Health Committee on Sept. 27th, 2023

[Dr. Celia Lourenco]

Thank you for the question.

In developing our cost recovery proposal, we have given significant thought to the impact on small business. We understand that a large percentage of manufacturers that market natural products in Canada are small businesses. We estimate that it's at least 60% of them. In our cost recovery proposal, we've put forward mitigations in terms of the impact on those businesses. We included a 25% to 50% reduction in the proposed fees, as well as a first submission from any small businesses being at no cost.

[Luc Thériault, Bloc, Montcalm, QC]

Yes, you said that earlier.

I'm going to take advantage of the fact that you're talking about costs to ask you what evidence you relied on to measure and establish costs.

By the way, there are no taxes on pharmaceuticals, but there are on natural health products. Have you taken this into account? Wouldn't the revenue from sales taxes on natural health products enable the government to implement these regulatory measures?

[Dr. Celia Lourenco]

Thank you for the question.

Our cost recovery proposal was developed based on strict Treasury Board guidelines for the development of costs, using a similar process as is used for other types of health products in terms of how these costs are developed. In terms of contributions of businesses to the economy, in terms of whether they pay GST or contribute in other ways, that does not factor into the development of the model for the cost recovery proposal.

As I've already said, we did very significantly look at the impact on small business and put in place mitigation measures to address small businesses.

[Luc Thériault, Bloc, Montcalm, QC]

However, you are aware that pharmaceutical companies benefit from patents and are therefore able to break even and absorb costs like those you want to recover here. It's peanuts to them.

Do you have a study? Does what you've established take into account an impact study and evidence as to the real effects? What did you base your criteria on?

[Dr. Celia Lourenco]

Thank you.

Our criteria, as I've mentioned, were developed based on very strict guidelines from the Treasury Board in terms of developing costs for services provided to industry. In that process, we look at what the costs would be of providing those services, and based on that we then determine what the costs would be to industry across the different types of services provided.

Other elements related to contributions to the economy or—

[Luc Thériault, Bloc, Montcalm, QC]

I apologize for interrupting, but I only have a minute left.

Are you open to accommodations in response to the industry's criticism? The regulations are in place. Now, in implementing the guidelines, are you open to the idea of different categories, for example? Let's take the case of an herbalist: it's going to cost so much for each of his products. Couldn't we establish a fixed cost for a given quantity of a product, for example?

Is there still a willingness to sit down with people and find a way not to damage their businesses to the point where they're going to disappear, along with the supply of their products? Is there an opening?

[The Chair, Liberal, Sean Casey]

Give a brief answer if possible, please.

[Dr. Celia Lourenco]

Yes, absolutely. We are taking into account all the comments, and we will be coming out with an updated proposal. We'll sit down with stakeholders to address their concerns.

[The Chair, Liberal, Sean Casey]

Thank you, Mr. Thériault.

Next we have Mr. Davies, please, for six minutes.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you, Mr. Chair. Thank you to the witnesses for being here.

There's some controversy, but I think there are some facts and points on which there is broad common agreement among everybody in Canada. I think everybody wants natural health products to be safe and properly labelled, and for the claims made to be backed up by evidence and science. We know that something like three out of four Canadians rely on natural health products in some way as an integral part of their daily or weekly health regimen.

I think the other thing that is often overlooked is that this is an industry that is well regulated now. Some of the comments made seem to suggest sometimes that we don't have a lot of regulation. Industry and product users are asserting to me and other members of this committee, and probably to you, that they believe that the current regulations are quite effective—or perhaps they're not enforced enough—and that the proposed regulations are, if I may paraphrase, perhaps a solution in search of a problem, or may even constitute a cure worse than the disease.

I want to test that thesis with you. I've done some research. I went back, and 25 years ago this committee studied natural health products and issued 53 recommendations to Health Canada. You're familiar with those.

What is more interesting is that I found a document on Health Canada's website from 2003, entitled “Natural Health Products Directorate (NHPD) Progress on the 53 Recommendations of the Standing Committee on Health”. This is from 20 years ago. I wanted to put a few things to you to test that thesis about where we are.

Health Canada said this about recommendation 18:

18. Inspection activities be performed consistently and on a regular basis by inspectors knowledgeable about the products.

Status:

a. The NHPD is developing an inspection strategy for [natural health products]. The goal of the strategy is to ensure an appropriate level of oversight for these products, and consistency in its application.

Are you telling me that did not happen?

[Linsey Hollett, Assistant Deputy Minister, Regulatory Operations and Enforcement Branch, Department of Health]

Over the last, I'm going to say, 15 years, what we've seen at Health Canada in terms of what we call postmarket oversight—inspection, in plain language—is a gradual ramp-up. In and around the time when the report that's being cited would have come out, there was little activity, and it was more reactive than proactive.

What we've seen, though, over the last eight or nine years is a solid ramp-up. By that I mean starting with very time-specific and small inspection-like projects, to an inspection pilot a couple of years ago in response to the Auditor General's report, and now an interim inspection approach whereby we're trying to keep momentum going until such time as we can fund a more permanent inspection program.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you. I have a lot to get through.

I want to move to risk assessment, and Dr. Sharma spoke of this.

Recommendation 20 of this committee from 25 years ago states:

20. Claims be assessed to ensure that there is reasonable evidence supporting the claim.

The status then reads:

c. A guidance document on the Standards of Evidence will be published before January 1, 2004, when the new Regulations come into force.

d. Prior to sale, all NHPs will be assessed to ensure there is reasonable evidence to support the claim and safety of the product.

Is it your evidence before us that in 2004, that did not happen?

[Dr. Supriya Sharma]

Before 2004, it did not happen.

Before we put the national health products regulations in, we did not have a premarket system, so before products were on the market, they weren't being reviewed. We have that now.

Actually, that is one part of the system—whether it's been the OAG or others who have looked at it—that is said to be running well. The standards for approval for authorization before the products go on the market are done, and they're working well.

[Don Davies, NDP, Vancouver Kingsway, BC]

More on risk, it says:

The level of evidence required to support a claim for a NHP is based on the level of claim and any safety concerns about one or more ingredients in the NHP.

I think we would all agree that's a wise move.

I take it that's been in place as well, and Health Canada has been ensuring that the claims made are based on the claim made about the safety impacts.

[Dr. Supriya Sharma]

Yes. The idea is that for these products, the level of evidence that's required should match the type of product it is and what it's being used for.

I will say that through the self-care framework, which was launched in 2018, we have also introduced classes of products based on the ingredients and whether or not there's something called a monograph there. Not only was a system put in place, but it's now being refined to more closely match the products.

[Don Davies, NDP, Vancouver Kingsway, BC]

I want to turn to adverse reactions. It says:

Status:

a. The NHPD is developing an adverse reaction reporting system for post-market monitoring.

b. Product licence holders are required to notify the NHPD within 15 days of any serious adverse reactions occurring in Canada, and any serious, unexpected adverse reaction occurring outside of Canada.

That's been in place, has it not, since about 2004? How many adverse reaction reports have you had since then?

[Dr. Supriya Sharma]

If you're saying from 2004 to 2021, we've had over 8,000 adverse reactions reported in which the natural health product use had a suspected role, and over 5,000 of those were labelled as serious. A serious adverse reaction is something that either causes you to be admitted to hospital or prolongs a hospital stay.

[Don Davies, NDP, Vancouver Kingsway, BC]

Was there a causal relationship established?

[The Chair, Liberal, Sean Casey]

That's your time, Mr. Davies.

Can you answer that very briefly, Dr. Sharma?

[Dr. Supriya Sharma]

Not for all of them, but we do causality assessments. In the vast majority of those, there was a causal link to the natural health product.

[Don Davies, NDP, Vancouver Kingsway, BC]

Could you supply that data to the committee, please?

[Dr. Supriya Sharma]

I will check. The only thing is that there are personal identifiers and personal information in those reports, so I don't know if redactions or other reviews would be necessary before submitting them.

[Don Davies, NDP, Vancouver Kingsway, BC]

Perhaps you can supply the metadata. Just the numbers.

[Dr. Supriya Sharma]

We'll take that back and we'll see what we can provide.

[The Chair, Liberal, Sean Casey]

Thank you, Mr. Davies, and thank you, Dr. Sharma.

We'll go to Dr. Kitchen, please, for five minutes.