Industry Committee on Nov. 1st, 2010

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

Clause 3 of Bill C-393 would remove the process that's currently in the Patent Act for adding or removing products from schedule 1, the list of eligible drugs for export under Canada's access to medicines regime. That process currently involves the Governor in Council making changes to the list based on the recommendations of the ministers: the Minister of Industry and the Minister of Health.

It would do a number of other things as well. It would collapse into one what are currently three schedules of countries in the Patent Act. This is all under Bill C-393. It would limit the process of amending to that list of countries, which was referred to as “the Schedule” in Bill C-393. That's basically what clause 3 of Bill C-393 would do.

As I understand Liberal amendment 1.2, it would reinsert the process for amending schedule 1, the list of eligible products for export under the Patent Act, because as a result of Liberal amendment 4 and Liberal amendment 2, which was withdrawn, schedule 1 has been reinserted into the Patent Act. That whole process of adding or removing to schedule 1 has been reinserted into the text of the Patent Act as a result of Liberal amendment 1.2.

I would say that there is no change to what is I guess now schedule 2, this list of countries, and the process of amending that schedule. That is not referred to in either Bill C-393 or in the Liberal amendments as far as I can see, but I'll have to check. It may be in further amendments.

[The Chair, Conservative, David Sweet]

Our conversation is isolated specifically on 1.2.

Are there any other comments or debate on 1.2?

Mr. Malo.

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

On Thursday, we adopted the fourth Liberal amendment, which restores to the bill the process related to Schedule 1, where it lists the medications that can be sent. I thought there was no provision in the current bill, Bill C-393, stating who could add medications to the list or remove them from it. So it was important to clarify that; otherwise, there would have been a gap in the bill.

Do I understand correctly?

[Mona Frendo]

I think that's correct that there is now a process or that there has been reinserted, effectively, the process for amending schedule 1 for the list of products.

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

Okay.

[The Chair, Conservative, David Sweet]

Is there any other debate?

Seeing none, does Liberal-1.2 carry? I had better get a show of hands.

Does Liberal-1.2 carry? Can I see a show of hands, please? Six hands? Okay. Those opposed?

(Amendment agreed to)

Okay. It's carried.

Now we're on Liberal-1.3.

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

It's clause 3 again? Okay.

[The Chair, Conservative, David Sweet]

Liberal 1.2 to 1.6 are all on clause 3. Now it's Liberal 1.3.

Is there any debate or a comment or a question?

Would you like to speak to it, Mr. Garneau?

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

As I understand it, Mr. Chair, this is really just to correct the fact that in Bill C-393 for the moment they refer to “the Schedule” because there is only one schedule. Now there are two schedules. This is to correct where it says “the Schedule” to say “Schedule 2”.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Garneau.

Is there any debate?

I'll call the question on amendment 1.3.

(Amendment agreed to)

Again, on clause 3, we have Liberal 1.4.

Mr. Garneau, we'll have a brief explanation, and then we'll see if there's any debate.

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

On Liberal amendment 1.4, it's just the same as what I said before.

[The Chair, Conservative, David Sweet]

Thank you, Mr. Garneau.

Is there any debate?

(Amendment agreed to)

On Liberal amendment 1.5, is it the same explanation, Mr. Garneau?

Mr. Lake.

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

Liberal amendment 1.5 deals with clause 4, I believe, so we should probably finish dealing with clause 3.

[The Chair, Conservative, David Sweet]

Yes, I'm sorry. We have a schedule that says it's clause 3, but you're absolutely correct, Mr. Lake. These are for clause 4.

Mr. Masse, did you have a comment?

All right. So now that we have it sorted out here that Liberal amendments 1.5 and 1.6 deal with clause 4, I'll call the question on clause 3.

Mr. Lake.

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

Sorry. I do have some questions now on clause 3. I just want to get back to the officials.

Again, what is the impact of clause 3 on the entire regime that we have? Could we have a conversation? Do you have hesitations on clause 3?

[The Chair, Conservative, David Sweet]

As it stands amended?

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

As it stands amended, yes.

[Colette Downie]

As it stands without the amendments that are proposed--just as clause 3 stands--or as the amendments are proposed to clause 3 in Bill C-393: is that the question?

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

Right. What does it impact and what concerns might you have, if you have any?

[Colette Downie]

This is the one that would have completely removed the process for amending schedule 1 to CAMR, the access to medicines regime. It would collapse schedules 2 to 4, the lists of countries, into one list, without any additional requirements or parameters around those lists.

So what it would mean is that a number of fairly well-developed countries would be eligible for exports of drugs under this proposed bill. Countries like Mexico, Singapore, Brazil, and China, which might or do otherwise have pharmaceutical manufacturing capacity, would be eligible to receive medicines under this regime.

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

Does that remain? Okay--

Sorry. Mr. Sutherland-Brown?

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

I'd just like to add to that briefly. In the waiver decision, the WTO negotiators set up different classes of what they called “eligible importer” and that's what the current schedules 2 to 4 do. So when you get rid of those, there is no distinction between eligibility that would be compliant with the scheme set out by the WTO negotiators.

The other thing it does is this. It seems to eliminate the requirement that a country or jurisdiction that wishes to use the scheme has to give notice to the WTO, written notice, or even verbal notice would do, but there has to be a notice to the WTO by the requesting country of the product they need and the quantum they need. That's all in the conditions that were set out in those “how you amend the lists”.

Thank you.

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

It strikes me in looking at the bill that we've struck out a substantial portion of the Patents Act and replaced it with 26 lines. In terms of what's being struck out there, what is the impact? On the things that have been struck out, what was the purpose for having those in there?

When we're making these changes or proposing these changes, I think it's important for us to understand. When I'm looking at what looks like dozens and dozens of lines that are being struck out that refer to WTO members and TRIPS councils and all sorts of different things that seem to be important from a trade standpoint, for example, it's important to know what is actually being struck out.

[Mona Frendo]

I'll try to answer that.

Paragraph 21.03(1)(a) of the Patent Act, which has been struck out—but then effectively some sort of mechanism has been reinserted—is the process of amending schedule 1, the list of drugs for export. Paragraphs 21.03(1)(b) to (d) and subsection 21.03(2) of the Patent Act—that's basically the rest of section 21.03—have also been effectively removed. Those paragraphs and the subsection describe the processes and requirements for adding and removing a country from what were schedules 2 and 3 of the Patent Act, those lists of countries Mr. Sutherland-Brown was referring to that had various requirements for using the WTO waiver as per the international rules.

What clause 3 of Bill C-393 would do is, for these lists of countries, effectively modify that process so that only two factors—and there were many more in the Patent Act—could be taken into consideration for adding or removing an eligible country from the new schedule. This would significantly limit the ability to amend that list and take action.

I can give you a couple of examples of what clause 3 would eliminate, if that would help.

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

Yes, it would.