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37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Monday, December 2, 2002

1105

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

Ms. Suzi Leather (Chair, Human Fertilisation and Embryology Authority, United Kingdom)

1110

1115

1120

The Chair

Mr. Rob Merrifield (Yellowhead, Canadian Alliance)

1125

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

The Chair

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

1130

Ms. Suzi Leather

Mr. Stan Dromisky

Ms. Suzi Leather

Mr. Stan Dromisky

Ms. Suzi Leather

Mr. Stan Dromisky

Ms. Suzi Leather

Mr. Stan Dromisky

Ms. Suzi Leather

Mr. Stan Dromisky

Ms. Suzi Leather

1135

Mr. Stan Dromisky

Ms. Suzi Leather

Mr. Stan Dromisky

Ms. Suzi Leather

Mr. Stan Dromisky

The Chair

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

Ms. Suzi Leather

Mr. James Lunney

Ms. Suzi Leather

Mr. James Lunney

Ms. Suzi Leather

1140

Mr. James Lunney

Ms. Suzi Leather

Mr. James Lunney

Ms. Suzi Leather

Mr. James Lunney

The Chair

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

1145

Ms. Suzi Leather

The Chair

Mr. Paul Szabo (Mississauga South, Lib.)

Ms. Suzi Leather

1150

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

1155

Ms. Suzi Leather

The Chair

1200

Ms. Suzi Leather

The Chair

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

1205

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

Ms. Suzi Leather

Mr. Rob Merrifield

The Chair

Ms. Carolyn Bennett

1210

Ms. Suzi Leather

Ms. Carolyn Bennett

The Chair

Mr. James Lunney

Ms. Suzi Leather

Mr. James Lunney

Ms. Suzi Leather

Mr. James Lunney

Ms. Suzi Leather

Mr. James Lunney

Ms. Suzi Leather

Mr. James Lunney

Ms. Suzi Leather

Mr. James Lunney

The Chair

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

1215

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

Mr. Paul Szabo

Ms. Suzi Leather

The Chair

Ms. Suzi Leather

The Chair

1220

Ms. Suzi Leather

The Chair

Mr. James Lunney

1225

The Chair

Mr. James Lunney

Ms. Suzi Leather

The Chair

Ms. Suzi Leather

The Chair

Ms. Carolyn Bennett

The Chair

Ms. Suzi Leather

Ms. Carolyn Bennett

Ms. Suzi Leather

Ms. Carolyn Bennett

Ms. Suzi Leather

1230

The Chair

Ms. Suzi Leather

The Chair

Professor Sam Weiss (Department of Cell Biology and Anatomy, University of Calgary)

1300

The Chair

Professor Timothy Caulfield (Canada Research Chair in Health Law and Policy, Faculty of Law and Faculty of Medicine and Dentistry, University of Alberta)

1305

1310

The Chair

Mr. Clement Persaud (Individual Presentation)

1315

The Chair

1320

Mr. James Lunney

Prof. Sam Weiss

Mr. James Lunney

Prof. Sam Weiss

Mr. James Lunney

Prof. Sam Weiss

1325

Mr. James Lunney

Prof. Sam Weiss

Mr. James Lunney

Prof. Sam Weiss

Mr. James Lunney

Mr. Clement Persaud

1330

The Chair

Prof. Timothy Caulfield

The Chair

Prof. Timothy Caulfield

The Chair

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.)

Prof. Sam Weiss

1335

Mr. Jeannot Castonguay

Prof. Timothy Caulfield

The Chair

Prof. Timothy Caulfield

The Chair

Mr. Clement Persaud

Mr. Jeannot Castonguay

Mr. Clement Persaud

M. Jeannot Castonguay

Mr. Clement Persaud

The Chair

Prof. Sam Weiss

Mr. James Lunney

Prof. Sam Weiss

The Chair

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

Prof. Timothy Caulfield

1340

Ms. Carol Skelton

The Chair

Prof. Timothy Caulfield

The Chair

Prof. Timothy Caulfield

The Chair

Prof. Timothy Caulfield

The Chair

Prof. Timothy Caulfield

The Chair

Prof. Timothy Caulfield

The Chair

Prof. Timothy Caulfield

Ms. Carol Skelton

1345

The Chair

Prof. Timothy Caulfield

The Chair

Mr. James Lunney

Prof. Sam Weiss

Mr. James Lunney

Prof. Sam Weiss

1350

The Chair

Mr. James Lunney

The Chair

Prof. Sam Weiss

The Chair

Prof. Sam Weiss

The Chair

Prof. Sam Weiss

Prof. Timothy Caulfield

The Chair

Prof. Timothy Caulfield

The Chair

Prof. Timothy Caulfield

The Chair

1355

Prof. Timothy Caulfield

The Chair

Mr. James Lunney

Mr. Clement Persaud

The Chair

Mr. Clement Persaud

The Chair

CANADA

Standing Committee on Health

NUMBER 008

2nd SESSION

37th PARLIAMENT

EVIDENCE

Monday, December 2, 2002

[Recorded by Electronic Apparatus]

Á (1105)

[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen.

It's my pleasure to welcome you to this meeting of the Standing Committee on Health, and to welcome to our midst via video conferencing Ms. Suzi Leather, who is the chair of the Human Fertilization and Embryology Authority in Great Britain, and Angela McNab, who is the chief executive of that body.

Good morning, ladies. We're delighted to have access to you and your wisdom on this topic as we are about to begin clause-by-clause study of a bill that relates to these matters. So without further ado, I would like to give you the floor, whichever one of you would like to speak first, and that will be followed by a question and answer period.

So please go ahead.

Ms. Suzi Leather (Chair, Human Fertilisation and Embryology Authority, United Kingdom): Thank you very much indeed, Madam Chair, and hello to all your colleagues from here in London. Thank you very much indeed for inviting us to appear before you. It's a great honour for me and for my chief executive, Angela McNab, who's with me here.

Angela has been in her post for a relatively short time, a matter of two or three weeks, so I will make the main presentation to you, and then we'd be delighted to answer questions.

I have e-mailed two slide presentations to you and I start with an apology that they are both in English only. I don't know if they're available to you.

The first is on the regulation of assisted reproductive technologies and human embryo research in the United Kingdom. This is a presentation that I gave in Washington in October to the President's Council on Bioethics.

The second is entitled “HFEA Licensing of Research on Human Embryos”. This was a presentation that was given at the first international stem cell conference that the British government organized in London in September. For English speakers, it may be helpful for you to have a set of the slides of the second talk with you.

But in any case, I thought I would spend a few minutes going over that because I see from your e-mail to us that how we license embryo research was one of the first things you wanted to ask about. So, Chair, if it would suit you, I will spend a few minutes talking about that. Then I will talk a little about other issues such as donor anonymity.

Is that how you want to play it?

The Chair: That's just fine, please go ahead.

Ms. Suzi Leather: The creation outside the body, the storage, use and treatment, and the scientific manipulation of embryos is regulated in the United Kingdom by the Human Fertilisation and Embryology Authority. The HFEA, as it is called, is a non-departmental public body. It is accountable to Parliament through the Secretary of State for Health. The HFEA has an important role in regulating embryonic cell research, embryo research, and particularly laterally in research involving embryonic stem cells.

I will outline that role and pay particular attention to showing how we ensure that embryonic stem cells are created legally and ethically. It's clearly very important in maintaining public confidence, not only in embryo research generally but particularly in stem cell research, which we regard as a new and promising territory for medical science.

We were set up as an organization in 1991 and we were the first regulatory authority of its kind in the world. All embryo research in the United Kingdom must be approved by the HFEA, and we don't make the distinction between research that is publicly or privately funded.

The procedure by which research licences are granted is principled and stringent. In considering embryo research applications, the authority determines first whether the research proposal passes the necessity test and the intended-purpose test. Under the 1990 act, a licence may not be granted unless the authority is satisfied that any proposed use of embryos is necessary for the purposes of the research. We cannot authorize any activity unless it appears to us to be necessary or desirable for the purposes set down by Parliament.

Now, the Human Fertilisation and Embryology Act, 1990, defines these purposes as:

Promoting advances in the treatment of infertility; increasing knowledge about the causes of congenital disease; increasing knowledge about the causes of miscarriage; developing more effective techniques of contraception; or developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation.

Á (1110)

In January 2001, following large majorities in both houses of Parliament--and I want to stress that both those votes were free votes--three additional research purposes were added. First was increasing knowledge about the development of embryos, second was increasing knowledge about serious disease, and third was enabling any such knowledge to be applied in developing treatments for serious disease.

In addition to passing the first hurdles I talked about--the necessity and appropriate-purpose tests--all research applications must have the approval of a properly constituted local research ethics committee. The research is then subject to our peer review. The research facilities are inspected, and the proposed licence holder for the project and some of their team are interviewed, before a final report is considered by an HFEA-licensed committee.

The peer review covers the following specific areas: whether the research fulfills the categories for which embryo research is permitted by Parliament; the importance of the research in the field; whether research has been done before, or novelty, in other words; whether the use of human embryos is justified; the suitability of the methods to be used; the proposed length of the study; and the applicant's qualifications.

In response to the recent additional permitted purposes from the 2001 legislation, the HFEA has enhanced its licensing process. In particular, applicants wishing to undertake research to derive stem cells from embryos will be required to first justify why embryonic stem cells are to be used, rather than other types of stem cells. Second, they must provide detailed information on what happens to the stem cells throughout the project. Third, they must place a sample of all stem cell lines established in the planned medical research council's stem cell bank--the U.K. stem cell bank. Researchers may not pass on stem cell lines directly to third parties, so anyone wishing to use cell lines generated in human embryo research must apply to the U.K. stem cell bank to obtain them.

Our regulatory function is also exercised through inspection of research facilities. These are required before a licence can be granted, or before an existing licence can be varied to include a new procedure or research project. The inspections must be satisfied that appropriate informed consents will be obtained without coercion; confidentiality will be maintained throughout; the researchers understand the requirements of the human fertilization and embryology act; and the facilities are appropriate, with adequate security arrangements in place.

As part of the regulation of research projects through licensing, and following stipulations in the act, the HFEA is very precise about the separation of embryos to be used in research, from embryos to be used in treatment; consents and the methods by which embryos are obtained; the length of time they may be kept in culture; and the manner in which they may subsequently perish.

You raised, in your questions to me, issues of consent, and these are important issues for us as well.

Infertility treatment in the United Kingdom is not generally available on our national health service. It's outside the normal rules of access to treatment under our socialized medical service. The costs per cycle of treatment, including the drugs required, range from about $5,000 to $10,000 Canadian.

There are likely to be connections between research and treatment organizations, and it's imperative that embryos or gametes donated to produce embryos for research are freely given, and that people donating them have made truly informed choices. For this reason, it's not permitted for donation to affect treatment in any way. The centres must ensure that a designated individual, who's not directly involved in the patient's treatment, is available to discuss the research and the possibility of donating material with patients. Furthermore, patients must be informed how the research is funded, including any benefits that will accrue to researchers and/or their departments.

Á (1115)

In order to ensure that the implications of donation are understood, including the potentially immortal nature of stem cell lines, the HFEA also requires patients to be informed that any stem cell lines created may continue indefinitely and may be used in many different research projects; that once an embryo has been used in their project of research, the donors have no control over any future use of the embryonic cells and any stem cell lines derived; and that stem cell lines may be used for commercial purposes, but the donor will not benefit financially from this.

Since the 2001 regulations came into force, we have granted two licences for embryo research under these new regulations. The two protocols approved will develop embryonic stem cell lines from embryos originally created for IVF treatment that are surplus to or not required for treatment and have thus been donated for research.

As chair of the HFEA, I would like to see a move toward keeping the public fully informed about research conducted using embryos. We are currently redesigning our website--www.hfea.gov.uk--with a view to including more details on the research projects we have licensed. We've yet to decide exactly what we will make public, and I think there is a balance to be struck between being transparent and protecting the confidentiality of those involved in research. But I think it's important that people know what embryo research is being carried out, and with what intended public benefit.

To conclude, among our other activities, the HFEA is responsible for controlling the creation and use in research of embryos up to 14 days. This includes research that may generate embryonic stem cells.

We continue to ensure that the use of embryos to source stem cell lines is conducted under strict controls and in a responsible and fair way, as we have done with all our embryo research. It's not lawful in the United Kingdom for embryonic stem cells to be generated without a licence from the HFEA.

That broadly covers the licensing procedure for research on human embryos. You also touched on the issue of donor anonymity and secrecy versus an open system for donation of sperm, eggs, and embryos.

In July of this year, the Human Fertilisation and Embryology Authority drew up a response to a government consultation on this matter. If I can just read to you what our recommendations are, they're very brief, but you may find them relevant.

First, we believe there should be a move toward the removal of donor anonymity. Second, we advise that any change in donor anonymity should not be applied retrospectively. We rejected the idea of having a two-track system, where prospective parents could choose whether to have anonymous donation or known donation, on the grounds of ethical and logistical problems. But lastly, we also felt there should be stronger guidelines developed on the counselling needs of those considering treatment with donor gametes, and donor offspring seeking information on donors.

In coming to our conclusions on donor anonymity, we felt there were two important things. Clearly we have to balance the interests of the various parties concerned, but we thought that the value of information--the importance of knowledge about origins and the circumstances of one's own conception--is a very important part of self-identity. We were powerfully persuaded of the need for people to have information about their genetic origins.

Á (1120)

I think the last point you asked me about was the issue of compensation and reimbursement for expenses for surrogacy and donation. In gametes and embryos, in the United Kingdom, as with other human tissue, we have a strong belief that this should be done for altruistic motives rather than market motives. We permit a very small donation fee of about $30 Canadian per donation for sperm or eggs. On top of that, people can claim reasonable expenses. I think you'll gather that this is a very different situation from, for instance, the United States.

So I hope those introductory remarks have been helpful. Both Angela and I will be very pleased to answer any questions.

The Chair: Thank you very much, Ms. Leather.

We'll move to the question and answer section and begin with the members of the opposition.

Mr. Merrifield.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you for your comments this morning. I guess it may be afternoon there. I certainly appreciate where you're at, in the difficult subject you're dealing with.

But I go back to the issue of ethics in this whole area of embryonic stem cell research. The dilemma is, when ethical considerations collide with scientific possibilities, who wins--science or ethics? Around the whole area of what is necessary for research, therein lies the dilemma.

How do you determine what is necessary and what is not necessary? What would you determine would not be necessary, if you ran into something that you would say was not and you defined it in a specific way?

Á (1125)

Ms. Suzi Leather: We had a long public discussion, as I'm sure you've also had in Canada, about the ethics of infertility research and embryo research. I think we've had the advantage of 10 or 12 years of good regulation in infertility treatment and embryo research before the stem cell debate came along.

I wouldn't posit the question as ethics versus science, because I think there are ethical arguments in favour of doing stem cell work, as well as ethical arguments against. If you accept, as our legislation expresses, that up to 14 days the pre-embryo is not a human person, and you can have infertility treatment and embryo research up to 14 days, it's not so difficult to accept that from those early embryos you can derive embryonic stem cell lines that clearly offer potential great advantage.

We're not saying that embryonic stem cells are more important than other stem cells. I think at this stage in the development of the science, the position of the U.K. is that all these aspects in stem cell work should be pursued.

Mr. Rob Merrifield: That takes me to another question. Up to 14 days, you do not see it as an embryo; it's pre-embryonic, I believe is what you just said. I think there are others who take the idea that it is an embryo from the time of conception.

Ms. Suzi Leather: Let me make myself clear. I do not regard it, and it is not regarded in this legislation, as a human person in the same sense as a two-year-old or you and me.

Mr. Rob Merrifield: Nor does anyone here, I think, believe that, although the ethical battle is whether it is human life from conception, with all the potential of human life, and therein lies the ethical dilemma we're in. We could argue and debate that; it's not really that important. But I'm wondering what you would say is not necessary as far as allowing research is concerned, then. We want to define the word “necessary”. How do you put parameters around that word?

Ms. Suzi Leather: Well, I read out to you the terms by which Parliament has defined “necessary”. We say it is necessary to promote the advances of treatment of infertility, to promote knowledge of the cause of congenital disease, to promote knowledge of the cause of miscarriage, to develop more effective techniques of contraception, to develop methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation; and in addition to that, to increase knowledge about the development of embryos, to increase knowledge about serious disease, or to enable any such knowledge to be applied in developing treatments for serious disease.

So we've significantly widened it in the 2001 legislation, but it still means that only for those reasons, and only having passed the other hurdles, will people be given research licences.

Mr. Rob Merrifield: The other hurdle is consent, I understand.

But if I just boil down your analysis of “necessary”, it really opens it up to a very broad amount of research that, in essence, does not limit it to really anything. I guess what I'm grasping at is, is there an area where you would say, no, it's not ethical to use the human embryo in that research?

Ms. Suzi Leather: There certainly are areas that we wouldn't consider ethical, and if you want me to send to you examples of research that we have refused, I can do that.

Mr. Rob Merrifield: Yes. Can you just tell us a couple, or...?

Ms. Suzi Leather: No, I can't, off the top of my head.

Mr. Rob Merrifield: That's all for now. I'll ask some questions in the next....

The Chair: Dr. Dromisky.

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): Thank you very much.

Thank you very much for your presentation. It's refreshing to hear someone else's viewpoints pertaining to this very, very sensitive area.

I would like some clarification regarding the role of the regulatory body that you have here. Under the Human Fertilisation and Embryology Act of 1990, there's a body where the majority of people on that body have to be lay people, and they have 21 members on it. I look at your flow chart here of the decision-making process, right up to the granting of a licence. Where does that body fit into that flow chart?

Á (1130)

Ms. Suzi Leather: Let me expand on what I said.

Under the terms of the act, authority is set up that comprises people from many different specialisms. But you are absolutely right in saying that there must at all times be a majority of lay people. Our interpretation of that is that scientists and clinicians in the field cannot be in the majority. In addition to that, the chair and the deputy chair also must be lay persons.

The licence committees, whether they be licensing research applications or licensing clinics to do treatments, are made up of authority members, usually five authority members. So under the legislation, the individual licence decisions do not have to be made by the entire authority, but are made by a subcommittee of the authority, a licence committee.

Mr. Stan Dromisky: You tell us here what they can do and what they cannot do as far as this body is concerned, and this whole question of credibility arises. This body is not like an ombudsman. I don't know what its powers really are for surveillance and for monitoring what is going on out in the field, in the private sector as well as in the public-sponsored sector. So where does that responsibility come?

Ms. Suzi Leather: We are set up under statute to monitor, regulate, and license treatments and embryo research up to 14 days, the storage of gametes and embryos, both in the public and the private sector.

Mr. Stan Dromisky: Whose responsibility is that?

Ms. Suzi Leather: I'm sorry, I don't quite understand your question. We are set up by legislation. We are constitutionally a non-departmental public body. So we are, to some extent, at arm's length from government, but we are accountable to Parliament through health ministers.

Mr. Stan Dromisky: I can understand that, but I still don't understand how you, in a sense, guarantee that everything is going well and everyone is following regulations, since you don't have an ombudsman to deal with complaints or any kind of concern that might be raised by anyone involved in the whole process, or any process.

Ms. Suzi Leather: The way we ensure that the wishes of Parliament are followed in research.... Let me take treatment first. We do annual inspections of treatment centres. We order all their records, we interview patients to find out what their views are, we look through the stored gametes and embryos to ensure that ties up with the paperwork, and on the basis of that, clinics are given a licence.

Research licences are also conducted by licence committees of the HFEA. Again, we do inspections and we can do spot checks, random inspections, and in the case of research, of course, we have the peer review process.

Mr. Stan Dromisky: That answers my question. Thank you very much.

Regarding the supply of embryos, quite a number of them are required in order to induce pregnancy, in a sense. Do you have an ample supply? Is it a generous supply that exists in your country and your clinics?

Ms. Suzi Leather: Do you mean of gametes?

Mr. Stan Dromisky: Yes, I'm sorry, gametes.

Ms. Suzi Leather: No, it is not a generous supply. The issue of market supply of gametes is an increasing problem in the United Kingdom. I think there has always been a shortage of eggs and it has been rather easier to get sperm. We now also find some local shortage of sperm, so I would say, both for eggs and sperm, there are difficulties in getting a supply.

Á (1135)

Mr. Stan Dromisky: In the case of sperm donors, for instance, how comprehensive and in-depth is the collecting of data pertaining to the donor of the sperm? How much information do you derive from that individual?

Ms. Suzi Leather: We do a health screen of all donors. They are screened for HIV, hepatitis B and C, we take a full family history...what else do we do? We set a limit on the number of times that any one donor may donate, to limit the number of children, as it were, that can be created by one donor. That applies to both the public and private sector.

Mr. Stan Dromisky: Thank you very much.

Ms. Suzi Leather: But we don't do more widespread genetic screening than that.

Mr. Stan Dromisky: Okay, thanks.

The Chair: Thank you, Dr. Dromisky.

Dr. Lunney.

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

I have several questions, but maybe I'll continue along the line Dr. Dromisky was pursuing about the donations.

Let's play devil's advocate here for a minute. You mentioned a number of things you screened for with sperm, HIV, hep C, hep B. You do a family history, and there's a limit to the number of donations. I guess my first question is, do you allow the import and export of gametes?

Ms. Suzi Leather: Yes, we do, but only under specific licence from the HFEA. We do allow that to meet both the local shortages... [Technical difficulty--Editor] ...and also, we have people travelling to the United Kingdom who may have started their family with sperm donated by one individual and they may want to create children who are siblings, so they may want to import sperm from that same individual.

Mr. James Lunney: One of the things we're concerned about here is that some of the clinics have been importing sperm from prisons in the United States. So we're screening for quality and this and that, in terms of various diseases that we recognize at this time. Mind you, you might remember with HIV that it was quite a while before we recognized the causative agent or had a test to screen. We might wonder what else we might be missing.

Let's play devil's advocate here and suggest that some people think that criminality, for instance, could be a genetic trait, not that I subscribe to that. However, suppose that turned out to be the case. How are you to control that when you're importing and exporting? It's hard enough to control things within your own borders, wouldn't you agree?

Ms. Suzi Leather: I would certainly agree that, whatever the state of the screening, it's not absolutely risk free, and I think patients should be told that. The number of things we screen for will continue to increase, and I think that would happen under a socialized medical system or under the free market.

I think we don't ask or require our clinics to ask for previous criminal records. If there was a good evidence base for certain behavioural traits having a genetic basis, it may then become difficult not to do that, but my understanding of the science is that's not the case so far.

Mr. James Lunney: Just moving on, I understood you to say there's a move toward the removal of donor anonymity, recognizing the importance of knowledge of origins for personal identification. I just wonder how you square that particularly with the concept of importing and exporting, and particularly from prisons, and so on. Is there not a stable and, we might say, if you went to an open system, a more responsible pool of donors that might be available?

Ms. Suzi Leather: I think the tensions you are suggesting may be there to some extent, yes, but it could be explained to people that they could have donors about whom they knew a great deal or about whom they knew much less, and you could devise a system that gave people a choice. I wouldn't advise you about doing that.

Á (1140)

Mr. James Lunney: There are a lot of concerns in this particular area.

Let me take it another way. You mentioned that it's important that embryos are freely given, without pressure, and so on. I'm curious about your comment that, because of the potential immortal nature of these stem cells, you say donors have to understand that although they may eventually be used for commercial purposes, they would have no further interest or would not have access to any commercial interests in derivations of these stem cells from their donated embryo. I'm just wondering how you square that.

In terms of immortality, I suppose you're referring to the fact that although these are taken from embryos that were destined to be full human beings, something like 80 trillion to 100 trillion cells, the immortality aspect you're talking about would be related to the fact that this growth, which would normally cease around 18 to 21 years, or slow right down, because of being frozen and being started and stopped, it can be given a sense of indefinite growth that some people want to describe as immortality. Is that what you're getting at?

Ms. Suzi Leather: No, it really was multiplication, rather than development, that I was implying.

Mr. James Lunney: Even for all the years that stem cell research has been going on, we understand that, of the some-60 lines that were available or thought to be available in the United States, only about 3 of them are actually being used, and that, in fact, they do derail very commonly. The stem cell lines eventually go off track and are not reproducing in the manner that they thought. I'm just thinking it's rather disingenuous to use the word “immortality” for something like an embryo, which would normally be growing, or these stem cells would grow, 18 to 21 years before you reached adult proportions and they would slow down. Nobody has been growing stem cells for anything like that period of time.

Ms. Suzi Leather: We thought it was important, when donors gave consent, that it was informed consent, and clearly what people are consenting to, in the case of donating embryos from which to derive stem cell lines, is different from giving embryos for use in finding out causes of miscarriage. I think people donating their embryos have a right to that information.

Mr. James Lunney: Thank you.

The Chair: Thank you, Dr. Lunney.

Dr. Bennett.

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

We in Canada also have been concerned about the need-to-know aspect of children conceived in special ways. As a family physician, I was always interested in what you called the balanced interest in it, especially around what you were saying in terms of the discussion paper not being retrospective. I think that people changing the rules on them mid-point is potentially hugely harmful to both the child and the parent. Could we get a copy of the discussion paper that was produced? I think that would be really helpful.

What we've heard over here is that since the release of that discussion paper there has been a measurable decline in gamete donation. I'd like you to comment on that.

I'd also like you to comment on if in your view there's a difference between somebody knowing the genetic origin of the biological donor and knowing their name and address. Is there in any capacity a necessity to keep up to date with what as a family physician I saw, namely, the changing family history that can take place--all of a sudden you get colon cancer, you get breast cancer, you get these things. Is there a necessity to keep your family history and your medical history updated as a donor?

Also, what we've seen from American examples is that unless there is in place some family law expectations around custody and access or support law suits.... Do you have that sort of protection? Is that something you've dealt with in the discussion paper in terms of what happens if? Is there a ban in terms of the local framework of family law to clarify and protect the gamete donors in family law?

I think those were my main questions.

Á (1145)

Ms. Suzi Leather: I think there were about four points there. In regard to the first, the issue of retrospectively applying a change in the law away from donor anonymity, I think we felt it contravened natural justice, really, to have people donate with a promise that it was anonymous and then 10 years down the line to change that. We also thought we should bear in mind the interests of the families of existing donors. I think it would be rather difficult if many people suddenly turned up on the doorstep and said, I think we may be brothers or sisters. You could imagine that would be quite damaging to existing families.

Certainly we thought you could consider setting up a voluntary contact register, as I think they did in Victoria in Australia, so that previous donors who were happy to be contacted could register as having been donors and have people contact them, but not make that compulsory.

The second point you made was about the impact of the move away from anonymity on the supply of gametes. I think it's too early to say whether the existing public consultation in the United Kingdom on donor anonymity has had an impact. But certainly we are experiencing more problems at the moment from clinics dealing with a shortage of sperm. There is, I think I detect, an increased desire to import sperm from out of the United Kingdom.

We discussed this within the authority. We felt that although the issue of the gamete supply was an important one, it didn't override the interests of people created as a result of infertility treatment through donor insemination to know their origins. We think there may be an impact on the supply, but we didn't think that was a sufficient reason not to move away from donor anonymity.

Your next point, then, was about what happens to the health of donors after they've donated. I think that is another reason you can argue in favour of moving away from donor anonymity. We do ask donors to keep up with the clinics where they donated and tell the clinics of any developments in their health status that may have an impact on children created as a result of their donation in earlier years. I think in reality few people do this. I don't think that has proved to be a very successful system.

Your last point was about legal parentage. In the legislation setting up the regulations of infertility treatment, and in subsequent family legislation, we've made it very clear that people who are gamete donors do not have any parental responsibility, or any parental rights, with the children who are created as a result of their donation. That is set down in law.

The Chair: Thank you, Dr. Bennett.

Mr. Szabo.

Mr. Paul Szabo (Mississauga South, Lib.): It's morning here. I assume it's pretty late there. Thank you for accommodating us on an important piece of legislation.

There was reference to a bank, I assume a bank of gametes or of embryos on stem cells. Why was that established?

Ms. Suzi Leather: This is a bank of stem cells, not of embryos but of stem cells. That is being set up in United Kingdom to provide a public good, in a way, so that there will be a repository with a sample of cell lines both from private and from publicly funded embryo research. [Inaudible—Editor] ...stem cell lines, and there is also the intended benefit that this would minimize the number of embryos used to create cell stem lines.

Á (1150)

Mr. Paul Szabo: The commercialization aspect is extremely important to us as well. Our draft legislation says that the donor shall not benefit in any commercial way, either from the donation or from future commercialization. You've now added this other dimension where the gametes, or embryos, or stem cells eventually, as they move down the line, land up in a bank. Is there any compensation....

Ms. Suzi Leather: Only a sample must be deposited in the bank.

Mr. Paul Szabo: So there's no consideration to the researchers who produce them?

Ms. Suzi Leather: It's part of the licensed procedure that the researchers agree that the samples of the stem cell lines derived will be deposited in this stem cell bank.

Mr. Paul Szabo: Is the bank under the authority's responsibility, and do you administer it?

Ms. Suzi Leather: The bank is not under the authority's responsibility, and I'm afraid I can't, off the top of my head, tell you the constitutional position of it. We have an interest in this, and I can e-mail you some relevant details.

Mr. Paul Szabo: That would be helpful.

Back in 1990 when the bill was first put together, I noticed that the legislators relied on schedules, but there were also regulations, which meant that after the bill passed all legislative stages and got royal assent, there was still some work to do to get the regulations in place. Do you have any idea how long it took before the authority could actually operate, following the passage of the legislation?

Ms. Suzi Leather: We started in August 1991.

Mr. Paul Szabo: That's almost a year and three-quarters later.

Ms. Suzi Leather: Well, slightly less.

Mr. Paul Szabo: So it was over a year later.

Was there some difficulty getting fertility clinics to comply with the legislation, since some were obviously private organizations? Was there a reaction, for instance, to standardizing consent forms and other documentations, as required?

Ms. Suzi Leather: Our authority developed out of a self-regulation model that the industry itself had set up. So we didn't start de novo, we developed from self-regulation. I think that probably helped. The clinics themselves, the clinicians and the scientists, saw there was benefit in having an authority that commanded public confidence, because that actually, in a sense, secured their future.

It was at a time of considerable public debate about the rights and wrongs of infertility treatment and embryo research. Although some were less enamoured of the idea of regulation than others, I don't think there was a general feeling that this was the wrong thing to do.

Mr. Paul Szabo: Schedule 3 of the legislation deals with consent, and I didn't notice anything in there to do with transitional provisions. I'm wondering how the legislators addressed pre-existing embryos, in terms of consent or equivalency of consent. Was there a process they went through, or was it simply a matter that if you required written consent prior to even the donation of gametes, pre-existing embryos would not fundamentally qualify for any research?

Ms. Suzi Leather: I will have to look that up and send it to you, I'm afraid. I've been in place since March this year, and some of that is historical fact I don't have access to, but I will certainly send that information to you.

Mr. Paul Szabo: Okay.

The authority has been in operation for more than 10 years. Were there unanticipated difficulties in operating it? I'm not familiar with the amendments that were made in 2001, but as you went through the process, the system got refined. Where did you need to change your approach to the authority to make it more streamlined in terms of its interaction with all of the interested parties?

Á (1155)

Ms. Suzi Leather: I think the founding legislation has proved to be good legislation. Our main difficulties have been keeping up with the increased demand for infertility treatments and the increasing complexity of infertility treatments; but perhaps more than anything else, responding to differences in public perception about the role of regulation within the health field.

I don't know what's happened in Canada, but we have certainly had some scandals in the health field that have put the spotlight much more on regulation in health. I think the demand for increased information and reassurance in these areas has also had a big impact, as has public debate about risk. The whole issue of risk, who bears risk and when it is right for some people to bear risk and not others, is a strand of public debate that has been very important in the last few years.

The Chair: Thank you, Mr. Szabo.

Before we begin a second round, I have a few questions of my own.

First, I compliment you on your use of the term “informed choice”. Throughout our hearings we have been trying to talk about informed choice, but we find that both scientists and the medical profession insist on “informed consent”. I'm wondering whether you use “consent” or “choice” in your legislation. So that's one question.

The second thing is that you talked about some pretty moderate compensation for gamete donors, of $30, based upon the idea that it should be altruistic, but you did not mention compensation or reimbursement of expenses for surrogates. I'm wondering if you had a ballpark figure for either of those two numbers.

The third thing was that you were asked some questions about importing and exporting. Perhaps you didn't know, but some of our sperm commercial enterprises import most of their sperm from another country. You used the example of a particular couple who wanted to commission some sperm from someone out of the country, and they had to get a specific licence for that. What about the suppliers of large amounts of sperm? Do you allow them to import large amounts or to export large amounts, or is it the specific individual cases that you were referring to?

The fourth thing is really my main question for you. It has to do with the funding of the authority. I understand that you license both research projects and infertility clinics, and I'm wondering if you have any cost recovery in that. For example, do people pay you a fee for reviewing their proposal and then getting a licence? Do infertility clinics apply and, after a primary inspection, pay you a fee to get a licence? If that is the case, does that not put the authority in somewhat of a conflict of interest situation, in that instead of the general public being its boss, those people whose fees keep it alive could become its boss? “Boss” is a bad word, but you know what I mean--its constituency.

We have some things here that have cost recovery elements, and we fear that is happening to them. Seeing as we're only just setting up an agency here, I want to know how yours is funded and what percentage of its budget is paid by the interests it manages as opposed to its board of directors and/or the general public.

Those are my questions. Thank you.

Â (1200)

Ms. Suzi Leather: I think the legislation is more likely to use the word “consent”.

My background is in consumerism. I have worked for consumer organizations and health organizations, and I tend to talk and think more in terms of informed choice. I think that's a personal issue.

Your second point was on altruism and the issue of paying for surrogacy. It is the same with surrogacy as it is with gamete donation. We do not allow payment for surrogacy beyond expenses.

Your third point was essentially about bulk importation of gametes. We did indeed do this on a case-by-case basis. Currently, we do not permit bulk import, nor do we permit selling on. If one clinic imports for their use, they're not permitted to sell to another clinic.

Your last point is a very important one, the issue of who pays the piper. When the Human Fertilisation and Embryology Authority was set up, it was with the understanding--although I don't think this was ever in the legislation--that the clinics, or perhaps I should say patients, would contribute about 70% of our income and the government about 30%. We have struggled throughout our history with this issue, and I think we're perfectly right in saying that it has to be watched. If you are entirely funded by an industry you're regulating, then there may be problems of capture, as it were.

We have recently seen, in fact last week, a very significant increase in our funding. We now have a funding base of about $11 million Canadian, which is well above what we had before. Most of our funding still comes from patients, because they pay a per-cycle fee to us, and this has gone up from £50 for a cycle of IVF to £100. Similarly, the contribution from central government to our costs has also gone up. It has gone up by, I think, 150%. So we are receiving significantly more from both clinics and the central exchequer.

The Chair: Thank you very much.

We'll now begin round two. Mr. Merrifield.

Mr. Rob Merrifield: For how many years have you been doing human embryonic stem cell research in the United Kingdom?

Ms. Suzi Leather: I can't answer that. That was part of the 1990 legislation on embryo research.

Mr. Rob Merrifield: So we can assume that it has gone on since the early 1990s.

Ms. Suzi Leather: Let me get back to you on that. I have a growing list of things I'm getting back to you on.

Mr. Rob Merrifield: Okay.

Can you tell us how large your stem cell bank is?

Ms. Suzi Leather: I don't think the stem cell bank has any stem cells in it at all at present. We have just started this idea. I'm on the steering committee, and we'll have our first meeting on this tomorrow. As I said, we have only recently licensed two research applications in stem cells, and I don't think they're yet producing stem cell lines.

Mr. Rob Merrifield: You talked about approving public and private. Can you tell us the degree of public and private research on the embryonic stem cell side? What percentage of the research that is done is privately funded compared to publicly funded?

Ms. Suzi Leather: Generally for stem cells, no, I can't tell you. Our responsibility is just for embryonic stem cells.

Mr. Rob Merrifield: For the embryonic stem cells, can you tell me the percentage that is publicly and privately funded?

Â (1205)

Ms. Suzi Leather: We have licensed two research applications so far this year. They are at the Centre for Genome Research in Edinburgh and at Guy's and St. Thomas' Hospital in London. I will have to get back to you with the details of the funding for those.

Mr. Rob Merrifield: Okay, thank you.

Ms. Suzi Leather: There are only the two projects.

Mr. Rob Merrifield: Okay, just the two. I would appreciate it if you could get back to us on this.

The other thing I'm wondering about in your legislation is the whole idea of patenting higher life forms and the patentability of any research that comes out of this. Do you have any provisions on this? Is patenting of human stem cell lines allowed in the United Kingdom?

Ms. Suzi Leather: We deal with a lot of difficult issues, but I'm very pleased to say that the patenting issue is not one of them. We do not have responsibility in the patenting area.

Mr. Rob Merrifield: I realize this, but is there anything curtailing the patenting of higher life forms in the United Kingdom?

Ms. Suzi Leather: My understanding is that this is in an area of legislation occupied by the European Union. I think there is European Union legislation on this, which would apply to the United Kingdom as well as to other member states.

Mr. Rob Merrifield: Are you aware of whether it's restrictive, or whether it's open, as far as patentability of research in this area is concerned?

Ms. Suzi Leather: I'm not going to make a comment on this.

Mr. Rob Merrifield: Okay.

Then my other question is about the regulatory body. I think it's the most important part of this piece of legislation, because it really is going to allow or not allow whatever research is going on into the 21st century. So as you move to open up your research in this area, I'm wondering if you are comfortable that all voices were heard and were listened to appropriately in this debate, or whether it was driven more by science.

Ms. Suzi Leather: You mean in the parliamentary debate?

Mr. Rob Merrifield: Yes, that's right.

Ms. Suzi Leather: I think you should read the Hansard transcripts of the debate, both in the House of Commons and in the House of Lords. You'll see that the participants came from a very wide range of backgrounds. Certainly, of course, there were scientists who spoke, but equally, ethicists and people of religious conviction spoke.

Mr. Rob Merrifield: Yes.

In your committee, was this debate talked about, and was there a recommendation to move forward to the Parliament on this?

Ms. Suzi Leather: No, I don't think we gave any advice on this to Parliament, although this was before my time. I think this was generated, first of all, by a report from the chief medical officer.

Actually, I think I'm wrong on this. I'm sorry. I think there was something that we did upon which the CMO based his report. But certainly the CMO's report was very persuasive.

Mr. Rob Merrifield: Yes, was this after a recommendation came from your board or committee? Is this right?

Ms. Suzi Leather: Let me get back to you on this, as it is well before my time.

Mr. Rob Merrifield: Thank you.

The Chair: Thank you, Mr. Merrifield.

Doctor Bennett.

Ms. Carolyn Bennett: One of the other controversies has obviously been reimbursement, or compensation, for donors and surrogates. Was the $30 or £30 set at something the same as jury duty? Is it tagged to anything, or does it have to be sorted out? Many people here have thought maybe it should be the same as the employment insurance rate, or that there should be some way...for surrogates, in particular.

I'd like to know what's included in the expenses. If someone, particularly a surrogate, were too sick to go to work for the first trimester, or another, would those days off work be receiptable? Is any consideration given for the sort of unreceiptable expenses that are really part of being pregnant?

These would be my main questions.

Â (1210)

Ms. Suzi Leather: Okay. As far as expenses for donors and for surrogacy are concerned, I think they are entitled to get travel and accommodation costs—there's a subsistence rate for this—and miscellaneous expenses, such as telephones, car parking, postal costs, and child-minding expenses. And financial loss is allowed up to a maximum of £50 a day. So, I suppose, the biggest components will be financial loss, child-minding expenses, and travel costs.

Ms. Carolyn Bennett: Thanks very much.

The Chair: Thank you, Dr. Bennett.

Dr. Lunney, then Mr. Szabo.

Mr. James Lunney: To go back to research again, does your legislation permit animal-human hybrids, or chimeras, for research purposes?

Ms. Suzi Leather: No, it does not.

Mr. James Lunney: That's interesting. Just carte blanche, no, because the researchers in our community seem to feel they need to have this opportunity. So the answer is just plain no.

Ms. Suzi Leather: I think that--

Mr. James Lunney: It's allowed here, except under licence.

Ms. Suzi Leather: --in order to demonstrate viability of sperm, you can put sperm into hamster eggs to see how active they are. But in general it's certainly not permitted to put a human embryo into an animal, or the other way around.

Mr. James Lunney: Yes, but our legislation--and I'll go to our own researchers for a second--would allow, under licence, the creation of animal-human hybrids.

No? Not for purpose of reproduction, but for research. I see.That's something we need to tighten up, quite apparently.

I want to go back to somebody's question--I think it was Dr. Bennett's--on the question of surrogacy. I'm changing directions here again, back to surrogacy. On the list of expenses there you noted a loss of income up to, was it £50 a day?

Ms. Suzi Leather: The loss of income up to £50 applies to donors. I will have to check with you whether that also applies to surrogacy.

Mr. James Lunney: I see.

Ms. Suzi Leather: It may not, but it certainly does for donors.

Mr. James Lunney: That is a concern to us here because there are people advocating that they be paid. They're called “gestational carriers”.

Ms. Suzi Leather: No, I think that is not the case for us.

Mr. James Lunney: Thank you.

The Chair: Thank you.

Mr. Szabo.

Mr. Paul Szabo: Thank you, Madam Chair.

I'm sorry, we probably have some naive questions, but without the regulations are there any provisions to set a limit on the number of eggs that can be harvested from a woman going through the IVF process?

Ms. Suzi Leather: I don't think there is a limit to the number of eggs that can be harvested, but certainly you cannot donate more sperm than to create 10 live births. The same would go for egg donations. And we have a very firm ruling that you are only allowed to transfer, under normal circumstances, two embryos into a woman for implantation. Only in rare circumstances are you allowed to implant three embryos. So this contrasts very markedly, for instance, with the United States.

Mr. Paul Szabo: We have a study going on now to determine whether there are enough embryos in cryogenic storage to support meaningful research. Nobody knows.

Is there anything in your regulations, or in your authority's guidelines, that would empower you, for instance if there was a shortage, to in fact bring those frozen embryos together under another type of bank, and whereby the authority would in fact have the authority to pick which researchers get access to the limited embryos?

Â (1215)

Ms. Suzi Leather: I don't believe we have that authority.

Mr. Paul Szabo: Your act doesn't refer specifically to cloning. I was looking at the definitions, and it deals all with gametes, or embryos, and--

Ms. Suzi Leather: We have outlawed--in fact, I think we were the first country to outlaw--reproductive cloning under a separate piece of legislation.

Mr. Paul Szabo: Thank you.

But specifically, in paragraph 3(3)(d), you prohibit therapeutic cloning. It's not stated as therapeutic cloning, but it's replacing the nucleus of an embryo. Why did you have to do that? Isn't that cloning?

Ms. Suzi Leather: No, we do permit therapeutic cloning. We do not permit reproductive cloning, but we permit therapeutic cloning.

I'm happy to furnish you with all the relevant legislation. There is some subsequent legislation pertinent to--

Mr. Paul Szabo: It says here:

(3) A licence cannot authorize

(d) replacing a nucleus of a cell of an embryo with a nucleus taken from a cell of any person, embryo or subsequent development of an embryo”.

Have I got an old version of the act?

Ms. Suzi Leather: Which piece of legislation are you looking at?

Mr. Paul Szabo: Human Fertilisation and Embryology Act of 1990, as amended. I don't know. I got it off your website.

Ms. Suzi Leather: Okay. I can send you some subsequent legislation that permits, in effect, therapeutic cloning. But we have an absolute ban on reproductive cloning.

Mr. Paul Szabo: Okay. I guess my last question really has to do with the whole idea of necessary.... Can you give me an example? I know it has been asked before, but is there an indication of what percentage of research applications have been denied? What percentage would it be? Would it be 5%, 10%, 50%--I don't know--in relation to the utilization of surplus embryos?

Ms. Suzi Leather: I will have to give you that when I give you the hard numbers. I can't give any indication. I'd be very surprised if it were 50%.

The Chair: Thank you, Mr. Szabo.

May I come back to the establishment of this agency with which you have 10 years of experience and we have none? We'd like to get it right. Two years ago when we interacted with your predecessor, she suggested to us the agency was underfunded--I hear you've recently had an increase in your funds, which is good--and she said she thought the agency had perhaps given out too many licences to fertility clinics too quickly, before they had the experience of all that was required with regard to inspection.

Based upon what you know of the history of your authority, would you suggest that we move fairly cautiously in the issuance of licences until we kind of understand our own capability around budgeting and the cost of inspections?

Ms. Suzi Leather: I think in this whole area a cautious permissiveness is probably the way forward. I don't know why my predecessor, Ruth Deech, said that. In fact, she was not the chair right at the beginning. There was a different chair in the first three years of the authority's existence.

I think it's perfectly true to say that in those early years the impact, the strength of the clinics, was probably more marked than it is today. I explained earlier that the authority model had developed out of the system of self-regulation in which, clearly, the clinics have quite an important role to play. I think if I were in your position, I would be seeking to retain a certain robust independence from the service you are regulating.

The Chair: Thank you.

You talked about this move away from anonymity of donors and surrogates and you've made some recommendations. For example, has the Standing Committee on Health of the House or the board of the authority moved that forward at all? You talked about it as a move, but I'm wondering when it's going to be debated or when you predict there might be some kind of resolution toward that. Or are you trying to do it from the bully pulpit and convince infertility clinics to begin to try to convince people not to demand anonymity?

The reason I am asking is that our testimony suggests to us that children born of reproductive technology, who are now adults, want to get rid of this anonymous feature. But people who want--that is, commissioning couples--to utilize reproductive technology today don't want any restrictions, essentially, on the donors.

Our own experience in visiting infertility clinics and examining some of the forms donors have been filling out suggests that if they can't remain anonymous and if they cannot be reimbursed for expenses, they would not be giving. This suggests that their giving is not too altruistic, if they wouldn't give without money. So to move toward anonymity, how do you think that might be accomplished in your setting?

Â (1220)

Ms. Suzi Leather: I think that in the not-too-distant future we may face the same problem you may be facing, which is whether you can have both a move away from anonymity and a secure supply of gametes. I believe it was also the case in Sweden that they saw a dip, as it were, in donations. I'll keep an open mind about that at this stage.

The decision about moving away from donor anonymity is not one for the Human Fertilisation and Embryology Authority. In fact, ministers in the government will have to make that decision. There will be considerable further debate about this. But I think our recommendation will weigh quite strongly in that debate.

Our experience of whether or not prospective parents want to have anonymity is the same as yours. I think that many parents of children created as a result of assisted reproduction through donation do not willingly tell their children what the situation is. I think very few of them in fact do. But as you have found, people moving through childhood into adolescence and adulthood do seem to have a strong desire to know, and the groups that represent those people have argued very cogently for many years in favour of moving away from anonymity.

The Chair: Thank you very much.

We'll have one quick question from Dr. Lunney and one from Dr. Bennett.

Dr. Lunney.

Mr. James Lunney: This might have been covered earlier. I didn't quite get it clear, so I want to go back to the composition of the committee. I understand that it's a mix of scientists and lay people. Could you, first of all, just give us an indication of how many members there actually are? How long are they allowed to serve? Is there a limit on the time? On the selection, are they appointed, and if so, by whom? That's the first question.

I'm looking at where you started with restrictions on the act, which said that no licence shall be granted unless any proposed use of embryos is necessary. In your attempt to define that, I see where you started with items related to the treatment of fertility and infertility. It involved the treatment of infertility, congenital disease, miscarriages, techniques of contraception, and then chromosome abnormalities in embryos before implantation. But with your recent amendments it went to increasing knowledge about the development of embryos and knowledge about disease or treatments for disease, which basically means drug research and probably anything scientists would like to do with human tissue from embryonic origin.

Â (1225)

The Chair: Is there a question there, Dr. Lunney, or just a comment?

Mr. James Lunney: That was a comment, that it went from being confined to being broad.

Ms. Suzi Leather: Our authority members are appointed by the Secretary of State for Health. We have up to 21 members. The majority have to be lay people. The scientists are in the minority, but they are nevertheless an important expertise to have there. We have in our other members medical ethicists, social workers, psychologists, people from a consumer background, and counsellors. We announced today some new members. One of them represents a patient organization, and one of them represents an organization of people created through donor inception. It's a very broad range of people.

Under the current U.K. rules for organizations of this kind, people are usually appointed for a term of three years. They may be reappointed, but that is not automatic.

The Chair: Thank you, Dr. Lunney.

Dr. Bennett, a quick question.

Ms. Suzi Leather: In addition to that, could I say that of course these posts are publicly advertised.

The Chair: Dr. Bennett.

Ms. Carolyn Bennett: Now I have two quick ones.

In our AIDS advisory committee here in Canada, there was a very strong movement from the AIDS community to make sure there were people with AIDS on any advisory committee to deal with the disease. Seeing that this bill that we're looking at is dealing with the infertile community and making sure they are able to have assistance in an ethical and safe framework, when you talk about consumers on the membership of your panel, what percentage would be from the infertile community, or is that viewed to be important?

Secondly, in the need to know, that self-identity piece around anonymity, what I heard you say, and this has certainly been my experience.... If parents aren't going to tell children that they were conceived in a special manner, isn't a lot of this anonymity talk sort of theoretical? If the children don't know enough to go and ask, is there not an issue that if the government thinks it's a right for these children to know, then the government, by definition, would have to send out a letter to these kids at age 18? Otherwise we're playing in some other thing where we're making ourselves feel better by making it anonymous, but we're actually doing nothing for these kids. So I think playing in this grey area where we feel better about an open system that isn't open at all, because these kids don't even know....

So I want to know how you feel about that. Is the government prepared to send these kids a letter at age 18 saying, this is your genetic makeup and here's the whatever? Or should we just stay out of this and leave it to the parents, in a voluntary system?

The Chair: Thank you, Dr. Bennett.

Ms. Suzi Leather: These are issues that we have also debated. It will be interesting to see what the government chooses to do in the end. There has been quite a lot of argument in favour of expecting parents to tell children but giving children the right to know at a certain age.

What was the other question you asked me?

Ms. Carolyn Bennett: The first one was just around the membership of the agency and representation from the infertile community.

Ms. Suzi Leather: Oh yes.

No, there's no requirement to have somebody from the infertile community on the authority. Indeed, I'm delighted that we're going to have a patients' representative as from today, but it's in fact going to be the first time we've had that. That was something that, from a consumer background, I felt very strongly that we should have, and I'm very glad the government has agreed. But that will be the first time.

Ms. Carolyn Bennett: Will one be enough?

Ms. Suzi Leather: I will see whether one will be enough. She's a very, very able person and extraordinarily persuasive, so I expect she'll do extremely well.

Â (1230)

The Chair: Thank you very much, Ms. Leather and Ms. McNab, for your assistance with this. I noticed you said “we'll see what the government decides about these things.” At this moment in time, the bill before the Canadian Parliament is in the hands of this committee, so we are urgently trying to get as much information as we can, because we have to decide.

You have been most helpful to us with your experience, and we very much appreciate your taking the time to meet with us, particularly at the end of your workday, whereas it's about noon here. So thank you very, very much.

Ms. Suzi Leather: Thank you very much indeed for the opportunity.

We will get back to you on the points that we said we would, but if there's anything else that you want to get back to us on, please do. I wish you the best of luck.

The Chair: Thank you so much.

I'll now call a recess, for a little bit of a break before we have the next two witnesses.

Â (1231)

Â (1255)

The Chair: Good afternoon, ladies and gentlemen. We'll now begin part two of this meeting of the Standing Committee on Health. I invite the witnesses to come to the table.

From the University of Calgary we have Dr. Sam Weiss, professor in the department of cell biology and anatomy.

Dr. Weiss, you have the floor.

Professor Sam Weiss (Department of Cell Biology and Anatomy, University of Calgary) Madam Chairperson and honourable members of the Standing Committee on Health, I would like to thank you for the honour and privilege of appearing before your committee to provide you with some of my impressions regarding Bill C-13, An Act respecting assisted human reproduction. Before I provide comments on the legislation, and specifically certain clauses within Bill C-13, please permit me to give you a brief background as to why I believe I've been asked to appear before your committee.

I am a basic scientist with an interest in understanding how the brain is formed and how it may be regenerated after injury or disease. In 1992 my laboratory was the first in the world to discover adult stem cells in the brains of mammals, specifically in mice. Over the past ten years, adult stem cells have also been found in human brains, and global research efforts suggest that these stem cells may be part of a new approach to brain regeneration and repair.

You may have heard some scientists or laypersons suggest that these adult brain stem cells may be reprogrammed to produce other cells, such as blood cells, muscle cells, etc. However, most current studies show that the most likely use of adult brain stem cells would be to repair brain tissue and brain tissue only.

My professional activities and interest in stem cells extend beyond the brain, and as such, I have been actively involved in developing a thorough understanding of different stem cells from different ages and tissues and how these may be used to advance the health and welfare of Canadians. What I have learned is that in several clear cases, one of which I'll elaborate on momentarily, embryonic stem cells may offer the greatest hope to cure otherwise incurable and debilitating diseases, and thus I'm compelled to believe that we are at the frontier of stem cell research, where parallel studies about embryonic and adult stem cells constitute the greatest promise of alleviating suffering for millions of Canadians who are experiencing devastating disease. It is in this context that I appear before you today.

I wish to begin by saying that I believe Bill C-13 is an important and fundamental piece of legislation for Canadians. The objective of safeguarding the health and welfare of Canadians and ensuring the dignity and protection of human life is paramount. The establishment of a regulatory agency to oversee activities related to human reproduction is important and insightful. However, I would contend that several clauses within the legislation are worthy of further consideration, as in their present form they may in fact be contrary to the stated principles of this bill.

My greatest concern is regarding clause 5, paragraphs (1)(a) and (b), which prohibit, ban, and criminalize the creation of a human clone or the creation of an in vitro embryo for any purpose other than creating a human being through assisted human reproduction. I contend that this clause and these two paragraphs specifically might be contrary to the principle of “promotion of human health”.

As regards paragraph 5(1)(a), to begin with, I do concur that we should not allow cloning of human beings to generate identical copies of humans past or present. On the other hand, banning of human clones in their entirety, as defined in the current version of the bill, will include banning of the creation of embryonic-like cells that are our best bet for generating new tissues that could be transplanted without being rejected. Moreover, if the science of adult human stem cells, for example from the brain, were to be advanced to the point where we could reprogram them to act like embryonic cells, that being with the potential to make many other cell types, this clause could conceivably ban and criminalize their use. Is this the intention of the legislation? Is this in the best interests of Canadians? I would say not.

As regards paragraph 5(1)(b), I am sure you all aware of the devastating impact that diabetes has on both children and adults who are unfortunate enough to have contracted this previously incurable disease. This disease results in a huge compromise in the quality and length of life of those affected, and a lifelong dependence on repeated daily injections of insulin. In addition, I'm sure you're aware that the increasing incidence of diabetes amongst our Canadian native population is reaching epidemic proportions.

You may have heard about the Edmonton protocol for diabetes. This world-heralded, made-in-Canada procedure has shown for the first time that it is possible to cure diabetes by transplanting islet cells from donors to recipients, allowing these recipients to live long, normal lives. Unfortunately, however, while thousands of Canadians are pleading with their physicians for this procedure, the number that can be treated is severely limited because islet cells can at present only be obtained from healthy cadavers, meaning organs that have been donated after death. On the other hand, recent compelling scientific evidence shows that embryonic stem cells can generate healthy islet cells that could cure and improve the health of and ensure long life for thousands of Canadians. As far as we know, there are no adult stem cells that can generate islet cells.

Paragraph 5(1)(b) will limit, if not prevent, the widespread curing of diabetes amongst Canadians. Those with financial resources may choose to go to other countries to receive the benefit of this promising therapy. Thousands of others will continue to suffer. In addition--and this will be reiterated when I discuss my concerns about one other clause--it is likely that the Edmonton pioneers may be compelled to move elsewhere, such as Europe or the U.S., where both therapeutic cloning and the creation of human embryos for generating stem cells are likely to continue to be controlled, but not banned or criminalized. Again, I would content that this is not in keeping with the principles of the bill.

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My experience as an academic leader suggests that if one is to criticize the proposal, one must have the proposal changed. I would suggest that clause 5 be redrafted to distinguish the use of clones or in vitro generated embryos for therapeutic purposes, the latter of which would become a controlled, rather than banned, activity.

My final concern is related to clause 11. This clause makes combining--and/or transferring--any part of the human genome with that of another species a controlled activity requiring a license. Over the past 25 years, advances in recombinant DNA technologies have permitted incredible research in therapies on human disease. In particular, the transfer of minute pieces of human DNA into mice—so-called transgenic mice—is a foundation of research on the basis of genetic disease. New cures have been discovered in hundreds of laboratories and biotechnology companies in this country. If, each time a new experiment of this nature were contemplated, a new licence were required, the breadth and competitiveness of Canada's biomedical enterprise would suffer immeasurably. Moreover, it would likely compel an additional group of researchers and entrepreneurs to leave Canada. Once again, I'm certain this is not the intent of this clause.

The suggestion here is to redraft this clause so as the clarify the amount of genetic material that is considered to require control—for example, whole chromosomes, which may be considered as conferring human traits to a non-human species.

As a final thought, please allow me to summarize. It is clear from an abundant number of recent surveys in this country and around the world that the lay community, the citizens of this country, understand the distinction between manipulating human embryos and reproductive material for non-therapeutic purposes, as opposed to therapeutic purposes and health. To ban and criminalize such activities—that is, the use and/or generation of human clones, or in vitro embryos, for therapeutic purposes—could result in three things happening. One, it could irreversibly limit Canada's ability to generate and offer its citizens the hope for stem cell based cures for devastating illnesses. It could potentially reduce the ability of Canadian scientists in both the public and private sectors to compete with their peers throughout the world. Finally, it stands to compromise Canada's future position in health care delivery and to compromise a developing industry dependent on knowledge-based biomedical technology. As such, it would place Canada in a potential third world position in these areas in the future.

I know this is not your intention, or the intention of Bill C-13. I thus encourage you to consider these issues carefully.

Thank you for your attention.

The Chair: Thank you very much, Mr. Weiss.

We'll move on to Mr. Caulfield, who is the Canada research chair in health law and policy in the Faculty of Law and Faculty of Medicine and Dentistry at the University of Alberta.

Professor Timothy Caulfield (Canada Research Chair in Health Law and Policy, Faculty of Law and Faculty of Medicine and Dentistry, University of Alberta): Thank you very much. It's a great honour to be here, and I welcome the opportunity to be in front of you again. Today's my birthday, and I can't think of a better birthday present than the opportunity to speak on something I feel passionately about.

Some hon. members: Oh, oh!

Prof. Timothy Caulfield: Before I begin, I'd also like to point out that much of the comments I make today is in a paper that is part of a collection. This collection is a special issue of the Health Law Review. On September 21, we held a symposium in Edmonton. We invited over a dozen academics from across Canada to critique Bill C-13, which was then Bill C-56. We brought individuals from a variety of disciplines and from a variety of perspectives. I had hoped that the journal would be published before I came before you today. It has not been published; so this is a rough draft of all the papers. I've given them to the clerk. I encourage the committee to read the journal. There are some fascinating pieces in it, and much of what I refer to today is contained in the papers.

Now, given the brief amount of time available, I've decided to focus my comments on one aspect. I didn't know my friend Sam was going to be here. But my comments are also going to go to the banning of therapeutic cloning. I am going to raise five reasons why I believe therapeutic cloning should not be statutorily banned, but should rather be tightly regulated. This is not a comprehensive list of the issues, but I think it's the issues that are before you today.

One, in liberal democracies we generally do not ban precursor technologies. It has been suggested that we should ban therapeutic cloning because it could be misused, or could lead to or facilitate, specifically, something like reproductive cloning. This is an argument for regulation, not for a statutory ban. We do not criminally ban dangerous chemicals, research on radioactive material, or pain medication because they could misused. In fact they could all be misused in a much more acute and obvious way than therapeutic clonings. Instead, we regulate these technologies.

Two, it is better to regulate areas of moral ambiguity. This is an area permeated with moral ambiguity, as you guys probably know better than anyone in Canada. There is no evidence of social consensus, nor will there ever be social consensus, as President Bush's committee concluded. In fact, our institute did a survey of all available qualitative and quantitative research—at least that we could find—and I believe there is no strong support for a ban on therapeutic cloning anywhere in the western world.

As you guys have probably heard numerous times, available research in Canada shows support for the technology. The well-known Ipsos-Reid poll of 2002 showed that 61% of Canadians approve of cloning of embryos for the collection or creation of stem cells. I think this is very interesting, because they don't attach that to therapy. And the Price-Waterhouse survey, which you're also well aware of, showed that Canadians approved of cloning to create tissue for therapeutic purposes.

To view the criminal ban in this context, I think, would be tremendously odd. I do believe that regulation is the better strategy, as noted by two well-known Australian scholars, who were commenting on their proposed law: “The public tends to demand prohibition of conduct that is universally opposed, but expects issues of moral ambiguity to be regulated”.

I also believe that a criminal ban sends the wrong message to the Canadian public. It sends the message that the discussion is closed, whereas regulation infers that ongoing and open dialogue is important. Indeed, I think the government should take a leadership role in this context and should encourage ongoing dialogue.

Three, I repeat something that you've heard many times, including from me, which is that we need flexibility. We need the flexibility to respond to the inevitable—and I do believe they are inevitable—new scientific advances and new social concerns. Despite comments to the contrary, which I know you have heard, it is a legal truism that a regulatory framework is more flexible than statutory prohibitions. I think this flexibility is needed in this context.

Four, the government should use great restraint when relying on criminal law. As noted in a document prepared by the federal government, Our Criminal Law, which was signed off by Jean Chrétien in 1982, criminal law should be used as an instrument of last resort. It should only used to respond to conduct that is culpable, seriously harmful, and generally conceived of as deserving punishment. None of these elements are satisfied in relation to therapeutic cloning.

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In fact, one of my colleagues, Barb Billingsley from the University of Alberta Faculty of Law, who is a constitutional expert, believes that the justifications for the ban on therapy cloning are so weak that it perhaps would not survive a charter challenge under section 2 of the charter, which as you know is the provision that guarantees freedom of expression, and that it would not survive a section 1 analysis.

Number five is the concern regarding commodification, which I believe is entirely legitimate and about which I have personal concerns, but I do not believe it is a concern that justifies a prohibition. It is true that therapeutic cloning could lead to an environment where the commodification of human reproductive material is more likely, but this again is not a justification for a ban. Just as we don't ban kidney transplantation because it could commodify human organs, we should not ban the technology of therapeutic cloning, but rather we should ban, regulate, and carefully monitor the commodification process.

In conclusion, I strongly believe there is no justification for a ban on therapeutic cloning. In fact, it's my sense--and this is an area that I've spent a good deal of time investigating--that there's an international trend to support therapeutic cloning, as exemplified by some of the comments you've heard earlier today and also by, for example, the California government's decision to ban reproductive cloning but in fact support therapeutic cloning. I believe therapeutic cloning could be effectively regulated under the existing agency.

Finally, I would like the committee to know that as a legal scholar I am most concerned about the ban not because of the loss of science and therapy that may come, and which I think is an issue, but because I think the ban stands as a poor policy-making precedent, one that I fear could exemplify how Canadians and the Canadian government deal with the many scientific issues that I know our society must face in the future.

Again, thank you for this opportunity.

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The Chair: Thank you very much, Mr. Caulfield, and welcome here again. I think it's been a couple of years now since we've heard from you.

We'll move on now to Mr. Clement Persaud, who is here as an individual.

Mr. Persaud.

Mr. Clement Persaud (Individual Presentation): Thank you, Madam Chair, ladies and gentlemen. I thank you for this opportunity to be part of your proceedings today. Unfortunately I was called fairly late in the day and there was not enough time for French translation, but the English is available, if you wish, at the front of the room.

So I'll proceed directly.

This presentation will provide two perspectives. The first is on embryo research and stem cells and the second is on the legislation governing the proposed Assisted Human Reproduction Agency of Canada, which I shall call AHRAC for short.

Embryo research and stem cells: We've made rapid strides since 1991, when Irving Weissman of Stanford University identified a stem cell in human bone marrow capable of differentiation to each blood cell type. I'll just cite three Canadian researchers and their work. Freda Miller, of McGill University, in 2001 showed that adult skin stem cells are versatile, being transformable to fat, neural, and muscle cells. Mick Bhatia, one of the star researchers on stem cells in Canada, working at the Robarts Research Institute in 2001, propagated adult stem cells through many generations without their differentiation. He used the molecule that has since been called the sonic hedgehog, an interesting name. The B.C. Cancer Agency this year announced a method of mass production of adult blood stem cells using a special gene.

These three findings show three important properties of adult stem cells: versatility, continuity, and quantity. Study after study has shown the therapeutic potential of adult stem cells in animal models of disease and humans.

I could be wrong, but I know of no published work citing clear clinical benefits from embryonic stem cells. What I think is that they're physiologically incompatible with adult body cells, and therefore they are for growth and differentiation, not repair, and they require complex embryonic cell signals for normal function. They are difficult to control and form teratomas when injected. Indeed, one test of embryonic stem cell pluripotency is teratoma formation in immuno-suppressed mice. Some have called for a moratorium on embryo research. I personally think by the time the necessary animal studies with embryonic stem cells are completed we will have had a moratorium by default.

The Wisconsin lab of James Thompson has said it will “likely be several years at best before technologies emerging from embryonic stem cells find clinical application”. But I'd like you to hear this startling statement by John Gearhart, who discovered pluripotent stem cells from aborted fetuses in 1998. He made this astonishing statement on November 14 of this year: “I am not sure these (e.s.) cells are going to be used therapies.” He says so.

A National Post article reported on October 25 of this year on a woman with leukemia who is now in remission after receiving an umbilical cord stem cell transplant from the baby she delivered 14 months ago. With more than one million umbilical cords discarded each year, I believe Health Canada should start looking at cord banks to exploit the potential of umbilical cord stem cells.

To conclude this section briefly, I believe that recent scientific findings have rendered embryonic stem cell research virtually obsolete and that adult and cord stem cells should be the scientifically superior choice for regenerative medicine. On the other hand, if this committee still supports embryonic research, I would suggest a compromise in the true Canadian spirit, ladies and gentlemen, that Parliament adopt the American model, allow the creation of a fixed number of embryonic stem cell lines, and outlaw embryonic research once these lines are in use.

I turn my attention to the agency, AHRAC. I submit that the bill is not robust enough and inclusive enough in its language concerning the mandate and operation of AHRAC. The bill has some worthy guiding principles in its declaration, but I'm disappointed that the human genome, paragraph 2(f), merits a guiding principle all by itself but not so the embryo. I suggest that the embryo, with its associated Canadian sensibilities, deserves its own guiding principle. Listen to the guiding principle of the Bush administration, of the Americans: “Embryos in experiments are human subjects whose welfare should be considered along with that of fetuses, children and adults”.

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On the matter of intracytoplasmic sperm injection, this method has real dangers. I won't have time to go into the dangers, but I suggest that Parliament consider banning the use of intracytoplasmic sperm injection in fertility clinics in Canada.

While surrogacy charges are dealt with in Bill C-13, the bill should clarify whether a woman who supplies embryos to a research institution may financially benefit from any patent resulting from research involving her embryos.

Subclause 25(1) states that the minister may issue policy directives to the agency. Strong policy direction is needed for standardized counselling questionnaires for all clients in the clinics. Some suggestions for informed consent include possible harms to the woman from multiple hormone injections, possible sepsis from overextraction, the rate of failure, multi-fetal pregnancies, prevalence of abnormalities, and a possible decision on selective destruction of fetuses before term.

Clause 31 states that the board of directors may make by-laws for the regulation of its proceedings. This board would need more precise guidelines from Parliament for its operation. I suggest the following in relation to the agency's regulations for IVF clinics.

The clinics should be licensed, and the language of the day should make it clear what is being licensed, whether it's the clinic or the research institution.

On research, there is no need for IVF clinics to provide instruction or conduct research on embryos in their care. This can easily be done with mammalian embryos.

On data, we've heard of high-profile mixups in some British clinics. Our act should require data from IVF clinics of the highest standard, on a regular basis, and conforming to good lab practices.

On embryo storage, the duration of storage of embryos, whether it's two years or five years, should be specified to IVF clinics by our act, based on evidence.

On inspectors, I suggest that inspections of IVF clinics and research institutions should be done with notification and without notification, as a way of increasing quality control.

On accreditation, in addition to being licensed by our act, all IVF clinics should be accredited by an external accrediting body.

On ethics, all IVF clinics should be encouraged to form their own internal ethics oversight committees.

As an aside on ovum storage, a recent report out of the United Kingdom, November 4, 2002, described the freezing of an ovum that was eventually fertilized and developed into a healthy baby. This, of course, carries great potential.

Let me conclude, ladies and gentlemen. I believe the language of Bill C-13, in relation to the operation of the Assisted Human Reproduction Agency, lacks the necessary rigour. It should be strengthened for the sake of the health of Canadians and the IVF industry in Canada.

Secondly, I believe that for scientific reasons quite apart from ethical concerns, embryonic stem cell research should be abandoned, in view of the demonstrated superiority of non-embryonic stem cells. Scarce health care dollars should be vigorously applied to ongoing clinical trials involving adult and umbilical cord stem cells, with their record of success.

Before closing, ladies and gentlemen, may I just say I came to Ottawa on Friday and I am reminded of the American soldier who said, “I came to die”, and his Australian colleague said, “I came yester-dye”. So I thank you all for being here “to-dye”.

The Chair: Thank you, Dr. Persaud.

We'll move on to the question and answer section of our meeting, and we'll begin with Dr. Lunney.

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Mr. James Lunney: Thank you, Madam Chair. Thank you again to all of our presenters for entering the debate and providing more fodder for the grist mill here. These are very important issues to Canadians and the research community. The committee has been wrestling with these issues, as you're well aware.

First, Dr. Weiss, could you tell us briefly about your research on adult neural stem cells, please?

Prof. Sam Weiss: My research has involved growing adult stem cells taken from the adult brain and differentiating them into the three major cell types of the brain. These cells may be useful for therapeutics, transplantation, and drug therapy. In addition, we've located these stem cells in the adult brain and used natural proteins to stimulate their growth within the brain as a means of trying to encourage regeneration and repair of damaged brain and spinal cord tissue.

Mr. James Lunney: This is particularly exciting.

Again, I want to raise the question about autologous transplant. I hear what you're saying. Although you recognize potential, perhaps, I'm curious that you're very enthusiastic about the embryonic stem cells. Is there not a very, very significant issue in relation to the rejection of embryonic stem cells if they're injected, particularly in the brain because the blood-brain barrier has its own isolation from the immune system? The real risk of pyrogenicity and so on in the brain, I would think, is particularly great. That certainly was the problem with the Parkinson's patient that had embryonic stem cells implanted.

Prof. Sam Weiss: Sure. There are concerns regarding immuno-compatibility, of course. However, in many of the Parkinson's patients that have been treated for the last 15 years, in Sweden and elsewhere, they have been treated with anti-rejection agents that have been successfully capable of maintaining the new cells that were introduced into the brains.

With regard to the issue of teratogenicity, this is actually a very important one. Again, I think it's very important to pay attention, as we do, to the scientific literature as opposed to the lay press in this matter. It turns out that much of what we learned recently is that regarding adult stem cells, particularly adult brain stem cells, which were touted originally to be able to generate all cell types, during continuous culturing adult stem cells seem to be more prone to transformation and ontogenesis, in fact, than embryonic stem cells. That's in cell culture before they're even introduced into the brain. As a result, I don't think there's any evidence to suggest that adult stem cells are less susceptible, when grown in cell culture, than embryonic stem cells are to be ultimately teratogenic when introduced into the body.

Mr. James Lunney: Let me go right to that point then, because it seems that the purpose of embryonic stem cells.... There seems to be quite a line-up of people in industry who would like to develop a stem cell line, one that's good for pancreas and one that's good for Parkinson's patients, perhaps, or one that's good for maybe 200 different conditions, that would require longevity and maintaining those characteristics. But with adult stem cells, if you're able to extract them from a patient, grow them in vitro, you wouldn't need extended periods of time; presumably, you'd be reinstating those cells into the same patient with an autologous transplant. You wouldn't have to worry about great lengthy periods and you wouldn't have the same commercialization aspects in terms of patenting and commercial co-modification that we see on the embryonic side. I wonder how you feel about that.

Prof. Sam Weiss: Those are important points. I think one would have to distinguish for various disease situations, of course. In one case where there's an extended period of time in which one could extract cells and grow them up and so on and so forth, it could possibly be useful for treatment of chronic diseases. Of course, on the other hand, there are acute diseases, such as a stroke or a brain injury, for example, in which case it would be impossible to consider the length of time necessary to extract cells and to grow them up, as opposed to having a bank of cells that have already been shown to be capable of generating brain cells when introduced into patients. So in many cases one would have to consider the disease situation and otherwise.

The other important point we've learned is that embryonic stem cells have a much greater potential. I think this is really clear. They can, in fact, experimentally produce every single cell type in the body, while adult stem cells, despite some announcements in the press, do not have that same capacity. In fact, they are very limited, and indeed, what we do know is that embryonic stem cells have been shown to be capable of reversing neurological disease in experimental animal systems. Adult brain stem cells have not yet been shown to reverse neurological disease in animal models.

I think this is a very important point. It's not yet one versus the other. In both cases, the research suggests that it may be disease-dependent, it may be case-by-case dependent, but one has not yet been shown to obviate the other.

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Mr. James Lunney: In terms of having a bank of cells available versus the advantage of having cells from the body that aren't going to be faced with rejection, let me go back to the issue of the plasticity of adult stem cells. A short time ago they thought there was no opportunity for cells to change or morph into other types of cells. Surely it's axiomatic that if an embryo can produce every type of tissue, it was on its way to becoming a full human being. So it doesn't take a real brain stretch to imagine that embryonic cells could do that. But why is some of the scientific community so negative, in spite of the remarkable breakthroughs we've seen in plasticity with adult cells?

Prof. Sam Weiss: I wouldn't say we're negative; I'd say we're cautious, as we are in every scientific endeavour. I think the point about the fact that embryonic stem cells or embryonic cells can make all the cell types, being axiomatic, may be true, but nevertheless to generate in a careful, controlled circumstance every single cell type--it doesn't happen automatically. In fact, it requires an enormous amount of research. The very exciting breakthroughs that show that you could make islet cells--the ones that can cure diabetes--out of embryonic stem cells took about six years of research, because it doesn't happen spontaneously in cell culture.

With adult stem cells, we're not precluding the potential of adult stem cells, but that's not what they normally do. So we would question, as scientists, the recent hoopla that suggests that because sometimes a cell could be changed enough to appear on the surface to be another cell, the true proof of principle is to introduce it back into the animal or into the body of an animal and show that it can actually function appropriately. Embryonic stem cells have already been shown to do this. They can both make a whole animal, as well as produce certain organs and reverse diseases. Adult stem cells are still at a much earlier stage of being able to do this, at least when cultured and grown up and then transplanted.

So we're not against it, but we're saying the research does not bear fruit yet to the point where you would say there's no need to work on embryonic stem cells--to the contrary.

Mr. James Lunney: But you are aware of successful models. Dr. Persaud mentioned cord cells here.

I'm aware of a patient, who I talked to just recently, who had undergone multiple myeloma treatment. Prior to his treatment to kill the cancer with chemo, they had extracted bone marrow cells and then reinstated his own bone marrow, and he's doing just fine. So that would be an autologous transplant.

But also on the skeletal muscle, for cardiac use, I'm sure you're aware of research just done in Italy, when they took immature skeletal muscle cells and infused them back into a patient with a myocardial infarct and showed some transformation of these cells setting up in the infarct zone.

Prof. Sam Weiss: Let me address the first point, and that is the hematopoietic or bone marrow cells. In fact, hematopoietic stem cell research is again a Canadian example of ingenuity. In fact, hematopoietic stem cells were discovered in Canada some 25 to 30 years ago.

Bone marrow and the ability to generate these cells to treat leukemias is a widespread therapy and a bona fide example of how important adult stem cells can be to treat the disease in which those cells normally contribute. However, they do not provide a very good example of transformation of those cells.

The case that you brought up, I think, again, is where adult stem cell researchers like me get very excited about the prospects of adult stem cells being able to be used when generated from one tissue for replacement of another tissue. But full-scale, complete scientific analysis of this just has not yet borne fruit.

So while we do this research--and I only work on adult stem cells--I would be remiss in my responsibilities of arguing that they are what will contribute to stem cell based therapies, when in fact embryonic stem cell research, at least as I observe it, offers more hope for certain diseases, for example for diabetes, where there are no adult stem cells, and no adult stem cells have ever been shown to produce islet cells. Closing the door on that would mean that one would close the door on thousands of diabetics who are suffering every day.

Mr. James Lunney: Dr. Persaud, Clem, do you have something to say about that?

Mr. Clement Persaud: I take your points. If I may just respond very quickly to some of the points you made, I agree with some of what you said, Dr. Weiss, but intuitively, wouldn't you say that an embryo with its cells developing, intuitively, so everyone can understand.... That embryo has cells, and they are doing two things: they are differentiating or they are growing. In an adult, adult cells are doing something: they are repairing. If I had a brain disorder, I would say, give me cells that will repair the injury in my brain, not differentiate and grow. That's not what I want.

But back to your comment about diabetes, in the United States, E.J. Abraham at the Massachusetts General Hospital transformed adult human pancreatic stem cells into insulin-secreting beta cells. It's a major breakthrough in diabetes, quoted in Endocrinology in 2002. He transformed adult pancreatic stem cells into beta insulin-producing stem cells.

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The Chair: I think Dr. Caulfield would like to comment.

Prof. Timothy Caulfield: Yes.

The Chair: At the end of Dr. Lunney's time, we'll--

Prof. Timothy Caulfield: It's Professor Caulfield.

I feel compelled to make this point because it is tremendously important and it's an issue that has, I think, inappropriately deflected the discussion around the bill. We can talk about the potentials of embryo research and the potentials of adult stem cells, but you don't ban something because it doesn't work. You have to have some other reason. We don't ban cold fusion and we don't ban perpetual motion machines. There has to be some other reason.

The scientific potential for something certainly goes to when you're weighing the ethical aspects or perhaps when you're weighing something in the research ethics board, but we are talking about using criminal law to ban something. There has to be some more compelling reason than that it may not work and that there may be other avenues that are just as promising. There has to be some reason for the ban. I know that people such as Freda Miller and others who are leaders in the world around adult stem cells will tell you the same things Sam has told you.

Then I ask the committee this question. If in fact we reach our goal with adult stem cells of coaxing them to be totipotent--this is a question Sam asked in his paper because that's one of the goals, to be pluripotent at least but hopefully totipotent, pluripotent but perhaps totipotent--is that an embryo? Well, let's say it's pluripotent, and we make use of it for autologous transfer. Is that an embryo and is it therefore banned? Should it be? If not, why not? What makes that different from an embryo in another context? There has to be a reason.

The Chair: It's Doctor Castonguay's turn.

[Translation]

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair. I thank our witnesses.

First of all, I think we are at a very early stage of research on stem cells of all origins. Am I right to think that way? That's my first question.

In our present state of ignorance – I really mean “ignorance” – can we afford at this stage not to do research on one kind of stem cells, pretending the other kind has more potential?

I'd like to have the opinion of our witnesses on this.

[English]

Prof. Sam Weiss: If I understood correctly, my answer is that at this stage it's true that we really cannot make a decision and conclude that one stem cell population is better than the other, adult versus embryonic. From a scientific perspective we would argue that if you cannot distinguish one from the other, it would be ludicrous to ban one versus the other. Controlling activities that might have moral or ethical issues in this country is indeed an important thing to do. However, we would suggest that banning them would be premature and would limit the potential for Canadians.

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Mr. Jeannot Castonguay: Thank you.

Prof. Timothy Caulfield: I'd like to comment on that also, and it goes to the concluding point in my presentation. My greatest concern is not in fact the loss of the science or the potential therapies but the nature of the decisions that are made, the policy-making around this issue. There have to be principled reasons for a ban, principled reasons for regulation, and certainly principled reasons when we're talking about a statutory ban that's difficult to change. That is the history of statutory bans in this country, as noted by numerous law--

The Chair: Professor Caulfield, the question was about adult versus embryonic stem cells; it was not about banning or not banning therapeutic cloning. You're going back to your favourite subject as opposed to answering the question.

Prof. Timothy Caulfield: I apologize.

The Chair: Would Dr. Persaud like to answer Dr. Castonguay's question?

Mr. Clement Persaud: I am truly sorry. My connection was made late. If you'll say it again, then I will try to--

Mr. Jeannot Castonguay: Basically, my understanding is that at this stage it is a very early stage of research, be it on adults stem cells or embryonic stem cells. Can we afford at this stage today not to do research, pretending that one kind of cell has more potential than the other?

Mr. Clement Persaud: It is true, your general statement that we're at an early stage of research with stem cells. Nevertheless, the data to date from trials with embryonic cells in adult humans indicates that some have had catastrophic effects, for example with Parkinson's patients. On the basis of that--and we're dealing with people and lives--I think a caution flag should go up. In principle, I believe that caution should lead us to continue along the lines of the beneficial adult stem cells until the picture is clearer.

M. Jeannot Castonguay: Okay, but the way I see it, if we say, okay, let's focus on this type of research on adult stem cells, we will never know about the potential of the other type of cells. To pretend today that there are no problems with adult stem cells, I'm sorry, but I don't agree with you. There are certainly problems.

At this early stage of research and with any type of research, you always have to be aware that there will be problems popping up as we go along. To pretend that because I believe something today--it's a gut feeling that there is more potential--we should ban the other type of research, well, I have some difficulties with this.

That's all I had to say.

Mr. Clement Persaud: I understand.

The Chair: Dr. Weiss.

Prof. Sam Weiss: I'm afraid I would have to disagree with my esteemed colleague Mr. Persaud here about the compelling evidence for embryonic cells having devastating consequences when transplanted into Parkinsonian patients. For one thing, of course, these were not embryonic stem cells. These were embryonic cells from aborted fetuses, and half the patients actually showed benefit.

Mr. James Lunney: It was very short term.

Prof. Sam Weiss: Well, they haven't done the longitudinal studies yet, but at least they showed initial benefit. Of course, adult stem cells haven't even been tried yet, so I would agree with the point that one can always point to examples of success and failure and then argue that under those circumstances one should abandon as soon as there is a failure.

I think that it would again be premature to draw conclusions when the science--which again, I'm sorry, is not in the lay press but in the scientific literature--argues that both adult and embryonic stem cells have great potential and need to be very carefully studied in a controlled fashion throughout the world.

The Chair: Ms. Skelton.

Ms. Carol Skelton (Saskatoon—Rosetown—Biggar, Canadian Alliance): This is for Professor Caulfield. This morning, when we had our teleconference from the United Kingdom, Ms. Leather suggested that she would like to see the word “choice” used instead of “consent” in the bill. Can I have your thoughts on that?

Prof. Timothy Caulfield: That's a very interesting question, and in fact it is the subject of a good deal of commentary in the legal and ethical literature because there is a subtle difference between choice and consent. I actually think they both deserve merit; they both have meritorious aspects to them. Traditionally, the law treats it as consent because it is not a relationship of equality, unfortunately. There is an asymmetry in power between the therapeutic provider and the patient, and therefore it really is a model of consent. People have argued that the idea of choice implies that the relationship is one of equality and that an individual is making a choice not unlike a contract.

On the other hand, I think people view the model of choice as more inclusive, and I think the modern bioethics literature has tried to advocate for choice for that very reason. It's more inclusive, and it's the idea that people are not making these decisions in a clinical vacuum, but rather they're impacted by a very complex context.

I'm afraid I'm not giving you a good answer. My legal hat tells me to stick with consent because that is reflective of the true nature of the legal relationship, but I do think there are some compelling arguments in the philosophical literature that push towards the idea of choice. Am I touching on the issues you had questions around?

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Ms. Carol Skelton: Yes.

The Chair: I didn't get your penultimate statement, which was to stick with consent because.... What was the rest of that?

Prof. Timothy Caulfield: As a legal scholar, I advocate the idea of consent because I do think it is reflective of the true nature of the legal relationship.

The Chair: That's the piece. Which legal relationship?

Prof. Timothy Caulfield: The legal relationship between a clinician, which is the case in a lot of these relationships, and a patient. The reason the courts treat it as consent and not choice is, for one reason, because of the asymmetry and power between a clinician and a patient. Therefore a patient is giving consent to an individual to act upon them. It's not a contract. There are certain advantages, from the patient's perspective, to conceptualizing it as consent. You're not--

The Chair: It seems to me that the advantage is to the clinician--

Prof. Timothy Caulfield: On the contrary--

The Chair: --to get consent as opposed.... The implication from that term “informed consent” is that somebody is probably going to say yes, whereas with choice, it seems to me, the obligation is to expose the options to the patient and the patient chooses which thing will be done or perhaps that nothing will be done.

Prof. Timothy Caulfield: I agree entirely. In fact, consent law in Canada, I think we can be proud, is probably the most onerous in the world. In fact, I agree with my colleague's comments about what should be part of the consent process. It's very onerous, and as part of the informed consent process, clinicians have a tremendous duty to disclose a huge amount of information, including commercial issues, on how this information is going to be used. That is part of current common law consent law in Canada already, and I think the bill re-emphasizes those consent provisions.

The point that you make about “choice” is exactly the reason that the philosophical community, and some of the legal community, would prefer to use that word. Some in the legal community are worried that the idea of choice may in fact backfire on patients because it pretends that this relationship is one of symmetry and therefore a choice that's made at that one time would be binding, for example. As you know, consent is not one moment. Consent is not a form. Consent is an ongoing process. Consent can be withdrawn at any time. Physicians have an obligation to ensure that patients understand the information that's provided to them and many--

The Chair: Patients often sign a document prior to an operation saying, I have been exposed to all the information and I'm comfortable that I've heard everything and I do consent. Are you telling me that's not valid five minutes later?

Prof. Timothy Caulfield: That is not consent. That document is evidence of consent. If you go before a judge with that and say, here, I have consent, the judge will say, that's just evidence that he signed it. I don't know if he understood it. Consent is a process that involves an ongoing relationship with the clinician.

The Chair: Most people don't know that. They think they're signing--

Prof. Timothy Caulfield: Most doctors don't know that, and most research ethics boards don't know that, and most pharmaceutical companies that put together these tremendously complex consent forms don't know that, but in fact that's the case. It's not a contract between a clinician and a patient but rather an ongoing process.

Canada actually has tremendously robust consent laws flowing from Reibl v. Hughes in 1980 forward. I think we can actually be proud because we've influenced the world in the area of consent law.

Having said all of that, I like the spirit of the idea of choice, because it does bring in this notion that it's a complex context and that many factors ought to be weighed, not just clinical issues.

I've probably not given a very satisfactory answer to the committee. I apologize.

Ms. Carol Skelton: No, it's fine. I really think it helps, because I was having real problems with choice and consent. I spoke to a fellow on an airplane going home, and he and his wife had gone through an infertility clinic and everything else and they finally gave up. He said, I didn't know until the very end what I was going to put my wife through. And so I'm having great problems with the thought of people having to do this and not knowing what they were consenting to or the choices they were being given. It's something that's been rolling around in my mind, so thank you.

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The Chair: Not only that, Mrs. Skelton, but you will recall that we asked some of the witnesses from the infertility community specifically if they had been exposed to a certain possibility as a course of action, and not one person in the room ever had; it had never even been mentioned to them. We really have serious concerns about whether or not.... And we're only looking at this very small piece of the practice of medicine, which has to do with infertility clinics, but based upon the evidence we got from a panel of infertile people, we were certainly dissatisfied. That makes you wonder about other areas of medical practice where people are supposedly being given a choice or being asked for their consent, but it's being suggested to them that this is the treatment, do you want it or not? There is no choice at all.

Prof. Timothy Caulfield: The standard in Canada, which has been affirmed numerous times by the Supreme Court of Canada, is that the clinician is supposed to disclose to the patient anything a reasonable person in the patient's position would want to know. It's tremendously inclusive. I think you're probably right that this information is not being conveyed—not only in the reproductive setting, but also in other settings.

My first reaction to the bill was that this shouldn't be in here, because it is already part of the common law. I'm worried that clinicians will read it down, saying they just have to do this, when in fact I think the common law is more inclusive. But upon reflection, I said, no, this is a good idea, because it's going to emphasize the importance of consent in this context.

The Chair: Yes.

Prof. Timothy Caulfield: I think this is the greater danger.

The Chair: Thank you.

Dr. Lunney's turn.

Mr. James Lunney: Thank you.

First of all, let me just say for the record, and I'm sure all committee members would agree, we want to see possibilities advance for cures for Canadians. There's no question of this.

On the question of the ban, it doesn't surprise us that a legal mind would not want a ban on any of this. Frankly, every lawyer who has testified here has objected to the ban. Lawyers don't like bans; they like regulations. Excuse me for saying that, but there are lots of opportunities for manoeuvring.

What we're concerned about here is commercialization and commodification. Frankly, not everyone would agree with you that we don't put a clinical ban on, for example, drug or chemistry testing but that we might on this. This involves human reproduction and human beings. Not everyone subscribes to the theory of convenience that life somehow begins at 14 days in an embryo.

So it is an emotionally charged issue, and it is an issue that defines life, and it is an issue that defines who we are as human beings. In Canada, we're dealing with this issue at a different time from other jurisdictions, like Great Britain and the United States, because of the breakthroughs in adult stem cell research.

Having said that, and coming back to this, Dr. Weiss and Dr. Persaud, do you see a greater aspect for commercialization on one side of this equation—on the embryonic side? Do you have concerns about commercialization and commodification of human tissue?

Prof. Sam Weiss: I also think these are very important issues.

I don't know that I would argue that there is more potential to commercialize embryonic cells than adult stem cells. In both cases, I think breakthroughs in genetic reprogramming may make both populations amenable to longevity, expansion, and commercialization. In each case there are going to be huge ethical issues surrounding commercializing somebody's cells. How this is dealt with will be for a regulatory body, and certainly for governments, to consider. But to my knowledge, at least, there is nothing that would suggest, at this stage, that we can be assured one would be more amenable to commercialization than the other. In both cases, I think that the school is still out, so to speak.

Mr. James Lunney: What about patenting? Is there not a greater potential with it, and does not industry see potential for patenting this stem cell line and that stem cell line—for cures, and for this and that?

Prof. Sam Weiss: In my experience, at least, usually its not so much the cells themselves that get patented as the procedures. I have nine U.S. patents issued on stem cells. But they are not on any particular stem cells grown in the lab; they are on the procedures to generate those cells and the ability to use them for specific applications. At least in my experience with stem cells, it's “use patents” as opposed to patenting the cells themselves.

I should just mention that the patent held by the University of Wisconsin is in fact on the generation of embryonic stem cells, period, not on the cells the laboratories of Gerhart and Thompson have generated. It's actually on the procedures to generate them, not the cells themselves.

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The Chair: Dr. Lunney, can I hop in here on the questions attached to this?

Mr. James Lunney: Yes.

The Chair: We're concerned about this whole commercial thing, whereby a company, like a drug or a biotech company, may end up owning a process or procedure by patent. We were told the other day by some university academics—which I, at least, think I understood—that even the processes are essentially shared among academics if the university owns the patent.

What do you know about a biotech company owning the patent on a process such as one you have a patent on? Do they share with universities, or do they charge a fee to replicate this process?

Prof. Sam Weiss: That's a very good question.

In most cases, to my knowledge, if a company, or even a university, holds a patent in a particular process, if the particular scientific basis of that patent is out in the public domain other scientists can use those types of technologies as long as they don't use them for commercial purposes. If a third party were to then try to employ that same technology for a commercial purpose, they presumably would have to address themselves to the patent holder.

The Chair: What if the patent holder, supposing it was the university, did not want to pursue the commercial possibilities? What would happen then? The company would still be breaking the patent by pursuing that commercial possibility?

Prof. Sam Weiss: That's correct.

The Chair: How safe are we, then, that these procedures do not get locked up? There's one example from a state on the Pacific coast, I think, Oregon maybe, and there was some procedure that was being used in B.C., and then the patent holder in Oregon started to charge a fee that was outrageous. Do you remember that case?

Prof. Sam Weiss: Right, I think it was for the breast cancer gene testing.

Prof. Timothy Caulfield: I think it was Myriad Genetics.

The Chair: Yes, that was it.

Prof. Timothy Caulfield: Right.

The Chair: And that was in the hands of a private company, I believe.

Prof. Timothy Caulfield: This is actually a topic that I've done a lot of writing on--

The Chair: Yes, I know that. That's one of the reasons I wanted to pursue it, because you're here.

Prof. Timothy Caulfield: --and I welcome the question.

I actually have grave concerns about the commodification issues and the commercialization issues. I must differ with my friend Sam. They can lock up the use of a technology, in fact, through a patent. The Myriad Genetics story is a wonderful example of how that can happen, but so is the patent on the stem cells from the University of Wisconsin, which caused a big controversy in the United States, actually from the industry side, because they were worried, because of the limited number of stem cells available in the U.S., that the patent would actually have an adverse impact on the research environment.

I think this is a real problem. What I would like to see the government do is marry the concerns that have been identified with gene patents and their impact on research, on access to useful technologies, with the emerging issues around stem cells. And there are going to be other patent issues in the area of science that the Canadian government needs to move on.

One of the big problems with patent law is that you're involving international agreements: NAFTA and TRIPS. I believe the World Trade Organization is softening on the issue of patents, particularly when public health is engaged. I think there is a possibility that we could use this as an argument for mandatory licensing to clarify the scientific exception that Sam alluded to, the research exception, which actually is not very clear. It's a little bit of a myth that you have this clear ability to do the research on something as long as you don't commercialize it. It's not that clear. I think we could use this, and the Myriad Genetics one, as an excuse to actually explore this further and try to get the international community to come to the table. I think they may be willing.

The Chair: Thank you very much. We always, at the very end of a study, get to these points about patenting and commercialization...actually, we talked about commercialization, but in a different way, but this particular set of ideas. It seems we just get there when it's time to move to another piece of the puzzle, which we're doing with clause-by-clause tomorrow.

But may I tell you there's a lady in the audience from the Department of Justice, in the white jacket, who might want to ask you a few questions about this.

I think you wrote a book about this, did you not, Tim?

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Prof. Timothy Caulfield: Yes.

The Chair: I'm not sure if she's ever met you, but, anyway, I think she's interested in some of the ideas that we are talking about.

Have you got another question?

Mr. James Lunney: May I ask Mr. Persaud to comment, Madam Chair.

Mr. Clement Persaud: I have one response, Madam Chair, to your question on commercialization. I put before you, by way of a rhetorical question, this scenario. I don't know how many IV clinics there are in Canada, but let's say about 20. And let us say that at any given point in time we take a snapshot and we have 40 “surplus” embryos. If there are a hundred institutions wanting embryos, how will we have criteria to respond to that demand? And suppose the research institution says, this cycle around I will take two embryos and I'll generate stem cell lines and I'll give you the stem cell lines, and it's as if you have the embryos. This leads me back to the suggestion that we might as well, for equity and fairness, generate stem cell lines so there's fairness to all research institutions.

What I'm saying, in summary, is that the potential for commercialization is to say to women, produce embryos and there will be rewards--not necessarily monetary. One analogy is that the pharmaceutical industry in the old days used to give a computer to a doctor for sometimes prescribing. Now it's banned. We have to be careful that commercialization doesn't occur there.

Thank you.

The Chair: Thank you very much.

On behalf of the committee--I won't apologize for them, because some of them had responsibilities at QP and they had to leave, depending on what their responsibility was--we've enjoyed having you very much. I want to thank you for taking time out of your week, because I know all of you came from a distance, and to tell you that we really do appreciate your attendance and your thought. We also appreciate, as Canadians, the work you do at home--the science and the investigation of these thorny legal topics, etc.

I understand you're retired, Dr. Persaud, but you're obviously still engaged in public policy. So thank you.

Mr. Clement Persaud: I'm refired too, you know. Thank you, Madam Chair.

The Chair: Thank you very much.

This meeting is adjourned.