Industry Committee on Oct. 28th, 2010

[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?