Health Committee on Sept. 27th, 2023

[Luc Thériault, Bloc, Montcalm, QC]

It hurts being limited to two and a half minutes.

You said earlier that there had been 5,000 serious cases in 17 years. I assume you're going to provide us with that information.

Since the model is copied from the one used to audit and inspect pharmaceutical products, do you have any figures for adverse reactions to pharmaceutical products over this same 17‑year period?

Could you provide us with these figures, in the same way? Could you share them with us? Do you have any idea of the proportion of adverse reactions, over 17 years, for the pharmaceutical products on which you collect information?

[Dr. Supriya Sharma]

Are you talking about the verification of prescription pharmaceuticals?

[Luc Thériault, Bloc, Montcalm, QC]

I'm talking about over-the-counter drugs. These are products that come from pharmaceutical companies.

[Dr. Supriya Sharma]

It's because there are categories.

[Luc Thériault, Bloc, Montcalm, QC]

These are not natural health products.

[Dr. Supriya Sharma]

There are natural health products, there are over-the-counter pharmaceuticals, but there are also...

[Luc Thériault, Bloc, Montcalm, QC]

We know that, but do you have any figures to give us?

[Dr. Supriya Sharma]

You want numbers on side effects, correct?

[Luc Thériault, Bloc, Montcalm, QC]

Yes.

[Dr. Supriya Sharma]

Yes, we do.

[Luc Thériault, Bloc, Montcalm, QC]

Are you going to provide them to us?

[Dr. Supriya Sharma]

Yes.

[Luc Thériault, Bloc, Montcalm, QC]

Thank you.

As for labelling, the Regulatory Impact Analysis says, and I'm quoting Health Canada here, that “a preliminary scan did not identify important environmental impacts and concluded that a detailed strategic environmental assessment is not required” and that “the additional environmental impact of this initiative over and above the normal labelling process is expected to be minimal.”

However, the industry has been testing labelling with the new requirements in mind. To comply, not only the labels, but also the containers will have to be bigger. You've been told that modifications are needed. In a regulatory impact assessment, you stated that “no evidence was presented to support the claims made” by industry regarding additional costs and environmental impact. However, you didn't have an environmental impact assessment either, because you hadn't deemed it necessary to do one.

Are you open to the idea of having a more updated labelling model, worthy of 2023? Already, the labelling is outdated. You're going to ask that we operate with paper, labels, boxes and so on. This model will be applied for the next 10 years, so why aren't you using QR codes? Otherwise, in three years' time, this will be obsolete and, on top of that, you'll have hurt the industry.

How do you see it? Are you open to changes in this regard?

[Dr. Supriya Sharma]

With respect to using a QR code on the label, there were a number of things that we looked at.

One was that, with a QR code.... It's not at the point of sale, so you're not able to do a comparison between products that have a similar label.

Also with respect to QR codes, the challenges are that not everyone has a cellphone, so they may not necessarily be able to use them. They may not want to use their data. If it goes to a website that has a lot of information, it might be long and they won't read it. It's very difficult to enforce the information on a website, because you can change it very quickly.

The other thing is this: If you take that key information off the label and just have the QR code, the only thing left on the label is the marketing.

It's a possibility, but there are a lot of reasons that, at the point of care, you don't have that information.

Mr. Chair, there was a question on the environmental impact of the labelling, if I may answer.

[The Chair, Liberal, Sean Casey]

Go quickly, please.

[Dr. Supriya Sharma]

When we did the survey of companies, they told us that within a six-year period they normally change their labels anyway, regardless of whether there are any other requirements or new regulations in place. That's why there's a six-year period to phase in.

There is no recall of products, so the enforcement is at the level of manufacturing. We're not destroying any product. We're not recalling any product, so the impacts, in terms of the environment, are minimal.

[The Chair, Liberal, Sean Casey]

Mr. Davies, go ahead, please, for two and a half minutes.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you.

Let's go back to 2003, if I can take you back 20 years. I'm going to read again from Health Canada's document. It says:

b. The [natural health product directorate] recognizes that product labels should assist consumers in making informed choices with respect to NHPs.

c. Labels should assist in selecting products that meet individual needs and expectations, as well as the merits and limitations of products.

d. Labels should allow consumers and others to fully understand how products are to be used and stored to ensure their maximum benefit, and to be aware of any adverse reactions or other risks associated with the use of the product.

33. [Natural health product] labelling provide[s] consumers with all relevant information needed to make informed choices.

For the recommendation that product labelling “be standardized to provide clear and consistent product information”, you reported the status as follows:

NHP labelling requirements apply to all NHPs, therefore clear and consistent product information will be available to consumers.

Now, there's a whole list of things that the NHP regulations in 2003 required: “the dosage form”; “the net amount of...weight, measure or number”; “a list by proper name...of each medicinal ingredient per dosage unit, and...the authorized potency”; “a qualitative list of all non-medicinal ingredients”; “the recommended use or purpose; the recommended route of administration; the recommended dose and...duration of use; the risk information...including any cautions, warnings, contra-indications or known adverse reactions associated...; the recommended storage...; the lot number; the expiry date [and] a description of the source material of each medicinal ingredient that the product contains...when the ingredient is a plant or plant material....”

My question is this: If that is what you were telling Parliament in 2003—that that's what was going to be captured by labelling—what is the case to be made 20 years later to say that we need to change the labelling so that consumers are aware of things? I know you weren't the author at the time, but either it was not true then, or it's not required now. Help me understand that.

[Dr. Supriya Sharma]

It was true then, and it is required now. We have done considerable consumer consultations and health professional consultations, and what we've found is that there are challenges with the labels. There are challenges in terms of a lack of contrast. They are difficult to read, and the font size in some cases might be four points, which is microscopic. There's no standardized way that the warnings are displayed. There isn't modernized information on how you contact the companies. There isn't allergen information on the labels. Overall, it isn't presented in a way that is standardized. It is different from product to product. It is very difficult to compare.

There is information there; it's just how legible it is and how easy it is to access. We have gotten a lot of feedback on that. The labelling is really putting it in a standardized way with all of that information that—

[Don Davies, NDP, Vancouver Kingsway, BC]

I think I've said this to you before, Doctor, but—

[The Chair, Liberal, Sean Casey]

That's your time. I'm sorry, Mr. Davies; you're over time.

Mr. Doherty, you have five minutes, please.

[Todd Doherty, Conservative, Cariboo—Prince George, BC]

Thank you, Mr. Chair, and thank you to our guests for being here today.

This is my first meeting with witnesses after coming back on this committee, so I apologize because I wasn't part of the study or previous studies.

I want to go to Mr. Davies' comment regarding the natural health product directorate.

Pardon me, but I believe, Dr. Lourenco, that you were part of Health Canada 22 years ago. You've been with Health Canada for 22 years.

Dr. Hollett, you probably have been there for 10 or 12 years. It's 20? Well, congratulations and thank you.

Dr. Sharma, you're just probably at 10 or 12 years, I think. You've been there for 20 as well. Okay, so collectively, you've all been here since around about the time that the testimony we just heard was ramping up.

There were 53 recommendations. Where are we with the 53 recommendations? Again, it's just in the last nine years that you've been ramping up on the recommendations. Is that correct?

[Dr. Celia Lourenco]

Those 53 recommendations go back to 1998, when the standing committee at that time recommended—

[Todd Doherty, Conservative, Cariboo—Prince George, BC]

That's right, and then, in 2003, you started working on them.

[Dr. Celia Lourenco]

We implemented new regulations in 2004. Then, from there, we made several improvements to the program, both operational improvements and improvements in terms of making sure that we use a risk-based approach to the regulation of these products and that we provide appropriate guidance and direction to industry wanting to market products in Canada. We've made several changes over the years.