Health Committee on June 12th, 2014

[Terence Young, Conservative, Oakville, ON]

Chair, under Bill C-17 the minister will have all kinds of new powers to direct pharmaceutical companies to issue new documents, new warnings, new safety warnings to clarify things, and to go back and retest a drug, etc.

Currently the Department of Health makes product monographs all publicly available on the Health Canada website. A monograph is a factual statement. It's the statement that the pharmaceutical companies provide to Health Canada to get their first notice of compliance. They're required to update it on occasion. It describes the properties, claims, indications, and conditions of use for a drug and all the other information, including reference to studies. Anyone, any independent researcher anywhere in the world, can have access to that document, just by going on the Internet, to draw their own scientific conclusions.

In fact, under Vanessa's law, the minister has committed to publishing drug reviews. For the first time, drug reviews for drugs that are on the market will be available to any scientist in the world who wants to examine that documentation, as they can in other countries.

This proposed motion would require the minister to actually do an independent review when there's already been a review. Drug monographs are approved by Health Canada in the first place.

In that sense, this would be redundant.

[The Chair, Conservative, Ben Lobb]

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

To go back to the testimony of Dr. Kahan, who I think was a very credible witness, he actually gave us some examples of where these monographs, which Mr. Young says are just factual, were actually inaccurate. He gave us two examples: the product monograph for OxyContin was inaccurate; and the monograph for the Hydromorph Contin is similarly inaccurate, in many ways.

So there are, apparently, serious situations where these monographs, whether they're meant to be factual, are not accurate. I think the need to have an independent review is something that's very important if we're talking about overall drug safety.

[The Chair, Conservative, Ben Lobb]

Are there any further comments on Ms. Davies' amendment, NDP-3?

Seeing none, all those in favour?

(Amendment negatived [See Minutes of Proceedings])

Next up is....

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

Mr. Chair, I would move CPC-4.

[The Chair, Conservative, Ben Lobb]

Is there any discussion on the amendment?

[Libby Davies, NDP, Vancouver East, BC]

Yes, I have a subamendment.

[The Chair, Conservative, Ben Lobb]

You have a subamendment to this one here?

[Libby Davies, NDP, Vancouver East, BC]

Yes.

My subamendment also comes from testimony that we heard from Professor Herder. Basically what we're suggesting is that the requirements for disclosure need to be more targeted.

We would change this part of the amendment:

prescribed information concerning the clinical trial or investigational test is

It would instead read:the registration and results, whether positive or negative, from all clinical trials and other investigative tests be

And then it would continue on.

So we would change some of the wording in Mr. Young's amendment, beginning with the word “prescribed”.

I think we have something to hand out.... Oh, sorry; we don't.

[The Chair, Conservative, Ben Lobb]

Okay, so that's in the third line in the amendment after “prescribed”.

We'll read it out again one more time for the committee, and if what I read doesn't sound right, then let me know.

You want it inserted after “prescribed”?

[Libby Davies, NDP, Vancouver East, BC]

Yes, starting with the word “prescribed”, so it would be “that...”.

So proposed paragraph 30(1.2)(c) “shall ensure that” and then it begins “registration...”.

[The Chair, Conservative, Ben Lobb]

Do you want that to be taken out?

[Libby Davies, NDP, Vancouver East, BC]

Yes, so the words “prescribed information concerning the clinical trial or investigational test” would be taken out and replaced with those words in bold.

[The Chair, Conservative, Ben Lobb]

Got that?

Just so that everybody's clear, Ms. Davies's subamendment says to take out where it starts at “prescribed” on the third line, and go all the way down to where it ends with “investigational test”, and then she would like to have inserted, after “that”, “the registration and results, whether positive or negative, from all clinical trials and other investigative tests be...” and then “is made public within the prescribed time and in the prescribed manner.”

So that is the subamendment to Mr. Young's CPC-4.

Is there any discussion on that subamendment?

Mr. Young.

[Terence Young, Conservative, Oakville, ON]

Chair, the minister will have the powers under the two words “prescribed information” to order the therapeutic product authorization holder to provide any necessary information. Anything, within a prescribed period of time, so this amendment is nothing.

[The Chair, Conservative, Ben Lobb]

Is there any more discussion on the subamendment?

(Subamendment negatived)

Any further discussion on CPC-4 amendment?

(Amendment agreed to [See Minutes of Proceedings])

Just bear with me for a moment.

I'd like to point out another amendment that you'll see in your listing here, and I apologize for not mentioning it earlier. CPC-6 is also considered adopted because it is similar to CPC-1 and CPC-2 where it was deemed to be consequential—

[Libby Davies, NDP, Vancouver East, BC]

Can you just hold on while I find it?

[The Chair, Conservative, Ben Lobb]

—to 4, not 1 and 2.

I apologize for that.

All right? I just wanted to make sure that we were clear on that before we went any further.

It looks as if the bells are ringing.

It probably makes a lot of sense to suspend and come back, but I'll just make sure that's what the committee wants to do.

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

We can do another 10 minutes if everyone is amenable to that, just so we try to work through as much as possible.

[The Chair, Conservative, Ben Lobb]

Okay.

[Libby Davies, NDP, Vancouver East, BC]

I don't know what the weather is like but if people are waiting for a bus, it can take forever to come.

[The Chair, Conservative, Ben Lobb]

Yes, that's true. It took me five minutes to get there; I walked there last time.

We'll do NDP-3.1.

Ms. Davies.

[Libby Davies, NDP, Vancouver East, BC]

Did we vote on CPC-4?

[The Chair, Conservative, Ben Lobb]

Yes, it's agreed to.

[Libby Davies, NDP, Vancouver East, BC]

Okay. NDP-3.1 also pertains to adding a clause after line 8 on page 5. We'd like to add a new number 2:

It is a condition of every authorization that the Minister be provided with all the results of clinical trials and investigational tests involving human subjects within the specified period.

Again, this is based on testimony from Professor Herder, and I think it's to give greater clarity to what the minister is authorized to receive.

So I would move that amendment.