International Trade Committee on Oct. 31st, 2023

[The Chair, Liberal, Judy Sgro]

Thank you very much.

Go ahead, Mr. Miao, for six minutes, please.

[Wilson Miao, Liberal, Richmond Centre, BC]

Thank you, Madam Chair, and thank you to the officials for being here today.

Could you provide an overview of the pathway that these proposed regulations have taken since 2019, including the engagement and consultation with industry and stakeholders in Canada?

[Dr. Celia Lourenco]

Madam Chair, I'm happy to provide details of that.

We have consulted very closely with industry stakeholders on the development of this pathway, starting out with engagements in 2019, as I've mentioned. Our idea was to make sure that our approach to the regulatory design would be met with good support from the different stakeholders, so leading up to the publication of the regulations in 2021, we consulted with stakeholders in July of 2019 and then through several months up to 2021, when the regulations were published.

We also considered a number of responses to surveys that we conducted on the cost-benefit analysis leading up to that publication, which occurred in May 2022.

[Wilson Miao, Liberal, Richmond Centre, BC]

Thank you.

I understand that currently biocides are regulated under two different legal frameworks. What impact does this have on oversight? You mentioned during your remarks that this can result in delays to market. What other factors are there?

[Dr. Celia Lourenco]

The new regulations will definitely provide additional ways for products to enter the market, but without sacrificing oversight of these products. We'll continue to ensure that the required scientific and regulatory standards are met, and then on the post-market side we'll continue as well to make sure that we monitor the safety of these products. If there are any incidents, we'll be able to follow up with compliance on these products, including revocation or suspension of an authorization if needed.

[Wilson Miao, Liberal, Richmond Centre, BC]

How will the proposed regulation increase our alignment with our neighbour, the United States, and internationally over a period of time?

[Dr. Celia Lourenco]

Can you repeat the question, please?

[Wilson Miao, Liberal, Richmond Centre, BC]

How will the current proposed regulation increase our alignment with our counterpart in the United States, and also with our international partners across the world?

[Dr. Celia Lourenco]

Thank you for the question.

One of the ways that will definitely increase the alignment is bringing it all under one regulatory framework. This will make sure that it's well aligned with how these products are regulated in other countries. They're all regulated similarly under a similar framework.

The other way that it will also align is in terms of the requirements that we're putting into the regulations. We're making sure that they're very much aligned with what the other requirements are internationally.

[Wilson Miao, Liberal, Richmond Centre, BC]

In your remarks, you also mentioned learning from the pandemic we just experienced.

How did this pandemic highlight or expose the challenges that can arise in getting biocides to the market and the impact of the cumbersome regulations that was experienced?

[Dr. Celia Lourenco]

Thank you for the question.

During the pandemic, we definitely experienced some challenges with availability of the products in the Canadian market.

First we experienced a significant number of shortages, and then we needed to react to make sure that we provided access to new products. We put in place an interim measure to allow for products to come in from other international jurisdictions, and the majority of them came in from the United States. We wanted to make sure that we had these kinds of products on the market to address the COVID-19 pandemic.

[Wilson Miao, Liberal, Richmond Centre, BC]

Do you see a rise in manufacturing of those biocide products here in Canada after this proposed regulation is sent forward?

[Dr. Celia Lourenco]

It's difficult to predict whether we would have an increase in the manufacturing of these products, but certainly there would be an ability for more products to enter the market and for more innovative products to enter the market from the United States, as an example.

In the future, we are looking to expand beyond the United States as a country of reference, but once those innovative products enter the market, there is the ability for companies in Canada to go under a licence agreement, as an example, to be able to also market the same product in Canada.

The pathways that we're putting in place will allow for that. They will allow for Canadian companies to be able to collaborate with international companies and market those international products in Canada through licensing agreements.

[Wilson Miao, Liberal, Richmond Centre, BC]

Thank you very much.

[The Chair, Liberal, Judy Sgro]

Thank you very much.

We'll move on to Monsieur Savard-Tremblay, please.

[Simon-Pierre Savard-Tremblay, Bloc, Saint-Hyacinthe—Bagot, QC]

Thank you, Madam Chair.

Thanks to the witnesses for being with us.

Why do the proposed regulations not apply to certain products, such as certain disinfectants and surface sanitizers?

[Dr. Celia Lourenco]

Thank you for the question.

This regulation applies only to a product that has a claim that it will prevent disease by preventing the growth of bacteria or viruses or by being able to kill microbes so that it prevents disease in humans. These are the types of products that we're targeting. They are products that are applied to non-living surfaces, whether hard surfaces or soft surfaces.

[Simon-Pierre Savard-Tremblay, Bloc, Saint-Hyacinthe—Bagot, QC]

As we know, there are currently two quite different markets. We are considering a proposed harmonization.

In Canada and Quebec, many small and medium-size businesses are developing in this field. In the United States, we mainly see multinationals, whose headquarters are mostly established outside Canada, and mainly in the United States.

How can we ensure that harmonization is bilateral? The United States is the only foreign country whose name is published in Part 1 of the Canada Gazette. How can we be sure that the United States offers reciprocal treatment for Canadian products that they import?

[David Lee, Chief Regulatory Officer, Health Products and Food Branch, Department of Health]

Madam Chair, the question is an important one about knowing that we have the right safety.

Essentially, we analyzed that the United States does the same testing as we do here to show that it works and that it's safe. That's very exact. The laws are intended to be harmonized, so there's not a difference.

In terms of other regulators, we do interact with other regulators in other markets, so the conversations with the European Union will be an important discussion. We're having those now, and as we get more confident, we will add jurisdictions to the list.

This is a beginning. Again, they're very well known. We work with the EPA quite often and we know their science. This gave us the confidence to put it on the list, but certainly there are others that will populate the list in the future.

[Simon-Pierre Savard-Tremblay, Bloc, Saint-Hyacinthe—Bagot, QC]

Is it very likely that other foreign regulatory organizations, other than those in the United States, will be added to the list? I would ask you to answer with a yes or no.

[David Lee]

We're in research and conversations even now.

[Simon-Pierre Savard-Tremblay, Bloc, Saint-Hyacinthe—Bagot, QC]

However, some stakeholders have told us about their concerns. We know that the important factor in gaining market access for new products is speed.

You mentioned streamlining and more flexible regulations. Under the current proposal, the review of products from the United States would be streamlined, but, at the same time, Canadian businesses seeking to sell their products here in Canada would be put at a disadvantage. Their products won't be pre-approved in the United States, and it will take more time to process their files.

What are your observations on that subject?

[Dr. Celia Lourenco]

The use of the foreign decisions pathway will be more efficient. The products coming in through that pathway would take 90 days to review. Products that require a full assessment would take a bit longer to review—180 to 210 days, as an example.

However, we do have other abbreviated pathways that Canadian companies can use. Two of the pathways that would rely on a smaller set of evidence that Canadian companies can use would be a 45-day review or a 60-day review, based on standards that Health Canada sets in advance. As long as the Canadian company can follow those standards, then they can also use those pathways, which would be faster than the use of a foreign review decision pathway.

[Simon-Pierre Savard-Tremblay, Bloc, Saint-Hyacinthe—Bagot, QC]

You're referring to a Canadian business wishing to sell its products in Canada, aren't you?

[Dr. Celia Lourenco]

Yes, that is a Canadian company selling products in Canada, but those other faster pathways would also be available to other companies if they wish to use those pathways in Canada.