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.
12:20 p.m.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
It was Mr. Ward, yes. I just wanted to make sure that it was covered. If I'm told that we already stipulate that anything that's going to go to schedule 1 is Health Canada approved, I would be happy with just removing clause 2, as has been suggested.
12:20 p.m.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
But it sounds as though that's not—
Sorry? Maybe Mr. Masse would....
12:20 p.m.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
That is not what I understood to be the correct interpretation. Departmental officials said that, based on the current wording of Bill C-393, if we do not add that drugs listed in Schedule 1 must be recommended by the Minister or another entity, in fact, we don't really know how drugs could be added or what process would have to be followed to add them to the schedule.
Now Mr. Masse is saying that he is going to remove a certain number of clauses from Bill C-393, so that there will not longer be an issue as to who would be authorized to add products to Schedule 1, and so as to ensure that this will in fact be done based on the recommendation from the Minister of Health.
I simply want to be sure that if we revert to the definitions as they currently appear in section 21.02 of the Act—and if Bill C-393 is subsequently passed—there will be some mechanism whereby we could actually identify the individual or entity authorized to add products to Schedule 1.
12:20 p.m.
Director, Patent and Trade-mark Policy Directorate, Department of Industry
The simple answer is no. If you revert to the pharmaceutical product definition that is in the Patent Act currently, there is no reference to any ability to add to that list on the recommendation of the Minister of Industry and the Minister of Health. That ability is found in section 21.03 of the Patent Act currently.
Clause 3 of Bill C-393 proposes to eliminate that section of the Patent Act. Therefore, if you revert to the definition of pharmaceutical product that is in the Patent Act without also considering the changes to clause 3 of Bill C-393, you will not have an amending ability for schedule 1.
12:20 p.m.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
I think I finally understand the point you're making, so let me ask the obvious question. If we were able to revert to section 21.02 but use the definition that I have provided in amendment Lib-1 insofar as “pharmaceutical product” is concerned, would we achieve the intention that I was hoping to achieve?
12:20 p.m.
Senior Counsel, Legal Services, Justice Canada, Department of Industry
Thank you, Chairman.
It's hard to know where to begin. As you have noted, this is very complex and very interrelated, and that's the way legislation is usually crafted, so that when it's presented in the House the interconnections between (a) and (b) and (c), etc., are clear.
But the question is, if you stay with the definition of “pharmaceutical product” that is in Bill C-393 now, that is defined by reference to the Food and Drugs Act, and the Food and Drugs Act definition of “drug” is everything in the world: any substance that can be used as a medicine, not only for humans but also for animals. It also includes disinfectants for cleaning kitchen surfaces and stuff like that.
So there is no need to amend if you stay with that. If you introduce the prospect of a Minister of Health or a Minister of Industry joint recommendation, they have to recommend to somebody. In the existing legislation--Bill C-9 or the Patent Act--it is the Governor in Council who makes amendments to the schedules that are in that act and does so on the recommendation of the appropriate ministers. In the case of a drug, that recommendation is given by both the Minister of Health and the Minister of Industry. Amendments to the other country schedules are done on the recommendation of the ministers for industry, international affairs, and CIDA, and I think for international trade as well.
The original legislation, the Patent Act, that purports to be amended by Bill C-393 has a mechanism that's built in for amendments to all those things and the circumstances that have to be met. If you use the definition that's proposed in amendment Lib-1, there is no mechanism left in the act, because Bill C-393 gets rid of all those mechanisms for amending. So it may say “on the recommendation of a minister”, but there is no mechanism in the legislation to permit it.
It's very intricate and very interrelated.
12:25 p.m.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
It certainly is very complicated. If we need this mechanism, if we want the medications to be Health Canada approved, what do we have to change in Bill C-393 to achieve that objective?
12:25 p.m.
Senior Counsel, Legal Services, Justice Canada, Department of Industry
The approval of a product for export under the Patent Act is done as the approval for drugs is domestically. That's not what we're talking about.
We're talking about amending the schedules to add a drug to them. That's not necessarily a health approval, although it would be implicit that Health Canada has examined a drug before it would be added. What it's saying is that this drug is useful for the purposes stated in the original purpose clause, which were the humanitarian purposes of making medicines available to the third world that address the named diseases or conditions as well as other epidemics.
The existing schedule 1 is a schedule created based on World Health Organization recommendations of the central medicines that are responsive to the named diseases; that's what is at issue there. As to whether they're safe and efficacious, that will be done through authorization.
Usually what we're talking about when a compulsory licence is given is the circumstance of a manufacturer who has not yet been to Health Canada to have its version of a product approved. We don't know whether that new or second version of an existing product has complied with Health Canada's standards of safety and efficacy and good manufacturing practice. That is something that is done in the course of the authorization; it's not done in terms of building the list.
I'm fearful that this probably didn't help.
12:25 p.m.
Conservative
The Chair Conservative David Sweet
I'm going to advise the committee that I'm just getting a clarification right now about whether it's at this meeting or on Monday, but if we don't complete this, the bill will go back to the House unamended.
Mr. Masse.
12:25 p.m.
NDP
Brian Masse NDP Windsor West, ON
The other option is to continue the meeting. That is an option for this committee.
12:25 p.m.
Conservative
The Chair Conservative David Sweet
It is an option, Mr. Masse, but I know that I'm due in a committee at 1 p.m. as well, and the subcommittee for human rights is also very important.
12:25 p.m.
Conservative
The Chair Conservative David Sweet
There seems to be no other discussion. I'll call the question on the amendment, then.
Oh, Monsieur Malo--I'm sorry.
12:25 p.m.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
Mr. Chairman, we can certainly dispose of the amendment and clause 2, or pass them, but either way, we are creating a problem. We have to resolve that problem before we can decide whether we want to accept or reject both the amendment and the clause.
We previously passed a schedule identifying which drugs could be sold in accordance with the Patent Act. However, Bill C-393 does not tell us either who or how that schedule could be amended.
My proposing a new definition of “pharmaceutical products”, Mr. Garneau was trying to identify the ideal mechanism whereby drugs could be added or removed from Schedule 1.
Department officials are saying that in terms of how as pharmaceutical products are currently defined, the mechanism is not sufficiently clear, refined and detailed. Before going any further, I think we have to find a way to fix this. If we just create problems by trying to dispose of the amendment and the clause too quickly, as framers of the legislation, we will not have done our job properly. I think that is what we should do, because that is what we're here for, Mr. Chairman.
12:30 p.m.
Conservative
12:30 p.m.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
I think in the interests of moving on, Mr. Malo, Mr. Masse has said that he's prepared to vote against clause 2 anyway. I'm pretty sure we'll be voting against clause 2, so in the end, we won't have to worry about a bad amendment to clause 2 anyway, I don't believe, and in the interests of time, maybe we can move on and get on to clause 3.
At this rate, it looks like we're not going to be finishing the bill.
12:30 p.m.
Bloc
Luc Malo Bloc Verchères—Les Patriotes, QC
If I'm not mistaken, according to what Mr. Lake just said, it doesn't matter what happens to the bill; we will simply leave a gaping hole in this bill, because we passed a number of clauses… including one that added Schedule 1 to the bill. We know there is a problem but we don't want to do anything about it because we don't have enough time. That's kind of a shame.
12:30 p.m.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
We can continue. We can continue the debate on this. I think I've been pretty clear right from the start. This is what happens when you take multiple pieces of complex and comprehensive legislation that have come into being through years of international negotiations and try to change them with a private member's bill. We see this time and time again in this place in terms of discussions.
I love having you at the table. You're enthusiastic, I think, in terms of wanting to solve the actual issues of the people of Africa and the challenges there; we're on the same page. But I think in terms of this piece of legislation, we're seeing here in this committee meeting what the challenges have been all along.
If we continue on the route that we're going and if we were to.... I mean, my fear as we go through this process now.... We're down to a deadline whether we spend an hour or 10 hours talking this out in committee in the way that we're doing right now...we're actually going to make a bill that had significant potential negative ramifications...we're actually going to make it worse, I think, in terms of some of the conversations that we're having, because we're trying to, under the pressure of a timeline, make changes that don't make any sense.
I really think we need to consider the actions that we're taking here in terms of amending the bill and in terms of the discussion. At the end of the day, what I want, and what I got involved in politics for, is to actually make a positive difference, not just to pass legislation that might make me feel good but is going to have significant negative ramifications down the line. I've said that right from the start.
We have several grandmothers in the room here who have put their heart and soul into the issue and I love that. I respect that. I think it's critically important. But I've said right from the start that this is not the way to make a change. In fact, in the end, we're going to have negative consequences through the process that we're going through on this particular bill.
This is tough. It's a tough process. I don't know where we're going here today with this. We're still on clause 2. It seems like the direction we're going in is actually heading to more confusion, and we need to move on.
If Mr. Masse, who is right now the person who is kind of.... At least if he is not officially holding the bill, he is unofficially holding the bill, and if he wants to remove clause 2 from the bill in the interests of moving on in the meeting, I think we need to consider that.
12:35 p.m.
NDP
Brian Masse NDP Windsor West, ON
Thank you.
I thank the parliamentary secretary for the intervention. I'd also add that they didn't have any amendments. If their government is so good at crafting legislation, it would have been interesting to see them actually propose those solutions as opposed to talking about them and not actually presenting them.
But having said that, I'm saying on this Liberal amendment that we should just go to in terms of discussing about whether it's going to pass or not and move on from there. I'm willing to find other solutions if we can, but we have a deadline on the clock here. Certainly if we have a problem with this legislation when it comes back out of this committee, it can also be amended in the House of Commons. That can happen. That is for sure. That is a reality. If there is a problem with this bill at any particular time, whenever it comes out of this committee, it can be changed in the House of Commons.
So we have doors open to us still, but we have to actually get to the bill and finish it first.