Health Committee on Sept. 27th, 2023

[The Chair, Liberal, Sean Casey]

I call this meeting to order.

Welcome to meeting number 79 of the House of Commons Standing Committee on Health.

Today's meeting is taking place in a hybrid format, pursuant to the Standing Orders. I believe all of our witnesses are here in person. There are just a couple of MPs who are remote, so I can dispense with all the notes with respect to hybrid participation. In accordance with our routine motion, I am informing the committee that all remote participants have completed the required connection tests in advance of the meeting.

Pursuant to Standing Order 108(2) and the motion adopted on September 18, 2023, the committee is holding a briefing session on natural health product regulations.

I am pleased to welcome our witnesses from the Department of Health: Linsey Hollett, assistant deputy minister, regulatory operations and enforcement branch; Dr. Celia Lourenco, associate assistant deputy minister, health products and food branch; and Dr. Supriya Sharma, chief medical adviser and senior medical adviser, health products and food branch.

Thank you for taking the time to appear today. I know that some of you have made some significant personal and professional sacrifices to be here.

You have up to five minutes to provide your opening statement. I understand that Dr. Lourenco is going to do that.

Welcome. You have the floor.

[Dr. Celia Lourenco, Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health]

Thank you.

Good evening, everyone.

I would like to thank the committee for the opportunity to appear before you today.

My name is Celia Lourenco. I am the associate assistant deputy minister of the health products and food branch at Health Canada. I'm joined by Dr. Supriya Sharma, chief medical adviser at Health Canada, and Linsey Hollett, assistant deputy minister of the regulatory operations and enforcement branch.

Natural health products, or NHPs, such as vitamins, minerals and herbal remedies, are used daily by Canadians to maintain and improve their health. These products are regulated under the natural health products regulations, which were established nearly two decades ago in response to a study undertaken by this very committee. The regulations take into account the lower risk profile of these products and their ability to make health benefit claims.

Since that time, Health Canada has estimated there are over 200,000 products available to Canadians on the market. Our highest priority is to ensure that Canadians have access to safe, high-quality products to help care for themselves and their families.

While progress has been made over the past 20 years, the 2021 audit by the Commissioner of the Environment and Sustainable Development found significant gaps in oversight, underscoring the need for more action. This includes the need for increased oversight of the quality of natural health products, improved product labelling, greater monitoring of labels and advertising, and introducing a proactive risk-based inspection program.

Following the audit, Health Canada made firm commitments to strengthen its oversight of natural health products, as we discussed last year with several of your colleagues at the Standing Committee on Public Accounts.

While NHPs are often perceived as lower risk, they are not without risk, especially if products contain contaminants or are used improperly. When Canadians reach for a product,it is essential that they have confidence in its safety. They also need to be able to trust that what's on the label accurately represents what's inside the bottle, and that the health claims the product makes are truthful.

Health Canada recently conducted a pilot to proactively search the web and identify potential instances of non-compliant advertising. The equivalent of 3,800 advertising incidents were identified, and our assessment confirmed that 2,070 made cancer claims not permitted by Health Canada.

Furthermore, when we looked at the NHP marketplace between 2021 and 2023, there were 100 voluntary recalls of licensed NHPs for safety issues.

Additionally, Health Canada launched a pilot inspection program between March 2021 and March 2022 during which 36 sites of manufacturers and importers were inspected for good manufacturing practices. The pilot revealed issues ranging in severity at all sites, reinforcing the need for a permanent inspection program.

These gaps are why we are making changes to improve the safety of NHPs. Last year, Health Canada introduced new labelling regulations to help ensure that consumers have the information they need when choosing products.

This year, new legislation was passed to allow Health Canada to act on serious safety issues like ordering recalls or requiring warnings on labels if a company doesn't take action voluntarily.

More recently, Health Canada completed open and transparent consultations, garnering close to 5,000 responses, on a proposal that would see industry pay fees so that the department can, among other things, inspect manufacturing sites to improve product quality and safety.

The regulatory activities currently conducted by Health Canada in overseeing NHPs are currently paid for fully by taxpayers. In comparison, regulatory services for all other health products are funded through a mix of service fees and public funding.

If Health Canada does not charge fees for its services, the department is unable to strengthen its oversight of NHPs. While NHPs undoubtedly offer public health benefits, they also benefit private enterprises that make up the multi-billion dollar industry for these products. Ensuring sustainable funding of the oversight of NHPs while preserving accessibility and quality requires balancing taxpayers' contributions and industry's contributions more equitably.

We understand that many small businesses worry about the additional cost new fees would bring, and about their ability to continue marketing their products to Canadians. This is why we are proposing significant mitigation measures, such as meaningful fee reductions and waivers for small businesses.

As we complete the review of the thousands of comments received on our recently concluded consultation, we are considering how best to adjust our proposed approach to address the many concerns raised prior to further engagement with stakeholders.

In closing, Mr. Chair, we have a commitment to Canadians to ensure that the natural health products they rely on every day to maintain and improve their health are safe, and we have a plan to do just that.

We will now be pleased to answer any questions you may have.

[The Chair, Liberal, Sean Casey]

Thank you very much, Dr. Lourenco.

We will now begin with rounds of questions, starting with the Conservatives.

Dr. Ellis, you have six minutes, please.

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

Thank you very much, Mr. Chair, and thank you to the witnesses for being here.

I'll ask Dr. Sharma first.

Dr. Sharma, we've known each other for some time. I thank you for being here. I appreciate that.

You've made some comments in the media about misinformation and disinformation related to what was going on here. It pains me a bit. I think there's a bit of a truism here: If you tax the farmer who grows the food and you tax the trucker who ships the food, then the person who buys the food is going to have to pay more for it.

If you could, briefly tell me the difference here in the scheme. If you're taxing people who make these products and people who distribute these products, then how is the consumer not going to have to pay more?

[Dr. Supriya Sharma, Chief Medical Advisor, Department of Health]

Thank you.

Chair, to first clarify the comment I made in the interview, when we were talking about misinformation and disinformation, it was specifically in the context of some of the initiatives that were insinuating that Health Canada was specifically anti-NHP. We've heard at times that we were going to ban parsley or go into people's gardens and pull out cilantro. It really was in the context of some rhetoric that was out there that the misinformation and disinformation comment was made. It was really to illustrate that we're happy to have the conversation about any regulation we put forward, including the cost recovery regulations, but it's constructive if it's based in fact.

We have a program where the costs of the entire regulatory framework are currently borne by taxpayers, so 100% of those taxes, those costs, are borne by the taxpayer. There are gaps in the system now. We know that, through pilot programs we have on inspections, on good manufacturing practices, on surveys we've done, on claims and on advertising, we have a compliance gap there. Necessary improvements need to be made in order to regulate these products effectively to ensure they're safe, effective and of high quality, and Canadians can go into a safe marketplace. That's the principle.

Then, the proposal is—

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

Thanks very much, Dr. Sharma.

I would point you back to the question, if I may, related to the cost recovery program. We also know very clearly that 20% of manufacturers and distributors in this industry have clearly said they're likely to go out of business, which will reduce consumer choice.

Once again, if we're going to put costs on the backs of small and medium-sized businesses in Canada, is it not true that consumers are going to have to pay more as well?

[Dr. Supriya Sharma]

We're very concerned about small and medium-sized businesses. We know they're the backbone of the economy and they want to have products for Canadians that are safe and effective. That's why we have fee mitigation for those small businesses, such as decreases of 25% to 50% in costs for small companies, and if it's their first submission there would be a complete fee waiver.

The proposals out there are for consultation, really. We have had, as Dr. Lourenco said, thousands of comments. We're in the process of looking at those and making modifications. We'll put forward a new proposal, but it comes down to the fact that there are improvements that need to be made. Those improvements require some resources, so the question is, where do those resources come from?

Really, this is the only health product line where 100% of the costs for the regulatory framework are from appropriations, from taxpayer dollars.

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

Did I hear you correctly—for everyone who's in attendance here—that through the consultation process there's an expectation that fees for small and medium-sized businesses are going to be less?

[Dr. Supriya Sharma]

That's part of the proposal. There's a definition for qualifying small businesses, so they can qualify for a reduction in fees of between 25% to 50%, and again, for their first submission the fees are waived completely.

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

I saw that originally, but what I heard you say was that through the consultative process that is going to change again and those fees will actually be less.

[Dr. Supriya Sharma]

I said that is part of the current proposal. No fees have been put in place at this point in time. It's just a proposal that's been out for consultation, and that's closed. The proposed fee mitigation was between 25% to 50%, but if we get comments that are different, then that could potentially change. We're open to comments.

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

With that being said, when can manufacturers and distributors expect to hear back on this consultation process and the reduced fee?

[Dr. Supriya Sharma]

We received 4,700 comments. The consultation period just closed. I will say, though, that in those comments there are a lot that simply say, “We do not want to pay fees at all.”

Only about one per cent to three per cent of all the comments were constructive suggestions on how to change the framework or the cost recovery fee structure. We're in the process of going through those now. In the coming weeks we can come back with a summary of the changes we may be putting forth in response to those comments.

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

What we heard originally from the minister in the House of Commons was that 700 people had been injured and hospitalized due to natural health products. Where is the reference for that?

[Dr. Supriya Sharma]

The reference was to adverse events reported to Health Canada in the last two years. We received over 1,000 reports of adverse reactions that were potentially linked to natural health products.

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

Where is it, though? I've searched and I can't find it anywhere.

[Dr. Supriya Sharma]

That's available in the Health Canada database. We actually put those out publicly. We've done that and compiled those numbers. You would have to do a search for “adverse events” and “natural health products”.

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

Would you table that with the committee, please, Dr. Sharma?

[Dr. Supriya Sharma]

We can provide the reference. Again, this is publicly available information, but we can provide that.

[The Chair, Liberal, Sean Casey]

Next we go over to Dr. Powlowski, please, for six minutes.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

Thank you all for being here.

I don't know about the rest of the MPs, but certainly my email inbox was inundated with complaints about this law. I received all kinds of postcards, and I have to say I'm a little perplexed as to why. I understand to a certain extent why, but certainly for parts of it it's hard to see why you wouldn't be advocating for it. My understanding is that previously Vanessa's Law, which requires hospitals and producers to report on the adverse effects of drugs, didn't apply to natural health products, but this is changing that.

I wanted to ask you a bit about the adverse effects of some medications, and I looked it up. With some of them, there can be interactions. For example, St. John's wort can interact with SSRIs —which are treatments for depression—and cause serotonin syndrome, which can be deadly. With regard to hepatotoxicity, there's a whole bunch of drugs implicated in that, particularly drugs in a class of pyrrolizidine alkaloids and ayurvedic medications that have it, such as comfrey and echinacea. Gingko biloba has antiplatelet, antithrombotic properties, so it interacts with Coumadin, NSAIDs and Aspirin.

I have another one here that I wrote down, from the Canadian Medical Association Journal this summer, August 2023. It had a case report of somebody presenting with lead toxicity. They eventually found out that the lead was coming from ayurvedic medicine the person was taking in order to try to get pregnant. They stopped it and she got better, but Public Health Ontario looked into ayurvedic medications and found one in which 13% of the content was lead.

First, do you agree with some of these? I don't believe my saying it is going to get it entered into the record. Secondly, have people been complaining? Have producers of naturopathic medications actually been complaining about having to report serious adverse effects, and have doctors been complaining? I find it hard to believe that people would actually complain about having to report such things. Am I wrong? Are they not complaining?

[Dr. Supriya Sharma]

The short answer is they're not complaining, because it's not in effect yet, that specific provision under Vanessa's Law.

Under the Vanessa's Law provisions, some have come into effect already. For example, there's the ability to compel a recall of a product. I think people were surprised to know that before June 2023, we could recall a head of lettuce but we didn't have the authority to compel a recall of a natural health product. So that's in effect.

The mandatory or the compulsory reporting of serious adverse events by health care institutions is a provision, but it needs regulations in order to come into effect, so it actually isn't in effect yet. We will be bringing forward regulations and will go through the full consultation process before we do that.

People haven't been complaining about that part of it.

With respect to the adverse events, I think you did a really good job of going through some of the challenges. What we've said is that “low risk” is not “no risk”, and there are products that present a risk by themselves. Comfrey is an example of that. It was used as a tea, and it has very severe hepatotoxicity, liver toxicity, associated with it. There have been deaths associated with comfrey. It still can be used as a topical, on the skin, but even then it shouldn't be used on broken skin, because it can be absorbed and cause liver toxicity as well. It can be quite dangerous.

There are other products that can be quite dangerous, either because they're contaminated or because they're being used in combination with other products. Again, it's rare to have very serious events, but in general if a product has an effect on the body, then it can have a negative effect or an adverse effect as well, and the question is, what's the likelihood of that and what can you do to mitigate that? It's really about having information for consumers so that they can use those products safely and we can monitor those products. Then, if safety issues come up, we can do that.

There have been products.... There's a product called aristolochia that has been used for over 2,000 years, but recently—it started in the nineties but really it was in the 2000s—we found out that it can cause renal failure and cancers in the urinary system as well.

The products are not “no risk”.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

One of the other parts of the law, in my understanding, is the requirement for honesty in advertising and not being able to make unsubstantiated claims.

I talked to a colleague of mine who was practising medicine, and he asked how big of a problem it is. I wondered, because I'm getting all these emails and postcards about this, whether it's really that big a problem. We're getting this big political hit because of this.

He said that he had a lot of patients who weren't taking their statins, which have been proven by a whole bunch of studies and medical analyses to reduce mortality—all-cause mortality but particularly cardiovascular-related mortality. I think the number he needed to treat was 35. A lot of his patients were not taking their statins because they were taking a natural health product that claimed to reduce cholesterol but was totally unproven.

My assertion about how many people are being hurt.... If you have presumably 35 people who are not taking statins because of that one person, there's going to be an adverse effect.

[The Chair, Liberal, Sean Casey]

Dr. Powlowski, you're out of time. I'm sorry about that.

It was a long preamble. It was interesting.

Mr. Thériault, you have the floor for six minutes.

[Luc Thériault, Bloc, Montcalm, QC]

Thank you, Mr. Chair.

We'll try to define what's at stake. My question is for all three of you, and whoever feels most comfortable can answer it.

From the outset, I must say that your regulatory intention is laudable. I think even the industry agrees on this one. We're talking about natural health products. We have people's health at heart.

The measure you propose stems from an audit by the Office of the Auditor General. However, as things stand, if we don't modulate the regulatory intent by establishing more appropriate guidelines in terms of implementation and how to achieve the objectives of this reform, if I may call it that, it could ultimately produce effects contrary to those sought. The industry, among others, has pointed this out. We're told that the financial burden will be far too great. I'll be discussing this with you later, if I get the chance. This burden will be detrimental to research, innovation and competitiveness, and will result in major job losses. We certainly don't want to destroy an industry.

If we were to go ahead, we could find ourselves in conditions of unequal competition for regulated products. We could then see products making their way into Canadian homes that have not been approved or scrutinized at all. We can't afford to do that. People would use the Web to bring in these products. That's what I mean by effects contrary to the original objective.

To remedy this, have you done any impact studies, particularly with regard to pricing to recover some of the costs associated with regulation?

What do you have to say about these issues?