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37th PARLIAMENT, 3rd SESSION

Standing Committee on Industry, Science and Technology

EVIDENCE

CONTENTS

Tuesday, April 20, 2004

1105

The Chair (Mr. Brent St. Denis (Algoma—Manitoulin, Lib.))

1110

Mr. Brian Masse (Windsor West, NDP)

The Chair

Mr. Brian Masse

The Chair

Hon. Joe Fontana (Parliamentary Secretary to the Prime Minister (Science and Small Business), Lib.)

Mr. Brian Masse

Hon. Joe Fontana

The Chair

Hon. Joe Fontana

Mr. Brian Masse

The Chair

Mr. Brian Masse

The Chair

Mr. Brian Masse

The Chair

Mr. Grant McNally (Dewdney—Alouette, CPC)

1115

The Chair

Hon. Joe Fontana

The Chair

Hon. Joe Fontana

The Chair

Mr. James Rajotte (Edmonton Southwest, PC)

The Chair

Mr. James Rajotte

The Chair

Mr. James Rajotte

The Chair

Mr. James Rajotte

1120

The Chair

Hon. Joe Fontana

The Chair

Mr. James Rajotte

Hon. Joe Fontana

Mr. Éric Dagenais (Acting Director, Patent Policy, Department of Industry)

The Chair

Mr. James Rajotte

The Chair

Mr. Brian Masse

The Chair

Mr. Brian Masse

1125

The Chair

Mrs. Marlene Jennings (Notre-Dame-de-Grâce—Lachine, Lib.)

The Chair

Mr. Paul Crête (Kamouraska—Rivière-du-Loup—Témiscouata—Les Basques, BQ)

The Chair

Mr. Rob Sutherland-Brown (Senior Counsel, Legal Services, Justice Canada; Department of Industry)

The Chair

Hon. Joe Fontana

The Chair

1130

Mr. Paul Crête

The Chair

Mr. Paul Crête

Mr. Éric Dagenais

Mr. Paul Crête

Mr. Rob Sutherland-Brown

The Chair

Hon. Joe Fontana

The Chair

Mrs. Marlene Jennings

The Chair

Hon. Joe Fontana

The Chair

1135

Hon. Lyle Vanclief (Prince Edward—Hastings, Lib.)

The Chair

Mrs. Marlene Jennings

The Chair

Mrs. Marlene Jennings

The Chair

Hon. Joe Fontana

The Chair

Mrs. Marlene Jennings

The Chair

Mrs. Marlene Jennings

The Chair

Mrs. Marlene Jennings

The Chair

Mr. Brian Masse

The Chair

Hon. Joe Fontana

The Chair

Mr. James Rajotte

The Chair

Mr. Brian Masse

1140

The Chair

Hon. Joe Fontana

Mr. Douglas Clark (Acting Senior Project Leader, Patent Policy, Department of Industry)

Mr. Brian Masse

Mr. Douglas Clark

Mr. Rob Sutherland-Brown

Mr. Brian Masse

The Chair

Mr. Brian Masse

The Chair

Mr. Brian Masse

The Chair

Mr. Brian Masse

1145

The Chair

Mr. Brian Masse

The Chair

Hon. Joe Fontana

The Chair

Mrs. Marlene Jennings

The Chair

Mr. James Rajotte

1150

The Chair

Dr. Robert Peterson (Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health)

Mr. James Rajotte

Mr. David Lee (Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health)

Mr. James Rajotte

The Chair

Hon. Joe Fontana

The Chair

Hon. Joe Fontana

The Chair

Mr. James Rajotte

Hon. Joe Fontana

The Chair

Mr. Éric Dagenais

1155

Mr. James Rajotte

Mr. Éric Dagenais

Mr. James Rajotte

Mr. Éric Dagenais

Mr. James Rajotte

Mr. Éric Dagenais

Mr. James Rajotte

Hon. Joe Fontana

The Chair

Mr. Brian Masse

The Chair

Hon. Joe Fontana

The Chair

Mr. Paul Crête

Hon. Lyle Vanclief

1200

Mrs. Marlene Jennings

The Chair

Mr. James Rajotte

Mr. Rob Sutherland-Brown

Mr. James Rajotte

Mr. Douglas Clark

Mr. Rob Sutherland-Brown

The Chair

Mr. Brian Masse

The Chair

Mr. Brian Masse

The Chair

Mrs. Marlene Jennings

1205

The Chair

Hon. Joe Fontana

The Chair

Mr. Brian Masse

The Chair

Mr. Brian Masse

The Chair

Mr. Brian Masse

The Chair

Mr. Douglas Clark

The Chair

Hon. Joe Fontana

The Chair

1210

Hon. Joe Fontana

The Chair

Hon. Joe Fontana

The Chair

Mr. Brian Masse

The Chair

Mr. Brian Masse

Mr. Rob Sutherland-Brown

The Chair

Mr. Brian Masse

The Chair

Hon. Joe Fontana

1215

The Chair

Mr. Paul Crête

The Chair

Mr. James Rajotte

Hon. Joe Fontana

The Chair

Mrs. Marlene Jennings

The Chair

Mr. Paul Crête

The Chair

Mr. Paul Crête

Hon. Joe Fontana

The Chair

Hon. Joe Fontana

The Chair

Hon. Joe Fontana

1220

The Chair

Mrs. Marlene Jennings

The Chair

Mrs. Marlene Jennings

The Chair

Mrs. Marlene Jennings

The Chair

Mrs. Marlene Jennings

The Chair

Mrs. Marlene Jennings

The Chair

Mr. James Rajotte

The Chair

1225

Mr. James Rajotte

The Chair

Mrs. Marlene Jennings

The Chair

Mr. James Rajotte

The Chair

Mr. Douglas Clark

Mr. James Rajotte

Mr. Douglas Clark

Mr. James Rajotte

Mr. Douglas Clark

Mr. James Rajotte

Mr. Éric Dagenais

Mr. Douglas Clark

Mr. James Rajotte

Mr. Douglas Clark

Mr. James Rajotte

Mr. Douglas Clark

Mr. James Rajotte

Mr. Douglas Clark

Mr. Rob Sutherland-Brown

Mr. James Rajotte

Mr. Rob Sutherland-Brown

The Chair

1230

Mr. Paul Crête

Mr. Douglas Clark

Mr. Paul Crête

Mr. Éric Dagenais

Mr. Paul Crête

Mr. Éric Dagenais

Mr. Paul Crête

Mr. Éric Dagenais

Mr. Paul Crête

1235

Mr. Douglas Clark

Mr. Paul Crête

Mr. Douglas Clark

Mr. Paul Crête

M. Éric Dagenais

Mr. Paul Crête

Mr. Rob Sutherland-Brown

Mr. Paul Crête

The Chair

Mr. Brian Masse

Mr. Douglas Clark

Mr. Brian Masse

The Chair

Mr. Brian Masse

The Chair

Hon. Joe Fontana

1240

Mr. James Rajotte

Mr. Éric Dagenais

Mr. James Rajotte

Mr. Éric Dagenais

Mr. James Rajotte

Mr. Éric Dagenais

Mr. James Rajotte

Mr. Éric Dagenais

Mr. James Rajotte

1245

Mr. Éric Dagenais

Mr. Rob Sutherland-Brown

Mr. James Rajotte

Mr. Rob Sutherland-Brown

Hon. Joe Fontana

The Chair

Hon. Joe Fontana

The Chair

Mr. James Rajotte

The Chair

Mr. Paul Crête

1250

Mr. Éric Dagenais

Mr. Paul Crête

Mr. Éric Dagenais

Mr. Paul Crête

Mr. Éric Dagenais

Mr. Paul Crête

Mr. David Lee

Mr. Paul Crête

The Chair

Mr. Paul Crête

The Chair

Hon. Lyle Vanclief

1255

The Chair

Mr. Paul Crête

The Chair

Hon. Joe Fontana

Mr. James Rajotte

Hon. Joe Fontana

Mr. James Rajotte

Hon. Joe Fontana

The Chair

Hon. Joe Fontana

The Chair

Mr. Brian Masse

The Chair

Mr. Brian Masse

The Chair

Mr. Brian Masse

The Chair

1300

Mrs. Marlene Jennings

The Chair

Mrs. Marlene Jennings

The Chair

Mr. Brian Masse

Mrs. Marlene Jennings

Mr. Brian Masse

The Chair

Hon. Joe Fontana

Mr. Brian Masse

Hon. Joe Fontana

The Chair

Mr. James Rajotte

The Chair

CANADA

Standing Committee on Industry, Science and Technology

NUMBER 010

3rd SESSION

37th PARLIAMENT

EVIDENCE

Tuesday, April 20, 2004

[Recorded by Electronic Apparatus]

Á (1105)

[English]

The Chair (Mr. Brent St. Denis (Algoma—Manitoulin, Lib.)): Good morning, everybody. I would like to welcome you to the Standing Committee on Industry, Science and Technology. We have an important job to begin this morning. Whether or not we will finish, I guess it depends.... Of course, we're doing the clause-by-clause of Bill C-9. You have the list of officials who are at the table and others who are in the seating behind them. I want to point out that Ms. Marie Gervais-Vidricaire may have to leave early, but Mr. Armstrong will take her place if needed.

The legislative clerks to assist me today are Joann Garbig and Jean-Michel Roy. You can bet that I will be depending on their help quite a bit today, so I ask your indulgence so that we get through this. As you all know, there are a considerable number of amendments proposed to Bill C-9. We want to get it done properly and correctly, so I will depend on their help quite a bit.

You should all have brought the white binder with the amendments in it. There are two additional packages that have been placed before you and in due course we will get to those. You have what is called a control chart, which is a summary of the amendments, and, again, Joann and Jean-Michel will help me keep track of things. They will be de facto co-chairing with me today.

Thank you, Joann and Jean-Michel.

If necessary, I propose that we continue tomorrow afternoon at 3:30, if we don't finish this morning, and if necessary beyond that, on Thursday morning at 11 o'clock, which would be a substitution for Bill C-2, which we were going to start then. So I would need unanimous consent to meet tomorrow; otherwise we can't meet. But we'll do that at the end of today's session, assuming we need to do that. I suggest that we have a short in camera meeting, if we get to Bill C-2 on Thursday, to discuss witnesses.

So with that, the way Ms. Garbig and Jean-Michel have planned this out for us is that government amendments G-1 and G-2, which relate directly and indirectly to the title and purpose... Amendment G-2 would be just before we do clause 1 approval.

Yes, Brian.

Á (1110)

Mr. Brian Masse (Windsor West, NDP): On a point of order, Mr. Chair, I'm waiting for some answers back from the witness from the government services department from four weeks ago. We have yet to have a response about those things, in particular testimony provided by Dr. Fred Abbott. I have not received that information. I would like to know when it will be coming, because I think as a committee member, when I ask a question and there is an answer, I should get a response. There was an admission that different departments did not listen to the testimony of Dr. Abbott.

I would appreciate knowing when that response will be forthcoming, because today we're talking about this issue and making decisions. I would have liked to have had that information. We did make several inquiries.

The Chair: I obviously can't answer that question for you, Brian. Whether it's a point that would require us to stop and not proceed with clause-by-clause, I'm not sure about that. I don't think so.

It's an issue that you could take up with the minister. I'm not sure we're going to finish this morning, so perhaps by the end of our work this morning, or before we get back to it tomorrow, if we have to, we can get an answer to that. Those were specific to the issues raised by Professor Abbott, correct?

Mr. Brian Masse: Yes, absolutely. For the integrity of the committee I think it's important that questions are answered, especially when there's a reasonable time allotment for them. I don't expect to have the struggle that has happened to try to get them answered.

The Chair: Joe, perhaps you can take that as advice and undertake to double-check with Brian on the questions he's referring to, and see if before we finish all this we can get some acknowledgement at least of the questions.

Hon. Joe Fontana (Parliamentary Secretary to the Prime Minister (Science and Small Business), Lib.): Mr. Chairman, I wonder if Brian could tell us what some of those questions are. I'm sure that all the amendments proposed by the government and by all the other parties around this table are in fact reflective of not only what we've heard from Mr. Abbott, but also from other witnesses. So if Brian could clarify for the committee which questions or what it is Mr. Abbott raised that you would want an answer to, perhaps we can find out whether or not a response was actually received by the clerk for this committee.

Mr. Brian Masse: At the time, there was a difference of opinion in the different government departments about the TRIPS agreement, the WHO decision, and the language that was used. Not everybody had heard Dr. Abbott's testimony. I wanted their professional opinion about those things, and also with regard to language of legal opinions related to the bill.

Hon. Joe Fontana: Brian, I think you will find that when you get to a particular clause in the bill--

The Chair: Through the chair, please.

Hon. Joe Fontana: Yes, through the chair--you can ask the officials who are here to answer those questions on TRIPS and on what is compliant and what is legal. We've come prepared to answer the very questions you might have. After all, we're not responsible to Mr. Abbott; we're responsible to the people of Canada and so on.

Mr. Brian Masse: Mr. Chair, it's about procedure. I asked some questions during an in camera meeting we had with the different departments. I thought they were reasonable questions. They took notes at the time. My office has followed up, and we have not received a response. Whether it's on this issue or another issue, I think it's reasonable to get some clarification as to whether or not committee questions are going to be answered.

The Chair: Are you asking that we suspend clause-by-clause till we get that?

Mr. Brian Masse: No, I'm not asking that. I'm asking that we follow up on an issue.

The Chair: We have two ways to proceed, as I see it. Either you raise those questions as we deal with those clauses and the officials present, or Joe specifically takes note of those questions or you provide those questions and we'll ask for answers prior to our finishing clause-by-clause. Those are the only two solutions I see, Brian.

Mr. Brian Masse: That's acceptable. I just want to have the resolution. If we're going to ask questions, are we going to get answers for them?

The Chair: Let's see how many you can deal with as we go through the clause-by-clause.

Grant, did you want to add something?

Mr. Grant McNally (Dewdney—Alouette, CPC): I just wanted to say that this happens all too often. A committee member asks for follow-up answers to questions and nothing ever comes. We may share differences of opinion on the topic, but I clearly remember that meeting. I remember my colleague from the NDP asking for clarification. That was about a month ago. As a committee, we should expect to get those kinds of answers to help us in our deliberations, just as a matter of procedure. I think that would be helpful to all of us. When any member raises a question, we should get those follow-up answers in a timely fashion.

Á (1115)

The Chair: Fair enough. It's also fair for members who put questions to monitor the responses and if necessary to write to the minister and say, “I have not received responses to these questions.”

If there are no further comments, we're going to begin.

Hon. Joe Fontana: I have a point of order. I know you've indicated that you have no difficulty with the purpose clause being held in abeyance until the end.

The Chair: Just on the question on clause 1.

Hon. Joe Fontana: Proposed section 21.01 in the bill says, “The purpose of sections 21.02 to 21.17 is to facilitate access to pharmaceutical products to address public health problems”. In G-2, the government amendment, while we're changing the name of the bill to better reflect the commitment made by the former Prime Minister and the Government of Canada with regard to the pledge to Africa, I should indicate to you that the government is in fact making substantive changes to the bill. G-9 reflects in 21.07 the requirement that at least 15 days prior to exporting a licensed pharmaceutical product, the licence must provide notice therefore to the patentee. In G-12, in 21.16 the requirement is that 15 days after the date of the authorization is granted, the date of the agreement to the importing counties was entered into; and in 21.17, there is the right of the patentee to challenge a licence in Federal Court on the grounds that the agreement it relates to is commercial in nature. Also, we are adding non-WTO countries to the list, and we are striking the right of first refusal from the bill.

I know that every one of the parties and every one of the amendments, as we get to them, will reflect that. I just want to put on the record that G-2, in changing the purpose clause, because let's face it, at the end of the day, that's what this bill is all about, what is the purpose and the intent...

At this point in time, Mr. Chair, I'd like to thank the members of the committee for being very patient and for doing their very hard work. I think we will see that not only the government amendments but also all the party amendments move toward making sure this is a humanitarian bill. We want to get the drugs to the people who actually need them. We're building in a whole bunch of safeguards in order to build capacity manufacturing so that the generic industry can proceed, as well as working together in partnership with the brands and the NGOs to accomplish what Canada wants to do now that it's the first country that will implement such an agreement. So let me take this opportunity to thank not only the witnesses but also the members of the committee, the brands, the generics, and the NGOs, who have worked really well with this committee and the government in doing a major rewrite of this bill. Thank you.

The Chair: Thank you for that.

Without further ado, we'll do G-2 before we do clause 1 overall.

James.

Mr. James Rajotte (Edmonton Southwest, PC): Is there an explanation as to why we are not doing G-1 first?

The Chair: It's the title; we always do the title of the bill at the end.

But you're up anyway. We're doing C-1.

(On clause 1)

The Chair: If you have amendments, colleagues, I'll be asking if you're moving them, because they're not moved till you say so.

Are you moving C-1?

Mr. James Rajotte: Yes.

The Chair: Did you want to speak to it, James?

Mr. James Rajotte: Yes. Mr. Chair, we actually provided explanations of all our amendments, but I see they're not with the amendment package. I wanted to be helpful for all members, so they understand exactly why we're moving these amendments.

The Chair: Perhaps you could summarize it.

Mr. James Rajotte: I'll read it into the record just for everyone's information. It is moved that Bill C-9 in clause 1 be amended by replacing line 8 on page 1 with the following: “products to address public health emergencies”.

The rationale for this is that the language of TRIPS and the Government of Canada is not of health problems but of epidemics and emergencies. Changing the word “problems” to “emergencies” will not cause a problem for those countries trying to secure medicines.

The WTO press release of August 30, 2003, stated that this agreement allows “poorer countries to make full use of the flexibilities in the WTO’s intellectual property rules in order to deal with the diseases that ravage their people.”

Also, the declaration on the TRIPS agreement of November 20, 2001, said:

Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.

Also, we can even quote from one of the government's own ministers, Aileen Carroll, the Minister for International Cooperation. On February 12, 2004, she said “The world's poorest countries cannot effectively fight poverty if their teachers, students, health-care workers and business people are debilitated by disease”.

That's essentially the rationale for the first amendment I'm moving.

Á (1120)

The Chair: Joe.

Hon. Joe Fontana: I appreciate where James is coming from with regard to the intent, and obviously sometimes we have to be very careful with words. If I could, I'll just point something out to the committee, and perhaps the officials might want to raise this question. I appreciate the explanation James put forward, but in fact changing the wording to health “emergencies” would be problematic in the sense that it would make it more restrictive than what's in the bill we've tabled and in fact more restrictive than what the WTO had envisioned in their decision. It talks about health “problems”, and health problems are a little bit broader than health emergencies.

I would hope that in keeping with the fact that Canada wants to respond to an urgent need, if in fact a country suggested it was a health problem and not only a health emergency... I'm not sure it's the intent of James—and perhaps it is—to restrict this by way of definition. So unfortunately, as the government we would say no to it, only because we think it's more restrictive than what's in the current bill and more restrictive than what the WTO had envisioned, where it was about health problems and not only health emergencies.

The Chair: James.

Mr. James Rajotte: Then perhaps along that line, if Mr. Fontana could provide to the committee the actual quote from the WTO document that talks about “problems”, we could--

Hon. Joe Fontana: I'm sure the officials, perhaps Mr. Dagenais, might be able to.

Mr. Éric Dagenais (Acting Director, Patent Policy, Department of Industry): It was in the original binder that was circulated, but I have a copy here of the November 14, 2001, document. The opening paragraph talks about recognizing “the gravity of the public health problems”. That's in the first line of the opening paragraph of the November 14, 2001, Doha declaration, and it's also followed up in the August 30 decision.

The Chair: Is that satisfactory, James?

Mr. James Rajotte: Yes. I'll withdraw the amendment.

(Amendment withdrawn)

The Chair: We're on NDP-1. Brian.

Mr. Brian Masse: Thank you, Mr. Chair.

I'll be moving the motion, and if I could, I'll speak to the motion.

The Chair: You don't have to, but you can if you'd like to.

Mr. Brian Masse: Yes, Mr. Chair, I would like to.

I think the motion, adding “other epidemics, by enabling countries with insufficient or no manufacturing capacities in the pharmaceutical sector to make effective use of compulsory licensing”, better represents than the government language today what the WTO adopted—and as well, the intent of the bill. We believe the restrictions that could ensue and on top of that the problems of adding potential solutions to countries with emerging problems would further complicate it.

We believe this bill was intended—or the intent of the WTO and its members was—to look at a broader scope of things. We feel the government is restricting the scope, in this sense, right here. A good message for Canada to send to the rest of the world is that we're going to see types of remedies other than just the ones prescribed in the bill right now. This will appear as a restrictive mechanism to other countries.

We're going to be setting the example. We know there has been some movement by other countries, but generally speaking this is the first legislation to go through. We feel this country could do better by it, and we want to see it opened up further to be more in line with the WHO decisions.

Á (1125)

The Chair: Are there any comments?

Marlene.

[Translation]

Mrs. Marlene Jennings (Notre-Dame-de-Grâce—Lachine, Lib.): I cannot support that amendment because it is actually much narrower in scope than what is in the TRIPS agreement. It is not in the preamble to the TRIPS agreement.

If I may speak for the government—and Mr. Fontana will certainly correct me if I am wrong —I believe that the government has said that the source of the drugs, whether it is generic drug companies or pharmaceutical innovation companies, does not matter. So, I do not feel that it would be appropriate to go directly to mandatory permits or licences.

I think that this is a humanitarian issue and that it is good that the bill allows or calls on the generic companies to enter into discussions on a voluntary licence, rather than claim that it is impossible. Mandatory licences are always a last resort.

[English]

The Chair: Monsieur Crête—Paul, please.

[Translation]

Mr. Paul Crête (Kamouraska—Rivière-du-Loup—Témiscouata—Les Basques, BQ): I would like the experts to tell us whether adding the amendment will change the thrust of the legislation, since this is the first part of the Patent Act. Will adding this have an impact on other provisions in the act, or does it just clarify an element?

[English]

The Chair: Give them a moment to consult.

Is anybody offering? Mr. Clark? Oh, no, I'm sorry. Your name fell down. What's your name, sir?

Mr. Rob Sutherland-Brown (Senior Counsel, Legal Services, Justice Canada; Department of Industry): My name is Rob Sutherland-Brown. I'm with the Department of Justice.

To address the question generally, the notion of allowing countries that don't have the capacity to manufacture pharmaceuticals is picked up in the WTO's definition of “eligible importer”, and it's reflected in the provisions of the bill, both as it was and as it's proposed to be amended.

The other thing I would say is that the idea of compulsory licensing is a popular one. It's not a term that is used within the Patent Act itself. The Patent Act talks about authorizations or licences, but the actual term “compulsory licensing”.... There would have to be some consequential amendments, were the committee to decide to adopt this amendment.

The Chair: Is that okay, Paul? Okay.

I will call the question then. Shall NDP-1 carry?

(Amendment negatived)

The Chair: That was a good try, Brian.

We're now on amendment G-3.

Joe.

Hon. Joe Fontana: On the nature of the change, proposed section 21.02 includes definitions from sections 21.03 to 21.17 in the existing bill. In our amendment G-3, the definitions in proposed section 21.02 will apply to sections 21.03 to 21.19 of the existing bill.

I'm sure that as we get into additional definitions, such as authorization and those others things, it will become clearer. This is technical in nature, and it changes proposed section 21.02 to better reflect what's coming.

The Chair: It's consequential to government amendment G-12. I want to point that out. It's in your index.

Paul.

Á (1130)

[Translation]

Mr. Paul Crête: I have the impression that the French and English do not say the same thing. In French, it just refers to...

[English]

The Chair: Can Mr. Dagenais or Mr. Clark comment on that?

[Translation]

Mr. Paul Crête: The French version states: " Que le projet de loi C-9, à l'article 1, soit modifié par substitution, à la ligne 17, page 1 de ce qui suit :". And here we just have 21.19.

Mr. Éric Dagenais: That is because they are not on the same line in the bill. So the entire line is replaced. If the words are not found in the same lines in the French and English versions of the bill, the change will not be the same.

Mr. Paul Crête: Yes, but the text itself does not say the same thing, in my opinion. In English, the text in line 14 is amended by putting:

[English]

“in this section and in sections 21.03 to 21.19”

[Translation]

and the French version just talks about 21.19. It does not mention 21.03 to 21.19.

[English]

Mr. Rob Sutherland-Brown: Mr. Chairman, may I speak to that?

Drafting a motion is very technical. The drafters will strike a line where the change is required and then replace it. So if you look at page 1 of Bill C-9 and go to the relevant line number, you will see that line 17 only has “21.17” in it, and that's what's being changed in French.

The Chair: Thank you, Paul.

Marlene, are you okay?

Shall G-3 carry?

(Amendment agreed to [See Minutes of Proceedings])

The Chair: I would just point out that G-12 will carry as well. It's consequential.

So we'll go to G-4.

Hon. Joe Fontana: I'll move G-4.

As you know, the definition of authorization in Bill C-9 is intended to clarify that the term refers not only to the initial compulsory licence granted by the Commissioner of Patents, but also to the commissioner's renewal of any such licence.

The purpose of the present motion is to simply change the reference in the definition of authorization to account for the renumbering of the provisions under which a licence is initially authorized--formerly proposed section 21.05 and now changed to proposed section 21.04--and under which it is renewed--formerly proposed section 21.12, now changed to proposed section 21.12(1). So it's technical in nature, where it refers to the bill and the definition of authorization.

The Chair: Thank you. Anybody else?

Marlene.

Mrs. Marlene Jennings: I have a clarification. You just said that by adopting G-3 it was consequential to G-12, and therefore G-12 was also adopted. Does that mean I cannot propose amendments to G-12?

The Chair: I would say that's correct, but I'm going to consult here.

One could argue that we should have talked about G-12 at the same time, Marlene.

On the same point...

Hon. Joe Fontana: Yes, it is. I think she is right. Amendment G-3 only meant technically to renumber.... G-12 is a very substantive motion that talks about websites; it talks about everything. Surely by changing a number on G-3 it wasn't intended by the government.... If you want to pass G-12 under G-3, that's perfectly fine by me, but I'm sure Marlene has raised an important procedural question that you might want to reconsider, all in the spirit of fairness. I wouldn't want to be accused of trying to hoodwink anybody.

The Chair: I think to solve this problem--there's a bit of a learning curve here--with your indulgence, we're going to go back to G-3 so that we can talk about G-12. Do I have consent to do that?

Á (1135)

Hon. Lyle Vanclief (Prince Edward—Hastings, Lib.): Then we'll talk about G-12 when we get there?

The Chair: We'll talk about G-3 and G-12 at the same time.

Mrs. Marlene Jennings: May I suggest, given that G-3 is only changing the number sequences, that we in fact put it in abeyance and we deal with G-12, and if amendments are brought and adopted that do not change the number sequencing, then we would go to G-3 and adopt it?

The Chair: You said to leave G-3--

Mrs. Marlene Jennings: In abeyance as though it was not adopted.

The Chair: Are we okay with this, colleagues, that we'll just stand G-3 and when we get to G-12 we'll do G-3?

Joe, are you okay with that?

Hon. Joe Fontana: You can do it one way or the other. Amendment G-3 was meant to renumber certain sections that will come later. I think you fixed the problem by saying G-12 obviously shouldn't be dealt with on a technical amendment of G-3. Whether or not you hold it in abeyance and deal with everything else and then come back to G-3 when you're at G-12, that's fine, except that I think it's a lot more complicated.

The Chair: My advice is we can do that.

Mrs. Marlene Jennings: Let's go to G-12 then. That way the confusion is completely dissipated by dealing with it immediately.

The Chair: By dealing with...

Mrs. Marlene Jennings: With G-12 immediately.

Mr. Chair, it seems to me I've created some consternation.

The Chair: I don't want to get into a situation where we.... There's a lot of work that's gone into putting everything in order. I'm going to ask, can we just stand G-3 and do G-12 right now?

Mrs. Marlene Jennings: Is everyone in agreement?

The Chair: Brian.

Mr. Brian Masse: I think we're going to get it more complicated. I know the intent is to clarify things to make it easier, but I think it will get even more complicated.

The Chair: We should then stand G-3. Then when we get to G-12, we'll deal with the two at the same time.

(Amendment allowed to stand)

The Chair: Let's go to G-4 then.

Joe.

Hon. Joe Fontana: I think we've already mentioned....

The Chair: Okay. All in favour of G-4? Opposed?

(Amendment agreed to)

The Chair: I just want to point out that with G-4 there are consequentials to G-9, and of course it has an impact on NDP-2, which cannot be put if G-4 is put, Brian, and also, having adopted G-4, L-1, BQ-2, NDP-9, and C-4 cannot be put.

Mr. James Rajotte: Can you repeat that, Mr. Chair?

The Chair: G-4 is consequential to G-9, so NDP-2 cannot be put and neither can L-1, BQ-2, NDP-9 or C-4. That's on your chart, page 2. We can't deal with NDP-2 by the sounds of it, Brian.

We're at NDP-3, so you're up to bat.

Mr. Brian Masse: Thank you, Mr. Chair.

I would like to move the amendment. The purpose of this amendment is to include a full definition of pharmaceutical product that more closely resembles the definitions included in the ministerial decision on November 1 and the general counsel decision on August 3. Note that a September 1, 2003, general counsel text on the August 30 decision reads in part 1 as follows:

(a) “pharmaceutical product” means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address the public health problems as recognized in paragraph 1 of the Declaration. It is understood that active ingredients necessary for its manufacture and diagnostic kits needed for its use would be included.

The proposed language here more accurately reflects the language that is used in the ministerial decision. Limiting our definition to schedule 1 limits the scope of the bill and the purpose behind those international agreements. Once again, in setting a standard for the world, we believe this should be a very bold and active piece of legislation.

Mr. Chair, I believe this is a reasonable way to deal with a lot of the witnesses who came forth and gave testimony about the restrictions of this potential schedule, and we feel this amendment would be very appropriate.

Á (1140)

The Chair: Thank you.

Joe.

Hon. Joe Fontana: Mr. Chairman, I would agree with what Brian has said, but the intent, as written here by some legal scholars, would be more restrictive than the current bill. Your supporting arguments are not reflected in the words the amendment uses, because it is even more restrictive than the current bill.

If I could ask the officials to give you an answer on that, I think it might be helpful.

Mr. Douglas Clark (Acting Senior Project Leader, Patent Policy, Department of Industry): As it stands with patented products, the definition doesn't place any limitations whatsoever on the meaning of the term. It would derive its meaning and interpretation from the context of the bill and would therefore reflect the purpose of the bill to get drugs to developing and least developed countries for humanitarian purposes. So our view would be that this is more restrictive, unless that was the intent.

Also, as was the case with the earlier motion, there are new terms in this provision, such as “ingredient” and “diagnostic kits”, that don't currently appear in the Patent Act. So that would be problematic as well, unless there are some corollary definitions coming forward in later motions.

Mr. Brian Masse: Can I follow up? Part of this is over process on how to move on new medicines and so on. Compare the two in terms of process, because that is really where the concern is, not the restriction. Obviously, we want to provide the ability to open it up further, but at the same time we are concerned about the process a country would have to go through.

Mr. Douglas Clark: I'm not sure how that would affect the process in any particular way. I think it's important to note that in Health Canada's amendments--and they can speak to that if they wish--they are getting jurisdiction, basically, to approve drugs and devices, which I think would encompass what you're talking about there. I really think, if anything, you're going to end up with a potentially more restrictive definition of the term.

Mr. Rob Sutherland-Brown: It might be useful to add that patented product is defined, and it is any product that is the making, constructing, or using of which would be an infringement without the consent of the patentee. Any invention in the world is potentially includable. In terms of the international process, it is up to the would-be importer to identify the product, and if it's patented in Canada it's therefore protected here. There would be the potential for a compulsory licence to be issued if they needed the other eligibility criteria.

Mr. Brian Masse: That's where I misunderstood. Okay. Stand it down.

The Chair: Did you say you withdrew it?

Mr. Brian Masse: Yes.

The Chair: Okay. Then you are back to NDP-4, Brian.

Mr. Brian Masse: I'm going to move the motion, Mr. Chair.

My apologies. I have the wrong page.

The Chair: It's similar to amendment NDP-6.

The good work by everybody has led to a rather complex piece of work for us to do in the next number of hours.

Mr. Brian Masse: Sorry, Mr. Chair.

Essentially this adds language about what can be included on schedule 1.

Á (1145)

The Chair: You are on amendment NDP-4?

Mr. Brian Masse: Yes, I am moving amendment NDP-4. It talks about any drug on WHA pre-qualified lists for HIV/AIDS, TB, and malaria treatment, anything on a country's national list of essential medicines, and if stated in writing, to TRIPS or to Canada, any product needed to address the public health problem.

We heard from numerous witnesses that schedule 1 as it currently exists is not only flawed in terms of the medications that are listed on it, but that the concept that there is a list at all seriously affects the workability of the bill.

We're concerned that the process--I guess the difficulty to add new medications--might be complicated. Hence, one of the reasons we heard testimony from Dr. Abbott, who was part of the negotiating team for numerous developing countries, was the fact that there wasn't a list or a clear definition of drug products that the WTO waiver affects. It was not a mistake, and in fact it was part of the discussions and the negotiations.

As a country we have traditionally upheld agreements that are reached after multilateral negotiations. It is important that we do not let this bill pass without it reflecting not only the purpose...but that the bill is also reflective of the negotiation process is our only guide as to why the language was used.

While I disagree wholeheartedly with there being a schedule of eligible drugs in the first place, I understand that because there is a schedule in the proposed form and we are procedurally not allowed to remove this schedule 1, I feel it is important to find other reference points for our committee as well as for the advisory committee that will be established to make recommendations to the governing council.

So basically we believe that once again the restrictions are going to be there and we want to eliminate those, and we feel this is what Dr. Abbott has been proposing. The fact that the list wasn't in existence before...adding it is not good.

The Chair: Joe.

Hon. Joe Fontana: Mr. Chairman, I think the committee heard some witnesses and had a discussion with regard to this. I know where Brian is coming from, but there needs to be a list, and you will see by the government amendments that we've added a number of drugs, and in fact cocktail drugs, to the schedule.

We also have an important provision in the bill that allows the government in council, or two ministers, to essentially put on the list any drug that becomes available and is approved by Health Canada.

You must have a list. That is why we have patented drugs. It's not as if, without a list...why then go through this exercise of waiving patent rights that the brand companies have to do? So it's only because we have patented drugs in this country that in fact we can waive as per a TRIPS agreement.

I think we've tried to achieve maximum flexibility so that the government can move to add any medicine as quickly as possible, once in fact Health Canada has approved a drug. Therefore, to have absolutely no list I think would cause absolute confusion and in fact would probably not work to the ends that Brian's amendment might.

Mr. Chairman, unfortunately, I think as I indicated, our amendment not only increases the list of drugs as per the original schedule 1, but in fact it has a provision that the government can move very quickly. Two ministers in fact can approve any drugs that are approved in Canada. Therefore I think Brian can be assured that if in fact we can move mountains with regard to other medicines, we will, but you must have a list. I think it would be incredible for us not to have a list.

The Chair: Marlene.

[Translation]

Mrs. Marlene Jennings: I find it curious that my NDP colleague does not want a list of drugs that are patented here in Canada, but he sees no problem with the WTO or the importing country having a list. Like my colleague, Mr. Fontana, I feel that the process the government has set out in the bill and through the amendments to ensure that the list will be adequate and will meet the needs of importing countries in a speedy and timely manner is more than adequate. I will therefore not be able to support your amendment.

[English]

The Chair: James. Sorry, I should have gone to you first.

Mr. James Rajotte: Thank you, Mr. Chairman.

I just want to ask Mr. Masse or the officials about whether the intent is actually to expand the list of schedule 1 to make it more inclusive or else to remove it entirely. Perhaps they would describe the difference between schedule 1 and the model list of essential medicines. Is there a substantive difference? If so, how much of a difference is there between those two lists?

Á (1150)

The Chair: Dr. Peterson.

Dr. Robert Peterson (Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health): Thank you, Mr. Chairman.

I believe schedule 1 constitutes a guidance to industry that allows for them to understand which products Health Canada has knowledge and experience on in order to allow them to negotiate a contract and submit an abbreviated new drug submission. The Minister of Health must advise the patents commissioner on whether the product meets Canadian regulatory requirements. We can only do so in a facilitated process, using an abbreviated new drug submission, if those products have been regulated in Canada as a brand or in another format.

So the list itself is essential in order for companies to bring that type of facilitated application to us.

Mr. James Rajotte: Just to follow up on that, how many more medicines would the model list of essential medicines by the WHO include in comparison with schedule 1? That was my question.

Mr. David Lee (Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health): The lists would take a little comparing, but I would observe that our basket could indeed be wider than the essential drugs list. It could be that Canada has some therapies here that are not currently on the list. So it could work that our list would be wider or broader in some respects. They're broken down into therapeutic categories, so there's some question of that as well.

Mr. James Rajotte: Thank you.

The Chair: I'm going to call the question on NDP-4.

(Amendment negatived [See Minutes of Proceedings])

The Chair: Okay. Thank you very much.

I'd point out that NDP-6 is off the table now--right, Brian?

We're going to go to G-5, which I think is just a French translation.

Hon. Joe Fontana: Yes, you're correct, Mr. Chairman, and I so move it.

(Amendment agreed to [See Minutes of Proceedings])

The Chair: Next is G-6. There are certain consequences to G-6.

Do you want to speak to it first, Joe?

I'll remind you to look at your list, and I'll point them out before we vote.

Hon. Joe Fontana: Mr. Chairman, this is a substantive amendment. As you know, schedule 2 lists both WTO and non-WTO least developed countries, of which Canada is including eligible-to-import licensed pharmaceutical products under the regime proposed by Bill C-9.

New proposed paragraph 21.03(1)(b) provides the governor in council with the authority to add additional LDCs who meet criteria set out in proposed paragraph 21.03(1)(b), in schedule 2. The purpose of paragraph (b) in the present motion is to specify that in light of their expertise and responsibilities in international matters, it is the role of the ministers of foreign affairs and international trade and cooperation to make recommendations to the GIC regarding the additions of least developed countries to schedule 2.

Therefore, the effect of this amendment, Mr. Chairman, is to essentially allow for the addition of least developed countries to the schedule 2 list.

The Chair: Any questions or comments?

I'll just point out that if adopted, amendments Bloc-1, NDP-5, and NDP-8 would not be offered. And when we get to G-7 and G-8, you'll have to bear in mind that we passed G-6, because you haven't got much choice when you get to G-7 and G-8. But we can discuss that then.

Mr. Rajotte.

Mr. James Rajotte: Mr. Chairman, I have a question for the officials or for whoever wants to answer this.

It's the intent of these amendments to clarify which ministers are responsible for adding to the list, either of medicines or of nations. It's not to make it more complicated to add to the list itself. Correct?

Hon. Joe Fontana: That's right.

The Chair: We'll also let the officials answer.

Mr. Éric Dagenais: We're also broadening...or we're saying that non-WTO developing member countries are also becoming eligible to be added to this list.

Á (1155)

Mr. James Rajotte: Based on the recommendations of the Minister of Foreign Affairs--

Mr. Éric Dagenais: And International Trade and International Cooperation.

Mr. James Rajotte: Can you describe the process they would recommend to cabinet to add certain nations?

Mr. Éric Dagenais: They would make a recommendation to the governor in council, who would then take a decision.

Mr. James Rajotte: Would Parliament have any opportunity to review that decision process at all?

Mr. Éric Dagenais: Usually that would be done through a regulatory amendment to the schedule.

Mr. James Rajotte: It almost seems like two different amendments, because the first amendment, in terms of identifying the ministers, deals with medicines, if I'm correct. The second half deals with nations, right?

I don't have a big disagreement with it, but it would be nice to have Parliament play some sort of role here, aside from just...I mean, if these pass, we parliamentarians have no role in adding to the list of medicines or the list of nations.

Hon. Joe Fontana: Mr. Chairman, maybe I can answer, instead of--

The Chair: Joe, just a second. Brian is going to jump in on this, and then maybe you can deal with both.

Brian.

Mr. Brian Masse: Will there be a particular form or a standard procedure for the whole process that will be public and that Parliament will be able to monitor? That's what I'm concerned about, that there isn't a role right now and there isn't the ability to review why a decision might be made in one context and maybe not in another. That's important to have if we want to change the way...in the future, we need to understand what decisions are made and how, the context of them, the information that's being used by the ministers.

The Chair: Okay, Joe.

Hon. Joe Fontana: But ultimately, to add medicines and to add countries based on health problems or emergencies--call it what you will--surely we wouldn't want to get it clogged up in parliamentary committees.

It would seem to me in the case of a non-WTO country or any country that obviously had a health problem and wanted Canada's assistance, we would want to move as quickly as possible. This prescribes the process by which we can add products and countries, and which responsible ministers are going to be able to deal with the process. In fact, if you look at the motion in its details, it outlines the responsibilities not only of the government but also of the country seeking assistance.

I understand in times of health problems and health emergencies you don't want to take an awful lot of time to add a medicine and add a country if they're saying, “Help me”. So I'm sure the process of transparency in government...that's what you're all talking about; there's oversight.

The only thing I could also say is that this bill has a three-year parliamentary review built into it, so at some point in time, or if the committee sought, after a year, to bring in the officials, we could see which countries we've added, which medicines we've added, who has responded to it. I'm sure if this committee wanted to be continually involved and to have it be transparent it could call people in and find out how well this bill is working.

But I would suggest we would want to move as quickly as possible on new health products as well as on new countries asking for assistance. Causing a whole bunch of sludge would not, I'm sure, help the situation.

The Chair: Paul, then Lyle, and then Marlene.

[Translation]

Mr. Paul Crête: Given the testimony that we have heard, amendment G-6 seems to me to be a worthwhile improvement. In fact, this part of the bill will probably be tested for a three-year period, and we will be able to see how well it works. In keeping with our aim of amending the bill to make it more operational, I think that this amendment represents good progress.

[English]

Hon. Lyle Vanclief: I just want to emphasize, Mr. Chairman, that parliamentarians always, whether it be through committee or in other ways, have an opportunity to raise an issue, to bring ministers forward and say, “Why has this country not been considered? Why has this product not been considered?”, and to exert the opportunities we all have as members of Parliament. So this does not usurp that process at all. If anything, I think it's bringing the process very close to individual members of Parliament and committee in order to move it along.

As Mr. Crête has just said, this motion, taking all into consideration, is exactly what all of us have been talking about, doing exactly that. So I would suggest it's a good one to adopt.

Â (1200)

[Translation]

Mrs. Marlene Jennings: I simply want to say that I agree with both Mr. Crête and Mr. Vanclief.

I always disagree with those who say that committees have their hands tied by the government. Committees are masters of their own fate. If they have not used their power in the past to bring bureaucrats, officials or ministers before them on issues that they deemed important, committee members, including myself and all my colleagues, have only themselves to blame.

So I agree that the committee can call a minister anytime the House is sitting—every day, if it wants—and ask him or her whether a country or a drug has been added. We could do that if we wanted to. And we could have done it for all the schedules that were already in the act. But we did not do that. If we do it now, all the better.

[English]

The Chair: James.

Mr. James Rajotte: I want to clarify a couple of small points. I think generally I'm fine with the amendment. But on the first one, in terms of the recommendations from the Minister of Industry and the Minister of Health, it would need the consent of both to recommend. With respect to the Ministers of Foreign Affairs, International Trade, and International Cooperation, you would have to have agreement of the three ministers, rather than just one of the three suggesting it.

Am I correct in that?

Mr. Rob Sutherland-Brown: I think that's the way you'd read the proposed statute, yes.

Mr. James Rajotte: Just in terms of process, we've heard you can call the committee, you can call the minister and ask why a nation has not been added. What would be the process if say a member of Parliament felt that a medicine or a nation should be added? Would that member then have to write to get both the Ministers of Health and Industry to agree?

Suppose one or both of the ministers say no, we will not take that through, or they take it to cabinet and cabinet does not agree. Is there a reason given? Just in terms of future process, I know the committee can call ministers at any time, but I have a list of 10 items on the committee agenda that have not been gotten to, so realistically it's not going to happen that often. I know there are members of this committee who would like to add nations. If the only way they can do so is by writing a letter to the minister...

Is there some form of public process we can put in place to review this, other than a three-year...

Mr. Douglas Clark: There's no legal duty to provide reasons or anything to that effect, but there's certainly a moral duty to respond to the request and explain why or why not the Ministers of Industry and Health consider it to be feasible.

Mr. Rob Sutherland-Brown: I think they might be informed by the purpose clause too. I think the ministers will pay attention to the purpose clause, which is to facilitate access.

The Chair: Brian, the last comment is to you.

Mr. Brian Masse: I have a subamendment that I think might be helpful. It adds, after “on the recommendation”, “in the prescribed form”, and that could be developed later in the regulations. To add “in the prescribed form” would just allow that there be some type of understanding about how the decisions are going to be arrived at. I think that's all we're looking for. Obviously, we want to see any minister be able to act as quickly as possible on any particular case.

The Chair: We need your amendment written down.

Mr. Brian Masse: Okay.

It's just after “on the recommendation”, to add “in the prescribed form”. Do we just submit this?

The Chair: Louise will come and get it from you.

Mrs. Marlene Jennings: It concerns the subamendment that's being proposed by Mr. Masse. I'm perplexed as to the objective he wishes to achieve.

If one reads amendment G-6 carefully and comes to paragraph (d), it begins “on the recommendation of the Minister of Foreign Affairs, the Minister of Foreign and International Trade and the Minister for International Cooperation, amend Schedule 4 by adding the name of”.

It outlines, under subparagraph (ii), how a country whose name is not on the schedule can have Canada add it to its schedule on the recommendation of the three ministers. It's simply providing the Government of Canada with a notice in writing through diplomatic channels, and then it gives a condition stating that it is faced with a national emergency or other circumstances of extreme emergency, specifying the name of the pharmaceutical product, etc.

If the object of your subamendment is to provide a process by which a country whose name is not on schedule 4 can have its name included on schedule 4 on the recommendation of the three ministers, it's already embodied in the government amendment.

If you're concerned, as members of Parliament, with the process by which they would bring that to our attention, if a country calls, writes, e-mails, or faxes you and says they want to get on Canada's schedule 4 so that they can have access, then you can provide them with the process, which is outlined in the government amendment, as to how to do it.

Â (1205)

The Chair: Joe.

Hon. Joe Fontana: I only want to restate what I think Marlene has said. If you read it carefully, there is a form. There is a responsibility not only of the Government of Canada, but there's a responsibility of non-WTO members and WTO members that want to get on the list. In fact, they have to sign declarations that they will be in keeping with the TRIPS agreement that this is for humanitarian reasons and not for commercial....

I think you will find a lot of those things too in the draft regulations that I know the committee saw and will probably want to see. I think G-6 essentially lays out the responsibilities and also the form that you talked about, Brian, as to what the responsibilities of both parties are before a country and/or a drug is added.

The Chair: For clarification, if I understand correctly, you want to add the words “in the prescribed form” after each use of the phrase “on the recommendation of” in G-6.

Mr. Brian Masse: Yes.

The Chair: It would be five times.

Mr. Brian Masse: Yes.

The Chair: Is that clear to everybody?

Mr. Brian Masse: All that will do is potentially create a paper trail, so to speak, for cabinet ministers so that we're able to evaluate and find the decision-making.

The Chair: Mr. Masse's subamendment to G-6 is to add the words “in the prescribed form” after each use of the phrase “on the recommendation of”.

Yes, Mr. Clark.

Mr. Douglas Clark: In terms of the regulatory process, there is a very specific protocol for approaching the governor in council and order in council to get regulations amended as dictated by the Statutory Instruments Act in regulations. The Privy Council Office sets up a very elaborate procedure for doing that. In essence, there is a prescribed process, if not a prescribed form, already entrenched in the law.

The Chair: Okay. I'm going to call the question.

(Subamendment negatived [See Minutes of Proceedings])

(Amendment agreed to [See Minutes of Proceedings])

The Chair: Because of a line conflict with G-6, I think C-2 is off the table.

Motion BQ-1, because of G-6, is also dealt with.

We already mentioned earlier that NDP-5, I believe, is dealt with because of G-6.

NDP-6 is....

Hon. Joe Fontana: NDP-6 is a duplication.

The Chair: Yes, NDP-6 is a duplicate of NDP-4, NDP-7, and NDP-8, because G-4 was adopted, so that gets us up to G-7.

We'll go to G-7 at the bottom of page 6 on your index. It's page 26 in your binder. Are there any comments?

Â (1210)

Hon. Joe Fontana: Mr. Chairman, as you know, we just talked a little bit about how a country might get on. G-7 talks about--I hope I have the right one here--

The Chair: I imagine it's consequential to G-7 and G-8, Joe. We've passed G-6 already.

Hon. Joe Fontana: Yes, and it pertains to G-8.

This motion amends, as we know, paragraph 21.03(3)(a), which allows the GIC to remove a country no longer recognized by the United Nations as a least developed country from schedule 2. Schedule 2 is a list of least developed countries that are eligible to import licensed versions of patented pharmaceutical products under the regime. Both WTO and non-WTO least developed countries are eligible to be listed on schedule 2.

In the case of the latter, as explained under paragraph (c) of the motion above, the additional language is being introduced under subparagraphs to require as a condition precedent to adding a non-WTO least developed country to schedule 2 that the country must include the following two statements in its notice to the Government of Canada: one, that any pharmaceutical products imported under the regime will not be used for commercial purposes; and two, that the country undertakes to adopt anti-diversion measures referred to in article 4 of the general council decision.

These statements, I believe, Mr. Chairman, reflect the essence of the obligations to which WTO members must subscribe in seeking to import licensed versions of patented pharmaceutical products under the terms of the general council decision. However, unlike WTO members, these other countries are not subject to the disciplines provided for under the WTO agreement in the case of non-compliance.

Therefore, the purpose of the present motion is thus to encourage non-WTO countries to respect the spirit of the general council decision by authorizing the governor in council to remove any such country that fails to honour its agreements not to use licensed pharmaceutical products for commercial purposes or fails to follow up on its undertakings to adopt anti-diversion measures.

The Chair: Are there any other comments?

Brian.

Mr. Brian Masse: Can I get the definition we're using for “commercial purposes”, specifically?

The Chair: You need the definition of “commercial purposes”?

Mr. Brian Masse: Yes, in the context of the way we're defining it, because it means different things to different people.

Mr. Rob Sutherland-Brown: I think the notion here is that the product is imported into the eligible importing jurisdiction and it's sold on the street as a commercial event rather than treating the public health problems that the legislation is designed to address.

The Chair: Is that clear enough, Brian?

Mr. Brian Masse: Yes, that's fine. I just wanted to be sure.

(Amendment agreed to [See Minutes of Proceedings])

The Chair: G-7 is carried and we're on G-8.

I want to remind you that it's a consequence of G-6. There's a line conflict for NDP-8 and Bloc-1.1.

G-8, Joe.

Hon. Joe Fontana: I think the intent of this amendment G-8 is to allow for the removal of non-WTO countries from schedule 4 if the circumstances that led to their being added no longer exist. An example would be the countries removed from the OECD list or that no longer face a health emergency.

Two, it's to allow for the removal of a non-WTO country from schedule 4 if it fails to honour its agreements not to use licensed pharmaceutical products for commercial purposes or it fails to follow up on its undertakings to adopt anti-diversion measures. The latter measure is considered necessary, because unlike WTO members, the countries in question are not subject to the disciplines I explained earlier.

In addition to these, the present motion also introduces paragraph (e), which allows the governor in council to remove a country or WTO member from schedules 3 or 4 in the unlikely event the country or member becomes recognized by the United Nations as a least developed country and therefore belongs in another schedule, i.e. schedule 2.

Finally, the present motion also introduces paragraph (f), which authorizes the governor in council to remove any country or WTO member from whichever of the relevant schedules when the country or member has formally notified its intention to no longer import licensed pharmaceutical products within the meaning of paragraph 1 of the general council decision.

Â (1215)

The Chair: Are there any other comments or questions on amendment G-8?

I will call the question on G-8. I point out that NDP amendment NDP-8 and Bloc amendment BQ-1.1 have line conflicts.

(Amendment agreed to [See Minutes of Proceedings])

The Chair: Correction, Paul. There is no conflict for Bloc amendment BQ-1.1, so you can move it or not move it.

[Translation]

Mr. Paul Crête: Yes, I know.

[English]

The Chair: You're not going to proceed with amendment BQ-1.1.

Let's go to amendment C-3. James.

Mr. James Rajotte: Mr. Chairman, the purpose of this amendment falls in line with some of the other amendments by the government, and it is to basically ensure that additions to the list are made in a timely manner. Many of the witnesses testified to concerns about the timeliness of adding either nations or medicines. We believe it is a fairly simple, beneficial amendment.

Hon. Joe Fontana: Mr. Chairman, there is really no objection other than the fact that I think we've already covered it off in form and process in prior amendments, but if we want to make sure that it says “timely”, it's not a problem. We'll accept.

The Chair: Are there any other comments on amendment C-3?

(Amendment agreed to [See Minutes of Proceedings])

The Chair: I'll just point out that L-1 and a number to follow will have an impact on G-9, and you've already passed G-4, which is related to G-9. Having said that, we ask Marlene to introduce, if she wishes, amendment L-1.

Mrs. Marlene Jennings: No, I agree to withdraw it.

The Chair: Amendment L-1 is not moved.

I'll call Bloc motion BQ-2.

[Translation]

Mr. Paul Crête: Where is it?

[English]

The Chair: It's not on the index, but I think we understood you weren't going to proceed with that. Is that correct? You put BQ-2.1 instead.

[Translation]

Mr. Paul Crête: I have a registration number, I do not have the number... Do you have the number ending in 007?

[English]

Hon. Joe Fontana: Perhaps I could be helpful. Amendment BQ-2 is no longer required because section 21.04 is being deleted and therefore you don't need to have an amendment for a section that is no longer in existence. Marlene's was the same thing.

The Chair: That should also apply to Bloc amendment BQ-2.1. Is that right?

Hon. Joe Fontana: I don't see amendment BQ-2.1.

The Chair: It's in that additional package you were given. Because amendment G-4 was adopted, amendment BQ-2.1 is not moved.

We are at amendment G-9.

Hon. Joe Fontana: Well, Mr. Chairman, as you know, amendment G-9 is a very substantive amendment to the bill. In fact, it perhaps is the most fundamental change that the government has heard and listened to, not only from witnesses but also from the other members of the committee.

It essentially replaces the right of first refusal with an obligation on the applicant to seek a voluntary licence from the patentee prior to applying for a compulsory licence. Perhaps I could explain that, as tabled in Bill C-9, it contemplated a two-step process for securing the compulsory licence.

The first step was proposed section 21.04, which is now being deleted and which was the right of first refusal. I think we all heard that the regime, as described above, was conceived with a number of considerations in mind, including timeliness, competition, predictability, and compliance with TRIPS. However, over the course of the Standing Committee on Industry, Science and Technology's examination of Bill C-9--and Brian might be interested because this refers to Mr. Abbott's concerns--representatives of both the generic pharmaceutical industries and the NGOs indicated their unwillingness to participate in this regime if the right of first refusal was retained.

I think representatives of the generic industry maintained that the ability of a patentee to execute the terms of a contract negotiated by a generic company meant that generic companies would be acting as unpaid business agents for their brand-name counterparts. In turn, representatives of various NGOs described the right of first refusal as a fundamental flaw. And we've heard, we've listened, and I think all the committee agrees that the purpose of this part is what we are suggesting in amendment G-9, which is to replace the two-step process envisioned by proposed section 21.04 and proposed section 21.05 with a one time only application procedure as set out in the new proposed section 21.04.

Under this provision an applicant for a compulsory licence must certify that it has sought--only sought, not notified, just to be clear--a voluntary licence from the patentee within a prescribed time before applying for a compulsory licence, but it is not otherwise required to notify the patentee of its intentions before entering into a supply agreement with the importing country.

Therefore, Mr. Chairman, the right of first refusal is gone, notification does not exist, and we obviously want the generic company to seek a voluntary licence from the brand-name company within a specified period of time. That specified period of time, I think, will be shown in the regulation, and it is probably something in the range of 30 days, at which point they move right to a compulsory licence from the commissioner.

So that's what amendment G-9 is all about, Mr. Chairman.

Â (1220)

The Chair: Thank you, Joe.

Marlene.

Mrs. Marlene Jennings: Given that this is the amendment that was consequential to amendment G-3 and we agreed to hold amendment G-3 in abeyance....

The Chair: It was amendment G-4 and amendment G-9. It was amendment G-3 and amendment G-12.

Mrs. Marlene Jennings: Well, I have a series of amendments to G-9.

I'm fine with proposed subsection 21.04(1) and paragraphs (a), (b), (c), (d), and (e) of proposed subsection 21.04(2). Everything on page 33 of amendment G-9 I'm fine with.

The Chair: What amendment number is this?

Mrs. Marlene Jennings: It's a subamendment to....

The Chair: Do you have them written out?

Mrs. Marlene Jennings: No, but I will write them out as long as I can get it on the transcript, one by one.

The Chair: How long would it take you to write them out?

Mrs. Marlene Jennings: Well, if you suspend for five minutes, because I have significant....

The Chair: You have a point of order, James.

Mr. James Rajotte: I don't know technically whether this is a point of order, whether you can rule it in order or not, but Mrs. Jennings and I and others submitted our amendments first. The government, as you know, submitted theirs very late. So I'm in the same position Ms. Jennings is in.

I have my amendments in that. If we approve this, my amendments are out of order. So I would like to amend amendment G-9 as well. I don't know exactly how to proceed here, but....

The Chair: Well, I think at this point I need something in writing. Is it a subamendment to amendment G-9 that you're talking about, as is Marlene's?

Â (1225)

Mr. James Rajotte: Yes.

The Chair: I need something in writing. I'm just going to ask Joann if we can keep going or not, while you work at that, if that's what you want to do. I need to know that.

Thank you, Marlene. What did you say?

Mrs. Marlene Jennings: I'm in the process of writing right now.

The Chair: Okay.

James, how long would it take you?

Mr. James Rajotte: I'd like some clarification as well. I know Mr. Fontana did a good job of laying it out, but perhaps the officials can lay out exactly what the process is between the generics and the brand names. Step by step, take us very slowly through what the process is, what the implication of this amendment actually is.

The Chair: Are there any takers?

Mr. Clark.

Mr. Douglas Clark: Within the context of just this single provision, proposed section 21.04, it's a short answer to your question, because the only interaction between the patentee and the generic would be at the point where the generic is required to approach the patentee and seek a voluntary licence. That's the extent of any communication between the two parties. That would take place, as I said here, at a prescribed time before the generic applicant for a compulsory licence would approach the commissioner.

Mr. James Rajotte: Perhaps I'm a little confused on that, because Mr. Fontana said there's no requirement for notification, but there's a requirement to seek a voluntary licence. Perhaps you could distinguish between those two.

Mr. Douglas Clark: I think “notification” has come to mean, between people familiar with the proposed legislation, notification of their desire, the generic company's desire, to seek and obtain a contract with an eligible importing country. So approaching the patentee before that contract was concluded I guess would constitute notification as Mr. Fontana meant.

Mr. James Rajotte: If you sought a voluntary licence, wouldn't that be a form of notification?

Mr. Douglas Clark: Sure. It is, but you could seek that voluntary licence after having concluded a contract. You're basically notifying somebody ex post facto of the appearance of an important event.

Mr. James Rajotte: If I'm a generic company and I seek a voluntary licence, do I have to tell the brand for which purpose I am seeking that voluntary licence, or can I just approach them and say I'm seeking a voluntary licence for this medicine, period, and stop there?

Mr. Éric Dagenais: The information they have to disclose to the brand is in the proposed amendment on page 33, proposed paragraphs 21.04(2)(a) to 21.04(2)(g).

Mr. Douglas Clark: When they approach the commissioner, they have to set out that information. A further requirement stipulates that the same information--substantially the same information--must have also been communicated to the patentee when they approached the patentee for a voluntary licence.

Mr. James Rajotte: Okay. So if I'm the generic company, whether I've concluded a contract or not, the process is that I approach the brand name and seek a voluntary licence. They can choose to grant that voluntary licence, in which case we would negotiate on a royalty rate--

Mr. Douglas Clark: And other terms as required.

Mr. James Rajotte: --and other terms. And if they do not agree to grant a voluntary licence it goes to the Commissioner of Patents for his determination. If we agree to a voluntary licence but do not agree on the rate, does it also then go to the Commissioner of Patents?

Mr. Douglas Clark: If you don't agree on the rate, de facto you haven't agreed on a voluntary licence.

Mr. James Rajotte: How long would the Commissioner of Patents then have to determine whether or not to grant the licence?

Mr. Douglas Clark: There's no prescribed limitation period, but given the circumstances of the application, one would expect him to act promptly. There's not much to review and analyse. It's really just a question of determining whether the necessary paperwork is present.

Mr. Rob Sutherland-Brown: That will be done in a prescribed form. It will be box A, B, C, D, and E, and if all those boxes are checked off with the name of an eligible importing country, a name of an eligible pharmaceutical product or diagnostic or active ingredient, if all those things are present, the authorization will issue.

Mr. James Rajotte: The commissioner must grant it then.

Mr. Rob Sutherland-Brown: Absolutely.

The Chair: We can either suspend or keep talking to officials until.... My sense of it is that Marlene is almost done.

Paul, go ahead.

Â (1230)

[Translation]

Mr. Paul Crête: I would like to ask three questions about parts of this so that I can get clarification and maybe move some subamendments.

In paragraph 21.04(2)(f), which Ms. Jennings was the first to raise, it says:

(2) The application must be in the prescribed form and set out

Subparagraph (f) specifies:

(f) the name of the person or entity to which the product is to be sold, and prescribed information, if any, concerning that person or entity;

Would it not be appropriate—and I would like to hear what the officials have to say on this—to add: “it is the name of the person or entity permitted by the government of the importing country”? Would it not be a good idea to make that kind of clarification?

Mr. Douglas Clark: Could I have a moment to find the French version of the motion?

Mr. Paul Crête: Yes. It is 21.04(2)(f), on the first page of the French version of amendment G-9. It is probably on the first page in English as well.

Mr. Éric Dagenais: The amendment was based on testimony from the various NGOs who were concerned that the bill did not include any role for them, because the word “agent” was used before. So, we simply removed the word “agent” to address the NGOs' fears that they would not be able to keep their role in procuring drugs. In this case, an NGO operating in a developing country could buy drugs under the Canadian regime if the government in that country took various measures. Depending on the schedule in which the country is listed, there are various measures to take.

Mr. Paul Crête: If we left this as is, would it not be possible for persons or entities to whom a product is sold that did not necessarily have a permit from the importing country's government?

Mr. Éric Dagenais: No, because when we look at the other provisions in the bill and the amendments, it is very clear that the patent commissioner cannot issue a mandatory licence without certain measures being taken by the government of the importing country. So if the government does not take those steps, the commissioner cannot issue a licence.

Mr. Paul Crête: Where is that restriction indicated?

Mr. Éric Dagenais: It is stipulated in various places in the bill. The country has to inform the WTO or, if it is not a WTO member, it has to inform the Canadian government of its intentions. So only a government can undertake this process. If the country is listed in schedule 3, it has to inform the WTO and the Canadian government that it does not have sufficient manufacturing capacity in the pharmaceutical sector. So it is once again the government of the country that has to take this action. If it is a country in schedule 4, it has to also certify that it is facing an emergency situation. So these are things that can only be done by a government. If they are not done, no mandatory licence is issued.

Mr. Paul Crête: In paragraph 21.04(3)(c), the amendment as such seems to be a good one overall, but there are some clarifications needed... It says:

(c) the applicant provides the commissioner with the solemn or statutory declaration in the prescribed form stating that the applicant had, within the prescribed time before filing the application,

In subparagraphs 21.04(3)(c)(i) and 21.04(3)(c)(ii), which follow, would it not be safer to indicate that an attempt was made to obtain a licence from the patentee or patentees by registered mail? Otherwise, there is no evidence. We may be opening the door to disputes if there is no documentation that can be provided.

Â (1235)

Mr. Douglas Clark: I do not think that such a requirement would do any harm. I think that we could live with that.

Mr. Paul Crête: Adding in “by registered mail”?

Mr. Douglas Clark: Yes. I do not think that it makes any significant change in the process.

Mr. Paul Crête: In a dispute, there could be a debate where someone says that it was sent but got lost, whereas if it is sent by registered mail there is a confirmation that can be used as evidence.

M. Éric Dagenais: Paragraph 21.04(3)(c) reads as follows:

By asking generic manufacturers to provide a solemn declaration stating that they have tried to obtain a licence, we have made this implicit. So we are talking about a second safety measure in a way. There is already a solemn declaration requiring the person to fill out a form, sign it and provide it to the commissioner.

Mr. Paul Crête: In this world where evidence is often essential, this bill might provide a living for a number of lawyers. So we need to make sure that we provide as little business for them as possible.

More seriously, I think that this responds in part to the question that I asked. We will see if it seems necessary to table a subamendment.

[English]

Mr. Rob Sutherland-Brown: It might be useful to add that the consequence of making a false declaration would be a termination of an authorization, and because it's a written document, this would also constitute an offence under section 76 of the Patent Act, which disciplines false documents.

[Translation]

Mr. Paul Crête: Your comment, sir, supports my argument. Not providing evidence would give rise to a debate as to whether or not there was a false declaration.

But, if we require this to be done by registered mail, where things are not done this way and the person therefore does not have a confirmation from registered mail, the situation will be resolved on its own. However, the fact that this is not indicated will give rise to interpretations as to whether people acted in good faith or not.

[English]

The Chair: I have Brian and then Joe.

Mr. Brian Masse: Thank you, Mr. Chair.

With respect to the two years and proposed section 21.12, explain the logic behind the two years and the potential effect it could have on genetic distribution.

Mr. Douglas Clark: Are we jumping ahead to later sections at this point?

Mr. Brian Masse: Well, I thought we were just waiting for questions.

The Chair: I have Marlene's subamendment for whenever we're ready.

Are we on G-9, Brian?

Mr. Brian Masse: Go ahead.

The Chair: Joe, and then Mr. Crête.

Hon. Joe Fontana: With regard to G-9, I think Paul's suggestion to add a safeguard--call it certified or whatever the case may be--would not be problematic if he wanted to introduce such a subamendment. I don't know if it's in his package; that's if he wanted to do that. I think it's there. I think the solemn and statutory declaration, as explained by the officials, is pretty clear, but I don't think we would have any objection if he wanted to further clarify it.

I just wanted to make one additional point. With regard to a form and a process by which a voluntary licence is sought--and it's all in legalese here in part of the legislation--I just wanted to clarify this. I think James wants to make it absolutely clear, and so do we, that while we've used the word “notification” to express what the right of first refusal is, no prior notification is required by the generic drug company of the brand-name company at all until such time as they want to seek a voluntary licence.

I want to make it clear. Notification, I know, is how we've used it. Before, they needed to notify them at a point where they were negotiating a contract or an agreement and there was an opportunity for the brand-name company to essentially go in there and do something else. Now we've taken that prior notification... So it's not prior notification. The generic can essentially only approach the brand when in fact they have a contract in hand, so to speak, and ask for that voluntary licence. There's a prescribed form as to what their responsibilities are, and failing that voluntary licence within the timeframe, then they immediately go and get a compulsory licence from the commissioner.

I just want to make sure you understand there's no prior notification prior to a contract or an agreement being sought at this point in time.

Â (1240)

Mr. James Rajotte: I just have a few points. First of all, I would agree with Mr. Crête's subamendment on adding registered mail; I think that's worthwhile.

Second, I just want to clarify--and I know Mr. Crête asked about this--proposed paragraph 21.04(2)(f) and “the name of the person or entity to which the product is to be sold” now. Maybe you could explain that again. I missed half the answer you gave to Mr. Crête, and if you could, explain that to me.

Mr. Éric Dagenais: Essentially, what I told Mr. Crête is that we've tabled the proposed amendment as a result of the testimony we heard, mostly from non-governmental organizations. They were worried they could not keep playing the role they're playing in developing countries, purchasing and distributing drugs, because they were not comfortable with the term “agent” as they do not view themselves as agents of a particular government. So we've changed it to “the person or entity”, which in our view would allow them--although the previous version also allowed them--without being called “agents”, to keep playing their role as purchasers and distributors of drugs in developing countries.

What I also mentioned is that this cannot take place absent the importing country's government playing a role. Depending on what schedule you're on, there are a number of steps a government must undertake in order for a compulsory licence to be issued in Canada. If you're on schedule 2, at the very least you have to notify the WTO or notify the Government of Canada of your intent to use. This is a government's role.

If you're on schedule 3, you have to do that, but you also have to certify that you have insufficient manufacturing capacity. Again, this is something a government has to do and submit as part of an application.

And if you're on schedule 4, you will also have the responsibility of certifying that you are faced with circumstances of extreme urgency or other circumstances of national emergency...or the other way around. But again, that's something that's there for the government to do. An NGO cannot step in and certify these things.

The other thing they have to do is if there is a patent present in the country, they have to issue a compulsory licence. These are steps the government has to take in the importing country so the NGO can operate to purchase and distribute the drug.

Mr. James Rajotte: But then the NGO would contract. Suppose a generic like Apotex had an agreement with Botswana. The generic, then, would contract with Apotex or with Botswana or with both?

Mr. Éric Dagenais: It could be either. It could be someone within the Ministry of Health in Botswana or it could be some NGO that has lined up all their ducks. If the Government of Botswana has issued a compulsory licence, advised the WTO--I don't know if Botswana is on schedule 2 or 3--and certified they have no manufacturing capacity, if the Government of Botswana has done all this, then the NGO can have a contract with Apotex to purchase and distribute the drug.

Mr. James Rajotte: But can the NGO contract, say, with Apotex if an importing nation like Botswana does not give its consent?

Mr. Éric Dagenais: Well, they can contract, but they can't get a compulsory licence.

Mr. James Rajotte: Within that nation?

Mr. Éric Dagenais: In Canada. The importing nation has to have taken steps. If you haven't advised the WTO or if you haven't advised the Government of Canada through normal diplomatic channels, we won't issue a compulsory licence.

Mr. James Rajotte: Can I ask why you don't say “non-governmental organization” instead of “person or entity”? The wording “person or entity” seems to me to be exceptionally broad. Why would we not use “non-governmental organization”?

Â (1245)

Mr. Éric Dagenais: I'll leave that to the lawyer, but “NGO” can be seen as very broad as well.

Mr. Rob Sutherland-Brown: I think the intention was that it should be broad because some NGOs may be incorporated, some may be not-for-profit, some may be for-profit, and some may just be loose organizations. There is a whole range of organizational forms. It's also designed to be broad enough to include something like a government department or an agency. It's simply a question of making sure that those who wish to be eligible can fit themselves within the nomenclature.

Mr. James Rajotte: My last question is this. I agree generally with where this is going, but I am somewhat concerned, just from past dealings with these two industries and associations. As you know, sometimes they don't agree, and I want to be sure we don't put the Commissioner of Patents in an impossible situation. I want to ensure that they have enough resources but also that they don't become entwined in legal battles. If you could, just clarify again in very simple terms as to what recourse the brand-name companies would have if, say, they didn't agree to a voluntary licence. What would they be able to do or not be able to do? What role would the Commissioner of Patents play?

You talked about A, B, C, D, and E. If you could, just outline what those areas are, so hopefully we can deal with them at this point instead of having problems later on.

Mr. Rob Sutherland-Brown: What has to be in an application is set out in proposed subsection 21.04(2). That's on page 33 of the motion in English, and I think it's page 42 in the French version. It includes the name of the pharmaceutical product that is to be manufactured and sold for export under an authorization; the prescribed information in respect of the version of the product to be manufactured for export, which is there to pick up things such as the size, shape, and colour, as well as other distinguishing attributes; the maximum quantity of the product, which will be taken from the WTO website; the name of the patentee or patentees and the number of the patented invention as recorded in the Patent Office; the name of the importing jurisdiction; the name of the purchaser if it's not the importing jurisdiction itself; and any other information that may be prescribed, which is a safety valve in case something else is needed.

Then they have to provide the documents set out in proposed subsection 21.04(3), which basically are documents that support the eligibility of the importing jurisdiction for inclusion in the program that has been sanctioned by the WTO.

They pay the fee. If that stuff happens, then there is no discretion in the commissioner's office. The licence must be issued. I would put it to you that the generic could probably force the issuance of the authorization if the Commissioner of Patents declined to do so. Because there's no discretion, I don't think there's a lot of opportunity for litigation. But as I think you noted, in this industry they're very imaginative, and they can usually find something to litigate.

Hon. Joe Fontana: I have a point of order. Let me supplement what the official said.

The Chair: It's not a point of order, though, is it?

Hon. Joe Fontana: Yes, it is.

The Chair: I have you on the list.

Are you finished, James?

Mr. James Rajotte: Yes.

The Chair: I'm going to go to Paul, followed by Brian and Joe.

[Translation]

Mr. Paul Crête: My question is on the amendment that you want to make to subsection 21.04(1). It reads:

21.04(1) Subject to subsection (3), the commissioner shall, on the application of any person and on the payment of the prescribed fee, authorize the person to...

The phrase “the person” bothers me. First of all, the bill states that only a country can make this request. I think that the term was added to broaden the process to include NGOs, but the word “person” is very broad. It could even open the door to people that the bill was not intending to include. In other words, do you not feel that this vague wording goes further than what is intended, given the testimony that we have heard?

Â (1250)

Mr. Éric Dagenais: Earlier in the bill, it states “any person who intends...” and now we have “the person”, which means, in fact, a generic drug manufacturer who would be seeking authorization to use a patent. As a result, anyone without the necessary equipment to produce generic drugs would not obtain authorization from the patent commissioner. Moreover, “the person” needs regulatory approval from Health Canada. So this provision would obviously apply to generic drug manufacturers. I do not believe that there is much risk that anyone else, without this equipment and the necessary expertise...

Mr. Paul Crête: Would it not be possible for a non-WTO member country which could be described, not as a tax haven, but as a drug production haven, could have an opportunity to sneak into this market in this way and build an ultramodern factory. The country would not be a member of the WTO and would not be governed by other similar agreements. Because of the way the bill is worded, would we not be unable to turn down such a request?

Mr. Éric Dagenais: A country that is not a member of the WTO, if it is a developing country, can be added to schedule 4 under the amendments we are tabling. However, if, in the situation you describe, a country that is not a member of the WTO were to ask the government...

Mr. Paul Crête: I am not talking about a country. If I understand correctly, the subclause in question applies to individuals who want to manufacture a patented product. Normally, a generic drug manufacturing company would make such requests. However, does the use of the words “any person” not mean that anyone, anywhere in the world, who found a loophole in the legislation could produce these products without having...

Mr. Éric Dagenais: The question is: where are they producing the products? Canadian patents apply in Canada. Consequently, if someone wants to manufacture or produce products outside Canadian borders, the Patent Act does not apply.

Mr. Paul Crête: I see. So, if it were someone in Canada, the words “any person” could not be interpreted by individuals who could stand to gain financially without necessarily being patent holders or...

[English]

Mr. David Lee: A person would have to meet the definition of “manufacturer” within the food and drug regulations, for the Minister of Health to give notice under paragraph (b), as is required before a commissioner issues.... So it's constrained in that sense.

[Translation]

Mr. Paul Crête: So the words “any person” have a restricted meaning. I see. That is fine.

I have another question now.

The Chair: A brief question, please.

Mr. Paul Crête: Yes.

Clause 21.07 states:

21.07 Before exporting any quantity of a product manufactured under an authorization, the holder of the authorization must, at least 15 days before the product is exported, provide... a notice specifying the quantity to be exported:

I would like there to be some way of identifying all the known stakeholders in the logistical chain between Canada and the importing country. I want to clarify the matter of Canada's liability in this. So, when the clause states, "before exporting any quantity [...] the holder of the authorization must, at least 15 days before the product is exported, provide a notice specifying the quantity to be exported" would it not be relevant to be able to identify all the known stakeholders in the logistical chain between Canada and the importing country, so as to be certain, when we authorize the export of a certain quantity of product, that we know exactly which routing the product will take, to ensure that we do not lose it along the way? In other words, this would be to ensure that it will not be easy to set up a smuggling operation because we were not demanding enough in this regard?

[English]

The Chair: Lyle, did you have a comment?

Hon. Lyle Vanclief: Mr. Chairman, is that not what (a), (b), and (c) do? They state very clearly who's notified, what country it is, and who purchased it. In order to get to that stage, you had to go through all of the other processes and provide all the information, as the officials have been saying.

Â (1255)

The Chair: Okay, Paul? D'accord?

[Translation]

Mr. Paul Crête: That does not confirm for me that in fact all those involved in the chain will be identified. If the product goes through various intermediaries, between the time it leaves Canada and the time it reaches its final destination, in order to be sure we can find it again afterwards... If all of a sudden, we realized that drugs that were produced properly are turning up on the black market, we would know whether there had been a chain... It is something like traceability, Mr. Vanclief.

[English]

The Chair: Is there a comment on that?

Joe, do you have a comment on that?

Hon. Joe Fontana: Yes, just to assist, I think Paul raises some very good questions. I think it's all trying to deal with this anti-diversionary thing.

Paul, if you read all of G-9, including 21.06, it talks about disclosure of the information on a website and maintenance of that website. Also, as Lyle indicated, the export notice needs to be specific as to who, where, and who's buying it. So I think it is to cover off or make sure there aren't any intermediaries. If in fact you had a word or two that further tightened that situation, we would not object.

While I'm at it, Mr. Chairman, just with regard to the answer to James' question about the commissioner, it's clear that the commissioner doesn't need any discretion. His or her job is essentially to issue the compulsory licence. As we move forward, there are a couple of other provisions in this bill for going to the Federal Court, if in fact there are a number of problems with regard to the licence and/or the royalty and/or the fact that this is not humanitarian but more commercial. In fact, the brands, or whoever, can take to Federal Court the fact that this is outside the intent of the legislation and the contract.

Mr. James Rajotte: Are those subsequent amendments?

Hon. Joe Fontana: Those are subsequent amendments with regard to the Federal Court. There are two opportunities for the Federal Court to be involved—not the commissioner, because we want to make sure the commissioner, who as you've indicated has no discretion, isn't burdened with all kinds of contractual questions that, as we know, may come up. We are talking about an important issue here. The Federal Court has a lot more status, we believe, than the commissioner.

So that's the other half of what Rob was telling you concerning what the commissioner's responsibilities are with respect to the voluntary and then to the compulsory licence.

Mr. James Rajotte: Should we get into those amendments, in dealing with this amendment, so that we do process A to Z and see and approve the entire process in and of itself?

Hon. Joe Fontana: I think the officials might tell you where it is specifically. It's all in amendment G-9, by the way.

If you can point out that section, I think that will help.

The Chair: Do you propose a subamendment to G-9, Joe? Is that what you're saying?

Hon. Joe Fontana: No, I'm saying it's all there. But I think for greater clarity, as it relates to what Paul was talking about concerning the issue in proposed section 21.07, paragraphs (a), (b), and(c), if there was further tightening up that he thought was absolutely essential, that would be fine--also with regard to any person or persons.

The Chair: Colleagues, it's one o'clock. I have Brian on the list, and then Lyle.Let's finish the discussion.

Brian, is it on this discussion or that it's one o'clock?

Mr. Brian Masse: The clock. I'm cognizant of the time, Mr. Chair.

Could we get those in writing? I have another commitment, and we need to discuss Wednesday, because it's conflicting with my schedule.

The Chair: Is there unanimous consent to meet Wednesday afternoon at 3.30? No?

Mr. Brian Masse: I've made another commitment. I'll meet all Thursday, all Friday—

The Chair: All right, then it would be Thursday—

Mr. Brian Masse: I'm scheduled out of here right now. I'm supposed to be somewhere else now.

The Chair: We need unanimous consent to meet before Thursday. Otherwise, it would be Thursday at 11 o'clock.

Maybe we could meet earlier. Is there unanimous consent to start earlier on Thursday? Is that agreeable? Say 9 o'clock on Thursday?

Is it on this question, Marlene?

· (1300)

Mrs. Marlene Jennings: Yes, it's on the question of not meeting on Wednesday rather than Thursday. I have a serious conflict on Thursday because I'm also vice-chair of the public accounts committee, and we have a key witness who's appearing on a summons.

The Chair: The problem for me as your chair, Marlene, is that I can call a meeting Thursday. As your chair I cannot call a meeting tomorrow without unanimous consent. That's your dilemma.

Mrs. Marlene Jennings: What about this afternoon?

The Chair: Is there unanimous consent to meet this afternoon at 3:30?

Mr. Brian Masse: No, I can't.

Mrs. Marlene Jennings: Can you not have someone replace you?

Mr. Brian Masse: There's nobody. I would if I could. We don't have anybody.

The Chair: Is it on this question, Joe, of the time of the next meeting?

Hon. Joe Fontana: Well, I thought we were coming back this afternoon, as long as we needed to.

Listen, this is an important bill. Sometimes we can't be here, but that's why we have caucus colleagues and replacements to assist. Surely to God, if we were to—

Mr. Brian Masse: Why don't you get your amendments in on time? Then we wouldn't be.... We have bent over backwards to deal with this issue—

Hon. Joe Fontana: Brian, are you telling me that the world needs now to wait for Brian Masse—

The Chair: Joe, Brian, as I understand it, I need unanimous consent to meet this afternoon, because our normal scheduled time is 11 o'clock to 1 o'clock on Tuesdays. That said, I don't see unanimous consent to meet this afternoon. I don't see unanimous consent to meet tomorrow afternoon.

Is it on this question, James?

Mr. James Rajotte: Are people available tomorrow afternoon at 3:30?

The Chair: Do you mean the officials?

I understand we have unanimous consent to meet at 9 o'clock on Thursday. So be it.

We're adjourned for now, and we'll deal with your subamendment on Thursday morning, Marlene.

The meeting is adjourned.