Evidence of meeting #41 for Industry, Science and Technology in the 40th Parliament, 3rd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was amendment.
A recording is available from Parliament.
Procedural Clerk
Yes it is, because there is still a reference to Schedule 1. Whether it's the new or the old document, it's still Schedule 1. However, you will be losing the reference to the Minister of Health.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
My question is for Mr. Garneau.
What does that new reference to the Minister of Health add?
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
That's a good question. I'm told that under the current legislation, in order for a product to be licensed, it has to be approved by Health Canada.
Under Bill C-393, without Schedule 1, products requiring approval could apparently be approved by someone other than Health Canada, in particular by the countries importing those drugs. My intention was to ensure that only drugs approved by Health Canada would be eligible. What we want to do is ensure that these products are all reviewed by Health Canada before being shipped to other countries.
If section 21.02 is reinstated, as opposed to clause 2 here, there is no mention of Health Canada in the definition of “pharmaceutical product”. But is it covered in other parts of the act--that it limits products to being Health Canada products approved by the Minister of Health?
October 28th, 2010 / 12:10 p.m.
Director, Patent and Trade-mark Policy Directorate, Department of Industry
Yes, in the sense that.... Section 21.03 of the Patent Act currently refers to schedule 1, the list of drugs, and the process for adding to those drugs on the recommendation of the Minister of Industry and the Minister of Health. Bill C-393 would delete not only schedule 1, but the process for amending that schedule.
So the reference that is in your definition, Mr. Garneau, to “on the recommendation of the Minister of Industry and the Minister of Health”, would not exist under Bill C-393.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
Correct, but if one looks at section 21.03, from what I've understood you to say there has to be an approval by Health Canada for a medication to be approved for CAMR use.
Director General, Marketplace Framework Policy Branch, Department of Industry
I was just going to add, which might bring clarity to your question, that there are two types of approvals in CAMR. There's approval to get on the list, so the idea is that it's a drug that's needed to deal with a health care emergency.
That's not the same as the Health Canada review for health, safety, and efficacy. That's done once somebody manufactures new product X. Health Canada will look at the chemical formulation of those pills and assess whether they're safe and efficacious. That is not the same as the authorization we're talking about in this clause.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
My intent is that anything that is listed in the new schedule 1 and approved to be on the CAMR list has had clearance from Health Canada before it goes anywhere--and no other eligible authorization but Health Canada's.
Director General, Marketplace Framework Policy Branch, Department of Industry
This change would not impact that second health approval process that is eliminated in CAMR.
Conservative
The Chair Conservative David Sweet
The complexity of this is quite high, and I want to make sure I continue to be on track here.
Madam Frendo, you mentioned that this bill removes the schedules, but amendment 5, which we've just passed, restores at least some aspect of those schedules, I'm certain. Would you comment on that before I go to Mr. Masse and then Mr. Lake?
Director, Patent and Trade-mark Policy Directorate, Department of Industry
If I understand what Liberal amendment 5 does, it restores Bill C-393's schedule of countries; it restores schedule 1 of the Patent Act, which currently lists the drugs that are eligible for export under CAMR, and it references Bill C-393's list of countries as schedule 2. That would not affect other clauses of Bill C-393 that eliminate the possibility of adding to schedule 1, for example.
So schedule 1 is currently— There are x number of products on that schedule and currently there is a process under the Patent Act on the recommendation of the Ministers of Industry and Health to add to that list to respond to countries' needs. That would no longer exist as a result of one of Bill C-393's proposed changes to CAMR.
Conservative
NDP
Brian Masse NDP Windsor West, ON
I think we just delete clause 2 and leave the definitions intact. As I identified earlier, the other side issue that confuses some people is the food and drug and safety act changes, which I've already indicated that we're going to drop as well. So that provides for those current definitions and the process to stay intact from the current legislation.
Conservative
The Chair Conservative David Sweet
Just for clarity for the people here, could you reference the clauses they're found in?
NDP
Brian Masse NDP Windsor West, ON
It's right on the back page of the legislation, pages 6 and.... When we get to it, if we get to it, they're clauses 16 and 17, all the way down there. That just kills that part of the thing; it's as simple as that. It doesn't take more than one second.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
We're still on the amendment for clause 2, and I don't know if.... No one's indicated a withdrawal of the amendment, I don't think, at this point, and I do want to get a clarification on—
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
Well, you didn't make the amendment, so you can't withdraw it.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
In looking at Mr. Garneau's amendment and then at the existing Patent Act, what this appears to be doing is simply reinstating the wording from the existing Patent Act. It talks about reinserting the words “patented product listed in Schedule 1...if applicable, the dosage form, the strength and the route of administration specified in that Schedule in relation to the product”.
But for some reason—and I guess this is what we're trying to figure out, Mr. Garneau--you're reinstating the old definition for pharmaceutical product, except for one little exception. You're adding the words “on the recommendation of the Minister and the Minister of Health”. Those words are found in the existing Patent Act in paragraph 21.03(1)(a).
I'm just wondering why you've mixed two clauses that have both been removed under Bill C-393 and have reinserted them under the definition of pharmaceutical product. I'm wanting an idea of what the rationale is there.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
Thank you, sir.
The only thing I can tell you is that I wanted to make sure Health Canada approval was in there and I took the word of the legislative expert who put the words in the definition here. I was not aware that it might have been covered already.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
Could we have that legislative expert here so we could maybe have them testify as to the reason why that was done?
Conservative