Public Accounts Committee on March 24th, 2022

[Peter Fragiskatos, Liberal, London North Centre, ON]

Thank you very much, Chair.

I'm just looking at the report. I just want to get clarification where it says—and I'm quoting now—“Health Canada does not have the authority to order a change to a label or force a mandatory recall of a natural health product for any reason, including when a product presents a serious or imminent risk of injury to health.” Why is that?

If you go into the substance of the report, it does say that, “Health Canada can enforce product and site-licence conditions for natural health products”, and it gives examples, “suspending or cancelling licences; directing a stop sale of products; seizing products; requesting voluntary product recalls; [and] issuing public alerts and advisories on the Health Canada website.” Those are substantive, but why is there no authority to change a label, or force, say, a mandatory recall? Is that a legislative gap? What does that relate to?

[Pamela Aung-Thin]

Thank you for the question. I can start, and certainly turn to my colleague Linsey if she has anything to add.

Certainly that was well documented in the report and is something that we are very conscious of and that we are responding to. In one response we indicated that we would be seeking Vanessa's Law powers for natural health products, which will allow us additional authorities, some of which you have outlined.

In terms of some of what we call post-market activities, perhaps I'll turn to Linsey.

[Linsey Hollett]

Thank you, Pam.

Thank you, Chair, for the question.

As the member suggests—and I will speak specifically to recalls—that is, as Pam says, a legislative issue that we are looking to fill. From the list that the member read out, one thing you may have noted was requesting voluntary recalls. Because that is there specifically, that is all we can do.

However, I will say, having now run the program for close to 18 years, that although it says “voluntary recalls”, we in many cases have great success in working with a company when making a voluntary request. In the small number of circumstances in which that is not successful, we are able to use one of the harder-hitting tools that you've heard mentioned a couple of times this morning.

[Peter Fragiskatos, Liberal, London North Centre, ON]

Thank you very much.

There are a number of recommendations, but one of the most important reads as follows, “Health Canada should, for licensed natural health products on the market, including on the Internet, take a risk-based approach.” I understand what the Auditor General has said there, but how does Health Canada define “risk-based approach” in relation to this recommendation? Where is the progress on this particular recommendation, as well? That's for whoever wishes to take it.

[Linsey Hollett]

Maybe I can start, Pam.

Thank you, Chair, for the question.

The term “risk-based” is something that, in the regulatory space especially, confines enforcement. You will hear us speak to it often. It directs much of our decision-making.

What we mean when we say “risk-based” is that when we are looking at a situation to determine the level of risk, we apply a fairly lengthy but consistent set of criteria. We look at the nature of the non-compliance, although all are important. We look at whether it is a labelling issue versus contamination, the type of non-compliance and what risk that represents. We then look at the target population of a product. Perhaps it's a vulnerable sub-population or something of that nature. We will look at the compliance history of the party we're dealing with.

What we do to ensure it is risk-based is to consistently apply those criteria. That dictates what action we take and how quickly. It really directs all of our decision-making.

Pam, do you have anything to add?

[Pamela Aung-Thin]

Yes. Thank you, Linsey.

I will add a little bit more to that, because there was also a component in the report that talked about a risk-based monitoring program to identify unlicensed products and take appropriate action. This is a recommendation that we agreed with.

We maintain a complaint-based program for regulatory advertising compliance oversight. We also recognize that an additional risk-based approach is required so that we ensure unauthorized activities are prevented or stopped. We are implementing this risk-based approach to monitor advertising, and we are taking steps to propose new tools that will strengthen our ability to do so.

I mentioned some of those earlier. We ran a pilot—

[The Chair, Conservative, John Williamson]

I'm going to stop you right there. Thank you.

We have the transcript, so we can refer to that. Thank you very much. I apologize.

Ms. Sinclair‑Desgagné, you have the floor for two and a half minutes.

[Nathalie Sinclair-Desgagné, Bloc, Terrebonne, QC]

Thank you, Mr. Chair.

I'd like to follow up on my colleague Mr. Fragiskatos's very good question. The risk mitigation approach is excellent, especially given the serious health risks. That's the most important factor.

I understand that other factors come into play, as our witnesses have clearly outlined. However, the medium- and long-term effects of certain products are to a large extent unclear, especially for more vulnerable groups like pregnant women. Very little information is available on the medium- and long-term effects that natural health products could have on pregnant women.

Is a risk mitigation strategy sufficient? Shouldn't a preventive strategy be developed instead?

That is still not the case, it seems. The products and manufacturing sites are not being inspected. No strategy has been put in place to prevent risk rather than trying to mitigate risk based on complaints. We need to ensure that all, or at least a reasonable sample, of the products that come to market in Quebec and in Canada are inspected to protect the health of Quebeckers and Canadians.

What guarantees do we have?

The question is for Health Canada officials.

[Pamela Aung-Thin]

Thank you for the excellent question.

We subject all natural health products that are on the market to some kind of oversight to ensure they are safe to use. If any risks are identified, we make sure that warnings are issued to the public, and we work very closely with the companies to ensure that labels are updated to reflect those risks.

Ms. Hollett, do you have anything to add?

[Linsey Hollett]

Thank you, Pam.

I would agree with the member, in that in our world, it is often much easier to identify and assess the immediate risk. Medium-term and longer-term are more in-depth processes.

However, in what you see in our management response action plan, I think there is a theme that goes throughout. There are multiple actions to gather more information so that we at Health Canada have more information about the products on the Canadian market.

That will have multiple benefits and uses, but certainly one of them is to inform a medium- and longer-term picture of the risks, as the member mentioned.

[The Chair, Conservative, John Williamson]

Thank you very much.

We will turn now to Mr. Desjarlais.

Mr. Desjarlais, you have the floor for two and a half minutes.

[Blake Desjarlais, NDP, Edmonton Griesbach, AB]

Thank you very much, Mr. Chair.

I want to, again, thank the witnesses for their very important discussion on how we make sure that these products continue to be regulated in a safe and effective way. There's room to ensure that we have a fair understanding, as a committee, as to how we can continue to do this better. It's very clear here that there's much improvement that's required to the system.

I understand, just from our discussion today, that it partly has to do with the lack of legislation. It has to do with a lack of authority in particular areas of jurisdiction that your department would like to see in order to empower itself to make these things more credible. I hear that point.

In terms of when we look at licensing and labelling, I was part of a process in Montreal that looked at the intellectual property of indigenous artists. That's also a very unregulated field. We have seen a huge abuse of indigenous people by non-indigenous people copying, creating fakes, or pretending to create art and selling that art across the country, particularly in Quebec, at enormous prices.

The Inuit community, of course, in collaboration with the Government of Canada came to an agreement that helped to enforce justice for the Inuit community, making this better by instituting a label that was a qualifiable label of Inuit quality. It was a quality stamp.

When I think of this process and best practices, and the fact the government has this procedure for art, can it employ procedures like this for labelling to make sure that indigenous people and others who want to enjoy indigenous products understand that these have been ethically sourced, understood, and handled in a good way? Is that something the department has ever thought of doing, in collaboration with indigenous people, in labelling protection?

[Pamela Aung-Thin]

I can perhaps take that one. It's a very important issue. I commend the work that's being done in the intellectual property space.

For natural health products, and in particular for products that are more traditional in nature, including indigenous traditional medicines, as I mentioned earlier, we only label those that are for sale in outlets that require labels.

Our realm of authority is limited to health and safety and to claims that are made on those products. It doesn't, unfortunately, extend to some of the broader issues that you are mentioning. We certainly hear your concern. We'll continue our work in terms of the actual [Inaudible—Editor] recommendations in ensuring the health and safety of Canadians through these various programs.

[The Chair, Conservative, John Williamson]

Thank you very much.

I'm turning again to the official opposition.

Mr. Lawrence, you have five minutes.

[Philip Lawrence, Conservative, Northumberland—Peterborough South, ON]

Thank you, Mr. Chair.

My first questions will go to the commissioner. I bring to your attention paragraph 2.45 on page 13 of your report. It states that “The department found problems at all sites,”—there were 35, as mentioned in the previous sentence—“including the use of expired raw materials, unacceptable amounts of contaminants, and product tests that did not confirm the product expiry date.”

I have a simple question for you, Commissioner. Is that concerning?

[Jerry V. DeMarco]

Yes, it is concerning. That was just a sample of 35 companies. If that situation holds true for many of the others that aren't inspected, then it implies that the situation is of a larger concern than mentioned in the sample. Yes, it is a concern. Health Canada can speak to how it is going to respond to those findings, and recommendation 2.47.

Member Desjarlais raised an issue a few times, and I don't think it's been addressed. I want to point him to the Nagoya Protocol on access and Benefit-Sharing under the UN Convention on Biodiversity. There's a huge international debate about the issues of biopiracy, bioprospecting, scientific imperialism, and so on. It's very important in the Canadian context. That's just so it doesn't appear that this issue has been left unaddressed.

[Philip Lawrence, Conservative, Northumberland—Peterborough South, ON]

Thank you.

Mr. Chair, I assume I'll get some of Blake's time for that answer. I'm just kidding.

[The Chair, Conservative, John Williamson]

You still have some time.

[Philip Lawrence, Conservative, Northumberland—Peterborough South, ON]

Thank you for that response.

To the health department, when will this issue be resolved and could you also explain, if you could, what expired raw materials and contaminants were found by these inspections of 35 manufacturing plants?

[Linsey Hollett]

Maybe I can take that one.

I would like to say, to use the member's terms and to support what the Auditor General said, that we do find those concerning. It is not at all unusual to make observations during any kind of inspection. In fact, in the vast majority of inspections, there would be observations. However, when they are of the nature of the sample that the member cited, then that is when, from a compliance and enforcement perspective, you are at the top level of addressing that—at the top level of response in terms of time, in terms of the tools we use and the severity of the actions we take to mitigate risk to health and safety.

As for when that issue will be addressed, I'm assuming that the issue we're talking about is addressing the most serious observations that were cited during inspections. I can say that observations cited in inspections that are included in the scope of that report have been addressed with the companies. Again, I know I've mentioned it before—

[Philip Lawrence, Conservative, Northumberland—Peterborough South, ON]

I have a question on that. My apologies for cutting you off, but my time is short. Of those 35 companies, how many had their manufacturing licences suspended?

[Linsey Hollett]

I will get the exact number for the committee. We have numbers of actual suspensions but also intentions to suspend. I would want to give accurate information so we can commit to get that for you.

[Philip Lawrence, Conservative, Northumberland—Peterborough South, ON]

And just for clarity, it does say in here that there was a notice of intent, I believe, for half. It does say that, but I was just wondering how many were actually suspended just for clarity.

The other question I have for you—and if you don't know, I would appreciate a written response—would be how many inspections were performed in 2020, 2021 and the first three months of 2022? On that, how many suspensions were there?

[Linsey Hollett]

Again, I can give you the number of inspections. In terms of licence suspensions, I will commit to get that information quite quickly after the meeting.

In 2020, we had not yet launched our pilot, but we did do what would be a “precursor” or a mini inspection program, if you like. They are cited in the report and are called “compliance monitoring projects”. There was one in 2020. That would have been 17 inspections, I believe, 17 to 18. In 2021, we would have launched our pilot, which carried over into the first three months of 2022. That included 36 inspections, the last couple of which we are in the process of wrapping up before March 31st.

[The Chair, Conservative, John Williamson]

Thank you. The committee looks forward to receiving the information that was requested.

We turn now to Ms. Shanahan.

You have the floor for five minutes, please.