[English]
EVIDENCE
[Recorded by Electronic Apparatus]
Wednesday, October 31, 2001
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[English]
The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good afternoon, ladies and gentlemen.
First, I apologize for the late start. It's the weather, I think. I have to blame something else.
We're very honoured to have with us this afternoon Dr. Alan Bernstein, who has the ominous task of being the head of the national institutes of health. As such, he is a person with a broad overview of the state of research in this country in the health field.
We're very happy to have him. He has had a chance to look at the proposed legislation. He has some opening remarks, but he's told me he would like to keep them to a minimum in order to be open to your questions. Anything about the draft legislation that you want his opinion on, he will attempt to answer.
• 1545
Dr. Bernstein.
Dr. Alan Bernstein (President, Canadian Institutes of Health Research): Thank you very much.
I very much appreciate this opportunity to be here with you today. I'm sorry I couldn't make it the other week when I was invited. I had personal reasons for not being able to be here.
I know that several of my colleagues have appeared in front of you already, including Dr. Janet Rossant, who chaired CIHR's working group on stem cell research; two of our researchers, Ron Worton from here in Ottawa and his colleague, Michael Rudnicki; as well as Dr. Thérèse Leroux, the new head of CIHR's office of ethics.
My remarks will be brief. I think stem cells, and the issues raised by them, are just an illustration, if you will, of the power and promise of health research in this new century to impact on human health and to deal with emerging threats, which we've become all too familiar with in the last few weeks.
I hope... well, certainly our attempt in the stem cell document, and the committee we struck almost a year ago now to provide advice to the governing council of CIHR on this, is to provide a balance that is respectful of, on the one hand, human dignity, the value of the individual, and the perspective of those who are against the use of human embryos in any kind of research, and those with serious life-threatening diseases. I know you appreciate that this is why this is an ethical, as opposed to a very cut and dried, issue.
That committee was struck about a year ago, as I said. It was composed of very senior researchers in Canada and abroad. Dr. Anne McLaren is a highly respected embryologist from the United Kingdom. She actually is the official U.K. adviser on stem cells. Dr. McLaren graciously gave up very much of her time in order to be part of that committee. In addition, that committee was composed of senior ethicists and law experts, some of whom you've met in this discussion.
In my judgment, they have done a superb job in providing advice not just to CIHR but also to Canada on how to proceed on this difficult opportunity, balancing those two things. Really, those recommendations have provided much of the framework for the legislation that Minister Rock has tabled, particularly in the section dealing with stem cells, obviously.
I will stop there. As the chair has said, I would be very happy to try to answer your questions and to have a discussion on where Canada should be going in this area.
The Chair: Thank you, Dr. Bernstein. You are the most succinct witness we've ever had. We don't have any prizes, unfortunately.
Mr. Manning.
Mr. Preston Manning (Calgary Southwest, Canadian Alliance): I want to thank you for joining us, Dr. Bernstein, and to compliment the CIHR on the funding you are doing in the health research field. I think certainly the members of this committee consider health-related research as being vitally important. We know you're playing a principal role in that.
I really have two questions. The second gets into therapeutic cloning and stem cells and how you regulate that, but the first is more general.
As you know, we have to decide on the form and nature of the regulatory body that is ultimately going to preside not just over assisted human reproduction and related research; ultimately, this will become the senior regulator of probably genetic science generally.
I wonder if you could tell us, particularly from the standpoint of the medical community and the science community, what are the most important characteristics that regulatory body should have. We've listened to people who think independence is the most important, or technical competence, or accountability. Particularly from the medical and scientific perspective, what characteristics would you put at the top?
Dr. Alan Bernstein: My answer might surprise you; I would put public trust at the top.
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I think an important function of such a national
oversight regulatory body would be to ensure that the
public has confidence in the processes
being put into place. Otherwise the whole thing
eventually collapses, if you will. So I would put that
as number one.
I take it almost as a given that there will be technical competence on the committee, so I'll put that lower. It's in there, but it's almost an assumption.
There's also independence, or arm's length, from CIHR certainly. We are not, as you know, simply a granting agency. Our institutes are developing thematic initiatives, including stem cells potentially, so I don't think we should be both promoter and regulator. I think that's inappropriate, and it's not the way to engender public trust. I think it has to be certainly at arm's length from us. How arm's length? It ultimately has to be answerable, so it can't be too arm's length or it loses that answerability.
As to how one structures that, I'm not quite sure. Whether it's out of Health Canada or some other neutral origin of government, I'm not sure, but I think the independence and the autonomy are important.
Lay participation on such a committee is also important. International participation is important.
Off the top of my head, I think those would be the qualities I would want.
Mr. Preston Manning: Coming back to your first point, in your judgment what has to be done to vest a regulatory body with trust? Maybe you can speak at least from the perspective of the medical and scientific community you represent. What does that body have to have in order to earn and hold that trust?
Dr. Alan Bernstein: I think it's partly its composition and partly its relationship to other bodies. The composition has to be above reproach in terms of the individual members who are there and why they are there, and this relationship has to be at arm's length but answerable. Structuring that somehow is I think the way to engender that public trust.
There are many publics, of course. The research community and the clinical community are also publics, and they will also look very carefully at who's on that committee. From their point of view, is the technical and ethical expertise that's there—again, I would take it as a given that it would be—both appropriate and knowledgeable in a rapidly changing science?
Mr. Preston Manning: Okay.
My second line of questioning is really twofold. I'd like to—if I can, Madam Chairman—take about two minutes and recite to you my layman's understanding of therapeutic cloning and its connection to stem cell research. Now, I may be completely wrong, but I'd prefer to be told I'm wrong by an authority. This is sort of gleaned from what we've listened to. I want to make sure I understand what those two things are and the connection between them.
And then my second question—if that understanding is correct, or else you give us a corrected version—is to ask exactly how you feel that should be regulated, all the way from prohibition to permission, subject to regulation, and all the other options in between.
Now, from what I've heard, therapeutic cloning involves removing the nucleus from a somatic cell, which is a non-reproduction cell, replacing it with the nucleus from another cell, and allowing it to develop into a blastocyst or early embryonic form from which stem cells can be derived. Of the two principal benefits we've heard for doing that, I guess the first is that stem cells so derived could contribute to the understanding of certain genetically transmitted diseases. If the replacement nucleus, for example, was taken from someone with a genetically transmitted disease, the resulting stem cells could be very useful, and tissue perhaps coming from them could be very useful, in gaining understanding of perhaps the cure for, or the origins of, that disease. That would be one benefit.
The second benefit would be perhaps ultimately producing replacement tissue and organs. Stem cells produced by therapeutic cloning would lead to stem cells and tissues, the genetic makeup being the same as the source of the contributed nucleus, and therefore being compatible, not susceptible to rejection and things like that.
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Those were the two benefits. The dangers and
concerns expressed with
respect to this research are, first and foremost,
that it does involve the destruction of the human
embryo, and second, that the benefits to be
derived are still quite
potential. They're perhaps down the road, but the
destruction is actual and the benefit is perhaps.
Third, there are alternative sources of
stem cells, although perhaps not as flexible, that don't
raise that ethical problem.
My first question to you is whether my layman's understanding of therapeutic cloning and its connection to stem cells, and the major benefits and concerns, is correct.
Dr. Alan Bernstein: It's very close. Let me just paraphrase it a little bit, Mr. Manning, just so we're on the same wavelength.
To start at the beginning, one would take the nucleus of a somatic cell, a body cell, and use it to put into and remove the nucleus of an egg and put that somatic nucleus in. That's really how Dolly was generated. You now use that new cell, if you will, not to clone—as with Dolly—a human being but to actually use these as cells now in a therapeutic sense—in a transplant to replace diseased tissue, for example, or to study in a laboratory the nature of the mutation or the disease if the source of the nucleus is from an individual with the disease in question.
I hope we're on the same...
I'm trying to remember the second half of your question.
Mr. Preston Manning: It was with regard to the benefits being basically understanding and then perhaps ultimately producing tissue that is compatible with the genetic makeup of the replacement nucleus.
Dr. Alan Bernstein: Exactly.
At the moment, we actually have good reason to think that the stem cells available, or any new stem cells that will be generated from a third party, from an anonymous donor... If I had a neuro-degenerative disorder and those cells were to be put in me, there would clearly be histocompatible differences between that donor and myself. It therefore would be likely that my body would reject those cells, except under very special circumstances, much like a blood cell transfusion or a bone marrow transplant. A bone marrow transplant is really a stem cell transplant.
So one is looking for good compatibility between the donor and the host.
Mr. Preston Manning: So the understanding is fairly...
My second question is with regard to your recommendation. I know the CIHR has its guidelines in this, but we're looking at it from the broader perspective of whether therapeutic cloning, to the end of producing stem cells, is something that should be prohibited at this point in time, prohibited by statute or prohibited by regulation. Or is it something that, in your judgment, should be permitted, subject to conditions, and if so, what conditions?
Dr. Alan Bernstein: The CIHR committee recommended that it not be permitted, certainly in a CIHR-funded universe. I would obviously then extrapolate that up to legislation or national regulations.
I think their reasons were several-fold. One is scientific. The efficiency of this process, if you look at Dolly from a reproductive cloning perspective, was extremely low. I think there's good reason to think that in our somatic tissue, whether it's skin or a cell from your heart or lung or brain, mistakes have accumulated with time. That is, if you will, the normal process of aging. To take the nucleus from such an aged cell and use it for therapeutic cloning means you are now perpetuating those mistakes and expecting that cell to have the horsepower to recapitulate things in early embryogenesis. That may be unrealistic, and may be why Dolly and other things were so inefficient.
So there's a great risk that it simply won't work because of the accumulated errors that happen with time and aging. I also think there's great concern internationally that from a reproductive cloning point of view and also from a therapeutic cloning point of view that would not be a wise course just on scientific grounds alone.
• 1600
Moving beyond the
science, I think the other arguments or other
considerations centre around slippery slope
arguments. For example, if one allows nuclear
transfer, is that the first step to
going from therapeutic cloning to reproductive
cloning—i.e., cloning in the sense that the public and popular
press understands it?
I think there's also the feeling that we're not quite ready at this point to really contemplate putting human stem cells into people, so the issues around histocompatibility differences are real but theoretical at the moment.
So in terms of guidelines that can be easily changed with changing science, we have a lot of basic research to do just on the properties of human stem cells and their capabilities under various experimental circumstances. When it actually comes time to put these cells into people, we might want to worry hard about histocompatibility differences, and then maybe other science will come along to a point where we can revisit the whole therapeutic cloning aspect.
Mr. Preston Manning: So you could support this draft legislation, which does prohibit both reproductive and therapeutic cloning at this stage.
Dr. Alan Bernstein: Personally, yes, and that certainly is the committee's recommendation.
Mr. Preston Manning: Okay. Thank you.
The Chair: Thank you, Mr. Manning.
Dr. Lunney.
Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): Thank you.
Perhaps, since it's come up, we can carry on with the issue of therapeutic cloning. Is there another issue with the nucleus transplant to the enucleated egg, that in fact there's still genetic material, mitochondrial DNA in the cytoplasm of the donor cell egg, and there are unknown consequences of how that might affect the new nucleus coming in? Is that also a factor to consider in the therapeutic cloning issue?
Dr. Alan Bernstein: It might be. I think the honest answer is that we don't know. My instinct as a scientist would be that it would be minor, but that's only instinct, and when it comes to experimenting with people, instinct is probably not good enough.
I think it's fair to say that we can do that kind of research in other mammals, such as mice, and gain deeper insight into the interactions, if you will, between the mitochondrial genome and the nuclear genome to get a better sense of whether that is an issue that needs to be addressed before we even think about it.
Mr. James Lunney: Thank you, yes. I think everyone around this committee supports scientific research. We're excited about the potential that science is offering us in this age, but of course this particular bill we've landed in the middle of has forced us all to do some boning up in a hurry.
On the issue of the age of the embryo, can you comment with regard to the 14 days that has been mentioned here as research on these so-called leftover or excess embryos? I understand the connection to the appearance of the notochord, but would you suggest this is a definitive moment for the embryo, or is it just another stage? Is it arbitrary, or is this a significant landmark for definition of the commencement of life?
Dr. Alan Bernstein: It certainly is a significant landmark. To be honest, development is a continuum, embryological development is a continuum, and whatever day one is picked as a demarcation point is to some extent arbitrary.
The beginning of the nervous system, of the notochord, is as logical a demarcation point as any. Obviously the earlier the better in terms of beyond which one would not allow the use of cells for experimental or research purposes, but from my perspective, it would be hard for me to say there's a magic point beyond which we go from a clump of cells to a nascent human being.
Mr. James Lunney: Thank you.
We noticed that you were quoted in a recent article that came out of McGill University with the breakthrough involving Dr. Freda Miller, a researcher who had some startling and very encouraging results with skin-based precursors; I think that's the term she used. They're basically adult stem cells that were able to morph into neurons and precursors for muscle cells and so on.
We've had a lot of discussion and we've heard in the industry enthusiasm about embryonic cells being necessary to develop cures for Parkinson's or diabetes or Alzheimer's and so on. As we've learned through our discussions on this, if you take embryonic cells and transplant them into the host you're dealing with issues of tissue rejection unless you take anti-rejection drugs, presumably for the rest of your life, so that your immune system doesn't dismantle them.
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Would you agree with some of our
witnesses that a preferred route would be
to use adult stem cells, autologous transplants, cells
taken from your own body and transplanted back into
your own body?
Dr. Alan Bernstein: The short answer? Yes. CIHR funded all of that research by Dr. Miller, so we are investing very heavily in that kind of research. And she's not the only one we're supporting.
Now, having given you the short answer, I know that Dr. Rossant and others who have come in front of you have said... and I agree with them. At the moment, I think it's also fair to say that the cells with the most developmental potential are early embryonic cells. We know that early embryonic cells can give rise to a human being. It happens all the time. That's the miracle of life, if you will.
Dr. Miller's work from McGill is a major breakthrough, but let me remind you, or tell you, that Dr. Miller's research involved taking these cells from the skin and looking at their potential, in a Petri dish, to differentiate into other cell types. We don't yet know and are looking for protein markers of various cell types. So with regard to taking skin cells to become neurons, there are particular proteins associated with our nervous system that are not found in our skin cells.
As exciting as that work is—and it is, so I'm happy to take credit for it, as the funder—some research still needs to be done in terms of the developmental potential of those cells in an organism in vivo, in a mouse, or a rat in her case. Can they really contribute to the nervous system or the pancreas, or whatever the tissue is that we're interested in, in intact organs? That indeed is the research that Dr. Miller's doing at the moment.
Mr. James Lunney: We've heard that this has been done with mice, in essence with myocardial infarc, that they've been able to grow muscle stem cells and insert those back into the adult with successfully growing, active cardiac tissue.
Dr. Alan Bernstein: There is some early data that, exactly, there may be some transdifferentiation and plasticity of stem cells that we didn't appreciate before and that can do that.
Again, as I said in response to one of Mr. Manning's questions, let me remind the committee that when we do a bone marrow transplant, the cells that are really repopulating your blood-forming system in a bone marrow transplant are the stem cells in the bone marrow from individual A going into individual B. That's taking adult cells, and they work. Bone marrow transplants are almost routine. I mean, they're a severe procedure, but they are done routinely now.
So we certainly know that there are adult stem cells. In that case, though, it's adult blood cells giving rise to blood cells. What we're hoping for here is transdifferentiation, going from cell type A and becoming a different cell type. The early new data is that this might actually be possible and it might be adult cells. If that were to work, it would be fabulous.
Mr. James Lunney: I have a question on the hemopoietic bone marrow transplants here. Do bone marrow transplant recipients have to take anti-rejection drugs, or, because of the short life of blood cells, is it not necessary? Can you help us with that?
Dr. Alan Bernstein: The answer is, yes, they do have to take anti-rejection drugs. With bone marrow it's particularly problematic, because the donor cells give rise to an immune system. So you get a situation where the host is trying to reject the graft, but quite often the graft is also actively giving rise to cells that can reject the host. So you get graft-versus-host disease, which is a terrible disease.
Mr. James Lunney: One final question. With the 14-day limit we talk about in the current draft legislation for the embryo to be used for research, there's somehow a sense that after 14 days that would be it. It would be the end of the story for the embryo, as it were. But would you agree with some of our witnesses that it isn't really the end, because stem cells extracted from that embryo could be grown in vitro, perhaps in perpetuity, for industrial purposes or commodification of tissue?
Dr. Alan Bernstein: Again, the short answer is, yes, that's a possibility.
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Mr. James Lunney: Thank you. Obviously this is something many find very objectionable, because in essence we're taking tissue that was destined to become a human being, spreading it out, and turning it into a farm, potentially for pharmaceutical use in the development of perhaps dopamine, insulin, or neurotransmitters. Basically, we're talking about the commodification or industrialization of human tissue. Would you agree with that?
Dr. Alan Bernstein: Yes and no; I guess that's my short answer here.
Again, I think it's balancing the respect for human life with the opportunities to treat people with serious disease. The day 14 point is one manifestation of that attempt to balance those two things, and not using embryos beyond day 14.
I've brought along what I think is the clearest statement of this. The Warnock committee in the U.K. in 1990 said that, on the one hand, the embryo of the human species has a special status, but not the same status as a living child or an adult. The human embryo is entitled to a measure of respect beyond that accorded to an embryo of other species, but such respect is not absolute. It may be weighed against the benefits that might arise from research or using those cells. Finally, the embryo of the human species should be afforded some protection in law.
As with other ethical considerations, I think we are talking about balancing the potential for doing good with the issues around commodification of life and respect for the human embryo.
The Chair: Thank you, Dr. Lunney.
Dr. Dromisky.
Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): Thank you very much.
I would like to switch direction here. I realize that you have a tremendous background and a great deal of knowledge—
Dr. Alan Bernstein: I wish my kids did.
Mr. Stan Dromisky: Oh, oh! I know where you're coming from.
I'm making an assumption here that you have gone through the document, the proposed draft, and that there has been a lot of contact between you and possibly your nearest staff members or other colleagues in the field, whether they be at social functions or just over the telephone, through letters, or wherever. In other words, since you and your colleagues have received the copy, there has been a tremendous amount of exchange of ideas, concerns, and so forth.
My question is going to be putting you on the spot. You don't have to answer any part of it if you don't want to, but I'm sure you could.
First of all, can you give us, honestly, the kinds of concerns in general that come from your community of professionals?
The second part of the question, which you can't really avoid because you're going to be tying it in with the first, or the first will be tied in with the second, is the personal concerns you might have regarding any aspect of the entire proposed draft.
That might lead to such a thing as a wish list—you know, it's too bad they're not doing this, they should be doing that. Do you know what I mean? You mentioned the United Kingdom and so forth. You may have little bits of information that you would like to share concerning the questions I'm presenting to you.
Dr. Alan Bernstein: Those are good questions.
The first thing I would say is that I think the committee that CIHR struck has done a fabulous job. As Canadians, we should take great pride in it. In my judgment, it is the best document in the world on this subject.
When we first released the draft document back on March 29, there was a write-up in Nature or Science; I can't remember which journal, but I can get you the write-up. In one of the world's pre-eminent scientific journals the title was “Canada takes the middle ground”. I think that was very accurate, and it sums up, in five words or so, exactly where I was hoping the committee would end up and where the committee did end up.
The three countries that have now come up with at least guidelines are the U.S., the U.K., and Canada. President Bush, as we all know, has said that only existing stem cell lines can be used. The research community in the United States is extremely unhappy with that. I'll come back to that, if you like, with the reasons why.
• 1615
The U.K. has been much
more permissive, allowing, for example, therapeutic
cloning in their guidelines. We have not, but we have
allowed the derivation of new stem cell lines prior to
day 14 and if informed consent is there in other
conditions. The article underneath that headline kind
of fleshed out what the headline said.
So I feel very satisfied and pleased with this document. It's very thoughtful. It has received much input from many groups. We had over 100 submissions when we put out this draft guideline.
My own personal view... and I am speaking personally now, as a scientist and as an individual. I don't think my own personal view should have any extra weight because I'm also president of CIHR. I am very comfortable, as a Canadian, with these guidelines. I can live with them. I'm very satisfied with them.
I think one of the things to remember is that many of those embryos generated for assisted human reproduction are put in freezers and eventually are thrown out anyway. That point was not made in this document, nor should it have been made. This was not an advocacy piece but a guidelines piece.
Mr. Stan Dromisky: How long do they save them?
Dr. Alan Bernstein: I don't know exactly, but it's months. They eventually throw them out because of the worry that those embryos are undergoing a change in the freezer and therefore shouldn't be implanted into a woman to give rise to a child. So they eventually are thrown out.
It's hard to actually know how many excess embryos are being generated. We know excess fertilized eggs are being generated. So if there really is a potential to treat human disease with these cells, I think we almost have an ethical obligation—I'm speaking personally now—to pursue that.
So this document, to my mind, is respectful of human life, of the human embryo, but at the same time it recognizes the potential for curing human disease. I know you've had disease groups appear in front of you to give those two perspectives.
The other point I would make is that the American guidelines, President Bush's guidelines, only apply to NIH-funded research, NIH in the States being the equivalent of CIHR. They do not apply at the moment to research that's carried out outside of the NIH funding. So one potentially has a situation in the United States where there are two sets of rules. One is very tight regulations for government- or NIH-funded research and the other is no regulations whatsoever. It's not ideal by any means. And these regulations are very strict, if you will. I think any serious stem cell researcher in the United States will do that research outside of NIH funding. That's a given, I think.
So we need coherent rules in this country to govern all of research.
Mr. Stan Dromisky: We can all remember and recall President Bush's statement. We watched it on television. He made reference to a very large number of stem cell lines. That shocked people in the United States and Canada, because most people, even the scientists who came on television, weren't aware that there was such a large number. It seemed to be a contradiction, or there seemed to be some kind of misunderstanding.
I'm asking this question because there are people who will think that we have a lot to work with, and that there's a huge surplus. Could you make a comment on that?
Dr. Alan Bernstein: The sixty is a very controversial number internationally. The serious caveat on it is that no one really has that inventory. Many were generated by companies that are not widely or freely available. Third, stem cells like to differentiate; that's what they do. They give rise to... Once they differentiate, they lose the power of being stem cells. Unless they're maintained carefully, they can be a cell line but they no longer are true stem cells. We know that very well from the twenty years of work with mouse stem cells. So as to how many of those sixty, even if they were all available, if there were sixty, have actually retained their stem cell characteristics, no one knows.
What we certainly know as researchers is that in this area there's a lot more research to be done, and that kind of artificial barrier is going to severely impede the research.
• 1620
Now, that may be the desired outcome, of course, but if we
want the research to go forward, it seems like an
arbitrary mechanism for impeding that research. That
has been the argument, and I think the research community
in the States has been very agitated about that.
Mr. Stan Dromisky: Thank you.
The Chair: Thank you, Dr. Dromisky.
Mr. Merrifield.
Mr. Rob Merrifield (Yellowhead, Canadian Alliance): I find absolutely interesting the ethics of the situation we're in and the grey zone we find in this whole subject. We know there are in vitro fertilization clinics for the sole purpose of bringing life forward for a couple who can't have it any other way. That's the intent, and yet we are amassing these massive numbers of embryos in storage. Part of me is saying, well, is it ethical to draw more when you know they're not going to be used to create life, and then just have them perish on the shelf, you might say?
I notice in your whole bill, and going through your book, you talk about a full ethical review. I find it absolutely fascinating that you argue that therapeutic cloning should not take place because of the slippery slope. For the first time as a civilization we're asked to kill our own with the sole intent of trying to ease the pain in someone else, and yet we don't argue the slippery slope there.
Can you somehow put that together in your own mind and explain where you're coming from on that?
Dr. Alan Bernstein: I think the key there is the phrase “to kill our own”. Clearly there are some people in society who would argue exactly that, that it's killing our own, and under no circumstance should we do that.
There are also some who would say full steam ahead; why not? These cells have potential. They're only cells, they're not human beings. They have the potential, perhaps, to become human beings, but they're only cells.
Then there's a sort of middle road that says they certainly have the potential to become human, but they are not yet human. If we take them under the appropriate conditions—day 14 and informed consent—they were being generated anyway, for reproductive purposes, and they have this potential to cure human disease, then, balancing and factoring in all of this, it's reasonable to go ahead.
I'm simplifying a little bit—again, it's a continuum—but I think all three perspectives are of course valid. They're honestly held views. I guess it's your role, and the CIHR committee's job when they were drawing up guidelines, to try to strike that balance. Certainly the CIHR committee's view was to take that middle view.
Mr. Rob Merrifield: I guess I would argue that the main words in that are not “kill our own” but “slippery slope”. I have a hard time when you sit here and argue that we should not go down the therapeutic cloning line because of the slippery slope, and yet you don't see it as being a slippery slope for your embryonic use of stem cells.
Dr. Alan Bernstein: I think that is a concern. I think that's why one has to think about the regulations or legislation or regulatory bodies—going back to Mr. Manning's first question—that need to be well put in place to ensure that we don't start to slide down that slope. I think that is part of the whole package. If we're going to go forward with this, that has to be in place and carefully thought through as well.
Mr. Rob Merrifield: I certainly would agree, and that takes me to two other questions. The regulatory body and the accountability of that regulatory body certainly concerns me, and I think it concerns everybody on our committee. We've had many witnesses come forward, and we're trying to wrestle with how that regulatory body would deal with this and be as accountable as it possibly can be.
I certainly haven't received any answers on that side of it in terms of how we can make it more accountable than we're seeing in some of the other countries that have gone down that road as well.
• 1625
Maybe I'll stop there. Do you have any
suggestions on... I know this leapfrogs from
Mr. Manning's question.
Dr. Alan Bernstein: Yes, I'll be repeating a little bit of what I said to Mr. Manning. I think who it answers to, whether it's a minister or Parliament directly, and the composition of that committee...
Perhaps I'm too much of an optimist, but with the right committee, answerable to the right body, I'm quite confident that we will not slide down that slope. Again, though, that's my own view.
Mr. Rob Merrifield: We have a body with ten years' experience in Britain. What's your view on that one? Has it slipped down the slippery slope?
Dr. Alan Bernstein: I don't think it has. I think internationally one would say that the British experience has been a positive one.
Mr. Rob Merrifield: But they just slipped down to therapeutic cloning, if you look at it that way.
Dr. Alan Bernstein: No, I think it was a conscious decision by a committee to recommend that therapeutic cloning be allowed. It didn't happen de facto. They didn't slide down the slope. They decided to walk down that hill. It was a conscious decision that committee recommended and the government and the House of Lords adopted. So it's a different scenario from what I think you're referring to.
Mr. Rob Merrifield: Well, as to whether we walk down the hill or we slide down the hill, we're really starting to split hairs here. I guess we're saying there's a regulatory body there that started out without the intent of cloning therapeutically, and it has now progressed, as some would say—other people would say “regressed”—to the place where it's now acceptable under that body. I guess my dilemma is, how do we make that accountable?
Dr. Alan Bernstein: I think it's a given that circumstances will change. Science changes. Public values change. I certainly don't know where the world will be ten years from now in either of those two areas. I would submit, though, that if we have the right regulatory structure in place, a change is not, per se, a slippery slope. A change is a change. It might be a good change. We might consciously, as a society, decide that this is really working. We're alleviating human suffering by using these cells, and isn't this wonderful.
So I wouldn't regard a change per se as a slippery slope—i.e., with the implication that it's bad—but rather as evolving values, evolving science. That's why this is an ethical discussion. Ethics, in this case, is a contextual discussion.
Mr. Rob Merrifield: That draws me to my last question. The issue is stem cell research and adult stem cells, or, let's say, non-embryonic stem cells; I understand we can get them from embryonic fluid as well as umbilical cords and other places in the human being.
From the perspective of dollars and cents, when you make decisions on research and where the dollars are going to be placed, there are only so many dollars to go around in research. I guess what alarms me is what I hear coming from some of our researchers, that we should rush down the road of embryonic stem cells. Would it not be at the expense of research on the non-embryonic side, and isn't that a much safer road to travel?
Dr. Alan Bernstein: Science, as you probably know, is like a river; it takes the path of least resistance. It's the art of the doable. So if Freda Miller's work for McGill holds up in terms of the in vivo potential of these cells, I can tell you that every stem cell researcher in the world will rush down that river and follow up on that. Science is the art of the doable.
At the moment we are funding no research on human embryonic stem cells, so it's not a resource issue at all. All our research is either on non-human sources of embryonic stem cells—mice, predominantly—or on adult stem cells from humans or other organisms like mice. So at the moment it's not a priority issue.
If some research shows that embryonic stem cells have great potential, yes, the research community will be clamouring to go down that road. As I said, if Freda Miller's work holds up, they'll want to go down this road, or other people's. So really, it's where are the opportunities, where are the breakthroughs going to come? I think that's the right way we should move forward within a regulatory, ethical framework.
• 1630
The Chair: Thank you, Mr. Merrifield.
Madame Picard.
[Translation]
Ms. Pauline Picard (Drummond, BQ): Thank you, Madam Chair. I'm beginning to get a little confused about all of this.
Institutes conduct research on embryos and stem cells. To produce human tissue, is it necessary to use the cloning procedure?
[English]
Dr. Alan Bernstein: I'm trying to see what's behind your question. The research we're funding at the moment does not involve at all the use, first of all, of human embryonic cells. No one is doing that at the moment in the country, or certainly not that I'm aware of. Second, it certainly does not involve reproductive or therapeutic cloning.
Now, if I take some skin cells from you and put them in a Petri dish, a single cell will divide and give rise to two daughter cells. Those daughter cells are essentially clones of the mother cell. Those cells have been cloned in a sense, but not in the sense I think you're worrying about, in terms of cloning another sheep or a human.
[Translation]
Ms. Pauline Picard: I'm trying to understand. In my opinion, there are some borderline issues involved. For research purposes, techniques are used which at some point result in the enucleation of an ovum in order to reprogram the egg.
[English]
Dr. Alan Bernstein: Can I just jump in here?
[Translation]
Ms. Pauline Picard: Yes.
[English]
Dr. Alan Bernstein: Actually, going back to what Mr. Manning started with, in terms of therapeutic cloning, at the moment CIHR's guidelines say, no, you cannot do that. You cannot take a nucleus from one cell and put it into an enucleated egg to reprogram it, as you said.
[Translation]
Ms. Pauline Picard: A person who uses an assisted reproduction method and who has surplus embryos may decide to donate those embryos for the purpose of research. If the procedure is done in vitro in a laboratory, the practice is not prohibited. According to the draft bill, all the person would have to do is obtain a licence.
Therapeutic cloning would be banned. However, if I decided to donate my eggs for research purposes, then that would be okay. All that is required is a licence to undertake the activity.
There's something I don't really understand here.
[English]
Dr. Alan Bernstein: I'm having some trouble understanding what you don't understand. At the moment, couples who are undergoing assisted human reproduction are generating embryos in vitro. Some of those embryos are reimplanted for the purpose of having a baby. Many of them are frozen and used in the future if the first procedure hasn't worked. Many of them are never used at all.
What the committee was trying to wrestle with was that given the potential of those cells for therapeutic purposes—they have stem cell qualities—under what conditions should they be allowed to go ahead? So they outlined about a half-dozen conditions under which those cells would be allowed to be used for research purposes initially—informed consent, before day 14, etc.
I'm not sure I'm answering your question, but I'm trying to understand what the issues are for you.
• 1635
[Translation]
Ms. Pauline Picard: You have provided a partial response, but it really doesn't answer all of my questions.
In order to ban a certain practice, the Criminal Code must be amended. People who ignore the ban will be deemed criminals and will receive prison sentences. However, as I said, if a person decides to donate eggs for research purposes, then a laboratory technique which would otherwise be banned would be allowed.
[English]
Dr. Alan Bernstein: If legislation is enacted, and if that legislation says it is a criminal offence to do such and such, that legislation would obviously supersede our guidelines. These guidelines are only there in the vacuum of no guidelines or legislation.
If this committee recommends certain legislation be enacted in the Criminal Code, and if that is passed by Parliament, then that's the law of the land. We would modify our guidelines to align with the legislation. These guidelines are here in the absence of any legislation or any regulations from Parliament.
Does that answer it?
[Translation]
Ms. Pauline Picard: Yes. Earlier, you stated that you were opposed to the therapeutic cloning of embryos and that you had advised Health Canada to ban the cloning of human embryos for such purposes. You then said that public opinion could change and that in order not to hinder the pace of research, we should perhaps revisit the issue in 10 years' time. If certain practices become criminal offences as a result of amendments to the Criminal Code, I'm not so sure that it will be easy to conduct further research in this field.
[English]
Dr. Alan Bernstein: I agree. As you know, several witnesses in front of this committee, including Dr. Caulfield from Alberta, a health law and ethics expert who was on our committee, have taken the position and urged you not to embody this into the Criminal Code so that there's more flexibility.
I think that's one of the things you will have to wrestle with. I have no special advice to give you here. I certainly know that the science will change. If the changing in the science is going to require a change in legislation, that's perhaps cumbersome. That's Dr. Caulfield's argument in brief.
So you'll have to wrestle with that perspective versus the other, that if you want to make sure you avoid the slippery slope, the only sure way is to embody it in the Criminal Code. Those are the balancing acts you'll have to go through.
There's no question that in an area of science that we know is going to change rapidly, I think there is a strong argument—Dr. Caulfield and Dr. Knoppers from the Université de Montréal have both advanced this argument—that perhaps regulations are a better way to go than embodying it the code.
Ms. Pauline Picard: Thank you very much.
The Chair: Thank you, Madame Picard.
Does anyone over here want to ask a question?
Mr. Reg Alcock (Winnipeg South, Lib.): I want to grab hold of Alan for a minute, but only when he's finished here.
The Chair: All right.
I have one question, and it has to do with, say, the enforcement of any laws we do come up with, whether it's by regulation or prohibition. The intention is that it will apply to both the public sector, meaning hospitals and labs and places that get dollars from your particular institutes... as opposed to the private sector, which, as you have pointed out, is going totally unregulated in the United States.
• 1640
We have heard that about 25 fertility clinics
are in operation in the country. To me, that seems a
manageable number to inspect, to keep a check on,
to collect data for us, and all those kinds of things.
What would be your prediction on the number of
private sector companies who, once the moratorium is
lifted, might enter this field? Would it be hundreds
or would it be...
Dr. Alan Bernstein: That's a hard one, in part because these are all promissory notes. We don't yet really know the therapeutic potential of these cells in humans.
Actually, my own best guess at the moment is we're not talking hundreds, we're maybe talking, in Canada, five to twenty. That may look foolish in a few years, but that's the number I'll put on the table at the moment. I don't see huge numbers of companies entering into this area. It certainly will not be in the hundreds. I'd be very surprised if it was more than a dozen or so.
The Chair: Just suppose even five companies enter the field once it's allowable, and suppose it is one of those private sector companies that makes the great breakthrough in, say, spinal cord repair or something like that. Do you have any understanding of the intellectual property act and how that would apply? For instance, would it mean that the company who discovered it, in the same way companies discover new medications, will own a patent lasting for years, and nobody else can replicate their work or their product?
I'm very worried about that aspect of it. To me, on the whole question raised earlier about commercialization, it's much more dangerous when this activity is in the hands of the private sector than when it's in the hands of a university researcher.
Dr. Alan Bernstein: I'm not a lawyer, and this is a very complicated area. There'll be two arguments put forward by the private sector. One is, yes, we should have the right to patent a process and its use. I think the research community, the clinical community, and perhaps the public, will argue the other. We've already seen that now with DNA testing in one province in this country, and in Europe. It's certainly not settled yet. It's very much up in the air.
I can tell you, going back to what I said earlier about bone marrow transplantation, that process has never been patented. So there is a precedent, a negative precedent, if you will.
Again, I'm not speaking as a lawyer, and I'm out of my depth, but I would predict that if a company tries to patent, an interesting discussion will ensue.
The Chair: I'm wondering if we should comment on it. I'm finding this piece of legislation overall to be very short-sighted in the sense that, I think in order to avoid all the potential arguments around abortion and what happens at the other end, they want to limit the discussion to what happens prior to the implantation of an embryo into a woman. I understand it, but I find it kind of irresponsible.
The other side of it is that it doesn't talk about anything to do with discoveries in this field and intellectual property laws, patents, or any of those kinds of things. I'm wondering if we should comment on that as well in order to preclude what I would consider to be abuses.
Dr. Alan Bernstein: I certainly would encourage you to do that. If these cells have true therapeutic potential, I think they should be widely available. And I think you've made one of my arguments as to why we need public bodies to fund research in this country—to guarantee it happens.
The Chair: One more.
Mr. Preston Manning: Thank you, Madam Chair.
Does the CIHR fund research in private laboratories?
Dr. Alan Bernstein: We fund partnerships between academic researchers and private laboratories in the biopharmaceutical sector.
Mr. Preston Manning: It really isn't your job to tell us this, but just while you're here, if were to try to get a couple of private sector outfits who are in this area and put these types of questions to them—for instance, with respect to their intentions, what they're looking at—are there any companies or particular researchers... MDS Proteomics comes to mind as a company that's spending a fair amount of money in this area.
Dr. Alan Bernstein: That's one I'm familiar with. I think another one would be the company that is also funding some of Dr. Miller's work. I think the company is Aeterna Laboratories in Montreal, a small biotech company. I know nothing about them, but I think it would be very useful to hear their perspective on this, particularly because they're intimately involved in this type of research at the moment.
• 1645
The Chair: Thank you very much, Dr. Bernstein. You've very generously given us an hour, and you've had to answer questions from a wide variety of angles. It's possible our researchers may want to tap into your knowledge later, and they might give you a call if we have your permission.
Again, thank you for your attendance and your generosity. Hopefully we can be generous in return when the moment comes.
Ladies and gentlemen, I asked those people who had some time between last week and this week—and for those who forgot, between yesterday and today—to perhaps put on paper...
We were going to go in camera for this, I'm sorry.
Do I have your agreement to go in camera for this discussion?
Some hon. members: Agreed.
[Editor's Note: Proceedings continue in camera]
