Health Committee on Nov. 28th, 2024

[The Chair, Liberal, Sean Casey]

Yes.

[Yasir Naqvi, Liberal, Ottawa Centre, ON]

We have some concerns with the amendment that Mr. Thériault has presented. The amendment would revoke all Vanessa's Law authorities for NHPs to manage serious health and safety risks, with the exception of the minister's ability to order a recall. Other authorities, including the supplementary rules authority that would allow Health Canada to take action on pseudoephedrine, would be revoked.

For example, it would allow the minister to direct a label change if an NHP is deemed to pose a serious risk to the environment but not if an NHP poses a serious risk to human health. That clearly does not make any sense. While we all agree that the ability to order a recall is an important tool, this amendment would not extend to other measures that can be used to address serious issues, such as the ability to apply to a court to impose an injunction, or to direct label or packaging changes when serious risks are identified. The injunction authority in particular is a critical power to deal proactively with cases of non-compliance, allowing the courts to direct a person to stop an action that contravenes the act. In addition, the effectiveness of the recall power relies on having an appropriate fines and penalties regime to ensure compliance.

We have heard from Health Canada officials that $5,000 is too low. For some large businesses, this is just the cost of doing business. While we understand that concerns that the maximum fine for therapeutic products is too high for NHPs, we are proposing to apply the maximum fine for food products to NHPs. This strikes a balance between a meaningful fines and penalties regime and recognizing that NHPs are distinct from prescription products.

I also want to emphasize that we think it's important for Parliament to determine appropriate fines and penalties, rather than have the Governor in Council determine this without parliamentary oversight. I would hope that all my colleagues would agree with that principle.

The subamendment that I have proposed would preserve the most essential authorities needed by the minister to protect health and safety in the most serious circumstances. This includes the authority for the minister to direct a label or package change, which is in section 21.2; the authority for a court to impose injunctions, which is in section 21.5, in relation to a recall; and the authorities that have been recently used to strictly regulate nicotine replacement therapies, which are contained in section 30.01. We firmly believe that these authorities are essential to address serious health and safety issues when they emerge.

This subamendment would also preserve tougher fines and penalties for contraventions of a recall or supplementary rules order. It proposes to use the fines and penalties named under section 31.1—the penalties used for food, not therapeutic products, as I mentioned a moment ago. It also includes the authority for a court to issue injunctions with respect to a contravention of a recall order. Fines and penalties for all other contraventions of regulatory requirements would return to the lower levels prior to Vanessa's Law.

Finally, the subamendment that I propose to BQ-2 is also to achieve the intent of BQ-3. We have added a provision that sets out what offence provisions apply to a contravention of the recall order, and a reference is added to the regulation-making power for recall in paragraph 30(1.2)(f) so that it applies to NHPs.

I wanted to present that to you and have that on the record.

I recognize that the subamendment has a lot of provisions, but it is very much in keeping with the amendment presented by Mr. Thériault, just ensuring that it covers the breadth and scope of the authorities that are given to the minister as they relate to nicotine replacement therapies. That's the extent of it.

I'll stop here, Chair. I do have some questions for the experts to help understand, for the benefit of all members, the intent behind this subamendment. If you're okay with that, I can pose those questions to the experts as well.

[The Chair, Liberal, Sean Casey]

You can pose the questions to the experts while you have the floor. If you want somebody else to intervene and then pose questions, just get back on the list, or you can do it now.

[Yasir Naqvi, Liberal, Ottawa Centre, ON]

I'd rather do it now while it's fresh in folks' minds.

[The Chair, Liberal, Sean Casey]

Go ahead.

[Yasir Naqvi, Liberal, Ottawa Centre, ON]

Let me start with question number one. I'll go to Mr. Lee. He seems to be answering questions, or Ms. Godard, whoever is capable. I just don't want to presuppose.

We've heard from colleagues that Health Canada wouldn't need the supplementary rules provision to take action on pseudoephedrine, which is a precursor to the production of meth. Can you explain what makes pseudoephedrine different from other precursors, and why other legislation couldn't be used in this particular case?

[David Lee]

Mr. Chair, it is correct that when it's just used as a precursor, ephedrine and pseudoephedrine are regulated in a different framework as controlled products. Because here it's a health product, it's approved for a therapeutic use—decongestion—and it's then used by organized crime, dismantled and made into methamphetamine. Because it's sitting under the Food and Drugs Act, we needed to find a way to make sure that it didn't go out in an uncontrolled way to those who wanted to use it for, again, lethal purposes.

That's really the difference. It's not a straight precursor. It's actually a health product that can be repurposed, and that's why we needed to deal with it specially. Having the supplementary measures would be very important to keeping it behind the counter, or in front of the counter, just to make sure that organized crime, for example, cannot get it and repurpose it.

[Yasir Naqvi, Liberal, Ottawa Centre, ON]

Thank you. That's a very specific purpose as to why this change is necessary.

Can you explain further when an injunction power could be used and why it's important?

[David Lee]

Mr. Chair, an injunction power is a very important enforcement tool. If you're prosecuting, it can take a very long time. In the case of something like a recall, if a company is not obeying the recall, it's very important to go to the court and get them to reinforce the fact that the company really needs to follow this order. You can do that in a very brief way. You can also make sure that, again, if there's ongoing contravention, the court can then supervise the situation. It's another tool of enforcement. Again, it goes to the courts. They adjudicate it, but it can be a very rapid measure, keeping in mind that recalls are really where there's an imminent threat to human safety.

[Yasir Naqvi, Liberal, Ottawa Centre, ON]

Again, you have to apply to the court to get an injunction if somebody fails to follow the recall order that has been issued.

Finally, Mr. Lee, can you also explain why the power to direct a label change when health risks are identified is important?

[David Lee]

Mr. Chair, again, just as a clarification, the reason the label change power was included in the act for therapeutic products in the first place was to make sure we didn't have to intervene by seizing a product or removing its licence. Actually, that's often not in the best interest of patients or consumers because, again, they don't get the product, and at that point it's just over a labelling issue.

Having a label change power that's really geared.... It's very important that the threshold is that you do it to prevent an injury and only then. It's really making sure that you can instruct that through an order, to have it become a safe labelling, again.

In terms of the regulations, they don't have the power to instruct a change in label. There are rules about complying with the label expectations, but if there's something dangerous on the label, then, basically, the idea of the order would be to mandate that change without disrupting supply. It gives the company a chance to relabel and to make sure that you're not taking the product away from Canadians. That's really the idea of a label change power. Again, it's reserved only for those times when there's a potential injury that we have to intervene in.

[Yasir Naqvi, Liberal, Ottawa Centre, ON]

That's it for me.

Thank you.

[The Chair, Liberal, Sean Casey]

Thank you, Mr. Naqvi.

We'll go to Dr. Ellis, please.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

Thanks very much, Mr. Chair.

In spite of the fact that Mr. Naqvi has an entire department at his disposal, it's clear that he didn't consider this beforehand. That's a sad state of affairs. This is a substantive amendment.

I mean no disrespect to you, Mr. Lee, but this certainly does not give anybody on this side of the table any chance to really consider and look at the act and understand how it may apply. You expect us to make this decision on the fly.

Mr. Naqvi, as the rest of us did, had the ability to put forward any amendments that he wanted to. Obviously, now at the eleventh hour, he chooses to make a substantive subamendment to a very straightforward BQ-2.

That being said, there are a couple of things to consider. If this bill went back to the House unamended, none of these powers would actually exist at all. I think the other ridiculous thing that we fail to consider here is that there is no substantiation that recall powers need to be extended at all. Nobody has provided one shred of evidence. In fact, we've asked for it. Sadly, the NDP-Liberal coalition voted against a common-sense Conservative motion to compel people who talked about serious adverse events to bring them forward. Then we wouldn't even have to have Mr. Julian's motion. We wouldn't even have to talk about it because we would have had evidence to consider, which, once again, he voted against in his lack of support to the natural health products industry. That being said—

[Peter Julian, NDP, New Westminster—Burnaby, BC]

I have a point of order, Mr. Chair.

That is complete disinformation. I moved the UC motion that actually compels that information.

[The Chair, Liberal, Sean Casey]

When you get the floor, you'll be able to address that, but it's not appropriate to do it through a point of order.

Go ahead, Dr. Ellis.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

Thanks very much, Mr. Chair.

Again, as you know, we have an experienced parliamentarian who clearly doesn't know the rules. That being said, he did vote against the Conservative motion to require those people who made disparaging remarks to provide that information to this committee, which didn't happen.

That being said, I think the other thing for folks around this table to consider is this: What's the evidence to say that ephedrine or pseudoephedrine are a significant problem inside the NHP industry and that we need this regulation? Does anybody have any evidence? Does Mr. Naqvi have any evidence? I see that there is no evidence to say that this is necessary.

I would like to ask the experts here from the department this: Are ephedrine and pseudoephedrine being addressed anywhere else by this government? If so, where? What is the likelihood of this substantive subamendment foisted upon the committee playing a significant role in the illegal trade and traffic of ephedrine and pseudoephedrine?

[David Lee]

There is presently in place an interim order addressing ephedrine and pseudoephedrine. It basically requires the intervention of a pharmacist to be able to access it. This is for the reason that we don't want it out being made into methamphetamine. There is a legal operation there.

It's being made under the interim order power, which only lasts for a year. The departmental intent or hope is to be able to move this over to the supplementary rules. You really landed in a spot where we can deal with the issue.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

Thanks very much.

What you're telling me is.... The requirement for ephedrine and pseudoephedrine to be held behind the counter in pharmacies is not something new. This has been going on for some time now. I see your concurrence on that.

That being said, why would we muddy the waters inside the natural health products legislation that we have before us and that we know is important to 80% of Canadians so that Health Canada...so that the clueless Minister of Health can introduce legislation because he can't figure out how to do it any other way? Is that the answer to the question?

[David Lee]

Mr. Chair, I think the departmental intent always was to mitigate the safety risk. That's why, after the body that makes suggestions for behind the counter or not stepped away from the issue. In fact, they made a ruling that they would not deal with natural health products anymore. The department intervened to make sure, again, that we're protecting against the manufacture of methamphetamine.

There's a law there now. It's sitting on the books. It's operating. It's functioning quite well, in fact. The only idea here is that we'd like to remake it. Again, the department would like to remake it to make sure that protection subsists and that it stays, making sure that the product doesn't go astray into organized crime.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

Thank you very much.

Through you, Chair, are you telling me that there is no other legislation besides this legislation that the Department of Health could have found to protect Canadians from using ephedrine and pseudoephedrine to create methamphetamine? That's question number one, so put that in your back pocket.

Number two, please enlighten the committee as to how many instances there have been inside the NHP industry of difficulty with ephedrine and pseudoephedrine specifically in its use to create meth or crystal meth.

[David Lee]

The answer to the first question, Mr. Chair, is basically that it is a health product, and it's under the Food and Drugs Act, and then under that are the natural health products regulations. Since it's there, we needed to find a way to allow it to still be sold as a natural health product.

One way to do it is to remove it from the market and to put it in a controlled scheme. We want it to still be presented to the market so that people can use it, but then cannot abuse it. The control is really on making sure it's not sold in large quantities to those who want to abuse it. That's really the mechanism.

I would refer you to the rationale given to the public in making the interim order. It had the evidence. It had discussions. We had discussions with law enforcement, who were in favour of this to make sure that we controlled the behaviour. It's pretty egregious to have the methamphetamine out there. Really that was the intent.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

Thanks very much, sir. I appreciate that.

Through you, Chair, one more time, since I didn't know this was coming, how could I possibly prepare and read the egregious reports to which you refer?

I'll ask you one more time. How many times have natural health product manufacturers or distributors been implicated in using ephedrine or pseudoephedrine in the creation of methamphetamines?

[David Lee]

Mr. Chair, it's not the industry. The industry makes their health product. After that, it leaves them. It's out on retail shelves. It's beyond their control at that point. It's really not the companies doing the repurposing. That's not really their business model. It's organized crime that buys a quantity and then repurposes it in their labs.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

I understand that, Mr. Lee. I guess what you're suggesting is that somebody could make a significant purchase of bulk amounts of natural health products containing ephedrine or pseudoephedrine and could use them for nefarious purposes.

My question for you is this: To the best of your knowledge, has that ever happened?