're anticipating to submit, but during this time you have the requirements and you're very clear what Health Canada is looking for, and it will be three to five days. We're hoping that in three weeks we will have a Canadian-made ventilator approved by Health Canada. Am I correct on that?
Arthur McDonald
View Arthur McDonald Profile
Arthur McDonald
2020-06-01 12:25
That's correct. We're hoping to start production at the end of this month.
View Emmanuella Lambropoulos Profile
Lib. (QC)
Good afternoon, witnesses. Thank you for being with us today.
Professor McDonald, I'd like to ask you a question with regard to the Health Canada approval. As my colleagues have already touched on, you are seeking the approval. We know that in the United States there are a lot more approvals happening at a much quicker rate, but they're not necessarily being as careful about what they are approving. I think it's a good thing that Canada is taking this approach of being careful and making sure that only the right equipment is being used and that the right tests are being approved.
From reading your testimony and hearing you this morning, I was under the impression that it's been a while that you've been seeking the approval, but you just said that you haven't even applied yet. Is that correct?
Arthur McDonald
View Arthur McDonald Profile
Arthur McDonald
2020-06-01 12:27
That is correct, and it is because what Health Canada will approve is what is manufactured in Canada. In the last three or four weeks, companies in Canada in combination with our partners in Europe have been industrializing the design and have been securing the supply chain. It was necessary in some instances to wait until there was a signed contract in order for them to make commitments on such supply chains.
This week we have a complete device in Italy. We have the start of production of devices of a similar nature here in Canada. It will take us a few weeks to test them. Then that will be submitted to Health Canada, but in the meantime our discussions with Health Canada are to define what we should be testing and the complete set of tests that they will require, which in some cases means going slightly beyond what the FDA has asked for. They have been very helpful that way.
View Earl Dreeshen Profile
CPC (AB)
Thank you very much. Indeed, it's an honour for me to be able to speak here today and to ask questions.
There was a comment earlier about the lack of Canadian taxpayer research dollars going to science and so on, but I remember a few years ago when I was in Germany with the science minister and we had an opportunity to talk to folks like those from the Liebniz and Helmholtz and Max Planck research institutes. Really, they were saying that per capita and per GDP, the Canadian taxpayer actually puts in just as much as any place else does. The fact is that we have difficulty getting our private sector linked in. Of course there are many reasons for that. One, of course, is that we have 37 million people. We have six time zones. We have 14 different government entities, and we aren't the main draw when it comes to businesses.
I think it's important that we recognize this. Canada has always done some amazing work, which is one of the reasons why amazing scientists, such as Mr. McDonald, are be able to do the great things that they do.
When we are talking about Health Canada, Mr. McDonald, you just mentioned that you were anticipating three to five days because that was what you were being assured by Health Canada. Unfortunately, a lot of other companies have been given similar assurances that once they have their applications in, things are going to happen for them. I hope that because of your appearance here at this committee, people will take note and we will see that happen.
I'm just wondering if there are certain things you have seen. Maybe you haven't experienced yet how approvals happen out of the United States or the European Union, while we are still waiting in Canada for Health Canada. Is the Canadian process working the way it should be in these particular times, and can we improve the approvals? Are there any impediments that you've heard about from those companies and researchers who have been trying to get their work onto the world stage ?
Arthur McDonald
View Arthur McDonald Profile
Arthur McDonald
2020-06-01 12:31
I really don't think I'm qualified to comment effectively on Health Canada's actions with respect to others.
Admittedly, as one of the four ventilator projects—StarFish being another one that was approved by the Canadian government—and having been given priority, we have exceptional access to Health Canada, so we have had, and I referred to this in terms of turnaround time, the preferred situation. It's very difficult for me to comment on the general situation, other than the fact that it's obvious there is an awful lot being looked at carefully by Health Canada right now. I certainly have some sympathy with them in terms of the workload that is on their plate.
View Earl Dreeshen Profile
CPC (AB)
Thank you very much. Of course, there are so many companies that have made applications. No doubt they have to be well scrutinized.
What you just mentioned was that, unless they are going to be manufactured here in Canada, they are not particularly going to become a priority. You mentioned the work that had been done in Italy and how those approvals by the EU seem to be moving along and that you still have to go through the due diligence here in Canada.
Is this also part of the reason we continue to hear about different things happening in the U.S., and people are saying, “Why don't we take a look at this now?” and wanting these new procedures or new technologies to be used in Canada?
If it is the case that we have this international conflict or at least slowdown, is there anything we as a committee could be doing here to try to help out in this situation?
Arthur McDonald
View Arthur McDonald Profile
Arthur McDonald
2020-06-01 12:33
I'm very pleased that we have been able to mobilize several Canadian companies to get into this needed technology. The companies themselves have been extremely co-operative and have brought expertise to the table. I'm sure it's also happening with the StarFish device, as that is company that already has experience in this area.
I think this is a case where, as you mentioned the discrepancy in terms of total expenditure in Canada is primarily associated with R and D done here in Canada. This is an example where company co-operation with national labs and universities has been a very positive experience. I think it's good for the country.
Stephen Lucas
View Stephen Lucas Profile
Stephen Lucas
2020-05-22 11:07
Indeed, on May 9, Health Canada cancelled the authorization for the importation and sale of a KN95 respirator and, in addition, contacted a number of other MDEL-holders to change the labelling, which does represent a recall in the definition we use to indicate that they don't meet the N95 filtration standards. Relabelled, they could be used as face masks. That process has happened, and we issued, on May 11, a public advisory to that end, in addition to contacting those medical device establishment licence-holders.
View Francis Drouin Profile
Lib. (ON)
Thank you, Mr. Chair.
I thank the minister for coming before this committee, as well as the staff who are here with us today. I also want to take this opportunity to thank all the front-line health care workers and to thank the minister's department and its staff, who have been working 24-7 on this particular issue. We are living in unprecedented times.
We're on the subject of personal protective equipment and discussing other medical supplies. Minister, I'm wondering if you could explain to us what the role of your department is. How are you working with the provinces to ensure that we get personal protective equipment to our front-line health care workers?
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