Public Accounts Committee on March 24th, 2022

[The Chair, Conservative, John Williamson]

I call this meeting to order.

Welcome to meeting number 10 of the House of Commons Standing Committee on Public Accounts.

Pursuant to Standing Order 108(3)(g), the committee is meeting today to undertake a study on “Report 2: Natural Health Products—Health Canada”.

Today's meeting is taking place in a hybrid format, in compliance with the House order of Thursday, November 25, 2021. Members can attend in person or remotely using the Zoom application.

The proceedings will be made available through the House of Commons website. So you are aware, the web broadcast will always show the person speaking rather than the entirety of the committee.

Given the current pandemic situation and in light of recommendations from public health authorities, as well as the Board of Internal Economy's directive of October 29, 2021, to remain healthy and safe, everyone attending the meeting in person must follow the health rules.

As the chair, I'll be enforcing these health measures for the duration of the meeting. I thank members in advance for their co-operation.

To ensure an orderly meeting, I would like to outline a few rules to follow.

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I'd now like to welcome our witnesses.

From the Office of the Auditor General, we have Jerry V. DeMarco, commissioner of the environment and sustainable development, and Heather Miller, Assistant Auditor General. From the Department of Health, we have Dr. Stephen Lucas, deputy minister; Pamela Aung‐Thin, associate assistant deputy minister; and Linsey Hollett, director general, health product compliance.

Before I begin, I'd like to let members know that Dr. Lucas will have to leave the meeting at 12:15. This is due to a scheduling conflict that we agreed to respect. If you have questions for the good doctor, who is the deputy minister, I'd ask that you be aware of this limitation and focus your questions on him for the next hour and a bit.

Thank you for being here today.

Mr. DeMarco, you have the floor for five minutes. Please proceed.

[Jerry V. DeMarco, Commissioner of the Environment and Sustainable Development, Office of the Auditor General]

Thank you, Mr. Chair.

We are happy to appear before your committee today to discuss our report on natural health products, which was tabled in the House of Commons in April 2021.

I want to start by acknowledging that this hearing is taking place on the traditional unceded territory of the Algonquin Anishinaabeg People.

Joining me today is Heather Miller, the assistant auditor general responsible for this audit.

Canada began regulating natural health products in 2004. At that time, the federal government wanted to balance consumer safety with freedom of choice and access to traditional medicine. To be lawfully sold in Canada, natural health products must be licensed by Health Canada. This is to ensure that products are safe and effective. Health Canada considers a natural health product to be safe when the product’s benefits outweigh the risks, so long as it is used as intended. The department considers a natural health product to be effective if the evidence supports that the product will provide the benefits described in the claims.

We focused our work on how Health Canada regulated the industry to make sure that the products were safe and effective. We looked at the licencing of manufacturers and the licencing of products. We further considered the monitoring of the marketplace once products were available for sale. Overall, we found weaknesses in Health Canada’s oversight. We were concerned that too much reliance was placed on up front licencing approvals but that not enough was done to inspect manufacturing facilities. Inspections are meant to ensure that products are manufactured according to good manufacturing practices, for example using a sterile environment when appropriate.

With upwards of 91,000 natural health product licences in existence in Canada at the time of our audit, it is important to know where, how and when these products are being manufactured. Natural health product licence-holders are required to inform the department which licensed facilities manufactured their products before selling them. However, fewer than 5% did so. This makes it extremely difficult to adequately monitor the production of these products as a whole.

When Health Canada conducted site inspections, it found problems with product manufacturing and product quality. In nearly half of its inspections, the department took regulatory action in response to health risks.

Generally speaking, once products were on the market there was very little monitoring and it was largely complaints-driven. Health Canada's monitoring was insufficient to ensure that the label on products matched the product that was licensed for sale.

We found that 88% of the products we examined carried potentially misleading information, including health claims that were not authorized by Health Canada. These included claims that products relieved fatigue, enhanced endurance or burned fat, as well as having incorrect dosage information. We also found that the department did not do enough to prevent the sale of unlicensed products.

We were completing our examination work as the COVID-19 pandemic began. We expanded the scope of our audit to include the work the department was doing related to natural health products and COVID-19. While we found some issues with the process, Health Canada responded to the urgent needs for COVID-19 products such as alcohol-based hand sanitizers. The department temporarily waived compliance with the specific regulatory requirements to afford Canadian manufacturers some flexibility without increasing the risk of serious safety concerns. It also increased its oversight of the products marketed for COVID-19.

Health Canada has agreed with all five recommendations provided in our report.

This concludes my opening remarks. We would be pleased to answer any questions the committee might have.

Thank you.

[The Chair, Conservative, John Williamson]

Thank you very much, Mr. DeMarco.

I now call on Dr. Lucas to make an opening statement.

You have the floor for five minutes.

[Dr. Stephen Lucas, Deputy Minister, Department of Health]

Thank you, Mr. Chair and committee members, for the opportunity to appear before you today.

Joining me today are Pam Aung-Thin, associate assistant deputy minister of the health products and food branch, which is responsible for product and site licensing, as well as monitoring of advertising; and Linsey Hollett, director general of health product compliance for the regulatory, operations and enforcement branch, which supports the compliance and enforcement of natural health products.

Natural health products are used by Canadians daily to care for themselves and their families. They include vitamin supplements, minerals, probiotics, herbal remedies, homeopathic products and traditional products, such as traditional Chinese medicines. Natural health products also include frequently used products such as toothpaste, mouthwash and sunscreen. Particularly relevant in the context of COVID-19, they also include alcohol-based hand sanitizers.

In Canada, these products are regulated under the Food and Drugs Act and the Natural Health Products Regulations. Through the natural health products program, Health Canada provides oversight to ensure that the natural health products available for sale in Canada are safe and effective.

Overall, the audit found both strengths and areas for improvement.

The audit found that Health Canada licensed products appropriately, based on evidence of safety and efficacy. The audit also found that, when an issue was brought to Health Canada’s attention, immediate action was taken.

It also identified areas for improvement, such as the need for increased oversight on the quality of natural health products, greater monitoring of labels and advertising and improving labelling compliance and enforcement activities. The recommendations validated key gaps that the department had already identified and started working on to address prior to the audit.

The audit supports the direction Health Canada is taking to strengthen the oversight of these products.

To address the recommendation to improve quality oversight, Health Canada has taken steps to require site licence applicants to demonstrate compliance with good manufacturing practices, such as by requiring test results instead of relying on an attestation-based approach.

In March 2021, Health Canada launched the natural health products good manufacturing practices inspection pilot to promote and verify industry compliance with the regulatory requirements through inspections of licence-holders across Canada. Results of the pilot to date are demonstrating a high rate of non-compliance and a need to further industry education as well as ongoing, proactive, risk-based oversight. In this regard, Health Canada is on track to implement a permanent good manufacturing practices inspection program to increase oversight of NHPs and better protect Canadians.

The department is building on work that began during the pandemic to expand its oversight of online advertising of natural health products to ensure that advertisements are consistent with the product license.

Additionally, the department recently consulted on a regulatory proposal to improve product labelling with the objective of ensuring that labels are clear, consistent and legible for consumers to support the safe use of these products.

In response to the audit, Health Canada indicated its intent to propose new tools to strengthen the department’s ability to deter and address non-compliance, notably the extension of powers under the Protecting Canadians from Unsafe Drugs Act to natural health products. Known as Vanessa's Law, which received royal assent in 2014, this law strengthened Health Canada’s ability to collect information and take quick and appropriate action when a serious health risk is identified for therapeutic products and medical devices. However, these authorities do not exist for natural health products, and as a result, we lack the authority to force a recall or a label change of a product, even in the case of a serious health risk such as contamination.

In our departmental response to the audit findings, Health Canada reaffirmed the need for sustainable and predictable funding through fees charged to industry to support increased oversight of these products. Natural health products are the only line of health products for which all regulatory activities are funded by the public. Revenues from fees would support pre- and post-market regulatory activities, including inspections of the facilities that make them.

In closing, Health Canada’s priority is the health and safety of Canadians. For many Canadians, natural health products are an important part of maintaining a healthy lifestyle. Health Canada welcomes the commissioner’s recommendations and is committed to the continuous improvement of the NHP program to ensure that the products sold in Canada are safe and effective.

Again, I would like to thank the committee for inviting me.

I will be pleased to answer any questions you may have.

[The Chair, Conservative, John Williamson]

Thank you very much to both our witnesses.

I now turn to the official opposition.

Mr. Lawrence, you have six minutes.

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

Thank you, Mr. Chair.

I'd just like to start with a brief statement, if I could. I want to start off by saying that, in the two years I've been on the public accounts committee, this is perhaps one of the most damning reports I've read. While, as a Conservative, I have some skepticism with respect to government intervention and regulations, this seems to have set up the worst of both worlds where we are peddling to the public a false sense of security.

On the first page of the report, it says that some products were found to cause “serious and unexpected adverse reactions”, including “septic shock, jaundice, and disruption of liver function”, to name some of them, some of which “required hospitalization”.

Instead of providing Canadians with the assurance they deserve for these products, numbers of them were unsafe, mislabelled and otherwise misleading. We are peddling, underneath Health Canada's, a false sense of security to Canadians.

With that, I'd like to start with the deputy minister, if I could. Specifically, I'd like to talk about some of the issues with respect to the withdrawal or the recall of products. I believe there were 36 out of 40 that were successfully recalled and three that were just simply unable to be recalled. Even for the ones that were recalled, it took multiple months. On average, I believe it was three months. Do you not find this disturbing, and are there any products out there right now that are supposed to be recalled and are not?

[Dr. Stephen Lucas]

Thank you, Mr. Chair.

I will respond and, as well, in course of my response, turn to Linsey Hollett to provide further information.

We are committed at Health Canada to working to ensure products available to Canadians are safe and effective and, in that regard, as I've noted, have accepted the recommendations of the commissioner.

Indeed, we're acting prior to the report and during the course of the audit to address a number of these areas, including increasing our good manufacturing practices inspections to ensure the quality of the facilities producing the products, and we have taken steps, including in the context of [Technical difficulty—Editor] and in a pilot program to look specifically at advertising to ensure that issues are addressed, in particular for—

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

[Technical difficulty—Editor] on that. My time is brief here.

I'm talking about specifically—and would just like the public to know—if there are any products you have recalled that haven't come off the shelves, because I think it's important for Canadians to know that.

[Dr. Stephen Lucas]

Okay. I will make one further point before passing this to Linsey Hollett on that point.

One of the recommendations in the audit and an area that Health Canada has been working to address is to strengthen our powers for mandatory recall, mandatory labelling changes and increased fines, for example. These were not included in Vanessa's Law, which was passed in 2014, as I noted, and we are working to have those included.

Linsey, can you speak specifically to the recall issue?

[Linsey Hollett, Director General, Health Product Compliance, Department of Health]

Yes. Thank you, Deputy.

As the deputy said, while we don't currently have a mandatory recall power for natural health products and we are pursuing that, what I can say is that our first step when an issue comes to our attention is to mitigate risk. That can look like many different things, including a stop sale, public communications.... While all recalls that we have requested may not have been followed [Technical difficulty—Editor] cases we've been able to take action to mitigate the risks to the health and safety of Canadians.

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

Just on that, since Vanessa's Law was passed in 2014, Deputy Minister, how many times have you asked the government to change the laws? Has the government responded in the, I guess, eight years now since then? How many times have you asked, when did you first ask, and what has been the government's response and when will they give you these powers?

[Dr. Stephen Lucas]

This is an area where Health Canada has provided advice. We are looking for an opportunity to bring those legislative changes forward to strengthen the powers as outlined and as committed to in our response to the audit of the commissioner.

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

With respect, I'd like to ask specific questions and I'd like some very specific answers. When was the first time your department asked for the strengthening of Vanessa's Law to include natural health products?

[Dr. Stephen Lucas]

I think it was initially advice provided in Bill C‑51 in 2008. It was not included in Vanessa's Law, which received royal assent in 2014. The department has been working and continues to work to see that these authorities—

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

While we have Canadians exposed to unsafe products, this government hasn't done anything in the past eight years to make sure that these products get off the shelves for Canadians.

[Dr. Stephen Lucas]

That—

[The Chair, Conservative, John Williamson]

That was a statement, so I'm going to leave it right there, Doctor. There was no question mark there.

You're out of time.

Next I'll turn to MP Bradford, please.

You have six minutes.

[Valerie Bradford, Liberal, Kitchener South—Hespeler, ON]

Thank you very much.

I do share the concerns stated by my colleague Mr. Lawrence.

When I read this report, I saw that a number of red flags that the Auditor General identified.

I just want to confirm the following. I'll address this to you, Mr. DeMarco. Are licences granted without inspections actually happening of the manufacturing facilities where the products are processed and manufactured?

[Jerry V. DeMarco]

Our audit found that the attestation process used by Health Canada for manufacturing facilities fell short because it didn't include, as you suggest, inspections. However, in terms of the work plan and the responses put forward from Health Canada, I believe that they are committed to taking a risk-based approach to inspections. One of the three witnesses from Health Canada can perhaps confirm that.

[Valerie Bradford, Liberal, Kitchener South—Hespeler, ON]

Thank you.

Ms. Hollett, I was wondering if you could please explain what an attestation-based approach is. What does that entail? I presume it's supplied by the actual manufacturer.

[Linsey Hollett]

I will invite, in a second, my colleague from the health products food branch to jump in, as that is the organization that overseas the attestation process.

What I can say, however, as has been mentioned, including by the Auditor General, is that we are indeed in the active process, and have been since 2017, of ramping up our proactive inspection activity. In the attestation process that is administered, it does include the oversight and the assessment of information submitted by a company that speaks to their adherence to or compliance with good manufacturing practices.

I will pass to my colleague who overseas the attestation process itself.

[Pamela Aung-Thin, Associate Assistant Deputy Minister, Department of Health]

Thank you, Linsey, and thank you for the question, Chair.

As we stated earlier, natural health products are an important part of maintaining our healthy lifestyle. Through our regulatory role, we provide oversight for safety and efficacy and quality. Before products can be sold in Canada, they are assessed before a licence is provided. This includes a review of the types of ingredients, the dosage and health claims to determine which products can be safely used by consumers.

As you noted, while the audit identified areas for improvement, I'll also note that our approach to assessing the safety and efficacy of natural health products prior to licence was found to be appropriate. The audit also found that when an issue was brought to our attention, the department took action to mitigate the risks.

I'll stop there.

[Valerie Bradford, Liberal, Kitchener South—Hespeler, ON]

Right, but you don't have the power to recall currently.

This question would also follow along the review, because I understand you're in charge of supervising the claims in the labelling, etc., right? Is that correct? Okay.

Do the labels of these natural health care products currently list the ingredients?

[Pamela Aung-Thin]

Yes, labels currently list the ingredients, but as noted in the report, we had started and continue to take measures to improve labelling of these products to make them more visible, more readable, with more evidence for consumers when they're purchasing these products.

[Valerie Bradford, Liberal, Kitchener South—Hespeler, ON]

Okay, thank you.

Back to you, Ms. Hollett.

Getting back to the supervision of the manufacturing facilities and inspections, you've done a pilot that showed there's a high rate of non-compliance, so you're going to implement a permanent good manufacturing practices inspection program. I see from the timeline this is not expected to be in place until November 2024. Given there's such concern that there are no real regular inspections right now but instead have a process of attestation, I wonder if Ms. Hollett could address why it's taking such a long time to get regular inspections in place to ensure that these products are being manufactured in clean facilities with no contamination. I say this given that many of these products are ingested: they're vitamins, supplements, etc.