Health Committee on June 12th, 2014

[The Chair, Conservative, Ben Lobb]

Thank you, Ms. Davies.

Are there any other comments on the subamendment?

[Terence Young, Conservative, Oakville, ON]

Chair, I'd like to defer to the legal counsel from Health Canada to describe their thinking on this.

Thank you.

[David Lee, Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health]

Mr. Chair, the inclusion of a list in this definition may be a very vulnerable way to introduce what the member is suggesting. There is a commonly understood international approach to what is protected, and that's really expressed in this definition. By saying what is not on that list.... Much of what's on that list would be considered protected in most countries, so it could attract international challenge.

What Mr. Young has gone through in terms of the appropriate way to deal with that information is really what flows to the other motions.

[The Chair, Conservative, Ben Lobb]

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

I'd like to ask you a question. In terms of the international list that you refer to, would safety and efficacy and what's listed there in our subamendment normally be considered part of confidential business?

[David Lee]

Yes, typically it would. If you look at article 39 in TRIPS and its equivalent article 1711 in NAFTA, it does contemplate that companies have to invest quite a bit of money to get the data that they would submit—and this is health-related, so it's safety and efficacy data—but then they have to give it to a third-party regulator, as it they wouldn't normally disclose that to competitors. So it is contemplated as being protected, and again, most people in the world would understand that this definition catches that.

What you do to disclose it, though, is a different issue.

[Libby Davies, NDP, Vancouver East, BC]

Okay. My response would be that I know this came from one of the witnesses we heard. When you look at this information, which we've now heard would normally be considered confidential business information, this is actually information that the minister does need to be aware of, so it's actually a very important point. I would still stand by our subamendment.

[The Chair, Conservative, Ben Lobb]

Is there any further discussion on Ms. Davies' subamendment? Seeing none, I will call the vote.

(Subamendment negatived)

Now we'll go back to the amendment itself, which is CPC-1. Is there any further discussion on that amendment? As I mentioned before, if this is adopted, amendment CPC-2 is as well. Does anyone want clarification on why amendment CPC-2 would also be adopted? Is everybody comfortable with that? Okay.

All those in favour of amendment CPC-1?

(Amendment agreed to [See Minutes of Proceedings])

Amendment CPC-1 is carried. Accordingly, amendment CPC-2 is carried.

Next on the list we have another couple of amendments to clause 2. As long as you have that in the package, we're good. I'm working off the chair for dummies package—

[Voices]

Oh, oh!

[The Chair, Conservative, Ben Lobb]

—so as long as you guys have the right package, which now reads “NDP-1”, we'll all be good to go. Okay?

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

Thank you.

We have NDP-1 and we have NDP-1.1. They're basically dealing with the same clause or the same line. It's just that we had submitted an earlier version, which is NDP-1, but based on the testimony that we heard from Ms. Gibson very recently, we reworded it. I did have a brief discussion with Mr. Young this morning. We're actually happy with either version, so I would be happy to move either NDP-1 or NDP-1.1, if the government members are inclined to vote for whichever version they think is preferable.

The issue here is that we're concerned that the bill, as it's currently outlined, doesn't recognize the full scope of adverse drug reactions. Of course, the example that's being used is the issue of the birth control, where it was sort of characterized as a lifestyle choice. In fact, a number of witnesses did raise this. As for the language that we have proposed here, I'll actually read NDP-1.1. We would add in these lines: “injury to health” includes cases in which a drug does not have its intended effect due to mislabelling or mispackaging of the product. The issue it's related to is the example we heard about the birth control.

If there are suggestions about how to make that better, we're open to them, but we want to tackle that issue because we don't think it's properly covered in the bill.

[The Chair, Conservative, Ben Lobb]

Ms. Davies, do you have a preference?

[Libby Davies, NDP, Vancouver East, BC]

I'll move NDP-1.1, because that's the latest version and it was based on Ms. Gibson's testimony, as opposed to what I think she'd written in before. So I'll use that one. But as I say, we're open to slightly different wording, if there are any suggestions on that.

[The Chair, Conservative, Ben Lobb]

Okay. Thank you very much.

Mr. Scarpaleggia.

[Francis Scarpaleggia, Liberal, Lac-Saint-Louis, QC]

On the issue of different wording, we would like to propose a subamendment, simply to change the word “drug” to “therapeutic product”.

[The Chair, Conservative, Ben Lobb]

Okay, was it Ms. Adams or Mr. Young?

Ms. Adams.

[Eve Adams, Conservative, Mississauga—Brampton South, ON]

Thank you.

Through you, Mr. Chair, I very much understand what Ms. Davies is getting at here; however, the department has already had an independent review on this very issue. The department has accepted all recommendations. We believe that this is now captured and that certainly, this type of incident would not be happening again. So for that reason, we are not able to support this amendment.

[The Chair, Conservative, Ben Lobb]

Mr. Young, you were next up. Did that cover it?

[Terence Young, Conservative, Oakville, ON]

That's fine. That explanation is adequate.

[The Chair, Conservative, Ben Lobb]

Okay, Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

Through you, Mr. Chair, could the parliamentary secretary explain what she means that they've approved all recommendations? I don't know what she's referring to.

[Eve Adams, Conservative, Mississauga—Brampton South, ON]

The Alysena issue was fully independently and thoroughly reviewed. A number of recommendations came out of that independent review, and Health Canada has accepted all of those recommendations.

[Libby Davies, NDP, Vancouver East, BC]

That's fair enough, but it doesn't necessarily mean it's covered legally for the future, and that's why we have this bill. So it may be helpful in terms of that one therapeutic product, but we don't know whether it will apply to other ones. I think we have to look at it systematically, and not just in terms of one product.

This is actually a very important amendment. A number of witnesses, I think, pointed out that the bill had a shortcoming around what the definition was.

[The Chair, Conservative, Ben Lobb]

Would it be okay if we had Mr. Lee, if he's prepared to provide a comment on it as well, just to give the committee further clarification?

[David Lee]

Certainly. Thank you, Mr. Chair.

On the first point, when we started discussing some of the text in the bill, this was raised by health care professionals. It's the first time you've had mandatory recall. It's very important that the threshold language be able to deal with the kind of event that we saw, a failure of a birth control pill to work.

So we went back and we pulled in our inspectors; we pulled in our legal team; and we really made sure that this new threshold, which we've never had before, would work for that. So we were satisfied that the language “serious and imminent” would do it. That was a very serious concern for us. We really made sure we looked at it.

On this other language, “injury to health”, that's a phrase that occurs in the existing act in different places and in other parts of what we're trying to amend through the bill. It's very important to understand how this language would operate throughout those, so any vagueness that this would introduce could prospectively be very troubling. It's something you'd have to be very careful about in introducing brand new language.

I will say that for NDP-1.1, we would include “in an adverse event or an injury to health”. Really what we're looking for there, especially if it's serious, if somebody is permanently debilitated or there's a life-threatening event to them, no matter how it happened, whether it was a package that went wrong, or the labelling, we would pick that up as a serious event.

And basically, the other thing I should mention is that in our label-change power later on, in that proposal it does contemplate changing package. So if there is a mistake around the package, if we do see that, then there's a decisive action that can be taken.