Health Committee on June 12th, 2014

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

Thank you, Mr. Chair.

I move CPC-8.

[The Chair, Conservative, Ben Lobb]

Are there any thoughts or comments on CPC-8?

Before we vote on this, I want to make a technical point that the legislative clerk has prepared. If CPC-8 is adopted, the Liberal amendment 3 won't proceed. It's to do with the definition of a clinical trial, which I think is what your amendment is trying to do.

That's just so everybody knows that before we vote.

We're still at CPC-8.

(Amendment agreed to [See Minutes of Proceedings])

We're now back to NDP-5.1.

[Libby Davies, NDP, Vancouver East, BC]

Thank you, and sorry for the mix-up.

In NDP-5.1, we're suggesting that clause 6 be amended by adding after line 30, on page 6, the following:

(c.l) respecting the registration of clinical trials and investigational tests involving human subjects and specifying the period within which the results of those clinical trials and investigational tests must be provided to the Minister.

Again, this comes out of the testimony that we heard from, I think it was Professor Herder. We believe that this amendment would add the range of clinical trials and observational studies to the mandate of Bill C-17, and give the Governor in Council the power to make regulations about clinical trial registration.

All investigational studies, including not just phase 1 to 4, but also observational studies, should be registered and otherwise subject to transparency. In fact, we did hear from our witnesses that the importance of observational studies is becoming more evident. They are more likely to be used in the future, particularly in the context of rare diseases.

I think this adds a better range, in terms of the clinical trials and observational studies to be added to the mandate of the bill.

[The Chair, Conservative, Ben Lobb]

Are there any comments on NDP-5.1?

Mr. Young.

[Terence Young, Conservative, Oakville, ON]

Chair, we don't think this clause is necessary, and I'd like to refer to legal counsel.

[David Lee]

I should mention that I'm just here as a departmental official, and the legal counsel is beside me. We're both David K.

[David Edwards]

I'll let my client speak.

[David Lee]

On this, there is a supporting ability to make regulations related to what will be at the legislative level to compel registration of clinical trials. It's the prescribed information in the prescribed time and manner. That would cover all of this.

Your point about observational studies, I think is a very interesting one. That's not yet well defined. It's not as well defined as pre-market studies, so you have the three well-known phases. There are very many different ways to do those.

The value of having the flexibility in the regulations is that as new types of studies come up—and they have in the rare disease area, where we're seeing more study varieties—then we can keep up with that kind of language. The ultimate flexibility is in the regulation-making that's associated with the basic commitment to register trial information.

[The Chair, Conservative, Ben Lobb]

Okay.

[Libby Davies, NDP, Vancouver East, BC]

As I understand it, the way this amendment is written would then provide the ability to deal with the regulations. But unless we spell it out, particularly given that observational studies are used more and more.... I certainly wouldn't want to just leave it to chance.

This has been raised as a very current issue, so I hope we can consider this amendment as giving clarity, so that the regulatory work can then go ahead, including the observational studies.

[The Chair, Conservative, Ben Lobb]

Are there further comments? We're on amendment NDP-5.1. Seeing no further discussion, I'll call the vote. All those in favour of NDP-5.1?

(Amendment negatived [See Minutes of Proceedings])

Next up is NDP-6.

[Libby Davies, NDP, Vancouver East, BC]

Again, I think we've moved a step ahead. We had amendment NDP-6. Then, based on further testimony, we rewrote it and did NDP-6.1. Again, I had it after amendment CPC-9. We want to withdraw NDP-6 and go to NDP-6.1. I don't know if that means we go back to CPC-9.

[The Chair, Conservative, Ben Lobb]

I think that's what we'll do. We'll go to amendment CPC-9 and come back to amendment NDP-6.1.

On CPC-9, go ahead.

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

Thank you, Mr. Chair.

I move amendment CPC-9.

[The Chair, Conservative, Ben Lobb]

Are there thoughts or comments on CPC-9?

Not seeing any comments for CPC-9, I'll call the vote.

(Amendment agreed to [See Minutes of Proceedings])

On amendment NDP-6.1, Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

Thank you very much.

This is a fairly long amendment. I won't read out it in the interests of time. I hope committee members have had an opportunity to read it.

Basically, this would add a new section or clause empowering Health Canada to publish positive and negative regulatory decisions. We think that at a minimum Health Canada should publish rationales for decisions concerning drugs that were approved for sale, drugs refused for reasons of safety or efficacy, and drugs that are suspended or recalled. It's a new section. I think there have been other similar government amendments, but I think this adds more clarity and better definition to the regulations.

[The Chair, Conservative, Ben Lobb]

Are there any thoughts or comments on amendment NDP-6.1?

Mr. Young.

[Terence Young, Conservative, Oakville, ON]

Thank you, Chair.

Chair, the motions in amendments CPC-3, 4, 5, 6, 7, and 10 require the minister to make publicly available recall, reassessment, label change, and test studies orders; require the minister to make publicly available positive and negative decisions and the reasons for them; and require the therapeutic authorization holder to make prescribed information about clinical trials and investigative tests publicly available. Consequently, the intent of this motion is already covered, with the exception of a section that says “results of clinical trials and investigational tests”.

However, in amendment CPC-10, the minister gets the authority to make regulations respecting the type of information. So it would be a simple matter for the minister to create that authority by regulation through the GIC to get the results of clinical trials and investigative tests, and I'm sure that would be done.

[The Chair, Conservative, Ben Lobb]

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

Well, it does seem that we're leaving an awful lot to regulation. I know there are things that are appropriate to regulation, but I do think that where we can give clarity in this bill, because it is such an important bill in terms of what the minister can do, it should be in the legislation.

Again, this amendment I think offers a sense of clarity and a better definition from which regulations can then flow, particularly in regard to new subparagraph 6(1.2)(d.1)(ii), which Mr. Young has just spoken about, those being the “results of clinic trials and investigational tests”, which aren't mentioned in the earlier government amendments. It's better to go for clarity in definition than not to.

[The Chair, Conservative, Ben Lobb]

Are there any further thoughts or comments on amendment NDP-6.1? All those in favour of NDP-6.1?

(Amendment negatived [See Minutes of Proceedings])

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

I'll read this. Amendment NDP-7 is adding after line 8 on page 7, in clause 6, the following:

(e.1) respecting the establishment of best practices, the promotion of standards of practice and the communication of information relating to the risk, safety, and effectiveness of therapeutic products;

This amendment is really focusing on the need for a federal role in ensuring better communication around drug safety and effectiveness. It enables the Governor in Council to work with other affected parties to implement and publish best practices and evidence-based prescribing standards. It's really about communicating work and making sure that is done. We put that forward as an amendment.

[The Chair, Conservative, Ben Lobb]

Okay.

Mr. Young.

[Terence Young, Conservative, Oakville, ON]

Chair, the proposed wording does not really make it clear to whom the provision would apply. There are concerns that the provision appears to be outside the federal jurisdiction, so I'd like to defer to our experts from Health Canada, please.

[David Lee]

It really matters whether, in making regulations under this section, Health Canada would be enforcing rules on the interchange between companies and physicians, for example, for which there are some rules already governing advertising and promotion. It's a little unclear to us who this rule would apply to.

Perhaps we can seek some clarification on that, Mr. Chair.