HEAL Committee Meeting

37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Thursday, November 28, 2002

À

1025

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance)

The Chair

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.)

The Chair

Ms. Yolande Thibeault (Saint-Lambert, Lib.)

The Chair

Mr. James Lunney

The Chair

Mr. James Lunney

À

1030

The Chair

Ms. Hedy Fry (Vancouver Centre, Lib.)

The Chair

Mr. Stan Dromisky

The Chair

Mr. James Lunney

The Chair

Mr. James Lunney

The Chair

Ms. Hedy Fry

The Chair

Ms. Hedy Fry

À

1035

The Chair

Mr. James Lunney

The Chair

Mr. James Lunney

The Chair

Mr. James Lunney

Mrs. Carol Skelton (Saskatoon—Rosetown—Biggar, Canadian Alliance)

The Chair

Mr. James Lunney

The Chair

Mr. James Lunney

The Chair

À

1040

Mr. James Lunney

The Chair

Ms. Hedy Fry

The Chair

Ms. Judy Sgro (York West, Lib.)

The Chair

Mrs. Carol Skelton

The Chair

Mrs. Carol Skelton

The Chair

The Chair

Á

1105

Ms. Freda Miller (Senior Scientist and Professor, Sick Children's Hospital of Toronto)

Á

1110

The Chair

Mr. Mick Bathia (Director of Stem Cell Biology and Regenerative Medicine, Robarts Research Institute, University of Western Ontario)

Á

1115

Á

1120

The Chair

Ms. Janet Rossant (Principal Researcher, University of Toronto)

Á

1125

The Chair

Mr. Chris Higgins (Director, Health Charities Council of Canada)

Á

1130

Mr. Yves Savoie (Member, Health Charities Council of Canada)

Á

1135

The Chair

Mr. James Lunney

Ms. Janet Rossant

Mr. James Lunney

Ms. Janet Rossant

Mr. James Lunney

Ms. Janet Rossant

Mr. James Lunney

Á

1140

Mr. Mick Bathia

Mr. James Lunney

Ms. Janet Rossant

Mr. James Lunney

Ms. Janet Rossant

Mr. James Lunney

Ms. Freda Miller

Mr. James Lunney

Ms. Freda Miller

Mr. James Lunney

Ms. Freda Miller

Á

1145

Mr. Mick Bathia

Mr. James Lunney

Ms. Freda Miller

Mr. James Lunney

Mr. Mick Bathia

Á

1150

The Chair

Mr. Stan Dromisky

Mr. Mick Bathia

Mr. Stan Dromisky

Ms. Janet Rossant

Mr. Stan Dromisky

Á

1155

Mr. Yves Savoie

Mr. Stan Dromisky

The Chair

Ms. Carolyn Bennett (St. Paul's, Lib.)

Ms. Janet Rossant

Â

1200

The Chair

Mr. Paul Szabo (Mississauga South, Lib.)

Â

1205

Ms. Freda Miller

Mr. Paul Szabo

Ms. Freda Miller

Mr. Paul Szabo

Mr. Mick Bathia

Mr. Paul Szabo

Â

1210

Mr. Mick Bathia

Mr. Paul Szabo

Mr. Mick Bathia

Mr. Paul Szabo

Ms. Janet Rossant

Mr. Paul Szabo

Ms. Janet Rossant

Mr. Paul Szabo

The Chair

Mr. James Lunney

Â

1215

Ms. Freda Miller

Mr. James Lunney

Ms. Freda Miller

Mr. James Lunney

Ms. Freda Miller

Â

1220

The Chair

Mrs. Carol Skelton

Ms. Freda Miller

Mrs. Carol Skelton

Mr. Yves Savoie

Mrs. Carol Skelton

The Chair

Mr. James Lunney

Ms. Freda Miller

Mr. James Lunney

Ms. Freda Miller

The Chair

Mr. Paul Szabo

Â

1225

Ms. Janet Rossant

Mr. Paul Szabo

Ms. Janet Rossant

Mr. Paul Szabo

The Chair

Mr. James Lunney

Ms. Janet Rossant

Mr. James Lunney

The Chair

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CANADA

Standing Committee on Health

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NUMBER 007

l

2nd SESSION

l

37th PARLIAMENT

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EVIDENCE

Thursday, November 28, 2002

[Recorded by Electronic Apparatus]

À  (1025)  

[English]

    The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen. I'll call this meeting to order, because we have some motions before us. I'd like to get rid of them before the witnesses arrive. You will see on your agenda the notices of motion that we received the other day, and the first one is from James Lunney.

    Mr. Lunney, would you like to address your motion?

    Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): The motion basically asks that our four regular meetings beginning Monday address the Romanow commission report, which has just been tabled, and following that, that we return to Bill C-13 to hear our witnesses, because we've had trouble scheduling them and we get the money to make sure we can get our witnesses here. Then we can proceed to clause-by-clause in an orderly fashion. That would give us time to get our amendments prepared and into the legislative clerks for translation, collation, and so on.

    Given the importance of the Romanow commission, the importance that Canadians attach to it, and the expectation that the government is going to move quickly, according to the Health Minister, on it, we feel this should warrant the full attention of the committee, and that should be in regular meetings, not jammed into evening one and a half hour sessions. That's why we make the motion in this manner. The committee, having done such good work to get this far for a year and a half plus, we feel it's important to finesse it and this minor interjection to consider the Romanow commission is a worthwhile commitment of committee time. So I would ask all members to help us to hear out the remainder of the witnesses who need to be heard, so that we can complete our work in a manner that's acceptable to Canadians and respects the work that's already gone into the bill.

    The Chair: Are there any other speakers?

    Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): Madam Chairperson, the intent I can understand, but the media will be super-saturated in the next few days with responses and critiques and reactions to the main recommendations in the Romanow report, there's no doubt about it. In the next few days we will be bombarded with it. So there's an opportunity for us to learn something from the kind of stuff we're going to pick up on television, from the newspapers, and so forth.

    There are two volumes that have been tabled in the House today. I have no intention of taking part in any kind of discussion until I have an opportunity to read the rationale pertaining to each of the recommendations presented in that report. And with all the workload I have--and I'm sure everybody else has the same--I'm not going to be just sitting there trying to get the two volumes digested in time to meet the intent of this motion. Therefore, I strongly oppose this motion.

    The Chair: Thank you, Dr. Dromisky.

    Are there any other speakers? Seeing none, I'll call the question.

    (Motion negatived: nays 7; yeas 3)

    In the absence of Mr. Ménard, who gave us notice of motion last week, is there someone who would like to move that motion?

    Madame Thibeault.

[Translation]

    Ms. Yolande Thibeault (Saint-Lambert, Lib.): Yes, Madam Chair, I would like to move Mr. Ménard's motion but I will slightly amend it so that the committee can sit longer if needed after the period from 3:30 p.m. to 6:00 p.m. The motion would then reads as follows:

That the Committee begin clause-by-clause study on Tuesday, December 3, that it continue on Wednesday, December 4, Thursday, December 5, and Monday, December 9, from 9:00 a.m. to 11:00 a.m. and from 3:30 p.m. to 6:00 p.m., or later if necessary, on each of these days, in order to complete clause-by-clause study on Monday, December 9; and that on Tuesday, December 10, Wednesday, December 11, and Thursday, December 12, the Committee consider the Romanow Report.

[English]

    The Chair: Thank you, that amendment is in order. I'm sure if Mr. Ménard were here he would consider it a friendly amendment.

    Are there any speakers to this motion?

    Mr. James Lunney: Could you just repeat it, please, because some of us haven't got translation going yet?

    The Chair: In the English in line 6 it says “to 6:00 p.m.” Now it says “or later if necessary”.

    Mr. Lunney would like to speak to this motion.

    Mr. James Lunney: The first objection I'd have is that our staff Christmas party is on the Thursday in the evening.

    The whole notion of moving to clause-by-clause on Tuesday presupposes that we have all our amendments in and that they're all ready by Tuesday. It also jams our time to hear witnesses into such a narrow framework that it really doesn't do justice to getting them here to complete our work. There are many important witnesses we have yet to hear on the proposed list. We're really remiss if we fail to hear them. This committee has from the beginning been one of the few, I think, in the House that has received recognition for a tremendous collaborative effort, beginning with the draft legislation and the way we worked through that to come up with our own plan, which has eventually ended up in a bill. To denigrate that process now by failing to hear the witnesses on this important subject.... Canada is dealing with this at an important time in history, it's different from other nations. The breakthroughs that have happened in stem cell research in time for us to consider this legislation provide a unique experience among legislators around the world, and we ought to give it adequate consideration before we proceed to clause-by-clause, and we ought to consider the legislative clerks who have to make sense of the amendments we're trying to put in.

    So with all due respect, I would ask my colleagues on the committee here to consider that. If we want to do this in an appropriate manner and respect the mandate we have from Canadians to do the best job we can with this legislation, we need to give it appropriate time to get our amendments in order and to hear the remainder of the witnesses.

À  (1030)  

    The Chair: Ms. Fry.

    Ms. Hedy Fry (Vancouver Centre, Lib.): Madam Chair, I want to speak in favour of this motion. I don't know how many of you read the Globe and Mail this morning and saw that scientists in North America are now making a chimera. I think that tells us we have to get this legislation out urgently, before the horse bolts the stable and we're not able to contain it any more. The urgency of this bill, for me, has been confirmed by what I read in the Globe and Mail this morning.

    The Chair: Thank you, Dr. Fry.

    Are there any other speakers?

    Seeing that, I'll call the question on Mr. Ménard's motion, put forward today by Madame Thibeault.

    Mr. Stan Dromisky: As amended?

    The Chair: As amended, yes.

    Mr. James Lunney: Recorded, please.

    The Chair: A recorded vote has been requested.

    Mr. James Lunney: Can I ask that the committee respect the fact that we have for some time had December 5 scheduled for our staff party, in the evening? We have members of our staff and family members coming and the whole bit.

    The Chair: My guess is that we wouldn't want to leave ourselves in a situation where we might have to go late on a Thursday, that's pretty traditional around here. I think Madame Thibeault's motion suggests that if we gauge, even after the first day, that we're not moving quickly enough, we could start staying later in order to prevent that scenario. Mr. Lunney, I will do my best not to have this thing still going on late Thursday afternoon, which would make that particular social event unfeasible for you. But then you would have to agree maybe to work Tuesday night. Well, I don't know, it could go very quickly; we don't know how many amendments there are. This might be more than enough time, but I think Madame Thibeault is just trying to say, if we don't have enough time, this little amendment gives us those options.

    Are there any other speakers?

    Seeing none, I'll call the question.

    (Motion as amended agreed to: yeas 7; nays 3)

    The Chair: We move on to motion 3, from Dr. Fry. Would you like to speak to it?

    Ms. Hedy Fry: I have a correction, Madam Chair. It should be “Monday, December 2”.

    The Chair: Thank you. I didn't notice that.

    Ms. Hedy Fry: I think, Madam Chair, this motion speaks for itself. It's in keeping with the intent of motion 2, which we have just passed, which allows us time on Monday, December 2, to see witnesses. It allows us to be very efficient and effective about the witnesses we would like to see, so they can give us the information we believe we need. We will do this efficiently in that one day, finances permitting, of course. It will be moot if we don't have any money to bring anybody in.

À  (1035)  

    The Chair: I might add the witnesses' ability to come. The clerk has tried to get these people warmed up to the idea that they might be asked to come. The clerk reports to me that the money we requested at the liaison committee on Tuesday has now been approved, so we can get people here next week.

    Are there any other speakers?

    Mr. Lunney.

    Mr. James Lunney: It's very disrespectful to witnesses, very high calibre and distinguished professional witnesses, to expect them to jam their schedule at such short notice. We're sitting here Thursday today to force them to come on Monday. That's minimal notice. They may not even be able to get flights. I think it's extremely disrespectful of the committee. Ms. Fry, I don't understand why you think it's going to make that much difference whether we finish this work this week, next week, or the following week, that it's really going to hold up the legislation that significantly. So I wish to register a protest. I think it's certainly going to be a challenge to get the appropriate witnesses here in time. Frankly, it's disrespectful to cut out some of these very highly qualified witnesses in the interest of what Ms. Fry refers to as efficiency at this stage of the game.

    The Chair: Are there any other speakers?

    Seeing none, I'll call the question on the motion by Ms. Fry.

    (Motion agreed to: yeas 7; nays 3)

    The Chair: Number 4 is from Judy Wasylcia-Leis. She is not here to move it, so someone else would have to move it if it's to get onto the table right now.

    Mr. James Lunney: I'll move it for her.

    The Chair: Would you like to speak to it, Mr. Lunney?

    Mr. James Lunney: I think the intent of Ms. Wasylcia-Leis' motion is to bring in appropriate witnesses to give their considered opinions on the report. I think the list she has suggested contains very qualified and capable people. I don't know how realistic it is to expect them to come in evening hours at the end of the day, but I would suggest that the list is worth consideration.

    Mrs. Carol Skelton (Saskatoon—Rosetown—Biggar, Canadian Alliance): They've amended it now. The motion has been amended to “the last four meetings of the committee”.

    The Chair: The last three, I think, unless we can fit in another one in that week. But they are all in the daytime.

    Mr. James Lunney: They are in the daytime?

    The Chair: Yes.

    Mr. James Lunney: What does “the last three meetings” mean? Could you explain that?

    The Chair: It was very clear as to the dates we would meet on Romanow, the 10th, the 11th, and the 12th.

    Mr. James Lunney: I don't have that on this work plan.

    The Chair: Are there any other speakers to this motion?

    Seeing none, I'll call the question. It's been moved by Mr. Lunney in place of Ms. Wasylcia-Leis.

    (Motion negatived: nays 7; yeas 3)

    The Chair: Mr. Lunney.

À  (1040)  

    Mr. James Lunney: May the record show that I think the committee should subtitle itself the railroad committee.

    The Chair: We have a fifth motion before us, from Mrs. Wasylycia-Leis, which I think is suggesting something for a work plan that obviously we wouldn't have time to get to until we return in either late January or early February. Is there anyone who would like to move this?

    Mrs. Sgro moves it.

    Dr. Fry.

    Ms. Hedy Fry: I move that the motion be tabled.

    The Chair: There's a motion to table motion 5.

    (Motion agreed to)

    Ms. Judy Sgro (York West, Lib.): Madam Chair, if we table it, when does it surface again?

    The Chair: Someone has to make a motion to lift it from the table. If you could stand a little bit of guidance from the chair, if indeed we finish the bill and we're satisfied with the work we do on the Romanow commission and write a letter to the minister, issue a report, or whatever it is we're thinking we're going to do with it, it would seem to me that when we come back, we will be discussing a work plan for February to June, and that would be the appropriate moment to lift it from the table.

    Mrs. Carol Skelton: Madam Chair, did we not have a motion to strike a steering committee to look at what we were going to do?

    The Chair: That motion was withdrawn by Mr. Ménard. That motion is not before us today.

    Mrs. Carol Skelton: Thank you.

    The Chair: Thank you very much, ladies and gentlemen. We have dealt with the five motions. Our witnesses are due at 11, so I think I'll adjourn the meeting for 15 minutes. I don't think our witnesses are here just yet. Thank you for coming at 10:15, because it gave us sufficient time in case we got into a lengthy debate.

À  (1043)  

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Á  (1104)  

    The Chair: On behalf of the committee, I would like to welcome the witnesses and thank them for coming. I know it was somewhat short notice, but you're all considered experts on this subject. I'm sure your views will enlighten us. We haven't met Dr. Miller before, so a special welcome to you. We've all been very impressed with the work you have done and published. We've heard your name around this table for about a year and a half now, and we're finally seeing you in person. Thank you for coming, and I believe you're the first witness on the list today.

Á  (1105)  

    Ms. Freda Miller (Senior Scientist and Professor, Sick Children's Hospital of Toronto): I think I'm here mainly to talk about the issue of adult versus embryonic stem cells, and I'd like to address you from a particular perspective, the perspective of somebody who's been working very hard over the past four years to develop adult stem cells as an alternative therapeutic source. As most of the people here are probably aware, my laboratory about a year ago reported our success in isolating a type of adult stem cell from the skin of both rodents and humans. We were particularly excited about that, because if this ever does come to fruition, for some therapies, it may allow you to use an autologous source of tissue to find stem cells, so you could transplant it in the same person, thereby avoiding rejection. Nonetheless, I'm a very strong proponent of the co-development, at this point in time, of human embryonic stem cells and adult stem cells, and what I'd like to do is enumerate for you the reasons.

    The first reason is simply that at this point of our knowledge, embryonic stem cells are still much more versatile than any of the reported adult stem cells that are out there. Moreover, even the adult stem cells, which are more pluripotent, still cannot make every cell in the body, even if they fulfil their potential as it is right now. So what you're faced with is a situation where you could treat any condition, theoretically at least, we would imagine treating using human embryonic stem cells, if things turn out right, whereas we don't even have that promise with the adult stem cells we have in our hands right now.

    To give you a more concrete example, as you've undoubtedly heard before, embryonic stem cells can theoretically make approximately 200 different cell types, whereas the ones we've isolated and are working very hard on to see how far we can drive them can still only make six or seven different cell types, and even Catherine Verfaillie's cells, of which you've heard, cannot, as far as I'm aware, make heart cells or pancreatic islet cells for diabetics. So if we're going to say no to embryonic stem cells at this point, what we're in essence doing is telling people who suffer from diabetes or cardiac disease that we're eliminating their chances of seeing a potential cure.

    The second reason is that these are very early days for adult stem cells. I'm sure you heard this from Catherine Verfaillie as well. This is a field in its infancy, we're discovering new things all the time, and even though we're very excited in my laboratory and working very hard, because our cells can make, for example, cells from your brain that look right in a dish, we have not yet put those into an adult animal in a functional recovery paradigm and seen that they actually become the cell types we need. Neither has Catherine Verfaillie put them into adult animals.

    So I'll be honest with you, my first big fear is that we're going to put in all this effort in my laboratory and in numerous laboratories around the world and find that we can't use adult stem cells to treat anything. That's still a possibility at this point, based on the evidence we have or have not derived yet. My second and bigger fear is that my work with adult stem cells, which may not come to fruition, would be used as a rationale for halting the work on human embryonic stem cells. Then, if the adult stem cells don't come to fruition, we're left with nothing. That is my biggest fear as a scientist, that my own work won't pan out and will be used as justification to stop something that actually does look like it will pan out, because embryonic stem cells have been put into adult animals and shown to generate the right cell types.

    The third reason is a more scientific one, and it has to do with the fact that all our work was based on work done in embryonic stem cells. Moreover, all our attempts and all Verfaillie's attempts to convince those cells to become ultimately, let's say, insulin-producing cells for diabetes have been based on work done on embryonic stem cells. So in a sense, by allowing the co-development of both sources, you're expediting the potential therapy that will be derived from adult stem cells, so that maybe one day we don't have to use the embryonic stem cells therapeutically. As a discovery tool that is far ahead of adult stem cells, embryonic stem cells are going to provide a guiding light for the adult stem cell work.

Á  (1110)  

    In summary then, those are my three big points for why I think we should co-develop them, but I really do believe, as an adult stem cell person, that if the therapeutic potential of these cells is to be met and many disorders that may never be treated with adult stem cells are going to be treated, we have to keep working on human embryonic stem cells.

    Since morals are obviously part of this whole issue for all of us, I hope, the moral question, for me, about whether these very early embryos are human beings and how they should be treated was actually decided by our society when we allowed the generation of the so-called spare embryos for in vitro fertilization. To me, the moral dilemma at this point, our society having allowed the generation of those spare embryos, is whether to throw them out or to attempt to treat people with devastating conditions like spinal chord injury, where my own work is aimed, using those particular spare embryos. As a scientist who wants to better the human condition, I would rather utilize them to treat incurable disorders than throw them out.

    The Chair: Thank you, Dr. Miller.

    We will move on to welcome Mr. Mick Bathia from the University of Western Ontario, my alma mater.

    Mr. Mick Bathia (Director of Stem Cell Biology and Regenerative Medicine, Robarts Research Institute, University of Western Ontario): Thanks.

    I'm a scientist who's interested in translating some of my research to clinical intervention. My laboratory was originally dedicated to studying adult stem cells, specifically those in the hematopoietic system. We've more recently undergone a change. We've also imported three of the existing embryonic stem cell lines--I'll refer to them as ES cell lines--the H1, the H7, and the H9. We've been doing extensive work over the last two years on those cells in in vitro culture. The point I want to make is that the research program is actually bent upon doing direct comparisons between the adult stem cells and the embryonic stem cells in a few disease models in animals, specifically diabetes, spinal cord injury, and making an entirely new blood system or reconstituting the blood system. So we're doing a direct comparison, which I think is echoing what Dr. Miller has suggested, that this is something that is necessary, and we've tried to contribute in any way we can in our lab. I think we have some in-depth and intensive knowledge in directly comparing some of the embryonic stem cell lines and what they can provide with the adult ones.

    What I want to try to do today is express my interpretation and scientific evaluation of what's happening currently in the field and indicate that I don't have any conflicts of interest with industry etc., because some of my work is funded by industry.

    First, the current status, from what I understand, is that embryos are currently being used for research for infertility drugs, contraceptives, etc. So although the bill pertains to stem cell lines, those embryos are already being used for, arguably, methods or approaches that may not provide some sort of lifesaving benefit or therapy in the future.

    Second, few people have actually collected enough data to suggest how many embryos are available for this type of research, those that are there and those that are eligible. From surveys or polling that has been done, it seems the number is far lower than one may have predicted. The point I'm trying to make here is that this is an extremely precious donated gift, and we have to think seriously about how those embryos are used and how they are allocated. It is probably something that requires, at least in my view, a bit of clarification within the bill, how the allocation of those embryos will occur.

    It's important on the scientific level also, because there are experiences we can call upon from other countries, including the U.S., Australia, and Sweden. They know there are features or properties one can address before use of human embryos is made for ES cell lines. Using that information is going to enable us to decrease the number of resources we put towards this initiative and the number of embryos used for this purpose. I just want to bring that to bear on any further decisions on Bill C-13.

    I want to echo, again, some of what Dr. Miller indicated about the adult stem cells. There is an ongoing debate on what adult stem cells provide versus the embryonic. In the scientific field there is very little agreement and a lot of controversy. The majority of the concepts about the use of adult stem cells, the ability for them to produce other cell types, have been predicated on work on the mouse. There has been some work done on humans, and it seems it may not be as frequent or as robust as we originally saw in the mouse. I think there is a lot of work to be done.

    Further, a lot of the references concern adult stem cell lines. There currently are not adult stem cell lines that grow to the same magnitude and level that you can generate with human embryonic stem cell lines. For basic research or potential clinical benefits in the future, there clearly are data to indicate that human embryonic stem cells will provide a greater number of cells, which, from a pragmatic point of view, is critical when you move ahead to think about transplantation therapies for regenerative medicine.

Á  (1115)  

    Another thing I'd like to point out is that there are properties that have been shown where adult stem cells can make other cell types. However--and I think, again, Dr. Miller made reference to this--the number of those cells and the physiological benefit that animal's receiving, for either injury or disease, has not been quantified. So we're making observations either in vitro or in a dish or we're making observations in an animal, where you can find, using rigorous techniques, a few cells of another lineage. That certainly does not mean you've corrected the disease, which was originally the hope, and there's an immense amount of work that has to be done there.

    My laboratory--we're hoping to publish this soon--has been able to at least discern one property of human embryonic stem cells that differs in the adult, which I think is important from the therapeutic side: human ES cells seem to be able to suppress the immune system or not be attacked by the recipient immune system. This is completely different from their adult counterparts. So there is a property that could provide significant benefit from using embryonic stem cells, as opposed to the adult. I'll leave that point for now.

    The other thing I wanted to indicate is that the derivation of embryonic stem cell lines is a skill set, a bit of an art form. There is experience now and data being collected, and I think it's important for the bill. There might be some clarity required that emphasis should be placed on these embryos--again I emphasize how precious they are--being used for the right projects, for the right purposes, at the right centres, by the right individuals. It seems, at least in my evaluation of the bill currently, the mechanisms and process haven't been really clarified.

    Also, the way the bill is currently written, a researcher would obtain a licence to do work on human embryos, for example, to derive lines, and then the researcher would have to approach the IVF clinic. I think that puts the IVF clinic director or the clinicians there in a situation of decision-making. I think allocation of embryos should be done at a higher level, maybe with a more collective decision. Suggestions might include a virtual bank of embryos, so that the allocation and the control mechanisms and pressures are not only thrust upon the IVF clinic director, but it's more of a national effort to do this work.

    Those are the points I wanted you to bear in mind. I'll leave it at that.

Á  (1120)  

    The Chair: Thank you very much, Dr. Bathia.

    We'll move now to Ms. Janet Rossant, principal researcher at the University of Toronto.

    Ms. Rossant.

    Ms. Janet Rossant (Principal Researcher, University of Toronto): My research has largely been over many years involved with trying to understand early development in the mouse embryo. We have extensive experience with mouse embryonic stem cells. One of the things we've learned with mouse embryonic stem cells is the enormous power of these cells to generate all tissues in the mouse and to proliferate indefinitely in cultures, as has already been said. So the transition from working on the mouse to recent discoveries that you can derive cells with similar properties in the human has obviously opened up a lot of potential for the use of pluripotent cells for therapy.

    I don't really want to spend my time reiterating what you've just heard from Freda and Dr. Bathia about the importance of research in this area. I think stem cell research, both adult and embryonic, does open up possibilities of cell therapy and the use of stem cells for repairing damaged tissue, and many diseases in which degeneration and damage occur are potentially susceptible to this kind of therapy.

    It's clear that we are at an early stage in the process of understanding both adult and embryonic stem cells. We need to know more about the biological signals that drive the differentiation of the cell types, and we need to work out how to go from the laboratory bench growing cells to doing this on an industrial scale, growing very large numbers of cells for therapeutic purposes.

    I think the scientific consensus is the one you've just heard from both of my colleagues. It is not clear whether pluripotent embryonic stem cells, with their full potential and their unlimited proliferative capacity, will be the tool we are going to use or whether adult stem cells, with their, at the moment, slightly more restricted capacity and lower potential for proliferation, but ease of derivation and fewer ethical concerns, are really going to be the way forward. I think we don't know, and we need research on both fronts.

    I'd like to talk a little about stem cell research in Canada and how the bill will affect it. As you know, it is an extremely active area. Stem cell scientists in Canada are at the forefront of international efforts in this area. The majority of research takes place on adult stem cells. There's extensive history and a continuing emphasis on understanding adult stem cells, in model systems and in humans. And there's extensive research on embryonic stem cells, largely in the mouse system. Given all this expertise in Canada and the consensus in the international scientific community about the need to explore all forms of research on stem cells, there is certainly interest in assuring that the expertise in Canada can be used to advance this global effort, moving stem cells from research tools to therapies.

    There are existing human embryonic stem cell lines, and you've just heard from Dr. Bathia about some of the research he is undertaking using those cell lines. They can be a start in this effort. It's an exciting opportunity that these lines exist. However, although you will read reports that there are many such cell lines available worldwide, and the NIH has a registry of over 60 ES cell lines, in fact, there are not 60 ES cell lines available, there are not 60 ES cell lines characterized to any extent at all. If you go to the NIH web page now, you will find that they have changed the website so that they list those that are available for distribution, and there are five worldwide. I would say, of those five, maybe two or three are really well-characterized, robust cell lines.

    So those cell lines are available to the community and they can undertake research with them, but at this point, with such a few cell lines available, we don't know the true range of capacity of this system. We don't know how robust it will be, we don't know how reproducible it will be. So I think, in this regard, globally, there is a need to generate more ES cell lines, not huge numbers, as we recognize there is a limited resource of embryos for this, but I think there is a need to generate more cell lines under conditions where people with expertise can bring it to bear on this system.

Á  (1125)  

    In general, Canadian researchers are very happy to see legislation that establishes a clear regulatory framework for research on human embryos and on their potential use for deriving stem cells. There is clearly some concern about the use of the criminal sanctions applying to certain prohibited activities, such as creation of embryos for research or use of cloning technologies. I would say neither of these is needed for the state of stem cell research today. To proceed today, they are not necessary, and they do clearly present some more contentious ethical concerns than just those that relate to the use of IVF embryos. I think it is going to be important to revisit these prohibitions over time. Science will change and society's response will change. The bill has a clause to allow it to be reviewed, and I think that's important.

    As you probably also know, I was the chair of the working group that drafted guidelines on stem cell research for CIHR. Those guidelines mirror the draft legislation in many ways. They would allow the derivation and the study of human embryonic stem cells from embryos produced from IVF programs and not used for reproductive purposes under very strict guidelines. The guidelines also do not support the creation of human embryos by either IVF or cloning technologies for the derivation of stem cells.

    I think it's important to point out that the CIHR guidelines actually go further than the legislation, in that they can cover areas not covered by the legislation. Specifically, they can actually propose guidelines for the research that's carried out with human pluripotent stem cells, embryonic or other in origin. Even when the legislation is passed and the regulatory body is in place to license the research use of embryos, the CIHR's oversight committee that deals with their guidelines will still have an important role to play in ensuring the ethical use of any stem cells that are derived this way in research.

    In sum, stem cell research does hold enormous promise for new therapies. I think we need research on multiple fronts, embryonic and adult. The kind of open debate that is taking place over this bill I think has really brought these issues to the fore in the public domain, with a careful weighing of the ethical and scientific issues, I think we can move forward, balancing the acknowledgment of the precious resource of the embryo with a desire to improve the quality of life for people with debilitating diseases.

    Thank you.

    The Chair: Thank you very much.

    I would ask Mr. Savoie and Mr. Higgins to come to the table. You have the floor.

    Mr. Chris Higgins (Director, Health Charities Council of Canada): Good morning. Thank you for the opportunity to appear before the committee this morning on behalf of the Health Charities Council of Canada. My colleague is Yves Savoie, a member of our science and research committee and the executive director of the Muscular Dystrophy Association of Canada.

    The Health Charities Council of Canada represents 46 national health charities of all kinds. Member organizations bring together a wealth of knowledge, expertise, experience, and resources. Our presentation today represents the broad consensus of our participating members, as well as the leadership and expertise of organizations such as the Parkinson Society of Canada, the Muscular Dystrophy Association, and the AmyothrophicLateral Sclerosis Society of Canada. The HCCC provides a strong common voice on interests of the members. It acts as a resource to member organizations. The goal of our all our activities is to support Canadians in being healthy, staying healthy, receiving world-class health care, and living well in their communities.

    Individually and collectively, national health charities make significant contributions in key areas, including research, information and surveillance, community and patient support, education and disease prevention, and health promotion. Across the country national health charities comprise thousands of staff and millions of volunteers who serve Canadians in their communities year-round. Formal volunteers contribute approximately 93 million hours a year to this cause.

    Because of the close ties between national health charities and Canadians, the HCCC provides an important channel for policy- and decision-makers to learn of the views and concerns of the people of Canada. Each charity is founded on voluntary contributions of time and funds by Canadians, Canadians who believe they will contribute to the health and well-being of their family members and other Canadians.

Á  (1130)  

[Translation]

    Mr. Yves Savoie (Member, Health Charities Council of Canada): Madam Chair, the government has shown a commendable commitment to the health of Canadians as demonstrated by the initiation of the Romanow Commission, the creation of the Canadian Institutes of health research and the recent initiation of a national healthy living strategy in the Speech from the Throne. This leadership has also been demonstrated by the proposed legislation regarding assisted human reproduction.

    Research that will address diseases, conditions and disabilities of Canadians is central to the purpose of health charities. Health charities raise over $300 million annually to contribute to this research. This money comes from Canadian men and women from ocean to ocean.

    There can be no clearer demonstration of the will and hopes of Canadians than their willingness to give so generously to this purpose. The Health Charities Council of Canada supports Bill C-13 with respect to stem cell research and potential stem cell therapies.

    This legislation provides a balanced framework that regulates stem cell research and faces important ethical and moral issues. By providing for the use of embryonic stem cells, from embryos generated by in vitro fertilization but not used for human reproduction, with informed consent from donors, it permits an important avenue of scientific research. This provision should be retained in the legislation.

    Our volunteers, donors and the people we serve, Canadians with all kinds of diseases and disabilities, all feel a sense of urgency about research. For them it is personal, not academic. Their hopes and trust are placed in the creative, diligent and timely research that holds the promise that the health challenges they face can be cured.

    Some will say that the experts to my left have a stake in research and could even be in a conflict of interest position. I can tell you that Canadians who have a disease welcome and support their efforts. They do not consider for a moment that these experts are motivated by self-interest.

    A further reason to move ahead with this urgent legislation lies in the need to provide a national environment for research, in order to keep our talented researchers here in Canada. The Innovation Strategy of the government will succeed in the field of research and more particularly health research if there is a clear framework that supports this important work. Given the very real promise of research and the urgency felt by the people we represent, we support the timely enactment of this legislation.

    There are obviously many promising approaches to the breakthroughs we need to address the health challenges of Canadians. Health charities are aware of that. This is why they use expert panels and peer review to channel their research efforts. But when people's lives and well-being are at stake, a linear one-at-a-time approach to research is difficult to accept for people and their families.

    Like Professor Freda Miller, I think that the required strategy is one of co-development involving parallel approaches from different perspectives, each enriching the other. It is for these reasons that we support the legislation's provisions that allow for research on pluripotent cells derived from both adult tissues and embryos.

    This perspective is not confined to the citizens affected by such illnesses. Needless to say, leading researchers share this view. In this regard, I would refer to Professor Verfaillie who was mentioned earlier. She said that no investigator currently knows which cell, adult or embryonic, will ultimately be the best cell for clinical use and treatment of a particular disease.

Á  (1135)  

    Therefore, any decision now regarding the funding or legality of adult vs. embryonic stem cell research would be premature and harmful to both the scientific process and to the patients who will benefit from treatments developed as a result of the research.

    The bill would establish the Assisted Human Reproduction Agency of Canada. Given the central and abiding interest of health charities and the people and families they represent in this agency, I as well as the council encourage you, as legislators, and the minister to find ways to ensure a fair representation of volunteers and leaders of health charities, in addition to experts and scientists, within the governing board of the agency, once the bill is approved.

    Madame Chair, to wrap up, with Bill C-13, the Parliament of Canada has an opportunity to provide important leadership in order to establish a framework for health research that is crucial to addressing the health needs and well-being of Canadians.

    It can do so with the support and cooperation of national health charities. When passed, the legislation would allow us to move ahead in the area of stem cell research, an area that we believe holds great promise for treatments of a number of serious disabling and life-threatening diseases and conditions.

    Thank you, Madam Chair.

[English]

    The Chair: Thank you very much.

    We'll now move to the second stage of our meeting, which is the question and answer period.

    Mr. Lunney.

    Mr. James Lunney: Thank you, Madam Chair.

    As the first one up, I'd like to thank our witnesses for coming, making their presentations, and adding to the body of knowledge we've been dealing with.

    Let me begin with a question for our researchers and scientists here. It has to do with the whole subject of embryonic stem cell research. Embryos have been used in other jurisdictions, in the U.K. and in the U.S., for some time. I understand from Dr. Rossant's presentation that of the 60 so-called stem cell lines only about five are really useful and productive. Can you tell us how long we have been experimenting with embryos for stem cells?

    Ms. Janet Rossant: With human embryos, the first paper was published in 1998, so it's only four years. There are five lines that are available for distribution. That is not to say there are only five lines potentially around the world, but if one is dealing with a resource you want many researchers to work on and really be able to compare their properties, the lines that are available for distribution are the important ones, and in fact, there are only five.

    Mr. James Lunney: Do you have any idea how many embryo lines are being studied world-wide at the present time? Could there be hundreds?

    Ms. Janet Rossant: There are 60 on the NIH registry. In the U.K., as you know, they have had the ability to generate cell lines for some considerable time, but they have not actually generated any cell lines at this point.

    Mr. James Lunney: Can you comment on why there are so few for all this research?

    Ms. Janet Rossant: There are several reasons. In many cases people were using embryos that were not of high quality. So high quality embryos are very important. Although in the initial stages people had a very low success rate in deriving new cell lines, we now have moved four years down the road in understanding more about how to grow these cells, and the recent reports I've heard from people in the U.S. and in Australia show a much higher success rate per embryo derived. So although, as in many fields, when you start, the efficiency is low, the success rate is low, we have learned and we can move forward. In future we will not require large numbers of embryos to derive some really nice successful cell lines.

    Mr. James Lunney: We've dealt with the issue here with other researchers. It's beiing said the embryonic cells, as opposed to adult cells, which maybe only grow a few divisions in vitro before they seem to be derailed, can grow, and some implied that they're immortal. I wonder whether that language is considered reasonable by you, or whether it's rather disingenuous to suggest that cells taken from an embryo that are on their way to becoming an 80 to a 100 trillion cell human being, which usually takes 18 to 21 years, are immortal.

Á  (1140)  

    Mr. Mick Bathia: I think you're maybe taking this slightly out of context. We're talking about in vitro growth of the cells to expand them for research purposes. If you measure the number of doublings, the adult cells, in all cases I'm aware of, fail to provide as many cells or as many doublings and to survive as long as the embryonic counterpart.

    Mr. James Lunney: These lines have only been grown for a few years, so it's a little premature to suggest immortality, wouldn't you agree?

    Ms. Janet Rossant: In a scientific sense and for our culture terms, the word immortal really means that they have been packaged for a great many cell generations. If you take tissues from your body, they only have a set number of divisions, and they will die. So it's a kind of scientific term of immortality.

    Mr. James Lunney: Which doesn't really mean what most laymen would understand immortality to mean.

    Ms. Janet Rossant: Maybe, but if we get them going forever, they would go forever.

    Mr. James Lunney: Can I just ask a question of the three researchers? Is your research funded independently by the CHIR, more or less, or is your research with matching grants, and therefore backed by industry? I think Dr. Bathia has already answered that he is co-funded.

    Ms. Freda Miller: My work was funded for about a year and a half by biotechnology, a partnership between a Canadian and an American company, but the biotech industry is in such bad shape right now that the particular company that was actually providing the funding is not doing stem cell work any more.

    The industry thing is a bit of an issue from two perspectives, as far as I'm concerned. I know a lot of people in the States were hoping a lot of this would be pushed by industry funds to move to therapy, and that's not going to happen in this economic climate. The second thing has to do with the fact that as everyone in this room undoubtedly knows, in the States the guidelines do not apply to industry. One of the fears of academic scientists is that if only people in companies go ahead and develop these things, they're motivated by profit, and frequently, as we know from drug trials, claims are made that have not been validated in the broader scientific community. So I think one of our big fears is that if this stays in the realm of industry in North America, they may be going out there and doing clinical trials on people with human embryonic stem cells--most of those lines are in industry hands, by the way--before anybody in the community, who may not be involved with industry, is even allowed to test or assess those claims. So that's another argument for having human embryonic stem cells in the academic community.

    Mr. James Lunney: Thank you.

    Dr. Miller, when your work first came out, the headlines read skin-based precursor or something to that effect--researchers discover gold. Do you remember that?

    Ms. Freda Miller: Yes. That's the media, isn't it?

    Mr. James Lunney: You've mentioned some of your hopes for adult cells, but also some of the reasons you still are a proponent of embryonic stem cells, You mentioned the heart, but has not a study recently come out from Italy, I think it was, where they used immature skeletal muscle cells that actually found their way into the infarct zone and were able to establish themselves in a heart?

    Ms. Freda Miller: Dr. Bathia was referring to a number of the studies. Because it's in its infancy, people are still at the point where they take these various populations and cells--and we're doing it ourselves--and tag them, and then look to see if any cell successfully gets there. There are reports on not just, I should add, the skeletal muscle cells, but another type of stem cells, called the mesenchymal stem cells, which come from bone marrow; there have been reports that they will go to the infarcted heart. They don't actually appear to go into the heart, they appear more to go into the blood vessels around it. So it's a rare event, and the identity of those cells has not been really established yet. So our hope, as adult stem cell researchers, is that some of those will turn out to be bona fide cardiac cells in an animal and that we can do it in spades, if you will. The problem is that we haven't shown that yet.

Á  (1145)  

    Mr. Mick Bathia: To follow up on that, the more pragmatic question is whether the animals in which they were transplanted are healthier than the animals in which they were not. Those types of measurements have not been done. That's what I refer to as physiological benefit. The perception would be that if the cells formed new cardiomyocytes, that heart would function better, its stroke volume would be better, those animals would survive longer. Those types of quantitative studies have not been done in the adult stem cell field.

    Mr. James Lunney: Right, it is early in the research.

    We're all aware that adult cells are being used in therapy, for example, in the celebrated case of the woman with leukemia; there was the chemo to kill the leukemia, and then reseeding with the core cells, and she's doing just fine so far. I talked to a patient myself just recently in Toronto who had undergone chemo for multiple myeloma. He had stem cells extracted, grown in vitro, reseeded, and he's doing fine.

    But I wanted to get to the point of autologous transplant. Though adult cells only grow a few divisions, perhaps you don't need a stem cell line here. The cells are coming from the patient's own body and going back into his own body. A few divisions to multiply them and then reseed them is the way adult cells perhaps can work. So you're not establishing a stem cell line with big profits and patents attached to it, which perhaps isn't an appropriate model for adult stem cells. Might you agree with that?

    Ms. Freda Miller: Maybe some day we'll find out how to make the adult stem cells grow better. I don't think the consensus is that they never will, it's just that we don't really know how to do it yet. So it would open up even more therapeutic avenues than you're suggesting.

    The stem cells you're talking about are the ones Mick used to work on actually, which are the ones for the blood system. There's no question, I don't think, among those of us who work in adult stem cells that if you get stem cells from the blood system, which have been worked on for 30 years, you do get a therapy at the end for the blood system. Or if we were to take brain stem cells--which come, by the way, from embryonic brains--and put them back into the brain of somebody, we would make appropriate brain stem cells. The issue is that many of the tissues we're talking about you can't just go in and harvest. So whether you're talking about heterologous or autologous, those are the ones where there's no alternative, in a sense, except embryonic.

    I agree, in a sense, with your issues. For some things we do have hope for adult stem cells, but all the things that don't fall into those categories are the ones we're worried about.

    Mr. James Lunney: Thank you.

    Dr. Bathia, because you work with the hemopoietic system, can you comment on our understanding that there is drug therapy to induce the bone marrow to release stem cells, which can then be extracted from a blood sample, centrifuged, grown in vitro, and restored to the circulation generally, and these will actually find their way to damaged tissue, seed themselves, and identify with the cells in the region?

    Mr. Mick Bathia: As a point of clarification, I think the precise example you're coming up with, with core blood cells and, in leukemia patients, chemotherapy, is a well appreciated use of adult stem cells. Bone marrow transplants, as they're called, have been done for years and years. So we're talking about a cell that is of one type, blood, making cells of another type, blood. Dr. Rossant mentioned pluripotency, the idea that a cell of one type can form other cell types, but this is a feature we're really not talking about in that context. There's no question autologous transplants work quite well. One can actually use drugs. The drug you're referring to, GCSF, granulocyte colony stimulating factor, can move stem cells from the bone marrow compartment into the peripheral blood system and make them more easily extractable. Those are all used for the blood system, blood recovering blood.

    I think what we're talking about here, to echo again what Dr. Miller was saying, is that when you have a situation where you have autoimmune disease, diabetes for example, taking autologous stem cells from the pancreas is not a viable option. A lot of the therapies and the potentials we're talking about are using stem cells of another type. In fact, it's even questionable whether other types of tissues necessarily have identifiable stem cells that can generate themselves, as with pancreatic stem cells generating a pancreas. I just want to clarify that we're talking about a specific example that's been well appreciated, done clinically in research with blood.

Á  (1150)  

    The Chair: Thank you, Dr. Lunney.

    We'll move to Dr. Dromisky now.

    Mr. Stan Dromisky: Thank you very much, Madam Chairperson.

    First I have to compliment the three doctors, Dr. Miller, Dr. Bathia, and Dr. Rossant. I don't know how much time you spend in your labs compared with how much time you are in contact with other people on the campus, those things called students, people who are learning. You are excellent teachers. I'm hoping you're not locked up in a lab someplace forever and don't have the opportunity to share in such a succinct, clear-cut, uncluttered manner of presenting information. I understood you, and that's amazing. Now I hope you'll be able to understand me, because my head is just zooming around here.

    You used very powerful words. You spoke of the enormous power of the embryonic cell. I believe, Dr. Bathia, you used words like robust. Yet you're talking about a parallel pattern of research with adult stem cells and embryonic and so forth. If the power is there, and if there is such a great awareness and sensitivity internationally, in the private as well as the public sectors of research, with regard to the power of the embryonic cells, do you think that would have a dramatic effect in the search for grants and the kind of research that would be carried out? In other words, why do research on adult cells? If you make a great discovery with embryonic cells, you'll become internationally famous. Why waste your time on an area where you know your chances of success aren't as great just using the embryonic cells?

    Mr. Mick Bathia: An approach in my program that I've taken is to look at adult and embryonic stem cells together. The goal, at least for me personally and the members of my lab, is not necessarily the accolades or international recognition. The goal is the disease state. It's critical to say that the target at least our research program is looking at is to solve a problem of disease that drugs or surgery have not been able to solve. Therefore, we have to use both potentials, the adult and the embryonic, and in the same model system. In my study looking at diabetes and pancreatic regeneration, the input cells, the stem cells, are both adult and embryonic, because--and I think you've heard this echoed several times--there's a need for comparison. I personally don't see in any of my colleagues or myself any drive for international recognition or a funding initiative that may come from work solely in the embryonic field. I would be so bold as to say that's probably not even scientifically sound.

    Mr. Stan Dromisky: What about on the international scene, pertaining to people doing research in these areas? If I took a survey of all the labs that are doing research, would it be the same kind of model as you are recommending, comparing one with the other, or would there be a larger percentage of people doing research just with the embryonic cells?

    Ms. Janet Rossant: If you look world-wide, as in Canada, still the majority of research will be individual labs working on a specific stem cell. Some labs, because of their experience, will perhaps be focusing on embryonic stem cells, some will be focusing on adult. I don't think you're going to see the whole of research in adult stem cells moving to the embryonic side. People who have experience in adult stem cells, as Mick has said, want to see whether that experience can help them understand how to drive embryonic stem cells, and vice versa, people with experience in embryonic stem cells are interested to see whether the information they gain there can be used to drive adult stem cells to differentiate.

    Mr. Stan Dromisky: Let's go to the charitable organizations. Is there any charitable organization that has a very specific goal in mind and is raising funds for a very specific type of research? In other words, is it possible that somebody is funding only embryonic research and not adult stem research?

Á  (1155)  

    Mr. Yves Savoie: I'll answer that from the perspective of my own organization, because the council of all the charities doesn't coordinate the research activities of our members. With the Muscular Dystrophy Association of Canada, our first foundation in respect of research is an investigator-driven competition, where we don't make any determination about the type of research as long as it relates to the muscular dystrophies and other neuromuscular disorders. We have, like the CIHR, developed a research program for targeted research, and in that targeted program we actually find gene and cell therapies for the repair of diseased muscle. In the context of that priority area, in the cellular-based therapies it is very much the co-development that we're interested in.

    You've talked about examples of where adult cells have generated some discoveries that are happy ones. For 15 years the use of adult muscle cells, what are called myoblasts, to actually cure muscular dystrophies has been an extremely disappointing story. I've seen parents crying because the hope that was generated in the mid-eighties about myoblast transfers, which are transfers of adult muscle cells to repair the diseased muscle, has simply not delivered results. In the mouse model it has, at a localized level, produced some gain of strength, but it is not lasting and it is not systemic. The hope is in the co-development approach, using embryonic stem cells and, as you've heard from Dr. Worton, maybe in combination with each other, because there are advantages and benefits to both types of cell.

    We certainly have not targeted the research, and I would dare say--and I can't speak for them--no charity would actually be so foolish as to focus their research in such a narrow way as to discount the possibility of a great victory in an area they would have not identified. I think this targeting of research is really establishing some fairly broad arenas of investigation.

    Mr. Stan Dromisky: Thank you very much.

    The Chair: Dr. Bennett.

    Ms. Carolyn Bennett (St. Paul's, Lib.): Thank you very much for your presentations.

    I guess one of the things Parliament does is want to put this in context with the rest of the world. Could you give us an overview of what's happening in other countries, the magnitude of the research going on elsewhere, the nature of their approval process? Is this a little club, a big club. What hurdles are in place, what are the various regulating approaches? Is it criminal, is it done in an agency, is it regulatory bodies? How do you, as researchers, feel the climate is here for you to do your job and keep researchers here?

    Ms. Janet Rossant: That's a broad question, and I'm sure you've had discussions around this committee about the regulatory system in other countries. If we want to look across the world, again we have to ask, are we talking embryonic stem cells, are we talking adult stem cells, are we talking model organisms, mouse, or are we talking humans? If we look broadly at stem cell research across the world using model organisms and human systems, it's an enormous endeavour. It's a very intensely active research area. There are many researchers in this area. There are many meetings--too many meetings--and a lot of emphasis on this area in many countries. Canada is right up there in its profile and activity in this area.

    If we ask where the intensive research is taking place on human embryonic stem cells right now, it is in the U.S., where they were first derived, as you know, outside the federal funding system, with industrial funds. The researchers who initiated that are still actively pursuing it. With the recent Bush decision to allow NIH funding for existing stem cells, there is now a broader basis of human embryonic stem cell research in the U.S.

    The other country where there is active ongoing research is Australia. The regulatory situation is not clear in Australia, but the research began there. The lines were derived in Singapore. This is what happens, I would say, when you don't have a clear regulatory framework. You end up in rather unusual partnerships, which I don't think is a good way forward. The Australian regulatory system is complex and not fully resolved.

    In Europe the U.K. is the one we hear most about. The U.K. has for a long time had a regulatory body in place to regulate the use of human embryos in research, the HFBA, and now that regulatory body will also potentially license the use of embryos for stem cell research. As you probably also know, it has the capacity to issue licences if they consider the research is necessary for creating embryos and for use of cloning technology to create embryos. With cloning technology, there has been no licence issued in the U.K. for that research. That research is not ongoing. It's not criminally banned, it's under the regulatory banner. That's different from what we have here. Research in the U.K. is going ahead. As I said, until recently anyway, they have not actually derived any new cell lines, but there are a number of groups active in this area.

    In Canada I think researchers in general have been waiting for this legislation, for the guidelines, for a clear framework in which to move forward. I think they recognize that this is a contentious area: it has enormous benefits, but there are ethical concerns. Nobody wants to go ahead in a situation where there are no clear guidelines. So guidelines, regulation, and legislation are important, and I think it's very important that this legislation go forward, not just for stem cells, but for the whole reproductive technology arena, which is in dire need of a regulatory framework.

  (1200)  

    The Chair: Thank you, Dr. Bennett.

    Mr. Szabo.

    Mr. Paul Szabo (Mississauga South, Lib.): Thank you, Madam Chairman.

    I would like to give questions to Mr. Bathia and Ms. Rossant first to think about while I ask Dr. Miller a question.

    Mr. Bathia, the aspect of limited availability of useful embryos has been raised with us before, and you've suggested that we should consider allocating them to get the best utilization of them in the research community. I wonder if you could tell us who should decide who would get access. Are there any precedents you're aware of? And do you believe this may lead to frustration on the part of other researchers who may not be in the loop?

    Dr. Rossant, the issue of immune rejection with regard to the utilization of embryonic stem cells is something people do not mention. Not one of you mentioned it. It is a big problem, and we have seen, for instance, with regard to diabetes and the transplanting of islet cells in the pancreas to produce insulin, numerous cases where the people who have received those transplants have indicated that the side effects of the anti-rejection drugs are worse than the problems they have with the disease in the first place. So I wonder if you could address the issue of rejection and how critical that is in ultimately providing cures and therapies, and indicate whether or not, to get around that, you agree with Dr. Alan Bernstein of the CIHR, who's on the public record as supporting therapeutic cloning and amending this bill at some point to provide for therapeutic cloning.

    This is my question to Dr. Miller. You said society allowed the spare embryos to exist. My understanding was that it was the tri-council policy statement that allowed that research, and neither Canadians, nor Parliament, nor anybody outside the research community had anything to do with the cryogenic process etc. Maybe you would like to comment on that.

  (1205)  

    Ms. Freda Miller: I'd just like to emphasize that most of the research on developing those spare embryos, the IVF embryos, was not performed in Canada. It was technology that was largely developed in Australia and other countries, some in Canada.

    Mr. Paul Szabo: My principal question for you, Dr. Miller, has to do with commercialization and patenting. I don't know how many hands down it is, but I understand that you have patents you'd like to apply for etc. and McGill University refused to defend your three patents. As a consequence--I'm not sure if it's a direct consequence--you are now with the University of Toronto, which has decided to defend your patents. Could you advise the committee about this aspect of patentability and whether you believe the issuance of patents with regard to biomedical research etc. may in fact restrict broader-based research that would be necessary to provide a more timely delivery of therapies and cures?

    Ms. Freda Miller: To clarify the record on the patents that were filed by McGill University, McGill doesn't have much money to pay for patents, so the initial filing, which was actually on stem cells from the nose, believe it or not, was funded by something called the NeuroScience Network, a network of centres of excellence whose mandate was to commercialize research. They had actually paid for that research. So it was a government body that paid for that. When the NeuroScience Network was terminated, nobody had the money, including McGill, to pick up the patent fees--the patent is owned by McGill. At that point it was licensed to a biotech firm, and since that point, until very recently--and I told you those companies have decided to get out of stem cells--the biotech firms had been paying the patent fees, although the patents are always owned by McGill. That had nothing to do with my move to U of T., which was completely for other reasons.

    With any new intellectual property, it's the mandate of most universities in Canada to go around on the network side, the Stem Cell Network and the Stroke Network, and to try to promote patenting. Those patents have not been issued. I don't think a single stem cell patent has been issued in Canada, and it's unclear whether they will be. That's something, presumably, our government will decide, together with the people responsible, whether things like that should be patented. In the U.S. and in Europe they're pending.

    What do I think that does? We show anybody who asks how to make our cells. We host them in our lab, we show them how to do it. I provide cells freely to people who want to use them. I just warn them that if they want to take them to a biotech company, they'll probably have to deal with the attorneys who are going to defend this thing for McGill. So in a sense, it probably does limit commercialization and other commercial money going in, but it puts no restraints whatsoever on academic things. As an example of that, those patents are owned by McGill and I'm at U. of T. working on them. The U. of T. has no ownership, the Hospital for Sick Children has no ownership, but there are no constraints on what I do or who I show. That's pretty much the situation for all those patents. Sam Weiss does have licensed patents on neural stem cells, and several companies have spun off from that. Again, neural stem cells are worked on by hundreds, if not thousands, of laboratories around the world in academia.

    Mr. Paul Szabo: Thank you.

    Mr. Mick Bathia: Would you mind repeating your question?

    Mr. Paul Szabo: It concerned the preciousness of them, maybe putting them in some sort of bank and allocating them to the best researchers with the best possibilities. You mentioned that. And I asked who would make the decision as to who got them. Who are you suggesting? Are there any precedents? Do you feel that kind of thing might frustrate other researchers who may not be in the loop? We heard during the hearings with the CIHR that up and coming researchers didn't seem to get enough attention.

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    Mr. Mick Bathia: I'd have to put a lot more thought into who would decide, but I can tell you at least what criteria should be used. It has to be people who have some experience in the area, certainly people who have experience in stem cells, mouse studies, embryonic cells, as Janet Rossant already indicated.

    Mr. Paul Szabo: Would the agency being created by this act be okay? Do you think this is something they should or could do?

    Mr. Mick Bathia: CIHR has a peer review process, but that's a funding issue. The issue I'm referring to here is whether you should receive a licence to obtain these precious embryos. At least for myself, I divide those two components.

    As to who should be doing the research, again, I think it should be the people who are most experienced, and I think there's some consensus. Canadian scientists in the stem cell field, because of things like the Stem Cell Network, have reached some consensus, and I think we know who might be the best people to do this work. I think that alleviates some of the concerns about who's in the loop. The benefits of driving new lines, which I think there's an argument for, will fall to all the researchers. Intellectual property rights on those should not be instated at all. They should be freely available, and so no one should feel that they're out of the loop at all.

    Mr. Paul Szabo: Dr. Rossant.

    Ms. Janet Rossant: You asked about immune rejection, particularly with regard to embryonic stem cells, which are obviously not autologous transplants. If we could take skin cells and put them back in ourselves, there would not be a rejection issue. In fact, Dr. Bathia did refer to this and mentioned some of his own recent research that suggests that embryonic stem cells are not highly immunogenic. There are some, again, immortal organism data to support that as well. Again, these are early days, and we don't know how well that is going to pan out, but that is one point to bear in mind, and I think it's an important one.

    Second, if we are to move forward in the long run with embryonic stem cells as sources for therapy, the question has been often raised whether we should try to generate stem cells that really are identical to those of people who need the graft and use cloning technology, somatic cell nuclear transfer, to do that. I think at this stage it's really way down the line. That kind of technology is very difficult. I've told you it's quite hard to derive stem cells from embryos at all, and to derive stem cells from embryos after nuclear transfer cloning is even less likely to be successful. So there are many technical issues with regard to generating stem cells that way that make it something that is not high on the agenda of stem cell researchers today.

    My personal view is that if embryonic stem cells are the way forward for therapy, we will find other ways of dealing with the immune rejection problem. I can think of several things one might do. First, one could generate banks, not huge banks, of the major tissue rejection genotypes, so there will be banks of the major transplantation differences between people. A large reason you reject an organ is that there are only a few molecules on the cell surface. So we can make stem cell banks.

    Mr. Paul Szabo: Is that genetic alteration you're talking about?

    Ms. Janet Rossant: No. Number one is, don't genetically alter, just select them from the right genotypes. Number two would be to, in fact, genetically alter them in certain ways to remove some of the antigens that cause rejection. If this turns out to be the technology we need, I think those next steps will occur, and then the issues of trying to use this personalized approach fall out of the way. A personalized medicine, where we'd have to make a stem cell for every person, would be ridiculously expensive, and I would not promote it, certainly in a public health care system, as something we should be moving forward on.

    Mr. Paul Szabo: Okay.

    Thank you, Madam Chair.

    The Chair: Thank you.

    Dr. Lunney.

    Mr. James Lunney: Thank you, Madam Chair.

    A couple of researchers mentioned that the moral dilemma, for them, was settled when society decided to use embryos for assisted human reproductive purposes, the decision was made when society went that way. We might suggest that this decision was never made in a public policy forum, it was done in an unregulated area, and society, by and large, was not aware that embryos were being used for this purpose. That's one comment.

    The other comment was with regard to muscular dystrophy, mentioned by Mr. Savoie. When we're talking about genetic failure, where you have the true genetic disease, an obvious genetic defect in trillions of cells, it's quite likely that stem cell research is not going to be applicable in displacing or replacing trillions of cells in the body anyway. I'd like our researchers to comment on that. This is probably an area where stem cell research is not going to find an application, as it would in another disease type where tissue is damaged, any of the degenerative diseases you might want to talk about, myocardial, arthritic, Parkinson's, and so on. I just leave that as a thought, though some of you may want to comment.

    I want to come back to the patenting. Dr. Miller, this is the first I've heard of wanting to patent adult cells. I wonder about the objective here. I rather understood that in an adult stem cell arrangement, you'd be taking cells out of a body, growing them in vitro, and putting them back into the body. What are you patenting in this case? Surely you're not trying to patent the cells that belong to the body they're coming from? Are you trying to patent a cell type?

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    Ms. Freda Miller: What the universities or the companies are patenting is a method of isolating a cell to be used for research or transplantation. I mean research in a commercial perspective, screening for drugs or whatever. That's what the patents that have been allowed in the States actually deal with. For example, the neural stem cell patents in the States relate to a method of growing neural stem cells from tissue.

    Mr. James Lunney: Let me just pose this question to you. We hear at the committee from researchers that industry seems to be keen to develop different stem cell lines that can be grown in vitro commercially, maybe 200 different cell lines, one that would be good for Parkinson's, one for diabetes, one for cardiac conditions, and so on, all with patents attached to them and profitability. It seems to me, on the adult side of the equation, if we're talking particularly about autologous transplants, the opportunities for patenting and for profits are much lower.

    Ms. Freda Miller: They're very low. As a matter of fact, I don't think any company is going to fund the kind of dream scenario you were talking about, autologous transplantation for individuals. That will all have to be funded by the public system, health charities, or somebody, as a purely medical treatment, because there just isn't any money to be made.

    Mr. James Lunney: Thank you. That was really the gist of my question, what confidence we can have that research is going to be channeled equally to both sides of this equation if profits are stacked up very heavily on one side of it.

    Ms. Freda Miller: To expand on that, I don't think profits are ever going to be made from any cell transplantation therapy. That's why the biotech companies are no longer funding it and pharmaceuticals won't go near it. They're no idiots. This is not something you make money on. They're trying to develop some of these adult stem cells and embryonic stem cells for things like drug screening, and that's a different game altogether. If they could make a human liver cell in a dish from an adult stem cell line, they could screen all their drugs for toxicity very easily. That's where they think they'll be able to use them commercially. None of those companies believes they're the ones who are going to develop cell transplantation.

    To come back, since I was the individual who made the original comment you mentioned about the societal decision, I think I could respect, from a very personal perspective, the decision that those embryos should never be generated and that IVF should be banned, as being consistent with not deriving human ES cells. I don't think you can have your cake and eat it too. I don't think you can say it's okay to have IVF and generate those spare embryos and then throw them out. I respect the decision, as long as there's consistency in the argument.

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    The Chair: Thank you.

    Ms. Skelton.

    Mrs. Carol Skelton: Dr. Bathia and Dr. Rossant mentioned problems they had with the present bill. Dr. Rossant identified criminal sanctions. Dr. Miller, do you see any problems with the bill as it is now?

    Ms. Freda Miller: I am very anxious that some legislative framework be in place. Scientists are people too, and we're seeing things going on that make us uncomfortable as well in this arena of reproductive medicine. I'd like to see a framework in place so those things can be outlawed in Canada, such as cloning humans. I believe regulatory bodies, together with oversight committees, to use that phrase, can deal with the specifics in a way a bill can't, because the science is moving forward. That's the reason I don't have problems with it. I see it as a regulatory framework for something we will have additional layers on top of to make sure the moving science can be monitored on a regular basis and we can change in response to that.

    Mrs. Carol Skelton: Mr. Savoie and Mr. Higgins, do you agree with Dr. Miller?

    Mr. Yves Savoie: I'd suggest, from the perspective of those who have been very actively involved, rather than the council as a whole, that the present bill is the one to act on. There are concerns about the way the agency is going to be implemented in regard to the membership of the board. We really hope there will be people on that board who reflect the experience of the voluntary health charities. We have that same concern about the CIHR. But at the moment I think what is required is urgent action.

    Mrs. Carol Skelton: Thank you very much.

    The Chair: Dr. Lunney has one quick question, he promises me.

    Mr. James Lunney: To pick up where we left off on the stem cell lines, are you saying nobody hopes to make a profit on stem cell lines?

    Ms. Freda Miller: I think no one hopes to make a profit on stem cell lines for cell therapy, which is what has been the focus of this discussion. I think companies imagine that either they'll be able to make a profit by doing things like drug screening or they'll be able to use them, for example, in pharmaceutical companies to help develop better drugs, which, in an indirect sense, will help to give them profits.

    Mr. James Lunney: There's a big controversy about the patenting of the Harvard oncomouse. I presume, if they get a patent on that mouse, it's going to be worth a lot of money to Harvard for developing this mouse that develops cancer in all its progeny. Surely you're not suggesting that there isn't profit in different lines. If you had a stem cell line that's good for diabetes or for Parkinson's, you could sell it all over the world, supposedly, for very generous profits.

    Ms. Freda Miller: Your average Parkinson's disease patient isn't very wealthy. I can't imagine that the public health care system is going to pay millions of dollars to do a cell transplant in one or even a couple of Parkinson's disease patients. Moreover, given the amount of research for the clinical trials alone, which are going to be small in number and hard to do, companies just aren't willing. They consider those small markets. A pharmaceutical company is not going to put the money in, so they're not going to have the intellectual property. They really want them for things like drug screening. These people don't think small. I guess this is sort of in your mandate as a committee. One of the issues with these kinds of therapies is that they have to move them to the clinic somehow. It's very expensive to do that. Industry won't do it, so who is going to do it?

    The Chair: I've got a request from Mr. Szabo for a quick question.

    Mr. Paul Szabo: We've been led to believe by Health Canada and by the Justice officials that following royal assent, it may take an additional two years before the regulations can be promulgated and the agency can be established to receive applications. In view of that fact, do you believe the CIHR should proceed with public funding of embryonic stem cell research prior to this act's coming into force?

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    Ms. Janet Rossant: I think the CIHR guidelines that have been put in place provide a very important framework that reflects the legislation, assuming the legislation passes in this form. Given that there will be this lag period, I would like to see the health committee urge CIHR to bring its guidelines and its oversight committee into place. That will then provide us with a framework to move forward. In the absence of that, we could enter a period such as we're in now, a period of limbo, where the regulatory framework for this research is unclear. I think the CIHR guidelines, which could apply to CIHR funding, but would be also applicable to funding from the private agencies who have agreed to the CIHR guidelines, would provide a mechanism to protect Canadians and the scientists in this interim period.

    Mr. Paul Szabo: For clarification, do you mean the guidelines as presented last March, including those with regard to consent and commercialization?

    Ms. Janet Rossant: That would be the intent, yes.

    Mr. Paul Szabo: Okay.

    The Chair: Okay.

    Mr. Lunney.

    Mr. James Lunney: The subject of somatic cell nuclear transfer was mentioned here, so-called therapeutic cloning. The purported intent of that would be to produce cells that are genetically identical to the recipient. Don't you still have a problem with mitochondrial DNA from the donor egg in that situation? In essence, you're going to have genetic material from two different people in the same body.

    Ms. Janet Rossant: You will. There will be a component of that, but in respect of tissue rejection, that is not likely to be a major concern.

    Mr. James Lunney: Thank you.

    The Chair: Thank you very much.

    On behalf of the committee, I thank our witnesses very much for coming and sharing so openly with us. We are trying to do our best with this bill, but as you can imagine, we don't very often have a panel where everybody agrees. We have had in the last couple of days, but prior to that we had panels where the debate raged on almost between the witnesses. So you've had an easy ride from that perspective, but we really needed to know what you are thinking, and we thank you for the work you're doing. Thank you for sharing it with us.

    For the advice of the members, I have had requests now for the people from the U.K. by videoconferencing, Olivia Pratten, as an individual, David Prentice, Catherine Verfaillie, Clement Persaud, Tim Caulfield, and Diane Irving. I will instruct the clerk to try to get those people for Monday. We had scheduled 11 a.m. as the start. If we can't get all of them, I may suggest we start a little bit later, which should make it easier for you to travel on Monday. So would you ask your staff members to keep their eyes open for the actual start time of Monday's meeting, so that we're all working on the same page.

    The clerk informs me that the videoconferencing with the people from the U.K. probably couldn't be later, because of the time difference. That's about as late as they can do it. So I guess, if they say yes, we'll have to start at 11. They have been alerted to our needs. The question is what they already have booked for Monday.

    Anyway, thank you for your suggestions. Not everyone has put a suggestion in yet. The clerk will be open for another couple of hours to receive them, but beyond that he has to get working on booking these people.

    Thank you very much. I'll see you on Monday. The meeting is adjourned.