Health Committee on June 12th, 2014

[The Chair, Conservative, Ben Lobb]

Welcome back.

We're continuing with our examination of Bill C-17. We're working right through.

We left off last time on amendment CPC-10. On that amendment to clause 6, we have Mr. Wilks.

[David Wilks, Conservative, Kootenay—Columbia, BC]

Thank you, Chair.

I move amendment CPC-10.

[The Chair, Conservative, Ben Lobb]

Is there any discussion or commentary on amendment CPC-10? Seeing none, I'll call the question.

(Amendment agreed to [See Minutes of Proceedings])

I just have a note here. If you go back to amendment CPC-8, you'll see that it affected amendment LIB-3. We'll skip over amendment LIB-3 and carry on with amendment NDP-9.

Go ahead, please.

[Libby Davies, NDP, Vancouver East, BC]

Thank you very much. I won't read the amendment. I'll just give the explanation.

First of all, we should explicitly state that the results of clinical trials are not proprietary and should be publicly disclosed, including things like de-identified patient-level data, post-market studies, and adverse drug reactions reported by drug manufacturers and health care institutions, which are covered under the term “clinical trials and investigational tests”. We believe this amendment will actually make sure that those results are not proprietary and are made public.

[The Chair, Conservative, Ben Lobb]

Very good. Are there any comments on amendment NDP-9 on clause 6?

Mr. Young.

[Terence Young, Conservative, Oakville, ON]

Chair, I'd like to ask the officials from Health Canada to comment on that, please. That would be helpful.

[David Lee]

Thank you, Mr. Chair.

I'll point out first that the language “business proprietary information” doesn't quite match up with the definition of “confidential business information”. That may be the intent of this wording. Could I get that as a clarification?

[Libby Davies, NDP, Vancouver East, BC]

I'm not sure. Keep going and I'll find out.

[David Lee]

Okay.

There is a motion already, a CPC motion, that allows regulations to be made to clarify when something is not confidential business information or ceases to be. With that regulation-making power, it provides the necessary ability for the Governor in Council to make any regulation that this would permit.

[The Chair, Conservative, Ben Lobb]

Mr. Young, do you have something else?

[Terence Young, Conservative, Oakville, ON]

Chair, we've already passed amendment CPC-9. Amendment CPC-9 allows the Governor in Council to make regulations that would specify under what conditions business information obtained under the Food and Drugs Act is not confidential business information or ceases to be. It's fairly prescriptive and broad, so we see this recommendation as unnecessary.

[The Chair, Conservative, Ben Lobb]

Okay. If there's no further discussion on amendment NDP-9, we'll call the question.

(Amendment negatived [See Minutes of Proceedings])

Now we're moving on to the clause itself.

Ms. Davies?

[Libby Davies, NDP, Vancouver East, BC]

We'd like to move a deletion in clause 6. Before we vote on the clause overall as amended, we'd like to move a deletion where it says “Subsection 30(3) of the Act is replaced by the following”, and then it begins with “(3)”. It's at line 11. It's that clause that deals with “Regulations— North American Free Trade Agreement and WTO Agreement”.

If the members will recall, we had a witness who came before the committee who was very concerned that these trade agreements would somehow trump this legislation and would then preclude some of the minister's authority. Just on the basis of caution, we'd like to see this clause deleted.

[The Chair, Conservative, Ben Lobb]

Just so we're 100% clear, it's on page 8, and it starts at line 11 and would run until line 22. Is that correct?

[Libby Davies, NDP, Vancouver East, BC]

That's right.

[The Chair, Conservative, Ben Lobb]

So everybody's with us on that? Okay.

Mr. Young.

[Terence Young, Conservative, Oakville, ON]

Chair, I think it would be helpful if we defer to the Health Canada officials and legal counsel for an explanation of why this is not appropriate.

[David Lee]

Mr. Chair, the proposal here was being made because in each of the grants related to the Governor in Council, the language is being modernized and made consistent. So you'll see this in each grant of power to the GIC to make regulations. That's all that was being changed here.

This is in fact a fairly old provision. It was put in so that Canada could implement its commitments under NAFTA and TRIPS. It's really worth mentioning because there is a concern or appears to be a concern that somehow trade would trump safety. Those commitments don't require that. I think some of the observations that Mr. Herder made are very important in this respect.

So what 39 of TRIPS and 1711 of NAFTA require is not that there be non-disclosure of information that's safety related. In fact, it does permit disclosure of safety-related information, but it's in such a way that it prevents unfair competition. The idea is that if a manufacturer has to do clinical studies and invest a lot of money and then hand all of that information, which it wouldn't normally disclose to competitors, to a government, the government can't turn around and give it to a competitor right away so that the competitor gets market access without doing that work.

This section was used in 2006 to implement data protection, which was not designed to prevent disclosure of information by the minister, it just creates a situation where generic companies can't file for a period of six years to copy a brand drug. Again, it would not impede upon the minister's ability to disclose information, it just goes to the unfair competition part.

[The Chair, Conservative, Ben Lobb]

Thank you very much for seeking some clarification. Is there any further discussion on Ms. Davies' amendment?

We'll call the question and it's to do with the deletion of lines 11 through 22 on page 8.

(Amendment negatived [See Minutes of Proceedings])

(Clause 6 as amended agreed to)

I have a request and I need unanimous consent to do so. From clause 7 to clause 13 there are no amendments, so I'm wondering if I have the permission of the committee to ask the question on all the clauses at one time. Do I have unanimous consent?

[Some hon. members]

Agreed.

[The Chair, Conservative, Ben Lobb]

Shall clauses 7 to 13 carry?

(Clauses 7 to 13 inclusive agreed to)

We have a new clause, 13.1.

Go ahead.

[Libby Davies, NDP, Vancouver East, BC]

Thank you, Mr. Chair, this is NDP-9.1. It's pretty straightforward and the reason we've brought this forward is that there's been an enormous amount of interest in this bill. I think there were more than 45 witnesses who wanted to be heard. We ended up hearing maybe 10 people. It is a significant change in terms of the overall regime, so we think there should be a review within two years, particularly because we've heard there's so much that's going to go into regulation and that's at the discretion of the minister.

I think it would be a very good idea if, in two years, there were a review of this legislation to see how it's operating and whether or not there are any other questions. There are issues around the natural health products. There have been no amendments to include them and we're not including them, but I think it would be a prudent thing to have a review of this legislation after it comes into force.

[The Chair, Conservative, Ben Lobb]

Are there any comments on that amendment?

Mr. Young.

[Terence Young, Conservative, Oakville, ON]

Bill C-17 represents the biggest change in 20 years, a major, major change, and—

[A voice]

In fifty years.