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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.

On the agenda

MPs speaking

Also speaking

Jim Keon  President, Canadian Generic Pharmaceutical Association
Walter Robinson  Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Nancy Abbey  Executive Director, Reuse of Single-Use Devices Task Force, MEDEC - Canada’s Medical Technology Companies
Keith McIntosh  Senior Director, Scientific and Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Linda Wilhelm  Chair, Operations Committee, Best Medicines Coalition
Jeff Morrison  Director, Government Relations and Public Affairs, Canadian Pharmacists Association
Helen Long  President, Canadian Health Food Association
Barry Power  Pharmacy Consultant, Canadian Pharmacists Association
David Lee  Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Supriya Sharma  Acting Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health
Philippe Méla  Procedural Clerk
David Edwards  Senior Counsel, Legal Services Unit--Health Canada, Department of Justice

10:20 a.m.

Liberal

Francis Scarpaleggia Liberal Lac-Saint-Louis, QC

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

10:20 a.m.

President, Canadian Health Food Association

Helen Long

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

10:20 a.m.

Liberal

Francis Scarpaleggia Liberal Lac-Saint-Louis, QC

In Canada. Okay, I understand.

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

10:20 a.m.

Conservative

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.

June 12th, 2014 / 10:20 a.m.

Conservative

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.

11:10 a.m.

Conservative

Eve Adams Conservative Mississauga—Brampton South, ON

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

11:10 a.m.

Conservative

The Chair Conservative Ben Lobb

Is there any comment or debate on—

11:10 a.m.

NDP

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?

11:10 a.m.

Conservative

The Chair Conservative Ben Lobb

You can if you like.

11:10 a.m.

NDP

Libby Davies NDP Vancouver East, BC

Well, normally, we would.

11:10 a.m.

Conservative

The Chair Conservative Ben Lobb

Sure, it's okay.

11:10 a.m.

Conservative

Eve Adams Conservative Mississauga—Brampton South, ON

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

11:10 a.m.

NDP

Libby Davies NDP Vancouver East, BC

So we're not going to hear any explanations?

11:10 a.m.

Conservative

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—

11:10 a.m.

Conservative

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.

11:10 a.m.

Conservative

The Chair Conservative Ben Lobb

Ms. Davies.

11:10 a.m.

NDP

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.

11:10 a.m.

Conservative

The Chair Conservative Ben Lobb

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

Okay.

11:10 a.m.

NDP

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.

11:15 a.m.

Conservative

The Chair Conservative Ben Lobb

Okay.

11:15 a.m.

NDP

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.

11:15 a.m.

Conservative

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?

11:15 a.m.

Conservative

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.

11:15 a.m.

Conservative

The Chair Conservative Ben Lobb

Yes, Ms. Davies.

11:15 a.m.

NDP

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.