Health Committee on June 12th, 2014

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

So they are the same requirements as drug manufacturing sites overseas.

[Helen Long]

No, the same requirements as natural health products in Canada.

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

In Canada. Okay, I understand.

That's fine, then. Thank you for your patience.

[The Chair, Conservative, Ben Lobb]

Thanks very much.

At this point in time, we'll suspend our meeting.

Thanks to our guests for taking the time. You're now excused.

When we get back, we'll get into the technical portion of our meeting and the clause by clause.

Thank you.

[The Chair, Conservative, Ben Lobb]

Welcome back. We're back in session.

We'll start going through the clause by clause portion of Bill C-17. We have the departmental officials at the table, at the ready, if there are any questions. So feel free to ask questions or for clarification.

In addition to that, similar to what we did for Bill C-442, the Lyme disease bill, we'll take our time and make sure everybody knows exactly what clause and what amendment we're talking about, so everybody feels good about what they're voting on.

There's lunch at the back and recognizing the fact that everybody wants to pay attention to the clauses and the amendments and to which way to vote, we can suspend at some point, when the committee feels like it, for five to 10 minutes, just to have a quick lunch so that everybody can stay focused on the clauses and the amendments, if that's okay with everybody.

We have two legislative clerks here to help us along the way if we have any technical questions. Karin is also still here as our analyst.

If everybody's ready to go, we'll get at it.

Similar to the case with the Lyme disease bill, the title and the preamble will wait until the end, and we'll get right at it.

(On clause 2)

We have amendment CPC-1. On that, I'll say that if this amendment is adopted, so will be amendment CPC-2 since they are consequential. Would somebody like to talk about the amendment?

Ms. Adams.

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

I'm moving amendment CPC-1 to clause 2.

[The Chair, Conservative, Ben Lobb]

Is there any comment or debate on—

[Libby Davies, NDP, Vancouver East, BC]

Are we not going to hear any explanation from the movers of the amendment on what it's about?

[The Chair, Conservative, Ben Lobb]

You can if you like.

[Libby Davies, NDP, Vancouver East, BC]

Well, normally, we would.

[The Chair, Conservative, Ben Lobb]

Sure, it's okay.

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

We're keen to allow you to continue through this as quickly as possible.

[Libby Davies, NDP, Vancouver East, BC]

So we're not going to hear any explanations?

[The Chair, Conservative, Ben Lobb]

No, we're just going to let Mr. Young get ready here. There are a lot of papers flowing around for everybody, so that's why we'll just take our time and—

[Terence Young, Conservative, Oakville, ON]

With regard to the definition of confidential business information, the definition sets out the three conditions that must be met in order for information to be considered confidential business information and appropriately safeguarded by the minister. The definition entrenches common-law principles and is consistent with the definition of the same in other domestic legislation, for example, the Canada Consumer Product Safety Act. It is also consistent with the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights— TRIPS—and the North American Free Trade Agreement.

The conditions set out in the definition are also consistent with the practice by regulators in other jurisdictions, such as the United States Food and Drug Administration, the FDA, and the European Union's European Medicines Agency. The definition is necessary to support the minister's power to disclose confidential business information for the purpose of identifying or responding to a serious risk of injury to human health—as identified in clause 3—to persons from whom the minister seeks advice or to a government or to a person who carries out functions related to the protection or promotion of human health—as identified in clause 3—and, for regulation-making authority, as identified in clause 6.

[The Chair, Conservative, Ben Lobb]

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

We have what we hope is a friendly amendment. Just by way of explanation, I did have a discussion with Mr. Young earlier and we tried to go over some of these amendments where we think there might be some agreement. So I hope that we can make some progress.

[The Chair, Conservative, Ben Lobb]

So you're proposing a subamendment then to Mr. Young's amendment?

Okay.

[Libby Davies, NDP, Vancouver East, BC]

Yes, a subamendment.

I also want to note that this process has been made very difficult by having the committee meet today instead of Monday—or maybe we're meeting Monday as well—and having the amendments basically go in at noon yesterday. We've been scrambling. As we go through them today, I hope you will be accommodating just because it's been a lot of stuff to get in order in less than 24 hours. So I just want to make that note.

In terms of our friendly amendment, what we would like to do is to add a paragraph (d). Mr. Young has got paragraphs (a), (b) and (c). We would like to add a paragraph (d) and the subamendment would be:

For greater clarity, confidential business information does not include safety and efficacy information including phase 1 to phase 3 pre-market trials or post-market safety assessments, clinical study reports and periodic safety update reports.

So we just want to make it clear that confidential business information doesn't include those things that I've just listed. That's just for greater clarity. We support the amendment but think that the subamendment would bring greater clarity.

[The Chair, Conservative, Ben Lobb]

Okay.

[Libby Davies, NDP, Vancouver East, BC]

I think we have a copy to hand out.

Do you have a copy?

We've got a copy to hand you. We don't have a lot of copies but at least the parliamentary secretary and the legislative counsel will have one.

[The Chair, Conservative, Ben Lobb]

So is everybody clear on what the subamendment is to Mr. Young's amendment, which is CPC-1? Does anybody have any discussion or debate on that subamendment?

[Terence Young, Conservative, Oakville, ON]

Mr. Chair, we have a number of concerns about it.

The first one is that by providing a list of what types of information the minister can order to be released courts at some point would look at the list and decide if something wasn't on the list that it therefore could not be ordered to be released by the minister. So that's a primary concern.

The secondary concern is that the government has amendments. I've presented amendments that deal later with when the minister can exercise the power. So Government amendment number 2 determines that:

(2) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk of injury to human health.

It's a very all-inclusive power. It further says:

(3) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public and the disclosure is to

(a) a government;

(b) a person from whom the Minister seeks advice; or

(c) a person who carries out functions relating to the protection or promotion of human health or the safety of the public.

It's an undefined and broad definition. So the minister has power to direct anyone who carries out functions relating to the protection and promotion of human health. Then it defines further in the section:

Government means any of the following of their institutions, the federal government, a corporation named in Schedule 3 to the Financial Administration Act, a provincial government or public body established under the act, legislature of the province. An aboriginal government is defined in Subsection 13.3 of the Access to Information Act, a government of a foreign state or subdivision of a foreign state or an international organization of states.

It's a very broad power given to the minister to issue cautions. By adding this amendment, it would appear that we're providing a list that the courts could interpret more narrowly.

[The Chair, Conservative, Ben Lobb]

Yes, Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

I have a very brief response.

I do understand the argument that Mr. Young is making about this being disputed in court and that if you added something to the list, it could possibly narrow it. But actually the reverse is true here, because with this subamendment we're just specifying that confidential business information does not include.... So it's actually not what's on the list; it's just making it clear that this would not be covered.

I do understand the argument he's making, but I don't think it would be a problem with this particular subamendment.