Industry Committee on Oct. 28th, 2010

[The Chair, Conservative, David Sweet]

Good morning, ladies and gentlemen.

Bonjour à tous. Welcome to meeting number 41 of the Standing Committee on Industry, Science and Technology.

We are going to be doing a clause-by-clause review of Bill C-393 today.

Before I begin, I'd like to introduce our experts from the public service who are with us today. We have with us Colette Downie, director general, marketplace framework policy branch, Department of Industry; Rob Sutherland-Brown, senior counsel, legal services, Justice Canada; and Mona Frendo, director, patent and trade-mark policy directorate, Department of Industry. From the Department of Foreign Affairs and International Trade, we have with us Edith St-Hilaire, director, intellectual property, information and technology trade policy division. Finally, from the Department of Health, we have Lisa Lange, associate director, bureau of policy, science and international programs, therapeutic products directorate.

Thank you very much for joining us today and giving us your expertise as we proceed to this bill.

Mr. Wallace.

[Mike Wallace, Conservative, Burlington, ON]

Are we proceeding or do you have more announcements to make?

[The Chair, Conservative, David Sweet]

No, sir. You can go ahead, Mr. Wallace.

[Mike Wallace, Conservative, Burlington, ON]

I just got six amendments put on the table here by our Liberal colleagues. I think that makes a difference to me. Can we deal with the amendments first as we do those clauses first and see how that goes and then go from there?

[The Chair, Conservative, David Sweet]

One moment please, Mr. Masse.

In fact, Mr. Wallace, the legal clerk who is assisting me today mentioned that because of the amendments and the fact that they impact on so many other areas, if we want to proceed through this bill, we really have to move to clause 15 for Liberal amendment 5, or Lib-5, because it has impacts on three other amendments.

[Mike Wallace, Conservative, Burlington, ON]

So can we do that, then?

[The Chair, Conservative, David Sweet]

We can do that, yes.

Mr. Malo, do you have a point?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Mr. Chairman, before we proceed with clause by clause consideration, if you don't mind, I would like to start by thanking Committee members.

As you know, I am not a regular member of this Committee. I want to extend my deepest thanks to all of you for the work we have been able to accomplish. I also want to thank the analysts and the clerk for their cooperation throughout this study.

I would just like to remind you, Mr. Chairman, that when we heard from officials at the Committee's first meeting, I pointed out that in examining Bill C-393, it would be important to look at the issue as a whole. I suggested considering an approach based on the model in Bill C-393, of course, in order to take advantage of APOTEX's experience with Rwanda. I suggested we take a look at our approach to be sure we could really help people, specifically in Africa, where they have a greater need for medications to treat HIV/AIDS.

At the time, I gave you a fairly extensive witness list. I want to thank you for trying to accommodate as many witnesses as possible so that, in a way, both perspectives could be heard.

However, now that we have heard from these witnesses, we are going to be moving to the next steps in this process, which means carefully considering the testimony we heard in order to find appropriate solutions. On the very first day of testimony, when we heard from officials, it was clear that, in their opinion, Bill C-393 was not the ideal solution, because a number of parameters had been defined in the bill with respect to our international commitments. That is something that should be preserved.

However, considering how the system has been used, we clearly have a 100% success rate. It was used there once and it worked well. It is clear that the goal of many of the witnesses we heard from, including those representing the National Action Committee of the Grandmothers-to-Grandmothers Campaign, who were here at our last meeting, was for more medications to be made available. So, I think there is good reason to review the system, all the commitments that have been made and the resources available to Canada to do more and do better.

Mr. Chairman, I know that the mandate of this Committee, both today and throughout this study, was to examine Bill C-393. I also know that the Committee has a full schedule, and that its work plan includes several bills and committee studies that have yet to be addressed. At the same time, however, I think we need to take the time to report the testimony we heard to the House and put down in writing some of the representations made as part of that testimony. That way, it would be possible to look for ways to improve the system while still keeping the current framework, and draft a list of irritants. We could also include in that report what is currently being done, as well as what we are suggesting in order for Canada to do better and do more.

I would like to repeat what representatives of the National Action Committee for the Grandmothers-to-Grandmothers Campaign said to us at the last meeting. They said that they had been to Africa, that they had seen a certain number of things, that they had made commitments to the grandmothers of Africa and would report back on what the House of Commons and the Committee decided to do for them. So, I think it would be sad if, upon completing our examination of Bill C-393, we simply closed our books and moved on to something else, without trying to go a little further.

Given the comments we've made and what we can do in relation to Canada's international obligations as a signatory, I think it would be rather sad if we didn't make the effort being asked of us, which is to refer this issue back to the House.

Thank you very much for your attention, Mr. Chairman.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Malo.

Certainly the committee might want to comment on what would be an additional report on the evidence we heard, on top of the issue we're seized with right now, which is the clause-by-clause consideration of Bill C-393.

But I have acknowledged that Mr. Masse wanted the floor, so go ahead, please, Mr. Masse.

[Brian Masse, NDP, Windsor West, ON]

We can provide.... We can go through clause-by-clause.

[The Chair, Conservative, David Sweet]

Okay. That's great.

We'll have to move directly to clause 15, then, because amendment Lib-5 would apply to amendments Lib-4 and Lib-6, and to the first amendment as well.

The only way we can propose those other amendments, Mr. Garneau, is if this passes first. This amendment creates several inconsistencies in the bill where references are made to the schedule, which would have to be changed to refer to schedule 2.

(On clause 15)

Are there any comments on the amendment?

Mr. Masse.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

I'm glad Mr. Malo led off with a discussion about compromise and willingness to work and make this bill better, because we still have an opportunity to do so.

So towards that common good, I have several suggestions today in support of this Liberal amendment. Although I don't believe it is necessary under WTO and TRIPS in the agreement, it has caused some concern for some members, and I certainly value their input and suggestion on that. This also, then, provides for CAMR to reach its current footprint, although restricted to some degree. At the same time, it would still be of benefit if we passed further amendments to the bill.

I'll suggest as well that I'll be dropping issues, such as the changes to the food and drugs safety act, as a compromise to make sure that we can actually get a bill passed in this chamber to report back to the House of Commons that will improve CAMR.

I'm hoping that the Bloc and the Liberals will be open to those amendments that are certainly going to strengthen the bill but also will serve the purpose at the end of the day. There are certain ones that will create some difficulty ,but there are other ones like this one, where I'm certainly willing to live with the consequences. Unfortunately, the drugs won't reach as many people in different nations, but at the same time, with all due respect, it still creates the environment we currently have.... There are other things we can do in Bill C-393 that will actually improve the bill. So in that spirit I will support this amendment and its consequential amendments.

[The Chair, Conservative, David Sweet]

Just one second, Mr. Wallace. You're on the speakers list.

I just wanted to advise Mr. Garneau that, by his nod, I assumed that he moved the amendment. I should say that verbally for the record.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

I did. Yes, sir.

[The Chair, Conservative, David Sweet]

Okay. I'll come back to you, Mr. Garneau, if you want to make any comments after the other members comment on your amendment.

Mr. Wallace and then Mr. Lake.

[Mike Wallace, Conservative, Burlington, ON]

I have a question. Based on the submission by Mr. Masse, are there other amendments? I have the six amendments from the Liberals in front of me. Were any amendments submitted by other parties? Can amendments be moved from the floor without any previous notice?

[The Chair, Conservative, David Sweet]

They can if they are germane to the business at hand, Mr. Wallace.

[Mike Wallace, Conservative, Burlington, ON]

Thank you very much. I just wanted to clarify.

[The Chair, Conservative, David Sweet]

Mr. Lake.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

I'd like just a quick clarification on this amendment. It refers to schedules 2 to 4 of the act, but my understanding is that there's only one schedule in the bill right now. Even with amendments, there's no schedule 3 or schedule 4 anyway. Is that correct? I'm trying to look at the amendments overall.

[The Chair, Conservative, David Sweet]

In fact, I'll let Mr. Garneau explain that, because there have been a number of changes.

Mr. Garneau.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

As you know, Bill C-393 deals with a part of the Patent Act that deals with the use of patents for international humanitarian purposes to address public health problems. In it there are four schedules. One of them is a list of drugs that are approved under CAMR. The other three are lists of countries that have a slightly different status.

As you know, Bill C-393 in clause 15 sort of eliminated those, so we're left with one schedule at the back, which is a schedule of countries only. My aim, with a couple of these amendments, is to reintroduce the schedule 1 that is in the Patent Act and that lists eligible drugs under CAMR as approved by the Minister of Health.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Mr. Chair, could I ask the officials to comment on the impact of this amendment at this point and perhaps maybe to comment on how clause 15 would impact the act in question?

[Mona Frendo, Director, Patent and Trade-mark Policy Directorate, Department of Industry]

My understanding is that, as Mr. Garneau mentioned, it would reinsert schedule 1 into Canada's access to medicines regime, along with potentially another amendment, which I suppose we'll discuss later. But it's not clear to me how the other schedules, the country schedules, would be reflected.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Mr. Chair, what I'm suggesting, essentially, is that we take schedule 1 that exists in the Patent Act and make it schedule 1 in Bill C-393. The existing schedule that's in there right now would become schedule 2, so we'd have schedules 1 and 2.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

But the amendment talks about schedules, about “replacing line 1 on page 6 with the following”, so it's adding schedules 2 to 4 of the act. It says you're replacing line 1 on page 6 with the following: “Schedules 2 to 4 of the Act are”. In my understanding, we really only have two schedules at this point with the changes that we're talking about. Am I reading that wrong?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

In the Patent Act, there are four schedules.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

But Bill C-393 takes all of them out except one--

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Except for the one that's in there, which is a kind of a composite of what were schedules 2 to 4. What I'm proposing is that the aim is to get a new schedule into Bill C-393, which is a list of drugs approved under CAMR, and that becomes the new schedule 1, and therefore the existing schedule in Bill C-393 becomes schedule 2.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Okay, but schedules 3 and 4--

[The Chair, Conservative, David Sweet]

Just one second, gentlemen. I've let this go casually because it was just some dialogue to make it clear, so I'll let Mr. Lake finish his rebuttal to the concern, but I need to go to Mr. Masse, in all due respect, because he's on the speakers list.

If you need to intervene again, Mr. Garneau, I will let you.

Go ahead, Mr. Lake.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Just to clarify, where are schedules 3 and 4? That's what I need to know here, because there's only one schedule. You're adding another one and that gives us two, but you're referring in your amendment to schedules 2 to 4.

[The Chair, Conservative, David Sweet]

Go ahead. Respond directly. Then I'll go to Mr. Masse.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

I'm not talking about changing schedules 2 to 4 in the Patent Act. I'm not touching them; they're not affected by this. It's only bringing schedule 1 from the Patent Act into Bill C-393 and moving the existing schedule of countries to become schedule 2.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Are we getting back to the officials?

[The Chair, Conservative, David Sweet]

Hang on, Mr. Lake. Just let me have Mr. Masse intervene here for a minute, because he has been on the list.

[Brian Masse, NDP, Windsor West, ON]

Essentially what it does is ensure that CAMR is consistent with Bill C-393 in terms of the drugs and the countries. That's what will happen by these consequential acts.

Although TRIPS and WTO didn't require that list, it was built in during the original CAMR, for a number of different reasons. I'm agreeing to them even though I don't believe it's necessary, but at the same time, it is what was done before and there has been some concern expressed about that, so that will allow the current Bill C-393 to be consistent with the drugs and the countries and the language from the previous bill.

[The Chair, Conservative, David Sweet]

Just before you comment, Mr. Lake, just so you know, in this wording in this amendment—and I could certainly give you the references if you'd like—there are at least eight references to “the schedule” that I can see right now, which is not germane to the wording in the amendment, so it will create some other issues with the bill as well.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

That's what I'm trying to clarify. I guess my question to the officials is what the impact of Bill C-393 is, so just for clarity, let's go back to the beginning.

What impact does Bill C-393, as it stands, have on the schedules?

[Mona Frendo]

Bill C-393 proposed, as Mr. Marc Garneau said, to remove schedule 1, which is a list of drugs that was contained in CAMR, the drugs that were eligible for manufacture and export under the regime. It also contained three lists of countries--so schedules 2 to 4.

The countries that were included were least developed countries, countries that were WTO members, and others. Each of those lists had varying responsibilities as per the WTO requirements and they were classified according to their pharmaceutical manufacturing capacity and their level of development.

My understanding of Bill C-393 would be that it would remove all four schedules, as per clause 15.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

And there would be only one schedule left?

[Mona Frendo]

That's right. It would be—

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

—one list of countries.

[Mona Frendo]

—one schedule of countries only, removed--

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

That's right. So the effect of this amendment refers to schedules 2 to 4, but there's only one left right now. I'm not understanding where schedules 2 to 4 come in. I understand that by adding one more schedule—the schedule of drugs—you get one more schedule, but you're referring to schedules 2 to 4.

Bill C-393 leaves us with only one schedule. You're adding one. We don't have a schedule 3 or a schedule 4. So what do schedules 2 to 4 of the act refer to?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

The schedules 1 to 4 that are referenced here under clause 15 refer, as I understand it, to schedules 1 to 4 in the Patent Act.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Could we get the officials to comment?

[Mona Frendo]

That is correct.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Okay.

[Mona Frendo]

That is correct, and the amendment, as I understand it, would refer to clauses 2 to 4.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

What is the consequence of having one country list and not three? That's a fair question.

[Colette Downie, Director General, Marketplace Framework Policy Branch, Department of Industry]

The consequence is that if you were to collapse the country list into one, without distinguishing between the requirements or the manufacturing capacity of different countries, what you would potentially see is the ability to have a compulsory licence to send products to countries that are well developed, or that have their own pharmaceutical manufacturing capacity, in situations where there's no emergency. Mexico would be on the list. Singapore would be on the list. I think India is on the list as well.

[The Chair, Conservative, David Sweet]

Mr. Garneau.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Mr. Chair, it's really understood in the context of what we're talking about now plus the first two amendments I've put in. If you look at these three together, it makes sense--I think it makes sense. The intent was to get the list of medications back into Bill C-393. It had been removed.

The other schedule, the existing schedule in there, is the schedule of countries. Whilst I may have some problems recognizing that Singapore should be eligible for CAMR medication, I'm not going to go after that in today's discussion.

[The Chair, Conservative, David Sweet]

Is there any other debate or comment?

Mr. Van Kesteren.

[Dave Van Kesteren, Conservative, Chatham-Kent—Essex, ON]

I need a little more clarification on that. I understand what you're saying, but doesn't it imply that the bill would put generic companies in a position to provide drugs for countries that wouldn't be, as we've deemed, necessary...? You rather left that hanging.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

If you look at the current schedule in Bill C-393, we can argue about whether countries such as Poland, Singapore, and Hong Kong should be on the list. I didn't tackle that issue in what we're talking about today.

The reason I wanted to put this schedule 1 list of medications back in is that at the moment, the way the legislation is written, there is no defined list of medications.

[Brian Masse, NDP, Windsor West, ON]

The list is also agreed to by the WTO, so there's consistency there. It's agreed to by the WTO, and the consistency would remain.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Masse.

Mr. Braid.

[Peter Braid, Conservative, Kitchener—Waterloo, ON]

Mr. Chair, if I may, I'd like to ask Mr. Garneau a question.

By implicitness, then, Mr. Garneau, do you accept the notion of a consolidated one country list, which this clause also speaks to?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Yes. I didn't go after changes to restore the original schedules 2, 3, and 4 from the Patent Act. I left the schedule the way it is.

[The Chair, Conservative, David Sweet]

Seeing no more debate, then....

Before I put the question, there are a couple of things you need to know. This vote essentially applies to the fourth amendment and the sixth amendment from Mr. Garneau. The first Liberal amendment can only be proposed if this is adopted.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Did you say the fourth and the sixth?

[The Chair, Conservative, David Sweet]

That's right. Essentially, once you pass this, you've passed Liberal-4 and Liberal-6. Do you want to take a second to make sure you understand where I'm going on this and look at the amendments? Liberal-1 can only be proposed if this is adopted.

Also, I would remind you, once you adopt this, of the inconsistencies I pointed out, by the highlights in the bill that refer to this schedule rather than the wording that is in the amendments.

Mr. Garneau.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Mr. Chair, I think what's related to Lib-5 is Lib-1 and Lib-6, or at least according to my....

[The Chair, Conservative, David Sweet]

No. I think Lib-4 is essentially part of it as well. Lib-4 has references to the schedule as well, Mr. Garneau.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Okay.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

So in voting on this amendment, we're not actually voting on Lib-4 at the same time, are we?

[The Chair, Conservative, David Sweet]

Well, essentially, because--

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Because it seems to be a different amendment. It may be tied to this one, but it's not the identical amendment.

[The Chair, Conservative, David Sweet]

Do you want to comment on it?

[Mike MacPherson, Procedural Clerk]

It's because of the consequential relationship. In a vote on Lib-5, because of the changes to the schedules, we would have schedules 1 and 2, whereas I think in Lib-4, the part it's deleting refers to “the schedule”, and if you've removed them, then that doesn't make sense anymore. So it's just consequential.

Lib-6 is just changing the title of the schedule to read “Schedule 2,” which seems a little more obvious.

[The Chair, Conservative, David Sweet]

Mr. Braid is next, and then Mr. Wallace.

[Peter Braid, Conservative, Kitchener—Waterloo, ON]

May I suggest a potential solution, then? Could the other clauses refer to “the schedules”, plural?

[Mike MacPherson]

No. I think several parts of the bill refer to the countries “listed in the Schedule”, and if one of the schedules is a list of pharmaceutical products or drugs, or whatnot....

[The Chair, Conservative, David Sweet]

Thank you.

Mr. Wallace.

[Mike Wallace, Conservative, Burlington, ON]

From a procedural point of view, Mr. Chair, if we vote on this and it passes, we still have an opportunity to debate clauses for the sections they're dealing with. We just assume those amendments that take place in this one are applied, but we could still ask officials about those clauses.

[The Chair, Conservative, David Sweet]

I think they essentially make no legal sense in the bill, unless after you pass Lib-5, Lib-4, and Lib-6, they're done as well.

[Mike Wallace, Conservative, Burlington, ON]

Thank you.

[The Chair, Conservative, David Sweet]

Mr. Lake.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

This probably highlights the importance of having our amendments in a little earlier. We just got these the night before, which makes it a little difficult.

But if we can talk about amendment 4 for a minute, I just to clarify. If we're voting on it as well, maybe I could ask the officials again to comment on the effects of Lib-4 on the legislation in question.

[Colette Downie]

If we understand the amendments in Lib-4, what they do is reinsert into CAMR the grounds on which the Federal Court can terminate an authorization under CAMR. Those grounds are where the product is diverted without knowledge of the patent holder, and the second one is really the connection to Lib-5 and Lib-6, which is where the product is exported to a country not named on the list or lists, and where more than the quantity authorized is exported, or where the product is exported to a non-WTO member country and then used for commercial purposes.

So it's linked to Lib-5 and Lib-6, but it also makes additional changes to reinsert this Federal Court challenge process back into the legislation.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

If this is done, what problems remain in this regard in Bill C-393?

[Colette Downie]

There is still a number of other issues, which we discussed when we appeared before. It still leaves the lack of a mandatory Health Canada review, the unlimited nature of the duration of a licence under CAMR, and some of the other transparency and enforceability safeguards would remain untouched.

[The Chair, Conservative, David Sweet]

Are there any other comments?

We'll go to the question, then, on Lib-5, clause 15. Shall the amendment carry? Could I have a show of hands, please? In favour? Opposed?

(Amendment agreed to)

The amendment carries. Shall clause 15 carry as amended? In favour? Opposed?

(Clause 15 as amended agreed to)

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

I'm just a little bit unclear there. Mr. Bouchard--was he in favour or opposed?

[A voice]

Pour.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Pour? Okay.

[The Chair, Conservative, David Sweet]

So clause 15 has carried as amended. We'll go back to clause 1, then, and Lib-1.

Shall clause 1 carry? I apologize--clause 2.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

We had a suggestion earlier that we do the amendments first. Is that what we're doing?

[The Chair, Conservative, David Sweet]

Yes, thank you very much for reminding me. It's okay, it's just our communication here.

(On clause 2)

So we'll go to clause 2, then, with the Lib-1 amendment.

I should bring something in the bill to your attention. I guess as long as there's consent, we can change it. We need somebody to move the change. There's a typo in the bill, the actual bill. You'll see that at the beginning of clause 2, it says “210.02”, and en français it's “21.02”. It should be “21.02” not “210.02”.

[Dan McTeague, Liberal, Pickering—Scarborough East, ON]

That's not a problem.

[The Chair, Conservative, David Sweet]

It's moved by Mr. McTeague, and it sounds like there's consent. Okay. We'll change that.

So for Lib-1, I assume, Mr. Garneau, that you are moving that amendment.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

You're correct, Mr. Chair.

[The Chair, Conservative, David Sweet]

Mr. Lake.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Could Mr. Garneau explain the amendment and give his rationale for it?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Yes. Essentially what happens here is that we are... As you know, in Bill C-393 there's a description of a pharmaceutical product, and we are now referring to pharmaceutical products that come under the new schedule 1 that we just finished talking about, that came from the Patent Act. There's the additional point that these are at the recommendation of the Minister of Health. So there's that fact that this is a list of medications approved by Health Canada.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Can I first get the officials to comment on the effect of the amendment? Or maybe on the clause on the whole? Maybe you can do both, if you would.

[Mona Frendo]

Clause 2 as it was put forward in Bill C-393 would have deleted the reference to schedule 1 and would have expanded the scope of eligible products for export under Canada's access to medicines regime to any drug as defined under section 2 of the Food and Drugs Act. That would have been the impact of clause 2 of Bill C-393. It would also have changed the definition of authorization under Canada's access to medicines regime to delete a reference that's currently in the act and that talks about a renewal system.

So together with other clauses in Bill C-393, it would have had the impact of removing any limits on the duration of an export authorization in CAMR. That would have been the impact of Bill C-393's clause 2.

In terms of the Liberal amendments, it does not affect Bill C-393's proposed changes to the definition of authorization, hence the issues with regard to no limits on duration continue. It also does not reinsert other definitions that were deleted by Bill C-393.

Currently the act defines things like “General Council Decision”, which is the WTO decision on which CAMR was based, and the meaning of “patented product”. There are a number of other technical definitions that, together with other elements of the regime, add clarity and help define what in fact the purpose of this regime is.

[The Chair, Conservative, David Sweet]

Mr. Malo, please.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

You have just referred to all the definitions that have been deleted, particularly with respect to the General Council, the WTO, TRIPs, what an authorization is or the TRIPs Council. Having heard the comments you just made in answer to a question from Mr. Lake, I believe I understood that, in your opinion, these definitions should not be deleted, and that they should in fact be put back in. Did I get that right?

Just so that we all have a proper understanding of the scope of this bill, could you explain in more detail if the definitions that have been deleted are important?

[Colette Downie]

I'll ask my colleague from Justice to explain the role of the definitions in the CAMR legislation.

[Rob Sutherland-Brown, Senior Counsel, Legal Services, Justice Canada, Department of Industry]

It's all very complex and interrelated, but essentially, the original CAMR legislation, Bill C-9, made reference to things like the WTO waiver decision. To do that, a number of the definitions were technical; WTO is used, so there's a definition of WTO to tell you what the World Trade Organization is.

For “General Council” and which General Council, it tells you that. But it also, importantly, tells you about the “Decision”, which is referred to throughout the legislation as somebody importing or exporting in conformity with the authorization.

For “patented product”, again, it's a technical definition to tell you what it means. It's defined in terms of infringement. That's what this is about. It's about authorizing otherwise unauthorized users to infringe.

So these play both a definitional and a drafting role throughout the original legislation. Those references have been removed in Bill C-393, so they may or may not have much impact on Bill C-393 itself, but they do have an impact on the overall schema, in the sense that it loses the tie to the WTO agreements, both the main agreement and the TRIPS, the trade-related aspects of intellectual property agreement.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

So, the fact that these definitions do or do not appear in the bill has no effect on its scope. Is that what you were saying?

[Rob Sutherland-Brown]

Some of them are just there for drafting convenience, but others do have an impact. For instance, where in Bill C-9 you see references to “in accordance with the General Council Decision”, that has substance to it. The circumstance of a manufacture and exportation and importation meets the restraints or the limitations that were imposed by the TRIPS agreement when it was initially negotiated.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

In your opinion, therefore, clause 2, as amended, could contain some gaps in terms of important definitions. Is that correct?

[Rob Sutherland-Brown]

As I said, some of them are definitional and they make sense within Bill C-9 because the terms were used throughout the legislation. Those are just sort of drafting techniques, but there are others. “General Council Decision” is used throughout the legislation to describe specific criteria that are going to have to be met in an application for an authorization.

[Mona Frendo]

I will just add that the intent.... When CAMR was first developed, when this legislation was first put in place, we were one of the first countries to do such legislation. We were developing the legislation without much precedent, so what was paramount was the interest in making sure we were closely aligned with the WTO General Council decision and the requirements stated in that decision.

That is why those definitions are in the text. That is why the references are carried through the legislation. It is to ensure there is a link between our Canadian implementation and the international requirements that were set out by the General Council decision.

[The Chair, Conservative, David Sweet]

Thank you.

Mr. Malo, if you have another question, I'll just ask you to wait. Mr. Garneau has been waiting.

Mr. Garneau, do you have a question?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

I don't know whether there is simply an error in the amendment, because the intent was simply to… In the previous amendment, we established a new list of products that is now part and parcel of Bill C-393. The intent was simply to include a definition that would be consistent with the criteria used to draft such a list, which is now the new list # 1 in the document. It was simply to have a definition of “pharmaceutical product” that would be consistent with the criteria used for the new list that is now in the bill.

[The Chair, Conservative, David Sweet]

Do you want to comment before I go to Mr. Malo?

[Mona Frendo]

I was only going to add that I think it is because clause 2 of Bill C-393 states, “Section 21.02 of the Act is replaced by the following”, and there are two definitions after that. One is for “authorization” and one is for “pharmaceutical product”. So the understanding was that when the Liberal amendment was put forward it was to deal with those two definitions and not--

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

For those lines, I guess maybe the numbering was, as I understand it, really just to address.... I guess that's really more like lines 20 to 24. That was the intent.

[The Chair, Conservative, David Sweet]

Lines 20 to 24? My wording here says “lines 18 to 22”.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

So does mine. I agree.

[The Chair, Conservative, David Sweet]

Do you have some input, Mr. Lake?

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

It's a point of order, I guess. Maybe we can take five minutes for the Liberals to get together and figure out what their amendment means, sir.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

I believe there's an error in the way the amendment is written and that it is really meant to say “lines 20 to 24” instead of “lines 18 to 22”, I guess. It's only touching on the definition, that was the only thing. Because we now have a new schedule 1 that contains a list, and the list is based on the new definition, the one that I'm proposing here for “pharmaceutical product”, which was really what used to be there in the Patent Act anyway.

[The Chair, Conservative, David Sweet]

We're going to have the legal clerk comment on it, please.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

All right.

[Mike MacPherson]

It appears that Bill C-393 is defining “pharmaceutical product” according to section 2 of the Food and Drugs Act, and the amendment is replacing that definition with a reference to schedule 1 of Bill C-393, which is actually the old schedule 1 of the Patent Act.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

With the new one....

[Mike MacPherson]

It's meant to be the new schedule 1.

So if you removed the first two lines of that definition, lines 18 and 19, it just grammatically wouldn't make any sense.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

It wouldn't make any sense? Well then, I'll admit that I'm not an expert on that and I'll defer to.... But the intention was just to harmonize.

[The Chair, Conservative, David Sweet]

Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Perhaps our legislative clerk could tell us how we could keep all the definitions that appear in the current legislation, while at the same time amending the definition of “pharmaceutical product”, as proposed by Mr. Garneau in order to ensure consistency with the other amendments made to the bill.

[Mike MacPherson]

Bill C-393 appears to be including a definition for the term “pharmaceutical product”. It states that it is the same definition as “section 2 of the Food and Drugs Act. If we go to section 2 of the Food and Drugs Act, we have “drug”, which is what this would be referring to, and there is a complete definition there of what a “drug” is. Mr. Garneau's amendment would replace that with a straight reference to section 1 of the Patent Act, which would now be the first section of Bill C-393.

[The Chair, Conservative, David Sweet]

Mr. Garneau, the legal clerk is here to assist us, but you have to work through your intentions and make sure that you craft the amendment the way you would like it. We'll certainly check it in that regard, but it's incumbent upon you to edit it in the fashion.... The way it's working right now.it...well, it's not workable.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

I'm confused, but I take your point.

[The Chair, Conservative, David Sweet]

I don't mind if you'd like to suspend for a few minutes. You can talk with the legal clerk and then we can move from there.

Is that agreed?

[Some hon. members]

Agreed.

[The Chair, Conservative, David Sweet]

We'll suspend for five minutes.

[The Chair, Conservative, David Sweet]

Ladies and gentlemen, we're back in session.

We've had consultations with the legal clerk, and I'll have Mr. Garneau explain, please, so we have some understanding of where we're going.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

Just to repeat, whether I missed something or not, under clause 2 there is a definition of “pharmaceutical product”. The intention is to replace that definition by the one that is written in amendment 1, no more, no less. What's significant about this definition is that it refers to the new schedule 1 that we dealt with in our first amendment. Secondly, it talks about the recommendation of the Minister of Health, which essentially says that this drug list has Health Canada approval.

[The Chair, Conservative, David Sweet]

Okay.

Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

I want this to be perfectly clear. By replacing this definition, clause 2 removes all the other definitions that are currently in the legislation. Proposed amendment LIB-4 refers to a certain number of definitions—for example, of the WTO, the TRIPs Agreement or that sort of thing, which would not longer appear in the list of definitions.

What I'm seeking to do, obviously, is to find a way to amend the definition of “pharmaceutical product” in order to ensure, as Mr. Garneau has said, that it is consistent with the schedules, motions and clauses passed previously, while at the same time maintaining those definitions that we will need in order to interpret proposed Liberal amendment LIB-4, for example.

[The Chair, Conservative, David Sweet]

Because my desire for clarity is as great as yours, I'm going to have the legislative clerk answer you directly, Monsieur Malo.

[Mike MacPherson]

What I'm going to suggest—and it's up to the committee—is that the vote on Liberal-5 be applied to Liberal-4, specifically because of the references to schedule 1 or 2. That was creating the confusion. That vote was a strictly consequential relationship. It appears that this has created a lot of confusion and there are a lot of elements in clause 12 that Liberal-4 impacts upon that members would appear to want to debate further.

My suggestion to the chair to suggest to the committee is that we no longer apply the vote on Liberal-5 to Liberal-4 and that we'll deal with that when we get to clause 12.

[The Chair, Conservative, David Sweet]

Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Mr. Chairman, if we reconsider our decision to pass clause 12 as amended by LIB-4 and we pass this amendment to the definitions in clause 2 of the bill, it will no longer be possible to add any definitions if there is a need to do so.

Earlier, I asked the officials who are here with us what definitions are needed in order to understand the Patent Act. Bill C-393 is obviously going to amend that Act, and we will be removing all the definitions that currently appear there if we pass clause 2 as amended, or even if we pass it as it appears in the bill.

So, I'd like to reformulate my question and ask it again. We are currently debating clause 2. What definitions are needed in order to understand the Act, whether or not it is amended by Bill C-393?

[Mona Frendo]

I'll answer that question by listing the definitions that are currently in CAMR. There are definitions for: “authorization”, “General Council”, “General Council Decision”, “patented product”, “pharmaceutical product”, “TRIPS Agreement”, “TRIPS Council”, and “WTO”. Bill C-393 would delete all of those definitions except for the definition of “authorization” and “pharmaceutical product”. And, as I heard Mr. Garneau say, he would choose to revise the definition for “pharmaceutical product” put forward in Bill C-393.

On the issue of the other definitions, “patented product”, for example, is referred to in the definition of “pharmaceutical product”. If you delete the definition of “patented product”, you are creating potential uncertainty in the definition of “pharmaceutical product” that Mr. Garneau has proposed.

In terms of deleting the definition of “WTO”, I just did a quick search of the provisions, and that term is referred to in subparagraph 21.13(d)(ii) and paragraphs 21.14(g) and 21.14(f), so there would be implications in other sections of the act. That word is referenced in other parts.

“General Council Decision” is referred to in at least one other place that I could find quickly, and that is subsection 21.17(2).

There would be implications if you delete a number of these definitions and only leave “authorization” and “pharmaceutical product”. You're going to have carry-through implications for other provisions in the bill.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Merci.

[The Chair, Conservative, David Sweet]

Thank you.

Mr. Malo, do you have a rebuttal question? Can I go to Mr. Garneau first?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Oui.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

This is one of the disadvantages of being an engineer instead of a lawyer. My intent was not to get rid of other definitions. I only see two definitions in Bill C-393. I wasn't aware of the existence.... I have to admit that I didn't pick up on all these other definitions. I have no problems with those other definitions being brought into here, if it will help the situation. My intent was to define “pharmaceutical product”.

[The Chair, Conservative, David Sweet]

Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

So now, our job is to keep the definitions currently in the legislation while at the same time amending the definition of “pharmaceutical product”, so that it jibes with the amendments and clauses we have already passed. So we have to do both of those things. That is the reason why we need clarification from our legislative clerk, in my opinion. He might be able to suggest an amendment which would enable us to do both simultaneously.

If he needs a little more time, perhaps we could suspend the meeting for a few minutes, Mr. Chairman. This is important.

[The Chair, Conservative, David Sweet]

In all fairness, Mr. Malo.... I mean, I'm going to talk to the clerk, but to ask the clerk to devise an amendment that is germane to the intent of the original one I think is asking a lot.

I will let him think about that for a second, I'll go to Mr. Lake, and then we'll deal with that.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Mr. Garneau referred to the other definitions that are in section 21.02 of the act that is being amended here. To be clear, the other definitions in the Patent Act that are struck out by clause 2 of Bill C-393 are references to “General Council”, “General Council Decision”, “TRIPS Agreement”, “TRIPS Council”, and “WTO”.

Now Mr. Garneau, I'm not sure if it's the Liberal position to wipe out all references in the Patent Act to “General Council”, “General Council Decision” “TRIPS Council”, and “WTO”, but that's the effect of clause 2 of Bill C-393.

Mr. Garneau's amendment changes the definition of “pharmaceutical product”, but it doesn't address the wiping out of all of the references to WTO, TRIPS Council, TRIPS agreement, and all of those things. Is that correct?

[Colette Downie]

That's correct. It also allows the definition of “authorization” to stand. That definition deletes the possibility of a renewal, so it also creates uncertainty about how long an authorization then stands for.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Right.

The information I'm reading on the Patent Act comes from the submission of the Canadian HIV/AIDS Legal Network, actually. It was a helpful reference earlier, and I'm finding it helpful here now. Looking at the definition of “authorization”, I believe the previous wording referred to “authorization granted under subsection 21.04(1)”. The part that's struck out is “and includes an authorization renewed under subsection 21.12(1)”. That is the part you are talking about being struck out. Mr. Garneau's amendment doesn't address the striking out of that provision.

[Colette Downie]

That's correct.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

I don't know if Mr. Garneau intended with his amendment to not bring back references to the TRIPS agreement, the TRIPS council and the WTO and whether he thinks those are not important definitions. Maybe he can clarify that.

[The Chair, Conservative, David Sweet]

I think he does. He can clarify it right after Mr. Masse comments.

[Brian Masse, NDP, Windsor West, ON]

Why don't we just delete clause 2 of Bill C-393 and restore the current system?

[The Chair, Conservative, David Sweet]

That is one answer to our dilemma right at the moment.

Mr. Garneau.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

If it's important for the interpretation for the rest of Bill C-393, as the experts seem to suggest, then it's an oversight on my part. My intent was to go to the “pharmaceutical product” definition. I have to admit that I did not realize that we'd left hanging some definitions here that might be important.

If they're really required for the rest of the act, which they appear to be, it would be good to bring them back in, although they weren't there with the current proposal.

[The Chair, Conservative, David Sweet]

Just to be clear, your amendment did not remove all the definitions. The bill itself removed the definitions.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

That's what I thought.

[The Chair, Conservative, David Sweet]

Your amendment clouded it a bit, but—

[An hon. member]

It didn't put them back in.

[The Chair, Conservative, David Sweet]

That's correct.

Mr. Lake.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

In fairness, I sometimes find this process confusing, too, and it is tough sometimes when we're looking at Bill C-393. You see what is replacing what was taken out, but you don't see what was actually taken out. That's sometimes the problem that causes confusion.

In this case, Bill C-393 takes out all the references I was talking about, but we don't see that in Bill C-393 itself. I think that's what you're speaking about in terms of the confusion, Mr. Garneau.

[The Chair, Conservative, David Sweet]

Absolutely.

I want to remind you about Mr. Masse's suggestion on just defeating clause 2.

Mr. Wallace.

[Mike Wallace, Conservative, Burlington, ON]

I will speak to that point.

My question is for the bureaucratic expert we have here in front of us today. If clause 2 is completely defeated, what was just mentioned by Mr. Lake as one of the issues that we're having problems with.... Would that then bring back the CAMR definitions that are already in there, in legislation that is already passed and is law and has been used? That would then eliminate that opportunity that Bill C-393 is trying to do in terms of the renewal aspects. So if clause 2 is completely defeated, the issue about renewal will not be an issue any more because we're using the CAMR definitions, which require a renewal.... That's where I'm getting....

I understand what Mr. Garneau was trying to do. I understand that he didn't try to put the definitions back in. The suggestion is to get rid of the whole clause altogether. I want to know what the ramifications are. One of the issues we've heard about at committee from all stakeholders was whether we want that renewal piece back in or not. It is an issue. Is it added back in if clause 2 is deleted?

[Mona Frendo]

Not alone, no. Clause 9, on section 21.09, of Bill C-393 and clause 10, on section 21.12, of Bill C-393 would also delete the renewal and that duration of the export, so--

[Mike Wallace, Conservative, Burlington, ON]

So all those clauses would have to be deleted for that issue to go away, based on what side of the piece you're on?

[Mona Frendo]

Yes.

[Mike Wallace, Conservative, Burlington, ON]

Thank you very much.

[The Chair, Conservative, David Sweet]

Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thanks again, Mr. Chairman, for giving me the floor. I would like to ask our legislative clerk for clarification.

Mr. Garneau's goal was to only amend the definition of the term “pharmaceutical product” in order to make it consistent with those clauses that are amended by amendments LIB-4, LIB-5 and LIB-6, and specifically amendment LIB-5.

Once clause 2 has been completely deleted from Bill C-393, will the definition of “pharmaceutical product” still be adequate considering the amendments we have just passed?

[Mike MacPherson]

Could you repeat that please?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

We are currently discussing potentially deleting clause 2 of Bill C-393 and restoring section 21.02, as drafted in the current Act, and thereby bringing all the definitions back in. However, Mr. Garneau's intention, in amending the definition of “pharmaceutical product” through amendment LIB-1, was to ensure that it would be appropriate, given the amendments we have just passed, and thereby to amend the schedules.

I'm just wondering whether, by retaining the definitions as they appear in the current Act, the definition of “pharmaceutical product” will still be comprehensible and correct.

[Mike MacPherson]

I don't know that it is.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

I didn't mean in the sense of being fair, but rather of being accurate.

[Mike MacPherson]

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.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

My question is for Mr. Garneau.

What does that new reference to the Minister of Health add?

[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?

[Mona Frendo]

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.

[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.

[Colette Downie]

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.

[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.

[Colette Downie]

This change would not impact that second health approval process that is eliminated in CAMR.

[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?

[Mona Frendo]

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.

[The Chair, Conservative, David Sweet]

Thank you for the clarification.

Mr. Masse.

[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.

[The Chair, Conservative, David Sweet]

Just for clarity for the people here, could you reference the clauses they're found in?

[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.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Masse.

Mr. Lake.

[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—

[Brian Masse, NDP, Windsor West, ON]

I withdraw the amendment, Mr. Chair.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Well, you didn't make the amendment, so you can't withdraw it.

[Voices]

Oh, oh!

[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.

[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.

[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?

[A voice]

Is Mr. Ward here?

[A voice]

I don't think so.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

That was done? No? Okay.

[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.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

But it sounds as though that's not—

Sorry? Maybe Mr. Masse would....

[The Chair, Conservative, David Sweet]

Monsieur Malo.

[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.

[Mona Frendo]

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.

[The Chair, Conservative, David Sweet]

Thank you.

Mr. Garneau.

[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?

[The Chair, Conservative, David Sweet]

Witnesses...?

[Rob Sutherland-Brown]

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.

[The Chair, Conservative, David Sweet]

Mr. Garneau.

[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?

[Rob Sutherland-Brown]

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.

[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.

[Brian Masse, NDP, Windsor West, ON]

The other option is to continue the meeting. That is an option for this committee.

[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.

[Brian Masse, NDP, Windsor West, ON]

You could get the whips to get subs in.

[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.

[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.

[The Chair, Conservative, David Sweet]

I think we're all agreed on that, Mr. Malo.

Mr. Lake.

[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.

[The Chair, Conservative, David Sweet]

Go ahead, Mr. Malo.

[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.

[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.

[The Chair, Conservative, David Sweet]

Mr. Masse and then Mr. Garneau.

[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.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Masse.

I have a speakers list now: Mr. Garneau, Mr. Malo, and then Mr. Lake.

Mr. Garneau.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Well, in the interests of moving forward, even though it's imperfect, I'm certainly willing to entertain the possibility of just eliminating clause 2 as it exists right now, if that's something my colleagues would agree with.

[The Chair, Conservative, David Sweet]

Mr. Garneau, I'll take that as your seeking unanimous consent to withdraw your amendment.

Does Mr. Garneau have unanimous consent to withdraw his amendment?

[Some hon. members]

Agreed.

[The Chair, Conservative, David Sweet]

(Amendment withdrawn)

The amendment is withdrawn and I'll go on to Mr. Malo.

You're on the list, Mr. Malo, or do you want me to go directly to...?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

No, it's just because Mr. Garneau says he is going to withdraw his amendment. But that creates a problem, and I believe officials already referred to it. Withdrawing the amendment creates a problem.

[The Chair, Conservative, David Sweet]

Mr. Malo, no, we have withdrawn the amendment. It has been voted on. It's gone. He wasn't thinking about it; it's done.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Yes, I know, but we have just created a problem.

Perhaps I could just put a question to Mr. Masse. When we voted earlier in favour of amendment LIB-5, which put Schedule 1 back in, it was clear that other amendments would have to be proposed subsequently in support of that schedule.

We all know that it's getting late, and I understand that he may want to move on to other clauses. I also noted his suggestion, which was that the problem we have just created be fixed when the bill is reviewed in the House.

Because the fact is that we did create a problem, and departmental officials told us so. So, we really have to address this when the bill is sent back to the House. Section 21.02 will have to be reviewed with a view to again providing a mechanism whereby the person or entity with the authority to add or remove drugs from Schedule 1 is clearly identified. As one of the officials suggested, what is needed is a proper mechanism setting out the parameters to be followed by ministers for that purpose.

That's what I wanted to say. I think it's unfortunate that, simply because we are running out of time, the Committee is not going to try to resolve a problem that it has already identified.

Thank you, Mr. Chairman.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Malo.

We'll go to Mr. Lake.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

I don't have anything to add.

[The Chair, Conservative, David Sweet]

All right. Then we'll move on to the question on clause 2. We're going to vote on it right now. Those for clause 2? Those against?

(Clause 2 negatived)

Clause 2 is defeated.

(On clause 4)

[The Chair, Conservative, David Sweet]

We'll move on to clause 4 and Liberal amendment 2.

[A voice]

Clause 3?

[The Chair, Conservative, David Sweet]

Clause 3 doesn't have an amendment. You wanted to do the amendments first.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Which amendment is it?

[The Chair, Conservative, David Sweet]

It is Lib-2 on clause 4.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Mr. Chair, the purpose of this amendment is to essentially reinstate the application process under CAMR, which of course, as you know, requires, in applying for a compulsory licence, including certain information: the version of the pharmaceutical product, the quantity of the product to be exported, the name of the patent holder, the name of the importing country, and the name of the importing entity. Deleting lines 15 to 18 in clause 4 will accomplish that purpose and will reinstate the original application process.

[The Chair, Conservative, David Sweet]

Thank you.

Go ahead, Mr. Masse.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

I'll be as brief as I can, but this is critical to the bill. This essentially guts the bill. It takes the one licence–one drug application down to nothing and leaves things virtually unchanged. This would be the net result of destroying all the work that has taken place and all the attempts to get there.

In an offer of goodwill, I'm looking at withdrawing a series of clauses--clauses 6, 7, 8, 11, 12, and 14, and then I also mentioned the food and drug and safety act--to clean up this bill in regard to the concerns of those who are in opposition to it. However, this clause right here essentially will remain status quo, which is not acceptable in my opinion, and which is the reason that so many Canadians and people care about making a difference and getting a change on this particular issue.

We've also heard testimony from the witnesses for WTO in a series with TRIPS. They said we were actually in compliance before this, but if there ever were a problem with anything in this bill we could immediately change it without any major repercussions. As well, we can also ensure that those things could actually be adjusted.

As for those concerns that have been expressed about copyright infringement, diversions, safety of drugs, all those elements are all taken out and cleaned up. I don't believe the concerns are always necessarily true, but the fact of the matter is that members are raising them as substantial barriers, and I will take those barriers out.

But taking this out essentially destroys the bill and the concept and I can't support this. We have to ensure that this Liberal motion does not go forward, because if it does, all the efforts from everyone trying to make a difference will have been exhausted.

For that, Mr. Chair.... I'm hoping that the intentions might be fair with this, but certainly we know the facts of the matter. Nobody can be fooled about the fact that this just basically destroys the concept and the bill itself.

[The Chair, Conservative, David Sweet]

Thank you.

Mr. Lake.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Could I ask the officials to comment on the amendment? What impact would the amendment have on Bill C-393? What might it fix and what might it not fix?

[Mona Frendo]

As I understand it, Liberal amendment 2 would reinsert into the Patent Act a number of requirements for an application to a Commissioner of Patents for export to a developing country in need. Some of those requirements would be the name of the product for export, prescribed information on the version of product that would be exported if it was applicable, the maximum quantity to be exported and sold for export, the name of the patentees that would be involved and affected by the export, and the name of the importing country.

[The Chair, Conservative, David Sweet]

Mr. Lake, did you have any follow-up?

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

No.

[The Chair, Conservative, David Sweet]

Okay.

Is there any other debate?

Monsieur Malo, is that your hand going up?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Yes, it is.

[The Chair, Conservative, David Sweet]

Okay.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

I would just like to ask Mr. Masse for clarification. He seemed to be saying he is prepared to amend that clause of Bill C-393.

Could you explain once again which clauses that are affected by subclause 4(2) that you would be willing to retain under the current Act?

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Malo.

We can drop clause 6, clause 7, clause 8, clause 11, clause 12, and clause 14. They deal with several issues that committee members have raised as concerns with the bill. That would provide a compromise, so that the process of acquiring and distributing the generic drugs would be changed because of situations like the one in Rwanda, for example, and others that never took place.

But the structures and some of the features would still be in place, addressing issues related to everything from diversions, the way drugs are shipped, and the processes in that. That's one of the reasons why we have backed off f some of the changes, even to the schedules, because the heart of the bill is changing the process through which a country can procure a generic drug through CAMR and how it can distribute a drug through CAMR, and, in this particular case, the volumes. This would provide a greater ability for that country and the NGOs to be able to apply CAMR in their respective countries.

The other issues, although important, are not nearly as important as this particular issue. So in the interests of time and compromise, we can't compromise on this one, but on other ones we can, to make the bill a little more efficient.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

If I understood you correctly, you are not in favour of any of the amendments that could be made to the amendment we are currently debating, which was proposed by the Liberals. In other words, you do not wish to add any of the elements that would be reintroduced into the Act under this amendment.

[Brian Masse, NDP, Windsor West, ON]

The amendment as presented basically deletes the one licence-one country process and the control of it.

When I received the Liberal amendments last night—and to be fair to Mr. Garneau, he followed due process—we decided at that point what we could do about this bill to make it work. Hence, we've taken out certain elements of the bill to provide that. If the spirit of the bill is to remain intact, this one has to be defeated.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you, Mr. Chairman.

I'm sure you would acknowledge that Mr. Garneau followed the proper process before presenting his amendments. They were submitted in advance so that members could review them. Now you have just talked about the clauses you would like to have removed from Bill C-393. Considering how little time we have left, it would be rather difficult to examine that suggestion properly. In terms of what you just said, I would like to hear from officials as to how they interpret this.

Considering how little time we have left, I am really just wondering if it will be possible to arrive at an informed opinion regarding Mr. Masse's suggestion.

[The Chair, Conservative, David Sweet]

I just want to make a comment here. You know I haven't been here long, but I refrain from comments and I'm at the behest of the committee all the time, but I was the one who had a witness very clearly tell me to make sure that we superintend this process as best as we possibly could.

The magnitude of change we're talking about here is troublesome: we're now talking about striking six clauses. We've already had some serious debate on some amendments. I'm just very concerned with the complexity of what we're dealing with here and the magnitude of change this bill will cause.

Mr. Lake, and then Mr. Masse.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

You know what? I'll let him finish. He was on a topic and we can come back.

[Brian Masse, NDP, Windsor West, ON]

What we're doing is looking at preserving the certain elements of CAMR that we had suggested changing, but we're willing to live with them. That's the bottom line. We got the amendments at 4:30, like everyone else; we were supposed to have them at noon.So we've done our best. Anybody can move an amendment, even on the floor of the House. Those are the rules, and those rules are fair.

But we're just trying to deal with what we've been dealt here, and this amendment has significant consequences at the heart of the bill. The other stuff restores CAMR back to where it was before.

[The Chair, Conservative, David Sweet]

By the way, Mr. Masse, my comment was not to cast aspersions on anybody, but simply to express a concern about the nature of what we're dealing with here.

[Brian Masse, NDP, Windsor West, ON]

I appreciate it.

[The Chair, Conservative, David Sweet]

Mr. Lake.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

What were the clauses that he's talking about striking?

[The Chair, Conservative, David Sweet]

Clauses 6, 7, 8, 11, 12, and 14.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

That is interesting, because my list of the places where there are primary problems with the bill shows clauses 2, 3, 4, 5, 9, 10, and 17, so they're almost the opposite clauses from the ones that Mr. Masse is talking about striking out.

Again, to go back to the issue at hand here, we were talking about clause 3.

[The Chair, Conservative, David Sweet]

Clause 4.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Clause 4, I'm sorry. That's right. We skipped clause 3 to get to clause 4.

Maybe the witnesses again could bring us back to the issue of clause 4 and the impact specifically, now going beyond the amendment, because we have to consider the amendment in the context of the entire clause. Mr. Masse says he's not prepared to accept the amendment, so that would leave the clause as it is.

What are the ramifications of clause 4?

[Mona Frendo]

Clause 4 of Bill C-393 would change the system of authorization that is currently in CAMR to a particular country and to a production of a particular drug. It would change this completely. It would allow the Commissioner of Patents to authorize any person to manufacture more than one pharmaceutical product and sell it for export to more than country. That would be a significant change. It would also eliminate the requirements that the manufacturer of the pharmaceutical product and the importing country be named in the application.

That's what Bill C-393 proposes to do in clause 4. It would also delete a number of the specifics that would have to be named by the generic manufacturer and the potential applicant under CAMR when applying to the Commissioner of Patents for an authorization.

Again, it's what I was mentioning earlier: the name of the product, the prescribed information about the product, the maximum quantity to be exported and sold, the name of the patentees, and the name of the importing country. It would delete that at the legislative level in the Patent Act.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Now, I'm struck as I look at the clause and what it would do. How much text...? If I'm not mistaken, this is one that wipes out a ton of text from the existing acts. Maybe Mr. Sutherland-Brown would be the appropriate person to answer.

I'm looking at the text that's being wiped out and all of the conversations about WTO members and General Council decisions and things like that. How much negotiation would have gone into coming up with that text in the first place, in the original act?

[Rob Sutherland-Brown]

I can't speak to the WTO negotiations because that was a very long multi-year process, but certainly when the WTO member states were trying to find a way to make compulsory licensing work in jurisdictions that had no pharmaceutical manufacturing capacity, there were a number of things that concerned them, and that was if you allowed jurisdictions with the capacity to manufacture without any constraint, this would eviscerate the patent system around the world. They said, okay, people who have a need to issue a compulsory licence but don't have local manufacturers can request products from the WTO and jurisdictions with capacity can then issue a compulsory licence domestically. The request from the putative importer to the WTO had to name the product involved and the quantum that they needed to treat their local health problems.

That was a critical element of the WTO agreement and it's a critical element of the Canadian implementing legislation that tried to put the system in place. The same is true, I guess, with the names of the importers, because what happens in the international drug markets is that a lot of product gets diverted. It seems critical that this kind of information be available about compulsorily licensed products, so that the patentees and the granting nations can control how the product is used, that in fact it gets to the destination that's intended.

It took a lot of negotiation here domestically when we were doing the legislation, because as Bill C-393 shows, there are a lot of interest groups that have ideas about what the perfect system would be. I think that in the course of developing the initial CAMR legislation, Canada was concerned that it remain compliant with its WTO obligations or that it didn't create a scheme that would go beyond the scope of the TRIPS waivers decisions. It's a long process, both domestically and internationally.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

I mean, it's very, very significant, what's being struck out here. On the information that I'm looking at, when we're talking about four pages or five pages of references to WTO decisions, TRIPS, and the General Council, this is a very significant amendment to the legislation and it could have serious ramifications in the future in terms of trade and other things, as we've said about clause after clause of the bill. I'll just end with that. That's not really a question, unless one of you wants to comment further.

[The Chair, Conservative, David Sweet]

Mr. Masse.

[Brian Masse, NDP, Windsor West, ON]

I would ask for unanimous consent to extend the meeting until we finish this legislation.

[The Chair, Conservative, David Sweet]

Does Mr. Masse have unanimous consent for that?

[A voice]

No.

[The Chair, Conservative, David Sweet]

No?

There is no consent, Mr. Masse.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

To add to that, I can't do that. We have other obligations and that's simply not doable.

[The Chair, Conservative, David Sweet]

All right.

Mr. Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Monsieur--

[A voice]

Shame, shame! If the poor people who are dying are not worth your time.... We have waited since last December for this committee to deal with this and for you to wait until the eleventh hour is shameful--

[The Chair, Conservative, David Sweet]

Madam, the committee is meeting right now. I'll need to ask you stay in order, please.

[Voices]

Shame, shame!

[A voice]

We're on our way out.

[Voices]

Shame!

[The Chair, Conservative, David Sweet]

Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you very much.

Earlier, I asked a question about Mr. Masse's proposal. Could you please comment on it and give us your view of the potential consequences of striking these clauses from Bill C-393, as proposed by Mr. Masse? I obviously realize that time is short and that we are dealing with a very complex issue.

[Colette Downie]

Are you asking if we could comment on the implications of withdrawing clauses 6, 7, 8, 11, 12 and 14? I think that's a very difficult thing to do without stopping and going through the amendments themselves, looking at what that means, and making an assessment of that. We need time to do that.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

You need a little more time to analyze this in relation to the structure of the current system and Act, in order to determine what kind of impact the deletion of these clauses could have--

[Colette Downie]

It still would leave some problematic clauses in place, in the government's view, particularly clause 4, which you've heard has some pretty significant implications. If it were to remain in place, then we would obviously have concerns about that, as you've heard.

[The Chair, Conservative, David Sweet]

Sorry, Mr. Malo, but it's one o'clock. Unless I have the majority of the committee that wants to do something else at the last--

Yes, Mr. McTeague.

[Dan McTeague, Liberal, Pickering—Scarborough East, ON]

This is more for clarification. I just want to be absolutely sure on whether we have run out of time here. There was already one extension given to this bill, and therefore it would be impossible for this committee to request a second extension, according to the procedures and rules of the House of Commons.

[The Chair, Conservative, David Sweet]

That is my understanding. We have until the end of the day on Monday to report this bill back to the House. It's deemed to be reported back the way we received it.

[An hon. member]

How about meeting on Monday?

[Dan McTeague, Liberal, Pickering—Scarborough East, ON]

Mr. Chair, I have no difficulty with meeting on Monday if necessary.

[An hon. member]

I'll meet on Monday.

[The Chair, Conservative, David Sweet]

All right. Is there a majority of people who would like to meet on Monday on this bill?

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Well, if we get some clarification on the time, I think.... Can we just get clarification, first of all, on when it needs to be reported back to the House?

[The Chair, Conservative, David Sweet]

By the end of the day Monday.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

By the end of the sitting day on Monday?

[The Chair, Conservative, David Sweet]

That's correct.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

So we could conceivably meet on Monday afternoon after question period.

[The Chair, Conservative, David Sweet]

Well, certainly, it depends on the timing of when other members can either make it or be subbed in.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Certainly I'd be willing to meet after question period in the afternoon on Monday.

[The Chair, Conservative, David Sweet]

I have one point of clarification, and then I'll go to Mr. Van Kesteren.

If we don't hit routine proceedings, then we'll need unanimous consent in the House to be able to report it in, so it would have to be by the time of routine proceedings on Monday, to be certain.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

That's the first thing in the morning, is it not?

[The Chair, Conservative, David Sweet]

Yes, it is.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

So in other words, we can't?

[The Chair, Conservative, David Sweet]

I'm informed that it's the first thing at 11 on Monday morning.

Mr. Van Kesteren.

[Dave Van Kesteren, Conservative, Chatham-Kent—Essex, ON]

Mr. Chair, what are we trying to prove? I think it's obvious that even if we spent a week on this bill.... There are just so many problems with this bill. I think Mr. Lake made the point well.

The reason we have officials from the different departments.... They have an army of lawyers who prepare these things and obviously the bill is flawed. We can try to placate and we can try to make ourselves look better to the grandmothers. I'm speaking to the Liberals now, and to the Bloc, too. If you really think we can amend this and put it in a form that's.... But you all know we're not going to be able to do that, not in an hour's time, not in a day's time. It's a waste of time. The bill has been presented. It will be presented to the House unamended. I know I'll be voting against that. I feel that.... Let's end this.

[The Chair, Conservative, David Sweet]

Mr. McTeague.

[Dan McTeague, Liberal, Pickering—Scarborough East, ON]

The purpose was simply to find more time if necessary. The reason I introduced this was to ensure that there were other considerations taken into account, subject, of course, to the rule of the House and the timing for the House to receive this. We have run out of time because of an extension.

However, as it goes back to the House unamended, that will also bring some consequences that, I'm sure from my perspective as the member of Parliament who first introduced this notion back in 1999-2000, are certainly unintended.

[The Chair, Conservative, David Sweet]

Absolutely.

Okay. Do we have a majority that desires to meet again before the Monday routine proceedings?

[Brian Masse, NDP, Windsor West, ON]

I would like a recorded vote, please.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

I need to get clarification on this. We would meet on Monday morning, then.

[The Chair, Conservative, David Sweet]

We would meet on Monday morning or this afternoon.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Routine proceedings are after QP. We just got clarification, too, so we'd have to meet in the morning on Monday to do it.

[A voice]

I can't.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Pardon? You can't make it?

[The Chair, Conservative, David Sweet]

Listen, we need to vote, because I know that people have to get to committee. Those in favour of another meeting?

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

A quick comment?

[The Chair, Conservative, David Sweet]

Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Mr. Chairman, if I'm not mistaken—Mr. Masse referred to this earlier—if amendments need to be presented, that can be done in the House when the bill is studied there.

[The Chair, Conservative, David Sweet]

We had better have direct clarification.

[Mike MacPherson]

Any motion to amend the bill submitted at report stage runs the risk of not being selected. The basic rule is that if it could have been done at committee, it should have been done at committee, so you run the risk of having the Speaker not select your motions for debate.

[Dan McTeague, Liberal, Pickering—Scarborough East, ON]

However, Chair, there's a question as to whether that's a duplication and if in fact it's something that is concurrent. I'm not challenging you, but I think....

[Mike MacPherson]

I'm just saying that you run the risk.

[Dan McTeague, Liberal, Pickering—Scarborough East, ON]

Well, let's be very clear. I'm not sure if that is quite a risk, especially if it's redundant.

[The Chair, Conservative, David Sweet]

Okay.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Just to clarify the motion, then, to be specific, are we talking about Monday at 10 or at 11? What's the specific motion we're voting on here? We need to know what time we're voting on to be here. We can't just have it be open-ended and say that we're going to meet some time in the next four days.

[The Chair, Conservative, David Sweet]

If you want, move a specific time. If not, somebody can give me a motion to adjourn as well.

Will we meet at ten o'clock on Monday? Those in favour? Opposed?

(Motion agreed to [See Minutes of Proceedings])

So we'll meet on Monday.

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Will it be a two-hour meeting?

[The Chair, Conservative, David Sweet]

It will be a two-hour meeting and we'll try to schedule it at a time that's most convenient for everybody, from 10 to 12 or from 9 to 11.

The meeting is adjourned.