Okay. Thank you for the explanation.
Ms. Davies.
Evidence of meeting #34 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site.) The winning word was clause.
A recording is available from Parliament.
Evidence of meeting #34 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site.) The winning word was clause.
A recording is available from Parliament.
11:30 a.m.
Conservative
11:30 a.m.
NDP
Libby Davies NDP Vancouver East, BC
I don't feel very comfortable that we have an assurance—no matter what you might say verbally; we're looking at the legislation—that we wouldn't have another instance where there was a lifestyle kind of thing. I can't think of another example, but I'm sure there must be others, or something else could come up.
I don't hear the assurance that if there were a similar kind of thing, even if it was around mislabelling, that Health Canada wouldn't then make a decision because they would consider it to be a lifestyle issue as opposed to an injury.
Where's the assurance for that?
11:30 a.m.
Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Mr. Chair, what I can say, again, is that in our discussions on prospective language, health care professionals, among others, and patient groups brought up this issue. They raised it very profoundly with us. As a regulator, we want to have this right. It's a threshold for a very serious moment as a regulator. We did run through scenarios to make sure that the language, “serious and imminent risk”, would catch anything we could think about.
It was as rigorous an analysis as we could provide for that language.
June 12th, 2014 / 11:30 a.m.
Dr. Supriya Sharma Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health
Yes.
Just to add, in terms of the Health Canada assessment around the Alysena issue, we did actually deem it to be a serious risk when we did do the risk assessment. When the testimony was given, I think the issue was that when the company had made the assessment, they had not raised the same issue.
Certainly the Health Canada assessment was that it was a serious risk, and we've had subsequent issues around recalls of similar products since that time. Again, it has been treated as it would apply in terms of the definition that we have moving forward.
11:30 a.m.
Conservative
11:30 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
Thank you. I think you've covered it.
I believe we had additional testimony from one the witnesses, who indicated that if a drug were ineffective that would then warrant a recall. We wouldn't need to engage in this debate about lifestyle or serious or adverse; it would simply be that if the drug were ineffective for the purposes it was prescribed, that would then trigger the recall.
Is that correct?
11:30 a.m.
Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health
The lack of effectiveness would have consequences. When we're looking at the definitions, we're really focusing on the consequence. Regardless of the upstream cause of it, you're looking at something that could have an impact on patient safety or endangering patient safety. Then we have the powers to do something about it, regardless of the actual cause. That lack of effectiveness, or for a drug to work, would get captured in the definition.
11:30 a.m.
Conservative
The Chair Conservative Ben Lobb
Yes.
First, Mr. Scarpaleggia, you proposed a subamendment to the subamendment around wording. Are you still moving that subamendment?
11:30 a.m.
Conservative
The Chair Conservative Ben Lobb
Okay.
In Mr. Scarpaleggia's subamendment to Ms. Davies' amendment, he was basically removing the word “drug” in the second line, and inserting “therapeutic product”.
Is that correct, sir?
11:30 a.m.
Conservative
The Chair Conservative Ben Lobb
If everybody is clear on that, all those in favour of Mr. Scarpaleggia's subamendment to Ms. Davies' amendment?
11:30 a.m.
NDP
Libby Davies NDP Vancouver East, BC
Could I clarify something? If his subamendment is defeated, do we still vote on my amendment?
11:35 a.m.
NDP
11:35 a.m.
Conservative
The Chair Conservative Ben Lobb
All right. All those in favour of Mr. Scarpaleggia's subamendment?
(Subamendment negatived [See Minutes of Proceedings])
Now we're on to the amendment itself, which is NDP-1.1.
NDP-1 wasn't moved, so we're going to vote on the amendment NDP-1.1
Ms. Davies has requested a recorded vote on this.
(Amendment negatived: nays 5; yeas 4 [See Minutes of Proceedings])
That gets us through the amendments on clause 2.
Do you have one other one?
11:35 a.m.
NDP
Libby Davies NDP Vancouver East, BC
I do have another amendment as a result of hearing the testimony today. We have written it up quickly, and we'll hand it out.
Basically, I'm suggesting that this amendment would go under the definitions under clause 2, page 3, after line 8. It has to do with the definition of a prescribed health care institution, which was just raised by the pharmacist. I would like to move an amendment that we add a four—
11:35 a.m.
Conservative
The Chair Conservative Ben Lobb
Just so we're clear on where we're at, you're talking about page 3 on the bill.
11:35 a.m.
Conservative
11:35 a.m.
NDP
Libby Davies NDP Vancouver East, BC
It could go somewhere else. I didn't have a lot of time to look. I just stuck it here because it's definitions, but the gist of it is that we would add the following: “definition of prescribed health care institutions shall include hospitals, community health centres and pharmacies”.
In the bill, of course, there's the provision about reporting adverse health effects, which is very important, and it spells out “prescribed health care institution” but it doesn't say what that is. I think we heard from the testimony today that it would be useful to spell it out, so that's why we're suggesting, as the witness did when I asked him, to include hospitals, community health centres and pharmacies.
11:35 a.m.
Conservative
The Chair Conservative Ben Lobb
Okay, thank you, Ms. Davies.
Before we go any further on this, can our legislative clerk provide a little clarification around this amendment just to make sure it's in order?
Go ahead.
