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.
11:55 a.m.
Conservative
The Chair Conservative Ben Lobb
Okay. We're still on amendment NDP-2. All in favour?
(Amendment negatived [See Minutes of Proceedings])
Ms. Davies, I believe you're up again.
11:55 a.m.
NDP
Libby Davies NDP Vancouver East, BC
This is NDP-2.1. It results from testimony that was given by MEDEC. It seems to me to be a housekeeping thing that's fairly straightforward. What they were saying is that some of these therapeutic products are very big, such as hospital equipment. In terms of withdrawing them from the market, it couldn't necessarily physically happen—or it would be very difficult—that you could move something to a central quarantine. We've proposed this amendment by just saying, after line 28 on page 3 the following, “quarantine the product; or”, so that it actually allows something to be quarantined where it is without it having to be moved.
It is based on something that MEDEC raised with us and it seemed to be a logical thing to do to prevent unnecessary damage or storage costs for some of the larger equipment.
11:55 a.m.
Conservative
11:55 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
Mr. Chair, can we turn to Mr. Lee for a comment?
11:55 a.m.
Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health
Thank you, Mr. Chair.
In contemplating the difficulty you sometimes see with devices, if you have an MRI in a hospital, for example, to recall it, you don't want to pull it out of the hospital. It would be a great expense, among other things. That's why, in proposed subsection 21.3(2), what's proposed there is a provision for the minister to ask for corrective action to be taken. If there is an issue that they have to correct out in the field—and this is quite usual for devices—it's contemplated within the wording of the order.
The effect would be that if the minister picked up and ordered a corrective action instead of a recall, the assumption is that the medical device would stay where it is and then the company would need to instigate that corrective action. They couldn't sell it or use it while that order is in place, but certainly, the corrective action would be subject to the order. Really, that picks up the point.
I would also point out that, to some extent, proposed paragraph 21.3(1)(b), in sending “to a place”, does contemplate quarantine, to the extent we're saying that instead of pulling it all back from the market and bringing it back to the person who put it into the supply chain, which is the usual recall model, we can actually have product directed to a certain place or stay where it is. The minister could use an order to effect that.
11:55 a.m.
Conservative
11:55 a.m.
Conservative
The Chair Conservative Ben Lobb
All those in favour of Ms. Davies' amendment, which is NDP-2.1? All those opposed?
(Amendment negatived [See Minutes of Proceedings])
Ms. Davies.
11:55 a.m.
NDP
Libby Davies NDP Vancouver East, BC
We have NDP-2.2, which is dealing with the same situation, again we're trying to give greater certainty to how this legislation reads. I move that Bill C-17 be amended in clause 3 by adding after 40 on page 3:
(2.1) For greater certainty, if the Minister makes an order under paragraph (1)(a) in respect of a therapeutic product, that therapeutic product must be withdrawn from the market.
Again, it follows on the same point that was raised by MEDEC in terms of larger equipment. I heard what Mr. Lee says, but I'm still moving this amendment.
Noon
Conservative
The Chair Conservative Ben Lobb
All right.
Are there any comments or debate on amendment NDP-2.2?
(Amendment negatived [See Minutes of Proceedings])
Next up.
Noon
Conservative
The Chair Conservative Ben Lobb
Is there any discussion or dialogue on amendment CPC-3?
(Amendment agreed to [See Minutes of Proceedings])
Next up is Liberal-1.
Noon
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
Yes, thank you, Chair.
This amendment comes primarily out of the testimony of Mr. Herder. We know that Mr. Young has a similar amendment. However, we believe that our amendment provides for a mandatory process that explicitly lays out in the act a public registry, as opposed to defining this in the regulations, and improves the safety and efficacy of therapeutic products.
Our amendment seeks, first, to ensure that all clinical trials and investigational tests are registered with the minister; second, that therapeutic product authorization would not be issued unless it were registered; and third, that results must be provided to the minister no later than one year after their completion—
Noon
Conservative
The Chair Conservative Ben Lobb
I don't want to interrupt you, sir, but we could just go right to the discussion if you like, because I'm sure everybody has read your amendment, unless you wanted to provide a commentary on it.
Noon
Conservative
June 12th, 2014 / noon
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
No problem.
The results must be provided to the minister no later than one year after the completion, with all results being reported for trials or tests that involved human subjects, and that results of clinical trials and tests must be provided to the minister, even if no authorization is issued within six months.
The next part of the amendment deals with publicly disclosing information on Health Canada's website, such as all clinical trials and investigational tests and the results; decisions respecting the issuance or refusal of authorizations and reasons; terms and conditions imposed on an authorization, as well as decisions respecting suspensions and revocations of authorizations and the reasons; the recalls of a therapeutic product and the reasons; and information about any serious adverse drug reactions. There is also a protection that any information cannot be issued to gain an unfair commercial advantage.
This amendments bring transparency to the clinical trial process and the decisions Health Canada makes in regard to issuing authorizations, safety warnings, or recalls, and the reasons for them by ensuring that this information is available on Health Canada's website.
Noon
Conservative
The Chair Conservative Ben Lobb
Again, I'm sorry for the interruption.
Is there any discussion on the amendment?
Mr. Young.
Noon
Conservative
Terence Young Conservative Oakville, ON
Chair, I think we're working towards the same purpose, but the government amendments address these issues and then empower the minister to create regulations. This is an industry that's driven by invention and technology, and I think it's really to the advantage of the regulator and to the government to be able to react quickly to changing conditions and changes that are driven throughout the industry. So we feel this is redundant.
Noon
Conservative
The Chair Conservative Ben Lobb
Is there any other discussion on the amendment?
Seeing none, all those in favour of Liberal-1?
(Amendment negatived [See Minutes of Proceedings])
Next up, we have amendment NDP-3.
Noon
NDP
Libby Davies NDP Vancouver East, BC
Thank you.
NDP-3 would amend the bill by adding, after line 3 on page 5, the following:
21.61 The Minister must undertake an independent review of all monographs of therapeutic products that the Minister has prepared since the coming into force of this section and must post the results of such reviews on the Department's Internet site.
The purpose of this amendment, Chairperson, is that we want to make sure that independent and objective reviews of Health Canada's approvals of product monographs are available. This requirement would only apply to new drugs.
This was brought forward in testimony by Dr. Meldon Kahan earlier in the spring. We think it's something that should be covered. Basically he said, as people on the committee might remember, that it's very important to ensure that product monographs are objective and are not influenced by pharmaceutical marketing, and that basically there should be an independent review of these monographs.
That is what this amendment deals with.