Yes.
Evidence of meeting #135 for Health in the 44th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was product.
A recording is available from Parliament.
Evidence of meeting #135 for Health in the 44th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was product.
A recording is available from Parliament.
Bloc
Luc Thériault Bloc Montcalm, QC
Okay.
Is there a requirement for some over-the-counter products that everything be written down? For example, isn't it true that more than frequent use of a product like Tylenol causes liver damage?
Chief Medical Advisor, Department of Health
I didn't quite understand the question. Can you repeat it?
Bloc
Luc Thériault Bloc Montcalm, QC
Is it possible that more than frequent use of a product like Tylenol could lead to liver damage?
Chief Medical Advisor, Department of Health
Yes, certainly Tylenol, or acetaminophen, has quite a narrow safety profile, so it is quite easy to go beyond.... If you go beyond the prescribed or the recommended dose, it can result in very severe liver toxicity.
Bloc
Luc Thériault Bloc Montcalm, QC
Did you require that adverse reaction to be mentioned on the packaging?
Bloc
Luc Thériault Bloc Montcalm, QC
So if I buy Tylenol, I'm going to see that more frequent use can cause liver damage.
Chief Medical Advisor, Department of Health
The acetaminophen label is very specific in terms of the dosing. We've done a lot of education, and we put out advisories on the concerns of exceeding those doses. There's been a lot of work on acetaminophen specifically.
Bloc
Luc Thériault Bloc Montcalm, QC
That's what I was getting at.
When it comes to drug interactions, isn't it Health Canada's role to do everything in its power to educate people and anticipate problems? This would prevent a number of adverse effects related to drug interactions. Obviously, there can be interactions between highly toxic pharmaceuticals and natural health products.
What are you waiting for to do that?
Chief Medical Advisor, Department of Health
Chair, at the base, the appropriate use of any health product is something that's shared across different players in the health care system. At Health Canada, from our perspective, we take our role very seriously in terms of the regulation of the products, in terms of sharing that information, and in terms of openness and transparency.
We do have information on the website regarding the way natural health products are regulated. Part of that does include some of the risks that are associated with them. We do make reference to interactions. Also, on each product, with respect to whether it's in a product monograph information, there's information around—
Bloc
Luc Thériault Bloc Montcalm, QC
However, there's been no targeted public awareness campaign.
I've asked you before about the methodology. The minister was talking about misinformation. Isn't it true that there was a problem with the methodology? Did you question the methodology that was used for the report?
Indeed, they weren't random inspections, but targeted: Inspections were conducted where problems were known. Subsequently, the figure that was given in connection with the industry suggested that everyone or a large percentage of people were non-compliant and had problems with inspection.
Why did you publish figures that didn't mention the methodology used?
Assistant Deputy Minister, Regulatory, Operations and Enforcement Branch, Department of Health
In any inspection program.... We regulate quite a few different commodities at Health Canada, as you know. One common basis of all inspection programs is that we make our decisions on a risk basis. Nowhere is that more evident than in inspection programs. We look at what we call the risk profile of entities. Many factors go into that risk profile. That is how we decide where we need to inspect. Especially in a sector where we haven't been inspecting for a long time, it is not at all unusual, and in fact it was quite intentional, that we would go where we thought the risk was highest.
NDP
Peter Julian NDP New Westminster—Burnaby, BC
Thank you to our officials for being here. We appreciate your service to the country. I apologize for some of my colleagues who have taken a very aggressive and inappropriate tone.
I want to come back to the issue of non-compliant companies, because this is really at the heart of the debate and discussion that we're having around the bill itself.
We were talking about 350 recall notices. From what date to what date is that?
Assistant Deputy Minister, Regulatory, Operations and Enforcement Branch, Department of Health
That's approximately the last five years, from 2019.
NDP
Peter Julian NDP New Westminster—Burnaby, BC
That's similar for the 31 public warnings, which come down to three companies that were not complying. Okay.
Are those three companies still in operation?
Assistant Deputy Minister, Regulatory, Operations and Enforcement Branch, Department of Health
I'm sorry, Chair. I would have to check that, but I can commit to getting that answer to the committee.
NDP
Peter Julian NDP New Westminster—Burnaby, BC
Those companies are subject to approval by Health Canada. In any of those three cases, was there a revocation of the natural health product number or a cancellation of their product, or were any other measures taken against those three companies?
Assistant Deputy Minister, Regulatory, Operations and Enforcement Branch, Department of Health
In all three cases, plus some of the additional 350, yes, other measures would have been taken, everything from intent to suspend a licence to revocation or stop-sale. With many of those tools, what is often the case is that something can be put in place temporarily or, as I said, some are on the basis of intention.
To give you a complete answer, I would want to check what the current status is of any additional tools that we used, keeping in mind that some of these go back to 2019.
Peter Julian NDP New Westminster—Burnaby, BC
Mr. Calkins did testify before this committee. He wasn't wrong to say that there are other provisions and tools that Health Canada can take.
I think it would be very helpful for this committee to understand each of those three cases, which seem to be the egregious ones. No one disagrees that the vast majority of companies in Canada work in a very responsible way. They believe in the natural health product industry. They want to make sure that they're offering the best-quality product. In the vast majority of cases, they comply voluntarily.
I think it's important for the committee to understand and for us to know, in those rare cases—one in a hundred, from the statistics that we seem to have before us—what other tools Health Canada has employed against the companies that simply refuse to be compliant and essentially stain the reputation of all the other companies, which are complying.
I want to come back to public notices, because you spoke earlier about the impact of delays. In those 31 cases, it appears that there were delays in the companies that were voluntarily complying. Can you give us a sense of the average length of time when a company didn't comply with an initial voluntary recall but then did comply once Health Canada provided a public warning?
Assistant Deputy Minister, Regulatory, Operations and Enforcement Branch, Department of Health
With respect to the first question, about what a norm would be, in the world that we're speaking of, we have three different types of risks: type I, II or III. They're all based on an imminent risk to health, and then it flows from there.
A type I risk, for example, is the most serious and carries the most possibility of negative health impacts or risk to Canadians. Our expectation is immediate action on the part of the company. They let us know of an issue or we let them know—it really doesn't matter—and if it is type I, we expect immediate action.
NDP
Peter Julian NDP New Westminster—Burnaby, BC
When you say “immediate”, is that 24 hours? Is it one week?
Assistant Deputy Minister, Regulatory, Operations and Enforcement Branch, Department of Health
We have a standard internally on what time to engage the company. When I say that we would expect immediate action, it would be an agreement to a plan and beginning the implementation of that plan in 24 hours or 48 hours.
I'll provide an example. I said that there were delays when potentially dangerous products were remaining on the market. We did have one instance when we asked multiple companies to recall. The majority of companies agreed. One company did not. We had to find another way to have the dangerous products removed. What we did in that instance, as I mentioned earlier, was engage other parts of the supply chain—in this case, distributors. It is not their responsibility; it is the licence holder's responsibility. By the time we were able to find someone else in the supply chain willing to do a recall, it was weeks, three or four weeks. We have another instance of six weeks.
