Finance Committee on May 6th, 2019

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

Thank you, Mr. Chair.

Subdivision C would amend the Food and Drugs Act to optimize patient safety, but to enable innovation.

Clause 164 would introduce a more organized way to determine classification. Right now, products can fall under more than one definition, such as a food and a drug, or a device and a drug. This would help increase transparency and cause the minister to consult. It would also reduce, especially for innovative smaller businesses, the uncertainties when you have to choose which pathway to take.

Clause 166 would introduce measures to modernize our clinical trial structure. Many advanced ways of conducting clinical trials are being developed. This will be especially good for physician-led research for our children with cancers. It would also include new abilities for clinical trials in foods such as infant formulas and hospital-given foods, for example, through a feeding tube. Right now, companies have to do those clinical trials in other countries because they're not enabled here.

Clause 169 and on would introduce a new pathway for advanced therapeutic products. This is very important because science and technology is really multiplying the developments that we're starting to see, a lot of in-hospital manufacturing of devices that can be embedded with cells. This is for a regulator to be very agile, and look after the safety but make sure we can tailor the requirements through what this pathway is intended to do.

Perhaps I can pass the floor to my colleague to go over the inspection measures.

[Greg Loyst, Director General, Policy and Regulatory Strategies Directorate, Department of Health]

Thanks for the opportunity to provide a brief overview of clauses 170 and 171, which deal in particular with the powers of inspection.

We work in an increasingly complex world, and technology is evolving at unprecedented speed, but our powers of inspection have not kept up with the pace of those developments.

The proposed amendments would clarify some of the powers conferred by the act and grant inspectors modern powers to enforce it, which would make it possible to adopt more flexible and adaptable approaches.

The proposed amendments are really intended to help us better protect the health and safety of Canadians. These are in keeping with powers that you would find in other modern federal legislation, including many of those acts that are administered within the health portfolio.

What I'll do is quickly run through some of the highlights of the authorities that we're seeking.

The proposed amendments would allow inspectors to order a person to provide an inspector with any document, information or sample specified by the inspector. This could be done without the inspector being on site. They would add electronic data to the list of records or documents that could be examined, by giving the inspector the ability to reproduce this electronic data or use a computer system or a means of telecommunication at the place being inspected. They would allow things like the inspectors taking photographs or making recordings and sketches during an inspection. An inspector would be able to examine, test or take samples of anything in the place being inspected, or remove anything from the place being inspected for those purposes.

Inspectors would be able to cause a person to identify themselves to the satisfaction of the inspector in the place being inspected. The inspector would be able to order a person to move or stop a conveyance for the purpose of inspecting that conveyance, or if a conveyance is blocking access to products in a warehouse, for example, to move that conveyance so that the inspector could get at it.

It would also allow an authority to pass through or over private property. This would not include a dwelling house. The sanctity of the home would remain. The only two ways we could get into a home would be with a warrant or with the consent of an owner, but this would allow us to pass over private property to execute our functions.

I'd also like to mention that in clauses 173 to 175 you'll find the offence provisions. What's important to note is that where there is a duty created by these new authorities, it would fit within the existing infrastructure of the offences that are currently in the act, so there is no increase to penalties or offences. In those clauses we've really just aligned the provisions that we're seeking here with the existing infrastructure of the penalties.

That's it.

[The Chair, Liberal, Wayne Easter]

We're open to questions, members.

Mr. Viersen, do you want in?

[Arnold Viersen, Conservative, Peace River—Westlock, AB]

Yes, please.

In clause 164, proposed subsection 2.4(1) “Classification — thing”, and in proposed subsection 2.4(2) “Classification — class of things”, can you explain that a little bit more? It just seems to me that food.... I understand why we want to pick one lane and stay in it, but what does that look like in reality?

[David Lee]

Basically there are four definitions at the act level: food, drug, cosmetic and device. Especially with the newer technology, we're seeing blurring across the lines.

If you think of yourself as a start-up company and you're getting ready to go through the device regulations, which are pretty complicated.... You have to meet all the requirements for clinical development, but then also quality, so you're lining up with that pathway. You would usually file the submission with Health Canada and then find out at that point that no, we think you're actually a drug. You should be on the drug side, or you have to meet both regulations. That is very late in the day. You've invested a lot of money at that point.

This would get out ahead. It would look at different product lines and be able to do it as a matter of keeping a schedule. The minister would propose and it would be like a ministerial regulation through an order. You go out and you consult and everybody gets a chance to weigh in, and then you schedule.

Then there is certainty. Once people see themselves as “I am a food” or “the kind of product I'm into is a food”, it just settles it down and gives certainty around the classification.

[Arnold Viersen, Conservative, Peace River—Westlock, AB]

Would there be any ability to move it from one to the other after the fact?

[David Lee]

No, we've prevented that because, again, these are pretty rigorous criminal prohibitions so you really don't want to shuttle one for the other. It's just where something can be more than one, you're settling on one of the pathways.

[Arnold Viersen, Conservative, Peace River—Westlock, AB]

Okay, thank you.

[The Chair, Liberal, Wayne Easter]

Do you have an actual definition for “thing” or ”class of thing”?

[David Lee]

We did spend a lot of time in the drafting room on that, Mr. Chair.

You needed something to identify the product before it was classified as a drug or a food, so “thing” was really chosen to be malleable enough that it could be all three. Chewing gum, for example, is a thing that could be a cosmetic if it whitens teeth. It could be a food. It could be a drug if it makes dental claims.

When we look at it prior to classification, we treat it as a thing in the act, and then we'll sort which lane it goes into.

[The Chair, Liberal, Wayne Easter]

Does anybody else have any questions?

Still on the inspection measures with various new authorities, what I get a lot of, because I come out of the farm sector, is CFIA.... With these new areas of endeavour, would there be an additional cost to business? Also, what kind of challenge can a company exercise in these areas of inspection, if it disagrees?

[Greg Loyst]

On the first part, it's not foreseen that there would be any additional cost to industry to comply. Really, what these powers are doing is to give more flexible authorities to our inspectors and bring the Food and Drugs Act into line with other acts that you would see, including the Safe Food for Canadians Act and a variety of others within the health portfolio. It's really giving them more ability to verify compliance and prevent non-compliance. There shouldn't, then, be additional resource requirements for industry.

With regard to challenges, these authorities, like all other administrative authorities exercised by government, are subject to judicial review. Any individual who has a challenge with any administrative decision made by the government has the opportunity to pursue a judicial review as well.

[The Chair, Liberal, Wayne Easter]

I'm not going to debate it, but from where I sit and what I hear, what Health Canada might see as flexible, someone in the business community might see as restrictive. I'll not get into them, but I could give you all kinds of examples on meat inspection, small slaughterhouses and so on.

These additional inspection measures would apply to basically everything that the Canadian Food Inspection Agency, the Canadian Grain Commission and other measures apply to, such as slaughter plants, grain elevators, etc.

[David Lee]

Mr. Chair, the CFIA was sort of involved in the discussions here, and this was really to align.... You're correct that many instruments apply to foods. The Food and Drugs Act is on the safety side and then you have the Safe Food for Canadians Act. These are to line up the powers that they will use on a regular day.

We have worked with the CFIA, and we are thinking along the lines of modernization. We have done past work to make things flexible, such as the food additives changes we made many years ago. We are considering things such as that.

This is just to line up the inspection powers as between instruments, basically.

[The Chair, Liberal, Wayne Easter]

I have one other question. It relates to service fees. You folks may not be able to answer.

As I understand it, Health Canada doesn't fall under the Service Fees Act. My question would be, why not?

We had this discussion, I think, a year ago at committee. We will get complaints about service fees being a substantial cost to the business side. Health Canada, if it doesn't fall under the Service Fees Act, doesn't have to justify those service fees in the same way that any other department in government has to do in justifying its service fees cost.

I'm not expecting you to have an answer, but if you have one, great. If you don't, pass it up the line. You can tell them that I'm very concerned that Health Canada doesn't fall under the Service Fees Act and that I think they should.

[David Lee]

We will take that back, Mr. Chair.

Thank you.

[The Chair, Liberal, Wayne Easter]

Mr. Dusseault.

[Pierre-Luc Dusseault, NDP, Sherbrooke, QC]

With regard to the possible addition of a list of advanced therapeutic products in schedule G, I'd like to know why the decision was made to include this provision and thus to enable the minister to add therapeutic products quite randomly.

[David Lee]

Actually schedule G is structured to eliminate randomness so that it instructs the minister to focus on certain things when scheduling.

Right now many companies can fit their filings in either the device side or the drug side, but more and more as you're seeing different manufacturing models, technology like artificial intelligence, it would require a regulatory change to really get right through the pathway. So, really the advantage of this is to lift it away from the device regulations, the drug regulations, and put it in a place where we can rapidly tailor the requirements.

It's not just for any product. It's really to make sure that this is for advanced scientific products. It's for products that don't fit in the regulations right now and that would be suitable to be governed in this particular way. There is a lot of deliberation on what the criteria would be, looking at the advancement of the science and technology, the level of uncertainty around the benefits and potential harms. For things like wearables, for example, we're all figuring out how to regulate those. Giving a licence for each one may not be possible. This actually creates a schedule in an orderly way that we list the products to go into that space.

Once we know more about regulating it, we may bring it back over to the normal regulations once we understand how to normalize that.

[Pierre-Luc Dusseault, NDP, Sherbrooke, QC]

In other words, schedule G doesn't yet exist. You want to create it, don't you?

[David Lee]

It's created through this enactment. It's empty so far. We have been consulting a great deal with innovation hubs in Montreal, Toronto, Vancouver, across the country, which are really bringing very advanced health products. It's exciting for patients, but to see which ones will go in, first we'll have a structured exercise to make sure that they meet the criteria.

[Pierre-Luc Dusseault, NDP, Sherbrooke, QC]

So the idea is to allow more flexibility. In that way, advanced therapeutic products can be approved more quickly. They'll be entered in the right category later on during the approval process.

[David Lee]

Exactly, so when a hospital is adopting, for example, brand new genetic therapies, they are not waiting for five years for us to make a regulation. These are happening in our cancer centres now, and so to really get that flexibility has been the aim of this instrument.

[Pierre-Luc Dusseault, NDP, Sherbrooke, QC]

How can someone apply to add a product to schedule G? Is the process official or informal? Will the minister have to be involved?

[David Lee]

This is not done through application. It is a power available to the minister. But having said that, our branch has been conducting a foresight exercise in consultation with companies, with other international regulators, because we're all wrestling with the same technologies coming in. We're going to need to organize discussions to be able to schedule because it won't be for just one company. It will be a product class or line of products that would be scheduled, and then people can get into that space and develop their products.