Industry Committee on Nov. 1st, 2010

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

Mr. Chair, before we vote on clause 4, since that is really the substance of this bill, would you be so kind as to suspend the sitting for a few minutes? I would like to speak with Mr. Bouchard before we vote. Could you give me ten minutes or so, until 11:30 a.m.?

[The Chair, Conservative, David Sweet]

The sitting is suspended.

[The Chair, Conservative, David Sweet]

Ladies and gentlemen, we'll now return to our meeting.

I sensed that there was agreement from the committee members, as they were leaving the table, to extend our time to 12:10 to make up for the suspension.

Monsieur Malo.

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

Thank you very much, Mr. Chair.

When we discussed clause 3, our Conservative colleagues voiced their concern that Bill C-393 would divert Canada's Access to Medicines Regime from its primary objective. They were concerned that the resulting bill, act or regime would serve commercial interests more than humanitarian ones. I am certain that is not the intention; nor is it the intention of all those witnesses who testified throughout the proceedings that we needed to provide appropriate aid to children with AIDS, to their families—those mothers, fathers and grandmothers who are worried about the future of their children and grandchildren. So that is not what the people who introduced Bill C-393 wanted; nevertheless, the concerns are there, and they are legitimate.

Throughout the debate on Bill C-393, I often encouraged the committee members to come up with other solutions. There are actually other solutions; there is a way to help facilitate the current regime, in order to build more examples, more experience, for analysis purposes.

If the committee does not adopt Bill C-393, there will be nothing to take its place—no report, no other solutions. There is only one solution before us, and that is Bill C-393, which seeks to amend the current regime.

I wonder how we can view this amended regime and ensure that it does not exceed the limits we want to see imposed. We do not want the regime to stop serving humanitarian interests, and humanitarian interests only. I was discussing it with my colleague, Robert Bouchard, and our only solution may be to adopt Bill C-393 and turn it into a pilot project.

I would encourage my colleague from the New Democratic Party to sit down, after the committee stage, and see what amendments could be made, at the report stage, to turn this into a pilot project. A sunset clause comes to mind first and foremost, in order to put a time limit on the bill.

The way I see it, we should have come up with a proposal when we originally began studying this bill. Unfortunately, this is the only proposal we have. The government members have not shown a willingness to find a way to improve the current regime and make it more usable. A system that has been used just one time has not really been used at all. We cannot even say whether it works or not. Well, I suppose it does work, since it has a 100% success rate based on the one time it was used.

As I already mentioned, Mr. Chair, we are going to support clause 4, we are going to support all the other clauses, and we are also going to support our colleague from the New Democratic Party, who wants to remove certain clauses to bring the regime in line with the Food and Drugs Act and to strengthen Parliament's role. Clearly, we will propose some amendments at the report stage to ensure that the regime serves solely humanitarian interests, as originally intended.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Malo.

Mr. Lake.

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

Thank you, Mr. Chair.

Thank you to my honourable colleague. There was some stuff in there that I agree with. We had a conversation the other day. He is very passionate about the issue of helping people in Africa who need help. He mentioned that we have one solution before us and I've said repeatedly that I would disagree with that. I don't think we have any solution before us in this bill. I don't think this bill offers the solution we're looking for.

He mentioned the government and what the government is or isn't doing. I would argue that what this government is doing is working on solutions that are making a difference and increasing funding, our investment, in the global fund. Where other countries are not doing that, our country is increasing the investment and taking advantage of our role in leading the G-8 this past summer to put forward an initiative on maternal and infant health. That is tremendously important and it is something that is looking forward, looking toward the solution.

Unfortunately, I don't see a solution in this bill. Maybe when this is all done, we'll have the chance to talk. Those of us in committee who want to continue to look at ideas that might help can have conversations. I have committed to continuing the conversation with some of the folks who have been before the committee as witnesses as it relates to trying to have an impact on the devastation that is happening in parts of the world, where things are a little different from what they are here.

To go back to the bill here, if I could, we're on clause 4 right now. If I can bring the discussion back to clause 4 and taking a look at what clause 4 does, I'll give some explanation as to why I would vote against the Liberal amendment.

Clause 4 takes section 21.04 of the Patent Act and basically and systematically, in three subclauses of Bill C-393, wipes out three subsections of the Patent Act. Again, large portions of the Patent Act will be wiped out by this one clause, clause 4, in Bill C-393, and are replaced with a few paragraphs. For subsection 21.04(1), I think it adds one word, for subsection 21.04(2) it adds one word, and for subsection 21.04(3) I think it adds 16 words in replacing paragraph after paragraph of references to the WTO and TRIPS and those things.

So again, we see wording in a bill amending something as important as the Patent Act in a way that wipes out massive portions of it, and again, I think with substantial potential for very negative unintended consequences in the long run. The Liberal amendment addressed only one of the subsections that was being wiped out and left completely unaddressed the most substantial parts that were wiped out. That would be why I voted against the amendment and will be voting against clause 4 of Bill C-393.

[The Chair, Conservative, David Sweet]

Seeing no other debate, we will do a recorded vote on clause 4.

Shall clause 4 carry as amended?

(Clause 4 as amended negatived [See Minutes of Proceedings])

The clause is defeated.

(On clause 5)

[The Chair, Conservative, David Sweet]

We'll carry on to clause 5.

I believe Liberal amendment 3 does not need to be moved here. From what I understand, this amendment is not required and it creates an actual conflict later. But I'll let Mr. Garneau speak to that.

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

I concur with you, Mr. Chair. I'd like to withdraw it.

(Amendment withdrawn)

[The Chair, Conservative, David Sweet]

That will be withdrawn, then, and we'll deal with the actual clause itself.

Is there any debate on clause 5 before we move to the question?

Mr. Lake.

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

If I could, I'd like to go to the officials to have them explain what section 21.05 of the act does, first, and how it came about, and what the rationale is for 21.05 in the first place, and then what clause 5 of Bill C-393 would do--and what the effect would be.

[The Chair, Conservative, David Sweet]

Ms. Frendo.

[Mona Frendo]

Section 21.05 of the Patent Act presently states that the quantity of the pharmaceutical product that can be authorized for export--so that's manufactured and sent--to an importing country, may not be more than the amount that the importing country stated in its notification. Again, it ties CAMR back to this WTO decision, this WTO waiver, that it was founded upon. In that decision it was specifically stated that the country that needed a particular amount of drug would say so in their notification to the WTO, and CAMR was developed to respond to that need. In our process, section 25.01 of the act says that you cannot export, under this special regime, more than the importing country specifically stated it needed.

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

On a point of clarification, I think you said section 25.01, but you meant section 21.05.

[Mona Frendo]

I'm sorry. I meant section 21.05.

Clause 5 of Bill C-393 would change the current provisions in section 21.05 of the Patent Act by deleting all the references to quantity. It would also add a new proposed section, 21.051, that would put the onus on the authorization holder—the first or the manufacturer who is authorized under Canada's access to medicines regime to export. You would put the onus on that person to bear the responsibility of ensuring that the products that are sent are correctly labelled, as prescribed in the regulations.

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

As opposed to...? Whose responsibility is it now?

[Mona Frendo]

I'm sorry. I didn't hear you.

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

Whose responsibility is it now?

[Mona Frendo]

Currently it's the Minister of Health who would verify that the labelling requirements, which are a WTO requirement, are met. That's currently in section 21.04 of the Patent Act.

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

Brian, what's the rationale for that, if you could answer?

[The Chair, Conservative, David Sweet]

Go right ahead, sir.

[Brian Masse, NDP, Windsor West, ON]

Thank you.

It's because of what we've seen. Because of this regime, countries have to guess at how many drugs they need when they go through the whole rigmarole of the application process. They're doing their best guesstimate. Yes, they can go back a second time to request more, but as we've seen in the case of Rwanda, that could be time-consuming, but it could also be larger than their original request.

This empowers them to have the capability to respond to those changing needs that would happen in the actual treatment, whether it be of HIV, malaria, tuberculosis, or whatever it is. With clause 4 not being adopted, it would be absolutely cruel to pass legislation in which, for example, just because they guessed wrong on the original application, they couldn't treat people with the increased drugs that are necessary.

The bill has already been pared down quite significantly with the defeat of clause 4. This is just at least a modest attempt to allow some flexibility. You have to remember that everybody still wants to be WTO compliant. The whole sinister set of stories and plots—of diversions and replicas and knock-offs, and that whole series of things—is unfounded; there's been no evidence of any of these things at all. At the very least, we could err on the side of flexibility, so that if their judgment is wrong when they apply for the number of medicines, there could be some flexibility to make sure that the shortfall can be made up at the end of the day, rather than making people and countries go through a whole new set of application processes.

It would also allow the generics to know that they could ramp up production, if necessary. It costs them to do this as well, and that's the worst thing: the pharmaceutical companies are going to get more profit, because they're actually getting royalties.

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

Could I come back to the officials, then, to comment on Mr. Masse's comments concerning the WTO? It sounds as though the trade arguments are rather fictitious. Maybe you could comment on that.

[Mona Frendo]

Perhaps I'll start, and then others can respond.

As I mentioned earlier on the WTO waiver decision, in light of the concern that there was a need in developing countries but that there was this existing international intellectual property obligation system in place and the model was not going to be revamped entirely, the decision was carefully defined and limited to provide this limited exception to existing intellectual property rights and standards.

Within that carefully defined model and structure, certain obligations were waived under the WTO decision, but it was specifically stated that the intent of the waiver was to respond to a country's need for a particular amount of drugs. To allow for an unlimited export may not be in the spirit of that decision.

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

Mr. Masse made a comment about how time-consuming it was to go back in the Rwanda case. Can you attach some numbers to that specific case? Are you able to do that in terms of the Apotex case?