Public Accounts Committee on March 24th, 2022

[Brenda Shanahan, Liberal, Châteauguay—Lacolle, QC]

Chair, I am giving my spot to Mr. Dong. .

[Han Dong, Liberal, Don Valley North, ON]

Thank you, MP Shanahan, and thank you, Chair.

I'm going to go back to my last question on the time frame for processing a licence application. How long does it take? I'm talking about for domestic products and for imports as well. I recognize there might be a difference. If you don't have this information, can you send it to the committee afterwards? Okay. That would be great.

I have a very small question about labelling. Is there an emphasis put on ingredients that might potentially be allergens? Allergy is a very risky thing. Both of my kids have severe allergies. Is there attention paid to that?

[Pamela Aung-Thin]

Yes, absolutely. Allergens—yes.

[Han Dong, Liberal, Don Valley North, ON]

Okay.

In terms of inspection, I think we really should differentiate between inspecting the manufacturing facilities and inspecting the retail facilities. I just want to talk about the retail facilities. Can you explain to me how these inspections are carried out? Is it carried out by an actual officer showing up at the door and looking through the product, or is it in written form?

[Linsey Hollett]

I can take that question.

Just to clarify, when we do inspections, they are focused on entities that conduct an activity for which you need a Health Canada licence. Right now, inspection programs—the one being piloted for natural health products but also more mature inspection programs we have—including for drugs, do not include retail inspections.

Especially during the pandemic, we have worked quite closely with the retail community—for example, on the hand sanitizer file—so there is a relationship there, but the inspection program I've been speaking of this morning and the pilot do not include retail inspections.

Maybe the last thing I can add is that for those that we do inspect, what that looks like is an announced, planned inspection on a date that is agreed to with the regulated party. We do unannounced inspections, but that is more on the reactive side—inspections for cause.

[Han Dong, Liberal, Don Valley North, ON]

Okay. I just want this to be on the record. I've heard positive feedback from the retail sector on dealing with Health Canada inspectors. They've been very sensitive and accommodating in trying to be the least intrusive and to cause the least interruption to their business. I just want to pass that on and encourage you to continue doing that.

On the licensing and inspection, have you looked at what countries around the world are doing for those best practices? I say this because I think that in Japan or Hong Kong they have different classifications—like level one and level two—and they require different licensing and inspections. Have we looked at them?

[Pamela Aung-Thin]

Yes. Certainly on the licensing side, we do look at international regulators for best practices and to get that information to inform our own policies and information.

[Han Dong, Liberal, Don Valley North, ON]

How much time do I have, Mr. Chair?

[The Chair, Conservative, John Williamson]

You have just about a minute and a half.

[Han Dong, Liberal, Don Valley North, ON]

That's good. I want to focus on TCM.

I want to say that I didn't believe in TCM, although I'm a Chinese Canadian, until 2005. My father actually went through rounds of chemo and was advised to use a TCM product: a traditional Chinese medicine product. These are in powder form. It was amazing. He didn't suffer any side effects of the chemo rounds. I know that this is very anecdotal evidence. My wife also recently benefited from TCM.

We have two provinces, B.C. and Ontario, that have regulated colleges for TCM and acupuncture. Can I have a commitment from Health Canada going forward, when you're tying up or fine-tuning your licensing and labelling, that you will consult with the provinces and, in MP Desjarlais' case, territorial governments, when it comes to labelling and licensing of traditional health products?

Is that a yes?

[Pamela Aung-Thin]

That is a yes. I'll just elaborate by saying that we do engage with a range of stakeholders, and that includes provincial regulators.

[Han Dong, Liberal, Don Valley North, ON]

That's excellent.

[The Chair, Conservative, John Williamson]

Thank you. That's your time.

Mr. Dong, I'm glad you clarified that “TCM” is traditional Chinese medicine. I thought it might be a cannabis product.

[Voices]

Oh, oh!

[The Chair, Conservative, John Williamson]

Thank you for that.

We now are entering our fourth and final round and returning to the official opposition.

Mr. Lawrence, you have the floor for five minutes, please.

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

I'm just going to ask a quick question and then I'll pass it on to my colleague Mr. Patzer.

I was asking earlier about the inspections of facilities and there were 35—17 and 35 or something like that. How many facilities or manufacturers are there in Canada that should be inspected? What's the denominator?

[Linsey Hollett]

Thank you for the question, Chair.

Maybe I can take this opportunity just to let the member know that I did misspeak earlier. In 2020, the number would have been 23 inspections.

Maybe I can turn to Pam on the number of site licence-holders. That is who would fall within the scope of an inspection program.

[Pamela Aung-Thin]

I'm madly searching for my numbers, but it is approximately 800 site licence-holders.

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

I'll turn it over to Mr. Patzer, but I'll make a quick comment that at 30 or so per year, we wouldn't circle through all of them in many decades. That might be an area of concern that I would point out to the Health officials.

[The Chair, Conservative, John Williamson]

Thank you.

Mr. Patzer, you have three and a half minutes.

[Jeremy Patzer, Conservative, Cypress Hills—Grasslands, SK]

Thank you.

I want to pick up on a theme I was working on earlier with regard to standardized regulations, because paragraph 2.23 references:

Health Canada relied on inspections, such as drug inspections, performed by domestic and regulatory authorities from other countries when licensing these sites. However, we found that the department did not have assurance that 10 of these 13 sites followed good manufacturing practices because the department did not have evidence that these inspections included the natural health product lines.

Going along with the theme of trying to make sure we have equal regulations and processes in place, Health Canada doesn't have a program to conduct routine on-site inspections for manufacturing sites, yet Australia and Europe do. Why is there a gap there, especially when we're relying on other countries?

If we're trying to streamline and standardize these regulations, there appear to be some existing gaps. I wonder if there are some comments there.

[Linsey Hollett]

There are two parts to that question.

In terms of a standardized set of regulations, what I would use as the comparator—which is almost a gold standard in the drug world—are the good manufacturing practices we have. There is a large community of countries in the world that follow the same standard practice, and that has allowed us to rely on mutual recognition quite heavily.

In the natural health product space, although there is progress in this area, with all countries you would think of that may usually collaborate and co-operate, there are still some differences in the regulatory framework, such as how natural health products are regulated and even what they're called. As the member points out, however, there are jurisdictions—and I would put us, with our plans for an inspection program, in that group—that are leading the work to get to the point on NHPs that we are at with drugs and to fill the gap that member mentions.

The ideal outcome would be that we get to a place, including with a pro-active inspection program, that lets us make use at some point in the future of mutual recognition agreements that also include NHPs.

[Jeremy Patzer, Conservative, Cypress Hills—Grasslands, SK]

I have one more question that I really want to get in, regarding confidence in the products. We've identified risks, and it's going to take time to address those risks, but it doesn't change the fact that Canadians are buying those products today.

The report also shows in paragraph 2.39 that “Health Canada did not know where all licensed products were manufactured.” It goes on to say that fewer than 5% of all active product licence-holders told the department “which licensed facilities manufactured their products before selling them.”

Again, there seem to be some issues. How do we make sure Canadians are confident in the products they're buying, when there are so many holes, gaps and issues, whether they be contaminated products, expired products or not even knowing where these products are manufactured or where they're coming from?

[Pamela Aung-Thin]

Perhaps I can start.

In terms of what you've noted in paragraph 2.39, we recognize that there is a gap. We are already taking steps to address this, including updating our product licence application forms, which include information to collect site information as part of the application. At the same time, we're working on longer-term solutions to incorporate this requirement in the regulations.

[The Chair, Conservative, John Williamson]

Thank you very much. That is the time for you for today.

We're turning now to MP Dong. I understand you'll be sharing part of your time with our NDP colleague.

It's over to you.