Health Committee on June 12th, 2014

[The Chair, Conservative, Ben Lobb]

Comments?

[Terence Young, Conservative, Oakville, ON]

Yes. Thank you, Chair.

With regard to the powers in the act, there are fines and injunctions available if companies refuse to register their clinical trials, and of course the regulator can always refuse to approve a drug without registration of trials.

I would like to defer to legal counsel for a more fulsome answer on that, please.

[David Lee]

I would begin with the observation that putting in the refusal criteria when a company applies to get on market is already something that the minister can do, or the GIC can do, under the current act. We can, in regulation, stipulate grounds of refusal without having this as an addition.

Having said that, there is a very important policy discussion here—that is, do you want to tie the refusal of an authorization of an important life-saving drug to a transparency measure, or is it a better discipline to go with fines because patients do need them? Really, it's in making the regulations about why you would refuse a drug submission that the conversation would be held—but in regulations.

[The Chair, Conservative, Ben Lobb]

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

Just briefly I would say it's always better to spell it out in the legislation than to leave it under some regulation. The fact that there would be a refusal of issuance of authorization would of course be a very serious penalty, but I think that's the message we want to get across. There may be fines, but this is partly about transparency. It's transparency related to safety, so it's not just transparency for no good reason. It's there for a reason. So I do think they are linked.

Again, this was brought up by witnesses. The registration of the trials is very important, and if the companies aren't doing that, I think there have to be consequences that say they're not going to go further. I think this is a better way to go than just leaving it as a fine at some later point. It's a lot clearer and a lot tougher.

[The Chair, Conservative, Ben Lobb]

Okay. Are there any other thoughts or comments on that amendment? I see none.

All those in favour of amendment NDP-4.1?

(Amendment negatived [See Minutes of Proceedings])

Mr. Wilks.

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

Thank you, Chair.

I move amendment CPC-7.

[The Chair, Conservative, Ben Lobb]

Are there any comments on that amendment?

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

We have a subamendment. It would be a subamendment to add paragraph 6(b.2) that would say the following:

The Minister must ensure the status of post-market studies are disclosed to the public on an annual basis.

This is just to ensure that regular disclosure takes place. We think this would be a good addition to the bill, to this particular amendment.

[The Chair, Conservative, Ben Lobb]

Would you happen to have a copy of that?

[Libby Davies, NDP, Vancouver East, BC]

We've been in such a rush to get these amendments in, I don't have it translated, but I do have it for the....That's why I read it into the record.

[The Chair, Conservative, Ben Lobb]

That's great. Thank you.

[Libby Davies, NDP, Vancouver East, BC]

It's a last-minute thing. Otherwise we would, of course, have had these translated.

[The Chair, Conservative, Ben Lobb]

Okay. I'll read it one more time. It's a proposal is to create paragraph 6(b.2):

The Minister must ensure the status of post-market studies are disclosed to the public on an annual basis.

Are there any thoughts on that subamendment?

Mr. Young.

[Terence Young, Conservative, Oakville, ON]

Bill C-17 empowers the minister to order the publication of a whole range of things, and one of them is drug reviews. Another one is the initial grant of the NOC powers.

I'd like to ask the counsel to comment on that one as well, please.

[David Lee]

Thank you, Mr. Chair.

There is an important principle of transparency around the conditions of an authorization, which is certainly very important in the regulatory cycle.

If a drug is approved and there are conditions to conduct further studies on market, there is an interest by all in knowing what progress has been made. There is an intention to bring that into regulation, but we can do that as a matter of obligation under the regulations without ensuring it through further language here. It's already something the GIC can make a regulation about. The intention to have the element of transparency is very important.

[The Chair, Conservative, Ben Lobb]

Are there any further comments on that? Seeing none, we're on the subamendment. All those in favour of the subamendment proposed by Ms. Davies? All those opposed?

(Subamendment negatived)

Now we're back to amendment CPC-7.

(Amendment agreed to [See Minutes of Proceedings])

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

Are we on amendment CPC-8?

[The Chair, Conservative, Ben Lobb]

No, we have it on our list as amendment NDP-5.

[Libby Davies, NDP, Vancouver East, BC]

I must have them in the wrong order. So we're on amendment NDP-5.1?

[The Chair, Conservative, Ben Lobb]

We're on NDP-5.

[Libby Davies, NDP, Vancouver East, BC]

In that case, do you have NDP-5.1?

[The Chair, Conservative, Ben Lobb]

We do. It's further down.

[Libby Davies, NDP, Vancouver East, BC]

All right. I'd like to withdraw NDP-5.

(Amendment withdrawn)

I would like to deal with NDP-5.1.

I think that's why we had CPC-8 first.

[The Chair, Conservative, Ben Lobb]

Fair enough.

We'll deal with CPC-8 and then we'll get to NDP-5.1.

Moving right along, CPC-8.