Health Committee on Sept. 27th, 2023

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you, Mr. Chair.

I want to thank everyone for being here. It's greatly appreciated. Thank you for your presentation.

Dr. Lourenco, in your comments you talked about a number of irregularities being identified. You gave certain numbers. Dr. Sharma touched on the 8,000 at this point in time, and those are since 2004. That's basically 470 reactions in a year, in simple math.

My question to you is this: If you've identified them and there's a regulatory process in place, what steps have you taken once you've identified them to go through the regulatory process and get answers?

[Dr. Supriya Sharma]

I'll just say that over the years, in terms of the adverse-reaction reports, they have been increasing. If you look at the last two years, we've had about 1,000 in the two-year period, with over 700 of them being serious, so they are increasing. We have more products, so it's understandable that we'll have more reports.

Overall, though, that's likely a very serious under-reporting, and that's the case for all health products.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

I appreciate that.

We're increasing over how many products?

[Dr. Supriya Sharma]

That's a good question. In terms of the products that have been authorized, there would be over 200,000 products. However, we believe that potentially only half of those are marketed. There's no requirement for companies to notify Health Canada if they're marketing the products, so we don't really have that number. We've tried. In April we tried to do a survey of companies to get an idea of the number of products that are marketed, and we got only about an 8.3% response rate on those—

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you.

In comparison to medicine, in particular pharmaceuticals, etc., when we look at, for example, grapefruit having a huge impact on ticagrelor or Lipitor, how many reactions do you get on that, how many responses? Comparing that numbers-wise, I anticipate that you'd have a significantly higher number along those lines.

[Dr. Supriya Sharma]

For pharmaceutical drugs, prescription drugs, we do have higher levels. It's in the tens of thousands. We also have a requirement for increased reporting under Vanessa's Law. We have the requirements for health institutions to be reporting those adverse events as well. That's already shown an increase in reports. Yes, in general, there are more adverse events reported.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you.

I'm just going to read here, and this is a quote from what the minister said in the House:

It is very disturbing that there were more than 700 cases last year where there was a serious adverse health impact, including hospitalization

Would you agree with that?

[Dr. Supriya Sharma]

I would say, for these products or any products that are taken to help people improve or maintain their health or prevent disease, if you have a serious adverse event—

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

I apologize for interrupting, but what I'm hearing is that you're not agreeing with that. The reality is that the minister reported this number. You've indicated that you have records of it, reference to it. I'm just asking you, can you give us an example of the 700-plus, by the sounds of it? I'd like to know how that research is collected, where it's stored and where it's provided to the public.

[Dr. Supriya Sharma]

In doing surveillance of the products once they're on the market, one of the inputs into that is the adverse reactions that get reported to Health Canada. We know those are vastly under-reported for all products. We know they're even more under-reported for natural health products. We did a pilot with poison control centres in the past and, for example, through poison control centres, in a three-month period, they got more reports related to natural health products than we did in an entire year, so we know it's under-reported.

That's not the only input in terms of looking at the safety of the products. We look at publications. We work with our international counterparts. There is a lot of information that we look at to make sure we're assessing the safety of the products.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you.

I've just brought a simple sample, a very small sample, of what I received from my constituent. All 338 of us here have received these, and I have significantly more back in my riding. They basically talk about the huge economic impact it's going to have. These inflationary taxes that you're putting on these natural health products are going to escalate this even more. There are big concerns, because the average Canadian, I would say to you, who utilizes or doesn't even know this is going on, is not going to know about it until all of a sudden—boom—it's going to be in their laps.

What economic impact work have you done to show the implications this will have on Canadians?

[Dr. Celia Lourenco]

We're hearing feedback through our consultation with all of the affected stakeholders. We've also received quite a large number of comments, up to about 5,000 comments through our consultations. We're taking that back, and we're reflecting on the proposals to put forward, and we'll make adjustments and do additional—

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Then you haven't done an economic impact?

[The Chair, Liberal, Sean Casey]

That's your time. Can you answer briefly?

[Dr. Celia Lourenco]

What we did was an assessment of what fees would need to be charged in order to support the program that we currently have and that we'd like to bolster in order to respond to the recommendations from the Auditor General that identified a number of gaps.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Lourenco.

Next we have Dr. Hanley, please, all the way from Whitehorse, for the next five minutes.

[Brendan Hanley, Liberal, Yukon, YT]

Thank you very much, and I add my thanks to the witnesses for appearing today.

I want to start with a bit of the big picture, Dr. Sharma. If you look at the effect of Vanessa's Law as it applies to therapeutic health products and medical devices since 2014, could you talk about the big picture of how that has helped to improve our information and consumer safety, basically, as regards therapeutic health products?

[Dr. Supriya Sharma]

Certainly. Vanessa's Law really was quite a shift in terms of the authorities we have to regulate products. One of the tools that comes with Vanessa's Law is the ability to compel a recall. Again, it's not that we would get to the point where we would force a company to do a recall, but having that ability in place makes it easier for companies to comply when we have to do a recall.

It would take months to do a recall. Sometimes we wouldn't have companies providing information. It would take a long time for that to happen. Now that we have those provisions, that process or that time has really shortened. We have the ability to require tests and studies. If a safety issue comes up, we have the ability to go to the company and, again, make that request.

Again, a lot of these things are regulatory backstops. If they know that we have the authority to compel something to happen, then they're more likely to comply with those requests. It really has made the regulation of the products more efficient. When we're responding to safety issues that are urgent, we have those tools at our disposal. It also gives us the ability, if needed, to levy fines and penalties up to $5 million. We have provisions in Vanessa's Law about the sharing of confidential business information for public health benefits, and we've done that as well.

There's a whole series of tools that have made that—

[Brendan Hanley, Liberal, Yukon, YT]

I'm sorry to interrupt, but I think that gives us a picture. I think what you're describing is already regulated products with additional measures that were broadened with Vanessa's Law, and now what we're proposing is to bring similar.... It's almost like there's a parallel between already regulated products—natural health products—now coming under this umbrella, so that we have additional measures in place to provide that safety and assurance for Canadians consuming natural health products. Would that be more or less accurate?

[Dr. Supriya Sharma]

That's correct.

I think we had very blunt instruments before. You know, if all you have is a hammer, everything looks like a nail. Now we have more refined tools to be able to regulate the products appropriately.

[Brendan Hanley, Liberal, Yukon, YT]

Do you think it would be a potential benefit for businesses that the additional safety assurance, labelling, etc., would reassure consumers? In my mind, that should be an advantage for businesses selling these products.

[Dr. Supriya Sharma]

Absolutely, and it creates a level playing field. If you're a compliant company, you won't feel the difference. You were already complying. You're already taking appropriate steps with respect to your products if a safety issue arises, so you won't feel the difference. For other companies that are potentially not compliant, it will bring them into compliance and give them the incentive to be in compliance.

Again, it's a level playing field. I think that's beneficial to all companies and, of course, to Canadians, because it improves the safety of the products they're taking.

[Brendan Hanley, Liberal, Yukon, YT]

On thresholds for businesses, I'm thinking of some very small businesses in my constituency that might make lotions or creams. What would be the implications for these local, very small businesses that are making natural health products?

[Dr. Celia Lourenco]

We certainly put in our proposal measures to reduce the impact on small businesses. As we've already discussed, we've received a number of comments, and we know that we have to take a look at the proposal we've put forward. We'll consider other potential measures to address businesses and perhaps to look at micro-businesses, even, and see if there are additional mitigation measures we can put in place to be able to support those businesses, because we understand that they are important for Canadians. They contribute to the economy, and we want to make sure Canadians will continue to have access to a variety of products—not just for current companies, but also for companies in the future that may want to have access to the market. We also want to support small companies in setting up shop in Canada and growing in Canada.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Hanley.

Thank you, Dr. Lourenco.

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