Evidence of meeting #142 for Health in the 44th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was amendment.

A video is available from Parliament.

On the agenda

MPs speaking

Also speaking

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

Luc Thériault Bloc Montcalm, QC

So I'm not the only one.

Could we be clearer, without spending too much time on the amendment?

I would like to introduce the words “or its salts,” but I still want us to maintain the part of the sentence that refers to nicotine replacement products, because that's what was mentioned in the ministerial order and presented to us here.

The Chair Liberal Sean Casey

Okay.

Luc Thériault Bloc Montcalm, QC

Would the people on the other side of the table accept that, to speed things up?

The Chair Liberal Sean Casey

We can't subamend a subamendment, so if it's not satisfactory in the form that it's been presented, the only option is to defeat it and to introduce new wording.

4:45 p.m.

Conservative

Laila Goodridge Conservative Fort McMurray—Cold Lake, AB

I'm going to ask for unanimous consent.

The Chair Liberal Sean Casey

If I understood correctly, Mr. Thériault wants a little more clarity before making a decision.

Go ahead, Ms. Goodridge.

4:45 p.m.

Conservative

Laila Goodridge Conservative Fort McMurray—Cold Lake, AB

Thank you, Mr. Chair.

I seek unanimous consent to move the following subamendment:

That Bill C-368 in clause 1 be amended by replacing lines 7 to 11 on page 1 with the following: “therapeutic product” means (a) a drug or device; (b) any combination of drug or device; or (c) a natural health product within the meaning of the Natural Health Products Regulations that contains nicotine, or its salts and is used in nicotine replacement therapy;

The Chair Liberal Sean Casey

Do we have unanimous consent to adopt that subamendment?

Luc Thériault Bloc Montcalm, QC

I would suggest that as well.

The Chair Liberal Sean Casey

All right.

(Subamendment agreed to)

(Amendment as amended agreed to [See Minutes of Proceedings])

BQ-1 as amended is carried. Therefore, CPC-1 cannot be moved.

Is there any debate on clause 1 as amended? Seeing none, shall clause 1 as amended carry?

(Clause 1 as amended agreed to [See Minutes of Proceedings])

That brings us to new clause 1.1.

(On clause 1.1)

We move to amendment BQ-2, proposed by Mr. Thériault.

Would you like to introduce your amendment, Mr. Thériault?

Luc Thériault Bloc Montcalm, QC

Yes, I'll introduce it.

Amendment BQ‑2 is to allow the minister's right of recall. Industry people told us that there was no problem in this area and that only bad actors would be affected. In addition, Health Canada told us that very few bad actors didn't co‑operate.

It's important to know that recalls are voluntary and that this isn't a problem. However, we were also told that the industry values its reputation and that it wanted to ensure that bad actors were punished. That's why I'm adding this element, which aims to maintain the current regulations and to restore a certain number of sections of the Food and Drugs Act.

This is amendment BQ‑2.

I move that Bill C‑368 be amended by adding after line 10 on page 1 the following new clause:

1.1 The Act is amended by adding the following after section 2.2: 2.21 Despite the definition of therapeutic product in section 2, sections 21.3 to 21.303 and regulations made under paragraphs 30(1.2)(f.01) and (f.02) apply to a in section 2, subsections 21.3 to 21.303 and regulations made under subsections 30(1.2)(f.01) and (f.02) apply to a natural health product within the meaning of the Natural Health Products Regulations.

I would like to clarify that subsections 30(1.2)(f.01) and (f.02) are part of amendment BQ‑3, which amends the penalties.

As I was saying, the minister's right to recall is guaranteed. We were asked whether there was a risk of serious harm to health. Subsection 21.3 responds to that. If there's no doubt that a health risk exists, which minister wouldn't want that authority?

This amendment takes nothing away from Bill C‑368 since it clarifies that under the natural health products regulations the minister will have a certain right of recall.

I have two pages of explanations, but I'll stop here, unless there's a problem.

The Chair Liberal Sean Casey

Thank you, Mr. Thériault.

I have Mr. Naqvi and then Mr. Julian.

Yasir Naqvi Liberal Ottawa Centre, ON

Thank you, Chair.

I'm just trying to understand the technical implications of this amendment.

Perhaps I can go back to either Mr. Lee or Ms. Godard, whoever is the appropriate person who can explain to us what the original clause meant that's in the bill as tabled, and what's the difference with the change that's being presented or moved by Mr. Thériault.

An hon. member

[Inaudible—Editor]

Yasir Naqvi Liberal Ottawa Centre, ON

No. This is the committee where we do the work. Welcome.

The Chair Liberal Sean Casey

Mr. Naqvi is entitled to put opinions on the record. It is relevant and pertinent to the discussions.

Go ahead, Mr. Lee, please.

4:50 p.m.

Chief Regulatory Officer, Health Products and Food Branch, Department of Health

David Lee

Could I just clarify, Mr. Chair? We're on new clause 1.1 and you want an explanation of how this has changed.

This seems to again add in the ability to recall, clearly, but also, it adds in certain environmental measures: getting information, being able to change a label, contrasted with changing a label for human health. That is of concern, but certainly the intent to make sure environmental changes can come up, recalls can take place both for human health and environment...it's clear there.

Also, making sure that regulations can be made underneath those, I think that part of the text is clear, but I think the absence of the label change power, for example, although including it for environmental measures...we were just trying to understand that inclusion.

Yasir Naqvi Liberal Ottawa Centre, ON

That's helpful. Thank you.

The Chair Liberal Sean Casey

I have Mr. Julian and then Mr. Thériault.

Peter Julian NDP New Westminster—Burnaby, BC

As I explained last week, we support the idea that Health Canada should continue to have the ability to order a mandatory recall of products in the rare cases where a company doesn't meet health and safety requirements.

It must be said that the industry has a good track record in this regard. For the rare cases that may arise, we have to give Health Canada that capacity. That's why I said last Monday that I supported amendment BQ‑2.

The Chair Liberal Sean Casey

Mr. Thériault, you have the floor.

Luc Thériault Bloc Montcalm, QC

I thought I could speed things up, but for Mr. Naqvi's benefit, I'll read my two pages.

The recall power that's left to the minister is found in subsection 21.3(1) on page 16 of the Food and Drugs Act. It reads as follows:

21.3(1) If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order the person who sells the product to (a) recall the product; or (b) send the product, or cause it to be sent, to a place specified in the order.

This recall power is accompanied by a provision in subsection 21.3(2) that allows for corrective action and the possibility, in subsection 21.3(3), on page 17, to prohibit the sale of a therapeutic product. It also includes a provision for products that pose a serious risk to the environment, which is to say, subsection 21.303, on page 17. This includes any prerogative associated with it, including the ability to change the label and packaging of a product in the event of a serious risk to the environment.

Subsection 21.2, which provides for the requirement to change the label in the case of a serious health risk and which may be of interest to Mr. Naqvi, is therefore not repeated. However, it's found in sections 16 and 17, on page 13, of the natural health products regulations. So the minister can require that the label be changed without Vanessa's Law applying.

As I was saying, we still have the recall power, but it's based on part of the sections of the current Food and Drugs Act and, above all, on the natural health products regulations, which we always forget and which govern the practices of this industry. As such, it's very clear from sections 16 and 17, page 13, that there are two possible scenarios where Vanessa's Law wouldn't intervene. If the product label is non-compliant, Health Canada may take enforcement action and use powers such as seizure and detention, in addition to stopping the sale of a product, suspending the product licence, and possibly cancelling it. Vanessa's Law isn't needed for that.

Second, if the product label is compliant, but Health Canada wants the company to modify it for safety reasons, Health Canada may require the company to make the modification or drop the product. If the company doesn't comply, Health Canada has the authority to issue a notice of discontinuance or suspend the product licence.

Section 16 of the current natural health products regulations allows Health Canada to ask a company to change its labelling, including adding new warnings, if the minister has reasonable grounds to believe that a natural health product may no longer be safe when used under the recommended conditions.

I don't know what Mr. Naqvi is looking for. Perhaps he doesn't want us to agree, but I hope that the work we are doing here will encourage the Liberals to vote in favour of the bill in the House. That's what I'm looking for. That's the common sense approach we want to take.

The Chair Liberal Sean Casey

I have Mr. Naqvi, please.

Yasir Naqvi Liberal Ottawa Centre, ON

Thank you very much, Chair.

I'm trying to understand the depth and scope of this particular amendment and have a clear view of it. I do want to move a subamendment to this motion, which will read as follows—and again, it has been—

4:55 p.m.

Conservative

Laila Goodridge Conservative Fort McMurray—Cold Lake, AB

I have a point of order.